FDA RFA-FD-25-020: Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01)

The Short Answer

RFA-FD-25-020 is an FDA grant that pays for rare disease clinical trials. It provides up to $650,000 in total costs per year for up to four years, and up to $900,000 per year if you use an innovative or efficient trial design. The money is non-dilutive, meaning you give up no equity and no intellectual property. Applications are due October 20, 2026 and October 19, 2027, and the opportunity expires May 31, 2028.

The program is run by the FDA Office of Orphan Products Development (OOPD), not by the NIH, even though you apply through Grants.gov and eRA Commons. FDA uses its own Objective Review Process, its own page limits, and its own review criteria.

Small businesses and for-profit companies are explicitly eligible, and companies win these awards regularly. More on that below.

RFA-FD-25-020 At A Glance

• Funding opportunity number: RFA-FD-25-020

• Title: Reissue of RFA-FD-23-001, Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

• Agency: U.S. Food and Drug Administration, Office of Orphan Products Development (OOPD)

• Activity code: R01 Research Project Grant

• Assistance Listing Number: 93.103

• Clinical trial status: Required. FDA will only accept applications proposing clinical trials.

• Award ceiling, standard: $650,000 total costs per year, years 1 through 4

• Award ceiling with innovative design justification: $900,000 total costs per year, years 1 through 4

• Maximum project period: 4 years

• Maximum possible total award: $3,600,000

• Cost sharing or matching: Not required

• Application types allowed: New, Renewal, Resubmission, Revision

• Next application deadline: October 20, 2026, by 11:59 PM Eastern Time

• Final application deadline: October 19, 2027, by 11:59 PM Eastern Time

• Resubmission-only deadlines: May 18, 2027 and May 16, 2028

• Opportunity expiration date: May 31, 2028

• Late applications: Not accepted under any circumstances

• Appeals of review outcome: Not accepted

• Foreign organizations: Eligible

Why Startups and Small Companies Should Pay Attention

The R01 label makes founders assume this is an academic-only program. It is not, and the award history proves it.

Under the immediately preceding version of this opportunity, RFA-FD-23-001, FDA funded roughly twenty distinct clinical trial projects. Four of those projects went to for-profit companies rather than universities or hospitals. Based on NIH RePORTER records, those company awards include:

• Ophirex, Inc. (California). Development of intravenous varespladib, a phospholipase A2 inhibitor, for snakebite envenoming. Approximately $2.89 million in cumulative reported funding across fiscal years 2023 through 2025.

• Extend Biosciences, Inc. (Massachusetts). A Phase 2 study of EXT608 in adults with hypoparathyroidism, conducted under IND 146180. Approximately $1.8 million in cumulative reported funding, with annual budgets of roughly $899,800, effectively at the top of the funding ceiling.

• Palvella Therapeutics, Inc. (Pennsylvania). SELVA, a multicenter Phase 3 baseline-controlled study of PTX-022 in microcystic lymphatic malformations. Approximately $1.13 million in cumulative reported funding across fiscal years 2024 and 2025.

• Targeted Therapy Technologies, LLC (New Jersey). A Phase II expanded access clinical trial in retinoblastoma. $1.3 million in cumulative reported funding across fiscal years 2024 and 2026.

Together, those four companies pulled in roughly $7.1 million from a single issue of this opportunity. That is close to one in five funded projects going to industry.

This is not new behavior at OOPD either. Under earlier issues of the same program, DNAtrix, Inc. won multi-year support for a Phase 2a study of DNX-2401 in glioblastoma, and Fibrocell Technologies, Inc. won multi-year support for a Phase 1/2 study of FCX-007 in recessive dystrophic epidermolysis bullosa. Companies have been winning orphan products clinical trials grants for a decade.

Three additional reasons this program fits a clinical-stage company unusually well:

1. None of the SBIR eligibility constraints apply. There is no 500-employee size standard, no requirement that the principal investigator be primarily employed by your company, no 51 percent United States ownership test, and no Phase I before Phase II sequencing. If your company can run the trial, you can apply.

2. Indirect costs are available even without a negotiated rate. If your organization has never established a federal indirect cost rate, FDA allows a de minimis rate of 10 percent of modified total direct costs. Most early-stage companies have no negotiated rate, and most assume that means zero overhead recovery.

3. The award is a regulatory asset, not just cash. OOPD holds regulatory milestone meetings with awardees and monitors progress toward approval. An FDA office is actively invested in your product reaching the market.

What FDA Is Actually Looking For

The purpose of RFA-FD-25-020 is to fund clinical trials that evaluate safety and efficacy in support of a new indication or a change in labeling for a product treating a rare disease or condition. That phrase is the center of gravity of the entire program. FDA is not funding discovery science, target validation, mechanism studies, or device engineering. FDA is funding the human trial data that moves a product closer to an approved label.

The problem FDA is trying to solve

There are more than 10,000 known rare diseases affecting roughly 30 million Americans, and only a few hundred of those diseases have approved treatments. The Orphan Products Grants Program has funded clinical trial research since 1983, and more than 80 of the studies it has funded have gone on to facilitate marketing approval of a rare disease product. That is the outcome FDA is buying with this money.

What is in scope

• Clinical trials in any phase of development, meaning Phase 1, Phase 2, and Phase 3 are all eligible

• Drugs, biologics, medical devices, and medical foods

• Studies of already approved products being evaluated for a new orphan indication

• Studies assessing multiple rare diseases at once, provided prevalence data is supplied for each disease

• Diagnostics and vaccines, but only where the United States population receiving them is fewer than 200,000 people per year

What FDA specifically rewards

Read the announcement closely and four preferences show up over and over. Applications that hit these read as responsive. Applications that ignore them read as academic proposals that wandered into the wrong program.

1. Efficient use of existing infrastructure. FDA wants you to plug into clinical trial networks, data standardization platforms, patient registries, electronic medical records, and CTSAs rather than building everything from scratch. Show that you are not reinventing infrastructure that already exists.

2. Genuine collaboration across stakeholders. FDA repeatedly names the combination of industry, academia, and patient organizations. A company applicant partnered with academic trial sites and a disease foundation is the archetype this program was written for.

3. Early and ongoing patient engagement. This is a scored review criterion in its own right, not a box to check. FDA wants documented evidence that patients and caregivers shaped the protocol design, the data elements, the feasibility assessment, and the data sharing approach. You also need to show how you reduced patient and caregiver burden, including impact on daily living. Letters from patients, caregivers, or patient organizations describing that engagement are required.

4. Innovative and efficient trial designs. This is where the extra $250,000 per year lives. FDA will consider additional funding for applications proposing seamless or adaptive designs that compress trial phases into one continuous trial, basket trials, umbrella trials, or platform trials that test multiple drugs or multiple diseases on common infrastructure. FDA will also consider it for innovative use of data modeling and simulation to study safety and efficacy. FDA strongly recommends engaging a review division about these approaches before you submit, through a preIND meeting, an INTERACT meeting, or another mechanism.

The rare disease definition you must document

FDA considers a product potentially eligible if it is indicated for a disease or condition with a prevalence of fewer than 200,000 people in the United States. For acute diseases lasting less than one year, the annual incidence must be fewer than 200,000 per year. You must document this in a dedicated subsection of your Rationale, using the exact heading "Rare Disease Population/Prevalence," with prevalence calculations and citations.

Orphan subsets of a non-rare disease can qualify, but only if you can explain, based on a characteristic of the product such as mechanism of action, toxicity profile, or prior clinical experience, why the product would be limited to that subset. An orphan subset argument cannot be based on unmet need alone or on how you would prefer to study or market the product. If you already hold OOPD orphan drug designation for the product and disease, include the designation number and date.

Funding Allowance in Detail

Annual budget caps

• Year 1: $650,000 total costs

• Year 2: $650,000 total costs

• Year 3: $650,000 total costs

• Year 4: $650,000 total costs

• Standard four-year maximum: $2,600,000 total costs

These are total costs, meaning direct plus indirect combined. This is the single most misread line in the announcement. Applicants who budget $650,000 in direct costs and then add overhead on top are over budget before review begins.

The innovation supplement

Applications proposing qualifying innovative and efficient trial approaches may request up to an additional $250,000 in total costs per year, raising the ceiling to $900,000 total costs per year for up to four years, or $3,600,000 across the full project period.

To access it you must submit a clear description and justification, limited to three pages, showing how you meet the innovative design requirements. That justification goes in the appendix, and the request must also be reflected in the budget request. FDA reviews the additional funding annually. Applications that request the supplement without meeting the requirements may be asked to reduce their budget.

Indirect costs

• If you request indirect costs, you must attach a copy of your most recent federal indirect cost rate or F&A agreement to the Research and Related Other Project Information component as line 12, Other Attachments.

• If you have never established an indirect cost rate and have no negotiated federal agreement, a de minimis rate of 10 percent of modified total direct costs is allowed. Modified total direct costs include direct salaries and wages, applicable fringe, materials and supplies, services, travel, and the first $25,000 of each subaward. It excludes equipment, capital expenditures, patient care charges, rental costs, tuition remission, scholarships, participant support costs, and any portion of a subaward above $25,000.

• Foreign and international organizations are funded at a fixed 8 percent of modified total direct costs.

Other budget rules

• Cost sharing is not required.

• Applications requesting multiple years must submit a separate detailed budget and narrative justification for each year.

• You must disclose other funds contributed to the study by any source, including your own company, both before and during the FDA funding period. Provide amounts, sources, and whether the funds are secured. Keep this separate from the FDA request justification.

• No award funds may pay any individual at a salary rate above Executive Level II of the Federal Executive Pay Scale.

• Awards provide one year of support with three additional recommended years contingent on annual appropriations, availability of funds, and satisfactory performance. Continuation also depends on enrollment progress, adequate product supply, and compliance with IND or IDE regulatory requirements.

Timeline and Key Dates

Recurring annual cycle

• Optional Letter of Intent: September 21, 2026, then September 20, 2027

• New application due dates: October 20, 2026, then October 19, 2027, both by 11:59 PM Eastern Time

• Resubmission-only due dates: May 18, 2027, then May 16, 2028

• Scientific merit review, new applications: February and March of 2027 and 2028

• Scientific merit review, resubmissions: June of 2027 and 2028

• Earliest project start date: July 2026 for the first cycle, with later cycles following the same pattern

• Opportunity expiration: May 31, 2028

The deadline before the deadline

The date that actually controls your timeline is not the application due date. It is the IND or IDE submission date.

Your protocol and all other required regulatory documents must be submitted to the applicable FDA IND or IDE review division a minimum of 30 days before the grant application deadline. For the October 20, 2026 cycle, that means the protocol needs to be with the review division on or before September 20, 2026.

The IND must be active, meaning not on clinical hold and not exempted, or the IDE must be approved, for your grant application to qualify for review. Miss this and the application is non-responsive regardless of scientific merit.

A realistic backward-planning schedule for an October cycle

• 6 to 8 months out: Request a preIND or INTERACT meeting if you plan to propose an innovative trial design, or if your regulatory path is unsettled.

• 4 to 6 months out: Confirm SAM.gov, UEI, eRA Commons, and Grants.gov registrations. Registration can take six weeks or longer, and failure to register in time is not an accepted excuse for late submission. Principal investigator eRA Commons accounts alone can take two weeks.

• 3 to 4 months out: Finalize the protocol, lock clinical sites, and begin collecting the three required categories of letters of support.

• 30 days plus before the deadline: Submit the final protocol to your IND or IDE. The version you submit to FDA in the grant application must be the same version submitted to the IND or IDE.

• 3 to 4 weeks out: Complete the Research Strategy, the innovation supplement justification if applicable, and the Data Management and Sharing Plan.

• 1 week out: Submit. Grants.gov and eRA Commons both run error checks, and any errors must be corrected and a changed or corrected application submitted before the deadline. A corrected application filed after the deadline is late, and late applications are not accepted.

Registration checklist

• System for Award Management (SAM) registration, active and renewed at least annually, which generates your Unique Entity Identifier and a CAGE code. Foreign organizations need an NCAGE code instead.

• eRA Commons accounts with at least one Signing Official and at least one Program Director or Principal Investigator. If the same person is both PI and Signing Official, they need two distinct accounts.

• Grants.gov registration, which requires active SAM registration first.

Who Is Eligible

Eligible organizations include:

• Public, state controlled, and private institutions of higher education

• Nonprofits with and without 501(c)(3) status

• Small businesses

• For-profit organizations other than small businesses

• State, county, city, township, and special district governments

• Federally recognized and non-federally recognized tribal governments and Native American tribal organizations

• Federal governments and United States territories or possessions

• Independent school districts, public housing authorities, faith-based and community-based organizations, and regional organizations

• Non-domestic, non-United States entities, and non-domestic components of United States organizations

Principal investigator requirements:

• Any individual with the skills, knowledge, and resources to carry out the research may serve as PD/PI.

• FDA expects an established investigator in the relevant scientific area who can provide both administrative and scientific leadership.

• Every PD/PI must hold an eRA Commons account, and the Commons ID must appear in the Credential field of the Senior/Key Person Profile. Omitting it causes the application to be rejected.

• Multiple PDs/PIs are allowed. One must be designated the Contact PI in item 14 of the SF424 (R&R). Multi-PI applications must include a Multiple PD/PI Leadership Plan covering governance, communication, decision-making on scientific direction, and conflict resolution.

• With multiple institutions, one must be the prime and all others must be funded through subcontracts, with their budgets attached to the Research and Related Subaward Budget Attachment form.

You may submit more than one application, provided each is scientifically distinct. FDA will not accept duplicate or highly overlapping applications under review at the same time.

Application Structure and Required Content

Page limits

FDA does not follow NIH page limitation guidelines or NIH review criteria. For this NOFO, the Research Strategy is limited to 12 pages. A resubmission adds a one-page Introduction addressing the prior Summary Statement.

Required Research Strategy sections

Your Research Strategy must contain these five sections, in this order, because they map directly onto the scored review criteria:

1. Rationale

2. Study Design including Data Quality and Interpretability

3. Inclusion of Patient Input

4. Investigator(s), Infrastructure, and Financial Resources

5. Ability to Advance the Current Field

Required subsections with mandated headings

Three subsections must appear under specific headings. Reviewers look for these headings literally.

• Under Rationale: "Rare Disease Population/Prevalence", documenting that the United States prevalence or incidence meets the rare disease threshold, with calculations and citations.

• Under Rationale: "Support of Product Development", explaining how the study will help support product approval or supply essential data for product development. If you propose multiple products or multiple diseases, describe how you intend to proceed with development, potentially across multiple sponsors.

• Under Study Design: "Study Monitoring Plan", describing your monitoring approach, whether a Data and Safety Monitoring Board, a Study Monitoring Committee, or an Independent Medical Monitor. Name the parties responsible, what will be monitored, the frequency, and the individual and study stopping guidelines.

Required letters of support

Letters of support do not go in the Research Strategy. They are uploaded to line 9 of the PHS 398 Research Plan form. Three categories are required:

1. Study sites. Leaders of the clinical research institutions conducting the study describe site support, resources, study infrastructure, and an estimate of how many patients with the target disease would be eligible.

2. Product availability. Evidence that the product is available to you in the form and quantity the trial needs. A current supplier letter is acceptable. If supply negotiations are underway but not final, submit a letter saying so. Verification of adequate supply is required before an award is made.

3. Patient engagement. Current letters from patients, caregivers, or patient organizations describing early and ongoing engagement in trial design.

Required appendices

• The full final protocol, specifically the version submitted to the IND or IDE

• Informed consent forms, assent forms, and any other information given to subjects, compliant with 21 CFR 50.25

• The innovative and efficient trial approach justification, limited to three pages, if you are requesting additional funding

• For resubmissions, the previous OOPD Summary Statement, with an optional point-by-point rebuttal

Do not use the appendix to get around page limits.

Other required elements

• A Data Management and Sharing Plan is required for all applications regardless of direct cost level, attached in the Other Plan(s) slot.

• At least one human subjects study record using the PHS Human Subjects and Clinical Trials Information form.

• The IND or IDE number and the date the final protocol version was submitted must appear with the project title on the face page of the application.

• If the IND or IDE sponsor is not the listed principal investigator, a letter from the sponsor permitting access to the IND or IDE must be submitted both in the IND or IDE and in the grant application.

How Applications Are Reviewed

Review happens in two stages.

Stage one, responsiveness screening. FDA grants management and program staff review every application against nine program responsiveness criteria. Applications found non-responsive receive notice that they will not be reviewed at all. The criteria include proposing a clinical trial that provides safety or efficacy data for a rare disease, using the generic name of the product, requesting no more than four years, documenting rare disease prevalence, explaining how the trial supports a new indication or labeling change, meeting the IND and IDE requirements under 21 CFR 312 for drugs and biologics or 21 CFR 812 for devices, providing the required appendices and letters, and complying with page and formatting limits.

Only medical foods that do not require premarket approval and devices classified as non-significant risk are exempt from the IND and IDE requirement. Non-significant risk device applicants must include a letter from the FDA Center for Devices and Radiological Health confirming the classification.

Stage two, objective review. Responsive applications go to an FDA Objective Review Committee of subject matter experts, which assigns an overall impact score reflecting the likelihood the project will exert a sustained and powerful influence on the field. FDA experts may be consulted on whether the study will generate data that could contribute to product approval. Funding decisions are made by the Commissioner of Food and Drugs or a designee, based on scientific and technical merit, availability of funds, and relevance to program priorities.

Every application receives a written critique. Appeals of objective review are not accepted for this NOFO.

Note that reviewers are told an application does not need to be strong in every category, and that a project which is not innovative in itself may still be essential to advance a field. The relative importance of strengths and weaknesses matters more than the count.

Additional items reviewers assess without separate scores

• Study timeline, including start-up activities, enrollment rate, follow-up, use of existing resources for efficiency, and contingency plans for enrollment shortfalls

• Protections for human subjects, across risk, adequacy of protection, potential benefits, importance of knowledge gained, and data and safety monitoring

• Biohazards

• Resource sharing plans

• Authentication of key biological and chemical resources

• Whether the budget and requested period of support are fully justified and reasonable

Common Reasons Good Science Loses This Grant

• The protocol was not submitted to the IND or IDE division at least 30 days before the deadline, or the IND is on clinical hold or exempted.

• The version of the protocol in the grant application does not match the version submitted to the IND or IDE.

• Budget built as $650,000 in direct costs, with indirect costs stacked on top, blowing the total cost cap.

• Prevalence documented in prose without the mandated "Rare Disease Population/Prevalence" heading, or without calculations and citations.

• Patient engagement described as an intention rather than evidenced with letters from patients, caregivers, or patient organizations.

• No letter confirming product availability in the form and quantity the trial requires.

• The innovation supplement requested without a three-page appendix justification meeting the stated design requirements.

• SAM, eRA Commons, or Grants.gov registration incomplete at the deadline, which is never an accepted reason for a late submission.

• Missing eRA Commons ID in the Credential field of the Senior/Key Person Profile, which causes outright rejection.

• Submitting close to the deadline, hitting Grants.gov or eRA Commons errors, and correcting them after 11:59 PM Eastern. Late is late.

Frequently Asked Questions

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What is RFA-FD-25-020?

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RFA-FD-25-020 is a Notice of Funding Opportunity from the FDA Office of Orphan Products Development that funds clinical trials of orphan products in support of a new indication or a change in labeling for a rare disease or condition. It is a reissue of RFA-FD-23-001 and uses the R01 activity code.

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How much money can I get from RFA-FD-25-020?

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Up to $650,000 in total costs per year for up to four years, which is $2.6 million maximum. If you propose a qualifying innovative or efficient trial design and justify it in a three-page appendix, you may request up to an additional $250,000 per year, raising the ceiling to $900,000 per year and $3.6 million across four years. All figures are total costs, meaning direct plus indirect combined.

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When are RFA-FD-25-020 applications due?

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New applications are due October 20, 2026 and October 19, 2027, both by 11:59 PM Eastern Time. Resubmission-only deadlines are May 18, 2027 and May 16, 2028. Optional letters of intent are requested by September 21, 2026 and September 20, 2027. The opportunity expires May 31, 2028. Late applications are not accepted.

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Can a small business or startup apply for RFA-FD-25-020?

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Yes. Small businesses and for-profit organizations are explicitly listed as eligible applicants. Under the previous issue of this opportunity, RFA-FD-23-001, roughly one in five funded projects went to for-profit companies, including Ophirex, Extend Biosciences, Palvella Therapeutics, and Targeted Therapy Technologies. Earlier issues funded companies including DNAtrix and Fibrocell Technologies.

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Is RFA-FD-25-020 an SBIR grant?

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No. This is an R01 research project grant, not an SBIR or STTR award. That means none of the SBIR eligibility restrictions apply. There is no small business size standard, no requirement that the principal investigator be primarily employed by the applicant company, no United States ownership percentage test, and no Phase I prerequisite. Companies of any size may apply.

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Do I need an active IND or IDE to apply?

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In almost all cases, yes. The protocol and all other required documents must be submitted to the applicable FDA IND or IDE review division at least 30 days before the grant application deadline. The IND must be active, meaning not on clinical hold and not exempted, or the IDE must be approved, for the application to qualify for review. The only exceptions are medical foods that do not require premarket approval and medical devices classified as non-significant risk, which need a letter from the Center for Devices and Radiological Health confirming the classification.

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What counts as a rare disease for this grant?

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For chronic diseases, a prevalence of fewer than 200,000 people in the United States. For acute diseases lasting less than one year, an annual incidence of fewer than 200,000 per year. Diagnostics and vaccines qualify only if the United States population receiving them is fewer than 200,000 people per year. Orphan subsets of non-rare diseases may qualify if a product characteristic such as mechanism of action or toxicity profile justifies limiting use to that subset.

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Which clinical trial phases are eligible?

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All of them. RFA-FD-25-020 supports clinical trials in Phase 1, Phase 2, and Phase 3 of product development, as long as the trial evaluates safety or efficacy in support of a new indication or a change in labeling.

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What kinds of products are eligible?

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Drugs, biologics, medical devices, and medical foods indicated for rare diseases or conditions. Already approved products being studied for a new orphan indication are eligible. Diagnostics and vaccines are eligible under the population limits described above.

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What are the innovative trial designs that unlock extra funding?

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Seamless and adaptive designs that compress trial phases into one continuous trial, plus basket, umbrella, and platform trials that test multiple drugs or multiple diseases on shared infrastructure. Innovative use of data simulation and modeling to study safety and efficacy also qualifies. FDA strongly recommends discussing these approaches with the relevant review division before applying, through a preIND or INTERACT meeting.

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Is cost sharing or matching required?

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No. RFA-FD-25-020 does not require cost sharing. You must still disclose other funds contributed to the study from any source, including your own company, with amounts, sources, and whether the funds are secured.

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Can I get indirect costs if my company has no negotiated federal rate?

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Yes. If your organization has never established an indirect cost rate and has no negotiated federal agreement, FDA allows a de minimis rate of 10 percent of modified total direct costs. If you do have a negotiated rate, attach the agreement to the Research and Related Other Project Information component as line 12, Other Attachments. Foreign organizations are funded at a fixed 8 percent.

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How long is the Research Strategy?

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Twelve pages for this NOFO. FDA does not follow NIH page limitation guidelines. Resubmissions add a one-page Introduction addressing the prior Summary Statement.

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Can foreign organizations apply?

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Yes. Non-domestic, non-United States entities are eligible, as are non-domestic components of United States organizations. Foreign components are allowed. Indirect costs for foreign and international organizations are capped at 8 percent of modified total direct costs.

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Can I submit more than one application?

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Yes, provided each application is scientifically distinct. FDA will not accept duplicate or highly overlapping applications under review at the same time, and will not accept a new application submitted before the summary statement issues from an overlapping prior application.

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Can I appeal if my application is not funded?

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No. Appeals of objective review are not accepted for applications submitted under this NOFO. The decision not to award, or to award at a particular funding level, is discretionary and not subject to appeal. You may, however, submit a resubmission application at a resubmission-only deadline, provided your prior application received a numeric score and does not require an IND protocol amendment before resubmission.

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Is this funding dilutive?

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No. This is a federal grant, not an investment. You give up no equity, no board seats, and no intellectual property rights. It is non-dilutive capital that also puts an FDA office in the position of tracking your product toward approval.

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How is FDA review different from NIH review?

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FDA uses its own Objective Review Process rather than NIH peer review, applies its own page limits rather than NIH page limitation guidelines, and applies its own review criteria. Applications are still submitted through Grants.gov and tracked in eRA Commons, and FDA still applies HHS grants policy, which is why the announcement reads like an NIH opportunity in places. When FDA program-specific instructions conflict with the general application guide, follow the FDA instructions.

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Who do I contact at FDA about this opportunity?

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Scientific and programmatic questions go to Katherine Needleman, Director of the Orphan Products Grants Program at OOPD, at katherine.needleman@fda.hhs.gov or 301-796-8660. Letters of intent go to OOPD_CTGrants@fda.hhs.gov. Peer review and grants management questions go to Patrick Johnson at the FDA Office of Acquisitions and Grants Services, at Patrick.Johnson@fda.hhs.gov. FDA encourages applicants to resolve responsiveness questions before submitting.

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What To Do Next

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If you have a rare disease product with a protocol at or near IND or IDE stage, the October cycle is winnable and the competition is smaller than founders assume. The gating item is regulatory, not scientific: the protocol has to be with the FDA review division 30 days before the application deadline.

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Where most companies lose this grant is not the science. It is the responsiveness screen, the total cost math, the patient engagement evidence, and the letters of support. Those are all solvable with enough runway.

