APPENDIX C FULL PROPOSAL FORMAT AND INSTRUCTIONS ver 2 4.10.2025.docx

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Ocular Laboratory for Analysis of Biomarkers (OCULAB)
Solicitation number
ARPA-H-SOL-25-115
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This document is an Appendix C detailing full proposal format and instructions for the Ocular Laboratory for Analysis of Biomarkers (OCULAB) program solicitation from the Advanced Research Projects Agency for Health (ARPA-H). The solicitation (ARPA-H-SOL-25-115) seeks proposals for innovative research, with a comprehensive template guiding proposers on submission requirements across two volumes: Technical and Management, and Cost Proposal. Key formatting specifications include using 8-1/2 by 11-inch paper, 1-inch margins, 12-point non-serif font, and specific page limits for different proposal sections.

Proposers must address technical challenges, provide an innovative claims table, develop a technical plan, outline risk mitigation strategies, and include sections on equity, commercialization, and team capabilities. The solicitation welcomes high-risk, high-reward projects and anticipates multiple awards across different organization types, including large businesses, small disadvantaged businesses, HBCUs, and nonprofit entities. Cost proposals must use a standard Excel spreadsheet, include detailed cost and pricing support documentation, and adhere to a federal salary cap at the Executive Level II rate. The proposal submission is for the Department of Health and Human Services' National Institutes of Health, with a minimum proposal validity period of 180 days.

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APPENDIX C: PROPOSAL FORMAT AND INSTRUCTIONS

[Instructions for Proposers: Use of this template is strongly encouraged for proposals submitted to this ISO. Instructional text and content recommendations in italics should be deleted.]

This document must include all components described herein and must be submitted in .pdf, .odx, .doc, or .docx formats. All submissions must be written in English and 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 12 point, using non-serif font like Avenir Next LT Pro Light. Font sizes of 8 or 10 point Avenir Next LT Pro Light font may be used for figures, tables, and charts.

Proposers are encouraged to submit concise, but descriptive, proposals. Specific examples of problems, approaches, or goals are preferred to qualitative generalities. ARPA-H will not consider pages in excess of the page count limitations, as described herein. Proposals with fewer than the maximum number of pages will not be penalized. Additional information not explicitly called for in the Technical and Management Volume 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.

The Technical and Management Volume shall not exceed maximum page limitations stated in the ARPA-H OCULAB ISO, ARPA-H-SOL-25-115

Page limit includes:
Page limits do NOT include:
Sections 1 - 9
Cover Sheet
Technical figures, tables, charts
Table of Contents

Bibliography (Optional)

Resumes

Task Description Document (TDD)

Software Component Technical Plan

Letters of Support from Hospitals and/or Equipment Manufacturers (as applicable)

NOTE: Each template attempts to provide proposers with guidance on development of proposal content. It is the proposer’s responsibility to ensure proposal content meets the evaluation criteria stated in the ISO.

<PRIME ORGANIZATION LOGO (OPTIONAL)>

ARPA-H ISO FOR OCULAB

VOLUME 1: TECHNICAL AND MANAGEMENT

ISO#
ARPA-H-SOL-25-115

Proposal Title

Proposer Organization

Type of Organization
Choose all that apply: Large Business, Small Disadvantaged Business, Other Small Business, HBCU, MI, Other Educational, or Other Nonprofit

Proposer’s Internal Reference Number, if any

Technical Point of Contact (POC)
Name:

Mailing Address:

Telephone:

Email:

Administrative POC
Name:

Mailing Address:

Telephone:

Email:

Award Instrument Requested
Other Transaction Agreement
Total Proposed Cost
Total: $

Place(s) of Performance

Other Team Members (subawardees and consultants) if any
Technical POC Name:

Organization:

Organization Type:

Proposal Submission Date

Proposal Validity Period (minimum 180 days)

Human Subjects Research (Yes/No)

Animal Subjects Research (Yes/No)

