Army Advanced Manufacturing (AdvM) Commercial Solutions Opening W9124P26SC001: Complete Guide for Startups

Executive Summary

The Army Advanced Manufacturing (AdvM) Commercial Solutions Opening asks for innovative commercial solutions that establish and advance manufacturing capability across the Army's Organic Industrial Base (OIB) and out to the tactical edge.

The CSO was first issued on July 15, 2026. Amendment 1 was posted on SAM.gov on August 27, 2026. It is an umbrella CSO with no deadline, and the document says it "will remain open and accept submissions continuously" until the Army cancels it.

Companies can respond in two ways:

• General submission. Submit at any time against one of 18 Active Capability Gap (ACG) areas of interest.
• Call for Solutions. Respond to a specific Call, which addresses a defined need and has its own short deadline.

Phase 1 is a one-page quad chart and a five-page white paper sent by email. Awards are firm-fixed-price only.

For a startup with a commercial manufacturing, automation, inspection or industrial software product, this is one of the broadest Army entry points open right now. The main thing to understand: a general submission gets you on file, and a Call usually means the Army has already identified a specific need.

Army AdvM CSO at a Glance

• Solicitation number: W9124P26SC001 (W9124P-26-S-C001), Amendment 1
• Issuing office: Army Contracting Command-Redstone Arsenal (ACC-RSA), Redstone Services and Information Technology Solutions Branch
• Customer: Headquarters U.S. Army Materiel Command (HQ AMC)
• Status: Open in perpetuity until canceled. Individual Calls for Solutions carry their own deadlines.
• Authorities:
  • The CSO document cites Section 803 of the FY2022 NDAA.
  • The SAM.gov notice also lists 10 U.S.C. § 3458 with DFARS RFO 212.70, 10 U.S.C. § 4022 prototype OTs, RFO 6.101(b)(3), and the Employee Stock Ownership Pilot Program.
• Areas of interest: 18 Active Capability Gap areas, and the CSO "is open to any novel advanced manufacturing solution"
• Phase 1 submission: One-page quad chart plus white paper of up to five pages, emailed as two separate PDFs
• Award type: Firm-fixed-price only, per DFARS RFO 212.7002(b)
• Instruments: RFO Part 12 purchase orders and BPAs, Part 12 and 15 contracts, Part 16 IDIQs and BOAs, or prototype OTs under 10 U.S.C. § 4022
• Eligibility: Industry, academia and nontraditional partners. Small businesses are generally nontraditional defense contractors under 10 U.S.C. § 3014. Active SAM.gov registration is required for award.
• Submission and questions: usarmy.redstone.acc.mbx.acc-rsa-advm-cso@army.mil (primary POC on SAM.gov: Stephanie Dillon)

The 18 Active Capability Gap Areas

The CSO says it is open to any novel advanced manufacturing solution. It names these 18 areas of particular interest:

1. Robotics and Automation. Automating manual manufacturing and depot maintenance processes, such as robotic welding, automated material handling and cobots for assembly.
2. Additive Manufacturing. On-demand polymer, metal or composite parts, including large-format and multi-material printing and quality assurance and certification for critical components.
3. Advanced Materials. High-strength alloys, composites, self-healing materials and other materials that improve performance, weight or corrosion resistance.
4. Digital Twin and Digital Thread. Virtual models of assets and processes for predictive maintenance, process optimization and lifecycle management.
5. Smart and Connected Factories (IIoT). Sensors, analytics and IIoT to monitor equipment health, track production and optimize the factory floor.
6. Advanced Non-destructive Testing and Inspection. Advanced ultrasonics, thermography, automated computer-aided inspection and similar methods.
7. Workforce Development and Manufacturing Skills. Training material, concepts or methods for a digital manufacturing workforce.
8. Supply Chain Risk Management. Tools to identify and address strategic manufacturing value chain vulnerabilities in the defense industrial base.
9. Cybersecurity. Tools to build DoW Risk Management Framework requirements into processes, product design and documentation.
10. Enterprise Data Integration. A centralized AdvM data repository for qualified part data, technical data packages and IP, with data exchange with the Defense Logistics Agency.
11. AdvM at the Tactical Edge. The right mix of AdvM capability in expeditionary and tactical environments, including point-of-need solutions.
12. Army AdvM Consortium. Managing an alliance of government, industry, nonprofits and academia to qualify AdvM vendors, processes and parts.
13. OIB and AdvM Innovation Centers. Machines, tooling, technology and talent for a network of innovation hubs.
14. Metrology. Advanced measurement systems, such as optical or blue light scanning, to verify machines and parts meet tolerances.
15. Qualification and Certification. Technologies and methods to qualify and certify manufacturing processes and parts.
16. Advanced Electronics Manufacturing. Flexible hybrid electronics and additively manufactured electronics.
17. Advanced Coatings and Surface Engineering. Coatings and surface modifications for durability, corrosion resistance, thermal management and signature management.
18. Predictive Maintenance Analytics. AI and machine learning models that predict component failures, optimize maintenance schedules and forecast sustainment needs.

The CSO's general invitation to "any novel advanced manufacturing solution" acts as a catch-all beyond these named areas.

Not sure which area your technology fits, or whether it fits at all? We can tell you on a short call.

What Recent Calls for Solutions Looked Like

The CSO says the Army "may issue specific 'Calls for Solutions' as amendments" to address focused gaps. In practice, recent Calls were posted as separate SAM.gov notices titled "AdvM Call for Solutions" and linked from the CSO page:

• Modern Radar Systems Organic Capability Development (PANRSA-26-P-0000-039852): closed August 14, 2026.
• Expeditionary Additive Manufacturing (EAM) Systems (PANRSA-26-P-0000040885): posted August 24, due August 31 at noon CT. Seven days to respond.
• Modernized Paint Line at Tobyhanna Army Depot (PANRSA-26-P-0000-040601): posted August 27, due September 16 at noon CT after amendment. The Army asked for a complete system: hardware, automated parts handling and open-architecture SCADA software for paint application, curing and shop operations.
• Automated Parts Handling for Plating at Tobyhanna Army Depot (PANRSA-26-P-0000-040599): posted August 27, due September 16 at noon CT after amendment.

No AdvM Call was active on SAM.gov as of October 1, 2026.

Two lessons stand out. The windows are short: seven days at the low end, about three weeks with extensions. And the Calls can ask for an integrated, working system. A startup that owns one piece of that system may be better positioned as a supplier or teammate to an integrator.

The SAM notice also says RFIs posted under the CSO are for market research only, and the government has no obligation to follow one with a Call.

How the Three-Phase Process Works

Phase 1: White paper and quad chart. You submit both as two separate PDFs by email to usarmy.redstone.acc.mbx.acc-rsa-advm-cso@army.mil. Use the subject line "CSO Submission – Advanced Manufacturing – [Your Company Name]". Content past the page limits will not be read.

The quad chart is one page and follows Attachment 1. Its four quadrants are:

• Objective and Description: objective, description of effort and commerciality.
• Graphic or Illustration.
• Benefits and Challenges: benefits, challenges and current maturity (TRL/MRL).
• Execution Plan: milestones, deliverables, proposed funding, period of performance and contact information.

The white paper follows Attachment 2: up to five pages, 8.5 x 11 inches, one-inch margins, single-spaced, 12-point Times New Roman. It has eight sections:

1. Project title, offeror, and area of interest or Call number
2. Executive summary
3. Description of effort, including why it is commercial in nature
4. Benefits to the Army
5. Technical challenges, with risks and mitigation
6. Rough order of magnitude cost and schedule
7. Corporate and personnel qualifications
8. Data rights

Phase 2: Oral presentation or demonstration. This happens at the government's discretion. Offerors with meritorious white papers may be invited to present or demonstrate to a panel of government subject matter experts. The government may skip Phase 2 and go directly to Phase 3.

Phase 3: Request for Solution Proposal. Offerors who are evaluated successfully may be invited to submit a full written proposal with technical, price and contractual portions. An award may follow a favorable evaluation.

The government does not pay for preparing or submitting documents or presentations in any phase.

How Submissions Are Evaluated

The government first checks compliance with the format rules in Section 4.1 and Attachments 1 and 2. A submission that fails the check may be excluded before technical review.

Submissions are evaluated on their own merit, not against each other. The factors, in descending order of importance, are:

1. Technical merit and relevance: applicability to the area of interest or Call, technical feasibility, and potential to enhance Army readiness and manufacturing capability.
2. Innovation and uniqueness: how new, underused or uniquely applied the solution is.
3. Company viability: relevant corporate experience in advanced manufacturing, industrial operations or commercializing similar technology, plus personnel qualifications and a sound business model.
4. Price and affordability.

All non-price factors combined are significantly more important than price.

After Phase 1, every submission gets one of three outcomes:

• Selected for Further Consideration: invited to the next phase.
• Retained for Future Consideration: the submission meets the criteria, and "will be retained in a repository for future consideration into the next phase once a Government need, manpower, and funding is available."
• Not Selected for Further Consideration.

The middle outcome matters most for general submissions. A strong white paper against an area of interest can sit in the repository until a depot need and funding line up.

Funding: What You Can and Cannot Expect

The CSO publishes no award ceiling or funding pool. It states, "Any award is subject to the availability of funds." The government may award some, all or none of the proposals. FY2027 began October 1 under a continuing resolution through December 11, 2026, which can slow new obligations.

The quad chart asks you to state proposed funding and a period of performance. The white paper asks for a rough order of magnitude cost and schedule. A scope the Army can fund and execute quickly is easier to move than a large multi-year program.

Depot modernization CSOs do produce real awards. In March 2026, Red River Army Depot awarded Hadrian $39.2 million, with up to $80 million in cumulative value, to establish advanced automation manufacturing at the depot. That award came through Red River's own OIB modernization CSO, not the AdvM CSO. It is not a ceiling or a typical award size, but it shows how quickly a depot can move once a need and funding align.

Data Rights

The government says it wants only the data rights it needs. Identify any data rights restrictions clearly in the proposal, and use section 8 of the white paper for a preliminary list. Negotiations follow DFARS data and software rights clauses.

How to Prepare Before the Next Call

1. Pick one problem. Choose one area of interest and one depot or field problem your technology solves. Describe it in measurable terms: throughput, turnaround time, labor hours, hazardous exposure, scrap, inspection backlog or downtime.
2. Build the package to the templates. Follow Attachments 1 and 2 exactly. The compliance check comes before technical review.
3. Submit against the general area now. Even a "Retained for Future Consideration" result puts your solution in the repository the Army draws on when a need is funded.
4. Make it reusable. Write the package so it can be tailored to a Call within 48 hours. Include the ROM, the period of performance and an implementation plan covering installation, training, cybersecurity and sustainment at a government facility.
5. Watch for Calls. Save a SAM.gov search for "AdvM Call for Solutions" and follow W9124P26SC001.
6. Decide your role early. If a likely Call needs a full system, line up the integrator or partner now.
7. Look at the depot CSOs too. See our guides to the Sierra Army Depot CSO and the Anniston Army Depot CSO.

Frequently Asked Questions

What is solicitation W9124P26SC001? The Army Advanced Manufacturing Commercial Solutions Opening, issued by ACC-Redstone for Headquarters Army Materiel Command, to acquire innovative commercial manufacturing solutions for the Organic Industrial Base and the tactical edge.

What is the deadline? The CSO itself has none. It is open in perpetuity until canceled. Each Call for Solutions has its own deadline, and recent Calls closed between seven days and about three weeks after posting.

Is there an open Call right now? No AdvM Call for Solutions was active on SAM.gov as of October 1, 2026.

What do I submit? A one-page quad chart and a white paper of up to five pages in 12-point Times New Roman, as two separate PDFs, emailed to usarmy.redstone.acc.mbx.acc-rsa-advm-cso@army.mil with the subject line "CSO Submission – Advanced Manufacturing – [Your Company Name]."

How much funding is available? No amount is published. Any award is subject to the availability of funds, and only firm-fixed-price arrangements can be awarded.

Can a startup with no government contracts apply? Yes. The CSO invites industry, academia and other nontraditional partners, and small businesses are generally nontraditional defense contractors. You need an active SAM.gov registration to receive an award.

What happens if my white paper is good but there is no funding? It can be marked "Retained for Future Consideration" and held in a repository until a government need, manpower and funding are available.

Does the government pay proposal costs? No. The government does not pay for preparation or submission in any phase.

Sources

• SAM.gov, Army Advanced Manufacturing (AdvM) CSO, W9124P26SC001, updated August 27, 2026, verified October 1, 2026: https://sam.gov/opp/7f9b0cd559494155a50c7e5af0f11bbd/view
• ACC-RSA, "Commercial Solutions Opening (CSO) Solicitation Number W9124P-26-S-C001 Amendment 1 for Advanced Manufacturing" (attachment on SAM.gov)
• SAM.gov, AdvM Call for Solutions, Expeditionary Additive Manufacturing Systems: https://sam.gov/opp/69a143cc118243b48a82fb5cfea2a3b8/view
• SAM.gov, AdvM Call for Solutions, Modernized Paint Line in SOD: https://sam.gov/opp/ab97e088933e40a5bf2289daed14d4b4/view
• SAM.gov, AdvM Call for Solutions, Automated Parts Handling for Plating in SOD: https://sam.gov/opp/64f3745e095c4cedb8d066f6da1bba33/view
• U.S. Army, "Army accelerates advanced manufacturing with contracting award at Red River," March 18, 2026: https://www.army.mil/article/291165

Get Ready Before the Next Call

AdvM Calls can close in seven days. BW&CO helps deep tech and dual-use founders pick the right area of interest, build a quad chart and white paper that follow the CSO templates, and tailor the package fast when a Call drops. We have helped clients secure more than $350 million in non-dilutive funding.

Featured image: U.S. Army photo by Mark Cleghorn. The appearance of U.S. Department of War visual information does not imply or constitute DoW endorsement.

GRA Development Grant: Executive Summary for Georgia Startups

Executive Summary

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

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

What the Development Grant Funds

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

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

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

Who Should Apply

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

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

Where It Fits in the GRA Funding Ladder

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

Why It Pairs Well With SBIR and STTR

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

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

How to Apply

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

Frequently Asked Questions

What is the GRA Development Grant?

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

Who is eligible for a GRA Development Grant?

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

What activities can a GRA Development Grant fund?

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

When are GRA Development Grant applications reviewed?

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

Does GRA take equity in exchange for a Development Grant?

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

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

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

Turn Your GRA Award Into Federal Funding

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

FAA Aviation Research BAA 692M15-25-R-00004: Executive Summary for Startups

Executive Summary

The Federal Aviation Administration (FAA) Aviation Research Broad Agency Announcement, solicitation number 692M15-25-R-00004, is a long-running open call for applied and basic research that advances aviation safety. It is sponsored by the Aviation Research Division at the William J. Hughes Technical Center for Advanced Aerospace in Atlantic City, New Jersey. White papers are accepted on a rolling basis, and the BAA remains open through December 4, 2034 unless it is terminated sooner or a topic is removed. Amendment 012, issued September 29, 2026, adds four new topics covering cybersecurity for autonomous airport ground vehicles, pilot decision-making training, nationwide pilot training data, and a pilot operational decision-making aid. There are now 15 active topics, with published project budgets ranging from about $100,000 per year to as much as $1.2 million per project.

Solicitation at a Glance

Solicitation number: 692M15-25-R-00004 (Amendment 012)

Full title: Broad Agency Announcement, Aviation Research 2025

Agency: Department of Transportation, Federal Aviation Administration, William J. Hughes Technical Center for Advanced Aerospace (Atlantic City, New Jersey)

Opportunity type: Broad Agency Announcement issued under the FAA Acquisition Management System (49 USC 106(l) and (m))

Latest amendment: Amendment 012, September 29, 2026

White papers due: Rolling, through December 4, 2034 or until a topic is removed

Response time: The FAA aims to respond within 60 calendar days of receiving a white paper

Funding: Roughly $100,000 to $1.2 million per project depending on topic; several topics set the budget based on the work proposed

Period of performance: Typically 12 to 36 months; no topic accepts efforts longer than 3 years

Award types: Purchase orders, contracts, agreements, or Other Transaction Agreements (OTAs); Firm Fixed-Price awards are preferred for initial phases

Set-aside: None. Open to industry, small businesses, universities, HBCUs, minority-serving institutions, and research organizations

NAICS code: 5417, Scientific Research and Development Services

Submission method: Email to the topic's Technical Point of Contact, with 9-ACT-AAQ-600-BAA@faa.gov copied

What Is the FAA Aviation Research Division?

The Aviation Research Division at the William J. Hughes Technical Center conducts applied research and development with industry, academia, and government to solve current and future air transportation challenges. It runs five program branches: Fire Safety, Airport Technology R&D, Software and Systems, Structures and Propulsion, and Separation Standards Analysis. Research results feed directly into FAA Advisory Circulars, certification guidance, design and evaluation software such as FAARFIELD and BAKFAA, and training material for the FAA workforce.

This BAA is the standing channel for outside organizations to bring research ideas to the FAA. It is open for ten years from December 5, 2024, and the FAA adds and removes topics through amendments. The FAA may also issue "Calls" on SAM.gov when it has a more urgent need in a specific topic area.

How This BAA Differs From SBIR and STTR

Many startups first encounter federal R&D through SBIR and STTR. This BAA works differently, and understanding the differences helps you plan.

• It is not a small business program. There is no set-aside, so startups are evaluated alongside universities, large companies, and research institutions.
• There are no phases. There is no Phase I or Phase II structure. Each topic publishes its own estimated budget and period of performance.
• It is a two-step process. You submit a white paper first. If the FAA is interested and funding is available, it requests a full proposal.
• Proposals are judged on their own merits. The FAA does not rank proposals against others in the same research area.
• Awards are often Other Transaction Agreements. The FAA has historically used OTAs for this BAA, which can offer more flexible terms than traditional contracts.

The 15 Topics of Interest: What the FAA Is Looking For

Every white paper must name the specific topic number and title it responds to. Topics marked as new were added in Amendment 012.

Airport Pavements (ARAP)

ARAP0010: Rational Overload Criteria for Airport Pavements in the ACR/PCR Method. Develop engineering-based criteria for occasional overloads on flexible and rigid pavements, drawing on full-scale test data from the National Airport Pavement Test Facility, suitable for the PCR module of FAARFIELD. Up to 3 years; ROM not to exceed $200,000 per project, per fiscal year.

ARAP0012: Engineering Analysis of Field Monitoring and Instrumentation Data. Improve pavement design, construction, and management using data from instrumented operational airports, including AI/ML, pavement instrumentation, signal processing, materials characterization, and remote data collection. Budget and duration set by proposal; multiple white papers welcome.

ARAP0013: Enhancement of Airport Pavement Layer Backcalculation Software (BAKFAA). Build faster, more accurate models for characterizing asphalt and concrete from Heavy and Falling Weight Deflectometer data, including machine learning or advanced search methods that run in real time or near real time. Up to 3 years; ROM not to exceed $200,000 per project, per fiscal year.

ARAP0014: Advancing Pavement Condition Assessment Practices for Airport Pavements. Compare emerging inspection methods with the ASTM D5340 standard on coverage, accuracy, repeatability, resource needs, and compatibility with pavement management programs. Non-proprietary approaches only. About $250,000 per project, per fiscal year; 12 to 36 months.

ARAP0015: Advancing Concrete Strength Evaluation for Airport Pavement Design and Construction. Explore alternatives or supplements to flexural beam testing, methods for estimating cracking-related properties, and continuous strength measurement for decisions such as early opening. Non-proprietary approaches only. $100,000 to $300,000 per project, per fiscal year; 12 to 36 months.

Airport Safety (ARAS)

ARAS0014: Cybersecurity Concerns with Autonomous Ground Vehicle Systems (AGVS) in the Airport Environment. (New) Applied research on identifying vulnerable system components, validating operational AGVS, preventing and detecting cyberattacks, and safely recovering from a successful attack. Covers self-driving tugs, jet bridges, baggage carts, shuttles, mowers, and perimeter inspection vehicles, plus their command and control systems and field devices. Up to 12 months.

Structures and Materials (ARSM)

ARSM0001: Structural Integrity of Metallic Components. Identify data sources, capabilities, and methods that support FAA risk assessment for metallic structures on transport category airplanes under the Monitor Safety/Analyze Data (MSAD) process in FAA Order 8110.107B. Budget and duration set by proposal.

Structures and Propulsion (ARSP)

ARSP0001: Nickel Anomaly Fatigue Testing. Low-cycle fatigue testing of premium wrought nickel alloy specimens containing subsurface melt anomalies such as "dirty white spots," with baseline testing, fractography, metallography, and a teaming plan with engine manufacturer experts. About 24 months; ROM approximately $350,000.

ARSP0002: Hydrogen Aviation Safety Research. Four research areas: hydrogen leak detection, hydrogen dispersion modeling and simulation, hydrogen risk assessment and mitigation, and integration of hydrogen-powered aircraft into the National Airspace System. Interdisciplinary teams are encouraged. Up to 36 months; ROM not to exceed $650,000 per award.

Software and Systems (ARSS)

ARSS0003: Integrated Flight and Propulsion Control for Rotorcraft. Data to support airworthiness criteria for multi-rotor, powered-lift, and eVTOL vehicles, covering stability, control bandwidth, performance, failure modes, system integration, and automation that backs up the pilot. Up to 3 years; budget set by proposal.

ARSS0008: Complex Digital Systems. Assurance and verification methods for AI/ML and autonomy in safety-critical airborne systems, including formal methods, assurance cases, explainability, diverse specifications, and large language models for classifying latent risk. Up to 3 years; ROM not to exceed $400,000 per project, per fiscal year.

ARSS0009: Future of Oversight. New concepts for performance-based and Safety Management System (SMS) based oversight, future oversight workforce needs, measures of oversight effectiveness, and lessons from other regulated industries. Up to 3 years; budget set by proposal.

ARSS0010: A Training Framework for Reducing Pilot Decision-Making Errors. (New) Academic and simulator-based training modules that expose pilots to realistic decision-making errors and teach mitigations, built for Part 121 carriers and extendable to Parts 135, 91K, and 61. About 24 months; ROM up to $910,000.

ARSS0011: Improving Airline Safety Using Nationwide Pilot Training Data. (New) A voluntary, privacy-conscious framework for collecting de-identified flight simulator training data, with standardized data structures, governance, objective performance metrics, and cross-airline benchmarking. About 36 months.

ARSS0012: Pilot Operational Decision Making Aid. (New) Research and test a structured tool that gathers information scattered across flight manuals and handbooks to support pilot decisions in complex situations, with testing on B-737 and A330 simulators. Responses that rely heavily on AI will be viewed less favorably. About 24 months; ROM up to $1.2 million.

Funding Allowance: What Startups Should Expect

Funding is set topic by topic. Some topics publish a firm ceiling, some publish an approximate figure, and some leave the budget entirely to the proposal. In practice:

• Your ROM must match the topic. The white paper's Rough Order of Magnitude cost should be consistent with any dollar value the topic lists and with the scope you propose.
• Many topics are funded annually. Several pavement and software topics cap funding per fiscal year, and continuation after each milestone is at the FAA's discretion.
• Partial awards are possible. The FAA may negotiate an award for only part of a proposal if funding is limited.
• Firm Fixed-Price is preferred for initial phases, and the FAA may change the award type during negotiation.
• Cost sharing is allowed on a cost reimbursement basis with no fee, if your accounting system can support it.

Timeline and Key Dates

December 5, 2024: BAA opened for white papers.

September 29, 2026: Amendment 012 added ARAS0014, ARSS0010, ARSS0011, and ARSS0012.

Anytime: White papers may be submitted on a rolling basis, or in response to a specific Call posted on SAM.gov.

Within about 60 days of submission: The FAA aims to respond, and may request a technical and cost proposal.

December 4, 2034: The BAA expires unless terminated sooner. Awards may still be made after expiration if the white paper was received before that date.

Because topics can be removed by amendment at any time, earlier submissions carry less risk.

How to Apply

Step 1: Contact the Contracting Officer

The FAA strongly encourages applicants to email 9-ACT-AAQ-600-BAA@faa.gov with "Question for the CO" in the subject line before writing, to confirm interest in the proposed effort and whether funding is available. Technical questions go to the topic's Technical Point of Contact (TPOC), and discussions with the TPOC about your white paper are permitted.

Step 2: Submit a White Paper

A white paper is required before any proposal. Offerors who submit a proposal without first submitting a white paper may not be eligible for award.

• Maximum of 5 pages, single sided, single spaced, Times New Roman 12 point, in Word or PDF
• The ROM cost estimate does not count toward the 5 pages
• State the topic number and title in the document and in the email subject line
• Email to the topic TPOC with 9-ACT-AAQ-600-BAA@faa.gov on the cc line

Each white paper must cover the purpose of the research, the research method and how its validity will be demonstrated, the expertise of each team member and any aviation industry partners or endorsements, the current state of development, a proposed timeline, testing and evaluation procedures, and a good faith ROM cost including any fee.

Step 3: Submit a Full Proposal (By Invitation)

If invited, you will receive a Request for Proposal with specific instructions. Proposals are submitted as three separate files, sent only to 9-ACT-AAQ-600-BAA@faa.gov without copying the TPOC:

• Cover letter on company letterhead with the topic, UEI, business type, place and period of performance, estimated cost, proposed award type, and an authorized signature
• Volume I, Technical: up to 25 pages covering background, objectives, feasibility, methodology, technical uncertainties, program management, key personnel resumes (up to 3 pages each, not counted), conflicts of interest, subcontracting, past performance, and intellectual property
• Volume II, Price/Cost: up to 10 pages with costs broken down by task and cost element, plus a funding profile

Proposals should remain valid for at least 180 days.

How Proposals Are Evaluated

Proposals go through peer review and technical feasibility assessment. They are judged on their own merit and relevance, not ranked against other proposals in the same area. The FAA considers:

• Scientific and technical merit: The overall quality and soundness of the proposed research.
• Mission relevance: Potential contribution to the FAA Aviation Research mission.
• Team competency: The experience and capability of the people doing the work.
• Project plan: An effective plan for completing the project.
• Risk: Technical and implementation risk.

Cost is not scored, but the FAA analyzes it for completeness, reasonableness, realism, magnitude, and affordability, including the cost impact of any intellectual property restrictions you assert.

Registration Requirements

Offerors cannot receive an award without an active SAM.gov registration, and Certifications and Representations must be completed there. The cover letter also requires your SAM Unique Entity ID. Registration can take several weeks, so startups without an active registration should begin now. Foreign-owned companies must submit disclosure information for an eligibility review.

A Note on Intellectual Property

Proposals must include a representation of ownership or licensing rights for all intellectual property used, and a list of any technical data or software to be delivered with restricted rights. If you do not submit that list, the FAA assumes it has unlimited rights. Awardees must deliver all technical data and software developed under the award, including source code. Startups should decide early what they will protect and mark it correctly.

Is This BAA a Good Fit for Your Startup?

This BAA tends to fit startups and research teams with a clear technical approach to a real FAA safety or certification problem. Strong candidates include companies working on:

• Airport pavement engineering, sensors, instrumentation, and materials testing
• Cybersecurity for autonomous vehicles and connected ground systems
• Hydrogen sensors, fuel systems, dispersion modeling, and hydrogen infrastructure
• Advanced air mobility, eVTOL, and powered-lift flight controls
• AI/ML assurance, formal methods, and safety-critical software
• Aviation human factors, pilot training, flight simulation, and safety data analytics
• Aerospace metallurgy, fatigue testing, and structural integrity

It is a weaker fit for companies whose main goal is validating a proprietary product, since several topics exclude that, and for companies that need a large, guaranteed award on a fixed timeline.

Strategic Tips for Startup Applicants

• Ask the Contracting Officer first. A short inquiry about interest and funding can save weeks of effort on a topic with no budget.
• Mirror the topic language. Use the topic's terminology and connect your work to the specific FAA guidance, software, or standard it is meant to improve.
• Lead with quality, not length. The FAA states that quality matters far more than quantity, and weak white papers may be declined without further review.
• Show industry support. White papers must describe aviation industry interest, endorsements, or partners, so line up letters or teaming partners early.
• Keep the ROM realistic. Match the topic's published range and tie costs to tasks and milestones.
• Watch for new Calls and amendments. Topics are added and removed regularly, and Calls can signal urgent FAA priorities.

Frequently Asked Questions

What is the FAA Aviation Research BAA 2025?

It is the FAA's Broad Agency Announcement 692M15-25-R-00004, an open call from the William J. Hughes Technical Center for applied and basic research that advances aviation safety across airport pavements, airport safety, structures and materials, propulsion, hydrogen safety, and software and systems.

What is the deadline for the FAA Aviation Research BAA?

White papers are accepted on a rolling basis. The BAA is open through December 4, 2034, unless it is terminated sooner or a specific topic is removed by amendment.

How much funding is available?

Funding varies by topic. Published estimates range from about $100,000 per project per fiscal year for pavement topics to as much as $1.2 million per project for the Pilot Operational Decision Making Aid topic. Several topics set the budget based on the work proposed.

What topics were added in Amendment 012?

Amendment 012, issued September 29, 2026, added ARAS0014 Cybersecurity Concerns with Autonomous Ground Vehicle Systems in the Airport Environment, ARSS0010 A Training Framework for Reducing Pilot Decision-Making Errors, ARSS0011 Improving Airline Safety Using Nationwide Pilot Training Data, and ARSS0012 Pilot Operational Decision Making Aid.

Can startups and small businesses apply?

Yes. The BAA has no set-aside and is open to industry, small businesses, small disadvantaged businesses, universities, HBCUs, minority-serving institutions, and research organizations. Teaming arrangements are welcome.

Is the FAA Aviation Research BAA an SBIR or STTR program?

No. It is a Broad Agency Announcement issued under the FAA Acquisition Management System. It has no phase structure and no small business eligibility requirement, and awards are often made as Other Transaction Agreements.

How long can a white paper be?

White papers may not exceed 5 pages, single sided, single spaced, in Times New Roman 12 point font. The Rough Order of Magnitude cost estimate does not count toward the page limit.

How do I submit a white paper?

Email the white paper to the Technical Point of Contact listed for your topic and copy 9-ACT-AAQ-600-BAA@faa.gov, with the topic number and title in the subject line. The FAA recommends first emailing the same mailbox with "Question for the CO" in the subject line to confirm interest and funding.

How long does it take to hear back?

The FAA aims to respond within 60 calendar days of receiving a white paper, but may take longer. It may respond by requesting a technical and cost proposal.

How are proposals evaluated?

Proposals are peer reviewed on scientific and technical merit, relevance to the FAA Aviation Research mission, team competency and experience, the project completion plan, and technical and implementation risk. Cost is analyzed for reasonableness and affordability rather than scored.

What type of award will the FAA make?

Awards may be purchase orders, contracts, agreements, or Other Transaction Agreements. The FAA has historically used Other Transaction Agreements for this BAA and prefers Firm Fixed-Price awards for initial research phases.

What registrations are required?

You must have an active SAM.gov registration with completed Certifications and Representations to receive an award, and your SAM Unique Entity ID is required in the proposal cover letter.

Get Help With Your FAA White Paper

BW&CO helps deep-tech, aerospace, and dual-use startups pick the right FAA topic, frame the Contracting Officer inquiry, write focused five-page white papers, and build compliant technical and cost proposals, including intellectual property assertions and OTA terms. With more than $350M in non-dilutive funding secured for our clients, we make innovation funding simple.

With rolling submissions and topics that can be removed at any time, the best time to start is now. Book a free strategy call to see if your technology fits.

NIH Highlighted Topic: Improving Diagnostic Safety and Quality in Healthcare

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

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

Eligible activities may include:

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

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

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

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

• Telehealth and digital health diagnostic solutions

• Clinical validation studies using real-world data

• Regulatory strategy, commercialization planning, and market validation

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

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

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have 500 or fewer employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

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

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: Microphysiological System Pilot Studies in Diabetes Research

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

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

Eligible activities may include:

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

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

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

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

• Models of diabetic kidney disease and urologic complications

• Standardization, reproducibility, and validation studies against human data

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

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

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

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have 500 or fewer employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

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

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

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

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

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

Eligible activities may include:

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

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

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

• Interoperable, modular digital twin architectures and reusable software platforms

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

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

• Commercialization planning, regulatory strategy, and market validation

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

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

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have 500 or fewer employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

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

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: Advanced Biomaterials for Biomedical Research

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

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research on advanced biomaterials that overcome a core limitation of today's research tools: traditional biomaterials fail to recapitulate the tissue complexity, heterogeneity, and dynamic change seen in living systems. This highlighted topic seeks new materials that let material scientists and biomedical researchers work together to solve fundamental biological problems.

NIH is particularly interested in biomaterials that enable dynamic physical properties, detect and respond to tissue-specific changes, behave in robust and predictable ways, and improve reproducibility in disease models. Multidisciplinary teams that combine materials scientists, physical scientists, bioengineers, and biomedical researchers are strongly encouraged.

Areas of interest include responsive and programmable biomaterials (pH, thermal, light, electrostatic, and stiffness responsive), functionalized materials that model the transition from normal tissue to tumor microenvironment, biomaterials that modulate immune, nerve, vascular, or lymphatic components, and approaches that pair material science with synthetic biology to study cancer.

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

This highlighted topic is supported by the National Cancer Institute (NCI) and the National Institute of Dental and Craniofacial Research (NIDCR). NIDCR notes it may give special consideration to meritorious applications in this area. The topic is active from September 9, 2026 through September 9, 2028.

How much funding would I receive?

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

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of advanced biomaterials, engineered tissue models, and enabling research tools that more faithfully reproduce living tissue.

Eligible activities may include:

• Stimuli-responsive and programmable hydrogels, scaffolds, and matrices

• Materials with tunable stiffness, porosity, and degradation for disease modeling

• Engineered tumor microenvironment models for cancer research and drug testing

• Biomaterials that incorporate immune, vascular, lymphatic, or nerve components

• Material platforms combined with synthetic biology and engineered cells

• Embedded sensing materials that detect and report tissue-specific changes

• Dental, oral, and craniofacial biomaterials and tissue models

• Standardized, reproducible biomaterial kits for research laboratories

• Scale-up and manufacturing process development for research-grade materials

• Characterization, quality control, and validation studies

• Prototype development and usability testing with research end users

• Commercialization planning and market validation

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

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

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have 500 or fewer employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

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

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NAVFAC EXWC Broad Agency Announcement N39430-26-S-5000: Executive Summary for Startups

Executive Summary

The Naval Facilities Engineering and Expeditionary Warfare Center (NAVFAC EXWC) Command Wide Broad Agency Announcement, solicitation number N39430-26-S-5000, is an open, year-long U.S. Navy solicitation for research, development, testing, and evaluation (RDT&E) across 13 technology topic areas, from expeditionary construction and shore energy to control systems cybersecurity and living marine resources. Abstracts are accepted on a rolling basis until June 14, 2027 at 4:00 PM PDT. There is no small business set-aside, no published funding ceiling, and no funding reserved in advance. Startups, small businesses, large businesses, universities, FFRDCs, UARCs, and nonprofits can all submit. Technologies must fall within applied research (6.2), advanced technology development (6.3), or advanced component development and prototypes (6.4).

Solicitation at a Glance

• Solicitation number: N39430-26-S-5000

• Full title: Command Wide Broad Agency Announcement for Naval Facilities Engineering and Expeditionary Warfare Center (NAVFAC EXWC) Research, Development, Testing, and Evaluation

• Agency: Department of Defense, Department of the Navy, NAVFAC, Expeditionary Warfare Center (Port Hueneme, California)

• Opportunity type: Broad Agency Announcement issued under FAR 6.102(d)(2) and FAR 35.016

• Published: June 15, 2026

• Abstracts due: June 14, 2027 at 4:00 PM PDT

• Review cadence: Technical Evaluation Boards meet approximately every 3 months

• Set-aside: None. Open to all organization types

• Research categories accepted: 6.2 applied research, 6.3 advanced technology development, 6.4 advanced component development and prototypes

• Funding: No ceiling published and no funding reserved in advance

• NAICS code: 5417, Scientific Research and Development Services

• Submission method: Email to both points of contact

• Points of contact: Nicole Mendes (nicole.m.mendes2.civ@us.navy.mil, 805-895-5260) and Katelyn Rydberg (katelyn.t.rydberg.civ@us.navy.mil, 805-895-5299)

What Is NAVFAC EXWC?

