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.

DARPA Quantum Benchmarking Initiative (QBI) 2026: What Startups Need to Know

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

Quick Answer

DARPA's Quantum Benchmarking Initiative (QBI) 2026 Program Announcement, DARPA-PA-26-02, is not a standard solicitation you propose directly against. It is an umbrella announcement that opens the door for individual QBI Topic (QBIT) calls, which is where the actual proposal opportunities, funding details, and deadlines will live. The program's mission is to independently verify and validate whether any approach to quantum computing can reach utility scale by 2033. DARPA is looking for revolutionary, high risk, high reward paths to a utility scale quantum computer (USQC), not incremental improvements to existing systems. The overarching PA closes December 30, 2026, following a July 29, 2026 amendment that also moved oversight from the Microsystems Technology Office (MTO) to the newly formed Multi X Office (MXO) and named a new Program Manager, Dr. Micah Stoutimore.

What Is QBI, in Plain Terms

QBI exists because nobody actually knows if or when a fault tolerant, utility scale quantum computer can be built. DARPA defines "utility scale" as a machine whose computational value exceeds its cost. Rather than betting on one architecture, DARPA created QBI as a rigorous, third party verification and validation program. If a company claims it has a credible path to utility scale quantum computing, QBI is how DARPA tests that claim, helps the company identify and burn down real risks, and then communicates validated results to other government stakeholders who might want to acquire or use the technology.

QBI 2026 is the newest on-ramp into that program. It builds on the original Underexplored Systems for Utility-Scale Quantum Computing program (US2QC, DARPA-PS-22-04) and the first QBI solicitation from August 2024 (DARPA-PS-24-26). The 2026 PA exists specifically to bring in new entrants that DARPA has not yet evaluated. If your company was already selected under a prior QBI or US2QC award, DARPA does not expect you to apply again under this PA, though you are not barred from doing so if your approach is genuinely new or distinct.

What DARPA Is Actually Looking For

DARPA is explicit that this program excludes evolutionary improvements to the current state of the art in quantum computing. They want proposals that describe a credible, near term path to a USQC, not incremental qubit count increases or modest error rate improvements on familiar architectures.

Every QBIT will fall somewhere within three verification and validation stages:

Stage A asks a company to describe a USQC concept with a plausible path to realization in the near term.

Stage B asks a company to lay out the research and development plan for realizing that USQC, including the technical risks involved, how those risks will be mitigated, and what prototypes are needed to prove the concept works.

Stage C is where DARPA and the performer work together to actually verify and validate that the USQC can be built as designed and will operate as intended.

Beyond describing a hardware concept, DARPA is also interested in companies that can build the verification tools themselves, meaning testing and evaluation methods or concepts that strengthen DARPA's own Independent Verification and Validation team.

How the Program Is Structured

This is the part that trips people up. DARPA-PA-26-02 is not something you submit a proposal against directly. It is a standing program announcement under which DARPA will issue individual QBIT calls over time. Each QBIT will define its own:

Technical focus area within the broader QBI mission

Proposal process, which may include an abstract phase, a written proposal, an oral presentation, or some combination

Submission instructions and deadlines

Evaluation criteria

Eligibility requirements

Funding amount and award instrument details

Proposals submitted directly to the PA itself, rather than to a specific QBIT, will be disregarded. If you are interested in QBI, the move is to monitor for QBIT announcements at darpa.mil/work-with-us/opportunities rather than trying to respond to the PA itself.

Funding and Award Structure

The PA specifies the funding category as 6.2, which is applied research funding under the DoD's research classification system. Multiple awards are anticipated across the program.

Awards will be made using Other Transaction (OT) authority, either an OT for Research agreement or an OT for Prototype agreement, with the exact instrument specified in each QBIT. OTs matter here because they let DARPA and the performer negotiate terms outside the standard Federal Acquisition Regulation process. In practice, that means fewer compliance burdens, milestone based payments instead of rigid cost reporting, and more flexibility to structure the deal around commercial transition goals.

The PA itself does not publish a dollar ceiling, per award funding range, or period of performance. Those figures are set at the individual QBIT level. Any company evaluating fit should treat the PA as a signal of direction and intent, and wait for a specific QBIT before building a budget.

Timeline

Original posting date: November 14, 2025

Original closing date: November 14, 2026

Amendment 01 posted: July 29, 2026

Current closing date, as amended: December 30, 2026

Amendment 01 also changed the responsible office from the Microsystems Technology Office (MTO) to the Multi X Office (MXO), and replaced the Program Manager, moving from Dr. Joseph Altepeter to Dr. Micah Stoutimore. Individual QBIT due dates will be specified within each topic call and have not yet been published as part of the base PA.

