75N95023Q00145

Submitted by whipple on
Post Date/ Solicitation Issue Date
Closing Response Date
Proposed Award Date
Project Title
Rat Liver Microsomes, Male
Contracting Office
National Center for Advancing Translational Sciences (NCATS)

Contact Points

Primary Contract Specialist

Michele
Pastorek
michele.pastorek@nih.gov
NAICS Code Number
325144
Biological Product (except Diagnostic) Manufacturing
Small Business Size Standard
1,250 Employees
FPDS Classification Code
6505 - Drugs and Biologicals
Delivery of Goods
30 Days ARO
Competition Status
Non-Competitive
Vendor Name
Discovery Life Sciences, LLC
Vendor Address
800 Hudson Way, Suite 700
Huntsville, AL 35806-2962
Single-Sole Source Determination
The essential characteristics of the RLM that limit the availability to a sole source are: This vendor has been used the past 10 years and developed QSAR models for the benefit of all Chemists at NCATS as well as the greater drug discovery scientific community. The activity of commercial microsomes can vary significantly between vendors and batches. This may be due to differences in animal-to-animal variation and preparation processes, such as the use of different inhibitors like phenylmethylsulfonylfluoride and EDTA. These differences can impact the efficacy of the microsomes in metabolizing drugs. 

Since we at NCATS have used this vendor for 10 years, changing vendors could result in variation in activities which would hamper projects as well as introduce error in the silico tools we have developed using this reagent. Therefore, it is imperative to use this exact brand of microsomes for our ADME studies.

Only this source can furnish the requirements, to the exclusion of other sources, because these RLM are manufactured only by DLS.
Background/Description of Requirement

NOTICE OF INTENT to Sole Source

  1. SOLICITATION NUMBER:

75N95023Q00145

  1. TITLE:  Rat Liver Microsomes, Male

 

  1. CLASSIFICATION CODE:

 

6505 – Drugs and Biologicals

NAICS CODE: 325414 – Biological Product (except Diagnostic) Manufacturing  

  1. RESPONSE DATE:

March 16, 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 Discovery Life Sciences, LLC for Rat Liver Microsomes, Male.

 

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

The intended procurement is classified under NAICS code 325414 – Biological Product (except Diagnostic) with a Size Standard of 1,250 Employees.  

 

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) 2023-01 dated December 30, 2022.

 

DESCRIPTION OF REQUIREMENT

PURPOSE AND OBJECTIVES:

The purpose of this requirement is to procure Rat Liver Microsomes, Male from Discovery Life Sciences, LLC.  The contractor shall provide the Government with a Qty of 500.

QTY:

500

 

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

 

The essential characteristics of the RLM that limit the availability to a sole source are: This vendor has been used the past 10 years and developed QSAR models for the benefit of all Chemists at NCATS as well as the greater drug discovery scientific community. The activity of commercial microsomes can vary significantly between vendors and batches. This may be due to differences in animal-to-animal variation and preparation processes, such as the use of different inhibitors like phenylmethylsulfonylfluoride and EDTA. These differences can impact the efficacy of the microsomes in metabolizing drugs. 

Since we at NCATS have used this vendor for 10 years, changing vendors could result in variation in activities which would hamper projects as well as introduce error in the silico tools we have developed using this reagent. Therefore, it is imperative to use this exact brand of microsomes for our ADME studies.

Only this source can furnish the requirements, to the exclusion of other sources, because these RLM are manufactured only by DLS.

 

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

 

The intended source is:

Discovery Life Sciences, LLC

800 Hudson Way, Suite 700

Huntsville, AL  35806-2962

 

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 75N95023Q00145. 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.

Interested parties may identify in writing their interest and capability in response to this requirement. 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 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.

All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.

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