ARPA-H-SOL-26-160 FASTPASS ISO.pdf

INNOVATIVE SOLUTIONS OPENING FOR

FAST ASSESSMENT OF SOLUTIONS, THERAPEUTICS,

PHARMACEUTICALS, AND SUPPLIES

(FASTPASS)

SCALABLE SOLUTIONS OFFICE

ARPA-H-SOL-26-160

DATE: AUGUST 20, 2026

TABLE OF CONTENTS

1. PROPOSERS’ DAY

2. INTRODUCTION TO FASTPASS

3. ELIGIBILITY INFORMATION

3.1 ELIGIBLE PROPOSERS

3.2 SYSTEM FOR AWARD MANAGEMENT (SAM.GOV)

4. SUBMISSION PROCESS

4.1 OVERVIEW

4.2 SOLUTION SUMMARIES

4.3 SOLUTION SUMMARY PRESENTATION REVIEW

4.4 PROPOSAL SUBMISSION REVIEW

4.5 PROPRIETARY INFORMATION

APPENDIX A: PROGRAM AND TECHNICAL DESCRIPTION [REQUIRED]

APPENDIX B: SOLUTION SUMMARY PRESENTATION TEMPLATE AND INSTRUCTIONS

APPENDIX C: PROPOSAL FORMAT, INSTRUCTIONS, AND EVALUATION

APPENDIX C.1: TECHNICAL & MANAGEMENT PROPOSAL MODEL

APPENDIX C.2: TASK DESCRIPTION DOCUMENT (TDD) MODEL

APPENDIX C.3: COST PROPOSAL NARRATIVE MODEL

APPENDIX C.4: MILESTONE AND PAYMENT SCHEDULE MODEL

APPENDIX D: COST PROPOSAL WORKBOOK

APPENDIX E: DRAFT OT AGREEMENT

APPENDIX F: ADMINISTRATIVE NATIONAL POLICY DOCUMENT

INNOVATIVE SOLUTIONS OPENING (ISO) SUMMARY INFORMATION

FEDERAL AGENCY: Advanced Research Projects Agency for Health (ARPA-H)

PROGRAM TITLE: Fast Assessment of Solutions, Therapeutics, Pharmaceuticals, and SupplieS

(FASTPASS)

ANNOUNCEMENT TYPE: Innovative Solutions Opening (ISO)

ISO NUMBER: ARPA-H-SOL-26-160

ISO CONTACT: FASTPASS@ARPA-H.GOV

ANTICIPATED AWARD(S): Multiple Other Transaction (OTs) Agreements

DATES: (All times listed are Eastern Time)

Proposers’ Day: 09/10/2026, 9:00 AM -5:00 PM ET Questions & Answers (Q&A) due date: 11/03/2026, 4:00 PM ET Solution Summary slides due date: 09/21/2026, 4:00 PM ET Proposals due date: 11/10/2026, 4:00 PM ET ISO closing date: 11/10/2026, 4:00 PM ET

WHERE TO SUBMIT:

Solution Summary Presentations: https://solutions.arpa-h.gov/Submit-Solution/ Questions: https://solutions.arpa-h.gov/Ask-A-Question/ Proposals: https://solutions.arpa-h.gov/Submit-Proposal/

Registration is required to submit documents via the ARPA-H Solutions site. Late submissions resulting solely from delays with registration may not be considered.

RESOURCE SHARING: Resource sharing is encouraged but not required.

https://solutions.arpa-h.gov/Submit-Solution/ https://solutions.arpa-h.gov/Ask-A-Question/ https://solutions.arpa-h.gov/Submit-Proposal/

1. PROPOSERS’ DAY

ARPA-H will host a Proposers’ Day in support of the FASTPASS program described in this ISO. The purpose of these engagements is to provide information, promote discussion, and encourage teaming and networking. Attendance is voluntary (but highly encouraged). Attendees should read the published FASTPASS ISO before attending, especially APPENDIX A, which includes the full program description and technical requirements. All materials presented at the event will be posted to the ARPA-H FASTPASS program website. ARPA-H will not reimburse entities for the cost of attendance.

See APPENDIX A for a complete description of program and technical requirements.

