National Cancer Institute (NCI) Small Business Innovation Research (SBIR) Innovative Concept Award Program – Fiscal Year 2027

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

Executive Summary:

The National Cancer Institute (NCI) plans to release its Small Business Innovation Research (SBIR) Innovative Concept Award Program – Fiscal Year 2027 to support highly innovative technologies addressing pediatric cancers and rare cancers.

This opportunity is designed to help small businesses demonstrate technical feasibility and proof-of-concept while preparing technologies for future SBIR funding. Unlike many funding opportunities, preliminary data is not required, provided the proposal has a sound scientific premise supported by the company's own research or published literature.

The solicitation is expected to focus on technologies with strong commercial potential and will also include entrepreneurship training and commercialization planning.

The current presolicitation response deadline is July 17, 2026, 5:00 PM EDT. The full solicitation is anticipated to be released on or around July 17, 2026, and is expected to close in late September 2026. An interim white paper deadline is expected in June to allow NCI to provide scope feedback, although no specific date is provided in the presolicitation.

How much funding would I receive?

The FY27 presolicitation does not specify award amounts.

Based on the FY2026 solicitation, Phase I Concept Awards provided up to $300,000 to perform proof-of-concept and feasibility studies for high-risk, high-reward cancer technologies. The full FY27 solicitation will confirm whether funding levels remain the same.

What could I use the funding for?

Funding is intended to support proof-of-concept and technical feasibility work for highly innovative technologies in one of two topic areas:

Topic 1

• Development of therapeutic or preventative technologies for the treatment or prevention of pediatric cancers and/or rare cancers.

Topic 2

• Development of devices, diagnostic technologies, or digital health tools for the treatment, detection, or diagnosis of pediatric cancers and/or rare cancers.

Applicants are expected to:

• Identify a specific product to be developed.

• Clearly describe the anticipated development pathway.

• Define the clinical problem and cancer type(s).

• Justify the proposed approach.

• Conduct experiments that generate initial de-risking and proof-of-concept data.

Are there any additional benefits I would receive?

In addition to potential funding, selected performers may receive several forms of Government support during the program.

Government technical support

DARPA anticipates support from:

• Jet Propulsion Laboratory (JPL)

• NIST's Precision Photonic Synthesis Group within the Time and Frequency Division

The Government expects to provide information, analysis, and support related to vibration-hardened optical reference cavities and photonic microwave generation techniques.

Government-furnished information

By Month 6, DARPA anticipates providing performers with:

• A Government reference design for a vibration-hardened chip-scale optical reference cavity

• Associated design details

• Test data

Government-furnished testing

At the end of Phase 2:

• Final noise-performance testing will occur at a Government test facility.

• Testing will use a Government-furnished airborne platform.

• The Government will coordinate and execute the testing.

• The Government will collect and post-process test data.

Potential follow-on opportunities

The solicitation states that:

• Follow-on production contracts or transactions may be awarded pursuant to 10 U.S.C. § 4022.

• During the transition between Phase 1 and Phase 2, DARPA intends to finalize technology application areas and notes there is potential for additional work based on architectural designs developed during Phase 1.

The solicitation does not guarantee any follow-on funding or production awards.

Are there any additional benefits I would receive?

The FY27 presolicitation states that awardees will receive entrepreneurship and commercialization support.

Based on last year's solicitation, awardees could also:

• Participate in the NIH I-Corps commercialization program.

• Receive an additional I-Corps option of up to $55,000 if selected.

• Request up to $6,500 for Technical and Business Assistance (TABA).

• Become eligible to pursue a Phase II SBIR award after successfully completing the Concept Award.

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

FY27 Presolicitation

• Presolicitation response deadline: July 17, 2026 at 5:00 PM EDT

• Full solicitation expected: On or around July 17, 2026

• Proposal deadline expected: Late September 2026

• White paper deadline expected: June 2026 (date not yet specified)

Based on the FY2026 solicitation

• White papers were due July 11, 2025

• Full proposals were due October 17, 2025

• Awards were anticipated in April 2026

• NCI anticipated making 5–15 awards.

Who is eligible to apply?

Eligible applicants include:

• Small business concerns eligible for the SBIR program.

• Businesses with no more than 500 employees, including affiliates, as required under 13 C.F.R. § 121.702.

• Companies proposing technologies aligned with one of the two solicitation topics.

The solicitation states that this is a Total Small Business Set-Aside.

Who is not eligible to apply?

The following are not eligible:

• Businesses with more than 500 employees, including affiliates.

• Organizations that do not meet SBIR eligibility requirements.

• Proposals that fall outside the scope of the solicitation topics.

No additional exclusions are specified in the presolicitation.

What companies and projects are likely to win?

The FY27 presolicitation provides high-level guidance.

Last year's evaluation criteria provide additional insight into what reviewers prioritized:

• Innovation (50%) — highly transformative ideas with the potential to change cancer diagnosis, prevention, or treatment.

• Scientific rationale and approach (20%) — a strong scientific premise and well-designed proof-of-concept plan.

• Commercialization potential (20%) — a credible path toward a future product.

• Personnel and resources (10%) — a capable team and appropriate research environment.

How competitive will this solicitation be?

The level of competition is not specified in the presolicitation.

However, the opportunity is a national SBIR competition focused on innovative technologies for pediatric and rare cancers. The inclusion of an optional white paper stage suggests NCI intends to provide early feedback on project fit before full proposal submission.

Are there any restrictions I should know about?

Applicants should note the following:

• Only eligible SBIR small businesses may apply.

• Businesses must have no more than 500 employees, including affiliates.

• Projects must align with one of the two solicitation topics.

• Rare cancers are defined according to the FDA Orphan Drug Act as malignancies with a total U.S. prevalence of fewer than 200,000 individuals.

• Applicants should support prevalence estimates using authoritative data sources or scientifically justified epidemiologic approximations.

• Preliminary data is not required, but proposals must present a sound scientific premise.

Additional requirements may be included in the full solicitation.

How long will it take me to prepare an application?

The presolicitation does not specify application preparation requirements.

Because applicants must define a commercialization pathway, scientific rationale, product development plan, and proof-of-concept experiments, companies should plan to begin preparing well before the anticipated late September proposal deadline.

How can BW&CO help?

BW&CO can help your team:

• Evaluate whether your technology fits the solicitation.

• Position your innovation around NCI's stated review priorities.

• Develop a compelling commercialization strategy.

• Build a clear technical development roadmap.

• Prepare a competitive SBIR proposal aligned with the solicitation requirements.

• Strengthen your proof-of-concept narrative and business case before submission.

Additional Resources

Review the solicitation here.

Development and Testing of a Multi-use Frameworks Playbook for Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) (U01 Clinical Trial Not Allowed)

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

Executive Summary:

The National Institutes of Health (NIH), through the Office of Strategic Coordination (Common Fund) and administered by the National Center for Advancing Translational Sciences (NCATS), is seeking applications to develop standardized frameworks that support the design, deployment, and adoption of multimodal artificial intelligence (AI) clinical decision support (CDS) tools.

Rather than funding development of a single AI application, this funding opportunity supports creation of practical frameworks—including standardized protocols, guidelines, and standard operating procedures—that will become part of the Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program "Playbook." These frameworks are intended to improve the development, validation, interoperability, and clinical adoption of multimodal AI tools that combine medical imaging with other health data.

Applicants must propose development of two or more distinct frameworks addressing separate framework topics. Projects that fail to propose at least two distinct frameworks will be considered non-responsive and will not be reviewed.

NIH intends to fund approximately five cooperative agreements through this opportunity.

Applications are due by October 09, 2026, at 5:00 PM local time of applicant organization. No late applications will be accepted.

How much funding would I receive?

NIH Common Fund intends to commit approximately:

• Approximately $2,000,000 in FY2027

• Approximately five awards, contingent upon availability of funds and receipt of a sufficient number of meritorious applications

Award budgets are limited to:

• Up to $300,000 in direct costs per year

Project periods may be:

• Up to two years

Budgets must reflect the actual needs of the proposed project.

What could I use the funding for?

Funding supports the design, development, and preliminary validation of practical frameworks that improve development and deployment of multimodal AI clinical decision support tools.

The resulting frameworks will populate the PRIMED-AI Playbook and are expected to be broadly usable across the biomedical AI community.

Applicants must develop two or more distinct framework topics, which may include areas such as:

• AI-enabled scientific discovery

• AI-ready dataset generation

• Clinical AI training frameworks

• Data quality

• Data leakage prevention

• Data lifecycle management

• Model uncertainty

• Data and model harmonization

• Generalizability across clinical environments

• Transparency and explainability

• Model cards and data cards

• Standards-based interoperability (including OMOP and FHIR)

• Privacy-enhancing technologies

• Regulatory navigation for clinical AI

Frameworks should:

• Address imaging data together with other multimodal health data

• Be practical and operational

• Adapt to the rapidly evolving AI landscape

• Clearly identify intended users

• Describe applicable data and model classes

• Define use cases and limitations

• Be suitable for adoption by the broader research community

Awardees are expected to work collaboratively to develop a shared Playbook that minimizes duplication and supports interoperability across the PRIMED-AI Program.

Are there any additional benefits I would receive?

In addition to funding, award recipients become members of the NIH PRIMED-AI Consortium and participate in collaborative development of the national PRIMED-AI Playbook.

Award recipients will:

• Collaborate with other Playbook awardees

• Participate in the PRIMED-AI Steering Committee

• Work with NIH program staff throughout the cooperative agreement

• Contribute frameworks to the PRIMED-AI web portal

• Participate in consortium meetings and working groups

• Attend annual in-person consortium meetings

• Participate in virtual tutorials and innovation meetings

• Participate in an in-person framework showcase at the end of Year 2

Recipients also benefit from coordination with NIH staff, Validation Centers, Logistics Centers, and other funded PRIMED-AI projects to improve consistency, dissemination, and adoption of developed frameworks.

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

Posted Date

June 30, 2026

Earliest Submission Date

September 09, 2026

Application Deadline

October 09, 2026, by 5:00 PM local time of applicant organization.

No late applications will be accepted.

Review timeline

• Scientific Merit Review: March 2027

• Advisory Council Review: May 2027

• Earliest Start Date: July 2027

Projects may last for up to two years, with awardees expected to meet defined milestones throughout the project period.

Where does this funding come from?

This funding opportunity is offered by the National Institutes of Health (NIH) as part of the Common Fund, through the Office of Strategic Coordination (OSC). The program is administered by the National Center for Advancing Translational Sciences (NCATS) on behalf of NIH.

The funding supports the Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program, which aims to accelerate the development and adoption of innovative, reliable, cost-effective, and sustainable AI-based clinical decision support tools that integrate clinical imaging with multimodal health data.

This NOFO specifically supports development of standardized frameworks that will be compiled into the PRIMED-AI Playbook for use across the broader biomedical AI community.

Who is eligible to apply?

Eligible applicants include:

Higher Education Institutions

• Public/state-controlled institutions of higher education

• Private institutions of higher education

Nonprofit Organizations

• Nonprofits with 501(c)(3) IRS status

• Nonprofits without 501(c)(3) IRS status

For-Profit Organizations

• Small businesses

• For-profit organizations other than small businesses

Government Organizations

• State governments

• County governments

• City or township governments

• Special district governments

• Federally recognized Tribal governments

• Non-federally recognized Tribal governments

• Eligible Federal agencies

• U.S. territories or possessions

Other Eligible Organizations

• Independent school districts

• Public housing authorities

• Native American Tribal organizations (other than federally recognized Tribal governments)

• Faith-based organizations

• Community-based organizations

• Regional organizations

NIH Intramural Research Program investigators may also participate under the specific requirements described in the solicitation.

Individual Program Directors/Principal Investigators (PDs/PIs) may apply if they have the skills, knowledge, and resources necessary to carry out the proposed project and are affiliated with an eligible applicant organization.

Applicant organizations may submit more than one application, provided each application is scientifically distinct.

Who is not eligible to apply?

The following are not eligible to apply:

• Non-domestic (non-U.S.) entities (foreign organizations)

• Non-domestic components of U.S. organizations

• Foreign components, as defined in the NIH Grants Policy Statement

Projects will also be considered non-responsive and will not be reviewed if they:

• Do not propose two or more distinct frameworks for development.

• Propose two methods addressing the same framework topic rather than two separate framework topics.

NIH will also not accept duplicate or substantially overlapping applications that violate NIH submission policies.

What companies and projects are likely to win?

The strongest applications will directly support the objectives of the PRIMED-AI Program by developing practical, broadly applicable frameworks that improve development and deployment of multimodal AI clinical decision support tools.

Competitive projects are likely to:

• Propose at least two distinct framework topics.

• Address important challenges in multimodal AI that integrate imaging with other health data.

• Produce frameworks that are practical, flexible, and usable across multiple clinical environments.

• Clearly identify intended users, applicable data types, use cases, and limitations.

• Demonstrate expertise in AI framework development.

• Include multidisciplinary teams with relevant stakeholders, such as clinicians, patients, software developers, regulators, and data scientists.

• Present strong collaboration plans with other PRIMED-AI award recipients.

• Include realistic milestones, timelines, and measurable performance metrics.

• Promote clinical AI adoption through user feedback and iterative framework improvement.

• Demonstrate how proposed frameworks will be shared and adopted by the broader research community.

NIH states that applications proposing frameworks that are duplicative of existing frameworks or represent only incremental advancements will be considered of low programmatic relevance, reducing their likelihood of funding.

How competitive will this solicitation be?

This funding opportunity is expected to be highly competitive.

NIH intends to make approximately five awards while committing approximately $2,000,000 in FY2027, contingent upon available funding and the receipt of a sufficient number of meritorious applications.

Applications will undergo NIH peer review and will be evaluated based on factors including:

• Importance of the proposed research

• Innovation

• Scientific rigor

• Feasibility

• Investigator expertise

• Institutional environment

In addition, reviewers will specifically evaluate:

• The need for the proposed frameworks.

