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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 Nat... 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 SOMALOGIC, INC for services to study the proteomic effects of different extreme metabolic states. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541380 with a Size Standard of $16.50. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2020-07 effective August 31, 2020. 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 the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements. BACKGROUND The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) conducts and supports research on many of the most serious diseases affecting public health. The Institute supports much of the clinical research on the diseases of internal medicine and related subspecialty fields, as well as many basic science disciplines. The Institute's Division of Intramural Research encompasses the broad spectrum of metabolic diseases such as diabetes, obesity, inborn errors of metabolism, endocrine disorders, mineral metabolism, digestive and liver diseases, nutrition, urology and renal disease, and hematology. Basic research studies include biochemistry, biophysics, nutrition, pathology, histochemistry, bioorganic chemistry, physical chemistry, chemical and molecular biology, and pharmacology. NIDDK extramural research is organized into 4 divisions: Diabetes, Endocrinology, and Metabolic Diseases; Digestive Diseases and Nutrition; Kidney, Urologic, and Hematologic Diseases; and Extramural Activities. The Institute supports basic and clinical research through investigator-initiated grants, program project and center grants, and career development and training awards. The Institute also supports research and development projects and large-scale clinical trials through contracts. PURPOSE AND OBJECTIVES Insulin resistance (IR) is frequently associated with liver disease since insulin signaling occurs in the liver to significantly affect carbohydrate and lipid metabolism. The issue is that biomarkers used to study IR and liver disease are often affected by both disease states, making it difficult to differentiate the effects of both conditions. By comparing levels of over 4,000 circulating proteins between patients with rare diseases of extreme insulin resistance and/or extreme liver disease, we hope to utilize NIH’s unique patient cohorts to differentiate between these two disease states. Patients with lipodystrophy have both IR and liver disease, patients with insulin receptor mutations only have IR, and patients with hepatitis D virus infection only have liver disease. By understanding protein differences among these extreme disease states, we can not only better understand the pathophysiologic differences between IR and liver diseases but be able to identify biomarkers that can be applied to less severe diseases like general obesity to better understand whether their IR or liver function requires treatment. The goal of the current study is to compare 30 patients with lipodystrophy not being treated with metreleptin to 30 patients with insulin receptor mutations matched for age, sex, and glycemia using hemoglobin A1c at the time of sample collection, 17 other patients with lipodystrophy before, 2 days, and 2 weeks after metreleptin therapy while other medications and patient diet were controlled, and 8 healthy control samples for comparison. We hypothesize that, by comparing patients with extreme insulin resistance and/or extreme liver disease using NIH’s cohorts of patients with rare disease, may reveal novel differences between the effects of insulin resistance and liver disease on levels of circulating proteins in the body. Separation, identification, and quantification of over 4,000 individual proteins in 118 samples of plasma from patients enrolled in an approved clinical trials on the vendor’s patented platform: this will enable us to obtain a through sense of all circulating protein changes that occur in patients with lipodystrophy, insulin receptor mutations, and extreme liver disease. Specifically, the NIDDK requires the following tasks: TASK AREAS TASK AREA 1 - The NIDDK sends to send the patient samples to SomaLogic, Inc. before the service can be provided. TASK AREA 2 – Samples will be shipped on dry ice using standard shipment. The services provided by SomaLogic, Inc. can be provided remotely once the services are provided. TASK AREA 3 – Access to the study deliverables (Word report, Excel data file). SomaLogic, Inc. also provides 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 SOMALOGIC, INC. to be the only reasonably available source to provide services to study the proteomic effects of different extreme metabolic states the NIDDK requires. SomaLogic is a world leader in the field of proteomics by pioneering and patenting the use of aptamers to measure the most extensive profile of proteins using small volumes of patient samples. There is no other vendor capable of measuring as many proteins as SomaLogic is now capable of measuring using limited quantities of patient samples. Thus, there is no other company that currently performs this service and provides the necessary support for analysis and interpretation. SomaLogic, Inc. is the sole source for the following reasons: • SomaLogic has the patented platform that is proprietary and only one capable of measuring and identifying over 4000 different proteins • SomaLogic has the proprietary software to analyze the results PERIOD OF PERFORMANCE Within 12 Months of Date of Award Place of Performance National Institutes of Health National Institute of Digestive, Diabetes & Kidney Diseases 10 Center Drive Bethesda MD 20814 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 responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.” All responses to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Tuesday, September 15, 2020 to the Contract Specialist, Amber Harris, at amber.harris@nih.gov . Assessment of Capability Lowest Price Technically Acceptable

