A06B_SBIR_STTR_BAA_FY26.pdf

The Advanced Research Projects Agency for Health (ARPA-H)

Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Broad Agency Announcement (BAA)

IMPORTANT DATES:

Virtual Proposer’s Day. All potential proposers are encouraged to attend the ARPA-H webinar for this opportunity. The webinar will highlight important aspects of the SBIR/STTR

Program, ARPA-H’s mission, Topic Areas, and this solicitation. The webinar is being held on

June 11, 2026.

Deadline for Questions. Questions must be received by June 25, 2026. All questions shall be submitted online via https://solutions.arpa-h.gov/ask-a-question.

Deadline for Receipt of Solution Summaries. The BAA will be open through September 30, 2027, with specific open/close dates for topics. It is anticipated that additional topics will be added to the BAA via amendment. Late Solution Summaries and Technical Presentations will not be accepted.

Stage 1 - Solution Summary Deadline: Topics 01 – 07: July 10, 2026

Stage 2 – Proposal Package and Technical Presentation Deadline: Topics 01 – 07: To be determined at a future date.

Please read the entire BAA carefully prior to submitting questions and/or Solution

Summaries. Paper proposals or proposals sent via email will not be accepted.

Proposers are encouraged to periodically check for updates to the BAA for amendments, including additional topics, date changes, or administrative changes. Any updates will be published on SAM.gov and https://arpa-h.gov/explore-funding/sbir.

Questions? Please contact: https://solutions.arpa-h.gov/ask-a-question/ https://solutions.arpa-h.gov/ask-a-question/ https://arpa-h.gov/explore-funding/sbir https://solutions.arpa-h.gov/ask-a-question/

Table of Contents

1 Program Description

1.1 Program Phases

1.1.1 Phase I: Feasibility

1.1.2 Phase II: Full Research/Research & Development (R&D) Effort

1.2 Award Types

1.2.1 Phase I

1.2.2 Direct-to-Phase II

1.2.3 Fast Track

1.3 ARPA-H’s Commercialization Support and Entrepreneur-in-Residence Program

1.4 Program Deliverables

1.5 Fixed Payment Milestones

2 Eligibility & Certifications

2.1 Summarized Small Business Eligibility Requirements

2.2 SBA Company Registry

2.3 Registration in the System for Award Management (SAM)

2.4 Required Disclosures of Foreign Affiliations or Relationships to Foreign Countries .. 11

2.5 Disclosure of Foreign Relationships Reporting Requirements

2.6 Funding Agreement Certification

2.7 Life Cycle Certification

2.8 Majority Ownership in Part by Multiple Venture Capital, Hedge Fund, and Private Equity Firms Certification

3 Proposal Preparation Instructions and Requirements

3.1 Stage 1: Solution Summary

3.2 Stage 2: Proposal Package with Technical Presentation

4 Submissions

4.1 Submission via ARPA-H Solutions site

4.2 Documents required at submission

Proposal Page/Length Limit Table

4.3 Submission Timeline

4.4 Reducing Administrative Burden

5 Method of Selection and Evaluation Criteria

5.1 Evaluation Criteria

5.1.1 Technical Merit

5.1.2 Technical Novelty

5.1.3 Team & Relevant Experience

5.1.4 Path to Impact and Health Outcomes

5.1.5 Cost Criteria

5.2 Award Decision

5.3 Denial of Awards

5.4 Pre-Award and Post Award Solicitation Protests

6 Policy Requirements, Considerations, and Other Information

6.1 Protecting proprietary information - Proposal Markings

6.2 Technical Data Rights

6.2.1 Rights in Data Developed Under SBIR Funding Agreement

6.2.2 Identification and Marking of SBIR/STTR Technical Data in Contract Reports and

Deliverables

6.2.3 Patents and Invention Reporting

6.3 Security Prohibitions and Exclusions Representations and Certifications

7 Scientific and Technical Information Sources

7.1 Human Subject Research (HSR)

7.2 Animal Subject Research (ASR)

8 Research Topics

Topic 1: Development of an annual test to inform women about their future fertility

Topic 2: Versatile Bioadhesives

Topic 3: Universal Platform for Living Adaptive Toxin-removal (UNI-PLAT)

Topic 4: Breaking Ground: The First Curative, Durable, Non-Surgical Therapy for Endometriosis

Topic 5: ARPA-H Lineage Topic

Topic 6: Rapid Comprehensive Diagnostic Test for Multi-System Autoimmune Disease

Topic 7: Virtual Human Brain for the Development of Neurosurgical Robotics

1 Program Description

The Advanced Research Projects Agency for Health (ARPA-H) invites small businesses to submit research proposals under this Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) solicitation. All eligible organizations with relevant expertise are encouraged to apply (See section 2 for eligibility requirements). The topics are described in Section 8 Research Topics, and new topics may be added periodically.

The mission of ARPA-H is to accelerate better health outcomes by supporting the development of high-impact solutions to society’s most challenging health problems.

Innovative small businesses can contribute to this mission through the ARPA-H Small Business Program (SBP). ARPA-H holds small business performers to the same rigorous technical standards as other ARPA-H performers. Commercialization and transition are key elements of the ARPA-H SBP, and ARPA-H provides tailored support to help performers overcome a range of challenges.

