Intent to Sole Source - Pharmacy cGMP Cleaning Supplies

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 the following vendor: VWR International. NATURE AND/OR DESCRIPTION OF THE ACQUISITION BEING APPROVED: This action will be awarded as a new sole source contract in accordance with Federal Acquisition Regulation (FAR) 6.302-1. The Government intends to make a one-time purchase of Good Manufacturing Practices (GMP) Cleaning Supplies with VWR International 1310 Goshen Parkway Westchester, PA 19380 DESCRIPTION OF THE SUPPLIES AND SERVICES REQUIRED, INCLUDING THE DELIVERY SCHEDULE AND/OR THE PERIOD OF PERFORMANCE AND DOLLAR VALUE OF THE ACQUISITON: The 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 cGMP Clean Rooms for delivery to Building 10, Room B2C-123 Bethesda, Maryland. 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. We specifically need cleaning supplies from VWR because 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. The statutory authority for this sole source requirement is 41 U.S.C. 253(c) (1) as implemented by FAR 6.302-1 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-26-002675) by 12:00 PM eastern standard time on 02/26/2026 to: valerie.gregorio@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.