MedTech Innovator Vantage Non-Dilutive Funding Program: Up to $200K for Health Security Diagnostics and Devices

MedTech Innovator Vantage is a joint partnership between MedTech Innovator and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services. Vantage is one of five specialized hubs in the BARDA Accelerator Network. Its Non-Dilutive Funding Program awards $50,000 to $200,000 for six-month, milestone-based projects that develop, evaluate, and validate diagnostic and medical device technologies for health security, preparedness, and response.

Deadline: Proposals are due October 15, 2026. Off-cycle applications for BARDA-aligned technologies are also accepted on a rolling basis.

Why This Opportunity Matters

Most early-stage medtech companies chase SBIR as their first federal dollar. Vantage is a faster, smaller entry point. A $50K to $200K award gives a startup proof-of-concept or validation data, a BARDA-aligned project record, and six months of project management and mentoring from subject matter experts. That record strengthens a later BARDA BAA, DRIVe, or SBIR application.

Key Facts at a Glance

• Sponsors: MedTech Innovator and BARDA (HHS), through the BARDA Accelerator Network
• Award size: $50,000 to $200,000
• Project length: 6 months, milestone-based
• Who can apply: Early-stage startups and university-backed projects
• Proposal window: September 1 to October 15, 2026
• Guided revisions: January 2027, with subject matter experts
• Award announcements: Anticipated March to April 2027
• Support included: Project management support and regular expert mentoring during the award
• Contact: vantage@medtechinnovator.org

Priority Technology Areas

Vantage funds diagnostic and medical device technologies that strengthen U.S. health security. Current priority areas include:

• Continuous patient monitoring: Platforms with advanced sensors, with emphasis on radiation injury and acute radiation syndrome
• Multiplexed point-of-care rapid tests: High-sensitivity tests, including botulinum toxin detection that distinguishes serotypes
• Deployable diagnostics: Low-cost tools for resource-limited settings
• Rapid triage diagnostics: Including low-throughput next-generation sequencing platforms for pathogen identification

What Is Out of Scope

• Oncology and chronic disease research
• Gain-of-function research involving pathogen manipulation

Is Your Company a Fit?

Vantage is a strong fit if your company:

• Is an early-stage startup or a university-backed spinout
• Is building a diagnostic, patient monitoring, or medical device technology with a clear health security use case
• Can define concrete, measurable milestones achievable in six months
• Plans to pursue larger BARDA or other federal funding after proof-of-concept

If your device targets cancer or a chronic disease without a preparedness or emergency response angle, other programs such as NIH SBIR are a better match.

How to Apply

1. Confirm alignment. Review BARDA's mission and the DRIVe target product profiles to map your technology to a stated health security need.
2. Define six-month milestones. Reviewers fund projects with specific development, evaluation, or validation outcomes that a $50K to $200K budget can deliver.
3. Submit by October 15, 2026. Proposals go to MedTech Innovator during the September 1 to October 15 window.
4. Revise with experts. Selected applicants refine proposals with subject matter experts in January 2027.
5. Award decision. Announcements are expected March to April 2027.

How BW&CO Helps

BW&CO has helped deep-tech, medtech, and biotech founders secure $350M+ in non-dilutive funding. We help you test fit against BARDA priorities, frame milestones reviewers trust, and plan the path from a Vantage award to BARDA BAA, DRIVe, and SBIR funding.

Frequently Asked Questions

What is the MedTech Innovator Vantage Non-Dilutive Funding Program?

It is a BARDA-aligned funding program run by MedTech Innovator that awards $50,000 to $200,000 for six-month projects developing, evaluating, and validating diagnostic and medical device technologies for health security.

When is the Vantage application deadline?

The 2026 proposal window runs September 1 to October 15, 2026. Off-cycle applications for BARDA-aligned technologies are accepted on a rolling basis.

Who is eligible to apply?

Early-stage startups and university-backed projects developing diagnostic or medical device technologies aligned with BARDA's health security mission.

Is Vantage funding dilutive?

No. Vantage awards are non-dilutive, so companies do not give up equity.

What technologies does Vantage prioritize?

Continuous patient monitoring for radiation injury, multiplexed point-of-care rapid tests such as botulinum toxin detection, low-cost deployable diagnostics, and rapid triage diagnostics including low-throughput NGS pathogen identification.

What is excluded from Vantage funding?

Oncology and chronic disease research, and gain-of-function research involving pathogen manipulation.

When are Vantage awards announced?

Selected applicants complete guided revisions in January 2027, and awards are anticipated in March to April 2027.

TRISH Catalyst Grants Program: NASA-Funded Space Health Awards for Companies and Researchers

The Translational Research Institute for Space Health (TRISH) funds disruptive, high-impact technologies and studies that protect astronaut health. TRISH is led by Baylor College of Medicine's Center for Space Medicine and funded through a NASA cooperative agreement with the NASA Human Research Program (HRP). The Catalyst Grants Program supports proof-of-concept projects and directed technology development. Tier 1 awards reach up to $150,000 over 12 months, and Tier 2 awards are $150,000 or more for larger projects.

Deadline: Rolling. Preliminary proposals are reviewed quarterly, and TRISH is accepting submissions through December 2026.

Why This Opportunity Matters

Many medtech problems in spaceflight mirror problems on Earth: remote monitoring, point-of-care diagnostics, blood clot prevention, behavioral health, and care with no specialist nearby. TRISH lets medtech and healthtech companies fund that work with NASA money, without the SBIR calendar. The two-page first step is light, U.S. companies are eligible, and a TRISH award builds a NASA track record that supports later NASA SBIR/STTR and HRP proposals.

Key Facts at a Glance

• Sponsor: TRISH at Baylor College of Medicine, funded by NASA's Human Research Program
• Tier 1: Under $150,000 total, up to 12 months
• Tier 2: $150,000 or more total, up to 18 months
• Budget rules: All direct and indirect costs count toward the total; minimum 10% cost share (cash or in-kind)
• Who can apply: U.S. institutions and companies with a documented base of ongoing R&D
• Submission: Rolling, with quarterly Step-1 reviews, through December 2026
• Notification: About 3 to 4 months after a Step-2 full proposal
• Contact: spacehealth-info@bcm.edu

What TRISH Funds

Catalyst projects must address critical human system risks on the NASA HRP roadmap, represent a unique, high-impact idea, and fall outside other open TRISH solicitations. Recent example topics include:

Ground-Based Research

• Countermeasures for internal jugular venous flow reversal
• Decompression sickness prevention
• Managing behavioral emergencies in remote environments
• Early detection of behavioral health decline

Flight Research

• Continuous characterization of venous flow during spaceflight
• Comparing venous thromboembolism countermeasures
• Evaluating post-flight motor control recovery

Is Your Company a Fit?

TRISH Catalyst is a strong fit if your company:

• Builds wearables, remote monitoring, point-of-care diagnostics, vascular, neuro, or behavioral health technology
• Can show how the technology reduces a specific spaceflight health risk
• Has ongoing R&D and preliminary data
• Can commit at least 10% cost share
• Wants a NASA relationship that extends into Earth-based clinical markets

How to Apply

1. Map to an HRP risk. Tie your technology to a named human system risk on the NASA Human Research Roadmap.
2. Submit a Step-1 preliminary proposal. Two pages maximum covering specific aims, deliverables, an implementation roadmap, TRISH alignment, and spaceflight health benefits. No institutional sign-off is required.
3. Prepare a Step-2 full proposal if invited. Tier 1 allows an 8-page project description and Tier 2 allows 15 pages, plus NASA SciENcv biosketches, Current and Pending Support, budget justification, a 2-page data management plan, and research security training certification.
4. Merit review. Reviewers score innovation, significance to NASA risk reduction, approach, and team, then assess budget, timeline, and data management.
5. Award. Decisions come about 3 to 4 months after Step-2, and start dates may shift with NASA budget availability.

How BW&CO Helps

BW&CO has helped deep-tech, medtech, and aerospace founders secure $350M+ in non-dilutive funding, including NASA awards. We help you frame your technology around NASA HRP risks, write a sharp two-page Step-1, and connect a TRISH award to NASA SBIR/STTR and Earth-based commercialization.

Frequently Asked Questions

What is the TRISH Catalyst Grants Program?

It is a NASA-funded program run by the Translational Research Institute for Space Health at Baylor College of Medicine that funds proof-of-concept projects and technology development addressing astronaut health risks.

Can companies apply for TRISH Catalyst grants?

Yes. U.S. institutions and companies are eligible if they have a documented base of ongoing research and development in science, healthcare, or technology.

How much funding does TRISH Catalyst provide?

Tier 1 awards are under $150,000 for up to 12 months. Tier 2 awards are $150,000 or more for up to 18 months. All direct and indirect costs count toward the total.

Is cost share required?

Yes. TRISH requires a minimum 10% cost share, which can be cash or in-kind.

What is the TRISH Catalyst deadline?

Submissions are rolling with quarterly Step-1 reviews, and TRISH is accepting applications through December 2026.

What does the Step-1 preliminary proposal require?

A two-page document covering specific aims, deliverables, an implementation roadmap, alignment with TRISH, and spaceflight health benefits. No institutional sign-off is needed.

How long does a TRISH award decision take?

Award notification is expected about 3 to 4 months after the Step-2 full proposal is submitted.

GRA Development Grant: Executive Summary for Georgia Startups

Executive Summary

Sponsor: Georgia Research Alliance (GRA), Innovation & Entrepreneurship Program
Award size: $10,000 to $250,000 per grant
Deadline: Six review cycles per year
Eligible applicants: Faculty researchers at accredited public or private universities in Georgia
Funding type: Non-dilutive grant (GRA takes no financial stake in the project)

The GRA Development Grant funds milestone-driven projects that move a Georgia university technology toward commercialization or startup formation. It is built for teams that have moved past the idea stage and now need to reduce technical risk, prove a competitive advantage, and generate the evidence that investors and federal reviewers expect to see.

What the Development Grant Funds

Projects are organized around a defined set of milestones. Typical activities include:

• Prototype refinement and technology validation
• Preclinical testing for medtech and biotech technologies
• Pilot manufacturing and scale-up studies
• IP landscape and regulatory pathway analysis
• Customer pilots and market validation

GRA may award more than one Development Grant to the same project as it continues to hit milestones, which makes the program a practical bridge from lab result to fundable company.

Who Should Apply

• Faculty founders at Georgia institutions such as Georgia Tech, Emory, the University of Georgia, Augusta University, Georgia State, and Kennesaw State
• Pre-spinout teams preparing to license university IP and form a company
• Deep-tech, biotech, medtech, and dual-use researchers whose technology shows commercial promise but still needs validation before outside investors will engage

Companies that were not founded on Georgia university technology are not eligible for GRA grants.

Where It Fits in the GRA Funding Ladder

• Exploratory Grant (up to $10,000, rolling): answers focused go/no-go questions on technical feasibility, early customer discovery, or lightweight whitespace analysis
• Development Grant ($10,000 to $250,000): advances commercialization or startup formation through defined milestones
• Startup Loan (up to $250,000): available after company formation to Georgia companies built on Georgia university technology, released in milestone-based tranches with a modest warrant and an option to convert in a future financing

Why It Pairs Well With SBIR and STTR

Federal SBIR and STTR reviewers reward proposals backed by strong preliminary data, a clear commercialization path, and evidence of customer demand. A GRA Development Grant pays for exactly that work. Georgia teams that use GRA funding to validate their technology are better positioned to pursue NIH, NSF, DoD, DOE, and NASA SBIR/STTR awards, and STTR in particular is a natural next step because it already requires a research institution partner.

GRA-backed projects have attracted more than $2.3 billion in follow-on investment, and GRA reports that 87% of its startups are still operating after four years.

How to Apply

• Download the Development Grant Application (MS Word) from the GRA Innovation & Entrepreneurship documents page
• Follow the instructions on pages 1 and 2 and complete the proposal inside the application file, not in a separate document
• Submit ahead of one of the six annual review cycles
• Plan for a progress report six months after funding begins and every six months after that
• Direct eligibility questions to Andrew Short, GRA Director of Innovation Programs, or grants@gra.org

Frequently Asked Questions

What is the GRA Development Grant?

The GRA Development Grant is a non-dilutive award of $10,000 to $250,000 from the Georgia Research Alliance Innovation & Entrepreneurship Program. It funds milestone-driven projects that advance Georgia university technologies toward commercialization or startup formation.

Who is eligible for a GRA Development Grant?

Faculty researchers employed by accredited public or private universities in Georgia are eligible. Companies not founded on Georgia university technology are not eligible for GRA grants.

What activities can a GRA Development Grant fund?

Typical activities include prototype refinement, technology validation, preclinical testing, pilot manufacturing, IP and regulatory analysis, and customer pilots.

When are GRA Development Grant applications reviewed?

GRA holds six Development Grant review cycles per year. Exploratory Grants of up to $10,000 are accepted on a rolling basis.

Does GRA take equity in exchange for a Development Grant?

No. GRA grants are non-dilutive and GRA holds no financial stake in grant-funded projects. GRA Startup Loans, available after company formation, do include a modest warrant component and an option to convert in a future financing.

How does a GRA Development Grant help with SBIR and STTR funding?

A Development Grant pays for the preliminary data, validation, and customer evidence that SBIR and STTR reviewers look for. Georgia faculty and spinouts can use GRA funding to strengthen proposals to NIH, NSF, DoD, DOE, and NASA. BW&CO helps teams build that full non-dilutive funding strategy.

Turn Your GRA Award Into Federal Funding

BW&CO helps Georgia founders and faculty map a GRA Development Grant into a full non-dilutive funding strategy, from milestone planning to SBIR and STTR proposals across NIH, NSF, DoD, DOE, and NASA. With more than $350M in funding secured for our clients, we know what reviewers look for.

NIH Highlighted Topic: Improving Diagnostic Safety and Quality in Healthcare

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging research that closes critical gaps in diagnostic safety and quality, particularly diagnostic failures that contribute to patient harm. The topic prioritizes three strategic areas: technology and innovation, infrastructure and system design, and advancing the science of diagnosis.

On the technology side, NIH highlights AI-enabled tools including large language models, telehealth and other digital health solutions, point-of-care diagnostic testing, enhanced data sources, sensors, and analytic methods, and other novel diagnostic tests. System-level priorities include coordinating care across the full diagnostic trajectory, integrating clinical tools with patient-reported information, and improving communication among patients, clinicians, and care teams.

NIBIB, the lead institute, focuses on technologies with broad applicability, such as AI to improve point-of-care imaging quality, motion correction for radiological imaging, 3D-printed phantoms, AI surveillance of diagnostic errors, workflow platforms that reduce diagnostic delays, and VR and AR visualization tools. NCI seeks faster, more accurate cancer diagnosis, including rare and early-onset cancers and quicker follow-up after abnormal screening results. NIDA is interested in AI, digital biomarkers, and neuroimaging for detecting substance use disorder and related conditions.

How to apply: This is a Highlighted Topic rather than a standalone NOFO, so it has no dedicated solicitation or deadline of its own. Small businesses should apply through the NIH SBIR omnibus (PA-27-100) or STTR omnibus (PA-27-102) and reference this Highlighted Topic by name in the Specific Aims or Significance section so program staff can connect the application to this priority. We also recommend contacting the central NIBIB scientific contact or the relevant institute contact to confirm fit before writing.

This highlighted topic is led by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) with participation from NCI, NIDA, NIDCR, and the Office of Behavioral and Social Sciences Research (OBSSR). NIDCR notes it may give special consideration to meritorious applications in this area. The topic is active from July 28, 2026 through July 28, 2028.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of diagnostic technologies and workflow tools that reduce diagnostic errors and delays.

Eligible activities may include:

• AI and large language model tools for diagnostic decision support and error surveillance

• Point-of-care diagnostic tests and imaging quality enhancements

• Motion correction, phantom, and advanced visualization technologies for radiology

• Workflow and reporting platforms that close the loop on abnormal test results

• Telehealth and digital health diagnostic solutions

• Clinical validation studies using real-world data

• Regulatory strategy, commercialization planning, and market validation

Funding may also support personnel, materials and supplies, equipment, contract research, academic collaborations, intellectual property protection, and commercialization activities necessary to advance a scalable and commercially viable diagnostic product aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. The next standard deadline is January 5, 2027. This Highlighted Topic remains active until July 28, 2028. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have 500 or fewer employees including affiliates.

• Are more than 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute's specific research mission, including an explicit connection to this Highlighted Topic.

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120 to 200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50 to 80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.

Breakthrough T1D Industry Discovery and Development Partnership (IDDP): Funding, Eligibility, and How to Apply

Below is a brief summary. Please check the full program details before applying (link in resources section).

Quick Answer

The Breakthrough T1D Industry Discovery and Development Partnership (IDDP) is a non-dilutive R&D funding program for for-profit companies developing therapeutics or devices to cure, treat, or prevent type 1 diabetes (T1D) and its complications. Inquiries are accepted year-round on a rolling basis. Award size and duration are negotiated project by project, and companies must commit their own funds equal to or greater than the amount requested. Breakthrough T1D takes no equity. Instead, it receives a modest, capped royalty tied to successful commercialization, and the company keeps ownership of its IP and product rights.

Program Overview

Breakthrough T1D (formerly JDRF) is the largest nonprofit funder of type 1 diabetes research. Most of its grant programs fund academic investigators. The IDDP is the exception: it is built specifically for biotech, pharma, medtech, and other for-profit organizations, whether public or private.

The program pairs a company's ability to move products toward market with Breakthrough T1D's scientific expertise, clinical networks, and advocacy reach. Its stated goals are to accelerate the development of therapeutics and devices for T1D and to build long-term collaborative relationships with industry.

For SBIR and STTR companies, the IDDP is a strong complement to federal funding. It is milestone-driven, it is negotiated rather than scored against a fixed solicitation, and it comes with a strategic partner that knows the T1D market, patient community, and regulatory landscape.

What Breakthrough T1D Is Looking For

Projects must closely align with Breakthrough T1D's priority research areas and address the discovery or development of therapeutics or devices that cure, treat, or prevent T1D, including its complications.

Cell Therapies

Approaches that replace or restore insulin-producing beta cells, including stem cell-derived islets, encapsulation, and strategies that reduce or eliminate the need for immunosuppression.

Disease-Modifying Therapies

Therapeutics that delay, prevent, or halt the autoimmune process behind T1D, including immunotherapies and interventions for people at risk or newly diagnosed.

Devices and Monitoring Technologies

Devices that improve daily management and outcomes. Recent Breakthrough T1D calls have focused on combined continuous glucose monitor (CGM) and insulin pump devices and on continuous C-peptide monitoring, which signals strong interest in medtech and digital health.

Complications

Products that address T1D-related complications, such as cardiovascular, kidney, eye, and nerve disease.

Funding and Award Structure

• Award amount: Not fixed. Budgets are approved project by project based on scope.

• Duration: Open. Timelines are set in the partnership agreement.

• Matching requirement: The company must commit funds equal to or greater than the amount requested from Breakthrough T1D for the full funding period.

• Milestone-based payments: Funding is released against agreed research and development milestones.

• Return on investment: Breakthrough T1D receives a modest ROI based on successful commercialization or agreed inflection points, typically through royalties. Royalties are capped at a proportion relative to the size of the award.

• No equity: The IDDP does not take an ownership stake, which keeps it non-dilutive.

Intellectual Property

The company owns the discoveries, IP, and product rights that come out of the funded research. If the company abandons development of the funded program, Breakthrough T1D gains access rights, including the ability to sublicense the IP to another party so the technology can still reach patients.

Eligibility

• For-profit organizations, public or private, including biotech, pharmaceutical, and medical device companies

• Companies may partner with academic investigators or contract research organizations

• Projects must align with Breakthrough T1D's priority research areas

• Companies must be able to meet the one-to-one (or greater) matching requirement

• Companies should be prepared to provide audited financial statements and financial projections during due diligence

Timeline

There is no fixed deadline. Breakthrough T1D welcomes inquiries year-round and reviews opportunities on a rolling basis. Timing depends on how quickly a company moves through the pre-LOI, LOI, peer review, and agreement stages.

How to Apply

1. Pre-LOI discussion: Contact Breakthrough T1D and share a non-confidential pitch deck. Staff assess whether the project fits the research strategy.

2. Letter of Intent: If invited, submit an LOI through Breakthrough T1D's RMS360 grant system. This stage may include negotiation of a non-binding term sheet.

3. Full proposal: Incorporate LOI feedback into a full proposal, which goes through confidential external peer review with a rebuttal opportunity.

4. Agreement: After a positive review, the parties finalize a definitive agreement covering governance, milestones, IP, and commercialization terms.

IDDP vs. the T1D Fund

Breakthrough T1D also runs the T1D Fund, a venture philanthropy fund that makes equity investments in T1D companies. The IDDP is different. It funds specific research programs through milestone-based agreements and a capped royalty, not equity. Companies that want to protect their cap table should start the conversation with the IDDP.

Why SBIR and STTR Companies Should Consider the IDDP

• Stackable funding: An IDDP partnership can extend runway alongside NIH SBIR and STTR awards, including NIDDK programs focused on diabetes.

• Rolling access: There is no need to wait for a federal receipt date.

• Strategic validation: A partnership with the leading T1D research funder strengthens investor and acquirer conversations.

• Device-friendly: Unlike many disease foundations, Breakthrough T1D actively funds devices and monitoring technologies.

How BW&CO Consulting Supports IDDP Applicants

BW&CO Consulting helps deep-tech, biotech, and medtech founders build non-dilutive funding strategies that combine federal SBIR and STTR awards with foundation and state programs. For the IDDP, we assess alignment with Breakthrough T1D's priorities, shape the non-confidential pitch deck, structure milestones and matching funds, and prepare a competitive LOI and full proposal. With $350M+ in funding secured for our clients, we know how to position R&D programs for funders who expect a clear path to patients.

If you are developing a T1D therapeutic or device, book a call to see whether the IDDP fits your roadmap.

Frequently Asked Questions

What is the Breakthrough T1D IDDP? The Industry Discovery and Development Partnership is a Breakthrough T1D program that funds for-profit companies conducting research on therapeutics or devices to cure, treat, or prevent type 1 diabetes and its complications.

Who is eligible for the IDDP? Public and private for-profit organizations, including biotech, pharma, and medical device companies. Companies may partner with academic investigators or CROs.

When is the IDDP deadline? There is no fixed deadline. Breakthrough T1D accepts inquiries year-round on a rolling basis.

How much funding does the IDDP provide? There is no published cap. Budgets are approved project by project, and companies must match the requested amount with their own funds, dollar for dollar or more.

Is the IDDP non-dilutive? Yes. Breakthrough T1D does not take equity. It receives a modest royalty tied to commercialization, and that royalty is capped relative to the award amount.

Who owns the IP from an IDDP project? The company owns the discoveries, IP, and product rights. Breakthrough T1D gains access rights only if the company abandons development of the funded program.

Does the IDDP fund medical devices and digital health? Yes. The program covers therapeutics and devices, and recent Breakthrough T1D calls have targeted integrated CGM and pump systems and continuous C-peptide monitoring.

How do I apply for the IDDP? Start with a pre-LOI conversation and a non-confidential pitch deck. If invited, submit an LOI through RMS360, then a full proposal for external peer review, followed by agreement negotiation.

Can I combine the IDDP with SBIR or STTR funding? The IDDP is a separate program from federal SBIR and STTR, so companies can pursue both. Confirm with Breakthrough T1D whether federal award dollars can count toward the company match.

What is the difference between the IDDP and the T1D Fund? The T1D Fund makes equity investments. The IDDP funds specific research programs through milestone payments and a capped royalty without taking equity.

Can BW&CO Consulting help with an IDDP application? Yes. BW&CO helps companies assess fit, build the pitch deck, structure milestones and matching funds, and prepare the LOI and full proposal.

Resources

• Breakthrough T1D Funding Opportunities

• IDDP Program Overview

• Breakthrough T1D Grant Handbook

NIH Highlighted Topic: Microphysiological System Pilot Studies in Diabetes Research

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging collaborative research that applies human microphysiological systems (MPSs), often called organ-on-chip or tissue-chip platforms, to cell and tissue types relevant to diabetes and its kidney and urologic complications. MPSs are a New Approach Methodology (NAM) that support long-term culture of human cells under physiologically relevant conditions, enable real-time observation, biosensing, and frequent sampling, and can connect multiple tissue or organ models.

A central goal is pairing engineering and device developers with biology and physiology researchers so MPSs can be more widely adopted in diabetes research. High-priority areas include systems with at least two diabetes-relevant human tissues that demonstrate stability and durability, validation of diabetes pathophysiology through biosensors and multiplexed monitoring, studies of crosstalk between tissues, models with mature cell types and interacting compartments such as vasculature, nerves, and stroma, disease phenotypes created through gene editing or environmental perturbation, and multi-tissue models of diabetic kidney disease and urologic complications.

Relevant tissues include pancreatic islets, liver, adipose tissue, gut, vasculature, and skeletal muscle. The topic is part of the NIH MAHA Chronic Disease Initiative and NIH's broader push for NAMs, which NIH, FDA, and EPA have all committed to using where appropriate.

How to apply: This is a Highlighted Topic rather than a standalone NOFO, so it has no dedicated solicitation or deadline of its own. Small businesses should apply through the NIH SBIR omnibus (PA-27-100) or STTR omnibus (PA-27-102) and reference this Highlighted Topic by name in the Specific Aims or Significance section so program staff can connect the application to this priority. NIDDK asks that responsive projects be tightly focused and short in duration (1 to 3 years) to establish proof of concept and demonstrate feasibility, which fits naturally with a focused SBIR Phase I scope. STTR is a strong option for company and university engineering partnerships. We also recommend contacting the listed NIDDK scientific contacts to confirm fit before writing.

This highlighted topic is supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). NIDDK notes it may dedicate funds to this area, depending on availability and the number of meritorious applications, and may give special consideration to meritorious applications. The topic is active from September 10, 2026 through September 10, 2028.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of microphysiological systems, biosensors, and enabling tools for diabetes research.

Eligible activities may include:

• Multi-tissue MPS platforms incorporating two or more diabetes-relevant human tissues

• Integrated biosensors and multiplexed sampling for real-time metabolic readouts

• Vascularized or innervated tissue models built with mature human cell types

• Disease-phenotype models created through gene editing or environmental perturbation

• Models of diabetic kidney disease and urologic complications

• Standardization, reproducibility, and validation studies against human data

• Commercialization planning and market validation with pharma and research end users

Funding may also support personnel, materials and supplies, equipment, contract research, academic collaborations, intellectual property protection, and commercialization activities necessary to advance a scalable and commercially viable microphysiological system product aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. The next standard deadline is January 5, 2027. This Highlighted Topic remains active until September 10, 2028. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have 500 or fewer employees including affiliates.

• Are more than 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute's specific research mission, including an explicit connection to this Highlighted Topic.

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120 to 200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50 to 80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.

NIH Highlighted Topic: Digital Twins for Biomedical, Biological and Behavioral Research

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research and prototype development of digital twin technologies for biomedical, biological, and behavioral research and human health. NIH uses the 2023 National Academies definition: a digital twin is a virtual model that mimics a real system, is dynamically updated with data from its physical counterpart, has predictive capability, and informs decisions. The two-way link between the virtual and the physical is central.

NIH wants fit-for-purpose digital twins that accelerate discovery, support intelligent medical technologies, and enable decision support across clinical, laboratory, and healthcare settings. Priority areas include verification, validation, and uncertainty quantification (VVUQ), real-time assimilation of multimodal and longitudinal data, interoperable and scalable computational architectures, and responsible governance of digital twin technologies.

Institute interests are broad. NCI wants cancer digital twins that predict treatment response and inform clinical trial design. NHLBI highlights patient-specific modeling and medical device design. NEI is interested in twins for glaucoma, macular degeneration, and diabetic retinopathy. NIBIB supports sensor-linked physical assets and readiness evaluation tools, while NIDDK, NIMH, NIDA, and NIGMS each outline uses ranging from clinical decision support to virtual clinical trials and drug-response prediction.

How to apply: This is a Highlighted Topic rather than a standalone NOFO, so it has no dedicated solicitation or deadline of its own. Small businesses should apply through the NIH SBIR omnibus (PA-27-100) or STTR omnibus (PA-27-102) and reference this Highlighted Topic by name in the Specific Aims or Significance section so program staff can connect the application to this priority. The Office of Data Science Strategy does not award grants itself, so applications must also fit the mission of at least one participating Institute or Center. We recommend contacting the relevant ICO scientific contact to confirm fit before writing.

This highlighted topic is led by the NIH Office of Data Science Strategy (ODSS) with participation from NCATS, NCCIH, NCI, NEI, NHGRI, NHLBI, NIAAA, NIAID, NIBIB, NIDA, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NLM, and ORWH. NCCIH, NIDA, NIDCR, NIDDK, and NIMHD note they may give special consideration to meritorious applications in this area. The topic is active from September 10, 2026 through September 10, 2028.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of digital twin platforms, software, and enabling tools for biomedical research and healthcare.

Eligible activities may include:

• Fit-for-purpose, bidirectional digital twin prototypes for a defined disease, organ system, or care setting

• Verification, validation, and uncertainty quantification (VVUQ) tools and benchmarking frameworks

• Real-time data assimilation pipelines linking sensors, wearables, imaging, and EHR data to virtual models

• Interoperable, modular digital twin architectures and reusable software platforms

• Virtual clinical trial and in silico testing tools for drugs, devices, and interventions

• Clinical decision support prototypes and usability testing with clinicians and research end users

• Commercialization planning, regulatory strategy, and market validation

Funding may also support personnel, materials and supplies, equipment, contract research, academic collaborations, intellectual property protection, and commercialization activities necessary to advance a scalable and commercially viable digital twin product aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. The next standard deadline is January 5, 2027. This Highlighted Topic remains active until September 10, 2028. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have 500 or fewer employees including affiliates.

• Are more than 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute's specific research mission, including an explicit connection to this Highlighted Topic.

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120 to 200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50 to 80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.

North Carolina SBIR/STTR Phase I Incentive Funds Program: Complete FY 2026-2027 Solicitation Guide

Executive Summary

The One North Carolina Small Business Program reimburses North Carolina companies for up to $12,000 of the money they spend preparing and submitting a federal SBIR or STTR Phase I proposal. It is not a competitive grant, it is a reimbursement. If your company is eligible, your proposal was received by a participating federal agency, and your paperwork is complete, you get paid. You do not have to win the federal award to qualify.

The FY 2026-2027 solicitation (Funding Opportunity Number NCBSTI-FY2627I) was released on September 14, 2026 by the North Carolina Board of Science, Technology & Innovation. It covers qualifying federal Phase I proposals submitted from July 1, 2026 through June 30, 2027, and it is funded at $210,000 total. Awards are made on a rolling, first-come, first-served basis until that money runs out.

At a Glance

• Program name: One North Carolina Small Business Program, SBIR/STTR Phase I Incentive Funds Program

• Funding Opportunity Number: NCBSTI-FY2627I

• Administering agency: North Carolina Board of Science, Technology & Innovation, supported by the Office of Science, Technology & Innovation at the N.C. Department of Commerce

• Authorizing statute: N.C. Gen. Stat. Section 143B-437.80

• Release date: September 14, 2026

• Solicitation period: July 1, 2026 through June 30, 2027

• Closing date: June 30, 2027 at 11:59 p.m. EST, or earlier if funds are exhausted

• Total funds available: $210,000

• Maximum award: $12,000 per company

• Reimbursement rate: 75 percent of eligible costs in Development Tier 1 and Tier 2 counties, 50 percent in Tier 3 counties

• Award basis: Rolling, first-come, first-served, non-competitive

• Submission system: CyberGrants, with online applications available as of September 14, 2026

What the Incentive Program Actually Does

Writing a competitive SBIR or STTR Phase I proposal is expensive before a single dollar of federal money arrives. Companies spend real cash on consultants, staff time, literature searches, dedicated lab or prototyping space, and supporting materials, and they spend it with no guarantee that the agency will fund the work. Federal SBIR success rates at most agencies sit well under 20 percent, so most of that spend is a sunk bet.

North Carolina created the Incentive Funds Program to take some of that risk off the table. The state reimburses a percentage of documented proposal preparation costs, which lowers the cost of entering the competition and makes it rational for a company to submit more proposals, to more agencies, at higher quality. The program goals written into the solicitation are explicit: increase the number and quality of North Carolina Phase I applications, pull in applicants from economically distressed counties, and raise the state's presence at federal agencies where North Carolina is underrepresented in Phase I awards, with the Department of Defense named as the specific example.

The practical effect for a founder is straightforward. Your out of pocket cost to run a serious federal proposal effort drops by half or by three quarters, capped at $12,000, and the check arrives whether or not the agency funds you.

Who Is Eligible

Company requirements

To qualify, an applicant must certify under oath, signed by an authorized official, that all of the following are true:

• The applicant is a for-profit small business with its principal place of business in North Carolina

• The applicant has not received concurrent funding from another source that duplicates the purpose of the Incentive award

• The applicant will conduct at least 51 percent of the activities described in the Phase I proposal in North Carolina, and will maintain significant North Carolina operations for the entire Phase I project if the federal award is made

• The applicant has a formal written policy addressing conflicts of interest

• The applicant has no overdue tax debts at the federal, state, or local level

The company must also have been registered with the North Carolina Secretary of State either before it submitted the federal SBIR or STTR application, or at least 90 days before it applies to the Incentive Program. Companies on the state's Suspension of Funding list are not eligible, and previous One NC Small Business Program recipients must be current on all prior award reporting.

Proposal requirements

• The proposal must be a Phase I or Fast Track SBIR or STTR proposal submitted to a participating federal agency

• The federal agency must have issued official notification of receipt during the solicitation period, meaning between July 1, 2026 and June 30, 2027

• Proposals submitted between July 1, 2026 and the September 14, 2026 release date are still accepted, as long as all other eligibility requirements are met and funding remains available

What does not qualify

• Direct to Phase II applications

• Phase II applications

• Proposals received by the federal agency outside the solicitation period

For STTR applications, the Board will only reimburse the fraction of expenses directly incurred by the small business applicant in the collaboration, not costs borne by the research institution partner.

Funding Allowance: How Much You Get Back

Reimbursement rates by county tier

Your reimbursement percentage depends on the North Carolina Development Tier designation of the county where your business is located. Tier designations are updated by the Department of Commerce every November and take effect the following January, so verify your county's current tier before you apply.

• Development Tier 1 and Tier 2 counties: 75 percent of eligible documented expenses, capped at $12,000

• Development Tier 3 counties: 50 percent of eligible documented expenses, capped at $12,000

What that looks like in practice

A company in a Tier 1 or Tier 2 county that documents $16,000 in eligible proposal preparation expenses receives the full $12,000, because $16,000 multiplied by 0.75 equals $12,000.

A company in a Tier 3 county needs to document $24,000 in eligible expenses to reach the same ceiling, because $24,000 multiplied by 0.50 equals $12,000.

If you document less than those thresholds, you receive the applicable percentage of whatever you actually documented. A Tier 3 company with $8,000 in documented eligible expenses receives $4,000.

Resubmissions

If a proposal that already received an Incentive award is revised and resubmitted, that resubmission is eligible for one additional award of up to $6,000, which is 50 percent of the statutory maximum. Eligible expenses on a resubmission are narrower than on an original: only additional data collection beyond what was gathered for the first proposal, and proposal preparation consulting fees paid to others.

Award limits

• One Incentive award per company during this solicitation period

• Ten Incentive awards per company over its lifetime

• A grant to a business partnered with a North Carolina public institution of higher education does not count against the lifetime maximum, subject to budget constraints

Eligible and Ineligible Expenses

Reimbursable costs

• Proposal preparation consulting fees paid to others. This is the single most important line item for most applicants. Fees paid to an outside grant consulting firm to develop and write the Phase I proposal are explicitly reimbursable

• Salaries paid to individuals directly involved in preparing the Phase I proposal, not to exceed the rate stated in the federal proposal budget, with proof of payment required

• Typing and word processing services

• Project related supplies and postage

• Database search fees for project related literature searches

• Rental of space or equipment directly related to preparing the federal proposal, such as dedicated lab space or a prototyping facility

• Educational program fees directly related to preparing the federal proposal

• USPTO utility patent application filing, search, examination, issue, and maintenance fees, for patents submitted within 36 months of the Phase I proposal submission and directly related to it

Non-reimbursable costs

• Travel

• Equipment purchases over $300

• Facility or leasehold improvements

• Legal fees, including legal fees associated with preparing a patent

• Fringe benefits

• Indirect costs, including rent paid for general operations

• In-kind services or deferred salaries

Documentation standards

Expenses that are incurred but not properly documented will not be reimbursed. Every receipt, invoice, or service contract must show that it was billed to the applicant with the applicant's address, the vendor name and address, the invoice date, a unique invoice number, quantity and description of the item or service with reference to the applicable SBIR or STTR proposal, unit price where applicable, total amount, and terms or due date.

Salary reimbursement requires proof of payment. That means pay stubs showing employee name, pay period dates, hours worked, rate of pay, total paid, and date and method of payment. In place of a pay stub or payroll service report, you can submit bank statements confirming the transaction plus the front and back of cleared company checks. If the hours you are claiming are less than the total hours on the pay stub, you must also submit a work log or certified statement identifying the hours that were directly related to federal proposal preparation.

USPTO receipts require payer name, payment date, payment amount, patent number, application number, fee code, fee code name, and attorney docket number.

Timeline and Key Dates

• July 1, 2026: Start of the eligible solicitation period. Federal Phase I and Fast Track proposals received by an agency on or after this date can qualify

• September 14, 2026: FY 2026-2027 Incentive solicitation released and online applications opened in CyberGrants

• Rolling, from September 14, 2026 forward: Complete applications are reviewed and approved first-come, first-served as they arrive

• Within 15 days of any request: Deadline to return supplemental materials requested by the Board or OSTI staff, or the application may be rejected without further review

• June 30, 2027 at 11:59 p.m. EST: Final deadline, or earlier if the $210,000 is exhausted before that date

• Within 30 days of federal Phase I award or denial notification: Final Report due in CyberGrants

• Three months after your fiscal year end: State Grant Compliance reporting due for the fiscal year in which you received or expended the award

Note that a separate FY 2027 Matching Funds Program solicitation is listed by N.C. Commerce with a December 14, 2026 release date. That is a different program with a different application. See the section below.

How to Apply

All applications are submitted electronically through CyberGrants, the Board's grant management system, linked from the One North Carolina Small Business Program page on the N.C. Commerce website. The system assigns an Application Reference Number when you begin. Applications missing any required response, document, or piece of information are considered incomplete and will not be funded.

The state requires DocuSign for electronic signatures. If you do not want to use DocuSign, you must use a wet signature. In-state virtual notarization is acceptable if it complies with the North Carolina Remote Electronic Notarization Act.

Required Application Documents

• A completed Grant Application and Agreement, generated by CyberGrants, including the sworn and signed eligibility attestation

• A Certificate of Existence or Certificate of Authorization from the North Carolina Secretary of State, issued no more than 90 days before your application date. This is the Certificate of Good Standing from the Secretary of State, not from the Department of Revenue, and first-time requesters need to create an Online Services account to obtain it

• A copy of the relevant pages of the federal SBIR or STTR Phase I solicitation showing the topic description, closing date, and topic reference number. A link to the solicitation does not satisfy this requirement

• A copy of the entire Phase I or Fast Track federal proposal, including the SF424 where applicable, submission cover, abstract, budget pages, key personnel, facility and performance site information, and the SBIR/STTR information page

• Evidence that the federal agency received your proposal, such as written or electronic confirmation showing the date of receipt

• A Supplier Electronic Payment Request Form with bank account verification

• A completed Certified Expense Table with supporting documentation in CyberGrants

• Copies of all receipts and supporting documents for every expense you are claiming

If your federal proposal contains proprietary or classified material that is not relevant to your Incentive eligibility, you may exclude it, but you must submit a notarized statement from an authorized official attesting that the excluded material is proprietary or classified and that economic harm or a violation of federal classification rules would result from submitting it. Applications that attempt to restrict dissemination of large amounts of information may be rejected.

How Applications Are Reviewed

There is no scoring panel and no competitive ranking. Applications are checked for compliance with the solicitation requirements and approved on a rolling, first-come, first-served basis through the end of the period or until funds are exhausted. Incomplete or non-compliant applications are rejected without further review, though the Board or OSTI staff may at their discretion request supplemental materials, which must come back within 15 days.

Once approved, the state issues payment electronically to the account listed on your Supplier Electronic Payment Form. If this is the first state payment your company has received, it may arrive as a paper check.

Reporting Requirements After Award

Recipients file a Final Report through CyberGrants within 30 days of being notified that the federal Phase I contract was awarded or denied. The report asks for the award date and contract amount if funded, an explanation if the contract was awarded but not accepted, whether the company will continue the research with its own resources if it was not funded, what material effect the Incentive award had on the firm, general comments on the program, and a summary of progress toward the original aims with significant results and any related publications.

Recipients that receive, use, or expend less than $1,000,000 in state funds in their fiscal year must also file State Grant Compliance reports within three months of fiscal year end, including a certification sworn by the treasurer and one other authorized officer, a State Grants Compliance report, and a Schedule of Grantee Receipts and Expenditures on a cash basis. Reporting delinquency is grounds for placement on the State Suspension of Funding list, which blocks future awards.

How Competitive Is It, Really

The program is non-competitive in the sense that applications are not scored against each other. The real constraint is the money. At $210,000 total and a $12,000 ceiling, this solicitation funds as few as 17 companies if applicants max out their awards.

Recent Incentive Program history gives a sense of the pace:

• FY 2026: 18 awards totaling $116,553

• FY 2025: 51 awards totaling $418,863

• FY 2024: 49 awards totaling $317,316

• FY 2023: 48 awards totaling $345,562

• FY 2022: 50 awards totaling $358,986

Across every year the Incentive Program has operated, 306 awards totaling roughly $1.8 million have gone out. Historical average awards have run well below the $12,000 ceiling, which means more than 17 companies will likely be funded this cycle. It also means companies that documented their expenses thoroughly captured substantially more than average. The two variables you control are how early you file and how completely you document.

What Comes Next: the Matching Funds Program

The Incentive Program is one half of the One North Carolina Small Business Program. The other half is the SBIR/STTR Phase I Matching Funds Program, authorized under N.C. Gen. Stat. Section 143B-437.81, which awards matching funds to North Carolina companies that have actually received a federal SBIR or STTR award. Its purpose is to bridge the funding gap between the final Phase I payment and the first Phase II payment, and to let companies intensify the Phase I research so they compete better for Phase II.

The Matching program is dramatically larger. In FY 2026 it made 32 awards totaling $2,368,507, and since 2006 it has made 662 awards totaling more than $42 million. Since its inception, the combined One NC Small Business Program has funded 525 North Carolina small businesses.

The sequence for a North Carolina company is therefore: submit your federal Phase I proposal, file for Incentive reimbursement of your proposal costs, and if you win the federal award, file for Matching funds. These are separate applications with separate solicitations and deadlines.

Common Mistakes That Cost Companies the Award

• Waiting. First-come, first-served with a hard funding cap means a complete application in October is worth more than a perfect one in May

• Thin receipts. An invoice without a unique invoice number, a vendor address, or a reference to the specific SBIR proposal is an invoice that does not get reimbursed

• Unproven salary claims. Claiming founder or staff time without pay stubs, cleared checks, or bank records, and without a work log separating proposal hours from other hours

• A stale Certificate of Existence. It expires for these purposes at 90 days, and first-time requests take time to process

• Submitting the wrong proposal type. Direct to Phase II and Phase II applications are not eligible, no matter how strong they are

• No conflict of interest policy on file. The solicitation includes a sample policy in its appendix. There is no reason to be missing this one

• Missing the 15 day supplemental materials window after the Board requests additional information

How BW&CO Helps

BW&CO Consulting is a non-dilutive federal funding advisory firm that has helped clients secure more than $350 million in government funding across NIH, NSF, DoD, NASA, DOE, and ARPA-H. Innovation Funding Simplified is not a slogan for us, it is the workflow.

For North Carolina companies, the two programs stack in a way that is worth being deliberate about. Proposal preparation consulting fees paid to an outside firm are an explicitly reimbursable expense under this solicitation, which means the state will cover 50 to 75 percent of what you spend on professional proposal development, up to the $12,000 cap.

When a company engages BW&CO to develop its federal SBIR or STTR Phase I proposal, we prepare and submit the North Carolina Incentive Funds application on your behalf at no additional cost. You focus on the science and the federal submission. We handle the expense table, the receipts package, the Certificate of Existence timing, the attestations, and the CyberGrants filing, and we file it early enough to matter.

Frequently Asked Questions

What is the One North Carolina SBIR/STTR Phase I Incentive Funds Program?

It is a North Carolina state reimbursement program that pays qualified North Carolina small businesses back for a portion of the costs they incurred preparing and submitting a federal SBIR or STTR Phase I proposal. It is authorized under N.C. Gen. Stat. Section 143B-437.80 and administered by the North Carolina Board of Science, Technology & Innovation. The FY 2026-2027 solicitation number is NCBSTI-FY2627I.

How much money can my company receive?

Up to $12,000. Companies in Development Tier 1 and Tier 2 counties are reimbursed 75 percent of eligible documented expenses, and companies in Tier 3 counties are reimbursed 50 percent. To hit the $12,000 ceiling, a Tier 1 or Tier 2 company needs $16,000 in documented eligible expenses and a Tier 3 company needs $24,000.

What is the deadline for the FY 2026-2027 solicitation?

June 30, 2027 at 11:59 p.m. EST, or earlier if the available funds are exhausted first. Because awards are made first-come, first-served against a $210,000 pool, the practical deadline is whenever the money runs out.

Do I have to win the federal SBIR award to get this money?

No. Reimbursement is triggered by proof that a participating federal agency received your qualifying Phase I or Fast Track proposal, not by whether the agency funds it. You do have to file a Final Report within 30 days of learning whether the federal award was made or denied.

Are SBIR consulting fees reimbursable under this program?

Yes. Proposal preparation consulting fees paid to others are the first item on the solicitation's list of reimbursable costs. Fees paid to an outside grant writing or proposal development firm qualify, as long as they are properly invoiced and documented.

Are Direct to Phase II or Phase II proposals eligible?

No. The FY 2026-2027 Incentive solicitation covers Phase I and Fast Track proposals only. Direct to Phase II and Phase II applications are explicitly excluded.

Is a Fast Track proposal eligible?

Yes. Fast Track proposals are eligible alongside standard Phase I proposals, provided the federal agency issued official notification of receipt during the solicitation period.

What proposals fall inside the eligible window?

Proposals for which a participating federal agency issued official notification of receipt between July 1, 2026 and June 30, 2027. Proposals submitted between July 1, 2026 and the September 14, 2026 release date are still accepted if all other eligibility requirements are met and funding remains available.

How do I find out which Development Tier my county is in?

The N.C. Department of Commerce publishes current County Distress Rankings, also called Tier designations. Tiers are recalculated each November and take effect the following January, so confirm your county's current designation before applying rather than relying on a prior year.

How many times can my company apply?

Once during this solicitation period, and no more than ten times over the life of the company. Awards to a business partnered with a North Carolina public institution of higher education do not count toward that lifetime limit, subject to budget constraints.

What if my proposal was declined and I want to resubmit?

A single resubmission of a proposal that already received an Incentive award can receive one additional award of up to $6,000. Eligible expenses on the resubmission are limited to additional data collection beyond what was gathered for the original proposal, plus proposal preparation consulting fees paid to others.

What expenses are not reimbursable?

Travel, equipment purchases over $300, facility or leasehold improvements, legal fees including patent preparation legal fees, fringe benefits, indirect costs such as general operating rent, and in-kind services or deferred salaries.

Do I need to be registered with the North Carolina Secretary of State?

Yes. Your company must have been registered with the North Carolina Secretary of State either before you submitted the federal SBIR or STTR application, or at least 90 days before you apply to the Incentive Program. Your application must include a Certificate of Existence or Certificate of Authorization issued no more than 90 days before the application date.

How is this different from the NC SBIR/STTR Matching Funds Program?

The Incentive Program reimburses what you spent writing the proposal and does not require a federal win. The Matching Funds Program, authorized under N.C. Gen. Stat. Section 143B-437.81, awards matching money to companies that have already received a federal SBIR or STTR award, to bridge the gap between Phase I and Phase II. They are separate programs with separate solicitations, and a company can use both in sequence.

How competitive is the program?

Applications are not scored against each other, so there is no competitive review. The constraint is the $210,000 funding pool and the first-come, first-served rule. Historically the Incentive Program has made between 18 and 51 awards per year, with average awards well under the $12,000 cap.

When should I apply?

As soon as you have official confirmation that the federal agency received your Phase I proposal and you have assembled complete expense documentation. Because funds are awarded in the order complete applications arrive, filing early in the period is a meaningful advantage over filing in spring.

Talk to Us Before You Spend the Money

The companies that capture the full $12,000 are the ones that decided how they would document the spend before they started spending. If you are a North Carolina company planning a federal SBIR or STTR Phase I submission this cycle, or you have already submitted one since July 1, 2026, we can tell you quickly whether you qualify and what your reimbursement is likely to be.

2027 NIA Start-Up Challenge and Accelerator: Complete Guide for Startups

Executive Summary

The 2027 NIA Start-Up Challenge and Accelerator is a prize competition from the National Institute on Aging (NIA), part of the National Institutes of Health (NIH), that awards up to $994,000 in non-dilutive cash prizes plus a five month entrepreneurial accelerator to early-stage innovators building technologies that improve the health and well-being of older adults. Submissions are accepted from December 1, 2026 through 11:59 p.m. ET on January 15, 2027. Up to 21 Stage 1 finalists each receive $24,000 and a seat in the accelerator, and up to 7 Stage 2 winners each receive an additional $70,000.

This is the fourth cycle of the Start-Up Challenge. It is run by the NIA Office of Strategic Extramural Programs under the America COMPETES Reauthorization Act of 2010, as amended (15 U.S.C. 3719). It is designed for researchers and innovators who are new to entrepreneurship, and it is explicitly built as a runway into the NIA SBIR and STTR programs.

Key facts at a glance

• Sponsor: National Institute on Aging (NIA), NIH, within the U.S. Department of Health and Human Services

• Program type: Prize competition and accelerator, not a grant or contract

• Total prize pool: Up to $994,000

• Stage 1 award: $24,000 each to up to 21 finalists, plus accelerator participation

• Stage 2 award: $70,000 each to up to 7 winners selected from the finalist pool

• Equity taken: None. Prize money is fully non-dilutive

• Submission window: December 1, 2026 to January 15, 2027 at 11:59 p.m. ET

• Informational webinar: December 3, 2026 at 1:00 p.m. ET

• Accelerator period: June 2027 through November 2027

• Who it is for: First-time or aspiring entrepreneurs with science-driven aging and healthspan technologies

• Key disqualifier: You cannot be the principal investigator on an active NIH SBIR or STTR award as of the close of the submission period

• Award Approving Official: NIA Director Richard J. Hodes, M.D.

Who should apply to the 2027 NIA Start-Up Challenge?

NIA is targeting a specific profile, and understanding that profile is the single largest driver of a competitive submission. The Challenge invites submissions from researchers and innovators who are new to entrepreneurship or actively seeking to pursue it, and who propose innovative, science-driven technologies with the potential to improve the health and well-being of older adults.

Unusually for a federal funding opportunity, the scoring rewards need as heavily as it rewards technical merit. Half of the Stage 1 score, 50 of 100 points, is allocated to the impact the Challenge would have on the submitter and the impact the submitter would have on NIA's small business research portfolio. A strong submission therefore has to make two arguments at once: that the technology is compelling, and that the applicant lacks the entrepreneurial training, mentorship, network, and capital that the Challenge provides.

Strong candidate profiles include:

• Academic investigators, postdocs, and clinician scientists with aging-relevant technology who have never commercialized

• Founders of very early stage companies with no prior NIH SBIR or STTR award as PI

• Teams with deep scientific expertise and acknowledged gaps in business, regulatory, or reimbursement strategy

• Innovators whose caregiving experience, clinical practice, or lived experience informs a differentiated approach to aging

• Individuals or teams planning to form a U.S. owned and operated small business ahead of an SBIR or STTR submission

Poor fits include established SBIR awardees, teams that already have institutional venture backing and full commercialization support, and applicants whose product is a modest variation on something already commercialized or already funded through the NIA SBIR and STTR programs.

What is NIA looking for? Detailed technology overview

NIA is seeking innovative tools, technologies, and interventions that prevent, diagnose, treat, monitor, or slow the progression of aging-related diseases and conditions, including Alzheimer's disease (AD) and AD-related dementias. The scope also extends well beyond disease treatment into the mechanics of daily life for older adults.

Core areas of interest

• Aging-related disease and condition management: prevention, diagnosis, treatment, monitoring, and slowing of progression, with explicit emphasis on Alzheimer's disease and AD-related dementias

• Healthy aging and healthspan: solutions that promote healthy aging across the population rather than treating a single endpoint

• Aging in place of choice: technologies that let older adults remain in the living setting they prefer

• Care delivery improvement: tools that improve how care is coordinated, delivered, and measured

• Caregiver burden reduction: solutions that reduce the practical, cognitive, and emotional load on formal and informal caregivers

Artificial intelligence is a stated priority

This cycle carries a particular interest in solutions leveraging artificial intelligence, including data-driven and machine learning approaches. NIA names four AI application areas specifically:

• Early detection of aging-related disease and decline

• Risk prediction and stratification

• Personalized interventions

• Rapid drug discovery and development

This interest is tied to a broader HHS priority to advance digital tools for the prevention of disease and to improve health status and health outcomes. If your technology has a credible AI or machine learning component, name it plainly and tie it to one of these four functions rather than describing AI as a generic feature.

Evidence, accessibility, and population reach

NIA asks submitters to prioritize evidence-based solutions that are broadly accessible and effective across the aging population. Reviewers expect you to account for the range of factors that determine whether a solution actually works in the field, including biological, social, behavioral, economic, environmental, and regional factors. A product that only performs for a narrow, well-resourced, technologically fluent subset of older adults will score poorly on reach.

Two differentiation requirements you cannot skip

Submissions must address both of the following, and weak submissions routinely ignore the second:

• Differentiation from existing commercialized products. Describe how your solution is substantially different from what is already on the market, not incrementally better.

• Expansion of the NIA SBIR and STTR portfolio. Describe how your approach would expand the types of technologies and approaches NIA already funds. NIA points applicants to the NIH RePORTER database to review existing and active NIA SBIR and STTR awards. Doing this research and referencing it directly is one of the cheapest ways to pick up points under the portfolio impact criterion.

Where this Challenge sits in the federal innovation pipeline

NIA positions the Start-Up Challenge as a bridge that prepares participants to pursue other programs, and it names several by way of context: the ACL Caregiver AI Challenge, FDA's READI-Home Innovation Challenge, a2 Collective pilot awards, and the NIA SBIR and STTR programs. Prior cohorts have gone on to raise follow-on venture capital, launch pilot studies, and win SBIR and STTR grants.

Funding allowance: how much money is available and how it can be used

NIA will award up to $994,000 in total cash prizes across two stages, alongside an accelerator program delivered at no cost to participants.

Stage 1: up to 21 finalists at $24,000 each

Up to twenty one Stage 1 finalists are selected from the initial submission pool. Each finalist receives a $24,000 cash prize and a seat in the five month accelerator. The prize is disbursed within three months of the start of the accelerator program, meaning cash typically lands during the summer of 2027.

The Stage 1 prize is intended to support critical early-stage business and product development activities identified during the program. At their discretion, finalists may also use a portion of the funds to cover participation in the two in-person events, including travel expenses.

Stage 2: up to 7 winners at $70,000 each

Up to seven Stage 2 winners are selected from the Stage 1 finalist pool, and each receives an additional $70,000 cash prize. Stage 2 is a closed competition among finalists, so no new applicants enter at this point. A single team that advances through both stages can therefore receive up to $94,000 in total prize money.

How prize money differs from grant funding

Because this is a prize competition rather than an assistance award, the money behaves differently from an SBIR or STTR grant. Points worth planning around:

• No line item budget or budget justification is submitted or approved

• No indirect cost rate, no fringe calculations, and no cost accounting requirements attach to the prize itself

• Prizes may be subject to federal income taxes. HHS and NIH comply with IRS withholding and reporting requirements where applicable, so plan for the tax treatment of the award

• Payment is by electronic funds transfer. Participants are encouraged, though not required, to obtain a free Unique Entity ID (UEI) through SAM.gov to expedite payment

• No equity, warrants, or repayment obligation. The award is fully non-dilutive

• Registration costs for both in-person events are covered by the program, but travel-related costs are paid by the participant

• NIH reserves the right to cancel, suspend, or modify the Challenge, and to decline to award prizes if no submissions are deemed worthy

What the accelerator program includes

The accelerator is arguably worth more than the Stage 1 cash prize for a first-time founder. It runs for approximately five months from June 2027 through November 2027 and is delivered at no cost to finalists.

• Weekly virtual education sessions led by industry experts

• One-to-one mentorship from experienced founders and investors

• Guidance on the NIH SBIR and STTR application process, requirements, and resources

• Business and regulatory guidance at no cost to the finalist

• In-depth pitch coaching

• A three-day entrepreneur bootcamp in June 2027, in person

• A three-day health innovation and investment conference in November 2027, in person

• Virtual and in-person networking with key industry partners

Time commitment

Finalists should expect to commit 6 to 8 hours per week for approximately five months, covering virtual education sessions, mentor meetings, and the two in-person events. This is a real operational load. Teams should decide in advance who will carry it.

