Contraceptive Development Program NICHD Contraceptive Clinical Trials Network Female Sites

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 AUGUST 22, 2019. 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 Research Branch and Reproductive Health Branch (CRHB) 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 CRB established the initial NICHD CCTN in order to conduct Phase I, II, and Ill clinical trials of new contraceptive methods. In 2017, the CCTN was moved to the Division of Intramural Population Health Research (DIPHR) into the newly formed Contraceptive Development Program. The NICHD CCTN is an important component of the Contraceptive Development Program's (CDP) contraceptive development capability. Products that have undergone formulation and successful pre-clinical testing, either through the CDP 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 female sites that will operate under IDIQ Task Order contracts. The female 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 female sites contractors will evaluate systematically the safety and efficacy of new female contraceptive drugs and devices as well as drug treatments of gynecologic conditions in Phase I, II, Ill 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 (NOA), Premarket notification 51 Ok, Premarket Approval (PMA) or lnvestigational Device Exemptions (IDE). It is estimated that the new NICHD CCTN will consist of approximately 16 sites capable of performing female contraceptive clinical trials. Please be advised that the NICHD will be issuing separate RFPs for each CCTN Topic Area (Female Contraceptive Clinical Trials & Male Contraceptive Clinical Trials) and the SCCC for the CCTN. This Pre-Solicitation announcement is for the RFP for the Female 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.