SOLICITATION NOTICE
A -- Antimicrobial Resistance Project Bioshield
- Notice Date
- 2/14/2019
- Notice Type
- Synopsis
- NAICS
- 541714
— Research and Development in Biotechnology (except Nanobiotechnology)
- Contracting Office
- Office of the Assistant Secretary for Preparedness & Response (ASPR) Department of Health and Human Services 330 Independence Ave. SW G640 Washington DC 20201
- ZIP Code
- 20201
- Solicitation Number
- 19-100-SOL-00011
- Response Due
- 3/1/2019
- Point of Contact
- Brooke Bernold , Contracting Officer , Phone 2022600690, - Christine Jihae Park, Contracting Specialist, Phone 2024015550
- E-Mail Address
-
brooke.bernold@hhs.gov, christine.park@hhs.gov
- Small Business Set-Aside
- N/A
- Description
- 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. 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. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (14-FEB-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link To Document
(https://www.fbo.gov/spg/HHS/OOS/OASPHEP/19-100-SOL-00011/listing.html)
- Record
- SN05222366-F 20190216/190214230010 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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