NAVFAC EXWC is the Navy's RDT&E center for specialized facility, ocean system, and expeditionary solutions that support the warfighter. Its work covers the full range of Navy infrastructure: advanced bases built in contested environments, ship-to-shore logistics, piers and dry docks, undersea cable and sensor infrastructure, shore energy, installation environmental compliance, and the science that keeps Navy at-sea training and testing in compliance with marine species protection laws.

This Command Wide BAA is the front door for outside organizations that want to bring a technology or methodology to NAVFAC EXWC. It is open for one year and is re-advertised annually, so it functions as a standing channel rather than a single competition.

How This BAA Differs From SBIR and STTR

Many startups first encounter the Department of Defense through SBIR and STTR. This BAA works differently, and understanding the differences helps you plan.

• It is not a small business program. There is no set-aside, so startups are evaluated alongside universities, large primes, FFRDCs, UARCs, and nonprofits.

• There are no phases. There is no Phase I or Phase II structure and no fixed award size. Your project scope and cost estimate define the ask.

• It is a two-step process. You submit an abstract first. If the Navy is interested, it requests a detailed proposal.

• Abstracts are judged on their own merits. They are not ranked against each other, so a strong abstract is not competing for a fixed number of slots.

• Funding is sought after acceptance. Because no money is reserved in advance, NAVFAC EXWC shares qualified abstracts with other federal activities to find test sites and funding sponsors.

Funding Allowance: What Startups Should Expect

The solicitation does not publish an award ceiling, an award floor, an anticipated number of awards, or a total program budget. It states plainly that no funding has been reserved in advance and that the Navy makes no commitment to issue any award or to cover any costs incurred before an award.

In practice, this means:

• Your budget is proposal-driven. You estimate what it takes to execute the project to completion, and the Navy evaluates whether that cost is appropriate relative to the technical approach.

• Accepted abstracts can reach multiple sponsors. NAVFAC EXWC shares qualified abstracts with other federal government activities to seek sites and funding, which can expand the pool of potential buyers for your technology.

• Cost realism is an evaluation criterion. The project plan, including cost, schedule, and execution plan, is scored relative to the technical approach. Oversized or thinly justified budgets weaken an abstract.

• Topic 11 has specific cost rules. Living Marine Resources abstracts must include a cost estimate broken out by calendar year, project management costs, and annual travel for the Principal Investigator to the LMR In-Progress Review in Santa Barbara, California. Details appear in the Topic 11 section below.

Timeline and Key Dates

• June 15, 2026: BAA published on SAM.gov and opened for abstracts.

• Ongoing, approximately every 3 months: Technical Evaluation Boards review submitted abstracts.

• Within about 3 months of your submission: If the Navy wants a detailed proposal, you will be notified. If you have not heard back within 3 months, the solicitation instructs you to assume non-selection.

• One year from your submission date: Your abstract remains valid for consideration, even if it was not selected in its first review cycle.

• June 14, 2027 at 4:00 PM PDT: Final deadline for abstracts under this BAA.

• June 29, 2027: The notice becomes inactive on SAM.gov.

• Annually: NAVFAC EXWC re-advertises the BAA, so organizations that miss this cycle can expect a future window.

• Each fall, for funded Topic 11 projects: The Principal Investigator attends the 3-day LMR In-Progress Review in Santa Barbara, California.

Because review happens on a rolling basis, earlier submissions get more chances. An abstract submitted early in the cycle can be reviewed by a board, remain valid for a year, and still be shared with other federal activities looking for solutions.

Technology Maturity Requirements

To be eligible, your technology or methodology must fall within one of three Department of Defense RDT&E budget activities:

• 6.2 Applied Research: Work that translates promising scientific findings into solutions for defined military needs, typically ending with a proof of concept or early laboratory demonstration.

• 6.3 Advanced Technology Development: Work that develops and integrates subsystems and components into prototypes, with demonstrations in relevant or simulated operational environments.

• 6.4 Advanced Component Development and Prototypes: Work that evaluates integrated technologies and prototypes in realistic operating environments to prepare for transition.

Basic research (6.1) is outside the scope of this BAA. For Topic 11, if your project contains basic research elements, the guide asks you to clearly separate the basic and applied portions and to provide evidence, including references, that the approach is mature enough for applied research funding.

The 13 Topic Areas: What NAVFAC EXWC Is Looking For

Every abstract must address at least one of the following topic areas and advance Naval capabilities.

Topic 1: Expeditionary Construction, Battle Damage Repair, and Advanced Naval Base Construction Technologies

Technologies for rapidly building, repairing, and developing infrastructure in austere, contested, or damaged environments. Interests include lightweight, multi-functional equipment for diverse terrain; advanced construction and repair materials; automated and robotic construction systems; site and damage assessment tools; modular and scalable structures; site preparation and soil stabilization; and mobile, self-sufficient solutions with a minimal logistics footprint.

Topic 2: Logistics Over the Shore Technologies

Technologies that move personnel, equipment, and supplies from ship to shore where port infrastructure is limited or unavailable. Interests include amphibious connector craft and lighterage, modular and rapidly deployable causeways and piers, automated cargo handling that reduces beach time and increases throughput, mobile fuel and water distribution, all-terrain material handling equipment, and real-time cargo tracking and visibility.

Topic 3: Waterfront Facilities and Systems

Technologies that sustain waterfront facilities in harsh marine environments, including cathodic protection, corrosion and weathering, metallurgy, concrete and pavements, and paints and coatings. Special interests include resilience of dry docks and harbor facilities to extreme weather; improved inspection of piers, wharves, water and fuel tanks, dams, and bridges; marine and offshore structures; fleet moorings; passive waterfront barriers; and underwater and waterfront construction tools and methods.

Topic 4: Undersea Facilities and Systems

Technologies for engineering, installing, and maintaining ocean and littoral underwater systems and magnetic silencing facilities. Interests include physical and numerical modeling, survey and route planning, installation and repair methods for fleet ranges, undersea surveillance and tactical communication facilities, undersea power infrastructure, and geotechnical engineering for seafloor interactions and heavy load handling of shipboard cabled sensor systems.

Topic 5: Shore Facilities, Equipment, and Systems

Technologies across the full lifecycle of Naval shore infrastructure, from planning and design through construction, operations, maintenance, repair, and disposal. Examples include advanced survey and design tools, industrialized and alternative construction methods, corrosion control, concrete and pavement materials, materials chemistry and testing, roofing, structural modeling, improvements to the safety and resilience of petroleum, oils, and lubricants infrastructure, and research that closes knowledge gaps in blast effects on structures.

Topic 6: Facilities Inspections

Technologies that advance inspection of Naval facilities, including unique high value facility inspections, interpretation of inspection data, and projection of how facility condition affects mission.

Topic 7: Shore Energy Technology

Technologies that improve energy security, efficiency, reliability, and resilience at Naval shore installations. Program expertise includes microgrid control systems, critical power applications, geothermal exploration and systems management, distributed energy resources, and alternatively fueled vehicles and supporting infrastructure.

Topic 8: Facilities Related Control Systems Cybersecurity and Cyber Warfare

Technologies that secure facilities infrastructure controls and expeditionary systems, spanning both Information Technology (IT) and Operational Technology (OT), to mitigate cyber threats and resolve cybersecurity incidents.

Topic 9: Installation Restoration, Munitions Response, and Groundwater Management

Technologies and methodologies that return military lands to use and reduce risk to human health. This includes assessing, managing, and remediating past releases of hazardous chemicals, munitions and explosives of concern, material potentially presenting an explosive hazard, and chemicals of emerging concern in soil, sediment, surface water, groundwater, and subsurface vapor. It also covers waste containment, remedy reliability, hydrogeologic investigation, and aquifer management for installation groundwater resources.

Topic 10: Installation Compliance and Water Resource Management

Technologies that help shore and marine operations meet regulatory requirements while lowering environmental risk and cost. Focus areas include drinking water, stormwater, wastewater, air quality, oil spill response, hazardous and solid waste, and water resource management covering supply, usage, infrastructure, and delivery systems at installations.

Topic 11: Living Marine Resources

Information and technology solutions that support the Navy's at-sea compliance and permitting for legally protected marine species. Focus areas include data to support the Navy Acoustic Effects Model (NAEMO), data processing and analysis tools, monitoring and mitigation technology demonstrations, and standards and metrics development. Topic 11 has its own abstract submission guide, covered in detail below.

Topic 12: Marine Energy Development

Technologies for generating, storing, managing, and distributing energy in the marine environment, both surface and undersea, to power persistent surveillance, autonomous vehicle recharging, communications nodes, and other applications where conventional power delivery is unavailable or limited.

Topic 13: Physical Security, Locks, and Barriers

Physical security and asset tracking for large facilities and expeditionary missions. Interests include lightweight, forced entry resistant security containers; finite element and physical modeling to validate security systems against mechanical, energetic, and ballistic threats; tamper detection for inventory and intermodal transit; personnel and force protection technologies; unmanned and remotely manned systems for perimeter defense and situational awareness; and integration of emerging technologies to multiply the effectiveness of security operations.

Topic 11 Deep Dive: Living Marine Resources Program

The Living Marine Resources (LMR) program is an applied RDT&E program with one core mission: protecting the Navy's ability to conduct uninterrupted at-sea training and testing. The Navy must hold permits and demonstrate compliance with marine species protection laws to train and test at sea. Without that compliance, training and testing can be interrupted, and without training and testing, readiness suffers. LMR funds Navy driven research that strengthens the science behind those permits.

LMR Investment Areas

The LMR program makes its primary investments in five areas:

• Data to Support Risk Threshold Criteria: Research that informs how the Navy estimates the effects of sound and other activities on marine species, including data that feeds the Navy Acoustic Effects Model (NAEMO).

• Data Processing and Analysis Tools: Software, algorithms, and analytical methods that turn large monitoring datasets into usable results.

• Monitoring Technology Demonstrations: Field demonstrations of sensors, platforms, and systems for monitoring and mitigating effects on protected species.

• Standards and Metrics: Development of standards, methods, and metrics that make data comparable, defensible, and repeatable.

• Emergent Topics: New needs that arise as Navy compliance requirements evolve.

Check the LMR Proposals Page First

Before submitting under Topic 11, visit the LMR program Proposals page at https://exwc.navfac.navy.mil/Products-and-Services/Environmental-Security/LMR/Proposals/ to check for specific need topics. The LMR guide describes an abstract as a response to a specific need topic, and it notes that the program accepts abstracts only during an open season specified on the BAA. If a need topic is posted, align your abstract directly to it. If none is posted, contact the BAA points of contact to confirm how the program will consider unsolicited Topic 11 abstracts before investing in a full submission. The LMR website also lists current and completed projects, publications, newsletters, and annual reports, which are the best available evidence of what the program has funded before.

Topic 11 Format Rules

• No specific template is required.

• Submit a single consolidated PDF file.

• The abstract may not exceed 10 pages.

• One-page CVs for the Principal Investigator and each key team member are required and do not count toward the 10-page limit.

Required First Page Information for Topic 11

• Submittal date

• Contact information: Name, address, phone, and email for both a technical point of contact and a contracting point of contact

• Organization information: Organization type (large business, small business, academia, FFRDC, UARC, or nonprofit), name and address, SAM Unique Entity Identifier (UEI), and CAGE code

• Solicitation number: N39430-26-S-5000

• Topic number and name: TOPIC 11: Living Marine Resources

• Project title

• Cost estimate by calendar year: A summary of total project costs to completion, broken out by calendar year

Required Project Management Costs for Topic 11

Project management must appear in the abstract, either within technical tasks or as its own task. Required project management activities include:

• Developing a project fact sheet

• Submitting quarterly status reports

• Managing budget and invoicing

• Presenting progress at the LMR In-Progress Review each year

• Writing a 1 to 2 page summary of the effort each year for the LMR annual report

Budgets must include a trip each fall for the Principal Investigator to attend the 3-day In-Progress Review (IPR) in Santa Barbara, California. The PI must attend all three days. No more than two people from the entire project team, including subcontractors, may attend. Teams with an existing LMR project that already covers IPR travel should not include those costs again.

Required Content for the Remaining Pages of a Topic 11 Abstract

• Technical approach: Describe the project and background, state clearly how it addresses the need topic, discuss any demonstration and validation phase, show evidence of maturity for applied research funding, define performance criteria for success, note any leveraged funding from other programs, identify limitations and technical risks, and break the approach into distinct tasks with deliverables.

• Offeror's related experience: Evidence that your organization has experience directly related to the proposed solution.

• Principal Investigator and key team member experience: A summary listing each person's name, highest degree, organization or affiliation, location, and years of experience, plus a one-page CV for each person.

• Project benefits: Expected benefits to the Navy, the key need topic issues addressed, potential applications of the results, and advantages over current technologies, methods, or costs.

• Schedule and milestones: Overall start and completion dates and a detailed breakdown of tasks, development stages, field tests or studies, deliverables, and publications with proposed dates.

• Product implementation: Three required elements. First, products and deliverables. Second, implementation requirements, including the intended end user (such as the Navy marine species monitoring program, the Navy environmental compliance community working under MMPA, ESA, and NEPA, or the broader scientific community), the transition method, how implementation differs across Navy, regulatory, and scientific audiences, any restrictions such as permits, patents, or proprietary data, and any proposed guidance documentation. Third, technical risks to successful implementation.

How Abstracts Are Evaluated

A peer review board evaluates each abstract on its own merits. Abstracts that meet all evaluation criteria are accepted into the BAA program. The four criteria are:

• Scientific and technical merit: The merits and objectives of the proposed work.

• Offeror qualifications: Your team's capabilities, related experience, techniques, or unique combination of these that are integral to achieving the objectives.

• Project plan: Cost, schedule, and execution plan relative to the technical approach.

• Topical alignment: Fit with current command priorities and availability of resources to pursue the work.

The fourth criterion matters more than many applicants realize. A technically excellent abstract can still be passed over if it does not match what the command is prioritizing right now, which is why reading the topic language closely and checking program pages for current needs pays off.

How to Submit

• Topics 1 through 10, 12, and 13: Use the BAA Abstract Submittal Form provided as Attachment 1 to the solicitation on SAM.gov.

• Topic 11: Follow the Topic 11 LMR Abstract Submission Guide. No template is required, but every required element in the guide must be included in a single PDF of no more than 10 pages, plus CVs.

• Delivery: Email your abstract to both nicole.m.mendes2.civ@us.navy.mil and katelyn.t.rydberg.civ@us.navy.mil before the deadline.

• Questions: Direct questions about the BAA to the same two points of contact.

Registration Requirements

No award will be made to any organization that is not registered, or in the process of registering, in the System for Award Management (SAM.gov). Registration provides your Unique Entity Identifier (UEI), and Topic 11 abstracts also require a CAGE code on the first page. SAM registration can take several weeks, so startups without an active registration should begin immediately rather than waiting until an abstract is selected.

A Note on Sensitive Information

Because NAVFAC EXWC shares qualified abstracts with other federal activities to find sites and funding, and some of those activities use civilian support contractors to evaluate technologies, the solicitation advises offerors not to submit information that would be sensitive to review by those personnel. Startups should write abstracts that demonstrate technical credibility without disclosing trade secrets, and should be deliberate about which details are held back for a detailed proposal.

Is This BAA a Good Fit for Your Startup?

This BAA tends to fit startups that have moved past pure discovery and can show a working concept, prototype, or field-ready method tied to a real Navy infrastructure or compliance problem. Strong candidates include companies working on:

• Robotic, automated, or additive construction and rapid repair materials for austere sites

• Corrosion control, coatings, advanced concrete, and structural health monitoring for marine infrastructure

• Inspection technologies such as drones, underwater robotics, and AI driven inspection data analysis

• Undersea cable installation, seafloor geotechnics, and undersea power systems

• Microgrids, distributed energy, geothermal systems, and marine energy harvesting

• Operational technology and industrial control system cybersecurity

• Environmental remediation, groundwater characterization, and water treatment

• Passive acoustic monitoring, marine species detection and classification tools, and at-sea monitoring platforms

• Tamper detection, asset tracking, forced entry resistant containers, and perimeter security

It is a weaker fit for companies still doing fundamental research, companies whose technology has no clear Navy facility, expeditionary, or compliance application, and companies that need a guaranteed, fixed award amount on a predictable timeline.

Strategic Tips for Startup Applicants

• Mirror the topic language. Reviewers score topical alignment directly. Name the specific topic, use its terminology, and connect your technology to the capability gap it describes.

• Prove maturity. Show where your technology sits within 6.2, 6.3, or 6.4, and back it up with data, prior demonstrations, or publications.

• Build a credible, task-based budget. Tie every cost to a task and deliverable. For Topic 11, include calendar year breakouts, project management, and IPR travel.

• Name the end user and the transition path. Explain who in the Navy uses the result and how it gets to them, whether through a publication, software tool, method, or fielded system.

• Submit early. Boards meet about every 3 months and abstracts stay valid for a year, so early submissions get more review opportunities.

• Use this BAA alongside SBIR and STTR. A NAVFAC EXWC abstract can open conversations with Navy stakeholders that support SBIR and STTR topic development, Phase III transitions, and other non-dilutive pathways.

Frequently Asked Questions

What is NAVFAC EXWC BAA N39430-26-S-5000?

It is the Command Wide Broad Agency Announcement for the Naval Facilities Engineering and Expeditionary Warfare Center, a year-long U.S. Navy solicitation that accepts abstracts for research, development, testing, and evaluation across 13 topic areas covering facilities, expeditionary, ocean, energy, cybersecurity, environmental, marine species, and physical security technologies.

When is the deadline for the NAVFAC EXWC BAA?

Abstracts are due by June 14, 2027 at 4:00 PM PDT. The BAA opened June 15, 2026 and accepts abstracts on a rolling basis, with Technical Evaluation Boards meeting approximately every 3 months.

How much funding is available under the NAVFAC EXWC BAA?

The solicitation does not publish a funding ceiling, award floor, or number of awards, and no funding has been reserved in advance. Award size depends on the scope and cost estimate in your proposal. NAVFAC EXWC shares qualified abstracts with other federal government activities to seek sites and funding.

Can startups and small businesses apply?

Yes. The BAA has no set-aside and is open to small businesses, large businesses, academic institutions, FFRDCs, UARCs, and nonprofit organizations. Startups compete on the merits of their abstract rather than in a small business only pool.

Is the NAVFAC EXWC BAA an SBIR or STTR program?

No. It is a Broad Agency Announcement issued under FAR 6.102(d)(2) and FAR 35.016. It has no phase structure, no small business eligibility requirement, and no fixed award amount. It can complement SBIR and STTR strategies by building relationships with Navy stakeholders.

What technology readiness level is required?

The technology or methodology must be in applied research (6.2), advanced technology development (6.3), or advanced component development and prototypes (6.4). Basic research is outside the scope. Topic 11 applicants with basic research elements must clearly separate basic and applied work.

What topics does the NAVFAC EXWC BAA cover?

There are 13 topics: expeditionary construction and battle damage repair, logistics over the shore, waterfront facilities, undersea facilities, shore facilities and equipment, facilities inspections, shore energy, facilities control systems cybersecurity, installation restoration and groundwater management, installation compliance and water resources, living marine resources, marine energy development, and physical security, locks, and barriers.

What is Topic 11 Living Marine Resources looking for?

Topic 11 funds information and technology solutions that support the Navy's at-sea compliance and permitting for legally protected marine species. Its investment areas are data to support risk threshold criteria including the Navy Acoustic Effects Model (NAEMO), data processing and analysis tools, monitoring technology demonstrations, standards and metrics, and emergent topics.

How long can a Topic 11 abstract be?

A Topic 11 abstract must be a single PDF of no more than 10 pages. No template is required. One-page CVs for the Principal Investigator and key team members are required and do not count toward the page limit.

What costs must a Topic 11 budget include?

Topic 11 budgets must be broken out by calendar year and include project management, covering a project fact sheet, quarterly status reports, budget and invoicing management, an annual In-Progress Review presentation, and a 1 to 2 page annual summary. Budgets must also include annual travel for the Principal Investigator to the 3-day fall In-Progress Review in Santa Barbara, California.

How do I submit an abstract?

Email your abstract to both nicole.m.mendes2.civ@us.navy.mil and katelyn.t.rydberg.civ@us.navy.mil. Topics 1 through 10, 12, and 13 use the BAA Abstract Submittal Form attached to the solicitation. Topic 11 follows the LMR Abstract Submission Guide.

How are abstracts evaluated?

A peer review board evaluates each abstract on its own merits against four criteria: scientific and technical merit, offeror qualifications and related experience, the project plan including cost and schedule, and topical alignment with current command priorities and available resources.

How long does it take to hear back?

If the Navy wants a detailed proposal, it will notify you, typically within about 3 months of submission. If you have not been notified within 3 months, the solicitation says to assume non-selection. Abstracts remain valid for one year from submission.

What registrations are required?

You must be registered, or in the process of registering, in SAM.gov to receive an award, which provides your Unique Entity Identifier (UEI). Topic 11 abstracts also require a CAGE code on the first page.

Will my abstract be kept confidential?

Not entirely. NAVFAC EXWC shares qualified abstracts with other federal government activities to seek sites and funding, and some of those activities use civilian contractors to evaluate technologies. The solicitation advises against submitting information that would be sensitive to review by those personnel.

What happens after an abstract is accepted?

Abstracts that meet all evaluation criteria are accepted into the BAA program. The Navy may then request a detailed proposal. Because funding is not reserved in advance, accepted abstracts may also be shared with other federal activities that could sponsor or host the work.

Get Help With Your NAVFAC EXWC Abstract

BW&CO helps deep-tech, defense-adjacent, and dual-use startups identify the right Navy topic, position their technology for 6.2 through 6.4 funding, build credible task-based budgets, and write abstracts that align with command priorities. With more than $350M in non-dilutive funding secured for our clients, we make innovation funding simple.

EPA SBIR 2026 Phase I Solicitation: Complete Guide for Startups

Status: Open. Proposals due November 8, 2026, 11:59 p.m. Eastern via FedConnect. About 25 Phase I awards of up to $100,000.

Book a Free Fit Call

Executive Summary

The U.S. Environmental Protection Agency (EPA) opened its 2026 Small Business Innovation Research (SBIR) Phase I solicitation (68HERW26R0102) on September 24, 2026. Proposals are due November 8, 2026, at 11:59 p.m. Eastern through FedConnect. EPA expects about 25 Phase I awards, which are firm fixed price contracts of up to $100,000 for a six month proof of concept, followed by Phase II awards of up to $400,000 over two years and an additional commercialization option of up to $100,000. Proposals must respond directly to one of EPA's ten published 2026 topics and are submitted through FedConnect, not Grants.gov.

EPA SBIR 2026 Phase I at a Glance

• Agency: U.S. Environmental Protection Agency, SBIR Program

• Solicitation: 68HERW26R0102, issued September 24, 2026

• November 8, 2026, 11:59 p.m. Eastern: November 8, 2026, 11:59 p.m. Eastern. Proposals go through the FedConnect response function, not FedConnect messages.

• Award instrument: contract, not a grant. This is a critical distinction that changes your registration setup and your reporting obligations.

• Phase I award: up to $100,000, including profit, for up to six months, as a firm fixed price contract. EPA expects about 25 awards. Technical and business assistance (TABA) of up to $6,500 is available in addition to the $100,000.

• Phase II award: up to $400,000 over two years, available only to companies that have completed an EPA Phase I

• Commercialization option: up to an additional $100,000 in Phase II for companies that secure third party investment

• Submission portal: FedConnect. Each company may submit one proposal, as a single PDF of no more than 36 pages.

• Topic count: 10 topics across 4 environmental focus areas

• Equity given up: none. SBIR is non dilutive funding.

What Is the EPA SBIR Program?

The EPA SBIR program funds U.S. small businesses developing commercially viable technologies that solve environmental problems within EPA's mission. EPA is one of eleven federal agencies participating in the SBIR program, and it runs a single annual Phase I solicitation.

Two features make EPA different from the larger SBIR agencies such as NIH, NSF, and the Department of Defense. First, EPA awards contracts rather than grants, which means your SAM.gov registration must be configured to accept contract awards and your proposal is evaluated as an offer under federal acquisition rules. Second, EPA runs a modest budget relative to other SBIR agencies, so responsiveness to the specific published topic is decisive. A brilliant environmental technology that does not map cleanly onto one of the eleven 2026 topics will not be competitive, no matter how strong the science is.

If your technology addresses PFAS, water reuse, air monitoring, food waste, critical minerals, battery recycling, safer chemicals, or lead detection, this solicitation deserves a serious look.

2026 EPA SBIR Phase I Topics: What EPA Is Actually Looking For

EPA published ten topics across four focus areas for the 2026 Phase I cycle. Topic areas change every year, so prior year topic language should not be reused. Below is an overview of each topic and the problem space behind it. The binding technical requirements, including any performance thresholds, exclusions, and deliverable expectations, live in the solicitation document itself, so read the topic text in full before writing.

Focus Area 1: Clean and Safe Water

Topic 1A: Monitoring Technologies for Water Reuse. Water reuse systems, whether municipal, industrial, agricultural, or onsite, need real time or near real time assurance that treated water is safe for its intended end use. EPA is looking for monitoring approaches that reduce reliance on slow offsite laboratory analysis and give operators actionable data on contaminants, pathogens, or treatment performance. Strong proposals typically address sensor durability in real matrices, calibration and drift, data integration with existing SCADA or operator workflows, and unit economics at the scale of a real reuse facility.

Topic 1B: Treatment of PFAS in Wastewater Sewage Sludge and Biosolids. PFAS accumulate in the solids stream at wastewater treatment plants, and land application of biosolids has become a major pathway for PFAS to reenter soil and groundwater. EPA wants treatment or destruction technologies that work on the sludge and biosolids matrix specifically, which is a far harder problem than treating clear water. Expect reviewers to focus on destruction efficiency, byproduct and incomplete fluorinated product formation, energy demand, and whether the approach can be retrofitted at a working treatment plant.

Topic 1C: Technologies for the Removal and/or Destruction of PFAS in Groundwater. This topic targets in situ or ex situ approaches for contaminated groundwater, including sites near airports, fire training areas, and manufacturing facilities. Competitive concepts usually show a cost or performance advantage over granular activated carbon and ion exchange, address the full range of chain lengths including short chain PFAS, and have a credible answer for what happens to the captured or concentrated PFAS. Note that EPA directs PFAS sensing concepts to Topic 2A rather than this topic.

Focus Area 2: Air Quality

Topic 2A: Sensors to Detect PFAS in Environmental Matrices. This is the detection topic, and it covers environmental matrices broadly, including water. The underlying need is field deployable, lower cost PFAS measurement that does not require shipping samples to a laboratory for liquid chromatography mass spectrometry. Reviewers will look closely at detection limits relative to current health advisory and regulatory levels, selectivity across PFAS species and against interferences, reusability, and the path toward method acceptance.

Topic 2B: Advancing Technologies to Monitor Carbon Monoxide. Carbon monoxide monitoring spans ambient air quality networks, indoor and occupational exposure, and combustion source characterization. EPA is looking for improvements in accuracy, cost, power consumption, size, or deployment density over current instrumentation. If your concept enables distributed or community scale monitoring, quantify the data quality tradeoff explicitly rather than leaving reviewers to guess.

Focus Area 3: Circular Economy and Sustainable Materials

Topic 3A: Innovative Technologies to Prevent and Recycle Food Waste. Food waste is one of the largest single streams in U.S. landfills and a significant source of methane. EPA's framing here covers both prevention, meaning technologies that keep food from becoming waste in the first place, and recycling, meaning conversion of food waste into usable products. Proposals should be specific about where in the supply chain the technology sits, what it displaces, and who pays for it.

Topic 3B: Critical Mineral Recovery from Lithium-Ion Batteries and Safe Recycling/Reuse of Batteries. This topic sits at the intersection of domestic critical mineral supply and battery end of life safety. EPA is interested in recovery of lithium, cobalt, nickel, graphite, and other critical materials, and in safer handling, sorting, discharging, and reuse pathways for spent cells and packs. Competitive proposals address recovery yield and purity, chemistry flexibility across cell types, fire and thermal runaway risk, and the economics against virgin material pricing.

Topic 3C: Technologies that Mitigate the Impacts of Critical Mineral Mining or Extract Critical Minerals from Acid Mine Drainage. Acid mine drainage is both an environmental liability and a potential feedstock, since it often carries rare earth elements and other critical minerals in solution. EPA wants technologies that either reduce the environmental footprint of critical mineral mining or turn legacy drainage into a recovery opportunity. Site access, real world water chemistry variability, and sludge management are recurring weak points in proposals here.

Focus Area 4: Safer Chemicals

Topic 4A: Rubber Anti-Degradants That Are Lower Concern for Human Health and The Environment. Antiozonants and antioxidants are essential to tire and rubber performance, but the transformation products of widely used compounds have drawn serious environmental scrutiny, most notably in connection with aquatic toxicity in stormwater runoff. EPA is looking for alternative chemistries that preserve rubber performance and service life while presenting lower hazard for people and ecosystems. Proposals need both a toxicological rationale for why the alternative is safer and real performance data against the incumbent.

Topic 4B: Improved Lead Test Kits. Field usable lead test kits remain a bottleneck for renovation, repair, and painting compliance and for consumer and community lead screening. EPA wants improvements in sensitivity, specificity, false positive and false negative rates, ease of use by non technical users, and applicability across substrates. If your kit targets EPA recognition, address the recognition performance criteria directly in the proposal.

EPA SBIR Funding Amounts and Award Structure

Phase I: Proof of Concept

Phase I provides up to $100,000 for a six month period of performance. The objective is to establish technical merit, feasibility, and commercial potential before EPA commits further federal support. Because the period of performance is only six months, the work plan has to be genuinely achievable in that window. Overscoped Phase I plans are a common reason strong technologies score poorly.

Phase II: Development and Commercialization

Phase II provides up to $400,000 over two years and is available only to companies that have received and completed an EPA Phase I award. Selection is based on results achieved in Phase I along with technical merit, commercial potential, and impact. EPA states that Phase II contracts typically start in mid October.

Commercialization Option: Matching Private Investment

EPA offers a commercialization option of up to an additional $100,000 during Phase II for companies that secure third party investment. This is effectively a non dilutive match on private capital and is one of the more underused levers in the EPA program. If you expect to raise or close a strategic partnership during your Phase II window, build that into your commercialization plan from the start.

Total Potential Non Dilutive Funding

A company that moves through the full EPA pathway can access up to $600,000 in non dilutive federal funding across Phase I, Phase II, and the commercialization option, without giving up equity, board seats, or IP ownership.

EPA SBIR 2026 Timeline and Key Dates

• September 16, 2026: EPA SBIR informational webinar covering the 2026 topics and proposal requirements. The recording, slides, and a Q and A document are posted on EPA's webinar resources page.

• September 24, 2026: 2026 Phase I solicitation (68HERW26R0102) opened on FedConnect.

• Closing date: Phase I proposals are due through the FedConnect response function. Plan a submission buffer of at least 48 hours.

• Early December (typical): Phase I contracts typically start, per EPA.

• Mid October (typical): Phase II contracts typically start, per EPA.

Work backward from registration, not from the deadline. EPA states that the required registrations can take 6 to 8 weeks. If you are not already registered in SAM.gov, FedConnect, and the SBA Company Registry, registration is your binding constraint on this cycle, not writing time.

Registration Requirements Before You Can Submit

All of the following must be complete before proposal submission. Start today if any are missing.

Employer Identification Number (EIN)

EPA requires the EIN prior to issuance of a funding award. For an organization this is the IRS Tax Identification Number.

System for Award Management (SAM.gov)

You must have an active SAM registration and maintain it with at least annual renewal. Renewal can take as long as the original registration, so check your expiration date now. Critical detail specific to EPA: because EPA SBIR awards are contracts, your SAM profile must be configured to allow the award of "contracts" or "all awards." A profile set up only for grants will block you.

Unique Entity Identifier (UEI)

DUNS numbers were retired in April 2022. Your UEI is assigned through SAM.gov and is visible in your SAM.gov profile.

FedConnect Registration

FedConnect is the portal EPA uses for proposal submission. Your company must be registered in FedConnect to submit. FedConnect support is reachable at (800) 899-6665 or support@fedconnect.net, Monday through Friday, 8:00 a.m. to 8:00 p.m. Eastern time.

SBA Company Registry

All applicants must register in the SBA Company Registry before submission and include the resulting SBC Control ID with the proposal. This is a frequent last minute scramble for first time applicants.

How EPA Evaluates Proposals

Internal and external reviewers score proposals against three criteria groups, and each group carries one third of the overall score. Commercial merit is weighted equally with technical merit, which surprises many first time applicants from research heavy backgrounds.

Technical Review (one third)

• Technical approach

• Company and team, technical capability

Relevancy Review (one third)

• Impact and relevance to the specific topic

Commercial Review (one third)

• Innovation and intellectual property

• Market opportunity

• Company and team, commercial capability

• Commercialization approach

Proposals are ranked by score, and EPA may also apply programmatic balance, agency priorities, and available funding in the selection decision. The practical implication is that a technically excellent proposal with a thin market section is leaving a full third of the score on the table.

Human Subjects Research and EPA Phase I

Research involving human subjects may fall under 40 CFR 26 and other federal and state requirements. Research is considered to involve human subjects if it obtains information or biospecimens through intervention or interaction with human subjects, or obtains data through using, studying, analyzing, or generating identifiable private information. Survey research counts. Any time you administer a survey, questionnaire, or other data collection instrument, you are interacting with human subjects.

Unless exempt under 40 CFR 26.104, human subjects research requires review and approval by a federally approved Institutional Review Board. EPA specifically does not recommend submitting Phase I offers that require human subjects research, because IRB approval can take 6 to 12 months and the Phase I period of performance is only six months. If your concept depends on human data, restructure the Phase I scope so that the six month work plan does not sit behind an IRB approval.

Who Is Eligible for EPA SBIR

EPA follows standard SBA SBIR eligibility rules. In general terms, the applicant must be a U.S. for profit small business with 500 or fewer employees, more than 50 percent owned and controlled by U.S. citizens or permanent residents, and the work must be performed in the United States with the principal investigator primarily employed by the company at the time of award and during the project. Ownership structures involving venture capital, private equity, or hedge fund investment, multiple affiliates, or foreign parent entities require a careful eligibility review before you invest weeks in a proposal. Confirm current requirements against the SBA SBIR site and the solicitation. Two EPA rules matter for 2026: the principal investigator must be primarily employed by your company at award and during the work, and EPA will not accept proposals from firms owned in majority part by multiple venture capital operating companies, hedge funds or private equity firms.

Common Reasons EPA SBIR Proposals Fail

• Weak topic responsiveness. The proposal describes a good technology but does not directly answer the topic as written. With a modest budget and a full third of the score tied to relevance, this is the fastest path to a low ranking.

• Six month scope creep. A Phase I work plan that implicitly needs twelve months signals poor project management to reviewers.

• Commercialization as an afterthought. Market size assertions without customers, pricing, channel, or a realistic competitive comparison against incumbent technologies.

• Registration failure. SAM lapsed, SAM configured for grants only, no FedConnect account, or no SBC Control ID.

• Submission mechanics. FedConnect deadlines are enforced to the minute, and EPA has historically required the full proposal as a single PDF. Do not test the portal for the first time on deadline day.

• Ignoring the byproduct question. In the PFAS and critical minerals topics especially, reviewers want to know what happens to the contaminant or residual stream after your process runs.

Frequently Asked Questions About the EPA SBIR 2026 Phase I Solicitation

Is the EPA SBIR 2026 Phase I solicitation open?

Yes. EPA issued the 2026 Phase I solicitation (68HERW26R0102) on September 24, 2026, and it is open now.

When is the EPA SBIR 2026 Phase I deadline?

Proposals are due November 8, 2026, at 11:59 p.m. Eastern. Submit through the FedConnect response function. EPA will not consider proposals sent through FedConnect messages.

How much funding does EPA SBIR Phase I provide?

EPA SBIR Phase I provides up to $100,000 for a six month proof of concept project.

How much is an EPA SBIR Phase II award?

Phase II provides up to $400,000 over two years, plus a commercialization option of up to an additional $100,000 for companies that secure third party investment. Total potential funding across the pathway is up to $600,000.