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BW&CO helps deep tech, biotech, and medtech companies win non-dilutive federal funding, with more than $350 million in funding secured for clients to date. If you are evaluating RFA-FD-25-020, we can assess fit against your regulatory timeline and build the application strategy around it.

NIH Blueprint MedTech Translator (PAR-25-383): The Complete Startup Guide to the UG3/UH3 Medical Device Funding Opportunity

What is the NIH Blueprint MedTech Translator program?

The NIH Blueprint MedTech Translator (PAR-25-383) is a milestone-driven UG3/UH3 cooperative agreement that funds medical device companies and academic innovators to take a novel device from late preclinical development through FDA regulatory clearance to conduct a clinical study, and then through that first clinical study in humans. It is one of the few federal programs that pays for the expensive, unglamorous middle of device development: GLP large animal safety testing, design verification and validation, biocompatibility, cybersecurity, quality systems, IDE preparation, and the first-in-human trial itself.

Two things make it unusual. First, application budgets are not capped. Second, NIH pays a network of contract research organizations and expert consultants directly, outside your budget, so a startup gets prototyping, bench testing, animal studies, regulatory consulting, reimbursement strategy, IP counsel, and clinical trial support at no cost to the award.

The funding is non-dilutive. You keep your equity and you keep your intellectual property.

Next application deadline: September 28, 2026. Subsequent deadlines run through January 28, 2028.

Blueprint MedTech Translator at a glance

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Here are the core facts a founder needs before deciding whether to pursue this opportunity.

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• Funding Opportunity Number: PAR-25-383

• Title: Blueprint MedTech Translator (UG3/UH3, Clinical Trial Optional)

• Agency: National Institutes of Health, Department of Health and Human Services

• Activity code: UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement

• Announcement type: Reissue of PAR-21-315

• Posted: June 17, 2025

• Expiration: January 29, 2028

• Award budget: not limited, but must reflect the actual needs of the project

• Cost sharing: not required

• Project period: UG3 phase up to four years, UH3 phase up to four years, five years total maximum

• Application types allowed: New, Resubmission, Revision

• Clinical trial: Optional at the UG3 stage, required in the UH3 stage

• Letter of intent: encouraged, not required

• Assistance Listing Numbers: 93.853, 93.372, 93.213, 93.279, 93.866, 93.273, 93.286, 93.242, 93.865, 93.121, 93.867

• Program email: Blueprint-MedTech@nih.gov

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Which NIH Institutes and Centers participate in Blueprint MedTech?

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Ten Institutes and Centers participate, and your device must address a disease or disorder within the mission of at least one of them. The Office of Behavioral and Social Sciences Research may co-fund awards.

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• Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative

  • There is a need to help transition BRAIN Initiative-relevant technologies from early device development to first-in-human studies. Projects that fit the following categories can be submitted through the Blueprint MedTech Program. BRAIN will support the following efforts coming into the BP MedTech UG3/UH3 funding opportunity:

  • Projects developing novel invasive neurostimulation devices for the human central nervous system (CNS).

  • Projects developing novel invasive brain recording devices for the human CNS.

  • Projects developing novel non-invasive brain stimulation devices for the human CNS. These devices should aim to achieve brain stimulation resolution of sub-millimeter at the cortical surface and depth. These approaches may incorporate electromagnetic, mechanical, or combination biological and device means (e.g., optogenetics).

• National Center for Medical Rehabilitation Research (NCMRR)

  • The National Center for Medical Rehabilitation Research within NICHD supports assistive and rehabilitation technology to improve the function of people with physical disabilities. NICHD will only accept applications related to the mission of the National Center for Medical Rehabilitation Research.

• Helping to End Addiction Long-term (HEAL) Initiative

  • Through Notice of Special Interest NOT-NS-24-075, the NIH HEAL Initiative encourages the development and translation of novel neurotechnologies, funded through the Helping to End Addiction Long-term (HEAL) Initiative and overseen by the NIH Blueprint MedTech program. Academic institutions and Small Business Concerns (SBCs) are encouraged to submit grant applications that propose non-clinical development and validation activities for subsequent clinical feasibility studies of medical devices for the diagnosis and treatment of pain and opioid use disorder (OUD). Applications supporting the development and translation of groundbreaking neurotechnologies that fit within the mission of the HEAL Initiative are encouraged.

• National Center for Complementary and Integrative Health (NCCIH)

  • The National Center for Complementary and Integrative Health (NCCIH) supports the development and validation of technologies that can facilitate the integration of complementary and integrative health approaches to enhance diagnosis, prevention, or treatment of diseases and/or associated symptoms, or promotion of well-being and whole person health relevant to the nervous and neuromuscular systems. In addition, NCCIH supports the integration of technologies with multisystem studies to understand the connections and interactions across systems involving the brain and the rest of the nervous system such as interoception, and/or the impact of multi-component interventions on multisystem connections and interactions in pre-clinical models or human subjects. NCCIH will not support clinical efficacy studies or pivotal trials of an intervention.

  • Complementary health approaches include a broad range of practices and interventions that are not typically part of conventional medical care. They can be classified by their primary therapeutic input, including nutritional (e.g., special diets, dietary supplements, herbs, probiotics, and microbial-based therapies), psychological (e.g., meditation, hypnosis, music-based interventions, relaxation therapies), physical (e.g., acupuncture, massage, chiropractic manipulation, other force-based manipulations, or devices related to these approaches), or a combination of psychological and physical (e.g., yoga, tai chi, dance therapies, some forms of art therapy such as music-based interventions).

• National Eye Institute (NEI)

  • The National Eye Institute is requesting applications for the development of FDA Class III medical devices, as well as invasive ocular implants and prosthetics (retinal or cortical) that can stimulate retinal or cortical neurons to produce visual percepts. NEI is not interested in projects focused on developing diagnostic/imaging devices or assistive devices through this program.

• National Institute of Biomedical Imaging and Bioengineering (NIBIB)

  • The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to transform, through technology development, our understanding of disease and its prevention, detection, diagnosis, and treatment. NIBIB may support the development of broadly applicable products, where the disease or organ being targeted is used as an initial model and could be adapted to other indications in the future. Before contacting NIBIB, applicants should first discuss the initial target with the Institute and/or Center on this page that is most relevant to the disease(s) being addressed by the proposed product.

• National Institute of Dental and Craniofacial Research (NIDCR)

  • Development of technologies for oral somatosensory or autonomic nerve stimulation to enable diagnosis and/or treatment of motor and sensory conditions, such as bruxism, sleep apnea, temporomandibular/facial pain, swallowing reflex, salivary gland production, and other dental, oral, and craniofacial related conditions and disorders related to the nervous system. These technologies can include the integration of intra- and extra-oral sensors and relevant treatment delivery mechanisms controlled by software systems that allow capture, analysis and display of target biosignatures including but not limited to neural activity.

  • Biofeedback & multimodal neurofeedback technologies for treatment of facial nerve disorders, as well as neurological (e.g., trigeminal neuralgia, peripheral neuropathy associated with Sjogren’s syndrome, burning mouth syndrome) and non-neurological (e.g., vascular/muscular, immune) facial pain. These technologies can include wearable and embeddable devices as well as virtual or augmented reality technology to address acute and chronic conditions.

  • Development, validation and testing of novel technologies to promote prevention and treatment of orofacial and craniofacial nerve injuries, including nerve regeneration.

  • Development, validation and testing of technologies that improve the accuracy and validity of dental, oral or craniofacial clinical pain measurements.

• National Institute of Mental Health (NIMH)

  • NIMH is specifically interested in novel brain stimulation/modulation technologies (invasive or noninvasive) for use in the treatment of psychiatric disorders, or in targeting specific domains of clinical functioning across psychiatric disorders, when appropriate (see RDOC). Devices capable of both recording and stimulating neural activity, with the ability for closed-loop control are also of interest (including synchronizing dense behavioral quantification with neural data); these devices should be able to demonstrate clear capability to record oscillations of interest to mental health applications. Devices can target specific age ranges, including vulnerable populations (pediatric, geriatric). Note: Animal studies to assess “efficacy” must follow NIMH criteria. Please contact NIMH staff above to ensure your project fits NIMH priorities, prior to application submission.

• Office of Behavioral and Social Sciences Research (OBSSR)

• National Institute of Neurological Disorders and Stroke (NINDS)

• National Institute on Aging (NIA)

  • NIA, as the primary federal agency for aging and Alzheimer’s Disease and related dementias (AD/ADRD) research, supports the development and application of innovative technology for early diagnosis and treatment of age-related disorders and AD/ADRD.

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  • NIAAA’s mission is to generate and disseminate fundamental knowledge about the adverse effects of alcohol on health and well-being and to apply that knowledge to improve diagnosis, prevention, and treatment of alcohol-related problems, including alcohol use disorder (AUD), across the life span. NIAAA is interested in wearable devices that can monitor blood alcohol concentration in real time, non-invasive methods for the treatment of fetal alcohol spectrum disorders (FASD) in children and adults, and in the treatment of AUD.

• National Institute on Drug Abuse (NIDA)

  • NIDA will support applications aiming to develop novel medical devices intended for use in the diagnosis of, or in the cure, mitigation, treatment, or prevention of Substance Use Disorder (e.g., Opioid Use Disorder, Stimulant Use Disorder). See the NIDA Mission for additional details.

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Projects may also fall under the NIH BRAIN Initiative (Brain Research through Advancing Innovative Neurotechnologies) or the HEAL Initiative (Helping to End Addiction Long-term). A Notice of Special Interest, NOT-NS-24-075, specifically invites HEAL-aligned diagnostic and therapeutic device applications through this NOFO.

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Each participating Institute publishes its own interest statement with additional requirements, clinical study limitations, and budget guidance. Reading the interest statement for your target Institute before you write anything is not optional in practice. Two applications with identical technology can succeed or fail on Institute fit alone.

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How much funding can a startup receive from Blueprint MedTech Translator?

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There is no published budget cap. NIH states that application budgets are not limited but need to reflect the actual needs of the proposed project, and that applicants should propose a budget that is reasonable and appropriate for completion of the research.

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That freedom comes with four practical rules that shape every Blueprint MedTech budget.

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Rule one: your budget covers only your own work. Application budgets should only cover work performed by the Program Director or Principal Investigator and their staff. NIH pays Blueprint MedTech contractors and consultants directly for their work, so those expenses must not appear in your budget. This is the single most common budgeting error on this NOFO. Startups accustomed to SBIR budgeting will instinctively line-item a CRO for large animal work or a regulatory consultant for the pre-submission, and both belong outside the budget here.

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Rule two: requests of $500,000 or more in direct costs in any single year require advance permission. If you plan to request $500,000 or more in direct costs in any year, excluding consortium facilities and administrative costs, you must contact a Scientific or Research Contact at least six weeks before submitting and follow NIH policy on acceptance for review of applications requesting $500,000 or more. Skipping this step can cost you the cycle.

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Rule three: funding may be throttled to $100,000 until FDA weighs in. Applicants who do not already have sufficiently relevant FDA feedback covering all planned activities will be expected to obtain it as the first milestone of the award. Until FDA feedback is received and is consistent with the likely success of the regulatory path to market and the overall device development plan, funding may be restricted to a maximum of $100,000 in direct costs. If FDA feedback contradicts the plan in the application, program staff will evaluate the concerns and the change of scope required, and any remaining funds from the original award will not be released.

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Rule four: budgets are negotiated, not simply awarded. As a cooperative agreement, milestones and budget are negotiated with NIH program staff before award, and the budget for the UH3 clinical phase is renegotiated at the transition point.

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Because Institute-specific budget expectations vary widely, contacting the program officer at your target Institute is the only reliable way to calibrate the number.

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What free resources does the Blueprint MedTech program provide?

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This is the part founders consistently undervalue. Beyond the cash award, Blueprint MedTech participants get streamlined access to NIH-funded service providers and contract research organizations that NIH pays for directly. The program provides:

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• Design optimization, prototype development, and pilot-scale manufacturing

• Bench and safety testing

• Biocompatibility, sterilization, and large animal testing

• Clinical study advising and clinical trial support, including medical monitoring

• Commercialization planning and business development

• Regulatory, quality system, and reimbursement support

• Legal support and intellectual property protection

• Access to industry expert mentors and meetings with an external oversight committee

• Planning resources for concept development, team building, and needs assessment

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For a seed-stage medtech company, the in-kind value of GLP large animal safety studies, biocompatibility panels, and regulatory consulting can rival or exceed the cash award.

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Applicants are required to submit a Resource Checklist attachment identifying which of these resources they intend to use. NIH encourages a specific statement along these lines: "If selected for funding, we expect that the following resources will be made available to this project by the Blueprint MedTech program. Since the program will provide these resources at no cost, this application does not request any labor or budget associated with these resources."

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What is NIH actually looking for in a Blueprint MedTech application?

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NIH is looking for a device that is nearly finished, aimed at a real clinical gap, backed by real data, and blocked mainly by the cost of regulatory-grade testing and a first clinical study.

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More precisely, the program wants novel medical device technologies that advance patient care toward new or improved therapeutics or diagnostics that are safe and effective. Responsive applications propose devices expected to be regulated by the FDA that present first-of-its-kind technologies, new safety questions, or new regulatory questions. Applications may also refine existing technologies toward a new intended use or use in a novel setting, for example translating a neuromodulation device approved only for healthcare settings into a home-use device.

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Expected regulatory pathway

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Proposed devices and indications will likely follow the De Novo or Premarket Approval (PMA) pathways. Devices that fit an existing 510(k) pathway may still be accepted, but only if the application demonstrates clear clinical and technological innovation beyond the state of the art of existing FDA-cleared predicates. Such devices should reasonably be expected to provide new clinically meaningful diagnostic or therapeutic options, or to improve the benefit-risk profile of a treatment or diagnostic through substantial safety innovations.

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Device maturity requirements

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Devices within scope of this program must meet at least one of three conditions:

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1. The device is very close to the final system and is manufactured using very close to the same manufacturing process as the device that will be marketed or studied in a larger clinical trial after this project, or

2. The device has received Pre-Submission feedback from the FDA, or

3. The device requires early feasibility clinical data to inform the final device design or manufacturing processes.

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Entry criteria

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For entry into the program, projects should have all three of the following:

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• Comprehensive supporting data based on bench, in vitro, and in vivo models representative of the intended patient population and indication

• One or more clinically meaningful device outcome measures identified with input from key stakeholders including clinicians, patients, and caregivers, supported by literature

• A compelling case for a successful IDE submission for a Significant Risk study, or IRB approval for a Non-Significant Risk study, by the end of the UG3 phase

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For novel devices, proof-of-concept data on device function is required, obtained using a prototype close to the final device design anticipated for clinical testing, ideally tested in an in vivo animal model representative of the intended patient population. For first-in-human studies, preliminary human data is not required.

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A note on market size

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NIH explicitly states that the market for these device categories may be small compared with other markets, and that applications should not be penalized for a comparatively smaller market provided the market is sustainable. NIH supports research for both rare and high incidence disorders within its mission. This is a meaningful opening for rare disease device companies that struggle to raise venture capital on total addressable market alone.

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How does the UG3 and UH3 phased structure work?

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Every project must have two phases, and every project starts in the UG3 phase. The UH3 phase is not guaranteed. Transition happens only after NIH administrative review.

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UG3 phase: get to an IDE or IRB approval

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The UG3 phase supports the translational device work needed to obtain an IDE and IRB approval for a Significant Risk clinical study, or IRB approval for a Non-Significant Risk study. Duration depends on project maturity at entry and the specific indication, and ranges from one to four years.

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Activities appropriate to the UG3 phase include:

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• Non-GLP animal studies to develop surgical techniques, optimize therapeutic or diagnostic parameters, and refine device design ahead of GLP testing

• Bench-top and animal testing to demonstrate compliance with FDA Recognized Standards

• GLP-compliant large animal safety testing of an implanted device

• Activities to become current Good Manufacturing Practice (cGMP) compliant

• Activities to bring development under Design Control and Quality Systems

• Usability and acceptability studies

• Device, software, firmware, and cybersecurity design verification and validation

• Development of packaging, connectors, and accessories needed for translation

• Regulatory activities including FDA pre-submission meetings, IDE submission, Humanitarian Device Exemption, Request for Risk Designation, 513(g) submission, and Breakthrough Device Designation

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UH3 phase: run the clinical study

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The UH3 phase supports a clinical study leading to one of three outcomes: a marketing application, if the study is sufficiently powered to demonstrate safety and effectiveness for regulatory approval; a larger clinical study that will lead to a marketing application; or use of the clinical experience to inform device design decisions. The UH3 phase can last up to four years.

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The clinical study must provide information about device function or final design that cannot practically be obtained through additional bench or animal work, because of the novelty of the device or its intended use.

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Activities appropriate to the UH3 phase include:

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• Optimization of device design with respect to human functional anatomy

• Identification of the simplest, most reliable, and most cost-effective device configuration for advanced clinical studies and eventual market approval

• Studies of key physiological variables that may affect device function in humans

• Initial device safety assessments, but only in conjunction with obtaining enabling data about device design or function

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What determines whether you transition from UG3 to UH3?

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Program staff conduct an administrative review, with possible input from independent consultants. The decision rests on:

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• Successful achievement of the defined UG3 milestones

• The competitive landscape

• Programmatic priorities and current portfolio balance

• For Significant Risk studies, documentation of final or conditional IDE approval from FDA

• IRB approvals

• Submission of the final clinical protocol and supporting documents to NIH for administrative review, and NIH notification of approval

• Agreement on updated timeline, milestones, and budget for the clinical study

• Availability of funds

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NIH is direct about the implication: expectations align with industry norms for advancing devices through the development pipeline, and an inherent rate of attrition is possible within this program. Not every UG3 award becomes a UH3 award. Build your company plan accordingly.

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Why milestones decide the outcome of a Blueprint MedTech award

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Blueprint MedTech is a milestone-driven cooperative agreement, which means milestones are not a formality in the application. They are the operating contract for the award.

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Each Specific Aim in the application should have at least one milestone associated with it. Each milestone should tie to tangible deliverables that are specific, measurable, achievable, relevant, and time-bound. NIH treats milestones as go or no-go decision points where significant uncertainty for the project is resolved. Applicants are advised to include aims, milestones, and deliverables addressing both technical and commercial feasibility.

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Two milestones are effectively mandatory in Year 1:

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• For projects that need non-clinical testing to support an IDE, an FDA pre-submission meeting with NIH program staff in attendance must be a Year 1 milestone. FDA feedback from that meeting must clearly indicate that the proposed non-clinical testing plan is sufficient to support a successful IDE submission by the end of the UG3 phase.

• For projects requiring non-clinical testing to support an IRB Non-Significant Risk designation, preliminary communication with the IRB about what non-clinical testing will be necessary must be a Year 1 milestone.

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After award, NIH program staff evaluate progress toward milestones every year and recommend whether further funds should be released. If a project does not meet its milestones, funding may be discontinued. Continued funding also depends on the overall robustness of the entire data package, overall progress, portfolio balance and program priorities, the competitive landscape, and availability of funds.

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Milestones are negotiated with NIH program staff before award and are written into the Notice of Award. In rare, well-justified cases, future-year milestones may be renegotiated based on data obtained during the previous year.

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Blueprint MedTech Translator deadlines and timeline

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Applications are due by 5:00 PM local time of the applicant organization. When a due date falls on a weekend or federal holiday, the deadline moves automatically to the next business day.

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Upcoming due dates and review cycles

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September 28, 2026 submission. Scientific merit review March 2027. Advisory Council review May 2027. Earliest project start July 2027.

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January 28, 2027 submission. Scientific merit review July 2027. Advisory Council review October 2027. Earliest project start December 2027.

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May 28, 2027 submission. Scientific merit review November 2027. Advisory Council review January 2028. Earliest project start April 2028.

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September 28, 2027 submission. Scientific merit review March 2028. Advisory Council review May 2028. Earliest project start July 2028.

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January 28, 2028 submission. Scientific merit review July 2028. Advisory Council review October 2028. Earliest project start December 2028. This is the final due date before the NOFO expires on January 29, 2028.

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The same dates apply to new, resubmission, and revision applications. There are no AIDS-related deadlines for this opportunity.

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The timeline you should actually plan against

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Count backward from the deadline, not forward from today.

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• Twelve weeks before the due date: contact NIH program staff at your target Institute. NIH states that when possible, applicants should contact program staff at least twelve weeks before a receipt date. Early contact is how you learn whether your indication fits, what the Institute expects on clinical study design, and what budget range is realistic.

• Six weeks before the due date: if you are requesting $500,000 or more in direct costs in any year, this is your hard deadline for contacting a Scientific or Research Contact.

• Six weeks or more before the due date: begin System for Award Management registration if you are not already registered. NIH warns that registration can take six weeks or more, and that failure to complete registrations in advance is not a valid reason for late submission.

• Two weeks before the due date: eRA Commons accounts can take up to two weeks to obtain. Every Program Director or Principal Investigator needs one, and their eRA Commons ID must appear in the Credential field of the Senior/Key Person Profile form.

• Several days before the due date: submit early. Errors found during the Grants.gov and eRA Commons validation process must be corrected and a changed or corrected application resubmitted on or before the due date and time.

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Add roughly nine to ten months from submission to earliest award start. A September 2026 submission that succeeds starts in July 2027.

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Who is eligible to apply for Blueprint MedTech Translator?

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Eligibility is broad, and startups are explicitly welcome. Individuals, institutions, and businesses developing their own devices, or that already have established collaborations with device manufacturers, may apply directly.

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Eligible organizations include:

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• Higher education institutions, both public and private

• Nonprofits with and without 501(c)(3) status

• For-profit organizations, including small businesses

• Local, state, county, city, township, and special district governments

• Federally recognized and other Native American tribal governments and organizations

• Eligible agencies of the federal government

• U.S. territories and possessions

• Independent school districts, public housing authorities, faith-based and community-based organizations, and regional organizations

• Non-domestic (non-U.S.) entities, including foreign organizations and foreign components of U.S. organizations

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Foreign components as defined in the NIH Grants Policy Statement are allowed.

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What this means for a venture-backed startup

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Three points matter for founders comparing this to SBIR and STTR.

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First, this is not an SBIR or STTR program. The SBIR ownership and size restrictions do not apply here, so majority venture-owned and larger private companies that have aged out of SBIR eligibility can still compete.

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Second, cost sharing is not required.

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Third, an organization may submit more than one application as long as each is scientifically distinct. NIH will not accept duplicate or highly overlapping applications under review at the same time.

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Required registrations

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All registrations must be complete before the application is submitted:

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• System for Award Management (SAM), which must be renewed at least annually and which assigns a CAGE code for domestic organizations

• NATO Commercial and Government Entity (NCAGE) code for foreign organizations, in lieu of a CAGE code

• Unique Entity Identifier (UEI), issued through the SAM registration process, which must match the identifier in eRA Commons

• eRA Commons, requiring at least one Signing Official and at least one Program Director or Principal Investigator account. If the PI is also the Signing Official, two distinct accounts are required.

• Grants.gov, which requires an active SAM registration first

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Applications may be submitted through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.

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What attachments does a Blueprint MedTech application require?

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This NOFO has an unusually heavy set of required attachments with strict page limits. Missing or oversized attachments cause withdrawal without review. Treat this list as a compliance checklist.

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Required attachments

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• Needs Assessment, three pages maximum, filed as "Needs Assessment.pdf"

• IP Strategy, three pages maximum, filed as "IP Strategy.pdf"

• Gantt Chart, one page maximum, filed as "Gantt.pdf"

• Long-term Care Plan for Patients, three pages maximum, filed as "Long-term Care.pdf"

• Resource Checklist, three pages maximum, filed as "Resource Checklist.pdf"

• UG3 Milestone Plan, included in the Research Strategy

• UH3 Milestone Plan, attached at Section 2.7 Study Timeline in the PHS Human Subjects and Clinical Trials Information form

• Team Management Plan, two pages maximum, attached at Section 3.5

• Data Safety and Monitoring Plan, attached at Section 3.3

• Data Management and Sharing Plan, required regardless of direct costs requested

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Optional attachments with enforced page limits

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Exceeding these limits also causes withdrawal.

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• Schematics, two pages maximum, filed as "Schematics.pdf"

• IRB Communications, five pages maximum, filed as "IRB Communications.pdf"

• FDA Communications, ten pages maximum including a one-page summary, submitted only in Section 4.5.a or as post-submission material. Pre-submissions themselves should not be included.

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What goes in the harder attachments

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Needs Assessment. Establish performance requirements with clear, quantifiable metrics. Identify significant issues faced by patients, clinicians, caregivers, and customers. Critically evaluate primary or secondary data used to identify deficiencies in current capabilities. Describe the beneficiaries and how their needs were identified. Distinguish wants from needs. Describe how finite resources will be deployed. Identify human factors and ergonomics incorporated into the design.

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IP Strategy. Describe the IP landscape around your device, including known constraints such as restrictions under transfer or sharing agreements, your own prior filings and publications, and similar patented or marketed technologies. If you are using technology your institution does not own, address anything that could constrain your freedom to operate, and include a letter from the IP owner stating whether they will provide the technology, any limits on studies performed with it, agreement on public disclosure of results including negative results, and whether an agreement is already in place. Give filing dates, patent types, application status, and USPTO links for relevant filings, and describe future filing plans. Academic applicants should prepare this with their technology transfer office.

