ARPA-H ADMIN & NATIONAL POLICY (Other Transaction).docx

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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 outlines the administrative and national policy requirements for proposals submitted to the Advanced Research Projects Agency for Health (ARPA-H) Scalable Solutions Office funding opportunity. Key details include: proposals are due by a specified date and must be valid for a minimum of 120 days; team members, including any non-U.S. organizations or individuals, must be identified; affirmations regarding organizational conflicts of interest and disclosure of prior support provided to ARPA-H are required; intellectual property assertions and plans for handling controlled unclassified information must be described. The related federal grant opportunity seeks scalable solutions that improve healthcare access and affordability through approaches such as drug repurposing, telemedicine, distributed manufacturing and collaborative networks. Areas of interest include scalable technologies and interventions, collaborative distribution networks, and biomanufacturing innovations. The funding is assigned under the Advanced Research Projects Agency for Health federal grant program within the Department of Health and Human Services.

ARPA-H ADMIN & NATIONAL POLICY (Other Transaction)

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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.

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 Proposal was Prepared

Proposal Validity Period (minimum 120 days)

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:YesNo
Non-U.S. Individual:YesNo

Subawardees/Consultants

Individual Name:
Organization:
Non-U.S. Organization:YesNo
Non-U.S. Individual:YesNo
Individual Name:
Organization:
Non-U.S. Organization:YesNo
Non-U.S. Individual:YesNo

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.]

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 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 Sketch[footnoteRef:3]:] [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: ]

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 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)

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) [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.]

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).]

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.]

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.

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.

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.]

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