SPECIAL NOTICE
65 -- Manufacture of Rapid Antigen Tests to Detect the SARS-CoV-2 Virus in Patient Samples Using Lateral Flow Immunoassay Based Platform
- Notice Date
- 7/9/2020 1:18:51 PM
- Notice Type
- Special Notice
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- W6QK ACC-APG NATICK NATICK MA 01760-5011 USA
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-20-S-0017
- Response Due
- 7/23/2020 1:30:00 PM
- Archive Date
- 08/07/2020
- Point of Contact
- Leo J. Fratis, Phone: 2405861523, Scott I. Hoffman, Phone: 3016198148
- E-Mail Address
-
leo.j.fratis.civ@mail.mil, scott.i.hoffman2.civ@mail.mil
(leo.j.fratis.civ@mail.mil, scott.i.hoffman2.civ@mail.mil)
- Description
- This is a Request for Information (RFI) for planning purposes only.� It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited.� No solicitation document exists or is guaranteed to be issued as a result of the RFI. THERE IS NO SOLICITATION AT THIS TIME. Defense Biological Product Assurance Office�s (DBPAO) mission is to employ best practices in providing the Department of Defense and its partners with a comprehensive collection of biological products that are: thoroughly characterized, of the highest quality, adaptable and traceable from source to application. The Government is seeking information from qualified companies with capabilities to support the DBPAO in their requirement for the manufacture of rapid lateral flow immunoassay-based antigen tests to detect the SARS-CoV-2 virus in samples from infected individuals or individuals suspected of viral exposure. Companies which have provided an Emergency Use Authorization package to the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for their antigen test, shall provide �copies of their EUA submission package or any available test data (e.g., analytical sensitivity, cross reactivity, microbial interference, hook effect, etc.) used in their EUA submission.� For companies who have not yet submitted their request for EUA approval, shall provide the date they expect to submit their EUA package to the FDA.� These companies shall also provide any product brochure/insert or fact sheets that include assay test data (e.g., analytical sensitivity, cross reactivity, microbial interference, hook effect, etc.) from analytical and clinical testing done on their antigen tests. The Government will retain comments and information received in response to the RFI.� Proprietary information should be identified as Company Proprietary.� Do not use Government Security classification markings.� All written responses must be received by 4:30PM Eastern Time, 23 July 2020.� The Government Contracting Officer for this notice is Mr. Leo Fratis. Responses should be sent by e-mail to: leo.j.fratis.civ@mail.mil Material that is advertisement only in nature is not desired.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/6c5d63670e7e4b4ebb0797f8b328ae26/view)
- Record
- SN05715854-F 20200711/200709230138 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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