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Long-term Care Plan for Patients. Describe anticipated care needs of participants after the trial ends that relate to their participation, such as continued device access, device maintenance, and explant. Consider post-trial scenarios including device or trial failure, success, regulatory approval options, and a manufacturer decision to discontinue the product. Then describe the actual plan, which may include explant of indwelling devices, surgical removal of batteries and capping exposed metals from leads and IS-1 connectors, manufacturer-supported device maintenance for responders, or manufacturer support for compassionate use exemption filings. Address post-trial obligations including hardware and software maintenance and device-related medical expenses.

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Team Management Plan. Define team structure and relationships, illustrated with an organizational chart. Describe governance, communication plans, decision processes for scientific direction and intellectual property, and conflict resolution procedures. Address authorship policies and decisions about what to publish, consistent with the interests of commercial partners. The plan must establish and name a Scientific Steering Group of senior and key team members that meets regularly. If organizations are partnering, the Scientific Steering Group must include representatives from each. Technology transfer officials are encouraged to be members.

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Neuroethics section. Within Protection of Human Subjects, describe ethical considerations related to the design and conduct of the study, for example therapeutic misconception where research is ancillary to a clinical procedure or offers no prospect of participant benefit, and the long-term implications of the study, such as psychosocial or legal implications of predictive biomarkers for pre-symptomatic individuals. Reference the Neuroethics Guiding Principles for the NIH BRAIN Initiative.

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Letters of support

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Include letters from consultants, contractors, and collaborators. Academic applicants must include a letter from the technology transfer official managing the project's IP. Multi-institution projects need a letter from each institution clarifying how IP will be shared or managed. Collaborations with private entities need a letter stating whether the entity will provide the device or technology, limits on studies, limits on data sharing, and whether licensing agreements are in place. CRO and CMO letters may summarize test results but should not contain detailed results of all testing, and generally run two pages maximum.

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What makes a Blueprint MedTech application non-responsive?

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Non-responsive applications are withdrawn and never reviewed. There are three categories.

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Activities that make an application non-responsive

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• Animal model development. All in vivo models must be established, characterized, and available to the applicant.

• Projects focused on technologies for augmentation of healthy individuals

• Delayed-onset clinical studies

• Device technologies not regulated by the FDA

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Omissions that make an application non-responsive

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• Specific Aims that do not cover activities for both the UG3 and UH3 phases

• Failure to plan a delayed-start clinical study or trial in the UH3 phase, including all required supporting documentation

• Missing any required attachment listed above

• Missing a UH3 Milestone Plan

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Formatting failures that make an application non-responsive

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• Any required or optional attachment that exceeds its page limit

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Note the distinction NIH draws between delayed onset and delayed start. A delayed-start study is one that can be described in full but will not begin immediately, which is exactly what the UH3 phase requires. A delayed-onset study is one that cannot yet be described, and those are not accepted.

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How is a Blueprint MedTech application reviewed?

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Applications are evaluated for scientific and technical merit by an appropriate Scientific Review Group under NIH peer review policy, using the revised NIH review framework that took effect for due dates on or after January 25, 2025.

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Reviewers consider three factors. Factors 1 and 2 each receive a separate factor score, and all three inform the overall impact score.

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Factor 1: Importance of the Research (Significance and Innovation)

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Reviewers assess whether the work addresses an important gap, solves a critical problem, or creates a valuable conceptual or technical advance, and whether it applies novel concepts, methods, or technologies.

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Specific to this NOFO, reviewers evaluate:

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• Whether there is a significant advantage over all existing clinically available approaches for the same indication, regardless of class, including drugs, biologics, and competing devices

• Whether the device reduces a known serious adverse event, a known device failure mode, or a use-related hazard or error, or improves the safety of another device or intervention

• For devices improving on earlier generations, whether the advantages are justified and whether the changes are likely to succeed where the predecessor did not

• Whether proof-of-concept data for a novel device was obtained with a prototype close to the final design

• Whether the device and its capabilities are described in enough detail to judge appropriateness for the proposed clinical study

• Whether the approach, targets, and patient population are justified

• Whether there are adequate plans to engage FDA early

• Whether the Needs Assessment incorporates input from patients, clinicians, and caregivers on device performance requirements, and identifies beneficiaries and their needs

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Factor 2: Rigor and Feasibility (Approach)

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Reviewers assess whether the work will produce unbiased, reproducible, robust data, whether design and controls are sound, whether sample size is sufficient and justified, and whether the studies can be done within the proposed timeframe.

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Specific to this NOFO, reviewers evaluate:

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• Whether the regulatory plan is reasonable in terms of the path to market and FDA data requirements for the applicable standard, meaning reasonable assurance of safety and effectiveness for PMA or substantial equivalence for 510(k)

• Whether the estimated timeline for clinical adoption reflects feasible benchmarks

• Whether and how key stakeholders will be engaged at each step

• Whether the project plan and timeline make an IDE at the end of the UG3 phase, or IRB approval for a Non-Significant Risk study, likely

• Whether neuroethical concerns are adequately addressed

• Whether any large animal safety study uses GLP and the final device design, or whether a clear reason it is unnecessary is provided, such as an FDA communication

• Whether the Long-term Care Plan anticipates key patient needs, is reasonable, and addresses financial liability for injury, device removal, device revision, and management of indwelling devices

• Whether the Gantt chart provides sufficient detail and demonstrates feasible plans

• Whether milestones are timely, robust, and tied to clear quantitative go or no-go criteria

• Whether milestone timelines are realistic, inclusive of necessary steps, and free of unnecessary ones

• Whether milestones reflect planned regulatory requirements such as FDA pre-submission meetings and IDE submission

• Whether potential challenges and solutions are presented, including strategies for enrollment shortfalls

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Factor 3: Expertise and Resources (Investigators and Environment)

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Reviewers assess investigator background and training, the leadership plan for multiple-PI applications, and institutional resources. Specific to this NOFO, reviewers evaluate whether the selection of Blueprint MedTech resources is adequately justified, whether team governance is appropriate, and whether the Scientific Steering Group members are appropriate and constitute an interdisciplinary team.

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Additional considerations

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Reviewers also consider, without scoring, the IP Strategy attachment, including whether IP landscape issues and barriers are addressed, whether known constraints could impede device development, whether filing plans are well described, and whether IP sharing across multiple institutions is adequately addressed. Human subjects protections, vertebrate animals, biohazards, authentication of key resources, and budget and period of support are also considered.

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After peer review

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Applications may undergo a committee process in which only those with the highest merit, generally the top half under review, are discussed and scored. Recommended applications then receive a second level of review by the appropriate national Advisory Council or Board. Funding decisions weigh scientific and technical merit, availability of funds, and relevance to program priorities.

‍ ‍

What does the cooperative agreement mean for your company?

‍ ‍

A cooperative agreement is not a grant you receive and then execute independently. NIH program staff have substantial programmatic involvement beyond normal stewardship. Founders should understand what they are signing up for.

‍ ‍

What you retain

‍ ‍

• Custody of and all rights to the data and technology developed under the award, subject to government rights of access consistent with HHS, PHS, and NIH policy

• Responsibility for defining objectives and approaches, planning, conducting, analyzing, interpreting, publishing, and sharing results

• The right and encouragement to pursue patent protection

‍ ‍

The program strongly encourages recipients and their collaborators to obtain and retain IP developed around the device during the project period, and to identify and foster relationships with licensing and commercialization partners early.

‍ ‍

What NIH expects from you

‍ ‍

• Developing and proposing rigorous milestones

• Progress reports complete enough to include experimental design, assumptions, results, interpretations, and a conclusion on whether milestones were met. If program staff request raw data, you agree to provide it.

• Participation in virtual progress meetings with NIH staff at least twice a year

• Communicating regulatory meeting dates and agendas to NIH program staff and inviting their participation

• Sharing CRO study reports, meeting minutes and data packages, letters, and other FDA communications, and providing IDE or IND numbers and ClinicalTrials.gov registration numbers

• Providing regulatory and clinical documents required for administrative review

• Verifying the clinical study follows Good Clinical Practices and Institute-specific data and safety monitoring guidelines

• Collaborating and communicating effectively with NIH service contractors

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What NIH does

‍ ‍

NIH program staff provide input on milestones and recommend their finalization, assess progress toward milestones, recommend whether further funds should be released, participate with your team in meetings with regulatory agencies, and may consult independent specialists under confidentiality agreements to protect intellectual property. In rare, well-justified cases, program staff may add critical experiments as additional milestones, sometimes with additional NIH funds.

‍ ‍

A Program Officer handles normal stewardship, but the Associate Division Director overseeing the program makes final decisions on project continuation, a second level of approval designed to mitigate perceived bias. Disagreements can be escalated through other Associate Division Directors to the Institute Director. A formal Dispute Resolution Panel process exists for scientific or programmatic disagreements. Final NIH decisions regarding a discontinuation are not appealable.

‍ ‍

Quality and compliance requirements

‍ ‍

Use of Design Control and Quality Systems processes to the degree specified by FDA is required. Intermediate steps such as design reviews, design verification, design validation, and design transfer should appear in annual milestones where appropriate, along with IDE submission. NIH recognizes the required degree varies substantially by device, and encourages applicants to discuss this with FDA and regulatory consultants before submitting so the extent of the requirement is clearly defined and verifiable in the application.

‍ ‍

Applicants should consider Quality System requirements at the IDE stage when planning device development activities, and should follow Institute-specific guidelines and policies for monitoring clinical research when forming a data and safety monitoring plan.

‍ ‍

How to build a competitive Blueprint MedTech application

‍ ‍

Six moves separate funded applications from withdrawn ones.

‍ ‍

Call the program officer first, not last. NIH says twelve weeks before the deadline. This program is a negotiated partnership, and the negotiation starts before you write. Program staff will tell you whether your indication fits their Institute's mission, what clinical study requirements apply, and what budget is realistic. The Institute contact list is published on the Blueprint MedTech website.

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Get FDA feedback before you submit if you possibly can. Pre-submission feedback is encouraged rather than required, but the alternative is a Year 1 milestone and a possible $100,000 funding restriction until FDA responds. Applications that arrive with approved pre-submission minutes showing FDA agreement on the non-clinical testing plan are substantially stronger and start faster.

‍ ‍

Write your milestones like an operating plan, not a research schedule. Every Specific Aim needs at least one milestone. Every milestone needs quantitative go or no-go criteria. Cover technical, regulatory, and commercial feasibility. These become the terms of your award and the basis of every annual funding decision.

‍ ‍

Build the whole application around one Institute's mission and one indication. Your device may have several uses. The application must focus on a disease or disorder within the mission of a participating Institute, and the target patient population and intended use should drive both device design and the proposed clinical activities.

‍ ‍

Treat the attachment checklist as a go or no-go gate. Five required other attachments, two milestone plans, a team management plan, a DSMP, and a data management and sharing plan, each with page limits that are enforced by withdrawal rather than by a request to fix. Assign an owner and a deadline to each one.

‍ ‍

Budget only your own work, and claim the free resources explicitly. Leave NIH-paid contractors and consultants out of the budget, name the Blueprint MedTech resources you will use in the Resource Checklist, and justify why you are not using the ones you skipped.

Frequently asked questions about the Blueprint MedTech Translator (PAR-25-383)

‍ ‍

What is the deadline for PAR-25-383?

‍ ‍

The next application deadline is September 28, 2026. Additional deadlines follow on January 28, 2027, May 28, 2027, September 28, 2027, and January 28, 2028. All applications are due by 5:00 PM local time of the applicant organization. The NOFO expires January 29, 2028.

‍ ‍

How much money can I request from Blueprint MedTech Translator?

‍ ‍

There is no budget cap. NIH states that application budgets are not limited but must reflect the actual needs of the proposed project. If you request $500,000 or more in direct costs in any single year, you must contact a Scientific or Research Contact at least six weeks before submitting and follow NIH policy on acceptance of applications requesting $500,000 or more.

‍ ‍

Can a startup or small business apply to Blueprint MedTech Translator?

‍ ‍

Yes. For-profit organizations, including small businesses, are explicitly eligible. Individuals, institutions, and businesses developing their own devices, or that already have established collaborations with device manufacturers, are welcome to apply directly. Foreign organizations are also eligible.

‍ ‍

Is Blueprint MedTech an SBIR or STTR program?

‍ ‍

No. Blueprint MedTech Translator is a UG3/UH3 cooperative agreement, not an SBIR or STTR award. SBIR ownership and company size restrictions do not apply, so companies that are majority venture-owned or otherwise ineligible for SBIR can compete here. Note that Blueprint MedTech also offers companion SBIR opportunities, so confirm which mechanism fits your company with program staff.

‍ ‍

Do I need FDA feedback before applying?

‍ ‍

Not strictly, but it matters a great deal. Applicants are encouraged, though not required, to consult FDA through a Pre-Submission meeting. If you do not have sufficiently relevant FDA feedback covering all planned activities at the time of application, obtaining it becomes your first milestone, and funding may be restricted to a maximum of $100,000 in direct costs until FDA feedback consistent with your regulatory path and development plan is received.

‍ ‍

How long does a Blueprint MedTech award last?

‍ ‍

The UG3 phase may run up to four years and the UH3 phase may run up to four years, but the total combined project period may not exceed five years. UG3 duration depends on how mature the project is at entry and on the specific indication, and can be as short as one year.

‍ ‍

Is the UH3 clinical phase guaranteed?

‍ ‍

No. All projects start in the UG3 phase. Only UG3 projects that meet defined criteria are eligible to transition after an NIH administrative review that considers milestone achievement, the competitive landscape, programmatic priorities and portfolio balance, IDE and IRB approvals, the final clinical protocol, agreement on updated timeline and budget, and availability of funds. NIH states plainly that an inherent rate of attrition is possible.

‍ ‍

What is the difference between a Significant Risk and Non-Significant Risk study here?

‍ ‍

A Significant Risk study requires an Investigational Device Exemption from FDA before the clinical study can begin, so the UG3 phase must deliver an IDE. A Non-Significant Risk study does not require an IDE, so the UG3 phase must deliver IRB approval instead. Your milestone plan, regulatory milestones, and non-clinical testing plan differ accordingly.

‍ ‍

What kinds of devices are in scope?

‍ ‍

Devices expected to be regulated by FDA that present first-of-its-kind technology, new safety questions, or new regulatory questions, and that address a disease or disorder within the mission of a participating Institute or Center or the BRAIN or HEAL Initiatives. Devices refining existing technology for a new intended use or a novel setting, such as moving a clinic-only neuromodulation device to home use, are also responsive. Expected pathways are De Novo or PMA, with 510(k) devices accepted only when innovation clearly exceeds the state of the art of existing cleared predicates.

‍ ‍

What will make my application be rejected without review?

‍ ‍

Four activity categories are non-responsive: animal model development, technologies for augmentation of healthy individuals, delayed-onset clinical studies, and device technologies not regulated by FDA. Applications are also withdrawn for missing Specific Aims that cover both phases, missing a planned delayed-start UH3 clinical study, missing any required attachment, missing a UH3 Milestone Plan, or exceeding any attachment page limit.

‍ ‍

Do I have to include a clinical trial?

‍ ‍

The NOFO is Clinical Trial Optional at the application stage, but in practice the structure requires a clinical study in the UH3 phase. Applications must include Specific Aims covering both phases and a delayed-start clinical study or trial planned in the UH3 phase with all required supporting documentation.

‍ ‍

What free services does Blueprint MedTech provide, and do they come out of my budget?

‍ ‍

Blueprint MedTech provides design optimization, prototype development and pilot-scale manufacturing, bench and safety testing, biocompatibility and large animal studies, clinical support, business development, regulatory and quality systems support, legal and IP support, and expert consultants. NIH pays these contractors and consultants directly, so those costs must not be included in your application budget. You identify what you plan to use in the required Resource Checklist attachment.

‍ ‍

Who owns the intellectual property?

‍ ‍

You do. Recipients retain custody of and all rights to data and technology developed under the award, subject to government rights of access consistent with HHS, PHS, and NIH policy. The program strongly encourages recipients and collaborators to obtain and retain IP developed around the device, and expects Principal Investigators to work closely with technology transfer officials on royalty agreements, patent filings, and commercialization plans.

‍ ‍

Is cost sharing required?

‍ ‍

No. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

‍ ‍

Can I submit more than one application?

‍ ‍

Yes, provided each application is scientifically distinct. NIH will not accept duplicate or highly overlapping applications under review at the same time, and will not accept a new application submitted before the summary statement issues from an overlapping application under review.

‍ ‍

Is a letter of intent required?

‍ ‍

No. A letter of intent is not required, is not binding, and does not enter into review, but NIH asks prospective applicants to submit one so staff can estimate review workload. Send it to Blueprint-MedTech@nih.gov with the descriptive title, PI names and contact information, other key personnel, participating institutions, and the funding opportunity number and title.

‍ ‍

How long does it take to get funded?

‍ ‍

Roughly nine to ten months from submission to earliest possible start. A September 28, 2026 submission goes to scientific merit review in March 2027, Advisory Council review in May 2027, and has an earliest start date of July 2027.

‍ ‍

Does a small market hurt my application?

‍ ‍

No. NIH states directly that the market for these device types may be small compared with other markets, that applications should not be penalized for a comparatively smaller market provided the market is sustainable, and that NIH supports research for both rare and high incidence disorders within its mission. For rare and ultra-rare diseases where commercialization is challenging, NIH encourages applicants to discuss alternative strategies with Scientific and Research staff.

‍ ‍

How much NIH involvement should I expect after award?

‍ ‍

Substantial. Expect virtual progress meetings with NIH staff at least twice a year, NIH participation in your FDA meetings, sharing of CRO reports and FDA communications with program staff, annual milestone evaluations that determine whether further funds are released, and the possibility that program staff request raw data. Milestones are negotiated before award and written into the Notice of Award.

‍ ‍

What registrations do I need and how early should I start?

‍ ‍

You need active SAM, UEI, eRA Commons, and Grants.gov registrations, plus an NCAGE code if you are a foreign organization. NIH warns that SAM registration can take six weeks or more and eRA Commons accounts up to two weeks. All registrations must be complete before submission, and incomplete registration is not a valid excuse for a late application.

‍ ‍

Who do I contact at NIH about Blueprint MedTech?

‍ ‍

The program email is Blueprint-MedTech@nih.gov. Institute-specific scientific contacts include Nick Langhals at NINDS, Leonardo Angelone at NIDA, Erin Burke Quinlan at NCCIH, Tony Douglas Gover and Paekgyu Lee at NEI, Elizabeth Powell at NIAAA, Eunyoung Kim at NIMH, Michael Wolfson at NIBIB, and Melissa Ghim at NIDCR. NIH recommends contacting program staff at least twelve weeks before a receipt date.

‍ ‍

Key NIH contacts for PAR-25-383

‍ ‍

Program email for all inquiries and letters of intent: Blueprint-MedTech@nih.gov

‍ ‍

Scientific and research contacts

‍ ‍

• Nick Langhals, PhD, NINDS, 301-496-1779, Blueprint-MedTech@nih.gov

• Leonardo Angelone, PhD, NIDA, Blueprint-MedTech@nih.gov

• Erin Burke Quinlan, PhD, NCCIH, 301-451-0636, erin.quinlan@nih.gov

• Tony Douglas Gover, NEI, 301-529-7370, tony.gover@nih.gov

• Paekgyu Lee, NEI, 301-435-8164, paek.lee@nih.gov

• Elizabeth Powell, PhD, NIAAA, 301-443-0786, elizabeth.powell3@nih.gov

• Eunyoung Kim, PhD, NIMH, 301-496-3513, eunyoung.kim@nih.gov

• Michael Wolfson, NIBIB, 301-451-4778, michael.wolfson@nih.gov

• Melissa M. Ghim, PhD, NIDCR, ghimm@mail.nih.gov

‍ ‍

Application submission support

‍ ‍

• eRA Service Desk, 301-402-7469 or 866-504-9552

• General NIH grants information, GrantsInfo@nih.gov, 301-480-7075

• Grants.gov customer support, 800-518-4726, support@grants.gov

‍ ‍

Is Blueprint MedTech Translator right for your company?

‍ ‍

This program is a strong fit if you have a device that works, data that proves it works, a clear FDA pathway, and a funding gap between your last preclinical result and your first patient. It is a poor fit if your animal model is not yet established, your device is not FDA regulated, your technology targets enhancement of healthy people, or you cannot yet describe the clinical study you intend to run.

‍ ‍

The application is demanding. Between the two milestone plans, five required attachments with hard page limits, a needs assessment grounded in stakeholder input, an IP strategy prepared with counsel, a long-term patient care plan, and a team management plan naming a Scientific Steering Group, this is a substantially heavier lift than a standard R01 or SBIR submission. It also rewards the work: uncapped budgets, free access to CROs and regulatory consultants, and a federal partner with an interest in getting your device to market.

‍ ‍

BW&CO helps deep tech, biotech, and medtech founders win non-dilutive federal funding. We have helped clients secure more than $350 million in funding across NIH, NSF, DoD, NASA, DOE, and ARPA-H. If you are evaluating Blueprint MedTech Translator for the September 28, 2026 deadline or a later cycle, the first step is a mission-fit conversation with the right Institute, and the second is an honest read on whether your data package clears the entry criteria.

NIH Highlighted Topic: Building Health through Multidomain Resilience Research from Molecules to Communities

Highlighted Topic 117 | Participating ICOs: NHLBI, NCCIH, NCI, NIA, NIAAA, NIMHD, OBSSR, ODP, ODS, ORWH, THRO | Posted August 28, 2026 | Expires August 25, 2028 | Apply through the NIH SBIR parent announcement (PA-27-100) or the NIH STTR parent announcement (PA-27-102).

Executive Summary

NIH has designated multidomain resilience research as a formal Highlighted Topic, with eleven Institutes, Centers, and Offices publishing their own areas of interest, spanning cardiopulmonary health, cancer, aging, alcohol use, minority health and health disparities, integrative health, dietary supplements, women's health, autoimmunity, disease prevention, behavioral science, and tribal health.

The framing is a genuine inversion of how most biomedical research is funded. Rather than asking why people get sick, NIH is asking why some people do not get sick despite carrying known risk. NHLBI illustrates it with four cases that make the concept concrete: hypertension without stroke, full recovery after heart valve surgery, preserved lung function despite tobacco exposure, and the interplay of resilience with sickle cell disease exacerbation such as vaso-occlusive crises. Resilience, in NIH's working definition, is a living system's capacity to resist, recover, adapt, or grow from challenges or stressors, tracked over time across interconnected individual, community, and environmental systems.

NIH also says plainly what has been holding the field back: heterogeneous definitions, models, and measures. That diagnosis is the opportunity. The named high-priority research areas are developing and refining resilience measures and metrics, data interoperability, mechanistic understanding of protective and restoring factors distinct from disease-risk reduction, and identifying biomarkers that reflect or predict resilience. Three of those four are measurement and infrastructure problems, which is to say they are product problems.

For a small business, the concentrated openings are validated resilience measurement instruments and digital assessments, biomarker panels that predict recovery capacity rather than disease risk, controlled-perturbation and challenge-recovery testing protocols paired with longitudinal monitoring hardware, multisystem phenotyping analytics, and data interoperability and federated analysis platforms. NIA in particular asks for dynamic resilience measures using controlled perturbations and longitudinal monitoring, plus advanced analytics for multisystem resilience phenotyping, which reads as an instrument-plus-software specification rather than a research question.

There is no dedicated funding and no separate application. A Highlighted Topic is a priority signal, not a Notice of Funding Opportunity. You apply through the standard NIH SBIR or STTR omnibus and compete in the normal pool, and NIH states that applying in a Highlighted Topic area will not affect referral or review. NIMHD states it may dedicate available funds to this topic area and may give special consideration to meritorious applications in it. NCCIH states it may give special consideration. The other participating ICOs make no such statement.

One structural trap to notice immediately. Of the eleven participating ICOs, five do not award grants: OBSSR, ODP, ODS, ORWH, and THRO. Two of those five, ODS and ORWH, published the most commercially concrete interests on the entire page, dietary supplement resilience biomarkers and federated data platforms respectively. Your application still has to land on the mission of one of the six that write checks: NHLBI, NCCIH, NCI, NIA, NIAAA, or NIMHD.

Under the current SBIR parent announcement, standard budget guidelines run up to $323,090 for Phase I and up to $2,153,927 for Phase II, and NIA is approved to exceed both. The next standard receipt dates are September 5, 2026, January 5, 2027, and April 5, 2027, and the topic stays live through August 25, 2028.

A Quick Note on the NIH SBIR and STTR Program

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The NIH, CDC, and FDA SBIR and STTR programs are the largest source of non-dilutive early-stage funding for health, biomedical, and life science technology in the United States. NIH alone sets aside well over a billion dollars a year. Awards are grants, not investments. No equity, no repayment, no board seat.

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The program runs in phases. Phase I funds proof of concept and feasibility. Phase II funds the substantive research and development that turns a validated concept into a product. Fast-Track combines both in one application, and Direct to Phase II lets companies that have already established feasibility skip Phase I. Phase IIB and the Commercialization Readiness Pilot extend funding for late-stage work such as validation, scale-up, and regulatory submissions. Applicants must be for-profit U.S. small businesses with 500 or fewer employees and majority U.S. ownership.

‍ ‍

For the complete breakdown of the NIH SBIR and STTR program, including all budget caps by Institute, clinical trial policies, eligibility mechanics, review criteria, and the full timeline, see our full executive summary here: NIH, CDC and FDA Parent SBIR Grant (PA-27-100).

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Everything below is specific to this Highlighted Topic.

‍ ‍

What Is a Highlighted Topic, and How Is It Different From a Funding Opportunity?

‍ ‍

A Notice of Funding Opportunity (NOFO) is a solicitation. It has an announcement number, its own application package, its own review criteria, and usually its own set-aside funding. You apply to it directly.

