UNIQUE-ISO-ARPA-H-SOL-26-162.pdf

ARPA-H-SOL-26-162, UNIQUE

INNOVATIVE SOLUTIONS OPENING

FOR

UNIFYING IMAGING WITH QUANTUM ENTANGLEMENT

UNIQUE

HEALTH SCIENCE FUTURES

ARPA-H-SOL-26-162

SEPTEMBER 16, 2026

Table of Contents

INNOVATIVE SOLUTIONS OPENING (ISO) SUMMARY INFORMATION .... Error! Bookmark not defined.

1. INTRODUCTION TO UNIQUE

1.1 BACKGROUND

1.2 PROGRAM OVERVIEW

2. THE PROGRAM

3. ELIGIBILITY INFORMATION

3.1 ELIGIBLE PROPOSERS

3.1.1 PROHIBITION OF PERFORMER PARTICIPATION FROM FEDERALLY FUNDED

RESEARCH AND DEVELOPMENT CENTERS (FFRDCs) AND OTHER GOVERNMENT

ENTITIES

3.1.2 CURRENT PROFESSIONAL SUPPORT

3.1.3 NON-U.S. ENTITIES

3.2 SYSTEM FOR AWARD MANAGEMENT (SAM)

4 SUBMISSION PROCESS

4.1 SUBMISSION PROCESS OVERVIEW

4.2 SOLUTION SUMMARY SUBMISSIONS

4.3 FULL PROPOSAL SUBMISSIONS

4.4 SUBMISSION INFORMATION

4.5 PROPRIETARY INFORMATION

5 SUBMISSION REVIEW AND EVALUATION PROCESSES

5.1 CONFORMING SUBMISSIONS

5.2 SOLUTION SUMMARY REVIEW PROCESS

5.3 PROPOSAL REVIEW PROCESS

5.4 EVALUATION CRITERIA FOR PROPOSALS

5.4.1 CRITERIA 1: OVERALL SCIENTIFIC AND TECHNICAL MERIT

5.4.2 CRITERIA 2: PROPOSER’S CAPABILITIES AND/OR RELATED EXPERIENCE

…………………………………………………………………………………………...16

5.4.3 CRITERIA 3: POTENTIAL CONTRIBUTION TO RELEVANCE TO THE ARPA-H

MISSION AND USER EXPERIENCE

5.4.4 CRITERIA 4: ASSESSMENT OF PROPOSED COST/PRICE

5.5 HANDLING COMPETITION SENSITIVE INFORMATION

5.6 EVALUTION AND AWARD DISCLAIMERS

6 POLICY REQUIREMENTS AND MISCELLANEOUS OTHER INFORMATION

6.1 CONTROLLED UNCLASSIFIED INFORMATION (CUI) ON NON-FEDERAL

INFORMATION SYSTEMS

6.2 ORGANIZATIONAL CONFLICTS OF INTEREST (OCI)

6.2.1 AGENCY SUPPLEMENTAL OCI POLICY

6.2.2 RESEARCH SECURITY DISCLOSURES

6.3 INTELLECTUAL PROPERTY

6.4 ANIMAL SUBJECTS RESEARCH

6.5 ELECTRONIC INVOICING AND PAYMENTS

6.6 PROCUREMENT OF SYNTHETIC NUCLEIC ACIDS OR BENCHTOP

SYNTHESIZERS

6.7 DANGEROUS GAIN OF FUNCTION RESEARCH

APPENDIX A: Solution Summary Content and Instructions

APPENDIX B: Full Proposal Content and Instructions

INNOVATIVE SOLUTIONS OPENING (ISO) SUMMARY INFORMATION

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

PROGRAM TITLE: UNifying Imaging with QUantum Entanglement (UNIQUE)

ANNOUNCEMENT TYPE: Innovative Solutions Opening (ISO)

ISO SOLICITATION NUMBER: ARPA-H-SOL-26-162

ISO CONTACT: UNIQUE@ARPA-H.gov

ANTICIPATED AWARDS: Other Transactions

DATES: (All times listed are Eastern Time)

Posting Date: September 16th, 2026

In Person and Virtual Proposers’ Day (PD): October 15th, 2026, 8:30 AM

Proposers’ Day Video Link: https://arpa-h.gov/explore-funding/programs/unique

Questions & Answers (Q&A) due date: October 10th, 2026, 1:00 PM

Lightning Talk / Sidebar session: October 15th, 2026, 3:00 - 5:00 PM

Solution Summaries Due: October 30th, 2026, 11:59 PM

Full Proposals Due: December 15th, 2026, 11:59 PM

WHERE TO SUBMIT:

Solution Summaries: https://solutions.arpa-h.gov/Submit-Solution/

Proposals: https://solutions.arpa-h.gov/Submit-Proposal/

Questions: https://solutions.arpa-h.gov/Ask-A-Question/

PROPOSERS’ DAY

ARPA-H will host a Proposers’ Day in support of the UNIQUE program as described in Special Notice ARPA-H-SN-26-126. The purpose is to provide potential proposers with information on the UNIQUE program, promote additional discussions, and encourage teaming and networking.

Interested proposers are not required to attend, and materials formally presented during Proposers’ Day will be posted to the ARPA-H Program Webpage (https://arpa-h.gov/explore-funding/programs/unique) and on SAM.gov.

