SOLICITATION NOTICE
Q -- GMP Real-time RT-PCR Oligonucleotide Primers and Probes
- Notice Date
- 5/24/2012
- Notice Type
- Presolicitation
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2012-N-14345
- Point of Contact
- Lisa D Brown, Phone: (770)488-2646
- E-Mail Address
-
tdc0@cdc.gov
(tdc0@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- The Influenza Division of the Centers for Disease Control and Prevention (CDC) monitors and investigates influenza viruses that are the causative agent of influenza disease in humans. Surveillance and diagnosis of influenza can be supported by the use of in vitro diagnostic (IVD) tests that detect the presence of influenza viruses in clinical specimens and virus culture. The CDC Influenza Division has developed numerous in vitro diagnostic tests that specifically detect known, circulating influenza viruses in humans and identify potentially new influenza viruses that emerge from avian and other animal sources. Recently, the CDC Influenza Division obtained Food and Drug Administration (FDA) clearance of an influenza diagnostic test and distributes the test to a network of public health laboratories. Development and manufacture of IVD tests in accordance with FDA regulations requires compliance with Title 21 of the Code of Federal Regulations (CFR). The CDC Influenza Division is seeking qualified vendors that can manufacture specific oligonucleotide primers and probes for incorporation into the CDC's FDA-cleared IVD test as well as Research Use Only (RUO) primers and probes for research applications. The purpose of the proposed competitive acquisition is: 1) to identify and pre-qualify multiple commercial laboratories capable of manufacturing RUO and IVD Quality Reagents of CDC-specified designs, in the event of an influenza pandemic; and, 2) to establish contracts to meet the current and anticipated requirements of CDC researchers for RUO and IVD Quality Reagents. NOTE: Prior to contract award, the government will perform on-site inspection of contractor facilities, to ensure that they meet or exceed FDA requirements for manufacture of IVD quality reagents, in accordance with Good Manufacturing Practices (GMP) Quality System (QS) Regulations, as set forth in Section 520 of the Food, Drug and Cosmetic (F,D&C) Act. Multiple contract awards are anticipated. The period of performance will be 60 months, which will be accomplished through a 12-month base period and four 12-month option periods. The Request for Proposal will be posted on or about 6/14/12. Offerors are expected to download all documents concerning this requirement, as no hard copies will be mailed. Questions/comments via telephone will not be honored. Offerors are advised to frequently view this website for updated posting. The associated NAICS code is 325414.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2012-N-14345/listing.html)
- Place of Performance
- Address: Contractor facility, United States
- Record
- SN02757464-W 20120526/120524235626-419210925acb5fe84b25e7de64f50217 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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