• The benefit of the frameworks to multimodal AI and precision medicine.

• Flexibility and usability across multiple clinical environments.

• How well dependencies between framework types are addressed.

• The quality of collaboration plans.

• Plans to promote clinical AI adoption and innovation.

• The experience of the project team in developing and deploying AI frameworks.

Following peer review, applications compete for funding based on:

• Scientific and technical merit.

• Availability of funds.

• Relevance to PRIMED-AI program priorities.

Are there any restrictions I should know about?

Yes. Applicants should carefully review the program requirements before beginning an application.

Key restrictions include:

Clinical trials are not allowed

This NOFO only accepts applications that do not propose clinical trials. Applications may include activities involving human subjects that are not considered clinical trials.

You must propose at least two distinct frameworks

Each application must propose two or more distinct frameworks addressing separate framework topics.

Projects proposing only one framework, or multiple approaches to the same framework topic, will be considered non-responsive and will not be reviewed.

Frameworks must be broadly usable

All frameworks developed under this award are expected to:

• Be shared with the broader research community.

• Be suitable for inclusion in the PRIMED-AI Playbook.

• Support extensibility and interoperability.

• Clearly identify intended users, applicable data classes, use cases, and limitations.

Collaboration is required

Recipients will be expected to:

• Participate in the PRIMED-AI Consortium.

• Collaborate with other Playbook award recipients.

• Participate in monthly Playbook Working Group meetings.

• Participate in annual in-person Consortium meetings.

• Attend virtual consortium activities.

• Participate in an in-person framework showcase at the end of Year 2.

Data sharing requirements

Applicants must submit a Data Management and Sharing (DMS) Plan.

Recipients are expected to comply with PRIMED-AI Consortium policies regarding:

• Data sharing

• Software release

• Metadata standards

• Quality control

• Public copyright licensing

• Standardization requirements

Recipients are also required to engage with the Common Fund Data Ecosystem (CFDE) for dissemination of PRIMED-AI resources.

Registration requirements

Organizations must complete all required registrations before submitting an application, including:

• System for Award Management (SAM)

• Unique Entity Identifier (UEI)

• eRA Commons

• Grants.gov

Program Directors/Principal Investigators must have:

• An eRA Commons account

• A linked ORCID ID

NIH notes that registration can take six weeks or longer, so applicants should begin the registration process as early as possible.

How long will it take me to prepare an application?

Applicants should expect this to be a significant proposal effort.

In addition to the standard NIH application requirements, applicants must prepare:

• Two or more distinct framework concepts.

• A detailed research strategy.

• A draft framework layout.

• Early standard operating procedures (SOPs).

• Framework management plans.

• A multidisciplinary team approach.

• Collaboration plans with other PRIMED-AI award recipients.

• A milestone plan with Gantt chart.

• Performance metrics.

• A Data Management and Sharing Plan.

• Resource sharing information.

• Required registrations for both the organization and PD(s)/PI(s).

Applicants must also budget for required consortium participation, including annual in-person meetings and the Year 2 framework showcase.

Because of these requirements, organizations should begin preparing well before the application deadline.

Applications are due by October 09, 2026, at 5:00 PM local time of applicant organization.

How can BW&CO help?

Developing a competitive NIH cooperative agreement application requires more than a strong technical concept. Applicants must also demonstrate program alignment, a clear development strategy, meaningful collaboration, measurable milestones, and compliance with NIH requirements.

BW&CO can help your team:

• Assess whether your project aligns with the goals of the PRIMED-AI Program.

• Refine your framework concepts to address NIH review criteria.

• Develop a compelling research strategy and project narrative.

• Create realistic milestones, timelines, and measurable deliverables.

• Strengthen collaboration and management plans.

• Prepare compliant budgets and application documents.

• Review your application for responsiveness before submission.

• Manage proposal development from kickoff through final submission.

Our team works with companies, universities, nonprofit organizations, and research institutions to prepare competitive federal funding applications while minimizing the administrative burden on technical teams.

Additional Resources

Review the solicitation here.

Battlefield Pain Management – Analgesic (HT942726RE009)

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

Executive Summary:

The Defense Health Agency (DHA), through the Defense Health Agency Contracting Activity (DHACA), is seeking proposals to develop an FDA-approved, single-use analgesic product for battlefield use to treat moderate to severe acute pain. The product is intended for Tactical Combat Casualty Care (TCCC), Prolonged Casualty Care (PCC), casualty evacuation (CASEVAC/MEDEVAC), and all Roles of Care.

The Government expects to make no more than two prototype Other Transaction Authority (pOTA) awards under 10 U.S.C. 4022. A successfully completed prototype project may lead to a follow-on production contract or transaction.

Proposal deadline: 30 July 2026. Companies pursuing this opportunity should begin preparing immediately because the solicitation requires a comprehensive technical, management, regulatory, and cost proposal with extensive FDA development planning.

How much funding would I receive?

The solicitation does not specify:

• Total program funding

• Individual award value

• Maximum or minimum award amount

The Government states only that it intends to make no more than two awards.

What could I use the funding for?

Funding is intended to support development of an FDA-approved, single-use analgesic product for battlefield use, including activities such as:

• Non-clinical studies

• Clinical studies and trials

• FDA regulatory strategy and submission

• Development activities compliant with:

  • 21 CFR Part 58

  • 21 CFR Part 11

  • Applicable FDA guidance documents

• Manufacturing planning

• Quality management

• Commercial manufacturing planning

The objective is to obtain FDA approval for a rapid, single-dose analgesic indicated for moderate to severe acute pain that can be used in austere military environments.

Are there any additional benefits I would receive?

The solicitation states that:

• A successfully completed prototype project may lead to a follow-on production contract or transaction under 10 U.S.C. 4022(f).

• The product could ultimately be fielded as part of the Battlefield Pain Management Family of Systems and potentially become part of standard issue equipment for the Joint Force.

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

The solicitation provides the following timeline:

• Request issued: 29 June 2026

• Questions due: 10 July 2026

• Proposal deadline: 30 July 2026

The solicitation estimates an overall project period of performance of eight years, consisting of:

• Objective 1: 3 years

• Objective 2 (non-clinical studies): 2 years

• Objective 3: 3 years

Funding is anticipated to be incremental, with the funding schedule provided after award.

The solicitation does not specify when awards will be made or when initial funding will be received.

Where does this funding come from?

Funding comes from:

• Defense Health Agency (DHA)

• Portfolio Acquisition Executive Medical Products (PAE MP)

• Warfighter Protection and Acute Care Project Management Office (WPAC PMO)

The solicitation is administered by the:

• Defense Health Agency Contracting Activity (DHACA)

Awards will be made using Prototype Other Transaction Authority (pOTA) under 10 U.S.C. 4022.

Who is eligible to apply?

To be eligible for award, a proposal must demonstrate at least one of the following:

• At least one nontraditional defense contractor participates to a significant extent.

• At least one nonprofit research institute participates to a significant extent.

• All significant non-government participants are small businesses or nontraditional defense contractors.

• At least one-third of total project costs are provided by non-federal sources.

Additional requirements include:

• Prime awardees must maintain an active SAM registration.

• Prime awardees must use their SAM Unique Entity Identifier (UEI).

• NAICS Code 541714 must be listed in SAM prior to award.

Who is not eligible to apply?

Companies that fail to demonstrate one of the statutory eligibility conditions described above may be determined ineligible.

The Government also states proposals may be eliminated if they:

• Fail preliminary screening

• Do not comply with proposal instructions

• Fail to demonstrate required nontraditional participation or cost sharing (when applicable)

The solicitation does not identify additional ineligible applicant categories.

What companies and projects are likely to win?

Based on the stated evaluation criteria, the most competitive proposals will demonstrate:

• A strong technical approach for achieving FDA approval

• Well-developed non-clinical and clinical development plans

• A credible FDA regulatory strategy

• Relevant FDA approval and commercialization experience

• Strong project management

• Realistic scheduling and risk management

• Quality management systems

• Commercial manufacturing planning

• Realistic, reasonable, and complete cost proposals

Projects must clearly address the Government's objectives for developing a battlefield-ready, single-use analgesic product.

How competitive will this solicitation be?

The solicitation is expected to be highly competitive.

Indicators include:

• No more than two awards are anticipated.

• Proposals undergo technical, management, and cost evaluations.

• Vendors must satisfy statutory OTA participation requirements.

• Extensive FDA regulatory planning and commercialization planning are required.

• The Government reserves the right to make no award depending on proposal quality and funding availability.

Are there any restrictions I should know about?

Key restrictions include:

• Proposal must be submitted as three separate volumes:

  • Technical

  • Management

  • Administrative and Cost

• Cost information may appear only in Volume III.

• Technical proposals must include FDA regulatory strategy.

• Project Management Plan must include:

  • Integrated Master Schedule

  • Risk Management Plan

  • Spend Plan

  • Quality Management Plan

  • Work Breakdown Structure

• Microsoft Project schedule is required.

• Searchable PDF submissions are required.

• Files may not be password protected.

• Files may not contain hyperlinks.

• Labor escalation may not exceed 3% per year.

• Foreign organizations or collaborators require additional justification.

• Accounting systems must comply with GAAP for expenditure-based agreements.

• Prime awardees must maintain active SAM registration throughout performance.

How long will it take me to prepare an application?

The solicitation does not specify an expected proposal preparation time.

However, the required submission includes:

• Technical volume

• Management volume

• Administrative and Cost volume

• FDA regulatory strategy

• Statement of Work

• Integrated Master Schedule

• Project Management Plan

• Commercial Manufacturing Sales Plan

• Detailed cost proposal

• Supporting documentation

• Required certifications and representations

Preparing a compliant submission is likely to require significant coordination across technical, regulatory, manufacturing, management, and finance teams.

How can BW&CO help?

BW&CO can support applicants by helping develop a compliant proposal package, including:

• Proposal strategy

• Technical narrative development

• Project management documentation

• Regulatory strategy alignment

• Cost proposal development

• Compliance review

• Proposal management through final submission

Additional Resources

Review the solicitation here.

Autonomous Closed Loop Control Mechanical Ventilation (ACLCMV) | MTEC-26-02-Ventilator

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

Executive Summary:

The Medical Technology Enterprise Consortium (MTEC), in support of the Defense Health Agency (DHA), is seeking one company to develop and demonstrate the core technologies for an Autonomous Closed Loop Control Mechanical Ventilation (ACLCMV) system. This one-year prototype project focuses on reducing technical risk by developing physiological closed-loop control (PCLC) algorithms, defining the system hardware architecture, and preparing for FDA regulatory activities before a future Engineering & Manufacturing Development (EMD) effort.

This opportunity is intended for FDA Registered Medical Device Companies with in-house ventilator manufacturing capabilities that can rapidly mature an autonomous military ventilator for use in austere and prolonged-care environments.

Enhanced White Paper Deadline: July 15, 2026, Noon Eastern Time.

How much funding would I receive?

The U.S. Government anticipates providing:

• Up to $1.9 million total for this effort.

• One Firm Fixed Price (FFP) award is expected.

• Initial Period of Performance not to exceed 12 months.

The Government may provide additional funding and/or additional time through award modifications for scope increases or follow-on efforts, depending on project results.

What could I use the funding for?

Funding supports research, design, development, and testing activities necessary to mature the ACLCMV concept during a 12-month technical risk reduction effort.

Required work includes:

• Development and demonstration of a Physiological Closed-Loop Control (PCLC) software algorithm.

• Definition of system hardware architecture and component selection.

• Preparation and submission of an FDA Investigational Device Exemption (IDE) application.

• Benchtop testing.

• System demonstration at Fort Detrick, Maryland.

• Program management and technical reporting.

The contractor is expected to deliver:

• System architecture

• PCLC algorithm

• Test and Evaluation Master Plan

• Benchtop validation

• Final technical report

• Monthly technical and financial reports

• Prototype demonstration

• Draft operations and user manuals

• Cybersecurity documentation

• FDA submission package

Are there any additional benefits I would receive?

Potential benefits include:

• Opportunity for non-competitive follow-on work under the OTA if the prototype effort is successful.

• Potential future production contract or transaction under 10 U.S.C. § 4022(f) following successful prototype completion.

• Potential additional funding or extended scope through award modification.

• Strategic oversight from the Joint Science and Technology Office.

The solicitation also states that competition is satisfied at the prototype stage, meaning additional competition may not be required for later development or production phases.

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

Milestone Timeline

Solicitation issued June 24, 2026

Proposers Conference July 2, 2026 at 11:00 AM EST

Enhanced White Paper deadline July 15, 2026, Noon Eastern Time

Selection notification Not specified

Expected project start September 2026 (subject to change)

Initial Period of Performance Up to 12 months

The solicitation states Offerors should plan for the project period to begin September 2026 (subject to change).

Where does this funding come from?

This Request for Project Proposals is issued by the Medical Technology Enterprise Consortium (MTEC) in support of the Defense Health Agency (DHA).

The project is funded through the MTEC Other Transaction Agreement (OTA) for prototype projects with the U.S. Army Medical Research and Development Command (USAMRDC) under 10 U.S.C. § 4022.

Strategic oversight will be provided by the Joint Science and Technology Office.

Who is eligible to apply?

Offerors must:

• Be MTEC Members in good standing.

• Become an MTEC member at least 3 days prior to Enhanced White Paper submission.

• Possess a UEI and CAGE Code.

• Be an FDA Registered Medical Device Company.

• Have in-house ventilator manufacturing capabilities.

Subcontractors are not required to be MTEC members.

Who is not eligible to apply?

The following are not eligible:

• Organizations that are not MTEC Members in good standing.

• Prime Offerors that do not become MTEC members at least three days before submission.

• Organizations that are not FDA Registered Medical Device Companies.

• Organizations without in-house ventilator manufacturing capabilities.

• Proposals that fail to satisfy mandatory Other Transaction Authority statutory requirements described in the Proposal Preparation Guide.