This solicitation contains specific topic areas where ARPA-H is seeking proposals from small businesses for high-impact solutions. Proposals are expected to use novel approaches to achieve revolutionary advances in science, technology, or systems.

Specifically excluded are proposals for open-ended research projects or that represent an incremental advance in the current state of the art. Additionally, proposals directed towards policy changes, traditional education and training, or construction of physical infrastructure are outside the scope of the ARPA-H mission and will not be considered.

SHORTCUT TO TECHNICAL TOPICS

1.1 Program Phases

The SBIR/STTR program organizes projects into three phases:

• Phase I: Feasibility

• Phase II: Full Research / Research & Development (R&D) Effort

• Phase III: Commercialization (Not part of this solicitation)

These phases build on each other, with each subsequent phase the maturity of the technology should advance so that the final output is ready for commercialization.

Once a performer has successfully completed a Phase I, ARPA-H (or any other agency) can invite them to submit a Phase II proposal to continue development.

Note: This solicitation does not accept Phase III proposals.

1.1.1 Phase I: Feasibility

The objective of Phase I is to determine the scientific or technical and commercial feasibility of the proposed solution. Typically, a Phase I proposer has a solution concept but has not yet built a prototype to test technical feasibility.

This phase is intended to de-risk the effort and is substantially smaller in scope and cost than subsequent phases. At ARPA-H, a typical Phase I lasts 6-12 months but may last longer in rare circumstances. The result of a Phase I is a proof-of-concept or early-stage prototype.

NOTE: Performers with a Phase I award from ARPA-H may submit a Phase II proposal to ARPA-H to continue the development of their technology. This usually occurs in the last quarter of the period of performance or shortly after contract completion. The performer should notify the ARPA-H SBP of their intention to submit a proposal, and

ARPA-H will provide submission instructions. While all Phase I participants are welcome to submit a Phase II proposal, not all will be selected for a Phase II award.

ARPA-H may also invite performers to submit a Phase II proposal outside of specified solicitation timeframes.

1.1.2 Phase II: Full Research/Research & Development (R&D) Effort

The objective of Phase II is to further develop a technology or R&D effort initiated in

Phase I. During Phase II, performers advance from a proof-of-concept into a commercially viable prototype. Phase II awards are larger in scope and cost than

Phase I efforts and typically last 12-24 months, although they can be longer or shorter.

Individual topics may include estimates regarding the anticipated project duration which are meant to guide proposers rather than be hard requirements.

While the specific Phase II activities in a project are case-specific, they usually include continued improvement of the technology along with evidence generation. This may include completing pre-clinical work, conducting enabling studies for an

Investigational New Drug (IND), or even first-in-human trials. At ARPA-H, it is common for a Phase II to conclude with an FDA submission (when applicable).

Additional emphasis is placed on commercialization during Phase II. Performers must submit a detailed Commercialization Plan and provide regular updates. This is a key activity of Phase II efforts at ARPA-H and necessary to prepare for a successful transition. During Phase II, performers often develop or initiate strategic partnerships, manufacturing plans, regulatory engagements, go-to-market strategies, and user-testing (these examples are meant to be illustrative rather than exhaustive or prescriptive).

A Phase II may be awarded as (a) a follow-on to a Phase I award, (b) a Direct-to-Phase

II, or (c) integrated into a Fast Track project.

1.2 Award Types

In some instances, ARPA-H will consider Fast Track proposals that combine Phases I and II, or Direct-to-Phase II proposals that skip Phase I. Not all phases or award types are eligible for all topics; proposers must check which types will be considered for their intended topic.

All awards will be made on a Firm-Fixed-Price (FFP) basis.

Note: This solicitation is only accepting proposals for Phase I, Direct-to-Phase II, and Fast Track. This solicitation is not accepting Phase III proposals.

Refer the information for individual topics at the end of this document to determine which phase will be considered. Submissions for phases not eligible for the associated topic will not be considered.

1.2.1 Phase I

A Phase I award is intended for proposers who have a promising concept aligned with the solicitation topic but have not yet demonstrated its technical feasibility or developed a working prototype. Phase I proposals should clearly outline the planned approach to establish feasibility and address the key risks associated with the concept. These awards are limited in scope and duration and are designed to support early-stage R&D efforts that lay the groundwork for potential advancement to Phase II.

Not all topics in this solicitation may accept Phase I proposals, so confirm eligibility before applying.

1.2.2 Direct-to-Phase II

In some instances, ARPA-H may permit proposers to bypass Phase I and submit a

Direct-to-Phase II proposal. This is intended for projects that already have evidence demonstrating their feasibility and where a Phase I would be unnecessary. Direct-to-

Phase II proposers must have already created a proof-of-concept or prototype and demonstrated its technical feasibility. Not all topics in this solicitation will accept

Direct-to-Phase II proposals, so be sure to confirm that the topic is accepting Direct-to-Phase II proposals.

1.2.3 Fast Track

A Fast Track award combines both Phase I and Phase II into a single project. This streamlines the process and reduces the likelihood of a gap between Phases I and II.

Fast Tracks are intended for early-stage projects that straddle Phases I and II. These projects require some development to complete the proof-of-concept and de-risk their approach (Phase I), yet enough work has been done to clearly define the Phase II activities.

