Intent to Sole Source - BD Bioscience Reagents

Form / Attachment / Pricing Sheet

This document is an Excel spreadsheet containing detailed pricing information for antibodies, reagents, kits, consumables, and parts. It appears to be a comprehensive list of potential items and their associated costs, likely intended for a multi-year procurement plan (5-year estimate provided).

• Sheets: The document contains several sheets: 'QC', 'PD', 'Ping additional', 'Rgt & kit_Rhapsody', 'Consumable-Parts', and '5 year_2026-2030 final'.
• Item Details: Each sheet lists specific items with descriptions, catalog numbers, estimated quantities, unit prices, and total prices.
• Pricing Projections: The '5 year_2026-2030 final' sheet provides a detailed 5-year cost projection for antibodies, consumables, and reagents/kits, including annual price increases.
• Cost Summaries: Totals are provided for individual sheets and for the 5-year plan by material category.

This document is crucial for bidders as it outlines the specific products and estimated quantities the government is considering for purchase over a five-year period. It provides detailed pricing, including projected annual increases, which is essential for developing accurate and competitive proposals. Bidders can use this information to understand the potential scope and value of the opportunity and to prepare their own pricing structures.

Statement of Work (SOW)

To provide the Product Assurance and Characterization Testing (PACT) Section of the Center for Cellular Engineering (CCE)/Department of Transfusion Medicine/NIH CC with monoclonal antibodies, disposables, and buffers for performing in-process and lot-release flow cytometry assays for products manufactured at CCE and administered to patients at the Clinical Center.

• Supply sufficient specific reagents and supplies to process approximately 100 flow cytometry assays per year using FACSLyris from BD Bioscience for Immunophenotyping and lot-release assays.
• Antibodies, reagents, and consumables may include, but are not limited to, a comprehensive list provided in the document (e.g., various BD™ antibodies, buffers, control beads, and consumables).
• Provide technical support for all reagents and supplies at no additional cost.

Anticipated: 02/01/2026 to 09/30/2030 (12-month base period and three 12-month option periods).

• Minimum shelf life for unopened reagents: 90 days from date of delivery.
• Minimum shelf life for disposables: 6 months from date of delivery.
• Reagents and disposables to be shipped overnight, Monday through Thursday.
• Contractor bears the cost of replacement for damaged or defective items.
• Total estimated cost for a 5-year contract: $1,776,695.83.

Other / Unclassified

This document is a Justification for Other Than Full and Open Competition (JOFOC) for the procurement of reagents and consumables for flow cytometry assays. The National Institutes of Health (NIH), specifically the Clinical Center's Department of Transfusion Medicine/Center for Clinical Engineering (CCE), requires these supplies for patient-care quality control using BD Bioscience's FACSLyris flow cytometer instrument.

This justification indicates a sole-source acquisition. The NIH intends to procure monoclonal antibodies, assay quality controls, buffers, sheath fluids, and disposable components exclusively from BD Biosciences. The rationale is that these specific BD Biosciences reagents are proprietary, validated under FDA guidelines, and essential for the CCE's existing, FDA-approved protocols. Substituting reagents would require extensive re-validation, posing significant risks to patient care, clinical trials, and introducing substantial delays and costs. The estimated value of this requirement is $1,776,695.83, with a contract type of Firm-fixed-price.

• Agency: HHS, National Institutes of Health (NIH)
• Sponsoring Organization: Clinical Center/Department of Transfusion Medicine/Center for Clinical Engineering (CCE)
• Product: Reagents and consumables for FACSLyris flow cytometry (monoclonal antibodies, controls, buffers, fluids, disposables)
• Purpose: Clinical patient-care quality control flow cytometry assays
• Contracting Authority: 10 U.S.C. 2304(c)(2) and 41 U.S.C. 253(c)(2) (FAR 6.302-1: Only one responsible source)
• Sole Source Vendor: BD Biosciences
• Estimated Value: $1,776,695.83
• Contract Type: Firm-fixed-price