Stage 1 learning objectives

By the end of the accelerator, participants should be able to:

• Assess the target market opportunity for the problem they have identified

• Develop a value proposition that solves an identified unmet need

• Create a scalable go-to-market strategy

• Evaluate applicable intellectual property, regulatory, and reimbursement pathways

• Generate basic pro forma financial projections and understand the principles of valuation

• Determine the legal and governance structure best suited to their venture

• Prepare and deliver a compelling 2 minute elevator pitch and 7 minute pitch presentation

• Understand the NIA SBIR and STTR grant application process, requirements, and resources

2027 NIA Start-Up Challenge timeline and key dates

• September 1, 2026: Challenge launched

• December 1, 2026: Registration and submission portal opens

• December 3, 2026 at 1:00 p.m. ET: Informational webinar, registration required

• January 15, 2027 at 11:59 p.m. ET: Submission deadline. Late submissions will not be accepted

• By May 2027: All submissions that reach technical review receive a brief summary of reviewer feedback

• May 2027: Stage 1 finalists announced

• June 2027: Accelerator begins, three-day in-person entrepreneur bootcamp

• June to November 2027: Stage 1 accelerator program, 6 to 8 hours per week

• By November 1, 2027: Stage 2 deadline to form an SBIR or STTR eligible company and meet with an NIH program officer

• November 2027: Three-day health innovation and investment conference, plus final Stage 2 submission and pitch due

• January 2028: Stage 2 winners announced

Practical planning note: the full arc from submission to Stage 2 award runs roughly thirteen months. Founders should treat the December 2026 to January 2027 window as the only entry point for this cycle.

Eligibility rules: who can win a prize

To be eligible to win a prize, a participant, whether an individual, a group of individuals, or an entity, must satisfy all of the following.

• Registered to participate under the rules published in the official Challenge announcement, and complied with all requirements set forth in it

• May not be the principal investigator on an NIH SBIR or STTR award that is active as of the submission period end date

• May not have been a finalist in a previous version of the NIA Start-Up Challenge

• Private entities must be incorporated in and maintain a primary place of business in the United States

• Individuals, whether competing alone or in a group, must be a U.S. citizen or permanent resident

• Non-U.S. citizens and non-permanent residents may participate as team members on an otherwise eligible team, but are not eligible to win a monetary prize in whole or in part. Their participation on a winning team may be recognized when results are announced

• May not be a federal entity or a federal employee acting within the scope of employment

• May not be an HHS employee, from any HHS component, acting in a personal capacity

• Employees of federal agencies other than HHS should consult an agency ethics official to determine whether federal ethics rules limit or prohibit accepting a prize

• May not be a Challenge judge, or any other party involved in the design, production, execution, or distribution of the Challenge, or an immediate family member of such a party, meaning spouse, parent, step-parent, child, or step-child

• Must be 18 years of age or older at the time of submission

Participation rules and federal funding restrictions

The small business formation commitment

By participating, each individual, group, or entity certifies that they have either already formed a U.S. owned and operated small business, or intend to form one by November 1, 2027, that meets the eligibility requirements to apply for NIH SBIR and STTR funding. You do not need an incorporated company at the time of submission, but you are committing to stand one up on that timeline.

Use of federal funds

• Participants may not use federal grant or cooperative agreement funds to develop a submission or to fund efforts supporting a submission unless that use is consistent with the purpose, terms, and conditions of the award

• Participants intending to use federal grant or cooperative agreement funds must register and participate as an Entity on behalf of the awardee institution or organization, not as an individual

• If federal grant or cooperative agreement funds are used and the participant wins, the prize must be treated as program income under the original award in accordance with 2 CFR 200

• Federal contractors may not use federal contract funds to develop a submission or fund supporting efforts

• Using federal facilities or consulting federal employees does not make a participant ineligible, provided those facilities and employees are available to all participants on an equitable basis

Risk, insurance, and compliance

• Participants assume all risks and waive claims against the federal government and related entities, except in cases of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits arising from participation

• No liability insurance, demonstration of financial responsibility, or indemnification agreement is required to participate in this Challenge

• Participants must follow all applicable federal, state, and local laws, regulations, and policies

• Participation constitutes full and unconditional agreement to abide by the Challenge rules, and winning is contingent on fulfilling all requirements

• Finalists and winners must complete and submit all requested winner verification and payment documents within 3 business days of formal notification. Missing that window can disqualify an otherwise winning submission

How to enter the 2027 NIA Start-Up Challenge

The registration and submission link opens December 1, 2026 on the official NIH Challenges page for this competition. Plan to register and submit by 11:59 p.m. ET on January 15, 2027.

Confidentiality warning

Do not include any confidential or proprietary information in your submission materials. By submitting, you agree to allow NIA to publish all or parts of your submission materials on nia.nih.gov. This has real consequences for intellectual property strategy. File provisionals before you describe protectable subject matter, and write the submission to be publishable.

For teams

Each team must identify a Team Lead who registers and submits on behalf of the team. The Team Lead manages all communication with Challenge sponsors and, if a cash prize is won, receives the full amount of the prize. The Team Lead must be a U.S. citizen or permanent resident to be eligible to receive a cash prize. If a dispute over the Team Lead's identity cannot be resolved to NIH's satisfaction, the submission is considered ineligible. Teams should settle internal allocation of prize funds in writing before submitting.

For entities

Each entity must identify a Point of Contact who registers and submits on its behalf and handles all communications. If a prize is won, payment goes to the entity, not to the Point of Contact. The entity must be incorporated in and maintain a primary place of business in the United States. Submitters intending to use federal grant or cooperative agreement funds must participate as an Entity on behalf of the awardee institution or organization.

Submission requirements

• Multiple submissions are allowed, but only one submission from each individual, team, or entity will be selected for participation as a finalist

• Late submissions will not be accepted

How submissions are scored

The four step review process

• Eligibility and programmatic review. NIA program staff review every submission for eligibility and programmatic relevance, conduct a preliminary evaluation, and assign an initial score. Only submissions with a competitive preliminary score advance

• Technical review. Submissions are individually evaluated and scored by reviewers with expertise in aging research, life science entrepreneurship and investment, business development, and product development, drawn from federal government, academia, industry, and other sectors

• Final evaluation by federal judges. A panel of federal employees reviews the submissions and technical evaluations, assigns a final score, and recommends top-performing teams for a screening call with NIA Challenge staff

• Screening and finalist selection. After screening calls, NIA Challenge staff recommend up to 21 finalists for approval by the Award Approving Official

Stage 1 evaluation criteria, 100 points total

• Significance, 0 to 15 points. How strong is the product's potential to address a significant unmet need in the older adult population, and to what extent does the scientific premise support the merits of the idea

• Innovation, 0 to 15 points. How novel is the idea, and what is the potential competitive advantage or the potential to refine the product to improve that advantage

• Commercialization, 0 to 10 points. How effectively is commercial potential explained, is there a clearly defined market, and does the business strategy have high potential for success

• Submitter or team, 0 to 10 points. Level of demonstrated commitment and collaboration, and relevant expertise each person brings

• Challenge Impact on the Submitter, 0 to 25 points. Does the submitter describe a scientific, technical, professional, or personal background, such as lack of access to resources and networks, that demonstrates a need for the training and resources the Challenge provides, and how they will significantly benefit at their stage of product development

• Challenge Impact on NIA Research and Development, 0 to 25 points. To what extent will participation enhance the impact and reach of NIA-funded small business research and development

The portfolio impact criterion, and how to earn it

For the 25 point Challenge Impact on NIA Research and Development criterion, submissions are evaluated on their potential to achieve at least two of the following:

• The submission addresses an underfunded area relevant to NIA small business research priorities. Active NIA SBIR and STTR awards can be reviewed in NIH RePORTER

• The product addresses a unique challenge or unmet need for older adults

• The individual or team brings relevant background, experience, or perspectives that would broaden and strengthen aging-related research and development

On that third point, NIA states that the race, ethnicity, or sex of the submitter may not be considered as part of any evaluation criteria. Permissible considerations named in the announcement include experience as a caregiver for older adults, including individuals with Alzheimer's disease or AD-related dementias; training or research experience that offers a complementary or innovative perspective; and lived experiences involving challenges or barriers that inform a unique approach to aging-related research and innovation.

Stage 2 requirements for finalists

To compete for the $70,000 Stage 2 prize, finalists must meet all of the following by the established deadlines:

• Form a company eligible to apply for an NIH SBIR or STTR grant, and meet with an NIH program officer to discuss the aims and objectives of a potential proposal, by November 1, 2027

• Successfully complete a comprehensive entrepreneurship training program and demonstrate proficiency in presenting the business concept to a wide public audience, including prospective partners and investors. Finalists are strongly encouraged to attend the in-person bootcamp and conference, but may propose an alternative comparable program with prior approval

• Submit a one-page document outlining the potential prize impact on advancing the business and innovation and on furthering the NIA mission

• Submit a 7-minute pitch video addressing the product's potential and the strength of the team

Stage 2 evaluation criteria, 100 points total

The Stage 2 panel is composed of NIA program staff, and it evaluates the one-page document, the 7 minute pitch, and a mentor assessment that offers an expert view on the anticipated impact of the prize based on the mentor's technical expertise and experience advising the finalist.

Mentor assessment and one-page document, 45 points:

• Prize Impact on Innovation Advancement, 0 to 30 points. Is there a clear, strong plan for how prize funds will play a critical role in accelerating development, through means including expanding the team, collecting pilot data, securing customers, and raising funds

• Prize Impact on NIA Research and Development, 0 to 15 points. Do the materials describe in detail at least one of the portfolio impact factors listed above

7-minute pitch video, 55 points:

• Significance, 0 to 15 points

• Innovation, 0 to 15 points

• Commercialization, 0 to 10 points, including strength of value proposition and clarity of the defined market

• Submitter or team, 0 to 10 points, including whether significant expertise gaps exist and how strong the plan is to fill them

• Pitch Delivery, 0 to 5 points, covering clarity of verbal delivery and visual slides

How to build a competitive submission

The scoring rubric rewards a specific kind of narrative. Based on how the criteria are weighted, the highest-leverage moves are:

• Lead with the unmet need in the older adult population, not the technology. Significance is scored on the need first and the scientific premise second

• Do the NIH RePORTER homework and cite it. Two separate criteria, one in each stage, reward showing that your approach sits in an underfunded area of the NIA SBIR and STTR portfolio. Very few applicants actually run this analysis

• Make the need for the Challenge explicit and specific. Twenty five points hinge on it. Name the gaps: no commercialization experience, no investor network, no regulatory or reimbursement expertise, no capital for pilot data. Vagueness is expensive here

• Tie AI claims to one of NIA's four named AI functions. Early detection, risk prediction, personalized interventions, or rapid drug discovery and development

• Address accessibility and population reach directly. Show that the solution works across the biological, social, behavioral, economic, environmental, and regional variation in the aging population

• Answer the differentiation question twice. Once against commercialized products, once against the existing NIA SBIR and STTR portfolio

• Write for publication. Since NIA may publish submission materials and confidential information is prohibited, sequence your IP filings before you submit

• Plan the operational load. Name who on the team will carry 6 to 8 hours per week from June through November 2027, and budget for travel to two three-day in-person events

How this fits a broader non-dilutive funding strategy

The Start-Up Challenge is best understood as an on-ramp rather than a destination. The $24,000 Stage 1 prize is real money for pilot data and formation costs, but the durable value is the SBIR and STTR readiness the accelerator builds and the Stage 2 requirement that you form an eligible company and meet with an NIH program officer by November 1, 2027. That program officer conversation is a standard precursor to a competitive NIH SBIR or STTR submission.

Two important caveats. First, NIA is explicit that Challenge participation or selection as a winner has no impact on grant funding decisions by NIA or any other NIH component. All grant applications remain subject to competition, peer review, and all other application and award requirements. Second, grant application technical assistance is not exclusive to Challenge participants. NIH resources are available to any entrepreneur through the NIH SEED program.

For teams that are already SBIR-ready, or whose PI holds an active NIH SBIR or STTR award and is therefore ineligible, the better path is to go directly at the NIA SBIR and STTR omnibus solicitations rather than at this Challenge.

Frequently asked questions

Is the NIA Start-Up Challenge a grant?

No. It is a prize competition authorized under the America COMPETES Reauthorization Act of 2010, as amended (15 U.S.C. 3719). There is no budget justification, no indirect cost rate, and no cost accounting requirement attached to the prize. Prize funds may be subject to federal income taxes, unlike most grant funds.

How much money can a startup win?

A single team can win up to $94,000, consisting of a $24,000 Stage 1 finalist prize and a $70,000 Stage 2 winner prize. NIA will award up to $994,000 in total across up to 21 finalists and up to 7 winners.

Does NIA take equity in exchange for the prize?

No. The prize money is fully non-dilutive. There is no equity, warrant, revenue share, or repayment obligation.

Do I need to have a company formed before I apply?

No. You may apply as an individual, a team, or an entity. By participating you certify that you have already formed a U.S. owned and operated small business or intend to form one by November 1, 2027 that meets NIH SBIR and STTR eligibility requirements.

Can I apply if I already have an NIH SBIR or STTR award?

Not if you are the principal investigator on an NIH SBIR or STTR award that is active as of the submission period end date of January 15, 2027. That is a hard eligibility bar.

Can previous NIA Start-Up Challenge finalists reapply?

No. Anyone who was a finalist in a previous version of the NIA Start-Up Challenge is not eligible to win a prize in this cycle.

Can international founders and non-U.S. citizens participate?

Non-U.S. citizens and non-permanent residents can participate as members of a team that otherwise meets eligibility requirements, and their participation on a winning team may be recognized publicly. They are not eligible to win a monetary prize in whole or in part. Individual participants must be U.S. citizens or permanent residents, and participating entities must be incorporated in and maintain a primary place of business in the United States.

When does the submission window open and close?

The submission portal opens December 1, 2026 and closes at 11:59 p.m. ET on January 15, 2027. Late submissions will not be accepted. An informational webinar is scheduled for December 3, 2026 at 1:00 p.m. ET.

How many submissions can I make?

Multiple submissions are allowed, but only one submission from each individual, team, or entity will be selected for participation as a finalist.

How much time does the accelerator require?

Participants should expect to commit 6 to 8 hours per week for approximately five months, from June through November 2027. That includes weekly virtual education sessions, mentor meetings, and two three-day in-person events.

Are travel costs to the in-person events covered?

Registration costs for both in-person events are covered by the program, but travel-related costs are paid by the participant. Finalists may use a portion of the $24,000 Stage 1 prize to cover travel.

Do I have to attend the in-person events?

Finalists are strongly encouraged to attend the June 2027 entrepreneur bootcamp and the November 2027 health innovation and investment conference. Finalists may propose an alternative, comparable training program or conference for prior approval.

Can I use federal grant funds to prepare my submission?

Only if that use is consistent with the purpose, terms, and conditions of the grant or cooperative agreement. If you do, you must register and participate as an Entity on behalf of the awardee institution, and any prize won must be treated as program income under the original award in accordance with 2 CFR 200. Federal contractors may not use federal contract funds for this purpose.

Does winning improve my chances of receiving an NIH SBIR or STTR award?

No. NIA states that Challenge participation or selection as a winner has no impact on funding decisions by NIA or any other NIH component. All grant applications remain subject to competition, peer review, and standard award requirements. Grant application technical assistance is also available to any entrepreneur through NIH SEED, not only to Challenge participants.

Is the prize money taxable?

Prizes awarded under this Challenge may be subject to federal income taxes. HHS and NIH comply with IRS withholding and reporting requirements where applicable. Prizes are paid by electronic funds transfer, and participants are encouraged though not required to obtain a free Unique Entity ID through SAM.gov to expedite payment.

What happens if I am not selected as a finalist?

All submissions that reach the technical review step will receive a brief summary of reviewer feedback by May 2027. That feedback is useful input for a future SBIR or STTR application.

Can I include confidential or proprietary information in my submission?

No. Confidential and proprietary information must be excluded. By submitting, you agree to allow NIA to publish all or parts of your submission materials on nia.nih.gov, so intellectual property filings should be sequenced before submission.

Who receives the prize money for a team submission?

For teams, the Team Lead receives the full amount of the prize and must be a U.S. citizen or permanent resident. For entities, the prize is paid directly to the entity rather than to the Point of Contact. Teams should document internal allocation of any prize funds in writing before submitting.

Official resources and next steps

• Challenge page: nih.gov/challenges/2027-nia-start-challenge-accelerator

• NIA program page: nia.nih.gov/research/sbir/start-challenge

• Challenge team email: niastartupchallenge@nih.gov

• Portfolio research: NIH RePORTER, to identify active NIA SBIR and STTR awards and underfunded areas

• Entity registration: sam.gov, to obtain a free Unique Entity ID

If you are weighing this Challenge against a direct NIA SBIR or STTR submission, or you want help building the portfolio gap analysis and need narrative that the scoring rubric rewards most heavily, reach out to our team. We help deep-tech, biotech, and medtech founders win non-dilutive federal funding, and we can tell you quickly whether this Challenge is the right entry point for your company or a detour.

FY2026 Reconstructive Transplant Research Program (RTRP): What Startups Need to Know

Executive Summary

The FY2026 Reconstructive Transplant Research Program (RTRP) is a Congressionally Directed Medical Research Programs (CDMRP) funding opportunity that supports research to advance the science and clinical practice of vascularized composite allotransplantation (VCA). The FY2026 appropriation is $12 million, and the program is soliciting applications through two separate award mechanisms: the Concept Award (up to $200,000 over 18 months) and the Investigator-Initiated Research Award (up to $1 million over 3 years). A Letter of Intent is required for both, due October 21, 2026, with full applications due November 4, 2026.

This is non-dilutive federal grant funding. Awards are made as grants under 31 USC 6304, so there is no equity, no repayment, and no cost sharing requirement. For-profit companies, including early-stage startups, are explicitly eligible.

What Is the Reconstructive Transplant Research Program?

Congress initiated the RTRP in 2012 to support research of high potential impact and exceptional scientific merit that refines approaches for, and increases access to, reconstructive transplants and state-of-the-art immunotherapy. Appropriations from FY2012 through FY2024 totaled $153 million. The FY2026 appropriation is $12 million.

VCA refers to the transplantation of multiple tissues such as muscle, bone, nerve, and skin as a functional unit, for example a hand or a face, from a deceased donor to a recipient with a severe injury. The program's stated goal is to return injured Service Members to duty and restore their quality of life, while also improving access, safety, and outcomes for Veterans and the American public.

Administratively, the program sits inside the CDMRP, which is located within Defense Health Agency Research and Development (DHA R&D), part of the Department of Defense. Both FY2026 announcements refer to DOD using the secondary title Department of War (DOW), so applicants will see "DOW" used throughout the solicitation documents. The Defense Health Agency Contracting Activity (DHACA) is soliciting applications under the delegated authority of 10 USC 4001. The Assistance Listing Number is 12.420.

The Two FY2026 RTRP Award Mechanisms

Both mechanisms share the same focus areas, the same deadlines, and the same submission process. They differ in eligibility, budget, duration, page limits, and, most importantly, whether preliminary data is allowed.

Concept Award (HT942526RTRPCA)

• Maximum funding: $200,000 in total costs for the entire period of performance, including direct and indirect costs

• Maximum period of performance: 18 months

• Expected awards: CDMRP expects to allot roughly $0.6 million to fund approximately 3 awards

• Eligible PI: Investigators at or above the level of postdoctoral fellow

• Preliminary data: Not allowed. Applications must instead demonstrate the ability to achieve interpretable results and provide a clear rationale

• Project Narrative: 2-page limit

• Clinical trials: Not allowed

• Announcement type: Modified. Version code CD26_01d

• Historical competitiveness: First offered in FY2015. Since then the program has received 196 Concept Award applications and recommended 26 for funding, a success rate of roughly 13 percent

The Concept Award exists to fund highly innovative new concepts or untested theories. It is designed for high-risk work that could reveal entirely new avenues of investigation, not the logical next step in an established research program. Innovation is the primary scored consideration, and research that represents an incremental advance on published data is explicitly not considered innovative.

Because the Concept Award is built for preliminary investigation, projects involving human subjects or human anatomical substances will not be supported unless they are exempt under 32 CFR 219.104(d) or eligible for expedited review under 32 CFR 219.110 or 21 CFR 56.110. Studies that do not qualify for exempt status or expedited review will be administratively withdrawn.

Investigator-Initiated Research Award (HT942526RTRPIIRA)

• Maximum funding: $1 million in total costs for the entire period of performance, including direct and indirect costs

• Maximum period of performance: 3 years

• Expected awards: CDMRP expects to allot roughly $8.0 million to fund approximately 8 awards

• Eligible PI: Independent investigators at all career levels

• Preliminary data: Required. Preliminary and/or published data relevant to reconstructive transplantation that support the rationale for the proposed work must be included

• Project Narrative: 10-page limit

• Clinical trials: Not allowed, although correlative studies associated with an existing clinical trial are permitted

• Announcement type: Initial. Version code CD26_01d

• Historical competitiveness: First offered in FY2016. Since then the program has received 253 applications and recommended 43 for funding, a success rate of roughly 17 percent

The Investigator-Initiated Research Award supports studies with the potential to make an important contribution to reconstructive transplant research, patient care, and quality of life. Applications may focus on any phase of research from basic through translational, including preclinical studies in animal models and clinical research in human subjects or human anatomical substances. Every project must demonstrate solid scientific rationale with military-relevant utility, a rigorous study design, and a statistical plan with appropriate power analysis.

FY2026 RTRP Deadlines and Timeline

Both award mechanisms follow the identical schedule. Note that the Concept Award deadlines were extended on August 11, 2026 so that both mechanisms share one receipt cycle.

• Pre-Application (Letter of Intent) deadline: October 21, 2026, 5:00 p.m. Eastern Time

• Full application deadline: November 4, 2026, 11:59 p.m. Eastern Time

• End of application verification period: November 9, 2026, 5:00 p.m. Eastern Time

• Peer review: January 2027

• Programmatic review: March 2027

• Funding recommendations posted to eBRAP: typically within 6 weeks after programmatic review

• Awards made: no later than September 30, 2027

• FY2026 funds expire for use: September 30, 2032

There are no grace periods. DHACA cannot make allowances or exceptions for submission problems encountered by the applicant, so registrations and portal access need to be resolved well ahead of October.

Who Is Eligible to Apply

Organizations: Extramural and intramural DOW organizations are eligible, including foreign and domestic organizations, for-profit and nonprofit organizations, and public or private entities. Awards are made to organizations, not to individuals.

Principal Investigators: Eligibility is set by mechanism. The Concept Award requires an investigator at or above the level of postdoctoral fellow. The Investigator-Initiated Research Award requires an independent investigator, and all career levels qualify. In both cases, eligibility applies regardless of ethnicity, nationality, or citizenship status, and PIs do not need to be affiliated with an academic organization.

Application limits: An investigator may be named as PI on no more than two Concept Award applications and no more than two Investigator-Initiated Research Award applications in FY2026. If more than two are received naming the same PI for a given mechanism, only the first two received will be accepted.

Cost sharing: Not required for either mechanism.

FY2026 RTRP Focus Areas: What the Program Is Looking For

Applications to either mechanism must address at least one focus area along with at least one of its accompanying sub-bullets. This is a compliance requirement, not a suggestion, and the focus areas are identical across both awards.

1. Improve or optimize VCA immunosuppression

• Define the unique targets and mechanisms of VCA immunogenicity and its regulation

• Develop novel tolerogenic agents or approaches for VCA immunosuppression

• Develop less toxic or personalized regimens for maintenance immunosuppression

2. Identify or validate biomarkers, methods, or tools for monitoring VCA graft rejection and immunosuppression

• Identify or validate reliable biomarkers for predicting and monitoring acute and chronic VCA rejection in the clinic, meaning in human clinical samples

• Develop assays, devices, or technology for clinical graft monitoring using biomarkers, with proposed devices accounting for human use factors unique to VCA recipients

• Identify or validate reliable approaches to measuring and monitoring in vivo or clinical immunosuppression levels

3. Advance VCA preservation strategies

• Develop promising static preservation strategies, active perfusion modalities, or other technologies for translation to the clinic

• Develop mitigation strategies for preservation-mediated injury, including immune activation or ischemia reperfusion injury

4. Develop tools for measuring VCA outcomes

• Performance or function-based measures

• Patient-reported measures

• Neurocognitive measures

Leveraging solid organ transplant findings

The RTRP explicitly allows applicants to bring novel findings from solid organ transplant research into a VCA setting, provided the rationale and benefits are justified. The solicitation offers three acceptable framings: explain why the anticipated result might be different in VCA, why it is important to confirm the result is the same in VCA, or why repeating the study in a VCA setting could produce new mechanistic insight into the unique aspects of VCA. If your company's platform was developed for kidney, liver, or heart transplant, this is the language to build your rationale around.

Funding Allowance and Budget Rules

Total cost caps include both direct and indirect costs. If your organization has a negotiated indirect cost rate, indirect costs must be budgeted in accordance with that rate. Collaborating organizations budget their own indirect costs at their own negotiated rates. All direct and indirect costs of any subaward or contract must be included in the direct costs of the primary award.

An applicant may request the full maximum funding amount even if the proposed period of performance is shorter than the maximum allowed. Budget appropriateness is assessed during peer review.

Travel that must be budgeted: Costs for the PI to present project information or disseminate results at one DOW-sponsored meeting, such as the Military Health System Research Symposium, during the period of performance. For planning purposes, assume the meeting will be held in the Central Florida area. For the Investigator-Initiated Research Award, assume this occurs in Year 2. This is in addition to allowable annual scientific meeting travel.

Travel that may be budgeted: Travel in support of multi-institutional collaborations, and costs for one investigator to attend one scientific or technical meeting per year in addition to the required DOW-sponsored meeting.

Costs that must not be requested: Travel beyond the limits above, and any clinical trial costs.

Separately, an organization may, at its own risk and without prior government approval, incur obligations and expenditures to cover costs up to 90 days before the start date of the initial budget period of a new award.

How to Submit: A Two-Step Process

Submission requires both a pre-application and a full application, and they go through different portals depending on your organization type.

Step 1: Pre-Application (Letter of Intent) through eBRAP

All pre-application components must be submitted by the PI through eBRAP. The Letter of Intent has a one-page limit and must provide a brief description of the research to be conducted along with the FY2026 RTRP Focus Area under which the application will be submitted.

eBRAP assigns each pre-application a unique log number. That log number is required for full application submission and must be entered in Block 4a, Federal Identifier, of the SF424 Research and Related form. The log number, application title, and all information for the PI, Business Officials, performing organization, and contracting organization must remain consistent across both submissions.

Two things worth understanding about the LOI: pre-applications are used for program planning purposes only, such as reviewer recruitment, and will not be screened. CDMRP will not issue an invitation to submit a full application. Applicants are encouraged to develop the pre-application and full application concurrently and submit the full application after the LOI has been successfully submitted. However, failure to submit the LOI results in automatic rejection of the full application.

Step 2: Full Application

• Extramural organizations, including startups and companies: must submit through Grants.gov Workspace

• Intramural DOW organizations only: may submit through eBRAP

An application from an extramural organization received through eBRAP may be administratively withdrawn, so the portal choice matters.

Step 3: Verify in eBRAP

Regardless of portal, the submitted application is transmitted to and processed in eBRAP, which can take up to 48 hours. The PI and organizational representatives then receive an email instructing them to log in, review, modify, and verify the submission. The Project Narrative and Research and Related Budget Form cannot be changed after the application deadline. Other components, including subaward budgets and justifications, may be changed until the verification period ends on November 9, 2026. Nothing can be modified after that.

Required registrations

Active SAM.gov, eBRAP.org, and Grants.gov registrations are required. Registration for each can take several weeks or longer. The applicant organization must be registered in SAM with an Active status and a Unique Entity Identifier before submitting through Grants.gov, and must maintain active SAM registration for as long as it has an active federal award or an application under consideration.

Application Components by Mechanism

Every attachment must be uploaded as an individual file using the exact filename specified, following the formatting guidelines in the General Application Instructions, version CD26_01.

Concept Award attachments

• Attachment 1: Project Narrative, 2-page limit, ProjectNarrative.pdf. Structured as Innovation, Hypothesis and Rationale, Aims and Objectives, Research Strategy, and Relevance

• Attachment 2: Supporting Documentation, Support.pdf. Includes References Cited, list of abbreviations, facilities and equipment, publications and patents, letters of support, Sex as a Biological Variable Strategy, Intellectual and Material Property Plan with optional Commercialization Strategy, and Research Sharing Plan

• Attachment 3: Statement of Work, 3-page limit, SOW.pdf

• Attachment 4: Innovation Statement, 1-page limit, Innovation.pdf

• Attachment 5: Post-Award Transition Plan, 1-page limit, Transition.pdf

• Attachment 6: Representations, Grants.gov submissions only, RequiredReps.pdf

• Attachment 7: Suggested Intragovernmental or Intramural Budget Form if applicable, IGBudget.pdf

Investigator-Initiated Research Award attachments

• Attachment 1: Project Narrative, 10-page limit, ProjectNarrative.pdf. Structured as Background, Rationale and Readiness, Hypothesis and Objective, Specific Aims, and Study Design and Feasibility

• Attachment 2: Supporting Documentation, Support.pdf. Same components as above, plus the Inclusion Enrollment Report if clinical research is proposed and, new for FY2026, a letter signed by the animal vendor or provider describing cost and timeline of availability for any proposed animal model

• Attachment 3: Technical Abstract, 1-page limit, TechAbs.pdf

• Attachment 4: Lay Abstract, 1-page limit, LayAbs.pdf

• Attachment 5: Statement of Work, 3-page limit, SOW.pdf

• Attachment 6: Impact Statement, 1-page limit, Impact.pdf

• Attachment 7: Military Relevance Statement, 1-page limit, MilRel.pdf

• Attachment 8: Animal Research Plan, 5-page limit, AnimalResPlan.pdf, required only for applications proposing animal studies

• Attachment 9: Post-Award Transition Plan, 1-page limit, Transition.pdf

• Attachment 10: Representations, Grants.gov submissions only, RequiredReps.pdf

• Attachment 11: Suggested Intragovernmental or Intramural Budget Form if applicable, IGBudget.pdf

Both mechanisms also require the Research and Related Senior/Key Person Profile with Biographical Sketches and Current and Pending Support, the Research and Related Budget, Project and Performance Site Locations, and subaward budget attachments where applicable.

How Applications Are Reviewed

All applications go through a two-tier review conducted by scientists, clinicians, and consumers. Peer review assesses technical merit against established criteria, with each application judged on its own merit. Programmatic review then compares high-merit applications for programmatic relevance. The highest-scoring applications from peer review are not automatically recommended for funding.

Concept Award review criteria, in decreasing order of importance

These criteria contribute to the overall evaluation but are not individually scored: Innovation, Relevance, Research Strategy and Feasibility, Personnel, Transition Plan, Research Sharing Plan, Budget, Environment, and Application Presentation.

Investigator-Initiated Research Award review criteria, in decreasing order of importance

Scored criteria: Study Design and Feasibility, Statistical Plan, Impact, Personnel, Transition Plan, and Research Sharing Plan. Unscored criteria that still contribute to the overall evaluation: Budget, Environment, and Application Presentation.

Programmatic review criteria for both mechanisms

• Ratings and evaluations of peer reviewers

• Adherence to the intent of the funding opportunity

• Program portfolio composition

• Programmatic relevance to military health and at least one FY2026 focus area

• Relative innovation for the Concept Award, or relative impact for the Investigator-Initiated Research Award

Compliance Traps That Sink Applications

CDMRP applies administrative actions mechanically. These are the failure modes to design around.

Automatic rejection: a missing Project Narrative, a missing Budget, or a Letter of Intent that was never submitted.

Automatic modification: pages exceeding stated limits are removed before review, and documents that were not requested are removed. Reviewers see what is left.

Possible administrative withdrawal:

• Including any URL outside the References Cited and Publications or Patents sections

• Proposing a clinical trial

• Submitting essentially the same research project to different funding opportunities within the same program and fiscal year

• Including classified research data, or proposing research that may produce classified outcomes or outcomes deemed sensitive to national security

• A PI who does not meet the eligibility criteria

• Involving a member of the FY2026 RTRP Programmatic Panel in concept design, application development, budget preparation, or supporting documentation. Panel members may only provide letters confirming PI eligibility and access to space, equipment, or resources as part of their regular institutional role

• Naming personnel from the CDMRP peer review or programmatic review contractors where conflicts cannot be mitigated

• Contacting persons involved in review or approval to obtain protected evaluation information or influence the process

• An extramural application received through eBRAP instead of Grants.gov

• Failing to conform to the program announcement description

• For the Concept Award only, human subjects or specimen work that does not qualify for exempt status or expedited review

Additional restrictions: Under Section 732 of the FY2026 National Defense Authorization Act, CDMRP does not support painful research in USDA pain category D or E involving domestic cats or dogs, except studies relating to military or service animals. Under National Security Presidential Memorandum-33, all applicant organizations must disclose foreign affiliations of every named key person. Failure to disclose leads to withdrawal of funding recommendations.

Post-Award Requirements

• Annual technical progress reports and quad charts, plus a final technical progress report and quad chart, prepared in accordance with the Research Performance Progress Report format

• A data management plan compliant with DoD Instruction 3200.12 will be requested if recommended for funding

• For the Concept Award, a Technical Abstract will be requested prior to award

• Annual In-Progress Review meetings held virtually, where award recipients may be invited to present progress to the Programmatic Panel

• For the Investigator-Initiated Research Award, an Award Expiration Transition Plan submitted with the final progress report, and PHS Inclusion Enrollment reporting if clinical research is proposed

• Research involving animals, human data, human specimens, human subjects, or human cadavers must be approved by the DHA R&D Office of Research and Regulatory Compliance in addition to local IACUC, IRB, or Ethics Committee review

• PI changes on a Concept Award are not allowed except under extenuating circumstances evaluated case by case. On the Investigator-Initiated Research Award, PI and organization changes are generally allowed case by case provided the intent of the mechanism is met

• Organizational transfer of an award is not allowed in the last year of the original period of performance or any extension

• New awards will not be issued to an organization with delinquent technical reporting on existing DHA or U.S. Army Medical Research and Development Command awards

Which Award Should a Startup Pursue?

Choose the Concept Award if your idea is novel but unproven, you have no preliminary data to show, and you need a small, fast award to generate the first interpretable results. At $200,000 over 18 months it functions as a de-risking step, and preliminary data is not merely unnecessary, it is prohibited. Innovation carries the most weight in review, so a genuinely new mechanism, target, or measurement approach matters more than a polished development plan. Early-career investigators are encouraged to apply.

Choose the Investigator-Initiated Research Award if you already have preliminary or published data supporting your rationale, your study design is mature enough to withstand scrutiny on controls, power analysis, blinding, and randomization, and you can articulate short-term and long-term impact. At $1 million over 3 years with roughly 8 awards expected, this is the mechanism that funds a real program of work. If you are developing a device, the application should explain how the design would support a regulatory filing with FDA or an international equivalent.

A note on pursuing both: the mechanisms have separate PI application limits, so a single investigator can be named on up to two applications in each. What is prohibited is submitting essentially the same research project to different funding opportunities within the same program and fiscal year. Two distinct projects, one high-risk and one data-backed, is a viable strategy. The same project dressed up twice will be withdrawn.

For both mechanisms, note that a Commercialization Strategy is an allowable component of the Intellectual and Material Property Plan, covering intellectual property, market size, financial analysis, strengths and weaknesses, barriers to market, competitors, and management team. Companies should use it. Multidisciplinary collaborations among academia, industry, DOW, and the Department of Veterans Affairs are highly encouraged, and collaboration with military researchers and clinicians is encouraged though not required.

Frequently Asked Questions

What are the FY2026 RTRP deadlines?

The Letter of Intent is due October 21, 2026 at 5:00 p.m. Eastern Time, and the full application is due November 4, 2026 at 11:59 p.m. Eastern Time. The application verification period in eBRAP ends November 9, 2026 at 5:00 p.m. Eastern Time. Both award mechanisms share these dates.

Is a Letter of Intent required?

Yes. A Letter of Intent is required for both the Concept Award and the Investigator-Initiated Research Award, and an application whose LOI was never submitted is administratively rejected. The LOI is limited to one page, is submitted by the PI through eBRAP, and must state the focus area being addressed. It is used for program planning only and is not screened, and no invitation to submit a full application will be issued.

Can a startup or for-profit company apply to the RTRP?

Yes. For-profit and nonprofit organizations, public and private entities, and foreign and domestic organizations are all eligible to apply to both FY2026 RTRP mechanisms. Awards are made to organizations rather than individuals, and the PI does not need to be affiliated with an academic institution.

How much funding can I request?

The Concept Award allows up to $200,000 in total costs over a maximum 18-month period of performance. The Investigator-Initiated Research Award allows up to $1 million in total costs over a maximum 3-year period of performance. Total costs include both direct and indirect costs, and all subaward direct and indirect costs must be carried in the direct costs of the primary award.

Do I need preliminary data?

It depends entirely on the mechanism. The Concept Award prohibits preliminary data, requiring instead a clear rationale and a demonstrated ability to achieve interpretable results. The Investigator-Initiated Research Award requires preliminary and/or published data that are relevant to reconstructive transplantation and support the rationale for the proposed work.

Are clinical trials allowed?

No. Neither FY2026 RTRP mechanism permits clinical trials, and proposing one may result in administrative withdrawal. Clinical trial costs must not be requested in the budget. The Investigator-Initiated Research Award does allow correlative studies associated with an existing clinical trial.

Is cost sharing required?

No. Cost sharing is not an eligibility requirement for either FY2026 RTRP award mechanism.

How many RTRP applications can one investigator submit?

An investigator may be named as PI on up to two Concept Award applications and up to two Investigator-Initiated Research Award applications in FY2026. If more than two are received for a given mechanism naming the same PI, only the first two received are accepted and the rest are administratively withdrawn. Submitting essentially the same project to more than one funding opportunity within the program in the same fiscal year is prohibited.

Can foreign organizations apply?

Yes. Foreign and domestic organizations are both eligible, and PI eligibility applies regardless of ethnicity, nationality, or citizenship status. All applicant organizations must disclose the foreign affiliations of every named key person under National Security Presidential Memorandum-33, and failure to disclose leads to withdrawal of any funding recommendation.

How competitive is the FY2026 RTRP?

CDMRP expects to fund approximately 3 Concept Awards from roughly $0.6 million and approximately 8 Investigator-Initiated Research Awards from roughly $8.0 million. Historically the Concept Award has received 196 applications and recommended 26 for funding, about 13 percent, while the Investigator-Initiated Research Award has received 253 applications and recommended 43 for funding, about 17 percent.

Where do I submit the LOI versus the full application?

The Letter of Intent is always submitted through eBRAP by the PI. Full applications from extramural organizations, including companies, must be submitted through Grants.gov Workspace. Only intramural DOW organizations may submit full applications through eBRAP, and an extramural application received through eBRAP may be administratively withdrawn.

Can I bring solid organ transplant research into an RTRP application?

Yes. The RTRP explicitly allows leveraging novel findings from solid organ transplant research for testing in a VCA setting, provided the rationale and benefits are explained and justified. Acceptable justifications include explaining why the result might differ in VCA, why confirming the same result in VCA matters, or why repeating the study in VCA could yield new mechanistic insight.

What happens if my application exceeds a page limit?

Pages exceeding the specified limits are removed before reviewers see any documents, and documents that were not requested are also removed. Including URLs anywhere other than the References Cited and Publications or Patents sections may result in administrative withdrawal.

When will FY2026 RTRP awards be made?

Peer review occurs in January 2027 and programmatic review in March 2027, with funding recommendations typically posted to eBRAP within 6 weeks after programmatic review. Awards supported with FY2026 funds will be made no later than September 30, 2027, and those funds expire for use on September 30, 2032.

What if my project involves animal studies?

Applications to the Investigator-Initiated Research Award proposing animal studies must include an Animal Research Plan of up to five pages addressing model justification, availability and access, procedures, controls, randomization and blinding, sample size with power calculations, and data handling. New for FY2026, the Supporting Documentation must also include a letter from the animal vendor or provider stating the cost and timeline for availability. CDMRP does not support painful research in USDA pain category D or E involving domestic cats or dogs, except for studies relating to military or service animals.

Next Steps

The FY2026 RTRP rewards applications that are technically strong and administratively flawless, and the compliance requirements alone remove a meaningful share of the competition before review begins. With the Letter of Intent due October 21, 2026 and the full application due November 4, 2026, the practical constraint is time: SAM.gov, eBRAP, and Grants.gov registrations can take weeks, and the Project Narrative and budget lock at the deadline.

BW&CO helps deep-tech, biotech, medtech, and dual-use companies pursue non-dilutive federal funding, with more than $350 million in funding secured for clients. Innovation Funding Simplified. If you are evaluating whether the Concept Award or the Investigator-Initiated Research Award fits your program, or you want a compliance review before you submit, reach out to start the conversation.

NIH Highlighted Topic: Health and Extreme Weather: Advancing Critical Research to Address the Direct and Indirect Health Impacts of Weather-Related Natural Disasters and Emerging Weather-Related Harms

Executive Summary

The National Institutes of Health has published a Highlighted Topic titled "Health and Extreme Weather: Advancing Critical Research to Address the Direct and Indirect Health Impacts of Weather-Related Natural Disasters and Emerging Weather-Related Harms." It is issued under the NIH Health and Extreme Weather Program, led by NIEHS, and eleven NIH Institutes award grants under it while four additional offices participate without awarding.

For a small business, the practical translation is this: there is no new application portal and no new deadline attached to this topic. A Highlighted Topic is a demand signal, not a Notice of Funding Opportunity. You capture the funding by submitting to the NIH SBIR or STTR parent announcement, requesting assignment to one of the eleven awarding Institutes, and aligning your Specific Aims to that Institute's stated interests.

Say the hard part first. This is the least small-business-native NIH Highlighted Topic in the current cycle. The great majority of what is described is epidemiology, cohort analysis, natural experiments, community-engaged research, and implementation science, all of which belong in R01 and related mechanisms rather than SBIR or STTR. A company that reads the topic broadly and writes a proposal to match will lose a cycle.

That said, there are real product lanes, and they are unusually concrete where they exist. NIAMS names wearable devices and environmental sensors for personal exposure assessment. NIDDK names the health effects of care discontinuity from lack of medications or electricity-dependent treatments. The topic purpose names methods to advance the aggregation, linking, accessibility, and interpretation of health and weather-related data. NHLBI names integration of environmental and health datasets, NIMH names measurement methods and data sharing methods, and NIAID names vector-borne and waterborne pathogen behavior including changes in susceptibility to anti-infective interventions. Those are sensors, diagnostics, medical device resilience, and data platforms, all of which a company can own and sell.

The topic was posted on September 1, 2026 and expires on May 1, 2028, which is a notably short window and makes April 5, 2028 the last available submission cycle. NIEHS is the only Institute that made both available funding statements, saying it may dedicate available funds and may give special consideration.

At a Glance

• Topic title: Health and Extreme Weather

• Program: NIH Health and Extreme Weather (HEW) Program, with a published HEW Strategic Framework available on the NIH site

• Issuing agency: National Institutes of Health, U.S. Department of Health and Human Services

• Awarding Institutes: NIEHS, NCCIH, NCI, NHLBI, NIA, NIAID, NIAMS, NIDDK, NIMH, NIMHD, and NINR

• Non-awarding participating offices: OBSSR, ODP, ORWH, and THRO

• Central scientific contact: Ashlinn Quinn, ashlinn.quinn@nih.gov, who is also the NIEHS contact

• Type: NIH Highlighted Topic. This is not a Notice of Funding Opportunity.

• Post date: September 1, 2026

• Expiration date: May 1, 2028. Shorter than the usual two-year window.

• Recommended small business mechanism: NIH SBIR (R43 and R44) or NIH STTR (R41 and R42) parent announcement

• Current parent announcements: PA-27-100 for SBIR, PA-27-102 for STTR, PA-27-101 for the Phase IIB Strategic Breakthrough Award, and PAR-27-098 for the Commercialization Readiness Pilot

• Standard annual due dates: January 5, April 5, and September 5

• SBA statutory guidelines this cycle: $323,090 Phase I, $2,153,927 Phase II, $4,191,495 CRP

• Institute limits vary widely and several published Institute pages still show older SBA figures. Use the current guideline for the dollar amount and treat Institute pages as authoritative for policy.

• Clinical trials: NIAMS accepts none under either parent. NIAID, NIDDK, and NIMHD do not accept them under STTR. NIDDK accepts them under SBIR. NCCIH restricts efficacy and effectiveness trials at Phase I. NIAID directs small business clinical trials to a separate cooperative agreement. Confirm before designing.

• Cost share: none for Phase I or Phase II. Phase IIB requires 100 percent third-party matching funds.

• Equity dilution: none. This is non-dilutive federal funding.

• Profit or fee: allowable, must be in the budget at submission, and normally will not exceed 7 percent of total costs

• Funding signals: NIEHS stated both that it may dedicate available funds and that it may give special consideration. NIMHD stated it may dedicate available funds. NCCIH, NIDDK, and NINR each stated they may give special consideration. NCI, NHLBI, NIA, NIAID, NIAMS, and NIMH made no statement.

• Initiative alignment: none stated. This topic is not issued under the Make America Healthy Again initiative, so there is no policy framing to reference.

What This Opportunity Actually Is

An NIH Highlighted Topic is a published statement of scientific interest from one or more NIH Institutes, Centers, and Offices. It tells the research community that an area of science is a priority without creating a separate funding announcement, deadline, or review process. There is no topic-specific number to search on Grants.gov, and applications are not scored against other applications to the topic.

This one is unusual in being tied to a standing NIH program rather than a one-off priority statement. The Health and Extreme Weather Program has its own Strategic Framework published on the NIH site, and NIEHS effectively runs it, supplying both the central scientific contact and its own Institute contact in the same person. That matters practically: reading the Strategic Framework before writing gives you the program's own language, and a single call to the central contact can help route you among eleven Institutes.

Six Institutes went on record with a funding advantage. NIEHS is the only one making both available statements, which is consistent with it being the lead. NIMHD stated it may dedicate available funds. NCCIH, NIDDK, and NINR each stated they may give special consideration. The remaining six made no statement.

Note also what is absent. Most NIH Highlighted Topics in this cycle are issued under the Make America Healthy Again initiative and list named policy alignments. This one does not, despite the obvious thematic overlap with chronic disease and environmental health. Do not reference an initiative alignment the topic does not claim.

Is This Topic a Fit for a Small Business?

For most companies, no. For a specific set, yes and clearly so. This section is the most useful part of the page, and it is worth being blunt.

Work in this topic that is not a small business fit. Assessing short and long-term health risks across the life course. Analysis of NIA-supported cohorts, which NIA strongly encourages. Natural experiments evaluating naturally occurring events, which NINR names. Epidemiological and mechanistic studies of disease development and progression. Community-engaged research where the company would be a subcontractor. Health disparities characterization. Training and capacity building across disciplines. Research translation and collaboration as ends in themselves. All of this is wanted by NIH and none of it is an SBIR project, because the deliverable is knowledge rather than a commercial product with unresolved technical risk that a company will own and sell.

Work in this topic that is a genuine small business fit.

• Wearables and environmental sensors for personal exposure assessment. NIAMS names this explicitly, asking for studies using personal exposure assessment methodologies including wearable devices and environmental sensors to provide stronger causal evidence linking extreme weather and other environmental exposures to disease outcomes. This is the single clearest product invitation in the topic and it comes with a stated scientific rationale you can quote.

• Exposure biomarkers. NIAMS asks for biomarkers of environmental exposures such as temperature extremes, air pollution, and wildfires that are associated with worsened disease status, naming flares in psoriasis, atopic dermatitis, and lupus. An assay or panel is a product.

• Care continuity and medical device resilience. NIDDK names observational studies and clinical trials addressing health effects of care discontinuity from lack of medications or electricity-dependent treatments. The topic body separately names patients using electricity-dependent equipment as a heightened-risk population, and NCI asks about effects on healthcare delivery among patients undergoing cancer treatment. Backup power, portable or off-grid therapy delivery, medication cold chain, and treatment-interruption management tools all sit here.

• Health and environmental data linkage platforms. The topic purpose names methods to advance aggregation, linking, accessibility, and interpretation of health and weather-related data. NHLBI names integration of environmental and health-related datasets. NIMH names data sharing methods supporting rigorous and reproducible findings. NCCIH names integrating health and environmental data. Five separate parts of this topic ask for the same category of software product, which is a strong signal.

• Measurement instruments and methods. NIMH asks for methods to accurately measure short and long-term mental illness attributable to extreme weather events. A validated instrument, screener, or digital assessment is a product with a customer.

• Digital and remote intervention delivery. NIMH names intervention development and testing to reduce weather-related mental health sequelae and evidence-based practices in real-world settings including communities and schools. NIA names interventions and educational resources for specific older adult populations including within care facilities. NCCIH names multicomponent whole-person interventions and scalable delivery.

• Infectious disease diagnostics and anti-infective susceptibility tools. NIAID names zoonotic, food, water, and vector-borne pathogens with respect to reproductive capacity, transmissibility, epidemiology, and virulence, including changes in susceptibility to anti-infective interventions. Detection, surveillance, and resistance testing are products.

• In vitro and in silico models. The topic purpose names in vivo, in vitro, and in silico models to understand mechanistic underpinnings. A company with a modeling platform, organ-on-chip system, or computational exposure model has a lane, and this overlaps directly with the NIH New Approach Methodologies push.

The pattern is worth naming: the fundable products here are instruments, assays, sensors, devices, and software. Where the topic asks for understanding, it is asking academics. Where it asks for measurement, detection, linkage, or delivery, it is describing something a company can build.

Which Institute Should You Target?

Eleven awarding Institutes makes the assignment request the highest-leverage decision on the application. Group by what you sell.

Sensors, wearables, and exposure assessment: NIAMS is the primary door and the only Institute naming wearables and environmental sensors outright. NIEHS is the natural second, given its interest in identifying, characterizing, and quantifying the influence of weather and natural disasters on environmental exposures and how weather-related exposures contribute to the exposome across the life course. NHLBI for cardiopulmonary and sleep outcomes.

Data platforms and analytics: NHLBI for integration of environmental and heart, lung, blood, and sleep datasets. NIMH for measurement methods and data sharing. NIEHS for computational studies. NCCIH for integrating health and environmental data. NIA for economic and systems research on healthcare preparedness and health services delivery.

Care continuity, devices, and treatment delivery: NIDDK is the clearest, naming care discontinuity from lack of medications or electricity-dependent treatments, plus acute kidney injury, chronic kidney disease, and kidney stones. NCI for effects on healthcare delivery and outcomes among patients undergoing cancer treatment and survivors. NIA for healthcare preparedness and interventions within care facilities.

Diagnostics and infectious disease: NIAID for airway disease, atopic dermatitis, food allergy, autoimmune and autoinflammatory disease under pollutant, heat, and humidity exposure, and separately for zoonotic, food, water, and vector-borne pathogens including anti-infective susceptibility.

Behavioral health and community intervention: NIMH for mental health measurement, intervention, and resilience. NCCIH for complementary and integrative health interventions targeting stress-related, multisystem, and chronic consequences. NINR for community and organization-level interventions. NIMHD for interventions in populations experiencing disparities, subject to its specific requirement below.

A requirement specific to NIMHD. NIMHD states that projects must focus on NIH-designated populations experiencing disparities and must include validated behavioral, clinical, or biomedical outcomes. That is written as a requirement rather than a preference. It also emphasizes academic-community partnerships and names outdoor workers and rural or coastal residents as example high-risk communities. If you cannot satisfy both the population focus and the validated outcome requirement, target a different Institute.

Quick reference: awarding Institutes, funding signals, and contacts

• NIEHS. Lead Institute. Environmental exposures associated with weather phenomena, exposome, epidemiology, mechanistic and computational studies, and interventions including implementation science. May dedicate available funds and may give special consideration, the only Institute making both statements. Contact: Ashlinn Quinn, ashlinn.quinn@nih.gov

• NCCIH. Complementary and integrative health interventions for stress-related, multisystem, and chronic consequences, whole-person interventions, community partnership, data integration. May give special consideration. Restricts efficacy and effectiveness trials at Phase I. Contact: NCCIHDERFunding@nih.gov

• NCI. Weather-related exposures and cancer etiology and outcomes, susceptibility of patients and survivors, and effects on healthcare delivery during treatment. No stated signal. Contact: Curt Dellavalle, Ph.D.

• NHLBI. Cumulative exposures and heart, lung, blood, and sleep health, naming sickle cell disease, anemias, asthma, COPD, heart failure, myocardial infarction, arrhythmias, and hypertension, with emphasis on children, older adults, and pregnant women. No stated signal. Contact: nhlbihighlightedtopics@mail.nih.gov

• NIA. Older individuals and caregivers, aging-related processes, pace of aging, functional and cognitive ability, preparedness behavior, healthcare preparedness economics, and interventions in care facilities. Analysis of NIA-supported cohorts strongly encouraged. No stated signal. Contact: Emerald Nguyen, Ph.D., and three additional program contacts

• NIAID. Airway and allergic disease, atopic dermatitis, food allergy, autoimmune and autoinflammatory disease, and zoonotic, food, water, and vector-borne pathogens. No stated signal. Directs small business clinical trials to a separate cooperative agreement. Contacts: Adriana Costero-Saint Denis for microbiology and infectious diseases, Patrice Becker for allergy, immunology, and transplantation

• NIAMS. Arthritis, musculoskeletal, and skin disease onset, severity, and treatment response, with explicit interest in wearable devices, environmental sensors, and exposure biomarkers. No stated signal. Accepts no clinical trials under either parent. Contact: Rebecca Lenzi, PhD

• NIDDK. Care discontinuity from lack of medications or electricity-dependent treatments, plus acute kidney injury, chronic kidney disease, and kidney stones. May give special consideration. Accepts clinical trials under SBIR but not STTR. Contact: Susan Mendley, M.D.

• NIMH. Mental health measurement, children and adolescents, intervention development, risk and resilience in at-risk populations, real-world evidence-based practices, and data sharing methods. No stated signal. Contact: Laura Thomas, Ph.D.

• NIMHD. Solution-oriented disparities research with a mandatory focus on NIH-designated populations experiencing disparities and validated outcomes. May dedicate available funds. Does not accept clinical trials under STTR. Contact: NIMHDDIBBSScientificTeam@mail.nih.gov

• NINR. Community and organization-level interventions, conditions of daily life such as housing stability and neighborhood environments, and natural experiments. Explicitly welcomes scientists from any discipline. May give special consideration. Contact: CDR Nadra Tyus, DrPH, MPH

Which NIH Mechanism Should a Small Business Use?

Small businesses should apply through the NIH SBIR or STTR parent announcement and request assignment to the Institute whose interests match. On this topic, resolve the clinical trial question before you choose either.

NIH Parent SBIR, currently PA-27-100 (R43 and R44). The default route. Accepts Phase I, Phase II, Direct to Phase II, and Fast-Track. Use it when your company performs the majority of the research and your Principal Investigator is primarily employed by the company.

NIH Parent STTR, currently PA-27-102 (R41 and R42). Requires a formal collaboration with a nonprofit research institution, with at least 40 percent of the research at the small business and at least 30 percent at a single partner institution. STTR permits the Program Director or Principal Investigator to be employed by either the small business or the partnering nonprofit while the award still goes to the small business, which is useful here because the exposure science, atmospheric science, and epidemiology expertise this topic calls for usually sits in universities. Note that companies more than 50 percent owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination are not eligible for STTR.

The clinical trial picture for this topic. This is where applications become non-responsive.

• NIAMS accepts no clinical trials under either parent announcement, despite asking for causal-evidence studies using wearables and sensors. Design around this or use a NIAMS-specific announcement.

• NIDDK names clinical trials twice in its published interests for this topic and accepts them under the parent SBIR announcement but not under STTR. A project with an academic PI and a trial component cannot use STTR here.

• NIMHD does not accept clinical trials under STTR.

• NCCIH operates a Phase-specific policy: it will not support clinical trials aiming to test efficacy or effectiveness as part of an SBIR or STTR Phase I application, meaning a study powered on a primary clinical outcome. It does accept basic experimental studies in humans, human mechanistic studies, and pilot feasibility testing at Phase I, and accepts clinical trials of all types at Phase II and Fast-Track. Given that NCCIH's entire interest here is rigorous intervention evaluation, this shapes how you stage the work.

• NIAID requires direct confirmation. NIAID is not on the exclusion list in the parent SBIR announcement, but NIAID's own small business program guidance states that it supports clinical trial research performed by small businesses only through a separate NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement, and that other Institutes may fund small business clinical trials through the parent announcements while NIAID does not. These two sources point in different directions, so anyone planning a trial with NIAID must confirm the current position with NIAID program staff rather than relying on the parent announcement alone.

A distinction worth stating. NIH small business phases are separate from and not aligned with clinical trial phases. An SBIR Phase I is a feasibility award, not a clinical Phase I trial. Run the NIH clinical trial determination against your actual design first, then pick the Institute, then pick the announcement.

Direct to Phase II. Available if you already hold the feasibility data a Phase I would generate and never received a Phase I award for that project. SBIR only. For a sensor or software company with a validated product in another exposure context, this is often the fastest route into this topic.

Fast-Track. Phase I and Phase II submitted together, reviewed once. Poor fit where Phase I results would change the Phase II design. Note that Fast-Track is also the point at which NCCIH accepts trials of all types.

Phase IIB Strategic Breakthrough Award, currently PA-27-101 (R44). For companies that completed an NIH SBIR or STTR Phase II and need a commercialization bridge. Requires documentation of not less than 100 percent matching funds from new private capital or from a government source other than a Phase I or Phase II SBIR or STTR award. Award periods must not exceed 4 years.

