Notice of Intent to Sole Source; Monument Medical

The purpose of this acquisition is to purchase compounded INTRAVENOUS (IV) Narcotics for patient Care at the National Institutes of Health (NIH) Clinical Center (CC). • Product Service Code: 6515 – Medical Instruments, Equipment, and Supplies • NAICS Code: 325412 - Pharmaceutical Preparation Manufacturing • Place of Performance:

Bethesda, MD 20892 USA POTS:

25-000116 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 firm fixed price purchase order to QuVA Pharma, Inc., located at 3 Sugar Creek Center Blvd, Ste 250, Sugar Land, TX 77478, on a sole source award basis to provide Intravenous Narcotics to the National Institutes of Health.

Below is a description of the item(s): Sterile compounded products that meet the quality expectations to provide to National Institutes of Health Clinical Center (NIH CC) patients on an ongoing basis. The manufacturer (QUVA PHARMA, INC) has not designated other distributors of IV narcotics in the U.S. Market research has been conducted with only two responses, from QUVA, the known COMPOUNDER and distributor for these IV narcotics.

Through trade shows, continuous learning seminars and trade journals, the CC Pharmacy Department stays abreast of the industry and is current on the availability of singular distribution outlets for these medications.

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 NIH, Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, to the attention of Kristin Nagashima, Contract Specialist via email to Kristin.nagashima@nih.gov by November 15th, 2024 at 10am EST.