PBS_2PAMAI_FY22_Pre-Sol_V2.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

Office of the Assistant Secretary for Preparedness & Response Washington, D.C. 20201

FEDERAL BUSINESS

OPPORTUNITIES PRESOLICITATION

NOTICE

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

ISSUED ON A LATER DATE.

Title: Project BioShield Procurement of Chemical Medical Countermeasures:

2-PAM Autoinjectors

General Information Document Type: Pre-Solicitation Notice Solicitation Number:

Product Service Code: A - Research & Development

NAICS Code: 541714 – Research and Development in Biotechnology (except Nanobiotechnology)

Synopsis

Organophosphate or nerve agent poisoning requires intervention to occur quickly given the rapid onset of symptoms, which manifest within minutes, rather than hours. Pralidoxime (2-PAM) and atropine, an anticholinergic, must be administered as soon as possible to prevent progression, which could potentially lead to death. Both drugs should be available as far forward as practical, in a presentation that allows for ease of use in a mass casualty scenario. Intramuscular autoinjectors fulfil this requirement. Modern, FDA-approved, atropine autoinjectors are available, but there are currently no 2-PAM autoinjectors aside from those found in MARK-1™ kits, a legacy set of nerve-agent countermeasure autoinjectors currently stocked by the Strategic National Stockpile (SNS) under the Shelf Life Extension Program. There is a requirement for SNS to stockpile a modern acetylcholinesterase reactivator (2-PAM, 600 mg) to complement existing atropine autoinjectors.

In order to address this unmet need, the Office of the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) intends to use Project BioShield (PBS) to support the for late-stage clinical development, regulatory approval for 2-PAM autoinjectors (as a drug/device combination product) to treat organophosphate (OP) poisoning, including nerve agents, in adult and pediatric populations, and procurement of 2-PAM autoinjectors for the SNS/CHEMPACK Program. The USG seeks therapeutics that meet the following mandatory criteria: 1) The Offeror must have the capability to manufacture 2-PAM (600 mg) autoinjectors to manufacture and deliver 2,000,000 of 600 mg 2-PAM autoinjectors to the SNS by September 30, 2029; 2) The Offeror must have FDA approval or in be late-stage development with the ability to achieve full FDA approval of the 2PAM (600mg) autoinjectors by end of 2024; and 3) The Offeror must demonstrate that their proposed autoinjectors will be able to meet the FDA 99.999% reliability standard for emergency use autoinjectors by the end of 2023.

75A50122R00022 devon.andres Cross-Out devon.andres Highlight devon.andres Highlight judith.laney Sticky Note CHANGE TO end of FY23 (SEPT 30 2023) judith.laney Highlight

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 July 2022. 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 2022. The anticipated period of performance for any resultant contract(s) will be a base period of performance up to three (3) years and a total contract period of performance (base plus option periods) up to 7 years with the exercise of options. 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:

Office of the Assistant Secretary for Preparedness & Response (ASPR) Department of Health and Human Services 200 C St. SW Washington, District of Columbia 20024 United States

Points of Contact:

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

Jennifer Taranto BARDA Contracting Specialist Jennifer.Taranto@hhs.gov

Devon Andres BARDA Project Officer devon.andres@hhs.gov https://www.sam.gov/ mailto:Jill.Johnson@hhs.gov https://sam.gov/content/home devon.andres Cross-Out devon.andres Highlight devon.andres Highlight judith.laney Inserted Text