A -- Establishment of a Research Resource for the Identification of Genetic and Environmental Factors Involved in the Development of Anencephaly

The National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health, Intends to Solicit Proposals for the Purpose of Establishing a Research Resource to Identify Factors That Independently or Through Interaction(s) with Genetic Factors, Foster the Development of Anencephaly. Anencephaly, Is a Neurulation Cranial Defect in Which the Skull Bones, Forebrain, and Cerebrum (Thinking and Coordinating Area of the Brain) Are Partially or Totally Absent. Part 1 of the Project, the Design and Planning Phase, Will Take Approximately One Year to Complete. Part 2 of the Project, the Recruitment Phase, Will Take Approximately Four Years to Complete. The Major Tasks in this Study Are To: (1) Recruit up to 500 Families at a Rate of 125 Families per Year (Father, Mother, Baby, and Siblings If Available) in Which the Mother Is Carrying or Has Had an Anencephalic Baby (Only Fetal Cadaveric Tissue Obtained Following an Elective Abortion, from a Stillborn Baby or after the Baby Dies If Liveborn, Will Be Used in this Study); (2) Collect Fresh Tissue from the Anencephalic Fetuses and Use this to Isolate DNA And, If Possible, to Establish Cell Lines; (3) Collect Blood from the Parents, and If Available Also from the Siblings, and Isolate DNA, Plasma and Serum from the Blood; (4) Measure RBC Folate Levels in the Mother's Blood; (5) Create and Administer a Comprehensive Questionnaire to Collect Epidemiological Data from the Parents; and (6) Enter Sample Tracking and Other Data into a Central Database Using the Internet. After Isolating DNA and Establishing Cell Lines from the Families Blood and Tissues, the Contractor(s) Will Aliquot and Freeze All DNA, Plasma and Serum Aliquots, and Cell Lines, and Ship These to the NIEHS or a Designated Archive. These Samples Will Be Assayed for Genetic Polymorphisms and Levels of Potential Toxicants Associated with Increased Risks for Anencephaly. (The Fetal Tissue Collected under this Contract Will Not Be Used for the Drivation of Human Embryonic Stem Cells or Transplantation Studies, and Therefore, Does Not Fall under the National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells (DHHS Code of Federal Regulations, 65 CFR 69951, Effective August 25, 2000). The Estimated Period of Performance Is Five Years. The Government Estimates That Approximately 29,640 Direct Labor Hours May Be Required to Complete this Project. The North American Industry Classification Code (NAICS) Is 541710. This Is a Full and Open Competition. The Anticipated Release Date of the RFP Is July 18 2003 with Proposals Due by September 8, 2003. Interested Organizations Should Request Either a Streamlined or Full RFP Package. If No Selection Is Made a Streamlined Version of the RFP Will Be Provided, Which Will Include Only the Statement of Work, Deliverables and Reporting Requirements, Special Requirements, Mandatory Qualification, and Technical Evaluation Criteria. Requests May Be Telefaxed, or E-mailed to the Points of Contact Listed Below. Electronic Copies of the Fed Bix Opps Synopsis and Rfp Will Be Made Available on the Internet at Http://www.niehs.nih.gov/dert/rcb/rfp.htm on or about July 25, 2003. GOVERNMENT-WIDE NUMBERD NOTE 26