75N95024Q00557

INTRODUCTION

PURSUANT TO FAR Subpart 5.2—Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT ACTION.   

THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). 

The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) intends to award to University of Kansas Center for Research Inc. (KU), 2385 Irving Hill Rd., Lawrence, KS 66045-7563, an order with an estimated value not to exceed $23,800 titled “Preliminary Solid Dosage Form Development Strategy for ALDH1A1 Inhibitor Drug Candidate for NCATS ETB.” This will be a firm-fixed-price purchase order with a period of performance of September 10, 2024, through May 9, 2025. The rationale is this work represents a continuation of the ongoing formulation efforts for this compound which have been performed by KU. This continuation is crucial as it marks the transition to the second phase of this ongoing project, and it is necessary to remain with KU to ensure the continuity of science.

The scope and objective of this acquisition is to develop a formulation strategy for a lead molecule to support preclinical and IND-enabling studies. It involves preliminary screening of physicochemical properties and the selection of polymers to create a viable formulation strategy that ensures extended supersaturation of the candidate compound from a solid dosage form. Actual feasibility testing for creating an effective solid dosage form is required.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541380, Testing Laboratories and Services, with a small business size tandard of $19 million.

REGULATORY AUTHORITY

The resultant task order will include all applicable provisions and clauses of the Federal acquisition Requlation (FAR) in effect through the Federal Acquisition Circular (FAC) 2024-5 with effective date of May 22, 2024.

STATUTORY AUTHORITY
This acquisition is conducted as non-competitive under the authority of 41 U.S.C. 1901 using the procedures in FAR Subpart 13.5.

DESCRIPTION OF REQUIREMENT 

Background
The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives. The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), which mission it is to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. The Early Translational Branch  (ETB) is tasked with identifying and developing novel small molecule leads for improving human health. 

In pursuit of this goal, the Center has a strong internal trans-disciplinary team of scientists who continually discover novel small molecules to modulate molecular targets to identify novel treatment strategies.  As such, discovering lead molecules that could serve as starting points for therapeutic development for patients is a key part of discovery.  Formulation of small molecule lead compounds is an important part of the discovery process and key to advancing a molecule for the treatment of patients. As such right formulation condition is essential for toxicity and IND studies.

Purpose and Objectives
The purpose of this requirement is to provide preliminary solid dosage form development strategy for the ALDH1A1 inhibitor drug candidate for NCATS ETB.

Project Description
A full description is available via email upon request as Attachment 1 – Statement of Work (SOW) from the Contrating Officer.

Period of Performance
September 10, 2024, through May 9, 2025 (6 months).

CLOSING STATEMENT

This synopsis is not a request for competitive proposals; however, all responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency

Responses to this solicitation must include clear and convincing evidence of the offeror’s technical capability of fulfilling the requirement. Responses that fail to include relevant technical capability information and all terms and conditions may be assessed as not capable of meeting the requirement.

The respondent must also provide their Unique Entity Identifier (UEI), organization name, address, point-of-contact, and size and type of business (e.g., 8(a), HubZone, etc.), pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. 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 09:00 AM Eastern Time, August 30, 2024, and reference number 75N95024Q00557.

All responses must be emailed to Mark McNally, Contracting Officer, at mark.mcnally@nih.gov. 

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