Is EPA SBIR a grant or a contract?

EPA SBIR awards are contracts, not grants. This matters practically, because your SAM.gov registration must permit the award of contracts or all awards, and your proposal is submitted as an offer through FedConnect rather than through Grants.gov.

Where do I submit an EPA SBIR proposal?

Proposals are submitted through the FedConnect portal using its response function. Your company must be registered in FedConnect before you can submit.

What registrations do I need before applying to EPA SBIR?

You need an EIN, an active SAM.gov registration configured for contract awards, a Unique Entity Identifier from SAM.gov, a FedConnect account, and an SBA Company Registry registration with an SBC Control ID. EPA advises that the full registration process can take 6 to 8 weeks.

How long do EPA SBIR registrations take?

EPA states the registration process may take 6 to 8 weeks. SAM.gov renewal can take as long as an initial registration, so verify your status early rather than assuming an existing registration is active.

What topics does the EPA SBIR 2026 solicitation cover?

The 2026 solicitation covers ten topics in four areas: Clean and Safe Water, which includes monitoring for water reuse and PFAS treatment in biosolids and groundwater; Air Quality, which includes PFAS sensors and carbon monoxide monitoring; Circular Economy and Sustainable Materials, which includes food waste, critical mineral recovery from lithium-ion batteries, and critical minerals from mining and acid mine drainage; and Safer Chemicals, which includes lower concern rubber anti-degradants and improved lead test kits.

Can I apply to EPA SBIR if my technology does not fit a published topic?

No. EPA requires proposals to be responsive to the specific topics listed in the annual solicitation. Given EPA's modest program budget, topic responsiveness is one third of your total score and is not something reviewers stretch on your behalf.

How are EPA SBIR proposals scored?

Reviewers score proposals in three equally weighted groups, each worth one third: technical review covering technical approach and technical team, relevancy review covering impact and relevance to the topic, and commercial review covering innovation and intellectual property, market opportunity, commercial team, and commercialization approach. EPA may also consider programmatic balance, agency priorities, and available funding.

Can I apply directly to EPA SBIR Phase II?

No. Phase II is available only to companies that have received an EPA Phase I award, and funding decisions are based on the results achieved in Phase I along with technical merit and commercial potential.

Does EPA SBIR take equity in my company?

No. SBIR is non dilutive funding. EPA does not take equity, board seats, or ownership of your intellectual property, and SBIR data rights protections apply to data generated under the award.

Can my EPA SBIR Phase I project involve human subjects?

EPA does not recommend it. Human subjects research generally requires Institutional Review Board approval under 40 CFR 26, which can take 6 to 12 months, and that conflicts with the six month Phase I period of performance. Survey and questionnaire research counts as human subjects research.

What happens if my EPA SBIR proposal is not funded?

EPA notifies applicants through FedConnect once funding decisions are made. If your proposal is not funded, you can request feedback on it. That debrief is valuable input for the next cycle and for other agency solicitations.

Is there a webinar or recording for the 2026 EPA SBIR solicitation?

Yes. EPA held an informational webinar on September 16, 2026 covering the 2026 topics and proposal requirements. The recording, presentation slides, and a Q and A document are available on EPA's webinar resources page.

Official EPA Notice

The EPA SBIR 2026 Phase I solicitation opened September 24, 2026. Proposals are due November 8, 2026, at 11:59 p.m. Eastern. Find more information on how to apply at the How to Apply Page. Please check back for updates or sign up for the EPA SBIR Listserv to receive notifications of new funding opportunities.

Next Steps for Your EPA SBIR Application

1. Confirm eligibility and registration status this week. Check whether your SAM.gov registration is active and whether it permits contract awards. Registration is the single most common reason companies miss a cycle.

2. Map your technology to a specific topic. Pick one topic and write to it. Hedging across two topics reads as a weak fit for both.

3. Scope a six month work plan with clear go and no go milestones. Feasibility, not full development, is the Phase I objective.

4. Build the commercialization case in parallel with the technical narrative. It is a full third of your score.

5. Read the full solicitation now and put the November 8, 11:59 p.m. Eastern deadline in your calendar with a submission buffer of at least 48 hours.

Work With BW&CO on Your EPA SBIR Proposal

BW&CO helps deep tech, cleantech, and environmental technology founders win non dilutive federal funding across EPA, NIH, NSF, DOE, DoD, NASA, and ARPA-H. Our team has supported more than $350M in funding secured for innovators building real technology. If you are evaluating whether the EPA SBIR 2026 Phase I solicitation is the right fit, or you want a proposal strategy built around the three part scoring rubric rather than a template, we should talk.

Sierra Army Depot Commercial Solutions Opening (CSO) W912GY-25-S-C001: Complete Guide for Startups

Executive Summary

The U.S. Army Contracting Command at Sierra Army Depot (ACC-SIAD) is running an open, continuously accepting Commercial Solutions Opening (CSO) for Organic Industrial Base (OIB) modernization under solicitation number W912GY-25-S-C001. The solicitation is posted on SAM.gov and is open until June 30, 2030, with no fixed proposal deadline. Companies submit a five page solution brief against one of eight published Areas of Interest (AoIs), and awards are made as fixed price contracts under FAR Part 12 commercial item procedures. Both traditional and nontraditional defense contractors are eligible, and no prior government contracting history is required.

For a venture backed startup or a commercially focused small business, this is one of the more accessible entry points into Army depot modernization. There is no 50 page proposal, no cost accounting standards burden at the front end, and no requirement to have an existing defense customer. What the Army wants is a commercially available or near commercially available product that solves a specific, physical, unglamorous depot problem.

Sierra Army Depot CSO at a Glance

• Solicitation number: W912GY-25-S-C001

• Issuing office: U.S. Army Contracting Command, Sierra Army Depot (ACC-SIAD), Herlong, California

• Program: Organic Industrial Base (OIB) Modernization

• Authority: 10 U.S.C. Section 3458, implemented by DFARS Subpart 212.70

• Solicitation type: Commercial Solutions Opening, a competitive procedure similar to a Broad Agency Announcement

• Where it is posted: SAM.gov (the Government Point of Entry)

• Status: Continuously open, currently reflecting CSO Amendment 02 and AoI Amendment 01, both dated August 18, 2026

• Closes: June 30, 2030, with the government reserving the right to extend by amendment

• Areas of Interest: Eight continuously open AoIs

• Phase 1 submission: Five single sided pages in 12 point font, or fifteen briefing slides

• Award type: Fixed price, including fixed price incentive fee, primarily FAR Part 12

• Typical period of performance: Generally not more than 12 months unless the AoI states otherwise

• Eligibility: Traditional and nontraditional defense contractors, small businesses, nonprofit research institutions, and foreign owned businesses subject to clearance limitations

• Contracting Officer: Ms. Melissa Kaarbo, melissa.m.kaarbo.civ@army.mil

• Additional point of contact: Ms. Kimberly Hunter, kimberly.a.hunter.civ@army.mil

What Is a Commercial Solutions Opening and Why It Matters for Startups

A Commercial Solutions Opening is a competitive acquisition procedure that lets Department of Defense contracting officers buy innovative commercial products, technologies, and services without running a traditional Request for Proposals. It was authorized permanently under 10 U.S.C. Section 3458 and is implemented through DFARS Subpart 212.70. Under a CSO, the government may competitively select proposals received in response to a general solicitation based on peer review by scientific, technological, or other subject matter experts.

Three features of the CSO make it materially different from a standard federal procurement, and all three favor a startup:

• It is a competitive procedure by statute. Selection under a CSO satisfies the competition requirements of 10 U.S.C. Chapter 221 and FAR 6.102. The Army does not have to justify a sole source, which removes a common source of internal friction and delay.

• Everything is treated as commercial. Contracting officers must treat products and services bought under a CSO as commercial products and services. That means FAR Part 12 terms, simplified contract clauses, and no default requirement to build a government approved accounting system before you can be paid.

• Your submission is evaluated on its own merits. The solicitation is explicit that solution briefs are evaluated against the stated criteria, not against other companies' submissions. You are not competing head to head against an incumbent prime for a single slot.

The solicitation itself lists five benefits of the process: a streamlined application requiring only minimal corporate and technical information, fast track evaluation timelines, negotiable payment terms for non-dilutive capital, negotiable intellectual property rights, and direct feedback from end users and mission partners inside the Department of Defense who actually operate the equipment.

What Sierra Army Depot Is Actually Trying to Solve

Sierra Army Depot is a major Army logistics and storage installation with a large footprint of open storage, maintenance shops, demilitarization operations, an airfield, and out-loading operations that push materiel to the field. The Organic Industrial Base is the network of Army depots, arsenals, and ammunition plants that manufacture, repair, and sustain equipment. The Army's stated position is that its decisive military advantage over peer competitors is steadily eroding and that modernizing the OIB is a prerequisite for closing that gap.

The solicitation names six technology domains where the Army says modernization is most needed: agile and flexible facilities, a connected digital enterprise, advanced manufacturing, digital twin, automation, and cyber security. The framing throughout the document is about throughput and speed, described as increasing the "Speed of Battle," rather than about basic research.

This matters for how you write. The Army is not asking for a science project. It is asking how your technology moves more materiel through the depot faster, with fewer people doing dangerous or repetitive work, at lower lifecycle cost, in compliance with environmental and safety rules.

The Eight Areas of Interest in Detail

All eight AoIs are continuously open, and all solution briefs submitted under them are evaluated against the Phase 1 criteria in Section 3.2.2 of the CSO. If government funding or resources are not available for a proposed effort, the solution brief is retained in the ACC-SIAD library rather than discarded, which means a strong brief can be pulled forward when funding appears later.

1. Agile and Adaptive Facilities

Scalable, world class facilities that can rapidly adapt to changing mission requirements. The stated emphasis is on integrating physical and virtual processes to create flexible production, maintenance, and demilitarization lines so the depot can respond quickly to engineering changes and supply chain variation.

Companies that fit here typically offer reconfigurable production cells, modular tooling and fixturing, digital twin and factory simulation software, rapid line changeover systems, modular or relocatable industrial structures, and manufacturing execution software that reconfigures workflows without a capital rebuild.

2. Advanced Manufacturing and Maintenance

Technologies that increase the speed, scale, and precision of depot operations, with a specific call out of the depot's maintenance processes and parts capabilities. The solicitation names wash, blast, weld, paint, preservation, and repair processes supporting a wide variety of systems and platforms, and it asks respondents to address safety, environmental compliance, capacity, and efficiency.

Relevant technologies include metal and polymer additive manufacturing for obsolete or long lead spare parts, cold spray and other repair deposition methods, robotic and automated welding, advanced coatings and surface preparation, laser ablation stripping, non-destructive inspection, reverse engineering and scan to part workflows, and predictive maintenance analytics. If you make legacy parts available on demand instead of through a 40 week procurement lead time, this is your AoI.

3. Automation and Robotics

The solicitation defines automation as an automatic control measure that uses feedback loops from sensors, cameras, encoders, lasers, and probes to control a process, mechanism, or system, achieved through mechanical, hydraulic, pneumatic, electrical, electronic, and computing means in combination. The applied focus is automated and robotic systems for materiel handling, warehousing (pick, sort, and store), and processing, with the goal of reducing manual labor in repetitive or hazardous tasks and increasing accuracy and speed.

Strong fits include autonomous mobile robots and automated guided vehicles, robotic piece picking and palletizing, automated storage and retrieval systems, machine vision inspection and sortation, collaborative robots for shop floor tasks, teleoperation for hazardous environments, and exoskeletons or lift assist systems. Hazardous task removal is called out directly, so demilitarization, chemical handling, and heavy lift use cases are well aligned.

4. Logistics and Inventory Management Modernization

Re-engineering inventory and warehouse management systems to increase accuracy, reduce loss, and improve efficiency. The solicitation specifically points to modern hardware and software, naming Warehouse Management Systems, to streamline receiving, storage, and picking.

This is the most software friendly AoI. Candidate solutions include warehouse management and warehouse execution platforms, RFID and passive sensing for asset tracking across large open storage areas, computer vision inventory audit, drone based cycle counting, digital yard management, demand forecasting and inventory optimization, and integration layers that connect commercial systems to Army logistics systems of record. Note that any software touching Army networks will eventually face cybersecurity and authority to operate requirements, so address your security posture early.

5. Airfield Maintenance

Comprehensive inspection, preservation, and repair of airport infrastructure and grounds required for safe and efficient aircraft operations. Named aspects include pavement markings and electrical systems, snow and ice management, debris and vegetation control, and coordination with air traffic control to minimize operational impact. The AoI explicitly includes the Automated Weather Observing System (AWOS), which provides continuous real-time weather information to airports, pilots, and aviation stakeholders.

Fits include automated pavement condition assessment, foreign object debris detection, runway marking and striping automation, airfield lighting systems, snow and ice removal or anti-icing technologies, vegetation management, and AWOS hardware, sensors, modernization, or data integration. The AWOS mention is unusually specific for a continuously open AoI, which generally signals a live need.

6. Energy, Environmental, and Chemical Management

Safe, sustainable, and efficient use of energy, fuels, and chemicals across depot facilities and operations. The AoI specifically asks for innovative solutions for surface coating, cleaning, stripping, and plating that reduce hazardous waste and improve sustainability.

Relevant technologies include hexavalent chromium and PFAS free coatings and platings, non-hazardous cleaning and degreasing chemistries, laser and dry media stripping that eliminates blast media waste, closed loop water and solvent recovery, VOC and emissions reduction, waste minimization and treatment, energy efficiency and on-site generation, microgrids and energy storage, and industrial process electrification. Regulatory and environmental compliance pressure on legacy depot chemistries makes this AoI durably funded across the Army.

7. Public Private Partnerships (P3) Opportunities

Collaborations with private industry that bring commercial innovation, investment, and expertise into the depot. The stated aim is to accelerate modernization, improve operational efficiency, and sustain critical depot capabilities through shared resources and shared risk.

This AoI is structurally different from the other seven. It is less about a discrete product and more about a business model: co-investment in depot capability, shared use of depot facilities or equipment, work share arrangements, technology transfer, or arrangements where a company brings capital equipment onto the installation in exchange for guaranteed throughput. If your go to market depends on placing capital equipment somewhere and operating it, read this AoI closely.

8. Advanced Packaging Manufacturing at the Point-of-Need

This AoI was added by AoI Amendment 01 dated August 18, 2026, and it is the most sharply defined requirement in the set. The Army is seeking on-site fabrication technologies and non-lumber material solutions that let Sierra Army Depot manufacture customized crates, pallets, skids, and blocking on demand.

The stated requirements are specific. Solutions must deliver a highly versatile, scalable manufacturing capability that can rapidly adapt to produce an effectively unlimited variety of dimensions, using lightweight, weather resistant, and easily recyclable materials. The technology must replace legacy carpentry operations in order to eliminate labor intensive bottlenecks, high material washout rates, continuous lumber procurement costs, and ISPM-15 Wood Packaging Material compliance risk. The stated outcome is modernized out-loading throughput and reduced lifecycle logistics costs.

If you work in automated packaging fabrication, on-demand box and crate manufacturing, thermoformed or molded composite packaging, honeycomb or engineered paperboard structures, recyclable polymer shipping containers, or CAD driven cut and assemble systems, this AoI is a direct match. The level of detail here, combined with the fact that it was added by amendment rather than included at the original posting, generally indicates an identified and prioritized requirement rather than general market research.

Funding Allowance: What You Can and Cannot Expect

This is the part most companies misread, so it is worth stating plainly. The CSO does not publish an award ceiling, a floor, or a reserved pool of funding. The solicitation states directly that because of government budget uncertainties, no specific dollars have been reserved for awards under this CSO, and that requests for a Commercial Solution Proposal are subject to the availability of government funds.

Here is what the solicitation does commit to:

• Award instrument: Contracts or agreements under this authority shall be fixed price, including fixed price incentive fee. The government intends to primarily award FAR-based contracts under Part 12 commercial item procedures, but reserves the right to award other contract or agreement types depending on the AoI and industrial base response.

• Period of performance: Generally no greater than 12 months for any solution brief or CSP submitted under this CSO, unless a specific AoI states otherwise. Size your proposed effort and your price to a 12 month scope.

• Payment terms: The solicitation lists negotiable payment terms for non-dilutive capital as a benefit of the process. The Contracting Officer reserves the right to negotiate terms and conditions directly with the company prior to execution, including payment terms. For a cash constrained startup, this is where you negotiate milestone or advance payment structures rather than pure cost reimbursement in arrears.

• Intellectual property: IP rights are negotiable. You are asked to identify any IP involved and any restrictions on the government's use of that IP. IP risk is an explicit scored evaluation factor at Phase 2, so unresolved or aggressive assertions cost you points.

• Pricing format: Phase 1 requires a rough order of magnitude price. Phase 2 requires a ROM in a range of minus 25 percent to plus 75 percent along with a notional schedule. Phase 3 requires a full price volume with enough detail for the government to test price reasonableness, which for time and materials line items means labor categories, direct labor hours, fully burdened fixed hourly rates, and material costs supported by vendor quotes or other bases of estimate.

And here is what the government will not pay for:

• Costs of preparing and submitting a Phase 1 solution brief.

• Costs associated with a Phase 2 presentation or pitch, unless a specific AoI says otherwise.

• Costs of developing a Phase 3 Commercial Solution Proposal, unless a specific AoI says otherwise.

• Proposal preparation costs are explicitly not recoverable and are not a direct charge to any resulting award or any other contract or agreement.

The practical read: treat this as an unfunded business development investment with a fast, cheap first step. A five page brief is a one to two week effort for most teams, which is a reasonable bet against a fixed price production or pilot contract with a customer that operates at depot scale.

Timeline and Key Dates

There is no single submission deadline. The CSO is continuously open on SAM.gov until June 30, 2030, and the government may extend that date by amendment if the underlying authority is extended. New AoIs may be added at any point during the solicitation's life, which is exactly what happened with the packaging AoI added in August 2026, so companies are advised to check SAM.gov frequently for new postings.

The internal clocks that do matter once you submit:

• Phase 1 evaluation: The government will attempt to complete evaluation of solution briefs within 30 calendar days of the close of the submittal period and to notify companies of results as soon as practicable.

• Phase 2 evaluation: The government aims to complete evaluation of presentations and pitches within 30 calendar days of the pitch.

• Pitch validity: Presentation and pitch submissions must remain valid for no less than 90 days after evaluation.

• The 90 day funding gate: If government funding or resources are not assigned to a Phase 3 CSP within 90 days after pitch evaluation, the government will issue a notification of non-eligibility and officially close that AoI selection process. This is the single most important date in the document, because it is where an otherwise successful submission can stall for reasons that have nothing to do with your technology.

• CSP validity: A Phase 3 Commercial Solution Proposal must remain valid for at least 120 days from the submission date.

• Notification of non-selection: Companies not advanced to the pitch or CSP phase are notified in writing as soon as practicable. Verbal feedback may be provided on request at the Contracting Officer's discretion, and it is worth asking for.

Realistically, a company entering at Phase 1 with funding already aligned to the requirement should plan for roughly three to six months from submission to award. A company entering against an AoI where funding has not yet been identified should expect the brief to sit in the ACC-SIAD library until a requirement and funding line converge.

How the Three Phase Process Works

Phase 1: Written Solution Brief

Unless a specific AoI says otherwise, the solution brief must not exceed five single sided pages in 12 point font, or alternatively may be submitted as briefing slides not exceeding fifteen slides. The brief must contain four elements:

• Title page: Company name, title, date, point of contact name, email address, phone, and address, and a specific identification of which AoI you are responding to. The title page does not count against the page or slide limit.

• Executive summary: A summary of the technology or service.

• Technology concept: How your solution represents an application of innovative commercial products, technologies, or services, or an adaptation of existing ones, to the AoI. Describe the unique aspects of your technology and the work as it relates to the AoI. State clearly whether you are proposing a pilot or demonstration of existing commercially ready and viable technology, or development of technology for potential defense application. If development or adaptation is proposed, identify a suggested path to mature the technology. Identify any data and software you consider proprietary.

• Price: A rough order of magnitude price for the proposed solution.

The executive summary, technology concept, and price sections all count against the limit. Unnecessarily elaborate brochures are explicitly not desired, and the use of a diagram or figure to depict the essence of the proposed solution is strongly encouraged. Companies may submit multiple solution briefs against a single AoI if each represents a separate and distinct concept, but an individual brief may only address one concept.

Phase 2: Presentation or Pitch, If Applicable

Companies whose briefs are evaluated to be of merit may be invited to pitch in person, virtually, or on paper, depending on the requirement. If a demonstration is required, the AoI will say so. The government may also request an additional written submission to supplement or clarify the Phase 1 brief. During the pitch you must address a description or demonstration of how the solution is an innovative application of commercial technology to the AoI, a ROM price in a minus 25 percent to plus 75 percent range with a notional schedule, any IP involved and associated restrictions on government use, and whatever additional detail the invitation specified.

Phase 3: Commercial Solution Proposal

Companies evaluated to be of merit through Phase 1, Phase 2, or a combination may be invited to submit a full written proposal in two separate volumes.

Volume I, Technical, must contain no cost information. It requires a detailed work plan showing how each objective will be accomplished, in as much detail as you consider necessary to fully explain your technical approach and all assumptions used to develop the solution and associated costs. It must demonstrate a clear understanding of the nature of the work, explain how the project will be organized, staffed, and managed, and include a list of suggested deliverables and deliverable dates.

Volume II, Price, must contain enough information for the government to perform a basic price analysis. The government reserves the right to request additional pricing support, including commercial price catalogs, previous commercial sales receipts, and other proprietary information used to determine reasonableness and future budgetary cost estimates.

Technical proposals are rated Acceptable or Unacceptable. Price proposals are rated Fair and Reasonable or Not Fair and Reasonable. Neither an Acceptable technical rating nor a Fair and Reasonable price determination guarantees award, because program priorities, negotiations, and availability of funds are also considered.

Phase Skipping Works in Both Directions

The government reserves the right to forgo Phase 1 and Phase 2 and directly request a CSP, and to move expeditiously through the phases if urgent requirements arise. Separately, companies may elect to forgo Phase 1 and Phase 2 and submit a written CSP directly. In practice, going straight to a full CSP is usually the wrong move for a first time entrant, because the five page brief is the cheapest way to test whether a real requirement and a funding line exist behind the AoI before you invest in a full proposal.

How Your Submission Will Be Evaluated

Phase 1 solution briefs are evaluated against four criteria, listed in the solicitation in descending order of importance:

• Responsiveness of the brief in addressing the AoI with a commercially available product, process, or service readily available to meet the government's immediate needs.

• Technical merit of the proposed solution, including the extent to which it is unique or innovative for government application.

• The extent to which funding is available for the proposed effort.

• The proposed milestone schedule and its ability to meet the AoI need within a relevant time period.

Read the first and third criteria together, because they set the strategy. The most heavily weighted factor is commercial readiness and immediate availability, not novelty. A mature product with fielded commercial installations outscores a more clever prototype. And because funding availability is itself a scored criterion, a brief that is cheap, fast, and scoped to a 12 month period of performance scores better than an ambitious multi-year program the depot cannot currently pay for.

Phase 2 pitches are scored on eight factors, also in descending order of importance: relevance of the solution to the AoI with a commercially available product or process, technical merit and demonstrated feasibility, uniqueness and innovation, technical risk and maturity, risk in the proposed ROM, risk in the proposed milestone schedule, risk in the company's viability and business solution, and potential risk in anticipated IP and data rights assertions.

Five of those eight factors are risk factors. Company viability is scored explicitly, which means an early stage company should proactively address runway, manufacturing capacity, key personnel, and supply chain rather than hoping the topic does not come up. The government may also use external market research to evaluate a company's viability, so assume your funding history and public footprint will be reviewed.

Both phases are evaluated on an absolute basis, not comparatively. The government reserves the right to select all, some, or none of the submissions received against any AoI.

Eligibility and Registration Requirements

• Nontraditional defense contractors are expressly welcome. A nontraditional defense contractor is defined in 10 U.S.C. Section 3014 as an entity that is not currently performing and has not performed, for at least the one year period preceding the solicitation, any DoD contract or subcontract subject to full coverage under the cost accounting standards. The definition includes all small business concerns meeting the size standards in 13 C.F.R. Part 121.

• Small businesses and nonprofit research institutions are both defined and contemplated in the solicitation.

• Foreign owned businesses may submit independently or as part of a teaming arrangement with one or more United States owned businesses, though the ability to receive an award may depend on obtaining the necessary clearances and approvals for proscribed information.

• Unique Entity ID and SAM registration are required before award. Companies are advised to begin SAM registration as soon as they identify an AoI of interest. Registration in the Procurement Integrated Enterprise Environment (PIEE) at piee.eb.mil is also required for invoicing, and PIEE registration cannot occur without an active SAM registration.

• Responsibility determination: The company must be determined responsible by the Contracting Officer and must not be suspended, debarred, or otherwise prohibited by executive order or law from receiving an award.

Proprietary Data, Export Control, and Classification Rules

The government acknowledges its obligation under 18 U.S.C. Section 1905 to protect confidential information, but that protection is conditional on how you mark your submission:

• Qualifying data must be clearly marked PROPRIETARY and accompanied by explanatory text so the government is clearly notified of the limitations being placed on it.

• Mark only what is truly confidential, and indicate the specific portions of a page using circling, underscoring, or highlighting.

• Do not mark data already in the public domain or already held by the government or third parties on an unrestricted basis. The government is not obligated to protect unmarked data.

• Do not submit classified data.

• Understand the tradeoff. The government sometimes uses support contractors to evaluate responses. Marking data as proprietary precludes disclosure to those support contractors, so heavily marked submissions may receive limited or no consideration. The government will use best efforts to evaluate proprietary submissions without support contractors, consistent with available resources. Mark surgically, not defensively.

• Technical data with military application may require approval, authorization, or license for lawful export. Confirm your ITAR and EAR posture before you submit.

The CSO process for FAR contracts is covered by the Procurement Integrity Act as implemented through FAR Part 3.104, so the usual ethical restrictions on procurement information apply to both sides.

How to Position a Winning Solution Brief

Five pages is not much room, and most unsuccessful briefs fail for the same avoidable reasons. Based on the stated evaluation criteria, the strongest submissions do the following:

• Name the AoI in the first sentence. Responsiveness is the top weighted criterion. Do not make an evaluator infer which of the eight AoIs you are answering.

• Lead with commercial readiness, not the technology. Open with what is already fielded, where, at what scale, and with what measured results. Commercial traction is evidence, and it is scored ahead of novelty.

• Quantify the depot outcome. Translate your capability into throughput, labor hours avoided, hazardous waste eliminated, lead time reduced, or lifecycle cost saved. Percentages tied to a baseline beat adjectives.

• Use a diagram. The solicitation strongly encourages a figure depicting the essence of the solution, and it is the highest information density you can buy within the page limit.

• Price to a 12 month scope and be realistic. Funding availability is a scored criterion. A credible six figure pilot that can be executed inside a fiscal year is easier to fund than a multi-year program.

• Address risk before you are asked. Company viability, schedule risk, ROM risk, and IP risk are four of the eight Phase 2 scoring factors. Retiring them early in writing converts a weakness into evidence of maturity.

• Be clear about maturity. The solicitation asks you to state explicitly whether you are proposing a pilot of commercially ready technology or development for defense application, and if the latter, to lay out a maturation path. Ambiguity here reads as risk.

• Submit more than one brief if you have more than one concept. Multiple distinct concepts are permitted, and several AoIs overlap. A robotics company, for example, may have separate credible answers for AoI 3 and AoI 4.

Frequently Asked Questions

What is solicitation W912GY-25-S-C001?

W912GY-25-S-C001 is the Commercial Solutions Opening issued by U.S. Army Contracting Command at Sierra Army Depot (ACC-SIAD) for Organic Industrial Base modernization. It is a continuously open competitive solicitation posted on SAM.gov that seeks innovative commercial products, technologies, and services across eight Areas of Interest, and it remains open until June 30, 2030.

What is the deadline to apply to the Sierra Army Depot CSO?

There is no single deadline. The CSO is continuously open until June 30, 2030, and the government may extend that date by amendment. Because new Areas of Interest can be added at any time and specific AoIs may carry their own open periods, companies should monitor SAM.gov regularly. Submissions received after a prescribed AoI open period has ended will not be considered, reviewed, or evaluated.

How much funding is available under this CSO?

No dollar ceiling or reserved funding pool is published. The solicitation states that due to government budget uncertainties, no specific dollars have been reserved for awards, and that requests for a Commercial Solution Proposal are subject to the availability of government funds. Awards are fixed price, generally with a period of performance of 12 months or less unless a specific AoI states otherwise, and the practical award size is driven by the scope you propose and the funding the depot has identified for that requirement.

Does the government pay for my proposal costs?

No. The government will not pay for costs associated with solution briefs, presentations or pitches, or development of a Commercial Solution Proposal, unless a specific AoI stipulates otherwise. Proposal preparation costs are explicitly not recoverable and are not a direct charge to any resulting award or other contract.

Can a startup with no prior government contracts apply?

Yes. Both traditional and nontraditional defense contractors may be awarded contracts or agreements under this CSO. A nontraditional defense contractor is defined as an entity that has not performed a DoD contract subject to full cost accounting standards coverage for at least one year preceding the solicitation, and the definition expressly includes small business concerns. You must obtain a Unique Entity ID, register in SAM, and register in PIEE before award.

How long is the solution brief and what must it contain?

Unless a specific AoI says otherwise, the solution brief is limited to five single sided pages in 12 point font, or alternatively fifteen briefing slides. It must include a title page, an executive summary, a technology concept section, and a rough order of magnitude price. The title page does not count against the limit, but the other three sections do.

What are the eight Areas of Interest at Sierra Army Depot?

The eight continuously open AoIs are agile and adaptive facilities, advanced manufacturing and maintenance, automation and robotics, logistics and inventory management modernization, airfield maintenance, energy, environmental, and chemical management, public private partnership opportunities, and advanced packaging manufacturing at the point-of-need. The eighth AoI, covering on-site fabrication of crates, pallets, skids, and blocking using non-lumber materials, was added by AoI Amendment 01 dated August 18, 2026.

How long does the evaluation take?

The government will attempt to complete Phase 1 solution brief evaluation within 30 calendar days of the close of the submittal period, and aims to complete Phase 2 pitch evaluation within 30 calendar days of the pitch. Pitch submissions must remain valid for at least 90 days after evaluation, and a Phase 3 proposal must remain valid for at least 120 days from submission.

What happens if my solution brief is good but there is no funding?

If government funding or resources are unavailable for the proposed effort, solution briefs are retained in the ACC-SIAD library rather than discarded. Separately, if funding or resources are not assigned to a Phase 3 proposal within 90 days after pitch evaluation, the government provides a notification of non-eligibility and officially closes that AoI selection process. Retained briefs can be revisited when a funding line materializes.

What kind of contract results from a CSO award?

Contracts or agreements under this authority are fixed price, including fixed price incentive fee. The government intends primarily to award FAR-based contracts under Part 12 commercial item procedures, but reserves the right to award other contract or agreement types depending on the AoI and the industrial base response. Only a Contracting Officer, under FAR 1.602, can enter into or modify a binding contract on behalf of the government.

Is my intellectual property protected?

IP rights are negotiable under this CSO, and you are required to identify any IP involved and any restrictions on government use. Proprietary information must be clearly marked and accompanied by explanatory text to receive protection under 18 U.S.C. Section 1905. Be aware that marking material proprietary precludes disclosure to support contractors assisting the evaluation, which may result in limited or no consideration of that material, so mark only what is genuinely confidential.

Can foreign owned companies submit?

Yes. Foreign owned businesses may submit independently or as part of a teaming arrangement with one or more United States owned businesses. However, the ability to receive a contract or agreement may depend on the foreign owned business obtaining the necessary clearances and approvals to access proscribed information.

Can I skip straight to a full proposal?

Yes. Companies may elect to forgo Phase 1 and Phase 2 and submit a written Commercial Solution Proposal directly, and the government likewise reserves the right to skip phases and request a proposal directly based on individual merit or urgency. For most first time entrants the five page brief is the better path, because it is a low cost way to confirm that a real, funded requirement sits behind the AoI.

Who do I contact about this solicitation?

The Contracting Officer is Ms. Melissa Kaarbo at melissa.m.kaarbo.civ@army.mil, and an additional point of contact is Ms. Kimberly Hunter at kimberly.a.hunter.civ@army.mil. Questions about the objectives or preparation of a solution brief should be directed to the points of contact listed in the respective AoI, and submissions must be made electronically exactly as prescribed in that AoI.

Why the CSO Path Is Worth Your Time

For a deep tech, advanced manufacturing, robotics, or industrial software company, the Sierra Army Depot CSO offers something SBIR does not: a direct route to a fixed price commercial contract with an operating customer, with no dilution, negotiable IP terms, a five page front door, and a decision cycle measured in weeks rather than a twice yearly cycle. The tradeoff is that funding is not guaranteed, which makes the quality and targeting of the first submission the whole game.

BW&CO helps deep tech and dual use founders identify the right Area of Interest, structure a responsive solution brief, price to a fundable scope, and manage the path from brief through pitch to proposal. We have helped clients secure more than $350 million in non-dilutive funding across the Department of Defense, NIH, NSF, NASA, DOE, and ARPA-H. Innovation funding simplified.

If you are evaluating whether your technology fits one of the eight Sierra Army Depot Areas of Interest, contact BW&CO for a fit assessment.

DCSA Innovation Gateway (HS0021-26-CSO-DCSA): The Complete Guide for Startups

Executive Summary

The DCSA Innovation Gateway is a five-year commercial solicitation from the Defense Counterintelligence and Security Agency (DCSA) that awards Other Transaction Agreements (OTAs) for prototype projects under 10 U.S.C. 4022. It is DCSA's front door for commercial innovators, and it is built specifically so that small businesses and companies with no prior defense contracting history can compete. Companies do not submit against the Gateway itself. They respond to individual Innovation Calls published on SAM.gov under the Gateway, starting with a 6-page Solution Concept Paper rather than a full proposal.

Solicitation number HS0021-26-CSO-DCSA. Open period: June 23, 2026 through June 22, 2031. NAICS code 541512, Computer Systems Design Services.

DCSA Innovation Gateway at a Glance

• Agency: Defense Counterintelligence and Security Agency (DCSA), Department of Defense

• Solicitation number: HS0021-26-CSO-DCSA

• Solicitation type: Commercial Solutions Opening style announcement resulting in prototype OTAs

• Award instrument: Other Transaction Agreement (OTA) for prototypes, 10 U.S.C. 4022

• Open period: June 23, 2026 to June 22, 2031

• First submission: 6-page Solution Concept Paper using the required template (Attachment 1)

• Where opportunities are posted: SAM.gov, as Innovation Calls referencing the DCSA Innovation Gateway

• Unsolicited proposals: Not accepted and not reviewed

• Cost share: Not required for most small businesses and nontraditional defense contractors

• Follow-on: Successful prototypes can move to a production contract or transaction without further competition

• Technical focus: Digital transformation, data and AI, cyber and industrial security, digital workforce and IT governance

What Is DCSA and Why Does This Solicitation Exist?

DCSA is the Department of Defense agency responsible for personnel vetting and background investigations, industrial security oversight of cleared contractor facilities, counterintelligence, insider threat detection, and security training across the National Industrial Security Program. It touches millions of security clearance records and thousands of cleared facilities, which makes it one of the most data-intensive agencies in the federal government.

The Innovation Gateway exists because DCSA wants commercial technology, not custom-built government software. The agency describes the Gateway as its commercially focused front door for innovators, with the goal of partnering with creative companies to solve its most critical mission challenges. Practically, that means DCSA is willing to skip the traditional FAR-based procurement path and use OTA authority to get prototypes on contract faster, with negotiable terms, negotiable intellectual property rights, and a direct path to production if the prototype works.

For a venture-backed startup or a small commercial software company, this is one of the more accessible defense entry points available, because the first submission is a short concept paper rather than a 50-page proposal with a full cost volume.

What DCSA Is Looking For: The Four Technical Priorities

The Gateway publishes four broad technical priority areas. Individual Innovation Calls narrow these into specific problem statements, but every concept must map back to one or more of these areas.

