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Code · REGISTER · 2024-06-21 · Food and Drug Administration, HHS · Rules and Regulations

Rules and Regulations. Final rule; technical amendment

496 words·~2 min read·/register/2024/06/21/2024-13678

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BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 515 and 558 [Docket No. FDA-2024-N-2731] Medicated Feed Mill License; Veterinary Feed Directive Drugs; Change of Address AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA or the Agency) is amending the regulations for medicated feed mill applications and for veterinary feed directive drugs to update addresses and simplify notification procedures.
These technical amendments are being made to improve the accuracy of the Agency's regulations and are non-substantive. DATES: This rule is effective June 21, 2024. FOR FURTHER INFORMATION CONTACT: Katherine Collins, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-796-6736, *Katherine.Collins@fda.hhs.gov.* SUPPLEMENTARY INFORMATION: 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. List of Subjects 21 CFR Part 515 Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements. 21 CFR Part 558 Animal drugs, Animal feeds.
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: PART 515—MEDICATED FEED MILL LICENSE 1. The authority citation for part 515 continues to read as follows: Authority: 21 U.S.C. 360b, 371. 2. In § 515.10, revise paragraphs
(c)and
(e)to read as follows: § 515.10 Medicated feed mill license applications.
(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.*
(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. PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 3. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 4. In § 558.6, revise paragraph (c)(7) to read as follows: § 558.6 Veterinary feed directive drugs.
(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.* Dated: June 17, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024-13678 Filed 6-20-24; 8:45 am]
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  • 21 CFR 515
  • 21 CFR 558
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Rules and Regulations
Final rule; technical amendment
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