SOLICITATION NOTICE
A -- Pertussis Diagnostics Clinical Validation Study
- Notice Date
- 8/6/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- 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
- 2008-Q-10835
- Archive Date
- 9/5/2008
- Point of Contact
- Gary L. Morgan, Phone: (770) 488-2639, Jeff A Miller,, Phone: 770-488-2651
- E-Mail Address
-
glm5@cdc.gov, afx2@cdc.gov
- Small Business Set-Aside
- N/A
- Description
- The Centers for Disease Control and Prevention (CDC) intends to award, on a sole source basis, a contract to the Montefiore Medical Center, 111 East 210th Street, Bronx, NY 10467. Because of the complex nature of this study, the CDC requires assistance from an organization with extensive experience conducting clinical research studies. Montefiore Medical Center has received the necessary training, has obtained the required state and Institutional Review Board (IRB) approvals to conduct this study and has successfully collected and tested specimens for this study since January of this year. This sole-source requirement will purchase an additional 6 enrollment hours per day for a 1 year period, which are needed to successfully reach our enrollment target for this study. The vendor will collect clinical specimens, clinical symptoms and epidemiologic-linkage information from patients with prolonged cough illness (cough lasting more than 5 days). Potential study participants will be identified by vendor employed study staff working at Montefiore Medical Center (MMC). Study staff will collect nasopharyngeal specimens for culture and PCR testing, blood specimens for serologic testing, and oral fluid specimens for sIgA testing. Nasopharyngeal, oral fluid and blood specimens will be collected immediately following enrollment, and for participants with a cough duration of <= 2 weeks, an additional convalescent blood specimen and oral fluid specimen will be collected 2 to 4 weeks post-enrollment. The vendor shall, as an independent organization, prepare the specimens, conduct culture and PCR, and accompanying documentation for transport to the CDC following CDC approved study specific procedures. Justification for other than full and open competition is considered due to the New York State Department of Health diagnostics approval that allows for test results within 24 hours. No other clinical research site could implement the study within the required timeframe. MMC is the only organization able to provide this service without program redundancy and an unneccessary reinvention of MMC services. Failure to procure this study via MMC will invariably cause a duplicative expenditure of considerable funds, and likely an inferior pertussis study being obtained by the CDC. Note 22 applies herein. The statutory authority permitting other-than-full-and-open competition is 41 U.S.C., 253(c)(1): FAR 6.302-1. Only one responsible source and no other services will satisfy agency requirements. Interested persons may identify their interest and capability to respond to the requirement. This notice is not a request for competitive proposals. A determination by the Government not to compete this proposed contract will be based on responses to this notice and is solely within the discretion of the government. Information received will be considered solely for informational purposes. This procurement is not set-aside for small business. For contractual questions contact Gary Morgan by email at glm1@CDC.gov or by fax to 770-488-2777.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=119bec88fd6fb0c8f943fb7bc863fef3&tab=core&_cview=1)
- Place of Performance
- Address: 111 East 210th Street, Bronx, New York, 10467, United States
- Zip Code: 10467
- Zip Code: 10467
- Record
- SN01632720-W 20080808/080807103355-119bec88fd6fb0c8f943fb7bc863fef3 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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