SOLICITATION NOTICE
B -- IMPACT: Evaluation of the contribution of the FDA spontaneous adverse event surveillance system to support safety-related regulation actions throughout a product's life cycle
- Notice Date
- 6/23/2009
- Notice Type
- Presolicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- 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-SOL-00116
- Point of Contact
- Patricia Wright, Phone: 301-827-7217
- E-Mail Address
-
patricia.wright@fda.hhs.gov
(patricia.wright@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Synopsis: The Food and Drug Administration (FDA) intends to solicit proposals for a contractor to fulfill a requirement for a program entitled IMPACT: Evaluation of the contribution of the FDA spontaneous adverse event surveillance system to support “safety-related regulatory actions” throughout a product’s life cycle. This is not related to the FDA Agency-wide Sentinel System project. In fulfillment of a Prescription Drug User Fee Act (PDUFA) IV commitment, FDA launched a project in 2008 entitled, “Initiative for Maximizing the Benefit of Passive Adverse Event Collection Throughout a Product’s Life Cycle” (IMPACT). Through IMPACT, FDA is undertaking an evaluation of its spontaneous AE surveillance system. The goal of IMPACT is to determine the role of spontaneous adverse event reports in detecting and characterizing drug safety risks and supporting safety-related regulatory actions. This will inform future efforts to determine the impact of safety-related regulatory actions on the safe and effective use of drugs and therapeutic biologics on public health. The primary objectives to be accomplished under this contract are to: 1) provide a detailed description of the FDA spontaneous AE surveillance system including key system objectives, components, and relevant laws, regulations, and guidances, 2) conduct a systematic review and analysis of the role of the FDA spontaneous AE surveillance system in supporting safety-related regulatory actions, 3) provide FDA with a report of study results, conclusions, and recommendations on how to maximize the impact of the FDA spontaneous AE surveillance system to support safety-related regulatory actions throughout a product’s life cycle. FDA intends to solicit this requirement as a full and open competitive requirement. The solicitation will be available for download on or about July 8, 2009 and may be accessed through the Federal Business Opportunities (FedBizOpps) website: https://www.fbo.gov. No hardcopies will be distributed. Any questions concerning this requirement must be submitted in writing by e-mail only, to Patricia Wright at patricia.wright@fda.hhs.gov. NO PHONES WILL BE ACCEPTED. All responsible sources may submit a proposal which will be considered by the Agency.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-09-223-SOL-00116/listing.html)
- Record
- SN01854130-W 20090625/090624001033-0d6c3f7e0c754f27f9d9ffa451c76591 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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