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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 Institute of Health, Clinical Center (CC) intends to award a fixed price purchase order to Miltenyi Biotech, Inc, Auburn, CA 95602 on a sole source basis to procure reagents and testing kits necessary for patient testing in the Cell Processing Section (CPS) of the Department of Transfusion Medicine. The CPS is responsible for the manufacture of human cells and tissue-based products utilized in clinical protocols for transplantation, adoptive immunotherapy, and gene therapy.

Miltenyi Biotech is the only known vendor that can supply the proprietary reagents and kits that are Federal Drug Administration (FDA) approved for clinical/human use. The stated reagents and kits are used for the preparation of highly purified but unique immunotherapy products for treatment of critically ill patients enrolled in FDA and Institutional Review Board (IRB) approved protocols. These specialized reagents and kits are the only known products compatible with the existing government owned Miltenyi CliniMACS®Plus cell separation instrument. Any deviation from the protocol must be reported to FDA for non-compliance.

The necessary estimated schedule of supplies is listed below for two months January-March 2023:

130-030-401 304-01 - CliniMACS CD4 MicroBeads - 1 vial 7,5 mL, For research use only, not for use in humans - 2 ea

130-030-801 308-01 - CliniMACS CD8 MicroBeads - 1 vial 7,5 mL. For research use only, not for use in humans - 2 ea

170-076-147 - MACS GMP Recombinant Human IL-2, 1 vial 500 μg - 1ea

130-019-011 - MACS GMP T Cell TransAct, RUO, 1 vial 4 mL 1ea

130-070-525 705-25 - CliniMACS PBS/EDTA Buffer for research use contents: 3 x 1L plastic bags, sterile, non-pyrogenic - 2 ea

130-021-201 212-01 - CliniMACS PBS/EDTA Buffer for Research Use consists of: 2 x 3L plastic bags, sterile, non-pyrogenic, 2 PC.

170-076-306 - TexMACS GMP Medium 1 bag 2000mL, 4 PC.

170-076-111 - MACS GMP Recombinant Human IL-7 1 vial 25 μg, 1 PC.

170-076-114 - MACS GMP Recombinant Human IL-15 1 vial 25 μg, 1 PC.

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 Malinda Dehner, Contract Officer, dehnerm@cc.nih.gov by the due date and time marked in this notice.

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