APPENDIX C_Proposal Format and Instructions_IGoR_Amendment 03.pdf
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- Attached to
- Intelligent Generator of Research (IGoR) - ISO
- Solicitation number
- ARPA-H-SOL-26-155
About this file
This document is Appendix C of a federal solicitation, providing proposal format instructions, evaluation criteria, and policy requirements for ARPA-H (Advanced Research Projects Agency for Health) funding opportunities.
Proposals must be submitted in PDF, ODX, DOC, DOCX, XLS, or XLSX format with 1-inch margins, sans serif font minimum 11 point (8-10 point acceptable for figures/tables/charts), and conform to specified page limits: Technical & Management Proposal (40 pages maximum), Task Description Document (no page limit), Cost Proposal and Workbook (no page limit), Administrative National Policy Document (no page limit), and Draft Other Transaction Agreement (no page limit). Submissions must address all four Technical Areas and all three Phases, demonstrate concept applicability to the stated program, verify proposer eligibility, and confirm the concept has not received prior funding or award negotiations from ARPA-H or other government agencies. A solution summary submission is required before full proposal submission. Proposals will be evaluated on four primary criteria in descending order of importance: Overall Scientific and Technical Merit (innovation, technical soundness, defined path to completion, risk identification and mitigation, IP rights structure, and open-source adherence); Proposer's Capabilities and Related Experience (team expertise, delivery track record, cost/schedule management ability, and similar completed/ongoing efforts); Potential Contribution to ARPA-H Mission and User Experience (R&D and commercial/clinical applications, unmet biomedical needs, transformation potential, interdisciplinarity, and end-user accessibility across geographies and affordability); and Assessment of Proposed Cost/Price (cost realism, consistency with technical approach, substantiated labor/materials/equipment costs, and leverage of prior research). The proposal must include completed OCI disclosures with mitigation plans, research security disclosures per CHIPS and Science Act Section 10631 (addressing Malign Foreign Talent Recruitment Programs and foreign countries of concern), vertebrate animal research documentation with IACUC approval plans (if applicable), human subjects research documentation with IRB Assurance (if applicable), IP ownership/licensing verification with preference for open-source alignment, software component standards adherence (leveraging existing consensus-driven standards or extending them), Genomic Data Sharing Policy compliance (if applicable), and electronic invoicing registration in Payment Management Services. Additional restrictions prohibit dangerous gain-of-function research, require synthetic nucleic acid procurement from OSTP Framework-compliant sources, and restrict synthetic biology funding with foreign entities in countries of concern.
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APPENDIX C: PROPOSAL FORMAT, INSTRUCTIONS, AND EVALUATION
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 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.
• Content and formatting meet requirements in the solicitation instructions. The submission includes the requirement to address all four Technical Areas and all three Phases in the proposal.
• 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).
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 o May occur any time during the proposal evaluation process.
o Will not include requests for proposal changes; changes to proposals will not be permitted at this stage.
• Notice of non-selection o The proposer will be advised that its proposal submission has not been selected for funding.
• Notice of selection o 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, xls, or .xlsx 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. Narrow or condensed fonts should not be used. 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:
Proposal Section Reference Page Limit
Technical & Management Proposal
Appendix C.1 40
Task Description Document (TDD)
Appendix C.2 Does Not Count Against Page Limit
Cost Proposal and Cost Proposal Workbook
Appendix C.3 Does Not Count Against Page Limit
Admin National Policy Document
Appendix D Does Not Count Against Page Limit
Draft Other Transaction Agreement
Appendix E Does Not Count Against Page Limit
(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 shall include a copy of the draft agreement with any redlines/comments/proposed edits as part of the proposal package. If no redline/comments/edits are proposed, ARPA-H will interpret that as the proposer’s acceptance of the draft other transaction agreement’s terms and conditions as-is. The redlined copy of the agreement does not count towards any page limitations for the proposal.
2. PROPOSAL EVALUATION
2.1 PROPOSAL REVIEW PROCESS
Submission of a solution summary is required before submission of a full proposal.
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 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 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 as soon as possible 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.
Criterion 3: Potential Contribution to Relevance to the ARPA-H Mission and User Experience Proposals will be evaluated on the potential future Research & Development-, commercial-, and/or clinical applications of the project proposed, including whether such applications may have the potential to address areas of currently unmet need within biomedicine and improve health outcomes; the degree to which the proposed project has the potential to transform biomedicine. 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 patients, providers, health systems or payers. For example, how would this solution fit inside the clinical workflow? Or, how will this be accessible to users in all geographies, and at an affordable cost?
Criterion 4: Assessment of Proposed Cost/Price
All proposals will be evaluated to determine the 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).
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 and resource contributions that align with program objectives.
Examples include cash, in-kind contributions, shared infrastructure, data, and IP access arrangements. Inclusion of such cost/resource sharing mechanisms is not required, but may be evaluated in the context of overall technical merit, reasonableness, value, and potential public benefit. Agreement Officers 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.
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
The proposer must provide a good faith representation that it 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 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 https://www.ecfr.gov/current/title-32/subtitle-B/chapter-XX/part-2002 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 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.
