ARPA-H Comprehensive Organ System Modeling in Outer Space (COSMOS) Innovative Solutions Opening

The Advanced Research Projects Agency for Health (ARPA-H) has issued an Innovative Solutions Opening (ISO), solicitation number ARPA-H-SOL-26-165, for the Comprehensive Organ System Modeling in Outer Space (COSMOS) program. This initiative seeks to negotiate multiple Other Transaction (OT) Agreements to investigate if microgravity in Low Earth Orbit (LEO) accelerates human tissue aging. Specifically, the program will quantify the Tissue Aging Rate in Space (TARIS) relative to the Tissue Aging Rate on Earth (TAROE) across four critical organs: brain, heart, uterus, and kidney. The program consists of two sequential phases over a 42-month period: - Phase I (27 months) focuses on establishing and validating microphysiological systems (organs-on-chips) and organoids across three adult age brackets (30, 45, and 65 years). Performers will conduct a LEO Twin Study utilizing autonomous hardware provided by government-selected Commercial Service Providers (CSPs), alongside a baseline terrestrial study and an in silico aging model. Phase I requires establishing a commercial public-private partnership (PPP) with a Fortune 100 biopharmaceutical company. - Phase II (15 months) will leverage tissue models where TARIS significantly exceeds TAROE to develop disease models and conduct high-throughput drug screening in LEO for pro-regenerative therapeutics in collaboration with the biopharmaceutical partner. Proposals must include a Technical Management Proposal (Volume I) and a Cost Proposal (Volume II), with submissions due by October 7, 2026, at 2:00 PM ET. Eligible proposers include universities, non-profits, and commercial entities, while FFRDCs and federal government entities are generally excluded from participating as primes or sub-performers.

This document is Attachment E (Administrative & National Policy Requirements Document) for the ARPA-H COSMOS program, which proposers must complete and submit when applying for Other Transaction (OT) Agreements. It establishes administrative, compliance, and national security requirements that proposers must address to ensure eligibility and alignment with federal policies. Key components of the document include: * **Team & Personnel Identification:** Proposers must identify all team members, indicate if they are "covered institutions" under NSPM-33, and submit biographical sketches, current/pending support forms, and collaborator details for key personnel. * **National Security & Disclosures:** Proposers must certify that no key personnel participate in malign foreign talent recruitment programs (FTRPs), disclose any foreign ownership or foreign-based work, and identify potential organizational conflicts of interest (OCI). * **Intellectual Property (IP):** Proposers must assert any background IP or restricted data incorporated into the project and define the associated government rights (e.g., Unlimited, Government Purpose, or Limited Rights). * **Regulatory Compliance:** The document requires disclosures and protocol details regarding Human Subjects Research (HSR), Animal Subjects Research (ASR), unpaid federal tax liabilities, and felony convictions. * **Cybersecurity & Biosecurity:** Proposers must describe their cybersecurity infrastructure and Controlled Unclassified Information (CUI) management strategies. Additionally, they must disclose involvement in dangerous gain-of-function research or the procurement of synthetic nucleic acids in compliance with biosecurity guidelines.

This document is "Attachment A.1: Technical & Management Proposal Model," a structured template and guideline for applicants submitting proposals to ARPA-H under the COSMOS solicitation. It outlines the required administrative, technical, and management sections that proposers must complete. The document is structured into specific parts, including: - **Administrative Cover Pages:** Collects key information such as the prime organization’s details, UEI, points of contact, requested funding, animal/human subjects usage, and sub-awardee/consultant team members. - **Executive Summary (1-page limit):** Demands a concise synopsis of the project’s goals, health impacts, novel approach, technical risks, and potential misuses. - **Goals and Impact (1-page limit):** Outlines qualitative and quantitative outcomes, technology adoption risks, and includes an "Innovative Claims Table" comparing the project to current state-of-the-art methods. - **Technical Plan (10-page limit):** Requires a detailed experimental design, risk mitigation strategies, a schedule matching the Task Description Document (TDD), and intermediate quantitative milestones. - **Capabilities & Management Plan (2-page limit):** Describes team expertise, organizational structure (including a required Project Manager/Integrator), and coordination plans. - **Supporting Technical Documents:** Details requirements for a non-proprietary Phase I TDD, a Data Management and Sharing Plan (DMSP), a Gantt chart timeline, references, and NIH Biosketches. The final section provides a "Document Descriptions" table summarizing the page limits for all proposal attachments, establishing a strict 14-page limit for the core Technical & Management Proposal (exclusive of bibliography and TDD).

This document details the template and instructions for the ARPA-H Standard Cost Proposal spreadsheet, a tool designed to assist government personnel in reviewing, negotiating, and evaluating cost proposals submitted by prime and subproposers. The spreadsheet facilitates a rapid and standardized analysis of proposed costs for Phase I (Base) and Phase II (Option) periods of performance. Proposers must provide comprehensive, fully supportable cost details, bearing the burden of proof to establish the reasonableness of all proposed costs. The template is divided into several linked worksheets requiring data entry for proposer constants, labor rates, and indirect rates before completing cost detail tabs. Key cost categories include direct labor, subproposers, consultants, materials and supplies, equipment, travel, other direct costs (ODCs), material handling, and General and Administrative (G&A) expenses. Critical instructions dictate that: * All options (Phase II) must be fully priced to be considered for an award. * Proposers must provide a breakdown of costs by task/milestone that matches the sum of costs by expense type. * Supporting documentation (such as vendor quotes or past invoices) is required for materials exceeding $50,000 and equipment exceeding $25,000. * Under ARPA-H guidelines, project teams are prohibited from receiving fees or profits on direct equipment costs, government entities, or cost-share arrangements. * Cost-share proposals must be detailed and justified, and foregone fee or profit cannot be counted as cost-sharing.

