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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.

POTS: 23-006238

The information gained from this market research will help the National Institutes (NIH), Center for 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.

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The National Institutes of Health, Clinical Center, Center for Cellular Engineering Department has a requirement for a contractor to furnish two (2) Sysmex XN1000-010-BPR (XN-20) Hematology Analyzers with Wagons.

Supplies:

Item: 0001

Quantity 2 - Sysmex XN1000-010-BPR (XN-20) Hematology Analyzers with Wagons.

The Center for Cellular Engineering manufactures cell-based therapies for patients who have either no, or have exhausted all other standard treatment options. The manufacturing operations are regulated by the Current Good Manufacturing Practices (CGMPs) as mandated by the Food and Drug Administration (FDA) in 21 CFR 210, 211, 600 and 1271. The Center for Cellular Engineering requires two (2) Sysmex XN1000-010-BPR (XN-20) Hematology Analyzers. This equipment is used to quantify cell number. The FDA requires cell numbers to be quantified in order to calculate the appropriate dosage of cell therapies. Inaccurate quantitation of cell therapy doses has the potential to expose patients to an inadequate cell therapy if the dose is too low, or to the risk of side effects such as cytokine storm if the dose is too high. The Sysmex XN1000-010-BPR (XN-20) Hematology Analyzer device is widely used in the cell therapy and is provided with an appropriate IQ/OQ/PQ package by the vendor, which meets the expectation of the FDA.

FOB Destination

Delivery Location:

National Institutes of Health

Center for Cellular Engineering Department

10 Center Drive

Building 10, Room TBD

Bethesda, MD 20892

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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 334516- Analytical Laboratory Instrument Manufacturing (Small Business Average Number of Employees 1,000).

PSC: 6640- Laboratory Equipment and Supplies.

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 at sheri.eiri@nih.gov

All information submissions shall be received no later than 12:00 pm Eastern Standard Time April 25, 2023.

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