APPENDIX B_Proposal Format Instructions and Evaluation_Amend 03.pdf

APPENDIX B: PROPOSAL FORMAT, INSTRUCTIONS, AND EVALUATION

ARPA-H-SOL-26-154

Amendment 03 Hearing Enhancement through ARtificially Intelligent NeurotechnoloGy (HEARING)

1. PROPOSAL FORMAT AND INSTRUCTIONS

1.1 CONFORMING SUBMISSION

(a) Conforming submissions contain all requirements detailed in this ISO.

Submissions that fail to include required information may be deemed non-conforming and may be removed from further consideration and/or rejected without further review. A submission may be deemed non-conforming if it does not meet the following solicitation requirements:

• The proposed concept does not respond to the metrics of the HEARING program.

• The proposers meet the eligibility requirements.

• The submission meets the submission requirements.

• The submission meets the content and formatting requirements in the attached instructions (see Section 4.4 of the HEARING ISO

ARPA-H-SOL-26-154).

• The proposer’s concept has not already received funding or been selected for award negotiations for another funding opportunity (whether from ARPA-H or another Government agency).

(b) ARPA-H may eliminate non-conforming proposals without further review or consideration. ARPA-H may not consider non-conforming proposals for negotiations or award. ARPA-H also reserves the right to reject proposals as nonconforming when it determines a previous submission was scientifically meritorious but was not reviewed due to lack of relevance to the ISO or not selected for award due to programmatic fit.

Proposers will be notified of non-conforming determinations via email correspondence.

(c) Proposers shall not generate solution summary and proposal text using generative AI.

1.2 NOTICES

The following Notices will be provided as applicable to the Technical and Administrative points of contact identified in the proposal on ARPA-H’s Solution Submission Portal:

• Request for clarifying details o May occur any time during the proposal evaluation process.

o Will not include requests for proposal changes; changes to proposals will not be permitted at this stage.

• Notice of non-selection o The proposer will be advised that its proposal submission has not been selected for funding.

• Notice of selection o The selection notice will notify the proposer that the government has selected its proposal for negotiation of a potential award. This notification may indicate that only a part of the effort has been selected for negotiation and may request a revised proposal for only those selected portions, if not apparent through the delineation of proposed tasks.

1.3 PROPOSAL SUBMISSION INSTRUCTIONS

(a) Proposal submissions are due by the date listed in the ISO Summary Information Section. All proposal documents must be submitted in .pdf, .odx, .doc, .docx, or .exe formats. All submissions must be written in English and all pages must be formatted for printing on 8-1/2 by 11-inch paper with 1-inch margins and Avenir Next LT Pro Light font size not smaller than 12 point. Font sizes of 8 or 10 point may be used for figures, tables, and charts. The government will not consider pages in excess of the page count limitations or excessive usage of tables to substitute for body text of the proposal, as described herein. Proposals with fewer than the maximum number of pages will not be penalized.

(b) Proposers are encouraged to submit concise and concrete proposals.

Specific examples of problems, approaches, or goals are preferred to qualitative generalities. Additional information not explicitly called for in the Technical & Management Proposal must not be submitted, but may be included as links in the bibliography. Any additional materials included in the proposal package will be considered for the reviewers’ convenience only and not evaluated as part of the proposal.

(c) Documents must be clearly labeled with the ISO number, proposer organization, and proposal title/proposal short title (in the header of each page). Use the following Title Format: “Volume I_XYZ Organization”, Volume II_XYZ Organization”, “Volume II Supporting Documents”, etc.

(d) Appendix G - Draft Other Transaction Agreement has been included to provide potential proposers an initial draft of the ARPA-H agreement for this effort. The proposer may include a copy of the draft agreement with any redlines/comments/proposed edits as a part of the proposal package. If no redline/comments/edits are proposed, the proposer must provide a written statement that there are no proposed changes. The redlined copy of the agreement or the statement of no proposed changes does not count towards any page limitations for the proposal.

(e) A Gantt chart has been included to provide potential proposers with an initial draft timeline that aligns tasks and milestones from Appendices D and G. Proposers may develop a Gantt chart format that best supports their documentation; however, it must include, at a minimum, the level of detail provided in Appendix H.

(f) The following matrix is designed to help proposers with their submission:

ADDITIONAL LINKS

42 U.S.C. § 290c(g)(1)(D) https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section290c&num=0&edition=prelim

ARPA-H’s public website https://arpa-h.gov/explore-funding/open-funding-opportunities

SAM.gov https://sam.gov/content/home

National Archives (CUI Registry) https://www.archives.gov/cui/registry/category-list

ARPA-H’s Solution Submission Portal https://solutions.arpa-h.gov/Ask-A-Question/

Volume Element Proposal Section Reference Page Limit I Technical &

Management Proposal

Appendix C 30 Pages

I Task Description Document (TDD)

Appendix D Does Not Count Against Page Limit

II Cost Proposal and Cost Proposal Workbook

Appendix E Does Not Count Against Page Limit

III Admin National Policy Document

Appendix F Does Not Count Against Page Limit

Draft Other Transaction Agreement

Appendix G Does Not Count Against Page Limit

Gantt Chart Appendix H

Does Not Count Against Page Limit

CHIPS and Science Act of 2022 https://www.govinfo.gov/content/pkg/PLAW-117publ167/pdf/PLAW-117publ167.pdf

50 U.S.C. § 3059 https://uscode.house.gov/view.xhtml?req=(title:50%20section:3059%20edition:prelim)

Controlled Unclassified Information on Non-Federal Information Systems

32 CFR § 2002

https://www.ecfr.gov/current/title-32/subtitle-B/chapter-XX/part-2002

Human Subjects Research (HSR)

45 CFR § 46

https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46

Office of Human Research Protection Federal Wide Assurance https://www.hhs.gov/ohrp/index.html

21 CFR § 56

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56

21 CFR § 50

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50

Animal Subjects Research

Department of Agriculture rules that implement the Animal Welfare Act of 1966 https://www.nal.usda.gov/animal-health-and-welfare/animal-welfare-act

7 U.S.C. § 2131-2159 https://www.govinfo.gov/content/pkg/USCODE-2015-title7/html/USCODE-2015-title7-chap54.htm

Public Health Service Policy on Humane Care and Use of Laboratory Animals https://olaw.nih.gov/policies-laws/phs-policy.htm

U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training https://olaw.nih.gov/policies-laws/gov-principles.htm

Guide for the Care and Use of Laboratory Animals: Eighth Edition, Copyright

2011, NAS

https://olaw.nih.gov/policies-laws/guide-care-use-lab-animals worksheet https://olaw.nih.gov/sites/default/files/VASchecklist.pdf

Research Security Disclosures National Security Policy Memorandum 33 https://www.nsf.gov/bfa/dias/policy/nspm-33-implementation-guidance

Electronic Invoicing and Payments

Payment Management Services https://pms.psc.gov/