MODIFICATION
A -- NICHD CONTRACEPTIVE CLINICAL TRIALS NETWORK (FEMALE CONTRACEPTIVE CLINICAL TRIAL TOPIC AREA)
- Notice Date
- 10/31/2002
- Notice Type
- Modification
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, MD, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- RFP-NICHD-2003-04
- Response Due
- 2/4/2002
- Archive Date
- 6/1/2003
- Point of Contact
- Charles Newman, Contracting Officer, Phone 301-435-6960, Fax 301-402-3676, - Charles Grewe, Deputy Chief, Contracts Management Branch, Phone 301-435-6957, Fax 301-402-3676,
- E-Mail Address
-
cn43m@nih.gov, cg59b@nih.gov
- Description
- The National Institutes of Health (NIH), National Institute of Child Health and Human Development (NICHD) is planning to issue an RFP for multiple Indefinite-Quantity, Indefinite-Delivery (IDIQ) Task Order contracts for the NICHD Contraceptive Clinical Trials Network (Female Contraceptive Clinical Trial Topic Area). The NIH, NICHD is the lead Federal agency for the conduct of basic, clinical and epidemiological research to develop new contraceptives and to evaluate existing methods of contraception and reproductive health. The Center for Population Research (CPR), within NICHD, was established in 1968 by the Secretary of Health Education and Welfare, with the important goal of developing new contraceptives through the use of contracts and grants. Within CPR, the Contraception and Reproductive Health Branch (CRHB) has long supported several preclinical contraceptive testing facilities, as well as facilities for chemical and peptide synthesis. To further expand their contraceptive development capabilities, in 1996 CRHB established the initial NICHD Contraceptive Clinical Trials Network (CCTN) in order to conduct Phase I, II, and III clinical trials of new female contraceptive methods. The NICHD CCTN is an important component of the CRHB contraceptive development capability. Products that have undergone synthesis and successful pre-clinical testing, either through the CRHB formulation and testing facilities or through outside sources, are candidates for clinical testing in the CCTN. The CCTN is particularly valuable for providing a venue for testing new contraceptive drugs and devices that have been developed by small companies that lack the resources to support large-scale Phase I, II, and III clinical trials of new female contraceptive methods. The new CCTN, that will operate under Indefinite-Quantity, Indefinite-Delivery (IDIQ) Task Order contracts, will be able to rapidly develop protocols and initiate clinical trials shortly after candidate products have completed the necessary preclinical testing. The resultant IDIQ contracts will consist of a one-year base period and six one-year option periods. Both female and male contraceptives will undergo Phase I, II, and III clinical trials in the new CCTN. It is estimated that the new CCTN will consist of approximately 12 sites capable of performing female contraceptive clinical trials and approximately four sites capable of performing male contraceptive clinical trials. Please be advised that the NICHD is issuing separate RFPs for each Topic Area (Female Contraceptive Clinical Trials & Male Contraceptive Clinical Trials) in order to better facilitate and coordinate the evaluation of Proposals. This announcement is for the RFP for the Female Contraceptive Trials Topic Area, only. Offerors may choose to propose on either RFP (Female Contraceptive Trials & Male Contraceptive Trials) or both RFPs depending on their organization?s capabilities. However, please be advised that the NICHD will not accept combined proposals (Female & Male) from offerors who wish to propose on both RFPs. Those offerors that propose on both RFPs must provide separate individual Technical and Business Proposals in response to each RFP. Organizations that believe they have the capabilities and recruitment ability necessary to participate in this network, may access the Request for Proposal(s), RFP-NICHD-2003-04, electronically on the FedBizOpps website, at http://www.eps.gov/spg/HHS/NIH/NICHD/postdate_1.html, on or about November 1, 2002. Please note that the NICHD does not intend to release hard copies of the RFP. The NICHD also reserves the right to cancel the requirement at any time prior to contract award. (See Numbered Note 26)
- Record
- SN00196994-W 20021102/021101073741 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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