Notice of Intent - Biovendor LLC Human MxA Protein ELISA Kits

The Food and Drug Administration (FDA) intends to negotiate on a sole-source basis with Biovendor LLC for 100 Human MxA Protein ELISA kits (96 wells; catalog number RD194349200R) under the authority of 41 U.S.C. 1901. Background Information and Basis for Sole Source The FDA’s Center for Drug Evaluation and Research’s (CDER’s) Office of Translational Sciences (OTS) Office of Clinical Pharmacology’s Division of Applied Regulatory Sciences (DARS) tackles emerging regulatory questions and develops and implements new regulatory review tools and approaches. FDA scientists rapidly form interdisciplinary teams of pharmacologists, biologists, chemists, computational scientists, and clinicians to respond to challenging regulatory questions for specific review issues and for longer-range projects requiring the development of predictive models, tools, and biomarkers to speed the development and regulatory evaluation of safe and effective drugs. To fulfill its mission, DARS has conducted a clinical research project to identify and evaluate the possible biomarkers for interferon treatment. The protein, MxA, is one of the potential biomarkers for interferon treatment. MxA is categorized as one of the pharmacodynamic markers for the clinical research project. Therefore, it is required to measure the MxA protein in human blood to evaluate its relevance. In support of the clinical research project, DARS has validated the MxA assay using Biovendor LLC ELISA kits and ran patient samples from patients in the clinical trial. Later, these kits were used for the method validation as per the FDA bioanalytical method validation guidance. DARS requires 100 Human MxA Protein ELISA to reanalyze a subset of the patient samples. To maintain uniformity and consistency with pre-existing data, it is critical that Biovendor LLC ELISA kits be applied to reanalyze the subset of patient samples. Biovendor LLC has no authorized resellers or distributors capable of providing the required MxA Protein ELISA kits. General The North American Classification System (NAICS) code for this acquisition is 325413 – In-Vitro Diagnostic Substance Manufacturing. The small business size standard is 1,250 employees. No solicitation package will be issued. This notice of intent is not a request for competitive quotations; however, responses received by 1:00 p.m. Eastern Time on July 26, 2021 will be considered by the Government. A determination by the Government not to compete the proposed acquisition based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Interested parties that believe they could satisfy the requirements listed above for FDA may clearly and unambiguously identify their capability in writing on or before the response date for this notice. This notice of intent is not a solicitation. Any questions regarding this notice must be submitted in writing via email to Adam Powell at [email protected]. All responses to this notice of intent must be submitted so that they are received at [email protected] no later than the aforementioned due date.