‍ ‍

A Highlighted Topic is a published statement of scientific priority maintained centrally by NIH. It has no application package and no guaranteed funding. You cannot apply to it. You apply through a broad opportunity such as the SBIR or STTR parent announcement, and the topic tells you what the participating ICOs want to fund inside their existing budgets.

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NIH is explicit about how this works:

‍ ‍

• Apply through an appropriate parent announcement or other broad NIH opportunity.

• Reach out early to the listed scientific contacts to discuss alignment.

• If an ICO chooses to dedicate funding to a topic, the amount depends on available funds, the number of meritorious applications, and competing priorities.

• Applying in a Highlighted Topic area will not affect NIH referral or review of your application.

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NIH reviews each topic annually for continued alignment and Institutes can post or retire topics at any time, so verify the topic is still live before each cycle you plan to submit in.

‍ ‍

There is no notice number to enter in the Agency Routing Identifier field, unlike the older Notice of Special Interest model. Make the alignment explicit in your cover letter and Specific Aims, and confirm handling with your target Institute's program officer before you submit.

‍ ‍

In this particular topic, the map matters more than usual. Resilience is not a study section. There is no established review culture for it, six different Institutes could plausibly claim the same project, and NIH has openly acknowledged the field lacks harmonized terminology. That combination means the Institute you land at will substantially determine how your application is read.

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What Are They Looking For? A Detailed Overview

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The Stated Purpose

‍ ‍

The topic aims to accelerate rigorous, reproducible, interdisciplinary resilience science to promote health and well-being across the lifespan and across populations. NIH describes resilience mechanisms as operating across scales and domains to maintain health, enabling prevention and recovery from chronic and acute disease despite known risk factors.

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The focus is research on:

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• Protective pathways and their biological mechanisms that maintain physiological function throughout the life course

• Harmonized terminology

• Standardized protocols

• Validated measures and biomarkers

• Implementation science to optimize evidence-based interventions, including lifestyle interventions, across populations

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NIH specifically names children, tribal communities, and groups at risk for health disparities as populations of interest.

‍ ‍

How NIH Defines Resilience

‍ ‍

NIH uses a broad definition: a living system's capacity to resist, recover, adapt, or grow from challenges or stressors, with outcomes tracked over time across interconnected individual, community, and environmental systems. NIH attributes this framing to Brown and colleagues, 2023.

‍ ‍

Those four verbs are not interchangeable and they are worth treating as a menu. Resistance means the stressor lands and nothing breaks. Recovery means function returns to baseline. Adaptation means the system reorganizes to a new functional state. Growth means it ends up better than before. A well-constructed application picks one and measures it, rather than gesturing at resilience generally.

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The Background Problem NIH Wants Solved

‍ ‍

NIH states that resilience spans whole-person systems, integrating molecular, cellular, physiological, and psychological levels within social communities and environmental contexts, and that translating this multiscale, multidomain nature has been limited by heterogeneous definitions, models, and measures.

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The named high-priority research areas follow directly from that:

‍ ‍

• Developing and refining resilience measures and metrics

• Data interoperability

• Advancing mechanistic understanding of protective and restoring factors distinct from disease-risk reduction

• Identifying biomarkers that reflect or predict resilience

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The Structural Requirement That Decides Most Applications

‍ ‍

This is the single most actionable sentence in the topic, and it functions as a checklist. NIH states that aligned applications would:

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1. Define the challenge or stressor

2. Define the system or systems

3. Define the resilience response or outcome

4. Include at least one domain of analysis, preferably across domains, to accelerate translation into implementable prevention, treatment, and recovery strategies

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Applications that skip step one are the most common failure mode in resilience science. Without a specified stressor there is no resilience to measure, only cross-sectional association. If you write to this topic, name the stressor explicitly and early, and design so that it is either naturally occurring and documented or experimentally applied.

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The Distinction That Separates Real Responsiveness From Repackaging

‍ ‍

Note carefully the phrase "distinct from disease-risk reduction." NIH is drawing a line, and reviewers will apply it.

‍ ‍

Lowering someone's blood pressure reduces disease risk. Understanding why a hypertensive person never has a stroke is resilience. Reducing tobacco exposure reduces risk. Understanding why some heavy smokers preserve lung function is resilience. A number of companies will reframe an existing risk-reduction product as resilience-promoting for this cycle. That reframing is visible, and it will be scored accordingly. The test is whether your work explains or enhances maintenance of health in the continued presence of risk rather than removal of the risk.

‍ ‍

A Methodological Signal Worth Reading Twice

‍ ‍

Both NIA and ODS ask for controlled perturbations and challenge-recovery designs with repeated measures. That is a design requirement, not a stylistic preference. A stressor is applied or occurs, and the system is measured before, during, and after. Cross-sectional designs cannot capture resist, recover, adapt, or grow, because all four are trajectories.

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For a company, this is actually favorable. Challenge-recovery designs with longitudinal monitoring are exactly where instrumentation, wearables, remote monitoring, and analytics create value, and they are exactly what a purely observational cohort study cannot deliver.

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Participating Institutes and Centers That Award Grants

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National Heart, Lung, and Blood Institute (NHLBI)

‍ ‍

NHLBI is interested in studies that:

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• Use data science and precision health to define individual heart, lung, blood, and sleep health signatures, including resilience metrics, stressors, tipping points, trajectories, and longitudinal outcomes across resistance, recovery, adaptation, and growth

• Leverage large biomedical resources including NHLBI-funded cohort studies, Trans-omics for Precision Medicine (TOPMed), Researching COVID to Enhance Recovery (RECOVER), All of Us, and LungMap

• Identify mechanisms that preserve, enhance, or restore homeostasis under stress and explain sustained health despite known risk, with the examples of hypertension without stroke, full recovery after heart valve surgery, preserved lung function despite tobacco exposure, and the interplay of resilience with sickle cell disease exacerbation such as vaso-occlusive crises

• Integrate multidomain exposures and biopsychosocial factors such as mindfulness, belief systems, and optimism, alongside community engagement, and include all populations within the NHLBI mission

‍ ‍

Contact: NHLBI Highlighted Topics (nhlbihighlightedtopics@mail.nih.gov).

‍ ‍

The resource-leverage bullet is the most useful thing on this page for a cash-constrained company. Building and validating analytics on TOPMed, RECOVER, All of Us, or existing NHLBI cohorts means you are not funding new cohort collection out of a Phase I budget. That is the difference between a fundable aim and an unfundable one at $323,090, and it also gives your validation claims a credibility that a small proprietary dataset never will. The phrase "tipping points" is worth noticing too, since it points toward early-warning and state-transition detection, which is a defensible product category.

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National Center for Complementary and Integrative Health (NCCIH)

‍ ‍

NCCIH is interested in research advancing understanding of resilience as a whole-person, multilevel process that informs strategies for health promotion, disease prevention, recovery, and overall well-being across the lifespan. Areas of interest:

‍ ‍

• Identifying, validating, and promoting modifiable protective pathways and factors contributing to resilience across molecular, cellular, physiological, behavioral, psychological, social, and environmental domains

• How complementary and integrative health approaches, lifestyle, and environmental factors affect the biological and behavioral mechanisms that enhance capacity to resist, recover, adapt, or grow

• Mechanistic research to identify and validate measures and biomarkers of resilience, and to generate evidence supporting implementation of effective resilience-promoting strategies across populations and settings

‍ ‍

NCCIH states it may give special consideration to support meritorious applications in this topic area.

‍ ‍

Contacts: Erin Burke Quinlan, PhD and Jennifer Baumgartner (NCCIHDERFunding@nih.gov).

‍ ‍

NCCIH matters disproportionately here for a reason that is not obvious from the topic page. Its standing small business portfolio already covers nutritional and natural products including dietary supplements and botanicals, psychological approaches such as meditation and music-based interventions, physical approaches including devices, and combined approaches such as yoga and tai chi. That makes NCCIH the natural funding home for several categories of resilience product that no other participating Institute would readily take, and the only one of the six signaling a preference alongside NIMHD.

‍ ‍

National Cancer Institute (NCI)

‍ ‍

NCI seeks projects advancing mechanistic understanding and interventions across cancer biology, prevention, and control, particularly studies that:

‍ ‍

• Develop, refine, or validate multilevel measures, biomarkers, and resilience signatures to defined stressors across cancer risk, tumor initiation, progression, treatment, and survivorship

• Identify protective factors and mechanisms enabling resistance to malignant transformation or favorable outcomes despite genetic, environmental, behavioral, or biological risk, including but not limited to DNA repair, immune surveillance, microbiome and host interactions, epigenetic stability, inflammation resolution, and metabolic adaptability

• Use advanced analytics in large, diverse longitudinal cohorts, and mechanistic studies in patients, human tissues, or model systems, to design, test, or implement interventions and strategies for risk stratification, early detection, prevention behaviors, treatment tolerance, and survivorship

‍ ‍

Contact: NCI Resilience HT Team (NCIResilienceHTTeam@mail.nih.gov).

‍ ‍

Note the phrase "resilience signatures to defined stressors." NCI has embedded the stressor requirement into its own bullet. Note also treatment tolerance, which is the most immediately commercial item in NCI's list: predicting which patients will tolerate a given regimen is a risk-stratification product with an obvious buyer, and it is framed here as resilience rather than toxicity prediction.

‍ ‍

National Institute on Aging (NIA)

‍ ‍

NIA's interests, as they relate to resilience in older individuals:

‍ ‍

• Development and validation of dynamic resilience measures using controlled perturbations and longitudinal monitoring

• Advanced analytics for multisystem resilience phenotyping

• The impact of age, early-life, psychosocial, and other factors on changes in neurobiological, molecular, cellular, physiological, social, and behavioral resilience mechanisms; how these factors individually and interactively influence severity of and recovery from stressors; and how dysregulation or modulation of these mechanisms, particularly in those with multiple contributors to impaired resilience, shapes aging-related clinical endpoints

• Shared and tissue-specific pathways and mechanisms of inter-organ or system-level coordination

• Mechanisms underlying sex differences

• Therapeutic targets for, and mechanisms by which, interventions improve resilience and preserve or restore clinical outcomes in representative populations

‍ ‍

Contact: Stacy Carrington-Lawrence, PhD (stacy.carrington-lawrence@nih.gov).

‍ ‍

NIA's first two bullets are the clearest product specifications in the entire topic. A validated perturbation protocol plus a monitoring modality plus an analytic layer that outputs a multisystem resilience phenotype is a commercial instrument, not a research finding. NIA also carries the most favorable budget ceilings of any participating Institute, discussed below.

‍ ‍

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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NIAAA seeks research on mechanisms shaping alcohol use, alcohol-related outcomes, recovery, and resilience across biological, behavioral, psychological, social, and environmental levels, and states that priority goes to reproducible studies that identify protective pathways and biomarkers, explain heterogeneity, and inform prevention and intervention. Named areas:

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• Longitudinal lifespan cohort studies using multimodal AI to integrate biological, behavioral, and environmental data and identify resilience to alcohol use disorder and alcohol harms, including resistance, recovery, and adaptation, and influences such as inter-brain synchrony, social enrichment, peer context, sleep, and community and environmental factors

• Reverse translational and New Approach Methodologies studies of cellular, molecular, and circuit mechanisms that promote resilience despite alcohol risk exposure

• Integrative multiomic studies of heterogeneity in resilience to alcohol use disorder, emphasizing protective pathways, validated biomarkers, and standardized, reproducible measures

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Contacts: Laura Kwako (laura.kwako@nih.gov) and Miri Gitik (miri.gitik@nih.gov).

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NIAAA's standing small business priorities already include biosensors and wearables for real-time monitoring, digital health and telehealth platforms, diagnostic tools and biomarkers, and advanced data analytics using machine learning on large health datasets. The overlap with this topic's multimodal AI and biomarker bullets is close to exact, which makes NIAAA one of the more mechanically straightforward routes for a data or sensor company.

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National Institute on Minority Health and Health Disparities (NIMHD)

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NIMHD supports solutions-oriented biological, behavioral, clinical, and population science research focused on resilience among populations with health disparities, including:

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• Identifying novel biological, behavioral, social, and environmental mechanisms that shape resilience across the life course, and elucidating pathways that buffer or mitigate stress-related health effects

• Developing measures, biomarkers, and scalable interventions that generalize across populations and community contexts

• Applying community-engaged, systems science, data science, and translational approaches to advance resilience research and its real-world impact

• Examining epigenetic processes, vagal nerve function, and environmental and biological interactions to identify mechanisms and clinical targets for resilience

• Investigating relationships between psychological resilience and the onset, severity, and progression of health events, as well as recovery duration, quality, and long-term outcomes

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NIMHD states it may dedicate available funds to support applications in this Topic area, depending on availability of funds, the number of meritorious applications, and competing ICO priorities, and separately that it may give special consideration to meritorious applications in this topic area.

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Contact: Rada Dagher, PhD, MPH (Rada.dagher@nih.gov).

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NIMHD is the only ICO in this topic making both statements, which makes it the strongest signal on the page. The word scalable in its second bullet is doing real work: NIMHD is asking for interventions that generalize and deploy, which is a commercial requirement rather than an academic one. Vagal nerve function is also named explicitly, which is a specific and measurable physiological target with existing device and wearable pathways.

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Participating Offices That Do Not Award Grants

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Five participating ICOs cannot fund your application. Their published interests are still worth reading, because they tell you what NIH leadership is prioritizing and because a well-aimed application can be responsive to an office's interest while being funded by an Institute. But you must land on an Institute's mission.

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Office of Dietary Supplements (ODS). ODS seeks research on how dietary supplements, meaning oral interventions of vitamins, minerals, natural products, botanicals, fatty acids, proteins, amino acids, or other bioactive food constituents, affect physiological, metabolic, cognitive, and immune resilience across the lifespan. Studies using repeated measures and challenge-recovery designs to test whether supplements help resist, recover, adapt, or grow after aging-related, infectious, metabolic, psychosocial, or environmental stressors are emphasized. Specific interests include elucidating biological mechanisms or protective pathways through which supplements influence adaptive responses to physiological stressors; identifying and validating supplement exposure biomarkers associated with maintenance or recovery of physiological function, resistance to defined stressors, or adaptive capacity; and developing and validating ways to measure resilience in a dietary supplementation context. Contact: Adam J. Kuszak, PhD (ods-funding@od.nih.gov).

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This is the most product-specific section on the entire NIH page, and ODS has no money. If you are a supplement, botanical, or nutraceutical company, the practical route is almost always NCCIH, whose small business program explicitly covers nutritional and natural products, or NIA if the framing is aging and older adults. Talk to ODS for scientific alignment, then talk to NCCIH or NIA about who would actually fund it.

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Office of Research on Women's Health (ORWH). ORWH is interested in projects that advance resilience research across the life course relevant to women's health, including pregnancy, menopause, and aging; incorporate sex as a biological variable in resilience mechanisms, measures, biomarkers, and trajectories; and address sex differences in multidomain resilience, including through computational models, to support rigorous, generalizable prevention, treatment, and recovery strategies. Contact: Marquitta White, MS, PhD (orwhinfo@nih.gov).

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The Office of Autoimmune Disease Research within ORWH (OADR-ORWH) is interested in the role of stressors on early immune changes in the prodromal phase of autoimmunity; resilience as an immunopreventative strategy for autoimmune disease; and utilizing federated data platforms to enhance pattern recognition in complex multiomic datasets, enabling deeper insight into the multimodal drivers of autoimmune disease pathogenesis and co-occurring autoimmune diseases. Contact: Victoria Shanmugam, MBBS, FRCP, FACR, CCD (oadrinfo@nih.gov).

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The federated data platform bullet is a software specification, and prodromal autoimmunity is a diagnostics opportunity. Neither office can fund it. Sex differences in resilience mechanisms is a named NIA interest as well, which gives you a funding route for the ORWH angle.

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Office of Disease Prevention (ODP). For this topic, ODP is particularly interested in projects testing interventions to promote health and well-being in individuals, families, communities, or populations facing biological, social, economic, or environmental challenges, and encourages research enhancing protective factors across the life course to prevent disease and disability, improve well-being, and reduce long-term disease burden. Contact: Valerie Robinson, PhD, MPhil, MHA (valerie.robinson@nih.gov).

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Office of Behavioral and Social Sciences Research (OBSSR). Participating, with Janine Simmons, MD, as contact (OBSSRNews@mail.nih.gov).

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Tribal Health Research Office (THRO). Participating, with Sheila Caldwell, PhD (throinfo@od.nih.gov) and Christopher Barnhart, PhD (christopher.barnhart@nih.gov) as contacts. Note that the topic's purpose statement names tribal communities explicitly as a population of interest.

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Where Does a Small Business Actually Fit?

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Be honest with yourself here: this is the most research-heavy of NIH's current Highlighted Topics, and a large share of what it describes belongs in an R01 rather than an SBIR. Mechanistic biology in model systems, secondary analysis of existing cohorts for scientific insight, and epidemiological characterization are not products. NIH SBIR and STTR awards fund research and development toward a commercially viable product or service.

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That said, NIH named measures, metrics, biomarkers, and data interoperability as high-priority areas, and those are all things that get built and sold. The genuine openings:

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Validated resilience measurement instruments. NIH says the field is limited by heterogeneous measures and asks for harmonized terminology, standardized protocols, and validated measures. A validated, licensable instrument, whether a clinical assessment, a digital measure, or a scored composite, is a real product with a real market, and NCCIH, NIMHD, NIA, and NCI all ask for measure development independently. Whoever produces the instrument the field standardizes on owns a durable position.

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Controlled perturbation and challenge-recovery testing systems. NIA's leading bullet, and echoed by ODS. A standardized stressor protocol plus a monitoring modality plus a scoring output is an instrument. This is the clearest hardware and software opportunity in the topic.

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Multisystem phenotyping analytics. NIA asks for advanced analytics for multisystem resilience phenotyping. NHLBI asks for health signatures including resilience metrics, tipping points, and trajectories. NIAAA asks for multimodal AI integrating biological, behavioral, and environmental data. Three Institutes, one product category.

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Biomarker panels that predict recovery rather than risk. NIH asks for biomarkers that reflect or predict resilience. This is a distinct diagnostic category from disease-risk biomarkers, and the clinical use cases are concrete: who will tolerate this treatment, who will recover from this surgery, who will decompensate under this stressor. NCI names treatment tolerance directly. NHLBI names recovery after heart valve surgery.

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Remote monitoring and wearables for longitudinal trajectory capture. Resist, recover, adapt, and grow are all trajectories, and trajectories require repeated measurement. Continuous monitoring is the enabling technology, and NIAAA's standing portfolio already funds wearables and biosensors.

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Data interoperability and federated analysis platforms. NIH names data interoperability as a high-priority area, and OADR-ORWH names federated data platforms specifically. Software with a plausible route to institutional customers.

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Scalable intervention delivery. NIMHD asks for scalable interventions that generalize across populations and community contexts, and it is the Institute most likely to dedicate funds. Digital and community-deployable intervention platforms fit here.

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Supplement and natural product mechanisms and exposure biomarkers. ODS's full list, funded through NCCIH or NIA.

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Vagal nerve function measurement or modulation. Named explicitly by NIMHD, with existing device and wearable pathways.

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What Will Not Work

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A risk-reduction product relabeled as resilience. Covered above, and it is the single most predictable failure here. NIH drew the line explicitly with the phrase "distinct from disease-risk reduction."

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A wellness or mindfulness app with no defined stressor and no measurement. NIH's structural requirement is to define the challenge or stressor, the system, and the resilience outcome. An application that cannot name its stressor is not responsive, regardless of how well the intervention is described.

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A cross-sectional study. All four resilience outcomes are trajectories. If your design measures once, it cannot detect resistance, recovery, adaptation, or growth.

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A measure with no validation plan. The field's problem is that everyone has a measure and none of them agree. Producing another unvalidated instrument adds to the problem NIH is trying to solve. Validation against an independent criterion is the whole value proposition.

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Two Strategic Notes

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Use the existing data assets. NHLBI explicitly invites leveraging TOPMed, RECOVER, All of Us, LungMap, and NHLBI cohorts. NCI asks for advanced analytics in large, diverse longitudinal cohorts. NIAAA asks for longitudinal lifespan cohort studies. For a small business, this is the difference between a feasible Phase I and an impossible one, because you can develop and validate an analytic or a measure without funding primary data collection. It also strengthens the generalizability claim that reviewers will otherwise attack.

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STTR deserves a hard look. NIH describes this topic as inherently interdisciplinary across molecular, cellular, physiological, psychological, social, community, and environmental levels, and NIMHD asks for community-engaged approaches. Very few small companies hold that range internally. Under STTR, a formal collaboration with a university or nonprofit research institution is required, at least 40 percent of the work is performed by the small business and at least 30 percent by the research institution, and the Principal Investigator may be primarily employed by either organization. If you need an academic cohort, a validated psychometric bench, or a community-engaged research partner to be credible, PA-27-102 is often the stronger application.

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How Much Funding Would I Receive?

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There is no funding amount attached to the Highlighted Topic itself. Budgets come from the parent announcement and from the Institute that funds you.

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Under the current NIH SBIR and STTR parent announcements, standard guidelines provide:

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• Phase I: up to $323,090, typically over one to two years

• Phase II: up to $2,153,927, typically over two to three years

• Fast-Track: Phase I and Phase II in a single application and review

• Direct to Phase II: available under SBIR for companies that have already established feasibility

• Phase IIB (PA-27-101): follow-on funding beyond Phase II

• Commercialization Readiness Pilot: late-stage, milestone-driven support, with amounts varying by Institute

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Cost sharing is not required.

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NIA Carries the Best Ceilings in This Topic

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Among the six participating Institutes that award grants, NIA holds approval to exceed the standard caps in both of its lanes:

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• Up to $700,000 for Phase I and $3 million for Phase II for Alzheimer's disease and AD-related dementia projects

• Up to $500,000 for Phase I and $2.5 million for Phase II for other projects within the NIA mission space

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That second line is easy to miss and it matters. A resilience-in-aging project that has nothing to do with dementia still carries a Phase I ceiling roughly 55 percent above standard and a Phase II ceiling about 16 percent above standard. Given that NIA also published the two most product-shaped bullets in the entire topic, dynamic resilience measures using controlled perturbations and multisystem resilience phenotyping analytics, the combination of scope fit and budget headroom makes NIA worth a conversation even if aging is not your primary framing.

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NCI supports CRP projects up to the SBA statutory maximum of $4,191,495, plus up to $500,000 for technical assistance. NIMHD operates under standard caps but is the only participating ICO signaling both possible dedicated funds and special consideration.

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Full Institute-by-Institute budget detail is in our NIH SBIR program executive summary.

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What Could I Use the Funding For?

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Funds support research and development toward a commercially viable product or service aligned with the mission of a participating Institute. Allowable costs include personnel, materials, instrument and device development, assay development, software development, validation studies, analysis of existing datasets, intellectual property protection, and other direct R&D expenses.

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Phase II, Phase IIB, and CRP funds may additionally cover scale-up, multi-site validation, regulatory preparation, and commercialization activities.

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Clinical trial policy depends on the Institute. Among the participating Institutes that award grants, NCI, NHLBI, NIA, and NIMHD accept clinical trials through their small business programs, and several accept them through Phase IIB as well. Policy for NCCIH and NIAAA under the current parent announcement should be confirmed directly with program staff before you design around it. Note that challenge-recovery and controlled-perturbation studies in human participants may or may not meet the NIH definition of a clinical trial depending on design, and that determination affects which announcement track and which forms apply. This is a specific question worth putting to your program officer in writing.

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What Is the Timeline?

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Highlighted Topic dates

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• Posted: August 28, 2026

• Expires: August 25, 2028

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SBIR and STTR standard receipt dates (PA-27-100 and PA-27-102)

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• September 5, 2026. This falls on a Saturday, and Labor Day is Monday, September 7, so submissions are accepted through Tuesday, September 8, 2026.

• January 5, 2027

• April 5, 2027

• September 5, 2027, which falls on a Sunday before Labor Day, so that cycle effectively closes Tuesday, September 7, 2027

• January 5, 2028

• April 5, 2028

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Because the topic expires on August 25, 2028, April 5, 2028 is the last standard receipt date inside the active window, giving you six cycles in total. The September 2028 date falls just outside it. All applications are due by 5:00 PM local time of the applicant organization.

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Review and award timeline for the September 2026 cycle

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• Scientific merit review: November 2026

• Advisory council review: January 2027

• Earliest project start date: April 2027

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Review and award timeline for the January 2027 cycle

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• Scientific merit review: March 2027

• Advisory council review: May 2027

• Earliest project start date: July 2027

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Review and award timeline for the April 2027 cycle

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• Scientific merit review: July 2027

• Advisory council review: August 2027

• Earliest project start date: December 2027

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A policy change that matters for planning. NIH tightened its late application policy under NOT-OD-26-064, effective for due dates on or after May 25, 2026. Small business applications no longer receive the discretionary late submission window. Submit early enough to resolve eRA Commons validation errors before the deadline.

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Practical planning guidance. Budget at least twelve weeks of lead time before your target due date, and more if your federal registrations are not complete. SAM.gov, UEI, the SBA Company Registry, eRA Commons, and Grants.gov registrations can take four to six weeks on their own and must all be finished before you can submit. For a first-time applicant, expect 120 to 200 hours of total effort.

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Two topic-specific timing items. If your plan depends on access to an existing NIH data resource such as TOPMed, RECOVER, or All of Us, start the data access request early, since approval processes have their own timelines and reviewers will want evidence that access is secured rather than hoped for. And if your design involves community-engaged research, which NIMHD asks for, community partnership agreements and letters with defined roles cannot be assembled in the final two weeks.