What companies and projects are likely to win?

The Government will evaluate proposals primarily on:

1. Technical Feasibility

2. Experience and Expertise

Competitive proposals will clearly demonstrate:

• Strong alignment with the solicitation objectives.

• Supporting preliminary data.

• A technically feasible approach.

• Ability to execute the work efficiently.

• Commercialization strategy beyond DoD.

• Manufacturing development plan.

• Experienced technical and management teams.

• Realistic project schedule.

• Appropriate budget.

Offerors are expected to explain how they meet or exceed the requirements rather than simply restating them.

How competitive will this solicitation be?

The solicitation is expected to be highly competitive because:

• The Government anticipates making one award.

• Awards will be based on a best value determination.

• Technical merit and organizational experience are evaluated before price.

• Only qualified MTEC members meeting the mandatory eligibility requirements may compete.

Are there any restrictions I should know about?

Key restrictions include:

• Enhanced White Papers are limited to 10 pages (excluding required appendices).

• Submission must follow the mandatory format.

• Submission must be made through the BIDS portal.

• Only Stage 1 Enhanced White Papers are submitted initially; full Price Proposals are requested only from Offerors recommended for funding.

• The MTEC Assessment Fee is 2% of the funded award value and cannot be charged to the Government award.

• Cost sharing above statutory minimums is not required, but statutory OTA conditions must be satisfied.

• Proposals that fail mandatory requirements may be eliminated during preliminary screening.

How long will it take me to prepare an application?

The solicitation uses an accelerated Enhanced White Paper process designed for rapid submissions.

Applicants must prepare:

• A 10-page Enhanced White Paper.

• Warranties and Representations.

• Statement of Work / Milestone Payment Schedule.

• Current and Pending Support.

• Intellectual Property and Data Rights Assertions.

The solicitation does not specify how long applicants should expect to spend preparing an application.

How can BW&CO help?

BW&CO can help your team:

• Determine whether your technology aligns with the solicitation.

• Develop a competitive Enhanced White Paper that addresses the stated evaluation criteria.

• Build a compliant Statement of Work and Milestone Payment Schedule.

• Prepare required submission documents.

• Develop commercialization and transition strategies aligned with Government expectations.

• Position your proposal to clearly demonstrate technical feasibility, execution capability, manufacturing readiness, and commercialization planning.

Additional Resources

Review the solicitation here.

PRimer and prObe Manufacturing PlaTform (PROMPT) MTEC-26-03-PROMPT

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

Executive Summary:

The Medical Technology Enterprise Consortium (MTEC), in support of the Defense Threat Reduction Agency (DTRA), is seeking proposals to develop a fully automated, man-portable, and ruggedized prototype platform capable of manufacturing clinical-quality nucleic acid primers and probes on demand in expeditionary environments. The goal is to eliminate reliance on centralized manufacturing and cold-chain logistics by enabling military personnel to rapidly produce high-quality PCR reagents in austere settings.

Applications are due by July 24, 2026, Noon Eastern Time. Companies interested in this opportunity should begin preparing immediately because the solicitation uses a competitive three-stage evaluation process beginning with a concise Solution Brief that must demonstrate both strong military relevance and technical merit.

The government is looking for prototype technologies that integrate nucleic acid synthesis, purification, and quality control into a compact system that can safely operate in forward environments with minimal operator training. Proposed solutions should also demonstrate a credible pathway toward military transition and future production.

How much funding would I receive?

Instead, the U.S. Government encourages Offerors to propose budgets that are appropriate for the scope, complexity, and duration of the proposed work. Budgets should include all direct and indirect costs across the full project period and should align with major project deliverables.

MTEC expects to make one or more awards. If no single proposal addresses the complete technical scope, multiple Offerors may be asked to collaborate.

The solicitation also states that, depending on project results, the Government may non-competitively provide additional funding, extend the period of performance, increase project scope, or pursue follow-on efforts through award modifications.

What could I use the funding for?

Funding is intended to support the development of a prototype platform capable of manufacturing clinical-quality nucleic acid primers and probes in forward operational environments. Specifically, proposed projects may include work to:

• Develop a fully automated, man-portable, ruggedized manufacturing platform.

• Integrate PCR primer and probe synthesis with automated purification and first-line quality control.

• Replace traditional hazardous synthesis chemistry with field-stable alternatives.

• Design compact instrumentation optimized for reduced size, weight, and power.

• Develop systems operable by minimally trained personnel.

• Design equipment capable of meeting MIL-STD-810 environmental requirements.

• Improve oligonucleotide production speed, yield, and throughput.

• Develop purification and verification methods comparable to laboratory gold standards such as HPLC and LCMS.

• Demonstrate end-to-end manufacturing workflows that replicate commercial PCR assays.

• Produce prototypes for independent government evaluation.

The government is specifically seeking technologies capable of producing sequence-verified, high-purity oligonucleotides from a digital sequence file within hours while operating without reliance on traditional laboratory infrastructure or cold-chain logistics.

Are there any additional benefits I would receive?

The solicitation identifies several potential advantages beyond the initial award.

If project performance is successful, the Government may:

• Provide additional funding.

• Increase project scope.

• Extend the period of performance.

• Award one or more non-competitive follow-on efforts.

• Potentially issue a non-competitive follow-on production contract or transaction pursuant to 10 U.S.C. § 4022(f).

The solicitation also identifies potential follow-on work that may include:

• Nonclinical studies supporting regulatory applications.

• Quality system development.

• Manufacturing process improvements.

• Manufacturing scale-up.

• Regulatory clearance or approval activities.

• Military environmental and operational assessments.

• Additional ruggedization.

• Advanced technical testing in relevant or simulated operational environments.

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

The solicitation follows a three-stage evaluation process.

Request Issue Date
June 24, 2026.

Application Deadline
July 24, 2026, Noon Eastern Time. Solution Briefs must be received by this deadline to be considered. Late submissions may not be accepted.

Stage 1 – Solution Brief
Applicants submit a Solution Brief using the required template. The Government evaluates submissions based on:

• Programmatic and technical relevance

• Personnel and team expertise

Successful Offerors are invited to the next stage.

Stage 2 – Solution Brief Pitch

Selected Offerors present a virtual pitch to Government evaluators. The pitch expands on the proposed technology, development strategy, commercialization or transition approach, partnerships, military relevance, and competitive advantages. Stage 2 proposals are evaluated based on:

• Technical feasibility

• Potential for commercialization and transition (identified elsewhere in the solicitation as scalability and sustainment in the stage summary)

Stage 3 – Selection for Award

Offerors selected for award are invited to submit a detailed Cost Proposal before final award negotiations.

Expected Project Start

The solicitation states that Offerors should plan for the Period of Performance to begin December 2026 (subject to change).

Period of Performance

The Period of Performance may not exceed 24 months.

Where does this funding come from?

This Request for Project Proposals (RPP) is issued by the Medical Technology Enterprise Consortium (MTEC) in support of the Defense Threat Reduction Agency (DTRA). Strategic oversight will be provided by the Joint Science and Technology Office.

Awards will be made through MTEC's Other Transaction Agreement (OTA) for prototype projects (Number W81XWH-15-9-0001) with the U.S. Army Medical Research and Development Command (USAMRDC). Successful Offerors will receive funding through a Research Project Award (RPA) issued under the member's MTEC Base Agreement.

Who is eligible to apply?

To be eligible, the prime Offeror must:

• Be an MTEC Member in good standing.

• Be an MTEC Member in good standing at least three (3) days prior to proposal submission.

• Submit a proposal in accordance with the solicitation requirements.

The solicitation also states:

• Subcontractors and lower-tier subawardees do not have to be MTEC members.

• Organizations that are not currently members may join MTEC before applying.

Who is not eligible to apply?

The solicitation identifies several situations that make an Offeror ineligible.

These include:

• Prime Offerors that are not MTEC Members in good standing at least three days before proposal submission.

• Proposals that fail to satisfy the statutory requirements governing the use of Other Transaction Authority described in the Proposal Preparation Guide.

• Proposals that fail to comply with mandatory submission requirements or required formatting and are eliminated during preliminary screening.

In addition, organizations represented by certain MTEC Officers and Directors are not eligible to submit proposals because those organizations are not MTEC members.

What companies and projects are likely to win?

The solicitation indicates that successful proposals will clearly demonstrate both military relevance and technical merit. It also outlines the characteristics evaluators will consider throughout the selection process.

Projects are likely to be competitive if they:

• Directly address the unmet military medical need described in the solicitation.

• Present a technically sound and well-supported approach.

• Demonstrate strong preliminary data and technical feasibility.

• Integrate synthesis, purification, and quality control into a compact field-deployable platform.

• Show a clear advantage over existing or emerging solutions.

• Include an experienced technical team with relevant facilities and resources.

• Present a realistic development strategy and military transition pathway.

• Include an effective risk mitigation plan.

• Demonstrate the potential to advance technical maturity during the project period.

• Show a viable commercialization or Government transition strategy where applicable.

The solicitation also states that merely restating requirements is insufficient. Offerors are expected to clearly explain how their proposed solution satisfies the program objectives and technical requirements.

How competitive will this solicitation be?

This solicitation is expected to be competitive because it uses a three-stage evaluation process that progressively narrows the field of applicants. Only Offerors that perform well during the initial Solution Brief evaluation will be invited to present a Solution Brief Pitch, and only selected Offerors will be invited to submit a full Cost Proposal.

The Government will evaluate proposals using multiple technical and programmatic factors throughout the process. During Stage 1, proposals are evaluated equally on:

• Programmatic and Technical Relevance

• Personnel and Team Expertise

During Stage 2, proposals are evaluated equally on:

• Technical Feasibility

• Potential for Commercialization and Transition (identified elsewhere in the solicitation summary as scalability and sustainment)

The solicitation also states that proposals must do more than restate the Government's requirements. Offerors are expected to clearly demonstrate how they will satisfy the technical objectives and reduce performance risk.

Are there any restrictions I should know about?

Yes. Applicants should be aware of several important administrative and program requirements.

MTEC Membership

Prime Offerors must be MTEC Members in good standing at least three days before proposal submission.

Proposal Format

Solution Briefs must follow the mandatory template and formatting requirements provided in the solicitation. Proposals that fail to meet mandatory formatting requirements may be eliminated during preliminary screening.

Submission Requirements

Solution Briefs must be submitted through the BIDS submission portal before July 24, 2026, Noon Eastern Time. It is the Offeror's responsibility to ensure a complete and timely submission.

Period of Performance

Projects may not exceed 24 months.

Cost Sharing

Cost sharing above the statutory minimum is not required for eligibility. However, proposals must satisfy at least one of the statutory conditions governing the use of Other Transaction Authority as described in the Proposal Preparation Guide. Cost sharing is strongly encouraged.

MTEC Assessment Fee

Recipients of a Research Project Award must pay MTEC an assessment fee equal to 2% of the total funded value of the research project. This fee:

• Must be paid within 90 days after execution of the Research Project Award.

• May not be charged as a direct project cost.

Intellectual Property

The solicitation states that deliverables are anticipated to be provided to the Government with Government Purpose Rights or unlimited data rights unless different rights are asserted in the proposal and accepted by the Government.

How long will it take me to prepare an application?

The solicitation does not specify how long applicants should expect to spend preparing a proposal.

However, applicants should plan sufficient time to:

• Confirm or obtain MTEC membership if necessary.

• Prepare the required Solution Brief using the mandatory template.

• Develop a complete project approach and Rough Order of Magnitude (ROM) cost estimate.

• Assemble all required supporting documents, including warranties and representations, current and pending support, intellectual property and data rights assertions, and any applicable letters of support.

• Submit all required materials through the BIDS portal before July 24, 2026, Noon Eastern Time.

How can BW&CO help?

BW&CO can help your team develop a competitive application by supporting every stage of the proposal process, including:

• Determining whether your technology aligns with the solicitation objectives.

• Developing a compliant proposal strategy.

• Preparing the required Solution Brief.

• Strengthening the technical narrative, military relevance, commercialization strategy, and transition plan.

• Developing a defensible project budget and Rough Order of Magnitude cost estimate.

• Coordinating teaming partners where appropriate.

• Managing proposal production, compliance reviews, and submission.

Early preparation is especially important because this solicitation uses a multi-stage evaluation process beginning with a concise Solution Brief and has a firm application deadline of July 24, 2026, Noon Eastern Time.

Additional Resources

Review the solicitation here.

FY27 Communications and Networking Applied Research Announcement for Office of Naval Research

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

Executive Summary:

The Office of Naval Research (ONR) is seeking applied research projects that advance communications and networking technologies for distributed maritime operations and the Naval Tactical Grid. This opportunity is focused on technologies that improve connectivity, resilience, throughput, and mission-critical information exchange across naval, joint, and coalition forces operating in challenging environments.

ONR is particularly interested in projects related to advanced communications systems, networking technologies, low-probability-of-detection communications, distributed network control, and predictive network performance algorithms. The agency plans to fund approximately five to six awards.

Although white papers are not required, they are strongly encouraged and provide an opportunity to receive feedback before submitting a full proposal. To ensure full consideration, white papers should be submitted no later than July 31, 2026, 4 pm Eastern Time.

How much funding would I receive?

ONR plans to fund five (5) to six (6) individual awards valued at $250,000 to $500,000 per year using research funds. Lower-cost and higher-cost proposals will also be considered.

The period of performance may be one, two, or three years.

What could I use the funding for?

Funding is intended for applied research projects that develop and mature communications and networking technologies for Naval operations. ONR identified the following focus areas:

• Development of long-range VHF-band data links using compact 4x4 MIMO systems based on 5G/COTS technologies and sub-MHz frequency channelization.

• Novel design and prototyping of compact electronically steered apertures for frequencies above Ka-band.

• Innovative approaches for low probability-of-detection communications against advanced electronic threats.

• Advanced techniques for distributed network control, synchronization, and scheduling.