Eligibility

Eligibility is not defined at the PA level. Each QBIT will specify its own eligibility criteria. What is defined at the PA level are the baseline requirements every awardee must meet regardless of QBIT:

Active registration in the System for Award Management (SAM.gov) at the time of proposal submission, maintained through the life of any award

Registration in Wide Area WorkFlow (WAWF) for electronic invoicing prior to award

A finding of responsibility from the DARPA Agreements Officer, and no suspension, debarment, or legal prohibition from receiving a federal award

DARPA also enforces an organizational conflict of interest policy. A company cannot simultaneously provide Scientific Engineering Technical Assistance (SETA) or Advisory and Assistance Services (A&AS) support to the government and act as a technical performer on the same effort.

Security and Data Handling

DARPA expects most QBI submissions to be unclassified but potentially Controlled Unclassified Information (CUI). All CUI must be handled in accordance with DoD Instruction 5200.48 and NIST Special Publication 800-171. A signed CUI Guide is attached to the PA as Attachment A. If a company believes its submission involves classified information, it must notify the MXO Program Security Officer by unclassified email before submitting anything classified.

Why This Matters for Startups

QBI is one of the few DoD funding mechanisms built specifically around unproven, high risk quantum computing architectures rather than incremental hardware improvement. If your company has a genuinely novel path to utility scale quantum computing, whether that is an unconventional qubit modality, a new error correction approach, or a fundamentally different system architecture, QBI is designed to fund exactly that kind of bet. It is also relevant if your core capability is testing, verification, or benchmarking methodology rather than building the quantum computer itself.

Because the PA has no fixed dollar amount, no single deadline for proposals, and no single eligibility standard, companies should treat this announcement as a heads up rather than an action item. The real opportunity, and the real deadline pressure, will show up when a specific QBIT drops.

Frequently Asked Questions

What is DARPA-PA-26-02? It is the Quantum Benchmarking Initiative (QBI) 2026 Program Announcement, an umbrella solicitation from DARPA that governs future QBI Topic (QBIT) calls focused on verifying whether any quantum computing approach can reach utility scale by 2033.

Can I submit a proposal directly to this PA? No. Proposals may only be submitted in response to a specific QBIT. Any proposal submitted directly against the PA will be disregarded.

When does DARPA-PA-26-02 close? The amended closing date is December 30, 2026. The original closing date was November 14, 2026 before Amendment 01 extended it.

Who runs the QBI program now? The Multi X Office (MXO), following Amendment 01's transfer of the program from the Microsystems Technology Office (MTO). The Program Manager is Dr. Micah Stoutimore.

How much funding is available? The PA does not specify a dollar amount. Funding levels, award sizes, and periods of performance are defined separately within each individual QBIT.

What type of award will this be? Other Transaction (OT) agreements, either for Research or for Prototype work, with the specific type determined by each QBIT.

Is this a competition between companies? Not in the traditional sense. While each QBIT call is competitive, DARPA has stated it wants to fund all viable approaches for which funding is available, rather than picking a single winner across the program.

Can companies already in QBI or US2QC apply again? DARPA does not intend this PA to solicit proposals from performers already selected under prior QBI or US2QC awards, but it does not prohibit them from applying if their new approach is genuinely distinct.

What kind of quantum computing approaches is DARPA interested in? Revolutionary, high risk, high reward approaches with a plausible near term path to utility scale operation. Evolutionary or incremental improvements to existing quantum computing approaches are explicitly excluded.

Does my company need to be registered anywhere before applying? Yes. Active SAM.gov registration is required at the time of proposal submission, and WAWF registration is required before any award can be made.

What if my technology involves classified information? You must notify the MXO Program Security Officer by unclassified email before submitting classified material. Security classification guidance will be issued by DARPA only if the award is determined to require it.

Where do I find the actual proposal opportunities? Monitor darpa.mil/work-with-us/opportunities for individual QBIT announcements, which will each carry their own deadlines, templates, and submission instructions.

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.

