ARPA-H ADMIN & NATIONAL SECURITY (Cooperative Agreement).pdf

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Scalable Solutions Office: Office-Wide Innovative Solutions Opening for Advanced Research Projects Agency for Health
Opportunity number
ARPA-H-SOL-24-105
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About this file

This document template provides guidance for proposals submitted to the Advanced Research Projects Agency for Health (ARPA-H) Scalable Solutions Office under the ARPA-H-SOL-24-105 funding opportunity. It requests key details on the proposing organization and team members, intellectual property, research plans involving human or animal subjects, and assurances for non-discrimination, lobbying, and controlled unclassified information. Submissions should describe scalable technologies and interventions, collaborative distribution networks, and biomanufacturing innovations to improve healthcare access and affordability in underserved areas. Priority areas include pediatric care, rural telemedicine, point-of-care diagnostics, modular facilities, rare disease treatments, surgical training, disaster response logistics, and active pharmaceutical ingredient manufacturing. Proposals are due by the closing date specified in the related ARPA-H-SOL-24-105 funding opportunity and may request cooperative agreements or other assistance instruments. The Advanced Research Projects Agency for Health program (CFDA 93.384) will fund successful applications to accelerate breakthrough healthcare solutions through the agency's Scalable Solutions office.

ARPA-H ADMIN & NATIONAL SECURITY (Cooperative Agreement) PDF

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File Type Posted
ARPA-H TECH & MANAGEMENT (Cooperative Agreement).pdf PDF
ARPA-H TECH & MANAGEMENT (Cooperative Agreement).docx DOCX document
ARPA-H RDD (Research Description Document).pdf PDF
ARPA-H RDD (Research Description Document).docx DOCX document
ARPA-H MODEL COOPERATIVE AGREEMENT.pdf PDF
ARPA-H MODEL COOPERATIVE AGREEMENT.docx DOCX document
ARPA-H COST PROPOSAL SPREADSHEET (Cooperative Agreement).xlsx XLSX spreadsheet
ARPA-H COST PROPOSAL (Cooperative Agreement).pdf PDF
ARPA-H COST PROPOSAL (Cooperative Agreement).docx DOCX document
ARPA-H ADMIN & NATIONAL SECURITY (Cooperative Agreement).docx DOCX document
ARPA-H TECH & MANAGEMENT (Other Transaction).pdf PDF
ARPA-H TECH & MANAGEMENT (Other Transaction).docx DOCX document
ARPA-H TDD ( Task Description Document).pdf PDF
ARPA-H TDD ( Task Description Document).docx DOCX document
ARPA-H MODEL OTHER TRANSACTION.pdf PDF
ARPA-H MODEL OTHER TRANSACTION.docx DOCX document
ARPA-H COST PROPOSAL SPREADSHEET (Other Transaction).xlsx XLSX spreadsheet
ARPA-H COST PROPOSAL (Other Transaction).pdf PDF
ARPA-H COST PROPOSAL (Other Transaction).docx DOCX document
ARPA-H ADMIN & NATIONAL POLICY (Other Transaction).pdf PDF
ARPA-H ADMIN & NATIONAL POLICY (Other Transaction).docx DOCX document
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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 volume 1 proposal submission. 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.

<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 Proposal was Prepared Proposal Validity Period (minimum 120 days)

1. TEAM MEMBER IDENTIFICATION

[Provide a list of all team members including the prime, subawardee(s), and consultant(s), as applicable.

Identify specifically whether any are a non-US organization or individual. Use the following format for this list.]

PRIME

Individual Name: Organization: Non-U.S. Organization: Yes No

Non-U.S. Individual: Yes No

SUBAWARDEES/CONSULTANTS

2. ORGANIZATIONAL CONFLICT OF INTEREST AFFIRMATIONS AND DISCLOSURE

[In accordance with the 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 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.]

3. APPLICATION FOR FEDERAL ASSISTANCE SF-424 (R&R)

[Please provide a completed SF-424 (R&R) Application for Federal Assistance form.]

4. 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 Guidance1, which requires certain individuals to disclose potential conflicts of interest (COI) and commitment (COC), PIs and other senior/key personnel that will serve as prime and subawardees are required to complete the Common Form for Current and Pending (other) Support 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

In populating these forms, the following is required for each PI and other Senior/Key Personnel that will serve as prime and subawardees.

i. Other organizational affiliations and employment

ii. Other positions and appointments2

iii. Participation in any foreign government-sponsored talent recruitment program(s)3

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

1 GUIDANCE FOR IMPLEMENTING NATIONAL SECURITY PRESIDENTIAL MEMORANDUM 33 (NSPM-33) ON

NATIONAL SECURITY STRATEGY FOR UNITED STATES GOVERNMENT-SUPPORTED RESEARCH AND

DEVELOPMENT (whitehouse.gov) 2 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).

3 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.

https://www.nsf.gov/bfa/dias/policy/nstc_disclosure.jsp https://www.whitehouse.gov/wp-content/uploads/2022/01/010422-NSPM-33-Implementation-Guidance.pdf https://www.whitehouse.gov/wp-content/uploads/2022/01/010422-NSPM-33-Implementation-Guidance.pdf https://www.whitehouse.gov/wp-content/uploads/2022/01/010422-NSPM-33-Implementation-Guidance.pdf

3. 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

4. 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 appointments2

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

5. 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.]

6. 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.

7. 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.]

8. 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.]

9. 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 provide evidence of or a plan for HSR protocol review by an institutional review board (IRB) as described in Section 6.1 of the ISO.]

10. 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 in the format here: https://olaw.nih.gov/guidance/vertebrate-animal-section.htm)]

11. 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)]

12. 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.]

13. 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.]

14. CONTROLLED UNCLASSIFIED INFORMATION (CUI)

[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.]

1. Team Member Identification
2. Organizational Conflict of Interest Affirmations and Disclosure
3. Application for Federal Assistance SF-424 (R&R)
4. Research Security Disclosure
5. Intellectual Property (IP)
6. Software Component Standards
Does your solution include software components that are proprietary or do not include commercial-friendly-open-source licenses? ☐ No ☐ Yes
7. Research and Related Other Project Information
8. Project Abstract Summary
9. Human Subjects Research (HSR)
10. Animal Use Research (ASR)
11. Lobbying
12. Assurance of Compliance with Non-Discrimination Laws and Regulations
13. Assurance of Compliance with the Office of Research Integrity (ORI)
14. Controlled Unclassified Information (CUI)

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