• New algorithms for predicting network behavior, network performance, or emerging operational requirements that can be translated into traffic engineering policies.

ONR also states that it is receptive to innovative communications and networking concepts that fall outside these focus areas if they are important to Navy and Marine Corps communications and networking needs.

Are there any additional benefits I would receive?

Offerors that submit white papers may receive Government feedback indicating whether the proposed technology appears to be of “particular value” to the Department of the Navy. This feedback is intended to help organizations assess the likelihood of funding.

ONR may also suggest modifications to project scope, budget, tasks, or applications to better align proposals with available funding and Navy priorities.

Organizations identified as offering technologies of particular value may be invited to provide an oral presentation to further discuss their approach and impact.

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

Key dates include:

• Recommended White Paper Submission Date: July 31, 2026, 4 pm Eastern Time

• Notification of White Paper Valuation: August 14, 2026

• Oral Presentations: September 10, 2026

• Notification of Selection: Full Proposals: October 5, 2026

• Recommended Full Proposal Submission: November 16, 2026, 4 pm Eastern Time

• Awards: April 15, 2027

The solicitation states that white papers should be submitted no later than July 31, 2026, 4 pm Eastern Time to ensure full and timely consideration.

Funding decisions should be made by October 5, 2026, and selected projects have an estimated award date of April 15, 2027.

Where does this funding come from?

This opportunity is offered by the Office of Naval Research (ONR) under BAA Call Number N0001426SBC11, titled FY27 Communications and Networking Applied Research. It is issued under the Navy and Marine Corps Long Range Broad Agency Announcement N0001425SB001.

The effort supports the Navy’s Information Warfare vision and communications and networking research priorities.

Who is eligible to apply?

The solicitation does not provide a standalone eligibility section within this announcement. Offerors are directed to submit white papers and proposals in accordance with the parent Broad Agency Announcement N0001425SB001 or its successor.

The announcement explicitly references participation by:

• Small businesses.

• Other-than-small businesses (large businesses).

• Non-profit organizations.

• Educational institutions.

Additional eligibility requirements are not specified in this announcement.

Who is not eligible to apply?

Not specified in this announcement. Offerors should review the parent Broad Agency Announcement N0001425SB001 or its successor for any eligibility restrictions.

What companies and projects are likely to win?

Based on the stated program objectives, ONR is seeking projects that directly advance communications and networking capabilities for Naval operations and distributed maritime operations. Competitive projects are likely to demonstrate:

• Strong technical innovation.

• Clear relevance to Navy and Marine Corps missions.

• Measurable operational performance improvements.

• Practical concepts of operation.

• Demonstrated plans for operational evaluation.

• Clear research goals and benchmarks.

• Alignment with Gold Standard Science requirements.

Projects aligned with one or more of the five identified focus areas may be particularly responsive to the solicitation.

How competitive will this solicitation be?

ONR plans to fund approximately five to six awards, indicating a limited number of available selections.

The solicitation does not specify the expected number of applicants, historical success rates, or anticipated competition levels.

Are there any restrictions I should know about?

Important requirements include:

• White papers should not exceed five single-sided pages, excluding the cover page, references, and principal investigator resume.

• White papers must use 12-point Times New Roman font and margins of at least one inch.

• White papers must be submitted through the ONR Submission Portal.

• White papers must include a rough order of magnitude cost estimate.

• White papers must address Gold Standard Science requirements.

• Principal investigator resumes are limited to one page.

• Other-than-small businesses, including large businesses, non-profits, and educational institutions, must submit a subcontracting plan with their research proposal.

The solicitation also requires compliance with Gold Standard Science policies under Executive Order 14303.

How long will it take me to prepare an application?

The solicitation does not specify the expected preparation time.

Applicants choosing to submit a white paper must prepare a technical concept, naval relevance discussion, operational concept, operational utility assessment plan, research goals and benchmarks, Gold Standard Science discussion, rough order of magnitude budget estimate, and principal investigator resume.

Organizations invited to continue will also need to prepare a full proposal in accordance with the requirements of N0001425SB001 or its successor.

How can BW&CO help?

BW&CO can help you:

• Assess alignment with ONR’s Communications and Networking priorities.

• Develop a competitive white paper that clearly demonstrates Naval relevance and technical innovation.

• Refine project scope, milestones, benchmarks, and transition strategy.

• Prepare full proposal technical and cost volumes.

• Strengthen positioning for oral presentations and ONR discussions.

• Ensure compliance with submission requirements and deadlines.

Review the solicitation here.

NIH & NIAID | RADIOLOGICAL OR NUCLEAR MEDICAL COUNTERMEASURE PRODUCT DEVELOPMENT SUPPORT (PDS)

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

Executive Summary:

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is seeking a single organization capable of providing comprehensive product development support for radiological and nuclear medical countermeasures (MCMs) and biodosimetry technologies. The awardee will support the development of products intended to achieve FDA approval, licensure, or clearance through a series of government-funded task orders. This opportunity is designed for organizations with broad product development capabilities spanning animal models, efficacy testing, nonclinical development, manufacturing, quality systems, and Phase I clinical studies. The proposal deadline is August 31, 2026 at 3:00 PM, Local Time. NIAID has explicitly stated that this deadline will not be extended.

How much funding would I receive?

The solicitation is structured as a single Indefinite Delivery, Indefinite Quantity (IDIQ) contract.

• Contract minimum: $2,500

• Contract maximum: $135,000,000

• One IDIQ contract is expected to be awarded.

The solicitation does not specify the value of individual task orders. Most sample task orders included in the solicitation list estimated costs as "TBD."

What could I use the funding for?

Funding will support product development activities related to radiological or nuclear medical countermeasures and biodosimetry technologies. The contractor must be capable of supporting activities across five task areas:

• Task Area A: Administrative and Technical Support

• Task Area B: Animal Model and New Approach Methodologies (NAMs) Development and Efficacy Testing of Candidate MCMs

• Task Area C: Non-Clinical Studies supporting IND, NDA, and BLA submissions

• Task Area D: Chemistry, Manufacturing, and Controls (CMC) Support

• Task Area E: Phase I Clinical Safety Studies and Support

Examples of supported activities include:

• Animal model development

• Efficacy testing in rodent and large animal models

• Biodosimetry support

• Pharmacology and toxicology studies

• Manufacturing and formulation development

• Quality assurance activities

• Phase I clinical safety studies

• Regulatory support toward FDA approval, licensure, or clearance

Are there any additional benefits I would receive?

The solicitation does not specify any non-financial benefits such as mentorship, commercialization support, technical assistance, networking programs, or investor introductions.

However, the contractor will work directly with NIAID through government-directed task orders and support the development of medical countermeasures intended for FDA approval, licensure, or clearance.

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

Key dates include:

• Solicitation issued: June 2, 2026

• Recommended deadline for questions: July 2, 2026 at 3:00 PM EST

• Proposal deadline: August 31, 2026 at 3:00 PM, Local Time (Unchanged)

• Contract period of performance: July 1, 2027 through June 30, 2034

The solicitation does not specify an anticipated award date.

Work and funding will be provided through task orders issued under the IDIQ contract after award.

Where does this funding come from?

Funding comes from:

• National Institute of Allergy and Infectious Diseases (NIAID)

• National Institutes of Health (NIH)

• U.S. Department of Health and Human Services (HHS)

Who is eligible to apply?

The solicitation does not provide a specific eligibility section limiting applicants by company type.

The solicitation states that one IDIQ contract will be awarded to an organization capable of providing comprehensive product development services and notes that products may originate from industry, academia, and government agencies.

Offerors must:

• Be registered in the System for Award Management (SAM) prior to award.

• Demonstrate the facilities, expertise, personnel, and capabilities necessary to perform all required task areas.

Who is not eligible to apply?

The solicitation does not explicitly identify categories of organizations that are ineligible to apply.

However, organizations that cannot demonstrate the required technical capabilities, facilities, staffing, regulatory compliance, and ability to perform across the required task areas may not be competitive. The solicitation also requires SAM registration prior to award.

What companies and projects are likely to win?

The solicitation strongly favors organizations capable of operating as a full-service product development partner for NIAID.

Competitive offerors will likely demonstrate:

• Experience developing radiological or nuclear medical countermeasures

• GLP-compliant animal efficacy testing capabilities

• Large-animal research capabilities

• Biodosimetry support capabilities

• Nonclinical pharmacology and toxicology expertise

• Current Good Manufacturing Practice (cGMP) manufacturing capabilities

• Regulatory support experience for INDs, NDAs, BLAs, and FDA submissions

• Phase I clinical research capabilities

• Ability to execute work across all five task areas through internal resources and/or integrated subcontractor teams

The solicitation states that the contractor must be capable of carrying out task orders in each of the five task areas identified in the Statement of Work.

How competitive will this solicitation be?

This solicitation is likely to be highly competitive.

Reasons include:

• Only one IDIQ contract is anticipated.

• Maximum contract ceiling of $135,000,000.

• Requirement to support all five technical task areas.

• Significant infrastructure, regulatory, manufacturing, animal research, and clinical capabilities are required.

The solicitation does not state the expected number of proposals or anticipated success rate.

Are there any restrictions I should know about?

Examples include:

• Offerors must comply with extensive human subjects, animal welfare, clinical trial, data reporting, and information security requirements.

• NIH-funded clinical trials must be registered and reported through ClinicalTrials.gov.

• Contract funds may not be used for abortion activities, human embryo research, or gene-editing technologies in human embryos.

• Contract funds may not be used for needle exchange programs.

• Contract funds may not be used to disseminate false or deliberately misleading information.

• Certain direct costs may require prior approval, including foreign travel, consultant fees, subcontracts, and other specified costs.

Proposal restrictions include:

• Technical proposal page limit is 250 pages inclusive of attachments, as clarified by Amendment 1.

• CVs may not exceed 3 pages.

• Pages exceeding the limitation will not be considered.

How long will it take me to prepare an application?

The solicitation does not specify an estimated preparation time.

However, the proposal requires:

• Detailed technical responses

• Responses to task-order scenarios

• Cost proposals

• Regulatory and compliance documentation

• Staffing and organizational information

• Potential subcontracting plans

• Capability demonstrations across five major technical areas

Given the complexity and breadth of the requirements, applicants should plan for a substantial proposal development effort.

How can BW&CO help?

BW&CO can help organizations:

• Assess fit before investing in proposal development

• Interpret the solicitation requirements

• Build a compliant proposal strategy

• Coordinate technical, management, and cost volume development

• Manage subcontractor contributions

• Develop win themes aligned with NIAID priorities

• Review proposals for compliance with page limits, formatting requirements, and evaluation criteria

• Support final submission preparation

Review the solicitation here.

ARPA-H REST (Restorative & health-Enhancing Sleep Time) Program

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

Executive Summary:

ARPA-H is seeking ambitious teams to develop the next generation of sleep technologies through the Restorative & health-Enhancing Sleep Time (REST) program.

The program aims to redefine sleep as a measurable and controllable biological system by funding technologies that can objectively measure sleep quality at home, diagnose poor sleep (with a primary emphasis on insomnia), and deliver personalized, real-time interventions throughout the night.

REST is structured around two technical areas:

• Technical Area 1 (TA1): Measure & Diagnose

• Technical Area 2 (TA2): Control & Treat

ARPA-H is specifically looking for interdisciplinary teams that combine expertise across areas such as sleep medicine, neuroscience, AI/ML, biosensing, wearable technologies, neuromodulation, clinical research, and regulatory strategy.

A Solution Summary is required before a team can be invited to submit a full proposal.

Application deadline: August 12, 2026 at 12pm ET.

How much funding would I receive?

The solicitation does not specify award amounts, award ranges, total program funding, or the number of awards anticipated, but typical ARPA-H awards range anywhere from $5 million to $50 million.

ARPA-H states that awards may be made through Other Transaction (OT) agreements.

What could I use the funding for?

Funding may be used to develop technologies within one or both of the following Technical Areas.

Technical Area 1 (TA1): Measure & Diagnose

• Consumer-grade in-home sleep monitoring systems

• Wearable or nearable sleep sensing technologies

• Sleep microstructure measurement technologies

• Mechanistic insomnia subtype classification systems

• In-home diagnostic systems

• Personalized sleep-related health risk prediction tools

• Human factors and usability validation

• Integration with broader REST program resources

Technical Area 2 (TA2): Control & Treat

• Closed-loop sleep intervention systems

• Noninvasive neuromodulation technologies

• Real-time physiological monitoring and feedback systems

• Adaptive treatment algorithms

• Personalized sleep intervention technologies

• Human subjects research

• Safety and tolerability validation

• Regulatory and commercialization planning

Examples of technologies referenced in the solicitation include:

• Wearable EEG

• Smartwatches

• Rings

• In/under-mattress sensors

• WiFi signal analysis

• Haptics

• Acoustics

• Transcranial electrical stimulation

• Focused ultrasound

• Targeted nerve stimulation

Are there any additional benefits I would receive?

Potential benefits include:

• Access to shared REST program resources

• Access to large-scale harmonized sleep datasets as they become available

• Participation in program-wide benchmarking efforts

• Support from a Research Integrator focused on interoperability and transition planning

• Independent verification and validation support

• Opportunities to collaborate with other REST performers

The solicitation also anticipates support for future clinical translation and commercialization activities.

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

Key dates currently identified in the solicitation are:

• Solicitation released: June 16, 2026

• Proposers' Day: July 13, 2026

• Solution Summary Deadline: August 12, 2026 at 12pm ET

• Full Proposal: By invitation only following Solution Summary review

• Full Proposal Due Date: Not specified in the solicitation

Important notes:

• Submission of a Solution Summary is mandatory.

• Only selected Solution Summaries will be invited to submit a Full Proposal.

• Submission of a Solution Summary does not guarantee invitation to submit a Full Proposal.

• Award timing is not specified in the solicitation.