ARPA-H will not reimburse potential proposers for participation at Proposers’ Day (or time and effort related to developing submissions in response to this ISO).

mailto:UNIQUE@ARPA-H.gov https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Farpa-h.gov%2Fexplore-funding%2Fprograms%2Funique&data=05%7C02%7Ckerrie.dempsey%40arpa-h.gov%7Cad6f6c9b63514dcb972008df0e9ab23c%7C5685c435011d4ece82365a545c0ff8a9%7C0%7C0%7C639245729811703867%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=EkLsLKQei4ruSCUtdMNFQ8A3IOQ4Zcm5Y8vHGfFY8co%3D&reserved=0 https://solutions.arpa-h.gov/Submit-Solution/ https://solutions.arpa-h.gov/Submit-Proposal/ https://solutions.arpa-h.gov/Ask-A-Question/ https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Farpa-h.gov%2Fexplore-funding%2Fprograms%2Funique&data=05%7C02%7Ckerrie.dempsey%40arpa-h.gov%7Cad6f6c9b63514dcb972008df0e9ab23c%7C5685c435011d4ece82365a545c0ff8a9%7C0%7C0%7C639245729811703867%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=EkLsLKQei4ruSCUtdMNFQ8A3IOQ4Zcm5Y8vHGfFY8co%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Farpa-h.gov%2Fexplore-funding%2Fprograms%2Funique&data=05%7C02%7Ckerrie.dempsey%40arpa-h.gov%7Cad6f6c9b63514dcb972008df0e9ab23c%7C5685c435011d4ece82365a545c0ff8a9%7C0%7C0%7C639245729811703867%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=EkLsLKQei4ruSCUtdMNFQ8A3IOQ4Zcm5Y8vHGfFY8co%3D&reserved=0

1. INTRODUCTION TO UNIQUE

1.1 BACKGROUND

Every major revolution in medical imaging has been driven by a new way to measure biology.

X-ray and computed tomography (CT) revealed internal anatomy; magnetic resonance imaging (MRI) revealed soft-tissue structure and physiology; positron emission tomography (PET) revealed molecular activity. Each new imaging contrast exposed previously inaccessible biological information and changed how disease is detected, understood, and treated.

Despite these advances, important dimensions of biology remain beyond the reach of today’s imaging technologies. Current modalities provide powerful but incomplete views of anatomy, physiology, and molecular activity. Even when combined, they cannot fully characterize the dynamic tissue microenvironment, including subtle changes in microstructure, oxygenation, metabolism, redox state, molecular organization, and other processes that may precede structural disease. As a result, many devastating conditions, including chronic traumatic encephalopathy (CTE), neurodegenerative disorders, pancreatic cancer, and other chronic diseases, are often detected only after substantial, and sometimes irreversible biological damage has occurred. Medicine remains fundamentally constrained by what it can measure.

Recent advances in quantum science suggest a new opportunity to expand the measurable biology of disease. Studies have shown that 511 keV photon pairs generated during positron annihilation can retain measurable quantum correlations. These quantum-derived observables, including photon correlation signatures, correlation loss or decoherence, and positronium-sensitive interactions, may encode biological information distinct from conventional imaging contrast. If measurable and interpretable in biomedical settings, these observables could provide a new window into tissue composition, microstructure, molecular organization, oxygenation, metabolism, and other features of the disease microenvironment.

However, major barriers remain. Scattering, environmental interactions, and detector noise can reduce or obscure measurable quantum correlations; current detector architectures are not optimized for high-rate, high-resolution quantum coincidence imaging; and existing reconstruction methods cannot yet translate multidimensional quantum observables into biologically meaningful images in real time. Such challenges have kept quantum biomedical imaging largely at the proof-of-concept stage.

UNIQUE asks whether quantum observables can open a new frontier in biomedical measurement, revealing disease biology that remains invisible to today’s imaging technologies.

1.2 PROGRAM OVERVIEW

UNIQUE will explore a fundamentally new imaging contrast for biomedicine, with quantum-derived observables. Rather than treating quantum correlations, decoherence, and positronium-sensitive interactions as artifacts or secondary physical effects, UNIQUE will establish whether they can serve as biologically meaningful signals that complement today’s anatomical, functional, and molecular imaging.

UNIQUE’s goal is not to replace existing imaging technologies, but to expand what medicine can measure. The effort will test whether entangled or otherwise quantum-correlated 511 keV photon pairs can support a unified imaging framework that integrates anatomical, functional, molecular, and quantum-derived information, including ghost-imaging-inspired approaches that infer biological information from photon-pair correlations. UNIQUE envisions this integrated quantum-derived biological signal space as a complementary imaging dimension that extends conventional anatomical, functional, and molecular characterization.

UNIQUE is organized around two integrated technical areas (TAs). TA1 will focus on the physical systems needed to generate and measure quantum observables in clinically relevant biomedical settings. This includes advances in quantum-correlated photon production and collection, engineered source materials and nanomaterials, quantum-aware detectors, other materials and methods to determine whether decoherence and correlation loss can become sources of biological contrast.

TA2 will develop a computational foundation for quantum-derived imaging, including physics-informed artificial intelligence, quantum-aware reconstruction, multimodal data fusion, uncertainty quantification, and real-time interpretation of multidimensional quantum observables.

Together, these TAs will demonstrate whether quantum observables can be reproducibly measured, reconstructed, and linked to meaningful biological states. If successful, UNIQUE would establish the feasibility of a new imaging paradigm that integrates anatomical, functional, molecular, and quantum derived information, laying the foundation for the next revolution of biomedical imaging.

