One Comprehensive Universal Radiotherapy for Everyone (1-CURE)

Form / Attachment / Pricing Sheet

This document is Appendix H, a "Dangerous Gain of Function Assessment" form. Its purpose is to assist the 1-CURE Proposal Review team in conducting an initial review of proposed initiatives to determine the risks of potentially dangerous gain of function research, in accordance with U.S. Government Executive Order 14292.

• Program Details: Includes fields for Program Title (1-CURE), Proposal Title, Principal Investigator, and a Proposal Description.
• Scope: Asks specific questions regarding research activities involving prions or prion-like agents, and whether the work seeks or achieves any of the seven defined outcomes that enhance harmful consequences, disrupt beneficial responses, confer resistance to interventions, increase stability/transmissibility, alter host range, enhance susceptibility, or enable prion-like infectious transmission.
• Societal Consequences: Inquires about potential significant societal consequences threatening public health, safety, economic, or national security.
• Foreign Involvement: Asks if any research will be conducted by foreign entities in foreign countries.
• Risk Assessment: Requires an assessment of the overall risk for dangerous gain of function research.
• Mitigation Plan: Requires a plan to avoid dangerous gain of function risk and mitigate other biosafety and biosecurity risks.

Bidders proposing research under the 1-CURE program must complete this form. It requires detailed information about the proposed research, potential risks related to gain of function and societal impact, foreign involvement, and mitigation strategies. This assessment is crucial for the government's review process to ensure compliance with Executive Order 14292 and to evaluate the safety and security of the proposed biological research.

Form / Attachment / Pricing Sheet

This document outlines the requirements for a Data Management and Sharing Plan (DMSP) that must be submitted with research applications involving the generation of scientific data. It details the expected components of the plan, which are designed to ensure responsible data management and sharing practices.

• Element 1: Data Type: Specifies the types and amount of scientific data to be generated, preserved, and shared, along with the rationale and associated metadata.
• Element 2: Related Tools, Software and/or Code: Identifies any specialized tools or software needed to access or manipulate the shared data.
• Element 3: Standards: Outlines the common data standards to be applied for interoperability.
• Element 4: Data Preservation, Access, and Associated Timelines: Details the repository for archiving data, how it will be findable and identifiable, and the timeline for availability.
• Element 5: Access, Distribution, or Reuse Considerations: Addresses factors affecting data access, distribution, or reuse, including privacy, confidentiality, and any limitations.
• Element 6: Oversight of Data Management and Sharing: Describes the monitoring and management of compliance with the plan.

Bidders proposing research that will generate scientific data must develop and submit a DMSP according to these guidelines. This document is crucial for understanding the data management and sharing obligations associated with the research, ensuring compliance with NIH policies, and preparing a complete application.

Form / Attachment / Pricing Sheet

This document, Appendix F, outlines the Administrative & National Policy Requirements for proposal submissions. It must be completed in full and included as part of Volume III of the proposal. Bidders must not delete any portion of this document.

• Formatting Requirements: Pages must be 8-1/2 by 11 inches with 1-inch margins and a sans-serif font size of at least 11 point (8- or 10-point for figures, tables, charts). No page limit.
• Submission Formats: Must be in .pdf, .doc, or .docx formats, written in English.
• Cover Page: Requires Proposal Title, Proposer Organization, Technical Point of Contact (TPOC), Administrative POC (APOC), Date of Proposal Submission, and Proposal Validity Period.
• Team Member Identification: A table to list all organizations/institutions comprising the team, their status (U.S./non-U.S.), and role.
• Senior/Key Personnel: A table to list Senior/Key Personnel, their organization, and confirmation of attached common forms (Biographical Sketch, Current & Pending Support).
• FFRDC Participation: Disclosure and justification if an FFRDC is included.
• Organizational Conflict of Interest (OCI): Affirmations and disclosures regarding potential conflicts of interest and commitment, including specific questions about support to ARPA-H and mitigation plans.
• Research Security Disclosure: Questions regarding participation in foreign talent recruitment programs (FTRPs), foreign ownership, and research conducted in foreign countries of concern (FCOCs).
• Novelty of Proposed Work: Disclosure if the proposed work has been submitted to other government solicitations or has received prior funding.
• Intellectual Property (IP): A table to identify background IP or restricted data, its expected role, basis for assertion, associated government rights, and the asserting entity. Specific guidance on rights categories (Unlimited, Government Purpose, Limited, Specially Negotiated/Other) is provided.
• Human Subjects Research (HSR) & Animal Subjects Research (ASR): Questions regarding involvement in HSR or ASR, requiring documentation of IRB/IACUC review and assurances.
• Representations: Declarations regarding unpaid delinquent tax liability or felony convictions.
• Cybersecurity: Questions about the organization's cybersecurity program, standards, incident response, and experience managing Controlled Unclassified Information (CUI).
• Biosecurity: Questions regarding dangerous gain-of-function research and the procurement of synthetic nucleic acids or benchtop nucleic acid synthesis equipment.