1. Digital Transformation Enablement

DCSA is seeking prototypes that accelerate agency-wide digital transformation by improving how digital capabilities are designed, delivered, governed, and sustained. The strong preference is for solutions that are reusable across multiple mission and business areas, reduce delivery timelines, improve user experience, and increase operational resilience and security. Enterprise applicability is the theme. A tool that solves one system's problem is far less compelling than a pattern that can be adopted across many systems.

• Digital Service Delivery Acceleration: Prototypes that shorten time-to-capability through repeatable delivery patterns such as standardized environments, automated pipelines, release orchestration, and operational readiness practices that work across diverse systems.

• Cloud and Infrastructure Modernization as an Enabler: Solutions that simplify adoption and operation of modern hosting through automation, resilience, performance optimization, and cost transparency, with a focus on enterprise applicability rather than single-system optimization.

• Modular Architecture and Incremental Modernization: Prototypes aligned with MOSA principles that promote modular, replaceable components, enable stepwise modernization, reduce vendor lock-in, and integrate with existing systems.

• Operational Excellence and Continuous Compliance: Efforts that build in observability, configuration management, incident readiness, and continuous compliance so modernized capabilities operate securely and reliably at scale.

2. Data Integration and Advanced Analytics

This priority sits at the center of DCSA's mission, because personnel vetting and industrial security are fundamentally data and risk problems.

• Data-Driven Decision Making: Enhancing data understanding, delivery, and management so DCSA can make faster and more accurate risk determinations in personnel and industrial security.

• AI and Machine Learning: Implementing AI capabilities that analyze large volumes of data, identify anomalies, and calculate potential risk, while keeping human judgment at the center of trust decisions. That last phrase matters. Concepts that fully automate a trust or clearance decision will not land well. Concepts that surface, rank, and explain risk for a human adjudicator will.

• Automated Data Ingestion: Tools that automatically ingest data to improve the speed and quality of background investigations.

3. Cyber and Industrial Security

• Securing the Defense Industrial Base: Protecting cleared facilities and IT systems from cyber attacks, foreign insider threats, and vulnerabilities.

• Behavioral Threat Analysis Capability (BTAC): Enhancing the ability to detect insider threats through advanced behavioral monitoring.

• Zero Trust Architecture: Strengthening cyber posture through modern, secure IT solutions that protect sensitive national security information.

4. Digital Workforce and Governance

• Digital Skills Training: Building a skilled digital workforce, including expanded AI experience and cybersecurity awareness.

• IT Governance: Establishing enterprise-wide IT, data, and cybersecurity governance to ensure compliance and efficiency.

What Counts as a Prototype Project

Under 10 U.S.C. 4022, a prototype project is defined broadly, which is helpful for software and services companies. It includes a proof of concept, model, or process (including a business process), reverse engineering to address obsolescence, a pilot or novel application of commercial technology for defense purposes, agile development activity, the creation, design, development, or demonstration of operational utility, or any combination of these. Adapting an existing commercial product to a DCSA use case qualifies. You do not need to invent something new from scratch.

Who Is Eligible: OTA Eligibility Rules Explained

Prototype OTAs have statutory eligibility conditions. Under 10 U.S.C. 4022, the awardee must meet at least one of the following three conditions.

• (A) Nontraditional participation: At least one nontraditional defense contractor or nonprofit research institution participates to a significant extent in the prototype project.

• (B) All small or nontraditional team: All significant participants other than the Federal Government are small businesses (including small businesses in a program under section 9 of the Small Business Act, 15 U.S.C. 638) or nontraditional defense contractors.

• (C) One-third cost share: At least one third of total project cost is paid from non-federal sources.

What Is a Nontraditional Defense Contractor?

A nontraditional defense contractor is an entity that is not currently performing, and has not performed for at least one year prior to the solicitation, any DoD contract or subcontract subject to full coverage under the Cost Accounting Standards (CAS). In plain terms, most commercial startups, most venture-backed companies, and most small businesses qualify automatically. If your company has never held a large cost-type DoD contract with full CAS coverage, you are almost certainly nontraditional, and condition (A) or (B) is satisfied without any cost share.

Security Requirements and Foreign Participation

Each Innovation Call specifies whether non-U.S. organizations or individuals may participate and what controls or security regulations apply. Some calls will require a facility clearance or cleared personnel, and some will not. If foreign participation is allowed under a given call, all forms of it must be clearly and fully disclosed in the proposal. For controlled unclassified information (CUI) and classified submissions, that includes disclosing and mitigating any Foreign Ownership, Control, or Influence (FOCI) issues before the submission is transmitted to DCSA. Foreign investors on your cap table are not automatically disqualifying, but they must be disclosed and mitigated, and they should be addressed early rather than discovered during negotiation.

Administrative Requirements Before Award

These are checked before an agreement can be executed, not at concept paper stage, but you should start them now because they take time.

• Active SAM.gov registration with a Unique Entity Identifier (UEI)

• A CAGE code

• Any facility or personnel security clearances required by the specific Innovation Call

• Registration and active status in the prescribed government invoicing system, such as the Procurement Integrated Enterprise Environment (PIEE)

• Not suspended or debarred, and not prohibited by law or Executive Order from receiving an award

• A responsibility determination by the Agreements Officer

• Any Organizational Conflicts of Interest (OCI) addressed and mitigated

Funding Allowance, Cost Share, and What to Put in Your ROM

The Innovation Gateway itself does not publish a dollar ceiling or a fixed award size. This is intentional. Award value is established through your Rough Order of Magnitude (ROM) and then negotiated during Phase 3, and individual Innovation Calls may state their own funding parameters or target ranges.

• You set the number. The Solution Concept Paper requires a total ROM plus a high-level cost estimate broken into major phases where applicable, showing project phase, estimated duration, and estimated cost range.

• Affordability is a scored criterion. DCSA evaluates whether the ROM is within an acceptable range for a prototype effort. A ROM that is too high for the scope described is a real rejection risk, and so is one that is obviously too low to deliver what you promised.

• Cost share is generally not required. Cost sharing is not required as a rule. OTs for prototypes require cost share only if the team fails the nontraditional or all-small-business conditions. If the proposing team does not meet those conditions, it must provide at least one third of total cost from its own funds unless a waiver is granted, and waivers are not common and require significant justification.

• Voluntary cost share is encouraged where there is commercial upside. DCSA encourages cost sharing where there is a reasonable probability of commercial application related to the effort. Any cost sharing arrangement should be noted in both the Solution Concept Paper and the Full Project Proposal.

• The real money is often downstream. Under 10 U.S.C. 4022(f), a successful prototype can transition to a follow-on production contract or transaction without further competition, covering additional units, scaling of the prototype technology, or implementation of the solution.

Scope your ROM to what can credibly be demonstrated as a prototype, phase it, and treat the prototype as the on-ramp to the production OTA rather than the end state.

How the Process Works: Three Phases

Phase 1: Solution Concept Paper

Vendors submit a 6-page Solution Concept Paper in response to a specific Innovation Call. DCSA reviews every concept paper submitted. Important nuance: this initial review may serve as the sole and entire evaluation. After review, the Government may select the most promising vendors and go straight to Phase 3, invite a limited number of vendors into Phase 2, or decide that no submission is suitable and make no selections.

Phase 2: Full Project Proposal (Optional, Invitation Only)

Selected vendors may receive an official invitation to a second evaluation phase. The invitation defines what is required, and it could be a Full Project Proposal, a technical demonstration, an oral presentation, or some combination. This phase is optional and is conducted only if the Government deems it necessary. Plan for the possibility that your 6 pages are the only thing DCSA ever reads.

Phase 3: Negotiation and Award

Vendors selected from either Phase 1 or Phase 2 proceed to collaborative negotiation. The goal is to jointly establish the framework for the prototype project, which includes refining the technical approach, developing a detailed Statement of Work, establishing well-defined milestones and deliverables, establishing a fair and reasonable price, and agreeing on mutual terms and conditions. The Agreements Officer is the only individual with authority to enter into, modify, or execute a binding agreement on behalf of the Government. Selection does not guarantee an award, and the Government may cancel at any point prior to execution.

Timeline and Key Dates

• June 23, 2026: DCSA Innovation Gateway published. The Gateway is the umbrella announcement, not a submission deadline.

• Ongoing through June 22, 2031: Individual Innovation Calls are published on SAM.gov at various times during the open period, each referencing the Gateway. Each call carries its own problem statement, submission email, deadline, security requirements, and timelines.

• Concept paper window: Set by each Innovation Call. These windows are typically short, which is why preparation before a call drops matters more than reaction speed after it.

• Within 24 hours of submission: All submissions are acknowledged with an email confirmation.

• At 48 hours: If you have not received confirmation, follow up to confirm delivery. DCSA is not responsible for email malfunctions or undeliverable email.

• After Phase 1 review: DCSA notifies vendors of results, including a Phase 2 invitation if applicable. No debriefs or feedback are provided on Phase 1 submissions.

• Phase 3: Negotiation timing varies with scope and complexity, and award occurs when collaborative and administrative activities are complete and funds are available.

The single most useful planning move is to monitor SAM.gov for Innovation Calls referencing HS0021-26-CSO-DCSA, and to have your company information, OTA eligibility certification, IP posture, and ROM structure drafted in advance so that only the problem-specific content needs to be written when a call opens.

What Goes in the 6-Page Solution Concept Paper

Proposers must use the Solution Concept Paper Template (Attachment 1). Any concept paper that does not use the required template will not be considered for review.

Format Rules You Cannot Change

• Page size 8.5 x 11 inches, 1 inch margins, single spacing

• Calibri Light, 11 point, black font in the final document

• Sections 1 through 6 are limited to 6 pages total

• Graphics and illustrations are allowed and are not subject to the format restrictions

• Tables are allowed but are subject to the format restrictions

• An acronym list or glossary is allowed outside the page count

• All grey instruction text in the template must be replaced or deleted before submission

• Altering template settings such as font, font size, line spacing, or margins is prohibited

• Do not include detailed project plans, formal quotes, or team resumes. The concept paper is not a full proposal, and the focus is meant to be exclusively on the quality of the concept.

• Email subject line format: DCSA - Innovation Call [insert #] - Concept Paper [insert Company Name]

Cover Page Contents (Outside the 6-Page Limit)

• Gateway number HS0021-26-CSO-DCSA, Innovation Call number and title

• A descriptive Solution Concept Paper title. Do not simply copy the Innovation Call title.

• Lead organization name, organization type, address, TIN or EIN, UEI, CAGE code, and NAICS code

• Subcontractors with name, email, business type, and CAGE code

• Technical POC (program manager or principal investigator) and administrative POC with full contact details

• Total ROM

• OTA eligibility certification under 10 U.S.C. 4022, with initials next to each applicable condition

• Proprietary data statement and page markings, if you are restricting data

• A table of contents

The Six Required Sections

• 1. Problem Understanding. Clearly describe your understanding of DCSA's operational problem and the desired end state for the user. This is where most commercial companies lose. Generic mission language reads as unfamiliarity. Name the workflow, the user, and the consequence of the status quo.

• 2. Proposed Concept and Vision. A one-page narrative describing your big idea, focused on the unique approach, the user experience, and the strategic value delivered. A simple concept diagram is encouraged, and since graphics are exempt from format restrictions, a strong visual buys you page space.

• 3. High-Level Technical Approach. Briefly outline your technical philosophy and explain why you recommend a particular technology stack, architectural style such as modular or open source, or development methodology such as Agile or DevSecOps for this specific problem. The emphasis is on rationale, not specifications.

• 4. Intellectual Property and Data Rights. State your data rights and licensing posture across three categories. Background IP: identify pre-existing software or algorithms delivered as proprietary background IP and state the specific license terms and user rights granted to the Government to run, integrate, and maintain it. Foreground IP: list proposed rights and license terms for custom software, code adapters, interfaces, or configurations developed under the effort. Dependencies: disclose third-party software, libraries, or data feeds required to sustain the prototype. This section is scored under Concept Viability, so a vague IP answer is a scored weakness, not a formality.

• 5. Risk and Opportunity Spotlight. Identify the single biggest technical or programmatic risk that could jeopardize the project, and the single biggest opportunity the Government might be overlooking. Answer both honestly. A paper that claims no meaningful risk reads as inexperienced.

• 6. Rough Order of Magnitude (ROM). A high-level cost estimate broken into major phases where applicable, with project phase, estimated duration, and estimated cost range, plus any cost share discussion.

How DCSA Evaluates Concept Papers

Concept papers are evaluated on their own merit against the Innovation Call and the criteria below, not against other concept papers submitted to the same call. This is a meaningful advantage. You are not fighting for a fixed number of slots against incumbents. You are clearing a bar.

• Concept Viability: Is the idea innovative, technically sound, and compelling? Are the proposed data rights and licensing viable for long-term integration?

• Mission Alignment: Does the vendor deeply understand the problem and its operational impact?

• Affordability: Is the ROM within an acceptable range for a prototype effort?

Note the phrase in Concept Viability about data rights being viable for long-term integration. DCSA is explicitly screening for lock-in risk. A restrictive license that leaves the Government unable to run, integrate, or maintain the capability can sink an otherwise strong technical concept.

Restrictive Markings, Proprietary Data, and FOIA

Data subject to use restrictions may be included in concept papers but must be clearly marked. You must identify and mark proprietary data intended for Government use only, and identify any technical data or computer software provided with use restrictions. In the absence of that identification, the Government will assume unlimited rights to all technical data and computer software in the concept paper. DCSA intends to treat concept papers as procurement sensitive before award and to disclose contents only to Government employees or designated support contractors for procurement related activities. Classified, sensitive, or critical technology information should not be included in a concept paper. Proposers are cautioned that portions may be subject to release under the Freedom of Information Act, 5 U.S.C. 552.

Non-Government advisors under signed NDAs may participate in evaluation of concept papers, full proposals, and negotiations. Submitting an offer constitutes a grant of authority for their use in all phases.

After Award: How Prototype OTAs Actually Run

• Iterative by design. Gateway OTAs are awarded with the intent to use an iterative development approach. The Government and the vendor may mutually agree to modify scope, objectives, and technical requirements during performance.

• Scope can expand without recompete. The agreement allows adapting the prototype based on technical discoveries and test results, expanding scope to address new or refined operational requirements, and implementing those changes within the existing OT without a new competitive action.

• Multiple paths to success. A prototype is successfully completed upon written determination that it met at least one of the following: fulfilled the key technical goals in the Statement of Work, satisfied the objective success metrics in the OT agreement, or achieved a favorable or unexpected result that provides significant operational utility and justifies transition to production.

• Partial completion is allowed. DCSA may declare a specific component successfully completed before the full effort concludes, which lets the Government transition valuable capabilities into production while other parts are still in development.

• Follow-on production without recompete. Under 10 U.S.C. 4022(f), a follow-on production contract or transaction may be awarded to prototype participants without further competition, contingent on successful completion to the Government's satisfaction.

Is the DCSA Innovation Gateway Right for Your Startup?

Strong fit signals:

• You sell commercial software, data infrastructure, AI and analytics, identity, or cybersecurity capability that can be adapted to a vetting, insider threat, or industrial security workflow

• You are a small business or nontraditional defense contractor, so no cost share is triggered

• Your architecture is modular and integrates with existing systems rather than requiring a rip and replace

• You can offer the Government license terms that support long-term integration and sustainment

• You want a path into DoD that does not require winning a full FAR-based competition first

Weaker fit signals:

• Hardware-heavy concepts with no clear digital or data integration tie to the four priority areas

• Fully automated trust or adjudication decisions that remove the human from the loop

• Highly proprietary, closed licensing that creates vendor lock-in

• Concepts that solve a single system's problem with no reuse potential across the enterprise

• Companies that cannot meet a clearance requirement if a specific Innovation Call imposes one

Frequently Asked Questions

What is the DCSA Innovation Gateway?

The DCSA Innovation Gateway (HS0021-26-CSO-DCSA) is a five-year competitive solicitation from the Defense Counterintelligence and Security Agency that results in the award of prototype projects through Other Transaction Agreements under 10 U.S.C. 4022. It announces DCSA's general areas of interest and the criteria for selecting Solution Concept Papers. Specific requirements are issued separately through Innovation Calls published on SAM.gov.

How do I apply to the DCSA Innovation Gateway?

You do not apply to the Gateway directly. You respond to a specific Innovation Call published on SAM.gov under the Gateway by emailing a 6-page Solution Concept Paper, using the required template, to the address named in that call, with the subject line format DCSA - Innovation Call [number] - Concept Paper [company name].

Can I submit an unsolicited proposal to DCSA under the Gateway?

No. The Government will only accept proposals submitted in response to an Innovation Call. Unsolicited proposals that are not in response to an Innovation Call will not be reviewed.

How much funding can I receive through a DCSA prototype OTA?

The Gateway does not publish a fixed award ceiling. You propose a total Rough Order of Magnitude cost in the concept paper, broken into phases with estimated durations and cost ranges, and the final value is negotiated during Phase 3. Affordability is an evaluation criterion, so the ROM must be defensible for a prototype effort. Individual Innovation Calls may specify their own funding parameters.

Is cost sharing required for a DCSA prototype OTA?

Cost sharing is not required in most cases. Prototype OTs require cost share only when the team does not include a significantly involved nontraditional defense contractor and is not composed entirely of small businesses or nontraditional defense contractors. In that case, at least one third of total cost must come from non-federal funds unless a waiver is granted, and waivers are uncommon and require significant justification. Voluntary cost share is encouraged where commercial application is likely.

Can a startup with no prior DoD contracts qualify?

Yes, and that is the intent. A nontraditional defense contractor is an entity that is not currently performing, and has not performed for at least one year prior to the solicitation, any DoD contract or subcontract subject to full Cost Accounting Standards coverage. Most commercial startups and small businesses meet that definition, which satisfies OTA eligibility without any cost share.

Do I need a security clearance to submit a concept paper?

It depends on the Innovation Call. Each call specifies its own security requirements, including whether facility or personnel clearances are required and whether non-U.S. organizations or individuals may participate. Clearance requirements are verified before award, so read the specific call carefully before investing in a submission.

Can a foreign-owned or foreign-invested company participate?

Each Innovation Call states whether non-U.S. organizations or individuals may participate. Where participation is allowed, all forms of foreign participation must be clearly and fully disclosed in the proposal, and for CUI or classified submissions any Foreign Ownership, Control, or Influence issues must be disclosed and mitigated before the submission is transmitted to DCSA.

How long is the Solution Concept Paper and what format is required?

Sections 1 through 6 are limited to 6 pages, in Calibri Light 11 point, single spaced, with 1 inch margins on 8.5 x 11 inch pages. The required template (Attachment 1) must be used, and a concept paper that does not use the template will not be considered for review. Graphics are exempt from format restrictions, and an acronym list or glossary does not count against the page limit.

What are the evaluation criteria for a Solution Concept Paper?

Three criteria: Concept Viability, meaning whether the idea is innovative, technically sound, and compelling, and whether the proposed data rights and licensing are viable for long-term integration; Mission Alignment, meaning whether the vendor deeply understands the problem and its operational impact; and Affordability, meaning whether the ROM is within an acceptable range for a prototype effort. Papers are judged on their own merit, not against competing submissions.

Will DCSA give me feedback if my concept paper is not selected?

No. DCSA notifies vendors of concept paper evaluation results, but debriefs and feedback on Phase 1 submissions are not provided.

Is Phase 2 guaranteed if my concept paper is strong?

No. The Phase 1 review may serve as the sole and entire evaluation. DCSA may select the most promising vendors and proceed directly to Phase 3 negotiation and award, invite a limited number of vendors to Phase 2, or make no selections at all. Phase 2 is optional and occurs only if the Government deems it necessary.

What happens after a successful prototype project?

Under 10 U.S.C. 4022(f), a follow-on production contract or transaction may be awarded to prototype participants without further competition, contingent on successful completion to the Government's satisfaction. Follow-on production may include procurement of additional units, scaling of the prototype technology, or implementation of the solution.

How is this different from SBIR or STTR?

SBIR and STTR are structured research programs with fixed phase sizes, set topic cycles, and statutory small business eligibility. The Innovation Gateway is an Other Transaction vehicle with negotiated scope, negotiated price, negotiated terms, no fixed award size, and a non-competitive path to production. The trade-off is that terms and IP are negotiated rather than standardized, so preparation on data rights matters more. Many companies pursue both, using SBIR for technology maturation and an OTA for mission integration.

What administrative registrations do I need before award?

An active SAM.gov registration with a Unique Entity Identifier, a CAGE code, registration in the prescribed Government invoicing system such as PIEE, any clearances required by the Innovation Call, no suspension or debarment, a favorable responsibility determination by the Agreements Officer, and mitigation of any organizational conflicts of interest.

How BW&CO Helps Companies Win DCSA Prototype OTAs

BW&CO is a non-dilutive funding advisory firm that has helped clients secure more than $350M in government funding. For the DCSA Innovation Gateway, the work starts well before an Innovation Call is published: positioning your technology against the four technical priority areas, confirming your OTA eligibility path, building a defensible ROM and phasing structure, and settling your background and foreground IP posture so that the data rights section strengthens your score instead of weakening it. When a call drops, the window is short, and companies that prepared in advance are the ones that submit something worth reading.

Innovation Funding Simplified. If you are evaluating the DCSA Innovation Gateway or any other defense prototype pathway, contact BW&CO for a funding fit assessment.

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

Executive Summary

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

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

At a Glance

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

• Funding Opportunity Number: NCBSTI-FY2627I

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

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

• Release date: September 14, 2026

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

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

• Total funds available: $210,000

• Maximum award: $12,000 per company

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

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

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

What the Incentive Program Actually Does

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

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

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

Who Is Eligible

Company requirements

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

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

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

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

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

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

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

Proposal requirements

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

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

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

What does not qualify

• Direct to Phase II applications

• Phase II applications

• Proposals received by the federal agency outside the solicitation period

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

Funding Allowance: How Much You Get Back

Reimbursement rates by county tier

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

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

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

What that looks like in practice

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

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

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

Resubmissions

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

Award limits

• One Incentive award per company during this solicitation period

• Ten Incentive awards per company over its lifetime

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

Eligible and Ineligible Expenses

Reimbursable costs

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

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

• Typing and word processing services

• Project related supplies and postage

• Database search fees for project related literature searches

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

• Educational program fees directly related to preparing the federal proposal

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

Non-reimbursable costs

• Travel

• Equipment purchases over $300

• Facility or leasehold improvements

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

• Fringe benefits

• Indirect costs, including rent paid for general operations

• In-kind services or deferred salaries

Documentation standards

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

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

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

Timeline and Key Dates

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

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

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

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

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

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

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

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

How to Apply

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

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

Required Application Documents

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

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

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

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

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

• A Supplier Electronic Payment Request Form with bank account verification

• A completed Certified Expense Table with supporting documentation in CyberGrants

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

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

How Applications Are Reviewed

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

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

Reporting Requirements After Award

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

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

How Competitive Is It, Really

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

Recent Incentive Program history gives a sense of the pace:

• FY 2026: 18 awards totaling $116,553

• FY 2025: 51 awards totaling $418,863

• FY 2024: 49 awards totaling $317,316

• FY 2023: 48 awards totaling $345,562

• FY 2022: 50 awards totaling $358,986

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

What Comes Next: the Matching Funds Program

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

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

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

Common Mistakes That Cost Companies the Award

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

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

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

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

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

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

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

How BW&CO Helps

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

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

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

Frequently Asked Questions

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

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

How much money can my company receive?

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

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

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

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

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

Are SBIR consulting fees reimbursable under this program?

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

Are Direct to Phase II or Phase II proposals eligible?

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

Is a Fast Track proposal eligible?

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

What proposals fall inside the eligible window?

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

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

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

How many times can my company apply?

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

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

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

What expenses are not reimbursable?

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

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

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

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

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

How competitive is the program?

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

When should I apply?

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

Talk to Us Before You Spend the Money

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

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

Executive Summary

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

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

Key facts at a glance

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

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

• Total prize pool: Up to $994,000

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

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

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

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

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

• Accelerator period: June 2027 through November 2027

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

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

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

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

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

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

Strong candidate profiles include:

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

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

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

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

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

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

What is NIA looking for? Detailed technology overview

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

Core areas of interest

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

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

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

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

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

Artificial intelligence is a stated priority

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

• Early detection of aging-related disease and decline

• Risk prediction and stratification

• Personalized interventions

• Rapid drug discovery and development

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

Evidence, accessibility, and population reach

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

Two differentiation requirements you cannot skip

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

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

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

Where this Challenge sits in the federal innovation pipeline

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

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

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

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

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

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

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

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

How prize money differs from grant funding

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

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

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

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

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

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

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

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

What the accelerator program includes

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

• Weekly virtual education sessions led by industry experts

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

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

• Business and regulatory guidance at no cost to the finalist

• In-depth pitch coaching

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

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

• Virtual and in-person networking with key industry partners

Time commitment

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

Stage 1 learning objectives

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

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

• Develop a value proposition that solves an identified unmet need

• Create a scalable go-to-market strategy

• Evaluate applicable intellectual property, regulatory, and reimbursement pathways

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

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

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

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

2027 NIA Start-Up Challenge timeline and key dates

• September 1, 2026: Challenge launched

• December 1, 2026: Registration and submission portal opens

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

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

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

• May 2027: Stage 1 finalists announced

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

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

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

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

• January 2028: Stage 2 winners announced

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

Eligibility rules: who can win a prize

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

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

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

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

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

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

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

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

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

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

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

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

Participation rules and federal funding restrictions

The small business formation commitment

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

Use of federal funds

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

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

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

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

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

Risk, insurance, and compliance

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

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

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

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

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

How to enter the 2027 NIA Start-Up Challenge

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

Confidentiality warning

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

For teams

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

For entities

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

Submission requirements

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

• Late submissions will not be accepted

How submissions are scored

The four step review process

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

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

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

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

Stage 1 evaluation criteria, 100 points total

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

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

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

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

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

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

The portfolio impact criterion, and how to earn it

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

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

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

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

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

Stage 2 requirements for finalists

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

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

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

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

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

Stage 2 evaluation criteria, 100 points total

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

Mentor assessment and one-page document, 45 points:

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

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

7-minute pitch video, 55 points:

• Significance, 0 to 15 points

• Innovation, 0 to 15 points

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

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

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

How to build a competitive submission

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

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

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

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

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

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

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

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

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

How this fits a broader non-dilutive funding strategy

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

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

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

Frequently asked questions

Is the NIA Start-Up Challenge a grant?

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

How much money can a startup win?

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

Does NIA take equity in exchange for the prize?

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

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

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

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

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

Can previous NIA Start-Up Challenge finalists reapply?

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

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

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

When does the submission window open and close?

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

How many submissions can I make?

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

How much time does the accelerator require?

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

Are travel costs to the in-person events covered?

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

Do I have to attend the in-person events?

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

Can I use federal grant funds to prepare my submission?

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

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

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

Is the prize money taxable?

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

What happens if I am not selected as a finalist?

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

Can I include confidential or proprietary information in my submission?

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

Who receives the prize money for a team submission?

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

Official resources and next steps

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

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

• Challenge team email: niastartupchallenge@nih.gov

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

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

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

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

Executive Summary

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

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

What Is the Reconstructive Transplant Research Program?

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

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

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

The Two FY2026 RTRP Award Mechanisms

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

Concept Award (HT942526RTRPCA)

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

• Maximum period of performance: 18 months

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

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

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

• Project Narrative: 2-page limit

• Clinical trials: Not allowed

• Announcement type: Modified. Version code CD26_01d

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

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

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

Investigator-Initiated Research Award (HT942526RTRPIIRA)

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

• Maximum period of performance: 3 years

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

• Eligible PI: Independent investigators at all career levels

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

• Project Narrative: 10-page limit

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

• Announcement type: Initial. Version code CD26_01d

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

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

FY2026 RTRP Deadlines and Timeline

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

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

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

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

• Peer review: January 2027

• Programmatic review: March 2027

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

• Awards made: no later than September 30, 2027

• FY2026 funds expire for use: September 30, 2032

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

Who Is Eligible to Apply

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

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

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

Cost sharing: Not required for either mechanism.

FY2026 RTRP Focus Areas: What the Program Is Looking For

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

1. Improve or optimize VCA immunosuppression

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

• Develop novel tolerogenic agents or approaches for VCA immunosuppression

• Develop less toxic or personalized regimens for maintenance immunosuppression

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

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

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

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

3. Advance VCA preservation strategies

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

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

4. Develop tools for measuring VCA outcomes

• Performance or function-based measures

• Patient-reported measures

• Neurocognitive measures

Leveraging solid organ transplant findings

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

Funding Allowance and Budget Rules

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

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

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

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

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

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

How to Submit: A Two-Step Process

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

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

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

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

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

Step 2: Full Application

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

• Intramural DOW organizations only: may submit through eBRAP

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

Step 3: Verify in eBRAP

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

Required registrations

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

Application Components by Mechanism

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

Concept Award attachments

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

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

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

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

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

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

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

Investigator-Initiated Research Award attachments

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

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

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

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

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

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

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

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

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

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

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

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

How Applications Are Reviewed

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

Concept Award review criteria, in decreasing order of importance

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

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

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

Programmatic review criteria for both mechanisms

• Ratings and evaluations of peer reviewers

• Adherence to the intent of the funding opportunity

• Program portfolio composition

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

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

Compliance Traps That Sink Applications

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

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

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

Possible administrative withdrawal:

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

• Proposing a clinical trial

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

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

• A PI who does not meet the eligibility criteria

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

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

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

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

• Failing to conform to the program announcement description

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

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

Post-Award Requirements

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

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

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

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

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

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

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

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

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

Which Award Should a Startup Pursue?

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

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

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

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

Frequently Asked Questions

What are the FY2026 RTRP deadlines?

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

Is a Letter of Intent required?

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

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

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

How much funding can I request?

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

Do I need preliminary data?

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

Are clinical trials allowed?

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

Is cost sharing required?

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

How many RTRP applications can one investigator submit?

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

Can foreign organizations apply?

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

How competitive is the FY2026 RTRP?

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

Where do I submit the LOI versus the full application?

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

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

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

What happens if my application exceeds a page limit?

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

When will FY2026 RTRP awards be made?

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

What if my project involves animal studies?

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

Next Steps

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

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

DOE ASPECT Funding Opportunity (DE-FOA-0003647): Executive Summary for Startups

Updated October 2026: This opportunity is closed. The deadline for this opportunity has passed. Browse currently open opportunities in our funding database.

The U.S. Department of Energy has released Accelerating Scale-up and Pre-piloting of Emerging Chemical Technologies (ASPECT), funding opportunity number DE-FOA-0003647, offering up to $58 million to advance chemical production technologies that use domestically sourced biomass and waste feedstocks. The opportunity is issued by the Alternative Fuels and Feedstocks Office (AFFO) within DOE's Critical Minerals and Energy Innovation (CMEI) organization.

ASPECT is built for companies that have moved past proof of concept and need capital to validate, de-risk, and scale a chemical process. Awards are cooperative agreements, cost share is required, and a concept paper is mandatory. If you do not submit a concept paper by October 9, 2026, you cannot submit an application at all.

ASPECT at a Glance

• Funding opportunity number: DE-FOA-0003647

• Agency: U.S. Department of Energy, CMEI, Alternative Fuels and Feedstocks Office (AFFO)

• Total available funding: up to $58,000,000

• Funding instrument: cooperative agreements (DOE has substantial involvement, including go/no-go authority)

• Assistance listing: 81.087, Renewable Energy Research and Development

• Announcement type: Research, Development, and Demonstration

• Individual awards: $2,000,000 to $10,000,000 under Topic Area 1; $10,000,000 to $20,000,000 under Topic Area 2

• Expected number of awards: 0 to 7 under Topic Area 1; 0 to 3 under Topic Area 2

• Minimum cost share: 20 percent for R&D tasks, 50 percent for demonstration and commercial application tasks

• Project period: 24 to 48 months (Topic Area 1); 24 to 60 months (Topic Area 2)

• Application process: required concept paper, then Stage 1 by invitation, then Stage 2 by invitation

• Submission portal: DOE eXCHANGE (eere-exchange.energy.gov)

• Program email: ASPECT@doe.gov

Key Dates and Deadlines

• NOFO issued: September 4, 2026

• Informational webinar: September 11, 2026, 1:00 p.m. ET

• Concept paper deadline (required): October 9, 2026, 5:00 p.m. ET

• Stage 1 application deadline: December 1, 2026, 5:00 p.m. ET

• Stage 2 application deadline: February 12, 2027, 5:00 p.m. ET

• Anticipated selection notification: April 8, 2027

• Anticipated award date: April 12, 2027

All deadlines are 5:00 p.m. ET. DOE will not extend deadlines for server congestion or upload problems, and applicants are advised to submit at least 48 hours early. SAM.gov registration alone can take several weeks, so registration work should start now rather than in October.

What DOE Is Actually Trying to Fund

ASPECT exists because U.S. chemical production has fallen more than 8 percent since 2017 while global production grew more than 17 percent. DOE's stated intent is to re-shore chemical manufacturing, reduce import reliance, strengthen domestic supply chains, and build out biomanufacturing capacity using America's biomass and waste resources.

Practically, that means DOE wants processes that convert an approved biomass or waste feedstock into a chemical with a real commercial advantage, backed by techno-economic analysis and an industrial partner who confirms the product is marketable. Two categories of target chemical qualify:

• Conventional chemicals that already have a market, provided the proposed pathway offers an additional advantage such as strengthening domestic supply chains, reducing imports, lowering cost, reducing pathway toxicity, or enabling significant market growth.

• Bio-advantaged chemicals that offer advantages in function, cost, or trade and national security benefits, such as enhanced durability, higher production efficiency, or decreased toxicity.

DOE also named two specific areas of interest under Topic Area 1: technologies that can be scaled by using or modifying existing U.S. ethanol fermentation infrastructure, and technologies that produce 3-hydroxypropionic acid. These are not exclusive, but they signal where reviewers expect strong fits.

Key Requirements That Apply to Every Application

• Justify the target chemical. It must be a conventional or bio-advantaged chemical, with the specific advantage explicitly articulated.

• Market size. Target chemicals should have annual U.S. production of at least 1 million metric tons. Smaller volumes may be considered with justification, but applications targeting small, niche, or fine chemical markets are specifically not of interest.

• Industrial partner. An industrial partner such as a chemical manufacturer is required on every project team, under both topic areas. Applications under both topic areas must include at least one for-profit industry entity as either the prime recipient or a subrecipient. If the industrial partner is not the prime applicant, a letter of commitment is required with the application.

• Approved feedstock. The primary feedstock must appear on the acceptable feedstock list in Appendix A of the NOFO.

• Verification process. All applicants selected for award negotiations must participate in a third-party verification process led by a non-conflicted DOE verification team.

• Peer review participation. Attendance and participation at the AFFO Biennial Peer Review Meeting is required.

• Domestic performance. The project must be located in the United States, and all work must be performed in the United States absent an approved waiver.

• Analysis. Preliminary techno-economic analysis (TEA) and life cycle analysis (LCA) are required, and Subtopic Area 1b requires detailed TEA and LCA rather than preliminary.

Topic Area 1: Bench ASPECT

Topic Area 1 supports research and development of new chemical production technologies, moving them beyond proof of concept toward bench and pre-pilot scale. Approximate total funding for this topic area is up to $28,000,000, with 0 to 7 awards, individual awards of $2,000,000 to $10,000,000, a 20 percent minimum cost share, project periods of 24 to 48 months, and budget periods of 12 to 24 months.

Subtopic Area 1a: Bench-Scale Technologies

Subtopic 1a is for technologies beyond proof of concept and ready for additional bench-scale process development and optimization at TRL 2. Each project is eligible for up to $5,000,000 in federal funding with a minimum 20 percent cost share. The envisioned structure is Budget Period 1 for verification of application data, a go/no-go decision, then Budget Period 2 for bench-scale work, across 12 to 24 months.

One caution specific to 1a: applications that use model compounds instead of real feedstocks after Budget Period 1 are specifically not of interest.

Subtopic Area 1b: Bench-Scale and Unit Operation Pre-piloting

Subtopic 1b combines bench-scale R&D in Phase 1 (TRL 2) with pre-piloting of one or more unit operations in Phase 2 (TRL 3 or TRL 4). Each project is eligible for up to $10,000,000 in federal funding, structured as up to $5,000,000 for Phase 1 and up to an additional $5,000,000 for Phase 2, with a minimum 20 percent cost share throughout.

