SOURCES SOUGHT
B -- Popolutation-Based Data to Answer Questions of Public Health Importance Regarding Biological Products
- Notice Date
- 3/6/2008
- Notice Type
- Sources Sought
- 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, MD, 20857-0001, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- FDA-SOL-08-1039956
- Response Due
- 3/24/2008
- Archive Date
- 4/8/2008
- Point of Contact
- Kimberly Davis, Contract Specialist, Phone 301-827-7179, Fax 301-827-7101, - Patricia Pemberton, Contracting Officer, Phone 301-827-1022, Fax 301-827-7106
- E-Mail Address
-
kimberly.davis@fda.hhs.gov, patricia.pemberton@fda.hhs.gov
- Description
- This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small business (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran owned small business, and women-owned small businesses) to provide Population-based data to answer questions of public health importance regarding biological products. The threat of a swine influenza pandemic in 1976-77 led to a mass vaccination effort in the United States. Unfortunately, the vaccine was subsequently found to cause rare cases of Guillain Barr Syndrome (GBS), a severe paralyzing neurologic condition. For any future large-scale influenza immunization campaign, it is important that the government be well prepared to detect a problem that occurred once before, and the public would expect no less. Although clinical pre-licensure studies may identify potential adverse events associated with a biologic product, rare adverse events associated with the biologic product will likely go unrecognized until there is widespread use of the biologic product in the population. The timely identification of serious rare adverse events is important for at least three reasons. First, the morbidity to the individual may be severe, representing an important safety issue. Second, unwarranted fear of adverse reactions can lead to a lack of confidence in, and inappropriately low use of, the biologic product such as a vaccine. Third, new and timely information that quantifies the incidence of serious vaccine adverse effects, if any, can facilitate benefit-risk analysis of continued use of the biologic product. The objective of this requirement is to development of large rapid systems for monitoring adverse events associated with a biologic product is important, and increasing this capacity currently for existing biologic products can help prepare for a biologic threat such as influenza pandemic that would require mass immunizations. This project would further enhance the ability of FDA to conduct biologic safety and effectiveness among large diverse populations, with respect to severe but uncommon adverse events. This requirements goal is to gain access to data resources that promote the Division Epidemiologys mission to assure the safety and effectiveness of biologic products. This project builds upon and expands on activities undertaken as part of previous FDA collaborative studies for biologic product safety, including evaluating adverse events after influenza vaccination among the elderly using Medicare data. During the course of the contract period of performance, the Contractor shall provide a work plan(s) and a cost estimate(s) for each specific biologic safety study requested. The Contractor will be required to:
- Record
- SN01525669-W 20080308/080306223555 (fbodaily.com)
- Source
-
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