PHO Open Office Innovation Solutions Opening.pdf

PROACTIVE HEALTH OFFICE

OFFICE-WIDE INNOVATIVE SOLUTIONS OPENING FOR

ADVANCED RESEARCH PROJECTS AGENCY FOR HEALTH

ARPA-H-SOL-24-106

March 14, 2024

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. SOLUTION SUMMARY AND PROPOSAL PREPARATION AND SUBMISSION INFORMATION

4.1 SOLUTION SUMMARY PREPARATION

4.2 SOLUTION SUMMARY SUBMISSION

4.3 PROPOSAL PREPARATION

4.4 PROPOSAL SUBMISSION INFORMATION

4.5 SOLUTION SUMMARY AND PROPOSAL SUBMISSION DEADLINES

4.6 PROPRIETARY INFORMATION

4.7 SECURITY INFORMATION

5. SOLUTION SUMMARY REVIEW AND EVALUATION OF PROPOSALS

6. AWARD ADMINISTRATION INFORMATION

6.1 ADMINISTRATION AND NATIONAL POLICY REQUIREMENTS

APPENDIX A: SOLUTION SUMMARY 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 PROACTIVE HEALTH OFFICE

INNOVATIVE SOLUTIONS OPENING (ISO)

ANNOUNCEMENT TYPE Research and Development Solicitation

SOLICITATION NUMBER: ARPA-H-ISO-24-01

ASSISTANCE LISTING NUMBER: 93.384

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

ATTN: ARPA-H-ISO-24-01

SOLUTION SUMMARY SUBMISSION SITE: https://solutions.arpa-h.gov

PROPOSAL SUBMISSION SITE: https://solutions.arpa-h.gov/Submit-Proposal/

NOTE: Proposers’ requesting a Cooperative Agreement are strongly encouraged to submit a proposals to the ARPA-H proposal link (https://solutions.arpa-h.gov/Submit-Proposal/); however, those proposals maybe submitted to Grants.gov.

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

DATES: (All times listed herein are Eastern Time)

DRAFT Release Date: 28 February 2024

Release Date: 14 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: Solution summary 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/ https://solutions.arpa-h.gov/Submit-Proposal/ https://solutions.arpa-h.gov/Submit-Proposal/ https://solutions.arpa-h.gov/Submit-Proposal/ https://grants.gov/ https://solutions.arpa-h.gov/Ask-A-Question/

2. DESCRIPTION OF THE SOLICITATION:

2.1 INTRODUCTION

Despite huge advances in the development of novel medical therapies, Americans still live with poor health outcomes and suffer from the ill-effects of disease. Current medical research and the medical delivery system in the United States focus primarily on the reactive treatment of illnesses, despite the fact that many diseases or their ill-effects are preventable.

The Proactive Health Office (PHO) at ARPA-H is seeking solutions to improve the healthspan and health outcomes of Americans prior to the onset of disease and/or the development of diminished quality of life from illness. Specifically, PHO hypothesizes that 1) population-level improvements in access to and uptake of disease prevention and wellness-promoting behaviors and 2) development of novel early-detection methods and prophylactic interventions could drastically improve the health of American throughout their lives, and 3) that system level innovations are required for delivery of proactive health effectively. Specific PHO interest areas include:

Novel prevention, detection and prophylactic treatment methods for disease:

• Novel and scalable methods for early detection of disease and illness including the use of low/no-cost sensing modalities.

• Prophylactic approaches to prevention of diseases and harmful disease outcomes.

• Methods for continuous and widespread sensing of health state and early disease indicators that can be deployed at population-scale.

Population-level approaches to increase the adoption of prevention and wellness behaviors:

• Early indicators of disease and pre-disease states and measures associated with proactive health outcomes that are both inexpensive and effective. Low-cost, high-uptake mental health resiliency and mindfulness building methods for individuals.

• Methods to inform and educate individuals about healthy behaviors including lifestyle and preventative medical measures.

• Methods that incentivize individuals to adopt and maintain healthy behaviors.

• Novel approaches to increasing individual health span and independence even in the absence of disease.

