Pre-Solicitation Notice: Intranasal Nalmefene Drug-Device Combination
Closed Pre-Solicitation Posted
This opportunity was awarded. See the award notice from , or the latest solicitation from .
- Solicitation number
- 75A50123R00003
- Agency
-
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- Place of performance
- United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Health and Human Services' Biomedical Advanced Research and Development Authority seeks to develop and procure an intranasal nalmefene drug-device combination to treat opioid overdoses through its Project BioShield authority. The agency intends to issue a request for proposal in June 2023 for a product that can deliver approximately 3 mg of nalmefene intranasally. Offerors must demonstrate the ability to gain FDA approval by September 2023 and manufacture a minimum of 1 million units between 2023 to 2028 to meet Strategic National Stockpile needs. Proposals will be evaluated based on technical approach, past performance, and cost. The deadline to submit any questions is August 1, 2023.
There is no set-aside designation for this procurement. The primary NAICS code is 325412 and PSC code is 6515. Any resultant contract would have both cost-plus-fixed-fee and firm-fixed-price line items, with a base period of 5 years and total period of performance up to 10 years. Offerors must show capability to deliver quantities of 200,000 units annually with a minimum 12-month shelf life.
Notice text
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 to 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.
PLEASE SEE ATTACHED PRESOLICITATION NOTICE FOR FULL DESCRIPTION.
Files
| File | Type | Posted |
|---|---|---|
| 75A50123R00003 Pre Solicitation Notice.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| Award Notice: Intranasal Nalmefene Drug-Device Combination | Award Notice | |
| RFP - Intranasal Nalmefene Drug-Device Combination | Solicitation | |
| This notice | Pre-Solicitation | |
| Request for Information - Project NextGen: Potential Market Shaping Strategies for Vaccine Development | Special Notice |
Similar open opportunities
| Opportunity | Agency | Set-aside | Responses due |
|---|---|---|---|
| Epinephrine Injector | Medical Supply Chain | No set-aside |
On GovTribe
Work this opportunity
- Track it in your pipeline
- Find teaming partners
- Similar opportunities
- Ask GovTribe AI about this opportunity