ARPA-H STREAM Program: Funding, Deadline, and How to Apply

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

Quick Answer

The STREAM program (Systems for Tracking and Resilience in Efficient Agricultural-input Management) is an ARPA-H research initiative that funds breakthrough technology to control weeds while reducing herbicide exposure for farmers, farm workers, consumers, and the environment. Launched by the Department of Health and Human Services through ARPA-H on August 17, 2026, STREAM seeks solutions across four technical areas: next-generation herbicides and formulations, precision and nonchemical weed control, low-cost chemical monitoring, and methods to remove or degrade herbicides in soil and water. Applications are made as Solution Summaries through the Scalable Solutions Office Innovative Solutions Opening (ISO), notice ID ARPA-H-SOL-24-105, which is posted and maintained on SAM.gov. Solution Summaries that select STREAM are due no later than September 14, 2026 at 11:59 pm ET. STREAM is funded through Other Transactions rather than SBIR or STTR grants, so awards are negotiated per project and there is no fixed application dollar cap published in the announcement.

Program Overview

STREAM is ARPA-H's push to modernize American agriculture at the intersection of crop chemistry and human health. Herbicides keep food affordable, support regenerative farming, and help farmers stay productive, but some herbicides and their formulation ingredients can affect people, animals, fish, and pollinators. Farmers, farm workers, and consumers are exposed through food, water, soil, and air, while weeds grow more resistant and off-target runoff harms nearby habitats and rural communities. Alternatives have been sought for years without resolving the core tradeoff between efficacy, health, safety, ecological impact, soil dynamics, and cost.

STREAM aims to close that gap. The program funds safer alternative crop protection formulations, better monitoring of where herbicides travel, and practical ways to break down or remove agricultural chemicals before they reach consumers. If it succeeds, STREAM will lower the cumulative chemical burden on consumers and agricultural workers, protect the soil and water the food supply depends on, and give farmers economically viable alternatives to the products they rely on today.

The program is one piece of a broader interagency commitment. HHS, the U.S. Department of Agriculture, and the U.S. Environmental Protection Agency have pledged to invest more than one billion dollars in farm modernization and long-term food security, and STREAM advances that effort along with the federal push toward regenerative agriculture. That one billion dollar figure is the joint interagency envelope, not a single STREAM award pool, so applicants should not read it as a per-project budget.

What ARPA-H Is Looking For

STREAM is organized around four coordinated technical areas. A submission must address one or more of these areas to be considered, and ARPA-H encourages interdisciplinary teams drawn from agricultural and weed sciences, artificial intelligence and machine learning, advanced chemistry, drone development, sensing, and related fields.

Technical Area 1: Next-generation herbicides and formulations. Use artificial intelligence and machine learning to discover novel chemical compounds, biologically derived herbicides, and advanced biological treatments that selectively target weeds, including resistant species, while minimizing impacts on the surrounding ecosystem. The goal is efficacy against hard-to-kill weeds without the collateral health and environmental cost of current products.

Technical Area 2: Precision and nonchemical weed control. Advance cost-effective physical weed-control approaches such as laser ablation and miniature autonomous weeders, machine vision-guided targeted herbicide application, real-time drift modeling, and U.S.-manufactured drone-based precision application systems. The aim is to cut chemical inputs while keeping farms productive. Domestic manufacturing of the drone platforms is called out specifically.

Technical Area 3: Improved monitoring of herbicides and associated chemicals. Develop accurate, low-cost, continuous sensing technologies for compounds that are currently difficult and expensive to measure. Better sensing enables community-level monitoring and faster response when a problem appears, rather than waiting on slow or costly lab analysis.

Technical Area 4: Remove or degrade herbicides and associated chemicals. Create methods to rapidly break down agricultural chemicals in soil and water, intercept runoff before it reaches waterways, and reduce residues absorbed by crops. This is the cleanup and containment side of the program, ensuring chemicals are removed from the environment after they do their work.

ARPA-H funds revolutionary rather than incremental ideas, and its programs typically target early-stage technologies with a clear path to maturity. Teams that combine a bold technical concept with a credible plan to reach real-world deployment tend to fit the agency's model best.

Funding and Award Structure

There is an important structural point that startups should understand before applying. STREAM is not an SBIR or STTR opportunity. It runs through a Mission Office Innovative Solutions Opening, and ARPA-H primarily uses Other Transactions and cooperative agreements rather than traditional grants. Other Transactions are flexible business arrangements that let the government adopt commercial-style terms and negotiate scope, milestones, intellectual property, reporting, and payments on a per-award basis.

Because awards are negotiated, the STREAM announcement does not publish a fixed dollar ceiling for applications. For context, ARPA-H operates on an annual budget of roughly 1.5 billion dollars and has historically supported large, milestone-driven awards that can range from single millions to tens of millions of dollars per project, depending on scope. Your budget is built in the Cost Proposal that accompanies a full proposal, and it must reconcile with the milestones and level of effort you commit to.

A few cost-related details from the current ISO documents are worth noting when you plan your budget. Proposers must provide supporting documentation for planned materials and equipment purchases once the unit cost reaches ten thousand dollars, an increase from the prior five thousand dollar threshold. Profit or fee is treated as not applicable unless you specifically include it in the Cost Proposal Workbook. The ISO also defines burdened labor rate and fully burdened labor rate for clarity, and it notes that fully burdened labor rates are not used in the Cost Proposal Workbooks.

Eligibility

ARPA-H opportunities are open to a broad range of performers, including companies, small businesses, startups, universities, and nonprofit research organizations, and the agency encourages collaborative teams. STREAM specifically invites experts across agricultural science, artificial intelligence, chemistry, drones, and sensing to team up on its objectives.

Two eligibility constraints matter for planning. ARPA-H prioritizes awards to domestic recipients, and it cannot award funding to entities organized under the laws of a covered foreign country, which include Russia, Iran, North Korea, and China. Applicants should also be prepared to address organizational conflicts of interest, research security, human and animal subjects considerations where relevant, and biosecurity, since the ISO documents include disclosure requirements in each of these areas.

Timeline

The program was launched on August 17, 2026. Solution Summaries that select STREAM are due no later than September 14, 2026 at 11:59 pm ET. After you submit a Solution Summary, you should wait to hear back from ARPA-H with feedback before proceeding to a full proposal. Only summaries that receive encouragement move forward, which protects you from investing in a full proposal that is not aligned.

It helps to understand how STREAM sits inside the broader solicitation. STREAM submissions flow through the Scalable Solutions Office ISO, notice ID ARPA-H-SOL-24-105, which is a rolling solicitation that remains active on SAM.gov with a much later administrative closing date in 2029. STREAM itself carries the firm September 14, 2026 cutoff, so treat that as your working deadline regardless of the ISO's longer horizon.

How to Apply

STREAM applications are made through the Scalable Solutions Office ISO on SAM.gov, and the steps are as follows.

First, access the Scalable Solutions solicitation, notice ID ARPA-H-SOL-24-105, on SAM.gov. This solicitation and its attachments provide the full details on eligibility, submission requirements, evaluation criteria, contacts, and the link to apply.

Second, download all documents in the Attachment section, including the ISO document, the Solution Summary template (Appendix A), and the bundle of attachments. Follow the instructions in the ISO document and its associated files when preparing your Solution Summary.

Third, submit your Solution Summary using the link provided in the solicitation documents, at the ARPA-H Solutions site. When prompted, select STREAM from the Solution Summary dropdown list. A sign-in is required to submit, and your summary must be in by September 14, 2026 at 11:59 pm ET.

Fourth, await feedback. Do not begin a full proposal until you hear back from ARPA-H on your Solution Summary.

If you have questions about the opportunity, submit them through the Ask A Question form on the ARPA-H Solutions site, select STREAM from the dropdown, and note that a sign-in is required.

How BW&CO Consulting Supports STREAM Applicants

BW&CO Consulting helps deep-tech, biotech, MedTech, agtech, and dual-use founders pursue non-dilutive federal funding across ARPA-H, NIH, NSF, DoD, NASA, DOE, and other agencies. Because STREAM runs on an Other Transactions ISO rather than a conventional SBIR or STTR grant, it rewards a sharp technical narrative, a credible commercialization and manufacturing story, and a milestone plan that a program manager can act on quickly. If you are weighing a STREAM Solution Summary, we can assess fit against the four technical areas, shape the concept for the ARPA-H model, and prepare a competitive submission ahead of the September 14, 2026 deadline. Reach out to start a fit conversation.

Frequently Asked Questions

What is the ARPA-H STREAM program? STREAM, short for Systems for Tracking and Resilience in Efficient Agricultural-input Management, is an ARPA-H program that funds breakthrough technology to control weeds while reducing herbicide exposure for farmers, farm workers, consumers, and the environment. It was launched by HHS through ARPA-H on August 17, 2026.

Who runs STREAM and what agency funds it? STREAM is run by the Advanced Research Projects Agency for Health (ARPA-H), which sits within the U.S. Department of Health and Human Services. The program manager is James Coburn, CAPT.

When is the STREAM application deadline? Solution Summaries that select STREAM are due no later than September 14, 2026 at 11:59 pm ET.

How do I apply to STREAM? You apply by submitting a Solution Summary through the Scalable Solutions Office ISO, notice ID ARPA-H-SOL-24-105, which is posted on SAM.gov. Download the solicitation attachments, prepare your Solution Summary using the provided template, submit it at the ARPA-H Solutions site, and select STREAM from the dropdown.

What are the four STREAM technical areas? The four technical areas are next-generation herbicides and formulations, precision and nonchemical weed control, improved low-cost monitoring of herbicides and associated chemicals, and methods to remove or degrade those chemicals in soil and water. A submission must address at least one of these areas.

How much funding does STREAM provide? STREAM does not publish a fixed award ceiling in its announcement because awards are negotiated per project through Other Transactions. For context, ARPA-H typically supports milestone-driven awards ranging from single millions to tens of millions of dollars, and STREAM advances a broader interagency commitment of more than one billion dollars in farm modernization shared across HHS, USDA, and EPA.

Is STREAM an SBIR or STTR opportunity? No. STREAM is offered through a Mission Office Innovative Solutions Opening and uses Other Transactions and cooperative agreements, not SBIR or STTR grants. This means the application pathway, budgeting, and terms differ from a standard SBIR solicitation.

What funding mechanism does ARPA-H use? ARPA-H primarily uses Other Transactions and cooperative agreements. Other Transactions are flexible, commercial-style agreements that allow scope, milestones, intellectual property, reporting, and payment terms to be negotiated on a per-award basis.

Who is eligible to apply for STREAM? Eligibility is broad and includes companies, startups, small businesses, universities, and nonprofit research organizations, and teaming is encouraged. ARPA-H prioritizes domestic recipients and cannot award funding to entities organized under the laws of a covered foreign country, including Russia, Iran, North Korea, and China.

Can startups and small businesses apply? Yes. Startups and small businesses can apply and are well suited to STREAM's emphasis on bold, early-stage technology, provided they can present a credible technical concept and a plan to reach real-world deployment.

What is a Solution Summary? A Solution Summary is a short initial submission that describes your proposed solution against the program objectives. ARPA-H reviews it and provides feedback before inviting a full proposal, which saves applicants from investing in a full proposal that is not aligned.

What happens after I submit a Solution Summary? After you submit, you wait for feedback from ARPA-H. You should not begin a full proposal until you have heard back, and only encouraged summaries advance to the full proposal stage.

Where do I submit my STREAM application? Solution Summaries are submitted at the ARPA-H Solutions site using the link in the solicitation documents, with STREAM selected from the dropdown. The underlying solicitation, ARPA-H-SOL-24-105, is accessed and downloaded from SAM.gov, and questions go through the Ask A Question form on the same ARPA-H Solutions site.

NIH SBIR Bioethics Research Funding for Startups: 2026 Guide

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

Quick Answer

The NIH Highlighted Topic "Strengthening Biomedical Research, Promoting Trust, and Improving Health through Bioethics Research" invites small businesses to develop actionable bioethics tools and approaches across artificial intelligence, research engagement, informed consent, and return of research results. This is not a standalone funding opportunity. It is a Highlighted Topic, which means you apply through the NIH, CDC and FDA Parent SBIR announcement (PA-27-100) or, if you are partnering with a university or other nonprofit, the Parent STTR announcement (PA-27-102). The topic is active from August 14, 2026 through January 12, 2028. Standard NIH SBIR due dates are September 5, 2026 (adjusted to September 8, 2026), January 5, 2027, and April 5, 2027. Phase I funding runs up to the current SBA guideline of about $323,090, with several participating Institutes offering waivers of $400,000 or $700,000. Phase II funding runs up to about $2,153,927 under the SBA guideline, with several Institutes offering waivers of $2.5 million or $3 million.

What Is the NIH Bioethics Research Highlighted Topic?

The Highlighted Topic is an area of science that NIH has flagged as a priority for its participating Institutes, Centers, and Offices. It signals to investigators that if they build a competitive application in this space, multiple NIH components are interested in funding it. A Highlighted Topic is not a Notice of Funding Opportunity. There is no separate application package, no dedicated funding number, and no set-aside budget attached to the topic itself. Instead, NIH directs you to submit through a broad parent announcement and to make your project relevant to at least one participating Institute or Center that awards grants.

For a small business, the practical path is the Parent SBIR announcement PA-27-100. If your project depends on a formal collaboration with a nonprofit research institution such as a university, the correct vehicle is the Parent STTR announcement PA-27-102. In both programs the award goes to the small business, and both are strong fits for bioethics work because much of the field's expertise sits inside academic centers.

The topic was posted on August 14, 2026 and expires January 12, 2028. Because that window spans more than a year, you can target any of the standard SBIR due dates that fall inside it, applying through whichever parent SBIR announcement is current at your chosen deadline.

How Do You Apply for This Bioethics Topic?

You apply by submitting an SBIR application to PA-27-100 (or an STTR application to PA-27-102) and making your project responsive to the bioethics areas of interest for at least one participating Institute or Center. You do not apply to the Highlighted Topic directly.

A few practical points shape a competitive submission. First, NIH's Center for Scientific Review assigns every application to the most appropriate Institute, so you are not required to name an awarding component in advance. You may request an assignment on the PHS Assignment Request Form, and you are strongly encouraged to contact program staff at the Institute you believe is the best fit before you apply. Second, several of the offices listed in the topic, including the Office of Science Policy, the Office of AIDS Research, the Office of Behavioral and Social Sciences Research, and the Office of Data Science Strategy, do not award grants. Your application must map to an Institute or Center that does. Third, because SBIR is a commercialization program, your bioethics work needs a product or service with commercial potential, not a purely academic study. More on that below.

What Kind of Research Is NIH Looking For?

The purpose of this topic is to advance bioethics research projects that are actionable, that build trust, and that improve how bioethical principles are integrated into biomedical and behavioral research. NIH wants work that strengthens science so that research generates evidence-based products communities will adopt more readily. The specific areas of interest fall into five buckets.

Artificial intelligence. NIH is interested in access to and use of AI models and algorithms, maximizing the generalizability of AI, strategies for AI transparency and data privacy, and the integration of digital health research. This is one of the most naturally commercializable areas for a startup, covering audit and transparency tooling, bias and generalizability testing, and privacy-preserving infrastructure.

Research engagement. NIH is interested in approaches for effective community engagement, co-developing research priorities with communities, building and sustaining research trustworthiness, and improving recruitment and access to clinical trials. Platforms and methods that make engagement measurable and repeatable are a fit here.

Informed consent. NIH is interested in strategies and structures for facilitating transparency and autonomy, community approaches to consenting for population-level public health research, and novel forms of consent, including consent for research use of electronic health records, wearables, linked data, and public health data. Consent management systems and dynamic consent tooling map directly to this area.

Return of research results. NIH is interested in approaches for returning aggregate and individual research results, strategies for communicating findings in ways that support health decision-making, and considerations for populations with unique needs or decision-making circumstances. Communication tools and result-delivery systems fit here.

Other cross-cutting issues. NIH also flags data access and sharing, biosafety and biosecurity, and emerging and novel technologies.

Individual Institutes layer their own priorities on top of these buckets. The National Human Genome Research Institute is focused on ethical, legal, and social implications of genetics and genomics. The National Institute of Biomedical Imaging and Bioengineering is focused on ethics across the technology development continuum, including AI and machine learning, point-of-care technologies, and re-identifiability risks from imaging data. The National Institute on Aging is focused on autonomy, consent tailored to older adults, and the ethical use of AI in aging populations. The National Institute on Drug Abuse is focused on return of results, stigma reduction, and vulnerable-population protections. The BRAIN Initiative, the National Institute of Neurological Disorders and Stroke, and the National Eye Institute each bring neurotechnology, neuroimaging, and vision-specific angles. Aligning your project to a specific Institute's stated priorities, rather than to the topic in general, is what separates a fundable application from a vague one.