2. THE PROGRAM

The UNIQUE Program will support research that combines quantum-enabled 511 keV photon-pair imaging technologies with computational methods capable of reconstructing and interpreting multidimensional anatomical, functional, molecular, and quantum-derived information. UNIQUE is an 18-month, 2-phase program that consists of two TAs. In Phase 1 (9-months), performers will establish feasibility of quantum-derived imaging signals in TA1 and develop foundational AI-driven reconstruction and fusion framework for TA2. During Phase 2 (9-months), performers will demonstrate integrated multidimensional quantum-derived imaging for TA1 and demonstrate unified multidimensional reconstruction and biological interpretation in TA2 work. Continuation into Phase II will be determined by the ARPA-H program manager and based on progress toward achieving the goals and metrics of Phase I below.

2.1 Technical Areas (TAs) and Milestones

UNIQUE will seed efforts for two (2) technical areas. Proposers must submit a comprehensive proposal addressing both TA1 and TA2.

TA1: Imaging Core

The goal of TA1 is to establish the feasibility of generating and measuring quantum-derived imaging contrast using entangled 511 keV photons, positronium-sensitive interactions, and decoherence-aware imaging architectures in controlled phantom and benchtop systems. A competitive submission should specify the mechanism(s) for producing entangled 511 keV photon pairs and the rationale for achieving the entanglement yield and usable flux in the Program Metrics [see Table 1] while balancing flux against imaging dose. It should describe how quantum correlations will be measured and verified across scattering media, and detail the phantoms, materials, detectors, timing, and filtering being employed to deliver the required signal-to-background and localization performance. Proposers should identify the candidate quantum-derived observables and biologically meaningful phantom states (e.g., pyruvate/lactate-linked microenvironments) used to demonstrate reproducible contrast separation, define the data products delivered to TA2, and articulate primary risks with mitigations.

TA1 Milestones:

1. Establish feasibility for ghost image reconstruction from correlated signal–idler measurements in controlled phantoms

2. Demonstrate reproducible quantum-derived contrast with repeatability variation

3. Demonstrate ≥3 metabolic phantom states (e.g., pyruvate/lactate-linked) or other states with statistically significant signal separation modeling neurodegenerative or tumor microenvironment states

TA2: Quantum AI Interpretation and Fusion

The goal of TA2 is to develop AI-driven reconstruction and fusion methods capable of integrating anatomical, functional, molecular, and quantum-derived observables into unified multidimensional imaging representations. A competitive submission should explain what is genuinely quantum-aware about its reconstruction methodology and why it suits correlated, sparse, or low-count data. It should describe how diagnostic features are extracted from quantum-derived signals (e.g., entanglement witnesses, decoherence signatures, positronium states) and fused with anatomical, functional, and molecular information into a single interpretable representation. Proposers should outline a plan for AI-based differentiation of distinct phantom microenvironments and a preliminary quantum-derived contrast atlas (e.g., quantum decorrelation tomography – QDT, or quantum derived index - QDI) that outperforms conventional observables, consistent with the Program Metrics [see Table 2]. Proposers should specify how outputs are validated against ground truth, how uncertainty and interpretability are addressed given limited data, define the TA1 interface for co-optimization, and detail risks and risk mitigation strategies.

TA2 Milestones:

1. Generate fused UNIQUE outputs integrating anatomical, functional, molecular, and quantum-derived information

2. Establish preliminary QDT/QDI atlas across multiple phantom microenvironment states and improved phantom-state differentiation versus conventional attenuation/scatter observables alone

Independent Verification and Validation (IV&V) UNIQUE performers addressing the TAs described above will interact throughout the program with an independent verification and validation (IV&V) team, established by ARPA-H that will help test and validate progress. The IV&V team may consist of subject matter experts from Government, Federally Funded Research and Development Centers (FFRDCs), academia and/or other relevant domains. Over the course of the program, the IV&V team will provide benchmark phantoms with relevance to the performers concept of operations to allow performers to demonstrate the reproducibility and performance of the developed systems.

To avoid potential conflicts of interest, UNIQUE performers will not be allowed to compete for the IV&V work. ARPA-H is not soliciting proposals for IV&V under this ISO.

2.2 Metrics and Deliverables

To evaluate the effectiveness of a proposed solution in achieving the program’s goal, the following metrics will serve as the basis for determination of satisfactory progress to warrant continued funding. Although the metrics are specified below, proposers should note that the Government has identified these goals with the intention of outlining the scope of effort while affording maximum flexibility, creativity, and innovation of proposed solutions to the goals.

Proposals must cite the quantitative and qualitative success criteria that the effort will achieve at each phase’s milestone, as well as the measurement of intermediary metrics. If the metrics are not meaningful for a particular case, proposing teams are expected to provide their own metrics and describe the quantitative improvement that those metrics represent over the state-of-the-art. Power analysis calculations may be needed to support the proposed metrics.

The expected metrics are listed in Table 1and Table 2.

Table 1

TA1 Milestones and Metrics

Metrics

P h a se

(9 m o s.)

• Demonstrate measurable non-classical entanglement correlations with entanglement witness: R > 1.6

• Achieve coincidence timing resolution: <300 ps; stretch <150 ps

• Achieve generated entangled 511 keV photon-pair flux: >10⁵–10⁶ pairs/s in benchtop/source geometry

• Demonstrate usable filtered coincidence rate: >10³–10⁴ events/s with signal-to-random ratio

>3:1

• Demonstrate measurable decoherence and positronium-sensitive variation across ≥3 controlled phantom microenvironment states

• Demonstrate preliminary ghost imaging feasibility using correlated signal-idler reconstruction in controlled phantom geometry

P h a se

(9 m o s.)