Commercialization Readiness Pilot, currently PAR-27-098 (SB1). Late-stage technical assistance and product development not fundable through Phase II or Phase IIB, including Investigational New Drug and Investigational Device Exemption enabling studies, independent replication of key studies, clinical studies, manufacturing costs, and regulatory assistance. Relevant here for a sensor, diagnostic, or device requiring regulatory clearance.

Funding Allowance

Layer one, the SBA statutory guidelines for the current cycle:

• Phase I: up to $323,090 in total costs, for a project period of 6 months to 2 years

• Phase II: up to $2,153,927 in total costs, for a project period of 1 to 3 years

• Commercialization Readiness Pilot: up to $4,191,495 in total costs, for a project period of up to 3 years

Total funding support means direct costs, indirect costs, and fee combined. A reasonable profit or fee is allowable but must be in the budget at submission and normally will not exceed 7 percent of total costs. NIH does not adjust budgets after submission, so a request at the wrong level cannot be corrected later.

A practical warning about published Institute figures. Several Institute small business pages, including NIDDK's and NIAID's, still display older SBA guideline amounts such as $314,363 for Phase I and $2,095,748 for Phase II, and some NIEHS-specific announcements reference figures older still. The SBA adjusts these annually. Use the current guideline for the dollar amount and treat Institute pages as authoritative for policy, waiver eligibility, and per-year constraints rather than for the headline number. When the two conflict, ask program staff.

Layer two, Institute-specific guidance for participants in this topic:

• Higher Phase I headroom. The participating component table in the parent SBIR announcement lists Phase I limits above the statutory guideline for several Institutes here, reaching $700,000 at the top tier, which includes NCI, NIA, NIAID, NIMH, and NCCIH. Others list $400,000 and some hold to the SBA guideline.

• NCI. Generally funds waiver-eligible Phase I up to $400,000 across up to 2 years and considers Phase II up to $2,250,000 across up to 3 years. NCI's separate Phase IIB Bridge Award, announced through its own solicitation, provides funding support up to $4,500,000 in total costs and accepts technologies previously funded under SBIR or STTR Phase II from any federal agency, which is a broader eligibility base than most bridge programs.

• NIAID. Applies a per-year constraint that reshapes budgets more than a total ceiling: NIAID will not generally allow Phase II or Phase IIB awards of any duration exceeding $1,000,000 in total costs per year. NIAID also notes that applicants are not limited to NIAID's own SBA-approved topic list, since all topics on the NIH list can be funded at a higher budget without a separate waiver request.

• NIDDK. Generally considers Phase I up to $350,000 across up to 2 years, Phase II up to $2,200,000 across up to 3 years, and Phase IIB up to $3,000,000, with Phase II and Phase IIB generally not exceeding $1,100,000 in any single year.

• NIEHS. Beyond the parent announcements, NIEHS runs targeted small business announcements that carry materially different terms, including some that accept Phase I applications only and some with substantially lower caps, such as its Superfund Research Program small business track. If NIEHS is your target, confirm which announcement you are applying under and what its budget language says before you build a budget, because the parent guideline may not apply.

• NCCIH, NHLBI, NIA, NIAMS, NIMH, NIMHD, NINR. Refer to the participating component table in the current parent announcement and confirm with program staff. These Institutes do not all maintain standing published SBIR budget pages, and NHLBI publishes its guidance through NOT-HL notices.

Two general cautions. A ceiling in a component table is not the number that gets awarded. BW&CO's analysis of a fiscal year 2026 NCI SBIR award slice found Phase I level awards ranging from roughly $305,000 to $404,000, with not one award in 44 records reaching the $700,000 headroom. And an Institute may reduce the recommended budget or shorten the award period for budgetary, administrative, or programmatic reasons even after a strong review score.

Timeline

The topic window runs from September 1, 2026 through May 1, 2028. That expiration is well short of the usual two years and sits between two standard due dates.

Standard annual due dates: January 5, April 5, and September 5. When a due date falls on a weekend or federal holiday, NIH moves it to the next business day. Applications are due by 5:00 p.m. local time of the applicant organization.

Cycles available under this topic:

• September 2026 cycle: the September 5, 2026 date shifted to Tuesday, September 8, 2026 because of the weekend and the Labor Day holiday. Since the topic posted on September 1, this cycle is not realistically available.

• January 5, 2027: the first realistic cycle for a company beginning preparation now.

• April 5, 2027

• September 5, 2027

• January 5, 2028

• April 5, 2028, the final cycle. The topic expires May 1, 2028, before the September 2028 date.

What the runway looks like: plan on roughly 9 months from submission to funds in the door. An application submitted in the January 2027 cycle typically reaches an earliest possible start date in the fall of 2027. Council decisions for the September and January cycles are often handled together, so deferring a cycle is not costless. With five cycles remaining and a May 2028 expiration, the effective planning horizon here is shorter than on most topics.

Work backwards from your target date:

• 16 to 18 weeks out: read the HEW Strategic Framework, identify your target Institute, run the NIH clinical trial determination, confirm the Institute's clinical trial policy for your chosen mechanism, contact program staff, and start or verify federal registrations

• 12 weeks out: lock the Specific Aims page and circulate to program staff

• 8 weeks out: complete the research strategy, commercialization plan, community or Tribal partnership documentation if applicable, data use agreements for any linked datasets, letters of support, and human subjects planning

• 4 weeks out: full internal review, budget finalization, and subaward paperwork for any STTR or academic partner

• 1 week out: submit early to leave room for eRA Commons error correction

Registrations are the most common cause of a missed deadline. You need SAM.gov with a Unique Entity ID, the SBA Company Registry, eRA Commons, and Grants.gov. eRA Commons access depends on the SBA Company Registry being complete first. Allow six weeks or more and begin before you write.

Also note the current SBIR parent, PA-27-100, closes in early April 2027, before this topic expires, so applicants targeting later cycles must confirm the active announcement number at submission.

Detailed Overview of What NIH Is Looking For

Program aims and scope

The HEW Program aims to support research increasing understanding of how extreme weather, including weather-related natural disasters and emerging weather-related harms, affects human health. Beyond mechanistic processes, the program prioritizes research to develop, test, implement, and evaluate interventions and prevention strategies protecting the health of communities and those at heightened risk for mortality, chronic disease, and lifelong health risks. It also prioritizes research connecting health and environmental data, training and capacity building, community engagement, research translation, and collaboration, and aims to promote collaborative science across biological sciences, atmospheric science, health economics, implementation science, and other disciplines.

The defined scope of extreme weather is broad and worth quoting in your Significance section because it is wider than most applicants assume. It covers extremes in temperature, precipitation, humidity, wind velocity, and other meteorological variables; wildfires, hurricanes, droughts, floods, heatwaves, harmful algal blooms, snowpack loss, and extreme storms; and weather's downstream influence on other environmental exposures and health-relevant outcomes.

That third element is the most useful for a company. A product that addresses a downstream exposure, air quality after wildfire smoke, waterborne pathogens after flooding, algal toxins, or heat-driven changes in medication stability, is in scope even if the product never measures weather directly.

The translational continuum

The topic states that projects may sit at different nodes on the translational continuum and names three application types: using in vivo, in vitro, and in silico models to understand mechanistic underpinnings; assessing short and long-term health risks across the life course and among populations at heightened risk; and developing, testing, implementing, and evaluating evidence-based interventions to prevent or reduce impacts.

It then adds two further categories: methods to advance the aggregation, linking, accessibility, and interpretation of health and weather-related data, and efforts to provide training and build capacity across disciplines. Community engagement, interdisciplinary collaboration, and research translation are encouraged throughout.

For a small business, the first and third of the named application types plus the data methods category are where products live. The second, risk assessment across populations, is epidemiology.

Priority populations, and why the list matters commercially

The topic names an unusually specific set of populations at heightened risk: children, people with chronic pre-existing medical conditions, pregnant women, newborns, agricultural and other outdoor workers, older adults, military personnel and veterans, first responders, patients using electricity-dependent equipment, residents of rural and urban areas, and those with limited economic resources.

Several of these are also identifiable customers or channels, which is unusual. Outdoor and agricultural workers imply an employer purchaser and an occupational health channel. First responders and military personnel imply institutional procurement and a possible bridge to Department of Defense funding. Patients using electricity-dependent equipment imply a payer, a durable medical equipment channel, and a device manufacturer partner. Care facilities, which NIA names directly, imply a facility purchaser. A commercialization plan that connects your named priority population to the entity that would actually pay is doing something most applications on this topic will not.

Institute reads worth acting on

NIAMS is the most product-friendly language in the topic. It asks for personal exposure assessment using wearable devices and environmental sensors specifically to provide stronger causal evidence, and adds that research advancing beyond associations and integrating cutting-edge exposure assessments, mechanistic insights, and longitudinal designs is encouraged. It names concrete disease endpoints, flares in psoriasis, atopic dermatitis, and lupus, which gives a sensor company a measurable clinical outcome to anchor to rather than a vague exposure metric. The constraint is that NIAMS accepts no clinical trials under either parent announcement, so the study design must stay observational, mechanistic, or technical.

NIDDK offers the clearest device and logistics problem. Care discontinuity from lack of medications or electricity-dependent treatments is a defined failure mode with identifiable products attached: backup power, off-grid or portable therapy delivery, cold chain integrity, and interruption management. NIDDK also names acute kidney injury, chronic kidney disease, and kidney stones, where heat and dehydration effects are well established. NIDDK stated it may give special consideration and accepts clinical trials under SBIR.

NIEHS is the lead and made the strongest funding statements, but its interests are the most academic. Exposome characterization, epidemiology, and mechanistic and computational studies dominate. The intervention bullet, studies focused on interventions to reduce health impacts of environmental exposures driven or exacerbated by weather including implementation science approaches, is the one to write against if NIEHS is your target. Also confirm which NIEHS announcement applies, since its targeted tracks carry different terms.

NIMH offers a measurement product opportunity that is easy to miss. Its first bullet asks for methods to accurately measure short and long-term mental illness attributable to extreme weather events. That is instrument development, not intervention research, and it is a distinct product category from the intervention bullets that follow. NIMH also names data sharing methods to support rigorous and reproducible findings.

NIAID splits into two very different lanes. The allergy and airway lane concerns immune responses under pollutant, heat, and humidity exposure across asthma, allergic rhinitis, chronic rhinosinusitis, respiratory viral susceptibility, atopic dermatitis, food allergy, and autoimmune or autoinflammatory disease. The infectious disease lane concerns zoonotic, food, water, and vector-borne pathogens, their reproductive capacity, transmissibility, epidemiology, and virulence, including changes in susceptibility to anti-infective interventions. That last clause is a resistance and susceptibility testing product. NIAID lists separate contacts for each lane, so call the right one.

NINR is the most discipline-open. It states that it supports research aligned with its mission conducted by scientists from any discipline, which is a lower barrier than most Institutes present, and it stated it may give special consideration. Its interest in conditions of daily life such as housing stability and neighborhood environments shaping resilience and recovery is largely academic, but community and organization-level intervention development and evaluation can support a delivery product.

What the non-awarding offices add

Four offices participate without awarding: OBSSR, ODP, ORWH, and THRO. Your application must be relevant to the objectives of at least one of the eleven awarding Institutes, and their interests function as additional strength.

ODP is the most directly useful to a product company, naming projects that develop, test, and implement preparedness, prevention, and recovery interventions, particularly for populations at heightened risk, and projects that evaluate strategies to prevent disruptions to screening and healthcare services following extreme weather events. That second bullet pairs precisely with the NIDDK care continuity and NCI healthcare delivery interests, and screening disruption is a defined operational problem.

ORWH gives priority to multidisciplinary studies using sex-disaggregated data, and names how extreme weather affects chronic conditions in women with risk varying by age, reproductive stage, and menopausal status; evaluation of disaster preparedness plans addressing women's mental health, chronic disease management, and reproductive health needs; resilience among women in rural and medically underserved communities; and effects of environmental displacement and changed living conditions. Sex-disaggregated analysis is a low-cost design decision that most applications will handle minimally.

THRO supports research on how extreme weather affects the health of American Indian and Alaska Native peoples, encouraging studies exploring Tribe and community-specific weather exposures, focusing on AI/AN people at heightened risk such as those who work outside or live in areas with severe weather, tapping existing resources and strengths, employing culturally grounded research approaches and health measures, and including AI/AN participants, practices, and ways of knowledge as much as possible. Claiming THRO alignment requires documented Tribal partnership, not an assertion of intent.

OBSSR participates without publishing specific interests for this topic.

Eligibility Requirements

To apply for an NIH SBIR or STTR award, your company must meet the core SBA criteria:

• Organized for profit, with a place of business located in the United States, and the primary research performed in the United States

• More than 50 percent directly owned and controlled by one or more individuals who are U.S. citizens or permanent resident aliens, by other for-profit small business concerns each majority owned by such individuals, or by a combination. Certain venture capital, hedge fund, and private equity structures may qualify for SBIR under specific conditions, but companies more than 50 percent owned by multiple such firms in combination are not eligible for STTR. Complex cap tables should be checked against 13 CFR Part 121.

• No more than 500 employees including all affiliates. A subsidiary counts its parent's employees.

• For SBIR, the Principal Investigator's primary employment must be with the small business at the time of award and for the duration of the project. For STTR, the PD/PI may be primarily employed by either the small business or the partnering nonprofit research institution, with the award still made to the small business.

• For SBIR Phase I, the small business must perform at least two thirds of the research or analytical effort. For SBIR Phase II, at least half. For STTR, the small business performs at least 40 percent and a single partner nonprofit research institution performs at least 30 percent.

Additional constraints. NIH will not accept similar applications with essentially the same research focus from the same applicant organization, including derivative applications proposing a single product applicable to multiple purposes with non-substantive modification, which is a live risk on a topic where one sensor or data platform could plausibly be pitched to five Institutes. You may not simultaneously submit identical or essentially identical applications under both parent announcements, and duplicate or highly overlapping applications under simultaneous review are not accepted. Applicants must disclose overlapping federal work under the essentially equivalent work rule. Companies with a substantial award history should confirm they meet the Phase I to Phase II Transition Rate and commercialization benchmarks. Heightened screening of foreign ownership and foreign influence applies under the 2026 reauthorization.

What a Competitive Application Looks Like

1. A product, stated plainly, in the first paragraph. Most applications to this topic will propose research. Reviewers assigned to a small business application are looking for a commercial product with unresolved technical risk. Make the product unmistakable early, because the surrounding topic language invites drift toward a study.

2. A named priority population that maps to a payer. The topic lists eleven heightened-risk populations, several of which come with an obvious purchaser: employers for outdoor workers, institutions for first responders and military personnel, durable medical equipment channels and payers for patients using electricity-dependent equipment, facilities for older adults in care settings. Connecting the population to the payer is a commercialization argument almost no competing application will make.

3. Causal evidence, not association. NIAMS asks for stronger causal evidence and for research advancing beyond associations. NIMHD requires validated behavioral, clinical, or biomedical outcomes. If your product generates exposure data, state what clinical outcome it is validated against and how.

4. Data linkage handled as engineering, not aspiration. Five parts of this topic ask for health and environmental data integration. Naming the specific datasets, the linkage method, the spatial and temporal resolution problem, and the data use agreements you will need reads as a technical plan rather than a wish.

5. The clinical trial determination resolved before the mechanism is chosen. Five participating Institutes carry restrictions and NIAID's position requires direct confirmation.

6. The HEW Strategic Framework read and reflected. The program publishes its own framework. Using its language is free and most applicants will not bother.

7. Program officer contact before writing. Eleven Institutes, six different funding signals, five clinical trial complications, and a central contact who can route you. This call is worth more here than on almost any topic.

Common Reasons Applications Miss

• Treating the Highlighted Topic as a NOFO and searching Grants.gov for a topic-specific number that does not exist

• Bringing an epidemiology, cohort analysis, or natural experiment project to a small business mechanism, where the deliverable is knowledge rather than a product the company will own and sell

• Proposing a clinical trial to NIAMS, which accepts none under either parent announcement

• Proposing a clinical trial to NIDDK or NIMHD through STTR, which neither accepts, when SBIR would have worked at NIDDK

• Proposing an efficacy or effectiveness trial to NCCIH at Phase I, which NCCIH does not support at that phase but does accept at Phase II and Fast-Track

• Planning a clinical trial with NIAID on the strength of the parent announcement alone, when NIAID's own guidance directs small business trials to a separate cooperative agreement

• Targeting NIMHD without a designated disparity population focus and validated behavioral, clinical, or biomedical outcomes, both of which NIMHD states as requirements

• Building a budget from an Institute page still displaying an older SBA guideline figure rather than the current amount

• Budgeting to the $700,000 Phase I ceiling rather than the roughly $400,000 that Institutes actually award, or concentrating Phase II costs in one year at NIAID, which will not generally allow more than $1,000,000 in total costs per year

• Applying to NIEHS under the parent guideline when a targeted NIEHS announcement with different terms and a lower cap actually governs

• Pitching one sensor or data platform to several Institutes at once, which runs into the prohibition on derivative applications proposing a single product applicable to multiple purposes

• Claiming THRO alignment without documented Tribal partnership, or community engagement without named partners and letters

• Referencing a Make America Healthy Again alignment that this topic, unlike most in the cycle, does not claim

• Starting federal registrations after drafting begins, then missing the receipt date on an eRA Commons validation error

Frequently Asked Questions

Is this a grant I can apply to directly?

No. This is an NIH Highlighted Topic, which is a statement of scientific priority rather than a Notice of Funding Opportunity. You apply through a broad NIH announcement, and for small businesses that means the NIH SBIR or STTR parent announcement, requesting assignment to one of the eleven awarding Institutes.

Which funding opportunity number do I actually use?

For most small businesses it is PA-27-100, the NIH, CDC, and FDA Parent SBIR announcement covering R43 and R44 awards. If your project depends on a formal university or nonprofit research partner, use PA-27-102, the Parent STTR announcement covering R41 and R42. If NIEHS is your target, confirm whether a targeted NIEHS announcement governs instead, since its terms and caps can differ.

Is this topic actually a fit for a small business?

For most companies, no. The majority of the described work is epidemiology, cohort analysis, natural experiments, community-engaged research, and implementation science, which belong in R01 and related mechanisms. Genuine small business lanes include wearables and environmental sensors for personal exposure assessment, exposure biomarkers, care continuity and medical device resilience for electricity-dependent treatments, health and environmental data linkage platforms, mental health measurement instruments, digital and remote intervention delivery, infectious disease diagnostics and anti-infective susceptibility testing, and in vitro or in silico models.

Which of the eleven Institutes should I target?

Sensors and exposure assessment point to NIAMS first, then NIEHS and NHLBI. Data platforms point to NHLBI, NIMH, NIEHS, NCCIH, or NIA. Care continuity and devices point to NIDDK, then NCI and NIA. Diagnostics and infectious disease point to NIAID. Behavioral health and community intervention point to NIMH, NCCIH, NINR, or NIMHD. NIEHS leads the program and is the only Institute that made both available funding statements.

How much money can my company request?

The SBA statutory guidelines this cycle are $323,090 for Phase I and $2,153,927 for Phase II in total costs, including direct costs, indirect costs, and fee. Several participating Institutes list Phase I headroom to $700,000. NCI generally funds waiver-eligible Phase I near $400,000 and Phase II up to $2,250,000, and its separate Phase IIB Bridge Award provides up to $4,500,000. NIDDK publishes $350,000 and $2,200,000. NIAID applies a per-year constraint of $1,000,000 in total costs on Phase II and Phase IIB. Note that several Institute pages still display older SBA figures, so confirm the current amount.

When is the deadline?

There is no deadline specific to this topic. You submit on the NIH standard small business receipt dates of January 5, April 5, and September 5 each year, with dates falling on weekends or federal holidays moving to the next business day. The topic expires May 1, 2028, which is earlier than the usual two-year window and makes April 5, 2028 the final available cycle.

Can I include a clinical trial?

It depends on the Institute and the mechanism, and this topic has more complications than most. NIAMS accepts none under either parent announcement. NIDDK and NIMHD do not accept them under STTR, though NIDDK does under SBIR. NCCIH will not support efficacy or effectiveness trials at Phase I but accepts trials of all types at Phase II and Fast-Track. NIAID's own guidance directs small business clinical trials to a separate cooperative agreement, so confirm directly with NIAID before planning one. Run the NIH clinical trial determination against your design first.

How long until I receive funding?

Plan on approximately 9 months from submission to award start. An application submitted in the January 2027 cycle would typically have an earliest possible start date in the fall of 2027.

Do I have to give up equity or match the funds?

No. NIH SBIR and STTR Phase I and Phase II awards are non-dilutive and require no cost share. The exception is the Phase IIB Strategic Breakthrough Award, which requires not less than 100 percent matching funds from new private capital or from a government source other than a Phase I or Phase II SBIR or STTR award.

What counts as extreme weather under this topic?

The defined scope is broad: extremes in temperature, precipitation, humidity, wind velocity, and other meteorological variables; wildfires, hurricanes, droughts, floods, heatwaves, harmful algal blooms, snowpack loss, and extreme storms; and weather's downstream influence on other environmental exposures and health-relevant outcomes. That third element means a product addressing a downstream exposure, such as post-wildfire air quality, post-flood waterborne pathogens, or algal toxins, is in scope even if it never measures weather directly.

Does my project have to involve a specific population?

Not universally, but the topic names eleven heightened-risk populations including children, people with chronic conditions, pregnant women, newborns, agricultural and other outdoor workers, older adults, military personnel and veterans, first responders, patients using electricity-dependent equipment, rural and urban residents, and those with limited economic resources. NIMHD, separately, requires a focus on NIH-designated populations experiencing disparities plus validated behavioral, clinical, or biomedical outcomes.

Does any Institute set aside dedicated funding for this topic?

Not guaranteed, but six made statements. NIEHS, the lead Institute, stated both that it may dedicate available funds and that it may give special consideration. NIMHD stated it may dedicate available funds. NCCIH, NIDDK, and NINR each stated they may give special consideration. NCI, NHLBI, NIA, NIAID, NIAMS, and NIMH made no statement. Treat these as a favorable tilt rather than a reserved pool.

I already have feasibility data. Do I still need a Phase I?

Not necessarily. SBIR Direct to Phase II allows a company that has demonstrated the scientific and technical merit and feasibility normally expected from a Phase I, without having received a Phase I award for that project, to apply directly for Phase II. This authority is available for SBIR only and is not available under STTR. A sensor or software product already validated in another exposure context is a common qualifying profile.

Does this topic align with the Make America Healthy Again initiative?

No. Unlike most NIH Highlighted Topics published in this cycle, this one lists no initiative alignment and no named policy efforts. It is instead tied to the NIH Health and Extreme Weather Program and its published Strategic Framework, which is what applicants should read and reference.

Do OBSSR, ODP, ORWH, and THRO award grants?

No. All four participate without awarding. Your application must be relevant to the objectives of at least one of the eleven awarding Institutes. ODP's interests are the most useful to a product company, particularly its focus on preventing disruptions to screening and healthcare services after extreme weather events.

What registrations do I need, and how long do they take?

SAM.gov with a Unique Entity ID, the SBA Company Registry, eRA Commons, and Grants.gov. eRA Commons access depends on completing the SBA Company Registry first, so the sequence matters. Allow at least six weeks, and start before you begin writing.

How BW&CO Helps

BW&CO is a non-dilutive federal funding advisory firm. We help deep-tech, biotech, medtech, and health technology founders convert agency priority signals like this one into funded awards.

On a topic this broad and this academically weighted, the first job is an honest fit assessment. If your project is research rather than product development, we will tell you so and point you at the right mechanism. If it is a sensor, diagnostic, device, or data platform, the work is Institute selection across eleven options with six different funding signals, resolving the clinical trial determination and the several Institute restrictions attached to it, confirming which NIEHS announcement governs, program officer engagement, Specific Aims development, full proposal build, budget and fee construction, commercialization planning that connects the priority population to an actual payer, and Phase IIB and CRP sequencing. Our team has helped clients secure more than $350 million in funding. Innovation Funding Simplified.

If you are building a product that measures, prevents, or manages the health effects of extreme weather and want a straight answer on whether this topic fits your company and whether you are competitive for the January 5, 2027 cycle, contact us for a fit assessment.

NIH Highlighted Topic: Next-generation Cellular Immunotherapy: Reprogramming Immune Cells Inside the Body

Executive Summary

The National Institutes of Health has published a Highlighted Topic titled "Next-generation Cellular Immunotherapy: Reprogramming Immune Cells Inside the Body." It signals that five NIH Institutes, NCI, NIAID, NIAMS, NIBIB, and NIDCR, want to fund basic research, preclinical development, and early clinical testing of in vivo immune cell engineering: approaches that reprogram T cells, natural killer cells, macrophages, and other immune cells inside the patient rather than extracting, modifying, and expanding them in a manufacturing facility.

The commercial thesis NIH lays out is unusually explicit. CAR-T therapies transformed treatment of hematologic malignancies, but current adoptive cellular therapies carry substantial practical barriers: lymphodepletion, leukapheresis, ex vivo cell modification and expansion, GMP manufacturing, specialized facilities, and weeks-long processing. NIH states that this complexity makes these therapies slow, costly, and inaccessible to many patients, and that in vivo engineering removes a major logistical bottleneck and offers true off-the-shelf cellular immunotherapy. That is a manufacturing and access argument as much as a scientific one, which makes this the most small-business-native Highlighted Topic NIH has published this cycle.

For a small business, the practical translation is this: there is no new application portal and no new deadline attached to this topic. A Highlighted Topic is a demand signal, not a Notice of Funding Opportunity. You capture the funding by submitting to the NIH SBIR or STTR parent announcement, requesting assignment to one of the five Institutes, and aligning your Specific Aims to that Institute's stated interests.

One structural fact should shape your plan before anything else. The topic explicitly invites early clinical testing, pilot clinical trials, and acceleration of clinical trials, yet only NCI among the five Institutes accepts clinical trial applications without restriction under the parent announcements. NIBIB accepts only early stage trials such as feasibility, first-in-human, and safety studies that inform early technology development. NIAID accepts clinical trials under SBIR but not under STTR. NIAMS and NIDCR accept no clinical trials under either parent announcement, despite NIAMS explicitly inviting clinical research. Matching your trial design to the wrong Institute or mechanism makes the application non-responsive and unreviewed regardless of scientific merit.

The topic was posted on September 2, 2026 and expires on September 2, 2028. If you build viral vectors, lipid nanoparticles or other synthetic nanocarriers, biodegradable nanomaterials, gene editing payloads, synthetic receptors or genetic circuits, biomaterials for immunotherapy, or microphysiological platforms for evaluating in vivo transduction, there is a well-signposted funding path here across multiple Institutes.

At a Glance

• Topic title: Next-generation Cellular Immunotherapy: Reprogramming Immune Cells Inside the Body

• Issuing agency: National Institutes of Health, U.S. Department of Health and Human Services

• Awarding Institutes: NCI, NIAID, NIAMS, NIBIB, and NIDCR

• Non-awarding participating office: the Office of Autoimmune Disease Research in the Office of Research on Women's Health (OADR-ORWH)

• Type: NIH Highlighted Topic. This is not a Notice of Funding Opportunity.

• Post date: September 2, 2026

• Expiration date: September 2, 2028

• Recommended small business mechanism: NIH SBIR (R43 and R44) or NIH STTR (R41 and R42) parent announcement

• Current parent announcements: PA-27-100 for SBIR, PA-27-102 for STTR, PA-27-101 for the Phase IIB Strategic Breakthrough Award, and PAR-27-098 for the Commercialization Readiness Pilot

• Standard annual due dates: January 5, April 5, and September 5

• SBA statutory guidelines this cycle: $323,090 Phase I, $2,153,927 Phase II, $4,191,495 CRP

• Institute headroom: NCI and NIAID are among the components listing Phase I limits above the statutory guideline, up to $700,000. Limits differ by Institute and must be confirmed.

• Clinical trials: NCI accepts them. NIBIB accepts only early stage, feasibility, first-in-human, safety, or other small trials informing early technology development, and will not support pivotal, efficacy, or effectiveness trials. NIAID accepts under SBIR but not STTR. NIAMS and NIDCR accept none under either parent.

• Cost share: none for Phase I or Phase II. Phase IIB requires 100 percent third-party matching funds.

• Equity dilution: none. This is non-dilutive federal funding.

• Profit or fee: allowable, must be in the budget at submission, and normally will not exceed 7 percent of total costs

• Funding signal: NIDCR is the only participating Institute that stated it may give special consideration to meritorious applications in this topic area.

• Initiative alignment: none stated. Unlike most Highlighted Topics published this cycle, this one is not issued under the Make America Healthy Again initiative, so there is no policy framing to reference.

• Central contact: none designated. Each Institute lists its own scientific contact.

What This Opportunity Actually Is

An NIH Highlighted Topic is a published statement of scientific interest from one or more NIH Institutes, Centers, and Offices. It tells the research community that an area of science is a priority without creating a separate funding announcement, deadline, or review process. There is no topic-specific number to search on Grants.gov, and applications are not scored against other applications to the topic.

What it does do is identify which Institutes are receptive, which determines your assignment request and your program officer conversations, and supply the vocabulary program staff already use internally, which your Specific Aims should mirror. On this topic only NIDCR went on record with a funding advantage, stating it may give special consideration to meritorious applications in the topic area. The other four Institutes made no such statement. That is a thinner set of stated signals than most topics carry, and it means Institute selection here rests on scientific and mechanism fit rather than on declared preference.

It is also worth noting what this topic lacks. Most NIH Highlighted Topics published in this cycle are issued under the Make America Healthy Again initiative and list named policy alignments that applicants can reference in a Significance section. This one does not. Do not manufacture an initiative alignment that the topic does not claim.

Why This Topic Is a Strong Small Business Fit

Most NIH Highlighted Topics require careful triage to separate the academically fundable work from the commercially fundable work. This one requires less of that, because nearly every area of interest across the five Institutes describes a product: a delivery vehicle, a payload, an editing tool, a receptor design, a biomaterial, or an evaluation platform.

NIH's own background section makes the commercialization case for you. It names lymphodepletion, leukapheresis, ex vivo modification and expansion, GMP manufacturing, specialized facilities, and weeks-long processing times as the barriers, and states that in vivo engineering offers true off-the-shelf cellular immunotherapy for rapidly progressing diseases where patients often cannot afford the wait. Cost of goods, manufacturing complexity, time to treatment, and site-of-care requirements are all named or implied. A commercialization plan that quantifies the delta between an ex vivo process and your in vivo approach is arguing exactly the case NIH already made.

The clearest product lanes across the five Institutes:

• Delivery vehicles. Viral vectors including lentiviral and adeno-associated viral vectors, engineered viruses, lipid nanoparticles, synthetic nanocarriers, biodegradable nanomaterials, and artificial cells. Named by NCI, NIBIB, and NIDCR.

• Targeting and specificity. Technologies increasing the specificity and efficiency of immune cell targeting and transduction in vivo, plus tissue, antigen, and cell specificity for enhancing protective immunity or eliminating and reprogramming pathogenic subsets. Named in the topic purpose and by NIAID.

• Payloads and editing tools. CARs, TCRs, costimulatory domains, other functional elements, mRNA and siRNA cargos, CRISPR/Cas9, base and prime editing, nucleases and genome editors, and epigenetic reprogramming. Named by NCI, NIBIB, and NIDCR.

• Synthetic biology and control. Synthetic receptors, transmembrane chimeric antigen receptors, and synthetic genetic circuits for engineering T cells, NK cells, and macrophages. Named by NIBIB. Control and reversibility of therapeutic activity is named by NIAID.

• Biomaterials. Biomaterials for enhancing immunotherapy, named by NIBIB.

• Evaluation platforms. Novel platforms to engineer immune cells in vivo using microphysiological systems to model and evaluate targeting, transduction efficiency, and therapeutic function. Named by NIBIB, and a distinct product category rather than a research method.

• Preclinical safety and biomarker work. Preclinical toxicity and safety studies, biodistribution improvement, and pilot clinical trials informed by biomarkers. Named by NCI and echoed in NIAID's safety priorities.

• Computational and AI tools. Advanced data science, artificial intelligence and machine learning, and computational modeling to elucidate mechanisms of action and optimize design and performance. Named by NIDCR, with a parallel interest from OADR-ORWH in computational interrogation of clinical trial data.

The ordinary SBIR test still applies. There must be a commercial product with unresolved technical risk that your company will own and sell. On this topic that test is easier to pass than usual.

Which Institute Should You Target?

With five awarding Institutes, the assignment request drives review assignment, budget ceiling, and whether your clinical design is even reviewable. Group yourself by disease area first, then check the clinical trial constraint.

NCI, for oncology. NCI encourages development of in vivo immune cell engineering methods for testing in preclinical models and early clinical trials in both hematologic and solid tumors. Its named topics span viral vector delivery of DNA carrying tumor-specific CARs, TCRs, and costimulatory domains; nonviral delivery using LNPs or other synthetic nanocarriers for mRNA, siRNA, and other cargos; novel delivery vehicles including biodegradable nanomaterials; novel gene editing methods such as CRISPR/Cas9 and base or prime editing delivered with nanovehicles for genetic or epigenetic reprogramming; preclinical toxicity and safety studies and pilot clinical trials informed by biomarkers; and combination use with immune checkpoint blockade or agents modulating the tumor microenvironment. NCI is also the only one of the five that accepts clinical trials without restriction, which makes it the default target for any project with a clinical component.

NIAID, for infectious, autoimmune, and immune-mediated disease. NIAID encourages basic, translational, and early clinical research on engineered cellular therapies, including targeted modulation of protective or pathogenic immune responses that induce durable disease control while preserving protective immunity. Its three named strategies are improving tissue, antigen, and cell specificity for enhancing protective immunity or eliminating and reprogramming pathogenic immune subsets including autoreactive innate and adaptive cells; improving scalability, cost reduction, and expansion of access to off-the-shelf or in vivo approaches that minimize preconditioning; and improving safety, covering mitigation of off-target effects, unintended tissue injury, prolonged immune dysregulation, oncogenic risk, and improved control and reversibility of therapeutic activity. NIAID accepts clinical trials under SBIR but not under STTR.

Note how commercial NIAID's second bullet is. Scalability, cost reduction, and access are business metrics, and minimizing preconditioning is a direct attack on the lymphodepletion barrier. If your platform's advantage is that it removes preconditioning or lowers cost of goods, NIAID has invited that argument in its own words.

NIBIB, for platform and enabling technology. NIBIB is interested in technologies to engineer immune cells in vivo across a range of diseases, listing new types of engineered viruses and artificial cells for genetic material delivery; novel delivery methods using LNPs, nanocarriers, biodegradable nanomaterials, or other vehicles; novel gene editing methods, synthetic receptors, and transmembrane chimeric antigen receptors; nucleases and genome editors for DNA manipulation and regulation; synthetic genetic circuits for engineering T cells, NK cells, and macrophages for immune regulation and cancer therapy; biomaterials for enhancing immunotherapy; and development of novel platforms using microphysiological systems to model and evaluate targeting, transduction efficiency, and therapeutic function.

NIBIB is the right door for a company whose product is the enabling technology rather than a therapy for a named indication, since its framing is deliberately disease-agnostic. NIBIB's clinical trial policy is narrower than NCI's but well matched to this topic: it supports feasibility, first-in-human, safety, and other small trials that inform early stage technology development, and will not support pivotal trials, later-phase trials, or trials whose primary outcome is efficacy, effectiveness, or a post-market concern. Mechanistic trials are supported only where the primary focus of the project is technology development.

NIAMS, for rheumatic, autoimmune, autoinflammatory, and musculoskeletal disease. NIAMS encourages basic, translational, and clinical research advancing in vivo immune cell engineering-based cell therapy for rheumatic, autoimmune, autoinflammatory, and musculoskeletal and bone diseases and conditions. That is the entirety of its published language, which is notably brief relative to the other four. Critically, NIAMS accepts no clinical trials under either parent announcement, so its invitation to clinical research must be satisfied through work that does not meet the NIH clinical trial definition, or through a NIAMS-specific announcement designed for trials.

NIDCR, for dental, oral, and craniofacial disease. NIDCR seeks research and technology advancement for dental, oral, and craniofacial diseases and conditions, listing novel viral vector-based delivery platforms and nonviral approaches using LNPs and other synthetic nanocarriers for efficient targeted delivery of nucleic acids or protein cargos; innovative gene editing including CRISPR/Cas9 and base or prime editing for precise and durable genetic and epigenetic modification of immune cells in vivo; combination strategies integrating immune engineering with immune checkpoint blockade, autoantigen and antibody-based therapies, and cytokine and chemokine-mediated modulation; and advanced data science, AI and machine learning, and computational modeling to elucidate mechanisms of action and optimize design and performance. NIDCR is the only Institute here offering a stated funding advantage, and the only one naming protein cargo delivery alongside nucleic acids. It accepts no clinical trials under either parent.

Quick reference: awarding Institutes, clinical trial posture, and contacts

• NCI. Hematologic and solid tumors, delivery, editing, preclinical safety, combination therapy. Accepts clinical trials. No stated funding signal. Contact: Zhang-Zhi Hu, M.D., zhang-zhi.hu@nih.gov

• NIAID. Infectious, autoimmune, and immune-mediated disease, with emphasis on specificity, scalability and access, and safety. Accepts clinical trials under SBIR only, not STTR. No stated funding signal. Contact: Jeffrey Rice, Ph.D., Jeffrey.Rice@nih.gov

• NIAMS. Rheumatic, autoimmune, autoinflammatory, musculoskeletal and bone disease. Accepts no clinical trials under either parent. No stated funding signal. Brief published language, so a program officer call matters more here. Contact: Marie Mancini, Ph.D., Marie.Mancini@nih.gov

• NIBIB. Disease-agnostic enabling technology, synthetic biology, biomaterials, microphysiological evaluation platforms. Accepts early stage, feasibility, first-in-human, safety, and other small trials informing technology development only. No stated funding signal. Contact: Tuba Fehr, PhD, tuba.fehr@nih.gov

• NIDCR. Dental, oral, and craniofacial disease, delivery, editing, combination strategies, AI and computational modeling. Accepts no clinical trials under either parent. May give special consideration to meritorious applications. Contact: Zhong Chen, MD, PhD, nidcr-program@mail.nih.gov

Which NIH Mechanism Should a Small Business Use?

Small businesses should apply through the NIH SBIR or STTR parent announcement and request assignment to the Institute whose interests match. On this topic the mechanism choice interacts with the clinical trial question more than usual, so decide both together.

NIH Parent SBIR, currently PA-27-100 (R43 and R44). The default route. Accepts Phase I, Phase II, Direct to Phase II, and Fast-Track. Use it when your company performs the majority of the research and your Principal Investigator is primarily employed by the company. Under PA-27-100, NIAMS and NIDCR do not accept clinical trials, and an application proposing a clinical trial that aligns only with one of those missions is non-responsive and will not be reviewed.

NIH Parent STTR, currently PA-27-102 (R41 and R42). Requires a formal collaboration with a nonprofit research institution, with at least 40 percent of the research at the small business and at least 30 percent at a single partner institution. STTR permits the Program Director or Principal Investigator to be employed by either the small business or the partnering nonprofit while the award still goes to the small business, which matters in this field because much of the foundational vector, editing, and receptor work sits in academic labs and the inventor often holds a faculty appointment. Under PA-27-102, NIAID, NIAMS, and NIDCR do not accept clinical trials, so a project with an academic PI and a clinical component cannot use STTR at NIAID even though SBIR would work.

A distinction worth stating plainly. NIH small business phases are separate from and not aligned with clinical trial phases. An SBIR Phase I is a feasibility award, and it is not the same thing as a clinical Phase I trial. NIBIB's policy supports clinical Phase I and first-in-human studies, which can be proposed within an SBIR Phase II or Fast-Track application. Confusing the two numbering systems is a common and expensive error on topics like this one that invite early clinical work.

Direct to Phase II. Available if you already hold the feasibility data a Phase I would generate and never received a Phase I award for that project. SBIR only, not available under STTR. For a company with a validated delivery platform in one context and new in vivo transduction data in an immune cell context, this is often the fastest route.

Fast-Track. Phase I and Phase II submitted together and reviewed once. Poor fit when Phase I results would change the Phase II design, which is frequently the case here because the choice of vector, payload, or dosing regimen often depends on what the first biodistribution and specificity data show.

Phase IIB Strategic Breakthrough Award, currently PA-27-101 (R44). For companies that completed an NIH SBIR or STTR Phase II and need a commercialization bridge. Requires documentation of not less than 100 percent matching funds from new private capital or from a government source other than a Phase I or Phase II SBIR or STTR award. Award periods must not exceed 4 years. Given the capital intensity of gene-modified cell therapy development, a Phase IIB matching plan should be sketched early rather than discovered later. Note that not all Institutes accept clinical trials through Phase IIB.

Commercialization Readiness Pilot, currently PAR-27-098 (SB1). This mechanism deserves particular attention on this topic. CRP supports later-stage work not typically fundable through Phase II or Phase IIB, and NIH names Investigational New Drug and Investigational Device Exemption enabling studies, independent replication of key studies, clinical studies, manufacturing costs, and regulatory assistance among eligible activities. For an in vivo immune cell engineering program, IND-enabling toxicology and manufacturing are precisely the expensive steps that fall between a successful Phase II and a first-in-human study. CRP permits substantial subcontracting, though the small business must maintain oversight and management of the research throughout.

Funding Allowance

The ceiling depends on two layers.

Layer one, the SBA statutory guidelines for the current cycle:

• Phase I: up to $323,090 in total costs, for a project period of 6 months to 2 years

• Phase II: up to $2,153,927 in total costs, for a project period of 1 to 3 years

• Commercialization Readiness Pilot: up to $4,191,495 in total costs, for a project period of up to 3 years

Total funding support means direct costs, indirect costs, and fee combined. A reasonable profit or fee is allowable but must be in the budget at submission and normally will not exceed 7 percent of total costs. NIH does not adjust budgets after submission, so a request at the wrong level cannot be corrected later.

Layer two, Institute-specific guidance. NIH holds SBA waivers permitting awards above the guideline for approved topics, and each Institute publishes its own limits.

• NCI. Among the components listing Phase I headroom above the statutory guideline, reaching $700,000 in the parent announcement's participating component table. NCI's own published guidance generally funds waiver-eligible Phase I applications up to $400,000 across up to 2 years and considers Phase II up to $2,250,000 across up to 3 years. NCI also runs a Phase IIB Bridge Award and caps its CRP support well below the government-wide figure.

• NIAID. Also listed in the higher Phase I tier, but NIAID publishes a per-year constraint that reshapes budgets more than a total ceiling does: NIAID will not generally allow Phase II or Phase IIB awards of any duration exceeding $1,000,000 in total costs per year. For a program with heavy vector manufacturing or toxicology costs concentrated in one year, this is a planning constraint worth designing around from the start.

• NIAMS, NIBIB, and NIDCR. Refer to the participating component table in the current parent announcement and confirm directly with program staff. These Institutes do not all maintain standing published SBIR budget pages, and NIBIB in particular has historically used targeted announcements with their own budget language for clinical work.

Two cautions. First, a ceiling in a component table is not the number that gets awarded. BW&CO's analysis of a fiscal year 2026 NCI SBIR award slice found Phase I level awards ranging from roughly $305,000 to $404,000, with not one award in 44 records reaching the $700,000 headroom. Budgeting to the ceiling budgets against an outcome that did not occur. Second, an Institute may reduce the recommended budget or shorten the award period for budgetary, administrative, or programmatic reasons even after a strong review score.

A candid note on capital adequacy. A Phase II at $2.15 million will not carry an in vivo gene-modified immunotherapy from concept to the clinic. The realistic financing picture is a Phase I or Direct to Phase II establishing specificity and transduction efficiency, a Phase II generating the preclinical package, CRP or Phase IIB covering IND-enabling studies and manufacturing, and private capital carrying first-in-human. Applications that show awareness of that full sequence read as commercially serious. Applications that imply a Phase II ends at an approved therapy do not.

Timeline

The topic window runs from September 2, 2026 through September 2, 2028.

Standard annual due dates: January 5, April 5, and September 5. When a due date falls on a weekend or federal holiday, NIH moves it to the next business day. Applications are due by 5:00 p.m. local time of the applicant organization.

Cycles available under this topic:

• September 2026 cycle: the September 5, 2026 date shifted to Tuesday, September 8, 2026 because of the weekend and the Labor Day holiday. Since the topic posted on September 2, this cycle is not realistically available.

• January 5, 2027: the first realistic cycle for a company beginning preparation now.

• April 5, 2027

• September 5, 2027

• January 5, 2028

• April 5, 2028, the last full cycle before the topic expires in September 2028.

What the runway looks like: plan on roughly 9 months from submission to funds in the door. An application submitted in the January 2027 cycle typically reaches an earliest possible start date in the fall of 2027. Council decisions for the September and January cycles are often handled together, so deferring a cycle is not costless.

Work backwards from your target date:

• 16 to 18 weeks out: identify your target Institute, run the NIH clinical trial determination against your actual design, confirm the Institute's clinical trial policy for your chosen mechanism, contact program staff, and start or verify federal registrations

• 12 weeks out: lock the Specific Aims page and circulate to program staff

• 8 weeks out: complete the research strategy, commercialization plan, vector or material sourcing agreements, institutional biosafety planning, letters of support, and any human subjects documentation

• 4 weeks out: full internal review, budget finalization, and subaward paperwork for any STTR or academic partner

• 1 week out: submit early to leave room for eRA Commons error correction

Registrations are the most common cause of a missed deadline. You need SAM.gov with a Unique Entity ID, the SBA Company Registry, eRA Commons, and Grants.gov. eRA Commons access depends on the SBA Company Registry being complete first. Allow six weeks or more and begin before you write.

Also note two moving parts. The current SBIR parent, PA-27-100, closes in early April 2027, well before this topic expires, so applicants targeting later cycles must confirm the active announcement number at submission. Separately, the 2026 reauthorization gave agencies authority to limit how many Phase I proposals a company may submit, and HHS has been reported to cap SBIR and STTR submissions at nine per small business per fiscal year. Confirm the current limit with program staff if you plan multiple submissions across Institutes.

Detailed Overview of What NIH Is Looking For

The problem NIH is trying to solve

The topic frames its case in two movements. The first is scientific. Adoptive cellular therapies such as CAR-T cells have transformed treatment of hematologic malignancies, but challenges remain in solid tumors because of poor immune cell trafficking, limited persistence, and immunosuppressive tumor microenvironments. Development for solid tumors is nonetheless expanding rapidly across autologous and allogeneic engineered T, NK, and other immune cells, and cellular therapies are being explored beyond oncology for autoimmune, infectious, and age-related disease and for regenerative medicine.

The second movement is logistical, and it is where the small business opportunity lives. NIH lists the practical barriers to current approaches directly: lymphodepletion, leukapheresis, ex vivo cell modification and expansion, GMP manufacturing, specialized facilities, and weeks-long processing times. It concludes that this complexity makes these therapies slow, costly, and inaccessible to many patients. In vivo engineering is presented as a transformative alternative that engineers immune cells inside the body using in vivo gene delivery, bypassing that process and offering true off-the-shelf cellular immunotherapy. NIH adds that this removes a major logistical bottleneck and enables treatment for rapidly progressing disease where patients often cannot afford the long wait.

Read strategically, that second paragraph is a specification. It names the incumbent's cost drivers and time drivers and identifies the patient population the incumbent cannot serve. A Significance section that quantifies your platform against those specific barriers, time from decision to dose, cost of goods, site-of-care requirement, and eligibility for patients too sick to wait for manufacturing, is arguing on the ground NIH chose.

The scope of the technology as defined

The topic's purpose statement is unusually detailed about what counts. It encourages basic and preclinical research and early clinical testing of in vivo immune cell engineering to reprogram immune cells within the body, including but not limited to T cells, NK cells, and macrophages, for cancer, autoimmune, infectious, and age-related disease and for regenerative medicine. Delivery may involve viral vectors such as lentiviral or adeno-associated viral vectors, or non-viral nanocarriers such as lipid nanoparticles, for delivery of genetic material such as DNA or mRNA. The genetic material could encode CARs, TCRs, or other functional elements, or gene editing machinery for in situ reprogramming.

The purpose statement then names four categories of acceptable work: development and testing of novel technologies and methodologies for increasing specificity and efficiency of immune cell targeting and transduction in vivo; improving biodistribution; improving safety; and enhancing efficacy and persistence of engineered immune cells in preclinical models and early clinical studies.

Two observations for an applicant. Macrophages appear alongside T and NK cells in the topic's own framing, which is a wider aperture than most CAR-focused programs and an opening for companies working outside the T cell mainstream. And specificity, efficiency, biodistribution, safety, and persistence are each named as standalone objectives. You do not need to propose a complete therapy. A Phase I that measurably improves one of those five parameters is responsive on its own terms.

The clinical trial constraint in detail

This deserves its own treatment because the topic invites clinical work that most of its participating Institutes cannot accept through the parent announcements.

The topic asks for early clinical testing in its purpose statement. NCI names pilot clinical trials informed by biomarkers. NIAID names early clinical research. NIAMS names clinical research. OADR-ORWH names acceleration of clinical trials for autoimmune disease. Against that, the parent announcements set the following:

• NCI. Accepts clinical trials under both SBIR and STTR. The only unrestricted door among the five.

• NIBIB. Supports only early stage clinical trials, specifically feasibility, clinical Phase I, first-in-human, safety, or other small trials that inform early stage technology development. Will not support pivotal trials, clinical Phase II, III, or IV, or trials whose primary outcome is efficacy, effectiveness, or a post-market concern. Mechanistic trials are supported only where the primary focus of the project is technology development. For a first-in-human study of a novel delivery platform, this policy is a good match rather than an obstacle.

• NIAID. Accepts clinical trials under the parent SBIR announcement but not under the parent STTR announcement.

• NIAMS and NIDCR. Accept no clinical trials under either parent announcement. An application proposing a clinical trial that aligns only with one of these missions is non-responsive and will not be reviewed.

The practical sequence is: run the NIH clinical trial determination against your actual design first, then choose the Institute, then choose SBIR or STTR. Doing it in the reverse order is how a strong application becomes unreviewable. Also confirm the definition rather than assuming, since NIH defines a clinical trial as a study prospectively assigning human subjects to one or more interventions to evaluate effects on health-related biomedical or behavioral outcomes, which captures more designs than founders expect.

What OADR-ORWH adds

The Office of Autoimmune Disease Research within ORWH participates but does not award grants. Your application must be relevant to the objectives of at least one participating Institute, which here means NCI, NIAID, NIAMS, NIBIB, or NIDCR. Its interests function as additional strength within an application already aimed at one of the five, and they are more specific than most non-awarding office statements.

OADR-ORWH is interested in design and engineering of next-generation cellular therapies including CAR-T and CAAR-T cells, regulatory T cells, NK cells, engineered CARs and TCRs, costimulatory domains, and other immunocytes and functional elements; development of data science and computational approaches to interrogate mechanisms of novel cellular therapies, including analysis of new or existing early-phase and pooled clinical trial data to define immunologic treatment windows and identify predictors of therapeutic response; and advancement of translational research to enable and accelerate clinical trials of cellular therapies for autoimmune disease. It strongly encourages engagement of people living with or at risk for autoimmunity to ensure direct relevance to human health.

Three things stand out. CAAR-T cells, chimeric autoantibody receptor T cells for depleting autoreactive B cells, are named explicitly and appear nowhere else in the topic, so a CAAR platform has a clear home. Regulatory T cells are named, which points toward tolerance induction rather than cytotoxic depletion. And the interest in analyzing existing and pooled early-phase clinical trial data to define immunologic treatment windows is a computational product opportunity that requires no wet lab at all, and it pairs naturally with NIDCR's parallel interest in AI and computational modeling. Patient engagement is cheap to do well and most applications will do it thinly or not at all.

Eligibility Requirements

To apply for an NIH SBIR or STTR award, your company must meet the core SBA criteria:

• Organized for profit, with a place of business located in the United States, and the primary research performed in the United States

• More than 50 percent directly owned and controlled by one or more individuals who are U.S. citizens or permanent resident aliens, by other for-profit small business concerns each majority owned by such individuals, or by a combination. Certain venture capital, hedge fund, and private equity structures may qualify for SBIR under specific conditions. Note that companies more than 50 percent owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination are not eligible for the STTR program, which is a distinction that catches venture-backed cell therapy companies specifically.

• No more than 500 employees including all affiliates. A subsidiary counts its parent's employees.

• For SBIR, the Principal Investigator's primary employment must be with the small business at the time of award and for the duration of the project. For STTR, the PD/PI may be primarily employed by either the small business or the partnering nonprofit research institution, with the award still made to the small business.

• For SBIR Phase I, the small business must perform at least two thirds of the research or analytical effort. For SBIR Phase II, at least half. For STTR, the small business performs at least 40 percent and a single partner nonprofit research institution performs at least 30 percent.

Additional constraints. NIH will not accept similar applications with essentially the same research focus from the same applicant organization, including derivative applications proposing a single product applicable to multiple purposes with non-substantive modification. This matters on a platform topic, where the temptation is to submit the same delivery technology against several disease areas and Institutes. You may not simultaneously submit identical or essentially identical applications under both parent announcements, and duplicate or highly overlapping applications under simultaneous review are not accepted. Applicants must disclose overlapping federal work under the essentially equivalent work rule. Companies with a substantial award history should confirm they meet the Phase I to Phase II Transition Rate and commercialization benchmarks. Heightened screening of foreign ownership and foreign influence applies under the 2026 reauthorization, with additional scrutiny possible for STTR because of the research institution partnership.

What a Competitive Application Looks Like

1. A quantified comparison against the ex vivo process. NIH named the barriers: lymphodepletion, leukapheresis, ex vivo modification and expansion, GMP manufacturing, specialized facilities, weeks-long processing. State what your approach does to each one, in numbers where you can. This is the argument the topic was written to invite, and most applications will gesture at it rather than quantify it.

2. One of the five named parameters as a measurable endpoint. Specificity, transduction efficiency, biodistribution, safety, and persistence are each named as standalone objectives. Pick one or two, define the metric, and state the success criterion. A proposal that improves everything vaguely improves nothing measurably.

3. A safety and control story. NIAID names off-target effects, unintended tissue injury, prolonged immune dysregulation, oncogenic risk, and control and reversibility of therapeutic activity. In vivo editing raises safety questions that ex vivo manufacturing partially contains through release testing, and reviewers know it. Addressing reversibility or a control switch directly is a differentiator.

4. The clinical trial determination resolved before the mechanism is chosen. Run the NIH definition against your design, then pick the Institute and announcement. Four of the five Institutes carry restrictions.

5. An honest capital sequence. Phase I or Direct to Phase II for specificity and transduction, Phase II for the preclinical package, CRP or Phase IIB for IND-enabling studies and manufacturing, private capital for first-in-human. Naming the sequence signals that you understand what this class of product costs to develop.

6. Program officer contact before writing. Five Institutes, four clinical trial postures, and two Institutes with brief published language. The call determines assignment, budget realism, and reviewability.

Common Reasons Applications Miss

• Treating the Highlighted Topic as a NOFO and searching Grants.gov for a topic-specific number that does not exist

• Proposing a clinical trial to NIAMS or NIDCR, which accept none under either parent announcement, making the application non-responsive and unreviewed

• Proposing a clinical trial to NIAID through STTR, which it does not accept, when SBIR would have worked

• Proposing an efficacy-powered or pivotal trial to NIBIB, which supports only early stage, feasibility, first-in-human, and safety trials informing technology development

• Confusing SBIR Phase I and Phase II with clinical trial Phase I and Phase II, which are separate and unaligned numbering systems

• Submitting the same delivery platform against multiple diseases and Institutes, which runs into the prohibition on derivative applications proposing a single product applicable to multiple purposes

• Applying for STTR while more than 50 percent owned by a combination of venture capital, hedge fund, or private equity firms, which is an STTR eligibility bar even where SBIR would permit it

• Designing a Phase II budget with costs concentrated in one year at NIAID, which will not generally allow more than $1,000,000 in total costs per year

• Budgeting to the $700,000 Phase I ceiling rather than the roughly $400,000 that Institutes actually award

• Omitting the fee from the budget or requesting the wrong level, neither correctable after submission

• Referencing a Make America Healthy Again alignment that this topic, unlike most others in the cycle, does not claim

• Implying a Phase II ends at an approved therapy, with no account of IND-enabling work, manufacturing, or the capital required to reach the clinic

• Starting federal registrations after drafting begins, then missing the receipt date on an eRA Commons validation error

Frequently Asked Questions

Is this a grant I can apply to directly?

No. This is an NIH Highlighted Topic, which is a statement of scientific priority rather than a Notice of Funding Opportunity. You apply through a broad NIH announcement, and for small businesses that means the NIH SBIR or STTR parent announcement, requesting assignment to one of the five awarding Institutes.

Which funding opportunity number do I actually use?

For most small businesses it is PA-27-100, the NIH, CDC, and FDA Parent SBIR announcement covering R43 and R44 awards. If your project depends on a formal university or nonprofit research partner, use PA-27-102, the Parent STTR announcement covering R41 and R42. Confirm the active number at submission, since PA-27-100 closes in early April 2027 while this topic runs to September 2028.

Can I propose a clinical trial under this topic?

It depends entirely on the Institute and mechanism. NCI accepts clinical trials under both SBIR and STTR. NIBIB accepts only early stage trials such as feasibility, clinical Phase I, first-in-human, safety, or other small trials that inform early technology development, and will not support pivotal or efficacy-powered trials. NIAID accepts clinical trials under SBIR but not STTR. NIAMS and NIDCR accept none under either parent. Run the NIH clinical trial determination against your design before choosing an Institute.

Is an SBIR Phase I the same as a clinical Phase I trial?

