Evaluating ADME of compounds from dystonia project

NOTICE OF INTENT to Sole Source

1. SOLICITATION NUMBER:

75N95023Q00574

1. TITLE:  Evaluating ADME of compounds from dystonia project

1. CLASSIFICATION CODE:

B504 – Special Studies/Analysis-Chemical/Biological

NAICS CODE: 541380 – Testing Laboratories and Services  

1. RESPONSE DATE:

August 17, 2023, 4:00 pm EST

1. PRIMARY POINT OF CONTACT:

Michele Pastorek       

michele.pastorek@nih.gov

Phone: 301.827.1739

1. DESCRIPTION:

INTRODUCTION

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

National Center for Advancing Translational Sciences (NCATS) intends to negotiate on a sole source basis with Pharmaron, Inc for evaluating ADME of compounds from dystonia.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS

The intended procurement is classified under NAICS code 541380 – Testing Laboratories and Services with a Size Standard of $19 Million.  

REGULATORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: For purchases not exceeding the simplified acquisition threshold, Contracting Officers may solicit from one source IF the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name OR industrial mobilization).

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2023-04 dated June 02, 2023

DESCRIPTION OF REQUIREMENT

PURPOSE AND OBJECTIVES:

The purpose of this requirement is to evaluate ADME of compounds from dystonia from Pharmaron, Inc.

QTY:

1

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION

The essential characteristics of these PK studies that limit the availability to a sole source are the required consistency of the results. Only this suggested source can furnish the requirements, to the exclusion of other sources, because only this suggested source (PHARMARON) is familiar with the class of compounds that are being evaluated. They have formulated and dosed analogs from the same chemical series, and in this contract will evaluate new analogs from the same chemical series.  Consistency and reproducibility are essential to draw meaningful conclusions and comparison to previous analogs from the same series.

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, Pharmaron, Inc., is the only vendor in the marketplace that can provide the services required by NCATS .

The intended source is:

Pharmaron, Inc.

201 E. Jefferson Streeet, Suite 304

Louisville, KY  40202-1249

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.

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

Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: 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 Unique Entity ID (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.

All responses must be received by the closing date and time of this announcement and must reference the solicitation number 75N95023Q00574. Responses must be submitted electronically to Michele Pastorek, Contract Specialist, at

Michele.pastorek@nih.gov and Valerie Whipple, Contracting Officer, at valerie.whipple@nih.gov.  U.S. Mail and fax responses will not be accepted.