Environmental Monitoring and ISO 14644 Certification Services for NIH Center for Cellular Engineering (CCE)
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), Clinical Center, intends to award a sole source firm-fixed-price contract to American Certified LLC for Environmental Monitoring and ISO 14644 Certification Services at the Center for Cellular Engineering (CCE) in Bethesda, MD. This notice is for informational purposes only, as a solicitation will not be issued. However, interested parties may submit capability statements.
Scope of Work
The contractor will provide essential environmental monitoring, testing, and certification services to ensure CCE facilities meet ISO 14644 room classification standards and FDA requirements for aseptic processing operations. Key tasks include:
- Sampling air quality for non-viable particulates.
- Performing viable and non-viable air sampling.
- Calculating air changes per hour (ACH).
- Conducting HEPA filter integrity testing.
- Measuring differential pressures between controlled rooms.
- Testing Biological Safety Cabinets (BSCs) per NSF/ANSI 49 standards. These services are critical for patient safety in cell-based therapy manufacturing, ensuring compliance with Current Good Manufacturing Practices (cGMP) and regulatory standards (21 CFR Parts 210, 211, 600, and 1271). Deliverables include comprehensive certification packages and detailed reports.
Contract & Timeline
- Type: Sole Source, Firm-Fixed-Price
- Anticipated Period of Performance: May 25, 2026, to October 25, 2026
- Set-Aside: None (Sole Source)
- Response Due: May 15, 2026, at 4:30 PM EST
- Published: May 5, 2026
Rationale for Sole Source
The NIH intends to award this contract to American Certified LLC based on FAR 13.106-1(b)(1), as they are deemed the only vendor approved and qualified to perform these services without risking regulatory compliance or patient safety. Acquisitions under FAR Part 13 are exempt from FAR Part 6 competition requirements.
Response Information
This is not a request for quotations. However, interested parties may submit a capability statement demonstrating their ability to meet the Government's requirements. Submissions must include:
- Company name and address
- Technical capability
- Proof of OEM authorization
- Relevant past performance The Government will evaluate statements, but the determination not to compete remains at its discretion.
Contact
Shasheshe Goolsby, Team Leader, Hospital and Laboratory Support Division, NIH. Email: shasheshe.goolsby@nih.gov