Attachment F_Administrative_National_Policy_Requirement.docx

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ARPA-H Emerging Health Innovators (EHI) Initiative
Solicitation number
ARPA-H-SOL-26-150
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About this file

This is an Administrative & National Policy Requirements template document that proposers must complete and submit as part of their proposal to ARPA-H under the Emerging Health Innovators (EHI) Initiative (Solicitation ARPA-H-SOL-26-150). The document must be submitted in PDF, DOC, or DOCX format with 1-inch margins and sans-serif font no smaller than 11 point, formatted for standard 8.5" x 11" paper with no specified page limit.

The template requires proposers to provide comprehensive disclosures across eleven major categories: team member identification for all prime awardees, sub-awardees, contractors, and vendors; FFRDC participation justification; organizational conflicts of interest (OCI) affirmations and mitigation plans per NSPM-33; research security disclosures including certification regarding foreign talent recruitment programs, foreign ownership of entities, and research execution in foreign countries of concern; novelty of work and prior government submissions; detailed intellectual property assertions with background IP descriptions and associated government rights (Unlimited, Government Purpose, Limited, or Specially Negotiated); human subjects research IRB approvals and Federal-wide Assurance documentation; animal subjects research IACUC approvals and Vertebrate Animal Section worksheets; representations regarding unpaid federal tax liability and felony convictions; cybersecurity program implementation and CUI management capabilities; and biosecurity assessments including dangerous gain-of-function research and synthetic nucleic acid procurement. Senior/key personnel must submit biographical sketches, current and pending support documentation, and collaborators and affiliations disclosures. The document serves as a critical compliance instrument ensuring research security, intellectual property transparency, and adherence to federal policy requirements.

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EHI Administrative FAQ Sep 25 2026.docx DOCX document
Attachment A_Solution Summary_Amendment 1.docx DOCX document
EHI ISO 2026_ARPA-H-SOL-26-150_Amendment 1.pdf PDF
Attachment G_ARPA-H Model Other Transaction.docx DOCX document
Attachment C_Technical and Management Proposal.docx DOCX document
Attachment A_Solution Summary.docx DOCX document
Attachment E_Milestone_Payment_Schedule.docx DOCX document
Attachment B_Pitch Slides.pptx PPTX presentation
EHI Administrative FAQ.docx DOCX document
EHI ISO 2026_ARPA-H-SOL-26-150_clean_Sep 15.pdf PDF
Attachment D_Task Description Document (TDD).docx DOCX document
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Administrative & National Policy Requirements Document

This Administrative & National Policy Requirements Document must be completed in full and included as part of the proposal submission. Other than the instructions in blue font, do not delete any portion of this document.

All pages must be formatted for printing on 8-1/2 by 11-inch paper with 1-inch margins and a sans-serif font size not smaller than 11 point. Sans-serif font sizes of 8- or 10 point may be used for figures, tables, and charts. There is no page limit for this document.

The Administrative & National Policy Requirements Document must be in .pdf, .doc, or .docx formats. Submissions must be written in English.

Administrative & National Policy Requirements

DARPA-BAA-16-22 2

Contents

Cover Page1
1.Team Member Identification2
2.Federally Funded Research and Development Center (FFRDC) Participation4
3.Organizational Conflict of Interest (OCI) Affirmations and Disclosure4
4.Research Security Disclosure5
5.Novelty of Proposed Work8
6.Intellectual Property (IP)8
7.Human Subjects Research (HSR)12
8.Animal Subjects Research (ASR)13
9.Representations Regarding Unpaid Delinquent Tax Liability or a Felony Conviction under Any Federal Law13
10.Cybersecurity13
11.Biosecurity14

<PRIME ORGANIZATION LOGO (optional)>

COVER PAGE

EHI ISO #

EHI Topic Area (Number and Title)

EHI Proposal Title

Proposer Organization

Technical Point of Contact (TPOC)
Name:

Address:

Telephone:

Email:

Administrative POC (APOC)
Name:

Address:

Telephone:

Email:

Date of Proposal Submission
(MM/DD/YYYY)
Proposal Validity Period (minimum 120 days)
______ Days

October 2025 version 1

TEAM MEMBER IDENTIFICATION

List the organizations/institutions that will comprise your team. Organization/Institution roles include prime awardees, sub-awardees, team members, contractors, and vendors that will be supplying components, information, data, or material that is critical to your proposal. Add rows as needed.

Organization /Institution Name
Status
Organization/Institution Role

☐ U.S. ☐ non-U.S.

☐ U.S. ☐ non-U.S.

☐ U.S. ☐ non-U.S.

☐ U.S. ☐ non-U.S.

☐ U.S. ☐ non-U.S.

☐ U.S. ☐ non-U.S.

☐ U.S. ☐ non-U.S.

