Office of Clinical Pharmacology / Division of Applied Regulatory Science (DARS) – Critical DARS Laboratory Supplies.

NOTICE OF INTENT TO SOLE SOURCE

In support of Project No: CDER-OTS-25-C-1691

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services, Facilities Support Branch intends to award a firm fixed price purchase order to Phenomenex Inc., 411 Madrid Avenue, Torrence, CA 90501 for the purchase of Phenomenex High Pressure Liquid Chromatography (HPLC) columns and consumables for the Office of Clinical Pharmacology / Division of Applied Regulatory Science (DARS) – Critical DARS Laboratory Supplies. DARS operates 6 total labs that provides mission- critical research supporting review questions, translational science, and emerging public health issues for the Center of Drug Evaluation and Research (CDER) and FDA. The division develops and evaluates 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 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. The group has also seen an increased workload of internal in vitro projects aimed at evaluating complex in vitro model systems as appropriate tools for regulatory submissions.

The current need is for the purchase of Phenomenex (High Pressure Liquid Chromatography) HPLC columns and consumables, as they will be used in bioanalysis of clinical samples.  In particular, the Bioanalytical group is actively working on projects that with validated methods that require Phenomenex HPLC columns. Methods would need to be re-developed and re-validated if columns from a different vendor were used due to the proprietary and unique nature of these specific column chemistries.

Consequently, this procurement is being conducted in accordance with FAR subpart 13.106-1(b)(1)(i) which allows for the Contracting Officer to solicit one source if only one source is reasonably available. The North American Industry Classification System Code (NAICS) is 541714 - Research and Development in Biotechnology (except Nanobiotechnology). The Product Service Code (PSC) is AJ12 General Science and Technology R&D Services; General science and technology; Applied Research.

This notice is being distributed through the System for Awards Management website (www.SAM.gov). As Phenomenex. is the only source that can meet the Government’s need at this time, this notice is not a request for competitive quotes. However, if any interested parties, especially a small business believes it can meet the Government’s needs, it may identify their interests and/or capability in relation to this procurement to the Contracting Officer, Brandon Rafus, at brandon.rafus@fda.hhs.gov no later than 4:00 PM EST on September 5, 2025.

The primary objective of this Notice of Intent is to inform potential contractors of the government's intent to proceed with a sole source procurement while providing an opportunity for other parties to demonstrate comparable capabilities. Although this is not a competitive solicitation and no formal solicitation document exists, interested parties may submit capability statements demonstrating their ability by the September 5, 2025 deadline. All capability statements must be submitted electronically via email to brandon.rafus@fda.hhs.gov in Microsoft Office Word, Excel, or Adobe PDF format. The government will consider all capability statements received by the closing date, though the final determination whether to compete the requirement remains at the government's sole discretion. This notice represents a standard pre-award transparency measure that allows the marketplace to respond before a sole source award is finalized.

.All responses must include the following business information:

1. Unique Entity Identification (UEI) Number
2. Company Name, address, primary point of contact and their email and phone number
3. Type of company as validated in SAM.gov. All interested parties must be registered in SAM.gov to receive consideration of government contracts.
4. Technical capability to meet the requirement need as detailed in the attached Statement of Work (SOW).