SOLICITATION NOTICE
A -- Drug Saftey Risk Assessment Modeline and Sinulation
- Notice Date
- 8/7/2009
- Notice Type
- Cancellation
- 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
- PRE-09-223-SOL-00219
- 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 Request for Proposal (RFP) for the Development of Technologies for Drug Safety Risk Assessment Modeling and Simulation This effort will be done in response to the Agency risk evaluation and mitigation strategy. Together, available data and explicit assumptions (from process and product knowledge) will be combined to express patient risk with respect to the safety and efficacy of a drug product. This will support the development and calibration of a probabilistic risk assessment tool that utilizes model-based simulation to relate clinical data to product and process quality variation. The objective of this contract is to develop a model to act as a framework for assembling safety and efficacy related product specifications that summarize the performance of a drug. Following development and calibration, the model will be used as a continuous improvement tool for assessing risk to patients. It is expected that the development of a probabilistic risk assessment tool will highlight gaps in the available information regarding a drug product. The model will facilitate ranking the importance of that missing information and thereby spur research into the most relevant facets of drug performance. As additional information becomes available, the model will be updated. The solicitation number for the procurement will be 09-223-SOL-00219 and the resultant award is expected to be a Labor Hour/Firm Fixed Price contract with a period of performance of two (2) years. The requirements under the solicitation will be designated for Full and Open Competition This will be is an unrestricted solicitation being conducted under FAR Part 15. The RFP will be posted on FedBizOpps (FBO) website: http://www.fbo.gov on or about August 21, 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 done so through the CCR website at http://www.ccr.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/PRE-09-223-SOL-00219/listing.html)
- Place of Performance
- Address: 5630 Fisher Lane, Rockville, Maryland, 20857, United States
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN01903532-W 20090809/090808000331-ea49b0e1b240d4943b998815fc74cde9 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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