SOLICITATION NOTICE
B -- Expression of genes related to platelet function, thrombosis, coronary heart disease, and other risk factors
- Notice Date
- 8/19/2009
- Notice Type
- Presolicitation
- NAICS
- 611310
— Colleges, Universities, and Professional Schools
- 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, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-PB-(HL)-2009-270-DDC
- Archive Date
- 9/3/2009
- Point of Contact
- Deborah - Coulter, Phone: (301) 435-0368
- E-Mail Address
-
dc143b@nih.gov
(dc143b@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation number is NHLBI-PB-(HL)-2009-270-DDC and is issued as a Request for Quotation (RFQ). The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2005-35. The North American Industry Classification (NAICS) Code is 611310 and the business size standard is $7.0M. This acquisition is being conducted using Simplified Acquisition Procedures in accordance with FAR Part 13. However, this solicitation is not set aside for small business. It is the intent of the National Institutes of Health (NIH) National Heart, Lung and Blood Institute, Office of Acquisition (OA), to procure the services from Laboratory of Jane Freedman, Whitaker Cardiovascular Institute, 80 E. Condord Street, Boston University School of Medicine, Boston, MA 02114, to procure the services for RNA extraction and gene expression in according with the statement of work. Brief History/Purpose/Description of Project: Cardiovascular disease (CVD) is the leading cause of death and serious illness in the United States. In 1948, the Framingham Heart Study -- under the direction of the National Heart Institute (now known as the National Heart, Lung, and Blood Institute; NHLBI) -- embarked on an ambitious project in health research. At the time, little was known about the general causes of heart disease and stroke, but the death rates for CVD had been increasing steadily since the beginning of the century and had become an American epidemic. The objective of the Framingham Heart Study was to identify the common factors or characteristics that contribute to CVD by following its development over a long period of time in a large group of participants who had not yet developed overt symptoms of CVD or suffered a heart attack or stroke. The Framingham Heart Study continues to make important scientific contributions by enhancing its research capabilities and capitalizing on its inherent resources. New diagnostic technologies, such as echocardiography (an ultrasound examination of the heart), carotid-artery ultrasound, and computerized tomography of the coronary arteries, are evaluated and integrated into ongoing protocols. While pursuing the study's established research goals, the NHLBI and the Framingham investigators are expanding their research into other areas such as the role of genetic factors in CVD. Framingham investigators also collaborate with leading researchers from around the country and throughout the world on projects in stroke and dementia, osteoporosis and arthritis, nutrition, diabetes, eye diseases, hearing disorders, lung diseases, and genetic patterns of common diseases. One area of particular interest is atherothrombosis, which involves the formation of a platelet thrombus in atherosclerotic plaque in the coronary arteries, leading to clinically apparent coronary heart disease. Other cardiovascular conditions and risk factors of interest include hypertension and chronic kidney disease (CKD). Our group has recently completed GWAS of platelet aggregability and hematology traits, multiple thrombosis factors, coronary artery calcificiation, as well as hypertension and CKD. This project seeks to characterize the presence of and levels of RNA transcript expression for a set of genes involved in platelet function and other hematology traits, thrombotic factors, subclinical and clinically apparent coronary heart disease, and other CV conditions and risk factors including hypertension and chronic kidney disease, extending knowledge gained from the recent genotyping of common genetic variation by the NHLBI Framingham SHARe project and other recent findings from genomics studies. Specifically, we will select a set of up to 92 candidate genes (and four reference genes known to be “housekeeping genes”) to undergo quantitative gene expression profiling using RNA derived from leukocytes and from platelets in over 2,000 Offspring cohort participants in the Framingham Heart Study. We will then examine the association of these genes with platelet aggregability, levels of thrombotic factors in the blood, prevalence of coronary artery disease determined by CT coronary calcium and by clinically apparent CHD, as well as other cardiovascular conditions and risk factors including hypertension and CKD. For genes selected due to prior associations in GWAS, we will select cis-acting SNPs from the SHARe program to examine for SNP-expression associations (ie, identify eSNPs). Through bioinformatics approaches, we examine for associations between expression and multiple phenotypes. This project involves the contractor performing RNA extraction and gene expression profiling of genes to be identified by Dr.Smith, Dr. O’Donnell and members of their CPS research team. The SNPs will be genotyped in plate sets from the Framingham Heart Study Offspring and Third Generation cohorts with a total sample size of approximately 7,357. I. Contractor Requirements A.Contractor will provide high quality RNA extracted from platelets and from peripheral blood mononuclear cells from 2112 FHS participants in 96 well plates. These samples were previously converted to cDNA and cDNA refrigerated and stored by the Contractor and will be drawn from the contractor’s frozen repository. B.The Contractor will process the NHLBI samples at contractor location using the quantitative real-time PCR (rtPCR) reactions with a BioMark instrument, after pre-amplification and then mixing with a TaqMan Universal Master Mix (Applied Biosystems). The Contractor will use TaqMan Gene Expression Assays (Applied Biosystems) C.The Contractor will provide high quality quantitative rtPCR results with a.a call rate in excess of 90% b.reproducibility in excess of 95% D.Quality control measures will be applied by the Contractor and rtPCR gene expression genotyping results from each plate will be accompanied by quality control information reflecting call rate, reproducibility rate, and other appropriate measures of