SOLICITATION NOTICE
A -- NICHD Contraceptive Clinical Trials Network - Male Sites
- Notice Date
- 4/2/2012
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- 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, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NICHD-CRHB-2012-04
- Point of Contact
- Katharine Minker, Phone: 301-402-7571, Alice M. Pagán, Phone: 301-435-6959
- E-Mail Address
-
km571h@nih.gov, alice.pagan@nih.gov
(km571h@nih.gov, alice.pagan@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION ANNOUNCEMENT ONLY. A REQUEST FOR PROPOSALS WILL BE ISSUED VIA FEDBIZOPPS ON OR ABOUT APRIL 17, 2012. The National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is planning to issue an RFP for multiple Indefinite/Delivery, Indefinite/Quantity (IDIQ) Task Order contracts for the NICHD Contraceptive Clinical Trials Network (CCTN). 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 CCTN in order to conduct Phase I, II, and III clinical trials of new contraceptive methods. The NICHD CCTN is an important component of the CRHB contraceptive development capability. Products that have undergone formulation and successful pre-clinical testing, either through the CRHB formulation and testing facilities or through outside sources, are candidates for clinical testing in the NICHD CCTN. The NICHD 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 clinical trials. This acquisition is for a re-competition of the male sites that will operate under an Indefinite/Delivery, Indefinite/Quantity (IDIQ) Task Order contracts. The male sites will be able to work with the CCTN Statistical and Clinical Coordinating Center (SCCC) and NICHD to rapidly develop protocols and initiate clinical trials shortly after candidate products have completed the necessary preclinical testing. The resultant IDIQ contracts will be for a seven (7) year period of performance. The CCTN male sites contractors will evaluate systematically the safety and efficacy of new male contraceptive drugs and devices as well as drug treatments for conditions in Phase I, II, III and IV trials. The results of these clinical trials would be the basis for advancing candidate drugs and devices through development with the ultimate goal of submission to the FDA in support of a New Drug Application (NDA), Premarket notification 510k, Premarket Approval (PMA) or Investigational Device Exemptions (IDE). It is estimated that the new NICHD CCTN will consist of up to 4 sites capable of performing male contraceptive clinical trials and up to 16 female sites. Please be advised that the NICHD is issuing separate RFPs for each CCTN Topic Area (Male Contraceptive Clinical Trials & Female Contraceptive Clinical Trials) and the SCCC for the CCTN. This Pre-Solicitation announcement is for the RFP for the Male Sites for the only. The RFP will be made available electronically only via the FedBizOpps website (http://www.fbo.gov). Offerors are responsible for routinely checking the FedBizOpps website for any possible solicitation amendments that may be issued.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NICHD-CRHB-2012-04/listing.html)
- Record
- SN02711268-W 20120404/120402234636-f9415bcaddbed158658f77878d922956 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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