The envisioned schedule runs Phase 1 across 18 to 30 months (verification, go/no-go, bench-scale work, pre-pilot design, then a stage gate approving the pre-pilot performance baseline) and Phase 2 across 12 to 18 months (procurement and construction, then commissioning and operations).

Additional 1b requirements include detailed TEA and LCA, the ability to demonstrate during initial verification that the unit operations of interest are at TRL 3 or TRL 4, proof that you can produce the final targeted chemical when the advantaged property appears only in the finished product, and Phase 2 downstream unit operations sized for the process streams produced from 0.5 dry tons per day (DTPD) of feedstock.

Specifically not of interest under 1b: work on heterogeneous catalysts in powder form for thermocatalytic processes, strain discovery for biochemical processes, development of electrocatalytic cells, and use of model compounds instead of real feedstocks in any budget period.

Topic Area 1 Expected Outcome

By the end of the performance period, projects must produce a sufficient quantity of the target chemical at a purity level appropriate for product or formulation testing. The quantity must be defined and justified for the specific chemical and application, and the performance metrics and purity requirements must be established in partnership with a manufacturer so the resulting material is actually marketable.

Topic Area 2: Pre-pilot ASPECT

Topic Area 2 funds the design, construction, and operation of pre-pilot scale facilities that convert alternative feedstocks into chemicals. Approximate total funding is up to $30,000,000, with 0 to 3 awards, individual awards of $10,000,000 to $20,000,000, project periods of 24 to 60 months, and budget periods of 12 to 24 months.

The minimum baseline is TRL 4, with a maximum of TRL 5 at project conclusion. Projects must build an integrated pre-pilot system capable of processing at least 0.5 DTPD of feedstock, and applicants must justify the chosen scale using sound engineering principles, prior-scale data, and scaling factors. DOE offers scaling to roughly 1/100th of a commercial-scale process for continuous operation as an example of an appropriate target.

Note the eligibility restriction here: institutions of higher education can participate in Topic Area 2 only as subrecipients, not as prime recipients.

Subtopic Area 2a: Unit Operation Pre-piloting and Pre-pilot System Integration

Subtopic 2a is for technologies with one or two unit operations that need further investigation on industrially relevant equipment before the integrated system can be designed. Each project is eligible for up to $20,000,000 in federal funding, with no more than $5,000,000 in Phase 1 and up to $15,000,000 in Phase 2. Cost share is 20 percent for Phase 1 activities and 50 percent for Phase 2 activities.

Phase 1 runs 18 to 24 months and covers verification of prior-scale data, unit operation pre-piloting, verification of unit operation results and system data correlation, and pilot design basis definition, with go/no-go decisions between steps. Phase 2 runs 24 to 36 months and covers planning and final design, final design approval, procurement and construction, then commissioning and operations.

Subtopic Area 2b: Pre-pilot System Integration Only

Subtopic 2b is for technologies already at TRL 5, supported by all necessary prior-scale data, and ready to begin design of the 0.5 DTPD pre-pilot facility. Each project is eligible for up to $15,000,000 in federal funding with a minimum 50 percent cost share. Phase 1 is roughly 12 months (verification and design basis definition, with a stage gate approving the pre-pilot performance baseline), and Phase 2 runs 24 to 36 months (final design, design approval, procurement and construction, commissioning and operations).

Topic Area 2 Time-on-Stream Requirements

By project conclusion, Topic Area 2 projects are expected to meet minimum operating hours:

• Subtopic 2a: 500 cumulative hours per unit operation and 1,500 cumulative hours on the pre-pilot system; 100 continuous hours per unit operation and 1,000 continuous hours on the pre-pilot system.

• Subtopic 2b: 1,500 cumulative hours and 1,000 continuous hours on the pre-pilot system.

Topic Area 2 applications must also include a block flow diagram (BFD) and supplemental data sheet using the DOE templates on eXCHANGE, and all major equipment in the pre-pilot plant must match the equipment type planned for the eventual commercial facility. If the commercial system uses a fluidized bed, the pre-pilot system must use a fluidized bed. Recipients will also be required to provide anonymized input to DOE's design cases to refine program TEA and LCA models.

Cost Share Requirements

Cost share is calculated as a percentage of total project cost, which includes the government share, FFRDC costs if applicable, and your recipient share. Minimum cost share by subtopic area:

• Subtopic 1a: 20 percent

• Subtopic 1b: 20 percent

• Subtopic 2a: 20 percent for Phase 1, then 50 percent for Phase 2

• Subtopic 2b: 50 percent

Applications that do not meet the minimum required cost share are deemed ineligible during the initial compliance review. Cost share must come from nonfederal sources unless otherwise allowed by law, and it can be cash, cash equivalents, or in-kind contributions that are verifiable at the time of submission.

Sources that cannot be used include federal funds or federally owned property, cost share derived from programs executed by the Office of Energy Dominance Financing, revenues or royalties from operations beyond the project period, proceeds from the prospective sale of an asset, expenditures reimbursed under another federal program, contributions already counted toward another federal project, and existing data donated as an in-kind contribution. Contractors may not provide cost share, and partial donations of goods or services count as discounts rather than cost share.

Who Is Eligible to Apply

The following domestic entities are eligible as prime recipients and subrecipients: institutions of higher education, for-profit organizations, nonprofit organizations, state and local government entities, and Indian Tribes. To qualify as a domestic entity, the organization must be legally formed in the United States and have a physical location for business operations in the United States.

Participation limits to note:

• Institutions of higher education may be prime recipients or subrecipients under Topic Area 1, but only subrecipients under Topic Area 2.

• DOE and non-DOE FFRDCs and other federal agencies and instrumentalities may participate only as subrecipients. The National Energy Technology Laboratory may participate only as a subrecipient.

• FFRDC effort in aggregate must not exceed 50 percent of total project cost, and FFRDC participation requires written authorization plus a CRADA or technical assistance agreement.

• Foreign entities are generally not eligible as recipients or subrecipients. A foreign entity may be included only with an explicit written waiver request submitted with the application, and DOE's decision is final and not appealable.

• Ineligible participants include debarred or suspended entities, entities on the OFAC Specially Designated Nationals list, and 501(c)(4) organizations that engaged in lobbying after December 31, 1995. Entities of Concern are prohibited from participating.

You may submit multiple concept papers if each addresses a distinct and scientifically unique project concept. DOE will consider only one Stage 1 application per eligible concept paper.

Acceptable Feedstocks

Applications proposing a feedstock not on DOE's acceptable list will not be considered. Acceptable feedstocks under ASPECT include:

• Lignocellulosic feedstocks, including crops, trees, forest residues, and agricultural residues not grown for food

• Algae, defined as eukaryotic microalgae, macroalgae, and cyanobacteria

• Organic wet waste, including municipal wastewater sludge and biosolids, food wastes, organic-rich industrial wastewaters, and manure slurries

• Sorted municipal solid waste, meaning the organic and plastic constituents of the landfill-bound stream

• Food waste from industrial, commercial, and residential sources

• Biogas

• Grain starch from yellow dent feed corn, wheat, and grain sorghum or milo

• Oilseed crops such as soybeans, cottonseed, sunflower, canola, rapeseed, peanuts, camelina, carinata, and pennycress

• Construction and demolition waste

• Waste carbon dioxide from fermentation, biomass combustion, biopower, or other anthropogenic utility and industrial sources

• Biointermediates, meaning stable intermediate products derived from another acceptable feedstock

Carbon dioxide captured from ambient air is not an acceptable feedstock under this NOFO.

Applications Specifically Not of Interest

DOE will not review these, and the determination cannot be appealed:

• Applications outside the technical parameters in the program purpose and topic areas

• Technologies not based on sound scientific principles

• Applications proposing primary products used solely as fuels

• Processes targeting food or protein (amino acids excepted) or biomass as the primary product

• Applications proposing ethanol as a final product

• Applications proposing pharmaceuticals, nutraceuticals, food additives, or cosmetics as final products

• Applications using model compounds instead of real feedstocks, excluding Subtopic 1a proposals

• Applications that do not use an allowable feedstock from Appendix A

• Technology that is already operating commercially

• Applications without an industrial entity as applicant or partner

• Processes targeting small, niche, or fine chemical markets, or potential markets under 1 million metric tons per year, absent justification

The Three-Stage Application Process

Stage 0: Concept Paper (Required)

The concept paper is required for every applicant and is limited to 5 total pages at no smaller than 12-point font. DOE provides a custom abbreviated template on eXCHANGE, and while the template is not mandatory, every element it requests must be addressed. The recommended allocation is 1 page for administrative information and 4 pages for characteristics of the proposed project. Anything beyond 5 pages will not be reviewed and may disqualify the submission.

Concept papers are scored on a single criterion at 100 percent weight: overall NOFO responsiveness and viability of the project. Reviewers confirm that the applicant meets eligibility requirements, that all key requirements and topic-area-specific requirements are addressed, and that the concept does not fall into an area specifically not of interest. Encouraged applicants are invited to submit a Stage 1 application. Decisions are final with no appeal.

Stage 1 Application (By Invitation Only)

Stage 1 is the technical review package. Technical volume page limits by subtopic area:

• Subtopic 1a: 15 pages

• Subtopic 1b: 25 pages

• Subtopic 2a: 30 pages

• Subtopic 2b: 25 pages

Page limits include the cover page, table of contents, citations, charts, graphs, photos, and all graphics. Required Stage 1 components include the SF-424, technical volume, block flow diagram (Topic Area 2 only, 5 pages), budget justification workbook, a biosketch and current and pending support disclosure for each Covered Individual, a digital persistent identifier such as ORCID for each Covered Individual, research security training certification, and Transparency of Foreign Connections disclosures for the applicant and each subrecipient.

Covered Individuals include the PI, project director, co-PI, co-project director, project manager, and anyone functionally performing those roles. Submitting a biosketch and disclosure for a person acknowledges that DOE designates them as a Covered Individual, which creates an ongoing disclosure obligation for the life of the award.

Stage 2 Application (By Invitation Only)

Stage 2 is the full application, requested only from proposals deemed meritorious in Stage 1. It adds letters of commitment (one page each), a Statement of Project Objectives (10 pages), a Project Management Plan (5 pages), SF-424A and subrecipient budget justifications, FFRDC work proposals and authorizations if applicable, foreign entity waivers if applicable, Impacted Indian Tribes documentation if applicable, a potentially duplicative funding notice, locations of work, an environmental questionnaire, lobbying forms, a one-page public summary, a one-slide summary, a pre-award information sheet, indirect cost rate documentation, and the most recent independent audit.

Documents already submitted at Stage 1 must be resubmitted at Stage 2 if anything has changed.

How Applications Are Scored

Stage 1 applications are evaluated against weighted technical review criteria, with all sub-criteria weighted equally.

Topic Area 1 Criteria

• Technical Merit, Innovation, and Impact: 40 percent

• Project Demonstration and Market Transformation Plan: 40 percent

• Team and Resources: 20 percent

Topic Area 2 Criteria

• Technical Approach and Impact: 30 percent

• Financial and Market Viability: 25 percent

• Management and Organization: 25 percent

• Workplan: 20 percent

The weighting tells you where to spend your pages. Under Topic Area 1, commercialization and market transformation carry the same weight as the science, so a technically brilliant application with a thin market plan will not score well. Under Topic Area 2, technical merit accounts for less than a third of the score, while financial viability, management capability, and workplan discipline together account for 70 percent. Reviewers at that level are assessing whether your team can actually build and operate a plant on schedule.

Beyond technical review, all applications undergo a Research, Technology, and Economic Security (RTES) due diligence review, and DOE may also conduct pre-selection interviews, pre-selection clarifications, entity risk assessments, and financial capability reviews. DOE's decisions on due diligence reviews are not appealable.

What Happens After Selection

Awards are cooperative agreements, which means DOE shares responsibility for project direction and can intervene, redirect, or stop funding at go/no-go decision points. Several post-award mechanics deserve attention during planning:

• Verification. Every selectee participates in an initial verification during months 0 to 3, conducted by a non-conflicted third-party team, to confirm the baseline data in your application. This must appear in your scope as Task 1, separated from the rest of the work by a go/no-go decision point, with roughly three months allocated. Intermediate verifications occur at go/no-go points, and a final verification occurs within three months of closeout.

• Go/no-go reviews and program down-select. Continuation funding depends on technical progress, appropriations, reporting compliance, RTES assessment, and DOE approval of a continuation application. Some projects will not receive funding past a decision point even when they are meeting predefined metrics.

• Milestones. Workplans require at least one milestone per quarter and at least one SMART technical milestone per year, each with a stated verification method.

• Davis-Bacon Act requirements apply to awards under this NOFO, including certified weekly payrolls and use of LCPtracker.

• Buy America Preference applies to infrastructure projects under this NOFO, though it does not apply to prime recipients that are for-profit entities. Equipment and supplies should be American made to the greatest extent practicable.

• Award negotiation takes at least 60 days, and pre-award costs require written approval from the Grants Officer.

• Audits. A for-profit recipient expending $1,000,000 or more in DOE awards in a fiscal year requires an annual independent compliance audit. Budget for it.

• Intellectual property. Small businesses, universities, and nonprofits may elect to retain title to subject inventions under Bayh-Dole. DOE has issued a class patent waiver covering domestic large businesses under this NOFO. The government retains a paid-up nonexclusive license and march-in rights, and U.S. manufacturing commitments apply.

Required Registrations

• SAM.gov registration with an active Unique Entity Identifier (UEI). This can take several weeks.

• DOE eXCHANGE account at eere-exchange.energy.gov, with a designated primary and backup point of contact.

• Grants.gov registration, which requires a Login.gov account, to receive NOFO modification notices.

• FedConnect registration, required to receive the executed award package. Registration can take up to three days.

How to Position a Competitive ASPECT Concept Paper

The concept paper is a gate, not a beauty contest. It is scored entirely on responsiveness and viability, which means most rejections at this stage are self-inflicted. A strong submission does five things clearly in five pages:

• Names the target chemical and its advantage in specific terms. Not "a platform chemical with sustainability benefits," but the molecule, the incumbent pathway, the annual U.S. production volume, and the measurable advantage in cost, performance, supply chain, or trade and national security.

• Names the feedstock from Appendix A. If your process runs on something outside the list, the concept paper will be screened out regardless of technical quality. Ambient-air carbon dioxide is explicitly excluded.

• Names the industrial partner. A chemical manufacturer on the team who will confirm purity and performance requirements is a requirement, not a differentiator. Missing it is a rejection criterion.

• Picks the right subtopic honestly. Overreaching into Topic Area 2 without TRL 4 data, or into 2b without complete prior-scale data, invites a bad review. Choosing 1a or 1b with a realistic phase plan is usually the better path for an early-stage company, and 1b provides an on-ramp to pre-pilot work without waiting for a new solicitation.

• Shows the cost share is real. Cost share must be verifiable at submission. A 50 percent match on a $15,000,000 Subtopic 2b project is a substantial commitment, so the source needs to be identified early, and letters of commitment will be required from third-party contributors.

The two most common reasons strong technologies lose here are structural rather than scientific: a target market under 1 million metric tons per year without a justification, and a commercialization plan that reviewers cannot connect to a specific customer. Both are fixable before October 9.

Frequently Asked Questions

What is the DOE ASPECT funding opportunity?

ASPECT stands for Accelerating Scale-up and Pre-piloting of Emerging Chemical Technologies. It is a DOE Alternative Fuels and Feedstocks Office funding opportunity offering up to $58 million for research, development, and pre-pilot testing of technologies that produce chemicals from domestically sourced alternative and waste feedstocks.

What is the ASPECT funding opportunity number?

The funding opportunity number is DE-FOA-0003647. Applications are submitted through DOE eXCHANGE at eere-exchange.energy.gov, and the program contact is ASPECT@doe.gov.

How much funding is available through ASPECT?

Up to $58,000,000 total. Topic Area 1 (Bench ASPECT) has up to $28,000,000 across 0 to 7 awards, and Topic Area 2 (Pre-pilot ASPECT) has up to $30,000,000 across 0 to 3 awards.

When are ASPECT concept papers due?

Concept papers are due October 9, 2026, at 5:00 p.m. ET. Stage 1 applications are due December 1, 2026, and Stage 2 applications are due February 12, 2027, both at 5:00 p.m. ET.

Is a concept paper required for ASPECT?

Yes. A concept paper is required from every applicant, and it is limited to 5 pages. If you do not submit a concept paper by the deadline, you cannot submit a Stage 1 application. Stage 1 and Stage 2 are both by invitation only.

Who is eligible to apply for ASPECT?

Eligible domestic entities include institutions of higher education, for-profit organizations, nonprofit organizations, state and local government entities, and Indian Tribes. FFRDCs and federal agencies other than DOE may participate only as subrecipients.

Can a university be the prime applicant on ASPECT?

A university can be the prime recipient under Topic Area 1 only. For Topic Area 2, institutions of higher education are eligible to participate solely as subrecipients.

Does ASPECT require an industry partner?

Yes. Every application under both topic areas must include at least one for-profit industry entity, such as a chemical manufacturer, either as the prime recipient or as a subrecipient. If the industrial partner is not the prime applicant, a letter of commitment must accompany the application. Applications without an industrial entity are specifically not of interest.

What is the cost share requirement for ASPECT?

Minimum cost share is 20 percent of total project costs for research and development tasks under Subtopics 1a, 1b, and Phase 1 of 2a. It rises to 50 percent for demonstration and commercial application tasks under Phase 2 of Subtopic 2a and all of Subtopic 2b. Applications below the minimum are ineligible at compliance review.

How large can an individual ASPECT award be?

Subtopic 1a is eligible for up to $5,000,000 in federal funding, Subtopic 1b up to $10,000,000, Subtopic 2a up to $20,000,000 with no more than $5,000,000 in Phase 1, and Subtopic 2b up to $15,000,000.

What feedstocks are acceptable under ASPECT?

Acceptable feedstocks include lignocellulosic biomass, algae, organic wet waste, sorted municipal solid waste, food waste, biogas, grain starch, oilseed crops, construction and demolition waste, waste carbon dioxide, and biointermediates. Carbon dioxide captured from ambient air is not acceptable. Applications using a feedstock outside the list will not be considered.

What kinds of chemicals is DOE looking for?

DOE is looking for conventional chemicals that offer added advantages such as stronger domestic supply chains, reduced imports, lower cost, reduced pathway toxicity, or market growth, and for bio-advantaged chemicals offering advantages in function, cost, or trade and national security, such as greater durability, higher production efficiency, or lower toxicity.

Does my target chemical need 1 million metric tons of annual U.S. production?

Target chemicals should have annual U.S. production of at least 1 million metric tons. Lower volumes may be considered with justification, but applications targeting small, niche, or fine chemical markets are specifically not of interest.

What technology readiness level is required for ASPECT?

Subtopic 1a targets bench-scale work at TRL 2. Subtopic 1b covers TRL 2 bench work in Phase 1 and TRL 3 or TRL 4 unit operation pre-piloting in Phase 2. Topic Area 2 requires a minimum baseline of TRL 4 with a maximum of TRL 5 at project conclusion.

What is the pre-pilot scale requirement under ASPECT?

Pre-pilot unit operations and integrated systems must be sized to handle the process streams produced from at least 0.5 dry tons per day of feedstock. DOE cites scaling to roughly 1/100th of a commercial-scale continuous process as an example of an appropriate target scale.

What applications will DOE reject outright?

DOE will not review applications proposing fuels as the primary product, ethanol as a final product, food or protein (other than amino acids), pharmaceuticals, nutraceuticals, food additives, or cosmetics, technologies already operating commercially, applications using model compounds instead of real feedstocks (except Subtopic 1a), applications without an approved feedstock, and applications without an industrial partner.

How are ASPECT applications scored?

Concept papers are scored on one criterion, overall NOFO responsiveness and viability, at 100 percent weight. Topic Area 1 Stage 1 applications are scored on technical merit, innovation, and impact (40 percent), project demonstration and market transformation plan (40 percent), and team and resources (20 percent). Topic Area 2 is scored on technical approach and impact (30 percent), financial and market viability (25 percent), management and organization (25 percent), and workplan (20 percent).

What is the ASPECT verification process?

Every applicant selected for award negotiations must participate in a verification process led by a non-conflicted third-party team identified by DOE. An initial verification occurs in months 0 to 3 to confirm baseline data from the application, intermediate verifications support go/no-go decisions, and a final verification occurs near closeout. Applicants must include the initial verification as Task 1 in their scope and allow roughly three months for it.

How long are ASPECT projects?

Topic Area 1 project periods run 24 to 48 months and Topic Area 2 project periods run 24 to 60 months, with budget periods of 12 to 24 months. Awards are structured with multiple budget periods and go/no-go decision points, and continuation funding is not guaranteed.

Can a foreign company participate in an ASPECT project?

Foreign entities are generally not eligible as recipients or subrecipients. Participation requires an explicit written waiver request submitted with the application, and DOE's determination is final and cannot be appealed. All work must also be performed in the United States absent a separate approved foreign work waiver.

Are cooperative agreements different from grants under ASPECT?

Yes. ASPECT awards are cooperative agreements, which means DOE has substantial involvement in directing the technical work, participates in major project decisions, and can redirect or stop funding at go/no-go decision points.

Talk to BW&CO Before the October 9 Concept Paper Deadline

ASPECT is a competitive, non-dilutive path to fund pre-pilot scale-up without giving up equity, and the concept paper gate rewards preparation over polish. BW&CO has helped deep tech and industrial innovators secure more than $350M in federal funding by getting the strategy, teaming, and compliance right before the first submission.

If you are evaluating ASPECT, we can help you confirm topic area fit, pressure test your target chemical and market justification, structure your cost share and industrial partnership, and build a concept paper that survives responsiveness review. Innovation Funding Simplified.

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

Executive Summary

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

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

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

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

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

At a Glance

• Topic title: Health and Extreme Weather

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

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

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

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

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

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

• Post date: September 1, 2026

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

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

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

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

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

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

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

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

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

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

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

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

What This Opportunity Actually Is

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

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

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

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

Is This Topic a Fit for a Small Business?

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

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

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

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

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

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

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

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

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

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

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

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

Which Institute Should You Target?

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

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

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

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

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

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

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

Quick reference: awarding Institutes, funding signals, and contacts

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

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

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

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

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

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

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

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

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

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

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

Which NIH Mechanism Should a Small Business Use?

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

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

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

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

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

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

• NIMHD does not accept clinical trials under STTR.

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

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

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

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

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

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

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

Funding Allowance

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Timeline

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

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

Cycles available under this topic:

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

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

• April 5, 2027

• September 5, 2027

• January 5, 2028

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

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

Work backwards from your target date:

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

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

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

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

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

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

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

Detailed Overview of What NIH Is Looking For

Program aims and scope

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

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

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

The translational continuum

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

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

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

Priority populations, and why the list matters commercially

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

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

Institute reads worth acting on

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

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

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

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

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

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

What the non-awarding offices add

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

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

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

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

OBSSR participates without publishing specific interests for this topic.

Eligibility Requirements

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

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

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

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

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

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

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

What a Competitive Application Looks Like

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

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

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

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

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

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

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

Common Reasons Applications Miss

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Frequently Asked Questions

Is this a grant I can apply to directly?

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

Which funding opportunity number do I actually use?

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

Is this topic actually a fit for a small business?

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

Which of the eleven Institutes should I target?

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

How much money can my company request?

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

When is the deadline?

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

Can I include a clinical trial?

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

How long until I receive funding?

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

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

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

What counts as extreme weather under this topic?

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

Does my project have to involve a specific population?

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

Does any Institute set aside dedicated funding for this topic?

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

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

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

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

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

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

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

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

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

How BW&CO Helps

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

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

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

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

Executive Summary

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

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

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

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

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

At a Glance

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

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

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

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

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

• Post date: September 2, 2026

• Expiration date: September 2, 2028

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

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

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

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

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

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

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

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

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

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

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

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

What This Opportunity Actually Is

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

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

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

Why This Topic Is a Strong Small Business Fit

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

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

The clearest product lanes across the five Institutes:

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

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

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

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

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

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

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

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

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

Which Institute Should You Target?

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

NCI, for oncology. NCI encourages development of in vivo immune cell engineering methods for testing in preclinical models and early clinical trials in both hematologic and solid tumors. Its named topics span viral vector delivery of DNA carrying tumor-specific CARs, TCRs, and costimulatory domains; nonviral delivery using LNPs or other synthetic nanocarriers for mRNA, siRNA, and other cargos; novel delivery vehicles including biodegradable nanomaterials; novel gene editing methods such as CRISPR/Cas9 and base or prime editing delivered with nanovehicles for genetic or epigenetic reprogramming; preclinical toxicity and safety studies and pilot clinical trials informed by biomarkers; and combination use with immune checkpoint blockade or agents modulating the tumor microenvironment. NCI is also the only one of the five that accepts clinical trials without restriction, which makes it the default target for any project with a clinical component.

NIAID, for infectious, autoimmune, and immune-mediated disease. NIAID encourages basic, translational, and early clinical research on engineered cellular therapies, including targeted modulation of protective or pathogenic immune responses that induce durable disease control while preserving protective immunity. Its three named strategies are improving tissue, antigen, and cell specificity for enhancing protective immunity or eliminating and reprogramming pathogenic immune subsets including autoreactive innate and adaptive cells; improving scalability, cost reduction, and expansion of access to off-the-shelf or in vivo approaches that minimize preconditioning; and improving safety, covering mitigation of off-target effects, unintended tissue injury, prolonged immune dysregulation, oncogenic risk, and improved control and reversibility of therapeutic activity. NIAID accepts clinical trials under SBIR but not under STTR.

Note how commercial NIAID's second bullet is. Scalability, cost reduction, and access are business metrics, and minimizing preconditioning is a direct attack on the lymphodepletion barrier. If your platform's advantage is that it removes preconditioning or lowers cost of goods, NIAID has invited that argument in its own words.

NIBIB, for platform and enabling technology. NIBIB is interested in technologies to engineer immune cells in vivo across a range of diseases, listing new types of engineered viruses and artificial cells for genetic material delivery; novel delivery methods using LNPs, nanocarriers, biodegradable nanomaterials, or other vehicles; novel gene editing methods, synthetic receptors, and transmembrane chimeric antigen receptors; nucleases and genome editors for DNA manipulation and regulation; synthetic genetic circuits for engineering T cells, NK cells, and macrophages for immune regulation and cancer therapy; biomaterials for enhancing immunotherapy; and development of novel platforms using microphysiological systems to model and evaluate targeting, transduction efficiency, and therapeutic function.

NIBIB is the right door for a company whose product is the enabling technology rather than a therapy for a named indication, since its framing is deliberately disease-agnostic. NIBIB's clinical trial policy is narrower than NCI's but well matched to this topic: it supports feasibility, first-in-human, safety, and other small trials that inform early stage technology development, and will not support pivotal trials, later-phase trials, or trials whose primary outcome is efficacy, effectiveness, or a post-market concern. Mechanistic trials are supported only where the primary focus of the project is technology development.

NIAMS, for rheumatic, autoimmune, autoinflammatory, and musculoskeletal disease. NIAMS encourages basic, translational, and clinical research advancing in vivo immune cell engineering-based cell therapy for rheumatic, autoimmune, autoinflammatory, and musculoskeletal and bone diseases and conditions. That is the entirety of its published language, which is notably brief relative to the other four. Critically, NIAMS accepts no clinical trials under either parent announcement, so its invitation to clinical research must be satisfied through work that does not meet the NIH clinical trial definition, or through a NIAMS-specific announcement designed for trials.

NIDCR, for dental, oral, and craniofacial disease. NIDCR seeks research and technology advancement for dental, oral, and craniofacial diseases and conditions, listing novel viral vector-based delivery platforms and nonviral approaches using LNPs and other synthetic nanocarriers for efficient targeted delivery of nucleic acids or protein cargos; innovative gene editing including CRISPR/Cas9 and base or prime editing for precise and durable genetic and epigenetic modification of immune cells in vivo; combination strategies integrating immune engineering with immune checkpoint blockade, autoantigen and antibody-based therapies, and cytokine and chemokine-mediated modulation; and advanced data science, AI and machine learning, and computational modeling to elucidate mechanisms of action and optimize design and performance. NIDCR is the only Institute here offering a stated funding advantage, and the only one naming protein cargo delivery alongside nucleic acids. It accepts no clinical trials under either parent.

Quick reference: awarding Institutes, clinical trial posture, and contacts

• NCI. Hematologic and solid tumors, delivery, editing, preclinical safety, combination therapy. Accepts clinical trials. No stated funding signal. Contact: Zhang-Zhi Hu, M.D., zhang-zhi.hu@nih.gov

• NIAID. Infectious, autoimmune, and immune-mediated disease, with emphasis on specificity, scalability and access, and safety. Accepts clinical trials under SBIR only, not STTR. No stated funding signal. Contact: Jeffrey Rice, Ph.D., Jeffrey.Rice@nih.gov

• NIAMS. Rheumatic, autoimmune, autoinflammatory, musculoskeletal and bone disease. Accepts no clinical trials under either parent. No stated funding signal. Brief published language, so a program officer call matters more here. Contact: Marie Mancini, Ph.D., Marie.Mancini@nih.gov

• NIBIB. Disease-agnostic enabling technology, synthetic biology, biomaterials, microphysiological evaluation platforms. Accepts early stage, feasibility, first-in-human, safety, and other small trials informing technology development only. No stated funding signal. Contact: Tuba Fehr, PhD, tuba.fehr@nih.gov

• NIDCR. Dental, oral, and craniofacial disease, delivery, editing, combination strategies, AI and computational modeling. Accepts no clinical trials under either parent. May give special consideration to meritorious applications. Contact: Zhong Chen, MD, PhD, nidcr-program@mail.nih.gov

Which NIH Mechanism Should a Small Business Use?

Small businesses should apply through the NIH SBIR or STTR parent announcement and request assignment to the Institute whose interests match. On this topic the mechanism choice interacts with the clinical trial question more than usual, so decide both together.

NIH Parent SBIR, currently PA-27-100 (R43 and R44). The default route. Accepts Phase I, Phase II, Direct to Phase II, and Fast-Track. Use it when your company performs the majority of the research and your Principal Investigator is primarily employed by the company. Under PA-27-100, NIAMS and NIDCR do not accept clinical trials, and an application proposing a clinical trial that aligns only with one of those missions is non-responsive and will not be reviewed.

NIH Parent STTR, currently PA-27-102 (R41 and R42). Requires a formal collaboration with a nonprofit research institution, with at least 40 percent of the research at the small business and at least 30 percent at a single partner institution. STTR permits the Program Director or Principal Investigator to be employed by either the small business or the partnering nonprofit while the award still goes to the small business, which matters in this field because much of the foundational vector, editing, and receptor work sits in academic labs and the inventor often holds a faculty appointment. Under PA-27-102, NIAID, NIAMS, and NIDCR do not accept clinical trials, so a project with an academic PI and a clinical component cannot use STTR at NIAID even though SBIR would work.

A distinction worth stating plainly. NIH small business phases are separate from and not aligned with clinical trial phases. An SBIR Phase I is a feasibility award, and it is not the same thing as a clinical Phase I trial. NIBIB's policy supports clinical Phase I and first-in-human studies, which can be proposed within an SBIR Phase II or Fast-Track application. Confusing the two numbering systems is a common and expensive error on topics like this one that invite early clinical work.

Direct to Phase II. Available if you already hold the feasibility data a Phase I would generate and never received a Phase I award for that project. SBIR only, not available under STTR. For a company with a validated delivery platform in one context and new in vivo transduction data in an immune cell context, this is often the fastest route.

Fast-Track. Phase I and Phase II submitted together and reviewed once. Poor fit when Phase I results would change the Phase II design, which is frequently the case here because the choice of vector, payload, or dosing regimen often depends on what the first biodistribution and specificity data show.

Phase IIB Strategic Breakthrough Award, currently PA-27-101 (R44). For companies that completed an NIH SBIR or STTR Phase II and need a commercialization bridge. Requires documentation of not less than 100 percent matching funds from new private capital or from a government source other than a Phase I or Phase II SBIR or STTR award. Award periods must not exceed 4 years. Given the capital intensity of gene-modified cell therapy development, a Phase IIB matching plan should be sketched early rather than discovered later. Note that not all Institutes accept clinical trials through Phase IIB.

Commercialization Readiness Pilot, currently PAR-27-098 (SB1). This mechanism deserves particular attention on this topic. CRP supports later-stage work not typically fundable through Phase II or Phase IIB, and NIH names Investigational New Drug and Investigational Device Exemption enabling studies, independent replication of key studies, clinical studies, manufacturing costs, and regulatory assistance among eligible activities. For an in vivo immune cell engineering program, IND-enabling toxicology and manufacturing are precisely the expensive steps that fall between a successful Phase II and a first-in-human study. CRP permits substantial subcontracting, though the small business must maintain oversight and management of the research throughout.

Funding Allowance

The ceiling depends on two layers.

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

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

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

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

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

Layer two, Institute-specific guidance. NIH holds SBA waivers permitting awards above the guideline for approved topics, and each Institute publishes its own limits.

• NCI. Among the components listing Phase I headroom above the statutory guideline, reaching $700,000 in the parent announcement's participating component table. NCI's own published guidance generally funds waiver-eligible Phase I applications up to $400,000 across up to 2 years and considers Phase II up to $2,250,000 across up to 3 years. NCI also runs a Phase IIB Bridge Award and caps its CRP support well below the government-wide figure.

• NIAID. Also listed in the higher Phase I tier, but NIAID publishes a per-year constraint that reshapes budgets more than a total ceiling does: NIAID will not generally allow Phase II or Phase IIB awards of any duration exceeding $1,000,000 in total costs per year. For a program with heavy vector manufacturing or toxicology costs concentrated in one year, this is a planning constraint worth designing around from the start.

• NIAMS, NIBIB, and NIDCR. Refer to the participating component table in the current parent announcement and confirm directly with program staff. These Institutes do not all maintain standing published SBIR budget pages, and NIBIB in particular has historically used targeted announcements with their own budget language for clinical work.

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

A candid note on capital adequacy. A Phase II at $2.15 million will not carry an in vivo gene-modified immunotherapy from concept to the clinic. The realistic financing picture is a Phase I or Direct to Phase II establishing specificity and transduction efficiency, a Phase II generating the preclinical package, CRP or Phase IIB covering IND-enabling studies and manufacturing, and private capital carrying first-in-human. Applications that show awareness of that full sequence read as commercially serious. Applications that imply a Phase II ends at an approved therapy do not.

Timeline

The topic window runs from September 2, 2026 through September 2, 2028.

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

Cycles available under this topic:

• September 2026 cycle: the September 5, 2026 date shifted to Tuesday, September 8, 2026 because of the weekend and the Labor Day holiday. Since the topic posted on September 2, this cycle is not realistically available.

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

• April 5, 2027

• September 5, 2027

• January 5, 2028

• April 5, 2028, the last full cycle before the topic expires in September 2028.

What the runway looks like: plan on roughly 9 months from submission to funds in the door. An application submitted in the January 2027 cycle typically reaches an earliest possible start date in the fall of 2027. Council decisions for the September and January cycles are often handled together, so deferring a cycle is not costless.

Work backwards from your target date:

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

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

• 8 weeks out: complete the research strategy, commercialization plan, vector or material sourcing agreements, institutional biosafety planning, letters of support, and any human subjects documentation

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

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

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

Also note two moving parts. The current SBIR parent, PA-27-100, closes in early April 2027, well before this topic expires, so applicants targeting later cycles must confirm the active announcement number at submission. Separately, the 2026 reauthorization gave agencies authority to limit how many Phase I proposals a company may submit, and HHS has been reported to cap SBIR and STTR submissions at nine per small business per fiscal year. Confirm the current limit with program staff if you plan multiple submissions across Institutes.

Detailed Overview of What NIH Is Looking For

The problem NIH is trying to solve

The topic frames its case in two movements. The first is scientific. Adoptive cellular therapies such as CAR-T cells have transformed treatment of hematologic malignancies, but challenges remain in solid tumors because of poor immune cell trafficking, limited persistence, and immunosuppressive tumor microenvironments. Development for solid tumors is nonetheless expanding rapidly across autologous and allogeneic engineered T, NK, and other immune cells, and cellular therapies are being explored beyond oncology for autoimmune, infectious, and age-related disease and for regenerative medicine.

