NOT-HD-03-003: NICHD CONTRACEPTIVE CLINICAL TRIALS NETWORK (MALE CONTRACEPTIVE CLINICAL TRIAL TOPIC AREA)

Department of Health
and Human Services (HHS)
NIH... Turning Discovery Into Health^®

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:  [email protected]

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:  [email protected]
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