SOLICITATION NOTICE
A -- Clinical Trial Site to Conduct Evaluations of Topical Microbicides
- Notice Date
- 6/4/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2003-N-00822
- Response Due
- 7/24/2003
- Archive Date
- 8/8/2003
- Point of Contact
- Janet Herrington, Contract Specialist, Phone 770-488-2729, Fax 770-488-2670, - William Ryan, Contract Specialist, Phone 770-488-2717, Fax 770-488-2670,
- E-Mail Address
-
auy2@cdc.gov, wrf4@cdc.gov
- Description
- The Centers for Disease Control and Prevention in Atlanta, Georgia intends to award a cost-reimbursement plus fixed fee type contract to a qualified offeror for a ?U.S. Clinical Trial Site to Conduct Evaluations of Topical Microbicides in Heterosexual Women and Men.? The purpose of this contract is to implement protocols for Phase I and Phase II clinical trials of the safety and acceptability of candidate topical microbicides. The Contractor will assist CDC investigators in the development of final protocols and preparation of materials for local and CDC IRB review, recruit and retain the desired number and type of study participants, implement clinical trial protocols, protocols in compliance with Good Clinical Practice (GCP) regulations, perform necessary laboratory studies in compliance with Good Laboratory Practice (GLP), ship biological specimens to designated laboratories, and maintain all data collected using methods and software designed by the CDC. Clinical trial protocols will be consistent with Food and Drug Administration (FDA) requirements; therefore, the Contractor will be required to use the clinical procedures, data points, and IRB-approved data collection procedures developed by the CDC in compliance with standards in the field of microbicide research. The date specified for receipt of offers will be approximately 30 days after the solicitation issue date, on or about July 24, 2003. Proposals may be subject to peer review. Peer review is the process that includes independent assessment of research by a panel of experts who provide written assurance that their reviews are free of real or perceived conflicts of interest. The performance period under this contract will be three years from date of contract award. The NAICS code is 541710 and all responsible offerors may submit a proposal that will be considered by the agency. See Numbered Note 26. Paper copies of the solicitation will not be made available; however, the solicitation will be available for retrieval at www.fedbizopps.gov, on or about June 19, 2003. It will be the responsibility of individual offerors to monitor the above website for additional postings regarding this solicitation. Telephonic/facsimile requests will not be accepted.
- Record
- SN00339452-W 20030606/030604213324 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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