SPECIAL NOTICE
B -- Procurement of UC-781, an Experimental Topical Anti-HIV Microbicide, for use in a Phase I Clinical Trial
- Notice Date
- 7/6/2004
- Notice Type
- Special Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- 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
- 2004-N-01468
- Response Due
- 7/22/2004
- Archive Date
- 7/24/2004
- Point of Contact
- Lisa Lombard, Contract Specialist, Phone 770-488-2636, Fax 770-488-2777, - Allyson Brown, Contract Specialist, Phone (770)488-2649, Fax (770)488-2670,
- E-Mail Address
-
lpl0@cdc.gov, ARBrown@CDC.GOV
- Description
- The Centers for Disease Control and Prevention is contemplating the award of a contract on an ?Other than Full & Open Competition? basis to BioSyn, Inc. in accordance with FAR part 6.302-1(b). The basis for this contemplation is that only one responsible source and no other supplies/services will satisfy agency requirements. The requirement is as follows: This contract is intended to obtain a drug product which is available exclusively from one specific entity. Biosyn, Inc. holds all right and patents for the development of UC-781 as a topical microbicide agent. Placebo for the trials, while it does not contain UC-781, needs to be formulated and packaged to appear as identical as possible to active UC-781 in order to best permit blinding of the clinical trial, Also, product and placebo need to be labeled accurately and records of labeling kept by a single entity so as to permit unblinding following the conclusion of the trial. It is therefore not feasible that placebo be provided by another entity. UC-781 was selected for the clinical trials described in this document through an open, competitive process. This process was initiated through an announcement soliciting collaboration from entities holding interest in potential anti-HIV topical Microbicides which appeared in the Federal Register in June, 2001. Proposals were received for a total of five different agents which were tested by CDC laboratory scientists for in vitro toxicity and anti-HIV activity. UC-781 was selected for clinical trial based upon its favorable performance in these in vitro studies. The anticipated performance period will not exceed two years from the date of contract award. It is believed that BioSyn, Inc. possesses the capability and is uniquely qualified to perform this requirement as stated above. All responsible sources that feel they should be considered qualified to provide the foregoing products/services may submit a response by no later than 2:00pm EST, on July 22, 2004 by e-mail to Lisa Lombard at LPL0@CDC.GOV (that is LPL ZERO). See Note 22.
- Place of Performance
- Address: Huntington Valley, PA
- Record
- SN00615443-W 20040708/040706211638 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |