NICHD CONTRACEPTIVE CLINICAL TRIALS NETWORK (MALE CONTRACEPTIVE CLINICAL
TRIAL TOPIC AREA)
RELEASE DATE: November 20, 2002
NOTICE: NOT-HD-03-003
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov/)
RFP AVAILABLE: RFP-NICHD-2003-05
The 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 (Male Contraceptive Clinical Trial Topic Area). 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 and reproductive health. 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
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, operating 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
pre-clinical 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 four
sites capable of performing male contraceptive clinical trials as well as
approximately 12 sites capable of performing female contraceptive clinical
trials. Please be advised that the NICHD is issuing separate RFPs for each
topic area (Male Contraceptive Clinical Trials and Female Contraceptive
Clinical Trials) in order to better facilitate and coordinate the evaluation
of proposals. This announcement is for the RFP for the Male Contraceptive
Trials Topic Area, only.
Offerors may choose to propose in response to either RFP (Male Contraceptive
Trials or Female Contraceptive Trials) or to both RFPs, depending on their
organization's capabilities. However, please be advised that the NICHD will
not accept combined proposals (Male and Female) from offerors who wish to
propose in response to both RFPs. Those offerors who 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-2003-05, electronically on the FedBizOpps website, at
http://www2.eps.gov/servlet/Solicitation/R/HHS/NIH/NICHD/RFP-NICHD-2003-05,
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.
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