APPENDIX-C.0-Proposal Format and Instructions.docx

APPENDIX C: PROPOSAL FORMAT, INSTRUCTIONS, AND EVALUATION

ARPA-H-SOL-26-160

Fast Assessment of Solutions, Therapeutics, Pharmaceuticals, and SupplieS (FASTPASS)

FASTPASS

ARPA-H-SOL-26-160

1. PROPOSAL FORMAT AND INSTRUCTIONS

1.1 CONFORMING SUBMISSION

(a) 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 if it does not meet the following solicitation requirements:

· The concept is applicable to the stated solicitation and program.

· The proposer meets the eligibility requirements.

· Meets the submission requirements, including content and formatting requirements in the solicitation instructions.

· The proposer’s concept has not received funding or been selected for award negotiations for another funding opportunity (whether from ARPA-H or another government agency).

(b) ARPA-H may eliminate non-conforming proposals without further review or consideration. ARPA-H may not consider non-conforming proposals for negotiations or award. ARPA-H also reserves the right to reject proposals as nonconforming when it determines a previous submission was scientifically meritorious but was not reviewed due to lack of relevance to the ISO or not selected for award due to programmatic fit. Proposers will be notified of non-conforming determinations via email correspondence.

1.2 NOTICES

The following Notices will be provided as applicable to the Technical and Administrative points of contact identified in the proposal on ARPA-H’s Solution Submission Portal:

· Request for clarifying details

· May occur any time during the proposal evaluation process.

· Will not include requests for proposal changes; changes to proposals will not be permitted at this stage.

· Notice of non-selection

· The proposer will be advised that its proposal submission has not been selected for funding.

· Notice of selection

· The selection notice will notify the proposer that the government has selected its proposal for negotiation of a 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.

1.3 PROPOSAL SUBMISSION INSTRUCTIONS

(a) Proposal submissions are due by the date listed in the ISO Summary Information Section. All proposal documents must be submitted in .pdf, .odx, .doc, .docx, or .exe formats. All submissions must be written in English and all pages must be formatted for printing on 8-1/2 by 11-inch paper with 1-inch margins and sans serif font size not smaller than 11 point. Font sizes of 8 or 10 point may be used for figures, tables, and charts. The government will not consider pages in excess of the page count limitations, as described herein. Proposals with fewer than the maximum number of pages will not be penalized.

(b) Proposers are encouraged to submit concise and concrete proposals. Specific examples of problems, approaches, or goals are preferred to qualitative generalities. Additional information not explicitly called for in the Technical & Management Proposal must not be submitted, but may be included as links in the bibliography. Any additional materials included in the proposal package will be considered for the reviewers’ convenience only and not evaluated as part of the proposal.

(c) The following matrix is designed to help proposers with their submission:

Cost Proposal Workbook

(d) Appendix E - Draft Other Transaction Agreement has been included to provide potential proposers an initial draft of the ARPA-H agreement for this effort. The proposer must include a copy of the draft agreement with any redlines/comments/proposed edits and supporting rationale as a part of the proposal package. If no redline/comments/edits are proposed, the proposer must provide a written statement that there are no proposed changes. The redlined copy of the agreement or the statement of no proposed changes does not count towards any page limitations for the proposal and will not be evaluated as part of the review and selection process.

2. PROPOSAL EVALUATION

2.1 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.

2.2 HANDLING SELECTION SENSITIVE INFORMATION

(a) It is ARPA-H’s intent to protect all proposals as selection-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 Freedom of Information Act (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.

(b) 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.

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

2.3 EVALUTION AND AWARD DISCLAIMERS

(a) 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.

(b) 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.

(c) 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, 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.

2.4 REVIEW AND SELECTION PROCESS

(a) It is ARPA-H policy to ensure impartial, fair, transparent, and comprehensive evaluations of proposals based on the evaluation criteria listed herein and to select the source (or sources) with the proposal(s) 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. Proposal evaluations will be based solely on the following evaluation criteria.

(b) ARPA-H intends to review proposals as soon as possible after receipt and strives to respond to each proposer within sixty (60) calendar days after receipt of their proposal(s). ARPA-H will not evaluate proposals against each other during the scientific technical review process; rather, ARPA-H will evaluate each proposal based on its own merits to determine how well it meets ISO criteria.

2.5 EVALUTION CRITERIA FOR PROPOSALS

ARPA-H will conduct a scientific and technical review of each conforming proposal, evaluating proposals on how well the submission meets the criteria stated in this ISO. All proposals will be evaluated using the following evaluation criteria, listed in descending order of importance.

Criterion 1: Overall Scientific and Technical Merit The proposed technical approach is highly innovative and technically sound 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.

Criterion 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 bio-sketches provided for the performer team members including the Principal Investigator, Project Manager, Regulatory expert, Product Development Lead (PDL), Commercialization Experts, and any other key personnel on the project team as requested by ARPA-H.

