SPECIAL NOTICE
B -- Supplement Safety Surveillance Project
- Notice Date
- 8/2/2007
- Notice Type
- Special Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical 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, MD, 20857-0001, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- FDA-SOL-07-00358
- Response Due
- 8/15/2007
- Archive Date
- 8/30/2007
- Description
- The Food and Drug Administration intends to award a follow on purchase order to the University of California at San Francisco. this is NOT a request for competitive quotes. The purchase order will be made on a sole source basis in accordance with FAR Part 13 - Simplified Acquisition Procedures for the following services. This order will support FDA in the dietary supplement safety surveillance project. DESCRIPTION OF WORK: The contractor shall work very closely with the project officer throughout the project. The contractor shall: Through a 6-month purchase order with the FDA, operate a dietary supplement safety surveillance program (DDSSP) for investigating of adverse health effects in individuals using dietary supplements. The goal is to apply a consistent, objective approach to evaluate reported adverse effects in order to be able to determine whether the event was related to the exposure (causation or association) and also to monitor trends in dietary supplement adverse event reporting. Our experience with the project they have recently computed provided us guidance on enhancements to improve the timeliness of case identification and ensure through follow-up for clinical and analytical data. The project will include the following objectives. 1) Monitor all calls made to 2 divisions of the CPCS hotline that involve dietary supplements, and collect cases that involve symptoms for prompt, follow-up and investigation. This doubles the catchments region for cases, and will include cases from distinct geographic segments of the state (Northern and Southern California). The ultimate goal is to incorporate the projects into all 4 divisions of the CPCS (serving the entire state of California). The second enhancement is the utilization of the CPCS module by the hotline staff to facilitate timely recognition of cases, notification of medical back-up, and case follow-up. 2) Carry out comprehensive clinical and laboratory investigation of reported events to obtain reliable and accurate data in a timely manner, including product analysis and biological fluid testing in our clinical laboratory, if appropriate. 3) Conduct quarterly peer-review sessions with a multi-disciplinary team to review incidents of serious adverse events and determine causation based on a validated causation assessment scale. The team will be expanded to include participation by the U.S. FDA for an added perspective and insight. 4) Provide quarterly reports and analysis of finding on adverse events to the FDA. The analysis may include comparative prevalence data on the particular ADR for the general population and any other data on associations with the product or ingredient. 5) Notify the FDA within 72 hours of a serious sentinel adverse event related to a dietary supplement that may be a signal of a new health risk or a highly injurious supplement product. PERIOD OF PERFORMANCE: September 2, 2007 ? March 2, 2008.
- Place of Performance
- Address: 10920 Wilshire Blvd #1200, Los Angeles, CA
- Zip Code: 90024-6523
- Country: UNITED STATES
- Zip Code: 90024-6523
- Record
- SN01359993-W 20070804/070802220603 (fbodaily.com)
- Source
-
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