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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 Institutes of Health (NIH) intends to award a fixed price contract to iPharmaSupports, on a sole source basis to provide F-DOPA (GMP europe) kit at the NIH Clinical Center (CC).

The CC/PET seeks to obtain Chemical Kits for the synthesis of F-18 FDOPA that will be used for PET human imaging scans under IND #35513. The chemical kits must be compatible with the Trasis All in One synthesis box that is used to prepare F-18 FDOPA via no-carrier-added nucleophile radiofluorination. IPharmaSupports is the sole North American supplier of the chemical kits (Part # S4000-7585). The FDOPA chemical kits are listed in the F-18 FDOPA IND and CC/PET must utilize such kits to be compliant with FDA current good manufacturing regulations. As such, no other vendor is capable of providing the Government with chemical kits.

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 Noelle DeCenzo, Contract Specialist, noelle.decenzo@nih.gov by the due date and time marked in this notice.

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