Criterion 3: Potential Contribution to Relevance to the ARPA-H Mission and User Experience

Proposals will be evaluated on the potential future Research & Development (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 pharmaceutical import assessment ; the degree to which the proposed project has the potential to transform pharmaceutical import assessment. The interdisciplinarity of the approach will also be considered. Further, the proposed solution contemplates the end user and reflects an understanding of the direct needs and benefits for stakeholders, whether they are regulators, patients, providers, health systems or payers. For example, how will this be accessible to users in all geographies, and at an affordable cost?

Criterion 4: Assessment of Proposed Cost/Price

(a) All proposals will be evaluated to determine the reasonableness or value of the estimated price/cost proposed to accomplish the technical approach. Analysis may be performed to ensure proposed costs are realistic for the proposed scientific and technical approach and capabilities/related experience, accurately reflect the technical goals and objectives of the solicitation, the proposed costs are consistent with the proposer’s technical approach and reflect a sufficient understanding of the costs and effort needed to successfully accomplish the proposed technical approach. 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).

(b) It is expected the effort will leverage all available relevant prior research to obtain the maximum benefit from the available funding. For efforts with a likelihood of commercial application, appropriate resource sharing may be a positive factor in the evaluation. Proposers are encouraged to incorporate creative approaches to cost-sharing, resource contributions, and/or return-on-investment (ROI) mechanisms that align with program objectives and anticipated project outcomes. Examples may include- but are not limited to- cash or in-kind performer contributions, shared-use infrastructure, data or IP access arrangements, or post-performance value-sharing models (e.g., revenue participation, discounted buy-back rights, or royalty considerations).

(c) Inclusion of such mechanisms is not required, and may be evaluated in the context of overall technical merit, reasonableness, value, and potential public benefit. AOs retain discretion to negotiate, adjust, or omit such provisions based on the unique nature, risk profile, and expected impact of the proposed effort. Proposers are encouraged to describe how their approach contributes to maximizing taxpayer value and sustaining long-term innovation outcomes.

Note: Proposers are encouraged to propose the best technical solution. For example, proposers are discouraged from proposing low-risk ideas with minimum uncertainty or to staff the proposed effort with junior personnel to be more appealing from a budget perspective. ARPA-H seeks novel solutions that are reflective of the level of effort and risk proposed.

3. POLICY REQUIREMENTS AND MISCELLANEOUS OTHER INFORMATION

3.1 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.

3.2 INTELLECTUAL PROPERTY (IP)

The proposer must provide a good faith representation that it 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 rules. Further, it is desired that all software (including source code), software documentation, and data generated and/or developed under the proposed project be provided as a deliverable to the government. IP delivered to the government should align with the project or program goals and should be aligned with the level of government funding provided to generate and/or develop the IP.

3.3 SOFTWARE COMPONENT STANDARDS

3.3.1 The health- and healthcare data eco-system is complex and multidimensional 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’s Open Systems Interconnection (OSI)[footnoteRef:2] Model. ARPA-H programs are likely to involve research that touches on multiple layers of the OSI model, from low-level radio frequency-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 (HER), lab results, and medical images related to a patient between healthcare facilities and health data brokers, including (but not limited to) Health Information Exchanges and Trusted Exchange Framework and Common Agreement (TEFCA) Qualified Health Information Networks using protocols such as HL7 Fast Healthcare Interoperability Resources (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. [2: https://www.iso.org/standard/20269.html]

3.3.2 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 information technology (IT) eco-system. With that in mind, we anticipate that the performer will develop software and data communication components that fall into three categories:

· components that can leverage today's existing standards without impeding the R&D,

· components where extensions to existing standards will be necessary to unlock new capabilities in an interoperable way, and

· 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.

3.3.3 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 the Office of the National Coordinator for Health Information Technology (ONC), and 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).

3.3.4 In the case of information relating to health- and healthcare data at higher layers of the OSI model, all health IT components should adhere to or (as needed) expand upon applicable national standards adopted by HHS, including the ONC (e.g., FHIR and United States Core Data for Interoperability).[footnoteRef:3] [3: https://www.healthit.gov/sites/default/files/page/202207/Standards_And_Implementation_Specifications_Adopted_Under_Section_3004.pdf]

3.3.5 Technical solutions that contain software elements with commercial-friendly open-source licenses (e.g., Massachusetts Institute of Technology, Berkley Software Distribution, or Apache 2.0) are preferred. If an open, consensus-based standard does not yet exist, the proposer 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. A strong proposal will explain how the performer will enhance data interoperability (including semantic interoperability) and expand the availability of open, consensus-based standards and data models.

3.3.6 A proposal 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, review the complete text of the regulations; a strong technical solution will also outline integration with the TEFCA. Adhering to International Standards Organization/Institute of Electrical and Electronics Engineers standard 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, etc.) other standards will be relevant, and strong technical solutions will seek to utilize or expand upon appropriate open, consensus-based standards[footnoteRef:4]. [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).]