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Who Is Eligible to Apply?

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Eligibility comes from the parent announcement, not from the topic. Applicants must be U.S. small business concerns that are:

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

• At or below 500 employees, including affiliates

• More than 50 percent owned and controlled by U.S. citizens or permanent resident aliens, by qualifying U.S. entities, or by a combination

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For STTR, the company must also have a formal collaboration with a U.S. research institution, with at least 40 percent of the work performed by the small business and at least 30 percent by the research institution.

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Foreign organizations are not eligible, and foreign subawards and subcontracts are not permitted.

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Are There Restrictions I Should Know About?

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• Only U.S. small business concerns are eligible; foreign organizations are not.

• Applications involving foreign subawards or subcontracts will not be considered for funding.

• Your application must be relevant to the mission of a participating Institute or Center that awards grants. For this topic that means NHLBI, NCCIH, NCI, NIA, NIAAA, or NIMHD. OBSSR, ODP, ODS, ORWH, and THRO do not award grants.

• Duplicate or highly overlapping applications submitted under multiple HHS announcements are not permitted.

• Companies must satisfy applicable SBA performance benchmark requirements, including the Phase I to Phase II transition rate benchmark and the Phase II commercialization rate benchmark for companies with substantial award histories.

• Phase I generally requires at least 67 percent of the research effort to be performed by the small business; Phase II at least 50 percent. Consultant and contractual arrangements in Phase I are generally limited to roughly 33 percent of the total amount requested, which is a real constraint if your design leans heavily on an academic cohort or a community partner. STTR is the cleaner structure in that case.

• Additional national security, foreign relationship, and foreign ownership disclosure requirements apply and may result in denial of award. The 2026 SBIR and STTR reauthorization tightened foreign risk management and due diligence review, and that screening now sits inside the review critical path.

• Cost sharing is not required.

• Applying under a Highlighted Topic does not change referral or review, and does not guarantee that funds have been set aside.

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What Kind of Application Is Likely to Win Here?

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NIH reviews small business applications on Significance, Investigators, Innovation, Approach, and Environment, with commercialization potential specifically evaluated for Phase II and Fast-Track. Within this topic, five things separate competitive applications.

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One: you named the stressor. NIH gave the structure explicitly: define the challenge or stressor, the systems, and the resilience response or outcome, and include at least one domain of analysis. Most weak resilience applications fail at the first item. Put the stressor in your Specific Aims page, not buried in the approach.

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Two: you picked one of the four verbs and measured it. Resistance, recovery, adaptation, and growth are different phenomena with different measurement requirements. Specificity here reads as rigor. Gesturing at resilience generally reads as vagueness.

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Three: you are not doing risk reduction in a new coat. NIH said "distinct from disease-risk reduction." Your work should explain or enhance maintained health in the continued presence of risk.

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Four: you picked the right Institute, and you picked it before writing. Six Institutes could plausibly claim a resilience measurement product, and five participating offices cannot fund it at all. This topic has more misrouting risk than any other current Highlighted Topic. Email the named contact, describe the technology in a paragraph, and ask whether it fits and which mechanism they would suggest. For supplement and natural product work specifically, ask ODS about science and NCCIH or NIA about funding.

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Five: your validation plan is the centerpiece, not an afterthought. NIH's stated problem is heterogeneous measures and lack of reproducibility, and NIAAA states outright that priority goes to reproducible studies. Whatever you build, the aim that matters is the one where you validate it against an independent criterion in a population that looks like the intended market.

Frequently Asked Questions

Is the NIH multidomain resilience Highlighted Topic a funding opportunity I can apply to directly?

No. An NIH Highlighted Topic is a published statement of scientific priority, not a Notice of Funding Opportunity. There is no application package and no separate deadline. Small businesses apply through a broad NIH opportunity, which means the SBIR parent announcement PA-27-100 or the STTR parent announcement PA-27-102.

How does NIH define resilience for this topic?

NIH defines resilience broadly as a living system's capacity to resist, recover, adapt, or grow from challenges or stressors, with outcomes tracked over time across interconnected individual, community, and environmental systems. NIH attributes this framing to Brown and colleagues, 2023. The four outcomes are distinct: resistance means function is maintained through the stressor, recovery means function returns to baseline, adaptation means the system reorganizes to a new functional state, and growth means it ends up better than before.

What does NIH require an aligned application to include?

NIH states that aligned applications would define the challenge or stressor, define the system or systems, define the resilience response or outcome, and include at least one domain of analysis, preferably across domains, in order to accelerate translation into implementable prevention, treatment, and recovery strategies. Failing to specify the stressor is the most common way a resilience application loses responsiveness.

How much funding is available under this Highlighted Topic?

The topic itself carries no funding amount. Standard SBIR guidelines provide up to $323,090 for Phase I and up to $2,153,927 for Phase II. Among the participating Institutes, NIA holds approval to exceed those caps, allowing up to $700,000 for Phase I and $3 million for Phase II on Alzheimer's disease and AD-related dementia projects, and up to $500,000 for Phase I and $2.5 million for Phase II for other projects in its mission space. NCI supports Commercialization Readiness Pilot projects up to the SBA statutory maximum of $4,191,495 plus up to $500,000 for technical assistance.

Does applying under this Highlighted Topic improve my chances of being funded?

Not in review. NIH states that applying in a Highlighted Topic area will not affect referral or review of applications. NIMHD states it may dedicate available funds to this topic area and may give special consideration to meritorious applications in it, and NCCIH states it may give special consideration. The other participating ICOs make no such statement. The main advantage is informational.

Which NIH Institutes and Centers participate, and which ones can actually fund my application?

Eleven ICOs participate. Six award grants: NHLBI, NCCIH, NCI, NIA, NIAAA, and NIMHD. Five do not: OBSSR, ODP, ODS, ORWH including the Office of Autoimmune Disease Research, and THRO. Your application must be relevant to the mission of at least one of the six that award grants.

I work on dietary supplements and the Office of Dietary Supplements published detailed interests. Can ODS fund my SBIR?

No. ODS does not award grants, despite publishing the most product-specific interests in this topic, including supplement exposure biomarkers and challenge-recovery designs testing whether supplements help resist, recover, adapt, or grow. The practical route is NCCIH, whose small business program explicitly covers nutritional and natural products including botanicals, or NIA if the framing is aging and older adults. Discuss science with ODS and funding with NCCIH or NIA.

What are the application deadlines?

The topic is open from August 28, 2026 through August 25, 2028. SBIR and STTR standard receipt dates are September 5, 2026, January 5, 2027, April 5, 2027, September 5, 2027, January 5, 2028, and April 5, 2028. Because the topic expires in August 2028, April 5, 2028 is the last standard receipt date inside the active window. September 5, 2026 falls on a Saturday before Labor Day, so that cycle accepts submissions through Tuesday, September 8, 2026, and September 5, 2027 falls on a Sunday before Labor Day, so that cycle closes Tuesday, September 7, 2027. All applications are due by 5:00 PM local time of the applicant organization.

What is the difference between resilience research and disease-risk reduction?

NIH explicitly asks for mechanistic understanding of protective and restoring factors distinct from disease-risk reduction. Lowering a risk factor reduces exposure to risk. Resilience explains or enhances maintained health in the continued presence of risk. NHLBI's examples make the distinction concrete: hypertension without stroke, preserved lung function despite tobacco exposure, and full recovery after heart valve surgery. Repackaging an existing risk-reduction product as resilience-promoting is visible to reviewers.

What kinds of resilience projects fit NIH SBIR rather than a research grant?

The strongest small business fits are validated resilience measurement instruments, controlled perturbation and challenge-recovery testing systems paired with longitudinal monitoring, multisystem phenotyping analytics, biomarker panels that predict recovery capacity rather than disease risk, remote monitoring and wearables for trajectory capture, data interoperability and federated analysis platforms, scalable intervention delivery, supplement and natural product exposure biomarkers, and vagal nerve function measurement or modulation. Mechanistic biology in model systems and secondary cohort analysis for scientific insight generally belong in an R01 instead.

Can I use existing NIH datasets instead of collecting new data?

Yes, and NIH encourages it. NHLBI explicitly invites leveraging its cohort studies, TOPMed, RECOVER, All of Us, and LungMap. NCI asks for advanced analytics in large, diverse longitudinal cohorts. For a Phase I budget this is often the difference between a feasible and an infeasible aim, and it strengthens generalizability claims. Start data access requests early, because approval has its own timeline and reviewers want evidence access is secured.

Why do NIA and ODS emphasize controlled perturbations and challenge-recovery designs?

Because resistance, recovery, adaptation, and growth are all trajectories, and a cross-sectional measurement cannot capture a trajectory. A stressor must be applied or occur, with the system measured before, during, and after. For companies this is favorable, since instrumentation, wearables, remote monitoring, and analytics are precisely what these designs require and precisely what an observational cohort cannot deliver.

Should my company apply for SBIR or STTR?

Choose SBIR if your company performs the majority of the research and your Principal Investigator is primarily employed by the company. Choose STTR if the project depends on a formal collaboration with a university or nonprofit research institution. Because NIH describes this topic as inherently interdisciplinary across molecular, physiological, psychological, social, community, and environmental levels, and because NIMHD asks for community-engaged approaches, STTR is frequently the stronger structural fit. Phase I SBIR generally limits consultant and contractual arrangements to roughly 33 percent of the total requested, which constrains designs that lean heavily on academic or community partners.

Can I run a clinical trial with this funding?

It depends on the Institute. Among the participating Institutes that award grants, NCI, NHLBI, NIA, and NIMHD accept clinical trials through their small business programs, and several accept them through Phase IIB as well. Confirm NCCIH and NIAAA policy directly with program staff. Note also that challenge-recovery and controlled-perturbation studies in human participants may or may not meet the NIH definition of a clinical trial depending on design, and that determination affects which forms and which track apply, so put the question to your program officer in writing.

Who is eligible to apply?

For-profit U.S. small business concerns with 500 or fewer employees including affiliates, more than 50 percent owned and controlled by U.S. citizens or permanent residents or by qualifying U.S. entities. Foreign organizations are not eligible, and foreign subawards and subcontracts are not permitted. STTR additionally requires a formal collaboration with a U.S. research institution.

How long will it take me to prepare an application?

For a first-time applicant, expect 120 to 200 hours in total. Start at least twelve weeks before your target due date. Federal registrations across SAM.gov, UEI, the SBA Company Registry, eRA Commons, and Grants.gov can take four to six weeks on their own and must be complete before you can submit.

What happens if I submit late?

It will not be accepted. NIH tightened its late application policy for due dates on or after May 25, 2026, and small business applications no longer receive the discretionary late submission window.

Could this Highlighted Topic be withdrawn before it expires?

Possibly. NIH reviews each Highlighted Topic annually for continued alignment with agency priorities, and Institutes can post and retire topics at any time. The posted expiration date is August 25, 2028, but verify the topic is still live before each cycle you plan to submit in.

How Can BW&CO Help?

BW&CO is a non-dilutive federal funding advisory firm. We have helped clients secure more than $350 million in federal funding, and this topic is a good example of where advisory work earns its keep: eleven participating ICOs, only six of which can fund anything, the two most product-specific bullet lists belonging to offices with no money, a definitional line between resilience and risk reduction that reviewers will enforce, and one Institute quietly carrying budget ceilings well above the standard caps.

We can:

• Identify the right Institute and mechanism for your technology, including routing supplement, natural product, women's health, autoimmune, and federated data platform concepts to an Institute that can actually fund them.

• Structure the application around NIH's own checklist, so the stressor, the system, the resilience outcome, and the domains of analysis are unmistakable on the Specific Aims page.

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

• Reduce your time spent on the proposal by 50 to 80 percent, so your team stays on the technology.

• Structure academic, cohort, and community partnerships so they strengthen the application without breaching the outsourcing limits.

NIH Highlighted Topic: Wastewater-Based Epidemiology as a Tool for Monitoring Environmental Chemicals, Medications, Drugs, and Pathogenic Exposures

Highlighted Topic 103 | Participating ICOs: NIEHS, NIAID, NIDA | Posted August 27, 2026 | Expires August 27, 2028 | Apply through the NIH SBIR parent announcement (PA-27-100) or the NIH STTR parent announcement (PA-27-102).

Executive Summary

NIH has designated wastewater-based epidemiology (WBE) as a formal Highlighted Topic, with NIEHS, NIAID, and NIDA each publishing their own areas of interest. Of the Highlighted Topics NIH has posted to date, this is one of the most product-shaped. Nearly every gap NIH names is a hardware, assay, or software problem rather than an open scientific question, which makes it unusually well suited to SBIR and STTR applicants rather than to academic investigators alone.

The premise is straightforward. Wastewater is a continuous, population-scale biological and chemical sample that nobody has to consent to, travel for, or remember to provide. NIH points out that it can indicate exposure to pesticides, plasticizers, personal care products, heavy metals, industrial releases, emerging contaminants, and disaster-related spills and fires, and that beyond pathogens it can also detect medications and drug metabolites. Compared with human biomonitoring, which requires collecting blood or urine from individuals, WBE is non-invasive and cost-effective, and it scales across both geography and time in a way individual sampling never will.

What NIH says is missing is the engineering and the standards layer. The named challenges are sampling variability driven by where and when samples are collected, analytical methods, data integration and statistical modeling, and data interpretation, meaning how a detection in wastewater actually correlates with real-world human exposure and what it implies for public health. NIH also names best practices, communication of findings, and ethical and privacy considerations as important open questions.

For a company, that list reads like a product roadmap: autosamplers and passive samplers that reduce variability, validated multi-residue chemical panels, molecular assays for targets that current methods miss, normalization and back-calculation methods that turn a concentration into a defensible population estimate, and data infrastructure that lets utilities, health departments, and labs actually share results.

The three participating Institutes divide the space cleanly. NIEHS wants chemical and environmental exposure work, including assay and biomarker development and bringing WBE to small and rural systems. NIAID wants pathogen and genomic epidemiology methods, human versus animal signal separation, and assays for chlorine-resistant protozoan parasites and cysts. NIDA wants substance use and overdose surveillance, emerging substance identification, and triangulation with other drug use data sources.

There is no dedicated funding and no separate application. A Highlighted Topic is a priority signal, not a Notice of Funding Opportunity. You apply through the standard NIH SBIR or STTR omnibus and compete in the normal pool, and NIH states that applying in a Highlighted Topic area will not affect referral or review. NIEHS states it may give special consideration to meritorious applications in this topic area. NIAID and NIDA make no such statement for this topic.

Under the current SBIR parent announcement, standard budget guidelines run up to $323,090 for Phase I and up to $2,153,927 for Phase II. One caveat matters specifically here: certain NIEHS program areas carry substantially lower caps, and that is discussed below. The next standard receipt dates are September 5, 2026, January 5, 2027, and April 5, 2027, and the topic stays live through August 27, 2028.

A Quick Note on the NIH SBIR and STTR Program

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The NIH, CDC, and FDA SBIR and STTR programs are the largest source of non-dilutive early-stage funding for health, biomedical, and life science technology in the United States. NIH alone sets aside well over a billion dollars a year. Awards are grants, not investments. No equity, no repayment, no board seat.

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The program runs in phases. Phase I funds proof of concept and feasibility. Phase II funds the substantive research and development that turns a validated concept into a product. Fast-Track combines both in one application, and Direct to Phase II lets companies that have already established feasibility skip Phase I. Phase IIB and the Commercialization Readiness Pilot extend funding for late-stage work such as validation, manufacturing scale-up, and regulatory submissions. Applicants must be for-profit U.S. small businesses with 500 or fewer employees and majority U.S. ownership.

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For the complete breakdown of the NIH SBIR and STTR program, including all budget caps by Institute, clinical trial policies, eligibility mechanics, review criteria, and the full timeline, see our full executive summary here: NIH, CDC and FDA Parent SBIR Grant (PA-27-100).

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Everything below is specific to this Highlighted Topic.

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What Is a Highlighted Topic, and How Is It Different From a Funding Opportunity?

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A Notice of Funding Opportunity (NOFO) is a solicitation. It has an announcement number, its own application package, its own review criteria, and usually its own set-aside funding. You apply to it directly.

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A Highlighted Topic is a published statement of scientific priority maintained centrally by NIH. It has no application package and no guaranteed funding. You cannot apply to it. You apply through a broad opportunity such as the SBIR or STTR parent announcement, and the topic tells you what the participating Institutes want to fund inside their existing budgets.

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NIH is explicit about how this works in practice:

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• Apply through an appropriate parent announcement or other broad NIH opportunity.

• Reach out early to the listed scientific contacts to discuss alignment.

• If an ICO chooses to dedicate funding to a topic, the amount depends on available funds, the number of meritorious applications, and competing priorities.

• Applying in a Highlighted Topic area will not affect NIH referral or review of your application.

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NIH also notes that Institutes can post new topics at any time and that each topic is reviewed annually for continued alignment with agency priorities. Topics do get retired. If you are building a multi-year federal funding plan around one, verify it is still live before each cycle.

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What the topic buys you is intelligence, not scoring advantage. Three Institutes have written down what they would fund in this space and named the program staff to call. In a field as new as WBE, where there is no established study section culture and no obvious default Institute, that mapping is worth more than a modest scoring bump. The most common way a strong WBE application fails is landing at the wrong Institute, because a chemical exposure project reviewed by pathogen reviewers, or vice versa, tends to score as out of scope rather than as weak.

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There is no notice number to enter in the Agency Routing Identifier field for a Highlighted Topic, unlike the older Notice of Special Interest model. Make the alignment explicit in your cover letter and Specific Aims, and confirm handling with your target Institute's program officer before you submit.

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What Are They Looking For? A Detailed Overview

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The Stated Purpose

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The topic encourages research on wastewater-based epidemiology approaches for understanding exposure to environmental contaminants, medications, drugs, and pathogens at the community level. That last phrase is the whole framing. This is not about diagnosing individuals. It is about characterizing populations.

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Why NIH Considers This Worth Prioritizing

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NIH's background statement makes four arguments, and each one is a section of your significance narrative if you write here.

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Wastewater is a broader signal than most people assume. NIH lists pesticides, plasticizers, personal care products, heavy metals, industrial releases, emerging contaminants, and disaster-related spills and fires as detectable exposures. It also states plainly that while wastewater has been used to detect pathogens, it can also detect medications and drug metabolites. If your mental model of WBE is still SARS-CoV-2 surveillance, this topic is considerably wider than that.

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It solves a real limitation of human biomonitoring. Individual biomonitoring requires collecting blood or urine from people. WBE is non-invasive and cost-effective, and it evaluates community exposure patterns across large populations both geographically and over time. That produces insight into community health and behavior that individual sampling cannot practically deliver at scale.

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It requires convergence. NIH describes WBE as combining advanced analytical chemistry, molecular biology, and epidemiological approaches, and notes that it inherently involves data sharing and collaboration across many scientific disciplines. This is an explicit invitation to build interdisciplinary teams, and it is one reason STTR deserves a hard look here.

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The unsolved problems are technical. This is the part to read closely, because it is where the fundable product work lives.

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The Named Technical Gaps

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NIH groups the open challenges into four clusters. Read these as product requirements.

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Sampling variability. Driven by sample location and timing of sample collection. This is the single most cited weakness in the WBE literature, and it is a hardware and protocol problem. Grab samples misrepresent diurnal patterns. Composite sampling helps but adds cost and complexity. Sample location within a sewer network determines what population you actually measured. Passive samplers, flow-proportional autosamplers, in-line sensors, and sample stabilization chemistry all sit directly on this gap.

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Analytical methods. Detection and quantification of targets that current methods handle poorly, in a matrix that is actively hostile to analysis. Wastewater is chemically complex, biologically active, and variable hour to hour. Recovery, matrix effects, degradation between collection and analysis, and limits of detection at environmentally relevant concentrations are all live problems.

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Data integration and statistical modeling. Turning measurements into population-level estimates requires normalization for flow, population size, in-sewer degradation, and per-capita excretion assumptions. Every one of those introduces uncertainty, and the field has not standardized any of them.

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Data interpretation. NIH states the question directly: how does detection in wastewater correlate with real-world human exposure, and what are the public health implications? This is the validation gap, and it is why parallel clinical and wastewater studies show up in NIAID's list. Any company selling a WBE product will eventually be asked to defend the inferential chain from a concentration in a pipe to a claim about a population.

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NIH additionally names best practices, communication of findings, and ethical and privacy issues as important considerations. Do not treat that as boilerplate. In a field where results can be attributed to a neighborhood, a building, or an institution, the ethics section of a WBE application carries real weight, and NIDA explicitly asks for research analyzing those implications.

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Participating Institutes and What Each One Wants

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Only three Institutes participate in this topic, which makes Institute selection simpler than usual but also raises the stakes on getting it right. Your application will be assigned to one, that Institute's budget will pay for it, and its priorities will decide whether it gets funded after review.

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National Institute of Environmental Health Sciences (NIEHS)

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NIEHS is the chemical and environmental exposure home for this topic, and it is the only participating Institute signaling any preference. NIEHS encourages multidisciplinary collaborations and partnerships with public health experts, epidemiologists, analytical chemists, and experts in contaminant fate and transport.

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Stated areas of interest:

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• WBE studies to identify known and emerging environmental contaminants impacting community health

• WBE to identify the origins of contaminants and quantify contaminant contribution to disease

• Studies promoting multi-level assessment of sewer networks at various scales, including single and multiple wastewater treatment plants, neighborhoods, and individual buildings

• Technology and methodology development to advance WBE, including biomarkers for monitoring community health and assays for detection and quantification of chemical exposures

• Creation and incorporation of data infrastructure and standardized protocols for WBE collaboration

• Increasing community awareness and bringing WBE to small-serving communities such as rural systems

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NIEHS states it may give special consideration to support meritorious applications in this topic area.

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ICO scientific contacts: Danielle Carlin, PhD, DABT (danielle.carlin@nih.gov); Yuxia Cui, PhD (yuxia.cui@nih.gov); Heather Henry, PhD (heather.henry@nih.gov).

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Two of these bullets are unusually direct invitations to small businesses. "Technology and methodology development, including biomarkers and assays for detection and quantification of chemical exposures" is a description of a product. So is "data infrastructure and standardized protocols." And the small-serving and rural communities bullet is a market-access argument that most competitors will ignore, which makes it a differentiator: the small utility that serves 3,000 people cannot afford a research-grade LC-MS workflow, and a low-cost, low-skill, ruggedized approach has both public health value and a genuinely underserved commercial market.

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National Institute of Allergy and Infectious Diseases (NIAID)

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NIAID owns the pathogen side. Stated areas of interest:

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• Genomic epidemiology method development to better detect and track microbes, predict microbial case surges, analyze and share WBE metadata and data, integrate WBE data across platforms, and identify novel applications for secondary analyses of WBE data

• Development of clearer methods to distinguish human versus animal and agricultural signals, and One Health integration

• Using WBE to study microbe biology, including transmission, evolution, and persistence

• Parallel clinical and WBE studies analyzing the contribution of microbes identified in the environment to human disease

• Development of novel assays and laboratory methods for detection and quantification of protozoan parasites and cysts that resist chlorination

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ICO scientific contacts: Brooke Bozick, PhD (brooke.bozick@nih.gov); M. "Kate" Bradford Plimack, PhD (kate.plimack@nih.gov).

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Two of these are exceptionally well-defined product problems. Human versus animal signal discrimination is a discrete, solvable technical question with immediate commercial value, because it determines whether a positive result triggers a public health response or gets written off as agricultural runoff, and no standardized solution has been adopted. Chlorine-resistant protozoan parasites and cysts, meaning organisms in the Cryptosporidium and Giardia class, is an even tighter specification: NIAID has essentially named the analyte class and the failure mode of existing methods. If you have an assay platform that concentrates and detects environmental cysts, this bullet was written for you.

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Note also that NIAID's standing small business portfolio already funds diagnostics and prevention strategies across bacterial, fungal, viral, and parasitic targets, so a WBE assay application does not require NIAID to stretch its mission.

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National Institute on Drug Abuse (NIDA)

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NIDA frames its interest around public health response rather than measurement for its own sake. NIDA is interested in WBE research that supports community and public health responses to substance use and overdose, and it makes two participation requests that function as near-requirements:

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• Applicants are encouraged to partner with local or state public health agencies to ensure public health relevance and the ability to respond to identified hotspots and outbreaks.

• Applicants are encouraged to engage people who may be affected by the research or the reporting of results, including people who use drugs and other community members.

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Stated areas of interest:

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• Tracking patterns of substance use or exposures, including illicit drugs, medications for opioid use disorder, and naloxone

• Identifying emerging substances

• Examining links between substances detected in wastewater and community-level health outcomes such as fatal and non-fatal overdose

• Triangulating WBE with other drug use data sources to inform public health surveillance and response

• Analyzing the ethical implications of wastewater surveillance of substance use and misuse detection

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ICO scientific contact: MeLisa Creamer (melisa.creamer@nih.gov).

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The naloxone and medications-for-OUD bullet is worth pausing on. Most WBE drug work measures consumption of illicit substances. NIDA is also asking about measuring treatment and harm reduction penetration, which is a fundamentally different and largely unbuilt product: a community-level indicator of whether interventions are actually reaching people. That is a metric health departments and payers would plausibly buy, and almost nobody is selling it.

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NIDA's standing small business priorities already include forensic testing technologies for identifying emerging drugs and diagnostic tools for detection and quantification of drug exposure, both of which map onto this topic without any stretching.

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Where Does a Small Business Actually Fit?

