HSF Open Office Innovative Solutions Opening DRAFT ONLY.pdf

DRAFT/PREDECISIONAL

HEALTH SCIENCE FUTURES

OFFICE-WIDE INNOVATIVE SOLUTIONS OPENING FOR

ADVANCED RESEARCH PROJECTS AGENCY FOR HEALTH

ARPA-H-SOL-24-104

TBD

TABLE OF CONTENTS

1. INNOVATIVE SOLUTIONS OPENING SOLICITATION OVERVIEW INFORMATION

2. DESCRIPTION OF THE SOLICITATION:

2.1 INTRODUCTION

2.2 ACQUISITION STRATEGY

3. ELIGIBILITY INFORMATION

3.1 ELIGIBLE APPLICANTS

3.2 FEDERALLY FUNDED RESEARCH AND DEVELOPMENT CENTERS (FFRDCS) AND GOVERNMENT

ENTITIES

3.3 CURRENT PROFESSIONAL SUPPORT

3.4 NON-U.S. ORGANIZATIONS

4. ABSTRACT AND PROPOSAL PREPARATION AND SUBMISSION INFORMATION

4.1 ABSTRACT PREPARATION

4.2 ABSTRACT SUBMISSIONS

4.3 PROPOSAL PREPARATION INFORMATION

4.4 PROPOSAL SUBMISSION INFORMATION

4.5 ABSTRACT AND PROPOSAL SUBMISSION DEADLINES

4.6 PROPRIETARY INFORMATION

4.7 SECURITY INFORMATION

5. ABSTRACT REVIEW AND EVALUATION OF PROPOSALS

6. AWARD ADMINISTRATION INFORMATION

RESEARCH SECURITY DISCLOSURES

APPENDIX A: ABSTRACT TEMPLATE

ATTACHMENT 1: BUNDLE OF ATTACHMENTS (OTHER TRANSACTION)

ATTACHMENT 2: BUNDLE OF ATTACHMENTS (COOPERATIVE AGREEMENT)

1. INNOVATIVE SOLUTIONS OPENING SOLICITATION OVERVIEW INFORMATION

FEDERAL AGENCY NAME: Advanced Research Projects Agency for

Health (ARPA-H)

SOLICITATION TITLE: ARPA-H HEALTH SCIENCE FUTURES OFFICE

INNOVATIVE SOLUTIONS OPENING (ISO)

ANNOUNCEMENT TYPE Research and Development Solicitation

SOLICITATION NUMBER: ARPA-H-SOL-24-104

ASSISTANCE LISTING NUMBER: 93.384

AGENCY CONTACT: Email: ARPA-H HSF ISO@arpa-h.gov

ATTN: ARPA-H-SOL-24-104

ABSTRACT SUBMISSION SITE: TBD

PROPOSAL SUBMISSION SITE: TBD

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

DATES: (All times listed herein are Eastern

Time)

DRAFT Release Date: TBD

Release Date: 15 March 2024

Questions & Answers (Q&A) due date: Questions may be submitted up to 6 months after the Release Date

Closing Date: The solicitation will remain open for

12-months after Release Date.

NOTE: Abstracts submissions must be received by March 3, 2025, 11:59PM ET.

ANTICIPATED AWARD: Multiple awards are anticipated.

TYPES OF INSTRUMENTS THAT MAY BE

AWARDED:

Other Transactions (OT) and Cooperative

Agreements

PARTICIPANTS/PROPOSERS: Universities, Non-Profit Organizations, Small

Businesses and Other than Small Businesses

ANY COST SHARING: Cost sharing may be encouraged or requested.

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

2. DESCRIPTION OF THE SOLICITATION:

2.1 INTRODUCTION

This ISO seeks abstract and proposal submissions for projects that fall within the general scope of the ARPA-H Health Science Futures (HSF) mission office. HSF expands what is technically possible by developing approaches that will remove the scientific and technological limitations that stymie progress towards the healthcare of the future. HSF supports cutting-edge, often disease-agnostic research programs that have the potential for translational real-world change.

Considering the current healthcare challenges that we face today, the goal of achieving better health outcomes is a moving target that requires daring and adaptable solutions. HSF awardees will develop innovative technologies, tools, and platforms that can be applied to a broad range of diseases. The following thrust areas define the ground-breaking research we seek to support:

Breakthrough Technologies: Paradigm shifting technologies that will change how we approach the diagnosis, treatment, and impact of diseases and conditions.