TABLE OF CONTENTS

1.EXECUTIVE SUMMARY27
2.INNOVATIVE CLAIMS TABLE27
3.GOALS AND IMPACT27
4.GANTT CHART TIMELINE27
5.TECHNICAL PLAN27
6.RISK MITIGATION/CONTINGENCY PLANS AND ALTERNATIVE APPROACHES28
7.EQUITY AND ACCESSIBILITY PLAN28
8.COMMERCIALIZATION PLAN28
9.CAPABILITIES/MANAGEMENT PLAN28
10.TASK DESCRIPTION DOCUMENT (TDD) – NOT INCLUDED IN THE PAGE LIMIT28
11.SOFTWARE COMPONENT TECHNICAL PLAN - NOT INCLUDED IN PAGE LIMIT28
12.BIBLIOGRAPHY (OPTIONAL) - NOT INCLUDED IN PAGE LIMIT28
13.RESUMES - NOT INCLUDED IN PAGE LIMIT28
14.LETTERS OF SUPPORT FROM HOSPITALS AND/OR EQUIPMENT MANUFACTURERS - NOT INCLUDED IN PAGE LIMIT28

ARPA-H-SOL-25-115, OCULAB

1. EXECUTIVE SUMMARY

[Summarize the technical approach. Provide a description of the key technical challenges, a concise review of the technologies proposed to overcome these challenges and achieve the project’s goal, and a clear statement of the novelty and uniqueness of the proposed work. The executive summary should capture answers to the following questions:

· What is the proposed work attempting to accomplish or do?

· How is it done today, and what are the limitations?

· What is innovative in your approach?

· What are the key technical challenges in your approach, and how do you plan to overcome these?

· Who or what will be affected and what will be the impact if the work is successful?

· What are specific applications of your project?]

2. INNOVATIVE CLAIMS TABLE

[The following table should be used to link the PROGRAM technical goals, technical challenges and the proposed innovation and evidence. Thus, this section should succinctly describe the uniqueness and benefits of the proposed approach relative to the current state-of-the-art alternative approach.]

ANNOUNCEMENT PG. PARA(S)
TECHNICAL CHALLENGE
INNOVATION AND EVIDENCE
PROPOSAL SECTION(S), PG., PARA(S).

3. GOALS AND IMPACT

[Describe how the proposed effort will make a difference (qualitatively and quantitatively) if successful. Describe the innovative aspects of the project in the context of existing capabilities and approaches, clearly delineating the relationship of this work to any other projects from the past and present. This section should include a summary of specific outcomes from the proposed research.]

4. GANTT CHART TIMELINE

[As applicable to the proposed TA or TAs, provide a detailed timeline in Gantt chart format]

5. TECHNICAL PLAN

[This section is the centerpiece of the proposal and should succinctly summarize the innovative claims for the proposed research and clearly describe the proposed approach without using jargon. Each TA should be addressed in this section as its own sub-section unless noted otherwise below.

(a) Present a credible plan to achieve the project’s goal. High-risk, high-reward projects are welcomed.

(b) Describe how the solution will achieve the Program Level and TA-specific requirements listed in the PROGRAM ISO.

(c) Outline and address technical challenges inherent in the approach and possible solutions for overcoming potential problems.

(d) Provide appropriate measurable milestones (quantitative if possible) at intermediate stages of the project to demonstrate progress; milestones should be clearly articulated and defined in time relative to the start of the project.

(e) Provide a description/narrative of the milestones, tasks, and the interrelationships among tasks. The task structure must be consistent with that in the Task Description Document (TDD).]

6. RISK MITIGATION/CONTINGENCY PLANS AND ALTERNATIVE APPROACHES

[Identify potential areas of risk (e.g., technical, managerial) and propose solutions that maximize the scientific and health impact, budget considerations, and timeliness of deliverables.]

7. EQUITY AND ACCESSIBILITY PLAN

[Outline strategies for and ways to improve equity and accessibility. See “Equity Requirements” Section O (1)(i) in PROGRAM ISO.]

8. COMMERCIALIZATION PLAN

[Include names of prospective transition partners, identify potential bottlenecks and hurdles to commercialization, and describe solutions for market access, sustainability, and scaling.]

9. CAPABILITIES/MANAGEMENT PLAN

[Provide a summary of expertise of the proposed team, including any subawardees/consultants and key personnel who will be executing the work. Identify a technical lead for the project and provide a clear description of the team’s organization including roles and responsibilities.]

10. TASK DESCRIPTION DOCUMENT (TDD) – NOT INCLUDED IN THE PAGE LIMIT

[Provide a detailed task breakdown, citing specific tasks and their connection to the metrics, as applicable. Do not include proprietary information. See the Task Description Document (TDD) Template within Attachment 1, Other Transaction Bundle (Volume 1) for content requirements and instructions.]