To receive a Fast Track award, a proposer must submit a proposal that contains both their Phase I and Phase II activities and all the required contents specified in Section

3: Proposal Preparation Instructions and Requirements. If selected, the resulting award contains a base scope with the initial Phase I with an option containing the Phase II activities. The Government can exercise this option to initiate Phase II without needing to re-solicit the topic or request a new proposal. However, the Government is not required to fund the Phase II Option and the performer may only begin executing

Phase II if the Government exercises the contract-option for Phase II.

Note: Receiving a Fast Track award is not a guarantee that ARPA-H will exercise Phase II. ARPA-H may down-select performers between Phases I and II.

1.3 ARPA-H’s Commercialization Support and Entrepreneur-in-Residence Program

ARPA-H offers commercialization resources and support to Small Business Program performers. Participation is not mandatory, is at the discretion of the ARPA-H Program

Manager (PM), and is contingent on funding availability. This support includes but is not limited to commercialization needs assessments, regulatory consultations, Entrepreneurs-in-Residence (EIR), and networking support.

The EIR Program provides experts to advise and support small businesses. EIRs are seasoned experts with experience commercializing innovative healthcare technologies. They provide strategic guidance in technology development, market analyses, intellectual property, and regulatory and reimbursement needs. All EIRs operate under a Non-Disclosure Agreement (NDA) to ensure confidentiality. The EIR program is designed to shorten the commercialization timeline by assisting

SBIR/STTR companies as they navigate critical inflection points like regulatory pathways, FDA meetings, Good Manufacturing Practice (GMP) manufacturing, clinical trial design, and fundraising.

Example EIR Support Services:

• Technology validation

• Assistance with customer discovery and stakeholder introductions

• Confirmation of regulatory and reimbursement strategies

• Market, customer, and competition research

• Review and provide recommendations of regulatory submission drafts

• IP and licensing strategy, freedom to operate analyses

Note: ARPA-H may offer Technical and Business Assistance (TABA) funding to selected performers during performance. ARPA-H does not guarantee or entitle performers that request TABA funding to utilize ARPA-H Entrepreneur-in-Residence (EIR) program and resources. Requests for EIR services will be provided on a case-by-case basis.

ARPA-H will offer SBIR/STTR awardees the option to request participation in I-Corps programs. Requests will be approved by ARPA-H depending on budget and I-Corps programming availability.

1.4 Program Deliverables

In addition to the completion of technical milestones, SBP performers must complete the following deliverables and reports to fulfill administrative and SBA/HHS reporting requirements:

• Funding Agreement Certification

• Kickoff Presentation

• Quarterly Reports

• (Phase II Only) Annual Commercialization Plan Update

• Draft Commercialization Report

• Draft Final Report

• Contract Impact & Outcomes Report

• Final Commercialization Report

• Final Report

• Final Presentation

• Lifecycle Certification

• Final Invention Statement

• Invention Disclosure Report

1.5 Fixed Payment Milestones

The ARPA-H Small Business Program only uses fixed payment milestones. These are fixed payments based on (1) submission and Government acceptance of the required deliverables and (2) successful completion of the associated technical milestones and objectives in the statement of work. Payment milestones evenly divide the overall cost of the project and are quarterly (not monthly), except for the kickoff, draft final deliverables, and final deliverables. Quarters are set reporting periods tied to the calendar year (as detailed below), not individualized to the period of performance.

Payment milestones will be defined in the awarded contract and may include kickoff, quarterly, draft final, and final milestones. Amounts may be equal or prorated as specified in the contract schedule. The table below illustrates a sample payment structure for a Phase I SBIR with a 1-year period of performance.

Example Phase I Payment Schedule

Description Payment Amount Kick-off Presentation (Month 1)

[1/6th total contract amount]

Quarterly Report 1 (Quarter 1)

[Prorated by weeks on contract during the quarter]

Quarterly Report 2 (Quarter 2)

[1/6th total contract amount]

Quarterly Report 3 (Quarter 3)

[1/6th total contract amount]

Draft Final Reports (Month 11)

[1/6th total contract amount]

Final Report & Associated Deliverables (Month 12)

[1/6th total contract amount + any remaining pro-rated amount]

Reporting/Quarterly Periods:

• January 1 to March 31

• April 1 to June 30

• July 1 to September 30

• October 1 to December 31

2 Eligibility & Certifications

This section describes the eligibility requirements for participating in the ARPA-H SBIR/STTR Program and the certifications that must be completed by proposers and performers. These certifications are required by SBA and HHS to fulfill reporting requirements. Some are completed during the proposal process, while others are completed during performance.

Copies of all the certification forms mentioned in the following sections can be found at: https://grants.nih.gov/grants/forms.htm?filter=small-business

Note: NIH maintains the small business certification forms for all of HHS. Only the forms specified in this section must be completed by the Proposer. Forms that are not listed, such as the SF424 Grant Application, are not required.

https://grants.nih.gov/grants/forms.htm?filter=small-business

2.1 Summarized Small Business Eligibility Requirements

To be eligible for SBIR or STTR awards, proposers must be valid Small Business Concerns (SBCs) that meet the eligibility requirements in 13 CFR 121.702 and the SBA’s SBIR/STTR Policy Directive (summarized in bullets below). Proposers attest to their eligibility by completing the Funding Agreement Certification.

