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FBO DAILY ISSUE OF APRIL 25, 2003 FBO #0512
SOLICITATION NOTICE

B -- Office of Women''s Health Clinical Research Studies

Notice Date
4/23/2003
 
Notice Type
Solicitation Notice
 
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
223-03-8720
 
Response Due
6/9/2003
 
Archive Date
6/24/2003
 
Point of Contact
Paul Scarborough, Contract Specialist, Phone (301) 827-7168, Fax (301) 827-7103, - Hamilton Brown, Contract Specialist, Phone (301) 827-7043, Fax (301) 827-7101,
 
E-Mail Address
pscarbor@oc.fda.gov, hbrown@oc.fda.gov
 
Description
The Food and Drug Administration’s Office of Women’s Health (FDA OWH) intends to solicit and award a new, three year Indefinite Delivery/Indefinite Quantity type contract with women’s health research networks for conducting human clinical drug studies and performing analytical work on collected biological specimens. These studies will be conducted in compliance with specific study protocols designated by the contractor and/or FDA OWH. The objectives of each study will be met by the issuance of separate task orders over the performance period of the contract. The types of clinical studies that could be requested include (1) Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies on Selected Drugs in Special Populations, (2) Clinical Studies on Drug/Drug and Drug/Dietary Supplement Interaction, (3) Sex Differences in the Safety and/or Efficacy of FDA-Regulated Products used by Men and Women, (4) Clinical Studies to Evaluate Genotypic and Phenotypic Factors Influencing Response to FDA Regulated Products. The objective of each task order will be to provide data and analysis to assist FDA OWH in advancing its regulatory science research program that will address gaps in current knowledge, encourage new directions, and set new standards of excellence in women’s health. 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 North American Industry Classification System (NAICS) Code for this requirement is 54171.
 
Web Link
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/FDA/DCASC/223-03-8720/listing.html)
 
Record
SN00310221-F 20030425/030424064620 (fbodaily.com)
 
Source
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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