Notice of Intent Sole Source.pdf

Notice 75N94023Q00060

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 (NIH), National Institute of Child Health and Human

Development (NICHD), Office of Acquisitions (OA) intends to award a contract action without providing for full and open competition (Including brand-name) to:

Pine Pharmaceuticals LLC:

355 Riverwalk Parkway Tonawanda, NY 14150

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 325412 with a Size Standard

1,250 employees.

REGULATORY AUTHORITY

The resultant contract action will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2023-03, May 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).

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.

GENERAL INFORMATION

Notice number - 75N94023Q00060

1. Title: Intravenous Stable Isotope

2. Background Information: The National Institute of Diabetes and Digestive and Kidney

Diseases (NIDDK) supports a wide range of medical research through grants to universities and other medical research institutions across the country. The Institute also supports government scientists who conduct basic, translational, and clinical research across a broad spectrum of research topics and serious, chronic diseases and conditions related to the Institute's mission. In addition, the NIDDK supports research training for students and scientists at various stages of their careers and a range of education and outreach programs to bring science-based information to patients and their families, health care professionals, and the public.

Stable isotopes have been used safely in clinical research for decades and have contributed seminal insights into human metabolism. In many cases, stable isotopes allow a generation of knowledge that may not be possible by any other method. Under the directive of the NIH Sterile Products for Human Administration (SPHA) Executive

Committee and the NIH Office of Research Services and Compliance (approved

10/2021), stable isotopes used in clinical human metabolic studies must meet certain specified minimum requirements. Pine pharmaceuticals was initially approved by the

NIH Office of Deputy Director of Clinical Care in August 2016 and the decision re-affirmed by the NIH Sterile Products for Human Research Committee (SPHA) on July

24th, 2018. The decision to continue using Pine Pharmaceuticals, LLC followed extensive year-long vetting and an external audit commissioned by the NIH CC Office of

Research Support and Compliance (ORSC). A quality agreement was implemented in

February 2019 and is in place between Pine Pharmaceuticals, LLC and NIH Pharmacy and NIDDK.

Period of Performance:

Base Period: June 30, 2023 - June 29, 2024 Option Period 1: June 30, 2024 – June 29, 2025 Option Period 2: June 30, 2025 – June 29, 2026

CLOSING STATEMENT

This 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 a technical proposal, a cost-price proposal, the period of performance, the Unique Entity Identifier (UEI) 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 must be received by June 9, 2023 at 4:00PM Eastern Standard Time and must reference solicitation number 75N94023Q00060. Responses may be submitted electronically to Mrs. Kimesha Leake, Contracting Officer at kimesha.leake@nih.gov.

Fax responses will not be accepted.

All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.