Attachment 4 Other Transaction Administrative and National Policy Requirements Document.docx

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Attached to
Emerging Health Innovators (EHI) Initiative
Opportunity number
ARPA-H-SOL-25-118
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About this file

This is an Administrative and National Policy Requirements document template that must be completed as part of the Step 2 Pitch Presentation for the ARPA-H Emerging Health Innovators (EHI) Initiative (ARPA-H-SOL-25-118). The document requires detailed information about organizational conflicts of interest, research security disclosures, foreign participation, intellectual property assertions, human subjects research, animal use research, tax liability representations, and cybersecurity protocols.

The template requires proposers to provide technical and administrative points of contact, disclose any SETA support to ARPA-H, complete Current and Pending Support Common Forms for senior personnel, detail foreign government-sponsored activities, identify IP restrictions on deliverables, and confirm compliance with human/animal research regulations. The document is administered by the Department of Health and Human Services under CFDA 93.384 for the Advanced Research Projects Agency for Health program. There is no page limit, and submissions must be in PDF, ODX, DOC, or DOCX format with 11-point font (8-10 point allowed for figures/tables).

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Administrative & National Policy Requirements Document Template

The Administrative and National Policy Requirements document must be completed in full and included as part of the Step 2 - Pitch Presentation and Supplementary Information Instructions. Do not delete any portion of this document.

All pages shall be formatted for printing on 8-1/2 by 11-inch paper with 1-inch margins and font size not smaller than 11 point. 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 and National Policy Requirements document must be in .pdf, .odx, .doc, or .docx formats. Submissions must be written in English.

DARPA-BAA-16-22 2

<PRIME ORGANIZATION LOGO (optional)>

Administrative and National Policy Requirements

Proposal Title

Proposer Organization

Technical Point of Contact (POC)
Name:

Address:

Telephone:

Email:

Administrative POC
Name:

Address:

Telephone:

Email:

Date of Proposal Submission

Proposal Validity Period (minimum 120 days)

Organizational Conflict of Interest Affirmations and Disclosure [In accordance with the EHI ISO, provide the following information.]

a. Are any of the proposed individual team members or their respective organizations (whether prime or subawardee or consultant) currently providing Systems Engineering Technical Assistance (SETA), Partnership Intermediary Agreement (PIA) or similar support to ARPA-H? ☐ No ☐ Yes

b. Did any of the proposed individual team members or their respective organizations (whether prime or subawardee or consultant) provide SETA or similar support to ARPA-H within one calendar year of this proposal submission? ☐ No ☐ Yes

[If you answered “Yes” to 2.a OR 2.b, provide the following information for each applicable team member:

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

· The prime contract number;

· Identification of proposed team member (subawardee, consultant) providing the support; and

· An OCI mitigation plan.]

c. Are there any other potential Organizational Conflicts of Interest involving any of the proposed individual team members or their respective organizations (whether prime or subawardee or consultant)? ☐ No ☐ Yes

[If yes, provide the following information for each applicable team member:

· Identification of applicable team member; and

· An OCI mitigation plan.]

Research Security Disclosure [In accordance with National Security Presidential Memorandum (NSPM)-33 and the associated White House Office of Science and Technology Policy Implementation Guidance[footnoteRef:2], which requires certain individuals to disclose potential conflicts of interest (COI) and commitment (COC), PIs and other senior/key personnel[footnoteRef:3] that will serve as prime and subawardees are required to complete the Current and Pending (other) Support Common Form as well as the Biographical Sketch Common Form. These forms can be found at: https://www.nsf.gov/bfa/dias/policy/nstc_disclosure.jsp]. [2: GUIDANCE FOR IMPLEMENTING NATIONAL SECURITY PRESIDENTIAL MEMORANDUM 33 (NSPM-33) ON NATIONAL SECURITY STRATEGY FOR UNITED STATES GOVERNMENT-SUPPORTED RESEARCH AND DEVELOPMENT (whitehouse.gov)] [3: 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, whether or not 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.]

a. In populating these forms, the following is required for each PI and other Senior/Key Personnel (whether they are supporting the prime or a subawardee (at any tier)).

i. Other organizational affiliations and employment

ii. Other positions and appointments[footnoteRef:4] [4: Both foreign and domestic, including affiliations with foreign entities and governments. This includes titled academic, professional, or institutional appointments whether or not remuneration is received, and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).]

iii. Participation in any foreign government-sponsored talent recruitment program(s)[footnoteRef:5] [5: The term “foreign government-sponsored talent recruitment program” or “foreign government-sponsored talent recruitment programs” means an effort directly or indirectly organized, managed, or funded by a foreign government or institution to recruit S&T professionals or students (regardless of citizenship or national origin, and whether having a full-time or part-time position). Compensation could take many forms including cash, research funding, complimentary foreign travel, honorific titles, career advancement opportunities, promised future compensation, or other types of remuneration or consideration, including in-kind compensation.]

iv. Current and pending support/Other support. For researchers, “Other Support” includes all resources made available to a researcher in support of and/or related to all of their professional R&D efforts, including resources provided directly to the individual rather than through the research organization, and regardless of whether or not they have monetary value (e.g., even if the support received is only in-kind, such as office/laboratory space, equipment, supplies, or employees).] This support includes:

