PBS AMR FY22_Pre-Sol Notice.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: Antimicrobial Resistance Project BioShield:

BARDA Antibiotic for AMR and Biothreat Pathogens

General Information

Document Type: Pre-Solicitation Notice Solicitation Number: 75A50122R00009 Product Service Code: AN13 – Health R&D Services; Health care services;

Experimental Development NAICS Code: 541 – Professional, Scientific, and Technical Services/

541714 – Research and Development in Biotechnology

Synopsis

A crisis has arisen from the simultaneous decrease in the number of pharmaceutical companies developing antibiotics and the prevalence of infections caused by antibiotic-resistant pathogens.

The transmissibility of these resistance markers to biothreat pathogens, either those occurring naturally or intentionally-engineered, is a serious threat to the health security of the United States.

In order to mitigate this threat 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 late-stage development and regulatory approval of an antibiotic for a biothreat indication as well as the procurement and stockpiling of the antibiotic. The procured antibiotic will either be delivered to the ASPR/Strategic National Stockpile or maintained as vendor managed inventory. The United States Government (USG) seeks an antibiotic for the treatment and, if feasible, post-exposure prophylasis of one or more of the following pathogen(s): Yersinia pestis, Francilla tularensis, or Burkholderia pseudomallei. An antibiotic for Bacillus anthracis will not be sought for this procurement.

Pre-Solicitaiton 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 set-aside for small business concerns may be available electronically through the Beta.Sam.gov website in January 2022. Once an RFP is posted, we encourage all responsible small business sources, to submit a proposal which will be considered by the agency.

It is the Offeror's responsibility to monitor this internet site (www.beta.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 will be for up to 120 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:

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:

Jill Johnson BARDA Contracting Officer Jill.Johnson@hhs.gov

Mark Albrecht BARDA Antibacterials Branch Chief Mark.Albrecht@hhs.gov https://www.sam.gov/ mailto:Jill.Johnson@hhs.gov mailto:Mark.Albrecht@hhs.gov