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Final Rule

Medicated Feed Mill License; Veterinary Feed Directive Drugs; Change of Address

Final rule; technical amendment.

📖 Research Context From Federal Register API

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.

Key Dates
Citation: 89 FR 51966
This rule is effective June 21, 2024.
Public Participation
Topics:
Administrative practice and procedure Animal drugs Animal feeds Confidential business information Reporting and recordkeeping requirements

In Plain English

What is this Federal Register notice?

This is a final rule published in the Federal Register by Health and Human Services Department, Food and Drug Administration. Final rules have completed the public comment process and establish legally binding requirements.

Is this rule final?

Yes. This rule has been finalized. It has completed the notice-and-comment process required under the Administrative Procedure Act.

Who does this apply to?

Final rule; technical amendment.

When does it take effect?

This document has been effective since June 21, 2024.

Document Details

Document Number2024-13678
FR Citation89 FR 51966
TypeFinal Rule
PublishedJun 21, 2024
Effective DateJun 21, 2024
RIN-
Docket IDDocket No. FDA-2024-N-2731
Pages51966–51966 (1 pages)
Text FetchedYes

Agencies & CFR References

CFR References:

Linked CFR Parts

PartNameAgency
21 CFR 558 New Animal Drugs for Use in Animal Feeds... -
21 CFR 515 Medicated Feed Mill License... -

Paired Documents

TypeProposedFinalMethodConf
No paired documents

External Links

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Full Document Text (546 words · ~3 min read)

Text Preserved
<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Parts 515 and 558</CFR> <DEPDOC>[Docket No. FDA-2024-N-2731]</DEPDOC> <SUBJECT>Medicated Feed Mill License; Veterinary Feed Directive Drugs; Change of Address</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Final rule; technical amendment. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective June 21, 2024. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Katherine Collins, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-796-6736, <E T="03">Katherine.Collins@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> 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. <LSTSUB> <HD SOURCE="HED">List of Subjects</HD> <CFR>21 CFR Part 515</CFR> Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements. <CFR>21 CFR Part 558</CFR> Animal drugs, Animal feeds. </LSTSUB> 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: <HD SOURCE="HED">PART 515—MEDICATED FEED MILL LICENSE</HD> <REGTEXT TITLE="21" PART="515"> 1. The authority citation for part 515 continues to read as follows: <HD SOURCE="HED">Authority:</HD> 21 U.S.C. 360b, 371. </REGTEXT> <REGTEXT TITLE="21" PART="515"> 2. In § 515.10, revise paragraphs (c) and (e) to read as follows: <SECTION> <SECTNO>§ 515.10</SECTNO> <SUBJECT>Medicated feed mill license applications.</SUBJECT> <STARS/> (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): <E T="03">MedicatedFeedsTeamMail@fda.hhs.gov.</E> <STARS/> (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. </SECTION> </REGTEXT> <HD SOURCE="HED">PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS</HD> <REGTEXT TITLE="21" PART="558"> 3. The authority citation for part 558 continues to read as follows: <HD SOURCE="HED">Authority: </HD> 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. </REGTEXT> <REGTEXT TITLE="21" PART="558"> 4. In § 558.6, revise paragraph (c)(7) to read as follows: <SECTION> <SECTNO>§ 558.6</SECTNO> <SUBJECT>Veterinary feed directive drugs.</SUBJECT> <STARS/> (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): <E T="03">MedicatedFeedsTeamMail@fda.hhs.gov.</E> <STARS/> </SECTION> </REGTEXT> <SIG> <DATED>Dated: June 17, 2024.</DATED> <NAME>Lauren K. Roth,</NAME> Associate Commissioner for Policy. </SIG> </SUPLINF> <FRDOC>[FR Doc. 2024-13678 Filed 6-20-24; 8:45 am]</FRDOC> </RULE>
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