services for the metabolomic process of plasma and spot urine samples from LCLF Diet Intervention Study

INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the on behalf of the National Institute of Digestive, Diabetes & Kidney Diseases intends to award a purchase order without providing for full and open competition (Including brand-name) to METABOLON INC for services for the metabolomic process of plasma and spot urine samples from LCLF Diet Intervention Study. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541380 with a Size Standard of $16.5. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2022-01 Effective December 6, 2021. This acquisition is conducted under the procedures as prescribed in FAR subpart 13'Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302- FAR 6.302-1'Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1). PERIOD OF PERFORMANCE Within 3 months after plasma and spot urine samples are shipped from NIDDK Place of Performance National Institutes of Health National Institute of Digestive, Diabetes & Kidney Diseases 10 Center Drive Bethesda, MD 20892 ? DESCRIPTION OF REQUIREMENT The NIDDK The Hall lab investigates how metabolism and the brain adapt in response to a variety of interventions to diet and physical activity. We perform experiments in both humans and rodents to better understand the complex mechanisms regulating macronutrient metabolism, body composition, and energy expenditure. A unique aspect of our laboratory involves the development of mathematical models to quantitatively describe, explain, integrate, and predict our experimental results. We would like to use Metabolon to analyze plasma and spot urine samples collected from Low-Carb vs. Low-Fat Diet (LCLF) study protocol in the Section of Integrative Physiology in the Laboratory of Biological Modeling, NIDDK. This study investigated ad libitum food intake of 20 healthy adult volunteers who completed a 4-week stay at the NIH. During their stay, they consumed a LCHF diet and a LFHC diet for 2 weeks each, in random order. The primary endpoints in this study were to collect information about energy intake and metabolic changes, in response to the two test diets. _________________________ PURPOSE AND OBJECTIVES The National Institutes of Health (NIH)s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has a requirement for services for the metabolomic process of 20 plasma samples and 60 spot urine samples from the LCLF diet intervention study and 24 bridging samples from the previous project for merging with a total of 104 samples. This study investigated ad libitum food intake of 20 healthy adult volunteers who completed a 4-week stay at the NIH. During their stay, they consumed a LCHF diet and a LFHC diet for 2 weeks each, in random order. The primary endpoints in this study were to collect information about energy intake and metabolic changes, in response to the two test diets. We have previously used this Metabolon Global Metabolomics platform in a collaborative study with NCI and need to use the same platform for this new study in order to compare results. SALIENT / REQUIRED FEATURES AND SPECIFICATIONS One key aspect of NIDDK's mission is to improve quality of life by understanding the metabolic basis of human disease. Our research goal is aligned well with this mission as we are seeking to understand (and ameliorate) the regulation of body weight and metabolism'the processes through which food is converted into the energy. We perform experiments in both humans and rodents to better understand the complex mechanisms that control metabolism of macronutrients'proteins, fats, and carbohydrates. The vendor must use the Metabolon Precision Metabolomics LC-MS global metabolomics platform. - Ability to identify and quantitate more than 5,400 metabolites within small urine samples, including endogenous metabolites and these deriving from the microbiome, lifestyle, or environmental factors (e.g. food, drugs, and chemicals). - Analysis tools for the data obtained. - Ability to directly compare to previously obtained results. TASKS AREAS Independently, and not as an agent of the Government, the contractor shall perform all of the detailed Task Areas listed below: Task Area 1 - Shipment NIDDK will ship the plasma and spot urine samples to the vendor. The vendor will process and provide data to NIDDK within 3 months of receiving the samples. Task Area 2 - Delivery The vendor will grant NIDDK access to their data portal for downloading the study deliverables. The portal should also provide data analysis and visualization tools that allow for further data exploration. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10'Market Research. Only one source is available: Per FAR 13.106-1(b)(1) the Contracting Officer has determined METABOLON INC to be the only reasonable available source to provide services for the metabolomic process of plasma and spot urine samples from LCLF Diet Intervention Study. This acquisition was pursued on a sole source basis centered on the following. The Precision Metabolomics LC-MS global metabolomics platform that was previously used in a collaborative study with NCI is proprietary to Metabolon. It is necessary to keep the platform the same so we can make meaningful comparison of results. Thus, Metabolon is the only vendor that can fulfill this requirement. The Metabolon Precision Metabolomics LC-MS global metabolomics platform is the only platform available to identify and quantitate more than 5,400 metabolites within small urine samples, including endogenous metabolites and these deriving from the microbiome, lifestyle, or environmental factors (e.g. food, drugs, and chemicals). The lab has previously used this platform in a collaborative study with NCI. It is necessary to keep the platform the same so we can make meaningful comparison of results. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties bona-fide capabilities for fulfilling the requirement and include: descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all the foregoing requirements, 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. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Friday, December 17, 2021 to the Contract Specialist, Amber Harris, at contact@example.gov . Assessment of Capability Lowest Price Technically Acceptable