APPENDIX-C.1-Technical and Management Proposal Model.docx

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Attached to
Fast Assessment of Solutions, Therapeutics, Pharmaceuticals, and SupplieS (FASTPASS) Innovative Solutions Opening
Solicitation number
ARPA-H-SOL-26-160
Issued by

About this file

This file is a Technical and Management Proposal Model template for the ARPA-H FASTPASS (Fast Assessment of Solutions, Therapeutics, Pharmaceuticals, and SupplieS) Innovative Solutions Opening (ARPA-H-SOL-26-160). The template serves as a standardized format for proposers responding to this solicitation from the Department of Health and Human Services National Institutes of Health, which seeks development of a near real-time, non-destructive, AI-enabled system for screening pharmaceutical products and inputs through their packaging at ports of entry and supply-chain nodes.

The template requires proposers to provide organizational information (prime contractor and sub-awardee/consultant team details), identify key personnel and points of contact, specify the award instrument requested (Other Transaction), declare whether animal or human subjects are involved, and indicate total funds requested from ARPA-H and resource-sharing arrangements. Proposals must include eleven substantive sections: Proposal Summary addressing project objectives and approach; Goals and Impact demonstrating qualitative and quantitative outcomes; Gantt Chart Timeline; Technical Plan with credible approach and measurable milestones; Risk Mitigation and Contingency Plans; Commercialization Strategy Narrative (including Executive Summary, Commercialization Roadmap, and Available Resources); Capabilities/Management Plan identifying the Principal Investigator and team structure; Software Component Technical Plan addressing HHS health IT standards; Biographical Information for key personnel; References Cited; and Letters of Support. The proposal must maintain a minimum 120-day validity period, with certain sections (biographical information, references, letters of support, and software component plans) excluded from page limits.

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<PRIME ORGANIZATION LOGO (optional)>

Proposal Title

Prime Organization Name

Organization Type
Choose all that apply:

☐ For-Profit ☐ Non-profit ☐ Academia

SAM.gov Universal Entity Identifier (UEI)

Contact Address - State

Proposer’s Internal Reference Number, if any

Key Personnel/Staff
Name:

Email:

Organization:

(Repeat, as necessary)

Prime Technical Point of Contact (POC)
Name:

Mailing Address:

Telephone:

Email:

Prime Administrative POC (APOC)
Name:

Mailing Address:

Telephone:

Email:

Award Instrument Requested
Other Transaction
Animal Subjects
☐ Yes ☐ No
Human Subjects
☐ Yes ☐ No
Total Funds Requested From ARPA-H (including all phases)
Total: $
Resource Sharing (if applicable)
Government: ____% or $_________________

Performer: _____% or $_________________

Place(s) of Performance

Date of Proposal Submission

Proposal’s Validity Period (minimum 120 days)

SUB-AWARDEE AND CONSULTANT

TEAM MEMBERS

(Add rows as necessary)

1. Organization Name:

Technical POC
Name:

Telephone:

Email:

Organization Type:
Choose all that apply:

2. Organization Name:

Technical POC
Name:

Telephone:

Email:

Organization Type:
Choose all that apply:

3. Organization Name:

Technical POC
Name:

Telephone:

Email:

Organization Type:
Choose all that apply:

4. Organization Name:

Technical POC
Name:

Telephone:

Email:

Organization Type:
Choose all that apply:

APPENDIX C.1: TECHNICAL & MANAGEMENT PROPOSAL MODEL

Table of Contents

1.PROPOSAL SUMMARY4
2.GOALS AND IMPACT5
3.GANT CHART TIMELINE5
4.TECHNICAL PLAN5
5.RISK MITIGATION/CONTINGENCY PLANS AND ALTERNATIVE APPROACHES5
6.COMMERCIALIZATION STRATEGY NARRATIVE5
7.CAPABILITIES/MANAGEMENT PLAN7
8.SOFTWARE COMPONENT TECHNICAL PLAN – NOT INCLUDED IN THE PAGE LIMIT7
9.BIOGRAPHICAL INFORMATION – NOT INCLUDED IN THE PAGE LIMIT7
10.REFERENCES CITED – NOT INCLUDED IN THE PAGE LIMIT7
11.LETTERS OF SUPPORT– NOT INCLUDED IN THE PAGE LIMIT7

1. Proposal Summary

A. OVERVIEW

Provide a synopsis of the proposed project, including answers to the following questions:

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

· How is the proposed work leading to improved health outcomes or improvements in the reliability of health systems?

