Attachment 5 Cooperative Agreement Administrative and National Policy Requirements Document.docx
DOCX document 57 KB Posted
- Attached to
- Emerging Health Innovators (EHI) Initiative
- Opportunity number
- ARPA-H-SOL-25-118
- Issued by
-
Department of Health and Human Services
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 ARPA-H's Emerging Health Innovators (EHI) Initiative (ARPA-H-SOL-25-118). The document requires detailed information about organizational conflicts of interest, research security disclosures, intellectual property assertions, human subjects research, animal use research, and cybersecurity protocols.
The template mandates specific formatting requirements (8.5x11 inch paper, 1-inch margins, 11-point font) and must be submitted in PDF, ODX, DOC, or DOCX format. Key components include SF-424 (R&R) Application forms, Research and Related Senior/Key Person Profile forms, disclosure of foreign government-sponsored talent recruitment programs, and documentation of compliance with non-discrimination laws. The document supports a Department of Health and Human Services grant program (CFDA 93.384) aimed at accelerating biomedical and health breakthroughs through ARPA-H's research initiatives.
Attachment 5
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Other files
| File | Type | Posted |
|---|---|---|
| Attachment 4 Other Transaction Administrative and National Policy Requirements Document.docx | DOCX document | |
| Attachment 3 Cost Proposal Spreadsheet.xlsx | XLSX spreadsheet | |
| Attachment 2 Track 2 Pitch Deck Template.pptx | PPTX presentation | |
| Attachment 1 Track 1 Pitch Deck Template.pptx | PPTX presentation | |
| ARPA_H_SOL_25_118_EHI_Solicitation.pdf | ||
| ARPA_H_SOL_25_118_EHI_Solicitation_Amendment 1.pdf |
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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, PIA, 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.] Application for Federal Assistance SF-424 (R&R) [Please provide a completed SF-424 (R&R) Application for Federal Assistance form.]
Research Security Disclosure
[Please provide a completed Research and Related Senior/Key Person Profile (Expanded) Form.
In addition, in accordance with National Security Presidential (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 must be included as attachments to the Research and Related Senior/Key Person Profile (Expanded) Form and 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.]
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.
Research and Related Other Project Information [Please provide a completed Research and Related Other Project Information Form. The summary may be included with the Research and Related Other Project Information Form. Please note that Section Nos. 8 through 12 do not need to be completed.] Project Abstract Summary [Please provide a completed Project Abstract Summary Form. The summary may be included with the Research and Related Other Project Information Form.] Human Subjects Research (HSR) Does the proposed work involve Human Subject Research? ☐ No ☐ Yes
[If yes, please complete the HSR section of the Research and Related Other Project Information Form. Please also provide a completed PHS Human Subjects and Clinical Trials Information Form. 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, please complete the ASR section of the Research and Related Other Project Information Form. Please also 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 provide the Vertebrate Animals Section (VAS) worksheet in the format here: https://olaw.nih.gov/guidance/vertebrate-animal-section.htm), 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
Lobbying [Please provide a completed Certification Regarding Lobbying form. If paragraph (2) of the Certification Regarding Lobbying form is applicable, please provide a completed SF‑LLL: Disclosure of Lobbying Activities form. The SF-LLL form may be provided as an attachment to the SF-424 (R&R)]
Assurance of Compliance with Non-Discrimination Laws and Regulations [Please ensure an “Assurance of Compliance with Non-Discrimination Laws and Regulations" is on file with HHS and provide documentation confirming the assurance is on file.]
Assurance of Compliance with the Office of Research Integrity (ORI) [Please ensure an “Assurance of Compliance with the Office of Research Integrity" is on file with ORI and provide documentation confirming the assurance is on file.]
15. 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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