Sources Sought Rees Scientific Environmental Monitoring Maintenance Services

THIS IS A SOURCES SOUGHT ANNOUNCEMENT ONLY.

It is neither a solicitation announcement nor a request for proposals or quotes and does not obligate the Government to award a contract. Requests for a solicitation will not receive a response. Responses to this sources sought must be in writing. The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Small Businesses interested and capable of providing the services described below.

The information gained from this market research will help the National Institutes (NIH) Center Cellular Engineering (CCE) plan for its acquisition strategy.

Potential Large and Small Businesses shall include business information outlined in the section below as a part of their response.

Complete responses to this notice shall be in the following format:

1. SAM UEI Number


2. Company Name


3. Company Address, City, State and Zip Code


4. Company Point of Contact, Email Address and Telephone Number


5. Current GSA Schedule appropriate to this Sources Sought


6. Socioeconomic Status: (i.e., HUBZone, 8a, Small Business, Women Owned Small Business, Veteran-Owned Small-Business, etc.) as validated in Central Contractor Registration (CCR). All offerors must register in CCR located in https://www.sam.gov.


7. Provide a capability statement that addresses the organizations qualifications and ability to perform as a contractor for the work described in the Statement of Work. Do not copy the SOW verbatim or cut and paste.

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The National Institutes of Health, Clinical Center, Center Cellular Engineering (CCE) has a requirement for an authorized Rees Scientific service provider to perform Rees Scientific Environmental Monitoring/Alarm (Centron Presidio) System validation, calibration, and preventative maintenance services.

The Department of Transfusion Medicine (DTM), Center for Cellular Engineering (CCE) operates several current Good Manufacturing Practices (cGMP) facilities which are utilized to manufacture cellular and gene therapies for patients enrolled on Clinical Trials at the National Institutes of Health. To be compliant with 21CFR 211.67 (Current Good Manufacturing Practice for Finished Pharmaceuticals, Subpart Equipment Maintenance and Cleaning), a service contract is required for the Rees Scientific Environmental Monitoring System that monitors the environmental conditions within facilities used to manufacture cell therapies, as well as the performance of all critical equipment used in manufacturing and storage of cell therapies. The contractor shall provide all the labor, material, equipment, and reference standards necessary to maintain the Rees Scientific monitoring/alarm system and perform validation, calibration services. See attached Draft Statement of Work.

Period of Performance: 05/15/2025 -05/14/2026

Delivery Schedule: See attached Draft Statement of Work

Delivery Location:

Attention: TBD

National Institutes of Health

10 Center Drive

Building 10, Room TBD

Bethesda, MD 20892-1288

Contractors shall not reach out to the customer for any questions or clarifications.

All communications must go through contracting.

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Important information: The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this source sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. No sub-contracting opportunity is anticipated.

NAICS: The North American Classification System (NAICS) code for this acquisition is 811210- (Small Business Average Size Standards $34 Annual Receipts).

PSC: J066- Maintenance/repair/rebuild Of Equipment- Instruments and Laboratory Equipment

Notice to potential offerors: All offerors who provide goods or services to the United States Federal Government must be registered and have an active registration in the System for Award Management (SAM) at www.sam.gov and complete Online Representations and Certifications Application (ORCA).

All interested Offerors should submit information by e-mail to sheri.eiri@nih.gov

All information submissions shall be received no later than 12:00 pm Eastern Standard Time November 07, 2024.