Intent to Sole Source - Media and Supplies needed to support the NIH cGMP program

This is a Notice of Intent, not a request for proposal. The National Institute of Health intends to negotiate on an other than full and open competition basis with the following vendor: Hardy Diagnostics.

Acquistion Background: Approval of a purchase order for 6 month’s supply of culture media and reagents needed to provide testing to support NIH Clinical Center patients. Due to the specificity and rigorous validation testing performed in lab that is required to meet cGMP regulations, Hardy Diagnostics is the only qualified vendor that can meet the needs of the testing that we conduct in the Sterility Testing Service DLM, CC, NIH. The statutory authority for this sole source requirement is 41 U.S.C.

253(c) (1) as implemented by FAR 6.302-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide the required may submit a capability statement that will be considered by email (subject line to reference NOI-OLAO-26-002531) by 12:00 PM eastern standard time on 03/06/2026 to:

valerie.gregorio@nih.gov. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.