Neurodegenerative Disease Research, Non-GMP Synthesis of Compounds

INTRODUCTION

PURSUANT TO FAR Subpart 5.2—Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT TO 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 Institute on Drug Abuse (NIDA), on behalf of the National Institute of Neurological Disorders and Stroke (NINDS), Biochemistry Section intends to negotiate and award a contract for a sole source Neurodegenerative Disease Research, Non-GMP Synthesis of Compounds for the NINDS Biochemistry Section without providing for full or open competition.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses of the Federal Acquisition Regulation (FAR) in effect through the Federal Acquisition Circular (FAC) FAC 2024-05.

STATUTORY AUTHORITY

This acquisition is conducted as non-competitive under the authority of 41 U.S.C.3304(a)(1) and 10 U.S.C. 2304(c)(1) under provisions of the statutory authority of FAR Subpart 6.302-1 – only one responsible source and no other supplies or services will satisfy agency requirements.

DESCRIPTION OF REQUIREMENT

Project Description

The purpose of this acquisition is to to identify molecules that bind KIAA0203 protein. Ultimately the synthesizing of compounds designed by the program area can lead to the potential creation of a new Alzheimer’s Drug. The vendor shall perform the synthesis of up to one hundred (100) compounds in 2-10 milligram quantities under non-GMP conditions.

Purpose and Objectives

The Government needs to contract with a full-service facility and staff to support a medicinal chemistry discovery program in developing a novel therapeutic effective in treatment dementias. Our drug discovery approach will be to synthesize novel ligands based on the high-throughput screen hits that bind our protein of interest, KIAA0203. The results of the efforts of this work will be the basis to advance preclinical candidate compounds for further development.

The proposed contract action is a follow on to an existing contract (75N95023P00469). With respect to the current proposed contract action, in order to maintain the integrity of the research data, specifically the scientific integrity of the project by benchmarking novel compounds to the previous generation, it is necessary that compounds be produced by the same vendor and facilities as under the predecessor contract.

Period of Performance:

The estimated period of performance shall be twelve months from the date of award, with four additional twelve month option periods.

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. 

An interested Offeror must be able to demonstrate its capabability to independently, and not as an agent of the Government,  perform experiments to synthesize up to 100 compounds in 2-10 milligram quantities under non-GMP conditions in each contract year (if options are exercised). To this end, the Contractor will provide two (2) full-time equivalent (FTE) scientists with a specialization in organics synthesis and/or medicinal chemistry and one (1) FTE at 25% effort dedicated to the project that can provide updates on its progress over the course of 12 months. Compounds will not be highly potent or controlled substances and shall have a purity of >95%. The compounds must be synethesized under the same procedures and standards, and at the same facilities, as under the predecessor contract.

Responses to this notice must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service.  The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision.  Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations.

In addition the Unique Entity Identifier (UEI) the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in http://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 July 28, 2024 2:00 p.m. Eastern Time.

Responses must be submitted electronically to Tracy Cain at tracy.cain@nih.gov.  

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