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More cleanly here than in most Highlighted Topics. NIH SBIR and STTR awards fund research and development toward a commercially viable product or service, and this topic's gaps are largely instrumentation, assay, and software gaps. The strongest fits:

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Sampling hardware and sample stabilization. Flow-proportional and passive samplers, in-sewer deployable devices, cold-chain-free preservation chemistry, and sampling designs that let a single device characterize a neighborhood rather than a whole treatment plant. NIEHS explicitly asks for multi-level sewer network assessment down to the building scale, which is a hardware and deployment problem before it is a science problem.

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Analytical assays and panels. Multi-residue chemical panels for pesticides, plasticizers, personal care products, heavy metals, and emerging contaminants. Molecular panels for pathogens. Concentration and detection methods for chlorine-resistant protozoan cysts, which NIAID names specifically. Assays for drug metabolites and for medications including buprenorphine, methadone, and naloxone.

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Field-deployable and decentralized testing. Everything above, but cheap enough and simple enough for a rural utility or a small health department to run without a PhD analytical chemist. NIEHS's small-serving communities bullet is the funding hook, and the addressable market is large and structurally underserved.

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Normalization, modeling, and interpretation software. Turning a concentration into a defensible population estimate is the field's central unsolved problem and it is pure software plus validation. This is the highest-margin, lowest-capital entry point in the topic, and NIH names it twice, under data integration and statistical modeling and again under data interpretation.

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Data infrastructure and interoperability. NIEHS asks for data infrastructure and standardized protocols for WBE collaboration. NIAID asks for the ability to analyze and share WBE metadata, integrate data across platforms, and enable secondary analyses. That is a platform specification written by two Institutes independently.

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Human versus animal source attribution. NIAID's One Health bullet. A validated discrimination method is a component that every other WBE product would want to license.

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Biomarkers of community health. NIEHS asks for biomarkers for monitoring community health, which is broader than contaminant measurement and largely undefined. This is the most scientifically speculative bullet in the topic and correspondingly the most defensible if you have real preliminary data.

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Surveillance-to-response platforms. NIDA's framing is explicit that measurement without response capability is not the goal. A system that detects an emerging substance and routes an actionable alert to a health department, with the ethical and privacy architecture built in rather than bolted on, addresses NIDA's stated interest directly.

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What Will Not Work

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Three failure modes are predictable here.

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A surveillance service with no technology development. Running existing assays on new samples in a new city is a service business, not research and development. SBIR reviewers will identify it immediately. The innovation has to be in the method, the instrument, the model, or the platform.

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A COVID-era pathogen dashboard repositioned. A number of companies built SARS-CoV-2 wastewater dashboards and are looking for a second act. Reviewers in this space have seen that pitch. If the underlying technology is a data pipeline that ingests third-party lab results, the innovation claim is thin unless the modeling and interpretation layer is genuinely novel and validated.

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Measurement with no validation against human exposure. NIH names data interpretation as a core gap. An application that produces numbers without addressing what those numbers mean for actual human exposure is answering the easy half of the question.

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Two Structural Considerations

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Partnering with a health department cuts both ways. NIDA encourages partnership with local or state public health agencies, and NIEHS encourages partnerships with public health experts and epidemiologists. Those partnerships are genuinely necessary for credibility and for site access. They also consume your outsourcing allowance: under SBIR, Phase I generally requires at least 67 percent of the research effort to be performed by the small business and Phase II at least 50 percent, and consultant plus contractual arrangements in Phase I are generally capped around 33 percent of the total requested. Structure the partnership as site access, sample provision, and advisory input rather than as a large subaward, or move to STTR where the collaboration allowance is built into the mechanism.

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STTR is often the better vehicle here. NIH describes WBE as inherently requiring analytical chemistry, molecular biology, and epidemiology together, plus data sharing across disciplines. Few small companies hold all of that in house. Under STTR, a formal collaboration with a university or nonprofit research institution is required, at least 40 percent of the work is performed by the small business and at least 30 percent by the research institution, and the Principal Investigator may be primarily employed by either organization. For a company that needs an academic environmental epidemiologist or a university analytical core to be credible, PA-27-102 is frequently the stronger application. One exception is noted in the funding section below.

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How Much Funding Would I Receive?

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There is no funding amount attached to the Highlighted Topic itself. Budgets come from the parent announcement you apply through and from the Institute that funds you.

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Under the current NIH SBIR and STTR parent announcements, standard guidelines provide:

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• Phase I: up to $323,090, typically over one to two years

• Phase II: up to $2,153,927, typically over two to three years

• Fast-Track: Phase I and Phase II in a single application and review

• Direct to Phase II: available under SBIR for companies that have already established feasibility

• Phase IIB (PA-27-101): follow-on funding beyond Phase II

• Commercialization Readiness Pilot: late-stage, milestone-driven support, with amounts varying by Institute

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Cost sharing is not required.

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The NIEHS Budget Caveat You Need to Check First

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This matters more in this topic than almost anywhere else in the NIH portfolio, because NIEHS is the most natural home for chemical-focused WBE work and NIEHS applies reduced caps to two of its program areas.

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NIEHS caps its Superfund Research Program topics at $200,000 for Phase I, $1.25 million for Phase II, and $300,000 for CRP. Its Worker Training Program topics are capped at $100,000, Phase I only. Both of those NIEHS programs accept SBIR applications only, not STTR.

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The Superfund Research Program focuses on detection and remediation technologies for hazardous substances relevant to Superfund and other contaminated sites. A WBE project framed around detecting industrial releases, heavy metals, disaster-related spills, or site-associated contaminants could plausibly be routed there, and the difference between the standard cap and the SRP cap is more than $900,000 in Phase II. It also removes STTR as an option, which changes your whole team structure.

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This is a five-minute email to a program officer that can reshape the entire application. Ask directly whether your project would be handled under general NIEHS mission or under the Superfund Research Program before you build a budget.

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NIAID and NIDA both operate under the standard caps and both accept STTR.

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Full Institute-by-Institute budget detail is in our NIH SBIR program executive summary.

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What Could I Use the Funding For?

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Funds support research and development toward a commercially viable product or service aligned with the mission of a participating Institute. Allowable costs include personnel, materials, prototype fabrication, assay development, instrument builds, field deployment and validation studies, method comparison work, software development, intellectual property protection, and other direct R&D expenses.

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Phase II, Phase IIB, and CRP funds may additionally cover scale-up, manufacturing, validation at multiple sites, regulatory preparation, and commercialization activities.

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For most WBE projects, human subjects considerations are lighter than founders expect. Wastewater collected at a treatment plant or sewer node is generally not individually identifiable and is typically not treated as human subjects research, though that determination belongs to your IRB and your Institute, not to you. Where it changes is in the parallel clinical and wastewater studies NIAID names, which do involve human participants and human specimens, and in any building-level or institution-level sampling where results could be attributed to a small identifiable group. If your design includes either, raise it with program staff early, because it affects which forms you file and how the application is reviewed.

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What Is the Timeline?

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Highlighted Topic dates

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• Posted: August 27, 2026

• Expires: August 27, 2028

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SBIR and STTR standard receipt dates (PA-27-100 and PA-27-102)

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• September 5, 2026. This falls on a Saturday, and Labor Day is Monday, September 7, so submissions are accepted through Tuesday, September 8, 2026.

• January 5, 2027

• April 5, 2027

• September 5, 2027, which falls on a Sunday before Labor Day, so that cycle effectively closes Tuesday, September 7, 2027

• January 5, 2028

• April 5, 2028

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Because the topic expires on August 27, 2028, April 5, 2028 is the last standard receipt date that falls inside the active window. That gives you six cycles in total. All applications are due by 5:00 PM local time of the applicant organization.

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Review and award timeline for the September 2026 cycle

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• Scientific merit review: November 2026

• Advisory council review: January 2027

• Earliest project start date: April 2027

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Review and award timeline for the January 2027 cycle

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• Scientific merit review: March 2027

• Advisory council review: May 2027

• Earliest project start date: July 2027

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Review and award timeline for the April 2027 cycle

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• Scientific merit review: July 2027

• Advisory council review: August 2027

• Earliest project start date: December 2027

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A policy change that matters for planning. NIH tightened its late application policy under NOT-OD-26-064, effective for due dates on or after May 25, 2026. Small business applications no longer receive the discretionary late submission window. Submit early enough to resolve eRA Commons validation errors before the deadline, not after.

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Practical planning guidance. Budget at least twelve weeks of lead time before your target due date, and more if your federal registrations are not complete. SAM.gov, UEI, the SBA Company Registry, eRA Commons, and Grants.gov registrations can take four to six weeks on their own and must all be finished before you can submit anything. For a first-time applicant, expect 120 to 200 hours of total effort on a competitive submission.

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One WBE-specific timing note: if your project requires access to a sewer network, a treatment plant, or a health department's data, secure those agreements and letters of support before you start writing. Utility and municipal approvals move on their own schedule, and a missing site access letter is a common reason otherwise strong environmental applications lose points on Environment and Approach.

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Who Is Eligible to Apply?

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Eligibility comes from the parent announcement, not from the topic. Applicants must be U.S. small business concerns that are:

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

• At or below 500 employees, including affiliates

• More than 50 percent owned and controlled by U.S. citizens or permanent resident aliens, by qualifying U.S. entities, or by a combination

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For STTR, the company must also have a formal collaboration with a U.S. research institution, with at least 40 percent of the work performed by the small business and at least 30 percent by the research institution. Note again that NIEHS Superfund Research Program and Worker Training Program topics accept SBIR only.

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Foreign organizations are not eligible, and foreign subawards and subcontracts are not permitted.

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Are There Restrictions I Should Know About?

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• Only U.S. small business concerns are eligible; foreign organizations are not.

• Applications involving foreign subawards or subcontracts will not be considered for funding. WBE has an active international research community, and collaborations that would be natural scientifically are not permissible under this mechanism.

• Your application must be relevant to the mission of a participating Institute. For this topic that means NIEHS, NIAID, or NIDA.

• Duplicate or highly overlapping applications submitted under multiple HHS announcements are not permitted.

• Companies must satisfy applicable SBA performance benchmark requirements, including the Phase I to Phase II transition rate benchmark and the Phase II commercialization rate benchmark for companies with substantial award histories.

• Phase I generally requires at least 67 percent of the research effort to be performed by the small business; Phase II at least 50 percent. Consultant and contractual arrangements in Phase I are generally limited to roughly 33 percent of the total amount requested.

• Additional national security, foreign relationship, and foreign ownership disclosure requirements apply and may result in denial of award. The 2026 SBIR and STTR reauthorization tightened foreign risk management and due diligence review, and that screening now sits inside the review critical path.

• Cost sharing is not required.

• Applying under a Highlighted Topic does not change referral or review, and does not guarantee that funds have been set aside.

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What Kind of Application Is Likely to Win Here?

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NIH reviews small business applications on Significance, Investigators, Innovation, Approach, and Environment, with commercialization potential specifically evaluated for Phase II and Fast-Track. Within this topic, five things separate competitive applications.

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One: you picked the right Institute before you started writing. Three Institutes with genuinely different scopes means the same instrument can be three different applications. A sampler validated on pesticides is NIEHS. The same sampler validated on protozoan cysts is NIAID. Validated on fentanyl analogs it is NIDA. Email the named contact, describe the technology in a paragraph, ask whether it fits and which mechanism they would suggest. It is the highest-return hour you will spend, and for NIEHS it is also how you find out which budget cap applies.

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Two: you addressed a named gap rather than a general capability. NIH gave you the list: sampling variability, analytical methods, data integration and modeling, data interpretation, best practices, communication, and ethics. An application that maps its aims onto those specific gaps is visibly responsive. One that describes a general WBE platform is not.

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Three: you have real validation data, ideally against an independent measure. The interpretation gap is the field's credibility problem. Applications that show their wastewater signal tracking something externally verifiable, whether clinical case counts, prescription data, overdose records, or paired human biomonitoring, are answering the question reviewers actually have.

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Four: you brought the partners. All three Institutes ask for collaboration in some form, and NIDA asks twice, for public health agency partnership and for engagement with affected community members including people who use drugs. Letters of support from partners with no defined role in the research plan are transparent to reviewers. Give each partner a named function, specific deliverables, and where appropriate a line in the budget.

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Five: you took ethics and privacy seriously as design, not as compliance. NIH names ethical and privacy issues in the background, and NIDA lists analyzing the ethical implications of wastewater surveillance as a fundable area in its own right. Building-level and institution-level sampling can attribute drug use to an identifiable group, and that has already generated public controversy in the field. An application that has thought through spatial resolution limits, data governance, and how findings get communicated is stronger on Approach and considerably more commercially credible, because your eventual customers will ask the same questions

Frequently Asked Questions

Is the NIH wastewater-based epidemiology Highlighted Topic a funding opportunity I can apply to directly?

No. An NIH Highlighted Topic is a published statement of scientific priority, not a Notice of Funding Opportunity. There is no application package and no separate deadline. Small businesses apply through a broad NIH opportunity, which means the SBIR parent announcement PA-27-100 or the STTR parent announcement PA-27-102.

How much funding is available under this topic?

The topic itself carries no funding amount. Standard SBIR guidelines provide up to $323,090 for Phase I and up to $2,153,927 for Phase II. One exception matters here: NIEHS caps Superfund Research Program topics at $200,000 for Phase I, $1.25 million for Phase II, and $300,000 for CRP, and caps Worker Training Program topics at $100,000 for Phase I only. Both of those NIEHS programs accept SBIR only, not STTR. Confirm with NIEHS program staff which program area would handle your project before building a budget.

Does applying under this Highlighted Topic improve my chances?

Not in review. NIH states that applying in a Highlighted Topic area will not affect referral or review of applications. NIEHS states it may give special consideration to meritorious applications in this topic area. NIAID and NIDA make no such statement for this topic. The real advantage is informational: three Institutes have documented what they want to fund and named the program staff to contact.

Which NIH Institutes participate in the wastewater-based epidemiology Highlighted Topic?

Three: the National Institute of Environmental Health Sciences (NIEHS), the National Institute of Allergy and Infectious Diseases (NIAID), and the National Institute on Drug Abuse (NIDA). NIEHS covers chemical and environmental contaminant exposure, NIAID covers pathogens and genomic epidemiology, and NIDA covers substance use and overdose surveillance.

What are the deadlines?

The topic is open from August 27, 2026 through August 27, 2028. SBIR and STTR standard receipt dates are September 5, 2026, January 5, 2027, April 5, 2027, September 5, 2027, January 5, 2028, and April 5, 2028. Because the topic expires in August 2028, April 5, 2028 is the last standard receipt date inside the active window. September 5, 2026 falls on a Saturday before Labor Day, so that cycle accepts submissions through Tuesday, September 8, 2026, and September 5, 2027 falls on a Sunday before Labor Day, so that cycle closes Tuesday, September 7, 2027. All applications are due by 5:00 PM local time of the applicant organization.

What specific technical problems is NIH asking companies to solve?

NIH names four clusters of challenges: sampling variability driven by sample location and timing of collection; analytical methods; data integration and statistical modeling; and data interpretation, meaning how detection in wastewater correlates with real-world human exposure and what it implies for public health. NIH also names best practices, communication of findings, and ethical and privacy issues as important considerations. Each of those is a defensible basis for an SBIR aim.

Can wastewater-based epidemiology detect more than pathogens?

Yes, and NIH says so explicitly. The topic states that wastewater can indicate exposure to pesticides, plasticizers, personal care products, heavy metals, industrial releases, emerging contaminants, and disaster-related spills and fires, and that while it has been used to detect pathogens it can also detect medications and drug metabolites. The topic is considerably broader than pathogen surveillance.

Who is eligible to apply?

For-profit U.S. small business concerns with 500 or fewer employees including affiliates, more than 50 percent owned and controlled by U.S. citizens or permanent residents or by qualifying U.S. entities. Foreign organizations are not eligible, and foreign subawards and subcontracts are not permitted. STTR additionally requires a formal collaboration with a U.S. research institution.

Should my company apply for SBIR or STTR?

Choose SBIR if your company performs the majority of the research and your Principal Investigator is primarily employed by the company. Choose STTR if the project depends on a formal collaboration with a university or nonprofit research institution. Because NIH describes WBE as requiring analytical chemistry, molecular biology, and epidemiology together, STTR is frequently the stronger structural fit. The exception is NIEHS Superfund Research Program and Worker Training Program topics, which accept SBIR only.

Is wastewater sampling considered human subjects research?

Usually not, but the determination is not yours to make. Wastewater collected at a treatment plant or sewer node is generally not individually identifiable and is typically not treated as human subjects research. That changes for the parallel clinical and wastewater studies NIAID names, which involve human participants and specimens, and for building-level or institution-level sampling where results could be attributed to a small identifiable group. Raise either scenario with program staff and your IRB early.

Do I need a partnership with a utility or health department?

Not formally required, but effectively yes for most designs. NIDA encourages partnering with local or state public health agencies and engaging affected community members including people who use drugs. NIEHS encourages partnerships with public health experts, epidemiologists, analytical chemists, and contaminant fate and transport experts. Beyond responsiveness, you need site access to collect samples. Secure those agreements before you begin writing, because municipal approvals move on their own schedule and a missing site access letter costs points on Environment and Approach.

How do partnerships interact with the SBIR work allocation rules?

Carefully. Phase I generally requires at least 67 percent of the research effort to be performed by the small business and Phase II at least 50 percent, and consultant plus contractual arrangements in Phase I are generally limited to roughly 33 percent of the total requested. Structure agency and academic partnerships as site access, sample provision, data sharing, and advisory input rather than as large subawards, or use STTR where a substantial research institution role is built into the mechanism.

What kinds of wastewater projects are unlikely to be funded?

Three patterns predictably fail. A surveillance service that runs existing assays on new samples in new locations is a service business rather than research and development. A repositioned COVID-era dashboard that ingests third-party lab results has a thin innovation claim unless the modeling and interpretation layer is genuinely novel. And measurement work that produces numbers without addressing what they mean for real human exposure answers only the easy half of the question NIH asked.

How long will it take me to prepare an application?

For a first-time applicant, expect 120 to 200 hours in total. Start at least twelve weeks before your target due date. Federal registrations across SAM.gov, UEI, the SBA Company Registry, eRA Commons, and Grants.gov can take four to six weeks on their own and must be complete before you can submit.

What happens if I submit late?

It will not be accepted. NIH tightened its late application policy for due dates on or after May 25, 2026, and small business applications no longer receive the discretionary late submission window.

Could this topic be withdrawn before it expires?

Possibly. NIH reviews each Highlighted Topic annually for continued alignment with agency priorities, and Institutes can post and retire topics at any time. The posted expiration date is August 27, 2028, but verify the topic is still live before each cycle you plan to submit in.

How Can BW&CO Help?

BW&CO is a non-dilutive federal funding advisory firm. We have helped clients secure more than $350 million in federal funding, and wastewater-based epidemiology sits at exactly the kind of intersection we handle well: an emerging measurement field with real hardware and software product opportunities, three possible Institute sponsors with meaningfully different scopes, one buried budget cap that can cost you $900,000 if you find it late, and partnership requirements that interact awkwardly with SBIR work allocation rules.

We can:

• Identify the right Institute and mechanism for your technology, and determine before you write whether NIEHS would handle your project under general mission or under the Superfund Research Program, which decides both your budget ceiling and whether STTR is available.

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

• Reduce your time spent on the proposal by 50 to 80 percent, so your team stays on the technology.

• Structure utility, health department, and academic partnerships so they strengthen the application without breaching the outsourcing limits.

NIH Highlighted Topic: Catalyzing Interdisciplinary Research on HIV-Associated Co-occurring Conditions

Highlighted Topic 99 | Lead Office: NIH Office of AIDS Research (OAR) | Posted July 28, 2026 | Expires July 28, 2028 | Apply through the NIH SBIR parent announcement (PA-27-100) or the NIH STTR parent announcement (PA-27-102).

Executive Summary

NIH has designated HIV-associated co-occurring conditions as a formal Highlighted Topic, and sixteen NIH Institutes, Centers, and Offices have attached their own stated interests to it. For a small business, this is one of the most cross-cutting priority signals NIH has published in the HIV space, because it opens the door to funding from cancer, cardiopulmonary, aging, metabolic, mental health, substance use, oral health, musculoskeletal, and integrative health budgets at the same time, all through a single application to the standard SBIR or STTR omnibus.

The science being requested is a shift in framing. Antiretroviral therapy has turned HIV into a manageable chronic condition, and the unsolved problem is no longer viral suppression. It is that people with HIV develop comorbidities earlier, carry more of them at once, experience treatment-related toxicities, and navigate mental health, substance use, and structural barriers that disease-specific care models were never designed to handle. NIH wants to fund work that treats those conditions as an interconnected system rather than a list of separate diseases, and it wants that work to reach patients through care models that actually get implemented.

For companies, the commercially relevant openings are concentrated in a handful of places: multi-condition risk prediction and early screening, point-of-care and decentralized diagnostics for comorbidities and coinfections, digital therapeutics and adherence technologies that address HIV alongside substance use or mental health, biomarkers of accelerated aging and organ injury, drug interaction and polypharmacy decision support, and platforms that let a single clinic deliver integrated care without adding staff.

There is no dedicated pot of money and no separate application form. A Highlighted Topic is a priority signal, not a Notice of Funding Opportunity. You apply through the normal NIH SBIR or STTR omnibus, you compete against every other small business application in that cycle, and NIH states plainly that applying in a Highlighted Topic area will not affect how your application is referred or reviewed. What the topic does give you is unusually specific intelligence about what sixteen ICOs want to buy, plus named program staff to call before you write a word. Two participating Institutes, NHLBI and NIDA, state they may dedicate funds to this topic area, and three, NCCIH, NIDA, and NIDCR, state they may give special consideration to meritorious applications in it.

Under the current SBIR parent announcement, standard budget guidelines run up to $323,090 for Phase I and up to $2,153,927 for Phase II, with several Institutes approved to exceed those caps. The next standard receipt dates are September 5, 2026, January 5, 2027, and April 5, 2027, and the topic stays live through July 28, 2028.

One timing change matters more here than almost anywhere else in the NIH portfolio: HHS eliminated dedicated AIDS-specific SBIR and STTR due dates for applications due on or after May 25, 2026. HIV-focused companies that built their calendars around the legacy AIDS cycles need to rebuild them around the standard September, January, and April dates.

A Quick Note on the NIH SBIR and STTR Program

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The NIH, CDC, and FDA SBIR and STTR programs are the largest source of non-dilutive early-stage funding for health, biomedical, and life science technology in the United States. NIH alone sets aside well over a billion dollars a year. Awards are grants, not investments. There is no equity, no repayment, and no board seat.

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The program runs in phases. Phase I funds proof of concept and feasibility. Phase II funds the substantive research and development that turns a validated concept into a product. Fast-Track combines both in a single application, and Direct to Phase II lets companies that have already established feasibility skip Phase I entirely. Phase IIB and the Commercialization Readiness Pilot extend funding for late-stage work such as clinical validation, manufacturing scale-up, and regulatory submissions. Applicants must be for-profit U.S. small businesses with 500 or fewer employees and majority U.S. ownership.

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For the complete breakdown of the NIH SBIR and STTR program, including all budget caps by Institute, clinical trial policies, eligibility mechanics, review criteria, and the full timeline, see our full executive summary here: NIH, CDC and FDA Parent SBIR Grant (PA-27-100).

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Everything below is specific to this Highlighted Topic.

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What Is a Highlighted Topic, and How Is It Different From a Funding Opportunity?

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This distinction trips up nearly every first-time applicant, so it is worth being precise.

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A Notice of Funding Opportunity (NOFO) is a solicitation. It has an announcement number, its own application package, its own review criteria, and in most cases its own set-aside funding. You apply to it directly.

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A Highlighted Topic is a published statement of scientific priority maintained centrally by NIH. It has no application package. It has no guaranteed funding. You cannot apply to it. Instead, you apply through a broad opportunity such as the SBIR or STTR parent announcement, and the topic tells you what the participating Institutes and Centers currently want to fund inside their existing budgets.

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NIH is explicit about the practical consequences:

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• Apply through an appropriate parent announcement or other broad NIH opportunity.

• Reach out early to the listed scientific contacts to discuss alignment.

• If an ICO chooses to dedicate funding to a topic, the amount depends on available funds, the number of meritorious applications, and competing priorities.

• Applying in a Highlighted Topic area will not affect NIH referral or review of your application.

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That last point is the one to internalize. The topic does not give you a scoring advantage. What it gives you is a map. Sixteen ICOs have each written down, in their own words, what they would fund in this space and who to call about it. That intelligence is worth considerably more than a modest scoring bump, because the single most common reason strong small business applications fail at NIH is misalignment with the Institute that ends up holding the application.

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Highlighted Topics replaced the older Notice of Special Interest (NOSI) model for this purpose. If you have applied to NIH before and are looking for a notice number to enter into the Agency Routing Identifier field, there is not one for a Highlighted Topic. The practical approach is to make the alignment explicit in your cover letter and in your Specific Aims, and to confirm handling with the program officer at your target Institute before you submit.

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What Are They Looking For? A Detailed Overview

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The Core Scientific Problem

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NIH frames the problem in terms that any founder in this space will recognize from the clinic.

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Antiretroviral therapy transformed HIV into a manageable chronic condition. But people with HIV still face high risk and early onset of comorbidities, adverse effects from ART itself, and a set of medical, psychosocial, and structural challenges that are tangled together rather than separable. The burden extends beyond people living with HIV: NIH specifically calls out HIV-exposed but uninfected children, who may carry elevated risks of immune, metabolic, and developmental problems compared with unexposed peers, particularly in low and middle-income settings.

