Acquisition of Laboratory Services for support of the Associations of fecal metabolites with body mass index and colorectal cancer.

National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Metabolic Epidemiology Branch (MEB), plans to procure on a sole source basis services for fecal metabolite testing from Metabolon, Inc.; 617 Davis Dr. Suite 400; Durham, NC 27713. The response close date of this notice for this requirement is in accordance with FAR 5.203(a)(1). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and 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 will be 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. MEB's research mission is to define causal relationships between diet, energy balance, hormones, tobacco, and cancer. The MEB conducts interdisciplinary research to understand the role of diet, energy balance, hormones, tobacco, and other exposures in causing and preventing cancer. It studies how these exposures relate to a broad variety of cancers with researchers focusing on breast, colon, endometrium, esophagus, liver, stomach, ovary, pancreas, and prostate. It uses traditional epidemiological methods combined with a variety of molecular methods including genomic analysis, metabolomics, microbiomics, and molecular pathology. The purpose of this procurement is to use metabolomics to identify fecal metabolites associated with BMI trajectories, colorectal cancer, and adenoma risk. The NCI will send 611 samples from for the contractor to do analysis using the Contractor's LC-MS and GC-MS technologies. Changes in body mass index (BMI) have been associated with changes in gut microbiota. These microbial changes in the gut may lead to changes in the metabolomic phenotypes due to altered microbial metabolism. It has been found that 37 serum metabolites, including 19 lipids and 12 amino acids, were significantly associated with BMI. In addition, emerging research from NCI collaborators estimates that over 35% of phenotypic variance in BMI is explained by gut microbial diversity. Colorectal cancer has also been observed to be associated with altered distal gut microbiota. These microbial changes in the distal gut may lead to changes in the metabolomic profiles due to changing metabolism, but only a few studies have investigated metabolomics in feces related to colorectal cancer. NCI has previously investigated the association of fecal metabolomics with colorectal cancer and found 41 metabolites out of 1043 were strongly associated with colorectal cancer case status after correction for multiple testing. CONTRACTOR TASKS: 1. Store samples immediately in -80 degrees Centigrade until ready for assays 2. Measure metabolites using ultrahigh performance liquid chromatography (UPLC)-tandem mass spectrometry (MS/MS). All samples 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 Technical Point of Contact immediately via email or phone call if any problems. The Contractor shall notify the NCI Technical Point of Contact 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 Technical Point of Contact 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 Technical Point of Contact. 5. After the assays are run on each batch, residual samples should be destroyed. 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 Technical Point of Contact. GOVERNMENT RESPONSIBILITIES The NCI Technical Point of Contact will ensure that the data delivered includes tables of named and unnamed biochemicals and relative concentrations, all linked to sample IDs. NCI shall send 611 samples for testing from the Frederick repository and/or an identified contractor. REPORTING REQUIREMENTS AND DELIVERABLES The Contractor shall provide to the NCI Technical Point of Contact 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 Technical Point of Contact. INSPECTION AND ACCEPTANCE CRITERIA The reports, containing relevant data items, per above, will be scrutinized and subsequently accepted within thirty (30) calendar days of receipt. This laboratory testing service is provided by Metabolon, Inc. To ensure scientific integrity, samples for its replication study need to be run at the lab of Metabolon Inc. in order to exactly replicate prior observations, since metabolites measured by Metabolon Inc. do not extensively overlap with those of other metabolomics platforms from other labs. The MEB'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 its cumulative results. For scientific comparability, it is imperative the analyses be performed by the proposed source. 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 4:00PM EDT, on September 09, 2016. All responses and questions must be in writing and faxed (240) 276-5401 or emailed to Seena Ninan, Contracting Officer via electronic mail at ninans@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: N02CP62659-88 on all correspondence.