This document is critical for bidders as it details the mandatory administrative, policy, and personnel information required for proposal submission. It outlines specific disclosure requirements related to conflicts of interest, research security, intellectual property, and compliance with federal regulations. Failure to complete and submit this appendix accurately and in the specified format may result in proposal rejection.

Form / Attachment / Pricing Sheet

This document provides instructions and content requirements for the "Solution Summary" submission, a critical component of the proposal for the ARPA-H 1-CURE program (Solicitation ARPA-H-SOL-26-147).

• General Instructions: Specifies formatting (English, 12-point font, 0.5" margins), page limits (4 pages, excluding cover page, basis of estimate, team qualifications, TPP, references), and submission format (PDF to ARPA-H Solution Submission Portal). Attachments and embedded links are prohibited.
• Content Requirements: Proposers must address relevance to ARPA-H mission and 1-CURE program, technical merit, team organization, capabilities, and qualifications. Responses should frame answers using the first four Heilmeier questions and include Team Qualifications, R&D timeline, and Rough Order of Magnitude (ROM).
• Cover Page Format: Details required information including Solution Summary Title, Technical Approach, Team Lead, Organization Type, UEI, POCs (Technical and Administrative), Basis of Estimate (Total $), Place(s) of Performance, and Other Team Members.
• Concept Summary: Requires identification of applicable technical areas and a description of the solution concept.
• Innovation and Impact: Demands clear identification of outcomes/problems, description of innovative/revolutionary solutions, and quantitative metrics comparing proposed technology to current/emerging technologies.
• Proposed Work: Outlines the need to describe final deliverables, milestones, technical approach, alternative approaches considered, supporting data/citations, adoption challenges, technical risks, and mitigation strategies.
• Target Product Profile (TPP): Requires a specific TPP (max 1 page, excluded from page limit) outlining characteristics, features, and performance specifications.
• Team Organization and Capabilities: Requires roles, responsibilities, and qualifications of key personnel and organizations.
• Basis of Estimate (BOE): Requires a detailed breakdown of timeline and requested federal funds, including direct labor, labor hours, subawards, materials, equipment, travel, indirect costs, profit, and cost sharing.

This document is essential for bidders to understand the specific content, format, and submission requirements for their Solution Summary. Adherence to these instructions is critical for proposal acceptance and evaluation. Bidders must pay close attention to page limits, required content sections, and formatting guidelines to ensure their submission is reviewed.

Form / Attachment / Pricing Sheet

This document provides detailed instructions and requirements for submitting a full proposal in response to the ARPA-H-SOL-26-147 solicitation. It outlines the structure, content, and formatting for each of the four required volumes.

Proposal Structure: Proposals must consist of four volumes:

• Volume I: Technical and Management Proposal: Includes Cover Page, Executive Summary, Solution Fit, Technical Plan, Management Plan, Capabilities, Commercialization Plan, Task Description Document (TDD), Target Product Profiles, Schedule and Milestones, Data Management and Sharing Plan (DMSP), and References. Page limits are specified for most sections, with a total maximum of 20 pages for core sections.
• Volume II: Cost Proposal: Includes Cover Page, Cost Proposal Spreadsheet (using provided template), and Cost and Pricing Data Support. No maximum page count is specified for this volume.
• Volume III: Administrative and Policy Requirements Submission: Includes Cover Page and sections for Team Member Identification, Organizational Conflict of Interest (OCI) Affirmations, National Security Disclosure, Novelty of Proposed Work, Intellectual Property (IP), Human Subjects Research, Animal Subjects Research, and Representations Regarding Unpaid Delinquent Tax Liability or Felony Conviction.
• Volume IV: Draft OT Response: Requires submission of a draft Other Transaction (OT) agreement with any redlines or comments, or a statement of no proposed changes.

Formatting Requirements:

• 8-1/2 by 11-inch paper with 1-inch margins.
• Font size no less than 11 point (Arial or non-serif).
• Page numbers at the bottom.
• Clear labeling with ISO number, organization, and proposal title.