Program duration:

• 66 months (5.5 years)

• Phase 1: Months 1–24

• Phase 2: Months 25–42

• Phase 3: Months 43–66

The Solution Summary deadline is August 12, 2026 at 12pm ET.

Where does this funding come from?

Funding comes from the Advanced Research Projects Agency for Health (ARPA-H) through the Proactive Health Office (PHO).

Program:

• Restorative & health-Enhancing Sleep Time (REST)

Solicitation Number:

• ARPA-H-SOL-26-159

Award Instrument:

• Other Transaction (OT)

Who is eligible to apply?

ARPA-H states it is primarily interested in proposals from:

• Commercial performers

• Academic institutions

• Non-profit organizations

Additional requirements include:

• Work must be conducted in the United States

• Active SAM.gov registration is required

• Unique Entity Identifier (UEI) is required

Restrictions include:

• Federally Funded Research and Development Centers (FFRDCs) are generally not permitted to participate as prime or sub-performers except under limited exceptions

• Government entities, including federal employees, are generally not permitted to respond

• ARPA-H will not make awards to entities organized under the laws of a covered foreign country per 42 U.S.C. 290c(n)(1)(D)

Non-domestic performers are encouraged to collaborate with a domestic entity.

What companies and projects are likely to win?

Based on the solicitation, competitive proposals are likely to:

• Focus on insomnia as a primary use case

• Deliver objective, physiological measurement of sleep quality

• Demonstrate clinically meaningful home-based performance

• Combine multiple technical disciplines

• Incorporate AI/ML approaches

• Include strong commercialization pathways

• Demonstrate integration with the broader REST ecosystem

• Provide clear plans for data sharing, benchmarking, and interoperability

• Show a credible path toward clinical translation

ARPA-H specifically encourages teams spanning:

• Sleep medicine

• Neuroscience

• Psychiatry

• Biomedical engineering

• Wearable and in-home biosensing

• Signal processing

• Machine learning

• Neuromodulation

• Clinical trials

• Regulatory science

For TA1, proposals should also include a credible industry cost-share strategy as technologies mature toward commercialization.

Are there any restrictions I should know about?

Out-of-scope TA1 activities include:

• General wellness tracking only

• Sleep hygiene tools only

• Conventional sleep scoring without a credible path to diagnosis, mechanistic characterization, or health-relevant prediction

Out-of-scope TA2 activities include:

• Pharmacologic treatment-only approaches

• Non-personalized interventions

• Systems that do not use objective physiological measurements to adapt treatment

For both Technical Areas:

• Standalone infrastructure efforts without direct contribution to REST research objectives are out of scope

Additional requirements include:

• Human subjects research approvals

• Participation in program coordination activities

• Benchmarking and integration activities

• Compliance with research security reviews

• Compliance with negotiated intellectual property and data rights requirements

How long will it take me to prepare an application?

The required Solution Summary is limited to:

• Maximum 6 pages for a single Technical Area

• Maximum 8 pages for proposals covering both Technical Areas

Required content includes:

• Technical Area selection

• Technical approach

• Team qualifications

• Key risks and mitigations

• Rough order of magnitude budget

• Preliminary cost-share strategy for TA1 applicants

Because REST emphasizes interdisciplinary teams, commercialization planning, human subjects considerations, regulatory strategy, and technical integration, applicants should expect substantial coordination and preparation effort.

The solicitation does not estimate preparation time.

How can BW&CO help?

BW&CO can support:

• Opportunity qualification

• Teaming strategy

• Technical narrative development

• Solution Summary preparation

• Commercialization strategy development

• Cost-share strategy development for TA1 applicants

• Proposal management

• Full Proposal preparation if invited

• Pitch preparation and coaching

• Reviewer-style compliance reviews

Review the solicitation here.

MTEC Pre-Announcement: Multi-Topic Request for Proposals: Military Medical Prototype Advancement

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

Executive Summary:

The Medical Technology Enterprise Consortium (MTEC) has released a pre-announcement for an upcoming "Multi-Topic Request for Proposals: Military Medical Prototype Advancement." This opportunity is expected to fund military-relevant medical prototype technologies, medical techniques, knowledge products, devices, drugs, and biologics across 14 focus areas spanning prevention, infectious disease, trauma care, pain management, musculoskeletal health, and operational medicine.

This is a pre-announcement, not the final solicitation. The Request for Project Proposals (RPP) has not yet been released, and many key details—including funding amounts by topic, number of awards, deadlines, and proposal requirements—will be provided in the upcoming RPP. Companies interested in any of the 14 focus areas should begin evaluating fit and preparing for submission now because the competition is expected to be highly competitive and will use a two-stage Enhanced White Paper process.

Application deadline: Not specified in the pre-announcement.

How much funding would I receive?

The funding amount for each Focus Area has not been specified and will be described in the upcoming Request for Project Proposals. Funding availability is contingent upon the availability of federal funds for each program.

For informational purposes, MTEC states that the average size of MTEC awards for the initial Period of Performance is approximately:

• $2.0M–$3.5M

• Over a 2–3 year Period of Performance

These figures are historical averages and are not guaranteed award amounts for this opportunity.

What could I use the funding for?

Each proposal must address only one Focus Area.

Proposed solutions may include:

• Medical techniques

• Knowledge products

• Medical devices

• Drugs

• Biologics

Military relevance is a key requirement.

Focus Areas:

• Focus Area 1: Policies and practices for cross-cutting prevention

  The aim of this focus area is to develop and evaluate non-training interventions/activities that address risk and protective factors for harmful behaviors. Priority risk/protective factors to address include: morale, fairness, work-life balance, passive leadership, toxic leadership, and workplace hostility.

• Focus Area 2: Fostering Service member physical fitness through integrated primary prevention

  The aim of this focus area is to develop interventions or trainings to combat the key contributors to obesity and physical inactivity. This focus area encourages offerors to consider resource/environmental constraints and social and psychological barriers present for warfighters when developing solutions.

• Focus Area 3: Identify and reduce barriers to help-seeking

  The aim of this focus area is to identify and develop solutions against key drivers of help-seeking. Solutions should prioritize high-impact resources/services and Service member populations at elevated risk for harmful behaviors.

• Focus Area 4: Prophylactic Solutions to Prevent Battlefield and Complex Traumatic Wound Infections in Austere or Contested Environments

  The aim of this focus area is thedevelopment of solutions to prevent or delay wound infections (bacterial, fungal, and/or antimicrobial-resistant) following battlefield and complex traumatic wounds, including in austere or contested environments, for use at the point of injury and in prolonged care environments (Roles 1 and 2), without negatively impacting wound healing. High-priority pathogens include Pseudomonas aeruginosa, Klebsiella pneumoniae, Acinetobacter baumannii, Staphylococcus aureus, and invasive fungal infections.

• Focus Area 5: Pathogen Agnostic Countermeasures for the Treatment of Sepsis Caused by Wound Infection

  The aim of this focus area is the development of products, including immune modulators, novel drugs, immunotherapeutics, and other pathogen-agnostic and/or host-directed approaches, to treat sepsis following battlefield and complex traumatic wounds (excluding burn wounds), including in austere or contested environments.

• Focus Area 6: Knowledge Product Solutions for the Prevention of Infection in Traumatic Penetrating Wounds

  The aim of this focus area is the development of knowledge product solutions to optimize clinical practice guidelines for the prevention of infection in traumatic penetrating wounds.

• Focus Area 7: Bacterial Diarrhea Prevention

  The aim of this focus area is the development of solutions to prevent bacterial diarrhea resulting from high-priority pathogens (Campylobacter jejuni, enterotoxigenic Escherichia coli, and Shigella) in operational settings.

• Focus Area 8: Dengue Fever Prevention and/or Treatment Solutions

  The aim of this focus area is the development of prophylactic drugs and vaccines, to prevent all four serotypes of Dengue Fever.

• Focus Area 9: Prevention and Treatment of Emerging Infectious Diseases

  The aim of this focus area is on developing pathogen-agnostic and/or broad-spectrum solutions for prevention or treatment of Lassa fever virus, Crimean-Congo Hemorrhagic Fever Virus (CCHFV), and various hantaviruses, which are high-consequence pathogens that pose distinct risks to the deployed Joint Force.

• Focus Area 10: Musculoskeletal Injury Treatment

  The aim of this focus area is the development of solutions for musculoskeletal injury interventions for the pre-hospital environment. Specifically, this focus area seeks (1) therapeutic interventions to accelerate recovery from musculoskeletal injury or (2) solutions for the preservation of musculoskeletal health.

• Focus Area 11: Operational Suitability of Existing Pain Treatments

  The aim of this focus area is for solutions that inform risk/benefit decisions and create evidence-based recommendations for the Joint Trauma System (JTS) to refine and optimize existing Clinical Practice Guidelines (CPGs) and Tactical Combat Casualty Care (TCCC) protocols.

• Focus Area 12: Repurposing and Novel Delivery of Approved Compounds

  The aim of this focus area is to accelerate the development of safer, opioid-sparing analgesics by leveraging the FDA's 505(b)(2) regulatory pathway for repurposed drugs delivered via novel administration methods. The desired end-state is a candidate drug/device combination ready to enter Phase I clinical trials.

• Focus Area 13: Development of Novel Non-Addictive Analgesics

  The aim of this focus area is to advance the preclinical development of a novel, non-addictive analgesic compound with a mechanism of action suitable for treating acute, combat-related trauma. The desired end-state is a promising lead candidate with a data package sufficient to justify further investment in IND-enabling studies.

• Focus Area 14: Advanced Anesthesia and Procedural Pain Solutions

  The aim of this focus area is to develop and demonstrate a prototype system or therapeutic for the management of anesthesia and procedural pain in austere environments (Role 1 and 2). The goal is to produce a solution that reduces the cognitive burden on providers and can be used by non-specialists.

Are there any additional benefits I would receive?

Potential additional benefits include:

• Potential award of one or more follow-on tasks based on successful project performance and milestone progression. Any follow-on work is expected to be awarded non-competitively to the original project awardee(s).

• Access to MTEC member teaming resources and member profiles to identify collaborators, innovators, service providers, and MTEC M-Corps subject matter experts.

• Potential access to MTEC's consortium network and relationships with the Defense Health Agency and other government agencies.

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

The application deadline is not specified in the pre-announcement.

The solicitation will use a two-stage Enhanced White Paper process:

Stage 1:

• Current MTEC members will submit Enhanced White Papers using a mandatory format provided in the forthcoming RPP.

Stage 2:

• Selected offerors will be invited to submit a full cost proposal and may be required to submit additional documentation or supplemental information.

The timing of funding availability has not been specified and will be described in the upcoming RPP.

Application deadline: Not specified in the pre-announcement.

Where does this funding come from?

The opportunity is being released through the Medical Technology Enterprise Consortium (MTEC). MTEC supports the Department of Defense (DoD), Defense Health Agency (DHA), DHA Research and Engineering Directorate, and other government agencies.

MTEC operates under a 10-year renewable Other Transaction Agreement (OTA), Agreement No. W81XWH-15-9-0001, with the Defense Health Agency Contracting Activity (DHACA).

Who is eligible to apply?

The pre-announcement states that current MTEC members will be invited to submit Enhanced White Papers during Stage 1.

Additional eligibility requirements include:

• Proposed projects must fit MTEC's prototype definition.

• Proposed projects must not be exploratory in nature and must have a foundation of preliminary data.

• A minimum KRL/TRL of 3 at the time of proposal submission is required to meet the prototype definition.

• Proposed solutions must not have been submitted to MTEC under previous RPPs within the past 2 years.

Any additional eligibility requirements have not yet been specified and will be provided in the upcoming RPP.

What companies and projects are likely to win?

MTEC states that selection will be based on:

• Technical merit

• Programmatic considerations, including portfolio composition

• Availability of funds

Selection will be highly competitive.

Projects that appear most aligned with the pre-announcement are those that:

• Directly address one and only one Focus Area

• Demonstrate military relevance

• Meet the prototype definition

• Have supporting preliminary data

• Meet the minimum KRL/TRL requirements

• Address clearly identified Department of Defense medical needs

These alignment factors are explicitly described in the pre-announcement.

The detailed evaluation criteria have not yet been specified and will be provided in the upcoming RPP.

Are there any restrictions I should know about?

Yes.

• Each proposal must address only one Focus Area. Projects that do not align with only one Focus Area may not be considered for funding.

• Proposed projects should not be exploratory in nature and require preliminary data.

• A minimum KRL/TRL of 3 is required at proposal submission to meet the prototype definition.

• Proposed solutions submitted to MTEC within the previous 2 years may not be resubmitted.

• Additional topic-specific requirements may be established in the forthcoming RPP.

How long will it take me to prepare an application?

The pre-announcement does not specify the expected preparation time.

Because the opportunity uses a two-stage Enhanced White Paper process and requires prototype-stage technologies with supporting preliminary data, applicants should begin preparation before the full RPP is released. The specific submission requirements will be provided in the upcoming RPP.

How can BW&CO help?

BW&CO can help your team:

• Assess fit against the 14 Focus Areas.

• Determine whether your technology satisfies MTEC's prototype requirements and minimum KRL/TRL expectations.

• Develop the Enhanced White Paper strategy.

• Build a compelling military relevance narrative.

• Identify teaming opportunities where additional capabilities are needed.

• Prepare the Stage 1 Enhanced White Paper and any invited Stage 2 proposal materials.

Review solicitation here.

Targeting RNA in Disease with Novel Technologies (TRDNT) Challenge

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

Executive Summary:

The NIH Targeting RNA in Disease with Novel Technologies (TRDNT) Challenge is seeking novel technologies that target endogenous RNA to address diseases driven by RNA dysfunction or difficult-to-drug protein targets. Unlike traditional grant programs, this is a prize competition that rewards promising concepts and technologies through multiple phases.

Phase I is focused on planning and proposal development. Applicants must describe a novel RNA-targeting technology, explain the health need it addresses, and provide a roadmap for developing the technology into a prototype in future phases.

