H.R. 3955 — RAPID Reserve Act

This section directs the Secretary of Health and Human Services to award contracts or cooperative agreements to eligible entities for maintaining reserves of critical drugs and active pharmaceutical ingredients determined to have vulnerable supply chains, with the list of such drugs and ingredients to be published. Eligible entities must (1) maintain a 6-month reserve (or other reasonable quantity, as determined by the Secretary) of the specified active pharmaceutical ingredient and finished drug product, regularly replenished with recently manufactured supply, in a satisfactory domestic facility registered under FDA section 510 or a satisfactory foreign facility in an OECD member country; (2) produce the drug or ingredient at the Secretary's direction and in specified quantities; and (3) agree to transfer portions of reserves to other manufacturers if needed or permit Secretary-directed allocation during public health emergencies, natural disasters, or CBRN threats. Not later than 180 days after enactment, the Secretary must issue guidance on vulnerability factors, entity eligibility (including quality systems and domestic/surge capacity commitments), and award requirements (including excess capacity and redundancy); awards must prefer domestic manufacturing or OECD sourcing and, to the greatest extent practicable, strengthen domestic resiliency while maximizing quality and minimizing costs and vulnerabilities. Contracts may include terms on procurement, storage, and delivery and support acquisition, construction, alteration, or renovation of non-federally owned facilities to ensure sufficient drug supplies.