No, and conflating them causes real problems. NIH small business phases are separate from and not aligned with clinical trial phases. An SBIR Phase I is a feasibility award. A clinical Phase I trial is a first-in-human safety study, which would typically be proposed within an SBIR Phase II, Direct to Phase II, or Fast-Track application, subject to the target Institute's clinical trial policy.

Which of the five Institutes should I target?

NCI for oncology, and the default for any project with a clinical component since it accepts trials without restriction. NIAID for infectious, autoimmune, and immune-mediated disease, especially where your advantage is specificity, cost reduction, access, or minimizing preconditioning. NIBIB for disease-agnostic enabling technology, synthetic biology, biomaterials, and evaluation platforms. NIAMS for rheumatic, autoimmune, autoinflammatory, and musculoskeletal disease. NIDCR for dental, oral, and craniofacial disease, and the only Institute here offering a stated funding advantage.

How much money can my company request?

The SBA statutory guidelines this cycle are $323,090 for Phase I and $2,153,927 for Phase II in total costs, including direct costs, indirect costs, and fee. NCI and NIAID are among the components listing Phase I headroom to $700,000, though NCI's own guidance generally funds waiver-eligible Phase I near $400,000 and Phase II up to $2,250,000. NIAID applies a per-year constraint of $1,000,000 in total costs on Phase II and Phase IIB. Confirm with your target Institute before setting a budget.

When is the deadline?

There is no deadline specific to this topic. You submit on the NIH standard small business receipt dates of January 5, April 5, and September 5 each year, with dates falling on weekends or federal holidays moving to the next business day. The topic expires September 2, 2028, making January 5, 2027 through April 5, 2028 the realistic competing cycles.

How long until I receive funding?

Plan on approximately 9 months from submission to award start. An application submitted in the January 2027 cycle would typically have an earliest possible start date in the fall of 2027.

Do I have to give up equity or match the funds?

No. NIH SBIR and STTR Phase I and Phase II awards are non-dilutive and require no cost share. The exception is the Phase IIB Strategic Breakthrough Award, which requires not less than 100 percent matching funds from new private capital or from a government source other than a Phase I or Phase II SBIR or STTR award.

My company is venture-backed. Are we still eligible?

For SBIR, possibly. Certain venture capital, hedge fund, and private equity ownership structures qualify under specific conditions, and complex cap tables should be checked against 13 CFR Part 121. For STTR, no: small business concerns more than 50 percent owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are not eligible for the STTR program. This distinction affects venture-backed cell therapy companies more than most.

Can NIH funding cover IND-enabling studies and manufacturing?

Yes, primarily through the Commercialization Readiness Pilot. CRP supports later-stage work not typically fundable through Phase II or Phase IIB, and NIH names IND and IDE enabling studies, independent replication of key studies, clinical studies, manufacturing costs, and regulatory assistance among eligible activities. CRP permits substantial subcontracting, though the small business must maintain oversight and management of the research throughout the award.

Does my project have to target cancer?

No. The topic names cancer, autoimmune disease, infectious disease, age-related disease, and regenerative medicine, and covers T cells, NK cells, and macrophages. NIBIB's framing is explicitly disease-agnostic, NIAID covers infectious and immune-mediated disease, NIAMS covers rheumatic and musculoskeletal disease, and NIDCR covers dental, oral, and craniofacial conditions.

Does any Institute set aside dedicated funding for this topic?

Not guaranteed. NIDCR is the only participating Institute that stated it may give special consideration to meritorious applications in this topic area. NCI, NIAID, NIAMS, and NIBIB made no such statement. Treat the NIDCR statement as a favorable tilt rather than a reserved pool of money.

I already have feasibility data. Do I still need a Phase I?

Not necessarily. SBIR Direct to Phase II allows a company that has demonstrated the scientific and technical merit and feasibility normally expected from a Phase I, without having received a Phase I award for that project, to apply directly for Phase II. This authority is available for SBIR only and is not available under STTR. A validated delivery platform plus new in vivo immune cell transduction data is a common qualifying profile.

Does this topic align with the Make America Healthy Again initiative?

No. Unlike most NIH Highlighted Topics published in this cycle, this one is not issued under the MAHA initiative and lists no named policy alignments. Applicants should not reference an initiative alignment the topic does not claim.

What registrations do I need, and how long do they take?

SAM.gov with a Unique Entity ID, the SBA Company Registry, eRA Commons, and Grants.gov. eRA Commons access depends on completing the SBA Company Registry first, so the sequence matters. Allow at least six weeks, and start before you begin writing.

How BW&CO Helps

BW&CO is a non-dilutive federal funding advisory firm. We help deep-tech, biotech, medtech, and health technology founders convert agency priority signals like this one into funded awards.

On this topic the decisive work happens before drafting: resolving the clinical trial determination, selecting among five Institutes with four different clinical trial postures, choosing SBIR versus STTR against your ownership structure and your PI's employment, engaging program officers, and sequencing Phase I, Phase II, CRP, Phase IIB, and private capital into a financing plan that actually reaches the clinic. That work also includes Specific Aims development, full proposal build, budget and fee construction, commercialization planning, and Phase IIB matching capital positioning. Our team has helped clients secure more than $350 million in funding. Innovation Funding Simplified.

If you are developing an in vivo immune cell engineering platform and want a straight answer on which Institute to target, whether your clinical plan is reviewable where you intend to send it, and whether you are competitive for the January 5, 2027 cycle, contact us for a fit assessment.

NIH Highlighted Topic: Catalyzing Interdisciplinary Research on HIV-Associated Co-occurring Conditions

Executive Summary

The National Institutes of Health has published a Highlighted Topic titled "Catalyzing Interdisciplinary Research on HIV-Associated Co-occurring Conditions." Twelve NIH Institutes award grants under it and five additional offices participate without awarding, making this one of the broadest cross-NIH topics published this cycle. The scientific premise is that antiretroviral therapy has turned HIV into a manageable chronic condition, but people with HIV now face early onset and elevated risk of comorbidities, treatment-related adverse effects, and interconnected medical, psychosocial, and structural challenges that disease-specific research models handle poorly.

For a small business, the practical translation is this: there is no new application portal and no new deadline attached to this topic. A Highlighted Topic is a demand signal, not a Notice of Funding Opportunity. You capture the funding by submitting to the NIH SBIR or STTR parent announcement, requesting assignment to one of the twelve awarding Institutes, and aligning your Specific Aims to that Institute's stated interests.

Two things about this topic deserve to be said plainly before you invest a cycle in it. First, a substantial share of the published language describes work that is not a small business fit: cohort analysis, mechanistic basic science, academically led community-based trials, and health disparities characterization. Those belong in R01 and related mechanisms. The slices that are genuinely SBIR-fundable are narrower and named below. Second, two of the twelve awarding Institutes, NIAMS and NIDCR, will not accept clinical trial applications under either parent announcement, even though both explicitly ask for research that develops and tests interventions. Two more, NIAID and NIDDK, accept clinical trials under SBIR but not under STTR. Getting this wrong makes an application non-responsive and unreviewed regardless of its scientific merit.

The topic was posted on September 1, 2026 and expires on July 28, 2028, which is a shorter window than the standard two years and eliminates the September 2028 cycle. The realistic competing cycles run from January 5, 2027 through April 5, 2028.

If you build diagnostics or screening tools for subclinical comorbidity, therapeutics or biologics for HIV-associated disease, medication optimization and polypharmacy tools, care coordination or clinical decision support software, point-of-care coinfection testing, or integrated behavioral health delivery platforms, there is real money here across multiple Institutes.

At a Glance

• Topic title: Catalyzing Interdisciplinary Research on HIV-Associated Co-occurring Conditions

• Issuing agency: National Institutes of Health, U.S. Department of Health and Human Services

• Awarding Institutes: NCCIH, NCI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NICHD, NIDA, NIDCR, NIDDK, and NIMH

• Non-awarding participating offices: OAR, OBSSR, ODP, ORWH, and THRO

• Central scientific contact: Office of AIDS Research, OARinfo@nih.gov

• Type: NIH Highlighted Topic. This is not a Notice of Funding Opportunity.

• Post date: September 1, 2026

• Expiration date: July 28, 2028. Note this is short of the usual two-year window.

• Recommended small business mechanism: NIH SBIR (R43 and R44) or NIH STTR (R41 and R42) parent announcement

• Current parent announcements: PA-27-100 for SBIR, PA-27-102 for STTR, PA-27-101 for the Phase IIB Strategic Breakthrough Award, and PAR-27-098 for the Commercialization Readiness Pilot

• Standard annual due dates: January 5, April 5, and September 5. HHS SBIR and STTR applications are not accepted on the AIDS and AIDS-related due dates, so the standard dates apply here despite the HIV subject matter.

• SBA statutory guidelines this cycle: $323,090 Phase I, $2,153,927 Phase II, $4,191,495 CRP

• Institute headroom: several participating Institutes list Phase I limits above the statutory guideline, up to $700,000, and Phase II limits up to $2.5 million or $3 million. Limits differ by Institute and must be confirmed.

• Clinical trials: not accepted by NIAMS or NIDCR under either parent announcement. Not accepted by NIAID or NIDDK under STTR, though both accept them under SBIR.

• Cost share: none for Phase I or Phase II. Phase IIB requires 100 percent third-party matching funds.

• Equity dilution: none. This is non-dilutive federal funding.

• Profit or fee: allowable, must be in the budget at submission, and normally will not exceed 7 percent of total costs

• Strongest funding signals: NIDA states both that it may dedicate available funds and that it may give special consideration. NHLBI states it may dedicate available funds. NCCIH and NIDCR each state they may give special consideration.

• Broader initiative alignment: Make America Healthy Again initiative, with eight named component efforts

What This Opportunity Actually Is

An NIH Highlighted Topic is a published statement of scientific interest from one or more NIH Institutes, Centers, and Offices. It tells the research community that an area of science is a priority without creating a separate funding announcement, deadline, or review process. There is no topic-specific number to search on Grants.gov, and applications are not scored against other applications to the topic.

What it does do is identify which Institutes are receptive, which determines your assignment request and your program officer conversations; supply the vocabulary program staff already use internally, which your Specific Aims should mirror; and in four cases here create an explicit stated advantage. NIDA is the only participating Institute that made both available statements, saying it may dedicate available funds to this topic area depending on the availability of funds, the number of meritorious applications, and competing priorities, and separately that it may give special consideration to meritorious applications in the topic area. NHLBI made the funds statement. NCCIH and NIDCR each made the special consideration statement. The remaining eight awarding Institutes made neither.

That distribution is worth reading carefully. It does not mean the other eight will not fund this work. It does mean four Institutes went on record and eight did not, which is the closest thing to a competitive signal a Highlighted Topic provides.

Is This Topic a Fit for a Small Business?

This topic is less small-business-native than most NIH Highlighted Topics, and an honest read saves cycles.

The topic language repeatedly emphasizes interdisciplinary collaborative science, multidisciplinary teams with multiple Program Directors and Principal Investigators holding complementary expertise, meaningful community engagement, cross-NIH alignment, and use of existing NIH resources. Those are hallmarks of investigator-initiated academic research, and much of what is described is best pursued through R01, R34, or cooperative agreement mechanisms rather than SBIR or STTR.

Work in this topic that is a poor small business fit: secondary analysis of existing cohorts; epidemiological characterization of comorbidity burden; mechanistic basic science with no identified product; health disparities documentation; academically led community-based behavioral trials where the small business would be a subcontractor rather than the developer of a commercial product.

Work in this topic that is a genuine small business fit:

• Screening and diagnostics for subclinical disease. NHLBI explicitly asks for novel methods to detect subclinical HIV-related heart, lung, blood, and sleep conditions. NCI asks for new biomarkers and diagnostics. NIDCR asks for early cancer detection in the oral and craniofacial complex. This is the clearest product lane in the entire topic.

• Therapeutics and biologics. NCI asks for therapeutics improving prevention, diagnosis, treatment, and outcomes in people with HIV. NIAAA asks for biomedical approaches to restore alcohol-induced organ dysfunction. NIDA asks for basic, clinical, and translational research on treatment of substance use disorder and overdose in people with HIV.

• Medication optimization and interaction tools. NIA asks for optimizing medications and care coordination. NCCIH asks for evaluation of risks including drug and herb interactions. Polypharmacy in an ART-treated aging population is a well-defined software and decision-support problem.

• Care coordination, clinical decision support, and digital delivery platforms. NIMH asks for scalable whole-person care models. NIDDK asks for strategies to improve implementation and delivery of evidence-based care. NIAMS prioritizes care models integrating musculoskeletal, rheumatic, and skin health into HIV settings.

• Point-of-care coinfection testing. NIAID names tuberculosis, viral hepatitis, and sexually transmitted infections across the lifespan from infant through adult.

• Integrated behavioral health and substance use interventions. NIDA names integrated interventions addressing HIV, substance use disorder, hepatitis C, and co-occurring mental health conditions. Digital therapeutics fit here.

• Complementary and integrative health products and delivery. NCCIH names mind-body and natural product interventions for symptom clusters, plus pragmatic and hybrid effectiveness-implementation studies and scalable delivery models.

The test is the ordinary SBIR test, applied honestly: is there a commercial product with unresolved technical risk that your company will own and sell? If the deliverable is knowledge, a publication, or a care model your company will not commercialize, the mechanism is wrong even though the science is wanted.

Which Institute Should You Target?

With twelve awarding Institutes, the assignment request is the highest-leverage decision on the application. Group yourself by what you sell, not by the disease you are adjacent to.

If you build diagnostics, biomarkers, or screening tools: NHLBI for cardiopulmonary, cardiometabolic, hematologic, and sleep-disordered breathing detection, including subclinical detection and vascular contributions to cognitive impairment and dementia. NCI for cancer biomarkers, diagnostics, and early detection in people with HIV. NIDCR for oral and salivary gland complications and HPV-associated cancer detection, subject to the clinical trial restriction below. NIDDK for kidney, urologic, hematologic, liver, and metabolic conditions that present differently or follow altered courses in the context of HIV.

If you build therapeutics or biologics: NCI for HIV-related tumor pathogenesis and therapeutics. NIAID for tuberculosis, viral hepatitis, and sexually transmitted infection coinfections. NIAAA for approaches restoring alcohol-induced organ dysfunction across cardiovascular, metabolic, neurocognitive, and immune complications. NIDA for substance use disorder and overdose treatment in people with HIV. NIA for interventions addressing HIV-associated conditions in midlife and older age, framed against the NIH Stage Model from Stage 0 basic science through Stage V implementation.

If you build software, digital health, or care delivery platforms: NIMH for neurocognitive and mental health screening, early intervention, and scalable whole-person care models, including implementation research identifying diagnosis and treatment barriers. NIDA for care engagement, ART adherence, and access in underserved populations. NIA for care coordination and medication optimization. NIDDK for implementation and delivery of evidence-based care. NIAMS for whole-person care models integrating musculoskeletal and skin health, subject to the clinical trial restriction.

If you build complementary or integrative health products: NCCIH is the only door, and it is a good one. NCCIH frames HIV as a chronic multisystem condition with complex symptoms including pain, fatigue, and neurocognitive and mental health challenges, well suited to Whole Person Health approaches, and it stated it may give special consideration to meritorious applications here.

If your work concerns pediatric or perinatal populations: NICHD participates but published no areas of interest for this topic, listing only a scientific contact. The topic body does note that HIV-exposed but uninfected children may face elevated immune, metabolic, and developmental risks compared with unexposed peers, particularly in low and middle-income settings. If this is your space, the program officer call is not optional, because there is no published language to write against.

Quick reference: awarding Institutes and stated funding signals

• NCCIH. Complementary and integrative health for symptom management. May give special consideration. Contact: Lanay Mudd, PhD, NCCIHDERFunding@nih.gov

• NCI. Cancer risk, pathogenesis, prevention, diagnosis, treatment, and bundled cancer and HIV interventions. No stated signal. Contact: Rebecca Liddell Huppi, Ph.D.

• NHLBI. Heart, lung, blood, and sleep comorbidity mechanisms and interventions. May dedicate available funds. Contact: nhlbihighlightedtopics@mail.nih.gov

• NIA. HIV-associated conditions in midlife and older age across the NIH Stage Model. No stated signal. Contact: Marcel E. Salive, MD, MPH

• NIAAA. Alcohol use and alcohol use disorder interactions with HIV pathophysiology and care. No stated signal. Contact: Kendall Bryant, Ph.D.

• NIAID. Coinfections across the lifespan, with attention to stigma and health system factors. No stated signal. Does not accept clinical trials under STTR. Contact: Robin E. Huebner, PhD, MPH

• NIAMS. Musculoskeletal, skin, and systemic rheumatic comorbidities, with priority to implementation science care models. No stated signal. Does not accept clinical trials under either parent. Contact: Heiyoung Park, PhD

• NICHD. No published areas of interest for this topic. Contact: Sonia Lee, Ph.D.

• NIDA. Drug use, addiction, and HIV interactions across the lifespan. May dedicate available funds and may give special consideration. The only Institute making both statements. Contact: NIDAHIVProgram@mail.nih.gov

• NIDCR. Oral and craniofacial comorbidities and integration of oral health into HIV care. May give special consideration. Does not accept clinical trials under either parent. Contact: NIDCR-Program@nih.gov

• NIDDK. Enteropathy and gastrointestinal homeostasis, liver disease and viral hepatitis coinfection, nutrition, obesity, diabetes, kidney, urologic, and hematologic disease. No stated signal. Does not accept clinical trials under STTR. Contact: Deepak Nihalani, Khoa Nguyen, Minnjuan Flournoy Floyd

• NIMH. Neuropsychiatric mechanisms of CNS comorbidity, shared pathways, and implementation research. No stated signal. Contact: NIMH.DAR.inquiries@nih.gov

Which NIH Mechanism Should a Small Business Use?

Small businesses should apply through the NIH SBIR or STTR parent announcement and request assignment to the Institute whose interests match. On this topic the SBIR versus STTR choice carries unusual weight for two reasons: the topic actively encourages multidisciplinary academic collaboration, and the clinical trial restrictions differ between the two announcements.

NIH Parent SBIR, currently PA-27-100 (R43 and R44). The default route. Accepts Phase I, Phase II, Direct to Phase II, and Fast-Track. Use it when your company performs the majority of the research and your Principal Investigator is primarily employed by the company. Under PA-27-100, NIAMS and NIDCR do not accept clinical trial applications, and an application proposing a clinical trial that aligns only with one of those missions is non-responsive and will not be reviewed.

NIH Parent STTR, currently PA-27-102 (R41 and R42). Requires a formal collaboration with a nonprofit research institution, with at least 40 percent of the research at the small business and at least 30 percent at a single partner institution. STTR carries a feature that matters a great deal on this topic: the Program Director or Principal Investigator may be employed by either the small business or the partnering nonprofit, while the award still goes to the small business. For a company whose scientific lead is a clinician-researcher with a primary academic appointment, which describes much of the HIV comorbidity field, STTR is the only NIH small business mechanism that works. The tradeoff is a longer clinical trial exclusion list: under PA-27-102, NIAID, NIAMS, NIDCR, NIDDK, and NIMHD do not accept clinical trials.

The combined clinical trial picture for this topic. NIAMS and NIDCR accept no clinical trials under either parent, despite both asking for research that develops and tests interventions. NIAID and NIDDK accept clinical trials under SBIR but not under STTR, so a project with an academic PI and a trial component cannot use STTR at those Institutes. Review the NIH Clinical Trial Definition before assuming your study is not a trial, because it captures more designs than founders expect, including many behavioral and care delivery interventions that sit at the center of this topic.

Multiple Program Directors and Principal Investigators. The topic strongly encourages teams with multiple PD/PIs holding complementary expertise. NIH small business awards do permit multiple PD/PI structures, but the employment rules still bind. Confirm with your target Institute how the primary employment requirement applies across a multiple PD/PI team before you build the team into the application, because this is the point at which an otherwise strong interdisciplinary structure can become an eligibility problem.

Direct to Phase II. Available if you already hold the feasibility data a Phase I would generate and never received a Phase I award for that project. SBIR only, not available under STTR.

Fast-Track. Phase I and Phase II submitted together, reviewed once. Poor fit when Phase I results would change the Phase II design, which is common where the Phase I is a feasibility or usability study feeding an intervention design.

Phase IIB Strategic Breakthrough Award, currently PA-27-101 (R44). For companies that completed an NIH SBIR or STTR Phase II and need a commercialization bridge. Requires documentation of not less than 100 percent matching funds from new private capital or from a government source other than a Phase I or Phase II SBIR or STTR award. Award periods must not exceed 4 years. Budget guidance varies by Institute, and not all Institutes accept clinical trials through Phase IIB.

Commercialization Readiness Pilot, currently PAR-27-098 (SB1). Late-stage technical assistance and product development that Phase II and Phase IIB cannot support, including regulatory and reimbursement work. Permits more outsourcing, though the small business must retain substantial project management and oversight.

Funding Allowance

The ceiling depends on two layers, and with twelve participating Institutes the second layer is where the planning happens.

Layer one, the SBA statutory guidelines for the current cycle:

• Phase I: up to $323,090 in total costs, for a project period of 6 months to 2 years

• Phase II: up to $2,153,927 in total costs, for a project period of 1 to 3 years

• Commercialization Readiness Pilot: up to $4,191,495 in total costs, for a project period of up to 3 years

Total funding support means direct costs, indirect costs, and fee combined. A reasonable profit or fee is allowable but must be in the budget at submission and normally will not exceed 7 percent of total costs. NIH does not adjust budgets after submission, so a request at the wrong level cannot be corrected later.

Layer two, Institute-specific guidance. NIH holds SBA waivers permitting awards above the guideline for approved topics, and each Institute publishes its own limits. For the participating Institutes here, the published picture as of this writing:

• Higher Phase I headroom. The participating component table in the parent SBIR announcement lists Phase I limits above the statutory guideline for several Institutes in this topic, reaching $700,000 for the highest tier, which includes NCI, NIA, NIAID, NIMH, and NCCIH. Other components list $400,000, and some hold to the SBA guideline.

• NCI. Publishes waiver-topic guidance generally funding Phase I up to $400,000 across up to 2 years and considering Phase II up to $2,250,000 across up to 3 years. NCI also runs a Phase IIB Bridge Award and caps its CRP support well below the government-wide figure.

• NIDDK. Generally considers Phase I up to $350,000 across up to 2 years, Phase II up to $2,200,000 across up to 3 years, and Phase IIB up to $3,000,000, with Phase II and Phase IIB generally not exceeding $1,100,000 in any single year.

• NIAAA. Publishes guidance that it will generally not fund Phase I applications to the omnibus above roughly $385,000 or Phase II awards above $3 million, even for topics on the SBA-approved waiver list.

• NIAID. Publishes a per-year constraint rather than only a total: NIAID will not generally allow Phase II or Phase IIB awards of any duration exceeding $1,000,000 in total costs per year. This reshapes a budget more than a total-cost ceiling does.

• NIDA. Publishes waiver-topic guidance permitting Phase II requests up to $2.5 million across up to 3 years where the research falls within its approved waiver topics and the justification is adequate.

• NHLBI. Publishes its budget guidance through NOT-HL notices rather than a single standing page. Confirm the current notice with NHLBI program staff before budgeting.

• NCCIH, NIA, NIAMS, NICHD, NIDCR, NIMH. Refer to the participating component table in the current parent announcement and confirm directly with program staff, as these Institutes do not all maintain standing published SBIR budget pages.

Two cautions. First, a ceiling in a component table is not the number that gets awarded. BW&CO's analysis of a fiscal year 2026 NCI SBIR award slice found Phase I level awards ranging from roughly $305,000 to $404,000, with not one award in 44 records reaching the $700,000 headroom. Budgeting to the ceiling budgets against an outcome that did not occur. Second, an Institute may reduce the recommended budget or shorten the award period for budgetary, administrative, or programmatic reasons even after a strong review score.

Timeline

The topic window runs from September 1, 2026 through July 28, 2028. That expiration is earlier than the usual two-year window and sits between two standard due dates, which removes a cycle other Highlighted Topics would offer.

Standard annual due dates: January 5, April 5, and September 5. When a due date falls on a weekend or federal holiday, NIH moves it to the next business day. Applications are due by 5:00 p.m. local time of the applicant organization.

Do not use the AIDS due dates. NIH runs a separate set of AIDS and AIDS-related receipt dates of January 7, May 7, and September 7 for many mechanisms, and researchers experienced with R01 submissions in this field will know those dates well. HHS SBIR and STTR grant applications are not accepted on the AIDS and AIDS-related due dates. The standard small business dates govern here despite the HIV subject matter. This is the most likely calendar mistake on this particular topic, and it is most likely to be made by an academic collaborator advising the team.

Cycles available under this topic:

• September 2026 cycle: the September 5, 2026 date shifted to Tuesday, September 8, 2026 because of the weekend and the Labor Day holiday. Since the topic posted on September 1, this cycle is not realistically available.

• January 5, 2027: the first realistic cycle for a company beginning preparation now.

• April 5, 2027

• September 5, 2027

• January 5, 2028

• April 5, 2028, the final cycle. The topic expires July 28, 2028, before the September 2028 date.

What the runway looks like: plan on roughly 9 months from submission to funds in the door. An application submitted in the January 2027 cycle typically reaches an earliest possible start date in the fall of 2027. Council decisions for the September and January cycles are often handled together, so deferring a cycle is not costless.

Work backwards from your target date:

• 16 to 18 weeks out: identify your target Institute, confirm its clinical trial policy for your chosen mechanism, contact program staff, and start or verify federal registrations. This topic warrants a longer lead time than most because of the Institute selection and clinical trial questions.

• 12 weeks out: lock the Specific Aims page, confirm the multiple PD/PI structure against employment rules, and circulate to program staff

• 8 weeks out: complete the research strategy, commercialization plan, letters of support, community partner documentation, and any IRB or human subjects planning

• 4 weeks out: full internal review, budget finalization, and subaward paperwork for any STTR or academic partner

• 1 week out: submit early to leave room for eRA Commons error correction

Registrations are the most common cause of a missed deadline. You need SAM.gov with a Unique Entity ID, the SBA Company Registry, eRA Commons, and Grants.gov. eRA Commons access depends on the SBA Company Registry being complete first. Allow six weeks or more and begin before you write.

Also note that the current SBIR parent, PA-27-100, closes in early April 2027, well before this topic expires. Applicants targeting later cycles must confirm the active announcement number at the time of submission.

Detailed Overview of What NIH Is Looking For

The problem NIH is trying to solve

The topic opens from a position of success. Antiretroviral therapy has transformed HIV into a manageable chronic condition. The consequence is a new problem: people with HIV face high risk and early onset of comorbidities, ART-related adverse effects, and interconnected medical, psychosocial, and structural challenges. The scope extends beyond people with HIV themselves. The topic notes that HIV and its treatment may also affect individuals exposed to HIV, and that HIV-exposed, uninfected children may face elevated immune, metabolic, and developmental risks compared with unexposed, uninfected peers, particularly in low and middle-income settings.

The named gap is mechanistic and specific: how HIV, ART, and psychosocial stressors interact to drive early onset and progression of comorbidities. NIH argues that many comorbidities involve intersecting pathways and shared risk factors even as they diverge into disease-specific trajectories, giving two examples. Metabolic syndrome increases risk for diabetes, cardiovascular disease, and chronic kidney disease. Certain coinfections increase cancer risk. Elucidating the shared factors, NIH argues, may inform preventive strategies addressing multiple outcomes at once.

The methodological critique follows from that. Traditional disease-specific models may insufficiently capture shared factors or multilevel implementation determinants. NIH instead points toward comprehensive whole-person care linking infectious diseases, endocrinology, psychiatry, nursing, pharmacy, and community health, with emphasis on early screening, lifestyle-based prevention, and sustained engagement in HIV care, while requiring careful attention to local context and health system factors for effective implementation.

Read strategically, that argument creates a specific opening for a product company. If NIH believes the shared upstream factors matter more than the disease-specific endpoints, then a screening tool, biomarker panel, or decision-support system that detects or manages a shared factor across multiple downstream comorbidities is more responsive than one addressing a single condition. A cardiometabolic risk platform that also informs kidney and cancer risk is speaking the topic's language. A single-indication tool is not.

The stated purpose

The topic aims to catalyze interdisciplinary research on HIV-associated co-occurring conditions and to expand multidisciplinary teams that develop and deliver preventive strategies improving health and quality of life for people with HIV across the lifespan. Emphasis falls on two things: research on shared factors and multi-organ effects to inform early preventive strategies, and implementation science approaches that identify barriers and facilitators, optimize multidisciplinary care approaches, and deliver scalable, sustainable care models. Multidisciplinary teams with multiple Program Directors and Principal Investigators holding complementary expertise in HIV and relevant conditions, cross-NIH alignment, and use of existing resources are all strongly encouraged.

Two phrases in that paragraph carry weight for a small business. "Scalable, sustainable care models" is commercialization language, and it invites a business model argument about who pays and how the model persists after grant funding ends, which most academic applications will answer weakly. "Use of existing resources" points toward NIH cohorts, data platforms, and networks, and a company that proposes to validate against an existing NIH resource rather than build a new cohort is both cheaper and more responsive.

Selected Institute areas of interest, with strategic reads

NHLBI seeks mechanisms and pathways contributing to HIV-associated heart, lung, blood, and sleep comorbidities, and interventions that improve care including implementation evaluation. Its named priorities are the combined effects of aging, HIV, and ART on those conditions; aging and HIV-related changes in hematopoiesis including hematopoietic stem cells and their niche; the impact of sleep deficiency and sleep-disordered breathing on HIV-associated cardiopulmonary and cardiometabolic disease pathogenesis; vascular contributions to cognitive impairment and dementia; implementation strategies improving uptake and sustainability of evidence-based interventions; mechanistic studies reducing the effects of HIV and aging including traditional risk factors and sex differences; and novel methods to detect subclinical HIV-related conditions plus strategies to mitigate clinical disease.

Read: the last bullet is the strongest product invitation in the topic. Subclinical detection is a diagnostics problem with a defined customer and a regulatory pathway. NHLBI also stated it may dedicate available funds. Sleep-disordered breathing is a notable inclusion for wearable and home-testing companies.

NCI seeks advancement in understanding risks, development, progression, prevention, diagnosis, and treatment of cancer in people with HIV, plus testing and implementation of bundled cancer and HIV interventions. It notes that people with HIV have increased incidence of certain cancers, are diagnosed later at higher stage, have worse overall and cancer-specific survival, and are less likely to receive cancer treatment. Its example topics are characterizing HIV's contribution to HIV-related tumor development and pathogenesis; discovering and developing new biomarkers, diagnostics, and therapeutics; and identifying factors influencing cancer disparities including improving adoption, implementation, and sustainment of effective interventions.

Read: "bundled cancer/HIV interventions" is unusual phrasing and signals interest in combined care products rather than single-purpose tools. The treatment access disparity NCI names is a care delivery problem as much as a clinical one.

NIDA seeks interdisciplinary research on how drug use, addiction, and HIV interact across the lifespan, spanning brain function, behavior, mood, sleep, pain, and cognition under HIV, ART, and polysubstance use; molecular, neurochemical, cellular, and circuit function underpinning HIV and co-occurring substance use disorders; shared pathways linking substance use, HIV, stress, trauma, and mental health; individual and community factors affecting prevention, care engagement, and ART adherence with focus on improving access in underserved populations; integrated interventions addressing HIV, substance use disorder, hepatitis C, and co-occurring mental health conditions; and basic, clinical, and translational research on substance use disorder and overdose treatment in people with HIV.

Read: NIDA is the only Institute here making both funding statements, and its list is unusually accommodating, spanning basic neuroscience through digital adherence tools through overdose therapeutics. If your product plausibly fits NIDA, that combination of breadth and stated signal makes it the strongest default target on this topic.

NCCIH supports complementary and integrative health approaches for symptom management, prioritizing testing of interventions such as mind-body and natural products to address symptom clusters and improve function and quality of life; elucidating biological, behavioral, and psychosocial mechanisms including inflammation, neuroimmune, and stress pathways and identifying biomarkers and patient characteristics; integrating these approaches into HIV care through pragmatic and hybrid effectiveness-implementation studies and scalable delivery models; and evaluating risks such as drug and herb interactions, synthesizing evidence, and developing decision-making guidance.

Read: the risk evaluation and guidance bullet is the least crowded. A drug and herb interaction screening tool for an ART-treated population is a clean software product with a real safety rationale, and NCCIH stated it may give special consideration.

NIAMS and NIDCR both ask for interventions while accepting no clinical trials. NIAMS seeks research on HIV-associated musculoskeletal, skin, and systemic rheumatic comorbidities including musculoskeletal pain, sarcopenia and cachexia, cartilage degeneration and osteoarthritis, osteoporosis and fractures, arthritis and rheumatic disease, and dermatologic manifestations, and states that priority is given to implementation science projects developing, testing, and scaling multidisciplinary whole-person care models. NIDCR seeks mechanisms of HIV-related oral disease; biological, behavioral, and contextual risk factors linking oral and systemic comorbidities including HPV-associated cancer; interdisciplinary preventive, diagnostic, and treatment approaches including probiotics, mucosal immunity modifiers, and early cancer detection; and integration of oral health into the HIV care continuum.

Read: this is the sharpest trap on the page. Both Institutes invite intervention development and both are on the clinical trial exclusion list for the parent announcements. The workable path is a project whose endpoints are technical, mechanistic, or feasibility-based rather than a trial testing safety or efficacy in human subjects, or a submission through an Institute-specific announcement designed for trials. Confirm the design with program staff before drafting, not after.

NIA, NIAAA, NIAID, NIDDK, and NIMH round out the awarding set. NIA works across the NIH Stage Model from Stage 0 basic science through Stage V implementation, interested in etiology and pathogenesis including chronic immune activation and antiretroviral and other drug toxicities, optimizing medications and care coordination alongside behavioral and social interventions, and developing, testing, implementing, and scaling evidence-based interventions. NIAAA focuses on heavy alcohol use and alcohol use disorder, noting it accelerates physiological vulnerability, impacts medication adherence and toxicities, and complicates care, with complications including cardiovascular disease, metabolic disorders, neurocognitive impairment, and cellular and immune dysfunction. NIAID focuses on coinfections from infant through adult, encouraging attention to stigma and intersecting behavioral, biological, and health system factors in diagnosing, preventing, and treating tuberculosis, viral hepatitis, and sexually transmitted infections. NIDDK spans enteropathy and gastrointestinal homeostasis, liver disease and viral hepatitis coinfection, digestive disease, nutrition, obesity, diabetes and complications, and kidney, urologic, and hematologic disease presenting differently under HIV, and gives high priority to studies of social, behavioral, and environmental factors affecting disease severity and treatment adherence. NIMH focuses on neuropsychiatric mechanisms of CNS comorbidity, how HIV biology, treatment exposures, and psychosocial burden converge on shared pathways driving neurocognitive and mental health disorders, and multidisciplinary implementation research identifying diagnosis and treatment barriers with emphasis on community engagement and sustainable delivery.

What the non-awarding offices add

Five offices participate without awarding grants: the Office of AIDS Research, which also serves as the central scientific contact for the topic; the Office of Behavioral and Social Sciences Research; the Office of Disease Prevention; the Office of Research on Women's Health; and the Tribal Health Research Office. Your application must be relevant to the objectives of at least one awarding Institute, and their interests function as additional strength rather than an independent route.

OAR is interested in interdisciplinary research including implementation science advancing understanding of common factors underlying HIV-associated co-occurring conditions, supporting early prevention, integrated whole-person care, and improved health and quality of life across the lifespan. ODP is particularly interested in innovative prevention research using rigorous study design, measurement, and analysis methods to test interventions, implementation strategies, and multidisciplinary care approaches. ORWH is interested in projects addressing HIV-associated co-occurring conditions in women. OBSSR and THRO participate without publishing specific interests for this topic.

Practical read: ODP's emphasis on rigorous design, measurement, and analysis is the most actionable of these, because methodological rigor is cheap to strengthen and is where small business applications most often lose points. Powering your study properly and pre-specifying your analysis is a low-cost, high-return decision. OAR being the central contact also means a single call to OAR can help route you among twelve Institutes if you are genuinely unsure where you fit.

MAHA alignment

This topic is issued as part of the Make America Healthy Again initiative and lists eight named alignments, more than any comparable topic: the NIH MAHA Chronic Disease Initiative's Whole-Person-Health approach; Food for Health, a joint HHS, VA, and USDA effort studying food and lifestyle interventions and their cost impact, coordinated by the NIH Office of Nutrition and including large-scale randomized controlled trials; Nutrition, spanning NIH partnership with FDA, USDA, and the Administration for a Healthy America, expanded research on dietary patterns supporting metabolic health, the FDA and NIH Joint Nutrition Regulatory Science Program, and precision nutrition; the Oral Health and Systemic Disease Connection, examining pediatric oral health links to cardiovascular disease, diabetes, and autoimmune conditions plus oral microbiome relationships with gut health and immune function; the Gut Microbiome Research Initiative; Longitudinal Research for Chronic Disease Prevention, naming the Adolescent Brain Cognitive Development Study, the Healthy Brain and Child Development Study, All of Us, and the Environmental Influences on Child Health Outcomes Program, with example areas including sleep, nutrition, insulin resistance, select high-quality supplements, and fitness as a vital sign; and Mental Health and Addiction Research, with a special focus on screentime in children and adolescents.

Practical read: pick one or two, not eight. The named longitudinal resources are the most useful, because "use of existing resources" is explicitly encouraged in the topic purpose, and proposing validation against All of Us or a named cohort is concrete, cheaper than new recruitment, and directly responsive. For a nutrition or metabolic product, Food for Health and the Nutrition alignment are the natural anchors. For oral health, NIDCR plus the Oral Health and Systemic Disease Connection is a coherent pairing.

Eligibility Requirements

To apply for an NIH SBIR or STTR award, your company must meet the core SBA criteria:

• Organized for profit, with a place of business located in the United States, and the primary research performed in the United States

• More than 50 percent directly owned and controlled by one or more individuals who are U.S. citizens or permanent resident aliens, by other for-profit small business concerns each majority owned by such individuals, or by a combination. Certain venture capital, hedge fund, and private equity structures may qualify for SBIR under specific conditions, and Tribal, Alaska Native Corporation, Native Hawaiian Organization, and joint venture paths exist. Complex cap tables should be checked against 13 CFR Part 121.

• No more than 500 employees including all affiliates. A subsidiary counts its parent's employees.

• For SBIR, the Principal Investigator's primary employment must be with the small business at the time of award and for the duration of the project. For STTR, the PD/PI may be primarily employed by either the small business or the partnering nonprofit research institution, with the award still made to the small business.

• For SBIR Phase I, the small business must perform at least two thirds of the research or analytical effort. For SBIR Phase II, at least half. For STTR, the small business performs at least 40 percent and a single partner nonprofit research institution performs at least 30 percent.

Additional constraints that matter on a topic this broad. NIH will not accept similar applications with essentially the same research focus from the same applicant organization, including derivative applications proposing a single product that can be applied to multiple purposes with non-substantive modification. You may not simultaneously submit identical or essentially identical applications under both parent announcements. Duplicate or highly overlapping applications under simultaneous review are not accepted. Applicants must disclose overlapping federal work under the essentially equivalent work rule. Companies with a substantial award history should confirm they meet the Phase I to Phase II Transition Rate and commercialization benchmarks, which can restrict new Phase I, Fast-Track, and Direct to Phase II eligibility for one year. Heightened screening of foreign ownership and foreign influence applies under the 2026 reauthorization, with additional scrutiny possible for STTR because of the research institution partnership.

What a Competitive Application Looks Like

1. A shared-factor story, not a single-condition story. The topic's central argument is that comorbidities share upstream pathways and risk factors. A product addressing a shared factor with consequences across multiple downstream conditions is answering the question asked. A single-indication tool is answering a different one.

2. The right Institute, confirmed by a call. Twelve awarding Institutes with different missions, different budget ceilings, and different clinical trial policies. The program officer conversation determines assignment, budget realism, and whether your design is even reviewable. On this topic that call is worth more than on almost any other.

3. A clinical trial determination made early. Review the NIH Clinical Trial Definition against your actual design before choosing a mechanism and Institute. Behavioral and care delivery interventions frequently meet the definition when founders assume they do not, and NIAMS, NIDCR, NIAID, and NIDDK all carry restrictions.

4. Validation against existing NIH resources. The topic explicitly encourages use of existing resources, and the MAHA alignment names specific longitudinal cohorts. Proposing to validate against an existing resource is cheaper, faster, and more responsive than proposing new recruitment.

5. A sustainability and payer argument, not just a care model. The topic asks for scalable, sustainable care models. For a company that means naming who pays after the grant ends: reimbursement pathway, health system purchaser, or payer. Academic applications will treat sustainability as an aspiration. Treating it as a business model is your advantage.

6. Community engagement that is documented, not asserted. Meaningful community engagement is strongly encouraged throughout the topic. Letters, agreements, and named partners carry weight. A stated intention does not.

7. An interdisciplinary team that survives the eligibility rules. Multiple PD/PIs with complementary expertise are encouraged, but SBIR employment rules still bind. Build the team and confirm the structure with program staff in the same step.

Common Reasons Applications Miss

• Treating the Highlighted Topic as a NOFO and searching Grants.gov for a topic-specific number that does not exist

• Submitting on an AIDS due date of January 7, May 7, or September 7, which HHS does not accept for SBIR or STTR applications

• Proposing a clinical trial to NIAMS or NIDCR, which accept none under either parent announcement, making the application non-responsive and unreviewed

• Proposing a clinical trial to NIAID or NIDDK through STTR, which neither accepts, when SBIR would have worked

• Assuming a behavioral or care delivery intervention is not a clinical trial without checking the NIH Clinical Trial Definition

• Pursuing SBIR when the scientific lead holds a primary academic appointment, where STTR permits that PD/PI arrangement and SBIR does not

• Bringing an academic research project to a small business mechanism, where the deliverable is knowledge rather than a commercial product the company will own and sell

• Targeting NICHD without a program officer conversation, since NICHD published no areas of interest for this topic

• Budgeting to the $700,000 Phase I ceiling rather than the roughly $400,000 that Institutes actually award, or ignoring NIAID's per-year constraint of $1,000,000 in total costs

• Omitting the fee from the budget or requesting the wrong level, neither correctable after submission

• Citing all eight MAHA alignments rather than the one or two that fit, which reads as unfocused

• Starting federal registrations after drafting begins, then missing the receipt date on an eRA Commons validation error

Frequently Asked Questions

Is this a grant I can apply to directly?

No. This is an NIH Highlighted Topic, which is a statement of scientific priority rather than a Notice of Funding Opportunity. You apply through a broad NIH announcement, and for small businesses that means the NIH SBIR or STTR parent announcement, requesting assignment to one of the twelve awarding Institutes.

Which funding opportunity number do I actually use?

For most small businesses it is PA-27-100, the NIH, CDC, and FDA Parent SBIR announcement covering R43 and R44 awards. If your project depends on a formal university or nonprofit research partner, use PA-27-102, the Parent STTR announcement covering R41 and R42. Confirm the active number at submission, since PA-27-100 closes in early April 2027 while this topic runs to July 2028.

When is the deadline, and do the AIDS due dates apply?

There is no deadline specific to this topic. You submit on the NIH standard small business receipt dates of January 5, April 5, and September 5, with dates falling on weekends or federal holidays moving to the next business day. The AIDS and AIDS-related due dates of January 7, May 7, and September 7 do not apply, because HHS does not accept SBIR or STTR grant applications on those dates. The topic expires July 28, 2028, making April 5, 2028 the final available cycle.

Which of the twelve Institutes should I target?

Group by what you sell. Diagnostics and screening point to NHLBI, NCI, NIDCR, or NIDDK. Therapeutics point to NCI, NIAID, NIAAA, NIDA, or NIA. Software and care delivery point to NIMH, NIDA, NIA, NIDDK, or NIAMS. Complementary and integrative health points to NCCIH. NIDA is the only Institute that stated both that it may dedicate funds and that it may give special consideration, which makes it a strong default where the fit is genuine.

How much money can my company request?

The SBA statutory guidelines this cycle are $323,090 for Phase I and $2,153,927 for Phase II in total costs, including direct costs, indirect costs, and fee. Institute limits differ substantially. Several Institutes in this topic list Phase I headroom to $700,000, NCI publishes waiver guidance near $400,000 for Phase I and $2,250,000 for Phase II, NIDDK publishes $350,000 and $2,200,000, NIAAA caps near $385,000 and $3 million, and NIAID applies a per-year constraint of $1,000,000 in total costs on Phase II and Phase IIB. Confirm with your target Institute before setting a budget.

Can I include a clinical trial in my application?

It depends entirely on the Institute and the mechanism. Under the parent SBIR announcement, NIAMS and NIDCR do not accept clinical trials. Under the parent STTR announcement, NIAID, NIAMS, NIDCR, NIDDK, and NIMHD do not. An application proposing a clinical trial that aligns only with an excluded component is non-responsive and will not be reviewed. Check the NIH Clinical Trial Definition against your design first, because many behavioral and care delivery interventions meet it.

My scientific lead is a university faculty member. Can we still apply?

Yes, through STTR. Under the parent STTR announcement the Program Director or Principal Investigator may be primarily employed by either the small business or the partnering nonprofit research institution, while the award still goes to the small business. SBIR requires the PI's primary employment to be with the company. Given how much of the HIV comorbidity field sits in academic clinical settings, this is often the deciding factor on mechanism.

The topic encourages multiple Principal Investigators. Does SBIR allow that?

NIH small business awards do permit multiple Program Director and Principal Investigator structures, but the employment requirements still apply. Because the interaction between a multi-PI team and the primary employment rule can create an eligibility problem, confirm the specific structure with your target Institute's program staff before building the team into the application.

How long until I receive funding?

Plan on approximately 9 months from submission to award start. An application submitted in the January 2027 cycle would typically have an earliest possible start date in the fall of 2027.

Do I have to give up equity or match the funds?

No. NIH SBIR and STTR Phase I and Phase II awards are non-dilutive and require no cost share. The exception is the Phase IIB Strategic Breakthrough Award, which requires not less than 100 percent matching funds from new private capital or from a government source other than a Phase I or Phase II SBIR or STTR award.

Is this topic really a fit for a small business, or is it academic research?

Both, and the distinction matters. Cohort analysis, mechanistic basic science, epidemiological characterization, and academically led community trials belong in R01 and related mechanisms. Genuine small business lanes include subclinical disease detection, biomarkers and diagnostics, therapeutics, medication optimization and drug interaction tools, care coordination and clinical decision support software, point-of-care coinfection testing, and integrated behavioral health delivery platforms. The test is whether there is a commercial product with unresolved technical risk that the company will own and sell.

Does any Institute set aside dedicated funding for this topic?

Not guaranteed, but four made statements. NIDA stated both that it may dedicate available funds and that it may give special consideration. NHLBI stated it may dedicate available funds. NCCIH and NIDCR each stated they may give special consideration. The remaining eight awarding Institutes made neither statement. Treat these as a favorable tilt rather than a reserved pool.

Why does NICHD list no areas of interest?

NICHD participates in this topic but published only a scientific contact rather than stated interests. The topic body does note elevated immune, metabolic, and developmental risks in HIV-exposed but uninfected children, particularly in low and middle-income settings. With no published language to write against, a program officer conversation is essential before investing in a NICHD-targeted application.

I already have feasibility data. Do I still need a Phase I?

Not necessarily. SBIR Direct to Phase II allows a company that has demonstrated the scientific and technical merit and feasibility normally expected from a Phase I, without having received a Phase I award for that project, to apply directly for Phase II. This authority is available for SBIR only and is not available under STTR.

Do OAR, OBSSR, ODP, ORWH, and THRO award grants?

No. All five participate without awarding. Your application must be relevant to the objectives of at least one awarding Institute. OAR does serve as the central scientific contact for the topic, which makes it a useful first call if you are unsure which of the twelve Institutes fits your technology.

What registrations do I need, and how long do they take?

SAM.gov with a Unique Entity ID, the SBA Company Registry, eRA Commons, and Grants.gov. eRA Commons access depends on completing the SBA Company Registry first, so the sequence matters. Allow at least six weeks, and start before you begin writing.

How BW&CO Helps

BW&CO is a non-dilutive federal funding advisory firm. We help deep-tech, biotech, medtech, and health technology founders convert agency priority signals like this one into funded awards.

This topic has twelve awarding Institutes, four different clinical trial policies, and budget ceilings that range from the statutory guideline to $700,000 at Phase I. Most of the value is created before drafting begins: honest fit assessment, Institute selection and assignment strategy, clinical trial determination and mechanism choice, program officer engagement, multi-PI structure review against eligibility rules, Specific Aims development, full proposal build, budget and fee construction, commercialization and sustainability planning, and Phase IIB matching capital positioning. Our team has helped clients secure more than $350 million in funding. Innovation Funding Simplified.

If you are building a product for people with HIV and want a straight answer on whether this topic fits your company, which Institute to target, and whether you are competitive for the January 5, 2027 cycle, contact us for a fit assessment.

NIH Highlighted Topic: Accelerating Disease Prevention Research by New Approach Methodologies

Executive Summary

The National Institutes of Health has published a Highlighted Topic titled "Accelerating Disease Prevention Research by New Approach Methodologies." It signals that four NIH awarding components, the National Cancer Institute (NCI), the National Center for Advancing Translational Sciences (NCATS), the National Institute on Aging (NIA), and the National Institute on Drug Abuse (NIDA), want to fund the development, validation, and use of human-relevant New Approach Methodologies that model precursor conditions and the process by which those conditions progress into overt disease.

The gap NIH names is specific and narrow. NAMs exist. NAMs that model precursor states, things like precancer, prediabetes, and preclinical Alzheimer's disease, and that capture the dynamics of progression rather than a static snapshot, do not exist in sufficient number. NIH calls this a high-priority unmet need. If your platform can model a disease before it becomes a disease, you are inside the target.

For a small business, the practical translation is this: there is no new application portal and no new deadline attached to this topic. A Highlighted Topic is a demand signal, not a Notice of Funding Opportunity. You capture the funding by submitting to the NIH SBIR or STTR parent announcement, requesting assignment to whichever of the four Institutes best fits your science, and aligning your Specific Aims to that Institute's stated areas of interest.

The topic was posted on September 3, 2026 and expires on September 3, 2028. Budget guidance varies substantially by Institute, which is the single most consequential planning fact on this page. The SBA statutory guidelines for the current cycle are $323,090 for Phase I and $2,153,927 for Phase II, but the participating component table in the parent SBIR announcement lists Phase I limits as high as $700,000 for NCI and NIA, while NCATS operates at the statutory guideline.

If you build organoids, microphysiological systems and organ-on-a-chip platforms, iPSC-derived tissue or immune models, bioengineered human tissues, advanced biomaterials for human-derived models, in silico or AI-based predictive models, or combinatorial NAMs, this is one of the broadest and best-signposted funding openings NIH has published for the tools and platforms community.

At a Glance

• Topic title: Accelerating Disease Prevention Research by New Approach Methodologies

• Issuing agency: National Institutes of Health, U.S. Department of Health and Human Services

• Awarding components: NCI, NCATS, NIA, and NIDA

• Non-awarding participating offices: ORWH, the Office of Autoimmune Disease Research in ORWH (OADR-ORWH), and the Tribal Health Research Office (THRO)

• Type: NIH Highlighted Topic. This is not a Notice of Funding Opportunity.

• Post date: September 3, 2026

• Expiration date: September 3, 2028

• Recommended small business mechanism: NIH SBIR (R43 and R44) or NIH STTR (R41 and R42) parent announcement

• Current parent announcements: PA-27-100 for SBIR, PA-27-102 for STTR, PA-27-101 for the Phase IIB Strategic Breakthrough Award, and PAR-27-098 for the Commercialization Readiness Pilot

• Standard annual due dates: January 5, April 5, and September 5

• SBA statutory guidelines this cycle: $323,090 Phase I, $2,153,927 Phase II, $4,191,495 CRP

• Component Phase I limits in the parent SBIR table: up to $700,000 for NCI and NIA, with NCATS at the statutory guideline. Confirm with the Institute before budgeting above the guideline.

• Cost share: none for Phase I or Phase II. Phase IIB requires 100 percent third-party matching funds.

• Equity dilution: none. This is non-dilutive federal funding.

• Profit or fee: allowable, must be in the budget at submission, and normally will not exceed 7 percent of total costs

• Funding signals: NCATS states it may dedicate available funds to this topic area. NIDA states it may give special consideration to meritorious applications in this topic area.

• Small business specific contact: NCI has designated Linda Zane, Ph.D. for small business product development and commercialization of NAMs, reachable at NCI-HT-NAM@nih.gov

• Broader initiative alignment: Make America Healthy Again initiative, New Approach Methodologies effort

What This Opportunity Actually Is

An NIH Highlighted Topic is a published statement of scientific interest from one or more NIH Institutes, Centers, and Offices. It tells the research community that an area of science is a priority without creating a separate funding announcement, a separate deadline, or a separate review process. There is no topic-specific number to search for on Grants.gov, and applications are not reviewed against other applications to the topic.

What it does do for a small business is threefold. It identifies which Institutes are receptive, which determines your assignment request and which program officer you call. It supplies the vocabulary that program staff and reviewers are already using internally, which is what your Specific Aims should mirror. And in two cases here it creates an explicit funding advantage: NCATS states it may dedicate available funds to applications in this topic area depending on the availability of funds, the number of meritorious applications, and competing priorities, and NIDA states it may give special consideration to meritorious applications in the topic area.

What it does not do is guarantee a set-aside or bypass peer review. Your application competes on scientific merit through the standard NIH study section route, and the topic language is a positioning advantage rather than a shortcut.

Which Institute Should You Target?

This is the decision that matters most on this topic, because four awarding components with materially different missions and budget ceilings are participating, and your assignment request determines which one reads your application.

NCI, if your work touches precancer or cancer prevention. NCI published the most detailed and most product-oriented set of interests here, covering human-derived precancerous organoids, iPSC-derived and bioengineered human tissue and immune system models of tumorigenesis, advanced biomaterials enabling human-derived NAMs, NAMs for discovery of preventive, interceptive, or reversive agents, NAMs for biomarker discovery supporting early detection and risk stratification, and microphysiological and combinatorial NAMs for predicting human safety and toxicity of candidate prevention agents. NCI also listed eight named scientific contacts for this topic, including one specifically for small business product development and commercialization of NAMs. That is an unusually strong signal that NCI expects and wants small business applications here.

NCATS, if your platform is disease-agnostic. NCATS is interested in NAMs that reveal the mechanisms of drug-induced organ injury so those reactions can be prevented before clinical symptoms emerge. The framing is deliberately not tied to one disease, which makes this the right door for a platform company whose technology is a tool rather than a disease model. NCATS asks for innovative, scalable, and reproducible platforms that enable earlier intervention, reduce reliance on traditional animal models, and generate broadly applicable knowledge. Note that scalability and reproducibility are named explicitly, which for a small business means manufacturing consistency and assay robustness are scientific aims, not afterthoughts.

NIA, if your work concerns aging, resilience, or dementia. NIA wants NAMs that identify biomarkers, protective pathways, and preventive therapeutics for age-related conditions including Alzheimer's disease and related dementias. Its interests include person-specific, cross-species, and combinatorial NAMs; neuronal and peripheral tissue NAMs derived from individuals with exceptional longevity, cognitive superagers, or people showing resistance or resilience to AD and ADRD, used to identify protective pathways and test whether those pathways can reduce or reverse disease phenotypes in patient-derived iPSCs; and in silico NAMs that model behavioral, cognitive, and functional phenotypes alongside extrinsic risk factors. The resilience donor angle is distinctive and worth noting: NIA is asking for models built from people who did not get sick.

NIDA, if your work concerns addiction biology or substance use. NIDA seeks human-relevant NAMs that accelerate addiction research and intervention discovery, including iPSCs, organoids, and bioengineered tissues that identify molecular changes induced by addictive drugs and mechanisms of vulnerability; tools and methods including in silico models that integrate and analyze epidemiological and electronic health record data to surface mechanisms, biomarkers, and candidate drugs; and NAMs that decipher interactions between biological factors such as age and sex, behavioral factors such as exercise, and environmental factors such as nutrition and substance exposure. NIDA's inclusion of data integration work makes this the most software-friendly of the four.

If your technology plausibly fits more than one, contact more than one program officer before choosing. Assignment requests are not binding on NIH, but an application written to a specific Institute's language and referred elsewhere reads as a poor fit to whoever receives it.

Which NIH Mechanism Should a Small Business Use?

Small businesses should apply through the NIH SBIR or STTR parent announcement and request assignment to the Institute whose interests match.

NIH Parent SBIR, currently PA-27-100 (R43 and R44). The default route for most companies. It accepts Phase I, Phase II, Direct to Phase II, and Fast-Track applications. Use it when your company performs the majority of the research and your Principal Investigator is primarily employed by the company.

NIH Parent STTR, currently PA-27-102 (R41 and R42). Use this when the project depends on a formal partnership with a U.S. nonprofit research institution. STTR requires at least 40 percent of the research at the small business and at least 30 percent at a single partner institution. This is the natural route for a company commercializing licensed organoid, iPSC, or microphysiological system technology where the originating academic lab retains essential capability, and for projects needing access to donor cohorts such as NIA's exceptional longevity and resilience populations.

Direct to Phase II. If you already have the feasibility data a Phase I would generate, and you never received a Phase I award for that project, you can apply straight to Phase II. This authority is SBIR only and is not available under STTR. Many NAMs companies with a validated platform in one disease context and new data in a precursor context are strong candidates here.

Fast-Track. Phase I and Phase II submitted together and reviewed once. It compresses the funding gap but requires a fully developed Phase II plan at first submission. Poor fit when Phase I results would change the Phase II design, which is common in early model development where the qualification strategy depends on what the first characterization shows.