DARPA IPTO Office-Wide BAA: HR001126S0011

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

Quick Answer

The Defense Advanced Research Projects Agency's Information Processing Techniques Office (IPTO) has issued an office-wide Broad Agency Announcement, HR001126S0011, to fund revolutionary information science and technology research across three thrust areas: AI Innovation and Execution, Inherent Security and Privacy, and Resilient Megasystems. This is a standing, rolling opportunity. Abstracts are due by June 22, 2027, at 2:00 PM ET, and full proposals are by invitation only following abstract review. DARPA anticipates multiple awards through Procurement Contracts, Grants, Cooperative Agreements, and Other Transaction (OT) Agreements for both prototypes and research. This BAA is best suited for organizations proposing unconventional, high-risk, high-reward approaches that go well beyond incremental improvements to the current state of the art.

What Is the DARPA IPTO Office-Wide BAA?

This solicitation is IPTO's standing mechanism for soliciting concepts that create technological surprise through groundbreaking information science and new information capabilities for national security. Rather than targeting a single narrow topic, it spans IPTO's full portfolio and welcomes proposals that fall outside its named thrust areas as long as they promise a decisive information or computational advantage for the United States and its allies. DARPA is explicit that it wants unconventional approaches that challenge accepted assumptions, and that research resulting only in evolutionary improvements to existing capability is out of scope.

A recurring theme throughout the BAA is software resilience. DARPA's preferred path to delivering secure, high-quality software is through formal methods, mathematically rigorous techniques that produce machine-checkable evidence that software does what it is supposed to do and does not do what it is not supposed to do. Proposers should expect this expectation to surface directly in proposal evaluation.

The Three IPTO Thrust Areas

AI Innovation and Execution focuses on energy-efficient, assured artificial intelligence systems that deliver trustworthy, understandable AI to warfighters at the edge of the network, along with work to mitigate risks of misalignment between machine actions and human interests.

Inherent Security and Privacy targets a new generation of systems that are inherently secure and inherently private by design, paired with security and privacy tools that are more adaptable than current solutions in both moving-target and reactive contexts, with the goal of creating an asymmetric cyberspace advantage.

Resilient Megasystems seeks machine-derived abstractions and models that expose the governing principles of highly complex, interconnected systems such as supply chains and power grids, in order to identify hidden systemic risk and enable precise, proactive intervention.

Key Dates:

Key Dates Posting date: June 22, 2026

Abstract due date: June 22, 2027, at 2:00 PM ET

Question submittal closes: June 22, 2027, at 2:00 PM ET

Proposal due date: By invitation only, following abstract review

Award Instruments and Cost Sharing

DARPA anticipates multiple awards under this BAA using Procurement Contracts, Grants, Cooperative Agreements, OT for Prototype Agreements, and OT for Research Agreements. Cost sharing may be required for OT for Prototype or OT for Research Agreements under 10 U.S.C. § 4022. The relevant NAICS code is 541715.

Two-Step Abstract and Proposal Review

Abstracts are required before any full proposal and go through a two-step review. Step 1 is a mandatory technical conformance check for scientific and technological originality, depth of mission understanding, and operational realism; generic or boilerplate abstracts are found non-conforming at this stage. Step 2 evaluates conforming abstracts on Technical Comprehension, Technical Ability, and Cost Considerations, in that order of importance.

Full proposals, submitted by invitation only, follow the same two-step structure. Step 2 evaluation criteria, in descending order of importance, are Overall Scientific and Technical Merit, Potential Contribution and Relevance to the DARPA Mission, Plans to Implement Resilient Software, and Cost Realism.

Security and Compliance Considerations

Proposers anticipating classified work must include a security plan and cannot generate classified material until DARPA issues a solicitation-specific DD Form 254. Unclassified submissions go through the DARPA BAAT tool or Grants.gov, and any Controlled Unclassified Information must be handled on systems meeting CMMC Level 2 requirements. CMMC Level 1 certification is required at proposal submission for awards structured as procurement contracts, with the government designating the applicable level at award. Proposers requesting a Grant, Cooperative Agreement, or OT Agreement for fundamental research must also complete DARPA's Fundamental Research Risk-Based Security (FRRBS) forms, including a Common Form Biographical Sketch and Common Form Current and Pending Support, for all proposed key personnel.

Who Should Apply

This BAA fits organizations, including small businesses, universities, and non-U.S. entities complying with applicable export control and security requirements, that can propose revolutionary rather than incremental advances in AI, cybersecurity, or complex systems modeling. It is not the right mechanism for teams whose approach amounts to an incremental improvement on existing capability, or who cannot support the security, CMMC, and FRRBS documentation requirements that come with DARPA-funded research. FFRDCs, UARCs, and government entities such as national laboratories may participate but must submit detailed eligibility documentation at the abstract stage.