• Demonstrate preserved entanglement through scattering media in phantom with entanglement witness R ≈ 2.0–2.3 in selected angular regimes

• Achieve usable filtered coincidence rate: >10⁴–10⁵ events/s; stretch toward >10⁶ events/s

• Demonstrate signal-to-random or signal-to-background ratio: >5:1, stretch >10:1 after timing/energy/angular filtering

• Demonstrate ghost image reconstruction from correlated signal–idler measurements in controlled phantoms

• Demonstrate reproducible quantum-derived contrast with repeatability variation <10%

• Demonstrate ≥3 metabolic phantom (e.g., pyruvate/lactate-linked) states or other states with statistically significant signal separation modeling neurodegenerative or tumor microenvironment states

Table 2

TA2 Milestones and Metrics

Metrics

P h a se

(9 m o s.)

• Develop simulation-to-reconstruction pipeline integrating timing, angle, scatter, and positronium observables

• Generate physics-informed synthetic and experimental datasets containing >10⁵ correlated events

• Generate prototype voxel-level QDT/QDI maps from phantom and synthetic datasets

• Demonstrate statistically distinguishable clustering of ≥3 phantom states using quantum-derived features

• Establish uncertainty-aware reconstruction framework with reproducible outputs across repeated phantom studies

P h a se

(9 m o s.)

• Generate fused outputs integrating anatomical, functional, molecular, and quantum-derived information

• Build preliminary QDT/QDI atlas across multiple phantom microenvironment states

• Demonstrate improved phantom-state differentiation versus conventional attenuation/scatter observables alone

• Generate scalable dataset with >10⁶ correlated events

• Demonstrate effective 3D localization/reconstruction resolution: target ≤2–3 mm, stretch sub-mm in simplified benchtop geometry

• Demonstrate AI-based differentiation of biologically distinct phantom microenvironments

(e.g. pyruvate/lactate-linked metabolic states) using quantum-derived observables

The metrics and timelines as outlined in the above tables may increase in difficulty and complexity over the course of UNIQUE. Monthly technical and financial status reports will be required and discussed with the ARPA-H Program Manager at monthly meetings. ARPA-H may request performer data as deemed necessary throughout the program to validate progress toward achieving the program’s goals.

At the time of submission, proposers must:

▪ Propose to meet all milestones and metrics for all TAs in accordance with the timelines outlined in the Phases.

2.3 TEAM REQUIREMENTS

Proposals are expected to involve teams with the expertise needed to collectively achieve the goals of the proposed TA(s). Communications, networking, and team formation are the sole responsibility of the proposer. Proposers must submit a single, integrated proposal led by a Principal Investigator, under a single lead proposer that addresses all program phases as applicable. Teaming (that considers access across geographies) is highly encouraged to accomplish the transformational goals set forth in the UNIQUE program.

Proposers may only submit one proposal as the lead proposer. The Government’s expectation is that all key members of the performer team will be onboard within 60 days of the award.

2.4 REPORTING

• Monthly Status Reports (MSRs) – Status reports outlining technical and financial updates will be required at monthly meetings with the PM and team.

o Minimally, monthly check-ins (virtually) to discuss project results, science, challenges and solutions, and other project-related topics.

o Attendance at meetings must include the performer Principal Investigator (PI), and in addition ARPA-H may request members of the performer teams to attend as it deems necessary.

• Principal Investigator (PI) Review Meetings – On a six-month basis, UNIQUE will organize, in-person, PI Review Meetings (site to be determined) where all performers will present progress and updates on their technology and will have the opportunity to meet representatives of key stakeholder organizations. The meetings will provide opportunities for participants to share knowledge, learn, network and grow collaborations. Teams should budget for participation at these meetings.

• Site Visits – ARPA-H may request performer data and arrange visits to their facilities as deemed necessary throughout the work timeline to validate technical progress

2.5 AWARD STRATEGY

The ISO constitutes a merit-based solicitation, and the number of awards made will depend on the quality of the proposals received and the availability of funds. Proposals are expected to use innovative approaches that include novel technology, enabling revolutionary advances in medicine and healthcare.

The Government may select for negotiation all, some, one, or none of the proposals received in response to this ISO and to make awards without negotiations with proposers. The

Government also may conduct negotiations if it is later determined to be necessary.

Additionally, ARPA-H may accept proposals in their entirety or to select only portions of proposals for negotiation and award. The Government may fund proposals in phases, including as optional phases, as applicable. ARPA-H may make multiple awards, a single award, or no awards. Multiple awards are anticipated.

Proposals identified for negotiation are expected to result in Other Transactions (OTs). The

Government may request additional necessary documentation, tailored to the individual proposals, during negotiations. The Government may remove proposals from award consideration should the parties fail to reach agreement on award terms, conditions, and/or cost/price within a reasonable time, and/or if the proposer fails to timely provide requested additional information. The Agreements Officer has sole discretion to negotiate all terms and conditions with selectees.

For-profit organizations, as determined in SAM.gov, that do not qualify as small businesses under the NAICS 541714 SBA size standard of 1000 employees are required to contribute a meaningful cost share to participate in the UNIQUE program. Cost shares may be provided in cash or in-kind (e.g., equipment, facilities, or technical labor) and must directly support the execution of proposed milestones. The level of cost share should reflect the scale, maturity, and resources of the proposing organization and must be explicitly detailed in the proposal’s budget justification. This requirement is intended to ensure sustained performer commitment and to increase the likelihood of rapid, cost-effective transition of UNIQUE technologies. Other organizations are not required to provide cost share but may do so voluntarily.

