APOL1 Long-term Outcomes Study Steering Committee Chairperson

REGULATORY AUTHORITY:

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2022-08 Effective 10/28/2022.

This acquisition is conducted under the procedures prescribed in FAR Part 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 for purchases not exceeding the simplified acquisition threshold.  Contracts awarded using FAR Part 13 - Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6 - Competition Requirements.

INTRODUCTION:

This is a notice of intent to award without providing for full and 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 National Institute of Digestive and Diabetes and Kidney Diseases (NIDDK) intends to award to Children’s National Medical Center for the procurement of services of a Chairperson for the Steering Committee of the APOL1 Long-term Outcomes (APOLLO) Study. The intended procurement is classified under NAICS code 541990 with a size standard of $17M.

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 OBJECTIVE:

The purpose of this procurement is to purchase the services of a Chairperson for the Steering Committee of the APOL1 Long-term Outcomes (APOLLO) Study. 

The objective is to have the Chairperson 1) represent the APOLLO Consortium at a panel of External Experts / Observational Studies Monitoring Board / Protocol Approval Committee to help periodically review and evaluate the accumulated study data for participant safety, study conduct and progress, and, when appropriate, efficacy, and 2) make recommendations to NIDDK concerning the continuation, modification, or termination of the study. The OSMB considers study-specific data as well as relevant background knowledge about the disease, study parameters, or patient population under study.

PERIOD OF PERFORMANCE:

Base Period: 1/1/2023 – 12/30/2023

Option Period 1: 1/1/2024 – 12/30/2024

Option Period 2: 1/1/2025 – 12/30/2025

Option Period 3: 1/1/2026 – 12/30/2026

Option Period 4: 1/1/2027 – 12/30/2027

PLACE OF PERFORMANCE:

National Institutes of Health

National Institute of Digestive and Diabetes and Kidney Diseases

10 Center Drive

Bethesda, MD 20892

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 Children’s National Medical Center’s Dr. Moxey-Mims to be the only reasonably available source to provide the services of a Chairperson for the Steering Committee of the APOLLO Study.   To have smooth continuance of ongoing Kidney and Urology programs, Dr. Moxey-Mims is the only Contractor who can provide instant assistance with these programs without further instruction and enduring a lengthy learning curve and additional cost to NIH.

Dr. Marva Moxey-Mims is uniquely qualified to lead this consortium. Dr. Moxey-Mims is an expert knowledgeable about kidney disease in pediatric and adult populations, including the kidney transplant population. She has unique extensive experience in studies of disparities, and relationships of ethnicity to outcome in the end-stage renal disease program.  Her expertise will be invaluable in assessing longitudinal outcomes, enhancing recruitment, and evaluating participant interactions with the study team. 

CLOSING STATEMENT:

This notice is not a request for competitive proposals. However, interested parties may identify their interest and capability in response 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 response meets all the foregoing requirements, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All respondents 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 requirement based upon responses to this notice is solely within the discretion of the Government. The information received will 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 Friday, December 16, 2022, to the Contract Specialist, Kerry-Ann Chisholm, at kerry-ann.chisholm@nih.gov.