System innovation for the delivery of proactive health outcomes:

• Novel, robust and predictive surrogates for long-term health outcomes with associated epidemiological models.

• Valuation models for long-term treatment effects for vaccination, screening and other public health interventions.

• New funding and delivery models for preventative interventions.

Other high-quality submissions that propose revolutionary technologies that meet the goals of PHO 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 PHO interest areas or 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 PHO Office-wide ISO is just one of several Office solicitations. Thus, each ISO has a targeted area of interest, may request submission of solution summaries and/or proposals and will contain instructions informing industry how to properly submit a responsive solution summary 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.

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

This ISO is targeting universities, non-profit organizations, small businesses and other than small businesses, hospitals, community health centers and non-Federal research centers capable of performing research and/or development of PHO interest areas.

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

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 a potential proposer 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 potential proposer to submit an official solution summary submission and include the proposal as an attachment to the solution summary.

2.3 SOLICITATION PROCEDURES

This ISO will be solicited through ARPA-H ISO external facing (public) website, SAM.gov and Grants.gov. See Section 4 for solution summary and proposal preparation 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 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 the Agreement type proposed. The ISO has two (2) attachment bundles that will contain proposal submission templates and a Model Agreements (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 https://arpa-h.gov/engage/baa/ https://sam.gov/content/home https://www.grants.gov/ 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 a solution summary 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 PHO interest area, the FFRDC or Government Entity should contact the ISO Contact 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. SOLUTION SUMMARY AND PROPOSAL PREPARATION AND SUBMISSION

INFORMATION

4.1 SOLUTION SUMMARY PREPARATION

Submission of a solution summary is a mechanism for potential proposers to get feedback prior to investing resources for a full proposal submission.

4.2 SOLUTION SUMMARY SUBMISSIONS

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.

All solution summary submissions must be written in English. All solution summaries submitted in response to this solicitation must comply with the content and formatting requirements in Appendix A. Potential proposers are strongly encouraged to use the template provided.

Information not explicitly requested in this ISO, Appendix A may not be reviewed.

Solution summary submissions must be submitted to: https://solutions.arpa-h.gov

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 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 submission should be submitted to https://solutions.arpa-h.gov/Submit-Proposal/.

NOTE: Proposers’ requesting a Cooperative Agreement are strongly encouraged to submit a proposals to the ARPA-H proposal link (https://solutions.arpa-h.gov/Submit-Proposal/); however, those proposals maybe submitted to Grants.gov.

4.5 SOLUTION SUMMARY AND PROPOSAL SUBMISSION DEADLINES

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

A solution summary must be submitted prior to proposal submission. If the solution summary is encouraged, ARPA-H will request that proposers submit a full proposal within 45 days from receipt of solution summary feedback unless an alternative timeline is provided.

Proposals may be submitted under this ISO while the solicitation remains open, currently https://solutions.arpa-h.gov/ https://sam.gov/content/home https://sam.gov/content/home https://sam.gov/content/home https://sam.gov/content/home https://solutions.arpa-h.gov/Submit-Proposal/ https://solutions.arpa-h.gov/Submit-Proposal/ https://grants.gov/ 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 6.1 for Controlled Unclassified Information (CUI) compliance requirements.

5. SOLUTION SUMMARY REVIEW AND EVALUATION OF PROPOSALS

5.1 SOLUTION SUMMARY REVIEW PROCESS

ARPA-H will review and provide written feedback to all solution summaries submitted in accordance with the instruction stated in Section 4. 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 solution summary cover page. ARPA- H strives to provide solution summary feedback within 30 business days of receipt of the solution summary.

NOTE: All parties, whether encouraged or discouraged to submit a proposal, are eligible to submit a proposal to the ISO. Solution summaries must be submitted, and feedback received prior to proposal submission, unless a PM has requested a solution summary submission with a proposal as an attachment as stated in Section 4.2.

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.