The application deadline is July 15, 2026, at 11:59 PM Eastern Time. Companies and research teams developing innovative RNA-targeting approaches should evaluate this opportunity quickly, as Phase I winners may be well-positioned for anticipated future prize phases totaling up to $13.1 million.

How much funding would I receive?

Phase I (Currently Open)

• Up to $20,000 per winner

• Up to 25 winners

• Total Phase I prize pool: up to $500,000

Future Phases (Anticipated)

Phase II: Prototype Development and Use Case Demonstration

• Interim Milestone Prize: Up to $120,000 per winner

• Up to 25 winners

• Final Submission Prize: Up to $320,000 per winner

• Up to 15 winners

Phase III: Final Iteration and Technology Dissemination

• Winner Prize: Up to $525,000 per winner

• Up to 8 winners

• Runner-Up Prize: Up to $200,000 per winner

• Up to 3 winners

NIH states that the announcement of Phases II and III is discretionary and contingent upon the availability of appropriated funds.

What could I use the funding for?

Phase I funding supports development of a proposal for a novel RNA-targeting technology.

Applicants must submit:

• A description of the technology

• The significant health need it addresses

• An early-stage technical concept

• A development plan for future prototype creation

• A proposed use case demonstrating future therapeutic potential

The challenge is focused on technologies that target endogenous RNA in disease and may include:

• RNA-RNA binding protein (RBP) interaction technologies

• Long non-coding RNA (lncRNA) targeting approaches

• RNA-protein interaction discovery platforms

• RNA-targeting small molecule screening technologies

• Technologies that modify aberrant RNA structures

Submissions are not limited to these examples but must align with the challenge goal.

Are there any additional benefits I would receive?

In addition to prize funding, participants may receive:

• Validation from NIH subject matter experts

• Visibility within the RNA therapeutics ecosystem

• Potential eligibility to participate in future challenge phases

• An opportunity to contribute technologies intended for broad scientific use

NIH also encourages winners to pursue future NIH funding opportunities, although no future funding is guaranteed.

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

Phase I Timeline

• Challenge Launch: January 30, 2026

• Submission Open: May 30, 2026

• Submission Deadline: July 15, 2026, at 11:59 PM Eastern Time

• Judging: July–August 2026

• Winners Announced: August 2026

Anticipated Future Phases

Phase II

• Launch: August 2026

• Interim Milestone Submission: November 2026–January 2027

• Interim Winners Announced: March 2027

• Final Submission: June–July 2027

• Final Winners Announced: October 2027

Phase III

• Launch: November 2027

• Submission Window: August–October 2028

• Winners Announced: January 2029

All future phase timelines are anticipated and subject to NIH discretion.

Where does this funding come from?

This challenge is funded by the National Institutes of Health (NIH) Common Fund through the NIH Venture Program.

The program is administered through the NIH Office of the Director and is intended to support innovative technologies that address priorities shared across multiple NIH Institutes and Centers.

The challenge is conducted under the America COMPETES Reauthorization Act of 2010, as amended.

Who is eligible to apply?

Eligible participants include:

• Individuals

• Teams of individuals

• Startups

• Small businesses

• Mid-size businesses

• Large businesses

• Nonprofit organizations

• Academic institutions

• Independent research institutions

To be eligible for a prize:

• Individuals must be U.S. citizens or permanent residents

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

• Participants must be at least 18 years old

Federal employees acting within the scope of their employment are not eligible.

Non-U.S. citizens and non-permanent residents may participate on eligible teams but are not eligible to receive prize money.

What companies and projects are likely to win?

NIH states that highly competitive submissions will:

• Target endogenous RNA to treat disease

• Address unmet medical needs

• Demonstrate relevance across multiple diseases

• Present innovative and novel approaches

• Avoid well-established and widely utilized technologies

• Provide sufficient technical detail to support future prototyping

• Demonstrate a realistic development plan

• Identify potential development risks and mitigation strategies

• Show that the team possesses, or can quickly obtain, the expertise required for execution

Phase I judging emphasizes:

• Potential clinical impact (30%)

• Novelty of the proposed solution (30%)

• Likelihood that the team can successfully develop the technology (30%)

• Completeness of the submission (10%)

Are there any restrictions I should know about?

Key restrictions include:

• Only technologies targeting endogenous RNA are considered competitive.

• Standard RNA therapeutic programs are not the focus unless they specifically target endogenous RNA in a manner aligned with challenge goals.

• Federal contractors may not use federal contract funds to support submissions.

• Participants using federal grant, cooperative agreement, or OT award funding must comply with applicable federal requirements.

• NIH receives a royalty-free, nonexclusive worldwide license to reproduce, publish, post, link to, share, and publicly display submissions.

• Participants retain their intellectual property rights.

• Winning technologies are expected to be made publicly available to the scientific community in future phases.

How long will it take me to prepare an application?

Applicants should expect a moderate preparation effort.

Phase I requires:

• A Title and Executive Summary

• A written proposal of up to 10 pages

• A development roadmap

• Technical concept documentation

• Discussion of expertise, resources, and potential development challenges

• References

For teams with an existing RNA-targeting technology concept, preparation may primarily involve organizing technical and commercialization plans. For earlier-stage concepts, additional time may be required to develop a credible prototype development strategy.

The solicitation does not specify an expected preparation timeline.

How can BW&CO help?

BW&CO can support applicants by:

• Assessing alignment with NIH's RNA-targeting objectives

• Positioning the technology against the evaluation criteria

• Developing a compelling clinical impact narrative

• Strengthening technical concept documentation

• Building a clear prototype development roadmap

• Identifying and addressing reviewer concerns

• Preparing submission materials for compliance with challenge requirements

• Managing the overall application process from kickoff through submission

Review solicitation here.

ARPA-H | BRAIN REPAIR OF ANY INJURED NEURAL STRUCTURE | BRAINS | HEALTH SCIENCE FUTURES | ARPA-H-SOL-26-148

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

Executive Summary:

ARPA-H’s Brain Repair of Any Injured Neural Structure (BRAINS) program is seeking breakthrough approaches to regenerate and replace damaged brain tissue in regions outside the neocortex and spinal cord. The goal is to develop technologies that can generate region-specific precursor brain tissue and demonstrate surgical engraftment into damaged brain regions, laying the groundwork for future therapies that restore lost neurological function.

This opportunity is designed for ambitious teams pursuing transformative—not incremental—approaches to brain repair. ARPA-H specifically seeks technologies that could enable replacement of damaged tissue in brain regions such as the hippocampus, amygdala, thalamus, hypothalamus, striatum, substantia nigra, brainstem, and cerebellum. Proposals focused on the neocortex or spinal cord will not be reviewed.

There are two application cycles. The first application deadline is July 9th, 2026, 5:00 PM Eastern Time for Solution Summaries. The second application deadline is January 7th, 2027, 5:00 PM Eastern Time for Solution Summaries.

How much funding would I receive?

ARPA-H anticipates:

• Phase I awards of $500,000 per team per Technical Area (TA)

• The possibility of an additional $500,000 per team per TA for Phase II

The solicitation also states that ARPA-H intends to negotiate multiple Other Transaction (OT) Agreements with selected performers.

The total number of awards is not specified.

What could I use the funding for?

Funding is intended to support projects addressing one or both of the following Technical Areas:

TA1: Defining and generating precursor tissue for any brain region

• Characterization of natural precursor tissue

• Identification of cellular and extracellular components

• Generation of human iPSC-derived precursor cells

• Development and validation of precursor tissue generation methods

TA2: Optimizing surgical engraftment of precursor tissue

• Development of transplantation methods

• Demonstration of graft survival and vascularization

• Demonstration of tissue maturation, structure, and connectivity in animal models

Projects must address all milestones and metrics associated with either one Technical Area or both.

Are there any additional benefits I would receive?

The solicitation states that selected performers may receive:

• Funding through an Other Transaction (OT) Agreement structure.

• Direct engagement with ARPA-H program leadership through:

  • Monthly technical status reporting

  • Monthly meetings with the ARPA-H Program Manager

  • Potential site visits and technical reviews by ARPA-H personnel throughout performance.

No other additional benefits are specified.

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

BRAINS has two intake groups. Applicants must first submit a Solution Summary and, if encouraged by ARPA-H, may then submit a Full Proposal.

Intake Group 1

• Solution Summaries Due: July 9th, 2026, 5:00 PM

• Full Proposals Due: August 6th, 2026, 5:00 PM

Intake Group 2

• Solution Summaries Due: January 7th, 2027, 5:00 PM

• Full Proposals Due: February 6th, 2027, 5:00 PM

Program structure:

• 18-month project duration

• Two 9-month phases

• Down-select at the end of Phase I based on milestone achievement.

The solicitation does not specify when award decisions will be made or when funding will be received.

Where does this funding come from?

This funding comes from the Advanced Research Projects Agency for Health (ARPA-H). The federal agency listed in the solicitation is ARPA-H.

Program title:
Brain Repair of Any Injured Neural Structure (BRAINS).

Who is eligible to apply?

The solicitation states that all responsible sources capable of satisfying the Government’s needs may submit a proposal. Eligible organizations include:

• Universities

• Non-profit organizations

• Small businesses

• Other than small businesses (large businesses)

ARPA-H states that early career investigators are preferred.

Additional eligibility requirements include:

• Active SAM.gov registration.

• Work conducted in the United States is prioritized.

• Non-U.S. entities may participate subject to applicable restrictions.

Ineligible entities include:

• Organizations currently providing contracted support services to ARPA-H where an unmitigable OCI exists.

• FFRDCs and Government entities acting as prime or sub-performers, except under limited circumstances described in the solicitation.

• Covered foreign entities and other restricted organizations identified in the solicitation.

What companies and projects are likely to win?

Based on the stated evaluation criteria, ARPA-H is looking for projects that are:

• Innovative, feasible, and technically strong.

• Led by teams with demonstrated expertise and relevant experience.

• Capable of transforming biomedicine and addressing unmet medical needs.

• Positioned for future research, commercial, and/or clinical impact.

• Pursuing revolutionary approaches rather than incremental improvements.

The solicitation specifically states that ARPA-H seeks approaches that will generate precursor tissue capable of restoring function in damaged brain regions and demonstrate successful engraftment in preclinical models.

Are there any restrictions I should know about?

The solicitation specifically excludes proposals that:

• Offer incremental improvements to the current state-of-the-art.

• Use human embryos.

• Use human fetal tissue.

• Do not address the objectives of the BRAINS Exploratory Topic.

Additional restrictions include:

• Proposals addressing the neocortex or spinal cord will not be reviewed.

• Cell-based and state-of-the-art organoid approaches will not be considered.

• Research must comply with applicable HHS stem cell policies and regulations.

• HHS funds may not be used for dangerous gain-of-function research.

• Various research security, foreign participation, and organizational conflict-of-interest requirements apply.

How long will it take me to prepare an application?

The application process requires:

Step 1

• A mandatory Solution Summary submission limited to three pages (excluding permitted attachments).

Step 2

• A Full Proposal if encouraged by ARPA-H. The Full Proposal includes:

  • Technical and Management Proposal

  • Cost Proposal

  • Administrative and Policy Requirements Submission

  • Supporting schedules, milestones, and compliance documentation.

The solicitation does not specify the expected preparation time required to develop an application.

How can BW&CO help?

BW&CO can support applicants by:

• Assessing fit with BRAINS technical objectives and evaluation criteria.

• Developing the Solution Summary.

• Building the technical narrative, milestones, and commercialization positioning.

• Structuring budgets and proposal volumes.

• Coordinating subcontractors and proposal compliance.

• Managing submission through the ARPA-H process.

Review solicitation here.

NIH Highlighted Topic: Biomarker Discovery and Validation for Alcohol-Related Cardiovascular Diseases

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 proposals focused on discovering and validating biomarkers for alcohol-related cardiovascular and cerebrovascular diseases (CVD). This highlighted topic supports multidisciplinary projects designed to improve early detection, risk prediction, disease phenotyping, prognosis, and mechanistic understanding of how alcohol exposure contributes to cardiovascular injury and disease progression.

NIH recognizes that alcohol-related cardiovascular disease is frequently underdiagnosed because current clinical assessments, imaging approaches, and commonly used biomarkers lack specificity for alcohol-associated pathology. The initiative is particularly interested in projects that distinguish alcohol-related disease mechanisms from non-alcohol-related or mixed etiologies using advanced biomarker strategies, AI-enabled analytics, multimodal datasets, and longitudinal population studies.

Companies developing cardiovascular biomarker platforms, AI-powered diagnostic systems, digital health monitoring technologies, predictive analytics tools, imaging technologies, EHR-integrated clinical analytics systems, or precision medicine platforms may be strong candidates for funding.

Areas of interest include alcohol-associated hypertension, atrial fibrillation, alcoholic cardiomyopathy, ischemic heart disease, ischemic stroke, hemorrhagic stroke, multimodal biomarker discovery, molecular phenotyping, digital biomarkers, imaging biomarkers, causal inference modeling, and sex-specific disease susceptibility analysis. NIH is also encouraging projects leveraging longitudinal cohorts, electronic health records (EHRs), Mendelian randomization, machine learning, and integrated multi-omics datasets to improve cardiovascular disease characterization and clinical translation.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional commercialization and follow-on funding depending on project scope and translational impact.

This highlighted topic is supported primarily by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), which is seeking transformative innovations that improve alcohol-related cardiovascular disease detection, biomarker science, precision diagnostics, risk stratification, and individualized prevention and treatment strategies.

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 cardiovascular biomarker technologies, AI analytics systems, precision diagnostics, digital monitoring tools, and translational cardiovascular research platforms related to alcohol-associated cardiovascular disease.

