Requirements Document.pdf

Statement of Work (SOW)

CDER-OTS-25-C-1768:

Purchase of Thermo Fisher reagents and supplies for immunology studies

1. BACKGROUND

The Division of Applied Regulatory Science (DARS) OCP/OTS/CDER Immunology laboratory is testing large molecule drug products to determine if the levels of immunogenicity for these products can be assessed through in vitro assays. These assays require that we use certain equipment (Luminex plate reader) and have supplies to setup the in vitro assays including cell lines and cell culture media and antibodies.

2. OBJECTIVES

This work develops standards and approaches that increase the regulatory efficiency of developing and reviewing safe and effective CDER products. These operational supplies are essential for the continuance of projects supporting BsUFA, GDUFA, and PDUFA research, and for continued preparedness to be able to respond to emergent public health issues when called upon.

3. SCOPE

The immunology laboratory requires a range of routine supplies to maintain operational readiness and conduct scientific experiments to support regulatory research. We perform a range of assays to answer scientific questions associated with the review of drug applications. The supplies listed include reagents for proper operation of the Luminex plate reader, cell culture assays and flow cytometry.

4. REQUIREMENTS

• Reagents should have at least a 6-month shelf life at the time of receipt.

• Items that require special refrigeration needs will be shipped on dry ice.

• It is mandatory that items be shipped on a Monday, Tuesday, or Wednesday for an AM delivery and to prevent delivery on weekends.

• Where possible, multiples of the same reagent/kit must be from the same batch/lot number.

5. DELIVERABLES / SPECIFIC TASKS

The Contractor shall provide the following deliverables on or before August 15, 2025, or within 2 weeks of receiving the purchase order.

List of 12 items included in the IGCE attachment, with catalog price listed.

Description Part/Product # Quantity Unit

Cost Total Cost

Total of items

Various (12 unique items) various various $14,981.02

Est shipping & handling 1 200.00 $200.00

Total: $15,181.02

• All deliverables required under this contract shall be packaged, marked, and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor’s name. The Contractor shall guarantee that all required materials shall be delivered in immediate new, usable and acceptable condition to the address as shown below.

• The items will be delivered to:

US Food and Drug Administration Attn: Kristina Howard 10903 New Hampshire Ave, WO Bldg 64 Rm 2061 Silver Spring MD 20993

Freight should be delivered to WO Bldg 62 Loading Dock, and then to WO64-2061

Deliveries must be coordinated with the Project Officer, Kristina Howard (Kristina.Howard@fda.hhs.gov), prior to shipment. No deliveries will be accepted without prior authorization from the Project Officer.

6. GOVERNMENT FURNISHED EQUIPMENT (GFE)/ GOVERNMENT

FURNISHED INFORMATION (GFI)

• NA

7. PLACE OF PERFORMANCE

FDA White Oak Campus US Food and Drug Administration 10903 New Hampshire Ave, WO Bldg 64 Rm 2037 Silver Spring MD 20993

8. PERIOD OF PERFORMANCE

The order will be completed during the period of July 31, 2025, to August 31, 2025.

9. INSPECTION AND ACCEPTANCE CRITERIA

Properly packed and shipped, received undamaged and viable. Shipments will be inspected by the Project Officer upon arrival at designated facility. Package contents will be compared with the accompanying packing slip and if all items are correct the Project Officer will sign the packing slip and forward it for receiving.

The Government will review all reporting requirement deliverables in accordance with specifications and standards identified in the statement of work or any directives issued by the COR. The contractor shall submit invoices via the Invoice Processing Platform (IPP) for payment. The COR will perform inspection and acceptance of materials provided in accordance with the SOW criteria. The Contractor shall implement necessary changes within 10 business days from the day of change notification.