Active

Contract Opportunity

NOTICE OF INTENT to Sole Source

1. SOLICITATION NUMBER: 75N95024Q00019

2. TITLE: Pharmacokinetics assessment in Mice and Rats.

3. CLASSIFICATION CODE:

6505 – Drugs and Biologicals

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

4. RESPONSE DATE:

November 7 2023, 4:30 pm EST

5. PRIMARY POINT OF CONTACT:

Giuliana C. Faller

Giuliana.faller@nih.gov

Phone: 301-480-9789

6. 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 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 translational science center that prides itself on its tremendously productive pipeline and is innovative in a number of ways. NCATS brings together a diverse range of scientists, including medicinal chemists, biologists, toxicologists, and engineers, in order to ultimately translate basic science into real products and services that help improve people’s lives. Included in this process is the development of unique small molecules as potential anticancer agents or as potential for regenerative medicine.

Pharmacokinetics plays a critical role in determining the available drug in an living system for the target of interest, by determining the overall level of the drug. This parameter is key to assessing the potential in vivo efficacy of the drug.

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

The intended procurement is classified under NAICS code 325414 – Biological Product (Except Diagnostic) Manufacturing with a Size Standard of 1,000 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) 2023-04 dated June 2, 2023.

DESCRIPTION OF REQUIREMENT

PURPOSE AND OBJECTIVES:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

1. 40 compounds in a Pharmacokinetics assay

a. The assay will have an N= 3 on the number of animals used

b. The animals to be used will be either CD-1 or C57 mice, or alternatively Sprague Dawley or Han Wistar rats

c. 8 time points will be assessed over 24 hours

d. Plasma levels of the given small molecule will be measured at each of these time points

e. An excel spreadsheet will be provided as a report with the necessary information

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 in the interest of continuity of science

The intended source is:

Pharmaron, Inc.

201 East Jefferson St.,

Louisville, KY, 40202

POC: Alvin Kalinda

Phone: 1-313-618-1689

E-mail: alvin.kalinda@pharmaron.com

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 75N95024Q00019. Responses must be submitted electronically to Giuliana Faller, Contract Specialist, at

giuliana.faller@nih.gov.U.S. Mail and fax responses will not be accepted.

NOTICE OF INTENT to Sole Source

1. SOLICITATION NUMBER: 75N95024Q00019

2. TITLE: Pharmacokinetics assessment in Mice and Rats.

3. CLASSIFICATION CODE:

6505 – Drugs and Biologicals

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

4. RESPONSE DATE:

November 7 2023, 4:30 pm EST

5. PRIMARY POINT OF CONTACT:

Giuliana C. Faller

Giuliana.faller@nih.gov

Phone: 301-480-9789

6. 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 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 translational science center that prides itself on its tremendously productive pipeline and is innovative in a number of ways. NCATS brings together a diverse range of scientists, including medicinal chemists, biologists, toxicologists, and engineers, in order to ultimately translate basic science into real products and services that help improve people’s lives. Included in this process is the development of unique small molecules as potential anticancer agents or as potential for regenerative medicine.

Pharmacokinetics plays a critical role in determining the available drug in an living system for the target of interest, by determining the overall level of the drug. This parameter is key to assessing the potential in vivo efficacy of the drug.

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

The intended procurement is classified under NAICS code 325414 – Biological Product (Except Diagnostic) Manufacturing with a Size Standard of 1,000 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) 2023-04 dated June 2, 2023.

DESCRIPTION OF REQUIREMENT

PURPOSE AND OBJECTIVES:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

1. 40 compounds in a Pharmacokinetics assay

a. The assay will have an N= 3 on the number of animals used

b. The animals to be used will be either CD-1 or C57 mice, or alternatively Sprague Dawley or Han Wistar rats

c. 8 time points will be assessed over 24 hours

d. Plasma levels of the given small molecule will be measured at each of these time points

e. An excel spreadsheet will be provided as a report with the necessary information

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 in the interest of continuity of science

The intended source is:

Pharmaron, Inc.

201 East Jefferson St.,

Louisville, KY, 40202

POC: Alvin Kalinda

Phone: 1-313-618-1689

E-mail: alvin.kalinda@pharmaron.com

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 75N95024Q00019. Responses must be submitted electronically to Giuliana Faller, Contract Specialist, at

giuliana.faller@nih.gov.U.S. Mail and fax responses will not be accepted.

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