Eligible activities may include:

• AI and machine learning platforms for alcohol-related cardiovascular disease risk prediction

• Biomarker discovery and validation technologies for alcohol-associated cardiovascular injury

• Multi-omics and systems biology analytics platforms

• Digital biomarker and wearable cardiovascular monitoring systems

• Imaging biomarkers and advanced cardiovascular imaging technologies

• EHR-integrated cardiovascular analytics and phenotyping platforms

• Precision diagnostics distinguishing alcohol-related versus non-alcohol-related CVD

• Predictive analytics for ischemic stroke, atrial fibrillation, hypertension, and cardiomyopathy

• Longitudinal cohort analysis and causal inference modeling systems

• Mendelian randomization and population health analytics technologies

• Sex-specific cardiovascular disease susceptibility and progression research platforms

• Prognostic biomarker development for disease progression and treatment response

• Clinical decision support systems for cardiovascular risk management

• Remote patient monitoring and cardiovascular digital health technologies

• Molecular pathway analysis and translational cardiovascular therapeutics research

• Integrated imaging, molecular, physiological, and digital biomarker platforms

• Prototype development, translational studies, and clinical validation research

• Commercialization planning, regulatory preparation, and manufacturing scale-up activities

Funding may also support personnel, laboratory testing, software engineering, cloud infrastructure, AI model development, cardiovascular imaging research, bioinformatics analysis, longitudinal cohort analytics, clinical trial preparation, wearable integration, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable cardiovascular or digital health solution aligned with NIH priorities.

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: Postnatal Human Developmental Stages and Transitions: Relationships to Aging Changes and Outcomes over the Life Course

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 proposals focused on understanding how postnatal developmental stages and biological transitions influence health, resilience, disease risk, and aging outcomes across the lifespan. This highlighted topic supports multidisciplinary projects investigating how physiological, metabolic, immune, neurobehavioral, and regenerative processes during childhood, adolescence, and maturation shape long-term functional capacity, chronic disease susceptibility, and healthy aging trajectories.

NIH is particularly interested in projects exploring how developmental timing, stage transitions, and biological plasticity influence protective phenotypes, stress responses, tissue repair, cognitive health, immune function, and metabolic regulation. Companies developing AI-enabled developmental analytics platforms, biomarker discovery systems, digital health monitoring tools, longitudinal health modeling technologies, neurodevelopmental assessment systems, precision aging platforms, or resilience-focused therapeutics may be strong candidates for funding.

Areas of interest include immune and endocrine maturation, neurodevelopment, metabolic programming, stress-response systems, regenerative biology, developmental biomarkers, sex differences, resilience mechanisms, cancer and aging interactions, complementary and integrative health approaches, nutritional influences, and translational interventions capable of sustaining or mimicking favorable developmental phenotypes into adulthood and aging. NIH is also encouraging projects using longitudinal cohort data, computational biology, multi-omics technologies, digital phenotyping, and translational model systems to improve understanding of life-course health trajectories.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional commercialization and follow-on funding depending on project scope and translational impact.

This highlighted topic is supported by multiple NIH Institutes and Offices including NIA, NCCIH, NCI, ECHO, OBSSR, and ONR, all of which are seeking transformative innovations that improve developmental health research, resilience science, aging biology, neurodevelopment, disease prevention, and life-course precision health strategies.

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 developmental health technologies, biomarker systems, AI analytics platforms, longitudinal monitoring tools, resilience-focused interventions, and precision aging solutions.

Eligible activities may include:

• AI and machine learning platforms for developmental trajectory and aging-risk prediction

• Biomarker discovery and validation systems for maturational transitions and resilience

• Longitudinal developmental and life-course health analytics platforms

• Neurodevelopmental, cognitive, and behavioral assessment technologies

• Immune, endocrine, and metabolic maturation monitoring systems

• Regenerative biology and tissue-repair research technologies

• Digital phenotyping and wearable monitoring systems for youth and aging populations

• Precision health and resilience-focused intervention platforms

• Computational biology and systems modeling for developmental and aging research

• Sex-specific developmental and disease-risk analytics technologies

• Nutritional status and developmental metabolism assessment platforms

• Complementary and integrative health intervention technologies for emotional resilience

• Cancer survivorship and treatment-related aging trajectory monitoring systems

• Stress-response and psychophysiological regulation analytics platforms

• Multi-omics, exposome, and environmental influence modeling technologies

• Translational therapeutics designed to sustain or mimic favorable developmental phenotypes

• Prototype development, translational studies, and longitudinal validation research

• Commercialization planning, regulatory preparation, and implementation scaling activities

Funding may also support personnel, software engineering, cloud infrastructure, AI model development, bioinformatics analysis, wearable integration, longitudinal cohort analysis, clinical research, biomarker testing, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable developmental health or precision aging solution aligned with NIH priorities.

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: Advancing the Science of Prenatal Dietary Supplements

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 proposals focused on advancing the science of prenatal dietary supplements to improve maternal health, fetal development, and long-term child health outcomes. This highlighted topic supports multidisciplinary projects designed to generate pregnancy-specific evidence for nutrient requirements, biomarker development, supplement formulation, bioavailability, and maternal-child health optimization across pregnancy and early life.

NIH recognizes that many pregnant women experience nutrient deficiencies while others may exceed safe nutrient levels due to inconsistent prenatal supplement formulations and limited pregnancy-specific evidence. The initiative is particularly interested in projects that modernize prenatal nutrition science through biomarker innovation, metabolomics, computational modeling, clinical nutrition studies, and translational supplement formulation research.

Companies developing prenatal nutrition technologies, AI-enabled nutrition analytics platforms, biomarker discovery systems, supplement formulation technologies, metabolomics tools, maternal-fetal monitoring systems, microbiome analytics platforms, or precision nutrition solutions may be strong candidates for funding.

Areas of interest include pregnancy-specific nutrient metabolism, micronutrient biomarkers, nutrient bioavailability, dietary supplement formulation science, maternal-child outcomes, fetal neurodevelopment, placental biology, prenatal exposure analytics, environmental interaction modeling, microbiome effects, and maternal cardiometabolic health. NIH is also encouraging projects leveraging stable isotope methods, multi-omics technologies, adaptive clinical trials, in vitro bioaccessibility models, and longitudinal maternal-child cohort data to improve prenatal nutrition recommendations and supplement safety.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional commercialization and follow-on funding depending on project scope and translational impact.

This highlighted topic is supported by multiple NIH Institutes and Offices including ODS, NIAAA, NIDCR, NIEHS, OBSSR, ODP, ONR, and ORWH, all of which are seeking transformative innovations that improve prenatal nutrition science, maternal-child health, fetal development, precision supplementation, and long-term health outcomes across the lifespan.

How much funding would I receive?

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

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of prenatal nutrition technologies, biomarker systems, supplement formulation platforms, maternal-fetal analytics tools, and precision nutrition solutions.

Eligible activities may include:

• AI and machine learning platforms for prenatal nutrition analytics and risk prediction

• Biomarker discovery and metabolomics technologies for pregnancy-specific nutrient assessment

• Prenatal dietary supplement formulation and bioavailability testing systems

• Stable isotope and nutrient metabolism research technologies

• Maternal-fetal monitoring and longitudinal health analytics platforms

• Precision nutrition and personalized prenatal supplementation systems

• In vitro bioaccessibility and nutrient absorption modeling technologies

• Multi-omics, microbiome, and maternal-fetal systems biology platforms

• Environmental exposure and nutrient interaction analytics systems

• Clinical nutrition trial infrastructure and adaptive study platforms

• Prenatal supplement stability, dissolution, and degradation testing technologies

• Alternative supplement delivery systems including encapsulation, emulsions, powders, and liquid formulations

• Neurodevelopmental, placental, immune, and cardiometabolic outcome monitoring technologies

• Fetal alcohol spectrum disorder (FASD) nutrition intervention platforms

• Craniofacial, dental, and skeletal development nutrition research technologies

• Real-world evidence and maternal-child cohort data integration systems

• Prototype development, translational studies, and clinical validation research

• Commercialization planning, regulatory preparation, and manufacturing scale-up activities

Funding may also support personnel, laboratory testing, software engineering, cloud infrastructure, AI model development, bioinformatics analysis, clinical nutrition research, analytical chemistry, toxicology testing, supplement formulation development, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable maternal health or nutrition science solution aligned with NIH priorities.

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: New Approach Methodologies (NAMs) for Dietary Supplement and Nutrition 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 proposals focused on developing and validating New Approach Methodologies (NAMs) for dietary supplement and nutrition research. This highlighted topic supports multidisciplinary projects aimed at replacing or complementing traditional animal models with more human-relevant systems capable of improving prediction of dietary supplement safety, efficacy, metabolism, and long-term health outcomes across the lifespan.

NIH is particularly interested in projects leveraging advanced human-based systems such as organoids, tissue chips, microphysiological systems, computational simulations, multi-omics platforms, and AI-enabled modeling tools to better understand how nutrients and bioactive compounds interact with human biology. Companies developing organ-on-chip systems, nutrition analytics platforms, AI-driven computational biology tools, dietary supplement testing systems, precision nutrition technologies, metabolomics platforms, or translational toxicology systems may be strong candidates for funding.

Areas of interest include nutrient absorption and metabolism, bioavailability and bioaccessibility modeling, microbiome interactions, chronic disease prevention, personalized nutrition, dietary supplement-drug interactions, aging-related nutrition changes, multi-organ physiology simulation, developmental nutrition impacts, and systems biology approaches for nutrition science. NIH is also encouraging projects focused on reproducibility, interoperability, longitudinal exposure modeling, and integration of genetics, sex, age, health status, and environmental factors into nutrition-related predictive systems.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional commercialization and follow-on funding depending on project scope and translational impact.

This highlighted topic is supported by multiple NIH Institutes and Offices including ODS, NCCIH, NEI, NHLBI, NIA, NIDDK, and ONR, all of which are seeking transformative innovations that improve dietary supplement evaluation, nutrition science, precision health, aging research, chronic disease prevention, and human-relevant biomedical modeling systems.

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 nutrition science technologies, organoid systems, computational modeling platforms, multi-omics analytics tools, and human-relevant NAMs for dietary supplement and food research.

Eligible activities may include:

• Organoid, tissue-chip, and microphysiological systems for nutrition and dietary supplement research

• AI and machine learning platforms for nutrition modeling and bioactive compound prediction

• Multi-omics, metabolomics, proteomics, and systems biology analytics technologies

• Computational simulations of nutrient absorption, metabolism, and longitudinal exposure

• Precision nutrition and personalized dietary intervention platforms

• Bioavailability and bioaccessibility testing systems for dietary supplements and processed foods

• Human-relevant toxicology and safety assessment technologies

• Microbiome and gut-brain interaction modeling platforms

• Chronic disease prevention and metabolic health nutrition technologies

• Aging-related nutrition and resilience prediction systems

• Ocular nutrition and vision-health modeling technologies

• Diet-related obesity, diabetes, GI, kidney, and endocrine disease simulation systems

• Nutrient-drug interaction and polypharmacy assessment platforms

• Biomarker discovery and validation systems for nutritional status and disease risk

• Food matrix interaction and multi-ingredient supplement evaluation technologies

• Real-world data integration and longitudinal nutrition analytics platforms

• Prototype development, translational studies, and validation research

• Commercialization planning, regulatory preparation, and manufacturing scale-up activities

Funding may also support personnel, laboratory testing, software engineering, cloud infrastructure, AI model development, bioinformatics analysis, organoid research, analytical chemistry, toxicology testing, translational modeling, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable nutrition science or biotechnology solution aligned with NIH priorities.

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: Unexplained Anemia in Older Persons: Elucidating Etiologies, Improving Diagnoses, and Identifying and Testing Potential Treatment Strategies

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 proposals focused on improving understanding, diagnosis, and treatment of unexplained anemia of aging (UAA) — a major unmet clinical challenge affecting older adults. This highlighted topic supports multidisciplinary research aimed at uncovering the biological, clinical, and mechanistic causes of anemia in older individuals whose condition cannot currently be explained by existing diagnostic categories.

NIH estimates that approximately 30–50% of anemia cases in adults over age 65 remain unexplained, despite anemia being strongly associated with increased morbidity, mortality, reduced physical function, and diminished quality of life. The initiative is particularly interested in projects that improve identification of novel anemia subtypes, clarify disease mechanisms, develop precision diagnostics, and evaluate targeted therapeutic interventions.

Companies developing AI-enabled diagnostics, biomarker discovery platforms, hematology analytics systems, precision medicine technologies, geriatric care solutions, microbiome analytics, digital health monitoring systems, or novel therapeutic platforms may be strong candidates for funding.

Areas of interest include inflammatory and immune-related mechanisms, cellular senescence, clonal hematopoiesis, hormone-related pathways, microbiome interactions, multimorbidity modeling, cancer-related anemia risk, predictive analytics, clinical screening strategies, and intervention studies targeting newly identified anemia subtypes. NIH is also encouraging projects using novel alternative methods (NAMs), computational biology, translational models, and longitudinal epidemiologic studies to better understand aging-associated hematologic dysfunction.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional commercialization and follow-on funding depending on project scope and translational impact.

This highlighted topic is supported by the National Institute on Aging (NIA) and the National Cancer Institute (NCI), both of which are seeking transformative innovations that improve diagnosis, risk stratification, treatment outcomes, survivorship, and quality of life for older adults affected by unexplained anemia.

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 diagnostics, biomarkers, predictive analytics systems, therapeutics, and translational research technologies related to unexplained anemia of aging (UAA).