2. INTRODUCTION TO FASTPASS

FASTPASS aims to develop a near real-time, non-destructive, AI-enabled system for screening pharmaceutical products and inputs through their packaging at ports of entry and other supply-chain nodes. The program addresses a growing national health and supply-chain challenge: the United States relies heavily on imported key starting materials, active pharmaceutical ingredients, and nished drug products. U.S. Food & Drug Administration (FDA) inspections provide gold standard quality assurance, but they only provide a snapshot of any site’s operations. Current import and product sampling quality assurance instrumentation is too slow, limited, destructive, and resource-intensive to support broad, high-throughput screening. FASTPASS will augment FDA inspections and existing manufacturing controls by adding a product-level quality intelligence layer capable of identifying contamination, adulteration, formulation variability, or other defects before unsafe or substandard medicines reach patients.

FASTPASS will advance the technology embedded in multiple through-packaging sensing modalities and integrate multiple of these sensing modalities with AI/ML-based signal processing, classication, calibration, and multimodal data fusion. The program is structured around two technical areas (TAs): TA1 for next-generation, eldable sensing technologies and TA2 for computational models and integrated system software that can interpret weak, noisy, heterogeneous signals under real-world conditions. Across three 18-month phases, performers will be evaluated through increasingly realistic demonstrations, moving from component-level performance to rugged, transportable prototypes capable of rapid screening, and extremely low false-alarm rates. If successful, FASTPASS would enable statistically meaningful screening of imported pharmaceutical shipments, reduce recalls and adverse patient outcomes, strengthen supply-chain resilience, and create a platform that could later extend to adjacent areas such as food safety and biothreat detection.

See APPENDIX A for a complete description of program and technical requirements.

3. ELIGIBILITY INFORMATION

3.1 ELIGIBLE PROPOSERS

Except as noted herein, all sources that can satisfy the government’s needs and that are neither debarred nor suspended from doing business with the government may respond to this ISO. Universities, non-profit organizations, small businesses and other commercial entities are encouraged to respond. Any submissions received will be fairly considered against the terms and conditions of the solicitation and may be selected for award.

3.1.1 PROHIBITION ON PARTICIPATION BY FEDERALLY FUNDED RESEARCH

AND DEVELOPMENT CENTERS (FFRDCS) AND GOVERNMENT

ENTITIES

(a) ARPA-H is primarily interested in responses to this solicitation from commercial entities, academia, and non-profit organizations; not from federal- or state governments. As such, Federally Funded Research and Development Centers (FFRDCs) and government entities (which includes government employees) will not be considered as either the prime or a sub-performer.

(b) However, an FFRDC or government entity may have unique capabilities that are not otherwise available. Accordingly, when a potential prime performer believes an FFRDC has a unique capability without which its solution is unachievable, it may provide documentation demonstrating it has exhausted all other options as part of its submission(s). ARPA-H will determine whether inclusion of the FFRDC is necessary for the solution.

(c) If an FFRDC or government entity is interested in working directly with the ARPA-H team supporting the research described by this ISO, contact [ARPA-H ISO Contact listed above or through portal] for guidance.

3.1.2 CURRENT PROFESSIONAL SUPPORT TO ARPA-H

Support services involve contracted labor providing technical, professional, and/or nancial expertise, and/or administrative assistance.

Individuals and entities providing support services to ARPA-H are ineligible for an award stemming from this ISO.

3.1.3 FOREIGN ENTITIES

While ARPA-H prioritizes awards to entities (organizations and/or individuals) that conduct funded work in the United States, foreign entities may participate to the extent that they comply with non-disclosure agreements, security regulations, export control laws, and other governing statutes applicable under the circumstances. In no case will award be made to:

• An entity of concern meeting any of the criteria in Section 10638(3) of the CHIPS and Science Act of 2022;

• An individual who is a party to a malign foreign talent recruitment program (MFTRP) as dened in Section 10638(4) of the CHIPS and Science Act of 2022;

• Non-domestic entities organized under the laws of a “covered” foreign country (as dened in 50 U.S.C. § 3059); or

• Entities suspended or debarred from doing business with the government.

3.2 SYSTEM FOR AWARD MANAGEMENT (SAM.GOV)

At the time of proposal submission, the proposer must be registered in the System for Award Management (SAM.gov) and have a valid Unique Entity Identifier (UEI). Proposers must also have an active, accurate registration in SAM.gov at the time of award and through its period of performance. SAM.gov requires certain information to register and obtain a UEI (e.g., Taxpayer Identication Number, Electronic Funds Transfer info, etc.); go to SAM.gov and click the “Get Started” button on the home screen to begin the registration process. New registrations take an average of 7-10 business days.

