FDA is amending the animal drug regulations for medicated feed mill notification applications at 21 CFR 515.10 and for veterinary feed directive drugs at 21 CFR 558.6 to update addresses and Agency notification procedure. These technical amendments are being made to improve the accuracy of the Agency's regulations and are non-substantive.
Publication of this document constitutes final action on the changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because this amendment to the regulations provides only technical or non-substantive, ministerial changes to update addresses and Agency notification procedure.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 515 and 558 are amended as follows:
1. The authority citation for part 515 continues to read as follows:
21 U.S.C. 360b, 371.
2. In § 515.10, revise paragraphs (c) and (e) to read as follows:
Medicated feed mill license applications.
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(c) Applications must be completed, signed, and submitted to the Food and Drug Administration, Center for Veterinary Medicine, Division of Food Compliance, 12225 Wilkins Ave., Rockville, MD 20852, or email (via attachment):
MedicatedFeedsTeamMail@fda.hhs.gov.
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(e) Upon approval, the application will be signed by an authorized employee of FDA designated by the Commissioner of Food and Drugs, and a copy will be returned to the applicant.
3. The authority citation for part 558 continues to read as follows:
21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
4. In § 558.6, revise paragraph (c)(7) to read as follows:
Veterinary feed directive drugs.
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(c) * * *
(7) The notifications cited in paragraphs (c)(5) and (6) of this section must be submitted to the Food and Drug Administration, Center for Veterinary Medicine, Division of Food Compliance, 12225 Wilkins Ave., Rockville, MD 20852, or email (via attachment):
MedicatedFeedsTeamMail@fda.hhs.gov.
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