Which NIH Institutes and Centers Participate?

The Institutes and Centers that award grants under this topic include the National Cancer Institute, the National Eye Institute, the National Human Genome Research Institute, the National Heart, Lung, and Blood Institute, the National Institute on Aging, the National Institute on Alcohol Abuse and Alcoholism, the National Institute of Allergy and Infectious Diseases, the National Institute of Biomedical Imaging and Bioengineering, the National Institute on Drug Abuse, the National Institute on Deafness and Other Communication Disorders, the National Institute of Dental and Craniofacial Research, the National Institute of Environmental Health Sciences, the National Institute of Mental Health, the National Institute of Neurological Disorders and Stroke, and the National Institute of Nursing Research. The BRAIN Initiative also participates, funding through its associated Institutes.

Several offices are interested in the topic but do not award grants, including the Office of Science Policy, the Office of AIDS Research, the Office of Behavioral and Social Sciences Research, and the Office of Data Science Strategy. Applications relevant to these offices must still be assigned to and funded by one of the participating grant-making Institutes or Centers.

How Much Funding Can a Startup Receive?

Funding depends on which Institute your application is assigned to, because budgets vary across NIH components. The default ceiling is the current SBA guideline, which NIH lists at about $323,090 in total costs for Phase I and about $2,153,927 for Phase II. Those figures include direct costs, indirect costs, and fee, and the SBA adjusts them annually, so confirm the current number on the NIH SEED website before you build your budget.

Many Institutes have secured waivers to exceed the SBA guideline. Among the components participating in this bioethics topic, the following Phase I ceilings apply. The National Cancer Institute, the National Institute on Aging, the National Institute of Allergy and Infectious Diseases, the National Institute of Mental Health, and the National Institute of Neurological Disorders and Stroke offer Phase I budgets up to $700,000. The National Heart, Lung, and Blood Institute, the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse, the National Institute on Deafness and Other Communication Disorders, and the National Institute of Nursing Research offer Phase I budgets up to $400,000. The National Eye Institute and the National Human Genome Research Institute set Phase I at $400,000. The National Institute of Biomedical Imaging and Bioengineering, the National Institute of Dental and Craniofacial Research, and the National Institute of Environmental Health Sciences follow the standard SBA guideline for Phase I.

On the Phase II side, the National Heart, Lung, and Blood Institute, the National Institute on Aging, the National Institute of Allergy and Infectious Diseases, the National Institute on Drug Abuse, the National Institute on Deafness and Other Communication Disorders, the National Institute of Mental Health, and the National Institute of Neurological Disorders and Stroke offer Phase II budgets up to $3 million. The National Cancer Institute, the National Institute on Alcohol Abuse and Alcoholism, and the National Institute of Nursing Research offer Phase II budgets up to $2.5 million. The National Eye Institute, the National Human Genome Research Institute, the National Institute of Biomedical Imaging and Bioengineering, the National Institute of Dental and Craniofacial Research, and the National Institute of Environmental Health Sciences follow the standard SBA guideline for Phase II.

In every case, NIH expects a budget that is reasonable and appropriate for the work, not a number anchored to the ceiling. Requests at or near a hard cap should be well justified. If you intend to request more than the SBA guideline, contact the participating Institute early in your planning process.

What Is the Timeline and What Are the Deadlines?

The Parent SBIR announcement opened for submissions on August 5, 2026. Its standard due dates are September 5, 2026, January 5, 2027, and April 5, 2027, each at 5:00 PM local time of the applicant organization. When a due date falls on a weekend or federal holiday, NIH automatically rolls it to the next business day. September 5, 2026 is a Saturday and September 7 is Labor Day, so the effective first deadline is Tuesday, September 8, 2026. The Parent SBIR announcement PA-27-100 itself expires April 6, 2027, and NIH typically reissues its parent announcements, so applicants targeting later cycles should apply through whichever parent SBIR is current at that time.

The review path is predictable. An application submitted for the September 2026 cycle receives scientific merit review in November 2026, advisory council review in January 2027, and an earliest possible start date of April 2027. A January 2027 submission maps to March 2027 review, May 2027 council, and a July 2027 earliest start. Build backward from your target start date, and remember that no late applications are accepted for this announcement.

Project periods are constrained by statute. Phase I awards normally may not exceed 6 months, and Phase II awards normally may not exceed 2 years. NIH also offers two accelerated paths that only apply to NIH components: Fast-Track, which submits and reviews Phase I and Phase II together to reduce the funding gap, and Direct to Phase II, for companies that have already demonstrated feasibility but never received a Phase I for that project.

Who Is Eligible to Apply?

Only United States small business concerns are eligible. To qualify, your company must be organized for profit with a place of business in the United States, must operate primarily in the United States or make a significant contribution to the US economy, and must have no more than 500 employees including affiliates. Ownership must satisfy one of the allowed structures: more than 50 percent directly owned and controlled by US citizens or permanent residents, or majority owned by multiple venture capital operating companies, hedge funds, or private equity firms under the specific limits in the announcement, where no single such firm owns more than 50 percent unless it independently qualifies as a small business.

The Program Director or Principal Investigator must be primarily employed by the small business at the time of award and during the project. For projects with multiple PDs or PIs, at least one must meet this primary employment requirement.

The work-share rules also matter. In SBIR Phase I, the small business normally performs at least two-thirds, or 67 percent, of the research or analytical effort. In SBIR Phase II, the small business normally performs at least one-half, or 50 percent. Consultant and contractual arrangements to third parties are generally capped at the remaining share. If your bioethics project leans heavily on academic collaborators, the STTR announcement PA-27-102 may be the better structural fit, since it allows a nonprofit partner to perform a larger share.

What Registrations Do You Need Before Applying?

You must complete and maintain several registrations before you can submit, and they can take six weeks or more in total, so start immediately. You need an active System for Award Management registration, which issues your Unique Entity Identifier and a CAGE Code. You need to register in the SBA Company Registry, which requires your UEI first. You need an eRA Commons account for your organization, with at least one Signing Official and one Program Director or Principal Investigator, and obtaining an account can take up to two weeks. You need a Grants.gov registration, which depends on an active SAM registration. Every PD or PI must also have an eRA Commons ID and must link a valid ORCID iD to their eRA Commons profile. Failure to complete registrations on time is not an accepted reason for a late submission.

What Are the Key Compliance and Foreign Risk Rules?

Two areas deserve early attention. The first is foreign involvement. Non-US entities and non-US components of US organizations are not eligible to apply. NIH will not issue awards that involve foreign subawards or subcontracts under this announcement, and any application that includes them will be deemed noncompliant and will not be funded. Unfunded international collaborations, funding for foreign consultants, and procurement of unique equipment or supplies from foreign vendors may still be allowed.

The second is foreign risk disclosure and security review. Applicants under consideration for award must submit the SBA Required Disclosures of Foreign Affiliations or Relationships to Foreign Countries form during the just-in-time process, covering all owners and covered individuals. HHS cannot make an award if the company has an owner or covered individual party to a malign foreign talent recruitment program, a parent company or subsidiary located in the People's Republic of China or another country of concern, or other disqualifying ties described in the announcement. NIH, CDC, and FDA will not provide an opportunity to cure an identified security risk before award, though a denial on security grounds does not bar the company from applying in a later cycle.

A few additional terms are worth knowing. This announcement is clinical trial optional, but some Institutes do not accept clinical trials, so confirm your target component accepts your study design. SBIR recipients may retain data rights for up to 20 years after the award date. Cost sharing is not required.

How Should a Startup Frame a Bioethics Project for SBIR?

This is the point most applicants miss. SBIR is a commercialization program, not a research grant program in the traditional academic sense. Reviewers score significance, investigators, innovation, approach, and environment, and for Phase II and Fast-Track they weigh a Commercialization Plan heavily. A bioethics project that reads like a scholarly study will struggle. A bioethics project framed as a product or service with a clear market, clear customers, and a clear path to revenue will compete.

The most commercializable angles in this topic are the ones that produce software, tooling, or repeatable methods. Examples include AI transparency, audit, and generalizability testing tools; privacy-preserving data infrastructure and de-identification systems; dynamic and electronic consent management platforms, including consent for wearables, EHR data, and linked datasets; community engagement platforms that make trust-building measurable; and return-of-results communication systems tailored to specific populations. If you can name the customer who would pay for your solution and explain how it solves a demonstrated need, you have the spine of a competitive application. If you cannot, the project may be better suited to a non-SBIR mechanism.

How BW&CO Helps

BW&CO helps deep-tech, health, and AI founders match their technology to the right NIH Institute, choose between the SBIR and STTR routes, structure a fundable budget within the correct ceiling, and build the commercialization narrative that NIH reviewers reward. If you are evaluating whether your product fits this bioethics topic, or which of the participating Institutes is the strongest home for your work, we can help you make that call before you invest in a full application.

Frequently Asked Questions

Is the NIH Bioethics Research topic a funding opportunity you can apply to directly?

No. It is a Highlighted Topic, not a Notice of Funding Opportunity. There is no separate application package or funding number. You apply through the NIH Parent SBIR announcement PA-27-100, or the Parent STTR announcement PA-27-102 if you are partnering with a nonprofit research institution, and you make your project responsive to at least one participating Institute or Center.

What is the deadline to apply?

The standard NIH SBIR due dates are September 5, 2026, January 5, 2027, and April 5, 2027, at 5:00 PM local time of the applicant organization. Because September 5, 2026 is a Saturday and September 7 is Labor Day, the effective first deadline is September 8, 2026. The Highlighted Topic remains active through January 12, 2028.

How much SBIR funding can my startup receive?

Phase I runs up to the current SBA guideline of about $323,090, with several participating Institutes offering waivers of $400,000 or $700,000. Phase II runs up to about $2,153,927 under the SBA guideline, with several Institutes offering waivers of $2.5 million or $3 million. The exact ceiling depends on which Institute your application is assigned to.

Who is eligible to apply?

United States small business concerns that are for-profit, have no more than 500 employees including affiliates, meet the ownership rules, and whose Program Director or Principal Investigator is primarily employed by the company at the time of award.

Can universities apply for this topic?

No. The award goes to the small business. A university can participate as a partner through the STTR announcement PA-27-102, or as a subaward or consultant within the SBIR work-share limits, which allow up to about one-third of the effort to third parties in Phase I and up to about one-half in Phase II.

Does my bioethics project need a commercial product?

Yes. SBIR is a commercialization program, so your project needs a product or service with commercial potential and a credible path to market. The strongest fits produce software, tooling, or repeatable methods, such as AI transparency tools, consent management platforms, or return-of-results communication systems.

Which NIH Institutes fund this topic?

Participating grant-making components include NCI, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIBIB, NIDA, NIDCD, NIDCR, NIEHS, NIMH, NINDS, and NINR, along with the BRAIN Initiative. Several offices are interested but do not award grants, so applications must be assigned to a grant-making Institute or Center.

Do I need to pick an Institute before I apply?

No. NIH's Center for Scientific Review assigns your application to the most appropriate component. You may request an assignment on the PHS Assignment Request Form, and you are strongly encouraged to contact program staff at your target Institute before submitting.

How long does registration take?

Plan for six weeks or more. You need active registrations in SAM, the SBA Company Registry, eRA Commons, and Grants.gov, and each PD or PI needs an eRA Commons ID linked to an ORCID iD. Late registration is not an accepted reason for a late submission.

Can foreign companies or foreign subawards be involved?

No. Only US small business concerns are eligible, and applications that include foreign subawards or subcontracts are deemed noncompliant and will not be funded. Unfunded international collaborations, foreign consultants, and procurement of unique equipment or supplies from foreign vendors may still be permitted.

NIH Connectedness Interventions SBIR Funding: A Guide for Startups

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

Quick Answer

The NIH Highlighted Topic on Interventions to Promote Health by Fostering Connectedness invites small businesses to develop and test interventions that improve health by strengthening people's connections to others, communities, culture, activities, and nature. It is part of the federal Make America Healthy Again (MAHA) Chronic Disease Initiative and its Whole-Person-Health approach. This topic is not a standalone funding announcement. Startups pursue funding through the NIH, CDC, and FDA Parent SBIR announcement PA-27-100 (R43/R44, Clinical Trial Optional). The topic is active from August 11, 2026 through August 11, 2028. Standard SBIR due dates fall on September 5, January 5, and April 5 of each cycle, and Phase I awards can range from roughly 400,000 dollars to 700,000 dollars depending on the funding Institute.

What Is the NIH Connectedness Interventions Highlighted Topic?

A Highlighted Topic is a signal from NIH about an area of science that its Institutes, Centers, and Offices want to fund. It tells applicants where the agency's scientific interest and money are pointed. It is not a Notice of Funding Opportunity, so there is no separate application form tied to the topic itself.

This particular topic, Interventions to Promote Health by Fostering Connectedness, encourages rigorous research that evaluates connectedness interventions to improve health or reduce risk factors for chronic disease. The scientific premise is that social isolation, loneliness, and poor mental health have risen alongside a widespread chronic disease crisis, and that stronger connections to people, culture, and activities can improve both mental and physical health. Epidemiological evidence links greater social connectedness to improved behavioral, cognitive, cardiovascular, and immune health, and to lower all-cause mortality.

The topic sits inside the Make America Healthy Again initiative and aligns with the NIH MAHA Chronic Disease Initiative, which promotes a Whole-Person-Health approach to chronic disease prevention. It also connects to current federal attention on social prescribing, the 2026 Surgeon General's Warning on the Harms of Screen Use, and the 2026 MAHA ELEVATE initiative for older Medicare recipients.

Which Funding Announcement Do I Actually Apply Through?

You apply through the NIH, CDC, and FDA Parent SBIR announcement, PA-27-100, titled the NIH, CDC and FDA Small Business Innovation Research Grant (Parent SBIR R43/R44 Clinical Trial Optional). This is the application vehicle for the connectedness topic.

When you submit, you do not need to name a specific Institute, but you are encouraged to identify the Institute or Center whose mission best matches your work and to contact its program staff before applying. NIH's Center for Scientific Review assigns each application to the most appropriate participating component.

A few companion announcements matter depending on your project:

• PA-27-100 is the SBIR route (R43 Phase I, R44 Phase II), where the small business does most of the work.

• PA-27-102 is the STTR route (R41 Phase I, R42 Phase II), used when your project depends on a formal collaboration with a nonprofit research institution such as a university. Connectedness research often involves academic or clinical partners, so the STTR route is worth evaluating.

• PA-27-101 is the standalone SBIR Phase II announcement, including Phase IIB Strategic Breakthrough applications.

• PAR-27-098 is the SB1 Commercialization Readiness Program.

If PA-27-100 expires before you are ready to apply, use whichever Parent SBIR announcement is active at that time. The connectedness topic remains valid through August 11, 2028, while PA-27-100 itself carries an expiration date of April 6, 2027 and is expected to be reissued.

Is My Startup Eligible?

To apply, your company must be a United States small business concern that meets all of the following at the time of a Phase I or Phase II award:

• Organized for profit with a place of business in the United States.

• No more than 500 employees, including affiliates.

• More than 50 percent directly owned and controlled by United States citizens or permanent residents, or by other qualifying United States small businesses, or majority owned by multiple venture capital operating companies, hedge funds, or private equity firms (with the condition that no single such firm owns more than 50 percent unless it independently qualifies as a United States owned small business).

For SBIR awards, the Program Director or Principal Investigator must be primarily employed by the small business at the time of award and during the project. In projects with multiple PIs, at least one must meet this employment requirement. If you take the STTR route instead, the PI may be primarily employed by either the small business or the nonprofit research partner.

Non United States entities are not eligible, and NIH will not issue awards that involve foreign subawards or subcontracts under this announcement. Unfunded international collaborations, funding for foreign consultants, or procurement of unique supplies from foreign vendors may still be allowed.

What Registrations Do I Need, and How Long Do They Take?

Plan for registration to take six weeks or more, and start early, because a late registration is never accepted as an excuse for a missed deadline. You need active registrations in:

• System for Award Management (SAM), which includes a Commercial and Government Entity (CAGE) Code and a Unique Entity Identifier (UEI).

• SBA Company Registry.

• eRA Commons, with at least one Signing Official and at least one PI account.

• Grants.gov.

Each PI must have an eRA Commons ID and a linked ORCID iD. The same UEI must be used across all systems and on the application.

What Kind of Projects Is NIH Looking For?

Connectedness can take many forms, including connections with people, communities, history, traditions, hobbies, sports, the arts, or nature. Interventions may be tested as adjuncts to healthcare or as stand-alone interventions in non-medical settings.

NIH strongly encourages projects that:

• Specify a clear conceptual model that identifies the hypothesized pathways between connectedness and health outcomes.

• Use validated measures of connectedness and health outcomes wherever possible, such as those in the PhenX Toolkit.

