Pharmacy cGMP Cleaning Supplies from VWR International (Notice of Intent to sole source)

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.

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 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.

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 and the Pharmacy cGMP Cleaning Supplies. - see attached Bill of Materials

Place of Performance or Delivery:

The estimated Period of Performance is:

04/02/2025 – 04/01/2026

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-25-002688) by 10:00 AM eastern standard time on 04/02/2025 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.