SOLICITATION NOTICE
B -- Pharmacokinetic Assessment
- Notice Date
- 9/1/2009
- Notice Type
- Presolicitation
- NAICS
- 621511
— Medical Laboratories
- 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
- FDA1062753
- Point of Contact
- Jacqueline Richardson, , 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 Food and Drug Administration intends to issue a Request for Quotes (RFQ) for Pharmacokinetic (PK) assessment of three extended release prescription products. With the introduction of Waxman-Hatch Act of 1984, the FDA has evaluated and approved thousands of therapeutic generic products as safe and equivalent to brand products. This is an enormous success story with some surveys estimating that about 65% of all prescriptions filled today are with generic products. Though successful, there is also a rising tide of skepticism about their safety and switch ability between products. Therefore, there is a need for an independent evaluation of some products with respect to their PK parameters. The objective of this contract is to provide: 1) to perform an independent evaluation of the PK of three extended release products at an academic clinical setting; and 2) to use this PK data to enhance their understanding on patient complaints and/or adverse events, and on their drug application reviews. The solicitation number for the procurement will be FDA-1062753 and the resultant award is expected is a Firmed Fixed Price Purchase Order with a period of performance of one (1) years. The requirements under the solicitation will be designated for Full and Open Competition. This will be be conducted under FAR Part 13. The RFQ will be posted on FedBizOpps (FBO) website: http://www.fbo.gov on or about September 14, 2009. All responsible sources may submit proposals which shall be considered by the agency. No bidder's list will be maintained. It is the offerors' responsibility to monitor the FedBizOpps for release of this acquisition and any associated amendments. Offeror must be registered in the Central Contract Registration (CCR) database before an award can be made to them. If the offeror is not registered in the CCR, it may be done so through the CCR website at http://www.ccr.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA1062753/listing.html)
- Place of Performance
- Address: 5630 Fisher Lane, Rockville, Maryland, 20857, United States
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN01935404-W 20090903/090902003642-588515a22b83f63044a7ba9d9fd2c2c0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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