• Address the multi-level factors that make connections possible and sustainable, for example providing transportation so urban youth can reach existing green spaces.

• Involve collaboration with organizations that can actually implement or deliver the intervention if it proves effective.

• Include a rigorous, sufficiently powered study design that accounts for the expected correlation of outcomes within clusters such as families, schools, clinics, or neighborhoods.

For a startup, the practical takeaway is that a competitive application pairs a strong commercial concept with a real conceptual model, validated measurement, a credible delivery partner, and a study design that will hold up under peer review.

Which NIH Institutes and Centers Are Funding This Topic?

Several Institutes and Centers participate, each with its own angle. Matching your intervention to the right one improves your odds. Your application must be relevant to at least one of the awarding Institutes or Centers below. Two offices, the Office of Disease Prevention (ODP) and the Office of Behavioral and Social Sciences Research (OBSSR), signal interest but do not award grants themselves.

• National Center for Complementary and Integrative Health (NCCIH): mind and body approaches that promote mental, emotional, and behavioral health, using feasibility, hybrid effectiveness-implementation, mechanistic, pragmatic, or community-based designs, including health information technology and partnerships with schools, health systems, and justice systems.

• National Cancer Institute (NCI): connectedness and cancer control outcomes, including risk behaviors, screening, treatment decision-making, symptom management, and patient and caregiver health, plus the effect of the online and social media environment on connectedness.

• National Eye Institute (NEI): the intersection of visual impairment, social isolation, and wellness, including accessibility technologies and care-delivery models for people experiencing vision loss.

• National Institute on Aging (NIA): how connectedness affects the physical, cognitive, social, and emotional health of people in midlife and older adulthood, including isolation among older adults aging in place, kinless individuals, and dementia caregivers, and the role of the built environment.

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): the role of connectedness in preventing and treating alcohol misuse and alcohol use disorder across the lifespan, including screening, brief interventions, and recovery outcomes.

• National Institute on Drug Abuse (NIDA): social connectedness and loneliness as levers to prevent or treat substance use disorders and support recovery, with strong emphasis on stakeholder engagement.

• National Institute of Mental Health (NIMH): connectedness and risk for mental illness, social prescribing including digital approaches, and connectedness among people living with HIV.

• National Institute on Minority Health and Health Disparities (NIMHD): community-engaged connectedness interventions that improve health and reduce risk among populations experiencing health disparities.

• National Institute of Nursing Research (NINR): interventions that promote mental well-being through social, cultural, or environmental connectedness, including school-based settings and the use of artificial intelligence in healthcare settings.

How Much Funding Can My Startup Receive?

Budget ceilings vary by Institute. Phase I supports a feasibility study and normally runs up to six months. Phase II continues research and development toward commercialization and normally runs up to two years. Total funding support includes direct costs, indirect costs, and fee.

For the Institutes participating in this topic, the Phase I and Phase II guidelines are:

• National Cancer Institute: Phase I up to 700,000 dollars, Phase II up to 2,500,000 dollars.

• National Institute on Aging: Phase I up to 700,000 dollars, Phase II up to 3,000,000 dollars.

• National Institute of Mental Health: Phase I up to 700,000 dollars, Phase II up to 3,000,000 dollars.

• National Center for Complementary and Integrative Health: Phase I up to 700,000 dollars, Phase II follows the SBA guideline.

• National Institute on Drug Abuse: Phase I up to 400,000 dollars, Phase II up to 3,000,000 dollars.

• National Institute on Alcohol Abuse and Alcoholism: Phase I up to 400,000 dollars, Phase II up to 2,500,000 dollars.

• National Institute of Nursing Research: Phase I up to 400,000 dollars, Phase II up to 2,500,000 dollars.

• National Eye Institute: Phase I up to 400,000 dollars, Phase II follows the SBA guideline.

• National Institute on Minority Health and Health Disparities: both phases follow the SBA guideline.

Where an Institute follows the SBA guideline, the ceiling is the standard SBA hard cap, which the Small Business Administration adjusts annually, so confirm the current figure before you budget. In all cases, propose a budget that is reasonable for the work. If you need to request more than the SBA guideline, contact the relevant Institute early, since some Institutes can exceed standard amounts for approved topics.

What Is the Timeline and What Are the Deadlines?

PA-27-100 was posted on May 28, 2026, with an earliest submission date of August 5, 2026. The standard application due dates are:

• September 5, 2026, with scientific merit review around November 2026, advisory council review around January 2027, and earliest start around April 2027.

• January 5, 2027, with review around March 2027, council around May 2027, and earliest start around July 2027.

• April 5, 2027, with review around July 2027, council around August 2027, and earliest start around December 2027.

All 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 to the next business day. No late applications are accepted.

Two expiration dates matter. The Parent SBIR announcement PA-27-100 expires April 6, 2027, and the connectedness Highlighted Topic expires August 11, 2028. If you apply after PA-27-100 expires, use the active Parent SBIR announcement at that time and align your project with the connectedness topic while it remains open.

What Are the SBIR Phases, and Which One Fits My Startup?

• Phase I establishes the technical merit and feasibility of your idea. It is the entry point for most companies.

• Phase II continues research and development to advance toward commercialization, and is submitted as a renewal of your Phase I project.

• Direct to Phase II (NIH only) is available if you have already demonstrated feasibility but never held a Phase I SBIR or STTR for that project.

• Fast-Track (NIH only) lets you submit and review Phase I and Phase II together to reduce the funding gap between them.

After Phase II, NIH expects you to fully commercialize the product using non-SBIR and non-STTR funds, whether federal or private.

How Is the Research Effort Split Between My Company and Partners?

In Phase I, the small business normally performs at least two-thirds (67 percent) of the research or analytical effort, and outside consultants and contracts generally account for no more than 33 percent of the total. In Phase II, the small business normally performs at least half (50 percent), with outside arrangements generally capped at 50 percent. Deviations can be considered case by case with written approval. If a formal university or nonprofit collaboration is central to your project, the STTR route under PA-27-102 may fit better.

Do Clinical Trials Fit This Topic?

PA-27-100 is Clinical Trial Optional, meaning it accepts applications that do or do not propose clinical trials. Many connectedness interventions will involve a clinical trial. The Institutes participating in this topic accept clinical trials, so a well-designed trial is on the table. If you propose one, you must include a two-page Regulatory Plan attachment, and you may not submit that attachment if your project does not include a clinical trial.

What Do Reviewers Evaluate?

Peer reviewers score five criteria and combine them into an overall impact score:

• Significance: does the product or service address an important problem or unmet need, and does it have commercial potential.

• Investigators: are the team and any partners suited to complete and eventually commercialize the work.

• Innovation: does the solution shift current practice and hold a real competitive advantage.

• Approach: are the aims, methods, milestones, and study design sound and appropriate for the stage.

• Environment: does the business and scientific environment support success and commercialization.

For Phase II and Fast-Track applications, reviewers also weigh a Commercialization Plan covering the market opportunity, barriers such as regulatory approval and reimbursement, a funding path, the management team, and how the project differs from or complements existing private-sector activity.

What Restrictions Should I Know About?

• Foreign entities are not eligible, and foreign subawards or subcontracts make an application non-compliant under this announcement.

• Applicants under consideration for award must complete foreign relationship disclosures during the Just-in-Time process, and awards can be denied for defined national security risks with no opportunity to cure before award.

• Applications may not simultaneously duplicate the same research focus across multiple HHS opportunities.

• SBIR recipients may retain rights to data generated under the award for up to 20 years.

How BW&CO Helps

BW&CO helps deep-tech and health-focused founders decide whether the SBIR or STTR route fits, identify the right Institute and program contact, sharpen the conceptual model and study design that reviewers reward, and build a Commercialization Plan that holds up under scrutiny. If you are weighing a connectedness intervention against the September or January cycle, the earlier we start, the more room you have to register, refine, and position the application.

Frequently Asked Questions

Is the connectedness Highlighted Topic a grant I can apply to directly? No. It is a statement of NIH scientific interest, not a Notice of Funding Opportunity. You apply through the Parent SBIR announcement PA-27-100 and align your project with the topic.

What is the funding announcement number I should use? PA-27-100 for SBIR, or PA-27-102 for STTR if your project depends on a formal nonprofit or university collaboration.

When are applications due? Standard due dates are September 5, 2026, January 5, 2027, and April 5, 2027, all by 5:00 PM local time of the applicant organization.

How much money can a startup receive? Phase I generally ranges from 400,000 dollars to 700,000 dollars and Phase II from about 2,500,000 dollars to 3,000,000 dollars, depending on the funding Institute. Some Institutes follow the standard SBA hard cap, which adjusts annually.

Who is eligible? United States small business concerns with 500 or fewer employees that meet the ownership rules, with a PI primarily employed by the small business for SBIR awards.

Which Institutes fund this topic? NCCIH, NCI, NEI, NIA, NIAAA, NIDA, NIMH, NIMHD, and NINR award grants for this topic. ODP and OBSSR signal interest but do not award grants.

Can I propose a clinical trial? Yes. PA-27-100 is Clinical Trial Optional, and the participating Institutes accept clinical trials. Clinical trial applications must include a Regulatory Plan attachment.

How long do registrations take? Six weeks or more. Complete SAM, UEI, SBA Company Registry, eRA Commons, and Grants.gov well ahead of your target due date.

What is the difference between SBIR and STTR here? SBIR (PA-27-100) requires the small business to perform most of the work. STTR (PA-27-102) is built around a formal collaboration with a nonprofit research institution and allows the PI to be employed by either the company or the partner.

How long is the topic open? The Highlighted Topic is active from August 11, 2026 through August 11, 2028. Apply through whichever Parent SBIR announcement is active at your time of submission.

NIH SBIR Funding for Time-Sensitive Environmental Health and Disaster Research: What Startups Need to Know

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

Quick Answer

NIH has flagged time-sensitive environmental health research as a current priority through a Highlighted Topic titled "Time-Sensitive Research Opportunities in Environmental Health Sciences" (posted August 10, 2026, active through August 10, 2028). This topic is not itself a funding opportunity, so small businesses cannot apply to it directly. Instead, a U.S. small business applies through the NIH Parent SBIR announcement, PA-27-100, and writes its research aims to match what the topic describes: capturing exposure and health data during the narrow window that follows a disaster or an emerging environmental threat. The next Parent SBIR deadline is September 5, 2026, which falls on a Saturday ahead of Labor Day and therefore moves to Tuesday, September 8, 2026. Phase I awards run up to roughly $323,090 and Phase II awards up to roughly $2,153,927 under current SBA guidelines, with several participating institutes offering higher caps.

What is the "Time-Sensitive Research Opportunities in Environmental Health Sciences" topic?

It is an NIH Highlighted Topic, which is a signal from a group of NIH Institutes, Centers, and Offices that they want to receive applications in a specific area of science. It is not a Notice of Funding Opportunity (NOFO), and it does not have its own application package, budget, or deadline. NIH is explicit on this point: applicants pursue the topic by applying through an appropriate NIH Parent Funding Announcement or another broad opportunity on Grants.gov.

The topic exists because disasters and emerging environmental threats create a short, often unpredictable window in which exposure and health data can be collected. Once that window closes, the scientific value is lost. NIH wants research that moves fast enough to capture that information and that lays the groundwork for later, longer-term analysis of how those exposures affect health. A strong application makes two things obvious: that the triggering event was genuinely unforeseen, and that the proposed study is both scientifically valuable and feasible inside that limited window.

For a small business, the practical takeaway is simple. If your technology or study can capture exposure, biospecimen, or health data quickly after a natural or human-made disaster, or in response to an emerging environmental public health threat inside the United States, this topic tells you that three parts of NIH are actively looking for that work right now. You reach them through the Parent SBIR.

How does a startup actually apply for this?

You apply through the NIH, CDC, and FDA Parent SBIR announcement, PA-27-100 ("Parent SBIR [R43/R44] Clinical Trial Optional"). This is the vehicle that turns the Highlighted Topic into a fundable application for a for-profit small business.

The workflow looks like this. You confirm your company is an eligible U.S. small business concern, you register in the required federal systems, you build your Phase I feasibility study (or a Direct to Phase II or Fast-Track application) around the time-sensitive environmental health science described in the topic, and you submit through ASSIST, Grants.gov Workspace, or an institutional system-to-system solution. In your application you signal fit with the topic and, where useful, name the most appropriate Institute on the assignment request form. NIH's Center for Scientific Review then assigns your application to the best-fit participating component.

If your project depends on a formal partnership with a university or other nonprofit research institution, the companion STTR announcement, PA-27-102, is the better route. Both SBIR and STTR make the award to the small business. Note also that the Highlighted Topic stays open until August 10, 2028, while PA-27-100 itself expires April 6, 2027, so applicants submitting after that date should apply through whatever reissued Parent SBIR announcement is current at that time.

What kind of research is NIH looking for?

Three parts of NIH are participating in this topic, and each brings a distinct angle. Reading their interests closely is the difference between a fundable application and a near miss.

The National Institute of Environmental Health Sciences (NIEHS) is the anchor. NIEHS wants studies that clarify the relationship between environmental exposure and health outcomes. That includes the immediate and short-term health effects that follow a disaster, methods for measuring and characterizing human exposure to environmental hazards, work that helps understand how contaminants move and predict where exposure will occur, and approaches to preventing or reducing exposure during a disaster event, including remediation technologies relevant to Superfund-type contamination. NIEHS specifically encourages exploratory and developmental work with clear time-sensitivity, and it will treat studies that use animals as stand-ins for human exposure as lower priority. Its Superfund Research Program is interested where the work applies to hazardous waste sites. Its Workers Training Program is not part of this topic. Scientific contact: Toccara Chamberlain, M.A., toccara.chamberlain@nih.gov.

The National Institute on Aging (NIA) is interested in the same time-sensitive framing but focused on older adults, whose bodies are less able to absorb the stress of a disaster and who often depend on medication, caregivers, and health services that a disaster can disrupt. NIA wants early exposure and health data captured in older populations, including people in assisted living, nursing homes, rural areas, and other at-risk settings, to understand effects on functional status, cognition, cardiometabolic health, mobility, resilience, and progression toward Alzheimer's disease and related dementias. Applications should point toward modifiable risk and protective factors that can inform prevention, preparedness, and recovery. Scientific contacts: Richard Kwok, PhD, richard.kwok@nih.gov, and Emerald Nguyen, PhD, emerald.nguyen@nih.gov.

The Office of Research on Women's Health (ORWH) focuses on how these unexpected events uniquely affect the health of women and girls. ORWH prioritizes rapid data and biospecimen collection that captures women's distinct health risks, including chronic disease management, reproductive and maternal health, and mental health, with attention to differences across life stages and to gaps in disaster preparedness for women with limited resources. One important detail: ORWH does not award grants directly, so any application it co-funds must still be relevant to the mission of at least one of the awarding Institutes or Centers in the topic. Scientific contact: Regine A. Douthard, M.D., M.P.H, orwhinfo@mail.nih.gov.

Across all three, the common thread is speed with scientific purpose. Reviewers and program staff want to see that the event was genuinely unforeseen, that the collection window is real, that the study is feasible inside it, and that the short-term data will feed longer-term understanding of exposure and health.

Who is eligible to apply?

Only a United States small business concern (SBC) can apply. To qualify, your company must be organized for profit with a place of business in the United States, and it must operate primarily in the U.S. or make a significant contribution to the U.S. economy. It must have no more than 500 employees, including affiliates. Ownership must meet one of two tests: either more than 50 percent owned and controlled by U.S. citizens or permanent residents (directly, or through other qualifying U.S.-owned businesses), or more than 50 percent owned by multiple venture capital operating companies, hedge funds, or private equity firms, with no single such firm owning more than 50 percent.

For an SBIR award, the Program Director or Principal Investigator must have their primary employment with the small business at the time of award and throughout the project. Foreign organizations and foreign components of U.S. organizations cannot apply, and NIH will not make awards under this announcement that involve foreign subawards or subcontracts. Companies also need to be aware of the foreign-risk and security screening that applies before award, including required disclosure of foreign affiliations for owners and covered individuals.

How much funding is available?

The dollar amount depends on which Institute your application is assigned to. The current SBA total-cost guidelines, which set the ceiling agencies can award without a waiver, are Phase I up to $323,090 and Phase II up to $2,153,927 as of April 2026. NIEHS, the lead Institute for this topic, uses those SBA guideline amounts for both phases, so an environmental exposure study routed to NIEHS would generally target up to about $323,090 for Phase I and up to about $2,153,927 for Phase II.

If your project skews toward aging and is assigned to NIA, the caps are higher: up to $700,000 for Phase I and up to $3,000,000 for Phase II. For applications ORWH co-funds, the Phase II reference is $2,500,000, though ORWH itself does not make the award. These are guideline amounts, and NIH may exceed them for approved waiver topics. If you plan to request more than the SBA guideline, NIH strongly encourages you to contact the relevant Institute early. No cost sharing is required, and SBIR does not take equity.

