SOLICITATION NOTICE
Q -- Metabolic Profiling and Renal Cell Cancer in the PLCO Screening Trial
- Notice Date
- 8/21/2015
- Notice Type
- Presolicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CP52589-76
- Archive Date
- 9/5/2015
- Point of Contact
- Catherine Muir, Phone: (240) 276-5434
- E-Mail Address
-
muirca@mail.nih.gov
(muirca@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E144, Bethesda, MD 20892, UNITED STATES Description: National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Nutritional Epidemiology Branch (NEB), plans to procure on a sole source basis the services for metabolomics to identify serum metabolites prospectively associated with RCC risk from Broad Institute of MIT and Harvard, 7 Cambridge Center, NE30-7023, Cambridge, MA 02142.. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(2) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 621511 and the business size standard is $32.5M. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The period of performance is twelve (12) months from date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. The Division of Cancer Epidemiology and Genetics (DCEG) is a research program of the National Cancer Institute (NCI), one of the National Institutes of Health (NIH). The Division is the world's most comprehensive cancer epidemiology research group. Its renowned epidemiologists, geneticists, and biostatisticians conduct population and multidisciplinary research to discover the genetic and environmental determinants of cancer and new approaches to cancer prevention. The Division's research impacts public health policy in the United States and around the world. The mission of the Nutritional Epidemiology Branch (NEB) is to define the causal relationships between diet/nutritional status, energy balance, metabolism, lifestyle factors, and cancer. Our research encompasses diet, energy balance/obesity/physical activity, specific nutrients and supplements, diet-related additives, contaminants, metabolites, and intermediate biologic markers. Kidney cancer is one of the most common cancers in the United States, and approximately 85% of kidney cancers are renal cell carcinomas (RCC). A hallmark of RCC is that perturbed metabolism plays a major role in its etiology. Obesity and hypertension are among the strongest risk factors for RCC, and multiple mechanistic pathways have been proposed to explain why these factors are related to RCC risk. However, despite substantial scientific inquiry on this topic, our understanding of the actual mechanistic pathways involved in RCC etiology remains quite poor. Metabolomics is a field of research devoted to the study of large numbers (400-800) of small molecules within biofluids, such as blood. Metabolomic profiles incorporate exposure from diet, lifestyle, the environment and genetics, among many other factors, that may be related to cancer risk. To better understand the role of metabolism in RCC etiology, the Nutritional Epidemiology Branch, Division of Cancer Epidemiology and Genetics (DCEG), of the National Cancer Institute (NCI) is conducting a metabolomics study that will examine how metabolites in prospectively collected serum are associated with RCC risk. Samples are to be run at the lab of Clary Clish at the Broad Institute, using up to three distinct metabolomics platforms. The Clary Clish lab is considered one of the leaders in the field of metabolomics and has superb reliability and technical properties. Contractor shall perform the following: 1. Store samples immediately in -80 degrees Centigrade until ready for assays 2. Measure metabolites using mass spectrometry on the PLCO and Health ABC samples The samples will be sent boxed in batches of thirty-two (32). All batches and samples within the batches should be assayed in the order provided by the NCI. All samples will be sent at the same time. All analytical work performed by the Contractor will be conducted under conditions of careful quality control and will follow the usual quality control procedures. All Contractor internal quality control charts will be provided to the NCI after the first batch and at completion of the work. The NCI will review the data for the blinded quality control samples to assure that satisfactory reproducibility is being provided. 3. Communicate to the Contracting Officer's Representative (COR) immediately via email or phone call if any problems. The Contractor shall notify the NCI COR immediately via e-mail or phone call if any unusual problems develop over the course of the project and/or explanations for repeating analyses, such as failure of analytical and quality control procedures, breakdown of freezers, instrumentation and equipment, and major changes in personnel that would produce delays or that would adversely influence the quality of the laboratory performance. 4. Deliver data to the NCI COR as tables of named and unnamed metabolites and relative concentrations. This will be delivered by e-mail as either an Excel file or text file, to be determined by the NCI COR. 5. After the assays are run on each batch, residual samples will be stored in the laboratory at -80 degrees Centigrade. All biological materials provided by the U.S. Government, all residual specimens, and all data generated shall be the property of the U.S. Government and shall be returned to the U.S. Government repository after the assays are completed and data approved by the NCI COR. • GOVERNMENT RESPONSIBILITIES The NCI COR will ensure that the data delivered includes tables of named and unnamed biochemicals and relative concentrations, all linked to sample IDs. • REPORTING REQUIREMENTS AND DELIVERABLES The Contractor shall provide to the NCI COR the tables of named and unnamed biochemicals and relative concentrations, all linked to sample IDs. Data shall be in Excel or text file, to be determined by the NCI COR. • INSPECTION AND ACCEPTANCE CRITERIA The reports, containing relevant data items, per above, defined above, will be scrutinized and subsequently accepted within thirty (30) calendar days of receipt. This laboratory testing service is provided by Broad Institute of MIT and Harvard. The Clish platform at the proposed source is the only known laboratory that can perform all the technical requirements needed in the Statement of Work. The proposed source has demonstrated extensive and unique experience in, and is one of the leaders in, the field of metabolomics and has superb reliability and technical properties. The platform is one of the most frequently used platforms in epidemiologic studies and it has yielded many important and replicable associations in prior epidemiologic studies. The platform has exceptionally high technical reliability and low batch to batch variability, and can measure hundreds of metabolites simultaneously. The proposed Vendor has extensive experience in metabolite profiling, that is not available from any other known source. The proposed study is part of a consortium effort to identify metabolic factors related to RCC. If the NCI uses an alternate platform, its results will not be comparable to those of other studies in the Consortium, because the exact metabolites measured by different metabolomics platforms will differ. The NEB's study is ongoing, and the performance characteristics and quality of the needed services are required for maintaining the integrity of on-going studies. A change would be disruptive to the ability to analyze our cumulative results. For scientific comparability, it is imperative the analyses be done at the Clish lab. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 5:00PM EDT, on Sept. 4, 2015. All responses and questions must be in writing and faxed (240) 276-5401 or emailed to Catherine Muir, Contracting Officer via electronic mail at muirca@mail.nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference: N02CP52589-76 on all corresponden
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