Active

Contract Opportunity

NOTICE OF INTENT to Sole Source

1. SOLICITATION NUMBER: 75N95023Q00198

1. TITLE: Pharmacokinetic study (PK) using a novel polymeric formulation developed by the University of Kansas on 1 compound (NCGC0084604) in male C57BL/6J mice using compound-in-chow dosing at 3, 10, and 30 mg/kg.

1. CLASSIFICATION CODE: Q301MEDICAL- LABORATORY TESTING

NAICS CODE: 541380 - Testing Laboratories

1. RESPONSE DATE:

April 14, 2023, at 4:00 PM EST

1. PRIMARY POINT OF CONTACT:

Maggie Brant

Maggie.brant@nih.gov

Phone: 301.827.1771

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).

The National Center for Advancing Translational Sciences (NCATS) intends to negotiate on a sole source basis with Pharmaron, Inc., 201 E Jefferson St Ste 304, Louisville, KY 40202-1249 for a Pharmacokinetic study (PK). The anticipated award date is May 1, 2023.

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

The intended procurement is classified under NAICS code 541380 - Testing Laboratories with a Size Standard of $19 million.

This acquisition is NOT set aside for small businesses, but rather is a sole source acquisition to Pharmaron, Inc.

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) 2023-02 dated March 16, 2023.

DESCRIPTION OF REQUIREMENT

The purpose of this requirement is to procure testing 1 compound (NCGC00846044) in compound in chow method of delivery at 3, 10 and 30 mg/kg. The obtained PK data will be used to guide compound dosing selection and advancement towards a multiple sclerosis (MS) and atherosclerosis efficacy studies.

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), whose 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.

NCATS is in need of testing 1 compound 6044 in a side -by-side mouse PK study, comparing the amorphous solid compound in mouse chow with the 6044 polymer formulated compound in mouse chow. The obtained PK data will be used to guide compound selection and advancement towards in-vivo efficacy studies for two disease states.

This service should provide the following deliverables:

1. Properly produce the polymer-formulated compound 6044 and the amorphous compound 6044 in 3 concentrations in mouse chow for oral administration to mice in 3, 10 and 30 mg/kg concentrations respectively.

2. Run a mouse PK study in B57BL6 mice for the compounds at 3, 10 and 30 mg/kg concentrations, analyzing heart, brain, lung, plasma and liver.

3. For each compound dose, complete PK analysis at 6 time points through 15 days with n=6 in tissues of interest:

- Plasma

- Lung

- Liver

The vendor must submit documentation of an approved OLAW Assurance (such as an Assurance number) (OLAW, IACUC) from PHS Policy on Humane Care and Use of Laboratory Animals, of IACUC approval within the prior 36 months (such as the approval letter), and AAALAC Accreditation.

NCATS intends to negotiate on a sole source basis with Pharmaron, Inc. for testing 1 compound (NCGC00846044) in compound in chow method of delivery at 3, 10 and 30 mg/kg.

ESTIMATED PERIOD OF PERFORMANCE:

Study should take 14 business days after the acquirement of mice and reagents. Data analysis and report generation should an additional two weeks, delivered by electronic copy.

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. 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 ST STE 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, 75N95023Q00198. Responses must be submitted electronically to Maggie Brant, Contract Specialist, at maggie.brant@nih.gov. U.S. Mail and fax responses will not be accepted.

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