Cleaning for cGMP facilities from Advanced Cleanroom Microclean (Notice of Intent to sole source)
Closed Pre-Solicitation Posted
- Solicitation number
- NOI-CC-25-008011
- Agency
-
NIH Clinical Center
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 561720 Janitorial Services
- PSC
- Q901 Healthcare Environmental Cleaning
- Place of performance
- Maryland 20814, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health Clinical Center is seeking specialized cleaning services for current Good Manufacturing Practice (cGMP) facilities and compounding pharmacies at their Bethesda, Maryland location. This is a Notice of Intent for sole source procurement with Advanced Cleanroom Microclean, not a request for proposals, as the agency requires urgent and immediate services to maintain continuity for patient safety and regulatory compliance. The contractor must be ISO 9001:2015 certified with extensive cleanroom facility experience and meet all regulatory requirements for cleaning approximately 32,000 square feet of aseptic processing facilities including pharmacy, engineering, nuclear medicine, and research spaces. The procurement is justified under 41 U.S.C. 1901(a)(1) as only one responsible source can satisfy the agency's requirements, though other qualified sources may submit capability statements by 4:00 PM Eastern Time on June 30, 2025. All capability statements must be submitted via email to lu-chang.lu@nih.gov with subject line referencing NOI-CC-25-008011.
This procurement does not utilize any set-aside designations and represents a "bridge" contract to maintain services from the current incumbent, Advanced Microclean, who has been providing cleaning services under contract #75N90020D00016. The company brings 40 years of industry experience in cleanroom facilities and 5 years of specific experience working at NIH, positioning them as the sole qualified source for this specialized requirement. The contract period of performance is approximately two months, spanning from July 2025 to August 2025, serving as a temporary continuation until a new main cleaning services contract can be competed and awarded. The services require seven-day-per-week operations with at least two staff members per facility, day porters in cleanroom attire, and strict adherence to cGMP regulatory standards. While no specific contract value is disclosed, the procurement falls under the Janitorial Services NAICS code 561720 and Healthcare Environmental Cleaning PSC code Q901.
Notice text
Acquisition Description:
This is a Notice of Intent, not a request for proposal. The National Institute of Health, Clinical Center (NIH-CC) intends to negotiate on an other than full and open competition basis with Advanced Cleanroom Microclean.
The National Institute of Health (NIH) requires cleaning services for cGMP manufacturing facilities and compounding pharmacies to continue to protect human safety and human healthcare. Advanced Cleanroom Microclean is ISO 9001:2015 certified with 40 years of industry experience in Cleanroom Facilities and 5 years working at the NIH. They meet all regulatory requirements with their accreditations and meet objectives within the current and proposed SOWs.
This is a sole source “bridge” contract because the services requested are urgent and immediate to provide continuity of service for patient safety and regulatory compliance. The existing contractor Advanced Microclean has been providing cleaning services under an existing contract and they meet all the necessary qualifications and certifications. This current requirement is to temporarily continue services from their previous contract under #75N90020D00016 until the new “main” cleaning services contract can be competed and awarded.
Requirement:
Cleaning services for approximately two months.
Place of Performance or Delivery:
The estimated Period of Performance is: Approximately two months, from July 2025 to August 2025.
Place of Performance: NIH Clinical Center in Bethesda, MD
The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 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-CC-25-008011) by 4:00 PM eastern standard time on 06/30/2025 to: lu-chang.lu@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.
Files
| File | Type | Posted |
|---|---|---|
| 1. New SOW -Statement of Work _PS-Lw_RAE24SEP24.docx | DOCX document |
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