Agentic AI-EnableD CardioVascular CAre TransfOrmation (ADVOCATE) Innovative Solutions Opening (ISO)

The ARPA-H Standard Cost Proposal Workbook is a critical tool for both prime and sub-proposers submitting cost proposals, particularly those involving Resource Sharing. This workbook guides users through a series of interconnected spreadsheets, including 'General,' 'Proposer Constants,' 'Labor Rates,' and 'Phase # Costs,' to detail all project expenditures. Key instructions emphasize completing the 'General' and 'Proposer Constants' tabs first, followed by 'Labor Rates' to establish labor categories and burdened rates. Proposers must input costs into 'Phase # Costs' sheets, which then feed into the 'Total Amount' spreadsheet. The document stresses the importance of accurate data entry, proper handling of additional rows for personnel or cost categories, and adherence to specific formatting to ensure calculations are correct. Deleting tabs or rows is prohibited; instead, users should hide unneeded sections. The workbook is designed to assist government personnel in reviewing and evaluating cost proposals, requiring proposers to provide comprehensive supporting data for all proposed costs.

The ARPA-H Standard Cost Proposal Workbook is a critical tool for both prime and sub-proposers submitting cost proposals for Other Transactions that do not involve Resource Sharing. This workbook streamlines the submission process by providing linked spreadsheets for various cost categories, including direct labor, subproposers, consultants, and other direct costs. Users must follow specific instructions for data entry, starting with general information, then proposer constants, and labor rates, ensuring all unshaded cells are completed. The workbook supports up to six fiscal years per phase, with automatic calculations for total costs. It emphasizes the importance of providing detailed, supportable cost data and prohibits deleting rows, columns, or tabs to maintain data integrity. Special attention is given to labor rate calculations and the breakdown of costs by task, ensuring alignment with the statement of work.

The “Cost Proposal Narrative” document outlines the requirements for submitting a cost proposal for government solicitations, grants, and RFPs. Proposers must complete a detailed written narrative alongside a Cost Proposal Workbook, substantiating all cost drivers with additional details and assumptions. The narrative must adhere to specific formatting guidelines, including 8-1/2 by 11 inch paper, 1-inch margins, and 11-point non-serif fonts. Key sections include identification of the prime organization and team members, technical and administrative points of contact, total proposed costs (separated by base and options), and the proposal's validity period. Detailed cost breakdowns are required for labor, materials, equipment, travel, other direct costs, consultant costs, and sub-awardee costs. Proposers must provide supporting documentation for items exceeding $10,000 and explain all assumptions. The document also includes optional sections for resource sharing and potential cost reductions, emphasizing that reductions should not impact the project's intended results. The government expects indirect costs and profit to be included in submissions.

This government file outlines an Other Transaction Agreement (OTA) used by the Advanced Research Projects Agency for Health (ARPA-H) for research and development projects. It details the agreement's scope, including program vision, technological context, and commercialization goals. The document defines key terms such as "Agreement Officer," "Subject Invention," and various data rights (Unlimited, Government Purpose, Limited). It covers the agreement's term, payment structure based on milestones, and procedures for modifications and dispute resolution. Crucially, it addresses intellectual property rights, specifying Performer and ARPA-H allocations for patents and data, along with disclosure requirements and protections for trade secrets. The file also includes provisions for foreign access to intellectual property, restrictions on certain telecommunications equipment, research security requirements, and special terms for human subjects research and associate performer agreements. The overarching purpose is to provide a comprehensive framework for ARPA-H's collaborative research initiatives, balancing government interests with Performer responsibilities and innovation.

The ADVOCATE Commercialization Roadmap provides a structured guide for commercializing products, likely within the healthcare or medical device sector, spanning from FY26 to a final commercialization plan. The roadmap outlines key activities across several phases: Phase 1A (FY26), Phase 1B (FY27), Phase 2 (FY28-29), and a Final Commercialization Plan. Each phase details specific actions related to End User/Market engagement (e.g., identifying initial adopters, UI/UX testing), Business Model development (e.g., competitive landscape monitoring, reimbursement strategies), Intellectual Property (IP) management (e.g., identification, risk assessment), Regulatory compliance (e.g., FDA meetings, IDE studies), and Exit Plan strategies (e.g., investor engagement, ownership summaries). The document emphasizes iterative development, stakeholder engagement, and strategic partnerships, culminating in a comprehensive plan for product development, health economics analysis, IP finalization, regulatory submissions, and an investor summary with an outlined exit strategy.

The ARPA-H-SOL-26-142 ADVOCATE program, an Innovative Solutions Opening (ISO) from the Advanced Research Projects Agency for Health (ARPA-H), seeks to transform cardiovascular care using agentic AI. This 39-month, two-phase program aims to develop, deploy, and clinically validate a patient-facing AI system (CVD Agent – TA1) for 24/7 specialist-level care. Concurrently, it will create a disease-agnostic Supervisory Agent (TA2) for real-time monitoring and regulatory compliance. Health organizations (TA3) will integrate and evaluate these agents in large-scale studies. The program emphasizes collaboration, data sharing, and regulatory engagement with the FDA for market authorization and MDDT qualification. Eligibility is open to various entities, excluding FFRDCs and government entities, with a focus on U.S.-based work. Proposals require a solution summary, a full proposal, and a commercialization strategy.