3.3.2 Whenever such an existing standard is available that meets the scientific, technical, and research needs of the proposed effort, proposers should 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.
3.3.3 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.
3.4 GENOMIC DATA SHARING (GDS) POLICY
If applicable, an award resulting from this ISO will include the requirement to comply with the National Institutes of Health’s GDS Policy (NOT-OD-14-124).
Information about the GDS policy can be found at:
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-24-157.html.
3.5 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.
3.6 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:
• The name of the ARPA-H office receiving the support
• The prime contract number and
• Identification of proposed team member (including any proposed sub-awardee) providing the support.
3.7 RESEARCH SECURITY DISCLOSURES
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-24-157.html
3.7.1 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 https://www.whitehouse.gov/wp-content/uploads/2022/01/010422-NSPM-33-Implementation-Guidance.pdf 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 requests for payment through, the Payment Management Services (PMS) at https://pms.psc.gov.
Requests must include the following justification (limited to 1,000 characters), due to the requirement for government approval in the Defend the Spend (DTS) System:
The payment is justified for the IGoR 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. 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 is not expected to be provided to performers.
3.12 HUMAN SUBJECTS RESEARCH
3.10.1 A proposal for funding that will involve engagement in human subjects research (HSR) (as defined in 45 CFR § 46) must provide documentation of one or more current Assurance(s) of Compliance with federal regulations for human subjects’ protection, including at least a Department of Health and Human Services (HHS), Office of Human https://pms.psc.gov/ https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46 https://www.hhs.gov/ohrp/index.html
Research Protection Federal Wide Assurance. All HSR must be reviewed and approved by an Institutional Review Board (IRB), as applicable under 45 CFR § 46 and/or 21 CFR § 56. The entity’s HSR 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 ARPA-H funded work. This includes, but is not limited to, laws, regulations, and policies regarding the conduct of HSR, 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.
3.10.2 The informed consent document utilized in HSR 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 HSR training by all investigators and key personnel who will be involved in the design or conduct of the ARPA-H funded HSR. Funding cannot be used toward HSR until ALL approvals are granted.
3.13 VERTEBRATE ANIMAL SUBJECTS RESEARCH
3.11.1 All entities submitting a proposal for funding that will involve engagement in vertebrate animal subjects research (award recipients performing research, experimentation, or testing involving the use of animals) shall comply with the laws, regulations, and policies on animal acquisition, transport, care, handling, and use as outlined in:
• 9 CFR parts 1-4, U.S. Department of Agriculture rules that implement the Animal Welfare Act of 1966, as amended, (7 U.S.C.
§ 2131-2159); and,
• the Public Health Service Policy on Humane Care and Use of Laboratory Animals, which incorporates the “U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training,” and "Guide for the Care and Use of Laboratory Animals" (8th Edition).”
3.11.2 Proposers must provide documentation of a current Animal Welfare
Assurance (AWA) on file with the Office of Laboratory Animal Welfare 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-21/chapter-I/subchapter-A/part-56 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 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-812 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 https://www.govinfo.gov/content/pkg/USCODE-2015-title7/html/USCODE-2015-title7-chap54.htm https://www.govinfo.gov/content/pkg/USCODE-2015-title7/html/USCODE-2015-title7-chap54.htm
(OLAW). The proposer must complete and submit the Vertebrate Animal Section worksheet for all proposed research anticipating Animal Subject Research (ASR). 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. For all proposed research anticipating animal use, proposals should briefly describe plans for IACUC review and approval as described in the Appendix D - Administrative & National Policy Document.
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
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://olaw.nih.gov/sites/default/files/VASchecklist.pdf https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section290c&num=0&edition=prelim https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section290c&num=0&edition=prelim https://arpa-h.gov/explore-funding/open-funding-opportunities https://sam.gov/content/home https://www.archives.gov/cui/registry/category-list https://solutions.arpa-h.gov/Ask-A-Question/ https://www.govinfo.gov/content/pkg/PLAW-117publ167/pdf/PLAW-117publ167.pdf https://uscode.house.gov/view.xhtml?req=(title:50%20section:3059%20edition:prelim) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46 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/ https://www.hhs.gov/ohrp/index.html https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50 https://www.nal.usda.gov/animal-health-and-welfare/animal-welfare-act https://www.govinfo.gov/content/pkg/USCODE-2015-title7/html/USCODE-2015-title7-chap54.htm https://www.govinfo.gov/content/pkg/USCODE-2015-title7/html/USCODE-2015-title7-chap54.htm https://olaw.nih.gov/policies-laws/phs-policy.htm https://olaw.nih.gov/policies-laws/gov-principles.htm https://olaw.nih.gov/policies-laws/guide-care-use-lab-animals https://olaw.nih.gov/sites/default/files/VASchecklist.pdf https://www.nsf.gov/bfa/dias/policy/nspm-33-implementation-guidance https://pms.psc.gov/
| 1. PROPOSAL FORMAT AND INSTRUCTIONS |
| 2. PROPOSAL EVALUATION |
| 3. POLICY REQUIREMENTS AND MISCELLANEOUS OTHER INFORMATION |
File details come from the government source that posted it. Updated .