Phase IIB Strategic Breakthrough Award, currently PA-27-101 (R44). For companies that have completed an NIH SBIR or STTR Phase II and need to bridge to commercialization. Requires documentation of not less than 100 percent matching funds from new private capital or from a government source other than a Phase I or Phase II SBIR or STTR award. Budget guidance varies by participating Institute.

Commercialization Readiness Pilot, currently PAR-27-098 (SB1). Funds late-stage technical assistance and product development that Phase II and Phase IIB cannot support, including specialized regulatory and qualification work. It permits more outsourcing than other mechanisms, though the small business must retain substantial project management and oversight. Note that NCI caps its CRP support well below the government-wide CRP figure, so contact NCI SBIR program staff before planning a CRP budget.

Funding Allowance

The ceiling on this topic depends on two layers, and on this particular topic the second layer varies more than usual because four Institutes are involved.

Layer one, the SBA statutory guidelines for the current cycle:

• Phase I: up to $323,090 in total costs, for a project period of 6 months to 2 years

• Phase II: up to $2,153,927 in total costs, for a project period of 1 to 3 years

• Commercialization Readiness Pilot: up to $4,191,495 in total costs, for a project period of up to 3 years

Total funding support means direct costs, indirect costs, and fee combined. A reasonable profit or fee is allowable on SBIR and STTR awards, but it must be built into the budget at the time of application and normally will not exceed 7 percent of total costs. NIH does not adjust budgets after submission, so a budget requested at the wrong level cannot be corrected later.

Layer two, Institute-specific guidance. NIH holds SBA waivers permitting awards above the statutory guideline for specific approved topics, and each Institute publishes its own limits. For the four awarding components here:

• NCI. The participating component table in the parent SBIR announcement lists a Phase I limit as high as $700,000. NCI's own program descriptions state that for waiver-eligible topics it generally funds Phase I applications up to $400,000 in total costs across up to 2 years, and will consider Phase II applications up to $2,250,000 across up to 3 years. NCI also runs a Phase IIB Bridge Award and caps its CRP support well below the government-wide figure.

• NIA. Listed among the components with a Phase I limit as high as $700,000 in the parent announcement table.

• NCATS. Operates at the stated statutory guideline rather than a waivered higher limit.

• NIDA. Publishes waiver-topic guidance permitting Phase I requests above the standard guideline with a project period up to 1 year, and Phase II requests up to $2.5 million with a project period up to 3 years, where the research falls within NIDA's approved waiver topics and the justification is adequate.

Two cautions on the headroom. First, the ceiling in a component table is not the number that gets awarded. BW&CO's own analysis of a fiscal year 2026 NCI SBIR award slice found Phase I level awards ranging from roughly $305,000 to $404,000, with not one award in 44 records using the $700,000 headroom. The realistic planning number for an NCI SBIR Phase I is closer to $400,000. Building a program plan around a waivered Phase I budgets against an outcome that did not occur. Second, an Institute may reduce the recommended budget or shorten the award period for budgetary, administrative, or programmatic reasons even after a strong review score.

The practical instruction is the same across all four: identify your target Institute, then contact its program staff with a draft Specific Aims page before you set the budget. Institutes generally do not pre-approve budget waivers, but they will tell you whether your topic is waiver-eligible and whether the number you have in mind is realistic.

Timeline

The Highlighted Topic window runs from September 3, 2026 through September 3, 2028. Within that window you submit against the NIH standard small business receipt dates.

Standard annual due dates: January 5, April 5, and September 5. When a due date falls on a weekend or federal holiday, NIH moves it to the next business day. Applications are due by 5:00 p.m. local time of the applicant organization.

Cycles available under this topic:

• September 2026 cycle: the September 5, 2026 date shifted to Tuesday, September 8, 2026 because of the weekend and the Labor Day holiday. Since the topic posted on September 3, this cycle is not realistically available.

• January 5, 2027: the first realistic cycle for a company beginning preparation now.

• April 5, 2027

• September 5, 2027

• January 5, 2028

• April 5, 2028, the last full cycle before the topic expires in September 2028.

What the runway looks like: plan on roughly 9 months from submission to funds in the door. An application submitted in the January 2027 cycle typically reaches an earliest possible start date in the fall of 2027. Council decisions for the September and January cycles are often handled together, which is one reason experienced applicants do not treat deferring a cycle as costless.

Work backwards from your target date:

• 14 to 16 weeks out: identify your target Institute, contact its program officer, confirm responsiveness and waiver eligibility, and start or verify federal registrations

• 12 weeks out: lock the Specific Aims page and circulate it to program staff

• 8 weeks out: complete the research strategy, the commercialization plan, letters of support, and any donor cohort or tissue sourcing agreements

• 4 weeks out: full internal review, budget finalization, and subaward paperwork for any STTR or academic partner

• 1 week out: submit early to leave room for eRA Commons error correction

Registrations are the most common cause of a missed deadline. You need SAM.gov with a Unique Entity ID, the SBA Company Registry, eRA Commons, and Grants.gov. eRA Commons access depends on the SBA Company Registry being complete first. Allow six weeks or more and begin before you write anything.

Also note that parent announcements are reissued periodically. The current SBIR parent, PA-27-100, carries a closing date in early April 2027, well before this topic expires, so applicants targeting later cycles must confirm the active announcement number at the time of submission.

Detailed Overview of What NIH Is Looking For

The problem NIH is trying to solve

The topic's premise is that prevention research is bottlenecked by a missing class of research tools. Beyond established risk-reduction strategies such as lifestyle change and smoking cessation, NIH argues that studying the etiologic processes by which precursor conditions initiate and progress opens new prevention opportunities: actionable targets, biomarkers for early detection and risk stratification, and therapeutics designed to prevent or intercept precursors before they become manifest disease, or even to revert them to normal.

NIH is direct about why animal models alone will not get there. Animal models remain vital, and nearly every modern pharmaceutical agent reached human clinical data on the strength of animal data, but only about 10 percent of agents entering clinical trials obtain regulatory approval. NIH attributes this to inadequate drug target validation, absent human efficacy, and unmanageable toxicity, and argues that human-relevant research tools designed to bridge interspecies differences in pathophysiology, environmental exposure, and disease characteristics, combined with in silico and AI-based tools, can improve the predictability of human efficacy and safety.

The specific gap is stated plainly: there is a scarcity of NAMs designed to mimic precursor conditions and the dynamic process of disease progression in humans. Development, validation, and integrated use of such NAMs is described as a high-priority unmet need across cancer and other chronic diseases, which NIH notes are frequently interconnected.

Read strategically, that sentence contains three requirements most applications will only partially satisfy. The model must represent a precursor state rather than established disease. It must capture progression as a process rather than a static endpoint. And NIH wants development, validation, and integrated use, which means a proposal that builds a model without a qualification and application strategy is answering one third of the question.

What counts as a NAM here

The topic states that NAMs within its scope may include, but are not limited to, microphysiological systems such as organ-on-a-chip, 2D and 3D tissue systems, bioengineered human tissue models, in silico NAMs, and combinatorial NAMs. The named precursor examples are precancerous conditions, prediabetes, and preclinical Alzheimer's disease.

The inclusion of in silico and combinatorial NAMs matters commercially. A company with no wet lab can be responsive here through computational modeling and data integration, and a company that pairs a physical model with a computational layer is directly addressing the combinatorial category NIH names in every one of the four Institute sections.

NCI areas of interest

NCI seeks NAMs that accelerate research on precancer biology, cancer prevention, and the discovery of prevention and interception interventions. Its listed interests, which it states are not exhaustive, are human-derived precancerous organoids or other NAMs that help identify molecular mechanisms of precancer growth and exploitable targets for high-risk precancer interception; iPSC-derived or other bioengineered human tissue and immune system models mimicking aspects of human tumorigenesis; advanced biomaterials enabling innovative human-derived NAMs for precancer research; NAMs for discovery of cancer preventive, interceptive, or reversive agents; NAMs for biomarker discovery supporting early detection, efficacy evaluation, and risk stratification; and microphysiological and other combinatorial NAMs to predict human safety and toxicity of candidate agents for cancer prevention and interception.

What this tells you: NCI has decomposed the space into discovery tools, agent screening, biomarker discovery, and safety prediction, and named a separate scientific contact for nearly each one, plus contacts for pharmaceutical agent development, cancer dormancy and recurrence, and small business product development. The presence of the word "reversive" alongside preventive and interceptive is notable. NCI is signaling interest in agents that reverse precursor lesions, not only ones that halt them, and very few applications will propose a reversion endpoint.

NCATS areas of interest

NCATS is advancing disease-agnostic research using NAMs to understand and ultimately prevent drug-induced organ injury. It encourages human-based in vitro and in silico NAMs that illuminate the factors contributing to drug-induced organ injury so those reactions can be avoided or prevented, revealing actionable prevention mechanisms before clinical symptoms emerge. Its scientific interests center on innovative, scalable, and reproducible NAMs platforms that enable earlier interventions, reduce reliance on traditional animal models, and generate broadly applicable knowledge that helps treat and prevent disease onset and promotes long-term health across different populations.

What this tells you: NCATS is the only one of the four framed around a safety and toxicity problem rather than a disease. If your platform predicts organ injury, hepatotoxicity, nephrotoxicity, cardiotoxicity, or neurotoxicity, this is your door, and the disease-agnostic framing means you do not need a disease indication to be responsive. NCATS is also the Institute here that stated it may dedicate available funds to the topic area. The words scalable and reproducible should appear in your aims with data behind them.

NIA areas of interest

NIA seeks NAMs that identify biomarkers, protective pathways, and preventive therapeutics for age-related conditions and diseases including Alzheimer's disease and related dementias, through studies of aging biology and the intrinsic and extrinsic factors underlying resilience. Its listed interests are person-specific, cross-species, and combinatorial NAMs for biomarker discovery, identification of preventive therapeutics and interventions for age-related conditions and AD or ADRD, and prediction of safety and toxicity; neuronal and peripheral tissue NAMs derived from individuals with exceptional longevity, cognitive superagers, or individuals with resistance or resilience to AD and ADRD, used to identify protective pathways and test their ability to reduce or reverse disease phenotypes in iPSCs from patients with AD or ADRD; and in silico NAMs modeling behavioral, cognitive, and functional phenotypes along with extrinsic factors influencing disease risk and resilience.

What this tells you: NIA has described a specific experimental architecture, not just a technology category. Take tissue from people who resisted the disease, find the protective pathway, then test that pathway in patient-derived cells. A proposal that runs that full arc is unusually well matched. The phrase person-specific also signals interest in individualized rather than pooled models. And NIA is one of the components listed with Phase I headroom as high as $700,000 in the parent announcement table.

NIDA areas of interest

NIDA seeks human-relevant NAMs that accelerate research on addiction biology, substance use prevention, and intervention discovery. Its listed interests are human-derived iPSCs, organoids, bioengineered tissues, or other NAMs to identify molecular changes induced by addictive drugs and mechanisms contributing to addiction vulnerability; development and application of tools and methods, including in silico models, to integrate and analyze data from sources including epidemiological data and electronic health records in order to identify mechanisms, biomarkers, and candidate drugs for prevention, early intervention, and treatment of substance use disorders; and application of NAMs to decipher interactions among biological factors such as age and sex, behavioral factors such as exercise, and environmental factors such as nutrition and exposure to drugs and other substances that influence the trajectory of addiction and its comorbidities.

What this tells you: NIDA is the most accommodating of the four for data and software companies, because it explicitly invites electronic health record and epidemiological data integration as a NAM activity. NIDA also stated it may give special consideration to meritorious applications in this topic area. The gene by environment by behavior interaction framing is a distinctive third bullet that most applicants will skip.

What the non-awarding offices add

ORWH, OADR-ORWH, and THRO participate but do not award grants. Your application must be relevant to the objectives of at least one participating Institute or Center, which here means NCI, NCATS, NIA, or NIDA. Their stated interests function as scoring advantages layered on top of your primary Institute fit.

ORWH seeks NAMs relevant to women's health, specifically human-derived NAMs modeling hormone homeostasis across the life course and sex influences on precursor conditions and disease progression; biomarker identification in human-derived NAMs for early detection, prevention, translation, or risk stratification of conditions prevalent in females; evaluation of sex differences in human-derived organoids, microphysiological systems, iPSC-derived models, and other bioengineered tissues; and human microphysiological or combinatorial NAMs predicting safety and toxicity in female-relevant contexts.

OADR-ORWH is interested in projects using human-derived organoids, iPSCs, or other bioengineered human tissue and immune system models to investigate pre-clinical and established autoimmunity.

THRO supports NAMs development and use to prevent disease progression in American Indian and Alaska Native communities, encouraging models of diseases that disproportionately affect AI/AN populations such as diabetes and cancer. THRO adds a requirement that most applicants will not be able to satisfy retroactively: research should be culturally grounded and involve AI/AN communities and practices as much as possible. If you intend to claim THRO alignment, community partnership must be real and documented in the application, not asserted.

Practical read: sex differences are the cheapest and most defensible of these to build in, because evaluating sex differences in an existing model architecture is a design decision rather than a new capability. Doing it deliberately, with powered comparisons rather than a minimal sex-as-a-biological-variable statement, distinguishes an application at almost no cost.

MAHA and NAMs policy alignment

This topic is issued as part of the Make America Healthy Again initiative and aligns specifically with the New Approach Methodologies effort, under which expanded NAMs use is expected to enable earlier and more predictive insight into chronic disease mechanisms through human-relevant models such as organoids, computational simulations, and real-world data integration, improving prevention, diagnosis, and personalized treatment while reducing reliance on animal studies that often fail to replicate complex human conditions. EPA, FDA, and NIH have all committed to using NAMs going forward where appropriate.

The framing consequence is significant and specific to this topic. On most NIH applications, a preclinical package light on animal data is a weakness to be explained. Here, replacing animal work with a qualified human-relevant model is the point of the solicitation. Do not apologize for the absence of animal studies. Argue affirmatively that your model predicts human outcomes better, and cite the tri-agency commitment as the policy context that makes a qualified NAM a durable asset rather than a research curiosity.

Eligibility Requirements

To apply for an NIH SBIR or STTR award, your company must meet the core SBA criteria:

• Organized for profit, with a place of business located in the United States, and the primary research performed in the United States

• More than 50 percent directly owned and controlled by one or more individuals who are U.S. citizens or permanent resident aliens, by other for-profit small business concerns each majority owned by such individuals, or by a combination. Certain venture capital, hedge fund, and private equity ownership structures may qualify for SBIR under specific conditions, and Tribal, Alaska Native Corporation, Native Hawaiian Organization, and joint venture paths exist. Complex cap tables should be checked against 13 CFR Part 121 rather than assumed either way.

• No more than 500 employees, including all affiliates. A subsidiary counts its parent's employees.

• For SBIR, the Principal Investigator's primary employment must be with the small business at the time of award and for the duration of the project. For STTR, the PI may be primarily employed by the small business or by the partnering research institution.

• For SBIR Phase I, the small business must perform at least two thirds of the research or analytical effort. For SBIR Phase II, at least half. For STTR, the small business performs at least 40 percent and a single partner nonprofit research institution performs at least 30 percent.

Companies with a substantial history of prior awards should confirm they meet the SBIR and STTR Phase I to Phase II Transition Rate and commercialization benchmarks, which can restrict new Phase I, Fast-Track, and Direct to Phase II eligibility for a period of one year. Applicants must also disclose overlapping federal work under the essentially equivalent work rule, which is a certification matter rather than a footnote. Heightened screening of foreign ownership and foreign influence applies under the 2026 reauthorization, and STTR applicants can face additional scrutiny because of the research institution partnership.

What a Competitive Application Looks Like

The trap on this topic is that NAMs are fashionable. NIH has funded organoids, microphysiological systems, and in silico models for years, and reviewers will have seen many applications proposing a model. The topic is not asking for a model. It is asking for a model of a precursor condition that captures progression, validated well enough to be used.

1. A precursor state, not a disease state. If your model represents established pathology, reframe it or propose the precursor version. Precancer, prediabetes, and preclinical Alzheimer's disease are the named examples, and the equivalent precursor in your indication is what NIH is asking for.

2. Progression as a measured process. NIH asks for the dynamic process of disease progression. That means longitudinal readouts and transition endpoints, not a single characterized timepoint. A model that shows a precursor becoming something else is answering the question a static model cannot.

3. A qualification and validation strategy, not just construction. The topic asks for development, validation, and integrated use. State what human outcome your model is claimed to predict, how you will demonstrate that predictivity, and against what reference data. This is also what makes the platform sellable, so it doubles as commercialization substance.

4. Scalability and reproducibility with data behind them. NCATS names both explicitly, and every buyer of a NAM platform, whether pharma or regulator, asks the same question. Batch-to-batch variability, operator independence, and throughput are legitimate Phase I aims.

5. A named customer and a regulatory posture. NIH small business awards are product development awards. For a NAMs platform the customer is usually a pharmaceutical developer, a CRO, or a regulator, and the value proposition is a decision they can make earlier or more confidently. Reference the FDA and EPA commitment to NAMs as the demand-side context.

6. Program officer contact before writing. With four Institutes, this is not optional here. The conversation determines your assignment request, tells you whether your topic is waiver-eligible for a larger budget, and surfaces overlap with existing awards. NCI has designated a small business product development contact for this topic specifically.

Common Reasons Applications Miss

• Treating the Highlighted Topic as a NOFO and hunting Grants.gov for a topic-specific number that does not exist

• Proposing a model of established disease when the topic asks for precursor conditions

• Proposing a static model when the topic asks for the dynamic process of progression

• Building the model and stopping there, with no validation, qualification, or use case, which answers one third of what the topic requests

• Leaving the assignment request blank or picking the wrong Institute, so the application is read by a component with no stake in the science

• Budgeting to the $700,000 component ceiling rather than the roughly $400,000 that Institutes actually award at Phase I

• Omitting the fee from the budget, or requesting the wrong level, neither of which can be corrected after submission

• Claiming THRO alignment without documented AI/AN community partnership

• Treating the absence of animal data as a weakness to apologize for rather than the point of the solicitation

• Starting federal registrations after drafting begins, then missing the receipt date on an eRA Commons validation error

Frequently Asked Questions

Is this a grant I can apply to directly?

No. This is an NIH Highlighted Topic, which is a statement of scientific priority rather than a Notice of Funding Opportunity. You apply through a broad NIH announcement, and for small businesses that means the NIH SBIR or STTR parent announcement, requesting assignment to one of the four participating Institutes.

Which funding opportunity number do I actually use?

For most small businesses it is PA-27-100, the NIH, CDC, and FDA Parent SBIR announcement covering R43 and R44 awards. If your project requires a formal university or nonprofit research partner, use PA-27-102, the Parent STTR announcement covering R41 and R42. Confirm the active number at the time you submit, since PA-27-100 closes in early April 2027 while this topic runs through September 2028.

Which of the four Institutes should I target?

NCI for precancer biology and cancer prevention or interception. NCATS for disease-agnostic platforms addressing drug-induced organ injury. NIA for aging, resilience, Alzheimer's disease and related dementias. NIDA for addiction biology, substance use, and data integration approaches. If your technology fits more than one, contact multiple program officers before choosing, because your assignment request shapes who reviews the application.

How much money can my company request?

The SBA statutory guidelines this cycle are $323,090 for Phase I and $2,153,927 for Phase II in total costs, including direct costs, indirect costs, and fee. Institute limits differ: the parent SBIR component table lists Phase I limits as high as $700,000 for NCI and NIA, while NCATS operates at the statutory guideline. In practice, NCI Phase I awards have clustered around $400,000 rather than at the ceiling. Contact your target Institute before budgeting above the guideline.

When is the deadline?

There is no deadline specific to this topic. You submit on the NIH standard small business receipt dates of January 5, April 5, and September 5 each year, with dates falling on weekends or federal holidays moving to the next business day. The topic expires on September 3, 2028, making January 5, 2027 through April 5, 2028 the realistic competing cycles.

How long until I receive funding?

Plan on approximately 9 months from submission to award start. An application submitted in the January 2027 cycle would typically have an earliest possible start date in the fall of 2027.

Do I have to give up equity or match the funds?

No. NIH SBIR and STTR Phase I and Phase II awards are non-dilutive and require no cost share. The exception is the Phase IIB Strategic Breakthrough Award, which requires not less than 100 percent matching funds from new private capital or from a government source other than a Phase I or Phase II SBIR or STTR award.

What counts as a New Approach Methodology under this topic?

The topic names microphysiological systems such as organ-on-a-chip, 2D and 3D tissue systems, bioengineered human tissue models, in silico NAMs, and combinatorial NAMs, and states the list is not exhaustive. The distinguishing requirement is not the technology type but the subject: the model should represent a precursor condition and the process of progression toward overt disease.

Does my model have to be human-derived?

Human relevance is the consistent thread across all four Institutes, and most listed interests specify human-derived material. NIA is the exception that explicitly includes cross-species NAMs among its interests. If your platform is not human-derived, the burden is to show why it predicts human outcomes better than the animal models NIH says are failing to translate.

Can I include a clinical trial?

The parent SBIR and STTR announcements are clinical trial optional, but acceptance varies by Institute and program, and several Institutes accept clinical trials through SBIR only. Given that this topic centers on preclinical model development, most responsive applications will not involve a clinical trial. If yours does, review the NIH Clinical Trial Definition and confirm with your target Institute, because the definition captures more study designs than founders expect.

Do I still need animal data?

Not necessarily, and on this topic the absence can be a strength. The topic is issued under the New Approach Methodologies effort, in which EPA, FDA, and NIH have committed to using human-relevant models to reduce reliance on animal studies that often fail to replicate complex human conditions. Argue that your model predicts human outcomes better rather than framing missing animal work as a limitation.

Does any Institute set aside dedicated funding for this topic?

Not guaranteed, but two made statements. NCATS states it may dedicate available funds to support applications in this topic area depending on the availability of funds, the number of meritorious applications, and competing priorities. NIDA states it may give special consideration to meritorious applications in the topic area. NCI and NIA made neither statement in this topic. Treat all of this as a favorable tilt rather than a reserved pool.

I already have feasibility data. Do I still need a Phase I?

Not necessarily. SBIR Direct to Phase II allows a company that has demonstrated the scientific and technical merit and feasibility normally expected from a Phase I, without having received a Phase I award for that project, to apply directly for Phase II. This authority is available for SBIR only and is not available under STTR. A validated platform plus new precursor-condition data is a common qualifying profile.

Do ORWH, OADR, and THRO award grants under this topic?

No. All three participate and publish areas of interest, but none awards grants. Your application must be relevant to the objectives of at least one of the awarding Institutes, meaning NCI, NCATS, NIA, or NIDA. Their interests are best used as additional strength within an application already aimed at one of the four.

What registrations do I need, and how long do they take?

SAM.gov with a Unique Entity ID, the SBA Company Registry, eRA Commons, and Grants.gov. eRA Commons access depends on completing the SBA Company Registry first, so the sequence matters. Allow at least six weeks, and start before you begin writing.

How BW&CO Helps

BW&CO is a non-dilutive federal funding advisory firm. We help deep-tech, biotech, medtech, and health technology founders convert agency priority signals like this one into funded awards.

On a topic with four awarding Institutes and four different budget ceilings, the highest-leverage work happens before a word of the application is written. That includes Institute selection and assignment strategy, program officer engagement, waiver eligibility assessment, Specific Aims development, full proposal build, budget and fee construction, commercialization and qualification planning, and Phase IIB matching capital positioning. Our team has helped clients secure more than $350 million in funding. Innovation Funding Simplified.

If you are building a New Approach Methodology and want an honest read on which Institute to target and whether you are competitive for the January 5, 2027 cycle, contact us for a fit assessment.

NIH Highlighted Topic: Novel Technologies to Improve Hormone Replacement Therapies for Type 1 Diabetes

Executive Summary

The National Institutes of Health has published a Highlighted Topic titled "Novel Technologies and Approaches to Improve Hormone Replacement Therapies for Type 1 Diabetes (T1D)." It signals that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), together with the Office of Research on Women's Health (ORWH) and the Office of Autoimmune Disease Research (OADR-ORWH), want to fund investigator-initiated research on mechanical, digital, biological, and biochemical technologies that make hormone replacement for T1D more physiologic, more automated, and more accessible.

For a small business, the practical translation is this: there is no new application portal and no new deadline attached to this topic. A Highlighted Topic is a demand signal, not a Notice of Funding Opportunity. You capture the funding by submitting to the NIH SBIR or STTR parent announcement, naming NIDDK as your assignment request, and aligning your Specific Aims to the topic language below.

The topic was posted on September 2, 2026 and expires on September 2, 2028, which gives small businesses roughly five standard SBIR submission cycles to compete against it. NIDDK generally considers Phase I budgets up to $350,000 and Phase II budgets up to $2,200,000 in total costs, with a Phase IIB pathway up to $3,000,000 for companies that have already completed a Phase II.

If you build cell therapy, gene therapy, closed-loop devices, glucose-responsive insulin or glucagon formulations, or AI-driven diabetes management tools, this is one of the clearest funding signals NIDDK has published for the small business community in this space.

At a Glance

• Topic title: Novel Technologies and Approaches to Improve Hormone Replacement Therapies for Type 1 Diabetes (T1D)

• Issuing agency: National Institutes of Health, U.S. Department of Health and Human Services

• Funding Institute: NIDDK

• Non-awarding participating offices: ORWH and OADR-ORWH

• Type: NIH Highlighted Topic. This is not a Notice of Funding Opportunity.

• Post date: September 2, 2026

• Expiration date: September 2, 2028

• Recommended small business mechanism: NIH SBIR (R43 and R44) or NIH STTR (R41 and R42) parent announcement

• Current parent announcements: PA-27-100 for SBIR, PA-27-102 for STTR, PA-27-101 for the Phase IIB Strategic Breakthrough Award, and PAR-27-098 for the Commercialization Readiness Pilot

• Standard annual due dates: January 5, April 5, and September 5

• NIDDK Phase I guidance: up to $350,000 total costs, project period up to 2 years

• NIDDK Phase II guidance: up to $2,200,000 total costs, project period up to 3 years

• NIDDK Phase IIB guidance: up to $3,000,000 total costs, project period up to 3 years

• Cost share: none for Phase I or Phase II. Phase IIB requires 100 percent third-party matching funds.

• Equity dilution: none. This is non-dilutive federal funding.

• Scientific contact at NIDDK: Guillermo Arreaza-Rubin, M.D., Ph.D., guillermo.arreazarubin@nih.gov

• Broader initiative alignment: Make America Healthy Again (MAHA) Chronic Disease Initiative

What Is an NIH Highlighted Topic?

An NIH Highlighted Topic is a published statement of scientific interest from one or more NIH Institutes, Centers, and Offices. It tells the research community that a specific area of science is a priority, without creating a separate funding announcement, a separate deadline, or a separate review process.

There are three things a Highlighted Topic does for a small business:

1. It tells you which Institute is receptive. In this case, NIDDK is the awarding IC, so your assignment request and your program officer conversations should point there.

2. It gives you validated language to write against. The "Areas of Interest" and the NIDDK responsiveness list are the vocabulary reviewers and program staff are already using internally.

3. It creates two possible funding advantages. NIDDK may dedicate funds to applications in this topic area depending on the availability of funds, the number of meritorious applications, and competing priorities, and NIDDK may give special consideration to meritorious applications in the topic area.

There are two things a Highlighted Topic does not do. It does not guarantee a set-aside, and it does not replace the peer review process. Your application still competes on scientific merit through the standard NIH study section route.

Which NIH Mechanism Should a Small Business Use?

Small businesses should apply through the NIH SBIR or STTR parent announcement and request assignment to NIDDK.

The NIH small business programs are the right home for this topic because nearly every area of interest listed is a product development problem: a device, an implant, a biomaterial, a formulation, an algorithm, or a cell product that needs to reach patients. Here is how the mechanism map works.

NIH Parent SBIR, currently PA-27-100 (R43 and R44). This is the default route for most companies. It accepts Phase I, Phase II, Direct to Phase II, and Fast-Track applications. Use it when your company performs the majority of the research and your Principal Investigator is primarily employed by the company. NIDDK accepts SBIR clinical trial applications through the parent announcement.

NIH Parent STTR, currently PA-27-102 (R41 and R42). Use this when the project depends on a formal partnership with a U.S. nonprofit research institution such as a university. STTR requires that at least 40 percent of the research be performed by the small business and at least 30 percent by the single partner institution. This is the natural fit for university spinouts commercializing licensed islet encapsulation, gene therapy, or organoid technology. Note that NIDDK currently accepts clinical trial applications through SBIR only, not through STTR.

Direct to Phase II. If you already have feasibility data that would ordinarily come out of a Phase I, and you never received a Phase I award for that specific project, you can skip straight to Phase II. This authority applies to SBIR only. It is not available under STTR.

Fast-Track. Phase I and Phase II are submitted together and reviewed once. This compresses the funding gap but requires a fully developed Phase II plan at first submission. It is a poor fit when your Phase I result could materially change the Phase II design, which is often the case in early cell therapy and immune protection work.

Phase IIB Strategic Breakthrough Award, currently PA-27-101 (R44). For companies that have finished an NIH SBIR or STTR Phase II and need to bridge to commercialization. NIDDK generally considers Phase IIB requests up to $3,000,000 in total costs. Applicants must document not less than 100 percent matching funds from new private capital or from a non-SBIR/STTR government source. NIDDK strongly encourages Phase II awardees to consider Phase IIB, particularly where the product requires clinical evaluation or federal regulatory approval.

Commercialization Readiness Pilot, currently PAR-27-098 (SB1). Funds late-stage technical assistance and product development activities that Phase II and Phase IIB cannot support, such as specialized regulatory and manufacturing work. It allows a higher degree of outsourcing than other mechanisms, though the small business must retain substantial project management and oversight.

Funding Allowance

The dollar ceiling depends on two layers: the statutory guideline set by the Small Business Administration, and the specific budget guidance published by NIDDK.

Layer one, the SBA statutory guidelines for the current cycle:

• Phase I: up to $323,090 in total costs, for a project period of 6 months to 2 years

• Phase II: up to $2,153,927 in total costs, for a project period of 1 to 3 years

• Commercialization Readiness Pilot: up to $4,191,495 in total costs, for a project period of up to 3 years

Layer two, what NIDDK generally considers:

• Phase I: up to $350,000 in total costs, with a project period up to 2 years

• Phase II: up to $2,200,000 in total costs, with a project period up to 3 years, and generally not exceeding $1,100,000 in total costs in any single year

• Phase IIB: up to $3,000,000 in total costs, with a project period up to 3 years, and generally not exceeding $1,100,000 in total costs in any single year

Total funding support includes direct costs, indirect costs, and fee. A reasonable profit or fee may be paid on SBIR and STTR awards, but it must be built into the budget at the time of application, not added later. Applicants seeking a budget above the NIDDK ranges are strongly encouraged to contact NIDDK program staff with a draft Specific Aims page before submitting.

Two points that founders regularly miss. First, budgets above the SBA guideline are possible where the science aligns with an SBA-approved waiver topic, and NIDDK will consider those requests with appropriate justification. Second, NIDDK may reduce the recommended budget or the award period for budgetary, administrative, or programmatic reasons even after a strong review score.

Timeline

The Highlighted Topic window runs from September 2, 2026 through September 2, 2028. Within that window, you submit against the NIH standard small business receipt dates.

Standard annual due dates: January 5, April 5, and September 5. When a due date falls on a weekend or federal holiday, NIH moves it to the next business day. Applications are due by 5:00 p.m. local time of the applicant organization.

Cycles available under this topic:

• September 2026 cycle: the September 5, 2026 date shifted to Tuesday, September 8, 2026 because of the weekend and the Labor Day holiday. Given that the topic posted on September 2, this cycle is effectively closed for anyone starting from scratch.

• January 5, 2027: the first realistic cycle for a company beginning preparation now.

• April 5, 2027

• September 5, 2027

• January 5, 2028

• April 5, 2028, which is the last full cycle before the topic expires in September 2028.

What the runway actually looks like: budget roughly 9 months from submission to money in the door. An application submitted in the January 2027 cycle typically reaches an earliest possible start date in the fall of 2027. Council decisions for the September and January cycles are often handled together, which is one reason experienced applicants do not treat "wait for the next cycle" as a free option.

Work backwards from your target date:

• 14 to 16 weeks out: contact the NIDDK program officer, confirm responsiveness, and start or verify your federal registrations

• 12 weeks out: lock the Specific Aims page and circulate it to program staff

• 8 weeks out: complete the research strategy draft, the commercialization plan, and letters of support

• 4 weeks out: full internal review, budget finalization, and subaward paperwork

• 1 week out: submit early to leave room for eRA Commons error correction

Registrations are the most common cause of a missed deadline. You need SAM.gov, a Unique Entity ID, SBA Company Registry, eRA Commons, and Grants.gov, and eRA Commons access depends on the SBA registration being complete first. Allow six weeks or more, and start before you write anything.

Also note that the parent announcements are reissued periodically. The current SBIR parent, PA-27-100, carries a closing date in early April 2027, so applicants targeting later cycles should confirm the active parent announcement number at the time of submission.

Detailed Overview of What NIH Is Looking For

The problem NIH is trying to solve

Type 1 diabetes results from immune destruction of the insulin-producing cells of the pancreas, which leads to elevated blood glucose and serious long-term complications. Insulin replacement is essential, but NIH is explicit that insulin alone is not the whole picture: other hormones, including glucagon and amylin, may also need to be supplemented for optimal management.

NIH acknowledges that it has already funded substantial progress in automated insulin delivery, cell replacement, and beta cell protection, along with newer work in glucose-responsive insulin and glucagon platforms, gene therapy, and AI-driven synthetic biology. The stated position is that these advances remain insufficient. Three gaps are named directly:

1. Current technologies do not adequately mimic natural physiology.

2. Disease management is still too burdensome for patients.

3. Behavioral and accessibility factors have not been addressed for all people with T1D.

NIH calls out two underserved populations by name. Shift workers, who face circadian rhythm disruption, irregular activity patterns, and a lack of facilities suitable for injection. And persons with disabilities, including people with visual, hearing, or cognitive impairment. If your technology has a credible story for either group, say so in your Specific Aims. This is one of the most specific and least contested differentiators in the entire topic.

The stated goal for the resulting generation of technologies is threefold: better daily disease management, prevention of acute and chronic complications, and improved quality of life at all ages.

Areas of Interest as published

NIH lists the following as examples, and states that the list is not exhaustive:

• Novel cell replacement therapies and related technologies, including immune protection, immune-evasion engineering, smart biomaterials and scaffolds, and functional organoid development

• Gene therapy strategies

• Advanced digital systems for automated closed-loop sensing and delivery

• Glucose-responsive insulin and glucagon platforms

• AI and synthetic biology applied to advance hormone replacement research and therapies

• Developing or adapting novel diabetes management technologies for older adults and populations with special needs

• Building multidisciplinary research teams to support novel approaches

The NIDDK responsiveness list, broken down

NIDDK published a more granular list of what it considers responsive. This is the section to write against, because it reflects how program staff think about the portfolio.

Cell replacement. Immune evasion cell engineering. Biocompatible materials for immune isolation or immune modulation. Enhanced vascularization and oxygenation of implanted constructs. Automation for cell generation and for functional stability assessment. Interventions to prevent cell exhaustion and preserve function over time. Novel in vitro and in vivo preclinical testing methods for cellular products.

What this tells you: NIDDK is interested in the unsolved engineering problems around cell therapy, not just the cells. Oxygen transport, graft survival, manufacturing consistency, and assay development are all fundable in their own right. A company with a biomaterial or a bioreactor rather than a cell line still has a clear lane here.

Gene therapies and editing for hormone replacement. Gene reprogramming to create alternative insulin-producing cells. DNA-based insulin gene therapy. Targeted gene delivery for production of glucose-responsive insulin. Gene-edited cells for sustained hormone replacement.

What this tells you: delivery and durability are the named pressure points. "Sustained" appears explicitly, so a Phase I aim that demonstrates persistence rather than only initial expression will read as responsive.

Glucose-responsive insulin and glucagon platforms. Dual smart insulin and glucagon closed-loop systems. Glucose-responsive implantable formulations.

What this tells you: NIDDK is signaling interest in bihormonal approaches, not insulin-only. If you have a glucagon component, or a platform that could accommodate one, foreground it.

Technologies for older adults and persons with disabilities. Algorithms and tools tailored for varying impairments. Telemonitoring and remote systems compatible with open-loop and closed-loop systems. Clinical validation of technologies, including closed-loop systems, for older adults.

What this tells you: this is where digital health and software companies fit most cleanly, and where clinical validation of an existing system is fundable rather than only novel hardware. Interoperability with open-source and commercial closed-loop systems is named directly.

What ORWH and OADR-ORWH add

ORWH and OADR-ORWH participate in this topic but do not award grants. Your application must still be relevant to the objectives of a participating Institute or Center, which in practice means NIDDK. Their participation matters because it defines a second axis on which your application can score well.

ORWH is interested in understanding sex-specific dynamics of hormone therapies and how those dynamics influence responsiveness to new T1D therapeutics and technologies. ORWH also wants to see evaluation of how new therapies serve women across the life course, accounting for hormonal status and responding to both reproductive and aging-related needs, in ways more likely to improve outcomes for women and men alike.

OADR-ORWH is interested in the development of novel therapies for Type 1 diabetes and in the implementation science of those novel therapies.

Practical read: build a sex-as-a-biological-variable analysis into your design that goes beyond the minimum NIH requirement, and if your product has an implementation or adoption question attached to it, name implementation science explicitly.

MAHA alignment and why it affects your framing

This topic is issued as part of the Make America Healthy Again initiative and is positioned against four named efforts. Referencing the right one in your Significance section is a low-cost way to demonstrate policy fluency.

• NIH MAHA Chronic Disease Initiative. Aligning existing NIH chronic disease research and generating actionable results for diseases arising in childhood and adulthood. Also a new Whole-Person-Health approach to chronic disease prevention, promoting wellness, resilience, and metabolic health at all life stages.

• Real World Data Platform. Linking claims data, electronic health records, and wearables into a single integrated dataset with rigorous privacy and consent protections. If your technology generates continuous glucose, activity, or device telemetry data, this is your hook.

• New Approach Methodologies. Expanded use of human-relevant models such as organoids, computational simulations, and real-world data integration to reduce reliance on animal studies that fail to replicate complex human conditions. EPA, FDA, and NIH have all committed to using NAMs where appropriate. If your preclinical package leans on organoids, organ-on-chip, or in silico modeling, frame it as a NAM contribution rather than apologizing for the absence of animal data.

Eligibility Requirements

To apply for an NIH SBIR or STTR award, your company must meet the core SBA criteria:

• Organized for profit, with a place of business located in the United States

• More than 50 percent directly owned and controlled by one or more individuals who are U.S. citizens or permanent resident aliens, by other for-profit small business concerns each majority owned by such individuals, or by a combination. Multiple venture capital, hedge fund, and private equity ownership structures may be permitted under certain conditions for SBIR.

• No more than 500 employees, including affiliates

• For SBIR, the Principal Investigator's primary employment must be with the small business at the time of award and for the duration of the project. For STTR, the PI may be primarily employed by the small business or by the partnering research institution.

• For SBIR Phase I, the small business must perform at least two thirds of the research. For SBIR Phase II, at least half. For STTR, the small business performs at least 40 percent and a single partner nonprofit research institution performs at least 30 percent.

Companies with a large volume of prior Phase I awards should also confirm they meet the SBIR and STTR Phase I to Phase II Transition Rate benchmarks, which can restrict eligibility for a period of one year if not met.

What a Competitive Application Looks Like

Reviewers on this topic will be looking for evidence that you understand where the field already is. NIH has stated that automated insulin delivery, cell replacement, and beta cell protection have all received substantial prior investment. An application that proposes an incremental improvement to insulin-only delivery, without addressing physiologic fidelity, patient burden, or accessibility, is competing against NIH's own stated view that such work is insufficient.

Five things strengthen an application against this specific topic:

1. A named unmet population. Shift workers, persons with visual, hearing, or cognitive impairment, or older adults. NIH wrote these into the topic. Very few applications will use them well.

2. A bihormonal or multi-hormone story. Glucagon and amylin are named alongside insulin. A platform that can extend beyond insulin reads as more physiologic.

3. A durability or sustained-function endpoint. Cell exhaustion, graft survival, and sustained hormone replacement all appear in the responsiveness list. Milestones that measure persistence rather than initial function align directly.

4. A credible commercialization plan. NIH small business awards are product development awards. Regulatory pathway, reimbursement thinking, manufacturing scale, and a specific customer are all scored, and they are where most first-time academic applicants lose ground.

5. Program officer contact before you write. NIDDK explicitly directs applicants to contact program staff with a draft Specific Aims page, particularly for budgets above their standard ranges. That conversation is free and it is the single highest-return hour in the process.

Common Reasons Applications Miss

• Treating the Highlighted Topic as a NOFO and searching Grants.gov for a topic-specific number that does not exist

• Submitting to the wrong Institute, or leaving the assignment request blank and letting the application route somewhere without a stake in T1D hormone replacement

• Choosing Fast-Track when Phase I results would have changed the Phase II design

• Choosing STTR for a project that includes a clinical trial, which NIDDK accepts through SBIR only

• Starting federal registrations after the writing begins, then missing the receipt date on an eRA Commons error

• Building the budget without the fee, then discovering it cannot be added after submission

• A research strategy with no unresolved technical risk, which reads as development work rather than research

• Omitting a Phase IIB matching funds plan when the technology clearly needs a later bridge, which signals a company that has not thought past the current award

Frequently Asked Questions

Is this a grant I can apply to directly?

No. This is an NIH Highlighted Topic, which is a statement of scientific priority rather than a Notice of Funding Opportunity. You apply through a broad NIH announcement, and for small businesses that means the NIH SBIR or STTR parent announcement.

Which funding opportunity number do I actually use?

For most small businesses it is PA-27-100, the NIH, CDC, and FDA Parent SBIR announcement covering R43 and R44 awards. If your project requires a formal university or nonprofit research partner, use PA-27-102, the Parent STTR announcement covering R41 and R42. Confirm the active announcement number at the time you submit, since NIH reissues these periodically.

How much money can my company request?

NIDDK generally considers Phase I budgets up to $350,000 in total costs and Phase II budgets up to $2,200,000 in total costs. The underlying SBA statutory guidelines for the current cycle are $323,090 for Phase I and $2,153,927 for Phase II. Requests above these levels require justification and a conversation with NIDDK program staff.

When is the deadline?

There is no deadline specific to this topic. You submit on the NIH standard small business receipt dates of January 5, April 5, and September 5 each year, with dates falling on weekends or federal holidays moving to the next business day. The topic itself expires on September 2, 2028, so January 5, 2027 through April 5, 2028 represent the realistic competing cycles.

How long until I receive funding?

Plan on approximately 9 months from submission to award start. An application submitted in the January 2027 cycle would typically have an earliest start date in the fall of 2027.

Do I have to give up equity or match the funds?

No. NIH SBIR and STTR Phase I and Phase II awards are non-dilutive and require no cost share. The exception is the Phase IIB Strategic Breakthrough Award, which requires not less than 100 percent matching funds from new private capital or from a non-SBIR/STTR government source.

Which NIH Institute will fund this?

NIDDK is the awarding Institute for this topic. ORWH and OADR-ORWH participate and have stated interests, but they do not award grants. Your application must be relevant to the objectives of a participating Institute or Center, which means NIDDK.

Can I include a clinical trial?

Yes, through SBIR. NIDDK currently accepts SBIR clinical trial applications through the parent omnibus but does not accept STTR clinical trial applications. Review the NIH Clinical Trial Definition before deciding, because the definition captures more study designs than most founders expect.

I already have feasibility data. Do I still need a Phase I?

Not necessarily. SBIR Direct to Phase II allows a company that has demonstrated the scientific merit and feasibility normally expected from a Phase I, without having received a Phase I award for that project, to apply directly for Phase II. This authority is available for SBIR only, not STTR.

Does NIDDK set aside money for this topic?

Not guaranteed. NIDDK states that it may dedicate available funds to support applications in this topic area depending on the availability of funds, the number of meritorious applications, and competing priorities, and that it may give special consideration to meritorious applications in the topic area. Treat it as a favorable tilt, not a reserved pool.

My company builds software, not biology. Is there a place for us?

Yes. The topic explicitly names advanced digital systems for automated closed-loop sensing and delivery, AI and synthetic biology applied to hormone replacement, algorithms and tools tailored for varying impairments, and telemonitoring or remote systems compatible with open-loop and closed-loop systems. Clinical validation of closed-loop systems for older adults is also named as responsive.

We use organoids and computational models instead of animal studies. Is that a problem?

It is an advantage if framed correctly. The topic aligns with the New Approach Methodologies effort, under which EPA, FDA, and NIH have committed to using human-relevant models such as organoids, computational simulations, and real-world data integration where appropriate. Present your approach as a NAM contribution.

Who should I contact at NIH before applying?

The NIDDK scientific contact listed for this topic is Guillermo Arreaza-Rubin, M.D., Ph.D., at guillermo.arreazarubin@nih.gov. NIDDK also directs applicants considering larger budgets to contact program staff with a draft Specific Aims page before submitting.

What registrations do I need, and how long do they take?

SAM.gov with a Unique Entity ID, the SBA Company Registry, eRA Commons, and Grants.gov. eRA Commons access depends on completing the SBA registration first. Allow at least six weeks, and start before you begin writing.

How BW&CO Helps

BW&CO is a non-dilutive federal funding advisory firm. We help deep-tech, biotech, medtech, and health technology founders convert agency priority signals like this one into funded awards. That work includes mechanism selection, program officer strategy, Specific Aims development, full proposal build, budget and fee construction, commercialization plan development, and Phase IIB matching capital positioning.

Our team has helped clients secure more than $350 million in funding. Innovation Funding Simplified.

If you are developing hormone replacement technology for Type 1 diabetes and want an honest read on whether you are competitive for the January 2027 cycle, contact us for a fit assessment.

FDA RFA-FD-25-020: Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01)

The Short Answer

RFA-FD-25-020 is an FDA grant that pays for rare disease clinical trials. It provides up to $650,000 in total costs per year for up to four years, and up to $900,000 per year if you use an innovative or efficient trial design. The money is non-dilutive, meaning you give up no equity and no intellectual property. Applications are due October 20, 2026 and October 19, 2027, and the opportunity expires May 31, 2028.

The program is run by the FDA Office of Orphan Products Development (OOPD), not by the NIH, even though you apply through Grants.gov and eRA Commons. FDA uses its own Objective Review Process, its own page limits, and its own review criteria.

Small businesses and for-profit companies are explicitly eligible, and companies win these awards regularly. More on that below.

RFA-FD-25-020 At A Glance

• Funding opportunity number: RFA-FD-25-020

• Title: Reissue of RFA-FD-23-001, Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

• Agency: U.S. Food and Drug Administration, Office of Orphan Products Development (OOPD)

• Activity code: R01 Research Project Grant

• Assistance Listing Number: 93.103

• Clinical trial status: Required. FDA will only accept applications proposing clinical trials.

• Award ceiling, standard: $650,000 total costs per year, years 1 through 4

• Award ceiling with innovative design justification: $900,000 total costs per year, years 1 through 4

• Maximum project period: 4 years

• Maximum possible total award: $3,600,000

• Cost sharing or matching: Not required

• Application types allowed: New, Renewal, Resubmission, Revision

• Next application deadline: October 20, 2026, by 11:59 PM Eastern Time

• Final application deadline: October 19, 2027, by 11:59 PM Eastern Time

• Resubmission-only deadlines: May 18, 2027 and May 16, 2028

• Opportunity expiration date: May 31, 2028

• Late applications: Not accepted under any circumstances

• Appeals of review outcome: Not accepted

• Foreign organizations: Eligible

Why Startups and Small Companies Should Pay Attention

The R01 label makes founders assume this is an academic-only program. It is not, and the award history proves it.

Under the immediately preceding version of this opportunity, RFA-FD-23-001, FDA funded roughly twenty distinct clinical trial projects. Four of those projects went to for-profit companies rather than universities or hospitals. Based on NIH RePORTER records, those company awards include:

• Ophirex, Inc. (California). Development of intravenous varespladib, a phospholipase A2 inhibitor, for snakebite envenoming. Approximately $2.89 million in cumulative reported funding across fiscal years 2023 through 2025.

• Extend Biosciences, Inc. (Massachusetts). A Phase 2 study of EXT608 in adults with hypoparathyroidism, conducted under IND 146180. Approximately $1.8 million in cumulative reported funding, with annual budgets of roughly $899,800, effectively at the top of the funding ceiling.

• Palvella Therapeutics, Inc. (Pennsylvania). SELVA, a multicenter Phase 3 baseline-controlled study of PTX-022 in microcystic lymphatic malformations. Approximately $1.13 million in cumulative reported funding across fiscal years 2024 and 2025.

• Targeted Therapy Technologies, LLC (New Jersey). A Phase II expanded access clinical trial in retinoblastoma. $1.3 million in cumulative reported funding across fiscal years 2024 and 2026.

Together, those four companies pulled in roughly $7.1 million from a single issue of this opportunity. That is close to one in five funded projects going to industry.

This is not new behavior at OOPD either. Under earlier issues of the same program, DNAtrix, Inc. won multi-year support for a Phase 2a study of DNX-2401 in glioblastoma, and Fibrocell Technologies, Inc. won multi-year support for a Phase 1/2 study of FCX-007 in recessive dystrophic epidermolysis bullosa. Companies have been winning orphan products clinical trials grants for a decade.

Three additional reasons this program fits a clinical-stage company unusually well:

1. None of the SBIR eligibility constraints apply. There is no 500-employee size standard, no requirement that the principal investigator be primarily employed by your company, no 51 percent United States ownership test, and no Phase I before Phase II sequencing. If your company can run the trial, you can apply.

2. Indirect costs are available even without a negotiated rate. If your organization has never established a federal indirect cost rate, FDA allows a de minimis rate of 10 percent of modified total direct costs. Most early-stage companies have no negotiated rate, and most assume that means zero overhead recovery.

3. The award is a regulatory asset, not just cash. OOPD holds regulatory milestone meetings with awardees and monitors progress toward approval. An FDA office is actively invested in your product reaching the market.

What FDA Is Actually Looking For

The purpose of RFA-FD-25-020 is to fund clinical trials that evaluate safety and efficacy in support of a new indication or a change in labeling for a product treating a rare disease or condition. That phrase is the center of gravity of the entire program. FDA is not funding discovery science, target validation, mechanism studies, or device engineering. FDA is funding the human trial data that moves a product closer to an approved label.

The problem FDA is trying to solve

There are more than 10,000 known rare diseases affecting roughly 30 million Americans, and only a few hundred of those diseases have approved treatments. The Orphan Products Grants Program has funded clinical trial research since 1983, and more than 80 of the studies it has funded have gone on to facilitate marketing approval of a rare disease product. That is the outcome FDA is buying with this money.

What is in scope

• Clinical trials in any phase of development, meaning Phase 1, Phase 2, and Phase 3 are all eligible

• Drugs, biologics, medical devices, and medical foods

• Studies of already approved products being evaluated for a new orphan indication

• Studies assessing multiple rare diseases at once, provided prevalence data is supplied for each disease

• Diagnostics and vaccines, but only where the United States population receiving them is fewer than 200,000 people per year

What FDA specifically rewards

Read the announcement closely and four preferences show up over and over. Applications that hit these read as responsive. Applications that ignore them read as academic proposals that wandered into the wrong program.

1. Efficient use of existing infrastructure. FDA wants you to plug into clinical trial networks, data standardization platforms, patient registries, electronic medical records, and CTSAs rather than building everything from scratch. Show that you are not reinventing infrastructure that already exists.

2. Genuine collaboration across stakeholders. FDA repeatedly names the combination of industry, academia, and patient organizations. A company applicant partnered with academic trial sites and a disease foundation is the archetype this program was written for.

3. Early and ongoing patient engagement. This is a scored review criterion in its own right, not a box to check. FDA wants documented evidence that patients and caregivers shaped the protocol design, the data elements, the feasibility assessment, and the data sharing approach. You also need to show how you reduced patient and caregiver burden, including impact on daily living. Letters from patients, caregivers, or patient organizations describing that engagement are required.

4. Innovative and efficient trial designs. This is where the extra $250,000 per year lives. FDA will consider additional funding for applications proposing seamless or adaptive designs that compress trial phases into one continuous trial, basket trials, umbrella trials, or platform trials that test multiple drugs or multiple diseases on common infrastructure. FDA will also consider it for innovative use of data modeling and simulation to study safety and efficacy. FDA strongly recommends engaging a review division about these approaches before you submit, through a preIND meeting, an INTERACT meeting, or another mechanism.

The rare disease definition you must document

FDA considers a product potentially eligible if it is indicated for a disease or condition with a prevalence of fewer than 200,000 people in the United States. For acute diseases lasting less than one year, the annual incidence must be fewer than 200,000 per year. You must document this in a dedicated subsection of your Rationale, using the exact heading "Rare Disease Population/Prevalence," with prevalence calculations and citations.

Orphan subsets of a non-rare disease can qualify, but only if you can explain, based on a characteristic of the product such as mechanism of action, toxicity profile, or prior clinical experience, why the product would be limited to that subset. An orphan subset argument cannot be based on unmet need alone or on how you would prefer to study or market the product. If you already hold OOPD orphan drug designation for the product and disease, include the designation number and date.

Funding Allowance in Detail

Annual budget caps

• Year 1: $650,000 total costs

• Year 2: $650,000 total costs

• Year 3: $650,000 total costs

• Year 4: $650,000 total costs

• Standard four-year maximum: $2,600,000 total costs

These are total costs, meaning direct plus indirect combined. This is the single most misread line in the announcement. Applicants who budget $650,000 in direct costs and then add overhead on top are over budget before review begins.

The innovation supplement

Applications proposing qualifying innovative and efficient trial approaches may request up to an additional $250,000 in total costs per year, raising the ceiling to $900,000 total costs per year for up to four years, or $3,600,000 across the full project period.

To access it you must submit a clear description and justification, limited to three pages, showing how you meet the innovative design requirements. That justification goes in the appendix, and the request must also be reflected in the budget request. FDA reviews the additional funding annually. Applications that request the supplement without meeting the requirements may be asked to reduce their budget.

Indirect costs

• If you request indirect costs, you must attach a copy of your most recent federal indirect cost rate or F&A agreement to the Research and Related Other Project Information component as line 12, Other Attachments.

• If you have never established an indirect cost rate and have no negotiated federal agreement, a de minimis rate of 10 percent of modified total direct costs is allowed. Modified total direct costs include direct salaries and wages, applicable fringe, materials and supplies, services, travel, and the first $25,000 of each subaward. It excludes equipment, capital expenditures, patient care charges, rental costs, tuition remission, scholarships, participant support costs, and any portion of a subaward above $25,000.

• Foreign and international organizations are funded at a fixed 8 percent of modified total direct costs.

Other budget rules

• Cost sharing is not required.

• Applications requesting multiple years must submit a separate detailed budget and narrative justification for each year.

• You must disclose other funds contributed to the study by any source, including your own company, both before and during the FDA funding period. Provide amounts, sources, and whether the funds are secured. Keep this separate from the FDA request justification.

• No award funds may pay any individual at a salary rate above Executive Level II of the Federal Executive Pay Scale.

• Awards provide one year of support with three additional recommended years contingent on annual appropriations, availability of funds, and satisfactory performance. Continuation also depends on enrollment progress, adequate product supply, and compliance with IND or IDE regulatory requirements.

Timeline and Key Dates

Recurring annual cycle

• Optional Letter of Intent: September 21, 2026, then September 20, 2027

• New application due dates: October 20, 2026, then October 19, 2027, both by 11:59 PM Eastern Time

• Resubmission-only due dates: May 18, 2027, then May 16, 2028

• Scientific merit review, new applications: February and March of 2027 and 2028

• Scientific merit review, resubmissions: June of 2027 and 2028

• Earliest project start date: July 2026 for the first cycle, with later cycles following the same pattern

• Opportunity expiration: May 31, 2028

The deadline before the deadline

The date that actually controls your timeline is not the application due date. It is the IND or IDE submission date.

Your protocol and all other required regulatory documents must be submitted to the applicable FDA IND or IDE review division a minimum of 30 days before the grant application deadline. For the October 20, 2026 cycle, that means the protocol needs to be with the review division on or before September 20, 2026.

The IND must be active, meaning not on clinical hold and not exempted, or the IDE must be approved, for your grant application to qualify for review. Miss this and the application is non-responsive regardless of scientific merit.

A realistic backward-planning schedule for an October cycle

• 6 to 8 months out: Request a preIND or INTERACT meeting if you plan to propose an innovative trial design, or if your regulatory path is unsettled.

• 4 to 6 months out: Confirm SAM.gov, UEI, eRA Commons, and Grants.gov registrations. Registration can take six weeks or longer, and failure to register in time is not an accepted excuse for late submission. Principal investigator eRA Commons accounts alone can take two weeks.

• 3 to 4 months out: Finalize the protocol, lock clinical sites, and begin collecting the three required categories of letters of support.

• 30 days plus before the deadline: Submit the final protocol to your IND or IDE. The version you submit to FDA in the grant application must be the same version submitted to the IND or IDE.

• 3 to 4 weeks out: Complete the Research Strategy, the innovation supplement justification if applicable, and the Data Management and Sharing Plan.

• 1 week out: Submit. Grants.gov and eRA Commons both run error checks, and any errors must be corrected and a changed or corrected application submitted before the deadline. A corrected application filed after the deadline is late, and late applications are not accepted.

Registration checklist

• System for Award Management (SAM) registration, active and renewed at least annually, which generates your Unique Entity Identifier and a CAGE code. Foreign organizations need an NCAGE code instead.

