SOURCES SOUGHT
A -- ASPR/BARDA Antimicrobial Resistance Project Bioshield
- Notice Date
- 1/31/2019
- 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
- SS_BARDA-2019-01A
- Response Due
- 2/11/2019
- Point of Contact
- Brooke Bernold, Phone 2027202823, - 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
- The purpose of this Small Business Sources Sought Notice is to use responses for planning potential future acquisitions. BARDA seeks pertinent marketplace data on availabilities and capabilities for procuring, stockpiling, and investing in the late stage development of antibiotic products for commercial use for treatment of multiple biodefense indications. BARDA seeks information on availabilities, capabilities, and other pertinent marketplace data to strengthen BARDA's understanding of the current and future marketplace enhance its ability to obtain quality services economically, and to efficiently and lawfully establish potential vendor source files and listings. BARDA will not award any contracts under this notice. 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. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (31-JAN-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/SS_BARDA-2019-01A/listing.html)
- Record
- SN05208156-F 20190202/190131230019 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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