There is one work-share rule that startups sometimes overlook and that shapes the budget. In Phase I, the small business normally performs at least two-thirds (about 67 percent) of the research or analytical effort, so consultants and subcontractors together are generally capped near 33 percent. In Phase II, the small business normally performs at least half (50 percent), so outside effort is generally capped near 50 percent. Deviations are possible but must be approved in writing.

What is the timeline and what are the deadlines?

The Parent SBIR (PA-27-100) was posted May 28, 2026, opened for submission on August 5, 2026, and carries three standard due dates before it expires on April 6, 2027:

• September 5, 2026, for the first cycle. Because September 5 is a Saturday and Labor Day falls on Monday, September 7, NIH's weekend and holiday policy moves the effective deadline to Tuesday, September 8, 2026. Confirm the displayed date in ASSIST or Grants.gov before you submit.

• January 5, 2027, for the second cycle.

• April 5, 2027, for the third cycle.

All applications are due by 5:00 PM local time of the applicant organization, and NIH does not accept late applications. After submission, an application moves through scientific merit review, then Advisory Council review, then the earliest possible start date. For the September 2026 cycle, that path runs through review in November 2026, Council in January 2027, and an earliest start around April 2027. The later cycles follow the same rhythm a few months out.

Because registration in SAM.gov, eRA Commons, Grants.gov, and the SBA Company Registry can take six weeks or longer, the practical deadline for a first-time applicant is well before the submission date. Start the registrations now if you have not.

What are the funding phases?

Phase I establishes technical merit and feasibility and normally runs up to six months. Phase II continues the research and development toward commercialization and normally runs up to two years. NIH also offers two accelerated paths that other agencies do not. Direct to Phase II lets a company that has already demonstrated feasibility, without ever holding a Phase I SBIR or STTR for that project, apply straight into Phase II. Fast-Track lets you submit and review Phase I and Phase II together to reduce the funding gap between them. After Phase II, NIH expects the company to commercialize using non-SBIR funds, whether private capital, sales, licensing, or other federal sources.

Is this a good fit for my company?

This topic is a strong fit if your company works on environmental exposure measurement, sensing, remediation, biomonitoring, rapid data or biospecimen collection, or health surveillance tied to disasters and emerging environmental threats, and if you can credibly move fast enough to capture data inside the event window. It fits especially well for teams building tools or study capabilities relevant to older adults or to the distinct health needs of women and girls, given NIA's and ORWH's participation. It is a weaker fit if your work has no time-sensitive collection element, relies mainly on animal surrogates for human exposure, or cannot meet the small business and PI employment rules. If you are unsure which Institute fits or whether SBIR or STTR is the right route, that is exactly the kind of question worth resolving before you write a single specific aim.

Frequently Asked Questions

Can I apply directly to the environmental health Highlighted Topic?
No. It is not a funding opportunity and has no application package. You apply through the NIH Parent SBIR announcement, PA-27-100, and align your research aims with the topic so it routes to NIEHS, NIA, or ORWH.

What is the next deadline?
The next Parent SBIR standard due date is September 5, 2026. That date is a Saturday just before Labor Day, so under NIH policy the effective deadline moves to Tuesday, September 8, 2026. The following cycles are January 5, 2027, and April 5, 2027.

How much money can a startup receive?
Under current SBA guidelines, Phase I runs up to about $323,090 and Phase II up to about $2,153,927. NIEHS uses those guideline amounts. NIA offers higher caps of up to $700,000 for Phase I and up to $3,000,000 for Phase II. The exact ceiling depends on the Institute your application is assigned to.

Who is eligible?
A U.S. small business concern with no more than 500 employees, organized for profit, and meeting NIH's ownership tests. For SBIR, the Principal Investigator's primary employment must be with the small business.

Do I need a university partner?
Not for SBIR. If your project depends on a formal collaboration with a university or nonprofit research institution, use the companion STTR announcement, PA-27-102, instead. In both programs the award goes to the small business.

What kind of research does NIH want here?
Time-sensitive studies that capture exposure and health data during the short window after a natural or human-made disaster or an emerging environmental threat in the United States, including short-term health effects, exposure measurement, contaminant movement, remediation, effects on older adults, and effects on women and girls.

Is the SBIR program still funded?
Yes. The SBIR and STTR programs were reauthorized in April 2026 and are currently authorized through September 30, 2031.

How long does it take to get funded?
Plan on several months from submission to award. For the September 2026 cycle, scientific review is expected in November 2026, Council review in January 2027, and the earliest start date around April 2027.

What if I miss the September deadline?
The Parent SBIR has additional standard due dates on January 5, 2027, and April 5, 2027. The Highlighted Topic itself stays active through August 10, 2028, so the priority persists across cycles, though the specific Parent SBIR announcement is reissued periodically.

ARPA-H ASCENT-IBO: Ibogaine Clinical Trials for Opioid Use Disorder (Funding Opportunity Overview)

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

Quick Answer

ASCENT-IBO (Accelerating Safe Clinical Evaluation of Novel Treatments: Ibogaine for Better Outcomes in Opioid Use Disorder) is a funding opportunity from the Advanced Research Projects Agency for Health (ARPA-H). It is issued as Special Notice ARPA-H-SN-26-158 under the Proactive Health Office Innovative Solutions Opening (ISO) ARPA-H-SOL-24-106. ARPA-H is seeking teams to design and run accelerated, combined Phase I and Phase II clinical trials that evaluate the safety and efficacy of ibogaine in high-risk patients with opioid use disorder (OUD). Interested organizations submit a Solution Summary of no more than six pages by October 15, 2026 at 5:00 p.m. ET. Commercial, industry-led teams with an active or imminent Investigational New Drug (IND) application are explicitly favored. This effort implements Executive Order 14401, Accelerating Medical Treatments for Serious Mental Illness.

What Is ASCENT-IBO and Who Issued It?

ASCENT-IBO is a Special Notice published by ARPA-H, the research funding agency within the U.S. Department of Health and Human Services that pursues high-risk, high-reward health breakthroughs. The full title is Accelerating Safe Clinical Evaluation of Novel Treatments: Ibogaine for Better Outcomes in Opioid Use Disorder.

The Special Notice carries identifier ARPA-H-SN-26-158. It builds on an earlier notice, ARPA-H-SN-26-156, which established a Proactive Health Office (PHO) area of interest tied to Executive Order 14401. ASCENT-IBO is supplementary to the underlying solicitation and does not change it. All submissions are made to, and must comply with, the PHO Innovative Solutions Opening ISO ARPA-H-SOL-24-106.

In plain terms, ARPA-H wants to close a specific gap: despite anecdotal reports of ibogaine reducing opioid cravings and withdrawal, there is currently no active U.S. clinical trial with an open IND studying ibogaine for OUD. ASCENT-IBO is the agency's push to change that quickly and safely.

Why Is ARPA-H Funding Ibogaine Research Now?

Opioid use disorder affects more than five million people in the United States, and more than 75 percent of individuals with OUD receive no treatment at all. Existing medications for OUD such as buprenorphine, methadone, and naltrexone, usually paired with psychotherapy, reduce overdose deaths and improve outcomes, but dropout and relapse rates remain high, and the period following treatment discontinuation or a nonfatal overdose is a well-documented window of elevated mortality risk.

Ibogaine belongs to a class of compounds ARPA-H refers to as neuroplastogens, rapid-acting interventions that may drive lasting, beneficial changes in brain function. Early and largely anecdotal evidence from unregulated clinics abroad suggests it may meaningfully reduce opioid cravings and withdrawal, but that evidence has never been tested in a rigorous, federally authorized U.S. trial.

The policy driver is Executive Order 14401, Accelerating Medical Treatments for Serious Mental Illness, signed April 18, 2026. The order directs the federal government to accelerate research models and drug approvals for psychedelic and neuroplastogen-based treatments, specifically naming ibogaine, and to partner with state governments advancing this work. Texas launched an ibogaine research consortium in 2025, which is one example of the state-level activity the order references.

What Is ARPA-H Actually Looking For?

ARPA-H is asking for a Solution Summary of no more than six pages that describes, at a high level, a plan to design and execute accelerated clinical trials of ibogaine for OUD. A competitive Solution must address all three of the following tasks. Partial responses that cover only one or two tasks are unlikely to advance.

Task 1: Combined Phase I/II Clinical Trial Design

The centerpiece of the ask is a study design that evaluates safety and efficacy at the same time, in patient cohorts with OUD who are at increased risk of mortality. ARPA-H wants the design described at a high level across four specific dimensions:

• Dosing strategy. Ibogaine dosing approaches that reach clinically relevant, psychoactive exposure levels associated with therapeutic effect.

• Set and setting. The therapeutic environment and psychological support framework used during and after ibogaine administration to maximize therapeutic potential.

• Placebo strategy. An appropriate placebo or active comparator that minimizes patient bias and preserves blinding as much as ibogaine's strong psychoactive profile allows, including a plan to measure patient unblinding so its effect on outcomes can be interpreted.

• Safety assessments and risk mitigation. Rigorous monitoring aligned with gold-standard scientific and regulatory principles. Solutions are expected to name known and anticipated risks in ibogaine and OUD populations, in particular drug-related cardiotoxicity, drug-drug interactions, and detoxification and opioid withdrawal management, and to describe active safety controls such as dose de-escalation or step-back actions that prioritize patient safety.

Task 2: Operational Plans for Trial Execution

Beyond the design, ARPA-H wants a high-level operational plan for actually running the trial. This includes staff training, integration planning, patient education, and a patient recruitment strategy that is scalable and ethically sound.

Task 3: Future Development Plans

Solutions should show a path forward, including high-level plans to prepare for accelerated entry into Phase III and plans to develop a Risk Evaluation and Mitigation Strategy (REMS).

There is also an encouraged but optional element. Solutions that consider using the FDA's Expanded Access program or the Right-to-Try Act to broaden access for eligible patients are described by ARPA-H as highly encouraged, though not required.

What Makes a Solution Competitive?

ARPA-H is unusually direct about what will rise to the top. A startup or company preparing a Solution Summary should weigh the following signals:

• Commercial, industry-led teams are favored. ARPA-H states that Solutions led by a commercial entity responsible for all clinical trial execution activities may be most advantageous for rapid advancement and eventual market entry.

• An IND is close to the center of the evaluation. Solutions with an IND application already submitted, or with imminent plans to submit to the FDA, will be prioritized.

• Combined Phase I and II design plus well-defined safety strategies are prioritization criteria in their own right.

• Full coverage of the statement of work is expected. Teams are responsible for every element of the SOW and are expected to have adequate personnel, including regulatory consultants with neuroplastogen drug development expertise.

• Existing relationships and state-level support should be spelled out. If a team has partnerships or state-level backing for ibogaine or neuroplastogen clinical development, ARPA-H wants those commitments described clearly.

• Affordability and public health thinking help. Because ARPA-H aims to increase patient access, the most competitive Solutions will include initial concepts for affordability, price transparency, and public health benefit models for the period after advanced clinical development.

What Is Out of Scope?

Some approaches are explicitly disqualified. ASCENT-IBO does not want Solutions that propose ibogaine-derived derivatives or analogues, other neuroplastogen compounds including but not limited to psilocybin and ketamine, or neuromodulation-based treatments. This notice is specifically about ibogaine itself for OUD.

How Much Funding Is Available?

The Special Notice does not publish a dollar figure, a ceiling, or a fixed number of awards for ASCENT-IBO. This is normal for this type of vehicle. ASCENT-IBO runs through the Proactive Health Office Innovative Solutions Opening (ISO ARPA-H-SOL-24-106), and ARPA-H funds ISO projects on an individual basis using its range of flexible mechanisms, which for this kind of translational work typically means Other Transaction agreements rather than standard grants. Award size is negotiated based on the scope of the proposed trial rather than set by a published cap.

Two practical points follow from this. First, ARPA-H will not reimburse any costs incurred in responding to this Special Notice, attending Proposers' Day, or preparing submissions to the ISO. Second, the ISO uses a two-step gate: proposers submit a Solution Summary first, ARPA-H provides written feedback on viability and interest, and a full proposal should only be submitted after that feedback is received. A full proposal submitted without ARPA-H's written response can be rejected.

What Are the Key Dates and Deadlines?

• Proposers' Day registration opened: August 5, 2026

• Proposers' Day registration deadline: September 7, 2026 at 5:00 p.m. ET

• Proposers' Day (Washington, D.C. metro area): September 15, 2026, 8:00 a.m. to 5:00 p.m. ET

• Solution Summary requested by: October 15, 2026 at 5:00 p.m. ET

All dates are subject to change, and the Special Notice on SAM.gov is the authoritative source. The underlying ISO itself remains open on a rolling basis, but ASCENT-IBO's Solution Summary target date is October 15, 2026.

What Is Proposers' Day and Should You Attend?

Proposers' Day is an optional event held in the Washington, D.C. metro area for organizations considering a Solution. It is not intended for patients, patient advocates, or general-interest audiences. The agenda includes an overview of the area of interest by government personnel, lightning talks where organizations can present one slide in three minutes on a first-come first-served basis, and a panel of federal agencies covering regulatory considerations, clinical guidance, and anticipated challenges.

Registration is required in advance through the ARPA-H Solutions events page, there is no fee, and there is no same-day registration. In-person attendees must present valid government-issued photo identification. Virtual attendance is available once registration is verified. If a team wants to give a lightning talk, it must flag that intent during registration, with no more than one submission per organization.

How Do You Apply?

Interested organizations submit a Solution Summary of no more than six pages, following Appendix A of the PHO ISO ARPA-H-SOL-24-106, through the ARPA-H Solutions site. The Solution Summary must be responsive to all three tasks described above. After review, ARPA-H contacts proposers with further guidance, and only teams that receive a positive written response should proceed to a full proposal.

ARPA-H expects that strong Solutions will require combining expertise, facilities, and capabilities across organizations, and it maintains a teaming page where prospective performers can post profiles and find collaborators. This is worth using early, since assembling clinical, regulatory, and commercial expertise before the deadline is one of the harder parts of a competitive submission.

Frequently Asked Questions

What does ASCENT-IBO stand for?

ASCENT-IBO stands for Accelerating Safe Clinical Evaluation of Novel Treatments: Ibogaine for Better Outcomes in Opioid Use Disorder. It is an ARPA-H funding opportunity focused on accelerated Phase I and Phase II clinical trials of ibogaine for opioid use disorder.

What is the Notice ID for ASCENT-IBO?

The Special Notice is ARPA-H-SN-26-158. Submissions are made through the Proactive Health Office Innovative Solutions Opening, ISO ARPA-H-SOL-24-106.

When is the ASCENT-IBO Solution Summary due?

The Solution Summary is requested by October 15, 2026 at 5:00 p.m. ET. Dates can change, so confirm against the Special Notice on SAM.gov before finalizing a submission.

How long is the Solution Summary?

No more than six pages, following Appendix A of the ISO ARPA-H-SOL-24-106.

Does a company need an IND to apply?

An IND is not an absolute requirement to submit a Solution Summary, but ARPA-H will prioritize Solutions that already have an IND application submitted or have imminent plans to submit one to the FDA. Teams without a clear IND path are at a competitive disadvantage.

Can academic institutions apply, or is this only for companies?

Academic and other organizations can participate, and teaming is encouraged. However, ARPA-H states that commercial, industry-led Solutions where a single commercial entity is responsible for all clinical trial execution may be most advantageous for rapid advancement and market entry. Many competitive teams will pair a commercial lead with academic and clinical partners.

Are psilocybin, ketamine, or ibogaine analogues eligible?

No. Solutions proposing ibogaine-derived derivatives or analogues, other neuroplastogens such as psilocybin and ketamine, or neuromodulation-based treatments do not align with this notice. ASCENT-IBO is specifically about ibogaine for OUD.

How much money can an awardee receive?

The Special Notice does not publish a specific dollar amount or ceiling. Funding runs through the PHO ISO, which uses ARPA-H's flexible mechanisms, commonly Other Transaction agreements, with award size scoped to the proposed trial. ARPA-H does not reimburse costs of responding to the notice.

Do you have to attend Proposers' Day to submit?

No. Proposers' Day is optional. It is a useful way to hear directly from federal agencies on regulatory and clinical considerations and to find teaming partners, but attendance is not a condition of submitting a Solution Summary.

What safety risks does ARPA-H specifically want addressed?

ARPA-H calls out drug-related cardiotoxicity, drug-drug interactions, and detoxification and opioid withdrawal management as known and anticipated risks, and it expects active mitigation strategies such as dose de-escalation or step-back actions to protect patient safety.

What executive order is this connected to?

ASCENT-IBO implements Executive Order 14401, Accelerating Medical Treatments for Serious Mental Illness, signed April 18, 2026, which directs the federal government to accelerate access to psychedelic and neuroplastogen treatments, including ibogaine, for serious mental illness.