The second movement is logistical, and it is where the small business opportunity lives. NIH lists the practical barriers to current approaches directly: lymphodepletion, leukapheresis, ex vivo cell modification and expansion, GMP manufacturing, specialized facilities, and weeks-long processing times. It concludes that this complexity makes these therapies slow, costly, and inaccessible to many patients. In vivo engineering is presented as a transformative alternative that engineers immune cells inside the body using in vivo gene delivery, bypassing that process and offering true off-the-shelf cellular immunotherapy. NIH adds that this removes a major logistical bottleneck and enables treatment for rapidly progressing disease where patients often cannot afford the long wait.

Read strategically, that second paragraph is a specification. It names the incumbent's cost drivers and time drivers and identifies the patient population the incumbent cannot serve. A Significance section that quantifies your platform against those specific barriers, time from decision to dose, cost of goods, site-of-care requirement, and eligibility for patients too sick to wait for manufacturing, is arguing on the ground NIH chose.

The scope of the technology as defined

The topic's purpose statement is unusually detailed about what counts. It encourages basic and preclinical research and early clinical testing of in vivo immune cell engineering to reprogram immune cells within the body, including but not limited to T cells, NK cells, and macrophages, for cancer, autoimmune, infectious, and age-related disease and for regenerative medicine. Delivery may involve viral vectors such as lentiviral or adeno-associated viral vectors, or non-viral nanocarriers such as lipid nanoparticles, for delivery of genetic material such as DNA or mRNA. The genetic material could encode CARs, TCRs, or other functional elements, or gene editing machinery for in situ reprogramming.

The purpose statement then names four categories of acceptable work: development and testing of novel technologies and methodologies for increasing specificity and efficiency of immune cell targeting and transduction in vivo; improving biodistribution; improving safety; and enhancing efficacy and persistence of engineered immune cells in preclinical models and early clinical studies.

Two observations for an applicant. Macrophages appear alongside T and NK cells in the topic's own framing, which is a wider aperture than most CAR-focused programs and an opening for companies working outside the T cell mainstream. And specificity, efficiency, biodistribution, safety, and persistence are each named as standalone objectives. You do not need to propose a complete therapy. A Phase I that measurably improves one of those five parameters is responsive on its own terms.

The clinical trial constraint in detail

This deserves its own treatment because the topic invites clinical work that most of its participating Institutes cannot accept through the parent announcements.

The topic asks for early clinical testing in its purpose statement. NCI names pilot clinical trials informed by biomarkers. NIAID names early clinical research. NIAMS names clinical research. OADR-ORWH names acceleration of clinical trials for autoimmune disease. Against that, the parent announcements set the following:

• NCI. Accepts clinical trials under both SBIR and STTR. The only unrestricted door among the five.

• NIBIB. Supports only early stage clinical trials, specifically feasibility, clinical Phase I, first-in-human, safety, or other small trials that inform early stage technology development. Will not support pivotal trials, clinical Phase II, III, or IV, or trials whose primary outcome is efficacy, effectiveness, or a post-market concern. Mechanistic trials are supported only where the primary focus of the project is technology development. For a first-in-human study of a novel delivery platform, this policy is a good match rather than an obstacle.

• NIAID. Accepts clinical trials under the parent SBIR announcement but not under the parent STTR announcement.

• NIAMS and NIDCR. Accept no clinical trials under either parent announcement. An application proposing a clinical trial that aligns only with one of these missions is non-responsive and will not be reviewed.

The practical sequence is: run the NIH clinical trial determination against your actual design first, then choose the Institute, then choose SBIR or STTR. Doing it in the reverse order is how a strong application becomes unreviewable. Also confirm the definition rather than assuming, since NIH defines a clinical trial as a study prospectively assigning human subjects to one or more interventions to evaluate effects on health-related biomedical or behavioral outcomes, which captures more designs than founders expect.

What OADR-ORWH adds

The Office of Autoimmune Disease Research within ORWH participates but does not award grants. Your application must be relevant to the objectives of at least one participating Institute, which here means NCI, NIAID, NIAMS, NIBIB, or NIDCR. Its interests function as additional strength within an application already aimed at one of the five, and they are more specific than most non-awarding office statements.

OADR-ORWH is interested in design and engineering of next-generation cellular therapies including CAR-T and CAAR-T cells, regulatory T cells, NK cells, engineered CARs and TCRs, costimulatory domains, and other immunocytes and functional elements; development of data science and computational approaches to interrogate mechanisms of novel cellular therapies, including analysis of new or existing early-phase and pooled clinical trial data to define immunologic treatment windows and identify predictors of therapeutic response; and advancement of translational research to enable and accelerate clinical trials of cellular therapies for autoimmune disease. It strongly encourages engagement of people living with or at risk for autoimmunity to ensure direct relevance to human health.

Three things stand out. CAAR-T cells, chimeric autoantibody receptor T cells for depleting autoreactive B cells, are named explicitly and appear nowhere else in the topic, so a CAAR platform has a clear home. Regulatory T cells are named, which points toward tolerance induction rather than cytotoxic depletion. And the interest in analyzing existing and pooled early-phase clinical trial data to define immunologic treatment windows is a computational product opportunity that requires no wet lab at all, and it pairs naturally with NIDCR's parallel interest in AI and computational modeling. Patient engagement is cheap to do well and most applications will do it thinly or not at all.

Eligibility Requirements

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

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

• More than 50 percent directly owned and controlled by one or more individuals who are U.S. citizens or permanent resident aliens, by other for-profit small business concerns each majority owned by such individuals, or by a combination. Certain venture capital, hedge fund, and private equity structures may qualify for SBIR under specific conditions. Note that companies more than 50 percent owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination are not eligible for the STTR program, which is a distinction that catches venture-backed cell therapy companies specifically.

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

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

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

Additional constraints. NIH will not accept similar applications with essentially the same research focus from the same applicant organization, including derivative applications proposing a single product applicable to multiple purposes with non-substantive modification. This matters on a platform topic, where the temptation is to submit the same delivery technology against several disease areas and Institutes. You may not simultaneously submit identical or essentially identical applications under both parent announcements, and duplicate or highly overlapping applications under simultaneous review are not accepted. Applicants must disclose overlapping federal work under the essentially equivalent work rule. Companies with a substantial award history should confirm they meet the Phase I to Phase II Transition Rate and commercialization benchmarks. Heightened screening of foreign ownership and foreign influence applies under the 2026 reauthorization, with additional scrutiny possible for STTR because of the research institution partnership.

What a Competitive Application Looks Like

1. A quantified comparison against the ex vivo process. NIH named the barriers: lymphodepletion, leukapheresis, ex vivo modification and expansion, GMP manufacturing, specialized facilities, weeks-long processing. State what your approach does to each one, in numbers where you can. This is the argument the topic was written to invite, and most applications will gesture at it rather than quantify it.

2. One of the five named parameters as a measurable endpoint. Specificity, transduction efficiency, biodistribution, safety, and persistence are each named as standalone objectives. Pick one or two, define the metric, and state the success criterion. A proposal that improves everything vaguely improves nothing measurably.

3. A safety and control story. NIAID names off-target effects, unintended tissue injury, prolonged immune dysregulation, oncogenic risk, and control and reversibility of therapeutic activity. In vivo editing raises safety questions that ex vivo manufacturing partially contains through release testing, and reviewers know it. Addressing reversibility or a control switch directly is a differentiator.

4. The clinical trial determination resolved before the mechanism is chosen. Run the NIH definition against your design, then pick the Institute and announcement. Four of the five Institutes carry restrictions.

5. An honest capital sequence. Phase I or Direct to Phase II for specificity and transduction, Phase II for the preclinical package, CRP or Phase IIB for IND-enabling studies and manufacturing, private capital for first-in-human. Naming the sequence signals that you understand what this class of product costs to develop.

6. Program officer contact before writing. Five Institutes, four clinical trial postures, and two Institutes with brief published language. The call determines assignment, budget realism, and reviewability.

Common Reasons Applications Miss

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

• Proposing a clinical trial to NIAMS or NIDCR, which accept none under either parent announcement, making the application non-responsive and unreviewed

• Proposing a clinical trial to NIAID through STTR, which it does not accept, when SBIR would have worked

• Proposing an efficacy-powered or pivotal trial to NIBIB, which supports only early stage, feasibility, first-in-human, and safety trials informing technology development

• Confusing SBIR Phase I and Phase II with clinical trial Phase I and Phase II, which are separate and unaligned numbering systems

• Submitting the same delivery platform against multiple diseases and Institutes, which runs into the prohibition on derivative applications proposing a single product applicable to multiple purposes

• Applying for STTR while more than 50 percent owned by a combination of venture capital, hedge fund, or private equity firms, which is an STTR eligibility bar even where SBIR would permit it

• Designing a Phase II budget with costs concentrated in one year at NIAID, which will not generally allow more than $1,000,000 in total costs per year

• Budgeting to the $700,000 Phase I ceiling rather than the roughly $400,000 that Institutes actually award

• Omitting the fee from the budget or requesting the wrong level, neither correctable after submission

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

• Implying a Phase II ends at an approved therapy, with no account of IND-enabling work, manufacturing, or the capital required to reach the clinic

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

Frequently Asked Questions

Is this a grant I can apply to directly?

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

Which funding opportunity number do I actually use?

For most small businesses it is PA-27-100, the NIH, CDC, and FDA Parent SBIR announcement covering R43 and R44 awards. If your project depends on a formal university or nonprofit research partner, use PA-27-102, the Parent STTR announcement covering R41 and R42. Confirm the active number at submission, since PA-27-100 closes in early April 2027 while this topic runs to September 2028.

Can I propose a clinical trial under this topic?

It depends entirely on the Institute and mechanism. NCI accepts clinical trials under both SBIR and STTR. NIBIB accepts only early stage trials such as feasibility, clinical Phase I, first-in-human, safety, or other small trials that inform early technology development, and will not support pivotal or efficacy-powered trials. NIAID accepts clinical trials under SBIR but not STTR. NIAMS and NIDCR accept none under either parent. Run the NIH clinical trial determination against your design before choosing an Institute.

Is an SBIR Phase I the same as a clinical Phase I trial?

No, and conflating them causes real problems. NIH small business phases are separate from and not aligned with clinical trial phases. An SBIR Phase I is a feasibility award. A clinical Phase I trial is a first-in-human safety study, which would typically be proposed within an SBIR Phase II, Direct to Phase II, or Fast-Track application, subject to the target Institute's clinical trial policy.

Which of the five Institutes should I target?

NCI for oncology, and the default for any project with a clinical component since it accepts trials without restriction. NIAID for infectious, autoimmune, and immune-mediated disease, especially where your advantage is specificity, cost reduction, access, or minimizing preconditioning. NIBIB for disease-agnostic enabling technology, synthetic biology, biomaterials, and evaluation platforms. NIAMS for rheumatic, autoimmune, autoinflammatory, and musculoskeletal disease. NIDCR for dental, oral, and craniofacial disease, and the only Institute here offering a stated funding advantage.

How much money can my company request?

The SBA statutory guidelines this cycle are $323,090 for Phase I and $2,153,927 for Phase II in total costs, including direct costs, indirect costs, and fee. NCI and NIAID are among the components listing Phase I headroom to $700,000, though NCI's own guidance generally funds waiver-eligible Phase I near $400,000 and Phase II up to $2,250,000. NIAID applies a per-year constraint of $1,000,000 in total costs on Phase II and Phase IIB. Confirm with your target Institute before setting a budget.

When is the deadline?

There is no deadline specific to this topic. You submit on the NIH standard small business receipt dates of January 5, April 5, and September 5 each year, with dates falling on weekends or federal holidays moving to the next business day. The topic expires September 2, 2028, making January 5, 2027 through April 5, 2028 the realistic competing cycles.

How long until I receive funding?

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

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

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

My company is venture-backed. Are we still eligible?

For SBIR, possibly. Certain venture capital, hedge fund, and private equity ownership structures qualify under specific conditions, and complex cap tables should be checked against 13 CFR Part 121. For STTR, no: small business concerns more than 50 percent owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are not eligible for the STTR program. This distinction affects venture-backed cell therapy companies more than most.

Can NIH funding cover IND-enabling studies and manufacturing?

Yes, primarily through the Commercialization Readiness Pilot. CRP supports later-stage work not typically fundable through Phase II or Phase IIB, and NIH names IND and IDE enabling studies, independent replication of key studies, clinical studies, manufacturing costs, and regulatory assistance among eligible activities. CRP permits substantial subcontracting, though the small business must maintain oversight and management of the research throughout the award.

Does my project have to target cancer?

No. The topic names cancer, autoimmune disease, infectious disease, age-related disease, and regenerative medicine, and covers T cells, NK cells, and macrophages. NIBIB's framing is explicitly disease-agnostic, NIAID covers infectious and immune-mediated disease, NIAMS covers rheumatic and musculoskeletal disease, and NIDCR covers dental, oral, and craniofacial conditions.

Does any Institute set aside dedicated funding for this topic?

Not guaranteed. NIDCR is the only participating Institute that stated it may give special consideration to meritorious applications in this topic area. NCI, NIAID, NIAMS, and NIBIB made no such statement. Treat the NIDCR statement as a favorable tilt rather than a reserved pool of money.

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

Not necessarily. SBIR Direct to Phase II allows a company that has demonstrated the scientific and technical merit and feasibility normally expected from a Phase I, without having received a Phase I award for that project, to apply directly for Phase II. This authority is available for SBIR only and is not available under STTR. A validated delivery platform plus new in vivo immune cell transduction data is a common qualifying profile.

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

No. Unlike most NIH Highlighted Topics published in this cycle, this one is not issued under the MAHA initiative and lists no named policy alignments. Applicants should not reference an initiative alignment the topic does not claim.

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

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

How BW&CO Helps

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

On this topic the decisive work happens before drafting: resolving the clinical trial determination, selecting among five Institutes with four different clinical trial postures, choosing SBIR versus STTR against your ownership structure and your PI's employment, engaging program officers, and sequencing Phase I, Phase II, CRP, Phase IIB, and private capital into a financing plan that actually reaches the clinic. That work also includes Specific Aims development, full proposal build, budget and fee construction, commercialization planning, and Phase IIB matching capital positioning. Our team has helped clients secure more than $350 million in funding. Innovation Funding Simplified.

If you are developing an in vivo immune cell engineering platform and want a straight answer on which Institute to target, whether your clinical plan is reviewable where you intend to send it, and whether you are competitive for the January 5, 2027 cycle, contact us for a fit assessment.

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

Executive Summary

The National Institutes of Health has published a Highlighted Topic titled "Catalyzing Interdisciplinary Research on HIV-Associated Co-occurring Conditions." Twelve NIH Institutes award grants under it and five additional offices participate without awarding, making this one of the broadest cross-NIH topics published this cycle. The scientific premise is that antiretroviral therapy has turned HIV into a manageable chronic condition, but people with HIV now face early onset and elevated risk of comorbidities, treatment-related adverse effects, and interconnected medical, psychosocial, and structural challenges that disease-specific research models handle poorly.

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

Two things about this topic deserve to be said plainly before you invest a cycle in it. First, a substantial share of the published language describes work that is not a small business fit: cohort analysis, mechanistic basic science, academically led community-based trials, and health disparities characterization. Those belong in R01 and related mechanisms. The slices that are genuinely SBIR-fundable are narrower and named below. Second, two of the twelve awarding Institutes, NIAMS and NIDCR, will not accept clinical trial applications under either parent announcement, even though both explicitly ask for research that develops and tests interventions. Two more, NIAID and NIDDK, accept clinical trials under SBIR but not under STTR. Getting this wrong makes an application non-responsive and unreviewed regardless of its scientific merit.

The topic was posted on September 1, 2026 and expires on July 28, 2028, which is a shorter window than the standard two years and eliminates the September 2028 cycle. The realistic competing cycles run from January 5, 2027 through April 5, 2028.

If you build diagnostics or screening tools for subclinical comorbidity, therapeutics or biologics for HIV-associated disease, medication optimization and polypharmacy tools, care coordination or clinical decision support software, point-of-care coinfection testing, or integrated behavioral health delivery platforms, there is real money here across multiple Institutes.

At a Glance

• Topic title: Catalyzing Interdisciplinary Research on HIV-Associated Co-occurring Conditions

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

• Awarding Institutes: NCCIH, NCI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NICHD, NIDA, NIDCR, NIDDK, and NIMH

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

• Central scientific contact: Office of AIDS Research, OARinfo@nih.gov

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

• Post date: September 1, 2026

• Expiration date: July 28, 2028. Note this is short of the usual two-year window.

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

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

• Standard annual due dates: January 5, April 5, and September 5. HHS SBIR and STTR applications are not accepted on the AIDS and AIDS-related due dates, so the standard dates apply here despite the HIV subject matter.

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

• Institute headroom: several participating Institutes list Phase I limits above the statutory guideline, up to $700,000, and Phase II limits up to $2.5 million or $3 million. Limits differ by Institute and must be confirmed.

• Clinical trials: not accepted by NIAMS or NIDCR under either parent announcement. Not accepted by NIAID or NIDDK under STTR, though both accept them under SBIR.

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

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

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

• Strongest funding signals: NIDA states both that it may dedicate available funds and that it may give special consideration. NHLBI states it may dedicate available funds. NCCIH and NIDCR each state they may give special consideration.

• Broader initiative alignment: Make America Healthy Again initiative, with eight named component efforts

What This Opportunity Actually Is

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

What it does do is identify which Institutes are receptive, which determines your assignment request and your program officer conversations; supply the vocabulary program staff already use internally, which your Specific Aims should mirror; and in four cases here create an explicit stated advantage. NIDA is the only participating Institute that made both available statements, saying it may dedicate available funds to this topic area depending on the availability of funds, the number of meritorious applications, and competing priorities, and separately that it may give special consideration to meritorious applications in the topic area. NHLBI made the funds statement. NCCIH and NIDCR each made the special consideration statement. The remaining eight awarding Institutes made neither.

That distribution is worth reading carefully. It does not mean the other eight will not fund this work. It does mean four Institutes went on record and eight did not, which is the closest thing to a competitive signal a Highlighted Topic provides.

Is This Topic a Fit for a Small Business?

This topic is less small-business-native than most NIH Highlighted Topics, and an honest read saves cycles.

The topic language repeatedly emphasizes interdisciplinary collaborative science, multidisciplinary teams with multiple Program Directors and Principal Investigators holding complementary expertise, meaningful community engagement, cross-NIH alignment, and use of existing NIH resources. Those are hallmarks of investigator-initiated academic research, and much of what is described is best pursued through R01, R34, or cooperative agreement mechanisms rather than SBIR or STTR.

Work in this topic that is a poor small business fit: secondary analysis of existing cohorts; epidemiological characterization of comorbidity burden; mechanistic basic science with no identified product; health disparities documentation; academically led community-based behavioral trials where the small business would be a subcontractor rather than the developer of a commercial product.

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

• Screening and diagnostics for subclinical disease. NHLBI explicitly asks for novel methods to detect subclinical HIV-related heart, lung, blood, and sleep conditions. NCI asks for new biomarkers and diagnostics. NIDCR asks for early cancer detection in the oral and craniofacial complex. This is the clearest product lane in the entire topic.

• Therapeutics and biologics. NCI asks for therapeutics improving prevention, diagnosis, treatment, and outcomes in people with HIV. NIAAA asks for biomedical approaches to restore alcohol-induced organ dysfunction. NIDA asks for basic, clinical, and translational research on treatment of substance use disorder and overdose in people with HIV.

• Medication optimization and interaction tools. NIA asks for optimizing medications and care coordination. NCCIH asks for evaluation of risks including drug and herb interactions. Polypharmacy in an ART-treated aging population is a well-defined software and decision-support problem.

• Care coordination, clinical decision support, and digital delivery platforms. NIMH asks for scalable whole-person care models. NIDDK asks for strategies to improve implementation and delivery of evidence-based care. NIAMS prioritizes care models integrating musculoskeletal, rheumatic, and skin health into HIV settings.

• Point-of-care coinfection testing. NIAID names tuberculosis, viral hepatitis, and sexually transmitted infections across the lifespan from infant through adult.

• Integrated behavioral health and substance use interventions. NIDA names integrated interventions addressing HIV, substance use disorder, hepatitis C, and co-occurring mental health conditions. Digital therapeutics fit here.

• Complementary and integrative health products and delivery. NCCIH names mind-body and natural product interventions for symptom clusters, plus pragmatic and hybrid effectiveness-implementation studies and scalable delivery models.

The test is the ordinary SBIR test, applied honestly: is there a commercial product with unresolved technical risk that your company will own and sell? If the deliverable is knowledge, a publication, or a care model your company will not commercialize, the mechanism is wrong even though the science is wanted.

Which Institute Should You Target?

With twelve awarding Institutes, the assignment request is the highest-leverage decision on the application. Group yourself by what you sell, not by the disease you are adjacent to.

If you build diagnostics, biomarkers, or screening tools: NHLBI for cardiopulmonary, cardiometabolic, hematologic, and sleep-disordered breathing detection, including subclinical detection and vascular contributions to cognitive impairment and dementia. NCI for cancer biomarkers, diagnostics, and early detection in people with HIV. NIDCR for oral and salivary gland complications and HPV-associated cancer detection, subject to the clinical trial restriction below. NIDDK for kidney, urologic, hematologic, liver, and metabolic conditions that present differently or follow altered courses in the context of HIV.

If you build therapeutics or biologics: NCI for HIV-related tumor pathogenesis and therapeutics. NIAID for tuberculosis, viral hepatitis, and sexually transmitted infection coinfections. NIAAA for approaches restoring alcohol-induced organ dysfunction across cardiovascular, metabolic, neurocognitive, and immune complications. NIDA for substance use disorder and overdose treatment in people with HIV. NIA for interventions addressing HIV-associated conditions in midlife and older age, framed against the NIH Stage Model from Stage 0 basic science through Stage V implementation.

If you build software, digital health, or care delivery platforms: NIMH for neurocognitive and mental health screening, early intervention, and scalable whole-person care models, including implementation research identifying diagnosis and treatment barriers. NIDA for care engagement, ART adherence, and access in underserved populations. NIA for care coordination and medication optimization. NIDDK for implementation and delivery of evidence-based care. NIAMS for whole-person care models integrating musculoskeletal and skin health, subject to the clinical trial restriction.

If you build complementary or integrative health products: NCCIH is the only door, and it is a good one. NCCIH frames HIV as a chronic multisystem condition with complex symptoms including pain, fatigue, and neurocognitive and mental health challenges, well suited to Whole Person Health approaches, and it stated it may give special consideration to meritorious applications here.

If your work concerns pediatric or perinatal populations: NICHD participates but published no areas of interest for this topic, listing only a scientific contact. The topic body does note that HIV-exposed but uninfected children may face elevated immune, metabolic, and developmental risks compared with unexposed peers, particularly in low and middle-income settings. If this is your space, the program officer call is not optional, because there is no published language to write against.

Quick reference: awarding Institutes and stated funding signals

• NCCIH. Complementary and integrative health for symptom management. May give special consideration. Contact: Lanay Mudd, PhD, NCCIHDERFunding@nih.gov

• NCI. Cancer risk, pathogenesis, prevention, diagnosis, treatment, and bundled cancer and HIV interventions. No stated signal. Contact: Rebecca Liddell Huppi, Ph.D.

• NHLBI. Heart, lung, blood, and sleep comorbidity mechanisms and interventions. May dedicate available funds. Contact: nhlbihighlightedtopics@mail.nih.gov

• NIA. HIV-associated conditions in midlife and older age across the NIH Stage Model. No stated signal. Contact: Marcel E. Salive, MD, MPH

• NIAAA. Alcohol use and alcohol use disorder interactions with HIV pathophysiology and care. No stated signal. Contact: Kendall Bryant, Ph.D.

• NIAID. Coinfections across the lifespan, with attention to stigma and health system factors. No stated signal. Does not accept clinical trials under STTR. Contact: Robin E. Huebner, PhD, MPH

• NIAMS. Musculoskeletal, skin, and systemic rheumatic comorbidities, with priority to implementation science care models. No stated signal. Does not accept clinical trials under either parent. Contact: Heiyoung Park, PhD

• NICHD. No published areas of interest for this topic. Contact: Sonia Lee, Ph.D.

• NIDA. Drug use, addiction, and HIV interactions across the lifespan. May dedicate available funds and may give special consideration. The only Institute making both statements. Contact: NIDAHIVProgram@mail.nih.gov

• NIDCR. Oral and craniofacial comorbidities and integration of oral health into HIV care. May give special consideration. Does not accept clinical trials under either parent. Contact: NIDCR-Program@nih.gov

• NIDDK. Enteropathy and gastrointestinal homeostasis, liver disease and viral hepatitis coinfection, nutrition, obesity, diabetes, kidney, urologic, and hematologic disease. No stated signal. Does not accept clinical trials under STTR. Contact: Deepak Nihalani, Khoa Nguyen, Minnjuan Flournoy Floyd

• NIMH. Neuropsychiatric mechanisms of CNS comorbidity, shared pathways, and implementation research. No stated signal. Contact: NIMH.DAR.inquiries@nih.gov

Which NIH Mechanism Should a Small Business Use?

Small businesses should apply through the NIH SBIR or STTR parent announcement and request assignment to the Institute whose interests match. On this topic the SBIR versus STTR choice carries unusual weight for two reasons: the topic actively encourages multidisciplinary academic collaboration, and the clinical trial restrictions differ between the two announcements.

NIH Parent SBIR, currently PA-27-100 (R43 and R44). The default route. Accepts Phase I, Phase II, Direct to Phase II, and Fast-Track. Use it when your company performs the majority of the research and your Principal Investigator is primarily employed by the company. Under PA-27-100, NIAMS and NIDCR do not accept clinical trial applications, and an application proposing a clinical trial that aligns only with one of those missions is non-responsive and will not be reviewed.

NIH Parent STTR, currently PA-27-102 (R41 and R42). Requires a formal collaboration with a nonprofit research institution, with at least 40 percent of the research at the small business and at least 30 percent at a single partner institution. STTR carries a feature that matters a great deal on this topic: the Program Director or Principal Investigator may be employed by either the small business or the partnering nonprofit, while the award still goes to the small business. For a company whose scientific lead is a clinician-researcher with a primary academic appointment, which describes much of the HIV comorbidity field, STTR is the only NIH small business mechanism that works. The tradeoff is a longer clinical trial exclusion list: under PA-27-102, NIAID, NIAMS, NIDCR, NIDDK, and NIMHD do not accept clinical trials.

The combined clinical trial picture for this topic. NIAMS and NIDCR accept no clinical trials under either parent, despite both asking for research that develops and tests interventions. NIAID and NIDDK accept clinical trials under SBIR but not under STTR, so a project with an academic PI and a trial component cannot use STTR at those Institutes. Review the NIH Clinical Trial Definition before assuming your study is not a trial, because it captures more designs than founders expect, including many behavioral and care delivery interventions that sit at the center of this topic.

Multiple Program Directors and Principal Investigators. The topic strongly encourages teams with multiple PD/PIs holding complementary expertise. NIH small business awards do permit multiple PD/PI structures, but the employment rules still bind. Confirm with your target Institute how the primary employment requirement applies across a multiple PD/PI team before you build the team into the application, because this is the point at which an otherwise strong interdisciplinary structure can become an eligibility problem.

Direct to Phase II. Available if you already hold the feasibility data a Phase I would generate and never received a Phase I award for that project. SBIR only, not available under STTR.

Fast-Track. Phase I and Phase II submitted together, reviewed once. Poor fit when Phase I results would change the Phase II design, which is common where the Phase I is a feasibility or usability study feeding an intervention design.

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

Commercialization Readiness Pilot, currently PAR-27-098 (SB1). Late-stage technical assistance and product development that Phase II and Phase IIB cannot support, including regulatory and reimbursement work. Permits more outsourcing, though the small business must retain substantial project management and oversight.

Funding Allowance

The ceiling depends on two layers, and with twelve participating Institutes the second layer is where the planning happens.

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

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

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

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

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

Layer two, Institute-specific guidance. NIH holds SBA waivers permitting awards above the guideline for approved topics, and each Institute publishes its own limits. For the participating Institutes here, the published picture as of this writing:

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

• NCI. Publishes waiver-topic guidance generally funding Phase I up to $400,000 across up to 2 years and considering Phase II up to $2,250,000 across up to 3 years. NCI also runs a Phase IIB Bridge Award and caps its CRP support well below the government-wide figure.

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

• NIAAA. Publishes guidance that it will generally not fund Phase I applications to the omnibus above roughly $385,000 or Phase II awards above $3 million, even for topics on the SBA-approved waiver list.

• NIAID. Publishes a per-year constraint rather than only a total: NIAID will not generally allow Phase II or Phase IIB awards of any duration exceeding $1,000,000 in total costs per year. This reshapes a budget more than a total-cost ceiling does.

• NIDA. Publishes waiver-topic guidance permitting Phase II requests up to $2.5 million across up to 3 years where the research falls within its approved waiver topics and the justification is adequate.

• NHLBI. Publishes its budget guidance through NOT-HL notices rather than a single standing page. Confirm the current notice with NHLBI program staff before budgeting.

• NCCIH, NIA, NIAMS, NICHD, NIDCR, NIMH. Refer to the participating component table in the current parent announcement and confirm directly with program staff, as these Institutes do not all maintain standing published SBIR budget pages.

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

Timeline

The topic window runs from September 1, 2026 through July 28, 2028. That expiration is earlier than the usual two-year window and sits between two standard due dates, which removes a cycle other Highlighted Topics would offer.

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

Do not use the AIDS due dates. NIH runs a separate set of AIDS and AIDS-related receipt dates of January 7, May 7, and September 7 for many mechanisms, and researchers experienced with R01 submissions in this field will know those dates well. HHS SBIR and STTR grant applications are not accepted on the AIDS and AIDS-related due dates. The standard small business dates govern here despite the HIV subject matter. This is the most likely calendar mistake on this particular topic, and it is most likely to be made by an academic collaborator advising the team.

Cycles available under this topic:

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

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

• April 5, 2027

• September 5, 2027

• January 5, 2028

• April 5, 2028, the final cycle. The topic expires July 28, 2028, before the September 2028 date.

What the runway looks like: plan on roughly 9 months from submission to funds in the door. An application submitted in the January 2027 cycle typically reaches an earliest possible start date in the fall of 2027. Council decisions for the September and January cycles are often handled together, so deferring a cycle is not costless.

Work backwards from your target date:

• 16 to 18 weeks out: identify your target Institute, confirm its clinical trial policy for your chosen mechanism, contact program staff, and start or verify federal registrations. This topic warrants a longer lead time than most because of the Institute selection and clinical trial questions.

• 12 weeks out: lock the Specific Aims page, confirm the multiple PD/PI structure against employment rules, and circulate to program staff

• 8 weeks out: complete the research strategy, commercialization plan, letters of support, community partner documentation, and any IRB or human subjects planning

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

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

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

Also note that the current SBIR parent, PA-27-100, closes in early April 2027, well before this topic expires. Applicants targeting later cycles must confirm the active announcement number at the time of submission.

Detailed Overview of What NIH Is Looking For

The problem NIH is trying to solve

The topic opens from a position of success. Antiretroviral therapy has transformed HIV into a manageable chronic condition. The consequence is a new problem: people with HIV face high risk and early onset of comorbidities, ART-related adverse effects, and interconnected medical, psychosocial, and structural challenges. The scope extends beyond people with HIV themselves. The topic notes that HIV and its treatment may also affect individuals exposed to HIV, and that HIV-exposed, uninfected children may face elevated immune, metabolic, and developmental risks compared with unexposed, uninfected peers, particularly in low and middle-income settings.

The named gap is mechanistic and specific: how HIV, ART, and psychosocial stressors interact to drive early onset and progression of comorbidities. NIH argues that many comorbidities involve intersecting pathways and shared risk factors even as they diverge into disease-specific trajectories, giving two examples. Metabolic syndrome increases risk for diabetes, cardiovascular disease, and chronic kidney disease. Certain coinfections increase cancer risk. Elucidating the shared factors, NIH argues, may inform preventive strategies addressing multiple outcomes at once.

The methodological critique follows from that. Traditional disease-specific models may insufficiently capture shared factors or multilevel implementation determinants. NIH instead points toward comprehensive whole-person care linking infectious diseases, endocrinology, psychiatry, nursing, pharmacy, and community health, with emphasis on early screening, lifestyle-based prevention, and sustained engagement in HIV care, while requiring careful attention to local context and health system factors for effective implementation.

Read strategically, that argument creates a specific opening for a product company. If NIH believes the shared upstream factors matter more than the disease-specific endpoints, then a screening tool, biomarker panel, or decision-support system that detects or manages a shared factor across multiple downstream comorbidities is more responsive than one addressing a single condition. A cardiometabolic risk platform that also informs kidney and cancer risk is speaking the topic's language. A single-indication tool is not.

The stated purpose

The topic aims to catalyze interdisciplinary research on HIV-associated co-occurring conditions and to expand multidisciplinary teams that develop and deliver preventive strategies improving health and quality of life for people with HIV across the lifespan. Emphasis falls on two things: research on shared factors and multi-organ effects to inform early preventive strategies, and implementation science approaches that identify barriers and facilitators, optimize multidisciplinary care approaches, and deliver scalable, sustainable care models. Multidisciplinary teams with multiple Program Directors and Principal Investigators holding complementary expertise in HIV and relevant conditions, cross-NIH alignment, and use of existing resources are all strongly encouraged.

Two phrases in that paragraph carry weight for a small business. "Scalable, sustainable care models" is commercialization language, and it invites a business model argument about who pays and how the model persists after grant funding ends, which most academic applications will answer weakly. "Use of existing resources" points toward NIH cohorts, data platforms, and networks, and a company that proposes to validate against an existing NIH resource rather than build a new cohort is both cheaper and more responsive.

Selected Institute areas of interest, with strategic reads

NHLBI seeks mechanisms and pathways contributing to HIV-associated heart, lung, blood, and sleep comorbidities, and interventions that improve care including implementation evaluation. Its named priorities are the combined effects of aging, HIV, and ART on those conditions; aging and HIV-related changes in hematopoiesis including hematopoietic stem cells and their niche; the impact of sleep deficiency and sleep-disordered breathing on HIV-associated cardiopulmonary and cardiometabolic disease pathogenesis; vascular contributions to cognitive impairment and dementia; implementation strategies improving uptake and sustainability of evidence-based interventions; mechanistic studies reducing the effects of HIV and aging including traditional risk factors and sex differences; and novel methods to detect subclinical HIV-related conditions plus strategies to mitigate clinical disease.

Read: the last bullet is the strongest product invitation in the topic. Subclinical detection is a diagnostics problem with a defined customer and a regulatory pathway. NHLBI also stated it may dedicate available funds. Sleep-disordered breathing is a notable inclusion for wearable and home-testing companies.

NCI seeks advancement in understanding risks, development, progression, prevention, diagnosis, and treatment of cancer in people with HIV, plus testing and implementation of bundled cancer and HIV interventions. It notes that people with HIV have increased incidence of certain cancers, are diagnosed later at higher stage, have worse overall and cancer-specific survival, and are less likely to receive cancer treatment. Its example topics are characterizing HIV's contribution to HIV-related tumor development and pathogenesis; discovering and developing new biomarkers, diagnostics, and therapeutics; and identifying factors influencing cancer disparities including improving adoption, implementation, and sustainment of effective interventions.

Read: "bundled cancer/HIV interventions" is unusual phrasing and signals interest in combined care products rather than single-purpose tools. The treatment access disparity NCI names is a care delivery problem as much as a clinical one.

NIDA seeks interdisciplinary research on how drug use, addiction, and HIV interact across the lifespan, spanning brain function, behavior, mood, sleep, pain, and cognition under HIV, ART, and polysubstance use; molecular, neurochemical, cellular, and circuit function underpinning HIV and co-occurring substance use disorders; shared pathways linking substance use, HIV, stress, trauma, and mental health; individual and community factors affecting prevention, care engagement, and ART adherence with focus on improving access in underserved populations; integrated interventions addressing HIV, substance use disorder, hepatitis C, and co-occurring mental health conditions; and basic, clinical, and translational research on substance use disorder and overdose treatment in people with HIV.