Summarized Eligibility Requirements:

• SBC has no more than 500 employees

• Majority ownership by U.S. Citizens or another U.S.-based Small Business

• All work will be performed in the United States

• SBIRs:

o Primary Investigator is >50% employed by the Small Business o Phase I: ≥66% of work performed by Small Business* o Phase II: ≥50% of work performed by Small Business*

• STTR:

o Small Business has a Research Institution partner (RI) o Primary Investigator is >50% employed by the Small Business or RI o Phase I & Phase II: ≥40% of the work performed by Small Business and

≥30% of the work must be performed by the RI

*The required work distribution applies to the subcontractors performing activities that involve meaningful programmatic decision making, contributions to scholarly/scientific conduct of the project, and/or requires considerable discretionary judgment and the unique expertise of the subcontractor in the performance of the work. This does not include standard goods or services such as those provided by a consultant, clinical research organization, or another fee-for-service organization that operate in a competitive environment and routinely provide similar goods/services to other organizations. The percentage of work is determined by the amount of project funding going to an entity.

2.2 SBA Company Registry (Required at Proposal Submission)

All proposers to this solicitation are required to register in the SBA Company Registry prior to proposal submission. The ARPA-H Solutions site requires proposers to input their SBC Control ID and upload their proof of registration (.pdf) as part of the proposal submission.

Follow the steps listed below to register and download your proof of registration:

• If you are a previous SBIR/STTR awardee from any agency, go to www.sbir.gov and login to your SBIR.GOV user account. Click on DASHBOARD and select ‘Download

SBC Registration (Proof of Registration/Certification)’ from MY DOCUMENT BOX.

https://www.sbir.gov/

• If you are a first-time applicant, navigate to the SBA Company Registry and use the registration tool to complete your company’s registration (may take approximately

1 business day to get approval).

• Download and save your SBA registry PDF locally. The name will be in the format of SBC_123456789.pdf, where the 9-digit number reflects your firm’s SBC Control

ID.

• Upload a copy of the completed SBA Company Registration for your organization when submitting your proposal to the ARPA-H Solutions site.

2.3 Registration in the System for Award Management (SAM) (Required at Proposal

Submission)

All proposers must have an active SAM.gov registration with current information at the time of proposal submission, at award, and at all times during performance.

Information on SAM.gov registration is available at SAM.gov. A Unique Entity Identifier (UEI) number will be assigned upon registration with SAM.gov. A UEI is required to submit your proposal to the ARPA-H Solutions site.

NOTE: New registrations and renewals may take more than 14 business days to process in SAM.gov. ARPA-H has no influence over SAM.gov processing times.

2.4 Required Disclosures of Foreign Affiliations or Relationships to Foreign Countries

(Required at Proposal Submission)

All proposers must disclose all funded and unfunded relationships with foreign countries, using the Required Disclosures of Foreign Affiliations or Relationships to

Foreign Countries form (referred to as the “Disclosure Form” hereafter), for all owners and covered individuals.

A “covered individual” is defined as all senior key personnel identified by the Small

Business Concern (SBC) in the application (i.e., individuals who contribute to the scientific development or execution of a project in a substantive, measurable way).

This certification must be uploaded to the ARPA-H Solutions site along with your proposal. The SBIR-STTR Foreign Disclosure form and instructions can be found at:

https://grants.nih.gov/grants-process/write-application/forms-directory/required-disclosures-foreign-affiliations-or-relationships-foreign-countries

2.5 Disclosure of Foreign Relationships Reporting Requirements (Required throughout performance period)

Performers are responsible for monitoring their relationships with foreign countries of concern for any changes that may impact previous disclosures. SBCs receiving an https://sam.gov/content/home https://sam.gov/content/home https://grants.nih.gov/grants-process/write-application/forms-directory/required-disclosures-foreign-affiliations-or-relationships-foreign-countries https://grants.nih.gov/grants-process/write-application/forms-directory/required-disclosures-foreign-affiliations-or-relationships-foreign-countries award under the SBIR-STTR program are required to submit an updated Disclosure

Form if there is:

• any change to a disclosure on the Disclosure Form;

• any material misstatement that poses a risk to national security; and

• any change of ownership, change to entity structure, or other substantial change in circumstances of the SBC that is determined to pose a risk to national security.

Note: this is reported using the same disclosure form listed in section 2.4.

Detailed Terms & Conditions

For changes that occur between progress reports, recipients must request prior approval for legal actions such as merger, acquisition, and successor-in-interest or any other change in ownership, entity structure, covered individual, or other substantive changes in circumstances no later than 30 calendar days before the proposed change. Disclosure Forms are required for any changes as described above.

If the contractor reports a covered foreign relationship that meets any of the risk criteria prohibiting funding described in this solicitation, ARPA-H may withhold funding until the covered relationship has been dissolved. The contractor will be required to submit documentation verifying the relationship has been terminated. If the risk cannot be resolved, ARPA-H may deem it necessary to terminate the award for material failure to comply with the federal statutes, regulations, or terms and conditions of the federal award. Contractors are encouraged to monitor their covered foreign relationships post-award and avoid entering into relationships, both funded and unfunded, that may pose a security risk and jeopardize their ability to retain their award.