2.6 Terms, Exclusions, and Regulations

ARPA-H intends to negotiate multiple Other Transaction (OT) Agreements with proposers whose proposals are most advantageous to the Government.

It is important to note that specifically excluded are proposals that: 1) offer incremental improvements to the existing state-of-the-art, 2) make use of human embryos or human fetal tissue, 3) do not address the objectives of the Program, and 4)all proposals must comply with all relevant HHS regulations on research and pre-clinical studies using human stem cells:

https://stemcells.nih.gov/research-policy/guidelines-for-human-stem-cell-research https://osp.od.nih.gov/wp-content/uploads/QA_Chimera_Policy_updated_1_Feb_2017.pdf

3. ELIGIBILITY INFORMATION

3.1 ELIGIBLE PROPOSERS

All responsible sources capable of satisfying the Government’s needs may submit a proposal to this ISO. Specifically, universities, non-profit organizations, small businesses and other than small businesses are eligible and encouraged to propose to this ISO. Early career investigators are preferred.

While there is statutory language that may suggest ARPA-H is limited in the number of awards it may make to one entity, there are circumstances in which ARPA-H may make more than three

(3) awards to a particular person or entity. ARPA-H encourages entities to submit their research ideas notwithstanding this perceived limitation. Any proposal received will be fairly considered for award and, if it is of interest to ARPA-H, will be selected for an award.

3.1.1 PROHIBITION OF PERFORMER PARTICIPATION FROM FEDERALLY FUNDED

RESEARCH AND DEVELOPMENT CENTERS (FFRDCs) AND OTHER GOVERNMENT

ENTITIES

ARPA-H is primarily interested in responses to this solicitation from commercial performers, academia, non-profit organizations, etc. In certain circumstances, FFRDCs and Government Entities may have unique capabilities that are not available to proposing teams through any other resource. Accordingly, the following principles will apply to this solicitation.

• FFRDCs and Government entities, including federal Government employees, are not permitted to respond to this solicitation as a prime or sub-performer on a proposed performer team.

• If an FFRDC or Government entity has a unique research idea that is within the technology scope of this solicitation that they would like considered for funding;

OR, if an FFRDC or Government entity, including a federal Government employee, is interested in working directly with the Government team supporting the research described by this solicitation, contact UNIQUE@arpa-h.gov.

https://stemcells.nih.gov/research-policy/guidelines-for-human-stem-cell-research https://osp.od.nih.gov/wp-content/uploads/QA_Chimera_Policy_updated_1_Feb_2017.pdf mailto:BRAINS@arpa-h.gov

• If a potential prime performer believes an FFRDC has a unique capability without which their solution is unachievable, they may provide documentation as part of their Solution Summary submission demonstrating they have exhausted all other options. ARPA-H will consider the documentation to determine if inclusion of the FFRDC is necessary for the Solution.

3.1.2 CURRENT PROFESSIONAL SUPPORT

Those individuals/entities currently providing contracted support services to ARPA-H have an organizational conflict of interest (OCI) that cannot be mitigated and are ineligible for award.

3.1.3 NON-U.S. ENTITIES

ARPA-H will prioritize awards to entities (organization and/or individuals) that will conduct funded work in the United States. Non-U.S. entities may participate to the extent that such participants comply with any necessary nondisclosure agreements, security regulations, export control laws, and other governing statutes applicable under the circumstances. In accordance with these laws and regulations, in no case will awards be made to entities organized under the laws of a covered foreign country [as defined in section 119C of the National Security Act of

1947 (50 U.S.C. Ch 44 § 3059)]; a foreign entity of concern meeting any of the criteria in section

10638(3) of the CHIPS and Science Act of 2022; an individual that is party to a malign foreign talent recruitment program, as defined in Section 10638(4) of the CHIPS and Science Act of

2022; or entities suspended or debarred from business with the government.

3.2 SYSTEM FOR AWARD MANAGEMENT (SAM)

All proposers must have an active registration in SAM.gov for their proposal to be found conforming. Proposers must maintain an active registration in SAM.gov with current information at all times during which a proposal is under consideration or a current award from ARPA-H is held. Information on SAM.gov registration is available at SAM.gov.

NOTE: New registrations as well as renewals may take more than 14 business days to process in SAM.gov. SAM.gov is independent of ARPA-H and thus ARPA-H representatives have no influence over processing timeframes.

Information related to updates to this ISO can be found on the SAM.gov listing along with ancillary material to support proposal submission. ARPA-H cannot provide technical support for software issues encountered while using these materials. If you believe there is an error in the content of these materials, please email UNIQUE@arpa-h.gov.

4 SUBMISSION PROCESS

4.1 SUBMISSION PROCESS OVERVIEW

Submissions for UNIQUE are as follows:

1. Proposers’ Day (Optional). ARPA-H organized event to allow interested proposers to meet and self-organize into comprehensive teams capable of meeting all UNIQUE technical and non-technical requirements.

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

2. Solution Summary. Required overview of the effort to be proposed summarizing the goals of the proposed work, the research plan, and the team.

3. Review of Solution Summaries. Based on the evaluation of Solution Summaries, selected teams will be encouraged or discouraged to submit full proposals.

4. Full Proposal. Required document package comprising a detailed description of the proposed effort, expected outcomes, performing team, timeline, budget, and any supporting materials.

