SOLICITATION NOTICE
B -- Popolutation-Based Data to Answer Questions of Public Health Importance Regarding Biological Products
- Notice Date
- 7/18/2008
- 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-SOL-08-00538
- Response Due
- 8/1/2008 12:00:00 PM
- Archive Date
- 8/16/2008
- Point of Contact
- Dominique H Malone, Phone: (301) 827-7227, Patricia M Pemberton,, Phone: 301-827-1022
- E-Mail Address
-
dominique.malone@fda.hhs.gov, patricia.pemberton@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- The FDA intents to issue and RFP 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:1) Analytic datasets and associated documentation (per terms of contract). 2) Medical record review and abstraction (necessity to be negotiated on a case-by-case basis. Note-not to be delivered to FDA directly). 3) Physician and/or Patient Survey (necessity to be negotiated on a case-by-case basis). 4) Work closely with FDA to develop feasibility studies (frequencies to be determined by FDAs identification of a biologic safety and/or effectiveness issue). 5) Work closely with FDA in the development of a detailed protocol for a formal pharmacoepidemiolgic study. The contract performance will be in the Washington DC/Maryland area. An indefinite delivery/indefinite quantity (ID/IQ) contract is anticipated, for five(5)years. This is a new requirement. FDA intends to solicit this requirement as “Full and Open” competitive requirement. This announcement is not a request for proposal (RFP). FDA anticipates release of the RFP on or around August 1, 2008 and it will be available on the Federal Business Opportunities (FedBizOpps) website. The anticipated award date for this effort is on or before September 20, 2008.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=3501a2a60b925f63ac284e0b21c2913a&tab=core&_cview=1)
- Place of Performance
- Address: Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857, United States
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN01618004-W 20080720/080718221800-3501a2a60b925f63ac284e0b21c2913a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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