SPECIAL NOTICE
B -- Stability Studies of Reference Virus Stocks
- Notice Date
- 8/2/2021 12:33:37 PM
- Notice Type
- Special Notice
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
- ZIP Code
- 20705
- Solicitation Number
- FDA-NOI-1239473
- Response Due
- 8/16/2021 12:00:00 PM
- Archive Date
- 08/31/2021
- Point of Contact
- Kimberly DeLong
- E-Mail Address
-
kimberly.delong@fda.hhs.gov
(kimberly.delong@fda.hhs.gov)
- Description
- The Food and Drug Administration intends to award a sole source contract for a research and development project, to test the stability of purified and concentrated virus preparations. The award will be made to: American Type Culture Collection (ATCC) 10801 University Boulevard Manassas, VA 20110 In accordance with FAR 6.302-1 the solicitation contains circumstances permitting other than full and open competition.� This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement within 15 days after the publication of this synopsis which shall be considered by the agency. Responses received after 15 days or without the required information may not be considered. For information concerning this proposed acquisition contact: The objective for this requirement is to test the stability of purified and concentrated virus preparations.� Independently, and not as an agent of the Government, the contractor will reassess the genome copy number and infectious virus titer of the following virus stocks which were prepared in accordance with HHSF223201510136A and are stored at the company�s facility (designated here as Group A): Porcine Circovirus (PCV1); CBER code: SC-VR-6000P, Lot no. 63856605 Mammalian Orthoreovirus 1, strain Lang; CBER code: SC-VR-6001P, Lot no. 63633442 Feline Leukemia virus, strain Thielen; CBER code: SC-VR-6002P, Lot no. 63856597 Human respiratory syncytial virus, strain A2; CBER code: SC-VR-6003P, Lot no. 63633439 Epstein-Bar virus (HHV-4) strain B95-8; CBER code: SC-VR-6004P, Lot no. 63633440 This will be the second stability testing performed by ATCC for these virus stocks since their production five (5) year ago, and the testing will evaluate the stability of the genome copy number and the infectivity titer of the viruses over that period of time. The results of this test will be used to update the certificate of analysis of the 5 WHO-CBER international reference virus stocks for NGS. Furthermore, the contractor will perform two (2) stability tests for the following new FDA virus stocks (designated here as group B), currently in preparation under contracts 75F40120P00620 and 75F40120P00690, to determine their genome copy number and infectivity titer over a 4- year storage period. The contractor will update the certificates of analysis of the 7 new reference virus stocks based on the results of the stability testing. Porcine Circovirus (PCV1) Mammalian Orthoreovirus 1, strain Lang Feline Leukemia virus, strain Thielen Epstein-Bar virus (HHV-4) strain B95-8 Betacoronavirus 1 (human coronavirus), Minute virus of mice, strain prototype (p) Human respiratory syncytial virus, strain A2
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/631bb740652144eda8318708474c2cb6/view)
- Place of Performance
- Address: Manassas, VA 20110, USA
- Zip Code: 20110
- Country: USA
- Zip Code: 20110
- Record
- SN06080906-F 20210804/210802230116 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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