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The stated knowledge gaps are where the fundable work lives:

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Mechanistic gaps. How do HIV, ART, and psychosocial stressors interact to drive the early onset and progression of comorbidities? This is the question underneath accelerated aging, chronic inflammation, and immune activation.

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Shared-pathway gaps. Many comorbidities intersect and share risk factors before diverging into disease-specific trajectories. NIH gives two examples directly: metabolic syndrome raising risk for diabetes, cardiovascular disease, and chronic kidney disease at once; and certain coinfections raising cancer risk. The implication is a real product thesis. If you can identify or intervene on a shared upstream factor, you address multiple outcomes with one technology, and that is a much stronger commercial story than a single-indication tool.

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Model gaps. Traditional disease-specific models do not capture shared factors, and they do not capture the multilevel determinants that decide whether an intervention actually gets implemented in a real health system.

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Care delivery gaps. NIH wants whole-person care that links infectious diseases, endocrinology, psychiatry, nursing, pharmacy, and community health, with emphasis on early screening, lifestyle-based prevention, and sustained engagement in HIV care, all while accounting for local context and health system constraints.

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The Stated Purpose

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The topic aims to catalyze interdisciplinary research on HIV-associated co-occurring conditions and to expand multidisciplinary teams that can develop and deliver preventive strategies improving health and quality of life across the lifespan. Three emphases are named:

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1. Shared factors and multi-organ effects, to inform early preventive strategies.

2. Implementation science approaches to identify barriers and facilitators, optimize multidisciplinary care, and deliver scalable, sustainable care models.

3. Multidisciplinary teams with multiple Program Directors and Principal Investigators holding complementary expertise, cross-NIH alignment, and use of existing NIH resources.

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Meaningful community engagement is strongly encouraged throughout.

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Alignment With the Make America Healthy Again Initiative

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This topic is being issued as part of the Make America Healthy Again (MAHA) initiative, and NIH lists the specific MAHA workstreams it aligns with. This matters strategically, because it tells you which vocabulary and which framings currently carry institutional weight. The named alignments include:

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• The NIH MAHA Chronic Disease Initiative, which aligns existing NIH chronic disease research and aims to generate actionable results for diseases arising in childhood and adulthood.

• The Whole-Person-Health approach to chronic disease prevention, including metabolic health at all stages of life.

• Prescribing patterns and impact on mental health, including evaluation of prescription patterns and overprescription trends.

• Food for Health, studying food and lifestyle interventions and their effect on outcomes and cost.

• Nutrition, including dietary patterns that support metabolic health and precision nutrition.

• The oral health and systemic disease connection, including oral microbiome relationships with gut health and immune function.

• The Gut Microbiome Research Initiative, on the microbiome's role in chronic disease development and progression.

• Longitudinal research for chronic disease prevention, leveraging existing NIH cohorts including All of Us, ABCD, HBCD, and ECHO.

• Clinical trial networks, strengthening existing networks through engagement with large public and private hospital systems including the VA.

• Mental health and addiction research, with focus areas including screen time in children and adolescents.

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If your technology touches metabolic health, nutrition, the microbiome, polypharmacy, or prevention, there is language here you should be borrowing.

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Participating Institutes, Centers, and Offices, and What Each One Wants

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This is the section to read closely. Your application will be assigned to one Institute, that Institute's budget will pay for it, and that Institute's priorities will determine whether it gets funded after review. Below is what each participating ICO has stated for this topic.

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Office of AIDS Research (OAR), lead office. OAR is interested in facilitating interdisciplinary research, including implementation science, to advance understanding of the common factors underlying HIV-associated co-occurring conditions, supporting early prevention, integrated whole-person care, and improved health and quality of life across the lifespan. OAR does not award grants. Your application must be relevant to at least one participating Institute or Center that does. OAR is the central scientific contact for the topic overall, and Geetanjali Bansal, PhD, is the ICO scientific contact.

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National Cancer Institute (NCI). NCI wants to advance understanding of the risks, development, progression, prevention, diagnosis, and treatment of cancer in people with HIV, and to test and implement bundled cancer and HIV interventions. NCI notes that people with HIV have increased incidence of certain cancers, are diagnosed at earlier ages and higher stages, have worse overall and cancer-specific survival, and are less likely to receive cancer treatment. Named example topics: characterizing how HIV infection contributes to the development and pathogenesis of HIV-related tumors; discovering and developing new biomarkers, diagnostics, and therapeutics to improve prevention, diagnosis, treatment, and outcomes; and identifying factors that drive cancer disparities for people with HIV, including work to improve adoption, implementation, and sustainment of effective interventions. Contact: Rebecca Liddell Huppi, PhD.

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National Heart, Lung, and Blood Institute (NHLBI). NHLBI is interested in mechanisms and pathways behind HIV-associated heart, lung, blood, and sleep (HLBS) comorbidities, and in interventions that improve care, including implementation research. Stated priorities: combined effects of aging, HIV, and ART on HLBS conditions; aging- and HIV-related changes in hematopoiesis, including hematopoietic stem cells and their niche; the impact of sleep deficiency and sleep-disordered breathing on HIV-associated cardiopulmonary and cardiometabolic disease; vascular contributions to cognitive impairment and dementia; implementation strategies that improve uptake and sustainability of evidence-based HLBS interventions; mechanistic studies to reduce the effects of HIV and aging on HLBS comorbidities, including traditional risk factors and sex differences; and novel methods to detect subclinical HIV-related HLBS conditions plus strategies to mitigate clinical disease. NHLBI states it may dedicate available funds to applications in this topic area, subject to funds, the number of meritorious applications, and competing priorities.

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National Institute on Aging (NIA). NIA supports projects addressing HIV-associated co-occurring conditions in midlife and older age, spanning the NIH Stage Model from basic science (Stage 0) through intervention development and refinement (Stage 1) to implementation (Stage V). Areas of interest: the etiologies and pathogenesis of these conditions, including the roles of chronic immune activation and antiretroviral and other drug toxic effects; optimizing medications, care coordination, and behavioral and social interventions to improve outcomes, function, and quality of life; and developing, testing, implementing, and scaling evidence-based interventions that address poor outcomes. Contact: Marcel E. Salive, MD, MPH.

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National Institute on Drug Abuse (NIDA). NIDA seeks interdisciplinary research on how drug use, addiction, and HIV interact across the lifespan. Named examples: how HIV, ART, and polysubstance use affect brain function, behavior, mood, sleep, pain, and cognition; molecular, neurochemical, cellular, and circuit functions underpinning HIV and co-occurring substance use disorders; shared pathways linking substance use, HIV, stress, trauma, and mental health conditions; individual and community factors affecting HIV prevention, care engagement, and ART adherence, with focus on improving access in underserved populations; integrated interventions addressing HIV, SUD, HCV, and co-occurring mental health conditions; and basic, clinical, and translational research on treatment of SUD and overdose in people with HIV. NIDA states it may dedicate available funds to this topic area and may give special consideration to meritorious applications in it.

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National Institute of Mental Health (NIMH). NIMH is interested in interdisciplinary biological and behavioral approaches to the neuropsychiatric mechanisms behind central nervous system comorbidities in people with HIV across the lifespan; how HIV biology, treatment exposures, and psychosocial burden converge on shared pathways driving neurocognitive and mental health disorders, in order to inform early intervention and scalable whole-person care models; and multidisciplinary implementation research identifying barriers to neurocognitive and mental health diagnosis and treatment in people with HIV, with emphasis on community engagement and sustainable care delivery. Contacts: Vasudev Rao, MBBS, MS, and Teri Senn, PhD. Note that NIMH's standing small business program already names technologies addressing basic, behavioral, and implementation science related to people living with HIV as an interest area, which makes it an unusually natural home for an SBIR application under this topic.

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National Institute of Allergy and Infectious Diseases (NIAID). NIAID is interested in coinfections affecting people with HIV across the lifespan, from infant through adult, and encourages multidisciplinary applications addressing the impact of stigma and other intersecting behavioral, biological, and health system factors on diagnosis, prevention, and treatment. The named coinfections are tuberculosis, viral hepatitis, and sexually transmitted infections. Contact: Robin E. Huebner, PhD, MPH.

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). NIDDK supports basic, clinical, and implementation science examining the impact of HIV on organs, tissues, and biological systems, including person-oriented comorbidity research. Priorities include enteropathy and gastrointestinal homeostasis; liver diseases and viral hepatitis coinfections; digestive diseases, nutrition, obesity, diabetes, and related complications; and kidney, urologic, and hematologic diseases that may present differently or follow altered clinical courses in the context of HIV. On the clinical side, NIDDK wants work that improves implementation and delivery of evidence-based care and develops strategies to improve HIV diagnosis and progression. Studies addressing social, behavioral, and environmental factors influencing HIV and comorbidities in diabetes, digestive, and kidney disease are named as high priority, particularly regarding disease severity and treatment adherence. Contacts: Deepak Nihalani, Khoa Nguyen, and Minnjuan Flournoy Floyd.

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National Institute on Alcohol Abuse and Alcoholism (NIAAA). NIAAA notes that heavy alcohol use, including alcohol use disorder, interacts with both behavioral risk and organ pathophysiology in people living with HIV, accelerating physiological and physical vulnerability, affecting medication adherence and toxicities, and complicating care. Research should improve understanding of the pathophysiology of alcohol-associated comorbidities; develop biomedical and behavioral approaches to restore alcohol-induced organ dysfunction; and implement interventions addressing alcohol and associated mental health, substance use, comorbidities, coinfections, and complications in vulnerable populations. Named complications include cardiovascular disease, metabolic disorders, neurocognitive impairment, and cellular and immune dysfunction. Contact: Kendall Bryant, PhD.

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National Center for Complementary and Integrative Health (NCCIH). NCCIH supports research on complementary and integrative health approaches for symptom management in people living with HIV, framing HIV as a chronic multisystem condition with complex symptoms including pain, fatigue, and neurocognitive and mental health challenges that suit a Whole Person Health approach. Priorities: testing complementary and integrative interventions such as mind-body approaches and natural products to address symptom clusters and improve function and quality of life; elucidating biological, behavioral, and psychosocial mechanisms including inflammation, neuroimmune, and stress pathways, and identifying biomarkers and patient characteristics; integrating these approaches into HIV care through pragmatic and hybrid effectiveness-implementation studies and scalable delivery models; and evaluating risks such as drug and herb interactions, synthesizing evidence, and developing guidance for informed decision-making. NCCIH states it may give special consideration to meritorious applications in this topic area. Contact: Lanay Mudd, PhD.

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National Institute of Dental and Craniofacial Research (NIDCR). NIDCR supports interdisciplinary research on shared risk factors influencing the onset and progression of HIV-associated comorbidities in the oral and craniofacial complex across the lifespan. Areas of interest: mechanisms of HIV-related oral disease, including immune dysregulation, inflammation, and ART effects; biological, behavioral, and contextual risk factors linking oral and systemic comorbidities and coinfections, including HPV-associated cancer and metabolic and inflammatory diseases; interdisciplinary preventive, diagnostic, and treatment approaches, including probiotics, mucosal immunity modifiers, early cancer detection, and management of oral and salivary gland complications; and integration of oral health into the multidisciplinary HIV care continuum. NIDCR states it may give special consideration to meritorious applications in this topic area. Contact: NIDCR Division of Extramural Research.

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). NIAMS seeks research on HIV-associated comorbidities affecting the musculoskeletal system, skin, and systemic rheumatic diseases, and encourages studies of how HIV infection, ART, and host or viral factors contribute to early onset, acceleration, or worsening of NIAMS-relevant comorbidities. Named conditions include musculoskeletal pain; muscle diseases such as sarcopenia and cachexia; cartilage degeneration and osteoarthritis; osteoporosis, osteopenia, and fractures; arthritis and other rheumatic diseases; and dermatologic manifestations. NIAMS supports basic, translational, and clinical research characterizing the burden, trajectory, and risk of these conditions across the lifespan, and states that priority is given to implementation science projects that develop, test, and scale multidisciplinary whole-person care models integrating musculoskeletal, rheumatic, and skin health into HIV prevention and treatment settings. Contact: Heiyoung Park, PhD. Important operational note for small businesses: NIAMS does not accept clinical trial applications under the SBIR parent announcement.

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). NICHD is listed as a participating ICO with a scientific contact, Sonia Lee, PhD, but has not published a topic-specific scope statement. Given the topic's explicit attention to HIV-exposed uninfected children and to outcomes across the lifespan, pediatric, maternal, and developmental angles are clearly in play, but this is an Institute where a pre-submission conversation is not optional.

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Office of Behavioral and Social Sciences Research (OBSSR). Participating, with Cathy Maulsby, PhD, as contact. OBSSR does not award grants.

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Office of Disease Prevention (ODP). ODP is particularly interested in innovative prevention research using rigorous study design, measurement, and analysis methods to test interventions, implementation strategies, and multidisciplinary care approaches that prevent co-occurring conditions in people with HIV across the lifespan. ODP does not award grants. Contact: JoyAnn Courtney, PhD.

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Office of Research on Women's Health (ORWH). ORWH is interested in research projects addressing HIV-associated co-occurring conditions in women. ORWH does not award grants. Contact: Balkissa Ouattara, MD, PhD, MPH.

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Tribal Health Research Office (THRO). Participating, with Sheila Caldwell, PhD, and Christopher Barnhart, PhD, as contacts. THRO does not award grants.

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Email addresses for every contact are published on the NIH topic page. Note carefully that five of the sixteen participating ICOs are offices that cannot fund anything. Your application still has to land on the mission of an Institute or Center that writes checks.

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Where Does a Small Business Actually Fit?

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This is the honest part, and it is the question a founder should ask before spending 150 hours on an application.

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A large share of what this topic describes is classic investigator-initiated academic research: mechanistic biology, cohort analyses, implementation science trials in health systems. Much of that is better suited to an R01 than to an SBIR. NIH SBIR and STTR awards fund research and development toward a commercially viable product or service. If the deliverable at the end of your project is a paper and a set of findings rather than something a customer buys, an SBIR reviewer will say so.

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The good news is that this topic contains an unusual density of genuine product opportunities, because "shared factors, multi-organ effects, early screening, and scalable care models" is a description of things that get built and sold. The strongest small business fits:

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Multi-condition risk prediction and early screening. The topic's central scientific bet is that shared upstream factors drive several downstream comorbidities. A validated tool that stratifies risk across cardiometabolic, renal, hepatic, neurocognitive, and oncologic outcomes at once maps directly onto NHLBI, NIDDK, NIA, and NCI interests simultaneously, and onto the MAHA prevention framing.

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Point-of-care and decentralized diagnostics. Coinfection detection for TB, viral hepatitis, and STIs sits squarely in NIAID's stated scope. Oral and salivary diagnostics sit in NIDCR's. Detection of subclinical HLBS disease is a named NHLBI priority.

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Biomarkers of accelerated aging, immune activation, and organ injury. NIA names chronic immune activation and drug toxic effects explicitly. NHLBI names hematopoietic changes. NCCIH names inflammation, neuroimmune, and stress mechanisms plus biomarker identification.

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Digital therapeutics and integrated behavioral health. NIDA's interest in integrated interventions addressing HIV, SUD, HCV, and co-occurring mental health conditions is one of the clearest commercial openings in the entire topic, and NIDA is one of the two Institutes signaling possible dedicated funds. NIMH's interest in scalable whole-person care models points the same direction.

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Adherence, polypharmacy, and interaction safety. ART adherence is named by NIDA. Medication optimization is named by NIA. Drug and herb interaction risk is named by NCCIH. Prescribing patterns are a named MAHA workstream. Clinical decision support that manages ART alongside comorbidity medications and supplements has an unusually broad set of sponsors.

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Care coordination and integration platforms. Nearly every ICO in the topic asks for something that in practice requires software: integrating oral health into the HIV care continuum, integrating musculoskeletal and skin health, bundling cancer and HIV interventions, coordinating care across infectious disease, endocrinology, psychiatry, pharmacy, and community health. Note that NIAMS explicitly prioritizes implementation science for exactly this, which is rare.

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Biosensors and wearables. NIAAA's standing small business priorities already include transdermal and wearable alcohol monitoring, which lands directly on this topic's alcohol and organ dysfunction thread.

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Therapeutics. Treatments targeting shared inflammatory or metabolic pathways, or targeting a specific comorbidity in the HIV context, fit multiple Institutes. This is the longest and most capital-intensive path, and Fast-Track or Direct to Phase II with a clear regulatory strategy is usually the right structure.

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One structural constraint to plan around. The topic repeatedly references low and middle-income settings and global context. The SBIR parent announcement does not permit foreign subawards or subcontracts, and applications involving them will not be considered for funding. If your work is genuinely LMIC-facing, the research plan has to be structured so that the funded work happens domestically, with international relevance argued rather than internationally performed. This is a common and avoidable reason HIV-focused SBIR applications get administratively withdrawn.

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STTR is worth a hard look here. This topic asks for multidisciplinary teams with complementary expertise and meaningful community engagement, which is exactly what the STTR mechanism is built for. Under STTR, a formal collaboration with a university or nonprofit research institution is required, and the Principal Investigator may be primarily employed by either the company or the research partner. For a company that needs an academic HIV clinician, an implementation scientist, or a community-engaged research partner in order to be credible, STTR (PA-27-102) is often the stronger vehicle than SBIR.

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How Much Funding Would I Receive?

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There is no funding amount attached to the Highlighted Topic itself. Budgets are set by the parent announcement you apply through and by the Institute that funds you.

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Under the current NIH SBIR and STTR parent announcements, standard guidelines provide:

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• Phase I: up to $323,090, typically over one to two years

• Phase II: up to $2,153,927, typically over two to three years

• Fast-Track: combines Phase I and Phase II in one application and one review

• Direct to Phase II: available under SBIR for companies that have already established feasibility

• Phase IIB (PA-27-101): follow-on funding beyond Phase II, with budgets that can run substantially larger

• Commercialization Readiness Pilot: late-stage, milestone-driven support, up to the SBA statutory maximum of $4,191,495 at NCI, with amounts varying by Institute

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Several Institutes participating in this topic hold approval to exceed the standard caps. NIA allows up to $700,000 for Phase I and $3 million for Phase II on Alzheimer's disease and AD-related dementias, and up to $500,000 and $2.5 million for other projects in its mission space, which is directly relevant given the topic's inclusion of neurocognitive comorbidity and vascular contributions to dementia. NIGMS allows Phase IIB budgets up to $3 million, or $4 million for Strategic Breakthrough awards involving clinical trials. NCI supports CRP projects up to the statutory maximum plus up to $500,000 for technical assistance.

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Cost sharing is not required. Phase I generally requires at least 67 percent of the research effort to be performed by the small business; Phase II generally requires at least 50 percent.

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Full Institute-by-Institute budget detail is in our NIH SBIR program executive summary.

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What Could I Use the Funding For?

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Funds support research and development toward a commercially viable product or service aligned with the mission of a participating Institute or Center. Allowable costs include personnel, materials, prototype fabrication, assay development, validation studies, testing, intellectual property protection, and other direct R&D expenses.

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Phase II, Phase IIB, and CRP funds may additionally cover scale-up, clinical validation, regulatory preparation including IND and IDE-enabling studies, and commercialization activities.

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Whether you can run a clinical trial depends entirely on which Institute funds you. Most ICOs with a direct clinical mission accept clinical trials, including NCI, NHLBI, NIA, NICHD, NIDA, NIMH, and NIDDK, all of which participate in this topic. NIAMS and NIDCR, which also participate in this topic, do not accept clinical trials under the SBIR parent announcement. If your project involves human subjects, confirm your target Institute's specific policy before you build the research plan around it.

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What Is the Timeline?

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Highlighted Topic dates

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• Posted: July 28, 2026

• Expires: July 28, 2028

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SBIR and STTR standard receipt dates (PA-27-100 and PA-27-102)

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• September 5, 2026. This falls on a Saturday, and Labor Day is Monday, September 7, so submissions are accepted through Tuesday, September 8, 2026.

• January 5, 2027

• April 5, 2027

• The same September, January, and April cycle continues into 2027 and 2028 while the topic remains active. September 5, 2027 falls on a Sunday ahead of Labor Day, so that cycle effectively closes Tuesday, September 7, 2027.

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All applications are due by 5:00 PM local time of the applicant organization.

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Review and award timeline for the September 2026 cycle

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• Scientific merit review: November 2026

• Advisory council review: January 2027

• Earliest project start date: April 2027

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Review and award timeline for the January 2027 cycle

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• Scientific merit review: March 2027

• Advisory council review: May 2027

• Earliest project start date: July 2027

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Review and award timeline for the April 2027 cycle

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• Scientific merit review: July 2027

• Advisory council review: August 2027

• Earliest project start date: December 2027

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Two timing changes that specifically affect HIV-focused applicants

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First, HHS eliminated dedicated AIDS and AIDS-related SBIR and STTR due dates for applications due on or after May 25, 2026. HIV-focused companies previously had access to a separate offset schedule that routed applications into AIDS-specific review. That is gone. You now compete on the standard small business calendar, which makes Institute alignment and cycle selection more consequential than before.

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Second, NIH tightened its late application policy under NOT-OD-26-064, effective for due dates on or after May 25, 2026. Small business applications no longer receive the discretionary late submission window. Plan to submit early enough to resolve eRA Commons validation errors before the deadline, not after it.

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Practical planning guidance. Budget at least twelve weeks of lead time before your target due date, and more if your federal registrations are not already complete. SAM.gov, UEI, SBA Company Registry, eRA Commons, and Grants.gov registrations can take four to six weeks on their own and must be finished before you can submit anything. For a first-time applicant, expect 120 to 200 hours of total effort on a competitive submission.

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Who Is Eligible to Apply?

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Eligibility comes from the parent announcement, not from the topic. Applicants must be U.S. small business concerns that are:

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

• At or below 500 employees, including affiliates

• More than 50 percent owned and controlled by U.S. citizens or permanent resident aliens, by qualifying U.S. entities, or by a combination

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For STTR, the company must also have a formal collaboration with a U.S. research institution, with at least 40 percent of the work performed by the small business and at least 30 percent by the research institution.

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Foreign organizations are not eligible, and foreign subawards and subcontracts are not permitted.

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Are There Restrictions I Should Know About?

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• Only U.S. small business concerns are eligible; foreign organizations are not.

• Applications involving foreign subawards or subcontracts will not be considered for funding. This is the single most important constraint to plan around given the topic's global framing.

• Your application must be relevant to at least one participating Institute or Center that awards grants. Five of the participating offices in this topic, OAR, OBSSR, ODP, ORWH, and THRO, do not.

• Clinical trials are not accepted by every Institute. Among the ICOs in this topic, NIAMS and NIDCR do not accept them under the SBIR parent announcement.

• Duplicate or highly overlapping applications submitted under multiple HHS announcements are not permitted.

• Companies must satisfy applicable SBA performance benchmark requirements, including the Phase I to Phase II transition rate benchmark and the Phase II commercialization rate benchmark for companies with substantial award histories.

• Additional national security, foreign relationship, and foreign ownership disclosure requirements apply and may result in denial of award. The 2026 reauthorization tightened foreign risk management and due diligence review, and this screening now sits inside the review critical path rather than beside it.

• Cost sharing is not required.

• Applying under a Highlighted Topic does not change referral or review, and does not guarantee that any funds have been set aside.

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What Kind of Application Is Likely to Win Here?

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NIH reviews small business applications on Significance, Investigators, Innovation, Approach, and Environment, with commercialization potential specifically evaluated for Phase II and Fast-Track. Within this topic, four things separate the competitive applications from the rest.

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One: you picked the right Institute, and you picked it before you started writing. Sixteen ICOs participating means sixteen possible framings of the same technology, and the framing determines which study section reviews you and which budget pays for you. A cardiometabolic risk tool assigned to NHLBI is a different application than the same tool assigned to NIDDK. Email the named contact, describe the technology in a paragraph, and ask directly whether it fits and which mechanism they would suggest. That conversation is free and it is the highest-return hour you will spend.

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Two: you actually addressed shared factors, not one disease. The intellectual center of this topic is that comorbidities in people with HIV intersect and share upstream drivers. An application that addresses a single condition in people with HIV is responsive to that Institute's general mission but not distinctively responsive to this topic. An application that shows how one intervention affects multiple outcomes through a shared mechanism is.

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Three: you took implementation seriously. NIH says outright that traditional disease-specific models insufficiently capture multilevel implementation determinants, and NIAMS goes further by prioritizing implementation science outright. For a company, this translates into concrete asks: who delivers this, in what clinic, paid for by whom, fitting into what workflow, sustained how after the grant ends. Applications that treat adoption as somebody else's problem read as naive here.

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Four: your team is genuinely multidisciplinary, and your community engagement is real. Multiple Program Directors and Principal Investigators with complementary expertise are strongly encouraged. Meaningful community engagement is strongly encouraged. Reviewers in this space are well practiced at spotting a letter of support from a community organization that has no role in the actual research plan.

Frequently Asked Questions

Is this a Notice of Funding Opportunity I can apply to directly?

No. This is an NIH Highlighted Topic, which is a published statement of scientific priority rather than a solicitation. There is no application package and no separate deadline. You apply through a broad NIH funding opportunity, and for small businesses that means the SBIR parent announcement PA-27-100 or the STTR parent announcement PA-27-102.

How much funding is available under this Highlighted Topic?

The topic itself carries no funding amount. Your budget is governed by the parent announcement you apply through: under standard guidelines, up to $323,090 for SBIR Phase I and up to $2,153,927 for Phase II, with several Institutes approved to exceed those caps. NHLBI and NIDA both state they may dedicate available funds to this topic area, subject to available funds, the number of meritorious applications, and competing priorities.

