THE NATIONAL INSTITUTES OF HEALTH (NIH), National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisition (OA), for the National Human Genome Research Institute (NHGRI) intends to negotiate and award a purchase order on a sole source noncompetitive basis to Hasan Albacha-Hejazi, M.D. Altal, Damascus 527 Syria in support of the NHGRI protocol # OH97-HG-N035, gene study regarding heritable oral clefts.



The reference number for this notice is NHLBI-PB(HG)-2008-300-KLW.



The resultant acquisition will be conducted in accordance with FAR Part 13, Simplified Acquisition Procedures and the resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-26.



The period of performance is twelve (12) months from the date of award.



The intended procurement will be classified under North American Classification System (NAICS) code applicable to this requirement is 541690 – Other Scientific and Technical Consulting Services and the associated small business size standard is $ 7.0 Million.



The total estimated amount of this contract is NOT expected to exceed the simplified acquisition threshold of $100,000.00.



Market Research conducted by the Government in accordance with the Federal Acquisition Regulations (FAR) Part 10, Market Research, has determined that Dr. Albacha-Hejazi’s clinic is one of only a few clinics able to collect data and biological specimens from families with a history of oral clefts. In order to ensure detection of all important genetic effects, data collection from multiple families and family members are needed to improve the power of the study. Dr. Hasan Albacha-Hejazi of the IBN Al-Nafees Hospital in Damascus, Syria has identified additional new families from Syrian individuals which will provide a larger sample pool.



This notice of intent is not a request for competitive proposals. The resulting acquisition will be entered into pursuant to the acquisition authority set forth in FAR 6.302-1 and 41 U.S.C. 253(c)(1) and HHSAR 306-302-1. Only one responsible source and no other supplies or services will satisfy agency requirements.



Interested parties may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive proposals. However, all responses received within 15 days after publication of this synopsis will be considered by the Government. Responses to this notice will be reviewed for the ability to collect data and biological specimens from individual who are members of families determined to have multiple family members affected with hereditary oral clefts.



A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.



The background, objectives and scope of work, is a follows:



Background: The National Human Genome Research Institute (NHGRI), Division of Intramural Research (DIR) overall mission is to develop and implement technology for the rapid isolation, analysis, and treatment of genetic diseases. The Division’ s research

Laboratories and clinical branches develop and use the most advanced techniques to study the fundamental mechanisms of inherited and acquired genetic disorders. Research also includes planning and conducting clinical trials to test DNA-based methods for treatment and perhaps the cure of such diseases. Researchers collect and study families in which important diseases are inherited as well as translate basic science advances into effective, reliable, and cost-effective DNA and cytogenetic-based diagnostics.



This requirement supports the continued collaborative efforts under the revised protocol OH97-HG-N035.



The purpose of this procurement is to provide professional services to the NHGRI Researchers dedicated to the study of families with a history of oral clefts. The services will include the determination of eligibility, patient registration, clinical evaluation of family members, and biological sample collection and shipment.



The objective of the study is to identify the gene(s) involved in heritable oral clefts by linkage analysis and gene mapping strategies. Characterization of genes involved in causing inherited oral clefts could provide important insight into the inheritance and pathogenesis of this disease.



The contractor will engage in several activities including: (1) determination of eligibility, (2) patient registration, (3) clinical evaluation of family members, (4) data and biological sample collection; (5) shipment of data and samples to the NHGRI, Bethesda, Maryland.



The contractor will work with the research team and other members of NHGRI on a weekly basis. The contractor will communicate progress and provide summary activities, either orally or in writing to the Principal Investigator on quarterly basis. In addition to the quarterly progress report, the contractor will deliver the pedigree data and biological specimens as the collection of each family is completed. The contractor will meet the Principal Investigator at a scientific meeting as needed for planning and development of the data collection efforts.



The contractor will work independently with no direct supervision by a Government employee. The study’s Principal Investigator and other research team members will provide guidance in terms of technical reporting needs and study requirements of the project.



The contractor will provide all supplies, computer equipment, and work space. On occasions when collaborative efforts occur, the contractor will have temporary use of Government space and computer equipment as needed.



As plans are developed, the contractor will provide draft documentation, reports, and progress of the work, using the services of a separate translation contract between the Principal Investigator and Dr. Hasan Albacha-Hejazi as needed to ensure accurate transmission of information. The Principal Investigator will review, inspect, and approve all documentation to ensure that work is in line and following the objectives of the study.



Inquires to this notice, referencing number NHLBI-PB(HG)2008-300-KLW, may be submitted to the National Heart, Lung, and Blood Institute, Office of Acquisitions, Procurement Branch, 6701 Rockledge Drive, Suite 6042, Bethesda, MD 20892-7902, Attention: Kesha L. Williams. Inquiries may be submitted electronically to williamk@nhlbi.nih.gov and by fax to (301) 480-3345. Responses will only be accepted if dated and signed by an authorized company representative.