• eRA Commons accounts with at least one Signing Official and at least one Program Director or Principal Investigator. If the same person is both PI and Signing Official, they need two distinct accounts.

• Grants.gov registration, which requires active SAM registration first.

Who Is Eligible

Eligible organizations include:

• Public, state controlled, and private institutions of higher education

• Nonprofits with and without 501(c)(3) status

• Small businesses

• For-profit organizations other than small businesses

• State, county, city, township, and special district governments

• Federally recognized and non-federally recognized tribal governments and Native American tribal organizations

• Federal governments and United States territories or possessions

• Independent school districts, public housing authorities, faith-based and community-based organizations, and regional organizations

• Non-domestic, non-United States entities, and non-domestic components of United States organizations

Principal investigator requirements:

• Any individual with the skills, knowledge, and resources to carry out the research may serve as PD/PI.

• FDA expects an established investigator in the relevant scientific area who can provide both administrative and scientific leadership.

• Every PD/PI must hold an eRA Commons account, and the Commons ID must appear in the Credential field of the Senior/Key Person Profile. Omitting it causes the application to be rejected.

• Multiple PDs/PIs are allowed. One must be designated the Contact PI in item 14 of the SF424 (R&R). Multi-PI applications must include a Multiple PD/PI Leadership Plan covering governance, communication, decision-making on scientific direction, and conflict resolution.

• With multiple institutions, one must be the prime and all others must be funded through subcontracts, with their budgets attached to the Research and Related Subaward Budget Attachment form.

You may submit more than one application, provided each is scientifically distinct. FDA will not accept duplicate or highly overlapping applications under review at the same time.

Application Structure and Required Content

Page limits

FDA does not follow NIH page limitation guidelines or NIH review criteria. For this NOFO, the Research Strategy is limited to 12 pages. A resubmission adds a one-page Introduction addressing the prior Summary Statement.

Required Research Strategy sections

Your Research Strategy must contain these five sections, in this order, because they map directly onto the scored review criteria:

1. Rationale

2. Study Design including Data Quality and Interpretability

3. Inclusion of Patient Input

4. Investigator(s), Infrastructure, and Financial Resources

5. Ability to Advance the Current Field

Required subsections with mandated headings

Three subsections must appear under specific headings. Reviewers look for these headings literally.

• Under Rationale: "Rare Disease Population/Prevalence", documenting that the United States prevalence or incidence meets the rare disease threshold, with calculations and citations.

• Under Rationale: "Support of Product Development", explaining how the study will help support product approval or supply essential data for product development. If you propose multiple products or multiple diseases, describe how you intend to proceed with development, potentially across multiple sponsors.

• Under Study Design: "Study Monitoring Plan", describing your monitoring approach, whether a Data and Safety Monitoring Board, a Study Monitoring Committee, or an Independent Medical Monitor. Name the parties responsible, what will be monitored, the frequency, and the individual and study stopping guidelines.

Required letters of support

Letters of support do not go in the Research Strategy. They are uploaded to line 9 of the PHS 398 Research Plan form. Three categories are required:

1. Study sites. Leaders of the clinical research institutions conducting the study describe site support, resources, study infrastructure, and an estimate of how many patients with the target disease would be eligible.

2. Product availability. Evidence that the product is available to you in the form and quantity the trial needs. A current supplier letter is acceptable. If supply negotiations are underway but not final, submit a letter saying so. Verification of adequate supply is required before an award is made.

3. Patient engagement. Current letters from patients, caregivers, or patient organizations describing early and ongoing engagement in trial design.

Required appendices

• The full final protocol, specifically the version submitted to the IND or IDE

• Informed consent forms, assent forms, and any other information given to subjects, compliant with 21 CFR 50.25

• The innovative and efficient trial approach justification, limited to three pages, if you are requesting additional funding

• For resubmissions, the previous OOPD Summary Statement, with an optional point-by-point rebuttal

Do not use the appendix to get around page limits.

Other required elements

• A Data Management and Sharing Plan is required for all applications regardless of direct cost level, attached in the Other Plan(s) slot.

• At least one human subjects study record using the PHS Human Subjects and Clinical Trials Information form.

• The IND or IDE number and the date the final protocol version was submitted must appear with the project title on the face page of the application.

• If the IND or IDE sponsor is not the listed principal investigator, a letter from the sponsor permitting access to the IND or IDE must be submitted both in the IND or IDE and in the grant application.

How Applications Are Reviewed

Review happens in two stages.

Stage one, responsiveness screening. FDA grants management and program staff review every application against nine program responsiveness criteria. Applications found non-responsive receive notice that they will not be reviewed at all. The criteria include proposing a clinical trial that provides safety or efficacy data for a rare disease, using the generic name of the product, requesting no more than four years, documenting rare disease prevalence, explaining how the trial supports a new indication or labeling change, meeting the IND and IDE requirements under 21 CFR 312 for drugs and biologics or 21 CFR 812 for devices, providing the required appendices and letters, and complying with page and formatting limits.

Only medical foods that do not require premarket approval and devices classified as non-significant risk are exempt from the IND and IDE requirement. Non-significant risk device applicants must include a letter from the FDA Center for Devices and Radiological Health confirming the classification.

Stage two, objective review. Responsive applications go to an FDA Objective Review Committee of subject matter experts, which assigns an overall impact score reflecting the likelihood the project will exert a sustained and powerful influence on the field. FDA experts may be consulted on whether the study will generate data that could contribute to product approval. Funding decisions are made by the Commissioner of Food and Drugs or a designee, based on scientific and technical merit, availability of funds, and relevance to program priorities.

Every application receives a written critique. Appeals of objective review are not accepted for this NOFO.

Note that reviewers are told an application does not need to be strong in every category, and that a project which is not innovative in itself may still be essential to advance a field. The relative importance of strengths and weaknesses matters more than the count.

Additional items reviewers assess without separate scores

• Study timeline, including start-up activities, enrollment rate, follow-up, use of existing resources for efficiency, and contingency plans for enrollment shortfalls

• Protections for human subjects, across risk, adequacy of protection, potential benefits, importance of knowledge gained, and data and safety monitoring

• Biohazards

• Resource sharing plans

• Authentication of key biological and chemical resources

• Whether the budget and requested period of support are fully justified and reasonable

Common Reasons Good Science Loses This Grant

• The protocol was not submitted to the IND or IDE division at least 30 days before the deadline, or the IND is on clinical hold or exempted.

• The version of the protocol in the grant application does not match the version submitted to the IND or IDE.

• Budget built as $650,000 in direct costs, with indirect costs stacked on top, blowing the total cost cap.

• Prevalence documented in prose without the mandated "Rare Disease Population/Prevalence" heading, or without calculations and citations.

• Patient engagement described as an intention rather than evidenced with letters from patients, caregivers, or patient organizations.

• No letter confirming product availability in the form and quantity the trial requires.

• The innovation supplement requested without a three-page appendix justification meeting the stated design requirements.

• SAM, eRA Commons, or Grants.gov registration incomplete at the deadline, which is never an accepted reason for a late submission.

• Missing eRA Commons ID in the Credential field of the Senior/Key Person Profile, which causes outright rejection.

• Submitting close to the deadline, hitting Grants.gov or eRA Commons errors, and correcting them after 11:59 PM Eastern. Late is late.

Frequently Asked Questions

‍ ‍

What is RFA-FD-25-020?

‍ ‍

RFA-FD-25-020 is a Notice of Funding Opportunity from the FDA Office of Orphan Products Development that funds clinical trials of orphan products in support of a new indication or a change in labeling for a rare disease or condition. It is a reissue of RFA-FD-23-001 and uses the R01 activity code.

‍ ‍

How much money can I get from RFA-FD-25-020?

‍ ‍

Up to $650,000 in total costs per year for up to four years, which is $2.6 million maximum. If you propose a qualifying innovative or efficient trial design and justify it in a three-page appendix, you may request up to an additional $250,000 per year, raising the ceiling to $900,000 per year and $3.6 million across four years. All figures are total costs, meaning direct plus indirect combined.

‍ ‍

When are RFA-FD-25-020 applications due?

‍ ‍

New applications are due October 20, 2026 and October 19, 2027, both by 11:59 PM Eastern Time. Resubmission-only deadlines are May 18, 2027 and May 16, 2028. Optional letters of intent are requested by September 21, 2026 and September 20, 2027. The opportunity expires May 31, 2028. Late applications are not accepted.

‍ ‍

Can a small business or startup apply for RFA-FD-25-020?

‍ ‍

Yes. Small businesses and for-profit organizations are explicitly listed as eligible applicants. Under the previous issue of this opportunity, RFA-FD-23-001, roughly one in five funded projects went to for-profit companies, including Ophirex, Extend Biosciences, Palvella Therapeutics, and Targeted Therapy Technologies. Earlier issues funded companies including DNAtrix and Fibrocell Technologies.

‍ ‍

Is RFA-FD-25-020 an SBIR grant?

‍ ‍

No. This is an R01 research project grant, not an SBIR or STTR award. That means none of the SBIR eligibility restrictions apply. There is no small business size standard, no requirement that the principal investigator be primarily employed by the applicant company, no United States ownership percentage test, and no Phase I prerequisite. Companies of any size may apply.

‍ ‍

Do I need an active IND or IDE to apply?

‍ ‍

In almost all cases, yes. The protocol and all other required documents must be submitted to the applicable FDA IND or IDE review division at least 30 days before the grant application deadline. The IND must be active, meaning not on clinical hold and not exempted, or the IDE must be approved, for the application to qualify for review. The only exceptions are medical foods that do not require premarket approval and medical devices classified as non-significant risk, which need a letter from the Center for Devices and Radiological Health confirming the classification.

‍ ‍

What counts as a rare disease for this grant?

‍ ‍

For chronic diseases, a prevalence of fewer than 200,000 people in the United States. For acute diseases lasting less than one year, an annual incidence of fewer than 200,000 per year. Diagnostics and vaccines qualify only if the United States population receiving them is fewer than 200,000 people per year. Orphan subsets of non-rare diseases may qualify if a product characteristic such as mechanism of action or toxicity profile justifies limiting use to that subset.

‍ ‍

Which clinical trial phases are eligible?

‍ ‍

All of them. RFA-FD-25-020 supports clinical trials in Phase 1, Phase 2, and Phase 3 of product development, as long as the trial evaluates safety or efficacy in support of a new indication or a change in labeling.

‍ ‍

What kinds of products are eligible?

‍ ‍

Drugs, biologics, medical devices, and medical foods indicated for rare diseases or conditions. Already approved products being studied for a new orphan indication are eligible. Diagnostics and vaccines are eligible under the population limits described above.

‍ ‍

What are the innovative trial designs that unlock extra funding?

‍ ‍

Seamless and adaptive designs that compress trial phases into one continuous trial, plus basket, umbrella, and platform trials that test multiple drugs or multiple diseases on shared infrastructure. Innovative use of data simulation and modeling to study safety and efficacy also qualifies. FDA strongly recommends discussing these approaches with the relevant review division before applying, through a preIND or INTERACT meeting.

‍ ‍

Is cost sharing or matching required?

‍ ‍

No. RFA-FD-25-020 does not require cost sharing. You must still disclose other funds contributed to the study from any source, including your own company, with amounts, sources, and whether the funds are secured.

‍ ‍

Can I get indirect costs if my company has no negotiated federal rate?

‍ ‍

Yes. If your organization has never established an indirect cost rate and has no negotiated federal agreement, FDA allows a de minimis rate of 10 percent of modified total direct costs. If you do have a negotiated rate, attach the agreement to the Research and Related Other Project Information component as line 12, Other Attachments. Foreign organizations are funded at a fixed 8 percent.

‍ ‍

How long is the Research Strategy?

‍ ‍

Twelve pages for this NOFO. FDA does not follow NIH page limitation guidelines. Resubmissions add a one-page Introduction addressing the prior Summary Statement.

‍ ‍

Can foreign organizations apply?

‍ ‍

Yes. Non-domestic, non-United States entities are eligible, as are non-domestic components of United States organizations. Foreign components are allowed. Indirect costs for foreign and international organizations are capped at 8 percent of modified total direct costs.

‍ ‍

Can I submit more than one application?

‍ ‍

Yes, provided each application is scientifically distinct. FDA will not accept duplicate or highly overlapping applications under review at the same time, and will not accept a new application submitted before the summary statement issues from an overlapping prior application.

‍ ‍

Can I appeal if my application is not funded?

‍ ‍

No. Appeals of objective review are not accepted for applications submitted under this NOFO. The decision not to award, or to award at a particular funding level, is discretionary and not subject to appeal. You may, however, submit a resubmission application at a resubmission-only deadline, provided your prior application received a numeric score and does not require an IND protocol amendment before resubmission.

‍ ‍

Is this funding dilutive?

‍ ‍

No. This is a federal grant, not an investment. You give up no equity, no board seats, and no intellectual property rights. It is non-dilutive capital that also puts an FDA office in the position of tracking your product toward approval.

‍ ‍

How is FDA review different from NIH review?

‍ ‍

FDA uses its own Objective Review Process rather than NIH peer review, applies its own page limits rather than NIH page limitation guidelines, and applies its own review criteria. Applications are still submitted through Grants.gov and tracked in eRA Commons, and FDA still applies HHS grants policy, which is why the announcement reads like an NIH opportunity in places. When FDA program-specific instructions conflict with the general application guide, follow the FDA instructions.

‍ ‍

Who do I contact at FDA about this opportunity?

‍ ‍

Scientific and programmatic questions go to Katherine Needleman, Director of the Orphan Products Grants Program at OOPD, at katherine.needleman@fda.hhs.gov or 301-796-8660. Letters of intent go to OOPD_CTGrants@fda.hhs.gov. Peer review and grants management questions go to Patrick Johnson at the FDA Office of Acquisitions and Grants Services, at Patrick.Johnson@fda.hhs.gov. FDA encourages applicants to resolve responsiveness questions before submitting.

‍ ‍

What To Do Next

‍ ‍

If you have a rare disease product with a protocol at or near IND or IDE stage, the October cycle is winnable and the competition is smaller than founders assume. The gating item is regulatory, not scientific: the protocol has to be with the FDA review division 30 days before the application deadline.

‍ ‍

Where most companies lose this grant is not the science. It is the responsiveness screen, the total cost math, the patient engagement evidence, and the letters of support. Those are all solvable with enough runway.

‍ ‍

BW&CO helps deep tech, biotech, and medtech companies win non-dilutive federal funding, with more than $350 million in funding secured for clients to date. If you are evaluating RFA-FD-25-020, we can assess fit against your regulatory timeline and build the application strategy around it.

NIH Blueprint MedTech Translator (PAR-25-383): The Complete Startup Guide to the UG3/UH3 Medical Device Funding Opportunity

What is the NIH Blueprint MedTech Translator program?

The NIH Blueprint MedTech Translator (PAR-25-383) is a milestone-driven UG3/UH3 cooperative agreement that funds medical device companies and academic innovators to take a novel device from late preclinical development through FDA regulatory clearance to conduct a clinical study, and then through that first clinical study in humans. It is one of the few federal programs that pays for the expensive, unglamorous middle of device development: GLP large animal safety testing, design verification and validation, biocompatibility, cybersecurity, quality systems, IDE preparation, and the first-in-human trial itself.

Two things make it unusual. First, application budgets are not capped. Second, NIH pays a network of contract research organizations and expert consultants directly, outside your budget, so a startup gets prototyping, bench testing, animal studies, regulatory consulting, reimbursement strategy, IP counsel, and clinical trial support at no cost to the award.

The funding is non-dilutive. You keep your equity and you keep your intellectual property.

Next application deadline: September 28, 2026. Subsequent deadlines run through January 28, 2028.

Blueprint MedTech Translator at a glance

‍ ‍

Here are the core facts a founder needs before deciding whether to pursue this opportunity.

‍ ‍

• Funding Opportunity Number: PAR-25-383

• Title: Blueprint MedTech Translator (UG3/UH3, Clinical Trial Optional)

• Agency: National Institutes of Health, Department of Health and Human Services

• Activity code: UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement

• Announcement type: Reissue of PAR-21-315

• Posted: June 17, 2025

• Expiration: January 29, 2028

• Award budget: not limited, but must reflect the actual needs of the project

• Cost sharing: not required

• Project period: UG3 phase up to four years, UH3 phase up to four years, five years total maximum

• Application types allowed: New, Resubmission, Revision

• Clinical trial: Optional at the UG3 stage, required in the UH3 stage

• Letter of intent: encouraged, not required

• Assistance Listing Numbers: 93.853, 93.372, 93.213, 93.279, 93.866, 93.273, 93.286, 93.242, 93.865, 93.121, 93.867

• Program email: Blueprint-MedTech@nih.gov

‍ ‍

Which NIH Institutes and Centers participate in Blueprint MedTech?

‍ ‍

Ten Institutes and Centers participate, and your device must address a disease or disorder within the mission of at least one of them. The Office of Behavioral and Social Sciences Research may co-fund awards.

‍ ‍

• Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative

  • There is a need to help transition BRAIN Initiative-relevant technologies from early device development to first-in-human studies. Projects that fit the following categories can be submitted through the Blueprint MedTech Program. BRAIN will support the following efforts coming into the BP MedTech UG3/UH3 funding opportunity:

  • Projects developing novel invasive neurostimulation devices for the human central nervous system (CNS).

  • Projects developing novel invasive brain recording devices for the human CNS.

  • Projects developing novel non-invasive brain stimulation devices for the human CNS. These devices should aim to achieve brain stimulation resolution of sub-millimeter at the cortical surface and depth. These approaches may incorporate electromagnetic, mechanical, or combination biological and device means (e.g., optogenetics).

• National Center for Medical Rehabilitation Research (NCMRR)

  • The National Center for Medical Rehabilitation Research within NICHD supports assistive and rehabilitation technology to improve the function of people with physical disabilities. NICHD will only accept applications related to the mission of the National Center for Medical Rehabilitation Research.

• Helping to End Addiction Long-term (HEAL) Initiative

  • Through Notice of Special Interest NOT-NS-24-075, the NIH HEAL Initiative encourages the development and translation of novel neurotechnologies, funded through the Helping to End Addiction Long-term (HEAL) Initiative and overseen by the NIH Blueprint MedTech program. Academic institutions and Small Business Concerns (SBCs) are encouraged to submit grant applications that propose non-clinical development and validation activities for subsequent clinical feasibility studies of medical devices for the diagnosis and treatment of pain and opioid use disorder (OUD). Applications supporting the development and translation of groundbreaking neurotechnologies that fit within the mission of the HEAL Initiative are encouraged.

• National Center for Complementary and Integrative Health (NCCIH)

  • The National Center for Complementary and Integrative Health (NCCIH) supports the development and validation of technologies that can facilitate the integration of complementary and integrative health approaches to enhance diagnosis, prevention, or treatment of diseases and/or associated symptoms, or promotion of well-being and whole person health relevant to the nervous and neuromuscular systems. In addition, NCCIH supports the integration of technologies with multisystem studies to understand the connections and interactions across systems involving the brain and the rest of the nervous system such as interoception, and/or the impact of multi-component interventions on multisystem connections and interactions in pre-clinical models or human subjects. NCCIH will not support clinical efficacy studies or pivotal trials of an intervention.

  • Complementary health approaches include a broad range of practices and interventions that are not typically part of conventional medical care. They can be classified by their primary therapeutic input, including nutritional (e.g., special diets, dietary supplements, herbs, probiotics, and microbial-based therapies), psychological (e.g., meditation, hypnosis, music-based interventions, relaxation therapies), physical (e.g., acupuncture, massage, chiropractic manipulation, other force-based manipulations, or devices related to these approaches), or a combination of psychological and physical (e.g., yoga, tai chi, dance therapies, some forms of art therapy such as music-based interventions).

• National Eye Institute (NEI)

  • The National Eye Institute is requesting applications for the development of FDA Class III medical devices, as well as invasive ocular implants and prosthetics (retinal or cortical) that can stimulate retinal or cortical neurons to produce visual percepts. NEI is not interested in projects focused on developing diagnostic/imaging devices or assistive devices through this program.

• National Institute of Biomedical Imaging and Bioengineering (NIBIB)

  • The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to transform, through technology development, our understanding of disease and its prevention, detection, diagnosis, and treatment. NIBIB may support the development of broadly applicable products, where the disease or organ being targeted is used as an initial model and could be adapted to other indications in the future. Before contacting NIBIB, applicants should first discuss the initial target with the Institute and/or Center on this page that is most relevant to the disease(s) being addressed by the proposed product.

• National Institute of Dental and Craniofacial Research (NIDCR)

  • Development of technologies for oral somatosensory or autonomic nerve stimulation to enable diagnosis and/or treatment of motor and sensory conditions, such as bruxism, sleep apnea, temporomandibular/facial pain, swallowing reflex, salivary gland production, and other dental, oral, and craniofacial related conditions and disorders related to the nervous system. These technologies can include the integration of intra- and extra-oral sensors and relevant treatment delivery mechanisms controlled by software systems that allow capture, analysis and display of target biosignatures including but not limited to neural activity.

  • Biofeedback & multimodal neurofeedback technologies for treatment of facial nerve disorders, as well as neurological (e.g., trigeminal neuralgia, peripheral neuropathy associated with Sjogren’s syndrome, burning mouth syndrome) and non-neurological (e.g., vascular/muscular, immune) facial pain. These technologies can include wearable and embeddable devices as well as virtual or augmented reality technology to address acute and chronic conditions.

  • Development, validation and testing of novel technologies to promote prevention and treatment of orofacial and craniofacial nerve injuries, including nerve regeneration.

  • Development, validation and testing of technologies that improve the accuracy and validity of dental, oral or craniofacial clinical pain measurements.

• National Institute of Mental Health (NIMH)

  • NIMH is specifically interested in novel brain stimulation/modulation technologies (invasive or noninvasive) for use in the treatment of psychiatric disorders, or in targeting specific domains of clinical functioning across psychiatric disorders, when appropriate (see RDOC). Devices capable of both recording and stimulating neural activity, with the ability for closed-loop control are also of interest (including synchronizing dense behavioral quantification with neural data); these devices should be able to demonstrate clear capability to record oscillations of interest to mental health applications. Devices can target specific age ranges, including vulnerable populations (pediatric, geriatric). Note: Animal studies to assess “efficacy” must follow NIMH criteria. Please contact NIMH staff above to ensure your project fits NIMH priorities, prior to application submission.

• Office of Behavioral and Social Sciences Research (OBSSR)

• National Institute of Neurological Disorders and Stroke (NINDS)

• National Institute on Aging (NIA)

  • NIA, as the primary federal agency for aging and Alzheimer’s Disease and related dementias (AD/ADRD) research, supports the development and application of innovative technology for early diagnosis and treatment of age-related disorders and AD/ADRD.

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  • NIAAA’s mission is to generate and disseminate fundamental knowledge about the adverse effects of alcohol on health and well-being and to apply that knowledge to improve diagnosis, prevention, and treatment of alcohol-related problems, including alcohol use disorder (AUD), across the life span. NIAAA is interested in wearable devices that can monitor blood alcohol concentration in real time, non-invasive methods for the treatment of fetal alcohol spectrum disorders (FASD) in children and adults, and in the treatment of AUD.

• National Institute on Drug Abuse (NIDA)

  • NIDA will support applications aiming to develop novel medical devices intended for use in the diagnosis of, or in the cure, mitigation, treatment, or prevention of Substance Use Disorder (e.g., Opioid Use Disorder, Stimulant Use Disorder). See the NIDA Mission for additional details.

‍ ‍

Projects may also fall under the NIH BRAIN Initiative (Brain Research through Advancing Innovative Neurotechnologies) or the HEAL Initiative (Helping to End Addiction Long-term). A Notice of Special Interest, NOT-NS-24-075, specifically invites HEAL-aligned diagnostic and therapeutic device applications through this NOFO.

‍ ‍

Each participating Institute publishes its own interest statement with additional requirements, clinical study limitations, and budget guidance. Reading the interest statement for your target Institute before you write anything is not optional in practice. Two applications with identical technology can succeed or fail on Institute fit alone.

‍ ‍

How much funding can a startup receive from Blueprint MedTech Translator?

‍ ‍

There is no published budget cap. NIH states that application budgets are not limited but need to reflect the actual needs of the proposed project, and that applicants should propose a budget that is reasonable and appropriate for completion of the research.

‍ ‍

That freedom comes with four practical rules that shape every Blueprint MedTech budget.

‍ ‍

Rule one: your budget covers only your own work. Application budgets should only cover work performed by the Program Director or Principal Investigator and their staff. NIH pays Blueprint MedTech contractors and consultants directly for their work, so those expenses must not appear in your budget. This is the single most common budgeting error on this NOFO. Startups accustomed to SBIR budgeting will instinctively line-item a CRO for large animal work or a regulatory consultant for the pre-submission, and both belong outside the budget here.

‍ ‍

Rule two: requests of $500,000 or more in direct costs in any single year require advance permission. If you plan to request $500,000 or more in direct costs in any year, excluding consortium facilities and administrative costs, you must contact a Scientific or Research Contact at least six weeks before submitting and follow NIH policy on acceptance for review of applications requesting $500,000 or more. Skipping this step can cost you the cycle.

‍ ‍

Rule three: funding may be throttled to $100,000 until FDA weighs in. Applicants who do not already have sufficiently relevant FDA feedback covering all planned activities will be expected to obtain it as the first milestone of the award. Until FDA feedback is received and is consistent with the likely success of the regulatory path to market and the overall device development plan, funding may be restricted to a maximum of $100,000 in direct costs. If FDA feedback contradicts the plan in the application, program staff will evaluate the concerns and the change of scope required, and any remaining funds from the original award will not be released.

‍ ‍

Rule four: budgets are negotiated, not simply awarded. As a cooperative agreement, milestones and budget are negotiated with NIH program staff before award, and the budget for the UH3 clinical phase is renegotiated at the transition point.

‍ ‍

Because Institute-specific budget expectations vary widely, contacting the program officer at your target Institute is the only reliable way to calibrate the number.

‍ ‍

What free resources does the Blueprint MedTech program provide?

‍ ‍

This is the part founders consistently undervalue. Beyond the cash award, Blueprint MedTech participants get streamlined access to NIH-funded service providers and contract research organizations that NIH pays for directly. The program provides:

‍ ‍

• Design optimization, prototype development, and pilot-scale manufacturing

• Bench and safety testing

• Biocompatibility, sterilization, and large animal testing

• Clinical study advising and clinical trial support, including medical monitoring

• Commercialization planning and business development

• Regulatory, quality system, and reimbursement support

• Legal support and intellectual property protection

• Access to industry expert mentors and meetings with an external oversight committee

• Planning resources for concept development, team building, and needs assessment

‍ ‍

For a seed-stage medtech company, the in-kind value of GLP large animal safety studies, biocompatibility panels, and regulatory consulting can rival or exceed the cash award.

‍ ‍

Applicants are required to submit a Resource Checklist attachment identifying which of these resources they intend to use. NIH encourages a specific statement along these lines: "If selected for funding, we expect that the following resources will be made available to this project by the Blueprint MedTech program. Since the program will provide these resources at no cost, this application does not request any labor or budget associated with these resources."

‍ ‍

What is NIH actually looking for in a Blueprint MedTech application?

‍ ‍

NIH is looking for a device that is nearly finished, aimed at a real clinical gap, backed by real data, and blocked mainly by the cost of regulatory-grade testing and a first clinical study.

‍ ‍

More precisely, the program wants novel medical device technologies that advance patient care toward new or improved therapeutics or diagnostics that are safe and effective. Responsive applications propose devices expected to be regulated by the FDA that present first-of-its-kind technologies, new safety questions, or new regulatory questions. Applications may also refine existing technologies toward a new intended use or use in a novel setting, for example translating a neuromodulation device approved only for healthcare settings into a home-use device.

‍ ‍

Expected regulatory pathway

‍ ‍

Proposed devices and indications will likely follow the De Novo or Premarket Approval (PMA) pathways. Devices that fit an existing 510(k) pathway may still be accepted, but only if the application demonstrates clear clinical and technological innovation beyond the state of the art of existing FDA-cleared predicates. Such devices should reasonably be expected to provide new clinically meaningful diagnostic or therapeutic options, or to improve the benefit-risk profile of a treatment or diagnostic through substantial safety innovations.

‍ ‍

Device maturity requirements

‍ ‍

Devices within scope of this program must meet at least one of three conditions:

‍ ‍

1. The device is very close to the final system and is manufactured using very close to the same manufacturing process as the device that will be marketed or studied in a larger clinical trial after this project, or

2. The device has received Pre-Submission feedback from the FDA, or

3. The device requires early feasibility clinical data to inform the final device design or manufacturing processes.

‍ ‍

Entry criteria

‍ ‍

For entry into the program, projects should have all three of the following:

‍ ‍

• Comprehensive supporting data based on bench, in vitro, and in vivo models representative of the intended patient population and indication

• One or more clinically meaningful device outcome measures identified with input from key stakeholders including clinicians, patients, and caregivers, supported by literature

• A compelling case for a successful IDE submission for a Significant Risk study, or IRB approval for a Non-Significant Risk study, by the end of the UG3 phase

‍ ‍

For novel devices, proof-of-concept data on device function is required, obtained using a prototype close to the final device design anticipated for clinical testing, ideally tested in an in vivo animal model representative of the intended patient population. For first-in-human studies, preliminary human data is not required.

‍ ‍

A note on market size

‍ ‍

NIH explicitly states that the market for these device categories may be small compared with other markets, and that applications should not be penalized for a comparatively smaller market provided the market is sustainable. NIH supports research for both rare and high incidence disorders within its mission. This is a meaningful opening for rare disease device companies that struggle to raise venture capital on total addressable market alone.

‍ ‍

How does the UG3 and UH3 phased structure work?

‍ ‍

Every project must have two phases, and every project starts in the UG3 phase. The UH3 phase is not guaranteed. Transition happens only after NIH administrative review.

‍ ‍

UG3 phase: get to an IDE or IRB approval

‍ ‍

The UG3 phase supports the translational device work needed to obtain an IDE and IRB approval for a Significant Risk clinical study, or IRB approval for a Non-Significant Risk study. Duration depends on project maturity at entry and the specific indication, and ranges from one to four years.

‍ ‍

Activities appropriate to the UG3 phase include:

‍ ‍

• Non-GLP animal studies to develop surgical techniques, optimize therapeutic or diagnostic parameters, and refine device design ahead of GLP testing

• Bench-top and animal testing to demonstrate compliance with FDA Recognized Standards

• GLP-compliant large animal safety testing of an implanted device

• Activities to become current Good Manufacturing Practice (cGMP) compliant

• Activities to bring development under Design Control and Quality Systems

• Usability and acceptability studies

• Device, software, firmware, and cybersecurity design verification and validation

• Development of packaging, connectors, and accessories needed for translation

• Regulatory activities including FDA pre-submission meetings, IDE submission, Humanitarian Device Exemption, Request for Risk Designation, 513(g) submission, and Breakthrough Device Designation

‍ ‍

UH3 phase: run the clinical study

‍ ‍

The UH3 phase supports a clinical study leading to one of three outcomes: a marketing application, if the study is sufficiently powered to demonstrate safety and effectiveness for regulatory approval; a larger clinical study that will lead to a marketing application; or use of the clinical experience to inform device design decisions. The UH3 phase can last up to four years.

‍ ‍

The clinical study must provide information about device function or final design that cannot practically be obtained through additional bench or animal work, because of the novelty of the device or its intended use.

‍ ‍

Activities appropriate to the UH3 phase include:

‍ ‍

• Optimization of device design with respect to human functional anatomy

• Identification of the simplest, most reliable, and most cost-effective device configuration for advanced clinical studies and eventual market approval

• Studies of key physiological variables that may affect device function in humans

• Initial device safety assessments, but only in conjunction with obtaining enabling data about device design or function

‍ ‍

What determines whether you transition from UG3 to UH3?

‍ ‍

Program staff conduct an administrative review, with possible input from independent consultants. The decision rests on:

‍ ‍

• Successful achievement of the defined UG3 milestones

• The competitive landscape

• Programmatic priorities and current portfolio balance

• For Significant Risk studies, documentation of final or conditional IDE approval from FDA

• IRB approvals

• Submission of the final clinical protocol and supporting documents to NIH for administrative review, and NIH notification of approval

• Agreement on updated timeline, milestones, and budget for the clinical study

• Availability of funds

‍ ‍

NIH is direct about the implication: expectations align with industry norms for advancing devices through the development pipeline, and an inherent rate of attrition is possible within this program. Not every UG3 award becomes a UH3 award. Build your company plan accordingly.

‍ ‍

Why milestones decide the outcome of a Blueprint MedTech award

‍ ‍

Blueprint MedTech is a milestone-driven cooperative agreement, which means milestones are not a formality in the application. They are the operating contract for the award.

‍ ‍

Each Specific Aim in the application should have at least one milestone associated with it. Each milestone should tie to tangible deliverables that are specific, measurable, achievable, relevant, and time-bound. NIH treats milestones as go or no-go decision points where significant uncertainty for the project is resolved. Applicants are advised to include aims, milestones, and deliverables addressing both technical and commercial feasibility.

‍ ‍

Two milestones are effectively mandatory in Year 1:

‍ ‍

• For projects that need non-clinical testing to support an IDE, an FDA pre-submission meeting with NIH program staff in attendance must be a Year 1 milestone. FDA feedback from that meeting must clearly indicate that the proposed non-clinical testing plan is sufficient to support a successful IDE submission by the end of the UG3 phase.

• For projects requiring non-clinical testing to support an IRB Non-Significant Risk designation, preliminary communication with the IRB about what non-clinical testing will be necessary must be a Year 1 milestone.

‍ ‍

After award, NIH program staff evaluate progress toward milestones every year and recommend whether further funds should be released. If a project does not meet its milestones, funding may be discontinued. Continued funding also depends on the overall robustness of the entire data package, overall progress, portfolio balance and program priorities, the competitive landscape, and availability of funds.

‍ ‍

Milestones are negotiated with NIH program staff before award and are written into the Notice of Award. In rare, well-justified cases, future-year milestones may be renegotiated based on data obtained during the previous year.

‍ ‍

Blueprint MedTech Translator deadlines and timeline

‍ ‍

Applications are due by 5:00 PM local time of the applicant organization. When a due date falls on a weekend or federal holiday, the deadline moves automatically to the next business day.

‍ ‍

Upcoming due dates and review cycles

‍ ‍

September 28, 2026 submission. Scientific merit review March 2027. Advisory Council review May 2027. Earliest project start July 2027.

‍ ‍

January 28, 2027 submission. Scientific merit review July 2027. Advisory Council review October 2027. Earliest project start December 2027.

‍ ‍

May 28, 2027 submission. Scientific merit review November 2027. Advisory Council review January 2028. Earliest project start April 2028.

‍ ‍

September 28, 2027 submission. Scientific merit review March 2028. Advisory Council review May 2028. Earliest project start July 2028.

‍ ‍

January 28, 2028 submission. Scientific merit review July 2028. Advisory Council review October 2028. Earliest project start December 2028. This is the final due date before the NOFO expires on January 29, 2028.

‍ ‍

The same dates apply to new, resubmission, and revision applications. There are no AIDS-related deadlines for this opportunity.

‍ ‍

The timeline you should actually plan against

‍ ‍

Count backward from the deadline, not forward from today.

‍ ‍

• Twelve weeks before the due date: contact NIH program staff at your target Institute. NIH states that when possible, applicants should contact program staff at least twelve weeks before a receipt date. Early contact is how you learn whether your indication fits, what the Institute expects on clinical study design, and what budget range is realistic.

• Six weeks before the due date: if you are requesting $500,000 or more in direct costs in any year, this is your hard deadline for contacting a Scientific or Research Contact.

• Six weeks or more before the due date: begin System for Award Management registration if you are not already registered. NIH warns that registration can take six weeks or more, and that failure to complete registrations in advance is not a valid reason for late submission.

• Two weeks before the due date: eRA Commons accounts can take up to two weeks to obtain. Every Program Director or Principal Investigator needs one, and their eRA Commons ID must appear in the Credential field of the Senior/Key Person Profile form.

• Several days before the due date: submit early. Errors found during the Grants.gov and eRA Commons validation process must be corrected and a changed or corrected application resubmitted on or before the due date and time.

‍ ‍

Add roughly nine to ten months from submission to earliest award start. A September 2026 submission that succeeds starts in July 2027.

‍ ‍

Who is eligible to apply for Blueprint MedTech Translator?

‍ ‍

Eligibility is broad, and startups are explicitly welcome. Individuals, institutions, and businesses developing their own devices, or that already have established collaborations with device manufacturers, may apply directly.

‍ ‍

Eligible organizations include:

‍ ‍

• Higher education institutions, both public and private

• Nonprofits with and without 501(c)(3) status

• For-profit organizations, including small businesses

• Local, state, county, city, township, and special district governments

• Federally recognized and other Native American tribal governments and organizations

• Eligible agencies of the federal government

• U.S. territories and possessions

• Independent school districts, public housing authorities, faith-based and community-based organizations, and regional organizations

• Non-domestic (non-U.S.) entities, including foreign organizations and foreign components of U.S. organizations

‍ ‍

Foreign components as defined in the NIH Grants Policy Statement are allowed.

‍ ‍

What this means for a venture-backed startup

‍ ‍

Three points matter for founders comparing this to SBIR and STTR.

‍ ‍

First, this is not an SBIR or STTR program. The SBIR ownership and size restrictions do not apply here, so majority venture-owned and larger private companies that have aged out of SBIR eligibility can still compete.

‍ ‍

Second, cost sharing is not required.

‍ ‍

Third, an organization may submit more than one application as long as each is scientifically distinct. NIH will not accept duplicate or highly overlapping applications under review at the same time.

‍ ‍

Required registrations

‍ ‍

All registrations must be complete before the application is submitted:

‍ ‍

• System for Award Management (SAM), which must be renewed at least annually and which assigns a CAGE code for domestic organizations

• NATO Commercial and Government Entity (NCAGE) code for foreign organizations, in lieu of a CAGE code

• Unique Entity Identifier (UEI), issued through the SAM registration process, which must match the identifier in eRA Commons

• eRA Commons, requiring at least one Signing Official and at least one Program Director or Principal Investigator account. If the PI is also the Signing Official, two distinct accounts are required.

• Grants.gov, which requires an active SAM registration first

‍ ‍

Applications may be submitted through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.

‍ ‍

What attachments does a Blueprint MedTech application require?

‍ ‍

This NOFO has an unusually heavy set of required attachments with strict page limits. Missing or oversized attachments cause withdrawal without review. Treat this list as a compliance checklist.

‍ ‍

Required attachments

‍ ‍

• Needs Assessment, three pages maximum, filed as "Needs Assessment.pdf"

• IP Strategy, three pages maximum, filed as "IP Strategy.pdf"

• Gantt Chart, one page maximum, filed as "Gantt.pdf"

• Long-term Care Plan for Patients, three pages maximum, filed as "Long-term Care.pdf"

• Resource Checklist, three pages maximum, filed as "Resource Checklist.pdf"

• UG3 Milestone Plan, included in the Research Strategy

• UH3 Milestone Plan, attached at Section 2.7 Study Timeline in the PHS Human Subjects and Clinical Trials Information form

• Team Management Plan, two pages maximum, attached at Section 3.5

• Data Safety and Monitoring Plan, attached at Section 3.3

• Data Management and Sharing Plan, required regardless of direct costs requested

‍ ‍

Optional attachments with enforced page limits

‍ ‍

Exceeding these limits also causes withdrawal.

‍ ‍

• Schematics, two pages maximum, filed as "Schematics.pdf"

• IRB Communications, five pages maximum, filed as "IRB Communications.pdf"

• FDA Communications, ten pages maximum including a one-page summary, submitted only in Section 4.5.a or as post-submission material. Pre-submissions themselves should not be included.

‍ ‍

What goes in the harder attachments

‍ ‍

Needs Assessment. Establish performance requirements with clear, quantifiable metrics. Identify significant issues faced by patients, clinicians, caregivers, and customers. Critically evaluate primary or secondary data used to identify deficiencies in current capabilities. Describe the beneficiaries and how their needs were identified. Distinguish wants from needs. Describe how finite resources will be deployed. Identify human factors and ergonomics incorporated into the design.

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IP Strategy. Describe the IP landscape around your device, including known constraints such as restrictions under transfer or sharing agreements, your own prior filings and publications, and similar patented or marketed technologies. If you are using technology your institution does not own, address anything that could constrain your freedom to operate, and include a letter from the IP owner stating whether they will provide the technology, any limits on studies performed with it, agreement on public disclosure of results including negative results, and whether an agreement is already in place. Give filing dates, patent types, application status, and USPTO links for relevant filings, and describe future filing plans. Academic applicants should prepare this with their technology transfer office.

‍ ‍

Long-term Care Plan for Patients. Describe anticipated care needs of participants after the trial ends that relate to their participation, such as continued device access, device maintenance, and explant. Consider post-trial scenarios including device or trial failure, success, regulatory approval options, and a manufacturer decision to discontinue the product. Then describe the actual plan, which may include explant of indwelling devices, surgical removal of batteries and capping exposed metals from leads and IS-1 connectors, manufacturer-supported device maintenance for responders, or manufacturer support for compassionate use exemption filings. Address post-trial obligations including hardware and software maintenance and device-related medical expenses.

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Team Management Plan. Define team structure and relationships, illustrated with an organizational chart. Describe governance, communication plans, decision processes for scientific direction and intellectual property, and conflict resolution procedures. Address authorship policies and decisions about what to publish, consistent with the interests of commercial partners. The plan must establish and name a Scientific Steering Group of senior and key team members that meets regularly. If organizations are partnering, the Scientific Steering Group must include representatives from each. Technology transfer officials are encouraged to be members.

‍ ‍

Neuroethics section. Within Protection of Human Subjects, describe ethical considerations related to the design and conduct of the study, for example therapeutic misconception where research is ancillary to a clinical procedure or offers no prospect of participant benefit, and the long-term implications of the study, such as psychosocial or legal implications of predictive biomarkers for pre-symptomatic individuals. Reference the Neuroethics Guiding Principles for the NIH BRAIN Initiative.

‍ ‍

Letters of support

‍ ‍

Include letters from consultants, contractors, and collaborators. Academic applicants must include a letter from the technology transfer official managing the project's IP. Multi-institution projects need a letter from each institution clarifying how IP will be shared or managed. Collaborations with private entities need a letter stating whether the entity will provide the device or technology, limits on studies, limits on data sharing, and whether licensing agreements are in place. CRO and CMO letters may summarize test results but should not contain detailed results of all testing, and generally run two pages maximum.

‍ ‍

What makes a Blueprint MedTech application non-responsive?

‍ ‍

Non-responsive applications are withdrawn and never reviewed. There are three categories.

‍ ‍

Activities that make an application non-responsive

‍ ‍

• Animal model development. All in vivo models must be established, characterized, and available to the applicant.

• Projects focused on technologies for augmentation of healthy individuals

• Delayed-onset clinical studies

• Device technologies not regulated by the FDA

‍ ‍

Omissions that make an application non-responsive

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• Specific Aims that do not cover activities for both the UG3 and UH3 phases

• Failure to plan a delayed-start clinical study or trial in the UH3 phase, including all required supporting documentation

• Missing any required attachment listed above

• Missing a UH3 Milestone Plan

‍ ‍

Formatting failures that make an application non-responsive

‍ ‍

• Any required or optional attachment that exceeds its page limit

‍ ‍

Note the distinction NIH draws between delayed onset and delayed start. A delayed-start study is one that can be described in full but will not begin immediately, which is exactly what the UH3 phase requires. A delayed-onset study is one that cannot yet be described, and those are not accepted.

‍ ‍

How is a Blueprint MedTech application reviewed?

‍ ‍

Applications are evaluated for scientific and technical merit by an appropriate Scientific Review Group under NIH peer review policy, using the revised NIH review framework that took effect for due dates on or after January 25, 2025.

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Reviewers consider three factors. Factors 1 and 2 each receive a separate factor score, and all three inform the overall impact score.

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Factor 1: Importance of the Research (Significance and Innovation)

‍ ‍

Reviewers assess whether the work addresses an important gap, solves a critical problem, or creates a valuable conceptual or technical advance, and whether it applies novel concepts, methods, or technologies.

‍ ‍

Specific to this NOFO, reviewers evaluate:

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• Whether there is a significant advantage over all existing clinically available approaches for the same indication, regardless of class, including drugs, biologics, and competing devices

• Whether the device reduces a known serious adverse event, a known device failure mode, or a use-related hazard or error, or improves the safety of another device or intervention

• For devices improving on earlier generations, whether the advantages are justified and whether the changes are likely to succeed where the predecessor did not

• Whether proof-of-concept data for a novel device was obtained with a prototype close to the final design

• Whether the device and its capabilities are described in enough detail to judge appropriateness for the proposed clinical study

• Whether the approach, targets, and patient population are justified

• Whether there are adequate plans to engage FDA early

• Whether the Needs Assessment incorporates input from patients, clinicians, and caregivers on device performance requirements, and identifies beneficiaries and their needs

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Factor 2: Rigor and Feasibility (Approach)

‍ ‍

Reviewers assess whether the work will produce unbiased, reproducible, robust data, whether design and controls are sound, whether sample size is sufficient and justified, and whether the studies can be done within the proposed timeframe.

‍ ‍

Specific to this NOFO, reviewers evaluate:

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• Whether the regulatory plan is reasonable in terms of the path to market and FDA data requirements for the applicable standard, meaning reasonable assurance of safety and effectiveness for PMA or substantial equivalence for 510(k)

• Whether the estimated timeline for clinical adoption reflects feasible benchmarks

• Whether and how key stakeholders will be engaged at each step

• Whether the project plan and timeline make an IDE at the end of the UG3 phase, or IRB approval for a Non-Significant Risk study, likely

• Whether neuroethical concerns are adequately addressed

• Whether any large animal safety study uses GLP and the final device design, or whether a clear reason it is unnecessary is provided, such as an FDA communication

• Whether the Long-term Care Plan anticipates key patient needs, is reasonable, and addresses financial liability for injury, device removal, device revision, and management of indwelling devices

• Whether the Gantt chart provides sufficient detail and demonstrates feasible plans

• Whether milestones are timely, robust, and tied to clear quantitative go or no-go criteria

• Whether milestone timelines are realistic, inclusive of necessary steps, and free of unnecessary ones

• Whether milestones reflect planned regulatory requirements such as FDA pre-submission meetings and IDE submission

• Whether potential challenges and solutions are presented, including strategies for enrollment shortfalls

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Factor 3: Expertise and Resources (Investigators and Environment)

‍ ‍

Reviewers assess investigator background and training, the leadership plan for multiple-PI applications, and institutional resources. Specific to this NOFO, reviewers evaluate whether the selection of Blueprint MedTech resources is adequately justified, whether team governance is appropriate, and whether the Scientific Steering Group members are appropriate and constitute an interdisciplinary team.

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Additional considerations

‍ ‍

Reviewers also consider, without scoring, the IP Strategy attachment, including whether IP landscape issues and barriers are addressed, whether known constraints could impede device development, whether filing plans are well described, and whether IP sharing across multiple institutions is adequately addressed. Human subjects protections, vertebrate animals, biohazards, authentication of key resources, and budget and period of support are also considered.

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After peer review

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Applications may undergo a committee process in which only those with the highest merit, generally the top half under review, are discussed and scored. Recommended applications then receive a second level of review by the appropriate national Advisory Council or Board. Funding decisions weigh scientific and technical merit, availability of funds, and relevance to program priorities.

‍ ‍

What does the cooperative agreement mean for your company?

‍ ‍

A cooperative agreement is not a grant you receive and then execute independently. NIH program staff have substantial programmatic involvement beyond normal stewardship. Founders should understand what they are signing up for.

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What you retain

‍ ‍

• Custody of and all rights to the data and technology developed under the award, subject to government rights of access consistent with HHS, PHS, and NIH policy

• Responsibility for defining objectives and approaches, planning, conducting, analyzing, interpreting, publishing, and sharing results

• The right and encouragement to pursue patent protection

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The program strongly encourages recipients and their collaborators to obtain and retain IP developed around the device during the project period, and to identify and foster relationships with licensing and commercialization partners early.

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What NIH expects from you

‍ ‍

• Developing and proposing rigorous milestones

• Progress reports complete enough to include experimental design, assumptions, results, interpretations, and a conclusion on whether milestones were met. If program staff request raw data, you agree to provide it.

• Participation in virtual progress meetings with NIH staff at least twice a year

• Communicating regulatory meeting dates and agendas to NIH program staff and inviting their participation

• Sharing CRO study reports, meeting minutes and data packages, letters, and other FDA communications, and providing IDE or IND numbers and ClinicalTrials.gov registration numbers

• Providing regulatory and clinical documents required for administrative review

• Verifying the clinical study follows Good Clinical Practices and Institute-specific data and safety monitoring guidelines

• Collaborating and communicating effectively with NIH service contractors

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What NIH does

‍ ‍

NIH program staff provide input on milestones and recommend their finalization, assess progress toward milestones, recommend whether further funds should be released, participate with your team in meetings with regulatory agencies, and may consult independent specialists under confidentiality agreements to protect intellectual property. In rare, well-justified cases, program staff may add critical experiments as additional milestones, sometimes with additional NIH funds.

‍ ‍

A Program Officer handles normal stewardship, but the Associate Division Director overseeing the program makes final decisions on project continuation, a second level of approval designed to mitigate perceived bias. Disagreements can be escalated through other Associate Division Directors to the Institute Director. A formal Dispute Resolution Panel process exists for scientific or programmatic disagreements. Final NIH decisions regarding a discontinuation are not appealable.

‍ ‍

Quality and compliance requirements

‍ ‍

Use of Design Control and Quality Systems processes to the degree specified by FDA is required. Intermediate steps such as design reviews, design verification, design validation, and design transfer should appear in annual milestones where appropriate, along with IDE submission. NIH recognizes the required degree varies substantially by device, and encourages applicants to discuss this with FDA and regulatory consultants before submitting so the extent of the requirement is clearly defined and verifiable in the application.

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Applicants should consider Quality System requirements at the IDE stage when planning device development activities, and should follow Institute-specific guidelines and policies for monitoring clinical research when forming a data and safety monitoring plan.

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How to build a competitive Blueprint MedTech application

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Six moves separate funded applications from withdrawn ones.

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Call the program officer first, not last. NIH says twelve weeks before the deadline. This program is a negotiated partnership, and the negotiation starts before you write. Program staff will tell you whether your indication fits their Institute's mission, what clinical study requirements apply, and what budget is realistic. The Institute contact list is published on the Blueprint MedTech website.

‍ ‍

Get FDA feedback before you submit if you possibly can. Pre-submission feedback is encouraged rather than required, but the alternative is a Year 1 milestone and a possible $100,000 funding restriction until FDA responds. Applications that arrive with approved pre-submission minutes showing FDA agreement on the non-clinical testing plan are substantially stronger and start faster.

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Write your milestones like an operating plan, not a research schedule. Every Specific Aim needs at least one milestone. Every milestone needs quantitative go or no-go criteria. Cover technical, regulatory, and commercial feasibility. These become the terms of your award and the basis of every annual funding decision.

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Build the whole application around one Institute's mission and one indication. Your device may have several uses. The application must focus on a disease or disorder within the mission of a participating Institute, and the target patient population and intended use should drive both device design and the proposed clinical activities.

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Treat the attachment checklist as a go or no-go gate. Five required other attachments, two milestone plans, a team management plan, a DSMP, and a data management and sharing plan, each with page limits that are enforced by withdrawal rather than by a request to fix. Assign an owner and a deadline to each one.

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Budget only your own work, and claim the free resources explicitly. Leave NIH-paid contractors and consultants out of the budget, name the Blueprint MedTech resources you will use in the Resource Checklist, and justify why you are not using the ones you skipped.

Frequently asked questions about the Blueprint MedTech Translator (PAR-25-383)

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What is the deadline for PAR-25-383?

‍ ‍

The next application deadline is September 28, 2026. Additional deadlines follow on January 28, 2027, May 28, 2027, September 28, 2027, and January 28, 2028. All applications are due by 5:00 PM local time of the applicant organization. The NOFO expires January 29, 2028.

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How much money can I request from Blueprint MedTech Translator?

‍ ‍

There is no budget cap. NIH states that application budgets are not limited but must reflect the actual needs of the proposed project. If you request $500,000 or more in direct costs in any single year, you must contact a Scientific or Research Contact at least six weeks before submitting and follow NIH policy on acceptance of applications requesting $500,000 or more.

‍ ‍

Can a startup or small business apply to Blueprint MedTech Translator?

‍ ‍

Yes. For-profit organizations, including small businesses, are explicitly eligible. Individuals, institutions, and businesses developing their own devices, or that already have established collaborations with device manufacturers, are welcome to apply directly. Foreign organizations are also eligible.

‍ ‍

Is Blueprint MedTech an SBIR or STTR program?

‍ ‍

No. Blueprint MedTech Translator is a UG3/UH3 cooperative agreement, not an SBIR or STTR award. SBIR ownership and company size restrictions do not apply, so companies that are majority venture-owned or otherwise ineligible for SBIR can compete here. Note that Blueprint MedTech also offers companion SBIR opportunities, so confirm which mechanism fits your company with program staff.

‍ ‍

Do I need FDA feedback before applying?

‍ ‍

Not strictly, but it matters a great deal. Applicants are encouraged, though not required, to consult FDA through a Pre-Submission meeting. If you do not have sufficiently relevant FDA feedback covering all planned activities at the time of application, obtaining it becomes your first milestone, and funding may be restricted to a maximum of $100,000 in direct costs until FDA feedback consistent with your regulatory path and development plan is received.

‍ ‍

How long does a Blueprint MedTech award last?

‍ ‍

The UG3 phase may run up to four years and the UH3 phase may run up to four years, but the total combined project period may not exceed five years. UG3 duration depends on how mature the project is at entry and on the specific indication, and can be as short as one year.

‍ ‍

Is the UH3 clinical phase guaranteed?

‍ ‍

No. All projects start in the UG3 phase. Only UG3 projects that meet defined criteria are eligible to transition after an NIH administrative review that considers milestone achievement, the competitive landscape, programmatic priorities and portfolio balance, IDE and IRB approvals, the final clinical protocol, agreement on updated timeline and budget, and availability of funds. NIH states plainly that an inherent rate of attrition is possible.

‍ ‍

What is the difference between a Significant Risk and Non-Significant Risk study here?

‍ ‍

A Significant Risk study requires an Investigational Device Exemption from FDA before the clinical study can begin, so the UG3 phase must deliver an IDE. A Non-Significant Risk study does not require an IDE, so the UG3 phase must deliver IRB approval instead. Your milestone plan, regulatory milestones, and non-clinical testing plan differ accordingly.

‍ ‍

What kinds of devices are in scope?

‍ ‍

Devices expected to be regulated by FDA that present first-of-its-kind technology, new safety questions, or new regulatory questions, and that address a disease or disorder within the mission of a participating Institute or Center or the BRAIN or HEAL Initiatives. Devices refining existing technology for a new intended use or a novel setting, such as moving a clinic-only neuromodulation device to home use, are also responsive. Expected pathways are De Novo or PMA, with 510(k) devices accepted only when innovation clearly exceeds the state of the art of existing cleared predicates.

‍ ‍

What will make my application be rejected without review?

‍ ‍

Four activity categories are non-responsive: animal model development, technologies for augmentation of healthy individuals, delayed-onset clinical studies, and device technologies not regulated by FDA. Applications are also withdrawn for missing Specific Aims that cover both phases, missing a planned delayed-start UH3 clinical study, missing any required attachment, missing a UH3 Milestone Plan, or exceeding any attachment page limit.

‍ ‍

Do I have to include a clinical trial?

‍ ‍

The NOFO is Clinical Trial Optional at the application stage, but in practice the structure requires a clinical study in the UH3 phase. Applications must include Specific Aims covering both phases and a delayed-start clinical study or trial planned in the UH3 phase with all required supporting documentation.

‍ ‍

What free services does Blueprint MedTech provide, and do they come out of my budget?

‍ ‍

Blueprint MedTech provides design optimization, prototype development and pilot-scale manufacturing, bench and safety testing, biocompatibility and large animal studies, clinical support, business development, regulatory and quality systems support, legal and IP support, and expert consultants. NIH pays these contractors and consultants directly, so those costs must not be included in your application budget. You identify what you plan to use in the required Resource Checklist attachment.

‍ ‍

Who owns the intellectual property?

‍ ‍

You do. Recipients retain custody of and all rights to data and technology developed under the award, subject to government rights of access consistent with HHS, PHS, and NIH policy. The program strongly encourages recipients and collaborators to obtain and retain IP developed around the device, and expects Principal Investigators to work closely with technology transfer officials on royalty agreements, patent filings, and commercialization plans.

‍ ‍

Is cost sharing required?

‍ ‍

No. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

‍ ‍

Can I submit more than one application?

‍ ‍

Yes, provided each application is scientifically distinct. NIH will not accept duplicate or highly overlapping applications under review at the same time, and will not accept a new application submitted before the summary statement issues from an overlapping application under review.

‍ ‍

Is a letter of intent required?

‍ ‍

No. A letter of intent is not required, is not binding, and does not enter into review, but NIH asks prospective applicants to submit one so staff can estimate review workload. Send it to Blueprint-MedTech@nih.gov with the descriptive title, PI names and contact information, other key personnel, participating institutions, and the funding opportunity number and title.

‍ ‍

How long does it take to get funded?

‍ ‍

Roughly nine to ten months from submission to earliest possible start. A September 28, 2026 submission goes to scientific merit review in March 2027, Advisory Council review in May 2027, and has an earliest start date of July 2027.

‍ ‍

Does a small market hurt my application?

