A -- Project on Ebsteins Anomaly in Children

PEACE - Market Research The National Heart, Lung, and Blood Institute is conducting study entitled: PEACE (Project on Ebsteins Anomaly Study in Children). Specifically, a contractor will be selected to recruit approximately 900 families over a three year period from communities in Ukraine. Children with Ebsteins anomaly/tricuspid valve disease (referred to as case) will be recruited to the study, and also parents of the children will be recruited to the study. Controls will be recruited from the same neighborhoods as the cases (children with Ebsteins anomaly) and will also include the parents. Controls will be matched by age, sex and region of origin to cases in a ratio of two controls for each case. If neither parent is available, at least one other blood relative will be recruited in place of the parents. The more general diagnosis of tricuspid valve disease is to be included in the selection of participants, since often those with mild forms of Ebsteins are not appropriately diagnosed. The subjects will be interviewed by a physician, and medically evaluated by Doppler echocardiography. Blood, cheek and saliva tissue samples will be collected to obtain DNA for a genome wide association analysis. Usually each family will only need to be seen once. A goal of PEACE, although not a requirement to be performed or funded as part of this acquisition, is the identification of the genetic basis for Ebsteins anomaly, a birth defect involving malformation of the tricuspid valve of the heart. Such findings may yield insight into disease mechanisms that may provide novel diagnostic tools as well as therapeutic strategies for medical remediation of this often life threatening and debilitating congenital heart disease. (The analyses associated with the collection of samples will take place at the NHLBI.) The technical requirements associated with this acquisition include the following: 1. Recruit approximately 300 subjects with Ebsteins anomaly and their parents and approximately 600 control subjects and their parents for PEACE. 2. Assist in explaining the nature of the PEACE study to subjects and/or parents of subjects and obtain signed consent/assent for participation in study. 3. Obtain from each family, information on family history with administration of questionnaire to assess possible environmental risk factors. 4. Assist NIH team in evaluating and validating subjects and parents of subjects with Ebsteins anomaly by Doppler echocardiography and obtaining electrocardiogram. In parallel, age matched neighborhood control subjects and their parents will be evaluated by Doppler echocardiography and using electrocardiogram to validate they do not have Ebsteins anomaly. 5. Provide nursing staff or physician who will obtain blood, buccal swab, and saliva tissue samples suitable for the extraction of genetic material (genomic DNA) for tests to analyze possible genetic causes for Ebsteins anomaly. Note: analysis of genetic DNA is not a technical requirement of this contract. 6. Store samples and securely package and ship all tissue and blood samples to NIH. 7. Copy onto CD/DVD all ultrasound and EKG data, and securely package and ship CD/DVD to NIH. 8. Coordinate and make all travel arrangements for subjects and their parents to come to the contractor site in conjunction with the schedule visits of the NIH site visit team. 9. Assist in making local housing arrangements, transportation, and English translator for NIH site visit team. 10. Provide appropriate private space for subject interview and evaluation, including sufficient room for housing ultrasound and electrocardiogram machines, and for conducting ultrasound and electrocardiogram evaluations. 11. Assist NIH team in the preparation of data obtained from PEACE for scientific publication(s) in appropriate biomedical journal to report and share findings with the biomedical research community. 12. Provide project administrator to coordinate PEACE activities at contractor site in Ukraine with work at NIH in Bethesda, MD. All responsible sources are welcome to submit a written capability statement demonstrating their ability to perform the aforementioned technical requirements by February 25, 2008. The estimated award date is July 31, 2008. The NAICS code is 541712. This is not a request for proposals. Questions may be directed to the Contracting Officer, Kristiane Cooper, cooperke@nhlbi.nih.gov, 301-435-4435 or the Contract Specialist, Nora Rivera, riveran@nhlbi.nih.gov, 301-434-0345. The capabilities statement shall include 1) the total number of employees, 2) the professional qualifications of scientific, medical expert, and technical personnel in accordance with the above requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, 4) any other information considered relevant to this program, and 5) if your institution is a small business, please provide certification of the type of small business as designated by the Small Business Administration. Do not include budget information. We ask that the capabilities statement not exceed 20 single sided or 10 double sided pages in length. Two (2) copies of the capabilities statement must be received at the following address no later than 15 days from the publication date of this notice. Responses that do not adhere to these guidelines will not be considered. Kristiane Cooper, Contracting Officer, Office of Acquisitions, DERA National Heart, Lung, and Blood Institute, NIH, DHHS 6701 Rockledge Drive, Rockledge II, Room 6124, MSC 7902 Bethesda, MD 20892-7902 For overnight deliveries use zip code 20817; no MSC is required.