SOLICITATION NOTICE
A -- Biopharmaceutics Classification System (BCS)
- Notice Date
- 7/11/2009
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- 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-09-223-01-00154
- Point of Contact
- Jacqueline Richardson, Phone: 301-827-7180, Doreen Williams ,
- E-Mail Address
-
jacqueline.richardson@fda.hhs.gov, doreen.williams@fda.hhs.gov
(jacqueline.richardson@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Synopsis: The Centers for Drug Evaluation and Research CDER), will be issuing a Request for Proposal (RFP) for capable contractors who have the technical experience in conducting a Biopharmaceutical Classification System (BCS) for class 3 drugs, specifically, drugs with transporter involvement during absorption. Objective: The Biopharmaceutics Classification System (BCS) characterizes drug substances based on their aqueous solubility and intestinal permeability. These properties, in addition to dissolution, control the rate and extent of drug absorption from immediate release, solid oral dosage forms. The prospective project would evaluate a number of commonly used excipients for possible impact on the permeability and absorption of several BCS Class 3 drugs, specifically, drugs with transporter involvement during absorption. This potential study would complement ongoing studies of drugs with passive diffusion as the main mechanism of absorption. In vitro as well as confirmatory in vivo studies would be conducted. The results could support extending biowaivers to drug products in this class. The contractor would be required to submit to the FDA, several written progress reports at scheduled intervals. At the completion of the program, a single report analyzing the results of the study would be provided to the FDA. The NAICS code for this forthcoming procurement is 541712. The solicitation number for the procurement will be 09-223-01-00154 and the resultant award is expected to be a combination Labor Hour/Fixed Price contract with a period of performance of for (1) year. The requirements under the solicitation will be designated for Full and Open Competition. The RFP is anticipated for release on or about July 27, 2009. Interested parties must respond to the RFP in order to be considered for award of any resultant contract. All responsible sources may submit proposals which shall be considered by the agency. No bidder's list will be maintained. Notifications will not be sent to offerors regarding the issuance of the solicitation nor any of its amendments. It is the offerors' responsibility to monitor the FedBizOpps for release of this acquisition and any associated amendments. **QUESTIONS WILL NOT BE ENTERTAINED**
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-09-223-01-00154/listing.html)
- Place of Performance
- Address: 5630 Fisher Lane, Rockville, Maryland, 20857, United States
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN01872648-W 20090713/090711233310-63286d674468c23ba5038e679dad43f7 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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