SPECIAL NOTICE
R -- Whole Genome Association Study to Identify and Validate Genes for Restenosis in the Ottawa Heart Study
- Notice Date
- 9/4/2007
- Notice Type
- Special Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-NHLBI-PB(HG)-2007-241-KLW
- Response Due
- 9/19/2007
- Archive Date
- 10/4/2007
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisitions (OA), for the National Human Genome Research Institute (NHGRI) intend to negotiate and award a purchase order on a noncompetitive sole source basis to the University of Ottawa, Heart Institute, 40 Ruskin Street, Ottawa, Ontario, Canada. The intent of this procurement is to acquire information regarding the genetic susceptibility to the vascular disease, restenosis. The NHGRI DIR, is conducting a study, entitled CardioGene(1), which is an analysis of the genomics of in-stent restenosis. NHGRI wish to validate genetic associations in an independent population of patients who have received bare metallic stents, to determine which specific polymorphisms may confer susceptibility to restenosis. The sole source determination is based upon the fact that the University of Ottawa Heart Institute?s Dr. McPherson, Dr. So, and others have recently published a report on genetic susceptibility to coronary artery disease(2) and the Genotypes are already available for these patients from the University of Ottawa Heart Institute. The University of Ottawa Heart Institute is the sole provider of the specific patient data that the NHGRI seeks: patients with existing genetic data and established coronary artery disease, who have undergone bare metallic stent implantation and have corresponding clinical data from which wer may determine whether in-stend restenosis occurred. Therefore, the Unviersity of Ottawa Heart Institute is the only known source that is currently able to assist the NHGRI in this area of research at this time. An award to any other source would result in a substantial duplication of cost to the Government that is not expected to be recovered through competition. The Statement of Work is as follows. Background Information - The purpose of this project is to acquire information regarding the genetic susceptibility to the vascular disease, restenosis. In the NHGRI DIR, we are conducting a study, entitled CardioGene(1), which is an analysis of the genomics of in-stent restenosis. We now wish to validate genetic associations in an independent population of patients who have received bare metallic stents, to determine which specific polymorphisms may confer susceptibility to restenosis. Dr. McPherson, Dr. So and others have recently published a report on genetic susceptibility to coronary artery disease(2). Genotypes are already available for these patients. Objectives - 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. To compare individuals who experience restenosis after the placement of a coronary artery stent versus those who did not experience restenosis of their stents within twelve months of coronary stent implantation. Existing genotype data on approximately 500,000 single nucleotide DNA polymorphisms will be used for this study. General Requirements - Independently, and not as an agent of the Government, the Contractor shall furnish all necessary labor, materials, supplies, equipment, and services (except as otherwise specific herein) and perform the work set forth below. All work under this contract shall be monitored by the Project Officer, whose position is defined elsewhere in this contract. Specific requirements - Collaborators at the Ottawa Heart Institute will be responsible for: 1) Identifying within the Ottawa Heart Study cohort all cases of in-stent restenosis and an equal number of controls 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. 2) 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. 3) 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. 4) All clinical data will be sent to the NIH without any direct patient identifiers, using assigned study numbers to code the samples and data. Reporting Requirements - Progress will be monitored over the estimated two to four months this activity will take through email and telephone conversations with the Project Officers. A final progress report will be submitted, after the conclusion of the clinical data reviews. Packaging and Marking - The items shall be packaged and marked in accordance with a mutually agreeable format. Inspection and Acceptance - The final results of this acquisition will be determined by the receipt of DNA samples and clinical data from patients, as specified. Acceptance will be based upon the delivery of useable clinical data. Deliverables - A final progress report will be submitted electronically to the Project Officers. The expected period of performance is four (4) months from the date of the award. This acquisition is being conducted under simplified acquisition procedures and is exempt from the requirement of Federal Acquisition Regulations (FAR) Part 6, Competition Requirements. The North American Industry Classification System (NAICS) applicable to this requirement is 541990 with a size standard of $6.5 M. This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this synopsis. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely with the discretion of the Government. Comments to this announcement, referencing synopsis number NHLBI-PB(HG)-2007-241-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, Contract Specialist.
- Record
- SN01393791-W 20070906/070904220253 (fbodaily.com)
- Source
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