Does applying under this Highlighted Topic improve my chances?

Not in review. NIH states that applying in a Highlighted Topic area will not affect referral or review of applications. Three participating ICOs, NCCIH, NIDA, and NIDCR, state they may give special consideration to meritorious applications in this topic area, and two, NHLBI and NIDA, state they may dedicate funds. The real advantage is informational: sixteen ICOs have documented what they want and named the staff to call about it.

What are the deadlines?

The topic is open from July 28, 2026 through July 28, 2028. SBIR and STTR standard receipt dates are September 5, 2026, January 5, 2027, and April 5, 2027, with the cycle continuing while the topic remains active. Because September 5, 2026 falls on a Saturday before Labor Day, that cycle accepts submissions through Tuesday, September 8, 2026. All applications are due by 5:00 PM local time of the applicant organization.

Are there separate AIDS-specific due dates for HIV-related SBIR applications?

Not anymore. HHS eliminated dedicated AIDS and AIDS-related SBIR and STTR due dates for applications due on or after May 25, 2026. HIV-focused companies now submit on the standard small business schedule and compete within it.

Which NIH Institutes participate in this topic?

Sixteen ICOs: the Office of AIDS Research as lead, plus NCCIH, NCI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NICHD, NIDA, NIDCR, NIDDK, NIMH, OBSSR, ODP, ORWH, and THRO. Five of those, OAR, OBSSR, ODP, ORWH, and THRO, are offices that do not award grants, so your application must also be relevant to a participating Institute or Center that does.

Who is eligible to apply?

For-profit U.S. small business concerns with 500 or fewer employees including affiliates, more than 50 percent owned and controlled by U.S. citizens or permanent residents or by qualifying U.S. entities. Foreign organizations are not eligible, and foreign subawards and subcontracts are not permitted.

My work focuses on low and middle-income settings, which the topic specifically mentions. Can SBIR fund that?

Only with careful structuring. The topic references low and middle-income settings and HIV-exposed uninfected children in those settings, but the SBIR parent announcement prohibits foreign subawards and subcontracts. The funded research has to be performed domestically. Global relevance can be argued in the significance and commercialization sections; it cannot be delivered through an international subaward under this mechanism.

Can I run a clinical trial with this funding?

It depends on the Institute. Most participating ICOs with a direct clinical mission accept clinical trials, including NCI, NHLBI, NIA, NICHD, NIDA, NIMH, and NIDDK. NIAMS and NIDCR, both participating in this topic, do not accept clinical trials under the SBIR parent announcement. Confirm your target Institute's policy before designing the project.

Should I apply for SBIR or STTR?

SBIR if your company performs the majority of the research and your Principal Investigator is primarily employed by the company. STTR if the project depends on a formal collaboration with a university or nonprofit research institution. Given that this topic explicitly asks for multidisciplinary teams and community engagement, STTR is often the better structural fit, and STTR allows the Principal Investigator to be primarily employed by either the company or the research partner.

Where do I reference the Highlighted Topic in my application?

Unlike a Notice of Special Interest, a Highlighted Topic has no notice number to enter in the Agency Routing Identifier field. Make the alignment explicit in your cover letter and in your Specific Aims, and confirm handling with the program officer at your target Institute before you submit.

What does NIH mean by "shared factors" and why does it matter commercially?

NIH's point is that many comorbidities in people with HIV intersect and share risk factors before diverging into disease-specific trajectories, using metabolic syndrome raising diabetes, cardiovascular, and kidney disease risk as one example and coinfection-driven cancer risk as another. Commercially this is favorable, because a technology addressing an upstream shared factor has a larger addressable market and a stronger clinical value proposition than a single-indication tool, and it can be framed to fit several Institutes at once.

How long will it take me to prepare an application?

For a first-time applicant, expect 120 to 200 hours in total. Start at least twelve weeks before your target due date. Federal registrations across SAM.gov, UEI, SBA Company Registry, eRA Commons, and Grants.gov can take four to six weeks on their own and must be complete before submission.

What happens if I miss the deadline?

Nothing good. NIH tightened its late application policy for due dates on or after May 25, 2026, and small business applications no longer receive the discretionary late submission window. Build in time to fix validation errors before the deadline rather than after it.

Is this topic connected to a broader federal initiative?

Yes. NIH issued it as part of the Make America Healthy Again initiative, and the topic page names the specific MAHA workstreams it aligns with, including the NIH Chronic Disease Initiative, the Whole-Person-Health approach, prescribing patterns and mental health, Food for Health, nutrition and metabolic health, the oral health and systemic disease connection, the Gut Microbiome Research Initiative, longitudinal cohort research, clinical trial networks, and mental health and addiction research. Framing your significance section in that vocabulary is a low-cost, high-signal move.

How Can BW&CO Help?

BW&CO is a non-dilutive federal funding advisory firm. We have helped clients secure more than $350 million in federal funding, and we specialize in exactly the problem this topic creates: a broad scientific priority with sixteen possible sponsors, no dedicated money, and no obvious front door.

We can:

• Identify the right Institute and the right mechanism for your technology, Phase I, Phase II, Fast-Track, Direct to Phase II, Phase IIB, or CRP, and position you with the program officer who controls that budget.

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

• Reduce your time spent on the proposal by 50 to 80 percent, so your team stays focused on the technology and the company.

• Structure the research plan so that foreign collaboration, clinical trial sequencing, and registration timelines do not sink an otherwise fundable application.

NIH SBIR Phase IIB Strategic Breakthrough Award (PA-27-101): Full Guide for Startups

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

Quick Answer

The NIH SBIR Phase IIB Strategic Breakthrough Award (PA-27-101) provides up to $30,000,000 in follow-on funding to small businesses that have already completed an NIH SBIR or STTR Phase II award and need additional capital to bridge the gap to commercialization, often called the Valley of Death. The award requires companies to secure 100 percent matching funds from a new private investor or another government agency before applying. Standard due dates are September 5, January 5, and April 5 each year, with the next deadline on September 5, 2026. Only prior NIH Phase II recipients are eligible. There is no Phase I step for this award.

What This Funding Opportunity Is

The Phase IIB Strategic Breakthrough Award is a reissue of two earlier NIH funding opportunities, PA-24-245 and PA-24-246, and it exists to solve one specific problem. Many biomedical, MedTech, and life sciences companies finish a strong Phase II award and still face years of additional work before they can commercialize, particularly if their product needs FDA clearance, involves a complex manufacturing process, or targets a small patient population. NIH calls this gap the Valley of Death, and this award is designed to bridge it with a second, larger Phase II style grant.

This is not a new company's first NIH grant. It is a continuation award available only to businesses that already hold or previously held an NIH SBIR or STTR Phase II grant, cooperative agreement, or contract. A company cannot apply for a Phase IIB award without that Phase II history, and the Phase IIB award can only begin after the original Phase II project has ended.

Nineteen NIH institutes, centers, and offices participate in this funding opportunity, including the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute of Allergy and Infectious Diseases, the National Institute of Mental Health, the National Institute of Neurological Disorders and Stroke, and others. Each participating component reviews applications aligned with its own mission and health research priorities.

Who Should Apply

This opportunity is a strong fit for a company if it can check most or all of the following boxes.

The company is a United States small business concern with 500 or fewer employees, including affiliates, and it already completed or is completing an NIH SBIR or STTR Phase II award.

The company has a product, therapeutic, device, or platform that needs a defined regulatory pathway, such as FDA clearance or approval, and that pathway requires more capital and more time than a standard Phase II budget allows.

The company can demonstrate, or is close to securing, a dollar-for-dollar match of the requested federal funds, drawn from new private capital such as venture investment, or from a non-SBIR federal or state award.

The company is within its first six standard due dates following the end of its Phase II budget period. Waiting longer than that risks losing eligibility for this specific mechanism.

If a company has Phase II results but does not yet have committed matching funds, or needs a smaller amount of technical assistance rather than a full second Phase II award, NIH recommends looking instead at the Commercialization Readiness Pilot Program (CRP) under PAR-27-098, which does not require a third-party match.

Funding Allowance and Budget Limits

Total funding support, meaning direct costs, indirect costs, and fee combined, cannot exceed $30,000,000 for a single Phase IIB Strategic Breakthrough award. Beyond that ceiling, each participating institute or center sets its own budget guideline, and applicants must stay within the guideline for whichever component will review their application. Representative examples include the National Cancer Institute at up to $15,000,000, the National Heart, Lung, and Blood Institute at up to $4,500,000, the National Institute on Alcohol Abuse and Alcoholism at up to $4,500,000, and most other participating institutes and centers at up to $3,000,000. A handful of components, including the National Eye Institute, the National Institute on Minority Health and Health Disparities, and the Office of Research on Women's Health, follow the standard SBA guideline rather than a fixed dollar figure.

The award period cannot exceed four years. Applicants should propose a project length that realistically matches the scope of the remaining development and commercialization work, not simply the maximum allowed.

Every dollar of federal funding requested must be matched by an equal dollar of third-party funding. This 100 percent match is a hard requirement under the Small Business Innovation and Economic Security Act, and it is one of the most heavily weighted factors in review. Matching funds must come from new private capital, such as another company, a venture capital firm, or another private investor, from a new government award other than a Phase I or Phase II SBIR or STTR grant, or from a combination of the two. Letters documenting committed matching funds should be included with the application's letters of support, and additional proof may be requested later during Just in Time review.

Key Dates and Timeline

The opportunity was posted on May 28, 2026, and the earliest applications can be submitted is August 5, 2026.

Applications are accepted on the standard NIH cycle three times per year, and every submission must be a Renewal, Resubmission, or Revision application type, except in the specific case of a Phase IIB tied to an underlying Phase II contract rather than a grant, which is submitted as New.

The upcoming due dates and their associated review timelines are as follows.

September 5, 2026 due date leads to scientific merit review in November 2026, advisory council review in January 2027, and an earliest possible start date of April 2027.

January 5, 2027 due date leads to scientific merit review in March 2027, advisory council review in May 2027, and an earliest possible start date of July 2027.

April 5, 2027 due date leads to scientific merit review in July 2027, advisory council review in August 2027, and an earliest possible start date of December 2027.

This same September, January, April cycle repeats through the expiration date of April 6, 2029. All applications are due by 5:00 PM local time at the applicant organization, and no late applications are accepted under this opportunity. If a due date falls on a weekend or federal holiday, it automatically moves to the next business day.

How to Apply

Applications are submitted electronically through one of three paths: the NIH ASSIST system, an institutional system to system solution, or Grants.gov Workspace, with application status then tracked in eRA Commons. Paper applications are not accepted.

Before submitting, a company must have several registrations active and current, and these can take six weeks or more to complete, so early preparation matters. The company needs an active registration in the System for Award Management (SAM.gov), which also issues a Unique Entity Identifier and a CAGE code. It needs an SBA Company Registry registration, which requires the UEI first. It needs an eRA Commons organizational account with at least one Signing Official and one Program Director or Principal Investigator listed, and every Program Director or Principal Investigator needs both a personal eRA Commons account and a linked ORCID iD. Finally, the company needs an active Grants.gov registration, which itself requires an active SAM.gov registration to complete.

The primary employment of the Program Director or Principal Investigator must be with the small business at the time of award and throughout the project, with limited exceptions for multi-PI teams.

Required application components include a Regulatory Plan of no more than two pages describing the regulatory pathway and milestone timeline, a Commercialization Plan addressing market opportunity, target customers, competitive landscape, and the source and evidence of 100 percent matching funds, and, where applicable, a VCOC Certification for companies majority owned by venture capital operating companies, hedge funds, or private equity firms. A Data Management and Sharing Plan is not required for this specific opportunity.

What NIH Reviewers Are Looking For

Reviewers score applications on the standard NIH criteria of Significance, Investigators, Innovation, Approach, and Environment, with extra weight placed on commercial trajectory given the Phase IIB context. For this award specifically, reviewers pay close attention to the progress made during the original Phase II project, whether market research supports the technology as an effective solution, and whether the applicant has provided compelling, documented evidence of its 100 percent match. Applications are also evaluated against Strategic Breakthrough criteria, including the technology's potential to advance national security capabilities, whether it offers new alternatives to existing approaches, whether a federal agency customer has expressed intent to adopt the technology, and whether the technology area is currently undercapitalized by private investors.

Funding decisions also weigh scientific merit alongside fund availability, demonstrated availability of the required match, and results of an HHS security risk assessment. Companies with certain ties to foreign countries of concern, or that appear on specified federal restricted entity lists, cannot receive an award under this opportunity, and all applicants under consideration for funding must submit an SBA Disclosure of Foreign Affiliations form during Just in Time review.

Common Reasons Applications Are Rejected Before Review

Applications are screened for completeness and responsiveness before they ever reach a review panel. The most common disqualifiers under this opportunity are applying without a completed NIH Phase II award as the foundation, applying for a clinical trial through an institute that does not accept clinical trials under this NOFO, such as NCATS or ORIP, missing or incomplete SAM.gov, UEI, or eRA Commons registrations at the time of submission, and failing to document credible progress toward the required 100 percent match.

Frequently Asked Questions

Does my company need a Phase I award to apply for Phase IIB? No. This opportunity is only for companies that already completed a Phase II award. There is no standalone Phase I component to this NOFO.

Can we apply if our matching funds are not fully secured yet? You should have strong, documented progress toward the full 100 percent match, ideally with signed or near final commitment letters, since this is one of the most heavily weighted review factors. If your match is not yet in place, the Commercialization Readiness Pilot Program under PAR-27-098 may be a better near-term fit.

How long do we have to apply after our Phase II award ends? You should submit within the first six standard NIH due dates following the end of your Phase II budget period to maintain eligibility for this mechanism.

What is the maximum award amount? Total funding support cannot exceed $30,000,000, though most participating institutes and centers set lower internal guidelines, commonly in the $3,000,000 to $4,500,000 range, with a few components following standard SBA guidelines instead.

Can foreign owned companies apply? No. Non-domestic entities and non-domestic components of United States organizations are not eligible. Companies with certain ownership ties, research affiliations, or listed relationships connected to countries of concern, including the People's Republic of China, are barred from receiving an award.

Is a clinical trial required? No. Clinical trials are optional under this opportunity, but applicants proposing a clinical trial should confirm their target institute or center accepts clinical trials, since NCATS and ORIP do not.

Can we submit more than one Phase IIB application? Yes, provided each application is scientifically distinct from any other pending or funded application, including any Commercialization Readiness Pilot application tied to the same underlying Phase II project.

What is the difference between Phase IIB and the Commercialization Readiness Pilot (CRP)? Phase IIB requires a full 100 percent third party match and functions as a second, larger Phase II award. CRP, under PAR-27-098, is designed for companies that need additional technical assistance or later stage research and development but do not yet have matching funds secured or need significant outsourced work. The two can run concurrently on the same underlying Phase II project if they are scientifically distinct.

Do we need a Data Management and Sharing Plan? No. This NOFO explicitly states a Data Management and Sharing Plan is not applicable.

What registrations do we need before we can submit? An active SAM.gov registration with an assigned UEI, an SBA Company Registry registration, an eRA Commons account for the organization and for each Program Director or Principal Investigator, an ORCID iD linked to each PD or PI's eRA Commons profile, and an active Grants.gov registration. Start this process early, since it can take six weeks or more from start to finish.

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

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

Quick Answer

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

Program Overview

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

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

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

What ARPA-H Is Looking For

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

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

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

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

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

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

Funding and Award Structure

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

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

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

Eligibility

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

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

Timeline

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

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

How to Apply

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

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

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

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

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

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

How BW&CO Consulting Supports STREAM Applicants

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

Frequently Asked Questions

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

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

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

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

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

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

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

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

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

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

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

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

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

NIH SBIR Bioethics Research Funding for Startups: 2026 Guide

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

Quick Answer

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

What Is the NIH Bioethics Research Highlighted Topic?

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

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

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

How Do You Apply for This Bioethics Topic?

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

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

What Kind of Research Is NIH Looking For?

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

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

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

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

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

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

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

Which NIH Institutes and Centers Participate?

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

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

How Much Funding Can a Startup Receive?

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

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

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

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

What Is the Timeline and What Are the Deadlines?

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

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

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

Who Is Eligible to Apply?

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

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

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

What Registrations Do You Need Before Applying?

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

What Are the Key Compliance and Foreign Risk Rules?

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

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

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

How Should a Startup Frame a Bioethics Project for SBIR?

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

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

How BW&CO Helps

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

Frequently Asked Questions

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

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

What is the deadline to apply?

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

How much SBIR funding can my startup receive?

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

Who is eligible to apply?

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

Can universities apply for this topic?

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

Does my bioethics project need a commercial product?

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

Which NIH Institutes fund this topic?

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

Do I need to pick an Institute before I apply?

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

How long does registration take?

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

Can foreign companies or foreign subawards be involved?

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

NIH Connectedness Interventions SBIR Funding: A Guide for Startups

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

Quick Answer

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

What Is the NIH Connectedness Interventions Highlighted Topic?

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

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

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

Which Funding Announcement Do I Actually Apply Through?

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

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

A few companion announcements matter depending on your project:

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

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

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

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

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

Is My Startup Eligible?

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

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

• No more than 500 employees, including affiliates.

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

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

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

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

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

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

• SBA Company Registry.

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

• Grants.gov.

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

What Kind of Projects Is NIH Looking For?

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

NIH strongly encourages projects that:

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

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

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

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

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

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

Which NIH Institutes and Centers Are Funding This Topic?

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

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

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

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

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

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

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

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

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

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

How Much Funding Can My Startup Receive?

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

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

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

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

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

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

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

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

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

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

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

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

What Is the Timeline and What Are the Deadlines?

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

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

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

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

All applications are due by 5:00 PM local time of the applicant organization. When a due date falls on a weekend or federal holiday, the deadline moves to the next business day. No late applications are accepted.

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

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

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

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

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

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

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

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

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

Do Clinical Trials Fit This Topic?

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

What Do Reviewers Evaluate?

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

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

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

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

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

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

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

What Restrictions Should I Know About?

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

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

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

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

How BW&CO Helps

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

Frequently Asked Questions

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

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

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

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

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

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

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

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

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

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

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

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

Quick Answer

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

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

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

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

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

How does a startup actually apply for this?

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

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

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

What kind of research is NIH looking for?

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

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

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

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

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

Who is eligible to apply?

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

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

How much funding is available?

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

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

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

What is the timeline and what are the deadlines?

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

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

• January 5, 2027, for the second cycle.

• April 5, 2027, for the third cycle.

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

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

What are the funding phases?

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

Is this a good fit for my company?

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

Frequently Asked Questions

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

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

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

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

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

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

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

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

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

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

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

Quick Answer

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

What Is ASCENT-IBO and Who Issued It?

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

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

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

Why Is ARPA-H Funding Ibogaine Research Now?

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

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

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

What Is ARPA-H Actually Looking For?

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

Task 1: Combined Phase I/II Clinical Trial Design

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

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

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

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

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

Task 2: Operational Plans for Trial Execution

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

Task 3: Future Development Plans

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

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

What Makes a Solution Competitive?

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

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

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

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

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

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

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

What Is Out of Scope?

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

How Much Funding Is Available?

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

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

What Are the Key Dates and Deadlines?

• Proposers' Day registration opened: August 5, 2026

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

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

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

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

What Is Proposers' Day and Should You Attend?

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

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

How Do You Apply?

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

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

Frequently Asked Questions

What does ASCENT-IBO stand for?

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

What is the Notice ID for ASCENT-IBO?

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

When is the ASCENT-IBO Solution Summary due?

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

How long is the Solution Summary?

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

Does a company need an IND to apply?

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

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

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

Are psilocybin, ketamine, or ibogaine analogues eligible?

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

How much money can an awardee receive?

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

Do you have to attend Proposers' Day to submit?

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

What safety risks does ARPA-H specifically want addressed?

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

What executive order is this connected to?

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

How BW&CO Can Help

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

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

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

Quick Answer

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

What This Opportunity Is

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

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

What the Program Is Looking For

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

Prevent breast cancer through primary prevention

Identify determinants of breast cancer initiation, risk, or susceptibility

Distinguish deadly from non-deadly breast cancers

Conquer the problems of overdiagnosis and overtreatment

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

Identify why some breast cancers become metastatic

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

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

Eliminate the mortality associated with metastatic breast cancer

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

Award Mechanism 1: Breakthrough Award

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

The award is structured across three funding levels.

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

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

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

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

Award Mechanism 2: Clinical Research Extension Award

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

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

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

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

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

Eligibility Snapshot

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

Clinical Research Extension Award: open to independent investigators.

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

Funding Details Summary

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

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

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

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

Timeline

Estimated application due date is September 30, 2026

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

How to Apply

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

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

Frequently Asked Questions

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

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

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

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

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

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

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

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

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

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

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

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

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

FY26 Reconstructive Transplant Research Program: Investigator-Initiated Research Award

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

Quick Answer

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

What This Opportunity Is

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

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

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

What the Program Is Looking For

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

Improving or optimizing VCA immunosuppression, including:

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

Developing novel tolerogenic agents or approaches for VCA immunosuppression

Developing less toxic or personalized regimens for maintenance immunosuppression

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

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

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

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

Advancing VCA preservation strategies, including:

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

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

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

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

Eligibility and Requirements

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

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

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

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

Funding Details

Total program funding is $8,000,000

Expected number of awards is 8

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

Maximum period of performance is 3 years

Cost sharing or matching is not required

Funding instrument type is a grant

Funding opportunity number is HT942526RTRPIIRA

Assistance Listing number is 12.420, Military Medical Research and Development

Timeline

Estimated posting date is August 24, 2026

Estimated application due date is November 4, 2026

Estimated award date is September 30, 2027

Estimated project start date is September 30, 2027

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

How to Apply

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

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

Frequently Asked Questions

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Quick Answer

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

Program Overview

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

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

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

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

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

Who Should Apply

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

You are a strong fit if:

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

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

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

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

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

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

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

Funding Allowance

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

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

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

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

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

Co-Funding Requirements

Unpartnered nonprofit applicants: no co-funding required.

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

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

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

Eligibility Requirements Snapshot

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

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

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

The applicant organization must be the named IND sponsor.

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

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

What CIRM Will Not Fund

Conducting a clinical trial beyond startup activities.

Patient recruitment, screening, or enrollment.

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

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

Costs incurred before the date of ICOC board approval.

Timeline

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

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

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

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

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

How Applications Get Reviewed and Scored

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

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

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

The five scored review criteria are:

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

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

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

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

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

Award Administration After Funding

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

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

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

Frequently Asked Questions

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

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

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

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

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

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

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

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

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

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

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

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

ARPA-H FASTPASS Program: Rapid Drug Quality Screening Funding

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

Quick Answer

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

What problem is FASTPASS trying to solve?

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

What is FASTPASS funding?

The program is structured around two technical areas.

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

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

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

When does FASTPASS open?

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

Are there events for proposers?

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

Does FASTPASS require teaming?

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

Who runs the FASTPASS program?

James Coburn, CAPT, serves as Program Manager.

FAQs

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

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

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

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

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

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

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

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

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

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

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

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

Overview of the Funding Opportunity

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

Program Areas of Interest

The BAA covers nine research portfolios:

• Military Infectious Diseases

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

• Combat Casualty Care

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

• Traumatic Brain Injury

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

• Psychological Health

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

• Sensory Systems

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

• Musculoskeletal Injury

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

• Environmental Exposures

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

• Directed Energy/Radiation Health

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

• DOD Working Dogs

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

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

Funding and Award Structure

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

Eligibility

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

Submission Process

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

Why This Matters for BW&CO Clients

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

FAQs

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

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

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

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

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

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

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

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

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

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

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

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

PCORI Broad Pragmatic Studies PFA: Cycle 3 2026

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

Quick Answer

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

What Is the PCORI Broad Pragmatic Studies PFA?

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

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

Key Dates

PFA opens: August 4, 2026

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

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

LOI status notification: October 14, 2026

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

Merit review: March 2027

Awards announced: August 2027 (subject to change)

Earliest start date: December 2027

Funding Amounts and Categories

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

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

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

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

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

Special Areas of Emphasis for Cycle 3 2026

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

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

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

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

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

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

Structured Mentorship

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

Application Deferral Policy

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

Research Project Agenda Topic Themes

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

Who Should Apply

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

Frequently Asked Questions

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

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

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

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

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When is the full application due?

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

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How much funding is available?

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

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What is the maximum project period?

Up to five years for all three funding categories.

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Does this PFA fund new product or device development?

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

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

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

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Is patient partnership required?

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

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Can applicants defer a submission to a later cycle?

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

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Where can applicants get more information or ask questions?

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

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

Quick Answer:

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

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

What Does This Opportunity Fund?

Four illustrative (non-exclusive) project types:

• Comparing digital measurements to traditional clinical trial measurements

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

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

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

What Makes This Different From a Standard NOFO?

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

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

• Applies to drugs/biologics only, not devices

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

How Is It Reviewed?

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

• Significance (20 pts)

• Investigator(s) (20 pts)

• Innovation (25 pts)

• Approach (25 pts)

• Environment (10 pts)

Who Is Eligible?

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

Key Dates

• Posted: July 20, 2026

• Open Date: July 20, 2026

• Application Due: August 20, 2026

• Expiration: August 21, 2026

How Can BW&CO Help?

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

NIH Highlighted Topic: Advancing Nutrition Research to Inform Regulatory Practice

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

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

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

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: Accelerating Otitis Media Research and Workforce Development

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

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

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

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.