cGMP Cleaning Supplies from VWR International for ORSC Department (Notice of Intent to sole source)

Closed Pre-Solicitation Posted

Solicitation number
NOI-CC-26-001796
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

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 (NIH-CC) is issuing a Notice of Intent to procure current Good Manufacturing Practice (cGMP) cleaning supplies for its biologics manufacturing and aseptic processing areas located in Building 10 on the Bethesda, Maryland campus. The supplies are essential for maintaining sterile pharmaceutical manufacturing environments and supporting pharmacy departments' compliance with Joint Commission and FDA certifications. Key requirements include the contractor's ability to provide Certificates of Analysis (COA), Certificates of Conformance (COC), packing inserts with each case, and website access for ordering. The government intends to conduct a sole-source negotiation rather than a full and open competition, with evaluation criteria centered on the contractor's ability to meet strict FDA and Joint Commission cGMP standards and deliver supplies within four business days. The pre-solicitation notice was posted on December 28, 2025, with a notice period deadline of January 2, 2026, allowing potential competitors a limited window to submit comments or evidence of why the sole-source justification is inappropriate.

This procurement includes no set-aside designations and identifies VWR International as the intended sole-source contractor, as program management asserts VWR is the only company capable of providing the required certificates, compliance documentation, tracking systems, and website access for this specialized application. The contract is structured as an Indefinite Delivery/Indefinite Quantity (IDIQ) firm fixed-price agreement with a base period running from January 2 through April 30, 2026. Specific cleaning supplies required include bucket liners, sterile wipes, decontamination sprays, and various disinfectant solutions, with precise quantities outlined in the Statement of Work's Technical Exhibit 1. While specific budget or award values are not disclosed in the pre-solicitation notice, the four-month base period contract involves delivery of multiple specialized cleaning products meeting rigorous pharmaceutical manufacturing standards. The procurement falls under NAICS code 325998 (All Other Miscellaneous Chemical Product and Preparation Manufacturing) and PSC code 7930 (Cleaning and Polishing Compounds and Preparations).

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 VWR International.

cGMP Cleaning Supplies from VWR International for ORSC Department

The National Institute of Health (NIH)’s MMESD, Storage & Distribution Section has a requirement for contamination control cleaning supplies for NIH biologics manufacturing sites and aseptic processing areas at the NIH CC (Bldg. 10) on the Bethesda, MD campus.  It is vital that the Contractor provides Certificates for Analysis (COA), Certificates of Conformance and Packing Inserts in each packaged case of supplies. The requirement is to obtain cleaning supplies for the NIH, Clinical Center pharmacy departments. It is critical to adequately clean these rooms with the needed Government approved cleaning supplies to be able to pass the Joint Commission and FDA Certifications for cGMP pharmaceutical development practices.

Justification:

The NIH Clinical Center MMESD, Storage & Distribution Section is the sponsoring institution at the National Institutes of Health responsible for providing medical/surgical and cleaning supplies in support of the GMP. These GMP Cleaning Supplies plays a pivotal role in direct support of GMP and patient care. It is critical to adequately clean the NIH’s laboratory, research, medical etc. rooms with the needed Government approved cleaning supplies to be able to pass the Joint Commission and FDA Certifications for cGMP pharmaceutical development practices. Program Management states VWR International is the only company that can provide the requested Certificate of Acceptance (COA), Certificate of Compliance (COC), Packing Slip and website access. VWR items comply with Joint Commission and FDA Certifications for cGMP, and VWR products have certificates and a unique VWR tracking system that confirms their products are suitable to be used in laboratory clean rooms.

Requirement:

ORSC cGMP Cleaning Supplies.

See Bill of Materials.

Place of Performance or Delivery:

The Period of Performance is: 01/02/2026 –  04/30/2026

Delivery within 30 days.

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-26-001796) by 10:00 AM eastern standard time on 01/02/2026 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.

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