SOLICITATION NOTICE
B -- Manufacturing of Lot Release Support Panel
- Notice Date
- 6/18/2008
- Notice Type
- Presolicitation
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-08-00714
- Point of Contact
- Patricia Wright,, Phone: 301-827-7217
- E-Mail Address
-
patricia.wright@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- The Food and Drug Administration (FDA) is seeking proposals for a contractor to fulfill a requirement for a program titled: Manufacturing of Lot Release Support Panel. FDA anticipates an award of a single cost reimbursement completion type contract with a maximum term of 5 years. FDA intends to solicit this requirement as a full and open competitive requirement. The FDA conducts lot release of in vitro diagnostic test kits developed by independent manufacturers for use in screening blood and blood products. The lot release process confirms the adequacy of each lot’s test performance using panels of specimens specifically selected and formulated to characterize the limits of test performance. Once potential samples have been identified, FDA has a need for service functions related to preparation, sterility, characterization, storage and possibly dissemination of panels. The potential offeror shall receive, store, aliquot, transport and distribute infectious and non-infectious biological materials. The FDA will need 2-3 panels made each year for a 5 year period of performance containing 5 to 10 members, with about 3,000 vials of each member. Samples for each panel will be provided by the FDA, or may need help from the contractor in acquiring and/or purchasing candidate samples for panel production. The solicitation will be available for download on or about July 3, 2008 and may be accessed through the Federal Business Opportunities (FedBizOpps) website. No hardcopies will be distributed. Any questions concerning this requirement must be submitted in writing by e-mail only, to Patricia Wright at patricia.wright@fda.hhs.gov. NO PHONES WILL BE ACCEPTED. All responsible sources may submit a proposal which will be considered by the Agency.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=488aaaec973d77f271711143cab736a4&tab=core&_cview=1)
- Record
- SN01596076-W 20080620/080618220025-488aaaec973d77f271711143cab736a4 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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