National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Bldg., Suite 7A07, 6100- Executive Blvd MSC 7510, Bethesda, MD 20892-7510

A -- PROSPECTIVE PREGNANCY STUDIES SOL RFP-NICHD-DESPR-97-07 DUE 070197 POC Mrs. Lynn Salo, 301-496-4611 WEB: National Institutes of Health, http://www.nih.gov. E-MAIL: National Institutes of Health, salol@hd01.nichd.nih.gov. The National Institute of Child Health and Human Development (NICHD)is proposing to negotiate with the National Institute of Public Health, FOLKEHELSA, Geitmyrsveien 75, N-0462 Oslo, Norway on a sole source basis to obtain data and biological specimens for studies of birth defects, preterm birth and other adverse pregnancy outcomes. The NICHD does not plan to provide funding to set up such a study but rather will provide monetary support for a study that has been done, is being done or soon will be done. Funding will be provided so that data on topics of interest to NICHD can be collected and analyzed. NICHD wants data collected prospectively (during the pregnancy of interest) including the following: 1) Blood samples -- including serum or plasma and material suitable for genetic studies collected during the pregnancy. 2) High quality medical data on the pregnant subjects collected during the pregnancy by individual interviews or self-administered questionnaires. At a minimum these data should include maternal socioeconomic data, medical history, obstetrical history, and pertinent exposure history (drugs, toxins, infections). 3) Follow-up information on pregnancy outcomes including late complications of pregnancy/delivery, presence of birth defects in offspring, neonatal problems, birth weight and other anthropometric measures. 4) Ability to recontact subjects (mothers and offspring) to obtain additional medical information. This should include at least minimal ability to link records and the ability to locate a large proportion of subjects, for example, by identification numbers. 5) The sample should be population or geographically based with evidence of geographically clearly defined cohort and the ability to identify virtually all pregnancies within that area. 6) A minimum of 50,000 pregnancies over a period of 3 years should be in the study. 7) The option of following children until they reach school age should be available. That is to say, there should be an efficient method of tracking the children. No RFP will be issued to the public. (See numbered Note 22) (0136)

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