This document outlines the cybersecurity requirements for the Agentic AI-Enabled Cardiovascular Care Transformation (ADVOCATE) program, which involves developing an agentic, GenAI system to process, store, and transmit sensitive medical data. Performers must submit a one-to-three-page cybersecurity strategy covering access controls, data protection, system connections, AI solution safeguarding, and incident response. Post-award, performers must implement security controls aligned with NIST SP 800-171 Revision 3 for Controlled Unclassified Information (CUI) and NIST SP 800-66 Revision 2 for HIPAA compliance, given the handling of electronic protected health information. A Plan of Action and Milestones must be maintained to address cybersecurity weaknesses, and performers accessing ARPA-H systems must comply with federal mandates like NIST FIPS PUB 201-3 and ARPA-H cybersecurity policies. Additional AI-focused cybersecurity requirements may be introduced due to the rapidly evolving AI industry.

The document outlines the requirements and instructions for preparing a solution summary for a government solicitation, likely an RFP or grant. It specifies formatting, page limits (10 pages total, excluding references and Rough Order of Magnitude), and content for various sections. Key sections include a cover page with detailed organizational and contact information, a one-page abstract with graphics, a six-page proposed work section detailing design, execution, and deliverables (with specific requirements for different technical areas), and a two-page team, organization, and capabilities section outlining roles, experience, and qualifications. The document also details the components of a Rough Order of Magnitude (ROM) for budget breakdown, which is not subject to the page limit. The overall purpose is to guide proposers in submitting comprehensive and compliant solution summaries.

The Advanced Research Projects Agency for Health (ARPA-H) Scalable Solutions Office has issued an Innovative Solutions Opening (ISO) for the Agentic AI-EnableD CardioVascular CAre TransfOrmation (ADVOCATE) program. This initiative seeks to develop and implement AI-enabled solutions to revolutionize cardiovascular disease (CVD) management. The program is structured into three technical areas (TAs): TA1 for developing a patient-facing CVD Agent, TA2 for creating a disease-agnostic Supervisory Agent for monitoring, and TA3 for scalable implementation within healthcare organizations through real-world studies. The 39-month program, divided into two phases, emphasizes collaboration among performers, regulatory compliance with the FDA, and a clear path to commercialization. Eligible proposers include universities, non-profits, and small businesses, with a strong emphasis on U.S.-based work. Submissions require a solution summary by February 27, 2026, and a full proposal by April 1, 2026.

The ADVOCATE program, ARPA-H-SOL-26-142, is an Innovative Solutions Opening seeking proposals for Agentic AI-Enabled Cardiovascular Care Transformation. Its vision is to modernize CVD care management through patient-facing autonomous AI systems, providing 24/7 specialist-level care at reduced costs. The program has three technical areas: TA1 focuses on developing a clinically validated, regulatory-compliant patient-facing multimodal autonomous AI agent (CVD Agent); TA2 on a disease-agnostic independent oversight agent for real-time monitoring and regulatory compliance (Supervisory Agent); and TA3 on integrating these agents into healthcare organizations for scalable implementation and evaluation in large scalability studies. The 39-month program is divided into two phases (1A and 1B for development and integration/validation, followed by Phase 2 for scalability studies), with anticipated multiple awards as Other Transaction (OT) Agreements. Eligibility is open to various entities, with prohibitions on FFRDCs and government entities as prime or sub-performers. Proposers can use prime/sub or multi-party teaming approaches, with an emphasis on collaboration and data sharing. All proposers must submit a solution summary, followed by a full proposal if encouraged, and must have an active registration in SAM.gov.

The document outlines the comprehensive format and instructions for submitting full proposals for federal government RFPs, federal grants, and state/local RFPs. Proposals must be in English, use a non-serif 11-point font, and maintain one-inch margins. Each page needs clear labeling with the ISO number, organization, and proposal title in the header. Submissions require three volumes: Volume I (Technical and Management Proposal), Volume II (Cost Proposal), and Volume III (Administrative and Policy Requirements Submission), along with a Cost Spreadsheet attachment. Volume I has a 30-page limit for key sections like the Executive Summary and Technical Plan, excluding templates for the Statement of Work and Schedule. Volume II has no page limit and includes a Cost Proposal Spreadsheet, a detailed cost narrative, and supporting data. Volume III, also without a page limit, covers administrative and policy requirements. The document emphasizes conciseness, adherence to templates, and detailed planning for technical, cost, and administrative aspects, ensuring all components are accurately completed for evaluation.

Appendix D outlines the administrative and national policy requirements for proposal submissions to ARPA-H, covering critical areas for federal grants and research. Proposers must provide detailed team identification, including FFRDC participation justification and disclosures regarding organizational conflicts of interest (OCI). Research security is paramount, requiring certifications against malign foreign talent recruitment programs and disclosures of foreign ownership or research execution in foreign countries of concern. The document also addresses intellectual property (IP) rights, human and animal subjects research protocols, representations on tax liability and felony convictions, and cybersecurity and biosecurity programs. Compliance with formatting, submission types, and detailed documentation for each section is mandatory, ensuring transparency and adherence to federal regulations.