RFP - Intranasal Nalmefene Drug-Device Combination

The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response seeks to procure up to approximately 2 million doses of intranasal nalmefene spray over 10 years through project BioShield. Proposals are due by September 15, 2023 for the base period of performance from September 2023 through September 2033. Offerors must propose pricing per dose and meet all FDA requirements for clinical development, regulatory submissions, stability studies, manufacturing, and delivery of intranasal nalmefene products into vendor-managed inventory to treat opioid overdoses in adult and pediatric populations. Proposals will be evaluated based on technical approach, past performance, and price.

There is no set-aside designation. The main NAICS code is 325412 and PSC code is 6515. No current contractors were identified. The potential award value is up to $200 million over 10 years to procure and deliver approximately 2 million doses into vendor-managed inventory with storage and distribution nationwide. The period of performance will take place through September 2033.