3.3.7 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 prior to proposal submission to discuss the deviation to the standards.

3.4 ORGANIZATIONAL CONFLICTS OF INTEREST (OCI)

Through submission of a proposal, the proposer is required to identify and disclose all facts relevant to a potential OCI involving the proposer, its organization, and/or any proposed team member (proposed sub-awardee). Along with the OCI disclosure, the proposer must submit an OCI 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. The government may reject the proposal and withdraw it from consideration for award if it determines the proposer failed to:

· fully disclose an OCI; or

· provide the affirmation of ARPA-H support; or

· reasonably provide additional information requested by the government to assist in evaluating the proposer’s OCI mitigation plan.

3.5 ORGANIZATIONAL 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 sub-awardee, 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:

3.6 RESEARCH SECURITY DISCLOSURES

3.6.1 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.

3.7.2 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 or key personnel.

3.7.3 After a proposal is selected for negotiations of a potential award, ARPAH 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.

3.7.4 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.

3.8 ELECTRONIC INVOICING AND PAYMENTS

Performers will be required to register in, and submit invoices for payment through, the Payment Management Services (PMS) at https://pms.psc.gov.

Invoices must include a justification (limited to 1,000 characters) such as the following, due to the requirement for government approval in the Defend the Spend (DTS) System:

The payment is justified for the FASTPASS program to [include the purpose of the project] for Milestones (s) (or TDD tasks/references) [x.x] that were accepted by the Program Manager on [date].

3.9 PROCUREMENT OF SYNTHETIC NUCLEIC ACIDS OR BENCHTOP SYNTHESIZERS

HHS funds may only be used to procure synthetic nucleic acids or benchtop nucleic acid synthesis equipment from sources adhering to the Office of Science and Technology Policy Framework for Nucleic Acid Synthesis Screening.

3.10 DANGEROUS GAIN-OF-FUNCTION RESEARCH

HHS Funds may not be used to conduct any dangerous gain-of-function research, per the definition in Section 8 of Executive Order (E.O.) 14292 on Improving the Safety and Security of Biological Research and the United States Government Policy for Stopping High-Risk Research. Further, per Section 3 of E.O. 14292, no HHS Funds may be used to fund life science research with foreign entities in countries of concern (e.g., China) pursuant to 42 U.S.C. 6627(c), or in other countries where there is not adequate oversight to ensure that the countries are compliant with United States oversight standards and policies.

3.11 GOVERNMENT FURNISHED PROPERTY/EQUIPMENT/INFORMATION

Government-furnished property/equipment/information may be provided to selected performers. Include any planned government-furnished property/equipment/information here.

ADDITIONAL LINKS

42 U.S.C. § 290c(g)(1)(D) https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section290c&num=0&edition=prelim

ARPA-H’s public website https://arpa-h.gov/explore-funding/open-funding-opportunities

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

National Archives (CUI Registry) https://www.archives.gov/cui/registry/category-list

ARPA-H’s Solution Submission Portal https://solutions.arpa-h.gov/Ask-A-Question/

CHIPS and Science Act of 2022 https://www.govinfo.gov/content/pkg/PLAW-117publ167/pdf/PLAW-117publ167.pdf

50 U.S.C. § 3059 https://uscode.house.gov/view.xhtml?req=(title:50%20section:3059%20edition:prelim)

Controlled Unclassified Information on Non-Federal Information Systems

32 CFR § 2002

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

ARPA-H does not anticipate human subjects research or animal research for FASTPASS. If proposing human subjects or animal research proposals must adhere to all application laws and best practices including those listed below.

Human Subjects Research (HSR)

45 CFR § 46

https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46

Office of Human Research Protection Federal Wide Assurance https://www.hhs.gov/ohrp/index.html

21 CFR § 56

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56

21 CFR § 50

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50

Animal Subjects Research

Department of Agriculture rules that implement the Animal Welfare Act of 1966 https://www.nal.usda.gov/animal-health-and-welfare/animal-welfare-act

7 U.S.C. § 2131-2159 https://www.govinfo.gov/content/pkg/USCODE-2015-title7/html/USCODE-2015-title7-chap54.htm

Public Health Service Policy on Humane Care and Use of Laboratory Animals https://olaw.nih.gov/policies-laws/phs-policy.htm

U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training https://olaw.nih.gov/policies-laws/gov-principles.htm

Guide for the Care and Use of Laboratory Animals: Eighth Edition, Copyright

2011, NAS

https://olaw.nih.gov/policies-laws/guide-care-use-lab-animals worksheet https://olaw.nih.gov/sites/default/files/VASchecklist.pdf

Research Security Disclosures National Security Policy Memorandum 33 https://www.nsf.gov/bfa/dias/policy/nspm-33-implementation-guidance

Electronic Invoicing and Payments Payment Management Services https://pms.psc.gov/