Agency Recovery Authority and Repayment of Funds An SBC will be required to repay all amounts received from ARPA-H under the award if either of the following determinations are made upon assessment of a change to their disclosure:

• the SBC makes a material misstatement that ARPA-H determines poses a risk to national security; or

• there is a change in ownership, change in entity structure, or other substantial change in circumstances of the SBC that ARPA-H determines poses a risk to national security.

2.6 Funding Agreement Certification (Required at Proposal Submission)

All proposers must submit either the SBIR or STTR Funding Agreement Certification form (links below) along with their proposal. Fast Track performers will need to re-submit this certification before beginning Phase II. This is required by SBA’s reporting requirements.

All proposers to this solicitation must submit this form despite the instructions on the form indicating otherwise.

SBIR Funding Agreement Certification: https://grants.nih.gov/grants-process/write-application/forms-directory/sbir-funding-agreement-certification

STTR Funding Agreement Certification: https://grants.nih.gov/grants-process/write-application/forms-directory/sttr-funding-agreement-certification

The SBA SBIR/STTR Policy Directive requires the collection of funding agreement information from firms at time of award and potentially during the award life cycle through the use of the SBIR or STTR Funding Agreement Certification. For purposes of this solicitation and contrary to the information found on the certification forms, all proposers are required to submit the appropriate and completed funding agreement certification document with the Solution Summary materials in accordance with this solicitation. This includes checking all applicable boxes and having an authorized officer of the awardee sign and date the certification each time it is requested in accordance with this solicitation.

The Federal government relies on this information to determine whether the business is eligible for a SBIR or STTR award. A similar certification, the Life Cycle Certification, will be used to ensure continued compliance with specific program requirements during the life of the funding agreement.

The definitions for the terms used in this certification are set forth in the Small Business Act, SBA regulations (13 CFR 121), the SBIR Policy Directive, and any statutory and regulatory provisions referenced in those authorities.

If the Contracting Officer believes that the business may not meet certain eligibility requirements at the time of award, the SBC/Proposer is required to file a size protest with the U.S. Small Business Administration (SBA), who will determine eligibility. At that time, SBA will request further clarification and supporting documentation to assist in the verification of any of the information provided as part of a protest.

https://grants.nih.gov/grants-process/write-application/forms-directory/sbir-funding-agreement-certification https://grants.nih.gov/grants-process/write-application/forms-directory/sbir-funding-agreement-certification https://grants.nih.gov/grants-process/write-application/forms-directory/sttr-funding-agreement-certification https://grants.nih.gov/grants-process/write-application/forms-directory/sttr-funding-agreement-certification

If the Contracting Officer believes, after award, that the business is not meeting certain requirements the agency may request further clarification and supporting documentation to assist in the verification of the information provided. Even if correct information has been included in other materials submitted to the Federal government, any action taken with respect to this certification does not affect the Government’s right to pursue criminal, civil, or administrative remedies for incorrect or incomplete information given in the certification. Each person signing this certification may be prosecuted if false information has been provided.

2.7 Life Cycle Certification (Required throughout performance period)

SBA requires the collection of information from all performers through the SBIR or

STTR Life Cycle Certification Form. All SBIR/STTR Phase I and Phase II recipients must complete this certification the following times:

1. For Phase I Recipients: at the time of final invoice or receiving final payment.

2. For Phase II Recipients: prior to receiving more than 50% of the total award amount and prior to final payment.

Note: There are separate forms for SBIR and STTR recipients. Links to the forms and instructions are below.

SBIR Life Cycle Certification: https://grants.nih.gov/grants-process/write-application/forms-directory/sbir-life-cycle-certification

STTR Life Cycle Certification: https://grants.nih.gov/grants-process/write-application/forms-directory/sttr-life-cycle-certification

2.8 Majority Ownership in Part by Multiple Venture Capital, Hedge Fund, and Private

Equity Firms Certification (Required at Proposal Submission)

Small Businesses that are owned in majority part by multiple venture capital operating companies (VCOCs), hedge funds, or private equity funds are only eligible for SBIR opportunities under this solicitation – they are not eligible for STTR opportunities.

These businesses must complete the “SBIR Application VCOC Certification” and upload it to the ARPA-H Solutions site when submitting their proposal.

Note: SBC’s that do not meet these criteria should NOT complete or submit the “SBIR Application VCOC Certification” form.

VCOC Form: https://grants.nih.gov/grants-process/write-application/forms-directory/sbir-vcoc-venture-capital-operating-companys-application-certification

Small businesses that are owned in majority part by multiple venture capital operating companies (VCOCs), hedge funds, or private equity funds are eligible to submit proposals for SBIR opportunities under this solicitation but are required to submit a “SBIR Application VCOC Certification” at time of their proposal submission per the SBIR Policy Directive. Download the “SBIR Application VCOC Certification.pdf” at the NIH SBIR Forms webpage. Answer the 3 questions and check the certification boxes. The authorized business official must sign the certification. The signed SBIR Application VCOC Certification must be submitted with the Solution Summary materials.

Applicant small business concerns who are NOT owned in majority by multiple venture capital operating companies (VCOCs), hedge funds, or private equity funds, as described above, should NOT fill out a “SBIR Application VCOC Certification” and should NOT attach it to their application package.

