NOI_75N94023Q00081.pdf

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, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), in support of the work of the National Institute of Diabetes, Digestive, and Kidney Disease (NIDDK), intends to award a purchase order without providing for full and open competition to Children’s Hospital of Philadelphia, 2716 South Street, Roberts – 17th Floor, Philadelphia, PA 19146 to acquire Base + 4 option years for support for Glomerular Disease Consortium.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541690 with a Size Standard $16.5 M.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Circular (FAC) 2023-04 effective 06/02/2023. 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) and FAR Subpart 12- Acquisition of Commercial Items.

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.

Place of Performance National Institutes of Health 9000 Rockville Pike Bethesda MD 20892 United States

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 objective of this requirement is to procure services of a chairperson for the steering committee of the Glomerular Disease Consortium. The objective is to have the chairperson oversee the steering committee for the Glomerular Disease Consortium. The steering committee is composed of the Principal Investigators (PIs) from the four clinical centers, the PIs from the Data Coordinating

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

Center, and the NIDDK Project Scientist and Program Official. The chairperson will lead the discussions and provide expert clinical direction to the study investigators and to the government.

PERIOD OF PERFORMANCE AND PAYMENT BREAKDOWN:

BASE YEAR: 09/01/2023 - 08/31/2024

OPT YR ONE 09/01/2024 - 08/31/2025

OPT YR TWO: 09/01/2025 - 08/31/2026

OPT YR THREE: 09/01/2026 - 08/31/2027

OPT YR FOUR: 09/01/2027 - 08/31/2028

A period of performance cannot exceed 12 consecutive months (Base + Option year contracts still have individual 12-month period of performance).

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 that Dr. Lisa Guay-Woodford is an internationally recognized pediatric nephrologist with a research program focused on identifying clinical and genetic factors involved in the pathogenesis of inherited renal disorders, most notably autosomal recessive polycystic kidney disease (ARPKD). Her unique expertise in kidney disease is crucial to the mission of KUH and NIDDK. KUH has not been able to find another medical expert with the knowledge that Dr. Guay- Woodford possesses, thus Dr. Guay-Woodford is the best person to chair the Glomerular Disease Consortium. Dr. Guay-Woodford is also familiar with NIH policies and KUH future goals.

The purpose of this study is to implement a network of clinical sites to study individuals with glomerular disease, specifically, minimal change nephropathy, membranous nephropathy, IgA nephropathy and focal segmental glomerulosclerosis. Studies will focus on phenotypic, genotypic and biochemical evaluation of study participants. Investigators are expected to interact with industry partners as well as the Food & Drug Administration (FDA). The ultimate goal of the Consortium is to obtain the necessary information to plan a future trial(s) for this group of diseases.

Investigators will collaborate on the design and conduct of the study as a consortium.

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. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provided feedback to respondents with respect to any information submitted. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement, 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 Vendor/Contractor’s (UEI) the Unique Entity ID from SAM.gov is now the authoritative identifier for those doing business with the federal government. The DUNS Number is no longer valid for federal award identification, 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.” Note to Contractor: The contractor shall provide a completed copy of

FAR 52.204-24, "Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment" with their quote in response to this solicitation.

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 July 23, 2023, to verne.griffin@nih.gov and shall include solicitation number 75N94023Q00081 in the subject line.