Fisher Scientific Reagents and Consumable Materials for Cell Therapy Manufacturing
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The National Institutes of Health Clinical Center plans to award a sole-source firm-fixed-price purchase order to Fisher Scientific for validated reagents and consumable materials essential to the manufacturing of FDA-regulated cell-based therapies used in NIH clinical trials. These materials have been rigorously validated and approved by the Center for Cellular Engineering’s Quality Assurance Department to ensure consistent quality, safety, and efficacy in producing cell therapies for patient care. Any substitution of these materials would necessitate extensive and costly revalidation of manufacturing processes, leading to significant delays and potential risks to ongoing clinical trials, making Fisher Scientific the only viable supplier capable of providing the required validated products and supporting documentation compliant with federal regulatory standards. The acquisition is authorized under FAR 13.106-1(b)(1)(i), which allows for single-source procurement when only one provider can meet the government’s specific requirements, and the value does not exceed the simplified acquisition threshold. The product service code is 6550, and the NAICS code is 325413, classifying the items as in-vitro diagnostic substances. Performance will occur at the NIH Clinical Center in Bethesda, Maryland. While this notice does not solicit bids or proposals, responsible parties may submit capability statements by August 13, 2026, at 6:00 p.m. Eastern Time, referencing POTS 26-008155, though the government retains full discretion to proceed without competition. All inquiries should be directed to Shasheshe Goolsby of the Hospital and Laboratory Support Division.
General Info
Agency
NAICS
Place of Performance
Bethesda, MD, 20892, USASet-Aside
Documents
(0)AI Contract Breakdown
Uniform Contract FormatNo contract breakdown available.
Cannot generate Contract Breakdown because no documents were found from this contract's source.
Timeline
Response Deadline
Organization & Contact Information
Full Description
NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT
Title: Fisher Scientific Reagents and Consumable Materials for Cell Therapy Manufacturing
Notice ID (POTS): 26-008155
Product Service Code (PSC): 6550 – In Vitro Diagnostic Substances, Reagents, Test Kits, and Sets
NAICS Code: 325413 – In-Vitro Diagnostic Substance Manufacturing
Place of Performance: National Institutes of Health
Clinical Center
Bethesda, MD 20892
Notice
The National Institutes of Health (NIH) Clinical Center intends to award a sole-source firm-fixed-price purchase order to Fisher Scientific for validated reagents and consumable materials required by the Center for Cellular Engineering (CCE) to manufacture FDA-regulated cell-based therapies for use in NIH clinical trials.
Requirement
The Center for Cellular Engineering (CCE) uses these reagents and consumable materials in the manufacture of FDA-regulated cell-based therapies for patients enrolled in clinical trials at the NIH Clinical Center. All materials have been validated for use in CCE manufacturing processes to ensure they consistently meet the quality standards required to produce safe and effective cell therapy products. Additionally, each material has been reviewed and approved by the CCE Quality Assurance Department, and substitution with alternative products would require extensive revalidation of manufacturing processes, resulting in increased costs, schedule delays, and potential impacts to patient care.
Sole-Source Rationale
The required reagents and consumables have been validated and approved for use in CCE manufacturing processes. Substituting alternate materials would require extensive requalification, increase costs, delay production, and negatively affect patient care. Fisher Scientific is the only vendor capable of providing the required validated materials and supporting documentation necessary for FDA-regulated manufacturing.
Authority
The intended sole-source acquisition is authorized under Federal Acquisition Regulation (FAR) 13.106-1(b)(1)(i), which permits solicitation from a single source when the Contracting Officer determines that only one source is reasonably available for an acquisition not exceeding the Simplified Acquisition Threshold.
Capability Statements
This notice is not a request for quotations or proposals. However, responsible sources that believe they can satisfy the Government's requirement may submit a written capability statement. The Government will evaluate all capability statements received; however, the determination not to compete this requirement remains solely within the Government's discretion.
Submission Instructions
Capability statements shall reference POTS 26-008155 and must be submitted electronically no later than August 13, 2026, at 6:00 P.M. Eastern Time (ET).
Point of Contact
Shasheshe Goolsby
Team Leader
Hospital and Laboratory Support Division
Office of Acquisitions and Logistics Management
National Institutes of Health
Email: shasheshe.goolsby@nih.gov
Similar Contracts
Same NAICS industry code
More opportunities from Department Of Health And Human Services → National Institutes Of Health Olao
Same awarding agency