STATISTICAL AND CLINICAL COORDINATING CENTER FOR THE NICHD CONTRACEPTIVE CLINICAL TRIALS NETWORK RELEASE DATE: November 20, 2002 NOTICE: NOT-HD-03-001 National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) RFP AVAILABLE: RFP-NICHD-2003-01 (100 Percent Set-aside for Small Business Concerns) The National Institute of Child Health and Human Development (NICHD) is planning to issue an RFP for an Indefinite-Quantity, Indefinite-Delivery (IDIQ) Task Order contract for a Statistical and Clinical Coordinating Center (SCCC) for the NICHD Contraceptive Clinical Trials Network (CCTN). The RFP will be a 100 percent set-aside for small business concerns. The North American Industry Classification System (NAICS) code for this acquisition is 541710 and the corresponding small business size standard is 500 employees or less. The 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. The Center for Population Research (CPR), 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 pre-clinical 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 female contraceptive methods. The SCCC for 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 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 clinical trials. This acquisition will be a recompetition of the SCCC for the CCTN that has been funded under a Cost plus Fixed Fee contract since 1996. The proposed SCCC, operating under an Indefinite-Quantity, Indefinite- Delivery (IDIQ) Task Order contract, will be able to work with the CCTN contractors to rapidly develop protocols and initiate clinical trials shortly after candidate products have completed the necessary pre-clinical testing. The resultant IDIQ contract will consist of a one-year base period and six one-year option periods. The SCCC Contractor will provide necessary technical support needed by the NICHD and the CCTN sites, such as the development of research protocols, on-site monitoring of clinical trials, the statistical analysis of data from these trials, and the development of Investigational New Drug (IND) applications and initiation of New Drug Applications (NDA). For devices, the SCCC Contractor will provide support for Premarket Notifications 510k, Premarket Approvals (PMA), and Investigation Device Exemptions (IDE). It is estimated that the new NICHD 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 CCTN topic area (i.e., Female Contraceptive Clinical Trials and Male Contraceptive Clinical Trials) and for the SCCC in order to better facilitate and coordinate the evaluation of proposals. This announcement is for the RFP for the SCCC for the NICHD CCTN, only. Small business concerns that believe they have the capabilities necessary to serve as the Statistical and Clinical Coordinating Center for the NICHD Contraceptive Clinical Trials Network may access the Request for Proposal(s), RFP-NICHD-2003-01, electronically on the FedBizOpps website, at http://www2.eps.gov/servlet/Solicitation/R/HHS/NIH/NICHD/RFP-NICHD-2003-05, on or about December 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. INQUIRIES Charles Newman Contracting Officer Contracts Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Suite 7A07, MSC 7510 Bethesda, MD 20892-7510 Telephone: 301-435-6960 Fax: 301-402-3676 Email: cn43m@nih.gov OR Charles Grewe Deputy Chief Contracting Officer Contracts Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Suite 7A07, MSC 7510 Bethesda, MD 20892-7510 Telephone: 301-435-6957 Fax: 301-402-3676 Email: cg59b@nih.gov

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