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:  [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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