AMR_Pre-Sol_Notice.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

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:

Antibiotic to treat biothreat infections, antimicrobial resistance

General Information

Document Type: Pre-Solicitation Notice

Posted Date: February 14, 2019 Solicitation Number: RFP#19-100-SOL-00011

Classification Code: A – Research & 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 dramatic increase in the prevalence of infections and deaths caused by antibiotic resistant pathogens. Additionally, the threat of naturally-occurring or intentionally-engineered antibiotic-resistant biothreat pathogens may also impact the effectiveness of the current stockpile of antibiotic medical countermeasures (MCMs) to treat these threats. The lack of diverse antibiotic products and the increased prevalence of antibiotic resistant infections threatens to complicate the Department of Health and Human Services (HHS) response to any public health emergency or natural disaster, and represents a significant threat to the national health security of the United States.

The year-over-year increase in hospital and community acquired bacterial infections due to antibiotic-resistant bacteria and the transmissibility of these resistant markers to sensitive bacteria represents a serious threat to the national health security of the United States. These health challenges also place a substantial health and economic burden on our society and will continue to do so if not adequately addressed. Antibiotic-resistant biothreat pathogens pose an equivalent risk to health security due to the limited treatment options for resistant infections and high mortality rates.

The illnesses and injuries caused by all national security threats can lead to secondary bacterial infections, and those secondary bacterial infections can be antibiotic-resistant pathogens. At the same time, a key objective of the 2018 National Biodefense Strategy is to reduce the emergence and spread of antibiotic-resistant pathogens domestically and internationally by accelerating research and development of new antibiotics. The Biomedical

Advanced Research and Development Authority (BARDA) and the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) recognize the critical need to prepare for an outbreak of natural or engineered drug resistant bacterial biothreat pathogens. Supporting the development and stockpiling of medical countermeasures that treat antibiotic resistant bacteria including biothreats will augment the USG response to any biothreat agent or public health emergency.

This acquisition will allow BARDA to procure, stockpile, and invest in the late stage development of antibiotic products which are developed or approved for commercial use but also have utility in treating multiple biodefense indications. The acquired products will directly address PHEMCE requirements established in the Product-Specific Requirement (PSR) for Medical Countermeasures to combat antibiotic-resistant bacterial infections, The National Strategy and Action Plan to Combat Antibiotic Resistant Bacteria, and the National Biodefense Strategy.

The Government seeks an FDA-approved antibiotic(s) for a biothreat indication (Y. pestis, B. anthracis, F.

tularensis, B. mallei and/or B. pseudomallei) for delivery to the Office of the Assistant Secretary for Preparedness and Response (ASPR)/Strategic National Stockpile (SNS). The antibiotic(s) must be FDA-approved or in Phase 3 clinical development and eligible for Emergency Use Authorization (EUA) pre-approval by FDA for a biothreat indication. If the antibiotic is not FDA approved for a pneumonic indication, the Offeror must seek development and FDA approval for a pneumonic indication that could support approval of a biothreat indication. The oral or parenteral antibiotic(s) must have demonstrated efficacy against drug resistant pathogen(s) to include demonstrated in vitro efficacy against one or more of the aforementioned biothreat pathogens. In addition, the manufacturing process for active pharmaceutical ingredient (API) and drug product must be developed and established, meeting and/or development data indicating acceptable product quality attributes during product shelf life. CMC Registration/Primary batches must be ongoing with plans for full process validation established or full process validation is complete. In consideration of the biothreat approval and inclusion in the SNS, extended stability of the antibiotic(s) must be considered to include an ongoing stability program agreed by FDA for bulk drug substance (BDS) and final drug product (FDP) process validation, registration batches and annual commercial manufacturing programs.

In addition, the Offeror shall provide required FDA regulatory documentation (i.e. investigator brochure, regulatory binder, etc.) that will be used to support use under EUA and/or approval for a biodefense indication.

Also, the Offeror shall provide documentation and/or plans to comply with Post-Marketing Commitments and/or Requirements (PMCR) as specified by the FDA. This effort will also support the necessary late-stage development to achieve approval of the alternative formulation of the product(s) being procured.

Procurement of the antibiotic(s) will include a pre-determined number of therapeutic treatment courses as FDP, which will depend upon program requirements for the number of treatment courses to be purchased, and the expected duration of stability for the antibiotic(s). The R&D development work and phase IV post marketing commitments will include late-stage development activities to support approval of the drug.

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. Furthermore, CMA 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 FedBizOpps website in March 2019 for 60 days with proposals being due in May 2019. Once any RFP is posted we encourage all responsible sources, particularly small businesses, to submit a proposal which will be considered by the agency. It is the Offeror's responsibility to monitor this internet site (www.fbo.gov) for the release of this 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.

It is anticipated that one or two contract(s) with both cost reimbursement and firm-fixed aspects will be awarded in or around August - September 2019. The anticipated period of performance for any resultant contract(s) will be for a total of 60 months and up to 120 months, if all Option periods are exercised. 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.

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:

Brooke Bernold BARDA Contracting Officer Brooke.Bernold@hhs.gov Phone: 202-720-2823

Christine Park BARDA Contracting Specialist Christine.Park@hhs.gov Phone: 202-401-5550

Mark Albrecht Acting BARDA Antibacterials Branch Chief Mark.Albrecht@hhs.gov Phone: 202-691-2015 mailto:Brooke.Bernold@hhs.gov mailto:Christine.Park@hhs.gov mailto:Mark.Albrecht@hhs.gov