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CVM Guidance for Industry 257 VICH GL57 #257 Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species Guidance for Industry VICH GL57 Submit comments on this guidance at any time. Submit electronic comments to https://www.regulations.gov/. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2016-D-4461. For further information regarding this document, contact [email protected]. Additional copies of this guidance document may be requested from the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, and may be viewed on the Internet at either https://www.fda.gov/AnimalVeterinary/default.htm or https://www.regulations.gov/. U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine August 2019 Contains Nonbinding Recommendations VICH GL 57 (MRK) –RESIDUES IN FISH For implementation at Step 7 Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species Adopted at Step 7 of the VICH Process by the VICH Steering Committee in March 2019 for implementation by February 2020 This Guidance has been developed by the appropriate VICH Expert Working Group and is subject to consultation by the parties, in accordance with the VICH Process. At Step 7 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and USA. 2 Contains Nonbinding Recommendations Table of Contents 1. INTRODUCTION ..........................................................................................................4 2. GUIDANCE ....................................................................................................................5 2.1. Purpose ...................................................................................................................5 2.2. Scope .......................................................................................................................5 2.3. Test Article .............................................................................................................5 2.4. Study Design ...........................................................................................................5 2.4.1. Animals ...............................................................................................................5 2.4.2. Critical Study Design Parameters ....................................................................6 2.4.3. Animal Husbandry.............................................................................................6 2.4.4. Single Species Claim ..........................................................................................7 2.4.5. Single Order Claim ............................................................................................8 2.5. Number of Animals for the Study ........................................................................9 2.6. Dosing and Route of Administration .................................................................10 2.6.1. General guidance .............................................................................................10 2.6.2. Immersion Treatment ......................................................................................10 2.6.3. In-feed Treatment ............................................................................................10 2.6.4. Injectable Treatment .......................................................................................10 2.7. Animal Euthanasia ..............................................................................................10 2.8. Sampling ...............................................................................................................10 2.8.1. General Considerations ...................................................................................10 2.8.2. Tissue Sampling ...............................................................................................11 2.8.3. Sampling of Eggs for Human Consumption from Treated Aquatic Species ...............................................................................................................12 2.9. Recommendations for Products Proposed for 0-Day Withdrawal Periods (Single Time-Point Studies) .................................................................................12 2.10. Analytical Method for Assay of Marker Residue .............................................12 3. GLOSSARY ..................................................................................................................13 3 Contains Nonbinding Recommendations Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. 1. INTRODUCTION This guidance is one of a series developed to facilitate the mutual acceptance of residue chemistry data for veterinary drugs used in food-producing animals by national/regional regulators. This guidance was prepared after consideration of the current national/regional requirements and recommendations for evaluating veterinary drug residues in the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) regions. The objective of this guidance is to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements. This document is an extension to the parent residue guidance: CVM Guidance for Industry (GFI) #207/VICH GL48, “Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal Periods.” This guidance, VICH GL57, provides recommendations on what should be included in a marker residue depletion study design for aquatic food- producing species. Metabolism studies based on CVM GFI #205/VICH GL46, “Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-producing Animals: Metabolism Study to Determine the Quantity and Identify the Nature of Residues,” can be used in aquatic food-producing species to identify a marker residue. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. 4 Contains Nonbinding Recommendations 2. GUIDANCE 2.1. Purpose Marker residue depletion studies for registration or approval, as applicable, of a new veterinary medicinal product in the intended species are recommended to: • demonstrate the depletion of the marker residue upon cessation of drug treatment to the regulatory safe level (e.g., maximum residue limit or tolerance). • generate data suitable for elaboration of appropriate withdrawal periods/withholding times to address consumer safety concerns. 2.2. Scope The intent is that a residue depletion study conducted according to the recommendations described in this guidance would satisfy the data requirements or recommendations for establishment of appropriate withdrawal periods in all VICH regions. Conducting a depletion study under worst-case conditions provides data for calculating the withdrawal period. It may be desirable to conduct an additional study or provide additional information to further define the withdrawal period under alternate management conditions or to adjust the withdrawal period based on the concept of degree days. The guidance encompasses food-producing aquatic species. The principles of this guidance are also applicable to eggs from aquatic species for human consumption. Studies should be conducted in conformity with the applicable principles of Good Laboratory Practice (GLP). The in vivo phase should be conducted under GLP conditions; if this is not practical, a justification for all deviations from GLP and the impact on the study results should be provided. 2.3. Test Article The test article used for the study should be representative of the commercial formulation. Use of final Good Manufacturing Practice (GMP) manufactured material (pilot scale or commercial scale) is the preferred source of test article; however, laboratory scale preparations characterized with respect to GLP could also be appropriate. 2.4. Study Design 2.4.1. Animals Animals should be healthy and, preferably, should not have been previously medicated. However, it is recognized
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