ARPA-H ADMIN & NATIONAL POLICY (Other Transaction).pdf
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- Opportunity number
- ARPA-H-SOL-24-105
- Issued by
-
Department of Health and Human Services
About this file
This document provides the administrative and national policy requirements template for proposals submitted to the ARPA-H Scalable Solutions Office funding opportunity. Key details include: proposals must include identification of team members and whether any are non-U.S. organizations or individuals; affirmations and disclosures regarding organizational conflicts of interest and research security; descriptions of the novelty of proposed work and how any intellectual property or patent implications would impact program goals; plans for human subjects research, animal use research, and controlled unclassified information management if applicable; and representations regarding unpaid tax liability or felony convictions. Additional requirements include software standards and validation timeframes. The funding opportunity aims to develop scalable and affordable health care solutions through innovative technologies, collaborative distribution networks, and biomanufacturing innovations.
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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
Individual Name: Organization: Non-U.S. Organization: Yes No
Non-U.S. Individual: Yes No
Individual Name: Organization: Non-U.S. Organization: Yes No Non-U.S. Individual: Yes No
2. ORGANIZATIONAL CONFLICT OF INTEREST AFFIRMATIONS AND DISCLOSURE
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) 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 3.a OR 3.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.]
a. 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. RESEARCH SECURITY DISCLOSURE
[In accordance with National Security Presidential Memorandum (NSPM)-33 and the associated White House Office of Science and Technology Policy Implementation Guidance1, which requires certain
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) 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 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 Common Form for Biographical Sketch2:]
a. For PIs and other senior/key personnel that will serve as prime and subawardees, please list:
i. Other organizational affiliations and employment
ii. Other positions and appointments3
iii. Participation in any foreign government-sponsored talent recruitment program(s)4
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
3 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).
4 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.
ii. Other positions and appointments3
iii. Participation in any foreign government-sponsored talent recruitment program(s)
4. 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
5. INTELLECTUAL PROPERTY (IP)
[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 applicable ARPA-H programmatic goals.]
6. HUMAN SUBJECTS RESEARCH
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).]
7. ANIMAL USE RESEARCH
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.]
8. 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.
9. 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. CONTROLLED UNCLASSIFIED INFORMATION (CUI) MANAGEMENT PLAN
[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. Research Security Disclosure |
| 4. Novelty of Proposed Work |
| 5. Intellectual Property (IP) |
| 6. Human Subjects Research |
| 7. Animal Use Research |
| 8. Software Component Standards |
| Does your solution include software components that are proprietary or do not include commercial-friendly-open-source licenses? ☐ No ☐ Yes |
| 9. Representations Regarding Unpaid Delinquent Tax Liability or a Felony Conviction under Any Federal Law |
| 10. Controlled Unclassified Information (CUI) Management Plan |
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