Draft Statement of Work-CDER-2025-128753.docx
DOCX document 2 MB Posted
- Solicitation number
- CDER-OTS-25-C-1691
About this file
This is a Draft Statement of Work (SOW) for the FDA's Center for Drug Evaluation and Research (CDER), specifically for the Division of Applied Regulatory Science (DARS) Bioanalytical Laboratory. The contract (CDER-OTS-25-C-1691) seeks to purchase 34 High-Pressure Liquid Chromatography (HPLC) columns from Phenomenex, including specific variants such as Kinetex 2.6 m XB-C18, EVO C18, Biphenyl, C8, and HILIC columns, each with 50 x 2.1 mm dimensions. The procurement supports mission-critical research for FDA, focusing on bioanalytical work including pharmacokinetics, toxicokinetics, bioequivalence, and emerging public health issues like opioid drug interactions and complex in vitro model evaluations.
The SOW emphasizes the critical nature of these supplies for DARS's six laboratories, which develop regulatory tools and standards for reviewing safe and effective drug products. The contractor must deliver the HPLC columns in new, usable condition, packaged according to government specifications and marked with the contract number. Delivery and acceptance will be managed by the Contracting Officer's Representative (COR), with the contractor required to implement any necessary changes within 10 business days of notification. The solicitation is currently in a pre-solicitation phase, inviting interested vendors to submit capability statements and vendor feedback forms.
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STATEMENT OF WORK
CDER-OTS-25-C-1691: Purchase of High-Pressure Liquid Chromatography (HPLC) columns and supplies for OCP/DARS Bioanalytical Laboratory Background DARS operates 6 total labs that provides mission- critical research supporting review questions, translational science, and emerging public health issues for CDER and FDA. We develop and evaluate novel tools, 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 these projects across all lab groups, and for continued preparedness to be able to respond to emergent public health issues when called upon.
The DARS bioanalytical group serves as a core lab group within the Division to support mission- critical research supporting review questions, translational science, and emerging public health issues for CDER and FDA. Bioanalysis is the quantitative measurement of both small molecule drugs and large biomolecules in biological systems for the purpose of pharmacokinetics, toxicokinetics, bioequivalence, and/or pharmacodynamics studies. The Division of Applied Regulatory Science (DARS) executes a variety of internal and external studies including clinical and nonclinical pharmacokinetic-pharmacodynamic modeling, bioequivalence, drug metabolism and transport, in-vivo/in-vitro correlations, and drug-drug interaction studies bioanalytical analyses at both the clinical and pre-clinical levels. Often these projects are of high-visibility, and mission critical (Opioids drug interaction, In-vivo conversion of ranitidine to carcinogen, sunscreens dermal absorption, cannabinoids, etc.) for the FDA leading to stringent deadlines and necessity for high quality data. We are also seeing an increased workload of internal in vitro projects aimed at evaluating complex in vitro model systems as appropriate tools for regulatory submissions. We are also providing bioanalytical support for a cross-center collaboration between CDER and CTP. This work requires highly specialized supplies.
OBJECTIVES
The objective of the contract is to obtain critical supplies of required for the bioanalytical lab to continue supporting mission- critical research focused on review questions, translational science, and emerging public health issues for CDER and FDA.
SCOPE
FDA is seeking to purchase the supplies necessary for the operation of the DARS bioanalytical lab.
REQUIREMENTS
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.
DELIVERABLES / SPECIFIC TASKS
· The Contractor shall provide the following deliverables:
| Description |
| Part/Product # |
| Quantity |
| Kinetex 2.6 µm XB-C18 100 Å, LC Column 50 x 2.1 mm |
| 00B-4496-AN |
| 10 |
| Kinetex 2.6 µm EVO C18 100 Å, LC Column 50 x 2.1 mm |
| 00B-4725-AN |
| 6 |
| Kinetex 2.6 µm Biphenyl 100 Å, LC Column 50 x 2.1 mm |
| 00B-4622-AN |
| 6 |
| Kinetex 2.6 µm C8 100 Å, LC Column 50 x 2.1 mm |
| 00B-4497-AN |
| 6 |
| Kinetex 2.6 µm HILIC 100 Å, LC Column 50 x 2.1 mm |
| 00B-4461-AN |
| 6 |
· 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.
Government Furnished Equipment (GFE)/ Government Furnished Information (GFI)
· NA
Inspection and Acceptance Criteria 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 the reporting Requirements/Deliverables to the COR in accordance with the delivery schedule. The COR will perform inspection and acceptance of materials and services provided in accordance with the criteria stated in Attachment 2, Quality Assurance Surveillance Plan, and established in the detailed requirements specifications. The Contractor shall implement necessary changes within 10 business days from the day of change notification.
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