PINE PHARMACEUTICALS LLC.NOTICE OF INTENT.75N94024Q00264.pdf

75N94024Q00264

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, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the on behalf of the National Institute of Digestive, Diabetes & Kidney Diseases intends to award a purchase order without providing for full and open competition (Including brand-name) to PINE PHARMACEUITICALS LLC for Acquisition of Intravenous Stable Isotopes.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 325414 with a Size Standard of 1,250.

PRIMARY PRODUCT/SERVICE CODE

6505 - DRUGS AND BIOLOGICALS

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular FAC 2024-05 Effective May 22, 2024.

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 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

Base Year: September 16, 2024 – September 15, 2025

Place of Performance National Institutes of Health National Institute of Digestive, Diabetes & Kidney Diseases 10 Center Drive Bethesda, MD 20892

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

DESCRIPTION OF REQUIREMENT

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 the current Contractor 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 the Contractor and NIH Pharmacy and

NIDDK.

PURPOSE AND OBJECTIVES

The objective of this requirement is to obtain intravenous stable isotope (6,6 d2-glucose and d5 glycerol) from Pine Pharmaceuticals for 1 batch. The contract with Pine Pharmaceuticals will encompass 1 batch (72 vials) of 6,6 d2-glucose; 72.9mg/mL; 30 ml vial and 1 batch of d5 glycerol; 11.7mg/mL; 30 ml vial. The majority of funds will be needed at the start of the contract to procure the raw material needed for compounding the batch.

SALIENT / REQUIRED FEATURES AND SPECIFICATIONS

The following isotopes will be needed, which include the following specifications and packaging. The certificate of analysis and/or the enhanced technical data package should meet the following requirements for the most recently manufactured lot with date.

The total project costs are as follows:

1. Individual production quotes per batch of 6,6 d2-glucose (72-unit vials for clinical research use). The quote should cover the cost for the procurement of raw materials, the production of the intravenous isotope product at Pine and the microbial and analytical testing to be performed by a third-party vendor.

2. Individual production quotes per batch of d5 glycerol (72-unit vials for clinical research use).

The quote should cover the cost for the procurement of raw materials, the production of the intravenous isotope product at Pine and the microbial and analytical testing to be performed by a third-party vendor.

Important Notes:

The raw material and finished product requirements are outlined in Appendix A. Minimum requirements for stable isotopes used in clinical (human) metabolic studies, V1.7.

The raw material 6,6 deuterated glucose must be obtained from Cambridge Isotope Laboratories – Catalog number: DLM-349-CTM.

The raw material d5 glycerol must be obtained from Cambridge Isotope Laboratories – Catalog number: DLM-1229-CTM.

These stable isotopes are needed for metabolic research protocols that are Internal Review Board (IRB) approved to meet NIDDK mission and goals. The requirements stated above are based on the minimum specifications for stable isotopes used in clinical (human) metabolic studies by the NIH SPHA Executive Committee and Office of Research Support and Compliance.

Stability testing for D5-glycerol over a 1-year period recommended as:

Quote Itemization Item Quantity Unit Price Extended Price Period Performance 6,6 D2-glucose (72.9 MG/ML (30 ML) for clinical trial use

72 Sept 2024

D5 glycerol (11.7 MG/ML (30 ML) for clinical trial use

72 Sept 2024

Total

TASKS AREAS

Independently, and not as an agent of the Government, the contractor shall perform all of the detailed Task Areas listed below:

Task Area 1 – Delivery Timelines – Contractor shall deliver the described supplies between September 16, 2024 and December 31, 2024.

Task Area 2 - Shipping – Contractor shall arrange shipment to: NIH Clinical Center, Pharmacy Department, Building 10, Room 1C230, MSC 1196 no later than 60-days after receipt of award (ARO).

Task Area 3- Sourcing- The Contractor shall be responsible for sourcing the raw material, packaging and/ or manufacturing the isotope product, and submitting and releasing the product to the NIH Clinical Center Pharmacy after microbial and analytical testing and provide certificate of analysis.

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 PINE PHARMACEUITICALS LLC to be the only reasonable available source to provide Intravenous Stable Isotopes (6,6 deuterated glucose and d5 glycerol) for Metabolic Research.

The NIH currently restricts the procurement of intravenous stable isotopes for metabolic research to materials supplied by Pine Pharmaceuticals. Pine Pharmaceuticals, under the directive of the NIH SPHA executive committee, will be responsible for sourcing the raw material, manufacturing the sterile intravenous isotope product, doing one-year stability analysis, and submitting and releasing the product to the NIH CC Pharmacy after microbial and analytical testing. The product in the specified formulation outlined in the SOW cannot be purchased from other vendors as those vendors are not approved by the NIH ORSC and NIH CC Pharmacy. This approval was obtained from the NIH CC Pharmacy and the NIH SHPA executive committee on July 24, 2018 and renewed in October 2021. The approval follows an external audit of the Pine Pharmaceuticals facility, a review of Pine’s response to recent FDA inspections, and a review of alternatives for isotope procurement (including using a Contract Management Organization or CMO). This NIH executive committee directed-process constitutes the basis for using Pine Pharmaceuticals and the sole-source justification needed for this SOW.

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: descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all the foregoing requirements, 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 9:00 am Eastern Standard Time, on Thursday, September 12, 2024 to the Contract Specialist, Amber Harris, at amber.harris@nih.gov .

Assessment of Capability Lowest Price Technically Acceptable http://www.sam.gov/ mailto:amber.harris@nih.gov