ContractSpecial Notice

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES• NOI-OLAO-26-002531

Response Deadline

Mar 6, 2026

Deadline passed

Days Remaining

Closed

Set-Aside

No Set aside used

Notice Type

Special Notice

Contract Opportunity Analysis

The National Institutes of Health (NIH) intends to negotiate a sole-source contract with Hardy Diagnostics for the procurement of culture media and reagents essential to support the cGMP microbiology testing program for NIH Clinical Center patients. This procurement, valued at approximately $50,000, will cover a six-month supply from April 1, 2026, to September 30, 2026, and is critical for the testing of cell therapy products, which must adhere to stringent cGMP regulations. Hardy Diagnostics is the only vendor qualified to meet these specific requirements due to its successful vendor qualification and consistent adherence to the necessary quality standards, making any change in suppliers impractical due to the extensive revalidation process that would be required. Interested parties may submit capability statements by email to valerie.gregorio@nih.gov by 12:00 PM EST on March 6, 2026, referencing NOI-OLAO-26-002531.

Classification Codes

NAICS Code

339113

Surgical Appliance and Supplies Manufacturing

PSC Code

6505

DRUGS AND BIOLOGICALS

Solicitation Documents

2 Files

SOW Hardy 2026-01-15.docx

Word•27 KB•Mar 2, 2026

AI Summary

The National Institutes of Health (NIH) Clinical Center's Department of Laboratory Medicine (DLM) is requesting to purchase culture media and reagents from Hardy Diagnostics. This procurement, estimated at $50,000, will support cGMP microbiology testing for NIH CC patients from April 1, 2026, to September 30, 2026. Hardy Diagnostics is the sole approved vendor due to its successful vendor qualification and adherence to stringent cGMP requirements, which other vendors have not consistently met. The agreement specifies that orders will be placed on an as-needed basis, ensuring same-lot release per order, the latest out dates for products, and verification with the lab for partial shipments. Only authorized personnel—Anna Lau, Amanda East, and Chung Shin—are permitted to place orders against the NIH-2S account and purchase order.

JUSTIFICATION FOR LIMITED COMPETITION 2026-01-15.docx

Word•25 KB•Mar 2, 2026

AI Summary

The National Institutes of Health (NIH) Clinical Center's Sterility Testing Service in the Department of Laboratory Medicine is seeking a limited competition justification for the sole-source procurement of culture media and supplies from Hardy Diagnostics. This six-month supply is essential for testing cell therapy products, supporting NIH Clinical Center patients. The justification cites FAR 8.405-6(a), stating that Hardy Diagnostics is the only qualified vendor due to the specific and rigorously validated testing required to meet cGMP regulations. Changing suppliers would necessitate extensive revalidation, incurring unacceptable delays and compromising efficiency. Market research confirms Hardy Diagnostics as the sole source capable of meeting the stringent quality and regulatory demands of the cGMP Sterility Testing Service.

Related Contract Opportunities

Project Timeline

postedOriginal Solicitation PostedMar 2, 2026

deadlineResponse DeadlineMar 6, 2026

expiryArchive DateMar 21, 2026

Agency Information

Department

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Sub-Tier

NATIONAL INSTITUTES OF HEALTH

Place of Performance

Bethesda, Maryland, UNITED STATES

Official Sources

View on SAM.gov