MODIFICATION
B -- Scientific Research for Center for Drugs and Evaluation Research
- Notice Date
- 6/12/2002
- Notice Type
- Modification
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Division of Construction and Agency Support Contracting, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 223-02-3003
- Response Due
- 7/12/2002
- Archive Date
- 7/27/2002
- Point of Contact
- Susan Pearlman, Contract Specialist, Phone (301) 827-7167, Fax (301) 827-7103, - Hamilton Brown, Contract Specialist, Phone (301) 827-7043, Fax (301) 827-7101,
- E-Mail Address
-
spearlma@oc.fda.gov, hbrown@oc.fda.gov
- Description
- The Food and Drug Administration?s (FDA) Center for Drug Evaluation and Research?s (CDER) Office of Pediatric Drug Development and Program Initiatives (OPPDI), in conjunction with FDA?s Office of Women?s Health, are writing a contract to support research on infant outcomes and/or maternal effects in pregnant women exposed to certain pharmaceuticals, which could be used to treat diseases or conditions resulting from a terrorist attack. The nation?s recent experience with bioterrorism has demonstrated that in the event of a terrorist attack it will be necessary to treat pregnant women with pharmaceutical agents for diseases or conditions that might otherwise be fatal. However, little is known about the safety of most drugs either to the woman or to her developing fetus when used during pregnancy. The objectives of the contracted research will be to develop information on infant outcomes and/or maternal effects in a cohort of women exposed to a drug of interest during pregnancy using large automated healthcare data systems data. The highest priority is to evaluate infant outcomes; however, a specific contract could also include a component to assess maternal effects of the drug during pregnancy. Also, a specific contract could study one or more drugs of interest. The contract shall have an eighteen-month basic period of performance. All responsible organizations may submit an offer in response to the solicitation. (NOTE: Guidelines will be provided with the solicitation.) This is a new contract (Contract Number 223-02-3003). The Request for Proposal (RFP) will only be available on the FedBizOpps web page at http://www.fedbizopps.gov/. Prospective offers are responsible for downloading the RFP and all attachments. It is the offeror?s responsibility to monitor the FedBizOpps web page for the release of the solicitation and amendments. The RFP should be available for downloading on/about fifteen (15) days after publication of this announcement. This requirement will be a full and open competitive requirement. The FDA reserves the right to award without discussions.
- Place of Performance
- Address: Contractor's Facility
- Country: United States
- Country: United States
- Record
- SN00092171-W 20020614/020613084048 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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