5. Review of Full Proposals.

6. Feedback and Awards.

4.2 SOLUTION SUMMARY SUBMISSIONS

Solution summaries shall not exceed three (3) pages, excluding the cover page, Rough Order of Magnitude (ROM), team qualifications, and references. The Government will not review pages beyond three (3) pages.

Based on the evaluation of solution summaries, selected teams will be encouraged or discouraged to submit full proposals. Although a proposal may be submitted regardless of the feedback provided, potential proposers are advised to give the government’s decision significant weight when making decisions regarding whether it is worth the investment of time and resources in the development of a proposal.

Solution Summary submissions are required and are due by the date listed in the ISO

Summary Information Section. See Appendix A for the required Solution Summary format.

4.3 FULL PROPOSAL SUBMISSIONS

All proposals submitted in response to this ISO must comply with the content and formatting requirements in the applicable Appendices. Proposers should use the templates provided in the Appendices. The Appendices includes the following five (5) templates:

1. Tech and Management (12 pages)

2. Task Description Document (TDD) (no page limit)

3. Cost Proposal (no page limit)

4. Cost Proposal Spreadsheet (fill in applicable tabs)

5. Administration & National Policy (no page limit)

Documents requested to be submitted with the templates should be included as attachments to the applicable template (e.g., HSR/ASR documents included as attachments to the

Administration & National Policy template, cost back-up as attachments to the Cost Proposal template, etc.). Each template includes instructions for completion.

Full proposal submissions are due by the date listed in the ISO Summary Information Section.

See Appendix B for the required Full Proposal format.

https://arpah.sharepoint.com/teams/ARPA-H-HSF-Front_Office/Shared%20Documents/Front_Office/Source%20Selection/Hebert%20Programs%20and%20Projects/BRAINS/ISO%20&%20SN/HYPERLINK#AppendixB

4.4 SUBMISSION INFORMATION

Non-conforming submissions that do not follow ISO instructions may be rejected without further review at any stage of the process.

All submissions in response to this solicitation must be written in English and must be consistent with the content and formatting requirements of Appendix A (Solution Summary Format and Instructions), and Appendix B (Full Proposal Format and Instructions).

Proposers are responsible for submitting all written submissions via the ARPA-H Solutions site and ensuring receipt by the date and time specified in the ISO. No other method of submission is permitted.

Registration is required to submit via the ARPA-H Solutions site.

4.5 PROPRIETARY INFORMATION

Proposers are responsible for identifying proprietary information in any submissions.

Submissions containing proprietary information must have the cover page and each page containing such information clearly marked with a label such as “Proprietary.”

NOTE: “Confidential” is a classification marking used to control the dissemination of U.S.

Government National Security Information as dictated in Executive Order 13526 and should not be used to identify proprietary business information.

ARPA-H is responsible for handling submissions in accordance with applicable federal law, including the Freedom of Information Act (FOIA). Protection of proprietary information is discussed below.

4.6 FUNDING RESTRICTION

Pre-award costs will not be reimbursed unless a pre-award agreement is negotiated prior to award.

4.7 QUESTION AND ANSWER (Q&A)

All questions regarding this ISO must be submitted to UNIQUE@arpa-h.gov. ARPA-H will post Q&As to the ARPA-H UNIQUE Website and SAM.gov on an on-going basis and may not respond directly to email inquiries. All questions must be in English and must include the name, email address, and telephone number of a point of contact, and must be submitted by the Q&A deadline posted with other key dates. Proposers submitting questions to individual Government team members (e.g., Program Manager) should not expect a response.

ARPA-H will attempt to answer questions in a timely manner; however, questions submitted after the due date may not be answered. Further, duplicative questions may be combined and rephrased to streamline responses.

https://solutions.arpa-h.gov/ mailto:1-CURE@arpa-h.gov mailto:1-CURE@arpa-h.gov https://arpa-h.gov/explore-funding/programs/unique/faqs https://sam.gov/

5 SUBMISSION REVIEW AND EVALUATION PROCESSES

5.1 CONFORMING SUBMISSIONS

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 under this ISO if it fails to meet one or more of the following solicitation requirements:

• The proposed concept is applicable to the UNIQUE 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.

• 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).

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

Please note that ARPA-H reserves the right, at its discretion, to reject as non-conforming proposals that it determines are duplicative of previously submitted solution summaries and proposals under this or other ARPA-H solicitations.

Prior to submission deadlines, errors in submitted materials may be corrected via resubmission to the Submission Portal, provided an email is sent to UNIQUE@arpa-h.gov documenting this action and its intent. After the submission deadline, the most recently received conforming proposal version will be reviewed.

5.2 SOLUTION SUMMARY REVIEW PROCESS

ARPA-H will review and respond to all proposers submitting solution summaries. Solution summaries will be reviewed to provide potential proposers with feedback on whether ARPA-H is interested in the proposed solution/concept. At a minimum the response will indicate whether a proposer is encouraged or discouraged from submitting a proposal. ARPA-H solution summary feedback is provided to ensure that potential proposers are making an informed decision on the investment of time and resources to submit a full proposal. Feedback will be provided to the administrative and technical points of contact noted on the solution summary cover page.

5.3 PROPOSAL REVIEW PROCESS

ARPA-H will conduct a scientific and technical review of each conforming full proposal, evaluating proposals on how well the submission meets the criteria stated in this ISO. At a minimum, proposers will be provided with notification of the Government’s decision on whether the proposal was selected for negotiation of an award. Notification of the

Government’s decision will be provided to the primary technical point of contact included in the solutions tool.

mailto:BRAINS@arpa-h.gov

5.4 EVALUATION CRITERIA FOR PROPOSALS

All proposals will be evaluated using the following evaluation criteria, listed in descending order of importance.