FAQs

What is the DARPA IPTO Office-Wide BAA HR001126S0011?

It is a standing Broad Agency Announcement from DARPA's Information Processing Techniques Office funding revolutionary research in AI, cybersecurity and privacy, and resilient complex systems, with multiple awards anticipated across several instrument types.

When is the abstract due?

Abstracts are due June 22, 2027, at 2:00 PM ET. Questions must also be submitted by that date and time.

When can a full proposal be submitted?

Full proposals are by invitation only. DARPA will provide a due date in the Invitation to Proceed after reviewing a proposer's abstract.

What types of awards can result from this BAA?

Procurement Contracts, Grants, Cooperative Agreements, OT for Prototype Agreements, and OT for Research Agreements. Cost sharing may apply to OT Agreements under 10 U.S.C. § 4022.

What are IPTO's three thrust areas?

AI Innovation and Execution, Inherent Security and Privacy, and Resilient Megasystems. Proposals outside these areas are still eligible if they offer a decisive information or computational advantage.

Does DARPA fund incremental improvements under this BAA?

No. DARPA specifically excludes research that primarily results in evolutionary improvements to the existing state of the art, and abstracts or proposals judged generic or boilerplate will be found non-conforming.

Is classified work allowed under this BAA?

Yes, but proposers must first receive a solicitation-specific DD Form 254 before generating any classified material, and must include a security plan addressing facilities, clearances, and related requirements.

Is CMMC certification required?

Yes, for awards that will result in procurement contracts. CMMC Level 1 is required at proposal submission, with the government designating the required level, 1, 2, or 3, in the resulting contract.

Are FFRDCs, UARCs, or government laboratories eligible to participate?

Yes, but each must submit specific eligibility documentation, such as sponsor letters or statutory authority citations, at the time of abstract submission, or their submission may be deemed non-conforming.

Where can proposers get more information?

Questions should be directed to HR001126S0011@darpa.mil. Proposers are also encouraged to contact DARPA Program Managers before submitting an abstract to confirm alignment with IPTO priorities.

PCORI Broad Pragmatic Studies PFA: Cycle 3 2026

Updated October 2026: PCORI announced the successor, Broad Pragmatic Studies Cycle 1 2027. The funding announcement opens November 17, 2026. Letters of intent are due January 6, 2027 and applications May 4, 2027.

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.

‍ ‍

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.

‍ ‍

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.

‍ ‍

What is the maximum project period?

Up to five years for all three funding categories.

‍ ‍

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.

‍ ‍

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.

‍ ‍

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.

‍ ‍

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.

NASA ROSES | C.4 Planetary Science Enabling Facilities

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

Quick Answer:

NASA's Planetary Science Enabling Facilities (PSEF) program element, amended July 21, 2026, funds experimental and analytical research facilities that support the planetary science community. This is a new addition to ROSES-2025, previously listed as not solicited for the year. Proposals are due November 10, 2026, and unlike prior PSEF cycles, no Step-1 submission or Notice of Intent is required this year. Proposals will be evaluated for the first time under NASA's dual-anonymous peer review process. The program expects to fund about 2 to 8 new awards from an annual budget of roughly 5 million dollars, with awards running up to 4 years.

What Is a Planetary Science Enabling Facility?

NASA defines a Planetary Science Enabling Facility as a combination of equipment, instrumentation, infrastructure, and staff, typically supporting complex or challenging experiments or measurements, that is not otherwise widely available to the research community. Facilities must enable or enhance research funded under Solar System Science, Interdisciplinary Consortia for Astrobiology Research, the Exoplanets Research Program, or the Planetary Science Internal Scientist Funding Model.

What Types of Facilities Can Be Proposed?

Eligible facilities must be dedicated to one or more of four activities: characterization of chemical, isotopic, or physical properties of materials; experimentation on materials under defined environmental conditions; synthesis of new materials under defined conditions; or sample preparation, which must also pair with one of the other three activities. Proposed activities can include acquiring instruments or equipment, supporting technicians and operational personnel, developing new laboratory instruments or analytical methods and standards, and supporting instrument maintenance.

What Is Excluded From This Program?

PSEF does not fund scientific research itself, reference dataset acquisition, development of new flight instruments, facilities primarily supporting mission development rather than fundamental research, computing facilities, astronomical or observing facilities, data archiving facilities, laboratory construction and outfitting, or sample curation and repository facilities.

What Priorities Does NASA Emphasize This Year?

