DNA Allocation and Chart Reviews

Reference Number: NHLBI-PB(HG)-2008-260 /TMB Title: Whole Genome Association Study to Identify and Validate Genes for Restenosis THIS IS A SOLE / SINGLE SOURCE, NON-COMPETITIVE NOTICE. This notice of intent is not a request for competitive proposals. This sole / single source, non-competitive notice is prepared in accordance FAR Parts 5 and 13. This notice of intent is not a request for competitive proposals. FAR Part 6 - Competition Requirements, is not applicable to contracts awarded using the simplified acquisition procedures of FAR Part 13, not expected to exceed the simplified acquisition threshold. This announcement constitutes the only notice; proposals are not being requested and a written solicitation will not be issued. The resultant acquisition will be conducted in accordance with FAR Part 13, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2005-26. The total estimated amount of this contract is NOT expected to exceed the simplified acquisition threshold of $100,000.00. The intended procurement will be classified under North American Industry Classification System code _541690___, with size standard of $7.0M___ . Market Research conducted by the Government in accordance with the Federal Acquisition Regulations (FAR) Part 10, Market Research, has determined that the sole / single source reference, is currently the only company that can provide the services / items specified herein. 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), Vascular Biology Section, intends to negotiate and award a purchase order on a sole source noncompetitive basis to Emory University, 201 Dowman Drive, Atlanta, GA 30322-1018, to provide DNA allocations and chart reviews from studying the human genetics of the vascular disease, in-stent restenosis. This study will determine which patients have the disease and which do not. National Human Genome Research Institute, Vascular Biology Section is in need of chart review services at the Emory University as part of a research collaboration to study the human genetics of the vascular disease, in-stent restenosis (the CardioGene Study) Chart review is necessary in order to determine which patients have the disease and which do not, a critical component of the study. Emory is the sole provider of the requested work, since patients were enrolled at the Emory's medical center, and medical charts requiring review are proprietary and located at this site. The purpose of the DNA allocations and chart reviews is to identify the genetic cause of restenosis by validating candidate genetic susceptibility loci identified by the CardioGene Study, by studying the genetic sequence of individuals who received a coronary artery stent versus those who did not and to apply this information to develop new drugs and DNA based diagnostics. By validating candidate susceptibility genes and regions in an independent population, we can determine true associations and identify functional candidate genes for this disease. This knowledge can, in turn, be used to gain a better understanding of the underlying biologic mechanisms of disease. The reviews will show comparison of individuals who experience restenosis after the placement of a coronary artery stent versus those who did not experience restenosis of their stents within six months of coronary stent implantation. The purpose of this project is to acquire information regarding the genetic susceptibility to the vascular disease, restenosis. NHGRI DIR is conducting a study entitled CardioGene, which is an analysis of the genomics of in-stent restenosis. The study will validate genetic associations in independent populations of patients who have received bare metallic stents, to determine which specific polymorphisms may confer susceptibility to restenosis. Identifying at least 50 cases and 50 control patients who have received a bare metallic stent in a coronary artery and clinical follow-up data 12 months post-procedure, to determine if restenosis occurred or not. Review all medical history, including cardiac catheterization history, so that in-stent restenosis events in any bare metallic stent may be identified and so that control patients are documented to have never had an in-stent restenosis episode in any bare metal stent placed in a na've coronary artery lesion. Provide basic medical history including demographic data, medical history, medication use and cardiac catherization data for the index procedure in which the bare metallic stent was placed as well as any follow-up catheterizations. Provide high quality genomic DNA (1.5ug, un-amplified) for each case and control patient identified. All clinical data and genomic DNA samples will be sent to the NIH without any direct patient identifiers, using assigned study numbers to code the samples and data. Interested parties may identify their interest and capability to respond to the requirement or submit a response. This notice of intent is not a request for competitive proposals. Responses to this announcement, referencing synopsis number NHLBI-PB-(HG)-2008-260-TMB 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: Tracy Brooks. Responses may be submitted electronically to brookstr@nhlbi.nih.gov or cbelt@nhlbi.nih.gov and fax to (301) 480-3345. Responses will only be accepted if dated and signed by an authorized company representative. Responses are due September, 9, 2008. 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.