National Institute of Environmental Health Sciences, Contracts and Procurement Management Branch, OM, 79 T.W. Alexander Drive, P.O. Box 12874, 4401 Building, Research Commons, Research Triangle Park, NC 27709

A -- PREGNANCY, HEREDITY, AND ENVIRONMENT: A CASE-CONTROL STUDY OF F FACIAL CLEFTS SOL NIH-ES-97-32 POC Contact Velvet M. Torain, Contract Specialist, 919/541-0440/Phillip D. Jones, Contracting Officer, 919/541-0426 The National Institute of Environmental Health Sciences intends to negotiate a contract with Bergen University Research Foundation (UNIFOB), in Bergen Norway to conduct a population-based case-control study in which all cases born live in Norway are identified soon after birth and compared with controls drawn randomly from all Norwegian live births. The necessary tasks shall be performed to enroll infants with cleft lip or palate as well as population controls selected randomly from among births surviving the first week of life. The Government shall provide questionnaires for interviews with the mothers and materials for collecting DNA samples from mothers and other family members. The contractor shall provide the following: (1) necessary space, equipment and supplies to enroll and collect data and biological specimens for cases and controls for the duration of this contract, (2) make the necessary arrangements with birthing clinics, treatment centers and the birth registry to enroll cases and controlsand obtain biological specimens and medical records, (3) questionnaire data for cases and controls. Approximately 120 infants with cleft lip or palate and 1l5 controls for each cleft lip case shall be enrolled per year. Cases shall be defined as any infant born in Norway and registered at either of the two centers in Norway that treat cleft lip and palate. The period of performance will be for five years with a planned award date on or before September 30, 1997. It is anticipated that this project will require approximately 28,275 man hours over five years. Authority: 41 USC 253(c)(1), as set forth in FAR 6.302-1 -- Only One Responsible Source. Clefting is one of the most common birth defects in Norway, and rates in Norway are among the highest in the world. All Norwegian babies with facial clefts are treated at one of two medical centers at the expense of the national government. The Medical Birth Registry maintains a file of all newborn babies, from which control infants can be randomly drawn from the population. Any other interested sources desiring consideration for this requirement must fully identify their interests and capabilities to the Contracting Officer listed above. See Numbered Notes 22 and 26. (0115)

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