How BW&CO Can Help

BW&CO Consulting helps deep-tech, biotech, medtech, and health-focused startups win non-dilutive federal funding. For an opportunity like ASCENT-IBO, that means positioning a combined Phase I/II design against ARPA-H's stated priorities, tightening the IND and regulatory narrative, structuring a commercial-led team with the right clinical and neuroplastogen expertise, and preparing a Solution Summary that clears ARPA-H's written-feedback gate on the first pass. If you are considering a submission, reach out before the October 15, 2026 target date so there is time to build the team and the trial narrative.

FY26 Breast Cancer Research Program: Breakthrough Award and Clinical Research Extension Award

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

Quick Answer

The FY26 Breast Cancer Research Program (BCRP) is a Department of War grant program, managed by CDMRP, that funds high-impact breast cancer research with clinical relevance. FY26 includes two award mechanisms: the Breakthrough Award, offered at two funding levels ranging from $750,000 to $3.35M depending on level and whether a Partnering PI is included, and the Clinical Research Extension Award, which funds deeper analysis of existing clinical trial data at up to $8.4M. A pre-application through eBRAP and a letter of intent are required before the full application. The estimated application due date is September 30, 2026.

What This Opportunity Is

This funding opportunity comes from the Breast Cancer Research Program, part of the Department of War's Congressionally Directed Medical Research Programs (CDMRP), operating under the Defense Health Agency's research and development structure. The FY26 Defense Appropriations Act provided funding to support innovative, high-impact breast cancer research with clinical relevance, aimed at accelerating progress toward ending breast cancer for Service Members and their families, Veterans, and the general public.

FY26 BCRP includes two distinct award mechanisms, each suited to a different stage of research maturity. The Breakthrough Award is built for research ranging from early, high-risk ideas through late-stage, clinically validated work. The Clinical Research Extension Award is built specifically for teams that already have an open, ongoing, or completed clinical trial or study and want to extend the value of that existing data.

What the Program Is Looking For

Applications submitted to the FY26 BCRP must address one or more of the following overarching challenges.

Prevent breast cancer through primary prevention

Identify determinants of breast cancer initiation, risk, or susceptibility

Distinguish deadly from non-deadly breast cancers

Conquer the problems of overdiagnosis and overtreatment

Identify what drives breast cancer growth and determine how to stop it

Identify why some breast cancers become metastatic

Determine why and how breast cancer cells lie dormant for years and then re-emerge, and determine how to prevent lethal recurrence

Revolutionize treatment regimens by replacing them with ones that improve survival, are more effective, and are less toxic

Eliminate the mortality associated with metastatic breast cancer

In practical terms, this program is a strong fit for companies and research teams working in oncology diagnostics, breast cancer risk stratification, metastasis biology, dormancy and recurrence research, novel treatment regimens, and clinical biomarker validation tied to existing trial data.

Award Mechanism 1: Breakthrough Award

The Breakthrough Award supports promising research with high potential to lead to breakthroughs in breast cancer. Research must have the potential for major impact and must accelerate progress toward ending the disease. The award includes a Partnering PI option that supports meaningful, productive partnerships between two principal investigators.

The award is structured across three funding levels.

Funding Level 1 supports innovative, high-risk and high-reward research in the earliest stages of idea development. Preliminary data is not required at this level. Maximum allowable total costs are $750,000 for a Single PI application and $1.25M under the Partnering PI Option. Maximum period of performance is 3 years.

Funding Level 2 supports research already backed by substantial preliminary or published data in breast cancer that strongly validates clinical translation. Maximum allowable total costs are $1.65M for a Single PI application and $2.50M under the Partnering PI Option. Maximum period of performance is 3 years.

Funding Level 2, Population Science Studies is a variation of Funding Level 2 for studies analyzing human data and biospecimens that meet the same qualification standards. Maximum allowable total costs are $2.50M for a Single PI application and $3.35M under the Partnering PI Option. Maximum period of performance is 4 years.

The Grants.gov funding opportunity number for this mechanism is HT942526BCRPBTA122. A letter of intent is required prior to full application submission. Each investigator may be named as Principal Investigator or Initiating PI on one application and as Partnering PI on one additional application under this opportunity. Investigators named on an application submitted under the related opportunity HT942526BCRPBTA12 are not eligible to submit the same research project under HT942526BCRPBTA122.

Award Mechanism 2: Clinical Research Extension Award

The Clinical Research Extension Award supports projects that go deeper into clinical samples and data that already exist, rather than starting new trials. Eligible work includes deeper molecular analysis of clinical samples, initiation of new correlative studies, biomarker validation, or continuing clinical follow-up of patients enrolled in an open, ongoing, or completed clinical trial or study.

Proposed research may be hypothesis-testing, hypothesis-generating, or designed to generate experimental platforms. Projects that propose initiating new clinical trials or studies, or that propose increasing enrollment in existing studies, do not meet the intent of this award and should not apply under this mechanism.

This award requires applications to include two or more breast cancer consumer advocates on the research team, which is a distinctive requirement compared to the Breakthrough Award. It also includes a Partnering PI option.

Maximum allowable total costs are $7.0M for a Single PI application and $8.4M under the Partnering PI Option. Maximum period of performance is 4 years.

The Grants.gov funding opportunity number for this mechanism is HT942526BCRPCREA2. A letter of intent is required prior to full application submission. Each investigator may be named as PI, Initiating PI, or Partnering PI on a single application under this opportunity. Investigators named on an application submitted under the related opportunity HT942526BCRPCREA are not eligible to submit the same research project under HT942526BCRPCREA2.

Eligibility Snapshot

Breakthrough Award: open to investigators, with post-doctoral fellows specifically encouraged to be named on applications.

Clinical Research Extension Award: open to independent investigators.

Both mechanisms require a letter of intent before full application submission, and both offer a Partnering PI option for two-investigator collaborations.

Funding Details Summary

Breakthrough Award Funding Level 1: $750,000 Single PI, $1.25M Partnering PI, 3 year maximum period of performance

Breakthrough Award Funding Level 2: $1.65M Single PI, $2.50M Partnering PI, 3 year maximum period of performance

Breakthrough Award Funding Level 2, Population Science Studies: $2.50M Single PI, $3.35M Partnering PI, 4 year maximum period of performance

Clinical Research Extension Award: $7.0M Single PI, $8.4M Partnering PI, 4 year maximum period of performance

Timeline

Estimated application due date is September 30, 2026

This is currently a forecasted date. The official funding opportunity announcements, including finalized pre-application and full application deadlines, will be posted to Grants.gov under the funding opportunity numbers listed above.

How to Apply

Before submitting a full application, CDMRP requires investigators to submit a pre-application through the electronic Biomedical Research Application Portal, known as eBRAP, ahead of the pre-application deadline. All applications must conform to the final funding opportunity announcements once posted on Grants.gov.

To find this and related CDMRP funding opportunities directly on Grants.gov, search using Assistance Listing number 12.420. Investigators can also subscribe to program specific email updates through the Email Subscriptions option on the eBRAP homepage to be notified as soon as the official announcements are released.

Frequently Asked Questions

What is the Breast Cancer Research Program? The Breast Cancer Research Program, or BCRP, is a Department of War research program managed by CDMRP that funds innovative, high-impact breast cancer research with clinical relevance, intended to accelerate progress toward ending breast cancer.

What award mechanisms are available under FY26 BCRP? FY26 BCRP includes two mechanisms: the Breakthrough Award, offered at multiple funding levels, and the Clinical Research Extension Award, which supports deeper analysis of data from existing clinical trials or studies.

How much funding is available under the Breakthrough Award? Funding Level 1 allows up to $750,000 for a Single PI or $1.25M with a Partnering PI. Funding Level 2 allows up to $1.65M for a Single PI or $2.50M with a Partnering PI. Funding Level 2 Population Science Studies allows up to $2.50M for a Single PI or $3.35M with a Partnering PI.

How much funding is available under the Clinical Research Extension Award? Up to $7.0M for a Single PI application or $8.4M under the Partnering PI Option.

Does the Breakthrough Award require preliminary data? Funding Level 1 does not require preliminary data, since it is designed for early-stage, high-risk and high-reward ideas. Funding Level 2 and Funding Level 2 Population Science Studies do require substantial preliminary or published data that strongly validates clinical translation.

Can the Clinical Research Extension Award be used to start a new clinical trial? No. This award is intended for deeper molecular analysis, new correlative studies, biomarker validation, or continued follow-up of patients already enrolled in an open, ongoing, or completed clinical trial or study. Proposals that initiate new trials or increase enrollment in existing studies do not meet the intent of this mechanism.

Does the Clinical Research Extension Award have any team composition requirements? Yes. Applications must include two or more breast cancer consumer advocates on the research team.

What is a Partnering PI? The Partnering PI option allows two principal investigators to collaborate on a single application, and is available under both the Breakthrough Award and the Clinical Research Extension Award.

Is a letter of intent required? Yes, for both award mechanisms, a letter of intent is required before the full application can be submitted.

What is eBRAP? eBRAP is the electronic Biomedical Research Application Portal. CDMRP requires investigators to submit a pre-application through eBRAP before the pre-application deadline, prior to submitting a full application.

When is the application due? The estimated application due date is September 30, 2026, though this is currently a forecasted date pending the official funding opportunity announcements on Grants.gov.

What are the Grants.gov funding opportunity numbers? The Breakthrough Award funding opportunity number is HT942526BCRPBTA122. The Clinical Research Extension Award funding opportunity number is HT942526BCRPCREA2.

Where can I find the official announcements? The official funding opportunity announcements will be posted on Grants.gov. Investigators can search using Assistance Listing number 12.420 to find CDMRP opportunities, and can subscribe to updates through the eBRAP homepage.

FY26 Reconstructive Transplant Research Program: Investigator-Initiated Research Award

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

Quick Answer

The FY26 Reconstructive Transplant Research Program (RTRP) Investigator-Initiated Research Award is a Department of War grant, managed by CDMRP, that funds research into vascularized composite allotransplantation (VCA), the field covering hand, face, and other tissue transplants. The program has $8,000,000 available across an expected 8 awards, with a maximum of $1.0M in total costs per award over up to 3 years. There is no cost sharing requirement. A pre-application through eBRAP is required before the full application. The estimated application due date is November 4, 2026.

What This Opportunity Is

This funding opportunity comes from the Reconstructive Transplant Research Program, a program within the Department of War's Congressionally Directed Medical Research Programs (CDMRP), operating under the Defense Health Agency's research and development structure. The FY26 Defense Appropriations Act provided funding specifically to advance the science and clinical practice of vascularized composite allotransplantation, or VCA.

VCA covers transplants involving multiple tissue types together, such as skin, muscle, bone, nerve, and blood vessels, most commonly seen in hand and face transplantation for patients recovering from severe trauma. This is an area with direct relevance to wounded Service Members, though the program also serves the broader civilian patient population.

The Investigator-Initiated Research Award is designed for independent investigators at all career levels. Unlike some CDMRP mechanisms, this award does not support clinical trials, but it does support preclinical research, translational research, and clinical research involving human subjects or human anatomical substances, so long as the work stays within the scope of a defined research study rather than a trial testing an intervention's efficacy.

What the Program Is Looking For

Applications must address at least one of the following FY26 RTRP focus areas.

Improving or optimizing VCA immunosuppression, including:

Defining the unique targets and mechanisms of VCA immunogenicity and its regulation

Developing novel tolerogenic agents or approaches for VCA immunosuppression

Developing less toxic or personalized regimens for maintenance immunosuppression

Identifying or validating reliable prognostic or diagnostic biomarkers, methods, or tools for monitoring VCA graft rejection and immunosuppression

Identifying or validating reliable biomarkers for predicting and monitoring acute and chronic VCA rejection in the clinic, using human clinical samples

Developing assays, devices, or technology for clinical graft monitoring that utilize biomarkers, with proposed devices expected to account for human use factors unique to VCA recipients

Identifying or validating reliable approaches to measuring and monitoring in vivo or clinical immunosuppression levels

Advancing VCA preservation strategies, including:

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

Developing mitigation strategies for preservation mediated injury, including immune activation or ischemia reperfusion injury

Developing tools for measuring VCA outcomes, including performance based, patient reported, and neurocognitive measures

In practical terms, this opportunity is a strong fit for companies and research teams working in transplant immunology, organ and tissue preservation technology, perfusion systems, biomarker development, diagnostic assays, and clinical monitoring devices for transplant patients.

Eligibility and Requirements

Eligibility is open to independent investigators at all career levels. There is no restriction limiting this to a specific organization type, which CDMRP designates as unrestricted eligibility.

Applications must demonstrate solid scientific rationale paired with military relevant utility. All projects must respond to the health care needs of military Service Members or Veterans recovering from traumatic injury, and may also address the needs of their family members, caregivers, or clinicians, as well as the general public. Collaboration with military researchers and clinicians is encouraged but not required.

Applicants must include preliminary or published data relevant to reconstructive transplantation that supports the rationale for the proposed research. A letter of intent is required as part of the process.

Study design should be rigorous, with a strong statistical plan and appropriate power analysis to support reproducibility and translational feasibility.

Funding Details

Total program funding is $8,000,000

Expected number of awards is 8

Maximum allowable funding per award is $1.0M in total costs

Maximum period of performance is 3 years

Cost sharing or matching is not required

Funding instrument type is a grant

Funding opportunity number is HT942526RTRPIIRA

Assistance Listing number is 12.420, Military Medical Research and Development

Timeline

Estimated posting date is August 24, 2026

Estimated application due date is November 4, 2026

Estimated award date is September 30, 2027

Estimated project start date is September 30, 2027

These are currently forecasted dates. The official funding opportunity announcement, including the finalized pre-application and full application deadlines, will be posted to Grants.gov.

How to Apply

Before submitting a full application, CDMRP requires investigators to submit a pre-application through the electronic Biomedical Research Application Portal, known as eBRAP, ahead of the pre-application deadline. All applications must conform to the final funding opportunity announcement once it is posted on Grants.gov.

To find this and related CDMRP funding opportunities directly on Grants.gov, search using Assistance Listing number 12.420. Investigators can also subscribe to program specific email updates through the Email Subscriptions option on the eBRAP homepage to be notified as soon as the official announcement is released.

Frequently Asked Questions

What is the Reconstructive Transplant Research Program? The Reconstructive Transplant Research Program, or RTRP, is a Department of War research program managed by CDMRP that funds research to advance the science and clinical practice of vascularized composite allotransplantation, the field covering hand, face, and similar multi-tissue transplants.

What does VCA stand for? VCA stands for vascularized composite allotransplantation, which refers to transplants that involve multiple connected tissue types, such as skin, muscle, bone, nerve, and blood vessels, transplanted together as a functional unit.

How much funding is available for the FY26 RTRP Investigator-Initiated Research Award? The program has $8,000,000 in total funding available and expects to make 8 awards, with a maximum of $1.0M in total costs allowed per award.

What is the maximum period of performance? The maximum period of performance for an award is 3 years.

Is cost sharing or matching required? No, this award does not require cost sharing or matching funds.

Does this award support clinical trials? No, the Investigator-Initiated Research Award does not support clinical trials. It does support research from basic through translational phases, including preclinical studies in animal models and clinical research involving human subjects or human anatomical substances.

Who is eligible to apply? Eligibility is unrestricted and open to independent investigators at all career levels.

Is preliminary data required? Yes, applicants must include preliminary or published data relevant to reconstructive transplantation that supports the scientific rationale of the proposed research.

Is a letter of intent required? Yes, a letter of intent is required before submitting the full application.

What is eBRAP? eBRAP is the electronic Biomedical Research Application Portal. CDMRP requires investigators to submit a pre-application through eBRAP before the pre-application deadline, prior to submitting a full application.

When is the application due? The estimated application due date is November 4, 2026, though this is currently a forecasted date pending the official funding opportunity announcement on Grants.gov.

What focus areas must an application address? Applications must address at least one FY26 RTRP focus area, which fall under two broad goals: improving or optimizing VCA immunosuppression, and advancing VCA preservation strategies. Specific focus areas include biomarker development, tolerogenic agents, personalized immunosuppression regimens, graft monitoring devices, perfusion and preservation technologies, and tools for measuring functional, patient reported, and neurocognitive outcomes.

Does the research need to have military relevance? Yes, all projects must be responsive to the health care needs of military Service Members or Veterans recovering from traumatic injury, and may also address their family members, caregivers, or clinicians, along with the general public. Collaboration with military researchers is encouraged but not a requirement.

What is the funding opportunity number? The funding opportunity number is HT942526RTRPIIRA.

Where can I find the official announcement? The official funding opportunity announcement will be posted on Grants.gov. Investigators can search using Assistance Listing number 12.420 to find CDMRP opportunities, and can subscribe to updates through the eBRAP homepage.

