NOT-HD-03-002: NICHD CONTRACEPTIVE CLINICAL TRIALS NETWORK (FEMALE CONTRACEPTIVE CLINICAL TRIAL TOPIC AREA)

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

NICHD CONTRACEPTIVE CLINICAL TRIALS NETWORK (FEMALE CONTRACEPTIVE CLINICAL 
TRIAL TOPIC AREA)
 
RELEASE DATE:  November 20, 2002  

NOTICE:  NOT-HD-03-002

National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov/)

RFP AVAILABLE:  RFP-NICHD-2003-04  

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 (Female 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.  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 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 
topic area (i.e., Female Contraceptive Clinical Trials and Male Contraceptive 
Clinical Trials) in order to better facilitate and coordinate the evaluation 
of proposals.  This announcement is for the RFP for the Female Contraceptive 
Trials Topic Area, only.  

Offerors may choose to propose in response to either RFP (Female 
Contraceptive Trials or Male Contraceptive Trials) or to both RFPs, depending 
on their organization's capabilities.  However, please be advised that the 
NICHD will not accept combined proposals (Female and Male) from offerors who 
wish to propose in response to both RFPs.  Those offerors who propose in 
response to 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-2003-04, 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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