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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 ADEERA LEVIN for the services of the Chairperson of the Chronic Kidney Diseases of UnceRtain Etiology (CKDu) in Agricultural Communities (CURE) Research Consortium Steering Committee. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541690 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 2022-04 Effective January 30, 2022. 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 Base Year: 05/31/2022-05/30/2023 Option 1*: 05/31/2023-05/30/2024 Option 2*: 05/31/2024-05/30/2025 Option 3*: 05/31/2025-05/30/2026 Option 4*: 05/31/2026-05/30/2027 Place of Performance National Institutes of Health National Institute of Digestive, Diabetes & Kidney Diseases 6707 Democracy Blvd Bethesda, MD 20817 ? DESCRIPTION OF REQUIREMENT 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 The purpose of this contract is to purchase the services of a chairperson for the steering committee of the Chronic Kidney Diseases of UnceRtain Etiology (CKDu) in Agricultural Communities (CURE) Research Consortium. The objective is to have the chairperson to represent the CURE Consortium at a panel of external experts to help periodically review and evaluate the accumulated study data for participant safety, study conduct and progress, and, when appropriate, efficacy, and make recommendations to NIDDK concerning the continuation, modification, or termination of the consortium. The chairperson considers study-specific data as well as relevant background knowledge about the disease, study protocols and parameters, and patient population under study. SALIENT / REQUIRED FEATURES AND SPECIFICATIONS The Contractor will perform the following duties: Consulting Objectives: Based on initial consultation with the Division Director, and the Program Officer (Dr. Deepak Nihalani) and Project Scientists (Dr. Susan Mendley, Dr. Bonnie Joubert and Dr. Kathleen Michels) for CKDu, the consultant will be available on the schedule below for assessing contract deliverables and specific research of interest to the NIDDK. Methodology: Consulting sessions will be focused on: 1) providing assistance in inspecting and analyzing contract deliverables (generally, documents including data tables, chapters, and others); 2) advising on ongoing administration of contracts including details of steering committee, OSMB (observational safety monitoring board), site visit, and other required meetings; 3) addressing problems in data validity concerns expressed by external investigators and other stakeholders in the contracts; 4) providing feedback and advice on minutes from meetings with contract personnel and other federal agencies; and 5) providing expertise in conduct of international studies of kidney disease. • The contractor must have a M.D. in Internal Medicine, with a concentration in Nephrology and specialization in chronic kidney disease. • Minimum of 20 years’ program oversight in the field of Nephrology. • Must have epidemiological training, clinical knowledge, and health outcomes research. • Must be active in international activities across the spectrum of kidney activities. • Major research areas of interest must include non-traditional risk factors for CVD in CKD patients (with particular focus on anemia, phosphate and vitamin D, and progression of CKD variability) as well as models of care. • Must have published at least 200 peer reviewed publications and/or book chapters. • Must serve on numerous editorial boards and reviews for major kidney and medicine journals. • Strong communication skills, both oral and written. • Fluency in both written and spoken English. TASKS AREAS Contractor will perform the following duties of the Chairperson of the CURE consortium Steering Committee: Task Area 1 – Convene and run regular meetings of the Steering Committee and participate in subcommittee meetings as needed. Each meeting will last for 1-2 hours. Task Area 2 – Review study data and progress, recruitment data and discuss recruitment and retention strategies with the Principal Investigators, Program Officer and Project Scientists. Task Area 3 – Review the proceedings and recommendations from all subcommittees and discuss further plans with subcommittee chairpersons and the Program Office and Project Scientists. Task Area 4 – Act as a spokesperson for the CURE consortium at major national and international meetings and will be called upon to represent and discuss the conduct of the study by the press and other community organizations. Task Area 5 – Represent the CURE Steering Committee at the meetings and conference calls of the OSMB. One to two face-to-face meetings and two to more conference calls are expected during the coming year. 