Notice of Intent NICHD-21-083.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, National Institute of Child Health and 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 Pennington Biomedical Research Center, Baton Rouge, LA, to expand the current study “Therapeutic Targets in African-American Youth with Type 2 Diabetes”.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541715 with a Size Standard 1,000 employees.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Circular (FAC) 2021-05 effective 03-10-2021. 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.

Place of Performance Pennington Biomedical Research Center 6400 Perkins Road Baton Rouge, LA 70808

Period of Performance Base Year: 4/16/2021 – 4/15/2022 Option Year 1: 4/16/2021 – 4/15/2022 Option Year 2: 4/16/2021 – 4/15/2022

DESCRIPTION OF REQUIREMENT

This project request is to expand our study “Therapeutic Targets in African-American Youth with Type 2 Diabetes” (ClinicalTrials.gov NCT02960659) to a multi-site research protocol to be conducted at the Pennington Biomedical Research Center (PBRC). Dr. Daniel Hsia is the Director of Pediatric Research at PBRC and will be the primary collaborator and site PI for this multi-site

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

project. The project contract will fund the specialized recruiting of a high-risk vulnerable population with all data collection and study procedures conducted at Pennington site.

This study “Therapeutic Targets in African-American Youth with Type 2 Diabetes” provides an integrative approach to therapeutic development and will evaluate whether combination therapy with metformin and liraglutide is superior to metformin alone for lowering glucose output from the liver. The study is approved by the National Institutes of Health Institutional Review Board and is actively recruiting participants at the NIH Clinical Center. It is a pilot prospective randomized treatment trial of African American youth with type 2 diabetes, ages 12-25 years, not on insulin therapy and within 5 years of diagnosis.

• The primary objective of this pilot study is to compare the ability of two anti-diabetic regimens (metformin and liraglutide and metformin alone) to lower gluconeogenesis (glucose produced by the liver) in African American youth with type 2 diabetes.

• The secondary objectives of this pilot study will evaluate the therapeutic effect on the following:

Glucose metabolism, including hepatic glucose production, and insulin sensitivity Insulin and incretin (glucagon like-1 peptide and gastrointestinal inhibitory peptide) concentrations.

Lipid metabolism, including lipolysis and fatty acid turnover

• Exploratory aims are to evaluate the relationship of metformin induced changes in gluconeogenesis with (1) known pharmacogenomic variants of metformin response and (2) distribution and composition of gut microflora.

The protocol utilizes specialized and deep phenotyping techniques and resources to accurately assess the above-mentioned outcomes. These tests can only be conducted at tertiary care institutions that support intensive clinical metabolic research trials.

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 Pennington Biomedical is the sole provider of the required services.

The PBRC is the only site that has an NIH-funded Nutrition and Obesity Research Center equipped with specialized clinical core and metabolic kitchen, access to participant population and skilled expert investigator who is interested in conducting this detailed metabolic research

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 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 3:00 PM Eastern Standard Time, on April 12, 2021.

http://www.sam.gov/