5.4.1 CRITERIA 1: OVERALL SCIENTIFIC AND TECHNICAL MERIT

The proposed technical approach is highly innovative, feasible, and with a well-defined path to completion. Task descriptions and associated technical elements provided are complete and in a logical sequence with all proposed deliverables clearly defined such that an outcome that achieves the goal is plausible. The proposal identifies major technical risks, expected for ARPA-H projects, and planned mitigation efforts are clearly defined and feasible. In addition, the evaluation may take into consideration the extent to which the proposed intellectual property (IP) rights structure and software components will potentially impact the ability to commercialize the technology and adhere to open-source solutions and/or standards.

5.4.2 CRITERIA 2: PROPOSER’S CAPABILITIES AND/OR RELATED EXPERIENCE

The proposed technical team has the expertise and experience to accomplish the proposed tasks; the proposer’s experience in similar efforts clearly demonstrates an ability to deliver products that meet the proposed technical performance within the proposed budget and schedule; the proposed team has the expertise to manage the cost and schedule and; similar efforts completed/ongoing by the proposer in this area are fully described, including identification of other government or commercial activities where they have led or participated.

In terms of capability, the Government will assess the Volume III bio-sketches provided for the performer team members including the Principal Investigator and any other key personnel on the project team as requested by ARPA-H.

5.4.3 CRITERIA 3: POTENTIAL CONTRIBUTION TO RELEVANCE TO THE ARPA-H

MISSION AND USER EXPERIENCE

Proposals will be evaluated on the potential future Research & Development, commercial, and/or clinical applications of the project proposed, including whether such applications may have the potential to address areas of currently unmet need within biomedicine and improve health outcomes; the degree to which the proposed project has the potential to transform biomedicine; and/or the potential for the project to take an interdisciplinary approach.

5.4.4 CRITERIA 4: ASSESSMENT OF PROPOSED COST/PRICE

All proposals will be evaluated to determine the reasonableness or value of the estimated price/cost proposed to accomplish the work in the Statement of Work (SOW). The costs for the prime proposer and proposed sub-awardees should be substantiated by the details provided in the proposal (e.g., the type and number of labor hours proposed per task, the types and quantities of materials, equipment and fabrication costs, travel and any other applicable costs including the basis for the estimates).

It is expected the effort will leverage all available relevant prior research to obtain the maximum benefit from the available funding.

Proposers are encouraged to propose the best technical solution. ARPA-H seeks novel solutions that are reflective of the level of effort and risk proposed.

Proposers are encouraged to structure their budgets to reflect this guidance.

5.5 HANDLING COMPETITION SENSITIVE INFORMATION

It is the intent of ARPA-H to protect all proposals as competition sensitive information and to disclose their contents only for the purpose of evaluation, and only to screened personnel for authorized reasons, in accordance with applicable federal laws and regulations, including FOIA. Restrictive notices notwithstanding, submissions may be handled by ARPA-H support contractors during the evaluation process for administrative purposes and/or to assist with technical evaluation.

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 proposal may be solicited by ARPA-H from non-government consultants/experts who are strictly bound by appropriate non-disclosure requirements. No submissions will be returned.

5.6 EVALUATION AND AWARD DISCLAIMERS

The Government reserves the right to select for negotiation all, some, one, or none of the proposals received in response to this ISO. In the event the Government desires to award only portions of a proposal, negotiations will commence upon selection notification. The Government reserves the right to fund proposals with phases or options for continued work, as applicable.

The government reserves the right to request any additional necessary documentation to support the negotiation and award process. The Government reserves the right to remove a proposal from award consideration should the parties fail to reach agreement on award terms, conditions, price, and/or if the proposer fails to provide requested additional information in a timely manner.

In all cases, the government Agreements Officer (AO) will have sole discretion to negotiate all terms and conditions with proposers. ARPA-H will apply publication or other restrictions, as necessary, if it is determined the research resulting from the proposed effort will present a high likelihood of disclosing sensitive information including Personally Identifiable Information (PII), Protected Health Information (PHI), financial records, proprietary data, any information marked Sensitive but Unclassified (SBU), etc. Any award resulting from such a determination will include a requirement for ARPA-H concurrence before publishing any information or results on the effort.

6 POLICY REQUIREMENTS AND MISCELLANEOUS OTHER INFORMATION

6.1 CONTROLLED UNCLASSIFIED INFORMATION (CUI) ON NON-FEDERAL

INFORMATION SYSTEMS

Information on Controlled Unclassified Information (CUI) identification, marking, protection, and control is incorporated herein and can be found at 32 CFR § 2002.

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

6.2 ORGANIZATIONAL CONFLICTS OF INTEREST (OCI)

The Proposer, through submission of a proposal, is required to identify and disclose all facts relevant to any potential OCI involving the Proposer, its organization, and/or any proposed team member (i.e. proposed subawardee). Along with the disclosure, the Proposer may be required to submit a mitigation plan, which is a description of the action the Proposer has taken to avoid, neutralize, or mitigate the stated OCI. The government may require the Proposer to provide additional information to assist the government in evaluating the OCI mitigation plan.

If the government determines the Proposer failed to fully disclose an OCI; or failed to provide the affirmation of ARPA-H support; or failed to reasonably provide additional information requested by the government to assist in evaluating the proposer’s OCI mitigation plan, the government may reject the proposal and withdraw it from consideration for award.