☐ U.S. ☐ non-U.S.

Senior/Key Personnel (i.e., Covered Personnel) Complete the following table for each Senior/Key Person[footnoteRef:2]. Add rows, as needed. [2: In addition to the Principal Investigator or Program/Project Director, Senior/Key Personnel includes individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, regardless of whether they receive salaries or compensation under the award. These include individuals whose absence from the project would significantly impact the approved scope of the project; in other words, were the individual to leave the program, the change would be so substantial that ARPA-H would need to be notified. It is typical that each awardee has at least one Principal Investigator or Program/Project Director, including one from each sub-awardee or teaming partner that is expected to perform critical work for the proposed effort.]

Senior/Key Personnel Names
Organization / Institution
Confirmation Common Forms Are Attached

Biographical Sketch Attached: ☐ Yes ☐ No Current & Pending Support Attached: ☐ Yes ☐ No

Biographical Sketch Attached: ☐ Yes ☐ No

Biographical Sketch Attached: ☐ Yes ☐ No

FEDERALLY FUNDED RESEARCH AND DEVELOPMENT CENTER (FFRDC) PARTICIPATION

Is any member of your proposed team an FFRDC?

☐ No ☐ Yes If yes, provide justification for inclusion of the FFRDC and separate documentation that indicates that no other source will meet the needs that the FFRDC will meet.

ORGANIZATIONAL CONFLICT OF INTEREST (OCI) AFFIRMATIONS AND DISCLOSURE

In accordance with the National Security Presidential Memorandum (NSPM)-33 and the associated White House Office of Science and Technology Policy Implementation Guidance, senior/key personnel are required to disclose potential conflicts of interest (COIs) and conflicts of commitment (COCs). Those disclosures are captured by senior/key personnel completing the Biographical Common Form, the Current and Pending (other) Support Common Form, and the Collaborators and Other Affiliations document as attachments to this template. These forms can be found at: https://www.nsf.gov/bfa/dias/policy/nstc_disclosure.jsp.

Additional information about potential collaborations can be found at: https://www.nsf.gov/funding/senior-personnel-documents#collaborators-and-other-affiliations-2b3.

a. Are any of the proposed team members or organizations (whether prime, sub-awardee, or consultant) providing support in the form of an Internal Support Contractor (ISC)/Systems Engineering Technical Assistance (SETA) Agreement, Partnership Intermediary Agreement (PIA), or similar support to ARPA-H?

☐ No ☐ Yes

b. Has any proposed team member or organization (whether prime or sub-awardee or consultant) provided ISC/SETA support or similar support to ARPA-H within one calendar year of this proposal submission?

☐ No ☐ Yes If the answer to 3.a. or 3.b. is yes, provide a separate document with the following information for each such team member:

· The name of the ARPA-H office receiving the support

· The prime contract number

· Name and type of support (e.g., prime, sub-awardee, consultant)

· An OCI mitigation plan

c. Are there other potential Organizational Conflicts of Interest involving a proposed team member or organization (whether prime, sub-awardee, or consultant)?

☐ No ☐ Yes If yes, for each team member for which an OCI or a potential OCI exists, provide a separate document with the following information:

· Identification (name), and

· An OCI mitigation plan

RESEARCH SECURITY DISCLOSURE

ARPA-H’s research security program (RSP) involves research security reviews (RSRs) to determine whether Proposers are covered individuals or have behaviors that: (a) may be contrary to federal policy; (b) undermine the integrity of ARPA-H-funded research; or (c) bring risk to the agency’s research programs. The RSP aims to mitigate the risk of unwanted knowledge and technology transfers to foreign countries of concern (FCOCs)[footnoteRef:3] [3: Public Law 117-167, The CHIPS and Science Act, Section 10612, Aug 9. 2022; the People’s Republic of China, the Russian Federation, the Islamic Republic of Iran, the Democratic People’s Republic of North Korea, and any other country so designated by the Department of State.]

In addition to the senior/key personnel disclosures, answer the following:

a. Has every PI and senior/key person certified (in writing or by digital signature) that they are (or are not) party to a malign foreign talent recruitment program (FTRP)? In accordance with 42 USC §19232, individuals are prohibited from being a party in a malign FTRP (as defined in 42 USC §19232).

☐ No ☐ Yes

b. Are any members of the proposal team participating in, or previously participated in, any FTRPs?

☐ No ☐ Yes If yes, please list the name(s) of the team member(s), the year(s) of their participation, the FCOC(s) in which the program(s) is/are based, and the terms of the FTRP.

c. Are any of the proposed team organizations/entities or partners (e.g., the prime proposer, sub-awardees) owned wholly or in part by foreign individuals, entities, or governments?