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 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. COST REALISM

Cost realism analysis will only be performed on selectable proposals that will be recommended for funding. Cost realism analysis ensures 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 to 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 cost 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 PHO 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 solution summaries 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

• 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

The health and healthcare data eco-system is complex and multi-dimensional with a variety of standards for data models, data transmission protocols, data routing methods etc.

that are similar to and extend the International Standards Organization (ISO) Open https://www.ecfr.gov/current/title-32/subtitle-B/chapter-XX/part-2002

Systems Interconnection Model (OSI)2. ARPA-H programs are likely to involve research that touches on multiple layers of the OSI model from low level radio frequency (RF) based protocols for transmission of data from implantable devices (potentially OSI layers 1-5), to secure and fault tolerant networking protocols for medical devices (potentially OSI layers 3-6) to the exchange of health information including Electronic Health Records, lab results and medical images related to a patient between healthcare facilities and health data brokers including but not limited to Health Information Exchanges (HIE) and Trusted Exchange Framework and Common Agreement (TEFCA) Qualified Health Information Networks using protocols such as HL7 FHIR (OSI Layer 7). This diversity requires careful consideration of the most appropriate standards to be used for the specific technologies in development and the layer at which they operate.

ARPA-H is committed to advancing interoperability in today’s health ecosystem through the adoption of open, consensus driven standards and laying the foundation for emerging technologies to interoperate in the health ecosystem of the future through the evolution of these standards across all layers of the health data IT eco-system. With that in mind, we anticipate that potential performers will develop software and data communication components that fall into three categories: (1) components that can leverage today's existing standards without impeding the 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.

Whenever such an existing standard is available that meets the scientific, technical, and research needs of the proposed effort, proposers must use the existing standard instead of creating their own. In cases where an existing standard provides only partial functionality, proposers should expand upon the existing standard, ideally in a way that does not prohibit or interfere with backward compatibility, and create sufficient documentation for Office of the National Coordinator for Health Information Technology (ONC), the U.S. Department of Health and Human Services (HHS) agencies or standards organizations, to evaluate extensions for potential inclusion in the standard (including open Application Programming Interfaces (APIs) and open data formats).

In the case of information relating health and healthcare data at higher layers of the OSI model, all health information technology (IT) components should adhere to or (as needed) expand upon applicable national standards adopted by HHS, including the ONC (e.g., Fast Healthcare Interoperability Resources (FHIR) and United States Core Data for Interoperability (USCDI)).3

Technical solutions 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.

2 ISO/IEC 7498 https://www.iso.org/standard/20269.html 3 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 https://www.healthit.gov/sites/default/files/page/2022-07/Standards_And_Implementation_Specifications_Adopted_Under_Section_3004.pdf

Proposals must include a technical plan to align with applicable standards based on the OSI layer at which they are operating including but not limited to 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 when applicable, strong technical solutions 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. At other layers of the OSI model, and for software components operating outside the network stack e.g. health databases, Picture Archiving and Communication Systems (PACS) etc. other standards will be relevant and strong technical solutions will seek to utilize or expand upon appropriate open, consensus-based standards4.

If a technical solution requires an extension of existing standards or development of technologies outside of the standards, the proposer must schedule a meeting with ARPA-H representatives to discuss the deviation to the standards prior to proposal submission.

HUMAN SUBJECTS RESEARCH

All proposers 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 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

4 Examples of such open, consensus based standards include but are not limited to, the Digital Imaging and Communications in Medicine (DICOM) standard for medical image storage, the Global Alliance for Genomics and Health standards for storage of genomic data such as the Variant Call Format (VCF).

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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 proposer 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 The prime contract number; and Identification of proposed team member (proposed subawardee) providing the support.

RESEARCH SECURITY DISCLOSURES

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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 Payment Management Services.

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: SOLUTION SUMMARY TEMPLATE

SOLUTION SUMMARY COVER LETTER

<PRIME ORGANIZATION LOGO (OPTIONAL)>

Innovative Solutions Opening Solution Summary 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 solution summary submission. Solution summaries have a limit of six pages. Citations do not count towards the six-page limit.

CONCEPT SUMMARY

Describe the solution summary concept with minimal jargon and explain how it addresses the PHO 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 PHO 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 solution summary 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)