The Advanced Research Projects Agency for Health (ARPA-H) requires Independent Validation and Verification (IV&V) services for its Resilient Extended Automatic Cell Therapies (REACT) program. The REACT program develops wireless implantable medical devices, 'Living Pharmacy' for therapeutic molecule delivery and 'Living Sentinel' for disease biomarker tracking, utilizing engineered cell lines. IV&V is critical for standardizing and reproducing these cells to scale manufacturing. The contractor will characterize unmodified pancreatic cells to establish an approach for performer cell characterization, then apply this to REACT performer cells, ensuring defined Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) for regulatory and scientific standards. Additionally, the contractor will validate the performance of performer cells through reproduction studies, providing written analyses and recommendations to the ARPA-H REACT team for production improvement and FDA alignment. The contract's period of performance includes a base year and multiple option periods, with work performed at contractor or performer sites. Deliverables include monthly progress reports and detailed task completion reports, focusing on outcomes, lessons learned, and recommendations.

The HHS Subcontracting Plan Template outlines requirements for federal contractors whose contracts exceed $900,000 ($2,000,000 for construction) to establish and maintain a subcontracting plan. This template, based on the Small Business Act and FAR Subpart 19.7, guides offerors in submitting individual subcontracting plans to promote the utilization of small businesses. It details specific subcontracting goals for various small business categories, including Small Business, Small Disadvantaged Business, Women-Owned Small Business, Service-Disabled Veteran-Owned Small Business, and HUBZone businesses. The document specifies plan types (Individual, Master, Commercial), requires detailed dollar and percentage goals for subcontracting, and mandates a description of subcontracting opportunities and methodologies for goal development. Furthermore, it outlines the responsibilities of the subcontracting program administrator, emphasizes outreach efforts, includes flow-down clauses for subcontractors, and details reporting, record-keeping, and good faith effort assurances, as well as timely payment to subcontractors.

This government Request for Proposal (RFP) outlines requirements for Independent Validation & Verification (IV&V) support services for the REACT program, managed by the Adv Research Projects Agency-Health (ARPA-H). The contract is a Time and Materials type with a ceiling price, covering a period from February 23, 2026, to August 22, 2028, with options for extension. Key services include characterizing pancreatic and performer cells, validating therapeutic production and biomarker sensing, and preparing technical reports with recommendations for FDA alignment. The solicitation emphasizes compliance with Federal Acquisition Regulation (FAR) and Department of Health and Human Services Acquisition Regulation (HHSAR) clauses, including those related to payment, invoicing, and electronic accessibility. Proposals are due January 5, 2026, and must include technical, management/staffing, and price volumes. The NAICS code is 541990 with a size standard of $19.5M.