quality. E.Contractor will specify any special packaging, marking, or shipping instructions for plates to be shipped for genotyping. F.Each cDNA sample used by the Contractor received will be identified by the Contractor using the identifiers provided by NHLBI. II. Government Responsibilities A.Using blinded replicates and family structure data, NHLBI will inspect the results provided by the Contractor and review them for fulfillment of the quality control measures stipulated above (Section IA). rtPCR data that does not fulfill quality metrics will be identified by NHLBI (Dr. Hwang at the NHLBI Framingham Heart Study). The Contractor will be notified about rtPCR quality failure within 30 days of receipt by NHLBI of the final genotyping results files. B.NHLBI will provide a list of identifiers for each cDNA sample within each plate. III. Reporting Requirements and Deliverables A.rtPCR results will be returned by Contractor to NHLBI in a standard format in a nonproprietary database in which each gene is identified by standard HUGO gene naming nomenclature. B.Return of rtPCR results by the Contractor will be accompanied by summary quality control measures for each DNA plate and for the project overall. C.rtPCR results will be returned to NHLBI within 10-12 weeks of receipt of a final list of candidate genes to be studied by Dr. O’Donnell / NHLBI. D.Contractor will maintain the cDNA plates in the event additional rtPCR reactions are required. IV. Program Management and Control Requirements No special management or control systems are required under this contract. The required period of performance is schedule for twelve months. The sole source justification is based on the fact that the examination of the function of candidate genes identified through genomewide association studies is a tremendously high research priority and one specific analytic approach of great interest is the determination of gene expression associated with candidate gene loci. Dr. Jane Freedman is an international expert in gene expression research and the Freedman laboratory has established itself as having considerable experience with the conduct of rtPCR for gene expression research using the protocols proposed in the SOW. As stated in her funded NIH grant, Dr. Freedman has extracted and stored high quality RNA samples from Framingham Offspring participants (both lymphocytes and platelets). Her lab has recently completed an analysis of 96 genes using the exact same rtPCR protocols proposed for this project. In the completed analyses for 96 genes, a high level of reproducibility has been demonstrated for the assays and levels of expression of specific housekeeping genes have been utilized for gene expression analysis. This project represents collaboration with Dr. Freedman and without the collaboration with Dr. Freedman; the Government would not have access to the necessary RNA samples in Framingham subjects in whom genomewide association study findings have been established in order to conduct this highly meritorious research project. De novo collection of RNA samples for conduct of the proposed project would be both time consuming and highly expensive, costing hundreds of thousands of dollars minimum. Therefore conduct of this project would not be possible within the next two academic years. By use of existing RNA samples that are housed in Dr. Freedman’s laboratory, the Government is able to leverage and use an existing RNA collection that is not currently publicly available, at no cost. The rtPCR protocols proposed to be conducted by Dr. Freedman’s laboratory under this contract are state of the art, and the per gene cost of rtPCR is highly competitive because we are paying only for reagents and technician time, not for extraction or processing of cDNA derived from RNA samples or for new machines or robotics to conduct this research. The offeror must include a completed copy of the following provisions: 1) FAR Clause 52.212-1 Instructions to Offerors Commercial; 2) FAR Clause 52.212-2, Evaluation Commercial Items. As stated in FAR Clause 52.212-2 (a), The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: Technical Evaluation and Price. 3) FAR Clause 52.212-3, Offeror Representations and Certifications Commercial Items; 4) FAR Clause 52.212-4, Contract Terms and Conditions Required To Implement Statues or Executive Orders Commercial Items, Contract Terms and Conditions Commercial Items; and 5) FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items Deviation for Simplified Acquisitions. This action is under the authority of 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1 and HHSAR 306-302-1. Only one responsible source and no other supplies or services will satisfy agency requirement. 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 quotations however; all responses received within five (5) days from the date of publication of this synopsis will be considered by the Government. A determination by the Government not to compete this proposed acquisition is based upon responses to this notice and is solely for the purpose of determining whether to conduct a competitive acquisition. The offeror must include in their quotation, the unit price, the list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. Note: In order to receive an award from the NHLBI contractors must have a valid registration in the Central Contractor Registration (CCR) www.ccr.gov. The clauses are available in full text at http://www.arnet.gov/far. Interested vendors capable of furnishing the government with the item specified in this synopsis should submit their quotation to the below address. Quotations will be due five (5) calendar days from the publication date of this synopsis or by August 25, 2009, 7:30am, Eastern Standard Time. The quotation must reference Solicitation number NHLBI-PB-(HL)-2009-270-DDC. All responsible sources may submit a quotation, which if timely received, shall be considered by the agency. Quotations must be submitted in writing to the National Heart, Lung and Blood Institute 6701 Rockledge Blvd., Room Suite 6100, Bethesda, Maryland 20892, Attention: Deborah Coulter. Faxed copies will not be accepted. Emails will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-PB-(HL)-2009-270-DDC/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN01918429-W 20090821/090820001325-b904a2b6be406055bed01abff99f7940 (fbodaily.com)
- Source
-
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