• Novel approaches to improve maternal and fetal medicine, decrease maternal morbidity and mortality during birth, and the post-partum period. Efforts should include new technology to monitor, detect, and/or treat maternal and/or fetal complications with less invasive and traumatic methods.

• Foundational advances in genetic, epigenetic, cellular, tissue, and organ replacement therapies that enable personalized medical interventions at scale in a manner that is accessible, cost-effective, and designed to impact the communities of greatest need.

• Interventions that target and reverse disease pathogenesis and/or enhance plasticity to address diseases of the nervous, neuromuscular, skeletal, lymphatic, cardiovascular, and other organ systems.

• Novel approaches to diagnose and treat diseases of the lymphatic system, particularly rare diseases, with a focus on the effects of genetic expression in the lymphatic system and/or models demonstrating the relationship between lymphatic dysfunction and health and disease.

Transformative Tools: Novel, agile solutions that will move from bench to bedside quickly, facilitating revolutionary advances in medical care.

• Development of tools that counter idiosyncratic, off-target, or chronic effects of medicines that are commonly used or that are being used experimentally to treat or prevent disease.

• Development of bionics to restore sight, hearing, taste, or smell.

• Site-selective neuromodulation to regulate specific physiological functions and treat chronic health conditions such as inflammation, pain, and metabolic or endocrine disorders.

• Synthetic biology approaches to diagnosing, treating, and/or curing a multitude of diseases.

• Novel physics and/or chemistry-based approaches to improve imaging that reduces cost, increases availability, expands capability, improves resolution, reduces exposure to radiation, and accommodates pediatric patient populations.

• Integrated sensing and delivery devices for treating and diagnosing chronic health conditions, including mental health conditions or substance use disorders.

• Miniaturization of complex hardware to enable broader access to pediatric and other patient populations, as well as portability, such as diagnostic, treatment, imaging, or other devices.

Platform Systems: Adaptable, multi-application systems and technologies that are reconfigurable for a wide variety of clinical needs

• Novel molecular platform approaches, including the modulation of host systems, delivery to targets with spatial and temporal precision, and mitigation of off-target effects to accelerate interventions that dramatically improve health outcomes.

• New approaches to accelerate and routinize mammalian and microbial cellular engineering to enable next generation therapeutic applications, develop multiscale interventions, and automate hypothesis generation and discovery to expand those applications to disease states in which cellular therapies have not traditionally been employed.

• Innovative approaches at the intersection of artificial intelligence, high performance computing (including quantum computing) and biological systems, including enabling de novo design of biomolecules with entirely new phenotypes.

Other high-quality submissions that propose revolutionary technologies that meet the goals of

HSF will be considered even if they do not address the topics listed above.

Proposals are expected to use innovative approaches to enable revolutionary advances in medicine and healthcare, and the science and technology underlying these areas. While approaches that are disease agnostic are encouraged, ARPA-H welcomes proposals that bring radically new insights to address specific diseases including, but not limited to, cancer, diabetes, neurological diseases, pediatric and maternal/fetal health, infectious diseases, and cardiovascular disease.

Specifically excluded are proposals that represent an evolutionary or incremental advance in the current state of the art or technology that has reached the clinical trial stage. An example of this type of proposal might include the request to fund clinical trials of an otherwise developed product. Additionally, proposals directed towards policy changes, traditional education and training, or center coordination, formation, or development, and construction of physical infrastructure are outside the scope of the ARPA-H mission.

2.2 ACQUISITION STRATEGY

ARPA-H is an R&D government agency tasked with accelerating better health outcomes for everyone by supporting the development of high-impact solutions to society’s most challenging health problems. ARPA-H primarily follows a program model structure where Program Managers

(PM) bring a well-defined problem to the agency. That problem is technically challenged and vetted before it becomes an ARPA-H program of record and is subsequently solicited to the public for solutions.

While the model has proven to be successful, R&D communities such as ARPA-H recognize the need for a mechanism to receive novel ideas that may or may not fit into a program of record. As such, this ISO affords the public the ability to submit novel ideas that fit within HSF interest areas and advance high-potential, high-impact biomedical and health research that cannot be readily accomplished through traditional research or commercial activities, ensuring ARPA-H will tackle the hardest health challenges and the highest-impact projects and programs.