‍ ‍

No. NIH states directly that the market for these device types may be small compared with other markets, that applications should not be penalized for a comparatively smaller market provided the market is sustainable, and that NIH supports research for both rare and high incidence disorders within its mission. For rare and ultra-rare diseases where commercialization is challenging, NIH encourages applicants to discuss alternative strategies with Scientific and Research staff.

‍ ‍

How much NIH involvement should I expect after award?

‍ ‍

Substantial. Expect virtual progress meetings with NIH staff at least twice a year, NIH participation in your FDA meetings, sharing of CRO reports and FDA communications with program staff, annual milestone evaluations that determine whether further funds are released, and the possibility that program staff request raw data. Milestones are negotiated before award and written into the Notice of Award.

‍ ‍

What registrations do I need and how early should I start?

‍ ‍

You need active SAM, UEI, eRA Commons, and Grants.gov registrations, plus an NCAGE code if you are a foreign organization. NIH warns that SAM registration can take six weeks or more and eRA Commons accounts up to two weeks. All registrations must be complete before submission, and incomplete registration is not a valid excuse for a late application.

‍ ‍

Who do I contact at NIH about Blueprint MedTech?

‍ ‍

The program email is Blueprint-MedTech@nih.gov. Institute-specific scientific contacts include Nick Langhals at NINDS, Leonardo Angelone at NIDA, Erin Burke Quinlan at NCCIH, Tony Douglas Gover and Paekgyu Lee at NEI, Elizabeth Powell at NIAAA, Eunyoung Kim at NIMH, Michael Wolfson at NIBIB, and Melissa Ghim at NIDCR. NIH recommends contacting program staff at least twelve weeks before a receipt date.

‍ ‍

Key NIH contacts for PAR-25-383

‍ ‍

Program email for all inquiries and letters of intent: Blueprint-MedTech@nih.gov

‍ ‍

Scientific and research contacts

‍ ‍

• Nick Langhals, PhD, NINDS, 301-496-1779, Blueprint-MedTech@nih.gov

• Leonardo Angelone, PhD, NIDA, Blueprint-MedTech@nih.gov

• Erin Burke Quinlan, PhD, NCCIH, 301-451-0636, erin.quinlan@nih.gov

• Tony Douglas Gover, NEI, 301-529-7370, tony.gover@nih.gov

• Paekgyu Lee, NEI, 301-435-8164, paek.lee@nih.gov

• Elizabeth Powell, PhD, NIAAA, 301-443-0786, elizabeth.powell3@nih.gov

• Eunyoung Kim, PhD, NIMH, 301-496-3513, eunyoung.kim@nih.gov

• Michael Wolfson, NIBIB, 301-451-4778, michael.wolfson@nih.gov

• Melissa M. Ghim, PhD, NIDCR, ghimm@mail.nih.gov

‍ ‍

Application submission support

‍ ‍

• eRA Service Desk, 301-402-7469 or 866-504-9552

• General NIH grants information, GrantsInfo@nih.gov, 301-480-7075

• Grants.gov customer support, 800-518-4726, support@grants.gov

‍ ‍

Is Blueprint MedTech Translator right for your company?

‍ ‍

This program is a strong fit if you have a device that works, data that proves it works, a clear FDA pathway, and a funding gap between your last preclinical result and your first patient. It is a poor fit if your animal model is not yet established, your device is not FDA regulated, your technology targets enhancement of healthy people, or you cannot yet describe the clinical study you intend to run.

‍ ‍

The application is demanding. Between the two milestone plans, five required attachments with hard page limits, a needs assessment grounded in stakeholder input, an IP strategy prepared with counsel, a long-term patient care plan, and a team management plan naming a Scientific Steering Group, this is a substantially heavier lift than a standard R01 or SBIR submission. It also rewards the work: uncapped budgets, free access to CROs and regulatory consultants, and a federal partner with an interest in getting your device to market.

‍ ‍

BW&CO helps deep tech, biotech, and medtech founders win non-dilutive federal funding. We have helped clients secure more than $350 million in funding across NIH, NSF, DoD, NASA, DOE, and ARPA-H. If you are evaluating Blueprint MedTech Translator for the September 28, 2026 deadline or a later cycle, the first step is a mission-fit conversation with the right Institute, and the second is an honest read on whether your data package clears the entry criteria.

NIH Highlighted Topic: Building Health through Multidomain Resilience Research from Molecules to Communities

Highlighted Topic 117 | Participating ICOs: NHLBI, NCCIH, NCI, NIA, NIAAA, NIMHD, OBSSR, ODP, ODS, ORWH, THRO | Posted August 28, 2026 | Expires August 25, 2028 | Apply through the NIH SBIR parent announcement (PA-27-100) or the NIH STTR parent announcement (PA-27-102).

Executive Summary

NIH has designated multidomain resilience research as a formal Highlighted Topic, with eleven Institutes, Centers, and Offices publishing their own areas of interest, spanning cardiopulmonary health, cancer, aging, alcohol use, minority health and health disparities, integrative health, dietary supplements, women's health, autoimmunity, disease prevention, behavioral science, and tribal health.

The framing is a genuine inversion of how most biomedical research is funded. Rather than asking why people get sick, NIH is asking why some people do not get sick despite carrying known risk. NHLBI illustrates it with four cases that make the concept concrete: hypertension without stroke, full recovery after heart valve surgery, preserved lung function despite tobacco exposure, and the interplay of resilience with sickle cell disease exacerbation such as vaso-occlusive crises. Resilience, in NIH's working definition, is a living system's capacity to resist, recover, adapt, or grow from challenges or stressors, tracked over time across interconnected individual, community, and environmental systems.

NIH also says plainly what has been holding the field back: heterogeneous definitions, models, and measures. That diagnosis is the opportunity. The named high-priority research areas are developing and refining resilience measures and metrics, data interoperability, mechanistic understanding of protective and restoring factors distinct from disease-risk reduction, and identifying biomarkers that reflect or predict resilience. Three of those four are measurement and infrastructure problems, which is to say they are product problems.

For a small business, the concentrated openings are validated resilience measurement instruments and digital assessments, biomarker panels that predict recovery capacity rather than disease risk, controlled-perturbation and challenge-recovery testing protocols paired with longitudinal monitoring hardware, multisystem phenotyping analytics, and data interoperability and federated analysis platforms. NIA in particular asks for dynamic resilience measures using controlled perturbations and longitudinal monitoring, plus advanced analytics for multisystem resilience phenotyping, which reads as an instrument-plus-software specification rather than a research question.

There is no dedicated funding and no separate application. A Highlighted Topic is a priority signal, not a Notice of Funding Opportunity. You apply through the standard NIH SBIR or STTR omnibus and compete in the normal pool, and NIH states that applying in a Highlighted Topic area will not affect referral or review. NIMHD states it may dedicate available funds to this topic area and may give special consideration to meritorious applications in it. NCCIH states it may give special consideration. The other participating ICOs make no such statement.

One structural trap to notice immediately. Of the eleven participating ICOs, five do not award grants: OBSSR, ODP, ODS, ORWH, and THRO. Two of those five, ODS and ORWH, published the most commercially concrete interests on the entire page, dietary supplement resilience biomarkers and federated data platforms respectively. Your application still has to land on the mission of one of the six that write checks: NHLBI, NCCIH, NCI, NIA, NIAAA, or NIMHD.

Under the current SBIR parent announcement, standard budget guidelines run up to $323,090 for Phase I and up to $2,153,927 for Phase II, and NIA is approved to exceed both. The next standard receipt dates are September 5, 2026, January 5, 2027, and April 5, 2027, and the topic stays live through August 25, 2028.

A Quick Note on the NIH SBIR and STTR Program

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The NIH, CDC, and FDA SBIR and STTR programs are the largest source of non-dilutive early-stage funding for health, biomedical, and life science technology in the United States. NIH alone sets aside well over a billion dollars a year. Awards are grants, not investments. No equity, no repayment, no board seat.

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The program runs in phases. Phase I funds proof of concept and feasibility. Phase II funds the substantive research and development that turns a validated concept into a product. Fast-Track combines both in one application, and Direct to Phase II lets companies that have already established feasibility skip Phase I. Phase IIB and the Commercialization Readiness Pilot extend funding for late-stage work such as validation, scale-up, and regulatory submissions. Applicants must be for-profit U.S. small businesses with 500 or fewer employees and majority U.S. ownership.

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For the complete breakdown of the NIH SBIR and STTR program, including all budget caps by Institute, clinical trial policies, eligibility mechanics, review criteria, and the full timeline, see our full executive summary here: NIH, CDC and FDA Parent SBIR Grant (PA-27-100).

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Everything below is specific to this Highlighted Topic.

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What Is a Highlighted Topic, and How Is It Different From a Funding Opportunity?

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A Notice of Funding Opportunity (NOFO) is a solicitation. It has an announcement number, its own application package, its own review criteria, and usually its own set-aside funding. You apply to it directly.

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A Highlighted Topic is a published statement of scientific priority maintained centrally by NIH. It has no application package and no guaranteed funding. You cannot apply to it. You apply through a broad opportunity such as the SBIR or STTR parent announcement, and the topic tells you what the participating ICOs want to fund inside their existing budgets.

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NIH is explicit about how this works:

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• Apply through an appropriate parent announcement or other broad NIH opportunity.

• Reach out early to the listed scientific contacts to discuss alignment.

• If an ICO chooses to dedicate funding to a topic, the amount depends on available funds, the number of meritorious applications, and competing priorities.

• Applying in a Highlighted Topic area will not affect NIH referral or review of your application.

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NIH reviews each topic annually for continued alignment and Institutes can post or retire topics at any time, so verify the topic is still live before each cycle you plan to submit in.

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There is no notice number to enter in the Agency Routing Identifier field, unlike the older Notice of Special Interest model. Make the alignment explicit in your cover letter and Specific Aims, and confirm handling with your target Institute's program officer before you submit.

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In this particular topic, the map matters more than usual. Resilience is not a study section. There is no established review culture for it, six different Institutes could plausibly claim the same project, and NIH has openly acknowledged the field lacks harmonized terminology. That combination means the Institute you land at will substantially determine how your application is read.

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What Are They Looking For? A Detailed Overview

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The Stated Purpose

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The topic aims to accelerate rigorous, reproducible, interdisciplinary resilience science to promote health and well-being across the lifespan and across populations. NIH describes resilience mechanisms as operating across scales and domains to maintain health, enabling prevention and recovery from chronic and acute disease despite known risk factors.

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The focus is research on:

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• Protective pathways and their biological mechanisms that maintain physiological function throughout the life course

• Harmonized terminology

• Standardized protocols

• Validated measures and biomarkers

• Implementation science to optimize evidence-based interventions, including lifestyle interventions, across populations

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NIH specifically names children, tribal communities, and groups at risk for health disparities as populations of interest.

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How NIH Defines Resilience

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NIH uses a broad definition: a living system's capacity to resist, recover, adapt, or grow from challenges or stressors, with outcomes tracked over time across interconnected individual, community, and environmental systems. NIH attributes this framing to Brown and colleagues, 2023.

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Those four verbs are not interchangeable and they are worth treating as a menu. Resistance means the stressor lands and nothing breaks. Recovery means function returns to baseline. Adaptation means the system reorganizes to a new functional state. Growth means it ends up better than before. A well-constructed application picks one and measures it, rather than gesturing at resilience generally.

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The Background Problem NIH Wants Solved

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NIH states that resilience spans whole-person systems, integrating molecular, cellular, physiological, and psychological levels within social communities and environmental contexts, and that translating this multiscale, multidomain nature has been limited by heterogeneous definitions, models, and measures.

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The named high-priority research areas follow directly from that:

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• Developing and refining resilience measures and metrics

• Data interoperability

• Advancing mechanistic understanding of protective and restoring factors distinct from disease-risk reduction

• Identifying biomarkers that reflect or predict resilience

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The Structural Requirement That Decides Most Applications

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This is the single most actionable sentence in the topic, and it functions as a checklist. NIH states that aligned applications would:

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1. Define the challenge or stressor

2. Define the system or systems

3. Define the resilience response or outcome

4. Include at least one domain of analysis, preferably across domains, to accelerate translation into implementable prevention, treatment, and recovery strategies

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Applications that skip step one are the most common failure mode in resilience science. Without a specified stressor there is no resilience to measure, only cross-sectional association. If you write to this topic, name the stressor explicitly and early, and design so that it is either naturally occurring and documented or experimentally applied.

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The Distinction That Separates Real Responsiveness From Repackaging

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Note carefully the phrase "distinct from disease-risk reduction." NIH is drawing a line, and reviewers will apply it.

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Lowering someone's blood pressure reduces disease risk. Understanding why a hypertensive person never has a stroke is resilience. Reducing tobacco exposure reduces risk. Understanding why some heavy smokers preserve lung function is resilience. A number of companies will reframe an existing risk-reduction product as resilience-promoting for this cycle. That reframing is visible, and it will be scored accordingly. The test is whether your work explains or enhances maintenance of health in the continued presence of risk rather than removal of the risk.

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A Methodological Signal Worth Reading Twice

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Both NIA and ODS ask for controlled perturbations and challenge-recovery designs with repeated measures. That is a design requirement, not a stylistic preference. A stressor is applied or occurs, and the system is measured before, during, and after. Cross-sectional designs cannot capture resist, recover, adapt, or grow, because all four are trajectories.

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For a company, this is actually favorable. Challenge-recovery designs with longitudinal monitoring are exactly where instrumentation, wearables, remote monitoring, and analytics create value, and they are exactly what a purely observational cohort study cannot deliver.

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Participating Institutes and Centers That Award Grants

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National Heart, Lung, and Blood Institute (NHLBI)

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NHLBI is interested in studies that:

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• Use data science and precision health to define individual heart, lung, blood, and sleep health signatures, including resilience metrics, stressors, tipping points, trajectories, and longitudinal outcomes across resistance, recovery, adaptation, and growth

• Leverage large biomedical resources including NHLBI-funded cohort studies, Trans-omics for Precision Medicine (TOPMed), Researching COVID to Enhance Recovery (RECOVER), All of Us, and LungMap

• Identify mechanisms that preserve, enhance, or restore homeostasis under stress and explain sustained health despite known risk, with the examples of hypertension without stroke, full recovery after heart valve surgery, preserved lung function despite tobacco exposure, and the interplay of resilience with sickle cell disease exacerbation such as vaso-occlusive crises

• Integrate multidomain exposures and biopsychosocial factors such as mindfulness, belief systems, and optimism, alongside community engagement, and include all populations within the NHLBI mission

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Contact: NHLBI Highlighted Topics (nhlbihighlightedtopics@mail.nih.gov).

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The resource-leverage bullet is the most useful thing on this page for a cash-constrained company. Building and validating analytics on TOPMed, RECOVER, All of Us, or existing NHLBI cohorts means you are not funding new cohort collection out of a Phase I budget. That is the difference between a fundable aim and an unfundable one at $323,090, and it also gives your validation claims a credibility that a small proprietary dataset never will. The phrase "tipping points" is worth noticing too, since it points toward early-warning and state-transition detection, which is a defensible product category.

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National Center for Complementary and Integrative Health (NCCIH)

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NCCIH is interested in research advancing understanding of resilience as a whole-person, multilevel process that informs strategies for health promotion, disease prevention, recovery, and overall well-being across the lifespan. Areas of interest:

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• Identifying, validating, and promoting modifiable protective pathways and factors contributing to resilience across molecular, cellular, physiological, behavioral, psychological, social, and environmental domains

• How complementary and integrative health approaches, lifestyle, and environmental factors affect the biological and behavioral mechanisms that enhance capacity to resist, recover, adapt, or grow

• Mechanistic research to identify and validate measures and biomarkers of resilience, and to generate evidence supporting implementation of effective resilience-promoting strategies across populations and settings

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NCCIH states it may give special consideration to support meritorious applications in this topic area.

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Contacts: Erin Burke Quinlan, PhD and Jennifer Baumgartner (NCCIHDERFunding@nih.gov).

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NCCIH matters disproportionately here for a reason that is not obvious from the topic page. Its standing small business portfolio already covers nutritional and natural products including dietary supplements and botanicals, psychological approaches such as meditation and music-based interventions, physical approaches including devices, and combined approaches such as yoga and tai chi. That makes NCCIH the natural funding home for several categories of resilience product that no other participating Institute would readily take, and the only one of the six signaling a preference alongside NIMHD.

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National Cancer Institute (NCI)

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NCI seeks projects advancing mechanistic understanding and interventions across cancer biology, prevention, and control, particularly studies that:

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• Develop, refine, or validate multilevel measures, biomarkers, and resilience signatures to defined stressors across cancer risk, tumor initiation, progression, treatment, and survivorship

• Identify protective factors and mechanisms enabling resistance to malignant transformation or favorable outcomes despite genetic, environmental, behavioral, or biological risk, including but not limited to DNA repair, immune surveillance, microbiome and host interactions, epigenetic stability, inflammation resolution, and metabolic adaptability

• Use advanced analytics in large, diverse longitudinal cohorts, and mechanistic studies in patients, human tissues, or model systems, to design, test, or implement interventions and strategies for risk stratification, early detection, prevention behaviors, treatment tolerance, and survivorship

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Contact: NCI Resilience HT Team (NCIResilienceHTTeam@mail.nih.gov).

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Note the phrase "resilience signatures to defined stressors." NCI has embedded the stressor requirement into its own bullet. Note also treatment tolerance, which is the most immediately commercial item in NCI's list: predicting which patients will tolerate a given regimen is a risk-stratification product with an obvious buyer, and it is framed here as resilience rather than toxicity prediction.

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National Institute on Aging (NIA)

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NIA's interests, as they relate to resilience in older individuals:

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• Development and validation of dynamic resilience measures using controlled perturbations and longitudinal monitoring

• Advanced analytics for multisystem resilience phenotyping

• The impact of age, early-life, psychosocial, and other factors on changes in neurobiological, molecular, cellular, physiological, social, and behavioral resilience mechanisms; how these factors individually and interactively influence severity of and recovery from stressors; and how dysregulation or modulation of these mechanisms, particularly in those with multiple contributors to impaired resilience, shapes aging-related clinical endpoints

• Shared and tissue-specific pathways and mechanisms of inter-organ or system-level coordination

• Mechanisms underlying sex differences

• Therapeutic targets for, and mechanisms by which, interventions improve resilience and preserve or restore clinical outcomes in representative populations

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Contact: Stacy Carrington-Lawrence, PhD (stacy.carrington-lawrence@nih.gov).

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NIA's first two bullets are the clearest product specifications in the entire topic. A validated perturbation protocol plus a monitoring modality plus an analytic layer that outputs a multisystem resilience phenotype is a commercial instrument, not a research finding. NIA also carries the most favorable budget ceilings of any participating Institute, discussed below.

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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NIAAA seeks research on mechanisms shaping alcohol use, alcohol-related outcomes, recovery, and resilience across biological, behavioral, psychological, social, and environmental levels, and states that priority goes to reproducible studies that identify protective pathways and biomarkers, explain heterogeneity, and inform prevention and intervention. Named areas:

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• Longitudinal lifespan cohort studies using multimodal AI to integrate biological, behavioral, and environmental data and identify resilience to alcohol use disorder and alcohol harms, including resistance, recovery, and adaptation, and influences such as inter-brain synchrony, social enrichment, peer context, sleep, and community and environmental factors

• Reverse translational and New Approach Methodologies studies of cellular, molecular, and circuit mechanisms that promote resilience despite alcohol risk exposure

• Integrative multiomic studies of heterogeneity in resilience to alcohol use disorder, emphasizing protective pathways, validated biomarkers, and standardized, reproducible measures

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Contacts: Laura Kwako (laura.kwako@nih.gov) and Miri Gitik (miri.gitik@nih.gov).

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NIAAA's standing small business priorities already include biosensors and wearables for real-time monitoring, digital health and telehealth platforms, diagnostic tools and biomarkers, and advanced data analytics using machine learning on large health datasets. The overlap with this topic's multimodal AI and biomarker bullets is close to exact, which makes NIAAA one of the more mechanically straightforward routes for a data or sensor company.

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National Institute on Minority Health and Health Disparities (NIMHD)

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NIMHD supports solutions-oriented biological, behavioral, clinical, and population science research focused on resilience among populations with health disparities, including:

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• Identifying novel biological, behavioral, social, and environmental mechanisms that shape resilience across the life course, and elucidating pathways that buffer or mitigate stress-related health effects

• Developing measures, biomarkers, and scalable interventions that generalize across populations and community contexts

• Applying community-engaged, systems science, data science, and translational approaches to advance resilience research and its real-world impact

• Examining epigenetic processes, vagal nerve function, and environmental and biological interactions to identify mechanisms and clinical targets for resilience

• Investigating relationships between psychological resilience and the onset, severity, and progression of health events, as well as recovery duration, quality, and long-term outcomes

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NIMHD states it may dedicate available funds to support applications in this Topic area, depending on availability of funds, the number of meritorious applications, and competing ICO priorities, and separately that it may give special consideration to meritorious applications in this topic area.

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Contact: Rada Dagher, PhD, MPH (Rada.dagher@nih.gov).

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NIMHD is the only ICO in this topic making both statements, which makes it the strongest signal on the page. The word scalable in its second bullet is doing real work: NIMHD is asking for interventions that generalize and deploy, which is a commercial requirement rather than an academic one. Vagal nerve function is also named explicitly, which is a specific and measurable physiological target with existing device and wearable pathways.

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Participating Offices That Do Not Award Grants

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Five participating ICOs cannot fund your application. Their published interests are still worth reading, because they tell you what NIH leadership is prioritizing and because a well-aimed application can be responsive to an office's interest while being funded by an Institute. But you must land on an Institute's mission.

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Office of Dietary Supplements (ODS). ODS seeks research on how dietary supplements, meaning oral interventions of vitamins, minerals, natural products, botanicals, fatty acids, proteins, amino acids, or other bioactive food constituents, affect physiological, metabolic, cognitive, and immune resilience across the lifespan. Studies using repeated measures and challenge-recovery designs to test whether supplements help resist, recover, adapt, or grow after aging-related, infectious, metabolic, psychosocial, or environmental stressors are emphasized. Specific interests include elucidating biological mechanisms or protective pathways through which supplements influence adaptive responses to physiological stressors; identifying and validating supplement exposure biomarkers associated with maintenance or recovery of physiological function, resistance to defined stressors, or adaptive capacity; and developing and validating ways to measure resilience in a dietary supplementation context. Contact: Adam J. Kuszak, PhD (ods-funding@od.nih.gov).

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This is the most product-specific section on the entire NIH page, and ODS has no money. If you are a supplement, botanical, or nutraceutical company, the practical route is almost always NCCIH, whose small business program explicitly covers nutritional and natural products, or NIA if the framing is aging and older adults. Talk to ODS for scientific alignment, then talk to NCCIH or NIA about who would actually fund it.

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Office of Research on Women's Health (ORWH). ORWH is interested in projects that advance resilience research across the life course relevant to women's health, including pregnancy, menopause, and aging; incorporate sex as a biological variable in resilience mechanisms, measures, biomarkers, and trajectories; and address sex differences in multidomain resilience, including through computational models, to support rigorous, generalizable prevention, treatment, and recovery strategies. Contact: Marquitta White, MS, PhD (orwhinfo@nih.gov).

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The Office of Autoimmune Disease Research within ORWH (OADR-ORWH) is interested in the role of stressors on early immune changes in the prodromal phase of autoimmunity; resilience as an immunopreventative strategy for autoimmune disease; and utilizing federated data platforms to enhance pattern recognition in complex multiomic datasets, enabling deeper insight into the multimodal drivers of autoimmune disease pathogenesis and co-occurring autoimmune diseases. Contact: Victoria Shanmugam, MBBS, FRCP, FACR, CCD (oadrinfo@nih.gov).

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The federated data platform bullet is a software specification, and prodromal autoimmunity is a diagnostics opportunity. Neither office can fund it. Sex differences in resilience mechanisms is a named NIA interest as well, which gives you a funding route for the ORWH angle.

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Office of Disease Prevention (ODP). For this topic, ODP is particularly interested in projects testing interventions to promote health and well-being in individuals, families, communities, or populations facing biological, social, economic, or environmental challenges, and encourages research enhancing protective factors across the life course to prevent disease and disability, improve well-being, and reduce long-term disease burden. Contact: Valerie Robinson, PhD, MPhil, MHA (valerie.robinson@nih.gov).

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Office of Behavioral and Social Sciences Research (OBSSR). Participating, with Janine Simmons, MD, as contact (OBSSRNews@mail.nih.gov).

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Tribal Health Research Office (THRO). Participating, with Sheila Caldwell, PhD (throinfo@od.nih.gov) and Christopher Barnhart, PhD (christopher.barnhart@nih.gov) as contacts. Note that the topic's purpose statement names tribal communities explicitly as a population of interest.

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Where Does a Small Business Actually Fit?

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Be honest with yourself here: this is the most research-heavy of NIH's current Highlighted Topics, and a large share of what it describes belongs in an R01 rather than an SBIR. Mechanistic biology in model systems, secondary analysis of existing cohorts for scientific insight, and epidemiological characterization are not products. NIH SBIR and STTR awards fund research and development toward a commercially viable product or service.

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That said, NIH named measures, metrics, biomarkers, and data interoperability as high-priority areas, and those are all things that get built and sold. The genuine openings:

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Validated resilience measurement instruments. NIH says the field is limited by heterogeneous measures and asks for harmonized terminology, standardized protocols, and validated measures. A validated, licensable instrument, whether a clinical assessment, a digital measure, or a scored composite, is a real product with a real market, and NCCIH, NIMHD, NIA, and NCI all ask for measure development independently. Whoever produces the instrument the field standardizes on owns a durable position.

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Controlled perturbation and challenge-recovery testing systems. NIA's leading bullet, and echoed by ODS. A standardized stressor protocol plus a monitoring modality plus a scoring output is an instrument. This is the clearest hardware and software opportunity in the topic.

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Multisystem phenotyping analytics. NIA asks for advanced analytics for multisystem resilience phenotyping. NHLBI asks for health signatures including resilience metrics, tipping points, and trajectories. NIAAA asks for multimodal AI integrating biological, behavioral, and environmental data. Three Institutes, one product category.

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Biomarker panels that predict recovery rather than risk. NIH asks for biomarkers that reflect or predict resilience. This is a distinct diagnostic category from disease-risk biomarkers, and the clinical use cases are concrete: who will tolerate this treatment, who will recover from this surgery, who will decompensate under this stressor. NCI names treatment tolerance directly. NHLBI names recovery after heart valve surgery.

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Remote monitoring and wearables for longitudinal trajectory capture. Resist, recover, adapt, and grow are all trajectories, and trajectories require repeated measurement. Continuous monitoring is the enabling technology, and NIAAA's standing portfolio already funds wearables and biosensors.

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Data interoperability and federated analysis platforms. NIH names data interoperability as a high-priority area, and OADR-ORWH names federated data platforms specifically. Software with a plausible route to institutional customers.

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Scalable intervention delivery. NIMHD asks for scalable interventions that generalize across populations and community contexts, and it is the Institute most likely to dedicate funds. Digital and community-deployable intervention platforms fit here.

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Supplement and natural product mechanisms and exposure biomarkers. ODS's full list, funded through NCCIH or NIA.

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Vagal nerve function measurement or modulation. Named explicitly by NIMHD, with existing device and wearable pathways.

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What Will Not Work

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A risk-reduction product relabeled as resilience. Covered above, and it is the single most predictable failure here. NIH drew the line explicitly with the phrase "distinct from disease-risk reduction."

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A wellness or mindfulness app with no defined stressor and no measurement. NIH's structural requirement is to define the challenge or stressor, the system, and the resilience outcome. An application that cannot name its stressor is not responsive, regardless of how well the intervention is described.

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A cross-sectional study. All four resilience outcomes are trajectories. If your design measures once, it cannot detect resistance, recovery, adaptation, or growth.

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A measure with no validation plan. The field's problem is that everyone has a measure and none of them agree. Producing another unvalidated instrument adds to the problem NIH is trying to solve. Validation against an independent criterion is the whole value proposition.

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Two Strategic Notes

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Use the existing data assets. NHLBI explicitly invites leveraging TOPMed, RECOVER, All of Us, LungMap, and NHLBI cohorts. NCI asks for advanced analytics in large, diverse longitudinal cohorts. NIAAA asks for longitudinal lifespan cohort studies. For a small business, this is the difference between a feasible Phase I and an impossible one, because you can develop and validate an analytic or a measure without funding primary data collection. It also strengthens the generalizability claim that reviewers will otherwise attack.

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STTR deserves a hard look. NIH describes this topic as inherently interdisciplinary across molecular, cellular, physiological, psychological, social, community, and environmental levels, and NIMHD asks for community-engaged approaches. Very few small companies hold that range internally. Under STTR, a formal collaboration with a university or nonprofit research institution is required, at least 40 percent of the work is performed by the small business and at least 30 percent by the research institution, and the Principal Investigator may be primarily employed by either organization. If you need an academic cohort, a validated psychometric bench, or a community-engaged research partner to be credible, PA-27-102 is often the stronger application.

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How Much Funding Would I Receive?

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There is no funding amount attached to the Highlighted Topic itself. Budgets come from the parent announcement and from the Institute that funds you.

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Under the current NIH SBIR and STTR parent announcements, standard guidelines provide:

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• Phase I: up to $323,090, typically over one to two years

• Phase II: up to $2,153,927, typically over two to three years

• Fast-Track: Phase I and Phase II in a single application and review

• Direct to Phase II: available under SBIR for companies that have already established feasibility

• Phase IIB (PA-27-101): follow-on funding beyond Phase II

• Commercialization Readiness Pilot: late-stage, milestone-driven support, with amounts varying by Institute

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Cost sharing is not required.

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NIA Carries the Best Ceilings in This Topic

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Among the six participating Institutes that award grants, NIA holds approval to exceed the standard caps in both of its lanes:

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• Up to $700,000 for Phase I and $3 million for Phase II for Alzheimer's disease and AD-related dementia projects

• Up to $500,000 for Phase I and $2.5 million for Phase II for other projects within the NIA mission space

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That second line is easy to miss and it matters. A resilience-in-aging project that has nothing to do with dementia still carries a Phase I ceiling roughly 55 percent above standard and a Phase II ceiling about 16 percent above standard. Given that NIA also published the two most product-shaped bullets in the entire topic, dynamic resilience measures using controlled perturbations and multisystem resilience phenotyping analytics, the combination of scope fit and budget headroom makes NIA worth a conversation even if aging is not your primary framing.

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NCI supports CRP projects up to the SBA statutory maximum of $4,191,495, plus up to $500,000 for technical assistance. NIMHD operates under standard caps but is the only participating ICO signaling both possible dedicated funds and special consideration.

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Full Institute-by-Institute budget detail is in our NIH SBIR program executive summary.

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What Could I Use the Funding For?

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Funds support research and development toward a commercially viable product or service aligned with the mission of a participating Institute. Allowable costs include personnel, materials, instrument and device development, assay development, software development, validation studies, analysis of existing datasets, intellectual property protection, and other direct R&D expenses.

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Phase II, Phase IIB, and CRP funds may additionally cover scale-up, multi-site validation, regulatory preparation, and commercialization activities.

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Clinical trial policy depends on the Institute. Among the participating Institutes that award grants, NCI, NHLBI, NIA, and NIMHD accept clinical trials through their small business programs, and several accept them through Phase IIB as well. Policy for NCCIH and NIAAA under the current parent announcement should be confirmed directly with program staff before you design around it. Note that challenge-recovery and controlled-perturbation studies in human participants may or may not meet the NIH definition of a clinical trial depending on design, and that determination affects which announcement track and which forms apply. This is a specific question worth putting to your program officer in writing.

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What Is the Timeline?

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Highlighted Topic dates

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• Posted: August 28, 2026

• Expires: August 25, 2028

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SBIR and STTR standard receipt dates (PA-27-100 and PA-27-102)

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• September 5, 2026. This falls on a Saturday, and Labor Day is Monday, September 7, so submissions are accepted through Tuesday, September 8, 2026.

• January 5, 2027

• April 5, 2027

• September 5, 2027, which falls on a Sunday before Labor Day, so that cycle effectively closes Tuesday, September 7, 2027

• January 5, 2028

• April 5, 2028

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Because the topic expires on August 25, 2028, April 5, 2028 is the last standard receipt date inside the active window, giving you six cycles in total. The September 2028 date falls just outside it. All applications are due by 5:00 PM local time of the applicant organization.

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Review and award timeline for the September 2026 cycle

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• Scientific merit review: November 2026

• Advisory council review: January 2027

• Earliest project start date: April 2027

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Review and award timeline for the January 2027 cycle

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• Scientific merit review: March 2027

• Advisory council review: May 2027

• Earliest project start date: July 2027

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Review and award timeline for the April 2027 cycle

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• Scientific merit review: July 2027

• Advisory council review: August 2027

• Earliest project start date: December 2027

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A policy change that matters for planning. NIH tightened its late application policy under NOT-OD-26-064, effective for due dates on or after May 25, 2026. Small business applications no longer receive the discretionary late submission window. Submit early enough to resolve eRA Commons validation errors before the deadline.

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Practical planning guidance. Budget at least twelve weeks of lead time before your target due date, and more if your federal registrations are not complete. SAM.gov, UEI, the SBA Company Registry, eRA Commons, and Grants.gov registrations can take four to six weeks on their own and must all be finished before you can submit. For a first-time applicant, expect 120 to 200 hours of total effort.

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Two topic-specific timing items. If your plan depends on access to an existing NIH data resource such as TOPMed, RECOVER, or All of Us, start the data access request early, since approval processes have their own timelines and reviewers will want evidence that access is secured rather than hoped for. And if your design involves community-engaged research, which NIMHD asks for, community partnership agreements and letters with defined roles cannot be assembled in the final two weeks.

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Who Is Eligible to Apply?

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Eligibility comes from the parent announcement, not from the topic. Applicants must be U.S. small business concerns that are:

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• Organized for profit with a place of business located in the United States

• At or below 500 employees, including affiliates

• More than 50 percent owned and controlled by U.S. citizens or permanent resident aliens, by qualifying U.S. entities, or by a combination

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For STTR, the company must also have a formal collaboration with a U.S. research institution, with at least 40 percent of the work performed by the small business and at least 30 percent by the research institution.

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Foreign organizations are not eligible, and foreign subawards and subcontracts are not permitted.

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Are There Restrictions I Should Know About?

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• Only U.S. small business concerns are eligible; foreign organizations are not.

• Applications involving foreign subawards or subcontracts will not be considered for funding.

• Your application must be relevant to the mission of a participating Institute or Center that awards grants. For this topic that means NHLBI, NCCIH, NCI, NIA, NIAAA, or NIMHD. OBSSR, ODP, ODS, ORWH, and THRO do not award grants.

• Duplicate or highly overlapping applications submitted under multiple HHS announcements are not permitted.

• Companies must satisfy applicable SBA performance benchmark requirements, including the Phase I to Phase II transition rate benchmark and the Phase II commercialization rate benchmark for companies with substantial award histories.

• Phase I generally requires at least 67 percent of the research effort to be performed by the small business; Phase II at least 50 percent. Consultant and contractual arrangements in Phase I are generally limited to roughly 33 percent of the total amount requested, which is a real constraint if your design leans heavily on an academic cohort or a community partner. STTR is the cleaner structure in that case.

• Additional national security, foreign relationship, and foreign ownership disclosure requirements apply and may result in denial of award. The 2026 SBIR and STTR reauthorization tightened foreign risk management and due diligence review, and that screening now sits inside the review critical path.

• Cost sharing is not required.

• Applying under a Highlighted Topic does not change referral or review, and does not guarantee that funds have been set aside.

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What Kind of Application Is Likely to Win Here?

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NIH reviews small business applications on Significance, Investigators, Innovation, Approach, and Environment, with commercialization potential specifically evaluated for Phase II and Fast-Track. Within this topic, five things separate competitive applications.

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One: you named the stressor. NIH gave the structure explicitly: define the challenge or stressor, the systems, and the resilience response or outcome, and include at least one domain of analysis. Most weak resilience applications fail at the first item. Put the stressor in your Specific Aims page, not buried in the approach.

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Two: you picked one of the four verbs and measured it. Resistance, recovery, adaptation, and growth are different phenomena with different measurement requirements. Specificity here reads as rigor. Gesturing at resilience generally reads as vagueness.

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Three: you are not doing risk reduction in a new coat. NIH said "distinct from disease-risk reduction." Your work should explain or enhance maintained health in the continued presence of risk.

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Four: you picked the right Institute, and you picked it before writing. Six Institutes could plausibly claim a resilience measurement product, and five participating offices cannot fund it at all. This topic has more misrouting risk than any other current Highlighted Topic. Email the named contact, describe the technology in a paragraph, and ask whether it fits and which mechanism they would suggest. For supplement and natural product work specifically, ask ODS about science and NCCIH or NIA about funding.

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Five: your validation plan is the centerpiece, not an afterthought. NIH's stated problem is heterogeneous measures and lack of reproducibility, and NIAAA states outright that priority goes to reproducible studies. Whatever you build, the aim that matters is the one where you validate it against an independent criterion in a population that looks like the intended market.

Frequently Asked Questions

Is the NIH multidomain resilience Highlighted Topic a funding opportunity I can apply to directly?

No. An NIH Highlighted Topic is a published statement of scientific priority, not a Notice of Funding Opportunity. There is no application package and no separate deadline. Small businesses apply through a broad NIH opportunity, which means the SBIR parent announcement PA-27-100 or the STTR parent announcement PA-27-102.

How does NIH define resilience for this topic?

NIH defines resilience broadly as a living system's capacity to resist, recover, adapt, or grow from challenges or stressors, with outcomes tracked over time across interconnected individual, community, and environmental systems. NIH attributes this framing to Brown and colleagues, 2023. The four outcomes are distinct: resistance means function is maintained through the stressor, recovery means function returns to baseline, adaptation means the system reorganizes to a new functional state, and growth means it ends up better than before.

What does NIH require an aligned application to include?

NIH states that aligned applications would define the challenge or stressor, define the system or systems, define the resilience response or outcome, and include at least one domain of analysis, preferably across domains, in order to accelerate translation into implementable prevention, treatment, and recovery strategies. Failing to specify the stressor is the most common way a resilience application loses responsiveness.

How much funding is available under this Highlighted Topic?

The topic itself carries no funding amount. Standard SBIR guidelines provide up to $323,090 for Phase I and up to $2,153,927 for Phase II. Among the participating Institutes, NIA holds approval to exceed those caps, allowing up to $700,000 for Phase I and $3 million for Phase II on Alzheimer's disease and AD-related dementia projects, and up to $500,000 for Phase I and $2.5 million for Phase II for other projects in its mission space. NCI supports Commercialization Readiness Pilot projects up to the SBA statutory maximum of $4,191,495 plus up to $500,000 for technical assistance.

Does applying under this Highlighted Topic improve my chances of being funded?

Not in review. NIH states that applying in a Highlighted Topic area will not affect referral or review of applications. NIMHD states it may dedicate available funds to this topic area and may give special consideration to meritorious applications in it, and NCCIH states it may give special consideration. The other participating ICOs make no such statement. The main advantage is informational.

Which NIH Institutes and Centers participate, and which ones can actually fund my application?

Eleven ICOs participate. Six award grants: NHLBI, NCCIH, NCI, NIA, NIAAA, and NIMHD. Five do not: OBSSR, ODP, ODS, ORWH including the Office of Autoimmune Disease Research, and THRO. Your application must be relevant to the mission of at least one of the six that award grants.

I work on dietary supplements and the Office of Dietary Supplements published detailed interests. Can ODS fund my SBIR?

No. ODS does not award grants, despite publishing the most product-specific interests in this topic, including supplement exposure biomarkers and challenge-recovery designs testing whether supplements help resist, recover, adapt, or grow. The practical route is NCCIH, whose small business program explicitly covers nutritional and natural products including botanicals, or NIA if the framing is aging and older adults. Discuss science with ODS and funding with NCCIH or NIA.

What are the application deadlines?

The topic is open from August 28, 2026 through August 25, 2028. SBIR and STTR standard receipt dates are September 5, 2026, January 5, 2027, April 5, 2027, September 5, 2027, January 5, 2028, and April 5, 2028. Because the topic expires in August 2028, April 5, 2028 is the last standard receipt date inside the active window. September 5, 2026 falls on a Saturday before Labor Day, so that cycle accepts submissions through Tuesday, September 8, 2026, and September 5, 2027 falls on a Sunday before Labor Day, so that cycle closes Tuesday, September 7, 2027. All applications are due by 5:00 PM local time of the applicant organization.

What is the difference between resilience research and disease-risk reduction?

NIH explicitly asks for mechanistic understanding of protective and restoring factors distinct from disease-risk reduction. Lowering a risk factor reduces exposure to risk. Resilience explains or enhances maintained health in the continued presence of risk. NHLBI's examples make the distinction concrete: hypertension without stroke, preserved lung function despite tobacco exposure, and full recovery after heart valve surgery. Repackaging an existing risk-reduction product as resilience-promoting is visible to reviewers.

What kinds of resilience projects fit NIH SBIR rather than a research grant?

The strongest small business fits are validated resilience measurement instruments, controlled perturbation and challenge-recovery testing systems paired with longitudinal monitoring, multisystem phenotyping analytics, biomarker panels that predict recovery capacity rather than disease risk, remote monitoring and wearables for trajectory capture, data interoperability and federated analysis platforms, scalable intervention delivery, supplement and natural product exposure biomarkers, and vagal nerve function measurement or modulation. Mechanistic biology in model systems and secondary cohort analysis for scientific insight generally belong in an R01 instead.

Can I use existing NIH datasets instead of collecting new data?

Yes, and NIH encourages it. NHLBI explicitly invites leveraging its cohort studies, TOPMed, RECOVER, All of Us, and LungMap. NCI asks for advanced analytics in large, diverse longitudinal cohorts. For a Phase I budget this is often the difference between a feasible and an infeasible aim, and it strengthens generalizability claims. Start data access requests early, because approval has its own timeline and reviewers want evidence access is secured.

Why do NIA and ODS emphasize controlled perturbations and challenge-recovery designs?

Because resistance, recovery, adaptation, and growth are all trajectories, and a cross-sectional measurement cannot capture a trajectory. A stressor must be applied or occur, with the system measured before, during, and after. For companies this is favorable, since instrumentation, wearables, remote monitoring, and analytics are precisely what these designs require and precisely what an observational cohort cannot deliver.

Should my company apply for SBIR or STTR?

Choose SBIR if your company performs the majority of the research and your Principal Investigator is primarily employed by the company. Choose STTR if the project depends on a formal collaboration with a university or nonprofit research institution. Because NIH describes this topic as inherently interdisciplinary across molecular, physiological, psychological, social, community, and environmental levels, and because NIMHD asks for community-engaged approaches, STTR is frequently the stronger structural fit. Phase I SBIR generally limits consultant and contractual arrangements to roughly 33 percent of the total requested, which constrains designs that lean heavily on academic or community partners.

Can I run a clinical trial with this funding?

It depends on the Institute. Among the participating Institutes that award grants, NCI, NHLBI, NIA, and NIMHD accept clinical trials through their small business programs, and several accept them through Phase IIB as well. Confirm NCCIH and NIAAA policy directly with program staff. Note also that challenge-recovery and controlled-perturbation studies in human participants may or may not meet the NIH definition of a clinical trial depending on design, and that determination affects which forms and which track apply, so put the question to your program officer in writing.

Who is eligible to apply?

For-profit U.S. small business concerns with 500 or fewer employees including affiliates, more than 50 percent owned and controlled by U.S. citizens or permanent residents or by qualifying U.S. entities. Foreign organizations are not eligible, and foreign subawards and subcontracts are not permitted. STTR additionally requires a formal collaboration with a U.S. research institution.

How long will it take me to prepare an application?

For a first-time applicant, expect 120 to 200 hours in total. Start at least twelve weeks before your target due date. Federal registrations across SAM.gov, UEI, the SBA Company Registry, eRA Commons, and Grants.gov can take four to six weeks on their own and must be complete before you can submit.

What happens if I submit late?

It will not be accepted. NIH tightened its late application policy for due dates on or after May 25, 2026, and small business applications no longer receive the discretionary late submission window.

Could this Highlighted Topic be withdrawn before it expires?

Possibly. NIH reviews each Highlighted Topic annually for continued alignment with agency priorities, and Institutes can post and retire topics at any time. The posted expiration date is August 25, 2028, but verify the topic is still live before each cycle you plan to submit in.

How Can BW&CO Help?

BW&CO is a non-dilutive federal funding advisory firm. We have helped clients secure more than $350 million in federal funding, and this topic is a good example of where advisory work earns its keep: eleven participating ICOs, only six of which can fund anything, the two most product-specific bullet lists belonging to offices with no money, a definitional line between resilience and risk reduction that reviewers will enforce, and one Institute quietly carrying budget ceilings well above the standard caps.

We can:

• Identify the right Institute and mechanism for your technology, including routing supplement, natural product, women's health, autoimmune, and federated data platform concepts to an Institute that can actually fund them.

• Structure the application around NIH's own checklist, so the stressor, the system, the resilience outcome, and the domains of analysis are unmistakable on the Specific Aims page.

• Triple your likelihood of success through proven strategy and insider-aligned proposal development.

• Reduce your time spent on the proposal by 50 to 80 percent, so your team stays on the technology.

• Structure academic, cohort, and community partnerships so they strengthen the application without breaching the outsourcing limits.

NIH Highlighted Topic: Wastewater-Based Epidemiology as a Tool for Monitoring Environmental Chemicals, Medications, Drugs, and Pathogenic Exposures

Highlighted Topic 103 | Participating ICOs: NIEHS, NIAID, NIDA | Posted August 27, 2026 | Expires August 27, 2028 | Apply through the NIH SBIR parent announcement (PA-27-100) or the NIH STTR parent announcement (PA-27-102).

Executive Summary

NIH has designated wastewater-based epidemiology (WBE) as a formal Highlighted Topic, with NIEHS, NIAID, and NIDA each publishing their own areas of interest. Of the Highlighted Topics NIH has posted to date, this is one of the most product-shaped. Nearly every gap NIH names is a hardware, assay, or software problem rather than an open scientific question, which makes it unusually well suited to SBIR and STTR applicants rather than to academic investigators alone.

The premise is straightforward. Wastewater is a continuous, population-scale biological and chemical sample that nobody has to consent to, travel for, or remember to provide. NIH points out that it can indicate exposure to pesticides, plasticizers, personal care products, heavy metals, industrial releases, emerging contaminants, and disaster-related spills and fires, and that beyond pathogens it can also detect medications and drug metabolites. Compared with human biomonitoring, which requires collecting blood or urine from individuals, WBE is non-invasive and cost-effective, and it scales across both geography and time in a way individual sampling never will.

What NIH says is missing is the engineering and the standards layer. The named challenges are sampling variability driven by where and when samples are collected, analytical methods, data integration and statistical modeling, and data interpretation, meaning how a detection in wastewater actually correlates with real-world human exposure and what it implies for public health. NIH also names best practices, communication of findings, and ethical and privacy considerations as important open questions.

For a company, that list reads like a product roadmap: autosamplers and passive samplers that reduce variability, validated multi-residue chemical panels, molecular assays for targets that current methods miss, normalization and back-calculation methods that turn a concentration into a defensible population estimate, and data infrastructure that lets utilities, health departments, and labs actually share results.

The three participating Institutes divide the space cleanly. NIEHS wants chemical and environmental exposure work, including assay and biomarker development and bringing WBE to small and rural systems. NIAID wants pathogen and genomic epidemiology methods, human versus animal signal separation, and assays for chlorine-resistant protozoan parasites and cysts. NIDA wants substance use and overdose surveillance, emerging substance identification, and triangulation with other drug use data sources.

There is no dedicated funding and no separate application. A Highlighted Topic is a priority signal, not a Notice of Funding Opportunity. You apply through the standard NIH SBIR or STTR omnibus and compete in the normal pool, and NIH states that applying in a Highlighted Topic area will not affect referral or review. NIEHS states it may give special consideration to meritorious applications in this topic area. NIAID and NIDA make no such statement for this topic.

Under the current SBIR parent announcement, standard budget guidelines run up to $323,090 for Phase I and up to $2,153,927 for Phase II. One caveat matters specifically here: certain NIEHS program areas carry substantially lower caps, and that is discussed below. The next standard receipt dates are September 5, 2026, January 5, 2027, and April 5, 2027, and the topic stays live through August 27, 2028.

A Quick Note on the NIH SBIR and STTR Program

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The NIH, CDC, and FDA SBIR and STTR programs are the largest source of non-dilutive early-stage funding for health, biomedical, and life science technology in the United States. NIH alone sets aside well over a billion dollars a year. Awards are grants, not investments. No equity, no repayment, no board seat.

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The program runs in phases. Phase I funds proof of concept and feasibility. Phase II funds the substantive research and development that turns a validated concept into a product. Fast-Track combines both in one application, and Direct to Phase II lets companies that have already established feasibility skip Phase I. Phase IIB and the Commercialization Readiness Pilot extend funding for late-stage work such as validation, manufacturing scale-up, and regulatory submissions. Applicants must be for-profit U.S. small businesses with 500 or fewer employees and majority U.S. ownership.

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For the complete breakdown of the NIH SBIR and STTR program, including all budget caps by Institute, clinical trial policies, eligibility mechanics, review criteria, and the full timeline, see our full executive summary here: NIH, CDC and FDA Parent SBIR Grant (PA-27-100).

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Everything below is specific to this Highlighted Topic.

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What Is a Highlighted Topic, and How Is It Different From a Funding Opportunity?

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A Notice of Funding Opportunity (NOFO) is a solicitation. It has an announcement number, its own application package, its own review criteria, and usually its own set-aside funding. You apply to it directly.

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A Highlighted Topic is a published statement of scientific priority maintained centrally by NIH. It has no application package and no guaranteed funding. You cannot apply to it. You apply through a broad opportunity such as the SBIR or STTR parent announcement, and the topic tells you what the participating Institutes want to fund inside their existing budgets.

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NIH is explicit about how this works in practice:

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• Apply through an appropriate parent announcement or other broad NIH opportunity.

• Reach out early to the listed scientific contacts to discuss alignment.

• If an ICO chooses to dedicate funding to a topic, the amount depends on available funds, the number of meritorious applications, and competing priorities.

• Applying in a Highlighted Topic area will not affect NIH referral or review of your application.

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NIH also notes that Institutes can post new topics at any time and that each topic is reviewed annually for continued alignment with agency priorities. Topics do get retired. If you are building a multi-year federal funding plan around one, verify it is still live before each cycle.

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What the topic buys you is intelligence, not scoring advantage. Three Institutes have written down what they would fund in this space and named the program staff to call. In a field as new as WBE, where there is no established study section culture and no obvious default Institute, that mapping is worth more than a modest scoring bump. The most common way a strong WBE application fails is landing at the wrong Institute, because a chemical exposure project reviewed by pathogen reviewers, or vice versa, tends to score as out of scope rather than as weak.

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There is no notice number to enter in the Agency Routing Identifier field for a Highlighted Topic, unlike the older Notice of Special Interest model. Make the alignment explicit in your cover letter and Specific Aims, and confirm handling with your target Institute's program officer before you submit.

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What Are They Looking For? A Detailed Overview

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The Stated Purpose

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The topic encourages research on wastewater-based epidemiology approaches for understanding exposure to environmental contaminants, medications, drugs, and pathogens at the community level. That last phrase is the whole framing. This is not about diagnosing individuals. It is about characterizing populations.

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Why NIH Considers This Worth Prioritizing

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NIH's background statement makes four arguments, and each one is a section of your significance narrative if you write here.

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Wastewater is a broader signal than most people assume. NIH lists pesticides, plasticizers, personal care products, heavy metals, industrial releases, emerging contaminants, and disaster-related spills and fires as detectable exposures. It also states plainly that while wastewater has been used to detect pathogens, it can also detect medications and drug metabolites. If your mental model of WBE is still SARS-CoV-2 surveillance, this topic is considerably wider than that.

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It solves a real limitation of human biomonitoring. Individual biomonitoring requires collecting blood or urine from people. WBE is non-invasive and cost-effective, and it evaluates community exposure patterns across large populations both geographically and over time. That produces insight into community health and behavior that individual sampling cannot practically deliver at scale.

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It requires convergence. NIH describes WBE as combining advanced analytical chemistry, molecular biology, and epidemiological approaches, and notes that it inherently involves data sharing and collaboration across many scientific disciplines. This is an explicit invitation to build interdisciplinary teams, and it is one reason STTR deserves a hard look here.

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The unsolved problems are technical. This is the part to read closely, because it is where the fundable product work lives.

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The Named Technical Gaps

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NIH groups the open challenges into four clusters. Read these as product requirements.

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Sampling variability. Driven by sample location and timing of sample collection. This is the single most cited weakness in the WBE literature, and it is a hardware and protocol problem. Grab samples misrepresent diurnal patterns. Composite sampling helps but adds cost and complexity. Sample location within a sewer network determines what population you actually measured. Passive samplers, flow-proportional autosamplers, in-line sensors, and sample stabilization chemistry all sit directly on this gap.

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Analytical methods. Detection and quantification of targets that current methods handle poorly, in a matrix that is actively hostile to analysis. Wastewater is chemically complex, biologically active, and variable hour to hour. Recovery, matrix effects, degradation between collection and analysis, and limits of detection at environmentally relevant concentrations are all live problems.

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Data integration and statistical modeling. Turning measurements into population-level estimates requires normalization for flow, population size, in-sewer degradation, and per-capita excretion assumptions. Every one of those introduces uncertainty, and the field has not standardized any of them.

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Data interpretation. NIH states the question directly: how does detection in wastewater correlate with real-world human exposure, and what are the public health implications? This is the validation gap, and it is why parallel clinical and wastewater studies show up in NIAID's list. Any company selling a WBE product will eventually be asked to defend the inferential chain from a concentration in a pipe to a claim about a population.

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NIH additionally names best practices, communication of findings, and ethical and privacy issues as important considerations. Do not treat that as boilerplate. In a field where results can be attributed to a neighborhood, a building, or an institution, the ethics section of a WBE application carries real weight, and NIDA explicitly asks for research analyzing those implications.

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Participating Institutes and What Each One Wants

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Only three Institutes participate in this topic, which makes Institute selection simpler than usual but also raises the stakes on getting it right. Your application will be assigned to one, that Institute's budget will pay for it, and its priorities will decide whether it gets funded after review.

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National Institute of Environmental Health Sciences (NIEHS)

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NIEHS is the chemical and environmental exposure home for this topic, and it is the only participating Institute signaling any preference. NIEHS encourages multidisciplinary collaborations and partnerships with public health experts, epidemiologists, analytical chemists, and experts in contaminant fate and transport.

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Stated areas of interest:

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• WBE studies to identify known and emerging environmental contaminants impacting community health

• WBE to identify the origins of contaminants and quantify contaminant contribution to disease

• Studies promoting multi-level assessment of sewer networks at various scales, including single and multiple wastewater treatment plants, neighborhoods, and individual buildings

• Technology and methodology development to advance WBE, including biomarkers for monitoring community health and assays for detection and quantification of chemical exposures

• Creation and incorporation of data infrastructure and standardized protocols for WBE collaboration

• Increasing community awareness and bringing WBE to small-serving communities such as rural systems

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NIEHS states it may give special consideration to support meritorious applications in this topic area.

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ICO scientific contacts: Danielle Carlin, PhD, DABT (danielle.carlin@nih.gov); Yuxia Cui, PhD (yuxia.cui@nih.gov); Heather Henry, PhD (heather.henry@nih.gov).

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Two of these bullets are unusually direct invitations to small businesses. "Technology and methodology development, including biomarkers and assays for detection and quantification of chemical exposures" is a description of a product. So is "data infrastructure and standardized protocols." And the small-serving and rural communities bullet is a market-access argument that most competitors will ignore, which makes it a differentiator: the small utility that serves 3,000 people cannot afford a research-grade LC-MS workflow, and a low-cost, low-skill, ruggedized approach has both public health value and a genuinely underserved commercial market.

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National Institute of Allergy and Infectious Diseases (NIAID)

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NIAID owns the pathogen side. Stated areas of interest:

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• Genomic epidemiology method development to better detect and track microbes, predict microbial case surges, analyze and share WBE metadata and data, integrate WBE data across platforms, and identify novel applications for secondary analyses of WBE data

• Development of clearer methods to distinguish human versus animal and agricultural signals, and One Health integration

• Using WBE to study microbe biology, including transmission, evolution, and persistence

• Parallel clinical and WBE studies analyzing the contribution of microbes identified in the environment to human disease

• Development of novel assays and laboratory methods for detection and quantification of protozoan parasites and cysts that resist chlorination

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ICO scientific contacts: Brooke Bozick, PhD (brooke.bozick@nih.gov); M. "Kate" Bradford Plimack, PhD (kate.plimack@nih.gov).

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Two of these are exceptionally well-defined product problems. Human versus animal signal discrimination is a discrete, solvable technical question with immediate commercial value, because it determines whether a positive result triggers a public health response or gets written off as agricultural runoff, and no standardized solution has been adopted. Chlorine-resistant protozoan parasites and cysts, meaning organisms in the Cryptosporidium and Giardia class, is an even tighter specification: NIAID has essentially named the analyte class and the failure mode of existing methods. If you have an assay platform that concentrates and detects environmental cysts, this bullet was written for you.

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Note also that NIAID's standing small business portfolio already funds diagnostics and prevention strategies across bacterial, fungal, viral, and parasitic targets, so a WBE assay application does not require NIAID to stretch its mission.

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National Institute on Drug Abuse (NIDA)

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NIDA frames its interest around public health response rather than measurement for its own sake. NIDA is interested in WBE research that supports community and public health responses to substance use and overdose, and it makes two participation requests that function as near-requirements:

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• Applicants are encouraged to partner with local or state public health agencies to ensure public health relevance and the ability to respond to identified hotspots and outbreaks.

