SOLICITATION NOTICE
B -- Research and Development in the Physical, Engineering, and Life Science
- Notice Date
- 3/11/2010
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- 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)-2010-111-DDC
- Archive Date
- 3/30/2010
- 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)-2010-111-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 2005-38 (12/10/2009). The North American Industry Classification (NAICS) Code is 541711 and the business size standard is 500. This acquisition is being conducted using Simplified Acquisition Procedures in accordance with FAR Part 13. However, this solicitation is set aside for small business. It is the intent of the National Institutes of Health (NIH) National Heart, Lung and Blood Institute to negotiate and award an order to Rules Based Medicine Inc., 3300 Duval Rd., Austin TX 78759, for Research in the Urinary Biomarkers in the Framingham Heart Study as outlined in 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. While pursuing the studies established research goals, the NHLBI and the Framingham investigators are expanding their research into other areas such as the role of metabolic risk factors in the pathogenesis of CVD. Chronic kidney disease (CKD) is an important risk factor for CVD and an important public health problem. The most severe stage of CKD, dialysis or transplantation, affects over 500,000 patients in the United States. Earlier stages of CKD are common, affecting 13% of adults in the United States, and 16 million individuals have reduced kidney function (CKD stages 3-5). In addition to increasing the risk for end-stage renal disease and a range of complications including anemia and bone disease, CKD increases the risk of cardiovascular disease and all-cause mortality. Hypertension and diabetes are key risk factors for chronic kidney disease (CKD), but do not fully identify individuals at risk for developing CKD. A recently developed algorithm for incident CKD demonstrates poor discrimination, highlighting the need to identify novel biomarkers for the development of CKD. Serum creatinine, as used in the MDRD equation, is the primary biomarker for CKD. However, creatinine is insensitive to early perturbations in renal function, particularly among individuals without overt clinical CKD. Further, serum creatinine provides no identification as to the nature of renal injury. This highlights the need for novel biomarkers that can more accurately identify individuals at risk for developing CKD, as well as provide prognostic information based on location of renal injury. Urinary biomarkers offer novel insight into renal health and may help identify individuals at risk for CKD before the development of overt clinical disease. Urinary assessment of biomarkers for CKD can provide information regarding the location of renal injury, which may have prognostic consequences for patients with CKD. Further, urinary biomarkers can provide insight into the biology of disease, and may help to better classify individuals at risk for developing CKD in the absence of overt clinical disease. The Human Kidney Damage Biomarker Panel (Rules Based Medicine) is a urinary biomarker panel recently developed to detect early renal disease. The panel contains the following urinary biomarkers: alpha-1microglobulin, beta-2 microglobulin, calbindin, clustering, connective tissue growth factor, cystatin C, glutathione s-transferase alpha, kidney injury molecule-1, neutrophil gelatinase-associated lipcalin, osteopontin, tamm-horsfall protein, tissue inhibitor of metalloproteinase-1, trefoil factor 3, and vascular endothelial growth factor. This SOW outlines pilot work to measure a panel of 14 urinary biomarkers in 2900 individuals from the Framingham Heart Study. All of these individuals have 10-year follow-up data available for the development of chronic kidney disease, CVD, and death. This project involves the contractor performing the urinary biomarker assays in 2900 individuals, and promptly returning the data within 30 days to NHLBI. I. Contractor Requirements A.Contractor will provide biomarker assay services to measure 14 analysts listed above in 2900 urine samples. The contractor will process NHLBI samples at contractor location using the bead luminex technology. B.The Contractor will provide high quality assay results with: a.CVs generally less than 10% C.Quality control measures will be applied by the Contractor and assay results will be accompanied by quality control information reflecting inter-assay CVs. D.Contractor will specify any special packaging, marking, or shipping instructions for sample shipment. E.Each urine sample received will be identified by the Contractor using the identifiers provided by NHLBI. II. Government Responsibilities A.NHLBI will provide to the Contractor 200 microliters of urine. In addition, NHLBI will provide a list of identifiers for urine samples. III. Reporting Requirements and Deliverables A.Assay results will be returned by Contractor to NHLBI in a standard format in a nonproprietary database in which each analyte is identified by a standard name. B.Return of assay results by the Contractor will be accompanied by summary quality control measures for each analyte. C.Assay results will be returned to NHLBI within 10 business days of receipt of urine samples. Program Management and Control Requirements No special management or control systems are required under this contract. The sole source determination is based on the fact that this project is to measure urinary biomarkers in 2900 individuals from the Framingham Heart Study. Chronic kidney disease is a major public health problem and biomarkers to identify early renal injury are limited. This project will capitalize on prior work Dr. Caroline Fox to identify new markers of kidney function to better identify individuals at risk for disease. Rules Based Medicine Inc., (RBM) is the sole provider of the Human Kidney MAP panel which measures 14 urinary biomarkers. RMB has optimized this panel to used a small amount of urine volume, and have achieved excellent reproducibility of the result. The Offeror must include a completed copy of the following provisions: 1) FAR Clause 52.212-1 Instructions to Offerors Commercial; 2) 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. 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 March 15, 2010, 7:30am Eastern Standard Time. The quotation must reference Solicitation number NHLBI-PB-(HL)-2010-111-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. coulterd@nhlbi.nih.gov. Faxed copies are not accepted. Emails are accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-PB-(HL)-2010-111-DDC/listing.html)
- Place of Performance
- Address: NIH, Framingham, Massachusetts, 01702, United States
- Zip Code: 01702
- Zip Code: 01702
- Record
- SN02089762-W 20100313/100311235135-2278c6b0c8df4a5de09fffa18e8425a1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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