NOTICE OF INTENT to Sole Source.pdf

NOTICE OF INTENT to Sole Source

1. SOLICITATION NUMBER: NIMH25001360_1

2. TITLE: Cambridge Isotope L-Glutamine

3. CLASSIFICATION CODE:R499 – Support – Professional: Other

NAICS CODE: 325199 – All Other Basic Organic Chemical Manufacturing

4. RESPONSE DATE: March 28, 2025, at 12:00 PM EST

5. PRIMARY POINT OF CONTACT:

Joe Kennedy Joseph.kennedy@nih.gov Phone: 262-391-7630

6. DESCRIPTION:

INTRODUCTION

This is a notice of intent, not a request for a quotation.

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT)

SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FULL OR

OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute of Mental Health (NIMH) intends to negotiate on a sole source basis with Cambridge Isotope Laboratories Inc., for a 12-month base contract.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

and SET ASIDE STATUS The intended procurement is classified under NAICS code 325199 – All Other Basic Organic Chemical Manufacturing with a Size Standard of 1,250 employees.

This intended procurement will be a small business set-aside requirement.

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) Number 2025-03, dated January 3, 2025.

DESCRIPTION OF REQUIREMENT

Purchase Description To provide all resources necessary as described in this Statement of Work (SOW). With these 13C labelled chemicals, we will be able to detect brain metabolism and to accurately measure the concentrations of several important metabolites. The 13C MR spectroscopy methods developed in our group is and will be applied to many other research groups in NIMH and NIH for various neural science studies. Without this chemical, the institute will lose a powerful method in neural science research.

Specific Requirements

The Spectroscopy Section has been conducting several in vivo carbon-13 (13C) spectroscopy projects with infusion of 13C labeled chemicals.

Due to natural abundance of 13C is only 1%, the 13C signal is too weak to be detected.

Therefore, we need to use chemicals with enriched 13C to increase 13C signal intensity.

In an ongoing project, 13C labeled amino acids are used to study brain metabolism. Each in vivo rodent study or phantom experiment will use between 10-50mg of chemical depending on the specific study.

Salient Characteristics:

Chemicals must be labeled at 99% enrichment with stable isotope 13C. Must be research grade and include CoA.

Delivery Date 30 days after receipt of purchase order.

Period of Performance The proposed period of performance shall be for one year, with two one-year option years.

Base: 4/15/2025 – 4/16/2026

Level of Effort n/a

Government Responsibilities The government’s responsibilities involve providing feedback to the contractor if a problem arises.

Reporting Requirements An initial written progress report in Word format will be submitted three months into the contract. A final report in Word format will be submitted to Dr. Lee at the end of the contract.

OTHER CONSIDERARTIONS:

Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in www.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Section 508—Electronic and Information Technology Standards The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. §

794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.

Confidentiality of Information:

The Contractor will not disclose, publish, divulge, release, or make known, in any manner or to any extent, to any individual other than the authorized government employee, the content of any sensitive information provided under this contract. For this requirement, the government may provide the contractor information or data of a personal nature about individual(s) or proprietary information or data pertaining to this project, which is confidential. This requirement is expected to generate information or data which is confidential. The Contractor shall handle all sensitive information or data in a secure manner and consult with the authorized government employee prior to any release, disclosure, dissemination, or publication.

(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, Cambridge Isotope Laboratory, Inc., is the only vendor in the marketplace that can provide the services required by National Institute of Mental Health.

http://www.sam.gov/

The intended source is:

Cambridge Isotope Laboratories, Inc.

1689 Burnett Drive Xenia OH 45385

Brand-name or Items peculiar to one manufacturer:

The essential characteristics of the labelled chemicals that limit the availability to a sole source are the ability to custom synthesize a reliable and repeatable organic pathway to the molecule. Only this suggested source can furnish the requirements, to the exclusion of other sources, because other vendors are unable to provide an organic pathway to the molecule at high enough purity level for our requirements.

Vendors without an established organic pathway will need to research and develop such a custom pathway at great time and cost. Cambridge has already identified a pathway and can guarantee analysis of 99% purity. The material or service must be compatible in all aspects (form, fit, and function) with existing systems presently installed. The current equipment is 99% pure, and the new item/service must coordinate, connect, or interface with the existing system by other 13C chemicals enriched to 99%.

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 purpose 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.

Responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). 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, NIMH25001360_1.

Responses must be submitted electronically to Joe Kennedy, Contract Specialist, at joseph.kennedy@nih.gov mailto:joseph.kennedy@nih.gov

U.S. Mail and fax responses will not be accepted.