· How is it done today and what are the limitations of current approaches?

· What is new in your approach? Why do you think it will be successful?

· What are the emerging trends to achieve the stated objective and why might your approach provide a radically superior solution?

· What are the key technical, programmatic, or translational risks in your approach, and how do you plan to mitigate or 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?

· To ensure equitable access to all people, how will cost, accessibility, and user experience be addressed?

· How might this effort be misperceived or misused (and how can you prevent that)?

The summary should include 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.

B. Innovative Claims Table The following table should be used to link the technical goals, technical challenges, and the proposed innovation and evidence. This section should succinctly describe the uniqueness and benefits of the proposed approach relative to the current state-of-the-art alternative approach and to emerging trends. Add rows as necessary.

ISO pages and paragraph(s)
Technical Challenge
Innovation and Evidence
Proposal pages, and paragraph(s).

2. 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. Address plans and risks to achieve accessibility and adoption of technology. This section should include a summary of specific outcomes from the proposed research.

3. Gantt Chart Timeline As Applicable to the proposed TA or TAs, provide detailed timeline in Gantt Chart Format.

4. Technical Plan

4.1 Present a credible plan to achieve the project’s goal.

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

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

4.4 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.

4.5 Provide a schedule showing milestones, tasks, and the interrelationships among tasks. The task structure must be consistent with that in the Task Description Document (TDD).

5. 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.

6. Commercialization Strategy Narrative Specify relevant TA proposers must submit a Commercialization Strategy Narrative that demonstrates the proposer team has given consideration to the commercial path of their work and brings the necessary expertise and partnerships to do so. Proposers will submit the Commercialization Strategy Narrative within Appendix C.1 as part of the proposal to include the following sections.

· Executive Summary In this section, address market need and potential options for transitioning the technology (e.g., list examples from strategy.). Address whether there are alternative off-ramps for any sub-technologies that may be developed alongside the primary technology (list examples from strategy.). Please ensure to be specific about what you think success looks like.

· Commercialization Roadmap Provide a narrative to address the commercialization roadmap below such as the overall approach to end user/market, business model, IP, regulatory and transition/exit plan. Proposers should include justification for any changes to the commercialization roadmap.

· Available Commercialization Resources and Expertise In this section, describe the commercialization resources you have available to address commercialization milestones (e.g., product development & prototyping facilities, intellectual property management resources, regulatory affairs support, financial resources and fundraising experience, etc.).

Following program kickoff, ARPA-H's Program Manager in reviewing the awarded performers’ Commercialization Strategy Narrative, may make any necessary changes to the roadmap, and provide feedback on key areas such as market landscape, regulatory, IP, investor and stakeholder outreach.

At the appropriate stage of program performance, usually after a significant technical achievement, as decided by the Program Manager, performers will turn their Commercialization Strategy Narrative into a Commercialization Plan. This plan will establish commercialization milestones that are assessed and updated regularly to optimize the likelihood for successful commercialization of the proposed technology.

7. Capabilities/Management Plan

7.1 Provide a summary of expertise of the proposed team, including any sub-awardees/consultants and key personnel who will be executing the work.

7.2 Identify a principal investigator (PI) for the project and provide a clear description of the team’s organization including roles and responsibilities.

8. Software Component Technical Plan – Not Included In The Page Limit Provide a software component technical plan illustrating the alignment of the technical solution with applicable Health and Human Services (HHS)-adopted health IT standards (45 CFR Part 170 Subpart B).

9. Biographical Information – Not Included In The Page Limit Provide a brief biosketch for each key personnel describing key qualifications pertinent to the project and citing relevant publications. The National Institute of Health (NIH) Biosketch format is acceptable.

10. References Cited – Not Included in The Page Limit For any references cited in the proposal, provide uniquely identifying bibliographic information in this section, including first author, title, source (e.g., journal or book), year of publication, volume and page numbers (if applicable), and a persistent identifier such as a DOI or PubMed ID, where available.

11. Letters of Support– Not Included In the Page Limit Provide letters of support.

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