1. all resources made available, or expected to be made available, to an individual in support of the individual’s research and development efforts, regardless of (i) whether the source is foreign or domestic; (ii) whether the resource is made available through the entity applying for a research and development award or directly to the individual; or (iii) whether the resource has monetary value;

2. in-kind contributions requiring a commitment of time and directly supporting the individual’s research and development efforts, such as the provision of office or laboratory space, equipment, supplies, employees, or students. This includes resource and/or financial support from all foreign and domestic entities, including but not limited to, (i) gifts provided with terms or conditions, (ii) financial support for laboratory personnel, and (iii) participation of student and visiting researchers supported by other sources of funding; and

3. Private equity, venture, or other capital financing.

b. For consultants, please additionally list the following (Note: current, pending, and other support not required):

i. Other organizational affiliations and employment

ii. Other positions and appointments3

iii. Participation in any foreign government-sponsored talent recruitment program(s)

c. Foreign Participation:

Do any members of the proposed team have any contracts associated with participation in programs sponsored by foreign governments, instrumentalities, or entities, including foreign government-sponsored talent recruitment programs? If yes, please provide a list of contracts and the nature of the sponsorship. ☐ No ☐ Yes

Do any members of the proposed team receive direct or indirect support (including, but not limited to, financial) that is funded by a foreign government-sponsored talent recruitment program, even where the support is provided through an intermediary and does not require membership in the foreign government-sponsored talent recruitment program. If yes, please provide a list of individuals and the nature of the support received. ☐ No ☐ Yes

Do any members of the proposed team have/participate in any other foreign government sponsored or affiliated activities. In accordance with 42 USC § 19232, individuals are prohibited from being a party in a malign foreign talent recruitment program. ☐ No ☐ Yes

Do any of the proposed individual team members or their respective organizations (whether prime or subawardee or consultant) participate in any foreign government-sponsored talent recruitment program(s)? ☐ No ☐ Yes

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 members of the proposed team are 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:

· Solicitation number ________________________

· Agency/Office ____________________________

· Proposed work has already received funding or a positive funding decision.

☐ No ☐ Yes ☐ Decision pending Intellectual Property (IP) [In accordance with the ISO, provide the following information, as applicable. Note: The Government will assume unlimited rights to all IP not explicitly identified as restricted in the proposal.]

a. Technical Data and Computer Software Are you asserting any IP restrictions on any technical data or computer software that will be delivered to the Government? ☐ No ☐ Yes

[If yes, list all anticipated proprietary claims to results, prototypes, deliverables, or systems supporting and/or necessary for the use of the proposed research, results, prototypes and/or deliverables. Provide a short summary for each item asserted with less than unlimited rights that describes the nature of the restriction and the intended use of the intellectual property in the conduct of the proposed research. Use the following format for these lists.]

NONCOMMERCIAL

Technical Data and/or Computer Software To be Delivered with Restrictions
Summary of Intended Use in the Conduct of the Research
Basis for Assertion

Asserted Rights Category

Name of Person Asserting Restrictions

COMMERCIAL

Technical Data and/or Computer Software To be Delivered with Restrictions
Summary of Intended Use in the Conduct of the Research
Basis for Assertion

Asserted Rights Category

Name of Person Asserting Restrictions

b. Patents Does the proposed effort involve using patented inventions that are owned by or assigned to the proposing organization or individual? ☐ No ☐ Yes

[If yes, provide documentation proving ownership or possession of appropriate licensing rights to all patented inventions to be used for the proposed project. If a patent application has been filed for an invention, but it includes proprietary information and is not publicly available, provide documentation that includes: the patent number, inventor name(s), assignee names (if any), filing date, filing date of any related provisional application, and 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).]

c. Ability to meet programmatic goals with IP/Patent implications

[Describe how IP assertions and/or patent implications impact the ARPA-H programmatic goals.]

Software Component Standards Does your solution include software components that are proprietary or do not include commercial-friendly-open-source licenses? ☐ No ☐ Yes [If you answered yes, please provide a technical plan in accordance with Section 6.1 of the ISO.] Human Subjects Research (HSR) Does the proposed work involve Human Subject Research? ☐ No ☐ Yes

[If yes, provide evidence of or a plan for review by an institutional review board (IRB). Please include evidence of a Federalwide Assurance for the Protection of human subjects. Please also complete the below table for each organization, including team members and subawardees, performing HSR. Add row as needed.]

Organization Performing HSR
Federalwide Assurance Number
Approved IRB Protocol (Y/N)

Animal Use Research (ASR) Does the proposed work involve animal use? ☐ No ☐ Yes

[If yes, provide a brief description of the plan for Institutional Animal Care and Use Committee (IACUC) review and approval as described in Section 6.1 of the ISO. Please also provide the Vertebrate Animal Section (VAS) worksheet (https://olaw.nih.gov/sites/default/files/VASchecklist.pdf), provided evidence of each applicable organization’s Animal Welfare Assurance, and compete the below table for each organization, including team members and subawardees, performing ASR. Add rows as needed.]

Organization Performing ASR
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 [Complete the following statements.]

The Proposer represents that –

(i) It 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,

(ii) It is ☐ is not ☐ a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.

10. Cybersecurity 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 their systems and/or networks.]

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

☐ No ☐ Yes

[Describe how the proposing institution and subcontract 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.]

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