ARPA-H is moving from an Agency wide Broad Agency Announcement (BAA), specifically the

Open-Office BAA (75N99223S0001), to individual Office-wide solicitations. The HSF Office-wide ISO is just one of several Office solicitations. Thus, each ISO has a targeted area of interest, may request submission of abstracts and/or proposals and will contain instructions informing industry how to properly submit a responsive abstract and/or proposal against the appropriate solicitation. Further, ARPA-H will leverage its broad acquisition authorities to create a fair and efficient process to solicit, evaluate, and select revolutionary ideas to achieve better health outcomes for all Americans. This ISO will award Other Transactions and Cooperative

Agreements; therefore, the Federal Acquisition Regulations (FAR) is not applicable to this solicitation nor subsequent awards. Rather, this solicitation and subsequent awards will be made in accordance with 42 U.S.C. § 290c(g)(1)(D) for the award of Other Transactions and 2 CFR

200, 45 CFR 75, and HHS Grants Policy Statement for the award of Cooperative Agreements.

This ISO is targeting universities, non-profit organizations, large businesses and small businesses capable of performing research and/or development of HSF interest areas.

This ISO requires potential proposers to first submit an abstract prior to submission of a full proposal in order for ARPA-H to review the idea for novelty and applicability to HSF.

NOTE: ARPA-H PMs are encouraged to have open dialogue with industry. It is not uncommon during open dialogue with industry that a PM may encourage an industry personnel to submit a white paper and/or email directly to them describing the intended research. After review, the PM may determine if he or she would like to pursue the research described. In this case, the PM may encourage the industry personnel to submit an official abstract submission and include the proposal as an attachment to the abstract.

2.3 SOLICITATION PROCEDURES

This ISO will be solicited through ARPA-H ISO external facing (public) website, SAM.gov and

Grants.gov. See Section 3 for application and submission information.

2.4 AWARD INFORMATION

Multiple awards are anticipated under this ISO; however, the number of awards selected will depend on the quality of the proposals received and the availability of funds.

The Government reserves the right to select for negotiation all, some, one, or none of the https://www.law.cornell.edu/uscode/text/42/290c https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200?toc=1 https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200?toc=1 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75 https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://arpa-h.gov/engage/baa/ https://sam.gov/content/home https://www.grants.gov/ proposals received in response to this ISO. If warranted, portions of resulting awards may be segregated into options. In the event that the Government desires to award only portions of a proposal, negotiations will commence upon selection notification. The Government reserves the right to fund proposals in phases with 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 and conditions, cost, and/or if the proposer fails to provide requested additional information in a timely manner.

In all cases, the Government Agreement Officer (AO) shall have sole discretion to select the award Agreement type, regardless of Agreement type proposed. The ISO has two (2) attachment bundles that will contain proposal submission templates and a Model Agreement (Other

Transaction and Cooperative Agreement) with basic terms and conditions. Proposers may submit red-line edits to the basic terms and conditions of the resulting instrument; however, the

Government AO shall have the sole discretion to negotiate any red-line edits.

NOTE: An Other Transactions allow for greater flexibility in negotiation of terms and conditions than Cooperative Agreements.

ARPA-H will apply pre-publication reviews, as necessary, if it is determined that 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) or Controlled Unclassified Information (CUI), etc. Any award resulting from such a determination will include a requirement for ARPA-H permission before publishing any information or results on the effort.

3. ELIGIBILITY INFORMATION

3.1 ELIGIBLE APPLICANTS

All responsible sources capable of satisfying the Government’s needs may submit an abstract and/or proposal to this ISO. Specifically, universities, non-profit organizations, small businesses and other than small businesses, hospitals, community health centers and non-Federal research centers are eligible and encouraged to propose to this ISO.

3.2 FEDERALLY FUNDED RESEARCH AND DEVELOPMENT CENTERS

(FFRDCS) AND GOVERNMENT ENTITIES

FFRDCs and Government Entities are subject to applicable direct competition limitations and cannot propose to this ISO in any capacity, including as subawardees. If a FFRDC or

Government Entity would like to assist ARPA-H with a HSF interest area, the FFRDC or

Government Entity should contact the ISO Coordinator Noted in Section 1.

3.3 CURRENT PROFESSIONAL SUPPORT

Those currently providing support services1 have an OCI that cannot be mitigated.

