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HEALTH AND HUMAN SERVICES, DEPARTMENT OF | FOOD AND DRUG ADMINISTRATION has floated a tender for Office of Clinical Pharmacology / Division of Applied Regulatory Science (DARS) - Critical DARS Laboratory Supplies.. The project location is USA and the tender is closing on 05 Sep 2025. The tender notice number is , while the TOT Ref Number is 125413895. Bidders can have further information about the Tender and can request the complete Tender document by Registering on the site.
Procurement Summary
Country: USA
Summary: Office of Clinical Pharmacology / Division of Applied Regulatory Science (DARS) - Critical DARS Laboratory Supplies.
Deadline: 05 Sep 2025
Other Information
Notice Type: Tender
TOT Ref.No.: 125413895
Document Ref. No.:
Financier: Self Financed
Purchaser Ownership: Public
Tender Value: Refer Document
Purchaser's Detail
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Login to see detailsTender Details
Description
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...
Active Contract Opportunity
Notice ID :
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : FOOD AND DRUG ADMINISTRATION :
General Information
Contract Opportunity Type: Special Notice (Original)
Original Published Date: Aug 29, 2025 08:13 pm EDT
Original Response Date: Sep 05, 2025 04:00 pm EDT
Inactive Policy: 15 days after response date
Original Inactive Date: Sep 20, 2025
Initiative: None
Classification
Original Set Aside: No Set aside used
Product Service Code: AJ12 - GENERAL SCIENCE AND TECHNOLOGY R&D SERVICES; GENERAL SCIENCE AND TECHNOLOGY; APPLIED RESEARCH
NAICS Code: 541714 - Research and Development in Biotechnology (except Nanobiotechnology)
Place of Performance: Silver Spring, MD USA
Documents
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