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Guidance Issuing OfficeCenter for Veterinary Medicine
Section 512(b) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. §360b) establishes the requirements for a new animal drug approval. FDA regulations specify the information you (the sponsor) must submit as part of your new animal drug application (NADA) and the proper format for the NADA submission. 21 CFR 514.1. As part of your NADA submission, you must describe analytical procedures capable of determining the active component(s) of the new animal drug within a reasonable degree of accuracy and of assuring the identity of such components. 21 CFR 514.1(b)(5)(vii). This includes a description of practicable methods of analysis (assay methods) that have adequate sensitivity to determine the amount of the new animal drug in the final dosage form. 21 CFR 514.1(b)(5)(vii)(a). In the case of a Type A medicated article, the Type C medicated feed is a final dosage form used to treat the animal. Thus, as part of the NADA review process, FDA looks at assay methods for determining the amount of a new animal drug in Type C medicated feed.
This guidance provides recommendations for protocols for conducting the transfer study of a single-laboratory validated Type C medicated feed assay method to laboratories that have no experience with the test method. Many testing laboratories, including state feed laboratories and contract laboratories, use Type C medicated feed assay methods to determine whether the drug in a medicated feed is within the assay limits. The term “assay limits” refers to the amount of the drug detected when a Type B/C feed is assayed. The limit is a range that is published at 21 CFR 558.4(d). When feed assay values fall within this range, it indicates that the feed has been prepared with the correct amount of Type A medicated article. Because many different laboratories use medicated feed assays, it is important that the assay methods are reproducible. Sponsors should conduct method transfer studies to evaluate reproducibility. A method transfer study is part of the evaluation process for a Type C medicated feed assay method and demonstrates the transferability of the feed assay method among different laboratories by comparing the results each laboratory obtains when using the method to analyze a specific set of feed samples. Sponsors may expand the method transfer study to include other medicated feed products, such as Top Dress Type C, Free-Choice Type C, and Type B medicated feeds.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2006-D-0230.