3.4 NON-U.S. ORGANIZATIONS

ARPA-H will prioritize awards to entities (organization and/or individuals) that will conduct funded work in the United States. However, 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.

4. ABSTRACT AND PROPOSAL PREPARATION AND SUBMISSION INFORMATION

4.1 ABSTRACT PREPARATION

Submission of an abstract is a mechanism for performers to get feedback prior to investing resources for a full proposal submission.

4.2 ABSTRACT SUBMISSIONS

All abstract submissions must be written in English. All abstracts submitted in response to this solicitation must comply with the content and formatting requirements in Appendix A. Proposers are strongly encouraged to use the template provided. Information not explicitly requested in this

ISO, Appendix A may not be reviewed.

Abstract submissions must be submitted to: TBD

4.3 PROPOSAL PREPARATION INFORMATION

SYSTEM FOR AWARD MANAGEMENT (SAM) REGISTRATION AND UNIVERSAL

IDENTIFIER REQUIREMENTS

All proposers must be registered in SAM and have a valid Unique Entity ID (UEI) number in order 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 have a current award with ARPA-H. Information on SAM.gov registration is available at

SAM.gov.

NOTE: New registrations take an average of 7-10 business days to process in SAM.gov.

Registration requires the following information:

• SAM UEI number

• Tax Identification Number (TIN)

• Commercial and Government Entity Code (CAGE) Code. If a proposer does not already

1 Support services are defined as contracted support providing technical, professional, financial expertise, and/or administrative assistance and may have access to internal and privileged information.

https://sam.gov/content/home https://sam.gov/content/home have a CAGE code, one will be assigned during SAM registration.

• Electronic Funds Transfer information (e.g., proposer’s bank account number, routing number, and bank phone or fax number).

4.4 PROPOSAL SUBMISSION INFORMATION

All proposal submissions must be written in English. All proposals submitted in response to this solicitation must comply with the content and formatting requirements in the applicable Bundle of Attachments. Proposers are strongly encouraged to use the templates provided in the Bundle of

Attachments. Information not explicitly requested in the Bundle of Attachments may not be evaluated.

Proposal submissions for OTs shall be submitted to the electronic Contract Proposal Submission

(eCPS)2. Proposal submissions for Cooperative Agreements shall be submitted to Grants.gov.

4.5 ABSTRACT AND PROPOSAL SUBMISSION DEADLINES

Abstracts may be submitted under this solicitation by close of business 3 March 2025.

An abstract must be submitted prior to proposal submission. If the abstract is encouraged, ARPA-

H will request that proposers submit a full proposal within 45 days from receipt of abstract feedback unless an alternative timeline is provided.

Proposals may be submitted under this ISO while the solicitation remains open, currently anticipated to be 12 months upon date of release.

Proposals and proposal modifications, unless requested by the Government AO, received after the solicitation closing date may not be evaluated.

4.6 PROPRIETARY INFORMATION

Proposers are responsible for clearly identifying proprietary information. 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.

4.7 SECURITY INFORMATION

See Section 5.2.2 for Sensitive but Unclassified (SBU) and Controlled Unclassified Information

(CUI) compliance requirements.

5. ABSTRACT REVIEW AND EVALUATION OF PROPOSALS

5.1 ABSTRACT REVIEW PROCESS

2 electronic Contract Proposal Submission (eCPS) is a component of an integrated, secure system for electronic submission, capture, tracking and review of contract proposals. Be advised eCPS requires user registration to submit a proposal response (https://ecps.nih.gov/).

https://ecps.nih.gov/ https://grants.gov/

ARPA-H will review and provide written feedback to all abstracts submitted in accordance with the instruction stated in Section 3. Feedback at a minimum will provide encouragement or discouragement to submit a proposal to the ISO. Feedback will be sent to the administrative and technical points of contact noted on the abstract cover page. ARPA-H strives to provide abstract feedback within 30 business days of receipt of the abstract.

NOTE: All parties, whether encouraged or discouraged to submit a proposal, are eligible to submit a proposal to the ISO. Abstracts must be submitted, and feedback received prior to proposal submission, unless a PM has requested an abstract submission with a proposal as an attachment as stated in Section 2.2.

