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Title: Notice of Intent for Preventive Maintenance and Service Agreement with Miltenyi Biotech, Inc.

• Product Service Code: J066


• NAICS Code: 811210- Electronic and Precision Equipment Repair and Maintenance


• Place of Performance: Bethesda, MD 20892

POTS: 23-008151

Description

This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested.

The National Institutes of Health (NIH) intends to award a fixed price contract to Miltenyi Biotec located in Gaithersburg, Maryland 20878 on a sole source basis to provide a one-year service agreement plus two (2) option years for the CliniMACS Prodigy Serial Number 917006 located in the Center for Cellular Engineering Facilities.

Anticipated Period of Performance

Base Year: 09/01/2023-08/31/2024

Option Year One (1): 09/01/2024-08/31/2025

Option Year Two (2): 09/01/2025-08/31/2026

Place of Performance:

National Institutes of Health

Building 10 / Room TBD

10 Center Drive

Bethesda, MD 20892

The purpose of this requirement is to acquire a service agreement needed for the CliniMACS Prodigy System. The Center for Cellular Engineering manufactures cell-based therapies for patient who either have 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 FDA in 21 CFR 210, 211, 600 and 1271. The Food and Drug Administration (FDA) mandates that critical equipment used in the manufacturing, processing and testing of drug product must maintained in a controlled manner under a preventative maintenance program (21 CFR 211.63, 21 CFR 211.67). In addition, it is imperative to maintain consistency for the outcome of the research. The ClinMACS Prodigy is Miltenyi Biotec proprietary in nature and require software patches and specialized parts. Miltenyi Biotec is the only contractor capable of providing authorized and trained service technicians with the knowledge and expertise to perform these services. Any failures due to service errors could negatively impact on patient care. The failure of the system being operational could result in the loss of extensive research efforts, and the current and future needs of NINDS investigators. A preventative maintenance agreement is required to maintain and ensure the equipment is fully operational. Use of a third-party service provider or unauthorized parts, maintenance, or repairs, may invalidate the warranty or any existing service agreement.

This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

Interested parties may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government.

Comments to this announcement, referencing this posting number, may be submitted to the CC, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Sheri Eiri Contract Specialist, sheri.eiri@mail.nih.gov by the due date and time marked in this notice.

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