The Advanced Research Projects Agency for Health (ARPA-H) has issued an Innovative Solutions Opening (ISO) for the "Genetic Medicines and Individualized Manufacturing For Everyone (GIVE)" program (ARPA-H-SOL-25-129). This initiative seeks to revolutionize biomanufacturing to enable rapid, affordable, and widespread access to genetic and personalized/individualized (P/I) medicines, particularly RNA-based therapies, for terminal, rare, and chronic diseases. The program envisions a distributed manufacturing network capable of producing GMP-quality genetic medicines in non-GMP environments like hospitals. GIVE is structured into two technical areas (TAs): Automated RNA Manufacturing (TA1) and Integrated Quality Control (TA2). The program spans 54 months over three phases, with a focus on developing highly automated, integrated, and digitally compliant systems for both manufacturing and quality control. Eligibility is open to all responsible sources, with an emphasis on U.S. entities, and proposals will be evaluated on scientific merit, proposer capabilities, contribution to the ARPA-H mission, and cost. Solution Summaries are due December 19, 2025, and Full Proposals by February 27, 2025.

The ARPA-H GIVE Attachment A outlines the Solution Summary Template for proposals, detailing formatting and content requirements for federal grants. Submissions must be in English, with an 11-point font minimum (smaller for figures). Page limits are 10 pages for a single Technical Area (TA) or 12 for both TAs, excluding the Title Page and References. Key sections include a Title Page (with team, cost, and contact details), a one-page Concept Summary, a Proposed Work section (up to 6 or 8 pages depending on TA count), a one-page Innovation and Impact section, a one-page Team Organization and Capabilities section, and a one-page Basis of Estimate. The document provides clear guidance for structuring proposals to address technical areas, articulate innovative solutions, detail team capabilities, and present a comprehensive budget breakdown.

The ARPA-H GIVE Attachment B1 outlines the comprehensive format and instructions for submitting full proposals. It details required components like the Title Page, Background, Technical Plan Overview, Technical Plan, Innovation and Impact, and Capabilities and Management Plan. The document specifies formatting requirements, including page limits (30 pages for single TA, 40 for both TAs) with certain sections excluded, such as the Title Page, Appendices, References, and Resumes. Proposals must address all program phases and relevant Technical Areas (TA1, TA2, or both) and include detailed technical approaches, challenges, and solutions. Appendices provide crucial information on Quality Target Product Profiles (QTPP) and Phase 2 and 3 product targets for various RNA formats, along with representative GMP Product Quality Attributes, emphasizing the need for comprehensive quality control and manufacturing plans.

Attachment B2 outlines the full proposal format and instructions for an Alternative Approach to the ARPA-H GIVE program, focusing on Manufacturing (TA1) and Quality Control (TA2) solutions. Proposers must submit an integrated proposal addressing the Program Vision, demonstrating why their alternative approach is superior to the existing ISO. Proposals can target one or both TAs and must adhere to strict formatting guidelines, including page limits (30 pages for a single TA, 40 for both) and specific content sections like Background, Technical Plan Overview, Technical Plan, Innovation and Impact, and Capabilities and Management Plan. Excluded from page limits are the Title Page, Appendices (A-D), References, and Resumes. Appendices detail Quality Target Product Profiles (QTPP) and product targets for Phase 2 (Non-GMP) and Phase 3 (GMP), along with representative GMP product quality attributes, providing critical metrics for RNA-based products. The document emphasizes conciseness, specific examples, and adherence to evaluation criteria.

ARPA-H GIVE's Attachment B2 outlines the full proposal format and instructions for an alternative approach to manufacturing (TA1) and quality control (TA2) solutions. Proposers must submit an integrated document addressing the Program Vision, demonstrating why their alternative is superior to the existing ISO approach. Proposals should not exceed 30 pages for a single TA or 40 pages for both, excluding the title page, references, resumes, and appendices. Key sections include Background, Technical Plan Overview, Technical Plan, Innovation and Impact, and Capabilities and Management Plan. The Technical Plan is central, requiring detailed tasks, metrics, milestones, and deliverables. Appendices A, B, C, and D provide templates for Quality Target Product Profiles (QTPP) and product quality attributes for Phase 2 and Phase 3, which must be completed by offerors. The document emphasizes conciseness, specific examples, and adherence to formatting guidelines to ensure proposals are reviewed.