CIRM PDEV: Preclinical Development Awards for Stem Cell and Genetic Therapies

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

Quick Answer

CIRM's Preclinical Development (PDEV) program funds California organizations developing stem cell based or genetic therapies that are ready to move through IND enabling studies toward FDA clearance and a first in human clinical trial. Awards go up to $13,000,000 total cost over as long as 5 years, split into an Early PDEV (Pre IND) stage worth up to $5,500,000 and a Late PDEV (IND Enabling) stage worth up to $7,500,000. Applications must show reproducible disease modifying activity in a relevant preclinical model before CIRM will consider funding. The program recurs once per year, and CIRM anticipates funding between 12 and 21 awards in FY26-27.

Program Overview

CIRM's mission is to accelerate world class regenerative medicine science for the benefit of California patients. Under its Strategic Allocation Framework, CIRM has set a goal of advancing 15 to 20 therapies to late stage clinical trials. PDEV is one of CIRM's core product development programs built to help hit that goal. Unlike many funding mechanisms, PDEV is not a passive check writer. CIRM commits internal staff and an external network of subject matter experts to actively work alongside the awardee team on regulatory strategy, CMC, and clinical planning.

The objective of PDEV is straightforward. Take a therapeutic candidate that already has reproducible disease modifying data, and fund the work needed to clear an IND with the FDA and start a first in human trial. CIRM structures this into two possible stages:

Early PDEV covers Pre IND activities. This includes finishing candidate optimization, conducting a Pre IND meeting with the FDA, and preparing everything needed to enter pivotal IND enabling studies.

Late PDEV covers IND Enabling activities. This includes GLP toxicology and safety studies, CMC and GMP manufacturing scale up, submission and clearance of the IND itself, and clinical trial startup activities to prepare for rapid patient recruitment.

An applicant can request funding for one stage or both in a single application.

Who Should Apply

This opportunity is built for companies and nonprofit research organizations developing a stem cell based therapy or a genetic therapy that already has strong preclinical proof of concept. If your candidate has not yet shown reproducible disease modifying activity in a model relevant to your target indication, you are not ready to apply. CIRM is explicit that it will refuse applications submitted before all eligibility prerequisites are met.

You are a strong fit if:

You are a California organization, nonprofit or for profit, under CIRM's definition of a California Organization.

You have a single, finalized human therapeutic candidate, not multiple candidates under parallel evaluation.

You can name your Principal Investigator, and that person can commit at least 15 percent effort.

You have or can bring on an experienced Project Manager at 50 percent effort and a Data Project Manager to handle data sharing obligations.

Your organization, not an outside partner, will be the IND sponsor of record.

You have at least one clinical trial site in California, or a solid justification for using outside sites.

You can be ready to start funded work within 90 days of award approval.

Funding Allowance

Maximum total award: $13,000,000 in total cost, over a maximum of 5 years (60 months).

Early PDEV (Pre IND) stage: up to $5,500,000, over up to 30 months. That 30 month window includes an optional 6 months specifically for candidate optimization work.

Late PDEV (IND Enabling) stage: up to $7,500,000, over up to 30 months. That window includes an optional 6 months for clinical trial startup activity that follows IND clearance.

Allowable costs include direct project costs, facilities costs, and indirect costs, all governed by the CIRM Grants Administration Policy for Clinical Stage Projects. For profit organizations cannot claim indirect costs. Nonprofit indirect costs are capped at 20 percent of allowable direct research funding, exclusive of equipment, tuition, patient care costs, and large subcontracts over $25,000.

Applicants requesting both stages in one application must budget them separately with no overlap, though CIRM allows up to $1,500,000 of well justified Late PDEV activity that is not dependent on FDA feedback to happen ahead of the Pre IND meeting, such as GMP manufacturing runs at a CDMO.

Co-Funding Requirements

Unpartnered nonprofit applicants: no co-funding required.

Nonprofit applicant with a for profit partner: the for profit partner must commit 20 percent of total allowable project costs.

For profit applicants: must commit 20 percent of total allowable project costs.

Co-funding can be cash based or warrant based. Warrant based co-funding lets a for profit applicant issue equity warrants to CIRM instead of cash, but requires signing a Warrant Term Sheet at the time of application and issuing the warrants at award start.

Eligibility Requirements Snapshot

The application must target a single IND for one stem cell based or genetic therapy candidate.

The candidate must have documented, reproducible disease modifying activity in a relevant preclinical model. If the candidate is manufactured from a single cell source, the exact test article used in that data must be identical to the candidate moving forward. If it comes from multiple cell sources or donors, disease modifying activity must be shown across at least two donor sources or cell lines using comparable manufacturing.

Allogeneic donor cell projects need documented donor consent covering clinical development and commercial sale, plus compliance with Good Tissue Practices under 21 CFR 1271.

The applicant organization must be the named IND sponsor.

The applicant must maintain at least one California clinical trial site.

The applicant organization must meet CIRM's definition of a California Organization, must demonstrate solvency if for profit, and must be in good standing.

What CIRM Will Not Fund

Conducting a clinical trial beyond startup activities.

Patient recruitment, screening, or enrollment.

Costs already covered by a prior, current, or future CIRM award.

Work performed by an out of state organization that would retain independent IP or publication rights over what comes out of the CIRM funded project.

Costs incurred before the date of ICOC board approval.

Timeline

The PDEV program runs once per year. After the application deadline, here is roughly what to expect:

Grants Working Group (GWG) selection happens approximately 60 days after the submission deadline.

GWG discussion of selected applications happens approximately 30 days after selection.

Award approval occurs at the next available Application Review Subcommittee (ARS) meeting of CIRM's governing board.

Awardees must be ready to start work within 90 days of award approval.

How Applications Get Reviewed and Scored

If the volume of submitted applications is too high for the GWG panel to discuss all of them, CIRM runs an initial screening round. Applications get a composite score built from a selection weight (60 percent) and a rank weight (40 percent), based on clinical impact potential, unmet need, and feasibility of patient uptake. Only the top scoring group advances to full GWG discussion.

Applications that make it to full review are scored by 15 outside scientific experts on a 1 to 100 scale. A median score of 85 or higher qualifies the application as having exceptional merit and eligible for funding if funds are available. A median score below 85 is not recommended for funding.

Separately, patient advocate and nurse members of the GWG apply a 1 to 5 Patient Perspective Score. This does not directly change the scientific score, but it can influence discussion and the ARS funding decision.

The five scored review criteria are:

Value Proposition, meaning the clinical improvement the therapy offers over existing options and its potential to address unmet need and improve access.

Rationale, meaning how strong the underlying science and preclinical data are.

Project Plan and Design, meaning whether the proposed activities, budget, and timeline realistically get the project to an active IND.

Project Team and Resources, meaning whether the team has the regulatory, CMC, clinical, and manufacturing expertise and facilities to execute.

Population Impact, meaning how well the applicant understands the demographics and genetic or environmental factors relevant to the target population.

Award Administration After Funding

CIRM disburses funds against Operational Milestones rather than as a lump sum or simple reimbursement schedule. Each milestone releases additional funds once it is achieved. If an awardee misses a milestone by more than four months without resolving it to CIRM's satisfaction, CIRM can cut off disbursements and terminate the award.

Awardees also get access to CIRM's Product Development Expert Network, a group of contracted specialists in CMC, clinical, preclinical, and regulatory strategy who advise on individual projects. Any awardee planning a Pre IND meeting must review their strategy and package with CIRM and this expert network before submitting to the FDA.

Awardees are required to participate in the PDEV Knowledge Network, a pre-competitive knowledge sharing structure across CIRM's portfolio of awardees, and must budget for data management and sharing consistent with FAIR principles.

Frequently Asked Questions

What is the CIRM PDEV program? PDEV is a California Institute for Regenerative Medicine funding opportunity that supports preclinical development of stem cell based and genetic therapies through IND clearance and clinical trial startup, with awards up to $13,000,000.

Who is eligible to apply for a PDEV award? Only California organizations, nonprofit or for profit, that meet CIRM's definition of a California Organization can apply. The applicant must be the IND sponsor, must have a candidate with proven disease modifying activity, and must maintain at least one clinical trial site in California.

How much funding can a PDEV award provide? Up to $13,000,000 total cost over up to 5 years. Early PDEV, the Pre IND stage, caps at $5,500,000 over 30 months. Late PDEV, the IND enabling stage, caps at $7,500,000 over 30 months.

Does PDEV require co-funding or matching funds? Unpartnered nonprofits do not need co-funding. For profit applicants, and nonprofits with a for profit partner, must commit at least 20 percent of total allowable project costs, either in cash or through equity warrants issued to CIRM.

What stage of development does my project need to be at? Your candidate needs reproducible, documented disease modifying activity in a preclinical model relevant to your target indication before you apply. This is a hard eligibility gate, not a scoring preference.

Can I apply for both the Pre IND and IND Enabling stages at once? Yes. Applicants can request funding across both Early PDEV and Late PDEV stages in a single application, though the two stages must be budgeted separately with defined, non-overlapping activities.

How long does the CIRM review process take? Roughly 60 days after the deadline for GWG selection, another 30 days for GWG discussion, then award approval at the next scheduled Application Review Subcommittee meeting. Once approved, awardees must start work within 90 days.

What review score does an application need to get funded? Applications need a median scientific score of 85 or higher out of 100 from the Grants Working Group to be considered to have exceptional merit and be eligible for funding.

Does CIRM fund the actual clinical trial? No. PDEV funds trial startup activities only, meaning protocol development, site preparation, and operational readiness. It does not fund patient recruitment, screening, enrollment, or the conduct of the trial itself.

How many PDEV awards does CIRM expect to fund this cycle? CIRM anticipates funding between 12 and 21 PDEV awards in FY26-27, depending on the mix of Early PDEV and Late PDEV applications recommended for funding.

Who is the IND sponsor under a PDEV award? The CIRM applicant organization itself, or the CIRM Principal Investigator in the case of an investigator sponsored IND. An outside partner cannot serve as the sponsor.

What kind of team does CIRM require on a PDEV application? At minimum a Principal Investigator at 15 percent effort, a Project Manager with relevant preclinical development experience at 50 percent effort, and a Data Project Manager responsible for data handling and sharing obligations.

ARPA-H FASTPASS Program: Rapid Drug Quality Screening Funding

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

Quick Answer

FASTPASS (Fast Assessment of Solutions, Therapeutics, Pharmaceuticals, and Supplies) is an ARPA-H program funding development of rapid, non-destructive screening tools that can verify pharmaceutical quality and safety through packaging, without opening boxes, in near real-time. The program targets ports, warehouses, and distribution centers where drug shipments currently face slow, low-coverage inspection. The solicitation is expected to release in mid-August 2026 and will be posted on SAM.gov. A virtual Proposer Workshop is scheduled for August 24, 2026, with registration required by August 20.

What problem is FASTPASS trying to solve?

Drug-related morbidity and mortality cost the U.S. healthcare system $528 billion per year. Drug recalls affect medication used by over 150 million Americans annually, and most recalls only surface after patients have already been exposed. Rising import volumes have outpaced FDA's ability to sample and test drugs at ports, where testing today only covers a small percentage of shipments and can take weeks to complete.

What is FASTPASS funding?

The program is structured around two technical areas.

TA1 SAMPLE funds advanced through-packaging sensing technologies that evaluate a product's chemical makeup using spectrographic or other non-contact, non-destructive methods.

TA2 DETECT funds analytics and models that transform existing spectroscopic techniques and address the technical gaps needed to bring next-generation detection methods into practice, building on what TA1 performers develop.

ARPA-H is looking for teams that combine expertise in non-contact spectroscopy, artificial intelligence and machine learning, pharmaceutical chemistry, and hardware engineering.

When does FASTPASS open?

The solicitation notice ID has not yet been assigned. ARPA-H expects to release the solicitation in mid-August 2026 on SAM.gov, with full details on requirements, deadlines, submission templates, and evaluation criteria to follow at that time.

Are there events for proposers?

Yes. A virtual Proposer Workshop (Notice ID ARPA-H-SN-26-157) is scheduled for August 24, 2026, with registration required by August 20 at 12:00 PM ET through the ARPA-H Solutions site. A second hybrid Proposers' Day will follow after the solicitation is published. ARPA-H recommends attending both to improve teaming opportunities.

Does FASTPASS require teaming?

ARPA-H anticipates teaming will be necessary given the breadth of expertise required. A teaming page is available on the ARPA-H Solutions site for proposers to post profiles and connect with potential partners. Listing on this page does not represent ARPA-H endorsement or evaluation of any team or individual.

Who runs the FASTPASS program?

James Coburn, CAPT, serves as Program Manager.

FAQs

Q: What does FASTPASS stand for?
A: FASTPASS stands for Fast Assessment of Solutions, Therapeutics, Pharmaceuticals, and Supplies. It's an ARPA-H program focused on rapid, non-destructive drug quality screening.

Q: When will the FASTPASS solicitation be released?
A: ARPA-H expects to release the solicitation in mid-August 2026. It will be posted and maintained on SAM.gov once available. A specific Notice ID has not yet been assigned.

Q: What are the two technical areas in FASTPASS?
A: FASTPASS has TA1 SAMPLE, which funds through-packaging sensing technology using spectrographic or other non-contact methods, and TA2 DETECT, which funds analytics and models that build on TA1 sensing data to support next-generation detection.

Q: What kind of companies should apply to FASTPASS?
A: Companies working in non-contact spectroscopy, sensor hardware, artificial intelligence and machine learning, pharmaceutical chemistry, or hardware engineering are strong candidates. ARPA-H is specifically looking for cross-disciplinary teams rather than single-domain solutions.

Q: Is teaming required for FASTPASS?
A: ARPA-H anticipates that teaming will be necessary given the breadth of expertise the program requires. A teaming profile page is available on the ARPA-H Solutions site for proposers to find potential partners. Being listed does not mean ARPA-H has endorsed or evaluated that team.

Q: What is the Proposer Workshop and when is it?
A: The Proposer Workshop is a virtual event for the proposer community to learn more about FASTPASS, ask questions, and make connections. It's scheduled for August 24, 2026, and registration is required by August 20, 2026 at 12:00 PM ET on the ARPA-H Solutions site.

Q: Is there a second event after the solicitation is released?
A: Yes. ARPA-H will hold a hybrid Proposers' Day after the solicitation publishes to give additional guidance on the process. ARPA-H recommends attending both events to maximize teaming opportunities.

Q: Who is the Program Manager for FASTPASS?
A: James Coburn, CAPT, is the Program Manager for FASTPASS.

Q: What problem is FASTPASS trying to solve?
A: Drug-related morbidity and mortality cost the U.S. healthcare system $528 billion annually, and drug recalls affect over 150 million Americans each year, usually only surfacing after patients are already exposed. Current port inspection only samples a small fraction of imported drugs and can take weeks. FASTPASS aims to close that gap with in-minutes, non-destructive screening.

Q: Where can I find the FASTPASS teaming and FAQ pages?
A: Both are hosted on the ARPA-H Solutions site. You'll need to create an account or sign in to submit teaming profiles or ask questions in the FAQ section.

USAMRDC/Defense Health Agency Broad Agency Announcement for Extramural Medical Research:

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

Overview of the Funding Opportunity

This is the USAMRDC/Defense Health Agency Broad Agency Announcement for Extramural Medical Research, funding opportunity number HT942523SBAA1. It's continuously open for a full five-year window, October 1, 2022 through September 30, 2027, so there's no application deadline in the usual sense. Instead, organizations submit a pre-proposal through eBRAP at any time, and if invited, follow with a full proposal/application. This is one of the largest standing military medical research vehicles in the federal system, and it funds applied research, preclinical research, clinical research, and clinical trials across nine program areas ranging from infectious disease to psychological health to traumatic brain injury.

Program Areas of Interest

The BAA covers nine research portfolios:

• Military Infectious Diseases

  • This portfolio covers the prevention, diagnosis, and treatment of infectious diseases that threaten deployed forces, including combat-associated wound infections and multidrug-resistant organisms that show up more often as casualties move through prolonged care. DHA is organizing this work around three capability buckets: preventing infections before they start, diagnosing them fast in far-forward settings, and treating both initial infections and resistant strains across the full continuum of care. Companies with diagnostics, prophylactics, or wound-care technology aimed at combat environments are a strong fit here.

• Combat Casualty Care

  • This is the broadest and most technology-forward portfolio in the BAA. It spans point-of-need trauma care, resuscitation, complex injury and organ support, forward surgical care, wound and burn recovery, transport physiology, en route care, virtual health and monitoring, scalable triage, and autonomous systems. DHA is specifically calling out AI-enabled decision support, telemedicine platforms, and autonomous or robotic evacuation and care technology as capability gaps, which makes this the natural landing spot for medtech and defensetech companies building anything that helps stabilize, monitor, or move a casualty when evacuation is delayed or contested.

