B SSJ_SSJ_MassSpec SSJ_LC210125172407_LC221017120817 (official).pdf

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Identification of the Agency and Contracting Activity.

Federal Agency and Contracting Activity Department of Health and Human Services National Institute of Health National Institute on Drug Abuse

Sponsoring Organization.

National Center for Advancing Translational Sciences Division of Pre-Clinical Innovation Therapeutics for Rare and Neglected Diseases (TRND)

Project Officer Information.

Project Officer Name. Xin Xu Mailing Address. 9800 Medical Center Dr-Bldg B, Rm 312, Rockville MD 20850-3370 E-mail Address. xin.xu3@nih.gov Telephone Number. 301.480.9844

Project Description.

Name of Item or Project Title.

Service contract for Mass Spectrometer in the DMPK core

Description of the Item or Service.

The ADME bioanalytical group in TRND biology facilitates drug discovery from basic research to the pre-clinical stage. Picking up where our Probe Development Group work leaves off, TRND will concentrate its efforts on the pre-clinical stage of drug development, where researchers develop clinical candidate in preparation for human testing. In doing so, TRND will help bridge the wide gaps in time and resources that often exist between basic research and clinical testing of new drugs. It is expected that in most cases, TRND’s clinical candidates will be licensed to biopharmaceutical companies for further development, thus allowing TRND to focus on the scientifically challenging pre-clinical stages of the drug development, and “de-risking” the projects sufficiently to make them adoptable by private sector companies.

To keep working towards this goal, TRND requires the continuation of a service contract for our Thermo instruments in the lab. The service agreement contract is for all of the items covered under the evaluation criteria as listed below.

Market Research. (see FAR Part 10) Market Research was conducted and the results of market research are detailed in the attached market research document.

Acquisition Type.

This acquisition exceeds $5,000 and is not expected to exceed $250,000, and is conducted in accordance with FAR Part 13- Simplified Acquisition Procedures.

Acquisition Authority.

Sole-Single Source (including Brand-Name) Justification mailto:xin.xu3@nih.gov

This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1 (b) Soliciting from a single source. (1) 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, or industrial mobilization).

Justification Rationale.

Only one source is available:

I hereby determine that the item or service listed herein is available from only one source and competition is precluded for the reasons indicated below. There are no substitutes available.

This acquisition is restricted to:

Company Name. Thermo Electron North America LLC Company Address. 1400 Northpoint Pkwy Ste 50, West Palm Beach, FL 33407 Point of Contact. AARON TAMBURELLO Contact Phone. 800-532-4752

The estimated cost of the required item or service is:

$218,522.88

The item or service is required to be delivered/performed on:

Brand-name or Items peculiar to one manufacturer:

The essential characteristics of the item or service that limit the availability to a sole source are:

This requisition is needed in order to service our Q Exactive HF-X Mass Spectrometer (s/n SN06486L) Only this suggested source can furnish the requirements to the exclusion of other sources, due to proprietary rights in the design of components and software used in the instrument, service is only available from Thermo Electron North America, LLC. The vendor has provided documentation that it is the sole source for parts, training, technical support, field service support and software.

Only this suggested source can furnish the requirements, to the exclusion of other sources, because :

Company Name: Thermo Electron North America, LLC Company Address: 1400 Northpoint Pkwy, Suite 50, West Palm Beach, FL 33407 Point of Contact: Aaron Tambruello Contact Phone: 1-800-532-4752

Include as appropriate:

The material or service must be compatible in all aspects (form, fit, and function) with existing systems presently installed and must coordinate, connect, or interface with the existing equipment or system by:

The new items are "direct replacement" parts / components for existing equipment.

Renewing existing contract.

Any other facts supporting the justification:

NA

Project Officer Certification. The undersigned program official(s) certifies that the information in support of this justification for the proposed acquisition has been reviewed, is completed and correct to the best of my knowledge and belief and recommends approval.

Signature: Digitally signed by Xin Xu -S Date: 2022.11.02 12:47:09 -04'00'

Contracting Officer Certification. The Contracting Officer certifies that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete and in accordance with FAR 13.106-1(b)(1), the facts of this acquisition preclude the use of full and open competition.

Signature:

Xin Xu -S

This form is signed by the CO due to an Adobe Error.