Intent to Sole Source - Media and Supplies needed to support the NIH cGMP program
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The National Institutes of Health (NIH), specifically the Sterility Testing Service of the Clinical Center's Department of Laboratory Medicine, has issued a Notice of Intent (NOI) to award a sole-source contract to Hardy Diagnostics. This contract is for the provision of culture media and reagents required to support the NIH cGMP microbiology testing program for NIH Clinical Center patients. This is not a Request for Proposal.
Purpose & Justification
The primary purpose is to secure a 6-month supply of specialized media and reagents essential for cGMP-compliant sterility testing. The justification for sole-sourcing to Hardy Diagnostics is based on FAR 6.302-1 (Only one responsible source). Hardy Diagnostics is identified as the only qualified vendor capable of meeting the stringent cGMP regulations and rigorous validation requirements necessary for clinical testing. Extensive market research confirmed no other source can provide materials at the required quality level without significant, costly re-validation.
Scope of Work
The requirement involves the procurement of specific culture media and quality control organisms from Hardy Diagnostics. These supplies will be ordered on an as-needed basis by the laboratory between April 1, 2026, and September 30, 2026. Key specifications include same lot release per order, latest out-date for all supplies, and vendor communication for partial shipments.
Contract Details
- Opportunity Type: Special Notice (Notice of Intent to Sole Source)
- Agency: Health And Human Services / National Institutes of Health
- Product Service Code: 6505 (Drugs And Biologicals)
- Intended Vendor: Hardy Diagnostics
- Period of Performance: April 1, 2026 – September 30, 2026
- Estimated Value: Approximately $50,000 (including shipping and handling)
- Set-Aside: None (Sole Source)
- Place of Performance: Bethesda, MD
Response & Deadline
Responsible sources who believe they can provide the required media and reagents may submit a capability statement. Submissions must be sent via email to valerie.gregorio@nih.gov with the subject line "NOI-OLAO-26-002531" by 12:00 PM Eastern Standard Time on March 6, 2026. The Government retains sole discretion in determining whether to compete this requirement based on responses.