• Traumatic Brain Injury

  • This program funds diagnosis, prognosis, and treatment of TBI across the full severity spectrum, from mild concussion to penetrating injury, including blast overpressure and polytrauma cases. Focus areas include noninvasive far-forward assessment tools, fluid-based biomarkers, minimally invasive intracranial access, and return-to-duty validation. Any TBI-related clinical research funded here that includes 50 or more subjects has to be shared through the DOD-NIH FITBIR data system, so companies should budget for that requirement. Training, chronic TBI management, neurodegenerative disease, and spinal cord injury are explicitly out of scope.

• Psychological Health

  • This portfolio funds research that assesses, protects, and optimizes the psychological readiness of Service Members, their families, and the broader military community. It's organized around seven capability areas: objective assessment tools, countermeasures tailored to military community needs, prevention strategies against emerging threats, better models of care for both early intervention and tailored treatment, return-to-duty guidelines, and tools that help Service Members and units build psychological readiness. It's intentionally broad across clinical conditions rather than tied to one specific diagnosis.

• Sensory Systems

  • This program covers pain, ocular, auditory, and vestibular injuries and illnesses tied to military service. The capability requirements focus on mechanistic characterization of injury, better assessment and diagnostic tools, point-of-injury stabilization, and treatment development, with named focus areas in pain control and anesthesia, temporary corneal repair, and auditory injury assessment. Chronic pain, regenerative or transplant approaches, and anything overlapping with TBI are out of scope.

• Musculoskeletal Injury

  • This portfolio funds prevention, diagnosis, treatment, and rehabilitation of musculoskeletal injuries, with the goal of reducing injury risk and speeding safe return to duty. Priority areas include rehabilitation interventions and technologies usable in pre-hospital settings, therapeutics that accelerate recovery, and broader musculoskeletal health preservation. Spinal cord injury treatment is excluded.

• Environmental Exposures

  • This program addresses health threats from extreme heat and cold, high altitude, military diving, toxic exposures, aviation medicine, and vibration or acceleration, across basic, applied, and advanced technology development research. Weaponized CBRN, blast injury, infectious disease, and noise are handled elsewhere in the BAA and are out of scope here. This is a narrower portfolio but a real fit for companies with environmental monitoring or countermeasure technology relevant to operational medicine.

• Directed Energy/Radiation Health

  • This portfolio splits into two lanes. Directed energy research looks at distinguishing a harmless "bioeffect" from an actual adverse health effect following radiofrequency, optical, or acoustic exposure, with an eye toward informing safety standards and clinical guidelines. Radiation health research covers pre-exposure prophylaxis, biomarkers for diagnosis and treatment, and characterization of radiation injury mechanisms, including combined injuries where radiation exposure overlaps with trauma like hemorrhage or burns.

• DOD Working Dogs

  • This is the only portfolio focused on military working dogs rather than human Service Members. It funds research into canine musculoskeletal injury prevention, wound recovery and therapeutics, and pain management, including breed and genetics-based risk factors and return-to-duty protocols for MWDs. It's a small niche but a real one, and it's worth flagging for any client with veterinary or animal health technology.

Each portfolio has its own capability requirements and detailed Research Areas of Interest laid out in Appendix I, and applicants are expected to align tightly to those before writing a pre-proposal. A few areas stand out for dual-use technology companies: Combat Casualty Care explicitly calls out autonomous systems, AI-enabled clinical decision support, and virtual health/telemedicine platforms as capability gaps, and Traumatic Brain Injury calls for noninvasive diagnostic tools and fluid-based biomarkers. Environmental Exposures and Directed Energy/Radiation Health are narrower but still open to biotech and medtech companies with relevant countermeasure or biomarker technology.

Funding and Award Structure

There's no funding ceiling or floor specified. Budgets should scale to the complexity of the proposed work, and awards can take the form of a grant, cooperative agreement, procurement contract, or Other Transaction Agreement for research or prototypes, at the government's discretion. Assistance agreements can run up to 4 years, contracts up to 5 years, and no proposal will be funded more than 24 months after it's submitted. There's no cost-sharing requirement in the general case.

Eligibility

Eligibility is broad: for-profit, nonprofit, academic, and public/private organizations of any size can apply, including international entities, as long as they're extramural to DOD (FFRDCs and DOD intramural investigators are excluded from direct awards, though teaming and collaborator arrangements are allowed). Small businesses, including veteran-owned, HUBZone, and woman-owned firms, get preference for subaward participation. Awards go to organizations, not individuals, so the PI needs an eligible organizational home.

Submission Process

This is a two-step process. Step one is a pre-proposal/pre-application submitted through eBRAP.org at any time before the BAA closes. It has to describe a specific idea or project tied to one of the nine program areas above, no vague capability statements. If DHA likes it, the organization is invited to submit a full proposal through Grants.gov. Because this BAA never closes and reopens on a schedule, companies with a clear technical fit can move whenever they're ready rather than waiting on a cycle.

Why This Matters for BW&CO Clients

This BAA is a strong long-running fit for any client doing combat casualty care tech, TBI diagnostics or biomarkers, psychological health tools, sensory injury devices, or musculoskeletal recovery technology, especially companies with AI-enabled monitoring, autonomous care, or diagnostic platforms that map to the Combat Casualty Care and TBI focus areas. Because there's no deadline pressure, this is a good one to keep in the pipeline as a standing opportunity rather than a one-time push.

FAQs

Is there a deadline to apply for this BAA?
No. It's continuously open from October 1, 2022 through September 30, 2027. Organizations can submit a pre-proposal at any time before it closes.

How do I actually apply?
It's a two-step process. First you submit a pre-proposal/pre-application through eBRAP.org describing a specific project idea tied to one of the nine program areas. If DHA is interested, you're invited to submit a full proposal through Grants.gov.

How much funding is available, and is there a cap on award size?
There's no specified funding limit and no set number of awards. Budgets should be sized to the complexity of the proposed research, and the government funds proposals based on technical merit, program fit, and available funding, which varies year to year.

What kind of award will I get, a grant or a contract?
That's up to the government. Awards can be procurement contracts, grants, cooperative agreements, or Other Transaction Agreements for research or prototypes. The choice depends on the nature of the work and the relationship the government wants with the recipient.

How long can the project run?
Assistance agreements (grants and cooperative agreements) can run up to 4 years. Contracts can run up to 5 years. Regardless of instrument type, no proposal will be considered for funding more than 24 months after it was submitted.

Is cost-sharing required?
No, not in the general case. There's no cost-sharing or matching requirement to be eligible, except in specific situations involving Other Transaction Agreements, where separate cost-sharing rules under 10 USC 4021/4022 or 32 CFR 37 apply.

Who's eligible to apply?
Any extramural organization: academic institutions, biotech and medtech companies, foundations, non-DOD government agencies, and research institutes, regardless of nationality. FFRDCs can't receive awards directly but can team with eligible organizations. DOD intramural investigators can't apply directly either, though they can participate as named collaborators with command authorization.

Do awards go to individuals or organizations?
Organizations only. A principal investigator has to be affiliated with an eligible organization to be part of a proposal.

Does this BAA fund clinical trials?
Yes. It supports applied research, preclinical research, clinical research, and clinical trials. Proposals involving a clinical trial have additional requirements laid out in Appendix II, including IRB-approved informed consent forms posted to a public federal website.

What happens if I want continuation or follow-on funding?
You'll need to submit a new pre-proposal and go through the invitation process again. Continuation funding isn't automatic.

Are there research areas that are explicitly out of scope?
Yes, and they vary by program. Examples include weaponized CBRN, blast, infectious disease, and noise under Environmental Exposures, chronic pain and regenerative/transplant work under Sensory Systems, and spinal cord injury under both TBI and Musculoskeletal Injury. Check Appendix I for the specific program you're targeting before writing a pre-proposal.

Where can I find the detailed research priorities for each program?
Appendix I of the BAA lists Research Areas of Interest for all nine portfolios in detail, and DHA strongly encourages applicants to review those before drafting anything.

PCORI Broad Pragmatic Studies PFA: Cycle 3 2026

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

Quick Answer

The Patient-Centered Outcomes Research Institute (PCORI) will open its Broad Pragmatic Studies (BPS) PCORI Funding Announcement (PFA) for Cycle 3 2026 on August 4, 2026. This funding opportunity supports patient-centered comparative clinical effectiveness research (CER) that compares two or more existing health treatments, services, or care delivery strategies. PCORI will commit up to $120 million in direct costs across three funding categories, with individual awards ranging from under $5 million to as much as $12 million and project periods of up to five years. The Letter of Intent (LOI) is due September 9, 2026, and the full application deadline is January 12, 2027. This opportunity is open to research teams, clinicians, health systems, and organizations conducting patient-centered CER, rather than early-stage product development, so it is best suited for applicants with an established research infrastructure and patient partnership plan already in place.

What Is the PCORI Broad Pragmatic Studies PFA?

The BPS PFA is one of PCORI's core recurring funding mechanisms, issued three times per year, designed to fund large-scale, high-impact comparative clinical effectiveness research. Unlike early-stage federal SBIR/STTR awards focused on technology development, PCORI funding is built around answering real-world clinical questions: which of two or more available treatments, services, or care delivery approaches produces better outcomes for patients. Studies must directly compare interventions already in use or shown to be efficacious, not develop new drugs, devices, or diagnostics from scratch.

Applicants are strongly encouraged to propose individual- or cluster-randomized controlled trials, though well-designed natural experiments and observational studies will also be considered. PCORI expects proposed outcomes to be clinically meaningful, validated, and important to patients themselves, and every application must meaningfully incorporate patient and stakeholder partnership consistent with PCORI's Foundational Expectations for Partnerships in Research.

Key Dates

PFA opens: August 4, 2026

Applicant Town Hall: August 13, 2026, 11:30 am ET

Letter of Intent deadline: September 9, 2026, 5 pm ET

LOI status notification: October 14, 2026

Full application deadline: January 12, 2027, 5 pm ET

Merit review: March 2027

Awards announced: August 2027 (subject to change)

Earliest start date: December 2027

Funding Amounts and Categories

PCORI will commit up to $120 million in direct costs across all categories in this cycle. The BPS PFA is structured into three distinct funding categories, and applicants must select the category that matches the scale and design of their proposed study.

Category 1 supports research projects with direct costs up to and including $5 million. This is the standard entry point for most single-site or moderately scaled pragmatic trials.

Category 2 supports research projects with direct costs greater than $5 million, up to a maximum of $12 million. Applicants pursuing Category 2 funding must provide additional justification in both the LOI and full application explaining why the scale, scope, and complexity of the research question requires the larger budget, and must include planned subgroup analyses that generate clinically actionable information.

Category 3 supports research projects with direct costs up to $12 million that use PCORnet, PCORI's national clinical research network, to conduct observational studies or pragmatic trials at a national scale. Category 3 studies must involve two or more Clinical Research Networks and are expected to leverage the PCORnet Common Data Model, along with sharing study progress and performance metrics across the network.

All three categories allow project periods of up to five years, and applicants may request coverage of patient care costs, including medical products, procedures, and care services, as part of the overall direct cost budget.

Special Areas of Emphasis for Cycle 3 2026

PCORI has identified five Special Areas of Emphasis (SAEs) it is particularly interested in for this cycle. These SAEs are meant to encourage, not restrict, applications, so proposals outside these areas remain eligible and competitive.

Mental health and substance use outcomes in pregnant and postpartum populations. PCORI is prioritizing research comparing efficacious or widely used interventions addressing mental health and substance use during pregnancy and through 12 months postpartum, including pharmacological approaches to perinatal mental health, suicide prevention strategies, and substance use treatment tailored to this population. Applicants proposing retrospective-only observational designs requesting more than $2 million in direct costs will receive lower funding priority.

Post-treatment follow-up care for cancer survivors. PCORI is interested in comparing different models of post-treatment follow-up care, including risk-based stratified approaches and models integrating rehabilitation and mental health services. Priority populations include adolescent and young adult survivors, older survivors with multiple chronic conditions, metastatic cancer survivors, long-term survivors, and studies addressing rural care settings or pediatric-to-adult care transitions.

Diabetes prevention, care, and treatment. This SAE covers pharmacological interventions and combination therapies, multi-component approaches integrating lifestyle and medication strategies, advanced diabetes technologies such as continuous glucose monitoring and automated insulin delivery, and care delivery or coordination models across settings and populations, including patients with multiple chronic conditions.

Management of neuropathic pain. PCORI seeks comparative research on strategies to improve screening, diagnosis, treatment, and management of pain associated with neuropathy, including painful diabetic neuropathy and neuropathy resulting from cancer treatment. Applications are encouraged to include at least one validated primary pain outcome.

Management of pain in individuals with intellectual and developmental disabilities or Alzheimer's disease and related dementias. This SAE covers comparative strategies for prevention, screening, diagnosis, treatment, and management of pain in these populations, again with a validated primary pain outcome encouraged.

Structured Mentorship

Applicants to any category of this PFA may propose coverage of structured mentorship activities to support early- or mid-career investigators, investigators transitioning into patient-centered CER, or patient and community partners. Specific criteria apply, and PCORI notes that funding for requested mentorship activities is not guaranteed even if proposed.

Application Deferral Policy

Applicants who submit an LOI and are invited to submit a full application may defer their submission one time to the immediate next PFA cycle, and this deferral may cross calendar years if needed. This gives teams additional runway to strengthen study design, secure partnerships, or finalize budgets without losing their place in the pipeline.

Research Project Agenda Topic Themes

Applicants may select up to three Topic Themes from PCORI's broader Research Project Agenda that best align with their proposed study, or select "other" if their research does not map cleanly to an existing theme. Selecting a Topic Theme or SAE is intended to help PCORI route and prioritize review, not to limit who can apply.

Who Should Apply

This opportunity is best suited for research teams, academic medical centers, health systems, and clinician-scientists with an existing capacity to conduct rigorous comparative effectiveness research at scale, along with genuine patient and stakeholder partnerships already established or in development. It is not the right mechanism for early-stage technology development, new drug or device discovery, or studies focused solely on implementation science, dissemination, or research methods development, as PCORI explicitly excludes these from consideration under this PFA.

Frequently Asked Questions

What is the PCORI Broad Pragmatic Studies PFA Cycle 3 2026?

It is a funding announcement from the Patient-Centered Outcomes Research Institute supporting large-scale, patient-centered comparative clinical effectiveness research comparing existing treatments, services, or care delivery strategies, with up to $120 million available across three funding categories.

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When does the PFA open and when is the Letter of Intent due?

The PFA is expected to open August 4, 2026. The Letter of Intent deadline is September 9, 2026, at 5 pm ET, with LOI status notifications sent October 14, 2026.

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When is the full application due?

The full application deadline is January 12, 2027, at 5 pm ET. Merit review takes place in March 2027, with awards expected to be announced in August 2027 and an earliest project start date of December 2027.

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How much funding is available?

PCORI will commit up to $120 million in direct costs across Category 1, Category 2, and Category 3 combined. Category 1 supports awards up to $5 million, Category 2 supports awards between $5 million and $12 million, and Category 3 supports awards up to $12 million for PCORnet-based national studies.

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What is the maximum project period?

Up to five years for all three funding categories.

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Does this PFA fund new product or device development?

No. This PFA funds comparative effectiveness research on treatments, services, or care delivery approaches that are already in use or already shown to be efficacious. It does not fund early-stage technology development, new drug discovery, or studies focused only on implementation, dissemination, or research methods.

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What are the Special Areas of Emphasis for Cycle 3 2026?

Perinatal mental health and substance use, post-treatment follow-up care for cancer survivors, diabetes prevention and care, management of neuropathic pain, and pain management in individuals with intellectual and developmental disabilities or Alzheimer's disease and related dementias.

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Is patient partnership required?

Yes. All applicants must address PCORI's Foundational Expectations for Partnerships in Research, ensuring patients and other research partners meaningfully contribute lived experience or professional expertise throughout the study.

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Can applicants defer a submission to a later cycle?

Yes. Applicants invited to submit a full application after an LOI may defer once to the immediate next PFA cycle, even across calendar years.

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Where can applicants get more information or ask questions?

Questions about Cycle 3 2026 can be directed to pfa@pcori.org. PCORI is also hosting an Applicant Town Hall on August 13, 2026, at 11:30 am ET.

FDA RFA-FD-26-012 | Digital Health Technologies for Drug Development Funding (U01)

Quick Answer:

FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are jointly funding a U01 Research Project Cooperative Agreement focused on using digital health technologies (DHTs) — actigraphy, photography, contactless sensors — for remote data acquisition in drug and biologic clinical trials. CDER intends to fund up to 2 awards, totaling $2.2 million in FY2026, with each award providing up to $1.1M/year across a 2-year project period. Unlike a standard SBIR, this is a cooperative agreement, meaning FDA scientific staff will be substantially involved in protocol review and study design throughout the project.