5.2 EVALUATION CRITERIA FOR AWARD

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

1. OVERALL SCIENTIFIC AND TECHNICAL MERIT

The proposed technical approach is innovative, feasible, and complete. Task descriptions and associated technical elements provided are complete and in a logical sequence with all proposed deliverables clearly defined such that a final outcome that achieves the goal can be expected as a result of award. The proposal identifies major technical risks and planned mitigation efforts are clearly defined and feasible. The proposal represents a revolutionary change rather than an incremental advance.

2. POTENTIAL CONTRIBUTION TO RELEVANCE TO THE ARPA-H MISSION

Potential future R&D, 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. Degree to which the proposed project has the potential to transform biomedicine. Potential for the project to take an interdisciplinary approach. In addition, the evaluation may take into consideration the extent to which the proposed intellectual property (IP) rights structure rights structure and software components will potentially impact the ability to commercialize the technology and adhere to open-source solutions and/or standards.

3. PROPOSER’S CAPABILITIES AND/OR RELATED EXPERIENCE

The proposed technical team has the expertise and experience to accomplish the proposed tasks. The proposer's prior 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. 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.

4. PRICE ANALYSIS

Price and/or value analysis will be performed to assess the reasonableness and value of the overall proposed price provides the Government for the technical solution selected for potential award.

When price and value analysis are inconclusive, cost realism analysis may be performed to ensure proposed costs are realistic for the technical and management approach, accurately reflect the technical goals and objectives of the solicitation, and the proposed costs are consistent with the proposer's Scope of Work and reflect a sufficient understanding of the costs and level of effort needed to successfully accomplish the proposed technical approach.

NOTE: Proposers are encouraged to propose the best technical solution. Proposers are discouraged from proposing low-risk ideas with minimum uncertainty and staff the proposed effort with junior personnel to be more appealing from a dollar threshold.

ARPA-H seeks novel solutions that are accompanied by a Volume 2 proposal that is reflective of the level of effort and risk proposed.

5.3 REVIEW AND SELECTION PROCESS

It is the policy of ARPA-H to ensure impartial, equitable, comprehensive proposal evaluations based on the evaluation criteria listed above and to select the source (or sources) whose proposal is determined to be the most advantageous to ARPA-H's mission objectives.

ARPA-H will conduct a scientific and technical review of each conforming proposal. All proposal evaluations will be based solely on the evaluation criteria in Section 5.2.

NOTE: proposals will not be evaluated against each other during the scientific technical review process, but rather evaluated on their own individual merit to determine how well the proposal meets the criteria stated in this ISO.

For the purposes of this proposal evaluation process, a selectable proposal is defined as follows:

SELECTABLE: A selectable proposal is a proposal that is a conforming proposal that has been evaluated by the Government against the evaluation criteria listed in this ISO, and the positive aspects of the overall proposal outweigh its negative aspects. Additionally, there are no accumulated weaknesses that would require extensive negotiations and/or a resubmitted proposal.

For the purposes of this proposal evaluation process, a non-selectable proposal is defined as follows:

NON-SELECTABLE: A proposal is considered non-selectable when the proposal has been evaluated by the Government against the evaluation criteria listed in this ISO, and the positive aspects of the overall proposal do not outweigh its negative aspects. Additionally, there are accumulated weaknesses that would require extensive negotiations and/or a resubmitted proposal.

CONFORMING PROPOSALS: Conforming proposals contain all requirements and fall within the scope detailed in this ISO. The same proposal, with only minor modifications, may not be submitted to multiple ISOs. Proposals that are out of scope may be referred to more appropriate

ISOs.

Proposals that fail to include required information may be deemed non-conforming and may be removed from consideration. Non-conforming submissions may be rejected without further review. A proposal will be deemed non-conforming under this ISO if the proposal fails to meet one or more of the following solicitation requirements:

• The proposed concept is applicable to the HSF interest areas.

• The proposers meet the eligibility requirements.

• The proposal met the submission requirements.

• The proposal met the content and formatting requirements in the attached bundle of attachments.

• 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)

Non-conforming proposals may be removed from consideration. 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 abstracts and proposals under this or other ARPA-H solicitations.

ARPA-H’s intent is to review proposals as soon as possible after they arrive and strives to respond to proposers within sixty (60) days after receipt of proposal.

5.4 NOTICES

The following notices will be provided as applicable:

• Request for clarifying details (if applicable)

• May occur at any time during the evaluation process.

• Will not include requests for proposal changes and changes will not be permitted.

