SOURCES SOUGHT
A -- Whole Genome Association Study
- Notice Date
- 2/8/2007
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- 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
- NHLBI-PB-HG-2007-064-KLW
- Response Due
- 2/20/2007
- Archive Date
- 3/7/2007
- Description
- Market Survey / Sources Sought Announcement The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), for the National Human Genome Research Institute (NHGRI) is seeking the assistance of an organization capable of providing information regarding genetic susceptibility to the vascular disease, in-stent restenosis in support to the CardioGene Study being conducted by the NHGRI. This market survey is being conducted through the FedBizOpps to reach the widest possible audience and to gather current market information. A market survey is being conducted to determine the availability and potential technical capability of businesses to provide support to The Nabel Laboratory, National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH). The intended procurement will be classified under North American Industry Classification System code 541710, Research and Development in the Physical, Engineering and Life Sciences, with a size standard of 500 employees. The Nabel Laboratory, NHGRI has conducted a genomic analysis of the vascular disease, in-stent restenosis. This study, titled the CardioGene (protocol #02-H-0102) is a large body of work that has been ongoing in Dr. Nabel?s laboratory for several years. We have identified several candidate genes that are linked to the disease. Scientifically, it is necessary to investigate whether these genes are linked with restenosis in another population. NHGRI is in need of finding a resource capable of providing a large biorepsoitory in which patients present to a cardiac catheterization laboratory and are enrolled in a longitudinal study with DNA samples and clinical data available for collaborative research. A crucial area of research in the Division of Intramural Research (DIR) of the NHGRI is to understand the genetic susceptibility to common, complex diseases. As a study of a complex cardiovascular disease, the CardioGene Study is an excellent example of a cardiovascular clinical study that aims to understand the genetic susceptibility of complex diseases. To determine the significance of findings from the CardioGene Study, further studies in independent cohorts is needed, and these are not available currently within the DIR. Therefore, the NHGRI DIR has a need to find a resource that can provide such patient samples and clinical data for analysis from several hundred unrelated patients who have received bare metallic stents and have restenosis outcomes after stenting. The data obtained from this study will significantly enhance the information gathered by the CardioGene Study. The merging of these scientific elements from the CardioGene Study and further validation analyses in an independent cohort of patients treated with stents will offer a direct benefit to patients in making a determination of which patients are likely to respond best to stent placement in addition to improving our understanding of the mechanisms of restenosis, which will assist with the development of new targets to prevent and treat restenosis. Specifically, the contractor shall: 1. Include a sufficient number of patients who have received bare metallic stents prior to the widespread use of drug-eluting stents in the United States (2003). 2. Provide clinical follow-up data for each patient is needed to determine restenosis outcomes 12 months post-stenting. 3. Provide a medical history review to determine whether any bare metallic stent did or did not develop restenosis, so that determination of whether a patient has ever experienced restenosis may be made. 4. Provide clinical data regarding demographics and catheterizations must be available. 5. Provide high quality genomic DNA, which is obtained by purifying DNA from a blood sample. 6. Provide assurance of patient confidentiality through the use of assigned study numbers to de-identify patient samples and clinical data. 7. Obtain IRB approval for such a study. This requirement will not involve either Government-furnished or contractor-acquired materials, facilities, and/or equipment. A fixed price, single award is anticipated, with an estimated performance period of seven (7) months from the date of award. If your organization has the potential capacity to perform these services, please provide the following information: 1) Organization name, address, email address, Web site address and telephone number as well as size and type of ownership for the organization, i.e., large business, small business, Small Disadvantaged Business, 8(a), woman-owned, Historically Underutilized Business Zone (HUBZone) concern, Veteran, and or Service-disabled Veteran; 2) Business size information which states, the business size, annual receipts (average gross revenue) for the last three (3) fiscal years, and whether or not the firm has been approved as a small business by the SBA under the applicable NAICS code; and 3) Tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability. Organizations responding to this market survey should keep in mind that only focused and pertinent information is requested. If significant subcontracting or teaming is anticipated in order to be considered technically capable in the performance this effort, organizations should address the administrative and management structure of such arrangements to demonstrate that small business prime contractors can maintain full-time labor, technical, and management control of the project, meeting the ?limitation on subcontracting? imposed on small business set-asides. The Government will evaluate the capability information using the following criteria: 1) documented evidence which clearly reflects their organizational experience in providing sufficient number of patients who have received bare metallic stents prior to the widespread use of drug-eluting stents in the United States (2003). 2) documented experience in conducting patient related clinical cardio genetic clinical trials of a similar magnitude. Interested organizations responding to this survey are encouraged to structure capability statements in the order of the area of consideration noted above. Responding firms should provide one printed (1) copy and an electronic copy of a tailored capability statement to the attention of Ms. Kesha L. Williams, Contract Specialist, within ten (10) calendar days from the date of publication of this notice to the National Heart, Lung, and Blood Institute, Office of Acquisitions, Procurement Branch, 6701 Rockledge Drive, Rockledge Building 2, Room 6145, Bethesda, MD 20892-7902. THERE IS NO SOLICITATION AT THIS TIME. THIS IS NOT A REQUEST FOR PROPOSAL (RFP) AND ONE IS NOT CURRENTLY AVAILABLE. This request for capability information does not constitute a request for proposals and submission of any information in response to this market survey is purely voluntary; the Government assumes no financial responsibility for any costs incurred.
- Place of Performance
- Address: Bethesda, MD
- Zip Code: 20892
- Country: UNITED STATES
- Zip Code: 20892
- Record
- SN01228389-W 20070210/070208220447 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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