NOTE: SBC that are more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are NOT eligible to apply to the ARPA-H/NIH STTR program.’

https://grants.nih.gov/grants-process/write-application/forms-directory/sbir-life-cycle-certification https://grants.nih.gov/grants-process/write-application/forms-directory/sbir-life-cycle-certification https://grants.nih.gov/grants-process/write-application/forms-directory/sttr-life-cycle-certification https://grants.nih.gov/grants-process/write-application/forms-directory/sttr-life-cycle-certification https://grants.nih.gov/grants-process/write-application/forms-directory/sbir-vcoc-venture-capital-operating-companys-application-certification https://grants.nih.gov/grants-process/write-application/forms-directory/sbir-vcoc-venture-capital-operating-companys-application-certification

3 Proposal Preparation Instructions and Requirements

Submissions will follow a two-step process. This is a phased approach that reduces paperwork and effort for both proposers and ARPA-H. All eligible SBIR/STTR mechanisms (Phase I, Direct-to-Phase II, and Fast Tracks) will follow the same process.

3.1 Stage 1: Solution Summary

The Solution Summary is an abstract that concisely describes the proposed solution and implementation approach. The Solution Summary is 4 pages of technical content with exceptions noted in the following paragraphs. It is required to use the Solution

Summary Template provided with this BAA. Proposers must clearly describe what they are developing and how they will do it. It must detail their overall approach and explain the technical challenges and innovations entailed. It must address how the proposer will achieve the metrics and milestones in the topic.

Direct-to-Phase II Only: Feasibility Statement. Proposers must address the scientific basis underpinning the proposed approach and provide evidence (whether from literature or prior work) that it will be successful. While ARPA-H seeks ambitious projects (not incremental advances), there should still be specific technical evidence underpinning the approach. This should not exceed 1-page of additional content.

Direct-to-Phase II and Fast Track Only: Commercialization Plan Statement.

Commercialization is an essential goal of the SBIR/STTR program and performers are required to conduct commercialization activities during Phase II. Proposers must describe their commercialization objectives and plans. This includes their strategy, customers/buyers/markets, regulatory objectives, and any anticipated transition challenges to overcome. This should not exceed 1-page of additional content.

See Section 5: Method of Selection and Evaluation Criteria, for how solution summaries are evaluated.

3.2 Stage 2: Proposal Package with Technical Presentation

Proposers will be notified if they are invited to continue to Stage 2 after the

Government completes the review of the Solution Summaries. The Technical

Presentation is a 50-minute technical presentation with the first 20-minutes set aside for the proposer’s presentation followed by 30-minutes for Q&A and technical discussion with the evaluation team. All presentations will be virtual, in-person, or hybrid as agreed upon between the Government and Proposer. Proposers will be limited to 3 virtual or in-person attendees, which must include the Principal

Investigator (PI) for the project. STTR proposers must also include (virtually or in person) a representative from the participating research institution. Any associated travel costs or preparation expenses will not be reimbursed by the government.

ARPA-H expects to notify invited proposers 1-month before the Technical

Presentation.

Proposers must provide advance copies of their slides, a Task Description

Document (TDD), a GANTT chart, a key personnel worksheet, and a cost proposal. These are due approximately 2-weeks before the scheduled presentation following the instructions provided by ARPA-H. The evaluation team will use these as reference materials and to prepare questions (Note: questions will not be shared in advance).

Technical Presentation Content Proposers should note that this is a technical presentation, not a sales pitch. This is

Proposers’ opportunity to voice-track their technical approach, their proposed statement of work, and why they will be successful. They should explain not only what they will do, but also how they will do it, why it will work, and why they will be successful. As necessary, the presentation should incorporate evidence to substantiate claims being made.

Presentations must also include slides describing the expertise of the organizations and key personnel participating in the project. Proposers must explain why they are qualified to not only create the technical innovation, but also to bring them to market and patients / users.

A maximum of 16 slides is permitted for the Technical Presentation. Proposers must use the template accompanying this solicitation and address each of the sections listed below. The suggested number of slides are also provided for each section.

• Technical Merit & Novelty (3 slides): Describe the technical merit and novelty of the solution being developed, the health problem being addressed, current limitations, the unique approach, expected impact, etc.

• Technical Milestones & Project Timeline (3 slides): Present the tasks and milestones from the TDD in a GANTT chart. The proposer should address the overall timeline and the most important milestones, but is not required to discuss all of them during the presentation.

• Technical Risks & Mitigation Strategies (2 slides): Identify the major technical risks and associated mitigation strategies to addressing them.

• Commercialization Plan (2-3 slides): Address the commercialization plans for the proposed solution. Includes the long-term vision commercialization and activities that will be executed during the proposed project. The content should include the anticipated end-state and additional steps that need to be taken to bring their project (if successful) to market. Proposers must also describe their overall strategy, key stakeholders, customer acquisition plans, market data, and articulate the key commercialization challenges and mitigation plans that need to be overcome to successfully transition their solutions.

• Team (2 slides): Detail your team’s qualifications by highlighting relevant expertise, roles, and experience supporting project success and commercialization.

• Research Organization Partner - STTR Only (1 slide): Describe the relationship with your partner research institution, the details of your agreement, and the proposed division of labor and activities.