• Notice of non-selection

• The Proposer will be advised their proposal submission has not been selected.

• Notice of selection

• The selection notice will notify the proposer that the Government has selected their proposal for negotiation of 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

Notices will be sent via email to the Technical and Administrative point of contacts identified in the proposal.

5.5 HANDLING OF COMPETITION SENSITIVE INFORMATION

It is the policy of ARPA-H to protect all proposals as competitive sensitive information and to disclose their contents only for the purpose of evaluation and only to screened personnel for authorized reasons, to the extent permitted under applicable laws. Restrictive notices notwithstanding, during the evaluation process, submissions may be handled by ARPA-H support contractors for administrative purposes and/or to assist with technical evaluation.

All ARPA-H support contractors are expressly prohibited from performing ARPA-H sponsored technical research and are bound by appropriate nondisclosure agreements. Input on technical aspects of the proposals 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.

6. AWARD ADMINISTRATION INFORMATION

6.1 ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS

CONTROLLED UNCLASSIFIED INFORMATION (CUI) ON NON-FEDERAL

INFORMATION SYSTEMS

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

INTELLECTUAL PROPERTY

Proposers must provide a good faith representation that the proposer either owns or possesses the appropriate licensing rights to all intellectual property (IP) that will be utilized for the proposed effort. ARPA-H strongly encourages IP rights be aligned with open-source regimes. Further, it is desired that all software (including source code), software documentation, and 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.

NOTE: IP rights assertions will be reviewed under evaluation criteria 2 stated in Section

5.2.

SOFTWARE COMPONENT STANDARDS

ARPA-H is committed to advancing interoperability in today's health ecosystem and laying the foundation for emerging technologies to interoperate in the health ecosystem of the future. With that in mind, we anticipate that performers will develop software components that fall into three categories: (1) components that can leverage today's existing standards without impeding R&D, (2) components where extensions to existing standards will be necessary to unlock new capabilities in an interoperable way, and (3) components in areas where consensus-based standards do not yet exist or where use of standards would seriously limit the ability to efficiently conduct R&D. For proposals in the first two categories, all health information technology (IT) components must adhere to or (as needed) expand upon applicable national standards adopted by the U.S. Department of Health and Human Services (HHS), including the Office of the National Coordinator for Health Information Technology (ONC) (e.g., Fast Healthcare Interoperability

Resources (FHIR) and United States Core Data for Interoperability (USCDI)).3 Whenever such an existing standard is available that meets the scientific, technical, and research needs of the proposed effort, performers must use the existing standard instead of creating their own. In cases where an existing standard provides only partial functionality, performers should expand upon the existing standard, ideally in a way that does not prohibit or interfere with backward compatibility, and create sufficient documentation for

3 https://www.healthit.gov/sites/default/files/page/2022-

07/Standards_And_Implementation_Specifications_Adopted_Under_Section_3004.pdf https://www.ecfr.gov/current/title-32/subtitle-B/chapter-XX/part-2002 https://www.healthit.gov/sites/default/files/page/2022-07/Standards_And_Implementation_Specifications_Adopted_Under_Section_3004.pdf https://www.healthit.gov/sites/default/files/page/2022-07/Standards_And_Implementation_Specifications_Adopted_Under_Section_3004.pdf

ONC, or other HHS agencies, to evaluate extensions for potential inclusion in the national standard (including open APIs and open data formats).

For proposals that contain software elements, commercial-friendly open-source licenses

(e.g., MIT, BSD, or Apache 2.0) are preferred. If an open, consensus-based standard does not yet exist, proposers should identify the aspects that lack an open standard, describe a plan to develop a general-purpose open data model and to prototype new open APIs.

Strong proposals will explain how the performer will enhance data interoperability

(including semantic interoperability) and expand the availability of open, consensus-based standards and data models. The development of open-source data translators, expansion of existing open standards, and interoperability enhancements for open data models are all of interest.

Strong proposers will develop and/or integrate existing open-source solutions aligning with existing national standards and regulatory guidance. Proposals must include a technical plan to align with applicable HHS-adopted health IT standards (45 CFR Part 170

Subpart B).(For the full description of standards adopted in CFR Part 170, Subpart B, please review the complete text of the regulations at https://www.ecfr.gov/current/title-

45/subtitle-A/subchapter-D/part-170/subpart-B.) Strong proposals will also outline the use of other open, consensus-based standards, such as Digital Imaging and Communications in

Medicine (DICOM).4 When applicable, strong proposals will also outline integration with the Trusted Exchange Framework and Common Agreement (TEFCA). Adhering to international standard ISO/IEEE 11073 will enable broad support for current and future devices, especially those developed internationally.