• Applicants are encouraged to engage people who may be affected by the research or the reporting of results, including people who use drugs and other community members.

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Stated areas of interest:

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• Tracking patterns of substance use or exposures, including illicit drugs, medications for opioid use disorder, and naloxone

• Identifying emerging substances

• Examining links between substances detected in wastewater and community-level health outcomes such as fatal and non-fatal overdose

• Triangulating WBE with other drug use data sources to inform public health surveillance and response

• Analyzing the ethical implications of wastewater surveillance of substance use and misuse detection

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ICO scientific contact: MeLisa Creamer (melisa.creamer@nih.gov).

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The naloxone and medications-for-OUD bullet is worth pausing on. Most WBE drug work measures consumption of illicit substances. NIDA is also asking about measuring treatment and harm reduction penetration, which is a fundamentally different and largely unbuilt product: a community-level indicator of whether interventions are actually reaching people. That is a metric health departments and payers would plausibly buy, and almost nobody is selling it.

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NIDA's standing small business priorities already include forensic testing technologies for identifying emerging drugs and diagnostic tools for detection and quantification of drug exposure, both of which map onto this topic without any stretching.

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Where Does a Small Business Actually Fit?

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More cleanly here than in most Highlighted Topics. NIH SBIR and STTR awards fund research and development toward a commercially viable product or service, and this topic's gaps are largely instrumentation, assay, and software gaps. The strongest fits:

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Sampling hardware and sample stabilization. Flow-proportional and passive samplers, in-sewer deployable devices, cold-chain-free preservation chemistry, and sampling designs that let a single device characterize a neighborhood rather than a whole treatment plant. NIEHS explicitly asks for multi-level sewer network assessment down to the building scale, which is a hardware and deployment problem before it is a science problem.

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Analytical assays and panels. Multi-residue chemical panels for pesticides, plasticizers, personal care products, heavy metals, and emerging contaminants. Molecular panels for pathogens. Concentration and detection methods for chlorine-resistant protozoan cysts, which NIAID names specifically. Assays for drug metabolites and for medications including buprenorphine, methadone, and naloxone.

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Field-deployable and decentralized testing. Everything above, but cheap enough and simple enough for a rural utility or a small health department to run without a PhD analytical chemist. NIEHS's small-serving communities bullet is the funding hook, and the addressable market is large and structurally underserved.

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Normalization, modeling, and interpretation software. Turning a concentration into a defensible population estimate is the field's central unsolved problem and it is pure software plus validation. This is the highest-margin, lowest-capital entry point in the topic, and NIH names it twice, under data integration and statistical modeling and again under data interpretation.

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Data infrastructure and interoperability. NIEHS asks for data infrastructure and standardized protocols for WBE collaboration. NIAID asks for the ability to analyze and share WBE metadata, integrate data across platforms, and enable secondary analyses. That is a platform specification written by two Institutes independently.

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Human versus animal source attribution. NIAID's One Health bullet. A validated discrimination method is a component that every other WBE product would want to license.

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Biomarkers of community health. NIEHS asks for biomarkers for monitoring community health, which is broader than contaminant measurement and largely undefined. This is the most scientifically speculative bullet in the topic and correspondingly the most defensible if you have real preliminary data.

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Surveillance-to-response platforms. NIDA's framing is explicit that measurement without response capability is not the goal. A system that detects an emerging substance and routes an actionable alert to a health department, with the ethical and privacy architecture built in rather than bolted on, addresses NIDA's stated interest directly.

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What Will Not Work

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Three failure modes are predictable here.

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A surveillance service with no technology development. Running existing assays on new samples in a new city is a service business, not research and development. SBIR reviewers will identify it immediately. The innovation has to be in the method, the instrument, the model, or the platform.

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A COVID-era pathogen dashboard repositioned. A number of companies built SARS-CoV-2 wastewater dashboards and are looking for a second act. Reviewers in this space have seen that pitch. If the underlying technology is a data pipeline that ingests third-party lab results, the innovation claim is thin unless the modeling and interpretation layer is genuinely novel and validated.

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Measurement with no validation against human exposure. NIH names data interpretation as a core gap. An application that produces numbers without addressing what those numbers mean for actual human exposure is answering the easy half of the question.

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Two Structural Considerations

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Partnering with a health department cuts both ways. NIDA encourages partnership with local or state public health agencies, and NIEHS encourages partnerships with public health experts and epidemiologists. Those partnerships are genuinely necessary for credibility and for site access. They also consume your outsourcing allowance: under SBIR, Phase I generally requires at least 67 percent of the research effort to be performed by the small business and Phase II at least 50 percent, and consultant plus contractual arrangements in Phase I are generally capped around 33 percent of the total requested. Structure the partnership as site access, sample provision, and advisory input rather than as a large subaward, or move to STTR where the collaboration allowance is built into the mechanism.

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STTR is often the better vehicle here. NIH describes WBE as inherently requiring analytical chemistry, molecular biology, and epidemiology together, plus data sharing across disciplines. Few small companies hold all of that in house. Under STTR, a formal collaboration with a university or nonprofit research institution is required, at least 40 percent of the work is performed by the small business and at least 30 percent by the research institution, and the Principal Investigator may be primarily employed by either organization. For a company that needs an academic environmental epidemiologist or a university analytical core to be credible, PA-27-102 is frequently the stronger application. One exception is noted in the funding section below.

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How Much Funding Would I Receive?

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There is no funding amount attached to the Highlighted Topic itself. Budgets come from the parent announcement you apply through and from the Institute that funds you.

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Under the current NIH SBIR and STTR parent announcements, standard guidelines provide:

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• Phase I: up to $323,090, typically over one to two years

• Phase II: up to $2,153,927, typically over two to three years

• Fast-Track: Phase I and Phase II in a single application and review

• Direct to Phase II: available under SBIR for companies that have already established feasibility

• Phase IIB (PA-27-101): follow-on funding beyond Phase II

• Commercialization Readiness Pilot: late-stage, milestone-driven support, with amounts varying by Institute

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Cost sharing is not required.

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The NIEHS Budget Caveat You Need to Check First

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This matters more in this topic than almost anywhere else in the NIH portfolio, because NIEHS is the most natural home for chemical-focused WBE work and NIEHS applies reduced caps to two of its program areas.

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NIEHS caps its Superfund Research Program topics at $200,000 for Phase I, $1.25 million for Phase II, and $300,000 for CRP. Its Worker Training Program topics are capped at $100,000, Phase I only. Both of those NIEHS programs accept SBIR applications only, not STTR.

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The Superfund Research Program focuses on detection and remediation technologies for hazardous substances relevant to Superfund and other contaminated sites. A WBE project framed around detecting industrial releases, heavy metals, disaster-related spills, or site-associated contaminants could plausibly be routed there, and the difference between the standard cap and the SRP cap is more than $900,000 in Phase II. It also removes STTR as an option, which changes your whole team structure.

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This is a five-minute email to a program officer that can reshape the entire application. Ask directly whether your project would be handled under general NIEHS mission or under the Superfund Research Program before you build a budget.

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NIAID and NIDA both operate under the standard caps and both accept STTR.

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Full Institute-by-Institute budget detail is in our NIH SBIR program executive summary.

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What Could I Use the Funding For?

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Funds support research and development toward a commercially viable product or service aligned with the mission of a participating Institute. Allowable costs include personnel, materials, prototype fabrication, assay development, instrument builds, field deployment and validation studies, method comparison work, software development, intellectual property protection, and other direct R&D expenses.

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Phase II, Phase IIB, and CRP funds may additionally cover scale-up, manufacturing, validation at multiple sites, regulatory preparation, and commercialization activities.

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For most WBE projects, human subjects considerations are lighter than founders expect. Wastewater collected at a treatment plant or sewer node is generally not individually identifiable and is typically not treated as human subjects research, though that determination belongs to your IRB and your Institute, not to you. Where it changes is in the parallel clinical and wastewater studies NIAID names, which do involve human participants and human specimens, and in any building-level or institution-level sampling where results could be attributed to a small identifiable group. If your design includes either, raise it with program staff early, because it affects which forms you file and how the application is reviewed.

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What Is the Timeline?

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Highlighted Topic dates

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• Posted: August 27, 2026

• Expires: August 27, 2028

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SBIR and STTR standard receipt dates (PA-27-100 and PA-27-102)

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• September 5, 2026. This falls on a Saturday, and Labor Day is Monday, September 7, so submissions are accepted through Tuesday, September 8, 2026.

• January 5, 2027

• April 5, 2027

• September 5, 2027, which falls on a Sunday before Labor Day, so that cycle effectively closes Tuesday, September 7, 2027

• January 5, 2028

• April 5, 2028

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Because the topic expires on August 27, 2028, April 5, 2028 is the last standard receipt date that falls inside the active window. That gives you six cycles in total. All applications are due by 5:00 PM local time of the applicant organization.

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Review and award timeline for the September 2026 cycle

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• Scientific merit review: November 2026

• Advisory council review: January 2027

• Earliest project start date: April 2027

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Review and award timeline for the January 2027 cycle

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• Scientific merit review: March 2027

• Advisory council review: May 2027

• Earliest project start date: July 2027

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Review and award timeline for the April 2027 cycle

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• Scientific merit review: July 2027

• Advisory council review: August 2027

• Earliest project start date: December 2027

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A policy change that matters for planning. NIH tightened its late application policy under NOT-OD-26-064, effective for due dates on or after May 25, 2026. Small business applications no longer receive the discretionary late submission window. Submit early enough to resolve eRA Commons validation errors before the deadline, not after.

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Practical planning guidance. Budget at least twelve weeks of lead time before your target due date, and more if your federal registrations are not complete. SAM.gov, UEI, the SBA Company Registry, eRA Commons, and Grants.gov registrations can take four to six weeks on their own and must all be finished before you can submit anything. For a first-time applicant, expect 120 to 200 hours of total effort on a competitive submission.

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One WBE-specific timing note: if your project requires access to a sewer network, a treatment plant, or a health department's data, secure those agreements and letters of support before you start writing. Utility and municipal approvals move on their own schedule, and a missing site access letter is a common reason otherwise strong environmental applications lose points on Environment and Approach.

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Who Is Eligible to Apply?

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Eligibility comes from the parent announcement, not from the topic. Applicants must be U.S. small business concerns that are:

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• Organized for profit with a place of business located in the United States

• At or below 500 employees, including affiliates

• More than 50 percent owned and controlled by U.S. citizens or permanent resident aliens, by qualifying U.S. entities, or by a combination

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For STTR, the company must also have a formal collaboration with a U.S. research institution, with at least 40 percent of the work performed by the small business and at least 30 percent by the research institution. Note again that NIEHS Superfund Research Program and Worker Training Program topics accept SBIR only.

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Foreign organizations are not eligible, and foreign subawards and subcontracts are not permitted.

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Are There Restrictions I Should Know About?

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• Only U.S. small business concerns are eligible; foreign organizations are not.

• Applications involving foreign subawards or subcontracts will not be considered for funding. WBE has an active international research community, and collaborations that would be natural scientifically are not permissible under this mechanism.

• Your application must be relevant to the mission of a participating Institute. For this topic that means NIEHS, NIAID, or NIDA.

• Duplicate or highly overlapping applications submitted under multiple HHS announcements are not permitted.

• Companies must satisfy applicable SBA performance benchmark requirements, including the Phase I to Phase II transition rate benchmark and the Phase II commercialization rate benchmark for companies with substantial award histories.

• Phase I generally requires at least 67 percent of the research effort to be performed by the small business; Phase II at least 50 percent. Consultant and contractual arrangements in Phase I are generally limited to roughly 33 percent of the total amount requested.

• Additional national security, foreign relationship, and foreign ownership disclosure requirements apply and may result in denial of award. The 2026 SBIR and STTR reauthorization tightened foreign risk management and due diligence review, and that screening now sits inside the review critical path.

• Cost sharing is not required.

• Applying under a Highlighted Topic does not change referral or review, and does not guarantee that funds have been set aside.

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What Kind of Application Is Likely to Win Here?

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NIH reviews small business applications on Significance, Investigators, Innovation, Approach, and Environment, with commercialization potential specifically evaluated for Phase II and Fast-Track. Within this topic, five things separate competitive applications.

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One: you picked the right Institute before you started writing. Three Institutes with genuinely different scopes means the same instrument can be three different applications. A sampler validated on pesticides is NIEHS. The same sampler validated on protozoan cysts is NIAID. Validated on fentanyl analogs it is NIDA. Email the named contact, describe the technology in a paragraph, ask whether it fits and which mechanism they would suggest. It is the highest-return hour you will spend, and for NIEHS it is also how you find out which budget cap applies.

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Two: you addressed a named gap rather than a general capability. NIH gave you the list: sampling variability, analytical methods, data integration and modeling, data interpretation, best practices, communication, and ethics. An application that maps its aims onto those specific gaps is visibly responsive. One that describes a general WBE platform is not.

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Three: you have real validation data, ideally against an independent measure. The interpretation gap is the field's credibility problem. Applications that show their wastewater signal tracking something externally verifiable, whether clinical case counts, prescription data, overdose records, or paired human biomonitoring, are answering the question reviewers actually have.

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Four: you brought the partners. All three Institutes ask for collaboration in some form, and NIDA asks twice, for public health agency partnership and for engagement with affected community members including people who use drugs. Letters of support from partners with no defined role in the research plan are transparent to reviewers. Give each partner a named function, specific deliverables, and where appropriate a line in the budget.

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Five: you took ethics and privacy seriously as design, not as compliance. NIH names ethical and privacy issues in the background, and NIDA lists analyzing the ethical implications of wastewater surveillance as a fundable area in its own right. Building-level and institution-level sampling can attribute drug use to an identifiable group, and that has already generated public controversy in the field. An application that has thought through spatial resolution limits, data governance, and how findings get communicated is stronger on Approach and considerably more commercially credible, because your eventual customers will ask the same questions

Frequently Asked Questions

Is the NIH wastewater-based epidemiology Highlighted Topic a funding opportunity I can apply to directly?

No. An NIH Highlighted Topic is a published statement of scientific priority, not a Notice of Funding Opportunity. There is no application package and no separate deadline. Small businesses apply through a broad NIH opportunity, which means the SBIR parent announcement PA-27-100 or the STTR parent announcement PA-27-102.

How much funding is available under this topic?

The topic itself carries no funding amount. Standard SBIR guidelines provide up to $323,090 for Phase I and up to $2,153,927 for Phase II. One exception matters here: NIEHS caps Superfund Research Program topics at $200,000 for Phase I, $1.25 million for Phase II, and $300,000 for CRP, and caps Worker Training Program topics at $100,000 for Phase I only. Both of those NIEHS programs accept SBIR only, not STTR. Confirm with NIEHS program staff which program area would handle your project before building a budget.

Does applying under this Highlighted Topic improve my chances?

Not in review. NIH states that applying in a Highlighted Topic area will not affect referral or review of applications. NIEHS states it may give special consideration to meritorious applications in this topic area. NIAID and NIDA make no such statement for this topic. The real advantage is informational: three Institutes have documented what they want to fund and named the program staff to contact.

Which NIH Institutes participate in the wastewater-based epidemiology Highlighted Topic?

Three: the National Institute of Environmental Health Sciences (NIEHS), the National Institute of Allergy and Infectious Diseases (NIAID), and the National Institute on Drug Abuse (NIDA). NIEHS covers chemical and environmental contaminant exposure, NIAID covers pathogens and genomic epidemiology, and NIDA covers substance use and overdose surveillance.

What are the deadlines?

The topic is open from August 27, 2026 through August 27, 2028. SBIR and STTR standard receipt dates are September 5, 2026, January 5, 2027, April 5, 2027, September 5, 2027, January 5, 2028, and April 5, 2028. Because the topic expires in August 2028, April 5, 2028 is the last standard receipt date inside the active window. September 5, 2026 falls on a Saturday before Labor Day, so that cycle accepts submissions through Tuesday, September 8, 2026, and September 5, 2027 falls on a Sunday before Labor Day, so that cycle closes Tuesday, September 7, 2027. All applications are due by 5:00 PM local time of the applicant organization.

What specific technical problems is NIH asking companies to solve?

NIH names four clusters of challenges: sampling variability driven by sample location and timing of collection; analytical methods; data integration and statistical modeling; and data interpretation, meaning how detection in wastewater correlates with real-world human exposure and what it implies for public health. NIH also names best practices, communication of findings, and ethical and privacy issues as important considerations. Each of those is a defensible basis for an SBIR aim.

Can wastewater-based epidemiology detect more than pathogens?

Yes, and NIH says so explicitly. The topic states that wastewater can indicate exposure to pesticides, plasticizers, personal care products, heavy metals, industrial releases, emerging contaminants, and disaster-related spills and fires, and that while it has been used to detect pathogens it can also detect medications and drug metabolites. The topic is considerably broader than pathogen surveillance.

Who is eligible to apply?

For-profit U.S. small business concerns with 500 or fewer employees including affiliates, more than 50 percent owned and controlled by U.S. citizens or permanent residents or by qualifying U.S. entities. Foreign organizations are not eligible, and foreign subawards and subcontracts are not permitted. STTR additionally requires a formal collaboration with a U.S. research institution.

Should my company apply for SBIR or STTR?

Choose SBIR if your company performs the majority of the research and your Principal Investigator is primarily employed by the company. Choose STTR if the project depends on a formal collaboration with a university or nonprofit research institution. Because NIH describes WBE as requiring analytical chemistry, molecular biology, and epidemiology together, STTR is frequently the stronger structural fit. The exception is NIEHS Superfund Research Program and Worker Training Program topics, which accept SBIR only.

Is wastewater sampling considered human subjects research?

Usually not, but the determination is not yours to make. Wastewater collected at a treatment plant or sewer node is generally not individually identifiable and is typically not treated as human subjects research. That changes for the parallel clinical and wastewater studies NIAID names, which involve human participants and specimens, and for building-level or institution-level sampling where results could be attributed to a small identifiable group. Raise either scenario with program staff and your IRB early.

Do I need a partnership with a utility or health department?

Not formally required, but effectively yes for most designs. NIDA encourages partnering with local or state public health agencies and engaging affected community members including people who use drugs. NIEHS encourages partnerships with public health experts, epidemiologists, analytical chemists, and contaminant fate and transport experts. Beyond responsiveness, you need site access to collect samples. Secure those agreements before you begin writing, because municipal approvals move on their own schedule and a missing site access letter costs points on Environment and Approach.

How do partnerships interact with the SBIR work allocation rules?

Carefully. Phase I generally requires at least 67 percent of the research effort to be performed by the small business and Phase II at least 50 percent, and consultant plus contractual arrangements in Phase I are generally limited to roughly 33 percent of the total requested. Structure agency and academic partnerships as site access, sample provision, data sharing, and advisory input rather than as large subawards, or use STTR where a substantial research institution role is built into the mechanism.

What kinds of wastewater projects are unlikely to be funded?

Three patterns predictably fail. A surveillance service that runs existing assays on new samples in new locations is a service business rather than research and development. A repositioned COVID-era dashboard that ingests third-party lab results has a thin innovation claim unless the modeling and interpretation layer is genuinely novel. And measurement work that produces numbers without addressing what they mean for real human exposure answers only the easy half of the question NIH asked.

How long will it take me to prepare an application?

For a first-time applicant, expect 120 to 200 hours in total. Start at least twelve weeks before your target due date. Federal registrations across SAM.gov, UEI, the SBA Company Registry, eRA Commons, and Grants.gov can take four to six weeks on their own and must be complete before you can submit.

What happens if I submit late?

It will not be accepted. NIH tightened its late application policy for due dates on or after May 25, 2026, and small business applications no longer receive the discretionary late submission window.

Could this topic be withdrawn before it expires?

Possibly. NIH reviews each Highlighted Topic annually for continued alignment with agency priorities, and Institutes can post and retire topics at any time. The posted expiration date is August 27, 2028, but verify the topic is still live before each cycle you plan to submit in.

How Can BW&CO Help?

BW&CO is a non-dilutive federal funding advisory firm. We have helped clients secure more than $350 million in federal funding, and wastewater-based epidemiology sits at exactly the kind of intersection we handle well: an emerging measurement field with real hardware and software product opportunities, three possible Institute sponsors with meaningfully different scopes, one buried budget cap that can cost you $900,000 if you find it late, and partnership requirements that interact awkwardly with SBIR work allocation rules.

We can:

• Identify the right Institute and mechanism for your technology, and determine before you write whether NIEHS would handle your project under general mission or under the Superfund Research Program, which decides both your budget ceiling and whether STTR is available.

• Triple your likelihood of success through proven strategy and insider-aligned proposal development.

• Reduce your time spent on the proposal by 50 to 80 percent, so your team stays on the technology.

• Structure utility, health department, and academic partnerships so they strengthen the application without breaching the outsourcing limits.

NIH Highlighted Topic: Catalyzing Interdisciplinary Research on HIV-Associated Co-occurring Conditions

Highlighted Topic 99 | Lead Office: NIH Office of AIDS Research (OAR) | Posted July 28, 2026 | Expires July 28, 2028 | Apply through the NIH SBIR parent announcement (PA-27-100) or the NIH STTR parent announcement (PA-27-102).

Executive Summary

NIH has designated HIV-associated co-occurring conditions as a formal Highlighted Topic, and sixteen NIH Institutes, Centers, and Offices have attached their own stated interests to it. For a small business, this is one of the most cross-cutting priority signals NIH has published in the HIV space, because it opens the door to funding from cancer, cardiopulmonary, aging, metabolic, mental health, substance use, oral health, musculoskeletal, and integrative health budgets at the same time, all through a single application to the standard SBIR or STTR omnibus.

The science being requested is a shift in framing. Antiretroviral therapy has turned HIV into a manageable chronic condition, and the unsolved problem is no longer viral suppression. It is that people with HIV develop comorbidities earlier, carry more of them at once, experience treatment-related toxicities, and navigate mental health, substance use, and structural barriers that disease-specific care models were never designed to handle. NIH wants to fund work that treats those conditions as an interconnected system rather than a list of separate diseases, and it wants that work to reach patients through care models that actually get implemented.

For companies, the commercially relevant openings are concentrated in a handful of places: multi-condition risk prediction and early screening, point-of-care and decentralized diagnostics for comorbidities and coinfections, digital therapeutics and adherence technologies that address HIV alongside substance use or mental health, biomarkers of accelerated aging and organ injury, drug interaction and polypharmacy decision support, and platforms that let a single clinic deliver integrated care without adding staff.

There is no dedicated pot of money and no separate application form. A Highlighted Topic is a priority signal, not a Notice of Funding Opportunity. You apply through the normal NIH SBIR or STTR omnibus, you compete against every other small business application in that cycle, and NIH states plainly that applying in a Highlighted Topic area will not affect how your application is referred or reviewed. What the topic does give you is unusually specific intelligence about what sixteen ICOs want to buy, plus named program staff to call before you write a word. Two participating Institutes, NHLBI and NIDA, state they may dedicate funds to this topic area, and three, NCCIH, NIDA, and NIDCR, state they may give special consideration to meritorious applications in it.

Under the current SBIR parent announcement, standard budget guidelines run up to $323,090 for Phase I and up to $2,153,927 for Phase II, with several Institutes approved to exceed those caps. The next standard receipt dates are September 5, 2026, January 5, 2027, and April 5, 2027, and the topic stays live through July 28, 2028.

One timing change matters more here than almost anywhere else in the NIH portfolio: HHS eliminated dedicated AIDS-specific SBIR and STTR due dates for applications due on or after May 25, 2026. HIV-focused companies that built their calendars around the legacy AIDS cycles need to rebuild them around the standard September, January, and April dates.

A Quick Note on the NIH SBIR and STTR Program

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The NIH, CDC, and FDA SBIR and STTR programs are the largest source of non-dilutive early-stage funding for health, biomedical, and life science technology in the United States. NIH alone sets aside well over a billion dollars a year. Awards are grants, not investments. There is no equity, no repayment, and no board seat.

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The program runs in phases. Phase I funds proof of concept and feasibility. Phase II funds the substantive research and development that turns a validated concept into a product. Fast-Track combines both in a single application, and Direct to Phase II lets companies that have already established feasibility skip Phase I entirely. Phase IIB and the Commercialization Readiness Pilot extend funding for late-stage work such as clinical validation, manufacturing scale-up, and regulatory submissions. Applicants must be for-profit U.S. small businesses with 500 or fewer employees and majority U.S. ownership.

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For the complete breakdown of the NIH SBIR and STTR program, including all budget caps by Institute, clinical trial policies, eligibility mechanics, review criteria, and the full timeline, see our full executive summary here: NIH, CDC and FDA Parent SBIR Grant (PA-27-100).

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Everything below is specific to this Highlighted Topic.

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What Is a Highlighted Topic, and How Is It Different From a Funding Opportunity?

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This distinction trips up nearly every first-time applicant, so it is worth being precise.

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A Notice of Funding Opportunity (NOFO) is a solicitation. It has an announcement number, its own application package, its own review criteria, and in most cases its own set-aside funding. You apply to it directly.

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A Highlighted Topic is a published statement of scientific priority maintained centrally by NIH. It has no application package. It has no guaranteed funding. You cannot apply to it. Instead, you apply through a broad opportunity such as the SBIR or STTR parent announcement, and the topic tells you what the participating Institutes and Centers currently want to fund inside their existing budgets.

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NIH is explicit about the practical consequences:

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• Apply through an appropriate parent announcement or other broad NIH opportunity.

• Reach out early to the listed scientific contacts to discuss alignment.

• If an ICO chooses to dedicate funding to a topic, the amount depends on available funds, the number of meritorious applications, and competing priorities.

• Applying in a Highlighted Topic area will not affect NIH referral or review of your application.

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That last point is the one to internalize. The topic does not give you a scoring advantage. What it gives you is a map. Sixteen ICOs have each written down, in their own words, what they would fund in this space and who to call about it. That intelligence is worth considerably more than a modest scoring bump, because the single most common reason strong small business applications fail at NIH is misalignment with the Institute that ends up holding the application.

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Highlighted Topics replaced the older Notice of Special Interest (NOSI) model for this purpose. If you have applied to NIH before and are looking for a notice number to enter into the Agency Routing Identifier field, there is not one for a Highlighted Topic. The practical approach is to make the alignment explicit in your cover letter and in your Specific Aims, and to confirm handling with the program officer at your target Institute before you submit.

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What Are They Looking For? A Detailed Overview

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The Core Scientific Problem

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NIH frames the problem in terms that any founder in this space will recognize from the clinic.

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Antiretroviral therapy transformed HIV into a manageable chronic condition. But people with HIV still face high risk and early onset of comorbidities, adverse effects from ART itself, and a set of medical, psychosocial, and structural challenges that are tangled together rather than separable. The burden extends beyond people living with HIV: NIH specifically calls out HIV-exposed but uninfected children, who may carry elevated risks of immune, metabolic, and developmental problems compared with unexposed peers, particularly in low and middle-income settings.

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The stated knowledge gaps are where the fundable work lives:

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Mechanistic gaps. How do HIV, ART, and psychosocial stressors interact to drive the early onset and progression of comorbidities? This is the question underneath accelerated aging, chronic inflammation, and immune activation.

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Shared-pathway gaps. Many comorbidities intersect and share risk factors before diverging into disease-specific trajectories. NIH gives two examples directly: metabolic syndrome raising risk for diabetes, cardiovascular disease, and chronic kidney disease at once; and certain coinfections raising cancer risk. The implication is a real product thesis. If you can identify or intervene on a shared upstream factor, you address multiple outcomes with one technology, and that is a much stronger commercial story than a single-indication tool.

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Model gaps. Traditional disease-specific models do not capture shared factors, and they do not capture the multilevel determinants that decide whether an intervention actually gets implemented in a real health system.

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Care delivery gaps. NIH wants whole-person care that links infectious diseases, endocrinology, psychiatry, nursing, pharmacy, and community health, with emphasis on early screening, lifestyle-based prevention, and sustained engagement in HIV care, all while accounting for local context and health system constraints.

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The Stated Purpose

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The topic aims to catalyze interdisciplinary research on HIV-associated co-occurring conditions and to expand multidisciplinary teams that can develop and deliver preventive strategies improving health and quality of life across the lifespan. Three emphases are named:

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1. Shared factors and multi-organ effects, to inform early preventive strategies.

2. Implementation science approaches to identify barriers and facilitators, optimize multidisciplinary care, and deliver scalable, sustainable care models.

3. Multidisciplinary teams with multiple Program Directors and Principal Investigators holding complementary expertise, cross-NIH alignment, and use of existing NIH resources.

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Meaningful community engagement is strongly encouraged throughout.

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Alignment With the Make America Healthy Again Initiative

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This topic is being issued as part of the Make America Healthy Again (MAHA) initiative, and NIH lists the specific MAHA workstreams it aligns with. This matters strategically, because it tells you which vocabulary and which framings currently carry institutional weight. The named alignments include:

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• The NIH MAHA Chronic Disease Initiative, which aligns existing NIH chronic disease research and aims to generate actionable results for diseases arising in childhood and adulthood.

• The Whole-Person-Health approach to chronic disease prevention, including metabolic health at all stages of life.

• Prescribing patterns and impact on mental health, including evaluation of prescription patterns and overprescription trends.

• Food for Health, studying food and lifestyle interventions and their effect on outcomes and cost.

• Nutrition, including dietary patterns that support metabolic health and precision nutrition.

• The oral health and systemic disease connection, including oral microbiome relationships with gut health and immune function.

• The Gut Microbiome Research Initiative, on the microbiome's role in chronic disease development and progression.

• Longitudinal research for chronic disease prevention, leveraging existing NIH cohorts including All of Us, ABCD, HBCD, and ECHO.

• Clinical trial networks, strengthening existing networks through engagement with large public and private hospital systems including the VA.

• Mental health and addiction research, with focus areas including screen time in children and adolescents.

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If your technology touches metabolic health, nutrition, the microbiome, polypharmacy, or prevention, there is language here you should be borrowing.

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Participating Institutes, Centers, and Offices, and What Each One Wants

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This is the section to read closely. Your application will be assigned to one Institute, that Institute's budget will pay for it, and that Institute's priorities will determine whether it gets funded after review. Below is what each participating ICO has stated for this topic.

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Office of AIDS Research (OAR), lead office. OAR is interested in facilitating interdisciplinary research, including implementation science, to advance understanding of the common factors underlying HIV-associated co-occurring conditions, supporting early prevention, integrated whole-person care, and improved health and quality of life across the lifespan. OAR does not award grants. Your application must be relevant to at least one participating Institute or Center that does. OAR is the central scientific contact for the topic overall, and Geetanjali Bansal, PhD, is the ICO scientific contact.

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National Cancer Institute (NCI). NCI wants to advance understanding of the risks, development, progression, prevention, diagnosis, and treatment of cancer in people with HIV, and to test and implement bundled cancer and HIV interventions. NCI notes that people with HIV have increased incidence of certain cancers, are diagnosed at earlier ages and higher stages, have worse overall and cancer-specific survival, and are less likely to receive cancer treatment. Named example topics: characterizing how HIV infection contributes to the development and pathogenesis of HIV-related tumors; discovering and developing new biomarkers, diagnostics, and therapeutics to improve prevention, diagnosis, treatment, and outcomes; and identifying factors that drive cancer disparities for people with HIV, including work to improve adoption, implementation, and sustainment of effective interventions. Contact: Rebecca Liddell Huppi, PhD.

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National Heart, Lung, and Blood Institute (NHLBI). NHLBI is interested in mechanisms and pathways behind HIV-associated heart, lung, blood, and sleep (HLBS) comorbidities, and in interventions that improve care, including implementation research. Stated priorities: combined effects of aging, HIV, and ART on HLBS conditions; aging- and HIV-related changes in hematopoiesis, including hematopoietic stem cells and their niche; the impact of sleep deficiency and sleep-disordered breathing on HIV-associated cardiopulmonary and cardiometabolic disease; vascular contributions to cognitive impairment and dementia; implementation strategies that improve uptake and sustainability of evidence-based HLBS interventions; mechanistic studies to reduce the effects of HIV and aging on HLBS comorbidities, including traditional risk factors and sex differences; and novel methods to detect subclinical HIV-related HLBS conditions plus strategies to mitigate clinical disease. NHLBI states it may dedicate available funds to applications in this topic area, subject to funds, the number of meritorious applications, and competing priorities.

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National Institute on Aging (NIA). NIA supports projects addressing HIV-associated co-occurring conditions in midlife and older age, spanning the NIH Stage Model from basic science (Stage 0) through intervention development and refinement (Stage 1) to implementation (Stage V). Areas of interest: the etiologies and pathogenesis of these conditions, including the roles of chronic immune activation and antiretroviral and other drug toxic effects; optimizing medications, care coordination, and behavioral and social interventions to improve outcomes, function, and quality of life; and developing, testing, implementing, and scaling evidence-based interventions that address poor outcomes. Contact: Marcel E. Salive, MD, MPH.

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National Institute on Drug Abuse (NIDA). NIDA seeks interdisciplinary research on how drug use, addiction, and HIV interact across the lifespan. Named examples: how HIV, ART, and polysubstance use affect brain function, behavior, mood, sleep, pain, and cognition; molecular, neurochemical, cellular, and circuit functions underpinning HIV and co-occurring substance use disorders; shared pathways linking substance use, HIV, stress, trauma, and mental health conditions; individual and community factors affecting HIV prevention, care engagement, and ART adherence, with focus on improving access in underserved populations; integrated interventions addressing HIV, SUD, HCV, and co-occurring mental health conditions; and basic, clinical, and translational research on treatment of SUD and overdose in people with HIV. NIDA states it may dedicate available funds to this topic area and may give special consideration to meritorious applications in it.

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National Institute of Mental Health (NIMH). NIMH is interested in interdisciplinary biological and behavioral approaches to the neuropsychiatric mechanisms behind central nervous system comorbidities in people with HIV across the lifespan; how HIV biology, treatment exposures, and psychosocial burden converge on shared pathways driving neurocognitive and mental health disorders, in order to inform early intervention and scalable whole-person care models; and multidisciplinary implementation research identifying barriers to neurocognitive and mental health diagnosis and treatment in people with HIV, with emphasis on community engagement and sustainable care delivery. Contacts: Vasudev Rao, MBBS, MS, and Teri Senn, PhD. Note that NIMH's standing small business program already names technologies addressing basic, behavioral, and implementation science related to people living with HIV as an interest area, which makes it an unusually natural home for an SBIR application under this topic.

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National Institute of Allergy and Infectious Diseases (NIAID). NIAID is interested in coinfections affecting people with HIV across the lifespan, from infant through adult, and encourages multidisciplinary applications addressing the impact of stigma and other intersecting behavioral, biological, and health system factors on diagnosis, prevention, and treatment. The named coinfections are tuberculosis, viral hepatitis, and sexually transmitted infections. Contact: Robin E. Huebner, PhD, MPH.

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). NIDDK supports basic, clinical, and implementation science examining the impact of HIV on organs, tissues, and biological systems, including person-oriented comorbidity research. Priorities include enteropathy and gastrointestinal homeostasis; liver diseases and viral hepatitis coinfections; digestive diseases, nutrition, obesity, diabetes, and related complications; and kidney, urologic, and hematologic diseases that may present differently or follow altered clinical courses in the context of HIV. On the clinical side, NIDDK wants work that improves implementation and delivery of evidence-based care and develops strategies to improve HIV diagnosis and progression. Studies addressing social, behavioral, and environmental factors influencing HIV and comorbidities in diabetes, digestive, and kidney disease are named as high priority, particularly regarding disease severity and treatment adherence. Contacts: Deepak Nihalani, Khoa Nguyen, and Minnjuan Flournoy Floyd.

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National Institute on Alcohol Abuse and Alcoholism (NIAAA). NIAAA notes that heavy alcohol use, including alcohol use disorder, interacts with both behavioral risk and organ pathophysiology in people living with HIV, accelerating physiological and physical vulnerability, affecting medication adherence and toxicities, and complicating care. Research should improve understanding of the pathophysiology of alcohol-associated comorbidities; develop biomedical and behavioral approaches to restore alcohol-induced organ dysfunction; and implement interventions addressing alcohol and associated mental health, substance use, comorbidities, coinfections, and complications in vulnerable populations. Named complications include cardiovascular disease, metabolic disorders, neurocognitive impairment, and cellular and immune dysfunction. Contact: Kendall Bryant, PhD.

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National Center for Complementary and Integrative Health (NCCIH). NCCIH supports research on complementary and integrative health approaches for symptom management in people living with HIV, framing HIV as a chronic multisystem condition with complex symptoms including pain, fatigue, and neurocognitive and mental health challenges that suit a Whole Person Health approach. Priorities: testing complementary and integrative interventions such as mind-body approaches and natural products to address symptom clusters and improve function and quality of life; elucidating biological, behavioral, and psychosocial mechanisms including inflammation, neuroimmune, and stress pathways, and identifying biomarkers and patient characteristics; integrating these approaches into HIV care through pragmatic and hybrid effectiveness-implementation studies and scalable delivery models; and evaluating risks such as drug and herb interactions, synthesizing evidence, and developing guidance for informed decision-making. NCCIH states it may give special consideration to meritorious applications in this topic area. Contact: Lanay Mudd, PhD.

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National Institute of Dental and Craniofacial Research (NIDCR). NIDCR supports interdisciplinary research on shared risk factors influencing the onset and progression of HIV-associated comorbidities in the oral and craniofacial complex across the lifespan. Areas of interest: mechanisms of HIV-related oral disease, including immune dysregulation, inflammation, and ART effects; biological, behavioral, and contextual risk factors linking oral and systemic comorbidities and coinfections, including HPV-associated cancer and metabolic and inflammatory diseases; interdisciplinary preventive, diagnostic, and treatment approaches, including probiotics, mucosal immunity modifiers, early cancer detection, and management of oral and salivary gland complications; and integration of oral health into the multidisciplinary HIV care continuum. NIDCR states it may give special consideration to meritorious applications in this topic area. Contact: NIDCR Division of Extramural Research.

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). NIAMS seeks research on HIV-associated comorbidities affecting the musculoskeletal system, skin, and systemic rheumatic diseases, and encourages studies of how HIV infection, ART, and host or viral factors contribute to early onset, acceleration, or worsening of NIAMS-relevant comorbidities. Named conditions include musculoskeletal pain; muscle diseases such as sarcopenia and cachexia; cartilage degeneration and osteoarthritis; osteoporosis, osteopenia, and fractures; arthritis and other rheumatic diseases; and dermatologic manifestations. NIAMS supports basic, translational, and clinical research characterizing the burden, trajectory, and risk of these conditions across the lifespan, and states that priority is given to implementation science projects that develop, test, and scale multidisciplinary whole-person care models integrating musculoskeletal, rheumatic, and skin health into HIV prevention and treatment settings. Contact: Heiyoung Park, PhD. Important operational note for small businesses: NIAMS does not accept clinical trial applications under the SBIR parent announcement.

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). NICHD is listed as a participating ICO with a scientific contact, Sonia Lee, PhD, but has not published a topic-specific scope statement. Given the topic's explicit attention to HIV-exposed uninfected children and to outcomes across the lifespan, pediatric, maternal, and developmental angles are clearly in play, but this is an Institute where a pre-submission conversation is not optional.

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Office of Behavioral and Social Sciences Research (OBSSR). Participating, with Cathy Maulsby, PhD, as contact. OBSSR does not award grants.

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Office of Disease Prevention (ODP). ODP is particularly interested in innovative prevention research using rigorous study design, measurement, and analysis methods to test interventions, implementation strategies, and multidisciplinary care approaches that prevent co-occurring conditions in people with HIV across the lifespan. ODP does not award grants. Contact: JoyAnn Courtney, PhD.

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Office of Research on Women's Health (ORWH). ORWH is interested in research projects addressing HIV-associated co-occurring conditions in women. ORWH does not award grants. Contact: Balkissa Ouattara, MD, PhD, MPH.

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Tribal Health Research Office (THRO). Participating, with Sheila Caldwell, PhD, and Christopher Barnhart, PhD, as contacts. THRO does not award grants.

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Email addresses for every contact are published on the NIH topic page. Note carefully that five of the sixteen participating ICOs are offices that cannot fund anything. Your application still has to land on the mission of an Institute or Center that writes checks.

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Where Does a Small Business Actually Fit?

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This is the honest part, and it is the question a founder should ask before spending 150 hours on an application.

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A large share of what this topic describes is classic investigator-initiated academic research: mechanistic biology, cohort analyses, implementation science trials in health systems. Much of that is better suited to an R01 than to an SBIR. NIH SBIR and STTR awards fund research and development toward a commercially viable product or service. If the deliverable at the end of your project is a paper and a set of findings rather than something a customer buys, an SBIR reviewer will say so.

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The good news is that this topic contains an unusual density of genuine product opportunities, because "shared factors, multi-organ effects, early screening, and scalable care models" is a description of things that get built and sold. The strongest small business fits:

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Multi-condition risk prediction and early screening. The topic's central scientific bet is that shared upstream factors drive several downstream comorbidities. A validated tool that stratifies risk across cardiometabolic, renal, hepatic, neurocognitive, and oncologic outcomes at once maps directly onto NHLBI, NIDDK, NIA, and NCI interests simultaneously, and onto the MAHA prevention framing.

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Point-of-care and decentralized diagnostics. Coinfection detection for TB, viral hepatitis, and STIs sits squarely in NIAID's stated scope. Oral and salivary diagnostics sit in NIDCR's. Detection of subclinical HLBS disease is a named NHLBI priority.

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Biomarkers of accelerated aging, immune activation, and organ injury. NIA names chronic immune activation and drug toxic effects explicitly. NHLBI names hematopoietic changes. NCCIH names inflammation, neuroimmune, and stress mechanisms plus biomarker identification.

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Digital therapeutics and integrated behavioral health. NIDA's interest in integrated interventions addressing HIV, SUD, HCV, and co-occurring mental health conditions is one of the clearest commercial openings in the entire topic, and NIDA is one of the two Institutes signaling possible dedicated funds. NIMH's interest in scalable whole-person care models points the same direction.

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Adherence, polypharmacy, and interaction safety. ART adherence is named by NIDA. Medication optimization is named by NIA. Drug and herb interaction risk is named by NCCIH. Prescribing patterns are a named MAHA workstream. Clinical decision support that manages ART alongside comorbidity medications and supplements has an unusually broad set of sponsors.

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Care coordination and integration platforms. Nearly every ICO in the topic asks for something that in practice requires software: integrating oral health into the HIV care continuum, integrating musculoskeletal and skin health, bundling cancer and HIV interventions, coordinating care across infectious disease, endocrinology, psychiatry, pharmacy, and community health. Note that NIAMS explicitly prioritizes implementation science for exactly this, which is rare.

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Biosensors and wearables. NIAAA's standing small business priorities already include transdermal and wearable alcohol monitoring, which lands directly on this topic's alcohol and organ dysfunction thread.

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Therapeutics. Treatments targeting shared inflammatory or metabolic pathways, or targeting a specific comorbidity in the HIV context, fit multiple Institutes. This is the longest and most capital-intensive path, and Fast-Track or Direct to Phase II with a clear regulatory strategy is usually the right structure.

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One structural constraint to plan around. The topic repeatedly references low and middle-income settings and global context. The SBIR parent announcement does not permit foreign subawards or subcontracts, and applications involving them will not be considered for funding. If your work is genuinely LMIC-facing, the research plan has to be structured so that the funded work happens domestically, with international relevance argued rather than internationally performed. This is a common and avoidable reason HIV-focused SBIR applications get administratively withdrawn.

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STTR is worth a hard look here. This topic asks for multidisciplinary teams with complementary expertise and meaningful community engagement, which is exactly what the STTR mechanism is built for. Under STTR, a formal collaboration with a university or nonprofit research institution is required, and the Principal Investigator may be primarily employed by either the company or the research partner. For a company that needs an academic HIV clinician, an implementation scientist, or a community-engaged research partner in order to be credible, STTR (PA-27-102) is often the stronger vehicle than SBIR.

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How Much Funding Would I Receive?

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There is no funding amount attached to the Highlighted Topic itself. Budgets are set by the parent announcement you apply through and by the Institute that funds you.

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Under the current NIH SBIR and STTR parent announcements, standard guidelines provide:

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• Phase I: up to $323,090, typically over one to two years

• Phase II: up to $2,153,927, typically over two to three years

• Fast-Track: combines Phase I and Phase II in one application and one review

• Direct to Phase II: available under SBIR for companies that have already established feasibility

• Phase IIB (PA-27-101): follow-on funding beyond Phase II, with budgets that can run substantially larger

• Commercialization Readiness Pilot: late-stage, milestone-driven support, up to the SBA statutory maximum of $4,191,495 at NCI, with amounts varying by Institute

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Several Institutes participating in this topic hold approval to exceed the standard caps. NIA allows up to $700,000 for Phase I and $3 million for Phase II on Alzheimer's disease and AD-related dementias, and up to $500,000 and $2.5 million for other projects in its mission space, which is directly relevant given the topic's inclusion of neurocognitive comorbidity and vascular contributions to dementia. NIGMS allows Phase IIB budgets up to $3 million, or $4 million for Strategic Breakthrough awards involving clinical trials. NCI supports CRP projects up to the statutory maximum plus up to $500,000 for technical assistance.

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Cost sharing is not required. Phase I generally requires at least 67 percent of the research effort to be performed by the small business; Phase II generally requires at least 50 percent.

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Full Institute-by-Institute budget detail is in our NIH SBIR program executive summary.

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What Could I Use the Funding For?

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Funds support research and development toward a commercially viable product or service aligned with the mission of a participating Institute or Center. Allowable costs include personnel, materials, prototype fabrication, assay development, validation studies, testing, intellectual property protection, and other direct R&D expenses.

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Phase II, Phase IIB, and CRP funds may additionally cover scale-up, clinical validation, regulatory preparation including IND and IDE-enabling studies, and commercialization activities.

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Whether you can run a clinical trial depends entirely on which Institute funds you. Most ICOs with a direct clinical mission accept clinical trials, including NCI, NHLBI, NIA, NICHD, NIDA, NIMH, and NIDDK, all of which participate in this topic. NIAMS and NIDCR, which also participate in this topic, do not accept clinical trials under the SBIR parent announcement. If your project involves human subjects, confirm your target Institute's specific policy before you build the research plan around it.

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What Is the Timeline?

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Highlighted Topic dates

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• Posted: July 28, 2026

• Expires: July 28, 2028

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SBIR and STTR standard receipt dates (PA-27-100 and PA-27-102)

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• September 5, 2026. This falls on a Saturday, and Labor Day is Monday, September 7, so submissions are accepted through Tuesday, September 8, 2026.

• January 5, 2027

• April 5, 2027

• The same September, January, and April cycle continues into 2027 and 2028 while the topic remains active. September 5, 2027 falls on a Sunday ahead of Labor Day, so that cycle effectively closes Tuesday, September 7, 2027.

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All applications are due by 5:00 PM local time of the applicant organization.

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Review and award timeline for the September 2026 cycle

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• Scientific merit review: November 2026

• Advisory council review: January 2027

• Earliest project start date: April 2027

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Review and award timeline for the January 2027 cycle

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• Scientific merit review: March 2027

• Advisory council review: May 2027

• Earliest project start date: July 2027

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Review and award timeline for the April 2027 cycle

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• Scientific merit review: July 2027

• Advisory council review: August 2027

• Earliest project start date: December 2027

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Two timing changes that specifically affect HIV-focused applicants

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First, HHS eliminated dedicated AIDS and AIDS-related SBIR and STTR due dates for applications due on or after May 25, 2026. HIV-focused companies previously had access to a separate offset schedule that routed applications into AIDS-specific review. That is gone. You now compete on the standard small business calendar, which makes Institute alignment and cycle selection more consequential than before.

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Second, NIH tightened its late application policy under NOT-OD-26-064, effective for due dates on or after May 25, 2026. Small business applications no longer receive the discretionary late submission window. Plan to submit early enough to resolve eRA Commons validation errors before the deadline, not after it.

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Practical planning guidance. Budget at least twelve weeks of lead time before your target due date, and more if your federal registrations are not already complete. SAM.gov, UEI, SBA Company Registry, eRA Commons, and Grants.gov registrations can take four to six weeks on their own and must be finished before you can submit anything. For a first-time applicant, expect 120 to 200 hours of total effort on a competitive submission.

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Who Is Eligible to Apply?

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Eligibility comes from the parent announcement, not from the topic. Applicants must be U.S. small business concerns that are:

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• Organized for profit with a place of business located in the United States

• At or below 500 employees, including affiliates

• More than 50 percent owned and controlled by U.S. citizens or permanent resident aliens, by qualifying U.S. entities, or by a combination

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For STTR, the company must also have a formal collaboration with a U.S. research institution, with at least 40 percent of the work performed by the small business and at least 30 percent by the research institution.

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Foreign organizations are not eligible, and foreign subawards and subcontracts are not permitted.

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Are There Restrictions I Should Know About?

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• Only U.S. small business concerns are eligible; foreign organizations are not.

• Applications involving foreign subawards or subcontracts will not be considered for funding. This is the single most important constraint to plan around given the topic's global framing.

• Your application must be relevant to at least one participating Institute or Center that awards grants. Five of the participating offices in this topic, OAR, OBSSR, ODP, ORWH, and THRO, do not.

• Clinical trials are not accepted by every Institute. Among the ICOs in this topic, NIAMS and NIDCR do not accept them under the SBIR parent announcement.

• Duplicate or highly overlapping applications submitted under multiple HHS announcements are not permitted.

• Companies must satisfy applicable SBA performance benchmark requirements, including the Phase I to Phase II transition rate benchmark and the Phase II commercialization rate benchmark for companies with substantial award histories.

• Additional national security, foreign relationship, and foreign ownership disclosure requirements apply and may result in denial of award. The 2026 reauthorization tightened foreign risk management and due diligence review, and this screening now sits inside the review critical path rather than beside it.

• Cost sharing is not required.

• Applying under a Highlighted Topic does not change referral or review, and does not guarantee that any funds have been set aside.

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What Kind of Application Is Likely to Win Here?

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NIH reviews small business applications on Significance, Investigators, Innovation, Approach, and Environment, with commercialization potential specifically evaluated for Phase II and Fast-Track. Within this topic, four things separate the competitive applications from the rest.

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One: you picked the right Institute, and you picked it before you started writing. Sixteen ICOs participating means sixteen possible framings of the same technology, and the framing determines which study section reviews you and which budget pays for you. A cardiometabolic risk tool assigned to NHLBI is a different application than the same tool assigned to NIDDK. Email the named contact, describe the technology in a paragraph, and ask directly whether it fits and which mechanism they would suggest. That conversation is free and it is the highest-return hour you will spend.

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Two: you actually addressed shared factors, not one disease. The intellectual center of this topic is that comorbidities in people with HIV intersect and share upstream drivers. An application that addresses a single condition in people with HIV is responsive to that Institute's general mission but not distinctively responsive to this topic. An application that shows how one intervention affects multiple outcomes through a shared mechanism is.

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Three: you took implementation seriously. NIH says outright that traditional disease-specific models insufficiently capture multilevel implementation determinants, and NIAMS goes further by prioritizing implementation science outright. For a company, this translates into concrete asks: who delivers this, in what clinic, paid for by whom, fitting into what workflow, sustained how after the grant ends. Applications that treat adoption as somebody else's problem read as naive here.

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Four: your team is genuinely multidisciplinary, and your community engagement is real. Multiple Program Directors and Principal Investigators with complementary expertise are strongly encouraged. Meaningful community engagement is strongly encouraged. Reviewers in this space are well practiced at spotting a letter of support from a community organization that has no role in the actual research plan.

Frequently Asked Questions

Is this a Notice of Funding Opportunity I can apply to directly?

No. This is an NIH Highlighted Topic, which is a published statement of scientific priority rather than a solicitation. There is no application package and no separate deadline. You apply through a broad NIH funding opportunity, and for small businesses that means the SBIR parent announcement PA-27-100 or the STTR parent announcement PA-27-102.

How much funding is available under this Highlighted Topic?

The topic itself carries no funding amount. Your budget is governed by the parent announcement you apply through: under standard guidelines, up to $323,090 for SBIR Phase I and up to $2,153,927 for Phase II, with several Institutes approved to exceed those caps. NHLBI and NIDA both state they may dedicate available funds to this topic area, subject to available funds, the number of meritorious applications, and competing priorities.

Does applying under this Highlighted Topic improve my chances?

Not in review. NIH states that applying in a Highlighted Topic area will not affect referral or review of applications. Three participating ICOs, NCCIH, NIDA, and NIDCR, state they may give special consideration to meritorious applications in this topic area, and two, NHLBI and NIDA, state they may dedicate funds. The real advantage is informational: sixteen ICOs have documented what they want and named the staff to call about it.

What are the deadlines?

The topic is open from July 28, 2026 through July 28, 2028. SBIR and STTR standard receipt dates are September 5, 2026, January 5, 2027, and April 5, 2027, with the cycle continuing while the topic remains active. Because September 5, 2026 falls on a Saturday before Labor Day, that cycle accepts submissions through Tuesday, September 8, 2026. All applications are due by 5:00 PM local time of the applicant organization.

Are there separate AIDS-specific due dates for HIV-related SBIR applications?

Not anymore. HHS eliminated dedicated AIDS and AIDS-related SBIR and STTR due dates for applications due on or after May 25, 2026. HIV-focused companies now submit on the standard small business schedule and compete within it.

Which NIH Institutes participate in this topic?

Sixteen ICOs: the Office of AIDS Research as lead, plus NCCIH, NCI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NICHD, NIDA, NIDCR, NIDDK, NIMH, OBSSR, ODP, ORWH, and THRO. Five of those, OAR, OBSSR, ODP, ORWH, and THRO, are offices that do not award grants, so your application must also be relevant to a participating Institute or Center that does.

Who is eligible to apply?

For-profit U.S. small business concerns with 500 or fewer employees including affiliates, more than 50 percent owned and controlled by U.S. citizens or permanent residents or by qualifying U.S. entities. Foreign organizations are not eligible, and foreign subawards and subcontracts are not permitted.

My work focuses on low and middle-income settings, which the topic specifically mentions. Can SBIR fund that?

Only with careful structuring. The topic references low and middle-income settings and HIV-exposed uninfected children in those settings, but the SBIR parent announcement prohibits foreign subawards and subcontracts. The funded research has to be performed domestically. Global relevance can be argued in the significance and commercialization sections; it cannot be delivered through an international subaward under this mechanism.

Can I run a clinical trial with this funding?

It depends on the Institute. Most participating ICOs with a direct clinical mission accept clinical trials, including NCI, NHLBI, NIA, NICHD, NIDA, NIMH, and NIDDK. NIAMS and NIDCR, both participating in this topic, do not accept clinical trials under the SBIR parent announcement. Confirm your target Institute's policy before designing the project.

Should I apply for SBIR or STTR?

SBIR if your company performs the majority of the research and your Principal Investigator is primarily employed by the company. STTR if the project depends on a formal collaboration with a university or nonprofit research institution. Given that this topic explicitly asks for multidisciplinary teams and community engagement, STTR is often the better structural fit, and STTR allows the Principal Investigator to be primarily employed by either the company or the research partner.

Where do I reference the Highlighted Topic in my application?

Unlike a Notice of Special Interest, a Highlighted Topic has no notice number to enter in the Agency Routing Identifier field. Make the alignment explicit in your cover letter and in your Specific Aims, and confirm handling with the program officer at your target Institute before you submit.

What does NIH mean by "shared factors" and why does it matter commercially?

NIH's point is that many comorbidities in people with HIV intersect and share risk factors before diverging into disease-specific trajectories, using metabolic syndrome raising diabetes, cardiovascular, and kidney disease risk as one example and coinfection-driven cancer risk as another. Commercially this is favorable, because a technology addressing an upstream shared factor has a larger addressable market and a stronger clinical value proposition than a single-indication tool, and it can be framed to fit several Institutes at once.

How long will it take me to prepare an application?

For a first-time applicant, expect 120 to 200 hours in total. Start at least twelve weeks before your target due date. Federal registrations across SAM.gov, UEI, SBA Company Registry, eRA Commons, and Grants.gov can take four to six weeks on their own and must be complete before submission.

What happens if I miss the deadline?

Nothing good. NIH tightened its late application policy for due dates on or after May 25, 2026, and small business applications no longer receive the discretionary late submission window. Build in time to fix validation errors before the deadline rather than after it.

Is this topic connected to a broader federal initiative?

Yes. NIH issued it as part of the Make America Healthy Again initiative, and the topic page names the specific MAHA workstreams it aligns with, including the NIH Chronic Disease Initiative, the Whole-Person-Health approach, prescribing patterns and mental health, Food for Health, nutrition and metabolic health, the oral health and systemic disease connection, the Gut Microbiome Research Initiative, longitudinal cohort research, clinical trial networks, and mental health and addiction research. Framing your significance section in that vocabulary is a low-cost, high-signal move.

How Can BW&CO Help?

BW&CO is a non-dilutive federal funding advisory firm. We have helped clients secure more than $350 million in federal funding, and we specialize in exactly the problem this topic creates: a broad scientific priority with sixteen possible sponsors, no dedicated money, and no obvious front door.

We can:

• Identify the right Institute and the right mechanism for your technology, Phase I, Phase II, Fast-Track, Direct to Phase II, Phase IIB, or CRP, and position you with the program officer who controls that budget.

• Triple your likelihood of success through proven strategy and insider-aligned proposal development.

• Reduce your time spent on the proposal by 50 to 80 percent, so your team stays focused on the technology and the company.

• Structure the research plan so that foreign collaboration, clinical trial sequencing, and registration timelines do not sink an otherwise fundable application.