- Docket Number:
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Guidance Issuing OfficeCenter for Veterinary Medicine
As part of the approval process for veterinary medicinal products in food-producing animals, national/regional regulatory authorities require data from marker residue depletion studies in order to establish appropriate withdrawal periods in edible tissues including meat, milk and eggs. The objective of this guidance is to provide study design recommendations which will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements.
The guidance encompasses the most common species, namely cattle, pig, sheep and poultry; however, the principles of this guidance can also be applied to related species not mentioned in this core group (e.g., cattle vs. all ruminants). The guidance does not provide study design recommendations for fish or honey bees (as producers of honey).
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-2010-D-0166.