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Notice of Intent to Sole Source – Advanced Cleanroom Microclean

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NOI-CC-26-001957Federal

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The National Institutes of Health Clinical Center intends to award a sole source bridge contract to Advanced Cleanroom Microclean for essential cleaning services at cGMP manufacturing facilities and compounding pharmacies in Bethesda, Maryland. This firm-fixed-price action, identified as NOI-CC-26-001957, is justified under FAR 6.302-2 and FAR Part 13 due to the urgent need for continuity of service to ensure patient safety and regulatory compliance. The contract is estimated at 249,000 dollars and covers a temporary performance period from December 30, 2025, to February 28, 2026, serving as a transition until a new competitive contract is awarded. Advanced Cleanroom Microclean was selected based on their ISO 9001:2015 certification, 40 years of industry experience, and a five-year track record of performance at NIH facilities. The scope of work requires strict adherence to current Good Manufacturing Practices and other regulatory standards to maintain sterile environments. The project is overseen by Project Officer Rachel Evans, with Ryssa Nix serving as the primary contract specialist. No options for extension are included in this temporary agreement.

General Info

Sole source bridge contract for cleaning services at NIH cGMP facilities in Maryland.

NAICS

561720 - Janitorial Services

Place of Performance

Bethesda, MD, 20892, USA

Set-Aside

NONE

Documents

2
PDF, High priority: read this firstjustification-and-authorization
High
DOCX, Low priority1 page · notice-of-intent
Low

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Timeline

Posted

special-notice

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health - Cc
Contacts1 person available
OfficeBETHESDA, MD, 20892, USA
Office AddressBETHESDA, MD, 20892, USA
Contacts
Chris Ryssa Nix

Full Description

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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 for ~2 months until the new “main” cleaning services contract can be awarded.

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The National Institutes of Health Clinical Center is issuing a Notice of Intent to Sole Source a preventative maintenance service contract for the PEAK Genius XE SCI gas generator. This acquisition is conducted under FAR Part 13 Simplified Acquisition Procedures, specifically 13.106-1(b)(1), as Peak Scientific Inc. is the sole manufacturer and authorized provider of proprietary parts, diagnostic tools, and certified technicians for this equipment in the United States. The contract consists of a one-year base period with three optional one-year extensions, for a total potential performance period of four years. All services will be performed on-site at the NIH Clinical Center in Bethesda, Maryland. The procurement utilizes the Complete Service Plan 48 (SL3), an all-inclusive package that eliminates unexpected costs by covering all labor, travel, and parts. Key deliverables include one to two annual on-site preventative maintenance visits featuring full system checks, component retrofits, and software upgrades. The plan provides 100 percent coverage for breakdowns, including internal compressor repair or replacement and a guaranteed on-site response time of 48 hours within the mainland USA. Additionally, the contract includes online technical support and adherence to Peak Scientific's warranty statements and terms and conditions.
Analytical Laboratory Instrument Manufacturing

POSTED

10 months ago

DEADLINE

N/A
View Details

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