Attachment C, the Administrative & National Policy Requirements Document, is a critical component of federal government proposals, outlining essential administrative, policy, and compliance requirements. It mandates comprehensive disclosure of team member identification, including U.S. and non-U.S. entities, and requires senior/key personnel to submit Biographical Common Forms and Current and Pending (other) Support Common Forms to address potential conflicts of interest and commitment. The document also addresses Federally Funded Research and Development Center (FFRDC) participation, Organizational Conflicts of Interest (OCI) with specific disclosure and mitigation plan requirements, and detailed research security disclosures concerning malign foreign talent recruitment programs and foreign ownership or research execution. Furthermore, it requires information on the novelty of proposed work, intellectual property (IP) assertions and associated government rights, and details regarding Human Subjects Research (HSR) and Animal Subjects Research (ASR), including necessary approvals. Representations on unpaid delinquent tax liability or felony convictions, cybersecurity protocols for securing systems and managing Controlled Unclassified Information (CUI), and biosecurity plans addressing dangerous gain-of-function research and synthetic nucleic acid procurement are also required. The document emphasizes accuracy, completeness, and adherence to federal policies, with certifications against misrepresentation.

The provided government file outlines the structure for a Task Description Document (TDD) and a Milestone Payment Schedule for federal government RFPs, grants, and state/local RFPs. The TDD details project tasks across a Base Period (Phase 1) and two Option Periods (Phases 2 and 3), broken down by technical area and individual tasks. Each task requires descriptions, responsible organizations, completion criteria (qualitative and quantitative metrics), and deliverables. The Milestone Payment Schedule links tasks to milestones with due dates, descriptions, exit criteria, deliverables, and associated payment values, including ARPA-H payments and performer cost-sharing. The document emphasizes clear, quantifiable criteria for tasks and milestones to track program progress and ensure verifiable outcomes.

The document "ATTACHMENT E: GANTT Chart Sample" provides a template for a project schedule, likely for government RFPs, grants, or similar initiatives. It outlines a structured approach to project management using a GANTT chart format, detailing tasks and milestones with specific start and end dates over a multi-quarter timeline. Key features include Go/No-Go indicators for critical milestones, fractional numbering for duration, and visual representations for tasks (blue bars) and milestones (triangles). The template emphasizes the importance of clear task titles, milestone descriptions with associated exit criteria, and a flexible timeline to represent project progression. It serves as a representative example, not a fixed schedule, allowing for adaptation to various project needs while ensuring all critical elements are tracked.

This government file, "ATTACHMENT F: Cost Proposal Spreadsheet," provides a comprehensive template for submitting cost proposals for multi-party or prime/sub government projects. It outlines detailed instructions for prime performers, sub-performers, and team members to ensure consistent and thorough cost reporting across all project phases (Phase I, II, and III). Key components include direct labor costs by category and technical area, sub-performer and team member costs, sub-contractor and consultant costs, and other direct costs such as materials, equipment, and travel. The spreadsheet also features sections for profit, cost share, and a detailed breakdown of costs by task/milestone. It emphasizes the need for separate spreadsheets from each entity, fully burdened labor rates, and clear explanations for cost share arrangements, assuming a March 1, 2026, project start date.

The document, "ATTACHMENT G: COST PROPOSAL NARRATIVE," outlines the requirements for submitting a cost proposal for government contracts, grants, or RFPs. It details the necessary components of a written narrative that substantiates price/cost drivers, in addition to a cost spreadsheet. Proposers must include an index for all cost details and supplemental information. Key sections of the proposal include organizational information, technical and administrative points of contact, period and place of performance, and team member details. The document specifies nine critical elements for price/cost details: level of effort, materials, equipment purchases, travel, other direct costs (ODCs), cost sharing, consultant costs, team member costs, and a value analysis explaining the return on investment for taxpayer dollars. Each section requires detailed breakdowns, supporting documentation, and assumptions to justify proposed costs, including indirect costs and profit/cost share. The proposal must adhere to specific formatting guidelines and remain valid for at least 120 days. This comprehensive guide ensures transparency and accountability in government procurement.

ARPA-H-SOL-25-129, GIVE, is an Innovative Solutions Opening (ISO) focused on Genetic Medicines and Individualized Manufacturing for Everyone (GIVE). This amendment outlines key changes to dates, including a Proposers’ Day on November 13, 2025, a question submission deadline of February 13, 2026, and full proposals due on February 27, 2026. The program seeks to revolutionize biomanufacturing of RNA-based genetic medicines, enabling rapid, cost-effective, and localized production in non-GMP environments like hospitals. It comprises two technical areas (TAs): Automated RNA Manufacturing (TA1) and Integrated Quality Control (TA2), both requiring a 54-month, three-phase development. Offerors must submit quality target product profiles for three distinct RNA products and address regulatory assessment, business models, and technoeconomic feasibility. The solicitation also welcomes alternative approaches that meet the GIVE vision.