Three priority areas are specifically emphasized for ROSES-2025: facilities enhancing lunar science in the Artemis era, with particular encouragement for proposals pushing technology limits such as quantum sensors, artificial intelligence, integrated systems, parallel sensing, robotics and automation, and cold or cryogenic analysis capabilities; facilities enhancing Mars science aligned with Mars Exploration Program Analysis Group goals; and facilities enhancing astrobiology and planetary protection research, including bioburden detection, terrestrial microbe classification, and contaminant transport studies.

Who Is Eligible?

Proposals are welcomed from all research institutions, including emerging research institutions, institutions that have rarely or never received Planetary Science Division funding, and Primarily Undergraduate Institutions and Community Colleges. Institution type may be considered as a programmatic factor in selection. Institutions may participate as proposing organizations, sub-awardees, or unfunded partners.

How Are Proposals Structured and Formatted?

This year's PSEF uses a single-step submission process with one deadline, replacing the two-step process used in PSEF22 and PSEF24. The anonymized Science/Technical/Management section is capped at 13 pages total, made up of Technical Capabilities (up to 12 pages), Anticipated Userbase (up to 1 page), and an optional Facility-Relevant Training Opportunities section (up to 2 pages). Proposals requesting equipment or instrumentation over 50,000 dollars must include a descope plan showing how the facility would operate without that equipment if it is not funded. An anonymized Open Science and Data Management Plan of up to 2 pages and an anonymized Table of Work Effort are also required, followed by references with no page limit.

What Goes in the Non-Anonymized Expertise and Resources Document?

A separate Expertise and Resources document includes a Facility Management Plan of up to 2 pages covering user access priority, access procedures, costs, and safety practices; a non-anonymized Table of Personnel and Work Effort; Biographical Sketches and Current and Pending Support in SciENcv format for all PIs and Co-Is spending 10 percent or more time on the project; facilities and equipment descriptions; and, if applicable, a High-End Computing request.

Is Research Security Training Required?

Yes. Any PI or Co-I dedicating 10 percent or more time to a proposed award must certify completion of research security training, satisfied by either the four NSF Research Security Training modules or the SECURE Center's condensed equivalent, effective August 5, 2026.

How Are Proposals Evaluated?

NASA evaluates PSEF proposals on three criteria: scientific and technical merit of the proposed facility, including the Open Science and Data Management Plan, appropriateness of equipment and staff, facility uniqueness, and expected volume of use; relevance to Planetary Science Division research priorities; and cost reasonableness, covering both proposed work effort and other direct costs such as supplies, equipment, travel, and anticipated tariff costs. The Facility Management Plan is also assessed for whether it ensures adequate community access and sound user request procedures. Cost sharing is not required or scored but may be a tiebreaker between proposals of otherwise equal merit.

What Is the Funding Amount and Timeline?

NASA expects to fund approximately 2 to 8 new awards from an annual budget of about 5 million dollars. There is no explicit cap on individual award size. Awards run up to 4 years, with funding expected to begin about 9 months after the proposal due date.

How Do I Submit a Proposal?

Proposals are submitted electronically through NSPIRES at nspires.nasaprs.com. No hard copies are accepted. Applicants who need to submit through Grants.gov must request access at least 30 days before the due date from the point of contact below, copying sara@nasa.gov. The Grants.gov funding opportunity number is NNH25ZDA001N-PSEF.

Key Dates

Proposal due date: November 10, 2026 No Step-1 or Notice of Intent required this year Anticipated funding start: approximately 9 months after the proposal due date

Program Contact

Michael Lienhard Email: HQ-PSEF@mail.nasa.gov

How Can BW&CO Help With a PSEF Proposal?

BW&CO Consulting helps research teams position competitive facility proposals for ROSES, including dual-anonymous peer review compliance, facility scope and userbase justification, cost reasonableness narrative, and NSPIRES submission logistics, so applicants can meet the November 10, 2026 deadline with a complete, evaluation-ready package.

Contact BW&CO Consulting to discuss NASA ROSES C.4 Planetary Science Enabling Facilities eligibility and proposal strategy.

NIH Highlighted Topic: Advancing Nutrition Research to Inform Regulatory Practice

Updated October 2026: NIH lists this Highlighted Topic as active through March 20, 2028. The next standard NIH SBIR/STTR due date is January 5, 2027, followed by April 5 and September 5, 2027.

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

Updated October 2026: NIH lists this Highlighted Topic as active through May 26, 2028. The next standard NIH SBIR/STTR due date is January 5, 2027, followed by April 5 and September 5, 2027.