This document is critical for bidders as it dictates the exact format, content, and submission requirements for their proposals. Adherence to these instructions, including page limits and formatting, is essential for a compliant and competitive submission. It details what information is required in each section of the proposal, including specific content for the Executive Summary, Technical Plan, Cost Proposal, and administrative/policy requirements.

Form / Attachment / Pricing Sheet

This document provides the Target Product Profile (TPP) Guidelines for the 1-CURE program. It outlines the acceptable product specifications for products developed under this program and details the minimum expectations for proposers when submitting a TPP for each selected TA (Therapeutic Area).

• Product Name: Example provided: '1-CURE Smart Radiotherapy System'.
• Product Description: Details the technology, such as immunogenic smart radiotherapy biomaterials (SRBs) and an Abscopal Treatment Planning System (ATPS) for integration with FLASH radiotherapy (FLASH-RT) machines.
• Critical Quality Attributes (CQA): Specifies requirements like image-guidance capability and predictable abscopal effects.
• Lead Indications & Target Population: Covers all indications for standard radiotherapy, plus efficacy against metastatic tumors for all cancer patients.
• Storage and Handling: Provides guidelines for storing SRBs (room temperature or 4ºC) and ATPS (cloud or memory device, meeting U.S. regulatory standards).
• Key Features: Outlines performance, comparators, clinical benefits, and regulatory strategy for both SRBs and ATPS.
• Economic Value: Discusses cost-effectiveness, potential reimbursement models, and cost reduction compared to current immunotherapies.

Proposers must submit a TPP for each TA selected, detailing technology capabilities. This document serves as the template and guide for developing that TPP, outlining the government's minimum expectations for product specifications, performance, and regulatory compliance within the 1-CURE program.

Form / Attachment / Pricing Sheet

This document is a template for a Task Description Document (TDD). It is intended to guide bidders in detailing their proposed approach to fulfilling the requirements of a solicitation. Bidders are strongly encouraged to use this template for their proposals.

• General Objective: A high-level description of the proposal's goal.
• Tasks/Subtasks: A breakdown of the work to be performed, including:
  • Objective of each task/subtask.
  • Detailed description of the approach.
  • Location where work will be performed (e.g., university campus).
  • Primary organization responsible for execution.
  • Deliverables (with IP assertions if applicable).
  • Whether human subjects or animal research is involved.
  • Measurable milestones for progress and completion.

This template provides a structured format for bidders to outline their technical approach. It requires specific details on task execution, responsibilities, deliverables, and compliance with research regulations. Completing this document thoroughly will be crucial for demonstrating a clear understanding of the requirements and a viable plan to meet them.

Form / Attachment / Pricing Sheet

This document is Appendix G, a Security Attestation Form required for the agreement. It requires the prime organization and covered individuals to make certifications regarding participation in Malign Foreign Talent Recruitment Programs (MFTRP).

• Certifications by the prime organization and the covered individual that they are not party to a Malign Foreign Talent Recruitment Program (MFTRP).
• Acknowledgement by the covered individual of annual recertification requirements.
• Assertion by the prime organization to report any new covered individuals or changes to conflict of commitment disclosures within 10 days of discovery.
• Acknowledgement by the prime organization that new personnel require a Research Security Assessment by ARPA-H before beginning work.
• Signature blocks for the covered individual and an official responsible for the transaction.

Bidders must complete and submit this form as part of their proposal or agreement process. It signifies compliance with security and research integrity requirements, specifically concerning foreign talent recruitment programs. Failure to provide these attestations may impact eligibility or award.

Other / Unclassified

This document is a draft "Other Transaction Agreement" (OTA) template intended for use by the Advanced Research Projects Agency for Health (ARPA-H). It outlines the standard terms and conditions that would govern an agreement between ARPA-H and a performer for research and development projects. The document includes detailed articles covering the scope of the agreement, term, project management, administration, payment, disputes, intellectual property rights, foreign access to intellectual property, property disposition, public release of information, and various compliance requirements.

While this is a template and not a specific solicitation, it provides potential bidders with critical insight into ARPA-H's standard contractual and administrative expectations for Other Transaction Agreements. Key areas of interest for bidders include:

• Intellectual Property Rights: Details how subject inventions and data developed under the agreement will be handled, including performer retention of rights, government licenses, and disclosure requirements.
• Payment Structure: Outlines a milestone-based payment system tied to deliverables.
• Reporting and Deliverables: Specifies requirements for technical status reports, program plans, milestone reports, and final reports.
• Foreign Access and Restrictions: Addresses controls on transferring intellectual property to foreign entities.
• Dispute Resolution: Defines the process for resolving disagreements.
• Prohibitions: Includes clauses related to telecommunications and video surveillance equipment.