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 ADEERA LEVIN to be the only reasonable available source to provide the services of the Chairperson of the Chronic Kidney Diseases of UnceRtain Etiology (CKDu) in Agricultural Communities (CURE) Research Consortium Steering Committee. This acquisition was pursued on a sole source basis centered on the following. The DKUHD provides research funding and support for basic science and clinical research studies of the kidney and urinary tract and disorders of the blood and blood-forming organs. The medicine expert and chairperson will be used to provide expert knowledge on CKDu (chronic kidney diseases of unknown etiology) and chair the steering committee (SC) that serves as the governing body of the consortium. This expertise will be used to help provide assistance to the program directors that have been given project administration of the Kidney and Urology programs at DKUHD. In order to have smooth continuance of the Kidney and Urology programs, immediate assistance with these programs without further instruction is necessary. The objectives of the chairperson are to 1) chair the SC of CKDu consortium and provide assistance in inspecting and analyzing contract deliverables (generally, documents including data tables, chapters, and others); 2) advise on ongoing administration of the consortium including details of steering committee, OSMB (observational safety monitoring board), site visit, and other required meetings; 3) address problems in data validity concerns expressed by external investigators and other stakeholders in the contracts, ; 4) provide feedback and advice on minutes from meetings with contract personnel and other federal agencies; and 5) provide expertise in conduct of international studies of kidney diseases. Dr. Adeera Levin, M.D., F.R.C.P.C is Professor and Head of Medicine at the University of British Columbia, Chief Executive Director of the BC Renal Agency in British Columbia and the consultant nephrologist at Providence Health Care/St Paul’s Hospital, in Vancouver, Canada. She is the President Elect for International Society of Nephrology (ISN), and Editor-in-Chief for the Canadian Journal of Kidney Health & Disease. Dr. Levin received her medical degree from McMaster University Medical School, Ontario, Canada, and completed her residency in internal medicine from the same University and fellowship in nephrology at the Toronto Western Hosp & St. Michael’s Hospital, Univ of Toronto. Dr. Levin has received numerous teaching and research awards from local and national groups. In 2013, she was awarded the Canadian Society of Nephrology Outstanding Contributions to Canadian Nephrology. In 2014 she received the Kidney Foundation Medal for Research Excellence, and in 2015 she received the Aubrey J. Tingle Prize, an award given to a British Columbia researcher, whose work in health research is internationally recognized and has significant impact on advancing clinical or health services and policy research. In 2015, Dr. Levin was also awarded “The Order of Canada”, one of our country’s highest civilian honors that was established in 1967, during Canada’s centennial year, to recognize outstanding achievement, dedication to the community and service to the nation. Dr. Levin is the third division head and first female professor in the Department of Medicine to receive this honor, in recognition of her leadership in the treatment of kidney disease. Dr. Levin’s major research areas of interest include non-traditional risk factors for CVD (cardiovascular disease) in CKD (chronic kidney disease) patients, (with particular focus on anemia, phosphate and vitamin D, and progression of CKD variability) as well as models of care. She is an outstanding clinician scientist in kidney diseases, who leads a strong group with international impact in nephrology. She has made significant contributions to the understanding of the determinants of kidney health and disease and has ensured this knowledge is shared with patients living with CKD and their health-care providers to improve clinical care and quality of life. She has more than 400 peer reviewed publications, numerous book chapters, and is co-editor of a textbook “Chronic Kidney Disease: a practical guide to understanding and management”. She serves on numerous editorial boards and reviews for major kidney and medicine journals. She is the inaugural Editor-in-Chief of the new Canadian Journal of Kidney Health & Disease. She is the Principal Investigator on a large cohort study CAN-PREDDICT and holds numerous peer reviewed grants. She collaborates with investigators across Canada and internationally. Dr. Levin is an expert knowledgeable about the risk factors in CKD and active in international activities across the spectrum of kidney activities, which is essential to the CURE Consortium. Moreover, her greater understanding of the CKDu disease burden, severity, and natural history, make her an ideal candidate to 1) serve as the chairperson for the SC of CKDu Consortium, where she will help with its governance, design and implementations of matters pertaining to the Consortium and the successful achievement of the goals of the consortium, and 2) make recommendations to NIDDK concerning the continuation, modification, or termination of the study. 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 Thursday, April 7, 2022 to the Contract Specialist, Amber Harris, at amber.harris@nih.gov . Assessment of Capability Lowest Price Technically Acceptable