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

Updated October 2026: NIH lists this Highlighted Topic as active through January 12, 2028. The next standard NIH SBIR/STTR due date is January 5, 2027, followed by April 5 and September 5, 2027.

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

Updated October 2026: NIH lists this Highlighted Topic as active through February 12, 2028. The next standard NIH SBIR/STTR due date is January 5, 2027, followed by April 5 and September 5, 2027.

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

Updated October 2026: NIH lists this Highlighted Topic as active through April 14, 2028. The next standard NIH SBIR/STTR due date is January 5, 2027, followed by April 5 and September 5, 2027.

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

Updated October 2026: NIH lists this Highlighted Topic as active through June 2, 2028. The next standard NIH SBIR/STTR due date is January 5, 2027, followed by April 5 and September 5, 2027.

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

Updated October 2026: NIH lists this Highlighted Topic as active through June 3, 2028. The next standard NIH SBIR/STTR due date is January 5, 2027, followed by April 5 and September 5, 2027.

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

Updated October 2026: NIH lists this Highlighted Topic as active through June 3, 2028. The next standard NIH SBIR/STTR due date is January 5, 2027, followed by April 5 and September 5, 2027.

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.

NIH Highlighted Topic: Food Is Medicine

Updated October 2026: NIH lists this Highlighted Topic as active through June 3, 2028. The next standard NIH SBIR/STTR due date is January 5, 2027, followed by April 5 and September 5, 2027.

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 rigorously evaluating Food is Medicine (FIM) approaches to prevent and address diet-related chronic diseases and associated health disparities across the lifespan, including cardiovascular disease, diabetes, obesity, certain cancers, and mental health disorders. This highlighted topic aims to advance the evidence base for FIM interventions through high-quality research measuring clinical and health outcomes within well-designed programs.

FIM approaches are expanding across the U.S. and show promise for improving diet quality and food security, but NIH notes their impact on clinical and health outcomes remains limited due to inconsistent results or insufficient magnitude. This topic is issued as part of the Make America Healthy Again initiative, aligning with NIH's Chronic Disease Initiative, Real World Data Platform, Food for Health collaboration with the VA and USDA, and expanded precision nutrition research. NIH is particularly interested in projects that assess economic impact and cost-effectiveness of FIM programs, validate biomarkers of dietary response, and develop training programs in culinary medicine for healthcare professionals.

Areas of interest include clinical trials combining FIM with other multi-domain interventions to address diet-related chronic disease, precision nutrition interventions to mitigate cancer treatment-related toxicities like malnutrition and sarcopenia, testing FIM effectiveness for hypertension, heart failure, and respiratory disease management, examining food's role in managing rheumatic, musculoskeletal, and skin conditions, incorporating FIM into oral health treatment strategies and early childhood dental caries prevention, mechanistic trials linking FIM interventions to psychiatric symptom domains, adapting and scaling FIM programs for populations experiencing health disparities, and testing dietary interventions for autoimmune disease onset, progression, and symptom management.

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 unusually broad coalition of ICOs, including the Office of Nutrition Research (ONR), National Center for Complementary and Integrative Health (NCCIH), National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Mental Health (NIMH), National Institute on Minority Health and Health Disparities (NIMHD), National Institute of Nursing Research (NINR), Office of AIDS Research (OAR), Office of Behavioral and Social Sciences Research (OBSSR), Office of Disease Prevention (ODP), and Office of Research on Women's Health (ORWH), reflecting how central Food is Medicine has become to NIH's chronic disease prevention strategy under the MAHA initiative.

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: Oral Health and Aging

Updated October 2026: NIH lists this Highlighted Topic as active through June 5, 2028. The next standard NIH SBIR/STTR due date is January 5, 2027, followed by April 5 and September 5, 2027.

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 the relationship between oral health and aging-related systemic and chronic disease. This highlighted topic aims to advance understanding of how oral diseases, which increase in frequency and severity with age, connect to cardiovascular, metabolic, respiratory, musculoskeletal, and neurological conditions across the lifespan.

The oral cavity serves as a key interface between the external environment and the body, and NIH notes that oral bacteria and their byproducts can enter circulation during routine activities, potentially reaching distant organs and tissues. Chronic oral inflammation, microbial translocation, and host immune responses have been proposed as pathways influencing systemic inflammation and cellular aging, though causal relationships remain incompletely understood. NIH is particularly interested in projects that integrate oral health measures into aging and chronic disease research, address gaps in longitudinal data, and develop harmonized oral health assessments across studies.