HUMAN SUBJECTS RESEARCH

All entities submitting a proposal for funding that will involve engagement in human subjects research (as defined in 45 CFR § 46) must provide documentation of one or more current Assurance of Compliance with federal regulations for human subjects protection, including at least a Department of Health and Human Services (HHS), Office of Human

Research Protection Federal Wide Assurance. All human subjects research must be reviewed and approved by an Institutional Review Board (IRB), as applicable under 45

CFR § 46 and/or 21 CFR § 56. The entities human subjects research protocol must include a detailed description of the research plan, study population, risks and benefits of study participation, recruitment and consent process, data collection, and data analysis.

Recipients of ARPA-H funding must comply with all applicable laws, regulations, and policies for the ARPA-H funded work. This includes, but is not limited to, laws, regulations, and policies regarding the conduct of human subjects research, such as the

U.S. federal regulations protecting human subjects in research (e.g., 45 CFR § 46, 21 CFR

§ 50, § 56, § 312, § 812) and any other equivalent requirements of the applicable jurisdiction.

The informed consent document utilized in human subjects research funded by ARPA-H must comply with all applicable laws, regulations, and policies, including but not limited to U.S. federal regulations protecting human subjects in research (45 CFR § 46, and, as applicable, 21 CFR § 50). The protocol package submitted to the IRB must contain evidence of completion of appropriate human subjects research training by all

4 https://www.healthit.gov/isa/ https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ecfr.gov%2Fcurrent%2Ftitle-45%2Fsubtitle-A%2Fsubchapter-D%2Fpart-170%2Fsubpart-B.&data=05%7C02%7CLisa.Wagner%40hhs.gov%7C159afe30fac74c25274608dc1c24d59d%7Cd58addea50534a808499ba4d944910df%7C0%7C0%7C638416191734435079%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=H9kouWydEjF6HLD7sKapna7cnd%2Bi1lVk2KoCCcZ%2Fcf0%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ecfr.gov%2Fcurrent%2Ftitle-45%2Fsubtitle-A%2Fsubchapter-D%2Fpart-170%2Fsubpart-B.&data=05%7C02%7CLisa.Wagner%40hhs.gov%7C159afe30fac74c25274608dc1c24d59d%7Cd58addea50534a808499ba4d944910df%7C0%7C0%7C638416191734435079%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=H9kouWydEjF6HLD7sKapna7cnd%2Bi1lVk2KoCCcZ%2Fcf0%3D&reserved=0 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46 https://www.hhs.gov/ohrp/index.html https://www.hhs.gov/ohrp/index.html https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50 investigators and key personnel who will be involved in the design or conduct of the

ARPA-H funded human subjects research. Funding cannot be used toward human subjects research until ALL approvals are granted.

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: (i) 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); (ii) 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 complete and submit the Vertebrate Animal Section worksheet for all proposed research anticipating Animal Subject Research.

All Animal Use Research must undergo review and approval by the local Institutional

Animal Care Use Committee (IACUC) prior to incurring any costs related to the animal use research.

ORGANIZATIONAL CONFLICTS OF INTEREST (OCI)

Proposers, through submission of a proposal, are required to identify and disclose all facts relevant to a potential OCI involving the proposer, the proposer’s organization and/or any proposed team member (proposed subawardee). Along with the disclosure, the proposer shall submit a mitigation plan, which is a description of the action the performer has taken to avoid, neutralize or mitigate the stated OCI. The Government may require proposers to provide additional information to assist the Government in evaluating the

OCI mitigation plan.

If the Government determines a 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.

AGENCY SUPPLEMENTAL OCI POLICY

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

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

▪ The name of the ARPA-H office receiving the support https://olaw.nih.gov/sites/default/files/VASchecklist.pdf

▪ The prime contract number; and

▪ Identification of proposed team member (proposed subawardee) providing the support.

RESEARCH SECURITY DISCLOSURES

In accordance with NSPM-33, Research Organizations should identify and mitigate conflicts of commitment and conflicts of interest (CoC/CoI) to receive federal funding.

