Pre-Solicitation Notice: Intranasal Nalmefene Drug-Device Combination   4

Background
The Office of the Biomedical Advanced Research and Development Authority within the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) intends to use Project BioShield (PBS) to support the procurement of an intranasal nalmefene drug-device combination product for use by adult and pediatric populations for the treatment of opioid, including fentanyl overdose.

Work Details
Opioids are lethal chemicals that pose both a public health and chemical mass casualty threat. The United States Government (USG) has supported development of opioid reversal medical countermeasures to combat opioid-related deaths, including from potential accidental or intentional mass casualty events, in the context of fentanyl or other synthetic opioid involvement.

The Biomedical Advanced Research and Development Authority (BARDA), within the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) intends to use Project BioShield (PBS) to support the late stage development and procurement of opioid reversal medical countermeasures. The procured therapeutic product will either be delivered to the ASPR Strategic National Stockpile or maintained as vendor managed inventory. The USG seeks opioid reversal medical countermeasures that meet specific mandatory criteria related to manufacturing capability, FDA approval or late-stage development, reliability standards, emergency use, delivery quantity, shelf-life, and more.

Period of Performance
The anticipated period of performance for any resultant contract(s) will be up to 120 months with an initial base period of 60 months.

Place of Performance
Contracting Office Address: Administration for Strategic Preparedness and Response (ASPR) Department of Health and Human Services, 200 C St. SW, Washington, District of Columbia 20024, United States