• Project Summary (1 slide): provides a high-level overview of the project and commercialization potential

4 Submissions

4.1 Submission via ARPA-H Solutions site

All submissions must occur using the ARPA-H Solutions site. The first time an individual uses the site, registration is required. Instructions for registration and troubleshooting issues are available on the Solution site landing page. The site for this solicitation contains a form and fields to upload all required documents and required certification forms. It is recommended that applicants register on the site and review the form contents early in the proposal preparation process. Additionally, a site submission resource will be posted with the special notice to help applicants prepare for the form fields in the site.

4.2 Documents required at submission

Proposal Page/Length Limit Table

Stage Submission Item Applies To Limit Notes

Stage 1 Solution Summary – core technical content All proposers 4 pages

Must use the Solution Summary Template.

Stage 1 Feasibility Statement Direct-to-Phase II only

+1 page max

Additional content beyond the 4-page Solution Summary. Must provide scientific basis and feasibility evidence.

Stage 1 Commercialization

Plan Statement

Direct-to-Phase II and Fast Track only

+1 page max

Additional content beyond the 4-page Solution Summary.

Stage 1 SBA Proof of Registration

All proposers No page limit Required upload; administrative document.

Stage 1 SBIR Funding Agreement Certification

SBIR only No page limit Required upload.

Stage 1 STTR Funding

Agreement Certification

STTR only No page limit Required upload.

https://solutions.arpa-h.gov/

Stage Submission Item Applies To Limit Notes

Stage 1 Foreign Disclosure

Form All proposers

No page limit

Required upload.

Stage 1 VCOC Certification If applicable No page limit Required only for applicable SBIR proposers.

Stage 2 Technical

Presentation Slides Invited proposers

16 slides max

This is a slide limit, not a page limit.

Stage 2 Technical

Presentation session Invited proposers

50 minutes total

20 minutes presentation + 30 minutes Q&A. Not a page limit, but a formal length limit.

Stage 2 Task Description Document (TDD)

Invited proposers No page limit stated Required 2 weeks before presentation.

Stage 2 GANTT Chart Invited proposers No page limit stated Required 2 weeks before presentation.

Stage 2 Cost Proposal Invited proposers No page limit stated Required 2 weeks before presentation.

Stage 2 Key Personnel

Worksheet Invited proposers

No page limit stated

Required 2 weeks before presentation.

Total Solution Summary Page Limits:

Phase I 4 page max Fast Track 5 page max Direct to Phase II 6 page max

4.3 Submission Timeline

ARPA-H will notify all proposers about the status of their solution summary submission within 60 calendar days after the closing date for the topic. At that time, ARPA-H will inform the proposer as follows:

a. ARPA-H has discouraged the proposer to provide a presentation; or

b. ARPA-H encouraged the proposer to submit a proposal package and participate in a technical presentation. If selected for a presentation, additional instructions for scheduling a presentation session will be provided.

After the proposal package submission, ARPA-H will respond to each proposer who has submitted a proposal package and completed their technical presentation within

60 days to inform the proposer that:

a. ARPA-H has not selected the proposer to move forward with the solution; or

b. ARPA-H is recommending the proposal for award, which may or may not require negotiations.

ARPA-H intends to make awards for a topic within 180 calendar days of its closing date. If this changes, ARPA-H will notify proposers of the delay and provide a revised timeline. Proposals packages submitted shall be valid for 180 calendar days after submission.

ARPA-H will not provide feedback during solution summary evaluations or after solution summaries have been evaluated and instead will provide an encourage/discourage designation. However, ARPA-H may provide Stage 2 proposal package feedback in the form of a written debrief after final Stage 2 selection decisions have been announced. If a written debrief is requested, ARPA-H will endeavor to provide a technical evaluation narrative to the proposer for each proposal package submitted to a topic.

4.4 Reducing Administrative Burden

The Small Business Innovation and Economic Security Act requires each agency head to set a maximum number of Phase I or Phase II proposals that a small business

(including affiliates) may submit to each agency in a single fiscal year. Unless otherwise stated in this solicitation, HHS sets the number of SBIR/STTR proposals that a small business including its affiliates can submit per fiscal year to 9 proposals across all HHS Operating Divisions. This includes submitting a Phase II proposal to continue development of a Phase I project. Proposers should note that some topics may be waived from this requirement. This section only applies to proposals submitted on or after October 1, 2026, through the closing date of the solicitation.

5 Method of Selection and Evaluation Criteria

Conforming submissions will be evaluated using the method of selection and evaluation criteria detailed in this section. Submissions that do not meet the

SBIR/STTR eligibility requirements (Section 2: Eligibility & Certifications), do not contain/conform to the required technical content (Section 3: Proposal Preparation

Instructions and Requirements), or do not adhere to the submission instructions

(Section 4: Submissions) will not be recommended to progress to Stage 2 or will not be evaluated nor considered for award. Proposers must make a complete Stage 1 submission by the topic deadline to be eligible to participate in Stage 2.

Stage 1: “Solution Summary” Basis of Evaluation Solution Summaries will be evaluated for technical merit and novelty against the specific topic, not against other Solution Summaries. All conforming Solution

Summaries submitted by the deadline will be evaluated against the criteria below:

1.) Non-Cost Evaluation Criteria: Technical Merit (see section 5.1.1)

2.) Non-Cost Evaluation Criteria: Technical Novelty (see section 5.1.2)

Based on the evaluation, applicants will be encouraged or discouraged from progressing to Stage 2. This is intended to save the time and cost of associated with preparing a full proposal package for Stage 2 when significant issues have been identified in the Solution Summary. While not recommended, “discouraged" companies have the option to progress to Stage 2. To do so, they must provide written notification to the contracting officer within 48 hours of receiving their Stage 1 recommendation.