Areas of interest include epidemiological and mechanistic research linking oral health to cognitive decline and Alzheimer's disease/related dementias, studying the oral microbiome's role in cancer risk and periodontal disease's connection to cancer outcomes, examining oral disease as a driver of autoimmunity and immune-mediated conditions following organ transplantation, investigating causal links between oral health and arthritis, musculoskeletal, and skin diseases, characterizing age-associated changes in oral microbiome homeostasis and dental implant outcomes among elderly populations with polypharmacy and dry mouth, and evaluating interventions to improve screening and prevention of dental caries, periodontal disease, and tooth loss across the lifespan.

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), with additional participation from the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Dental and Craniofacial Research (NIDCR), Office of Behavioral and Social Sciences Research (OBSSR), and Office of Disease Prevention (ODP), all of which are seeking research connecting oral health to systemic aging-related disease 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: Implementation Science to Optimize HIV Prevention and Treatment

Updated October 2026: NIH lists this Highlighted Topic as active through December 2, 2027. The next standard NIH SBIR/STTR due date is January 5, 2027, followed by April 5 and September 5, 2027.

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 implementation strategies to deliver biomedical HIV prevention and treatment options toward ending the HIV epidemic. This highlighted topic aims to advance the uptake and adoption of long-acting therapeutic options, behavioral interventions for viral suppression, and practices that integrate and sustain evidence-based HIV prevention and care across diverse settings.

Effective HIV prevention and treatment tools already exist, but NIH notes that uptake and adoption remain suboptimal, widening the gap between those who benefit from scientific advances and those who don't. NIH is particularly interested in projects that address provider, clinic, and systems-level barriers to adoption, document implementation costs in comparative trials, and engage meaningful partnerships with communities, public health providers, and people living with or impacted by HIV from idea generation through dissemination. As people with HIV age and experience more comorbid conditions, implementation research addressing this intersection is a growing priority.

Areas of interest include integrating cancer control interventions and care coordination into HIV healthcare settings, overcoming barriers to HIV intervention adoption among older adults, combining alcohol-focused behavioral and pharmacological interventions given elevated Alcohol Use Disorder rates among people with HIV, preparing for implementation of next-generation interventions like long-acting injectable antiretroviral therapy, scaling up evidence-based strategies from single sites to county- or state-wide catchment areas, addressing HIV and oral disease burden through cross-sector community partnerships, and developing female-specific and dual-purpose HIV prevention modalities and community-led implementation projects for women across the life course.

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 especially broad coalition of ICOs, including the Office of AIDS Research (OAR), National Cancer Institute (NCI), 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), NICHD, National Institute on Drug Abuse (NIDA), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Mental Health (NIMH), National Institute on Minority Health and Health Disparities (NIMHD), National Institute of Nursing Research (NINR), National Library of Medicine (NLM), Office of Disease Prevention (ODP), Office of Research Infrastructure Programs (ORIP), and Office of Research on Women's Health (ORWH), reflecting the scale of NIH's coordinated effort to end the HIV epidemic through real-world implementation 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: Environmental Contributors to Infertility

Updated October 2026: NIH lists this Highlighted Topic as active through June 11, 2028. The next standard NIH SBIR/STTR due date is January 5, 2027, followed by April 5 and September 5, 2027.

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 how environmental exposures contribute to infertility in males and females, including longer time to conception and pregnancy loss. This highlighted topic aims to advance understanding of the molecular and cellular mechanisms by which hazardous physical, chemical, and biological agents disrupt reproductive function, and to support development of tools to identify and mitigate that risk.

Environmental exposures have been linked to declining male fertility through impaired sperm count, quality, hormonal balance, and genetic integrity, while conditions such as endometriosis, polyendocrine metabolic ovarian syndrome (formerly PCOS), and uterine fibroids are common female-specific conditions tied to environmental and endocrine-disrupting exposures. NIH is particularly interested in projects spanning fundamental mechanisms, epigenetics and small RNA regulation of germ cell development, New Approach Methodologies such as organoids and organ-on-chip systems, exposure science and biomonitoring, extracellular vesicle signaling in reproductive communication, and assisted reproductive technology outcomes in exposed populations.