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SOURCES SOUGHT NOTICE (Proteomic Effects of Different Extreme Metabolic States) AGENCY: The National Institutes of Health, National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) TIT... SOURCES SOUGHT NOTICE (Proteomic Effects of Different Extreme Metabolic States) AGENCY: The National Institutes of Health, National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) TITLE: Proteomic Effects of Different Extreme Metabolic States PROPOSED SOLICITATION NUMBER: NICHD-20-234 PROJECT SERVICE CODE: Q301 - MEDICAL- LABORATORY TESTING This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. There is no solicitation available at this time. The purpose of this notice is to obtain information regarding: (1) the availability and capability of all qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification according to the North American Industry Classification System, (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set- aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. BACKGROUND: Insulin resistance (IR) is frequently associated with liver disease since insulin signaling occurs in the liver to significantly affect carbohydrate and lipid metabolism. The issue is that biomarkers used to study IR and liver disease are often affected by both disease states, making it difficult to differentiate the effects of both conditions. By comparing levels of over 4,000 circulating proteins between patients with rare diseases of extreme insulin resistance and/or extreme liver disease, we hope to utilize NIH’s unique patient cohorts to differentiate between these two disease states. Patients with lipodystrophy have both IR and liver disease, patients with insulin receptor mutations only have IR, and patients with hepatitis D virus infection only have liver disease. By understanding protein differences among these extreme disease states, we can not only better understand the pathophysiologic differences between IR and liver diseases but be able to identify biomarkers that can be applied to less severe diseases like general obesity to better understand whether their IR or liver function requires treatment. The goal of the current study is to compare 30 patients with lipodystrophy not being treated with metreleptin to 30 patients with insulin receptor mutations matched for age, sex, and glycemia using hemoglobin A1c at the time of sample collection, 17 other patients with lipodystrophy before, 2 days, and 2 weeks after metreleptin therapy while other medications and patient diet were controlled, and 8 healthy control samples for comparison. We hypothesize that, by comparing patients with extreme insulin resistance and/or extreme liver disease using NIH’s cohorts of patients with rare disease, may reveal novel differences between the effects of insulin resistance and liver disease on levels of circulating proteins in the body. Independently, and not as an agent of the Government, the contractor shall provide services to study the separation, identification, and quantification of over 4,000 patients in 118 samples of plasma from patients enrolled in an approved clinical trial on the vendor’s patented platform: this will enable us to obtain a through sense of all circulating proteomic changes that occur in patients with lipodystrophy, insulin receptor mutations, and extreme liver disease.. This Sources Sought is for an organization or institution to provide the NIDDK with services studying the effects of insulin resistance and liver disease. The purchase of these services are necessary to maintain the high quality of our research. All qualified small businesses, whether they are small businesses; HUBZone small businesses; service-disabled, veteran owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; interested in submitting a corporate capability statement should demonstrate their capability to provide equipment that meets the characteristics below. SALIENT / REQUIRED FEATURES AND SPECIFICATIONS: Separation, identification, and quantification of over 4,000 individual proteins in 118 samples of plasma from patients enrolled in approved clinical trials on the vendor’s patented platform: this will enable us to obtain a through sense of all circulating protein changes that occur in patients with lipodystrophy, insulin receptor mutations, and extreme liver disease. Task Area 1 –The NIDDK sends to send the patient samples to the vendor before the service can be provided. This will occur once shipping and working restrictions are lifted due to the ongoing COVID-19 crisis. Task Area 2 – Samples will be shipped on dry ice using standard shipment. The services provided by SomaLogic, Inc. can be provided remotely once the services are provided. Task Area 3 – Access to the study deliverables (Word report, Excel data file). SomaLogic, Inc. also provides data analysis and visualization tools that allow for further data exploration. Task Area 4 – The Project Officer or the Project Officer Supervisor will perform inspection and acceptance of materials and services to be provided. Inspection and acceptance will be performed at the place of installation – National Institutes of Health, NIDDK, 9000 Rockville Pike, Maryland 20892. SPECIAL INSTRUCTIONS: This acquisition is being conducted under the authority of FAR Part 13.5 Simplified Acquisition Procedures. The vendor will be evaluated on their quoted product meeting the specifications under section SALIENT / REQUIRED FEATURES AND SPECIFICATIONS. If you or your firm/business has an interest and possess the required expertise we invite you to submit a corporate capability statement to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502-2(b) whether or not this procurement will be set-aside for any of the programs described above. The associated NAICS code is 541380, Testing Laboratories, and the small business size standard is $16.50. All respondents are requested to identify their firm's size and type of business. Interested firms responding to this Sources Sought Notice should adhere to the following: (a) Provide a capability statement demonstrating relevant experience, skills and ability to fulfill the Government's requirements for the above. The capability statement should contain sufficient detail for the Government to make an informed decision regarding your capabilities. The capability statement should not exceed 15 pages using a font size 10 or larger. (b) Small business concerns that possess the capabilities necessary to undertake the efforts should submit complete documentation of their capabilities to the Contracting Officer. This capability statement should include: 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as they relate to the requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, and 4) any other specific and relevant information that would improve the Government's consideration and evaluation of the information presented. Further, Past Performance documentation, which should include, but not be limited to, a minimum of two (2) contracts performed for either Government or commercial organizations shall be provided. References shall include for each contract: names, titles, contract number, total price or cost, telephone numbers of government Contracting Officer Representative and Contracting Officers. (c) All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to the Point of Contact below in MS Word or Adobe Portable Document Format (PDF). The subject line must specify NICHD-20-234. Facsimile responses will not be accepted. Electronically submitted capability statements are due no later than 9:00 AM (Eastern Prevailing Time) seven (7) calendar days (including date of submission to https://beta.sam.gov) after posting of the Small Business Sources Sought Notice. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED This notice is for information and planning purposes only and is not to be construed as a commitment by the Government, nor will the Government pay for information solicited.