Laboratory Cultures and Organism Supplies

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 Firm-Fixed price purchase order to Hardy Diagnostics, Santa Mariam, CA 93455 on a sole source basis to procure culture media and organism supplies to be utilized for the cGMP Sterility Testing Service.

Hardy Diagnostics is the only known vendor that can provide cGMP quality material that has been rigorously validated by the Sterility Testing Service to meet cGMP regulations enforced by the FDA. The culture media and organism supplies approved for testing that must remain standardized and supplied from the same manufacturer to comply cGMP regulations and laboratory validated Individualized Quality Control Plans (IQCP).

The stated culture media and organism supplies are used for the isolation and identification of pathogens (bacteria, yeasts, and molds) that cause infection in NIH patients for the treatment of critically ill patients enrolled in the CLIA regulated and laboratory validated Individualized Quality Control Plans (IQCP) approved protocols. Any deviation from the protocol must be reported to the FDA for non-compliance.

The estimated product list and quantity is attached to this notice and titled – List of Supplies - 24-003476. The exact quantity of products cannot be estimated at the time of award. The government reserves the right to increase quantities pursuant to FAR 52.217-6. The six (6) months purchase order shall not exceed the simplified acquisition threshold. This acquisition is being conducted under the authority of the FAR Subpart 13.106-1(b)(i) allowing the Contracting Officer (CO) to solicit from one source.

Interested concerns capable of providing the same or similar products or services as described in this notice may submit a capability statement outlining their capabilities. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A determination to compete this proposed contract based on 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 competitive procurement. Each response should include the following Business Information:

a. DUNS.

b. Company Name, address, POC, Phone and Email address c. Current GSA Schedules or NAICS codes appropriate to this Award. d. Type of Company (i.e., small business, 8(a), woman owned, HubZone, veteran owned, etc.) as validated in System For Award Management (SAM). All offerors must register on the SAM located at http://www.sam.gov/portal/SAM/#1 e. Capability Statement Comments to this announcement may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Kimala Winfield, kimala.winfield@nih.gov or Malinda Dehner, dehnerm@cc.nih.gov by the due date and time marked in this notice.