75A50123R00003 Pre Solicitation Notice.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES

Administration for Strategic Preparedness and Response Washington, D.C. 20201

PRESOLICITATION NOTICE

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION MAY BE

ISSUED ON A LATER DATE.

Title: Intranasal Nalmefene Drug-Device Combination

General Information

Document Type: Pre-Solicitation Notice Solicitation Number: 75A50123R00003 Product Service Code: AN13 – Health R&D Services; Health care services;

Experimental Development NAICS Code: 541714 – Research and Development in Biotechnology

(except Nanobiotechnology)

Synopsis

Opioids are lethal chemicals that pose both a public health and chemical mass casualty threat. Synthetic opioids, such as fentanyl, are highly lethal. According to the Centers for Disease Control, in 2021, there were 80,816 opioid-related deaths, with 71,238 fentanyl-related. The continuing U.S. opioid epidemic, with about 150 fentanyl-related deaths per day, highlights the i m m e d i a t e threat to public health. 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. In addition, synthetic opioids, including fentanyl, pose a threat to national security if purposely released as a chemical weapon. Procurement of opioid reversal medical countermeasures is urgently needed to enable the USG’s preparedness and response to the current public health emergency and to mitigate the threat of chemical attacks.

In order to address this unmet need, 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 the following mandatory criteria: 1) The Offeror must have the capability to manufacture a nalmefene drug-device combination that delivers ~3 mg nalmefene via intranasal (IN) administration that is FDA approved or in late-stage development, with the ability to achieve full FDA approval by end of September 2023 (end of FY23); 2) the Offeror must have already shown their proposed drug delivery device meets the FDA reliability standard for emergency use medical devices (99.999% reliability, see Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA | FDA); 3) The Offeror must have demonstrated their drug delivery device can be used in emergency situations by both first responders and untrained/minimally trained personnel (Human Factors Studies are acceptable); 4) the Offeror must have demonstrated capability to manufacture and deliver up to 1,000,000 FDA-approved nalmefene drug-device product, preferably in increments of 200,000, to the USG by September 30, 2028; and 5) The Offeror must have demonstrated that the shelf-life of their drug-device combination is at minimum 12-months, or preferably, 24-months or longer, in room temperature conditions.

Pre-Solicitation Notice Objective

This Pre-solicitation Notice is issued pursuant to FAR Subpart 5.2. It does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. This Pre-solicitation Notice does not commit the Government to contract for any supply or service whatsoever. Updates to the details provided could arise based on information and insight gained in the interim. Furthermore, BARDA is not at this time seeking proposals, and will not accept unsolicited proposals.

It is anticipated that an RFP may be available electronically through the Sam.gov website in June 2023. Once an RFP is posted, we encourage all responsible sources that meet the mandatory criteria detailed above, to submit a proposal which will be considered by BARDA. It is the Offeror's responsibility to monitor this internet site (www.sam.gov) for the release of the solicitation as well as any amendments. Potential Offerors will be responsible for downloading their own copy of the solicitation and any amendments via this website. No collect calls will be accepted. No facsimile transmissions will be accepted.

BARDA may elect to make more than one contract award from the RFP solicitation. Any contract(s) awarded from the RFP solicitation will have both cost-plus-fixed-fee and firm-fixed- price line items and will be awarded in or around September 2023. The anticipated period of performance for any resultant contract(s) will be up to 120 months with an initial base period of 60 months. Additional details and requirements will be described in the solicitation.

Furthermore, all respondents must be registered in the System for Award Management (SAM):

https://www.sam.gov.

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

Points of Contact:

Yifan Yang BARDA Contracting Officer Yifan.Yang@hhs.gov

Jonathan Gonzalez BARDA Contracting Officer Jonathan.Gonzalez@hhs.gov

Judy Laney, Ph.D.

BARDA Chemical Medical Countermeasures Branch Chief Judith.Laney@hhs.gov

Nellie Byun, Ph.D.

BARDA Chemical Medical Countermeasures Project Officer Nellie.Byun@hhs.gov https://sam.gov/content/home https://www.sam.gov/ https://www.sam.gov/ http://www.sam.gov/ mailto:Jill.Johnson@hhs.gov mailto:Yifan.Yang@hhs.gov mailto:Mark.Albrecht@hhs.gov mailto:Jonathan.Gonzalez@hhs.gov mailto:Judith.Laney@hhs.gov mailto:Nellie.Byun@hhs.gov

PRESOLICITATION NOTICE