4. SUBMISSION PROCESS

4.1 OVERVIEW

Submissions for FASTPASS are as follows:

✓ Step 1: Read the full program description and technical requirements in Appendix A

✓ Step 2 (Optional, Encouraged): Submit teaming prole on webpage.

✓ Step 3: Mandatory Solution Summary Presentation with FASTPASS team (Proposers will be given verbal feedback that they may incorporate in Step 4).

✓ Step 4: Submit Full Proposals (Proposers may submit full proposals, regardless of whether they were encouraged to during Step 3).

NOTE: ARPA-H will not reimburse entities for costs incurred in responding to this ISO.

4.2 SOLUTION SUMMARIES

Solution Summary Presentations are required in order to submit a full proposal.

At least one person from each organization in the proposing team must participate in the presentation. After the submission deadline, slides may not be changed and should be presented as they were submitted. See Appendix B for the slide deck format, and instructions. No written feedback will be provided.

Presentations and discussions are intended to facilitate communication with the FASTPASS team and ensure alignment with program needs. Verbal feedback will be provided during the discussion, and a notication will be sent via email to the point of contact listed in the submission encouraging or discouraging teams to submit a full proposal to ensure that proposers are making an informed decision on devoting time and resources to a full proposal.

Regardless of whether the proposer is encouraged to submit a full proposal in response to this ISO, it is eligible to do so after having participated in solution summary presentations. However, it is strongly recommended that only proposers who are encouraged to submit a full proposal do so.

ARPA-H will not evaluate the Solution Summary Presentations or use any information obtained during the presentation in the selection process. Any feedback provided during the presentation may be incorporated into the full proposal at the proposer’s discretion. Presentations will be virtual. A link will be shared with proposers after the submission deadline.

• Submit to: https://solutions.arpa-h.gov/submit-summary

• Solution Summary Deadline: September 21, 2026 at 4:00 PM ET

4.3 SOLUTION SUMMARY PRESENTATION REVIEW

ARPA-H will respond to each Solution Summary Presentation, generally within 30 business days of the presentation. Solution Summary Presentations are for the purpose of receiving feedback regarding whether ARPA-H is interested in the solution/concept. At a minimum, the government’s written response after the presentation will indicate whether submission of a proposal is encouraged or discouraged. Although a proposal may be submitted regardless of the feedback provided, potential proposers are advised to give the government’s decision signicant weight when making decisions regarding whether it is worth the investment of time and resources in the development of a proposal.

It is ARPA-H’s intent to protect all Solution Summary Presentations and to disclose their contents only for the purpose of review, and only to screened personnel for authorized reasons, in accordance with applicable federal laws and regulations, including Freedom of Information Act (FOIA). Restrictive notices notwithstanding, submissions may be handled by ARPA-H support contractors during the review process for administrative purposes and/or to assist with technical review.

https://solutions.arpa-h.gov/submit-summary

ARPA-H support contractors are expressly prohibited from performing ARPA-H-sponsored technical research and are bound by appropriate non-disclosure agreements. Input on technical aspects of a solution summaries may be solicited by ARPA-H from non-government consultants/experts who are strictly bound by appropriate non-disclosure requirements.

When large language models (LLMs) are used (to extract data elements, summarize text, and generate text), all data will be transmitted exclusively through secure Application Program Interface (API) calls, with external tool calls such as web searches disabled. Vendor contracts and technical controls enforce strict security measures: data sent for inference is never used to train public models, and all access, retention, and logging are tightly restricted and fully auditable.

4.4 PROPOSAL SUBMISSION REVIEW

After completing a Solution Summary Presentation, ARPA-H will notify each proposer whether it is ‘encouraged’ to or ‘discouraged’ from submitting a Proposal. Please see Appendix C for additional details on submitting a Proposal.

4.5 PROPRIETARY INFORMATION

The originator of a submission is responsible for identifying all proprietary information therein. Submissions containing proprietary information must clearly mark the cover page and each page that contains such information with a label such as “Proprietary”.

NOTE: “Condential” is a classication marking used to control the dissemination of information related to National Security and should not be used to identify proprietary business information. ARPA-H handles submissions in accordance with applicable federal law, including the FOIA.

3.2 SYSTEM FOR AWARD MANAGEMENT (SAM.GOV)