11. SOFTWARE COMPONENT TECHNICAL PLAN - NOT INCLUDED IN PAGE LIMIT

[Provide a software component technical plan illustrating the alignment of the technical solution with applicable HHS-adopted health IT standards (45 CFR Part 170 Subpart B).]

12. BIBLIOGRAPHY (OPTIONAL) - NOT INCLUDED IN PAGE LIMIT

[Provide a brief bibliography with links to relevant papers, references, reports, etc.]

13. RESUMES - NOT INCLUDED IN PAGE LIMIT

[ Provide key personnel resumes. Only one resume, per key personnel, per TA should be provided, in addition to a resume for the technical lead of the overall effort.]

14. LETTERS OF SUPPORT FROM HOSPITALS AND/OR EQUIPMENT MANUFACTURERS - NOT INCLUDED IN PAGE LIMIT [ Provide letters of support from hospital partners (TA1) and/or equipment manufacturers (TA2, TA3, TA4).]

PROGRAM NAME

ARPA-H-SOL-25-115

APPENDIX C VOLUME II: COST PROPOSAL & INSTRUCTIONS

[Instructions for Proposers: Use of this template is strongly encouraged for proposals submitted to this ISO. Instructional text and content recommendations in italics should be deleted.]

There is no maximum page count for Volume II. The Cost Proposal shall be comprised of the editable Excel Cost Proposal spreadsheet and associated supporting materials ideally provided in a single attachment (e.g., Adobe pdf) led by a Cover page as follows.

Cover Page

Innovative Solutions Opening
ARPA-H-SOL-24-115

Full Proposal Title

Submitter Organization

Unique Entity Identifier of prime proposer/awardee (UEI)

Technical Area (TA) Selection:

(TA1, TA2 or both TA1 & TA2)

Type of Organization
Choose all that apply: LARGE BUSINESS, SMALL DISADVANTAGED BUSINESS, OTHER SMALL BUSINESS”, Historically Black Colleges and Universities (HBCUs), Minority Institution (MI), OTHER EDUCATIONAL, OR OTHER NONPROFIT (including non-educational government entities) (NOTE: The Small Business Administration’s (SBA) size standards determine whether or not a business qualifies as small.). Size standards may be found here: https://www.ecfr.gov/current/title-13/chapter-I/part-121#121.201

Technical Point of Contact (POC) Name:

Mailing Address: Telephone: Email:

Administrative POC Name:

Mailing Address: Telephone: Email:

Other Team Members (subawardees and consultants) if any
Technical POC Name: Organization:

Organization Type:

Total proposed cost separated by base and option(s) (if any)

Date proposal was submitted

Commercial and Government Entity (CAGE) Code

Proposal validity period (Minimum of 120 days)

A. Cost Proposal Spreadsheet: ARPA-H Standard Excel Cost Proposal Spreadsheet (See Bundle of Attachments for OT, or Cooperative Agreement provide via SAM.gov). All tabs and tables in the cost proposal spreadsheet should be developed in an editable format with calculation formulas intact to allow traceability of the cost proposal. The cost proposal spreadsheet must be used by the prime organization and all subcontractors at any tier.

While the prime proposer is ultimately responsible for submission of all required documents via email to IMMUNE@ARPA-H.gov.

B. Cost and Pricing Data Support: In addition to using the cost proposal spreadsheet, the cost proposal must include documentation to support the proposed price/budget. Supporting documentation must be in sufficient detail to substantiate the summary cost estimates and should include a description of the method used to estimate costs (e.g., vendor quotes). For indirect costs provide the most current indirect cost agreement (e.g., Colleges and Universities Rate Agreement, Forward Pricing Agreement, Provisional Billing Rates, etc.).

Cost and pricing support may also facilitate a value analysis by the Government through information other than detailed cost and pricing data. Proposers are encouraged to include information related to value-added resources or conditions that are not immediately obvious in the Cost Proposal Spreadsheet or the traditional forms of cost and pricing support information like vendor quotes (e.g., intended intellectual property terms and conditions with perceived future value).

C. Salary Cap: None of the federal funds awarded under this program shall be used to pay the salary of an individual at a rate in excess of the rate identified by the Office of Personnel Management for Executive Level II positions. Nor may the proposed and later negotiated salaries escalate in excess of the Executive Level II rate for the purposes of invoicing for salary support.

Note: The salary rate limitation does not restrict the salary that an organization may pay an individual working under an award; it merely limits the portion of that salary that may be paid with federal funds.

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