The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking to negotiate a sole source contract with Advanced Cleanroom Microclean for cleaning services at its Clinical Center in Bethesda, Maryland. The requirement is for cleaning services to maintain compliance with Good Manufacturing Practice (cGMP) regulations, ensuring a sterile environment crucial for patient safety and healthcare during clinical research. This contract serves as a temporary "bridge" to provide continuity of service while a new main cleaning services contract is being finalized, with an estimated performance period of approximately two months from July to August 2025. Interested parties may submit capability statements by June 30, 2025, to Lu Chang at lu-chang.lu@nih.gov for consideration.

1.+New+SOW+-Statement+of+Work+_PS-Lw_RAE24SEP24.docx

The National Institutes of Health (NIH) Clinical Center is issuing a request for proposals (RFP) for a contamination control and cleaning services project to maintain a sterile environment for clinical research. The project focuses on the Cleaning and Disinfection Program to ensure adherence to Good Manufacturing Practice (cGMP) regulations and to protect patient safety when conducting specialized medical research. The selected vendor must demonstrate substantial experience in the pharmaceutical industry and provide a detailed cleaning program to manage classified aseptic processing facilities.

The contract encompasses various responsibilities, including staffing, adherence to Standard Operating Procedures (SOPs), and managing cleaning supplies. Contractors must maintain a qualified workforce that meets NIH’s strict training and background standards, including continuous quality assurance and adherence to cleaning schedules. The contractor is held financially accountable for damages due to negligence and must prepare for potential ad hoc cleaning requests. Deliverables include monthly cleaning schedules, key performance indicators (KPIs), and compliance documentation.

Overall, this RFP outlines the NIH's commitment to maintaining high sterilization standards while seeking experienced contractors capable of ensuring a clean and safe research environment.

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.

Buyer

NAICS

PSC

Set Aside

Original Source