Eligible activities may include:

• AI and machine learning platforms for anemia subtype identification and risk prediction

• Biomarker discovery and precision hematology diagnostic technologies

• Computational biology and multimorbidity analytics systems

• Microbiome and metabolomics research platforms related to aging-associated anemia

• Inflammatory, immune, and cellular senescence pathway analysis technologies

• Clonal hematopoiesis and genomic profiling systems

• Wearable and remote monitoring technologies for geriatric health and anemia progression

• Precision medicine and targeted therapeutic development platforms

• Novel alternative methods (NAMs), organoid systems, and translational disease models

• Longitudinal aging and epidemiological analytics infrastructure

• Clinical screening, recruitment, and trial-matching technologies for older adults

• Cancer survivorship and anemia-related treatment toxicity monitoring systems

• Predictive analytics for therapy tolerance, recurrence, and mortality risk

• Digital health and geriatric care coordination platforms

• Hormone-related and metabolic pathway intervention technologies

• Functional health and quality-of-life monitoring systems

• Prototype development, translational studies, and clinical validation research

• Commercialization planning, regulatory preparation, and manufacturing scale-up activities

Funding may also support personnel, laboratory testing, software engineering, cloud infrastructure, AI model development, bioinformatics analysis, preclinical studies, clinical trial preparation, microbiome research, biomarker validation, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable hematology or aging-health solution aligned with NIH priorities.

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: Breaking Barriers: Integrating Immunology and Neuroscience to Transform AD/ADRD Research and Bring a Better Understanding of the Aging Brain

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 proposals focused on integrating immunology, neuroscience, and aging research to transform understanding, prevention, diagnosis, and treatment of Alzheimer’s Disease (AD) and Alzheimer’s Disease-Related Dementias (ADRD). This highlighted topic supports multidisciplinary projects investigating how immune system dysfunction, neuroinflammation, infections, autoimmunity, environmental exposures, and aging-related immune changes contribute to neurodegeneration and cognitive decline.

NIH is particularly interested in projects that bridge traditionally separate disciplines — including immunology, neuroscience, infectious disease, computational biology, and environmental health — to uncover novel mechanisms underlying AD/ADRD pathogenesis. Companies developing neuroimmunology platforms, AI-enabled biomarker systems, precision diagnostics, computational modeling tools, organoid systems, immunotherapeutics, microbiome analytics platforms, or neurodegenerative disease monitoring technologies may be strong candidates for funding.

Areas of interest include neuroimmune crosstalk, innate and adaptive immune dysfunction, immunosenescence, neuroinflammation, infectious disease interactions, autoimmunity, microbiome effects, exposome-related neurotoxicity, environmental exposure modeling, biomarker discovery, risk stratification, and immunotherapeutic development. NIH is also encouraging projects leveraging organoids, microphysiological systems, human tissues, AI and machine learning, computational neuroscience, and translational model systems to improve understanding of aging brain biology and AD/ADRD progression.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional commercialization and follow-on funding depending on project scope and translational impact.

This highlighted topic is supported by the National Institute on Aging (NIA), National Institute of Allergy and Infectious Diseases (NIAID), and National Institute of Environmental Health Sciences (NIEHS), all of which are seeking transformative innovations that improve neurodegenerative disease diagnostics, immune-based therapies, environmental health understanding, and precision approaches to Alzheimer’s disease and aging brain research.

How much funding would I receive?

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

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of neuroimmunology technologies, biomarkers, computational systems, diagnostics, immunotherapies, and translational neuroscience platforms related to AD/ADRD and aging brain research.

Eligible activities may include:

• AI and machine learning platforms for AD/ADRD biomarker discovery and risk prediction

• Neuroimmune interaction and neuroinflammation research technologies

• Immunotherapeutic and vaccine development platforms for neurodegenerative diseases

• Organoid, microphysiological, and human tissue modeling systems

• Computational neuroscience and neuroimmunology simulation platforms

• Microbiome and infectious disease analytics related to neurodegeneration

• Precision diagnostics and early detection technologies for Alzheimer’s disease

• Immunophenotyping and immune-aging monitoring systems

• Environmental exposure and exposome analytics platforms

• Autoimmunity and neurodegeneration biomarker research tools

• Longitudinal cognitive monitoring and digital health assessment systems

• Translational neuroscience and neurodegenerative disease modeling technologies

• Predictive analytics for cognitive decline and disease progression

• Behavioral, social, and environmental factor integration platforms

• Multi-omics and systems biology technologies for aging brain research

• Novel therapeutic target discovery and validation systems

• Prototype development, translational studies, and clinical validation research

• Commercialization planning, regulatory preparation, and manufacturing scale-up activities

Funding may also support personnel, laboratory testing, software engineering, cloud infrastructure, AI model development, computational modeling, bioinformatics analysis, preclinical studies, organoid research, environmental health analytics, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable neuroscience or biotechnology solution aligned with NIH priorities.

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: Research on Chatbots and their Usage

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 proposals focused on understanding the benefits, harms, safety, and long-term impacts of conversational chatbot technologies in healthcare and health-related settings. This highlighted topic supports multidisciplinary projects designed to rigorously evaluate how chatbot design, personalization, safeguards, and patterns of use influence health outcomes, clinical decision-making, autonomy, behavior, and trust across diverse populations and real-world contexts.

NIH recognizes that chatbots are increasingly used for symptom interpretation, chronic disease management, mental health support, caregiving, treatment decision-making, health information access, and social interaction — often without professional oversight. The initiative is particularly interested in projects that move beyond proof-of-concept to investigate causal mechanisms, unintended consequences, misinformation risks, automation bias, dependency, delayed professional care, and safe deployment practices.

Companies developing healthcare chatbots, AI safety platforms, conversational AI systems, digital therapeutics, clinical decision support tools, chatbot evaluation frameworks, governance systems, behavioral analytics platforms, or AI monitoring technologies may be strong candidates for funding.

Areas of interest include chatbot safety benchmarking, longitudinal user behavior analysis, AI transparency, guardrails and escalation systems, misinformation mitigation, mental health and substance use chatbot interventions, cancer care support tools, chatbot-human clinical integration, explainable AI systems, conversational AI for older adults and caregivers, and responsible AI frameworks aligned with healthcare interoperability standards such as FHIR and SMART on FHIR.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional commercialization and follow-on funding depending on project scope and translational impact.

This highlighted topic is supported by multiple NIH Institutes and Offices including NIA, NCCIH, NCI, NIDA, NIDCR, NIMH, NLM, OBSSR, and ODSS, all of which are seeking transformative innovations that improve safe, ethical, evidence-based deployment of conversational AI and chatbot technologies in healthcare and public health environments.

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, implementation, and commercialization of healthcare chatbot technologies, AI safety systems, conversational AI governance platforms, behavioral analytics tools, and clinical decision support solutions.

Eligible activities may include:

• Healthcare chatbot and conversational AI platform development

• AI safety monitoring, guardrails, and escalation systems

• Chatbot benchmarking, validation, and misinformation detection frameworks

• Clinical decision support and symptom interpretation technologies

• Mental health, substance use disorder, and behavioral health chatbot systems

• Cancer care support, patient education, and survivorship chatbot platforms

• Longitudinal user engagement and dependency analytics systems

• Explainable AI, transparency, and responsible AI governance tools

• Conversational AI systems for older adults, caregivers, and vulnerable populations

• AI-enabled risk stratification and safety monitoring technologies

• Digital therapeutics and chatbot-assisted intervention platforms

• FHIR, SMART on FHIR, and healthcare interoperability integration systems

• Behavioral and social science analytics related to chatbot usage patterns

• Human-centered AI design and co-development frameworks

• Clinical workflow integration and provider oversight systems

• Privacy-preserving conversational AI and secure data-sharing infrastructure

• Prototype development, translational studies, and real-world validation research

• Commercialization planning, regulatory preparation, and implementation scaling activities

Funding may also support personnel, software engineering, cloud infrastructure, AI model development, cybersecurity systems, user research, behavioral analytics, implementation science, interoperability integration, stakeholder engagement, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable healthcare AI or conversational technology solution aligned with NIH priorities.

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: Strengthening Biomedical Research, Promoting Trust, and Improving Health through Bioethics Research

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

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research proposals focused on strengthening biomedical research, improving public trust in science, and advancing actionable bioethics research across biomedical, behavioral, clinical, and data-driven health research ecosystems. This highlighted topic supports multidisciplinary projects designed to integrate ethical principles into emerging technologies, artificial intelligence, genomics, neuroscience, clinical trials, digital health, and data science to improve transparency, autonomy, equity, and long-term public engagement in research.

NIH is particularly interested in projects that address ethical challenges related to AI systems, digital health technologies, informed consent, data sharing, community engagement, participant autonomy, return of research results, privacy, neurotechnology, genomics, and biomedical innovation. Companies developing AI governance platforms, healthcare consent systems, ethical data-sharing infrastructure, digital health ethics tools, research engagement technologies, privacy-preserving analytics systems, or bioethics-focused clinical research platforms may be strong candidates for funding.

Areas of interest include AI transparency and generalizability, ethical design of neurotechnology and biomedical AI systems, genomic privacy, informed consent for wearables and electronic health records, community-centered clinical trial recruitment, ethical use of imaging and biometrics, return-of-results frameworks, health equity, data security, responsible AI deployment, implementation science, and trust-building approaches for underserved and vulnerable populations.

Funding is available through the NIH SBIR/STTR Program and related NIH research mechanisms, with opportunities for Phase I and Phase II commercialization support depending on project scope and translational impact.

This highlighted topic is supported by numerous NIH Institutes and Offices including OSP, BRAIN Initiative, NCI, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIBIB, NIDA, NIDCR, NINDS, ODSS, OBSSR, and others, all of which are seeking transformative innovations that strengthen ethical biomedical research, trustworthy AI, responsible data use, participant engagement, and equitable healthcare innovation.

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, implementation, and commercialization of bioethics technologies, AI governance systems, informed consent platforms, data privacy tools, and community-engagement solutions for biomedical research and healthcare innovation.

Eligible activities may include:

• AI governance, transparency, and explainability platforms for healthcare and biomedical research

• Ethical data-sharing and privacy-preserving analytics systems

• Digital informed consent and participant autonomy technologies

• Community engagement and clinical trial recruitment platforms

• Ethical AI and neurotechnology assessment tools

• Genomics, imaging, and biometric privacy infrastructure

• Return-of-results communication and decision-support systems

• Research trust-building and public engagement technologies

• Data stewardship and FAIR/CARE-aligned research infrastructure

• Bioethics analytics and compliance monitoring systems

• Ethical frameworks for wearables, EHRs, linked data, and public health research

• AI bias detection and generalizability validation platforms

• Clinical trial transparency and adaptive research governance technologies

• Neuroethics and brain-computer interface ethics platforms

• Digital health ethics, implementation science, and health equity technologies

• Educational and workforce development tools supporting responsible biomedical innovation

• Prototype development, translational studies, and implementation research

• Commercialization planning, regulatory preparation, and deployment scaling activities

Funding may also support personnel, software engineering, cloud infrastructure, AI model development, cybersecurity systems, community-engaged research, data governance implementation, usability testing, stakeholder engagement, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable bioethics or healthcare technology solution aligned with NIH priorities.

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

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

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 proposals focused on understanding, preventing, and mitigating the direct and indirect health impacts of extreme weather events and weather-related natural disasters. This highlighted topic supports multidisciplinary projects designed to improve resilience, strengthen healthcare preparedness, develop evidence-based interventions, and better understand how environmental and meteorological exposures influence human health across the lifespan.

The NIH Health and Extreme Weather (HEW) Program is particularly interested in research addressing health risks associated with heatwaves, floods, hurricanes, droughts, wildfires, harmful algal blooms, extreme storms, humidity, air pollution, and other downstream environmental exposures influenced by weather-related phenomena. Companies developing environmental health technologies, climate-health analytics platforms, AI-enabled predictive systems, remote sensing technologies, wearable exposure monitoring tools, public health infrastructure systems, telehealth platforms, or resilience-focused healthcare technologies may be strong candidates for funding.

Areas of interest include environmental exposure modeling, population health surveillance, community resilience interventions, implementation science, disaster preparedness systems, longitudinal health monitoring, environmental data integration, wearable sensors, behavioral health interventions, healthcare continuity technologies, and predictive analytics related to weather-driven disease risks. NIH is also encouraging projects focused on vulnerable populations including children, older adults, pregnant women, first responders, rural populations, outdoor workers, cancer patients, and individuals with chronic health conditions.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional commercialization and follow-on funding depending on project scope and translational impact.

This highlighted topic is supported by numerous NIH Institutes and Offices including NIEHS, NHLBI, NIA, NIAID, NIMH, NIMHD, NINR, NCI, NIAMS, NCCIH, ODP, ORWH, and OBSSR, all of which are seeking transformative innovations that improve climate resilience, environmental health monitoring, healthcare preparedness, and population health outcomes related to extreme weather.

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, implementation, and commercialization of climate-health technologies, environmental monitoring systems, predictive analytics platforms, public health tools, and resilience-focused healthcare solutions.

Eligible activities may include:

• AI and machine learning platforms for extreme weather health risk prediction

• Environmental exposure monitoring and wearable sensor technologies

• Climate-health analytics and population surveillance systems

• Public health preparedness and disaster response technologies

• Telehealth and healthcare continuity platforms during natural disasters

• Environmental data integration and exposome analytics systems

• Community resilience and implementation science intervention platforms

• Heat stress, wildfire smoke, air pollution, and environmental toxin monitoring tools

• Predictive modeling for infectious disease, respiratory illness, and chronic disease exacerbation

• Remote patient monitoring for vulnerable and high-risk populations

• Behavioral health and mental health intervention systems related to disaster exposure

• Rural and underserved community healthcare infrastructure technologies

• Environmental justice and health disparities intervention platforms

• Cancer survivorship, cardiovascular, respiratory, and neurological resilience technologies

• Data interoperability and longitudinal climate-health research infrastructure

• Natural disaster recovery and healthcare systems coordination tools

• Prototype development, translational studies, and implementation research

• Commercialization planning, regulatory preparation, and deployment scaling activities

Funding may also support personnel, software engineering, cloud infrastructure, AI model development, environmental sensing hardware, epidemiological analysis, implementation science research, healthcare systems integration, community engagement, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable environmental health or healthcare technology solution aligned with NIH priorities.

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.