Areas of interest include characterizing known and emerging exposures such as pesticides and micro/nanoplastics in fertility-relevant biological samples, defining core signaling pathways and DNA repair mechanisms governing gametogenesis and meiosis, applying sex as a biological variable to uncover hormonal disruption and oxidative stress pathways affecting implantation and ovarian reserve, studying autoimmune diseases linked to infertility such as autoimmune oophoritis and antiphospholipid syndrome, and examining environmental exposures and reproductive health disparities among American Indian and Alaska Native communities through culturally grounded, Tribe-specific research.

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 Environmental Health Sciences (NIEHS), with additional participation from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of General Medical Sciences (NIGMS), Office of Research on Women's Health (ORWH), and the Tribal Health Research Office (THRO), all of which are seeking mechanistic and exposure-based research into environmental drivers of infertility.

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: Integrating Environmental Science and Engineering with Biomedical Research for Effective Exposure Prevention and Disease Intervention

Updated October 2026: NIH lists this Highlighted Topic as active through June 18, 2028. The next standard NIH SBIR/STTR due date is January 5, 2027, followed by April 5 and September 5, 2027.

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 multidisciplinary team science that pairs environmental science and engineering (ESE) innovators with biomedical researchers to prevent harmful chemical exposures and reduce disease burden. This highlighted topic aims to close the gap between technologies that remove contaminants from water, air, and soil and the biomedical research needed to validate that these solutions actually reduce toxicity and health risk.

Humans are routinely exposed to mixtures of chemicals, including heavy metals, PFAS, pesticides, and phthalates, through air, water, food, and everyday products, and NIH notes these harmful exposures pose risks across the entire lifespan. NIH is particularly interested in team-based projects where ESE researchers develop exposure-reduction or sensor technologies while biomedical researchers evaluate their effectiveness through validated toxicology models, or where communities affected by hazardous substances partner directly with biomonitoring teams and sensor developers to refine exposure measurement.

Areas of interest include hypothesis-driven research to reduce the amount and toxicity of hazardous substances in environmental media, developing sensor technologies for improved personal and community exposure monitoring, confirming hazard reduction through novel toxicology assays and internal dose biomonitoring, improved clean-up and monitoring approaches at Superfund and other hazardous substance sites, and interdisciplinary research to detect, characterize, and remediate chemical mixtures with attention to sex-specific biology, women-relevant health outcomes, and autoimmune disease risk across the lifespan.

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 Environmental Health Sciences (NIEHS), including its Superfund Research Program, with additional participation from the Office of Research on Women's Health (ORWH), both of which are seeking team-based ESE/biomedical collaborations that translate exposure-reduction technology into measurable health impact.

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: Computational Modeling of Complex Processes Across Biological Scales

Updated October 2026: NIH lists this Highlighted Topic as active through April 17, 2028. The next standard NIH SBIR/STTR due date is January 5, 2027, followed by April 5 and September 5, 2027.

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 developing multiscale computational models that integrate biological processes across spatial and temporal levels, from molecular to organismal to epidemiologic scales. This highlighted topic aims to build a collaborative research community that improves the replicability and reproducibility of these models, advancing their reuse across the biomedical research enterprise.

Multiscale computational models offer a comprehensive understanding of complex systems by revealing how molecular and cellular interactions influence larger population-, geographical-, or global-scale phenomena. NIH is particularly interested in projects that leverage these models as Novel Alternative Methods (NAMs) to investigate the mechanism and safety of medical interventions in preclinical, translational, and clinical development, reducing reliance on animal studies while accelerating discovery.

Areas of interest include modeling infection and transmission mechanisms and immune system regulation for allergic and infectious diseases, developing whole-person computational frameworks for complementary and integrative health outcomes, building scalable modeling capabilities for cancer biomarker discovery and patient stratification, integrating sex differences and heterogeneous data to simulate heart, lung, blood, and sleep disease trajectories, modeling aging clocks and hallmark interactions relevant to Alzheimer's disease, linking molecular changes to systemic effects in alcohol use disorder and fetal alcohol spectrum disorders, developing brain-body models of substance use disorder and HIV, modeling dental and craniofacial disease processes from molecular to population levels, and building digital phenotypes that mechanistically link genetic and circuit-level processes to mental health outcomes.

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 unusually broad coalition of ICOs, including the National Institute of Allergy and Infectious Diseases (NIAID), National Center for Complementary and Integrative Health (NCCIH), National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institute on Drug Abuse (NIDA), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Mental Health (NIMH), National Library of Medicine (NLM), Office of Data Science Strategy (ODSS), and Office of Research on Women's Health (ORWH), reflecting how foundational multiscale modeling has become across nearly every corner of NIH's research mission.

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.