Applications are due August 20, 2026, by 11:59 PM local time.

What Does This Opportunity Fund?

Four illustrative (non-exclusive) project types:

• Comparing digital measurements to traditional clinical trial measurements

• Developing novel DHT-based endpoints for unmet drug development needs (e.g., contactless sensors detecting pediatric apnea)

• Comparing continuous measurement metrics (e.g., activity/stamina)

• Capturing early manifestations of chronic disease through DHTs (e.g., balance or reaction-time testing for early dementia signs)

What Makes This Different From a Standard NOFO?

• Cooperative agreement (not a grant) — FDA retains substantial programmatic involvement, including protocol review at milestones

• Clinical Trial Optional — applicants can propose a trial or non-trial project

• Applies to drugs/biologics only, not devices

• Research Strategy section capped at 12 pages (FDA does not follow standard NIH page limits)

How Is It Reviewed?

Standard FDA Objective Review Process, scored across five weighted criteria:

• Significance (20 pts)

• Investigator(s) (20 pts)

• Innovation (25 pts)

• Approach (25 pts)

• Environment (10 pts)

Who Is Eligible?

Broad eligibility — universities, nonprofits, small businesses, other for-profits, and eligible government entities. Foreign organizations and foreign components are not eligible. No cost-sharing required. Multiple applications allowed if scientifically distinct.

Key Dates

• Posted: July 20, 2026

• Open Date: July 20, 2026

• Application Due: August 20, 2026

• Expiration: August 21, 2026

How Can BW&CO Help?

This is a cooperative agreement, not a typical grant — framing the Research Strategy to anticipate FDA's ongoing programmatic involvement (not just initial review) is critical. Our approach helps clients position DHT-based endpoints and study designs that align with FDA's DHT Framework priorities from the outset.

NIH Highlighted Topic: Advancing Nutrition Research to Inform Regulatory Practice

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 focused on advancing gold standard nutrition and food science to inform regulatory practice, with participation from experts spanning nutrition, toxicology, risk analysis, behavioral science, infant and child development, and chronic disease research. This highlighted topic aims to address rising diet-related chronic disease rates through a cross-governmental research agenda co-developed by NIH and FDA to safeguard the health of all Americans.

Priority research spans three major areas: ultra-processed foods, early life nutrition and feeding practices, and nutrition-related toxicology. NIH is particularly interested in identifying which characteristics of highly processed foods, such as specific additives, processing steps, or food matrix alterations, are most predictive of adverse health outcomes, and whether objective biomarkers of exposure to these foods exist. On early life nutrition, NIH highlights the need to understand physiological differences between formula-fed and breastfed infants, the role of Human Milk Oligosaccharides in immune and neurocognitive development, and variability in human milk composition across lactation phases.

Areas of interest include mechanisms linking ultra-processed food consumption to metabolic health and satiety hormone regulation, standardized approaches for evaluating bioactive infant formula ingredient safety, exposure of infants and young children to heavy metals and contaminants in the food supply, moderating effects of nutrients on heavy metal toxicity in child health, relationships between infant feeding practices and oral health outcomes including dental caries, and identification of environmental contaminants such as PFAS and microplastics introduced during food growing, processing, and packaging.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures.

This highlighted topic is supported primarily by the Office of Nutrition Research (ONR), with additional participation from the National Cancer Institute (NCI), National Institute on Aging (NIA), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Environmental Health Sciences (NIEHS), National Institute of Nursing Research (NINR), Office of Behavioral and Social Sciences Research (OBSSR), Office of Disease Prevention (ODP), Office of Dietary Supplements (ODS), Office of Data Science Strategy (ODSS), and Office of Research on Women's Health (ORWH), all of which are seeking rigorous nutrition science to inform food and regulatory policy.

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 technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Accelerating Otitis Media Research and Workforce Development

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 workforce development focused on accelerating basic, clinical, and translational research into otitis media (OM), one of the most common childhood illnesses and a leading cause of pediatric antibiotic prescriptions. This highlighted topic aims to build research capacity by cultivating the next generation of OM investigators alongside advancing the science itself.

More than 80% of children experience at least one episode of OM by age three, and NIH notes that recurrent or chronic disease can substantially affect development, including prolonged conductive hearing loss and delays in speech, language, and learning, with annual U.S. healthcare costs estimated at over $4.5 billion. Current prevention relies primarily on the pneumococcal conjugate vaccine, which has had only modest effects due to pathogen replacement, and NIH notes that the factors distinguishing OM-susceptible from OM-resistant children remain poorly understood. NIH is particularly interested in expanding treatment options beyond antibiotics and pressure equalization tubes.

Areas of interest include mentored research training experiences for pre- and post-doctoral trainees focused on OM, support for early-stage researchers building OM research programs, and opportunities for investigators at any career stage to redirect existing expertise in biofilm, metabolomics, genomics, pathogenesis, immunity, pharmacology, infectious disease, epidemiology, or bioinformatics toward OM-specific questions. Scientific topics of interest span the epidemiology, etiology, pathophysiology, diagnosis, prevention, and treatment of OM.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures. Given the explicit workforce/training framing, this topic is also a strong fit for fellowship (F-series), career development (K-series), and training grant (T-series) mechanisms alongside standard R-series awards.

This highlighted topic is supported by the National Institute on Deafness and Other Communication Disorders (NIDCD), with additional participation from the National Institute of Allergy and Infectious Diseases (NIAID), both of which are seeking to expand research capacity and innovation in understanding and treating this high-burden childhood illness.

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 technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Strengthening Biomedical Research, Promoting Trust, and Improving Health through Bioethics 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 focused on integrating bioethics principles across the full spectrum of biomedical and behavioral research, from fundamental science through clinical research and dissemination of findings. This highlighted topic aims to advance actionable bioethics projects that build public trust, promote participant autonomy, and sustain community engagement in science.

NIH notes that integrating bioethics considerations strengthens research rigor and impact, helping ensure that evidence-based products are more readily adopted by the communities they serve. NIH is particularly interested in projects spanning artificial intelligence ethics and transparency, effective community engagement and co-development of research priorities, informed consent strategies for emerging data sources like wearables and electronic health records, approaches for returning aggregate and individual research results, and cross-cutting issues in data sharing and biosecurity.

Areas of interest include ethical implications of broad access to emerging neurotechnologies and invasive neural techniques, ethical, legal, and social implications of genomics across research design and healthcare delivery, bioethical aspects of gene editing and organ transplant shortages for heart and lung conditions, informed consent approaches tailored to older adults with cognitive or sensory limitations, stigma's impact on clinical trial recruitment for alcohol use disorder, community acceptance of controlled human infection trials and genome editing for infectious disease research, ethical frameworks for biomedical technology development including AI/ML and point-of-care devices, and neuroethical issues around brain organoid research, neuroimaging, and populations with limited consent capacity.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures.

This highlighted topic is supported by an exceptionally broad coalition of ICOs and initiatives, including the Office of Science Policy (OSP), the BRAIN Initiative, National Cancer Institute (NCI), National Eye Institute (NEI), National Human Genome Research Institute (NHGRI), National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institute on Drug Abuse (NIDA), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Nursing Research (NINR), Office of AIDS Research (OAR), Office of Behavioral and Social Sciences Research (OBSSR), and Office of Data Science Strategy (ODSS), reflecting how foundational bioethics considerations have become across virtually every domain of NIH-supported research.

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 technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Advancing Autoimmune Disease Research: Integrating Genetic, Environmental, and Immunological Factors to Improve Diagnosis and Treatment

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 focused on integrating genetic, environmental, and immunological factors to advance understanding of autoimmune disease development, progression, and treatment. This highlighted topic aims to improve diagnosis and health outcomes for the 23.5-50 million Americans affected by more than 140 different autoimmune diseases and conditions.

A common feature of many autoimmune diseases is an asymptomatic prodromal period marked by autoantibodies and immune activation markers, and NIH notes that people with one autoimmune disease face elevated likelihood of developing additional ones, suggesting shared pathogenic mechanisms and risk factors. While genetics contributes to susceptibility, it cannot explain the rapidly rising incidence and prevalence of autoimmune diseases, pointing to the exposome as a critical but understudied factor complicated by exposure latency and life-stage-dependent effects. NIH is particularly interested in projects that integrate exposome research into longitudinal studies spanning the pre-clinical period through disease course, and that develop New Approach Methodologies exploring shared mechanisms across co-occurring autoimmune disorders.

Areas of interest include studying immune surveillance breakdown at the cancer-autoimmunity intersection and immune-related adverse events from cancer immunotherapy, advancing diagnosis and treatment of ocular autoimmune diseases like uveitis and Sjogren's syndrome, developing generalizable genomic and computational methods applicable across multiple autoimmune diseases, investigating immunosenescence and autoimmune disease's impact on brain aging and Alzheimer's risk, understanding autoimmune inner ear disease and sudden hearing loss, characterizing autoimmune manifestations in oral and craniofacial tissues, examining links between autoantibodies and pediatric neuropsychiatric syndromes like PANDAS/PANS, addressing health disparities in autoimmune disease incidence across U.S. regions and populations, and developing point-of-care technologies, wearables, and imaging tools for autoimmune disease monitoring.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures.

This highlighted topic is supported by an exceptionally broad coalition of ICOs, including the Office of Research on Women's Health (ORWH)/Office of Autoimmune Disease Research, National Cancer Institute (NCI), National Eye Institute (NEI), National Human Genome Research Institute (NHGRI), National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Biomedical Imaging and Bioengineering (NIBIB), NICHD, National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Environmental Health Sciences (NIEHS), National Institute of Mental Health (NIMH), National Institute on Minority Health and Health Disparities (NIMHD), National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Nursing Research (NINR), and National Library of Medicine (NLM), reflecting how autoimmune disease intersects with nearly every organ system and NIH mission area.

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 technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Training and Career Development in Dissemination and Implementation Science

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 training focused on dissemination and implementation (D&I) science to build capacity for translating evidence-based innovations into clinical practice and everyday life. This highlighted topic aims to advance career development through Fellowships, Career Development Awards, Institutional Research Training Grants, and Education Projects that build expertise in D&I theories, strategies, outcome measurement, and analytical methods.

D&I research remains an emerging area across many health specialties, and NIH notes that fields need to build capacity for high-quality research examining how evidence-based practices, programs, and policies get adopted, distributed, and sustained in real-world settings. NIH is particularly interested in training that spans D&I theories and frameworks, community-engaged research approaches, qualitative and mixed methods, human-centered design, pragmatic and hybrid effectiveness-implementation trial designs, and methods to understand and reduce health disparities.

Areas of interest include building D&I expertise in sensory and communication disorder research where theory-guided studies remain scarce, training scientists to integrate complementary and integrative health approaches into real-world care settings, advancing mechanistic D&I methods across the cancer care continuum, preparing genomic medicine researchers for evidence-based information dissemination, developing implementation science expertise for heart, lung, blood, and sleep disorder interventions, building dual expertise in substance use and implementation science, training in D&I methods for pediatric, reproductive health, and disability populations, and developing HIV-focused implementation science training emphasizing mentorship and community engagement.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures. Given the training/career-development framing, this topic is also a strong fit for institutional training grant (T-series) and individual fellowship (F-series) mechanisms specifically, alongside R-series awards.

This highlighted topic is supported by an unusually broad coalition of ICOs, including the National Institute on Deafness and Other Communication Disorders (NIDCD), National Center for Complementary and Integrative Health (NCCIH), National Cancer Institute (NCI), National Human Genome Research Institute (NHGRI), National Heart, Lung, and Blood Institute (NHLBI), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), NICHD, National Institute on Drug Abuse (NIDA), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Nursing Research (NINR), Office of AIDS Research (OAR), Office of Behavioral and Social Sciences Research (OBSSR), and Office of Disease Prevention (ODP), reflecting the widespread recognition across NIH that D&I science training capacity needs strengthening.

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 technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Biology- and Physics-Informed Explainable AI Across the Lifespan

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 focused on applying explainable artificial intelligence (XAI) that is mechanistically grounded in physics-based or biology-based principles across the lifespan. This highlighted topic aims to advance interpretable AI approaches that enhance understanding of biological and health-related mechanisms, heterogeneity, and temporal dynamics, while supporting robust prediction of health and disease risks across the life course.

While AI and machine learning have demonstrated utility in predicting health-related outcomes, NIH notes that many existing approaches function as black boxes, limiting mechanistic insight, biological interpretability, and translational relevance. NIH is particularly interested in projects that move beyond purely statistical prediction to incorporate mechanistic constraints, causal or dynamical systems models, domain-informed priors, or hybrid models integrating data-driven learning with first-principles knowledge, ensuring reproducibility and enabling hypothesis generation.

Areas of interest include XAI approaches that model within-person aging dynamics and identify critical transitions or inflection points tied to underlying mechanisms, methods characterizing inter-individual variability and aging subtypes with interpretable explanations of resilience and vulnerability, interpretable models that predict future health and functional decline while enabling retrospective interpretation of prior exposures, and explainable integration of molecular, cellular, physiological, behavioral, environmental, and clinical data across time.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures.

This highlighted topic is supported primarily by the National Institute on Aging (NIA), which is seeking mechanistically grounded, interpretable AI research that advances understanding of aging trajectories and health dynamics across the lifespan.

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 technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Epidemiological Studies of Vaccination and Health Outcomes Across the Lifespan

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 focused on comprehensively evaluating the relationships between vaccination and both positive and negative long-term health outcomes across the lifespan. This highlighted topic aims to advance large-scale epidemiological studies that move beyond the short-term outcomes examined in most prior adverse event research, using newer data sources and more robust study designs.

NIH notes that prior reports, including the 2013 Institute of Medicine report on the childhood immunization schedule and CDC's Vaccine Safety Datalink white paper, have identified a need to evaluate various aspects of vaccination schedules, including limited ability to compare schedule variations and insufficient integration of clinical outcomes with biological and environmental data. This topic is issued as part of the Make America Healthy Again initiative, aligning with HHS's new vaccine injury research program at the NIH Clinical Center. NIH is particularly interested in projects that combine real-world data, large-scale longitudinal cohorts, and biomarker identification to support causal inference and precision vaccination strategies for vulnerable subpopulations, with careful attention to confounding bias and multiple comparisons.

Areas of interest include leveraging large-scale longitudinal cohorts and real-world data to assess rare or delayed vaccine-associated events, evaluating vaccine schedules, components, platforms, and timing including cumulative and interacting exposures, identifying biomarkers and immune signatures underlying heterogeneous long-term responses, integrating multi-omics and systems biology data to understand vaccines' effects on the immune system over time, and studying interactions between vaccine exposures and environmental factors such as air pollutants, endocrine-disrupting chemicals, and microplastics.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures.

This highlighted topic is supported primarily by the National Institute of Allergy and Infectious Diseases (NIAID), with additional participation from the National Institute of Environmental Health Sciences (NIEHS) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), all of which are seeking rigorous, data-driven epidemiological research into vaccine benefits and potential adverse outcomes.

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 technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Using Clinical Studies and Human-Based Models to Understand Vaccine Mechanisms Impacting Efficacy and Safety

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 focused on using clinical studies and human-based models to understand the biological mechanisms underlying vaccine efficacy, safety, non-target effects, and susceptibility to adverse events. This highlighted topic aims to advance New Approach Methodologies (NAMs), including human cell-based systems, organoids, microphysiological systems, and computational models, to move beyond descriptive associations toward causal, mechanistic understanding of vaccine responses.

Traditional animal models are limited in capturing human-specific pathways, susceptibility factors, and long-term health effects, and NIH notes that existing post-market surveillance systems generally capture disease outcomes without exploring the biomarkers that could illuminate mechanistic pathways. This topic is issued as part of the Make America Healthy Again initiative, aligning with NIH's expanded commitment to NAMs alongside the EPA and FDA, and with HHS's new vaccine injury research program at the NIH Clinical Center. NIH is particularly interested in projects that identify susceptibility factors such as genetic background, sex, and developmental stage, and that integrate NAMs with clinical and epidemiological data.

Areas of interest include validation and regulatory alignment of NAM approaches, elucidating immune activation pathways and reactogenicity mechanisms, modeling neuroimmune and neurodevelopmental effects, characterizing maternal-fetal and early-life immune interfaces, evaluating cumulative and schedule-related vaccine effects, distinguishing protective from atypical or exaggerated immune responses linked to adverse outcomes, and studying interactions between vaccine mechanisms and environmental exposures such as air pollutants, endocrine-disrupting chemicals, and microplastics.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures.

This highlighted topic is supported primarily by the National Institute of Allergy and Infectious Diseases (NIAID), with additional participation from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Environmental Health Sciences (NIEHS), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), all of which are seeking mechanistic, human-relevant research into vaccine safety and efficacy.

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 technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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.