The Indian Health Service, Navajo Area, Gallup Service Unit in Gallup, New Mexico intends to negotiate a sole-source award with Cepheid for test kits to perform PCR testing for SARS-Cov-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV) compatible with the Cepheid Infinity Analyzer. Cepheid has confirmed compatibility of supplies with the testing platform and has performed validation studies that conform to CLIA 88 laboratory standards on the same testing platform either directly or with the cooperation of other laboratory partners. In addition, the testing supplies are approved by the FDA or covered under the provisions of an applicable Emergency Use Authorization.

NAICS 334516, Analytical Laboratory Instrument Manufacturing with a small business set aside standard of 1,000 employees applies. In accordance with FAR 13.501(a)(1), acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements in FAR 6. However, sole-source justifications for actions above the simplified acquisition threshold but not exceeding $7.5M (non-urgent and non-compelling as described in FAR 13.500(c)) must use the format at FAR 6.303-2 with proper tailoring. The action is being accomplished using the principles of FAR 12 Acquisition of Commercial Items in conjunction with FAR 13 Simplified Acquisition Procedures - particularly FAR 13.5 in accordance with 41 U.S.C. 1901, "...to promote efficiency and economy in contracting and to avoid unnecessary burdens for agencies and contractors..."purchases not exceeding the simplified acquisition threshold may be solicited from one source if it is determined that the circumstances of the contract deems only one source available.

This notice of intent is not a request for quotations and a solicitation will not be issued in conjunction with the notice of intent. Any vendor that believes it can provide the stated supplies may provide a capability statement. Verbal responses are not acceptable and will not be considered.

Responses to this notice shall be received no later than 10:00 am MDT on February 10, 2023.

A determination by the Government whether to compete this proposed requirement based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competition or proceed with a single-source award.

The point of contact for this action is Misty Billy, Contract Specialist and can be reached at misty.billy@ihs.gov.

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