EPIDEMIOLOGY STATISTICAL CONSULTING

Modification to Description 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. The National Institutes of Health, National Institute of Child Health and Development (NICHD), in support of the work of the National Institute of Diabetes, Digestive, and Kidney Disease (NIDDK), Laboratory of Cellular and Developmental Biology intends to award a purchase order without providing for full and open competition for Base + 4 Options years with Dr. Paul Eggers 4017 Evangeline Terrace, Olney, Maryland 20832 to provide services of a Epidemiology Statistical Consulting. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541690 with a Size Standard 15.0 Million. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Circular (FAC) 2020-05 effective 03-30-2020. 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 ($150,000) and FAR Subpart 12- Acquisition of Commercial Items. 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 May 1, 2020 – April 30, 2025 Place of Performance National Institutes of Health National Institute of Diabetes, Digestive, and Kidney Disease (NIDDK)/DKUHD 6707 Democracy Boulevard II Democray Plaza, Room 6107 Bethesda, MD 20892, United States Description of the Requirement : Consulting Objectives: Based on initial consultation with the Division Director, and the Program Officer for USRDS and UDA (Dr. Kevin Abbott), the consultant will be available on the schedule below for assessing contract deliverables and specific research of interest to 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, External Expert Panel, site visit, and other required meetings; 3) addressing problems in data validity concerns expressed by external investigators and other stakeholders in the contracts, and; 4) providing feedback and advice on minutes from meetings with contract personnel and other federal agencies. 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 previous 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 Contractor shall work with the Director of the DKUHD, NIDDK, on an as needed basis. As the Director of Kidney and Urology Epidemiology in the DKUHD, NIDDK, NIH, Dr. Eggers served as the Program Official for both the USRDS and the UDA since 2000. Dr. Eggers has been working as a part time re-employed annuitant since retiring in January 2013 and has officially retired on February 6, 2016. Dr. Eggers’ departure will negatively impact critical operations of the Division in the scientific direction, oversight, and conduct of the two aforementioned contracts which are central to the mission of NIDDK. Dr. Eggers has been the Project Officer for these two contracts since 2000. His oversight of both projects includes not only the day to day administrative tasks but leadership in the scientific direction of the studies. His knowledge of epidemiological research principles, kidney and urologic diseases, and familiarity with the Medicare program (the primary payer for these conditions) has enabled both projects to attain the unparalleled status they have in their respective arenas. Dr. Eggers' sustained contribution to leadership and management of these contracts have been critical to their successes. His complete unavailability for consultation will negatively impact the ability of these contracts to continue with the sustained progress each has shown, given the importance of knowledge of legislation from decades ago, along with knowledge of the inner workings and processes of CMS. Dr. Eggers has been with the NIH for 13 years during which he has acquired in-depth knowledge and a unique skill set that he has used in his oversight of epidemiologic studies. Because of these skills he has served on a number of inter-IC working groups involving advances in data base construction, comparative effectiveness research, and electronic health record integration with clinical research. He is in demand by other agencies such as AHRQ and CMS for advice on renal issues and serves as a scientific reviewer for a number of journals including the New England Journal of Medicine, the Journal of the American Medical Association, the Journal of the American Society of Nephrology and the Clinical Journal of the American Society of Nephrology. Dr. Eggers is still well known and remembered at CMS, CDC, and many federal agencies critical to the role of the USRDS and UDA, respectively. His opinions and contributions have often been crucial in resolving obstacles to the missions of these contracts. The duties and responsibilities for contract management and oversight outlined above require a consultant with considerable knowledge, epidemiologic expertise and abilities in a wide range of areas. In the absence of Dr. Eggers’ expertise in this area a major gap will be created in the ability of the NIDDK to carry out its research and informational activities in kidney and urologic diseases in a continuous fashion. Even though a full-time replacement, Dr. Kevin Abbott, has been hired, Dr. Eggers’ unique knowledge and skills will provide an invaluable asset for the institute, in the role of a consultant. Dr. Eggers has been the Program Official at NIDDK for both the USRDS and the UDA for 16 years, and as mentioned above was instrumental in establishing the ESRD program at CMS before moving to NIH. He thus has irreplaceable institutional knowledge of often historical details that are sometimes poorly documented, making him uniquely qualified to serve in this role. He is the only individual in the nation with firsthand experience of USRDS from both CMS and the NIDDK. Given his unique skills and experience, he can provide NIDDK and KUH with the best, most informed feedback on critical contract details and deliverables. 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: unit price, list price, shipping and handling costs, the delivery period after contract award, 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 11:00 am Eastern Standard Time, on April 22, 2020 to Verne Griffin, [email protected] and shall reference solicitation number. Assessment of Capability Award will be made to the contractor who provides the most advantageous quote to the government. Technical factors and price considered. In order to be considered technically acceptable the offeror must provide the services listed under “Description of the Requirement”.