SOLICITATION NOTICE
A -- Statistical and Clinical Coordinating Center
- 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-2012-05
- Point of Contact
- David Fitton, Phone: 301-443-5239
- E-Mail Address
-
fittond@mail.nih.gov
(fittond@mail.nih.gov)
- Small Business Set-Aside
- Total Small Business
- 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 an Indefinite/Delivery, Indefinite/Quantity (IDIQ) Task Order contract for the NICHD Contraceptive Clinical Trials Network (CCTN) Statistical and Clinical Coordinating Center (SCCC). This will be a 100% small business set-aside IDIQ Task Order contract. 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 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 is for a re-competition of the SCCC that will operate under an Indefinite/Delivery, Indefinite/Quantity (IDIQ) Task Order contract. The SCCC will be assisting with protocol development, preparation of study materials, regulatory document coordination, clinical monitoring, coordination of laboratory services, data collection and data analysis for the Female and Male sites. The resultant IDIQ contract will be for a seven (7) year period of performance. 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 16 sites capable of performing female contraceptive clinical trials and approximately 4 sites capable of performing male contraceptive clinical trials. Please be advised that the NICHD is 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 Statistical and Clinical Coordinating Center 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-2012-05/listing.html)
- Record
- SN02711332-W 20120404/120402234726-4be37cae425c618f9069609e60c95da1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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