☐ No ☐ Yes If yes, provide the name(s) of the foreign-owned entities, and the name(s) of the owner(s) (e.g., individual(s), partner(s), or government(s), etc.) and identify the percentage(s) owned.

d. Is any of the proposed research projected to be executed within an FCOC?

☐ No ☐ Yes If yes, please identify each FCOC, each entity executing research in an FCOC, and a narrative discussing the criticality of executing research to your proposal.

e. Do any of the proposing entities (e.g., prime, sub-awardee, or consultant) intend to rely on technology, information, data sets, or equipment (including known supply chain) that will be provided by or transmit data to or through an FCOC?

☐ No ☐ Yes If yes, identify each entity that intends to do so, and provide a narrative discussing the criticality to your proposal.

By submitting this document to ARPA-H, you are certifying that the information provided in this section is current, accurate, and complete. This includes (but is not limited to) information related to current-, pending-, and other support (both foreign and domestic) as defined in 42 U.S.C. § 6605.

By submitting this document to ARPA-H, you are also certifying that at the time of submission, no member of the proposed team is a party in a malign foreign talent recruitment program.

By submitting this document to ARPA-H, you acknowledge that misrepresentations and/or omissions may be subject to prosecution and liability pursuant to, but not limited to, 18 U.S.C. §§ 287, 1001, 1031 and 31 U.S.C. §§ 3729-3733, and 3802.

NOVELTY OF PROPOSED WORK

Has the proposed work been submitted to any other government solicitation?

☐ No ☐ Yes If yes, provide the following information (and change the font color to black):

· Solicitation number ________________________

· Agency/Office ____________________________

· Has the proposed work already received funding or a positive funding decision?

☐ No ☐ Yes ☐ Decision pending

INTELLECTUAL PROPERTY (IP)

Proposer information regarding IP and data restrictions promotes transparency, impacts ARPA-H’s proposal evaluation efforts, and allows ARPA-H to evaluate how this information will affect the project/program and the government’s rights in deliverables. Complete and accurate information also reduces the chances of delays and conflicts affecting negotiations and eventual project performance.

For the primary proposer or any teaming partner or sub-awardee, identify background IP or otherwise restricted data (e.g., data subject to confidentiality agreement) that would be relevant to/incorporated into the proposed work and any deliverables in the table below. Furthermore, identify what rights the government can expect to have in that data or IP.

· Background IP consists of trade secrets, patents, data, or non-provisional patent applications owned or controlled by the proposer team that exist prior to the date of any future agreement with ARPA-H or are conceived and otherwise created outside the scope of any future agreement with ARPA-H.

Use the following rights categories in completing the “Associated Rights” column of the table.

Unlimited Rights: The government’s right to use, disclose, reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, in any manner and for any purpose, and to have or permit others to do so.

Government Purpose Rights: The government’s right to use, modify, reproduce, perform, display, release, or disclose, in whole or in part and in any manner, for government purposes only, and to have or permit others to do so for government purposes only. Government purposes are activities in which the U.S. government is a party, including cooperative agreements with international or multi-national organizations, or sales or transfers by the U.S. government to foreign governments or international organizations. Government purposes include competitive procurement, but do not include the rights to use, modify, reproduce, release, perform, display, or disclose for commercial purposes or authorize others to do so.

Limited Rights: The government’s right to use, modify, reproduce, release, perform, display, or disclose, in whole or in part, within the government. The government may not, without the written permission of the Performer, release or disclose outside the government, use for manufacture, or authorize use by another party. The government may release or disclose to a covered government support contractor in performance of a covered government support contract.

Specially Negotiated/Other Rights: Rights proposed by the Performer that differ from the standard categories described above. Open Source/End User License Agreements/Data Use Agreements might fall under this category. Include a description of the license proposed.

The table below includes an example to assist Proposers complete it. Add rows to the table if needed. In general, Proposers can assume the following in completing this table.

1. ARPA-H does not, unless specified in the solicitation, intend to own IP. Rather, ARPA-H's expectation is that it will receive licenses to IP sufficient to meet the needs of the project or program.

2. ARPA-H generally expects to receive license rights commensurate with its contribution to the IP’s/data’s development. Where ARPA-H has funded some or all of the IP/data, the agency would typically expect at least Government Purpose Rights. This may vary based on the needs of the program or in recognition of a proposer’s heavy prior/internal investment. Where IP/data has been created entirely at private expense, Limited Rights or Specially Negotiated/Other Rights would be appropriate, though Government Purpose Rights are also common. Proposed resource share may be a factor in the rights proposed. The “Basis for Assertion” would typically have to do with the source of the IP, how it was funded, and when the IP/data was created.