This document is the Task Description Document (TDD) Model (Attachment A.2) for an ARPA-H federal program proposal. It provides instructions and templates for proposers to outline their project's technical tasks, subtasks, and milestones across different phases. Proposers must include an executive summary and detailed descriptions for each task, specifying objectives, technical approaches, performance locations, responsible organizations, and deliverables. Deliverables and milestones must match the technical proposal (Attachment A.1) and the Milestone and Payment Table (Attachment A.3). Milestones must be quantitative and measurable, serving as the basis for single-payment technical achievements rather than partial payments. Proposers must also state if the work involves human or animal subject research and align tasks with the Cost Workbook. The document outlines a three-level hierarchical structure for task narratives and provides a standardized template table to capture crucial details, including task objectives, responsible points of contact, intellectual property assertions, and associated milestones. Proprietary information must be excluded.

This document is a federal solicitation template titled "Attachment B: Eligibility and Conformance Certification Sheet." It is used to verify that proposing entities and their subperformers meet specific technical and compliance requirements for a research project involving microphysiological systems (MPS) in spaceflight and terrestrial environments. The checklist requires applicants to certify key elements of their proposal, including: - Adherence to donor heterogeneity requirements and a focus on a single target organ (such as the heart, brain, uterus, or kidney). - Utilization of at least four planned -omics approaches to validate Phase I experiments. - The capability to create and maintain up to 384 autonomous MPS units (including 192 for spaceflight) for a Low Earth Orbit (LEO) twin experiment. - Monitoring protocols incorporating tissue-agnostic and tissue-specific biomarkers of aging, age-related biological pathways, tissue integrity markers, and optically clear chip designs. - Computational modeling plans, including in silico models of organ aging, integration of terrestrial data into the TAROE alpha model, TARIS alpha modeling, and variance analysis between spaceflight and terrestrial cells. - A prospective list of relevant biopharma partners.

This document outlines a multi-year program timeline spanning Fiscal Years 2027 through 2030 (FY27–FY30), structured across four Program Years (Year 1 to Year 4) and divided into Phase I, Phase II, and a Launch Phase. The schedule tracks program activities, milestones, and key phases over a 42-month period to guide development, testing, and implementation. Key program activities and milestones include: - **Development & Testing:** Focuses on Microphysiological Systems (MPS) model development, scale-up, and integration testing. - **Design Locks:** Establishes critical design specifications, including the Twin Study MPS design lock and the Carrier Science Platform (CSP) housing design lock. - **Launches & Validation:** Details preparation and execution phases, including pre-launch integration, a Hardware Validation Launch (HVL), and scheduled launches (L1 through L4). - **Review & Showcase:** Features regular Scientific Review Meetings (SRM), structured data analysis periods following launches, and final program showcases in the latter half of Year 3 and Year 4. This timeline serves as a master schedule for tracking deliverables, integration phases, and hardware validation, ensuring systematic progress from design finalization to launch and data analysis.

This document outlines the tasks, milestones, and deliverables for a federal research initiative focused on tissue aging in space. The project is divided into Phase I and Phase II, centered around quantifying the Tissue Aging Rate in Space (TARIS) compared to the Tissue Aging Rate on Earth (TAROE) using microphysiological systems (MPSs) and organoids. Key milestones in Phase I include establishing Material Transfer Agreements with commercial flight and hardware providers, developing a commercialization plan, and creating TARIS-TAROE models of tissue changes in Low Earth Orbit (LEO). By the end of Phase 1, participating teams must secure a signed contractual partnership and licensing agreement with at least one commercial pharmaceutical discovery or manufacturing partner. Phase II focuses on scaling the disease models and commercial partnerships. This phase requires demonstrating a credible, reproducible disease model for tissues where TARIS exceeds TAROE, and performing proof-of-concept high-throughput drug testing. This testing utilizes microgravity-leveraged MPS models to identify therapeutic candidates that can prevent or reverse age-related tissue dysfunction and disease. The template also provides a structured framework for teams to detail tasks, milestones, timelines, quantitative exit criteria, and cost estimates.

The Advanced Research Projects Agency for Health (ARPA-H) has issued an Innovative Solutions Opening (ISO), solicitation number ARPA-H-SOL-26-165, for the Comprehensive Organ System Modeling in Outer Space (COSMOS) program. The initiative seeks to negotiate multiple Other Transaction (OT) Agreements to investigate if microgravity in Low Earth Orbit (LEO) accelerates human tissue aging. COSMOS aims to definitively measure the Tissue Aging Rate in Space (TARIS) against the Tissue Aging Rate on Earth (TAROE) using microphysiological systems (organs-on-chips) and organoids. The program targets four critical organs associated with high morbidity and mortality: brain, heart, uterus, and kidney, across adult donor age brackets of 30, 45, and 65 years. The program is structured into two sequential phases over 42 months: * **Phase I (27 months):** Focuses on establishing and validating autonomous, twin LEO-terrestrial MPS systems to determine if microgravity accelerates aging, alongside creating pre-flight and flight-refined in silico aging models. * **Phase II (15 months):** Leverages tissues where TARIS substantially exceeds TAROE to build disease models for high-throughput, autonomous LEO drug screening. Performers must collaborate with government-selected Commercial Service Providers (CSPs) for spaceflight logistics. Additionally, participants must secure a signed public-private partnership with at least one Fortune 100 biopharmaceutical partner by the end of Phase I to test therapeutic assets and establish a commercial pipeline. Proposals are due by October 7, 2026, at 2:00 PM Eastern Time.