Understanding these terms is crucial for bidders to assess the feasibility and implications of participating in an ARPA-H opportunity structured as an OTA.

Solicitation / RFP / RFQ

This solicitation, "One Comprehensive Universal Radiotherapy for Everyone (1-CURE)", seeks innovative solutions to develop a revolutionary radiotherapy (RT) approach for all cancers. The program aims to integrate ultra-high dose rate (FLASH)-RT with multifunctional immunogenic smart radiotherapy biomaterials (SRBs) to boost the abscopal effect, leading to regression of both local and metastatic tumors with minimal toxicities. The goal is to achieve a universal curative treatment approach.

This solicitation is divided into two Technical Areas (TAs):

• TA1: Immunogenic Nanoparticle SRBs: Develop multi-functional nanoparticle SRBs that can guide FLASH-RT, boost abscopal responses, and deliver immunoadjuvants for high therapeutic efficacy.

• TA2: Abscopal Treatment Planning System (ATPS): Develop an ATPS that integrates FLASH-RT and immunogenic SRBs to plan 1-CURE treatments for effective abscopal responses (>90%) with minimal toxicities.

• Anticipated Awards: Multiple Other Transaction (OT) Agreements.

• Period of Performance: 60 months, structured into three phases (Phase I: 18 months, Phase II: 18 months, Phase III: 24 months).

• Submission Process: Includes optional Proposers' Day, mandatory Solution Summary submission, followed by Full Proposal submission for selected teams.

• Key Deadlines:

  • Questions & Answers (Q&A) due: April 8, 2026
  • Solution Summaries due: April 15, 2026
  • Full Proposals due: May 22, 2026

• Evaluation Criteria:

  1. Overall Scientific and Technical Merit
  2. Proposer's Capabilities and/or Related Experience
  3. Potential Contribution to Relevance to the ARPA-H Mission and User Experience
  4. Price/Cost

• Eligible Proposers: Universities, non-profit organizations, small businesses, and other than small businesses are eligible. Federally Funded Research and Development Centers (FFRDCs) and other Government entities are prohibited from responding as prime or sub-performers.

• Cost Share: For-profit organizations not qualifying as small businesses are required to contribute a meaningful cost share.

• Proposals must address both TA1 and TA2.

• Teams must include a Lead Principal Investigator (PI), Project Manager, and Product Development Lead (PDL).

• Proposers are encouraged to team across geographies.

• Awards are expected to result in Other Transactions (OTs).

Form / Attachment / Pricing Sheet

This document, "APPENDIX A: SOLUTION SUMMARY CONTENT AND INSTRUCTIONS," provides detailed guidance for proposers on how to prepare and submit a Solution Summary for the ARPA-H 1-CURE program (ISO-26-147). It outlines the required content, formatting, and submission procedures.

• General Instructions: Specifies English language, minimum 12-point font (except for figures/tables), 0.5" margins, and deletion of all formatting instructions prior to submission. Solution Summaries are limited to four (4) pages, excluding cover page, basis of estimate, team qualifications, target product profile (TPP), and references.
• Submission Format: Must be submitted in PDF format to the ARPA-H Solution Submission Portal. Attachments and embedded links are not allowed.
• Content Requirements: Must address relevance to ARPA-H mission and 1-CURE program, technical merit, team organization, capabilities, and qualifications. Proposers must frame responses using the first four Heilmeier questions and include Team qualifications, R&D timeline, Rough Order of Magnitude (ROM), and Basis of Estimate (BOE).
• Cover Page: Specific format required, including Solution Summary Title, Technical Approach (TA) Selection, Team Lead/Organization, Type of Organization, UEI, POCs (Technical and Administrative), Basis of Estimate (Total $), and Place(s) of Performance.
• Other Sections: Includes guidance on Concept Summary, Innovation and Impact, Proposed Work, Target Product Profile (TPP), Team Organization and Capabilities, and Basis of Estimate (BOE).

This document is critical for bidders as it dictates the structure, content, length, and submission method for the Solution Summary. Adhering to these instructions is essential for a compliant and competitive submission. It highlights the specific information ARPA-H expects to evaluate, including technical approach, team strength, innovation, and cost estimates.