Research organizations proposing to this ISO must provide additional documentation as requested for Senior/Key Personnel for ARPA-H to determine any risk. The format for this submission can be found in the Bundle of Attachments, Administration and National

Security.

ELECTRONIC INVOICING AND PAYMENTS

Performers will be required to register in and submit invoices for payment in https://www.ipp.gov/

GOVERNMENT-FURNISHED PROPERTY/EQUIPMENT/INFORMATION

Government-furnished property/equipment/information may be provided to selected performers, depending on award vehicle negotiated and applicable law and/or regulation.

QUESTIONS & ANSWERS

All questions regarding this ISO should be submitted to https://solutions.arpa-h.gov/Ask-A-Question/. ARPA-H will post Q&As to the ARPA-H ISO Website on an on-going basis.

ARPA-H will attempt to answer questions in a timely manner. ARPA-H highly encourages parties to review the Q&As prior to submitting a question.

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APPENDIX A: ABSTRACT TEMPLATE

ABSTRACT COVER LETTER

<PRIME ORGANIZATION LOGO (OPTIONAL)>

Innovative Solutions Opening

Abstract Title

Submitter Organization

Type of Organization

Choose all that apply: Large Business, Small

Disadvantaged Business, Other Small Business, HBCU, MI, Other Educational, or Other Nonprofit

Technical Point of Contact (POC)

Name:

Mailing Address:

Telephone:

Email:

Administrative POC

Name:

Mailing Address:

Telephone:

Email:

Total Basis of Estimate Total: $

Place(s) of Performance

Other Team Members (subawardees and consultants) if any

Technical POC Name:

Organization:

Organization Type:

NOTE: All submissions must be written in English with font type NOT smaller than 12-point font.

Smaller font may be used for figures, tables, and charts. Delete all formatting and content instructions prior to submission. Content recommendations are displayed in blue font and should be deleted prior to abstract submission. Abstracts have a limit of six pages. Citations do not count towards the six page limit.

CONCEPT SUMMARY

Describe the abstract concept with minimal jargon and explain how it addresses the HSF interest areas of the ISO

INNOVATION AND IMPACT

Clearly identify the outcome(s) sought and/or the problem(s) to be solved with the proposed technology concept. Describe how the proposed effort represents an innovative and potentially revolutionary solution to the HSF interest areas. Explain the concept’s potential to be disruptive compared to existing or emerging technologies and how the proposed approach will go far beyond current existing capabilities.

To the extent possible, provide quantitative metrics in a table that compares the proposed technology concept to current and emerging technologies which may include:

▪ A progression of increasingly complex technical challenges.

▪ State of the art / emerging technology “baseline.”

▪ Aggressive metrics in for each year of the proposed project.

▪ Summary of specific outcomes from the proposed research.

PROPOSED WORK

Describe the final deliverable(s) for the project, key interim milestones, and the overall technical approach used to achieve project objectives. Discuss alternative approaches considered, if any, and why the proposed approach is most appropriate for the project objectives. Describe the background, theory, simulation, modeling, experimental data, or other sound engineering and scientific practices or principles that support the proposed approach. Provide specific examples of supporting data and/or appropriate citations to the scientific and technical literature. Identify adoption challenges to be overcome for the proposed technology to be successful. Describe why the proposed effort is a significant technical challenge and the key technical risks. At a minimum, the abstract should address:

▪ Does the approach require one or more entirely new technical developments to succeed?

▪ How will technical risk be mitigated?

▪ What use cases, capabilities, or demonstrations will be featured?

TEAM ORGANIZATION AND CAPABILITIES

Indicate the roles and responsibilities of the organizations and key personnel that comprise the Project

Team. Provide the name, position, and institution of each key team member and describe in 1-2 sentences the skills and experience they bring to the team.

BASIS OF ESTIMATE (BOE)

Please include a BOE of timeline and federal funds requested, as well as the total project cost including cost sharing, if applicable. The BOE should also include a breakdown of the work by direct labor (fully burden), labor hours, subcontracts, materials, equipment, other direct costs (e.g., travel), profit, cost sharing, and any other relevant costs. The below table may be used for this breakdown:

Categories Amount

Direct Labor (Fully burden)

Labor hours

Subawardees

Materials

Equipment

Travel

Other Direct Costs

Profit

Total

Cost Sharing (if applicable/appropriate)