6.2.1 AGENCY SUPPLEMENTAL OCI POLICY

ARPA-H restricts Performers from concurrently providing professional support services, including Advisory and Assistance Services or similar contracted support services, in addition to performing as an R&D technical Performer. Therefore, the Proposer must affirm whether it or any proposed team member (proposed subawardee, etc.) is providing professional support services to any ARPA-H office(s) under: (1) a current award or subaward; or (2) a past award or subaward that ended within one calendar year prior to the proposal’s submission date.

If any professional support services are or were provided to any ARPA-H office(s), the proposal must include:

• The name of the ARPA-H office receiving the support,

• The prime contract number, and

• Identification of proposed team member (including any proposed subawardee) providing the support.

6.2.2 RESEARCH SECURITY DISCLOSURES

Conforming proposals selected for negotiation of a potential award will undergo a Research Security Review (RSR). The RSR involves a review of the proposer’s disclosures made as part of the Administrative & National Policy Requirements document, and a validation and comparison of those disclosures utilizing publicly available information and commercially available information tools. Section 10631 of the CHIPS and Science Act of 2022 prohibits federal research agencies, such as ARPA-H, from providing R&D awards in response to any proposal in which a covered individual is participating in a Malign Foreign Talent Recruitment Program (MFTRP). It also requires federal agencies to require recipient institutions to prohibit covered individuals participating in MFTRPs from working on projects supported by federal R&D awards.

In accordance with NSPM-33, to receive federal funding, research organizations should identify and mitigate conflicts of commitment (COCs) and conflicts of interest (COIs). COCs and COIs involving foreign countries of concern (FCOCs), including the People’s Republic of China, the Russian Federation, the Islamic Republic of Iran, and the Democratic People’s Republic of Korea (also known as North Korea), will require risk mitigation plans. A research organization proposing in response to this ISO must provide research security disclosures as described in the Administrative & National Policy Requirements document and the Office of Science and Technology Policy-identified Common Forms. The Common Forms are required for all senior https://trumpwhitehouse.archives.gov/presidential-actions/presidential-memorandum-united-states-government-supported-research-development-national-security-policy/ or key personnel. The format for this submission can be found in the Administration and National Security Document Template (Appendix H on SAM.gov). Additional information can be found at https://arpa-h.gov/explore-funding/submission-resources-and-FAQs/research-security-review.

After a proposal is selected for negotiations of a potential award, ARPA-H will conduct an RSR of each proposer and its senior or key personnel. The RSR is not part of the ARPA-H scientific merit review process. The RSR reviews include assessments of potential risks associated with covered individuals’ disclosed or undisclosed participation in MFTRPs, funding received from FCOCs, collaboration with FCOC entities (including researchers and research institutions that have been identified on various entity lists), foreign ownership control or influence with regard to FCOCs identified in proposals, and the pursuit of foreign patents stemming from U.S.

government funded research prior to obtaining U.S. patent protections.

If ARPA-H determines the proposer failed to provide all requisite research security disclosures or failed to reasonably provide information requested by ARPA-H to assist in evaluating the proposer’s disclosures and/or research security mitigations, ARPA-H may eliminate the proposal from award consideration. ARPA-H may also eliminate the proposal from award consideration if ARPA-H determines the proposer did not or cannot properly mitigate research security-related risks.

6.3 INTELLECTUAL PROPERTY

Proposers must provide a good faith representation that the proposer either owns or possesses the appropriate licensing rights to all IP that will be utilized for the proposed effort. ARPA-H strongly encourages IP rights to be aligned with open-source regimes. Further, it is desired that all non-commercial software (including source code), software documentation, and technical data generated and/or developed under the proposed project is provided as a deliverable to the Government. IP delivered to the Government should align with project or Program goals and should be aligned with the level of government funding provided to generate and/or develop the IP.

6.4 VERTEBRATE ANIMAL SUBJECTS RESEARCH

All entities submitting a proposal for funding that will involve engagement in animal subjects research (award recipients performing research, experimentation, or testing involving the use of animals) shall comply with the laws, regulations, and policies on animal acquisition, transport, care, handling, and use as outlined in:

• 9 CFR parts 1-4, U.S. Department of Agriculture rules that implement the Animal Welfare Act of 1966, as amended, (7 U.S.C. § 2131-2159); and,

• the Public Health Service Policy on Humane Care and Use of Laboratory Animals, which incorporates the “U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training,” and "Guide for the Care and Use of Laboratory Animals" (8th Edition).”

Proposers must provide documentation of a current Animal Welfare Assurance (AWA) on file with the Office of Laboratory Animal Welfare (OLAW).

The Proposer must complete and submit the Vertebrate Animal Section worksheet for all proposed research anticipating Animal Subject Research (ASR).

https://arpa-h.gov/explore-funding/submission-resources-and-FAQs/research-security-review https://arpa-h.gov/explore-funding/submission-resources-and-FAQs/research-security-review chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https:/www.govinfo.gov/content/pkg/COMPS-10262/pdf/COMPS-10262.pdf chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https:/www.govinfo.gov/content/pkg/COMPS-10262/pdf/COMPS-10262.pdf https://www.govinfo.gov/content/pkg/USCODE-2015-title7/html/USCODE-2015-title7-chap54.htm https://olaw.nih.gov/sites/default/files/VASchecklist.pdf

All Animal Use Research must undergo review and approval by the local Institutional Animal Care Use Committee (IACUC) prior to incurring any…