The Pediatric Epidemiology Section (PES) of the Epidemiology Branch (EB), an intramural research group within the Division of Epidemiology Statistics and Prevention Research (DESPR) of the National Institute of Child Health and Human Development (NICHD), conducts research on identifying risk factors for abnormal childhood development. An area of particular interest is the genetic contribution to birth defects. The PES conducts much of its research via contracts, collaborating scientifically with the Contractors. The mapping of the human genome has made it possible to identify genes that are etiologically important in birth defects. For example, the knowledge that folate was important in the etiology of neural tube defects (NTDs) (Medical Research Council, Czeizel) led to the identification of a variant in the enzyme methylenetetrahydrofolate reductase that increases the risk of having an NTD (Whitehead). There is great potential for finding other gene related birth defects because recurrence risks indicate that there is a genetic component and because of the enormous genetic variability in the human population–any two individuals have approximately 3,000,000 differences in their genomes. One of the limiting factors in this research area has been the availability of samples from a sufficient number of affected subjects (or families). Because the etiology of many birth defects is multifactorial and because the penetrance of these genes is low (sometimes because of environmental factors), large numbers of cases must be studied to identify risks. The possibility that defects are the result of gene-gene interactions also demands larger sample sizes to identify enough subjects with the combination of alleles in question. Even a relatively common type of birth defect, such as neural tube defect occurs in only about one (1) pregnancy in 1000. Hundreds of cases of any birth defect are required to address even the simplest of research questions. Other birth defects of interest are much less common than neural tube defects. Therefore, a large underlying population is needed to identify enough defects of interest. Many important defects are too uncommon for even a large institution to accrue enough cases to etiologic investigations. There are few resources available to redress these problems. Therefore, the NICHD is intends to contract with an institution to acquire from a large population in a defined geographical area (e.g. births within a given state): 1) already collected samples containing DNA from a large number of children who have major birth defects and medical documentation sufficient to describe the birth defects; 2) already collected samples containing DNA from normal control children; 3) any and all existing data currently in the possession of the resultant Contractor on factors that may influence pregnancy outcome and birth defects. Additionally, as a contract option the NICHD is looking to obtain for the children who have major birth defects and for the normal control children: 1) maternal serum, plasma, amniotic fluid or other biological samples obtained during the pregnancy that produced the affected or normal control child; 2) samples containing DNA from the mothers; 3) samples containing DNA from the fathers, where maternal samples containing DNA are present. Please note that offerors are not required to propose on the Contract Option requirements. Proposals without the option requirements will still be considered for award, though there is a small (10 points) Technical Evaluation Criterion based on the Option requirements. Furthermore, offerors that elect to propose on the Contract Option may elect to propose to provide all of the Contract Option requirements or they may elect may elect to propose to provide just the following Contract Option requirements: #1 only, #2 only, #1 and #2, #2 and #3 or #1, #2 and #3. Please note that it is the intent of the Government to make only one (1) award as a result of the RFP. This procurement is defined as code 541710 under the North American Industry Classification System (NAICS). It is anticipated that the RFP will be available on or about June 15, 2006 through the FedBizOpps website at http://FedBizOpps.gov. All proposals must be submitted on or before the due date and time stated in the RFP to: Jason Williams, Contracting Officer, NICHD R&D Contracts Management Branch, 6100 Executive Boulevard, Suite 7A07, MSC 7510, Bethesda, Maryland, 20892-7510 (if sending by overnight carrier, use 6l00 Executive Boulevard, Suite 7A07, Rockville Maryland, 20852). The reference number to be used for this announcement is: RFP-NIH-NICHD-2006-08. All correspondence must cite the reference number as provided. Questions may be directed to Jason Williams, Contracting Officer, at (301) 402-6775 and E-mail [email protected] or Charles Newman, Contracting Officer, at 301-435-6960 and E-mail [email protected]. The Government does not intend to release hard copies of the RFP. The Government also reserves the right to cancel this procurement at any time prior to contract award. This announcement does not commit the Government to award a contract. Numbered note number 26 applies.

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