Note: ARPA-H is not obligated to provide detailed feedback to Stage 1 submissions or to offer proposers an opportunity to correct errors.

Stage 2: Proposal Package Basis of Evaluation In stage 2, proposal packages will be evaluated using the criteria below; they will be evaluated on their own merits and not in comparison to one another. The proposal package includes the technical presentation, the task description document (TDD), cost proposal, key personnel worksheet, and GANTT chart. The contents of the proposal package will be evaluated along with the oral presentation and Q&A using the following criteria:

1.) Non-Cost Evaluation Criteria: Technical Merit (see section 5.1.1)

2.) Non-Cost Evaluation Criteria: Technical Novelty (see section 5.1.2)

3.) Non-Cost Evaluation Criteria: Team & Relevant Experience (see section 5.1.3)

4.) Non-Cost Evaluation Criteria: Path to Impact and Health Outcomes (see section 5.1.4)

5.) Cost Evaluation Criteria (see section 5.1.5)

The Government will evaluate each proposal package in its entirety, documenting strengths and weaknesses relative to each evaluation criteria. Based on these identified strengths and weaknesses, the Government will determine the proposal’s overall selectability for funding.

For the purposes of this evaluation process, a selectable proposal is defined as follows:

Selectable: A selectable proposal is a proposal that the Government has evaluated against the evaluation criteria listed in the BAA, and the strengths of the overall proposal outweigh its weaknesses. Additionally, there are no accumulated weaknesses that would require extensive negotiations and/or a resubmitted proposal.

For the purposes of this proposal evaluation process, a non-selectable proposal is defined as follows:

Non-Selectable: A proposal is considered non-selectable when the

Government has evaluated the proposal against the evaluation criteria listed in the BAA, and the strengths of the overall proposal do not outweigh its weaknesses or if there are accumulated weaknesses that would require extensive negotiations and/or a resubmitted proposal.

The government reserves the right to limit the number of proposers to be awarded a contract (with or without negotiations). As such, a proposer’s submission may be evaluated as “Selectable” but not invited to negotiate or receive an award.

5.1 Evaluation Criteria

The following non-cost evaluation criteria will be used to evaluate the stages:

5.1.1 Technical Merit

The proposed technical approach meets or exceeds the objectives of the corresponding topic. The proposed technical approach is feasible and complete. Task descriptions and associated technical elements provided are complete and in a logical sequence with all proposed deliverables clearly defined such that an outcome that achieves the goal can be expected because of the award. The proposal identifies major technical risks and planned mitigation efforts are clearly defined and feasible.

All claims should be substantiated with evidence provided. In addition, the evaluation may take into consideration the extent to which the proposed intellectual property

(IP) rights structure and software components will potentially impact the ability to commercialize the technology and adhere to open-source solutions and/or standards.

5.1.2 Technical Novelty

The proposed technical approach is novel, innovative and highly ambitious, not incremental or basic research. This includes the development of new technologies/capabilities, novel applications or adaptations of existing technologies, and new interdisciplinary approaches. The proposal clearly identifies the novel elements of the proposed approach and the associated advancements created. The proposals illustrate how these advancements improve upon the status quo, enhance the state of science, advance overall capabilities in the field, and meet unmet needs within biomedicine to improve health outcomes. The proposed approach aligns to the ARPA-H mission of funding transformative advancements and gaps that are not being funded by other government agencies or the private sector.

5.1.3 Team & Relevant Experience

The proposed technical team has the expertise and experience to accomplish the proposed tasks, to fulfill the objectives of the topic, and to successfully commercialize the capabilities being developed. The technical team includes Principal

Investigators/Project Managers, supporting staff, consultants, and other personnel/partners involved in completing or commercializing the work. The proposer’s prior experience in similar efforts is articulated and clearly demonstrates an ability to deliver products that meet the proposed technical performance within the proposed budget and schedule and to overcome regulatory and commercialization challenges incumbent in fielding the technology. It is important that teams demonstrate their ability to work together and have a proven track record of successfully developing technologies. Because the small business program seeks to develop novel capabilities, not incremental research, track records of developing and fielding new biomedical technologies is more important than publication histories.

5.1.4 Path to Impact and Health Outcomes

The proposal clearly demonstrates an understanding of the pathway to field, commercialize, or otherwise transition the solution being developed. The proposal articulates the key stakeholders involved, such as beneficiaries, economic buyers, users, entrenched incumbents, etc. The proposer articulates a commercialization strategy that is viable and demonstrates an understanding of the challenges that must be overcome and the operational constraints that must be accommodated. Other considerations include notional business model, freedom to operate and intellectual property, regulatory pathway, payment / reimbursement, evidence of commercial potential, and indicators of market readiness.

The ARPA-H Small Business Program seeks to fund performers and technologies that can ‘survive in the wild’ and are not perpetually reliant on government funding.

Strong proposals will address how ARPA-H’s funds will enable them to achieve an inflection point from…