Read: NIDA is the only Institute here making both funding statements, and its list is unusually accommodating, spanning basic neuroscience through digital adherence tools through overdose therapeutics. If your product plausibly fits NIDA, that combination of breadth and stated signal makes it the strongest default target on this topic.

NCCIH supports complementary and integrative health approaches for symptom management, prioritizing testing of interventions such as mind-body and natural products to address symptom clusters and improve function and quality of life; elucidating biological, behavioral, and psychosocial mechanisms including inflammation, neuroimmune, and stress pathways and identifying biomarkers and patient characteristics; integrating these approaches into HIV care through pragmatic and hybrid effectiveness-implementation studies and scalable delivery models; and evaluating risks such as drug and herb interactions, synthesizing evidence, and developing decision-making guidance.

Read: the risk evaluation and guidance bullet is the least crowded. A drug and herb interaction screening tool for an ART-treated population is a clean software product with a real safety rationale, and NCCIH stated it may give special consideration.

NIAMS and NIDCR both ask for interventions while accepting no clinical trials. NIAMS seeks research on HIV-associated musculoskeletal, skin, and systemic rheumatic comorbidities including musculoskeletal pain, sarcopenia and cachexia, cartilage degeneration and osteoarthritis, osteoporosis and fractures, arthritis and rheumatic disease, and dermatologic manifestations, and states that priority is given to implementation science projects developing, testing, and scaling multidisciplinary whole-person care models. NIDCR seeks mechanisms of HIV-related oral disease; biological, behavioral, and contextual risk factors linking oral and systemic comorbidities including HPV-associated cancer; interdisciplinary preventive, diagnostic, and treatment approaches including probiotics, mucosal immunity modifiers, and early cancer detection; and integration of oral health into the HIV care continuum.

Read: this is the sharpest trap on the page. Both Institutes invite intervention development and both are on the clinical trial exclusion list for the parent announcements. The workable path is a project whose endpoints are technical, mechanistic, or feasibility-based rather than a trial testing safety or efficacy in human subjects, or a submission through an Institute-specific announcement designed for trials. Confirm the design with program staff before drafting, not after.

NIA, NIAAA, NIAID, NIDDK, and NIMH round out the awarding set. NIA works across the NIH Stage Model from Stage 0 basic science through Stage V implementation, interested in etiology and pathogenesis including chronic immune activation and antiretroviral and other drug toxicities, optimizing medications and care coordination alongside behavioral and social interventions, and developing, testing, implementing, and scaling evidence-based interventions. NIAAA focuses on heavy alcohol use and alcohol use disorder, noting it accelerates physiological vulnerability, impacts medication adherence and toxicities, and complicates care, with complications including cardiovascular disease, metabolic disorders, neurocognitive impairment, and cellular and immune dysfunction. NIAID focuses on coinfections from infant through adult, encouraging attention to stigma and intersecting behavioral, biological, and health system factors in diagnosing, preventing, and treating tuberculosis, viral hepatitis, and sexually transmitted infections. NIDDK spans enteropathy and gastrointestinal homeostasis, liver disease and viral hepatitis coinfection, digestive disease, nutrition, obesity, diabetes and complications, and kidney, urologic, and hematologic disease presenting differently under HIV, and gives high priority to studies of social, behavioral, and environmental factors affecting disease severity and treatment adherence. NIMH focuses on neuropsychiatric mechanisms of CNS comorbidity, how HIV biology, treatment exposures, and psychosocial burden converge on shared pathways driving neurocognitive and mental health disorders, and multidisciplinary implementation research identifying diagnosis and treatment barriers with emphasis on community engagement and sustainable delivery.

What the non-awarding offices add

Five offices participate without awarding grants: the Office of AIDS Research, which also serves as the central scientific contact for the topic; the Office of Behavioral and Social Sciences Research; the Office of Disease Prevention; the Office of Research on Women's Health; and the Tribal Health Research Office. Your application must be relevant to the objectives of at least one awarding Institute, and their interests function as additional strength rather than an independent route.

OAR is interested in interdisciplinary research including implementation science advancing understanding of common factors underlying HIV-associated co-occurring conditions, supporting early prevention, integrated whole-person care, and improved health and quality of life across the lifespan. ODP is particularly interested in innovative prevention research using rigorous study design, measurement, and analysis methods to test interventions, implementation strategies, and multidisciplinary care approaches. ORWH is interested in projects addressing HIV-associated co-occurring conditions in women. OBSSR and THRO participate without publishing specific interests for this topic.

Practical read: ODP's emphasis on rigorous design, measurement, and analysis is the most actionable of these, because methodological rigor is cheap to strengthen and is where small business applications most often lose points. Powering your study properly and pre-specifying your analysis is a low-cost, high-return decision. OAR being the central contact also means a single call to OAR can help route you among twelve Institutes if you are genuinely unsure where you fit.

MAHA alignment

This topic is issued as part of the Make America Healthy Again initiative and lists eight named alignments, more than any comparable topic: the NIH MAHA Chronic Disease Initiative's Whole-Person-Health approach; Food for Health, a joint HHS, VA, and USDA effort studying food and lifestyle interventions and their cost impact, coordinated by the NIH Office of Nutrition and including large-scale randomized controlled trials; Nutrition, spanning NIH partnership with FDA, USDA, and the Administration for a Healthy America, expanded research on dietary patterns supporting metabolic health, the FDA and NIH Joint Nutrition Regulatory Science Program, and precision nutrition; the Oral Health and Systemic Disease Connection, examining pediatric oral health links to cardiovascular disease, diabetes, and autoimmune conditions plus oral microbiome relationships with gut health and immune function; the Gut Microbiome Research Initiative; Longitudinal Research for Chronic Disease Prevention, naming the Adolescent Brain Cognitive Development Study, the Healthy Brain and Child Development Study, All of Us, and the Environmental Influences on Child Health Outcomes Program, with example areas including sleep, nutrition, insulin resistance, select high-quality supplements, and fitness as a vital sign; and Mental Health and Addiction Research, with a special focus on screentime in children and adolescents.

Practical read: pick one or two, not eight. The named longitudinal resources are the most useful, because "use of existing resources" is explicitly encouraged in the topic purpose, and proposing validation against All of Us or a named cohort is concrete, cheaper than new recruitment, and directly responsive. For a nutrition or metabolic product, Food for Health and the Nutrition alignment are the natural anchors. For oral health, NIDCR plus the Oral Health and Systemic Disease Connection is a coherent pairing.

Eligibility Requirements

To apply for an NIH SBIR or STTR award, your company must meet the core SBA criteria:

• Organized for profit, with a place of business located in the United States, and the primary research performed in the United States

• More than 50 percent directly owned and controlled by one or more individuals who are U.S. citizens or permanent resident aliens, by other for-profit small business concerns each majority owned by such individuals, or by a combination. Certain venture capital, hedge fund, and private equity structures may qualify for SBIR under specific conditions, and Tribal, Alaska Native Corporation, Native Hawaiian Organization, and joint venture paths exist. Complex cap tables should be checked against 13 CFR Part 121.

• No more than 500 employees including all affiliates. A subsidiary counts its parent's employees.

• For SBIR, the Principal Investigator's primary employment must be with the small business at the time of award and for the duration of the project. For STTR, the PD/PI may be primarily employed by either the small business or the partnering nonprofit research institution, with the award still made to the small business.

• For SBIR Phase I, the small business must perform at least two thirds of the research or analytical effort. For SBIR Phase II, at least half. For STTR, the small business performs at least 40 percent and a single partner nonprofit research institution performs at least 30 percent.

Additional constraints that matter on a topic this broad. NIH will not accept similar applications with essentially the same research focus from the same applicant organization, including derivative applications proposing a single product that can be applied to multiple purposes with non-substantive modification. You may not simultaneously submit identical or essentially identical applications under both parent announcements. Duplicate or highly overlapping applications under simultaneous review are not accepted. Applicants must disclose overlapping federal work under the essentially equivalent work rule. Companies with a substantial award history should confirm they meet the Phase I to Phase II Transition Rate and commercialization benchmarks, which can restrict new Phase I, Fast-Track, and Direct to Phase II eligibility for one year. Heightened screening of foreign ownership and foreign influence applies under the 2026 reauthorization, with additional scrutiny possible for STTR because of the research institution partnership.

What a Competitive Application Looks Like

1. A shared-factor story, not a single-condition story. The topic's central argument is that comorbidities share upstream pathways and risk factors. A product addressing a shared factor with consequences across multiple downstream conditions is answering the question asked. A single-indication tool is answering a different one.

2. The right Institute, confirmed by a call. Twelve awarding Institutes with different missions, different budget ceilings, and different clinical trial policies. The program officer conversation determines assignment, budget realism, and whether your design is even reviewable. On this topic that call is worth more than on almost any other.

3. A clinical trial determination made early. Review the NIH Clinical Trial Definition against your actual design before choosing a mechanism and Institute. Behavioral and care delivery interventions frequently meet the definition when founders assume they do not, and NIAMS, NIDCR, NIAID, and NIDDK all carry restrictions.

4. Validation against existing NIH resources. The topic explicitly encourages use of existing resources, and the MAHA alignment names specific longitudinal cohorts. Proposing to validate against an existing resource is cheaper, faster, and more responsive than proposing new recruitment.

5. A sustainability and payer argument, not just a care model. The topic asks for scalable, sustainable care models. For a company that means naming who pays after the grant ends: reimbursement pathway, health system purchaser, or payer. Academic applications will treat sustainability as an aspiration. Treating it as a business model is your advantage.

6. Community engagement that is documented, not asserted. Meaningful community engagement is strongly encouraged throughout the topic. Letters, agreements, and named partners carry weight. A stated intention does not.

7. An interdisciplinary team that survives the eligibility rules. Multiple PD/PIs with complementary expertise are encouraged, but SBIR employment rules still bind. Build the team and confirm the structure with program staff in the same step.

Common Reasons Applications Miss

• Treating the Highlighted Topic as a NOFO and searching Grants.gov for a topic-specific number that does not exist

• Submitting on an AIDS due date of January 7, May 7, or September 7, which HHS does not accept for SBIR or STTR applications

• Proposing a clinical trial to NIAMS or NIDCR, which accept none under either parent announcement, making the application non-responsive and unreviewed

• Proposing a clinical trial to NIAID or NIDDK through STTR, which neither accepts, when SBIR would have worked

• Assuming a behavioral or care delivery intervention is not a clinical trial without checking the NIH Clinical Trial Definition

• Pursuing SBIR when the scientific lead holds a primary academic appointment, where STTR permits that PD/PI arrangement and SBIR does not

• Bringing an academic research project to a small business mechanism, where the deliverable is knowledge rather than a commercial product the company will own and sell

• Targeting NICHD without a program officer conversation, since NICHD published no areas of interest for this topic

• Budgeting to the $700,000 Phase I ceiling rather than the roughly $400,000 that Institutes actually award, or ignoring NIAID's per-year constraint of $1,000,000 in total costs

• Omitting the fee from the budget or requesting the wrong level, neither correctable after submission

• Citing all eight MAHA alignments rather than the one or two that fit, which reads as unfocused

• Starting federal registrations after drafting begins, then missing the receipt date on an eRA Commons validation error

Frequently Asked Questions

Is this a grant I can apply to directly?

No. This is an NIH Highlighted Topic, which is a statement of scientific priority rather than a Notice of Funding Opportunity. You apply through a broad NIH announcement, and for small businesses that means the NIH SBIR or STTR parent announcement, requesting assignment to one of the twelve awarding Institutes.

Which funding opportunity number do I actually use?

For most small businesses it is PA-27-100, the NIH, CDC, and FDA Parent SBIR announcement covering R43 and R44 awards. If your project depends on a formal university or nonprofit research partner, use PA-27-102, the Parent STTR announcement covering R41 and R42. Confirm the active number at submission, since PA-27-100 closes in early April 2027 while this topic runs to July 2028.

When is the deadline, and do the AIDS due dates apply?

There is no deadline specific to this topic. You submit on the NIH standard small business receipt dates of January 5, April 5, and September 5, with dates falling on weekends or federal holidays moving to the next business day. The AIDS and AIDS-related due dates of January 7, May 7, and September 7 do not apply, because HHS does not accept SBIR or STTR grant applications on those dates. The topic expires July 28, 2028, making April 5, 2028 the final available cycle.

Which of the twelve Institutes should I target?

Group by what you sell. Diagnostics and screening point to NHLBI, NCI, NIDCR, or NIDDK. Therapeutics point to NCI, NIAID, NIAAA, NIDA, or NIA. Software and care delivery point to NIMH, NIDA, NIA, NIDDK, or NIAMS. Complementary and integrative health points to NCCIH. NIDA is the only Institute that stated both that it may dedicate funds and that it may give special consideration, which makes it a strong default where the fit is genuine.

How much money can my company request?

The SBA statutory guidelines this cycle are $323,090 for Phase I and $2,153,927 for Phase II in total costs, including direct costs, indirect costs, and fee. Institute limits differ substantially. Several Institutes in this topic list Phase I headroom to $700,000, NCI publishes waiver guidance near $400,000 for Phase I and $2,250,000 for Phase II, NIDDK publishes $350,000 and $2,200,000, NIAAA caps near $385,000 and $3 million, and NIAID applies a per-year constraint of $1,000,000 in total costs on Phase II and Phase IIB. Confirm with your target Institute before setting a budget.

Can I include a clinical trial in my application?

It depends entirely on the Institute and the mechanism. Under the parent SBIR announcement, NIAMS and NIDCR do not accept clinical trials. Under the parent STTR announcement, NIAID, NIAMS, NIDCR, NIDDK, and NIMHD do not. An application proposing a clinical trial that aligns only with an excluded component is non-responsive and will not be reviewed. Check the NIH Clinical Trial Definition against your design first, because many behavioral and care delivery interventions meet it.

My scientific lead is a university faculty member. Can we still apply?

Yes, through STTR. Under the parent STTR announcement the Program Director or Principal Investigator may be primarily employed by either the small business or the partnering nonprofit research institution, while the award still goes to the small business. SBIR requires the PI's primary employment to be with the company. Given how much of the HIV comorbidity field sits in academic clinical settings, this is often the deciding factor on mechanism.

The topic encourages multiple Principal Investigators. Does SBIR allow that?

NIH small business awards do permit multiple Program Director and Principal Investigator structures, but the employment requirements still apply. Because the interaction between a multi-PI team and the primary employment rule can create an eligibility problem, confirm the specific structure with your target Institute's program staff before building the team into the application.

How long until I receive funding?

Plan on approximately 9 months from submission to award start. An application submitted in the January 2027 cycle would typically have an earliest possible start date in the fall of 2027.

Do I have to give up equity or match the funds?

No. NIH SBIR and STTR Phase I and Phase II awards are non-dilutive and require no cost share. The exception is the Phase IIB Strategic Breakthrough Award, which requires not less than 100 percent matching funds from new private capital or from a government source other than a Phase I or Phase II SBIR or STTR award.

Is this topic really a fit for a small business, or is it academic research?

Both, and the distinction matters. Cohort analysis, mechanistic basic science, epidemiological characterization, and academically led community trials belong in R01 and related mechanisms. Genuine small business lanes include subclinical disease detection, biomarkers and diagnostics, therapeutics, medication optimization and drug interaction tools, care coordination and clinical decision support software, point-of-care coinfection testing, and integrated behavioral health delivery platforms. The test is whether there is a commercial product with unresolved technical risk that the company will own and sell.

Does any Institute set aside dedicated funding for this topic?

Not guaranteed, but four made statements. NIDA stated both that it may dedicate available funds and that it may give special consideration. NHLBI stated it may dedicate available funds. NCCIH and NIDCR each stated they may give special consideration. The remaining eight awarding Institutes made neither statement. Treat these as a favorable tilt rather than a reserved pool.

Why does NICHD list no areas of interest?

NICHD participates in this topic but published only a scientific contact rather than stated interests. The topic body does note elevated immune, metabolic, and developmental risks in HIV-exposed but uninfected children, particularly in low and middle-income settings. With no published language to write against, a program officer conversation is essential before investing in a NICHD-targeted application.

I already have feasibility data. Do I still need a Phase I?

Not necessarily. SBIR Direct to Phase II allows a company that has demonstrated the scientific and technical merit and feasibility normally expected from a Phase I, without having received a Phase I award for that project, to apply directly for Phase II. This authority is available for SBIR only and is not available under STTR.

Do OAR, OBSSR, ODP, ORWH, and THRO award grants?

No. All five participate without awarding. Your application must be relevant to the objectives of at least one awarding Institute. OAR does serve as the central scientific contact for the topic, which makes it a useful first call if you are unsure which of the twelve Institutes fits your technology.

What registrations do I need, and how long do they take?

SAM.gov with a Unique Entity ID, the SBA Company Registry, eRA Commons, and Grants.gov. eRA Commons access depends on completing the SBA Company Registry first, so the sequence matters. Allow at least six weeks, and start before you begin writing.

How BW&CO Helps

BW&CO is a non-dilutive federal funding advisory firm. We help deep-tech, biotech, medtech, and health technology founders convert agency priority signals like this one into funded awards.

This topic has twelve awarding Institutes, four different clinical trial policies, and budget ceilings that range from the statutory guideline to $700,000 at Phase I. Most of the value is created before drafting begins: honest fit assessment, Institute selection and assignment strategy, clinical trial determination and mechanism choice, program officer engagement, multi-PI structure review against eligibility rules, Specific Aims development, full proposal build, budget and fee construction, commercialization and sustainability planning, and Phase IIB matching capital positioning. Our team has helped clients secure more than $350 million in funding. Innovation Funding Simplified.

If you are building a product for people with HIV and want a straight answer on whether this topic fits your company, which Institute to target, and whether you are competitive for the January 5, 2027 cycle, contact us for a fit assessment.

NIH Highlighted Topic: Accelerating Disease Prevention Research by New Approach Methodologies

Executive Summary

The National Institutes of Health has published a Highlighted Topic titled "Accelerating Disease Prevention Research by New Approach Methodologies." It signals that four NIH awarding components, the National Cancer Institute (NCI), the National Center for Advancing Translational Sciences (NCATS), the National Institute on Aging (NIA), and the National Institute on Drug Abuse (NIDA), want to fund the development, validation, and use of human-relevant New Approach Methodologies that model precursor conditions and the process by which those conditions progress into overt disease.

The gap NIH names is specific and narrow. NAMs exist. NAMs that model precursor states, things like precancer, prediabetes, and preclinical Alzheimer's disease, and that capture the dynamics of progression rather than a static snapshot, do not exist in sufficient number. NIH calls this a high-priority unmet need. If your platform can model a disease before it becomes a disease, you are inside the target.

For a small business, the practical translation is this: there is no new application portal and no new deadline attached to this topic. A Highlighted Topic is a demand signal, not a Notice of Funding Opportunity. You capture the funding by submitting to the NIH SBIR or STTR parent announcement, requesting assignment to whichever of the four Institutes best fits your science, and aligning your Specific Aims to that Institute's stated areas of interest.

The topic was posted on September 3, 2026 and expires on September 3, 2028. Budget guidance varies substantially by Institute, which is the single most consequential planning fact on this page. The SBA statutory guidelines for the current cycle are $323,090 for Phase I and $2,153,927 for Phase II, but the participating component table in the parent SBIR announcement lists Phase I limits as high as $700,000 for NCI and NIA, while NCATS operates at the statutory guideline.

If you build organoids, microphysiological systems and organ-on-a-chip platforms, iPSC-derived tissue or immune models, bioengineered human tissues, advanced biomaterials for human-derived models, in silico or AI-based predictive models, or combinatorial NAMs, this is one of the broadest and best-signposted funding openings NIH has published for the tools and platforms community.

At a Glance

• Topic title: Accelerating Disease Prevention Research by New Approach Methodologies

• Issuing agency: National Institutes of Health, U.S. Department of Health and Human Services

• Awarding components: NCI, NCATS, NIA, and NIDA

• Non-awarding participating offices: ORWH, the Office of Autoimmune Disease Research in ORWH (OADR-ORWH), and the Tribal Health Research Office (THRO)

• Type: NIH Highlighted Topic. This is not a Notice of Funding Opportunity.

• Post date: September 3, 2026

• Expiration date: September 3, 2028

• Recommended small business mechanism: NIH SBIR (R43 and R44) or NIH STTR (R41 and R42) parent announcement

• Current parent announcements: PA-27-100 for SBIR, PA-27-102 for STTR, PA-27-101 for the Phase IIB Strategic Breakthrough Award, and PAR-27-098 for the Commercialization Readiness Pilot

• Standard annual due dates: January 5, April 5, and September 5

• SBA statutory guidelines this cycle: $323,090 Phase I, $2,153,927 Phase II, $4,191,495 CRP

• Component Phase I limits in the parent SBIR table: up to $700,000 for NCI and NIA, with NCATS at the statutory guideline. Confirm with the Institute before budgeting above the guideline.

• Cost share: none for Phase I or Phase II. Phase IIB requires 100 percent third-party matching funds.

• Equity dilution: none. This is non-dilutive federal funding.

• Profit or fee: allowable, must be in the budget at submission, and normally will not exceed 7 percent of total costs

• Funding signals: NCATS states it may dedicate available funds to this topic area. NIDA states it may give special consideration to meritorious applications in this topic area.

• Small business specific contact: NCI has designated Linda Zane, Ph.D. for small business product development and commercialization of NAMs, reachable at NCI-HT-NAM@nih.gov

• Broader initiative alignment: Make America Healthy Again initiative, New Approach Methodologies effort

What This Opportunity Actually Is

An NIH Highlighted Topic is a published statement of scientific interest from one or more NIH Institutes, Centers, and Offices. It tells the research community that an area of science is a priority without creating a separate funding announcement, a separate deadline, or a separate review process. There is no topic-specific number to search for on Grants.gov, and applications are not reviewed against other applications to the topic.

What it does do for a small business is threefold. It identifies which Institutes are receptive, which determines your assignment request and which program officer you call. It supplies the vocabulary that program staff and reviewers are already using internally, which is what your Specific Aims should mirror. And in two cases here it creates an explicit funding advantage: NCATS states it may dedicate available funds to applications in this topic area depending on the availability of funds, the number of meritorious applications, and competing priorities, and NIDA states it may give special consideration to meritorious applications in the topic area.

What it does not do is guarantee a set-aside or bypass peer review. Your application competes on scientific merit through the standard NIH study section route, and the topic language is a positioning advantage rather than a shortcut.

Which Institute Should You Target?

This is the decision that matters most on this topic, because four awarding components with materially different missions and budget ceilings are participating, and your assignment request determines which one reads your application.

NCI, if your work touches precancer or cancer prevention. NCI published the most detailed and most product-oriented set of interests here, covering human-derived precancerous organoids, iPSC-derived and bioengineered human tissue and immune system models of tumorigenesis, advanced biomaterials enabling human-derived NAMs, NAMs for discovery of preventive, interceptive, or reversive agents, NAMs for biomarker discovery supporting early detection and risk stratification, and microphysiological and combinatorial NAMs for predicting human safety and toxicity of candidate prevention agents. NCI also listed eight named scientific contacts for this topic, including one specifically for small business product development and commercialization of NAMs. That is an unusually strong signal that NCI expects and wants small business applications here.

NCATS, if your platform is disease-agnostic. NCATS is interested in NAMs that reveal the mechanisms of drug-induced organ injury so those reactions can be prevented before clinical symptoms emerge. The framing is deliberately not tied to one disease, which makes this the right door for a platform company whose technology is a tool rather than a disease model. NCATS asks for innovative, scalable, and reproducible platforms that enable earlier intervention, reduce reliance on traditional animal models, and generate broadly applicable knowledge. Note that scalability and reproducibility are named explicitly, which for a small business means manufacturing consistency and assay robustness are scientific aims, not afterthoughts.

NIA, if your work concerns aging, resilience, or dementia. NIA wants NAMs that identify biomarkers, protective pathways, and preventive therapeutics for age-related conditions including Alzheimer's disease and related dementias. Its interests include person-specific, cross-species, and combinatorial NAMs; neuronal and peripheral tissue NAMs derived from individuals with exceptional longevity, cognitive superagers, or people showing resistance or resilience to AD and ADRD, used to identify protective pathways and test whether those pathways can reduce or reverse disease phenotypes in patient-derived iPSCs; and in silico NAMs that model behavioral, cognitive, and functional phenotypes alongside extrinsic risk factors. The resilience donor angle is distinctive and worth noting: NIA is asking for models built from people who did not get sick.

NIDA, if your work concerns addiction biology or substance use. NIDA seeks human-relevant NAMs that accelerate addiction research and intervention discovery, including iPSCs, organoids, and bioengineered tissues that identify molecular changes induced by addictive drugs and mechanisms of vulnerability; tools and methods including in silico models that integrate and analyze epidemiological and electronic health record data to surface mechanisms, biomarkers, and candidate drugs; and NAMs that decipher interactions between biological factors such as age and sex, behavioral factors such as exercise, and environmental factors such as nutrition and substance exposure. NIDA's inclusion of data integration work makes this the most software-friendly of the four.

If your technology plausibly fits more than one, contact more than one program officer before choosing. Assignment requests are not binding on NIH, but an application written to a specific Institute's language and referred elsewhere reads as a poor fit to whoever receives it.

Which NIH Mechanism Should a Small Business Use?

Small businesses should apply through the NIH SBIR or STTR parent announcement and request assignment to the Institute whose interests match.

NIH Parent SBIR, currently PA-27-100 (R43 and R44). The default route for most companies. It accepts Phase I, Phase II, Direct to Phase II, and Fast-Track applications. Use it when your company performs the majority of the research and your Principal Investigator is primarily employed by the company.

NIH Parent STTR, currently PA-27-102 (R41 and R42). Use this when the project depends on a formal partnership with a U.S. nonprofit research institution. STTR requires at least 40 percent of the research at the small business and at least 30 percent at a single partner institution. This is the natural route for a company commercializing licensed organoid, iPSC, or microphysiological system technology where the originating academic lab retains essential capability, and for projects needing access to donor cohorts such as NIA's exceptional longevity and resilience populations.

Direct to Phase II. If you already have the feasibility data a Phase I would generate, and you never received a Phase I award for that project, you can apply straight to Phase II. This authority is SBIR only and is not available under STTR. Many NAMs companies with a validated platform in one disease context and new data in a precursor context are strong candidates here.

Fast-Track. Phase I and Phase II submitted together and reviewed once. It compresses the funding gap but requires a fully developed Phase II plan at first submission. Poor fit when Phase I results would change the Phase II design, which is common in early model development where the qualification strategy depends on what the first characterization shows.

Phase IIB Strategic Breakthrough Award, currently PA-27-101 (R44). For companies that have completed an NIH SBIR or STTR Phase II and need to bridge to commercialization. Requires documentation of not less than 100 percent matching funds from new private capital or from a government source other than a Phase I or Phase II SBIR or STTR award. Budget guidance varies by participating Institute.

Commercialization Readiness Pilot, currently PAR-27-098 (SB1). Funds late-stage technical assistance and product development that Phase II and Phase IIB cannot support, including specialized regulatory and qualification work. It permits more outsourcing than other mechanisms, though the small business must retain substantial project management and oversight. Note that NCI caps its CRP support well below the government-wide CRP figure, so contact NCI SBIR program staff before planning a CRP budget.

Funding Allowance

The ceiling on this topic depends on two layers, and on this particular topic the second layer varies more than usual because four Institutes are involved.

Layer one, the SBA statutory guidelines for the current cycle:

• Phase I: up to $323,090 in total costs, for a project period of 6 months to 2 years

• Phase II: up to $2,153,927 in total costs, for a project period of 1 to 3 years

• Commercialization Readiness Pilot: up to $4,191,495 in total costs, for a project period of up to 3 years

Total funding support means direct costs, indirect costs, and fee combined. A reasonable profit or fee is allowable on SBIR and STTR awards, but it must be built into the budget at the time of application and normally will not exceed 7 percent of total costs. NIH does not adjust budgets after submission, so a budget requested at the wrong level cannot be corrected later.

Layer two, Institute-specific guidance. NIH holds SBA waivers permitting awards above the statutory guideline for specific approved topics, and each Institute publishes its own limits. For the four awarding components here:

• NCI. The participating component table in the parent SBIR announcement lists a Phase I limit as high as $700,000. NCI's own program descriptions state that for waiver-eligible topics it generally funds Phase I applications up to $400,000 in total costs across up to 2 years, and will consider Phase II applications up to $2,250,000 across up to 3 years. NCI also runs a Phase IIB Bridge Award and caps its CRP support well below the government-wide figure.

• NIA. Listed among the components with a Phase I limit as high as $700,000 in the parent announcement table.

• NCATS. Operates at the stated statutory guideline rather than a waivered higher limit.

• NIDA. Publishes waiver-topic guidance permitting Phase I requests above the standard guideline with a project period up to 1 year, and Phase II requests up to $2.5 million with a project period up to 3 years, where the research falls within NIDA's approved waiver topics and the justification is adequate.

Two cautions on the headroom. First, the ceiling in a component table is not the number that gets awarded. BW&CO's own analysis of a fiscal year 2026 NCI SBIR award slice found Phase I level awards ranging from roughly $305,000 to $404,000, with not one award in 44 records using the $700,000 headroom. The realistic planning number for an NCI SBIR Phase I is closer to $400,000. Building a program plan around a waivered Phase I budgets against an outcome that did not occur. Second, an Institute may reduce the recommended budget or shorten the award period for budgetary, administrative, or programmatic reasons even after a strong review score.

The practical instruction is the same across all four: identify your target Institute, then contact its program staff with a draft Specific Aims page before you set the budget. Institutes generally do not pre-approve budget waivers, but they will tell you whether your topic is waiver-eligible and whether the number you have in mind is realistic.

Timeline

The Highlighted Topic window runs from September 3, 2026 through September 3, 2028. Within that window you submit against the NIH standard small business receipt dates.

Standard annual due dates: January 5, April 5, and September 5. When a due date falls on a weekend or federal holiday, NIH moves it to the next business day. Applications are due by 5:00 p.m. local time of the applicant organization.

Cycles available under this topic:

• September 2026 cycle: the September 5, 2026 date shifted to Tuesday, September 8, 2026 because of the weekend and the Labor Day holiday. Since the topic posted on September 3, this cycle is not realistically available.

• January 5, 2027: the first realistic cycle for a company beginning preparation now.

• April 5, 2027

• September 5, 2027

• January 5, 2028

• April 5, 2028, the last full cycle before the topic expires in September 2028.

What the runway looks like: plan on roughly 9 months from submission to funds in the door. An application submitted in the January 2027 cycle typically reaches an earliest possible start date in the fall of 2027. Council decisions for the September and January cycles are often handled together, which is one reason experienced applicants do not treat deferring a cycle as costless.

Work backwards from your target date:

• 14 to 16 weeks out: identify your target Institute, contact its program officer, confirm responsiveness and waiver eligibility, and start or verify federal registrations

• 12 weeks out: lock the Specific Aims page and circulate it to program staff

• 8 weeks out: complete the research strategy, the commercialization plan, letters of support, and any donor cohort or tissue sourcing agreements

• 4 weeks out: full internal review, budget finalization, and subaward paperwork for any STTR or academic partner

• 1 week out: submit early to leave room for eRA Commons error correction

Registrations are the most common cause of a missed deadline. You need SAM.gov with a Unique Entity ID, the SBA Company Registry, eRA Commons, and Grants.gov. eRA Commons access depends on the SBA Company Registry being complete first. Allow six weeks or more and begin before you write anything.

Also note that parent announcements are reissued periodically. The current SBIR parent, PA-27-100, carries a closing date in early April 2027, well before this topic expires, so applicants targeting later cycles must confirm the active announcement number at the time of submission.

Detailed Overview of What NIH Is Looking For

The problem NIH is trying to solve

The topic's premise is that prevention research is bottlenecked by a missing class of research tools. Beyond established risk-reduction strategies such as lifestyle change and smoking cessation, NIH argues that studying the etiologic processes by which precursor conditions initiate and progress opens new prevention opportunities: actionable targets, biomarkers for early detection and risk stratification, and therapeutics designed to prevent or intercept precursors before they become manifest disease, or even to revert them to normal.

NIH is direct about why animal models alone will not get there. Animal models remain vital, and nearly every modern pharmaceutical agent reached human clinical data on the strength of animal data, but only about 10 percent of agents entering clinical trials obtain regulatory approval. NIH attributes this to inadequate drug target validation, absent human efficacy, and unmanageable toxicity, and argues that human-relevant research tools designed to bridge interspecies differences in pathophysiology, environmental exposure, and disease characteristics, combined with in silico and AI-based tools, can improve the predictability of human efficacy and safety.

The specific gap is stated plainly: there is a scarcity of NAMs designed to mimic precursor conditions and the dynamic process of disease progression in humans. Development, validation, and integrated use of such NAMs is described as a high-priority unmet need across cancer and other chronic diseases, which NIH notes are frequently interconnected.

Read strategically, that sentence contains three requirements most applications will only partially satisfy. The model must represent a precursor state rather than established disease. It must capture progression as a process rather than a static endpoint. And NIH wants development, validation, and integrated use, which means a proposal that builds a model without a qualification and application strategy is answering one third of the question.

What counts as a NAM here

The topic states that NAMs within its scope may include, but are not limited to, microphysiological systems such as organ-on-a-chip, 2D and 3D tissue systems, bioengineered human tissue models, in silico NAMs, and combinatorial NAMs. The named precursor examples are precancerous conditions, prediabetes, and preclinical Alzheimer's disease.

The inclusion of in silico and combinatorial NAMs matters commercially. A company with no wet lab can be responsive here through computational modeling and data integration, and a company that pairs a physical model with a computational layer is directly addressing the combinatorial category NIH names in every one of the four Institute sections.

NCI areas of interest

NCI seeks NAMs that accelerate research on precancer biology, cancer prevention, and the discovery of prevention and interception interventions. Its listed interests, which it states are not exhaustive, are human-derived precancerous organoids or other NAMs that help identify molecular mechanisms of precancer growth and exploitable targets for high-risk precancer interception; iPSC-derived or other bioengineered human tissue and immune system models mimicking aspects of human tumorigenesis; advanced biomaterials enabling innovative human-derived NAMs for precancer research; NAMs for discovery of cancer preventive, interceptive, or reversive agents; NAMs for biomarker discovery supporting early detection, efficacy evaluation, and risk stratification; and microphysiological and other combinatorial NAMs to predict human safety and toxicity of candidate agents for cancer prevention and interception.

What this tells you: NCI has decomposed the space into discovery tools, agent screening, biomarker discovery, and safety prediction, and named a separate scientific contact for nearly each one, plus contacts for pharmaceutical agent development, cancer dormancy and recurrence, and small business product development. The presence of the word "reversive" alongside preventive and interceptive is notable. NCI is signaling interest in agents that reverse precursor lesions, not only ones that halt them, and very few applications will propose a reversion endpoint.

NCATS areas of interest

NCATS is advancing disease-agnostic research using NAMs to understand and ultimately prevent drug-induced organ injury. It encourages human-based in vitro and in silico NAMs that illuminate the factors contributing to drug-induced organ injury so those reactions can be avoided or prevented, revealing actionable prevention mechanisms before clinical symptoms emerge. Its scientific interests center on innovative, scalable, and reproducible NAMs platforms that enable earlier interventions, reduce reliance on traditional animal models, and generate broadly applicable knowledge that helps treat and prevent disease onset and promotes long-term health across different populations.

What this tells you: NCATS is the only one of the four framed around a safety and toxicity problem rather than a disease. If your platform predicts organ injury, hepatotoxicity, nephrotoxicity, cardiotoxicity, or neurotoxicity, this is your door, and the disease-agnostic framing means you do not need a disease indication to be responsive. NCATS is also the Institute here that stated it may dedicate available funds to the topic area. The words scalable and reproducible should appear in your aims with data behind them.

NIA areas of interest

NIA seeks NAMs that identify biomarkers, protective pathways, and preventive therapeutics for age-related conditions and diseases including Alzheimer's disease and related dementias, through studies of aging biology and the intrinsic and extrinsic factors underlying resilience. Its listed interests are person-specific, cross-species, and combinatorial NAMs for biomarker discovery, identification of preventive therapeutics and interventions for age-related conditions and AD or ADRD, and prediction of safety and toxicity; neuronal and peripheral tissue NAMs derived from individuals with exceptional longevity, cognitive superagers, or individuals with resistance or resilience to AD and ADRD, used to identify protective pathways and test their ability to reduce or reverse disease phenotypes in iPSCs from patients with AD or ADRD; and in silico NAMs modeling behavioral, cognitive, and functional phenotypes along with extrinsic factors influencing disease risk and resilience.

