APPENDIX F_Administrative National Policy Document.docx

Administrative & National Policy Requirements Document For Other transaction (OT) Agreements

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 sans-serif font size not smaller than 11 points. 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.

Contents

Administrative & National Policy Requirements

DARPA-BAA-16-22 2

<PRIME ORGANIZATION LOGO (optional)>

COVER PAGE

Proposal Title

Proposer Organization

SAM.gov Unique Entity Identifier (UEI)

Address:

Telephone:

Email:

Address:

Telephone:

Email:

TEAM MEMBER IDENTIFICATION

List the team member entities (organizations, institutions, or others) that comprise your team. These roles include prime awardees, sub-awardees, contractors, and vendors that will be supplying components, information, data, or material that is critical to your proposal. Identify the status of each team member entity and indicate if they are a covered institution. Add rows as needed.

Covered Institution ☐ Yes ☐ No

☐ Yes ☐ No

☐ Yes ☐ No

☐ Yes ☐ No

☐ Yes ☐ No

Per the National Security Presidential Memorandum (NSPM)-33, covered institutions are required to establish and maintain a Research Security Program. A covered institution is an institution of higher education, a nonprofit research institution, or a federally funded research and development center receiving in excess of $50 million per year, under the three-year average of federal R&D obligations. The government will provide instructions and deadlines for certification as part of award negotiations, if applicable. All team member entities who anticipate meeting the definition of a covered institution will be required to certify their program. Team member entities who do not meet the definition are recommended to review the Research Security Program requirements and implement them as practicable.

Senior and Key Personnel Senior and Key Personnel include individuals (in addition to the Principal Investigator or Program/Project Director) who contribute to the scientific development or execution of a project in a substantive, measurable way, regardless of whether they receive salaries or compensation directly under the award. It is typical that each team member entity expected to perform critical work for the proposed effort has at least one senior or key person.

Complete the following table for each Senior or Key Person. Add rows as needed.

Current & Pending Support & Certification Attached:

☐ Yes ☐ No Collaborators & Other Affiliations Attached:

☐ Yes ☐ No

Current & Pending Support & Certification Attached:

☐ Yes ☐ No

☐ Yes ☐ No

Current & Pending Support & Certification Attached:

☐ Yes ☐ No

☐ 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

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 and 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 entity or senior or key person?

☐ 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

In accordance with NSPM-33 and the associated White House Office of Science and Technology Policy Implementation Guidance, senior and key personnel are required to disclose potential conflicts of interest (COIs) and conflicts of commitment (COCs). Those disclosures are captured by senior and key personnel completing the Biographical Sketch Form, the Current and Pending (Other) Support Common Form, and the Collaborators and Other Affiliations document as attachments to this template.

Biographical Sketches and Current and Pending (Other) Support Forms To generate Biographical Sketches and Current and Pending (Other) Support Forms, senior and key personnel must use the SciENcv portal: https://www.ncbi.nlm.nih.gov/sciencv/.

Resources on how to navigate the portal can be found here: https://nsf-gov-resources.nsf.gov/files/SciENcvFAQs.pdf.

Additional information on what senior and key personnel are required to disclose on both forms can be found here: https://www.nsf.gov/policies/nspm-33/disclosures.

Collaborators and Other Affiliations (COA) To complete the COA form, senior and key personnel should use their downloadable template from the National Science Foundation, which also provides additional information on what senior and key personnel disclose: https://www.nsf.gov/funding/senior-personnel-documents#collaborators-and-other-affiliations-2b3.

ARPA-H conducts reviews to determine whether team member entities and/or senior or key personnel 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. ARPA-H aims to mitigate the risk of unwanted knowledge and technology transfers to foreign countries of concern (FCOCs).[footnoteRef:2] [2: 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.]

NOTE: Proposers must notify ARPA-H of any material changes in the composition of team member entities (e.g., change in ownership, senior and key personnel, etc.). Proposers must also notify ARPA-H of any security incidents (e.g., cyberattacks) impacting team member entities participating directly or indirectly (i.e., suppliers) in the proposed project.

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

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

☐ No ☐ Yes

b. Are any senior or key personnel 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 country in which the program(s) is/are based, and the terms of the FTRP.

c. Are any of the proposed team member entities (e.g., the prime proposer, sub-awardees, vendors) 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 work projected to be executed within a foreign country?

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

e. Do any of the proposing team member entities or senior or key personnel (e.g., prime, sub-awardee, or consultant) intend to rely on vendors, 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)

6.1 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.

6.2 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.

6.3 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.

6.4 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.

a. 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.

b. 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

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.

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.

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:3]? [3: 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.