Background IP and Data Assertions

General description of background IP or restricted data (e.g. inventions, proprietary information or data subject to confidentiality agreements, computer software, etc.). For inventions, please provide the application/patent number if available
Expected role of this IP or data in performance of the work
Basis for Assertion
Associated Rights (see rights categories above)
Name of person/entity asserting the restriction and their role in the requirement (i.e., primary proposer, teaming partner, or sub-awardee)

ARPA-H Example

Background IP (“Image-recognition software” or “wireless biosensor technology”) ARPA-H Example

Used as a core software module in the prototype system or Embedded into the device as the primary sensing component ARPA-H Example

Developed exclusively at private expense. or Developed under agreement number ABC.

ARPA-H Example

Limited or Government Purpose Rights ARPA-H Example

(“Company Name (Prime)” or “Company Name (Sub-Awardee)”)

PATENTS

For patents identified above, provide documentation demonstrating ownership or possession of appropriate licensing rights for the proposed work.

If a patent application has been filed for an invention, but it includes proprietary information and is not publicly available, provide the following information:

· The patent number

· The inventor name(s)

· The assignee names (if any)

· The filing date

· The filing date of any related provisional application and

· A summary of the patent title, with either:

(1)a representation of invention ownership; or
(2)proof of possession of appropriate licensing rights in the invention (i.e., an agreement from the owner of the patent-granting license to the proposer).

If any IP listed was developed in whole or in part with government funding from any Agency, specify under what agreements that IP was developed.

Background IP of teaming partners and sub-awardees should be included if restrictions on that IP have implications for the success of the award or the rights the Government can expect to receive.

HUMAN SUBJECTS RESEARCH (HSR)

Does the proposed work involve Human Subjects Research?

☐ No ☐ Yes If yes, provide separate documentation showing evidence of, or a plan for, review by an Institutional Review Board (IRB) and include evidence of a Federal-wide Assurance for the Protection of Human Subjects. Complete the following table to identify each organization, team member, and sub-awardee performing HSR. Add rows as needed.

Organization Performing HSR
Institution Site
Federal-wide Assurance Number
Approved IRB Protocol (Y/N)

ANIMAL SUBJECTS RESEARCH (ASR)

Does the proposed work involve Animal Subjects Research?

☐ No ☐ Yes If yes, provide

· separate documentation that gives a brief description of the plan for Institutional Animal Care and Use Committee (IACUC) review and approval

· the Vertebrate Animal Section (VAS) worksheet, found at:

(https://olaw.nih.gov/sites/default/files/VASchecklist.pdf)

· evidence of each applicable organization’s Animal Welfare Assurance

Complete the following table to identify each organization, team member, and sub-awardee performing ASR. Add rows as needed.

Organization Performing ASR
Institution Site
Approved IACUC Protocol (Y/N)
Completed VAS (Y/N)
Animal Welfare Assurance Number

Representations Regarding Unpaid Delinquent Tax Liability or a Felony Conviction under Any Federal Law The Proposer represents that it –

a. Is ☐ Is not ☐ a corporation that has any unpaid federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability.

b. Is ☐ Is not ☐ a corporation that was convicted of a felony criminal violation under a federal law within the preceding 24 months.

CYBERSECURITY

a. Does your organization implement a cybersecurity program leveraging industry and/or government standards to secure and defend your systems, networks, and/or data?

☐ No ☐ Yes If yes, provide a brief description of the program, including the specific standard(s) that guide the program, the abilities of the organization to respond to a cybersecurity incident, and how the organization assesses the security posture of its systems and/or networks.

b. Does your organization have experience with managing and securing Controlled Unclassified Information (CUI)?

☐ No ☐ Yes Describe how the proposing institution and sub-awardee/subcontractor organizations manage CUI, including details of access control for research designated as CUI, information systems security protocols, storage, communicating unclassified fundamental research with foreign nationals, and risk mitigation strategies for unclassified research that may ultimately become CUI as the research proceeds.

BIOSECURITY

a. Dangerous Gain-of-Function Research: Does the proposal involve dangerous gain-of-function research, per the definition in Section 8 of Executive Order (E.O.) 14292 on Improving the Safety and Security of Biological Research[footnoteRef:4]? [4: https://www.whitehouse.gov/presidential-actions/2025/05/improving-the-safety-and-security-of-biological-research/]

☐ No ☐ Yes

b. Synthetic Nucleic Acids or Benchtop Nucleic Acid Synthesis Equipment: Does the proposed work include the potential to procure synthetic nucleic acids or benchtop nucleic acid synthesis equipment?

· This includes, but is not limited to, procuring synthetic DNA and RNA, as well as whole organism genomes (e.g., viruses, bacteria) containing any synthetic nucleic acid 200 nucleotides or greater, and benchtop equipment capable of synthesizing nucleic acids.

☐ No ☐ Yes If yes, refer to the OSTP Framework for Nucleic Acid Synthesis Screening for guidance, attestation requirements, and definitions of terms. The requirement to use the framework applies to all work performed under the award.

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