What this tells you: NIA has described a specific experimental architecture, not just a technology category. Take tissue from people who resisted the disease, find the protective pathway, then test that pathway in patient-derived cells. A proposal that runs that full arc is unusually well matched. The phrase person-specific also signals interest in individualized rather than pooled models. And NIA is one of the components listed with Phase I headroom as high as $700,000 in the parent announcement table.

NIDA areas of interest

NIDA seeks human-relevant NAMs that accelerate research on addiction biology, substance use prevention, and intervention discovery. Its listed interests are human-derived iPSCs, organoids, bioengineered tissues, or other NAMs to identify molecular changes induced by addictive drugs and mechanisms contributing to addiction vulnerability; development and application of tools and methods, including in silico models, to integrate and analyze data from sources including epidemiological data and electronic health records in order to identify mechanisms, biomarkers, and candidate drugs for prevention, early intervention, and treatment of substance use disorders; and application of NAMs to decipher interactions among biological factors such as age and sex, behavioral factors such as exercise, and environmental factors such as nutrition and exposure to drugs and other substances that influence the trajectory of addiction and its comorbidities.

What this tells you: NIDA is the most accommodating of the four for data and software companies, because it explicitly invites electronic health record and epidemiological data integration as a NAM activity. NIDA also stated it may give special consideration to meritorious applications in this topic area. The gene by environment by behavior interaction framing is a distinctive third bullet that most applicants will skip.

What the non-awarding offices add

ORWH, OADR-ORWH, and THRO participate but do not award grants. Your application must be relevant to the objectives of at least one participating Institute or Center, which here means NCI, NCATS, NIA, or NIDA. Their stated interests function as scoring advantages layered on top of your primary Institute fit.

ORWH seeks NAMs relevant to women's health, specifically human-derived NAMs modeling hormone homeostasis across the life course and sex influences on precursor conditions and disease progression; biomarker identification in human-derived NAMs for early detection, prevention, translation, or risk stratification of conditions prevalent in females; evaluation of sex differences in human-derived organoids, microphysiological systems, iPSC-derived models, and other bioengineered tissues; and human microphysiological or combinatorial NAMs predicting safety and toxicity in female-relevant contexts.

OADR-ORWH is interested in projects using human-derived organoids, iPSCs, or other bioengineered human tissue and immune system models to investigate pre-clinical and established autoimmunity.

THRO supports NAMs development and use to prevent disease progression in American Indian and Alaska Native communities, encouraging models of diseases that disproportionately affect AI/AN populations such as diabetes and cancer. THRO adds a requirement that most applicants will not be able to satisfy retroactively: research should be culturally grounded and involve AI/AN communities and practices as much as possible. If you intend to claim THRO alignment, community partnership must be real and documented in the application, not asserted.

Practical read: sex differences are the cheapest and most defensible of these to build in, because evaluating sex differences in an existing model architecture is a design decision rather than a new capability. Doing it deliberately, with powered comparisons rather than a minimal sex-as-a-biological-variable statement, distinguishes an application at almost no cost.

MAHA and NAMs policy alignment

This topic is issued as part of the Make America Healthy Again initiative and aligns specifically with the New Approach Methodologies effort, under which expanded NAMs use is expected to enable earlier and more predictive insight into chronic disease mechanisms through human-relevant models such as organoids, computational simulations, and real-world data integration, improving prevention, diagnosis, and personalized treatment while reducing reliance on animal studies that often fail to replicate complex human conditions. EPA, FDA, and NIH have all committed to using NAMs going forward where appropriate.

The framing consequence is significant and specific to this topic. On most NIH applications, a preclinical package light on animal data is a weakness to be explained. Here, replacing animal work with a qualified human-relevant model is the point of the solicitation. Do not apologize for the absence of animal studies. Argue affirmatively that your model predicts human outcomes better, and cite the tri-agency commitment as the policy context that makes a qualified NAM a durable asset rather than a research curiosity.

Eligibility Requirements

To apply for an NIH SBIR or STTR award, your company must meet the core SBA criteria:

• Organized for profit, with a place of business located in the United States, and the primary research performed in the United States

• More than 50 percent directly owned and controlled by one or more individuals who are U.S. citizens or permanent resident aliens, by other for-profit small business concerns each majority owned by such individuals, or by a combination. Certain venture capital, hedge fund, and private equity ownership structures may qualify for SBIR under specific conditions, and Tribal, Alaska Native Corporation, Native Hawaiian Organization, and joint venture paths exist. Complex cap tables should be checked against 13 CFR Part 121 rather than assumed either way.

• No more than 500 employees, including all affiliates. A subsidiary counts its parent's employees.

• For SBIR, the Principal Investigator's primary employment must be with the small business at the time of award and for the duration of the project. For STTR, the PI may be primarily employed by the small business or by the partnering research institution.

• For SBIR Phase I, the small business must perform at least two thirds of the research or analytical effort. For SBIR Phase II, at least half. For STTR, the small business performs at least 40 percent and a single partner nonprofit research institution performs at least 30 percent.

Companies with a substantial history of prior awards should confirm they meet the SBIR and STTR Phase I to Phase II Transition Rate and commercialization benchmarks, which can restrict new Phase I, Fast-Track, and Direct to Phase II eligibility for a period of one year. Applicants must also disclose overlapping federal work under the essentially equivalent work rule, which is a certification matter rather than a footnote. Heightened screening of foreign ownership and foreign influence applies under the 2026 reauthorization, and STTR applicants can face additional scrutiny because of the research institution partnership.

What a Competitive Application Looks Like

The trap on this topic is that NAMs are fashionable. NIH has funded organoids, microphysiological systems, and in silico models for years, and reviewers will have seen many applications proposing a model. The topic is not asking for a model. It is asking for a model of a precursor condition that captures progression, validated well enough to be used.

1. A precursor state, not a disease state. If your model represents established pathology, reframe it or propose the precursor version. Precancer, prediabetes, and preclinical Alzheimer's disease are the named examples, and the equivalent precursor in your indication is what NIH is asking for.

2. Progression as a measured process. NIH asks for the dynamic process of disease progression. That means longitudinal readouts and transition endpoints, not a single characterized timepoint. A model that shows a precursor becoming something else is answering the question a static model cannot.

3. A qualification and validation strategy, not just construction. The topic asks for development, validation, and integrated use. State what human outcome your model is claimed to predict, how you will demonstrate that predictivity, and against what reference data. This is also what makes the platform sellable, so it doubles as commercialization substance.

4. Scalability and reproducibility with data behind them. NCATS names both explicitly, and every buyer of a NAM platform, whether pharma or regulator, asks the same question. Batch-to-batch variability, operator independence, and throughput are legitimate Phase I aims.

5. A named customer and a regulatory posture. NIH small business awards are product development awards. For a NAMs platform the customer is usually a pharmaceutical developer, a CRO, or a regulator, and the value proposition is a decision they can make earlier or more confidently. Reference the FDA and EPA commitment to NAMs as the demand-side context.

6. Program officer contact before writing. With four Institutes, this is not optional here. The conversation determines your assignment request, tells you whether your topic is waiver-eligible for a larger budget, and surfaces overlap with existing awards. NCI has designated a small business product development contact for this topic specifically.

Common Reasons Applications Miss

• Treating the Highlighted Topic as a NOFO and hunting Grants.gov for a topic-specific number that does not exist

• Proposing a model of established disease when the topic asks for precursor conditions

• Proposing a static model when the topic asks for the dynamic process of progression

• Building the model and stopping there, with no validation, qualification, or use case, which answers one third of what the topic requests

• Leaving the assignment request blank or picking the wrong Institute, so the application is read by a component with no stake in the science

• Budgeting to the $700,000 component ceiling rather than the roughly $400,000 that Institutes actually award at Phase I

• Omitting the fee from the budget, or requesting the wrong level, neither of which can be corrected after submission

• Claiming THRO alignment without documented AI/AN community partnership

• Treating the absence of animal data as a weakness to apologize for rather than the point of the solicitation

• Starting federal registrations after drafting begins, then missing the receipt date on an eRA Commons validation error

Frequently Asked Questions

Is this a grant I can apply to directly?

No. This is an NIH Highlighted Topic, which is a statement of scientific priority rather than a Notice of Funding Opportunity. You apply through a broad NIH announcement, and for small businesses that means the NIH SBIR or STTR parent announcement, requesting assignment to one of the four participating Institutes.

Which funding opportunity number do I actually use?

For most small businesses it is PA-27-100, the NIH, CDC, and FDA Parent SBIR announcement covering R43 and R44 awards. If your project requires a formal university or nonprofit research partner, use PA-27-102, the Parent STTR announcement covering R41 and R42. Confirm the active number at the time you submit, since PA-27-100 closes in early April 2027 while this topic runs through September 2028.

Which of the four Institutes should I target?

NCI for precancer biology and cancer prevention or interception. NCATS for disease-agnostic platforms addressing drug-induced organ injury. NIA for aging, resilience, Alzheimer's disease and related dementias. NIDA for addiction biology, substance use, and data integration approaches. If your technology fits more than one, contact multiple program officers before choosing, because your assignment request shapes who reviews the application.

How much money can my company request?

The SBA statutory guidelines this cycle are $323,090 for Phase I and $2,153,927 for Phase II in total costs, including direct costs, indirect costs, and fee. Institute limits differ: the parent SBIR component table lists Phase I limits as high as $700,000 for NCI and NIA, while NCATS operates at the statutory guideline. In practice, NCI Phase I awards have clustered around $400,000 rather than at the ceiling. Contact your target Institute before budgeting above the guideline.

When is the deadline?

There is no deadline specific to this topic. You submit on the NIH standard small business receipt dates of January 5, April 5, and September 5 each year, with dates falling on weekends or federal holidays moving to the next business day. The topic expires on September 3, 2028, making January 5, 2027 through April 5, 2028 the realistic competing cycles.

How long until I receive funding?

Plan on approximately 9 months from submission to award start. An application submitted in the January 2027 cycle would typically have an earliest possible start date in the fall of 2027.

Do I have to give up equity or match the funds?

No. NIH SBIR and STTR Phase I and Phase II awards are non-dilutive and require no cost share. The exception is the Phase IIB Strategic Breakthrough Award, which requires not less than 100 percent matching funds from new private capital or from a government source other than a Phase I or Phase II SBIR or STTR award.

What counts as a New Approach Methodology under this topic?

The topic names microphysiological systems such as organ-on-a-chip, 2D and 3D tissue systems, bioengineered human tissue models, in silico NAMs, and combinatorial NAMs, and states the list is not exhaustive. The distinguishing requirement is not the technology type but the subject: the model should represent a precursor condition and the process of progression toward overt disease.

Does my model have to be human-derived?

Human relevance is the consistent thread across all four Institutes, and most listed interests specify human-derived material. NIA is the exception that explicitly includes cross-species NAMs among its interests. If your platform is not human-derived, the burden is to show why it predicts human outcomes better than the animal models NIH says are failing to translate.

Can I include a clinical trial?

The parent SBIR and STTR announcements are clinical trial optional, but acceptance varies by Institute and program, and several Institutes accept clinical trials through SBIR only. Given that this topic centers on preclinical model development, most responsive applications will not involve a clinical trial. If yours does, review the NIH Clinical Trial Definition and confirm with your target Institute, because the definition captures more study designs than founders expect.

Do I still need animal data?

Not necessarily, and on this topic the absence can be a strength. The topic is issued under the New Approach Methodologies effort, in which EPA, FDA, and NIH have committed to using human-relevant models to reduce reliance on animal studies that often fail to replicate complex human conditions. Argue that your model predicts human outcomes better rather than framing missing animal work as a limitation.

Does any Institute set aside dedicated funding for this topic?

Not guaranteed, but two made statements. NCATS states it may dedicate available funds to support applications in this topic area depending on the availability of funds, the number of meritorious applications, and competing priorities. NIDA states it may give special consideration to meritorious applications in the topic area. NCI and NIA made neither statement in this topic. Treat all of this as a favorable tilt rather than a reserved pool.

I already have feasibility data. Do I still need a Phase I?

Not necessarily. SBIR Direct to Phase II allows a company that has demonstrated the scientific and technical merit and feasibility normally expected from a Phase I, without having received a Phase I award for that project, to apply directly for Phase II. This authority is available for SBIR only and is not available under STTR. A validated platform plus new precursor-condition data is a common qualifying profile.

Do ORWH, OADR, and THRO award grants under this topic?

No. All three participate and publish areas of interest, but none awards grants. Your application must be relevant to the objectives of at least one of the awarding Institutes, meaning NCI, NCATS, NIA, or NIDA. Their interests are best used as additional strength within an application already aimed at one of the four.

What registrations do I need, and how long do they take?

SAM.gov with a Unique Entity ID, the SBA Company Registry, eRA Commons, and Grants.gov. eRA Commons access depends on completing the SBA Company Registry first, so the sequence matters. Allow at least six weeks, and start before you begin writing.

How BW&CO Helps

BW&CO is a non-dilutive federal funding advisory firm. We help deep-tech, biotech, medtech, and health technology founders convert agency priority signals like this one into funded awards.

On a topic with four awarding Institutes and four different budget ceilings, the highest-leverage work happens before a word of the application is written. That includes Institute selection and assignment strategy, program officer engagement, waiver eligibility assessment, Specific Aims development, full proposal build, budget and fee construction, commercialization and qualification planning, and Phase IIB matching capital positioning. Our team has helped clients secure more than $350 million in funding. Innovation Funding Simplified.

If you are building a New Approach Methodology and want an honest read on which Institute to target and whether you are competitive for the January 5, 2027 cycle, contact us for a fit assessment.

NIH Highlighted Topic: Novel Technologies to Improve Hormone Replacement Therapies for Type 1 Diabetes

Executive Summary

The National Institutes of Health has published a Highlighted Topic titled "Novel Technologies and Approaches to Improve Hormone Replacement Therapies for Type 1 Diabetes (T1D)." It signals that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), together with the Office of Research on Women's Health (ORWH) and the Office of Autoimmune Disease Research (OADR-ORWH), want to fund investigator-initiated research on mechanical, digital, biological, and biochemical technologies that make hormone replacement for T1D more physiologic, more automated, and more accessible.

For a small business, the practical translation is this: there is no new application portal and no new deadline attached to this topic. A Highlighted Topic is a demand signal, not a Notice of Funding Opportunity. You capture the funding by submitting to the NIH SBIR or STTR parent announcement, naming NIDDK as your assignment request, and aligning your Specific Aims to the topic language below.

The topic was posted on September 2, 2026 and expires on September 2, 2028, which gives small businesses roughly five standard SBIR submission cycles to compete against it. NIDDK generally considers Phase I budgets up to $350,000 and Phase II budgets up to $2,200,000 in total costs, with a Phase IIB pathway up to $3,000,000 for companies that have already completed a Phase II.

If you build cell therapy, gene therapy, closed-loop devices, glucose-responsive insulin or glucagon formulations, or AI-driven diabetes management tools, this is one of the clearest funding signals NIDDK has published for the small business community in this space.

At a Glance

• Topic title: Novel Technologies and Approaches to Improve Hormone Replacement Therapies for Type 1 Diabetes (T1D)

• Issuing agency: National Institutes of Health, U.S. Department of Health and Human Services

• Funding Institute: NIDDK

• Non-awarding participating offices: ORWH and OADR-ORWH

• Type: NIH Highlighted Topic. This is not a Notice of Funding Opportunity.

• Post date: September 2, 2026

• Expiration date: September 2, 2028

• Recommended small business mechanism: NIH SBIR (R43 and R44) or NIH STTR (R41 and R42) parent announcement

• Current parent announcements: PA-27-100 for SBIR, PA-27-102 for STTR, PA-27-101 for the Phase IIB Strategic Breakthrough Award, and PAR-27-098 for the Commercialization Readiness Pilot

• Standard annual due dates: January 5, April 5, and September 5

• NIDDK Phase I guidance: up to $350,000 total costs, project period up to 2 years

• NIDDK Phase II guidance: up to $2,200,000 total costs, project period up to 3 years

• NIDDK Phase IIB guidance: up to $3,000,000 total costs, project period up to 3 years

• Cost share: none for Phase I or Phase II. Phase IIB requires 100 percent third-party matching funds.

• Equity dilution: none. This is non-dilutive federal funding.

• Scientific contact at NIDDK: Guillermo Arreaza-Rubin, M.D., Ph.D., guillermo.arreazarubin@nih.gov

• Broader initiative alignment: Make America Healthy Again (MAHA) Chronic Disease Initiative

What Is an NIH Highlighted Topic?

An NIH Highlighted Topic is a published statement of scientific interest from one or more NIH Institutes, Centers, and Offices. It tells the research community that a specific area of science is a priority, without creating a separate funding announcement, a separate deadline, or a separate review process.

There are three things a Highlighted Topic does for a small business:

1. It tells you which Institute is receptive. In this case, NIDDK is the awarding IC, so your assignment request and your program officer conversations should point there.

2. It gives you validated language to write against. The "Areas of Interest" and the NIDDK responsiveness list are the vocabulary reviewers and program staff are already using internally.

3. It creates two possible funding advantages. NIDDK may dedicate funds to applications in this topic area depending on the availability of funds, the number of meritorious applications, and competing priorities, and NIDDK may give special consideration to meritorious applications in the topic area.

There are two things a Highlighted Topic does not do. It does not guarantee a set-aside, and it does not replace the peer review process. Your application still competes on scientific merit through the standard NIH study section route.

Which NIH Mechanism Should a Small Business Use?

Small businesses should apply through the NIH SBIR or STTR parent announcement and request assignment to NIDDK.

The NIH small business programs are the right home for this topic because nearly every area of interest listed is a product development problem: a device, an implant, a biomaterial, a formulation, an algorithm, or a cell product that needs to reach patients. Here is how the mechanism map works.

NIH Parent SBIR, currently PA-27-100 (R43 and R44). This is the default route for most companies. It accepts Phase I, Phase II, Direct to Phase II, and Fast-Track applications. Use it when your company performs the majority of the research and your Principal Investigator is primarily employed by the company. NIDDK accepts SBIR clinical trial applications through the parent announcement.

NIH Parent STTR, currently PA-27-102 (R41 and R42). Use this when the project depends on a formal partnership with a U.S. nonprofit research institution such as a university. STTR requires that at least 40 percent of the research be performed by the small business and at least 30 percent by the single partner institution. This is the natural fit for university spinouts commercializing licensed islet encapsulation, gene therapy, or organoid technology. Note that NIDDK currently accepts clinical trial applications through SBIR only, not through STTR.

Direct to Phase II. If you already have feasibility data that would ordinarily come out of a Phase I, and you never received a Phase I award for that specific project, you can skip straight to Phase II. This authority applies to SBIR only. It is not available under STTR.

Fast-Track. Phase I and Phase II are submitted together and reviewed once. This compresses the funding gap but requires a fully developed Phase II plan at first submission. It is a poor fit when your Phase I result could materially change the Phase II design, which is often the case in early cell therapy and immune protection work.

Phase IIB Strategic Breakthrough Award, currently PA-27-101 (R44). For companies that have finished an NIH SBIR or STTR Phase II and need to bridge to commercialization. NIDDK generally considers Phase IIB requests up to $3,000,000 in total costs. Applicants must document not less than 100 percent matching funds from new private capital or from a non-SBIR/STTR government source. NIDDK strongly encourages Phase II awardees to consider Phase IIB, particularly where the product requires clinical evaluation or federal regulatory approval.

Commercialization Readiness Pilot, currently PAR-27-098 (SB1). Funds late-stage technical assistance and product development activities that Phase II and Phase IIB cannot support, such as specialized regulatory and manufacturing work. It allows a higher degree of outsourcing than other mechanisms, though the small business must retain substantial project management and oversight.

Funding Allowance

The dollar ceiling depends on two layers: the statutory guideline set by the Small Business Administration, and the specific budget guidance published by NIDDK.

Layer one, the SBA statutory guidelines for the current cycle:

• Phase I: up to $323,090 in total costs, for a project period of 6 months to 2 years

• Phase II: up to $2,153,927 in total costs, for a project period of 1 to 3 years

• Commercialization Readiness Pilot: up to $4,191,495 in total costs, for a project period of up to 3 years

Layer two, what NIDDK generally considers:

• Phase I: up to $350,000 in total costs, with a project period up to 2 years

• Phase II: up to $2,200,000 in total costs, with a project period up to 3 years, and generally not exceeding $1,100,000 in total costs in any single year

• Phase IIB: up to $3,000,000 in total costs, with a project period up to 3 years, and generally not exceeding $1,100,000 in total costs in any single year

Total funding support includes direct costs, indirect costs, and fee. A reasonable profit or fee may be paid on SBIR and STTR awards, but it must be built into the budget at the time of application, not added later. Applicants seeking a budget above the NIDDK ranges are strongly encouraged to contact NIDDK program staff with a draft Specific Aims page before submitting.

Two points that founders regularly miss. First, budgets above the SBA guideline are possible where the science aligns with an SBA-approved waiver topic, and NIDDK will consider those requests with appropriate justification. Second, NIDDK may reduce the recommended budget or the award period for budgetary, administrative, or programmatic reasons even after a strong review score.

Timeline

The Highlighted Topic window runs from September 2, 2026 through September 2, 2028. Within that window, you submit against the NIH standard small business receipt dates.

Standard annual due dates: January 5, April 5, and September 5. When a due date falls on a weekend or federal holiday, NIH moves it to the next business day. Applications are due by 5:00 p.m. local time of the applicant organization.

Cycles available under this topic:

• September 2026 cycle: the September 5, 2026 date shifted to Tuesday, September 8, 2026 because of the weekend and the Labor Day holiday. Given that the topic posted on September 2, this cycle is effectively closed for anyone starting from scratch.

• January 5, 2027: the first realistic cycle for a company beginning preparation now.

• April 5, 2027

• September 5, 2027

• January 5, 2028

• April 5, 2028, which is the last full cycle before the topic expires in September 2028.

What the runway actually looks like: budget roughly 9 months from submission to money in the door. An application submitted in the January 2027 cycle typically reaches an earliest possible start date in the fall of 2027. Council decisions for the September and January cycles are often handled together, which is one reason experienced applicants do not treat "wait for the next cycle" as a free option.

Work backwards from your target date:

• 14 to 16 weeks out: contact the NIDDK program officer, confirm responsiveness, and start or verify your federal registrations

• 12 weeks out: lock the Specific Aims page and circulate it to program staff

• 8 weeks out: complete the research strategy draft, the commercialization plan, and letters of support

• 4 weeks out: full internal review, budget finalization, and subaward paperwork

• 1 week out: submit early to leave room for eRA Commons error correction

Registrations are the most common cause of a missed deadline. You need SAM.gov, a Unique Entity ID, SBA Company Registry, eRA Commons, and Grants.gov, and eRA Commons access depends on the SBA registration being complete first. Allow six weeks or more, and start before you write anything.

Also note that the parent announcements are reissued periodically. The current SBIR parent, PA-27-100, carries a closing date in early April 2027, so applicants targeting later cycles should confirm the active parent announcement number at the time of submission.

Detailed Overview of What NIH Is Looking For

The problem NIH is trying to solve

Type 1 diabetes results from immune destruction of the insulin-producing cells of the pancreas, which leads to elevated blood glucose and serious long-term complications. Insulin replacement is essential, but NIH is explicit that insulin alone is not the whole picture: other hormones, including glucagon and amylin, may also need to be supplemented for optimal management.

NIH acknowledges that it has already funded substantial progress in automated insulin delivery, cell replacement, and beta cell protection, along with newer work in glucose-responsive insulin and glucagon platforms, gene therapy, and AI-driven synthetic biology. The stated position is that these advances remain insufficient. Three gaps are named directly:

1. Current technologies do not adequately mimic natural physiology.

2. Disease management is still too burdensome for patients.

3. Behavioral and accessibility factors have not been addressed for all people with T1D.

NIH calls out two underserved populations by name. Shift workers, who face circadian rhythm disruption, irregular activity patterns, and a lack of facilities suitable for injection. And persons with disabilities, including people with visual, hearing, or cognitive impairment. If your technology has a credible story for either group, say so in your Specific Aims. This is one of the most specific and least contested differentiators in the entire topic.

The stated goal for the resulting generation of technologies is threefold: better daily disease management, prevention of acute and chronic complications, and improved quality of life at all ages.

Areas of Interest as published

NIH lists the following as examples, and states that the list is not exhaustive:

• Novel cell replacement therapies and related technologies, including immune protection, immune-evasion engineering, smart biomaterials and scaffolds, and functional organoid development

• Gene therapy strategies

• Advanced digital systems for automated closed-loop sensing and delivery

• Glucose-responsive insulin and glucagon platforms

• AI and synthetic biology applied to advance hormone replacement research and therapies

• Developing or adapting novel diabetes management technologies for older adults and populations with special needs

• Building multidisciplinary research teams to support novel approaches

The NIDDK responsiveness list, broken down

NIDDK published a more granular list of what it considers responsive. This is the section to write against, because it reflects how program staff think about the portfolio.

Cell replacement. Immune evasion cell engineering. Biocompatible materials for immune isolation or immune modulation. Enhanced vascularization and oxygenation of implanted constructs. Automation for cell generation and for functional stability assessment. Interventions to prevent cell exhaustion and preserve function over time. Novel in vitro and in vivo preclinical testing methods for cellular products.

What this tells you: NIDDK is interested in the unsolved engineering problems around cell therapy, not just the cells. Oxygen transport, graft survival, manufacturing consistency, and assay development are all fundable in their own right. A company with a biomaterial or a bioreactor rather than a cell line still has a clear lane here.

Gene therapies and editing for hormone replacement. Gene reprogramming to create alternative insulin-producing cells. DNA-based insulin gene therapy. Targeted gene delivery for production of glucose-responsive insulin. Gene-edited cells for sustained hormone replacement.

What this tells you: delivery and durability are the named pressure points. "Sustained" appears explicitly, so a Phase I aim that demonstrates persistence rather than only initial expression will read as responsive.

Glucose-responsive insulin and glucagon platforms. Dual smart insulin and glucagon closed-loop systems. Glucose-responsive implantable formulations.

What this tells you: NIDDK is signaling interest in bihormonal approaches, not insulin-only. If you have a glucagon component, or a platform that could accommodate one, foreground it.

Technologies for older adults and persons with disabilities. Algorithms and tools tailored for varying impairments. Telemonitoring and remote systems compatible with open-loop and closed-loop systems. Clinical validation of technologies, including closed-loop systems, for older adults.

What this tells you: this is where digital health and software companies fit most cleanly, and where clinical validation of an existing system is fundable rather than only novel hardware. Interoperability with open-source and commercial closed-loop systems is named directly.

What ORWH and OADR-ORWH add

ORWH and OADR-ORWH participate in this topic but do not award grants. Your application must still be relevant to the objectives of a participating Institute or Center, which in practice means NIDDK. Their participation matters because it defines a second axis on which your application can score well.

ORWH is interested in understanding sex-specific dynamics of hormone therapies and how those dynamics influence responsiveness to new T1D therapeutics and technologies. ORWH also wants to see evaluation of how new therapies serve women across the life course, accounting for hormonal status and responding to both reproductive and aging-related needs, in ways more likely to improve outcomes for women and men alike.

OADR-ORWH is interested in the development of novel therapies for Type 1 diabetes and in the implementation science of those novel therapies.

Practical read: build a sex-as-a-biological-variable analysis into your design that goes beyond the minimum NIH requirement, and if your product has an implementation or adoption question attached to it, name implementation science explicitly.

MAHA alignment and why it affects your framing

This topic is issued as part of the Make America Healthy Again initiative and is positioned against four named efforts. Referencing the right one in your Significance section is a low-cost way to demonstrate policy fluency.

• NIH MAHA Chronic Disease Initiative. Aligning existing NIH chronic disease research and generating actionable results for diseases arising in childhood and adulthood. Also a new Whole-Person-Health approach to chronic disease prevention, promoting wellness, resilience, and metabolic health at all life stages.

• Real World Data Platform. Linking claims data, electronic health records, and wearables into a single integrated dataset with rigorous privacy and consent protections. If your technology generates continuous glucose, activity, or device telemetry data, this is your hook.

• New Approach Methodologies. Expanded use of human-relevant models such as organoids, computational simulations, and real-world data integration to reduce reliance on animal studies that fail to replicate complex human conditions. EPA, FDA, and NIH have all committed to using NAMs where appropriate. If your preclinical package leans on organoids, organ-on-chip, or in silico modeling, frame it as a NAM contribution rather than apologizing for the absence of animal data.

Eligibility Requirements

To apply for an NIH SBIR or STTR award, your company must meet the core SBA criteria:

• Organized for profit, with a place of business located in the United States

• More than 50 percent directly owned and controlled by one or more individuals who are U.S. citizens or permanent resident aliens, by other for-profit small business concerns each majority owned by such individuals, or by a combination. Multiple venture capital, hedge fund, and private equity ownership structures may be permitted under certain conditions for SBIR.

• No more than 500 employees, including affiliates

• For SBIR, the Principal Investigator's primary employment must be with the small business at the time of award and for the duration of the project. For STTR, the PI may be primarily employed by the small business or by the partnering research institution.

• For SBIR Phase I, the small business must perform at least two thirds of the research. For SBIR Phase II, at least half. For STTR, the small business performs at least 40 percent and a single partner nonprofit research institution performs at least 30 percent.

Companies with a large volume of prior Phase I awards should also confirm they meet the SBIR and STTR Phase I to Phase II Transition Rate benchmarks, which can restrict eligibility for a period of one year if not met.

What a Competitive Application Looks Like

Reviewers on this topic will be looking for evidence that you understand where the field already is. NIH has stated that automated insulin delivery, cell replacement, and beta cell protection have all received substantial prior investment. An application that proposes an incremental improvement to insulin-only delivery, without addressing physiologic fidelity, patient burden, or accessibility, is competing against NIH's own stated view that such work is insufficient.

Five things strengthen an application against this specific topic:

1. A named unmet population. Shift workers, persons with visual, hearing, or cognitive impairment, or older adults. NIH wrote these into the topic. Very few applications will use them well.

2. A bihormonal or multi-hormone story. Glucagon and amylin are named alongside insulin. A platform that can extend beyond insulin reads as more physiologic.

3. A durability or sustained-function endpoint. Cell exhaustion, graft survival, and sustained hormone replacement all appear in the responsiveness list. Milestones that measure persistence rather than initial function align directly.

4. A credible commercialization plan. NIH small business awards are product development awards. Regulatory pathway, reimbursement thinking, manufacturing scale, and a specific customer are all scored, and they are where most first-time academic applicants lose ground.

5. Program officer contact before you write. NIDDK explicitly directs applicants to contact program staff with a draft Specific Aims page, particularly for budgets above their standard ranges. That conversation is free and it is the single highest-return hour in the process.

Common Reasons Applications Miss

• Treating the Highlighted Topic as a NOFO and searching Grants.gov for a topic-specific number that does not exist

• Submitting to the wrong Institute, or leaving the assignment request blank and letting the application route somewhere without a stake in T1D hormone replacement

• Choosing Fast-Track when Phase I results would have changed the Phase II design

• Choosing STTR for a project that includes a clinical trial, which NIDDK accepts through SBIR only

• Starting federal registrations after the writing begins, then missing the receipt date on an eRA Commons error

• Building the budget without the fee, then discovering it cannot be added after submission

• A research strategy with no unresolved technical risk, which reads as development work rather than research

• Omitting a Phase IIB matching funds plan when the technology clearly needs a later bridge, which signals a company that has not thought past the current award

Frequently Asked Questions

Is this a grant I can apply to directly?

No. This is an NIH Highlighted Topic, which is a statement of scientific priority rather than a Notice of Funding Opportunity. You apply through a broad NIH announcement, and for small businesses that means the NIH SBIR or STTR parent announcement.

Which funding opportunity number do I actually use?

For most small businesses it is PA-27-100, the NIH, CDC, and FDA Parent SBIR announcement covering R43 and R44 awards. If your project requires a formal university or nonprofit research partner, use PA-27-102, the Parent STTR announcement covering R41 and R42. Confirm the active announcement number at the time you submit, since NIH reissues these periodically.

How much money can my company request?

NIDDK generally considers Phase I budgets up to $350,000 in total costs and Phase II budgets up to $2,200,000 in total costs. The underlying SBA statutory guidelines for the current cycle are $323,090 for Phase I and $2,153,927 for Phase II. Requests above these levels require justification and a conversation with NIDDK program staff.

When is the deadline?

There is no deadline specific to this topic. You submit on the NIH standard small business receipt dates of January 5, April 5, and September 5 each year, with dates falling on weekends or federal holidays moving to the next business day. The topic itself expires on September 2, 2028, so January 5, 2027 through April 5, 2028 represent the realistic competing cycles.

How long until I receive funding?

Plan on approximately 9 months from submission to award start. An application submitted in the January 2027 cycle would typically have an earliest start date in the fall of 2027.

Do I have to give up equity or match the funds?

No. NIH SBIR and STTR Phase I and Phase II awards are non-dilutive and require no cost share. The exception is the Phase IIB Strategic Breakthrough Award, which requires not less than 100 percent matching funds from new private capital or from a non-SBIR/STTR government source.

Which NIH Institute will fund this?

NIDDK is the awarding Institute for this topic. ORWH and OADR-ORWH participate and have stated interests, but they do not award grants. Your application must be relevant to the objectives of a participating Institute or Center, which means NIDDK.

Can I include a clinical trial?

Yes, through SBIR. NIDDK currently accepts SBIR clinical trial applications through the parent omnibus but does not accept STTR clinical trial applications. Review the NIH Clinical Trial Definition before deciding, because the definition captures more study designs than most founders expect.

I already have feasibility data. Do I still need a Phase I?

Not necessarily. SBIR Direct to Phase II allows a company that has demonstrated the scientific merit and feasibility normally expected from a Phase I, without having received a Phase I award for that project, to apply directly for Phase II. This authority is available for SBIR only, not STTR.

Does NIDDK set aside money for this topic?

Not guaranteed. NIDDK states that it may dedicate available funds to support applications in this topic area depending on the availability of funds, the number of meritorious applications, and competing priorities, and that it may give special consideration to meritorious applications in the topic area. Treat it as a favorable tilt, not a reserved pool.

My company builds software, not biology. Is there a place for us?

Yes. The topic explicitly names advanced digital systems for automated closed-loop sensing and delivery, AI and synthetic biology applied to hormone replacement, algorithms and tools tailored for varying impairments, and telemonitoring or remote systems compatible with open-loop and closed-loop systems. Clinical validation of closed-loop systems for older adults is also named as responsive.

We use organoids and computational models instead of animal studies. Is that a problem?

It is an advantage if framed correctly. The topic aligns with the New Approach Methodologies effort, under which EPA, FDA, and NIH have committed to using human-relevant models such as organoids, computational simulations, and real-world data integration where appropriate. Present your approach as a NAM contribution.

Who should I contact at NIH before applying?

The NIDDK scientific contact listed for this topic is Guillermo Arreaza-Rubin, M.D., Ph.D., at guillermo.arreazarubin@nih.gov. NIDDK also directs applicants considering larger budgets to contact program staff with a draft Specific Aims page before submitting.

What registrations do I need, and how long do they take?

SAM.gov with a Unique Entity ID, the SBA Company Registry, eRA Commons, and Grants.gov. eRA Commons access depends on completing the SBA registration first. Allow at least six weeks, and start before you begin writing.

How BW&CO Helps

BW&CO is a non-dilutive federal funding advisory firm. We help deep-tech, biotech, medtech, and health technology founders convert agency priority signals like this one into funded awards. That work includes mechanism selection, program officer strategy, Specific Aims development, full proposal build, budget and fee construction, commercialization plan development, and Phase IIB matching capital positioning.

Our team has helped clients secure more than $350 million in funding. Innovation Funding Simplified.

If you are developing hormone replacement technology for Type 1 diabetes and want an honest read on whether you are competitive for the January 2027 cycle, contact us for a fit assessment.