Data / Federal rules / 2024-04840
Labeling Requirements for Approved or Conditionally Approved New Animal Drugs
The Food and Drug Administration published this proposed rule in the Federal Register on March 12, 2024. Comments closed on June 10, 2024.
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What the agency says
The Food and Drug Administration (FDA) is proposing to revise the requirements for the content and format of labeling for approved or conditionally approved new animal drugs to provide for a more comprehensive set of requirements in one location in the Code of the Federal Register (CFR). As part of this revision, certain current requirements would be updated and moved, and certain obsolete requirements would be removed. The proposed requirements would apply to the labeling of prescription and over-the-counter (OTC) new animal drugs, as well as new animal drugs for use in animal feeds.
Key facts
- Document number
- 2024-04840
- Type
- Proposed rule
- Action
- Proposed rule
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- March 12, 2024
- Comments due
- June 10, 2024
- Dates
- Either electronic or written comments on the proposed rule must be submitted by June 10, 2024. Submit written comments (including recommendations) on information collection issues under the Paperwork Reduction Act of 1995 by April 11, 2024.
- Docket
- Docket No. FDA-2023-N-5160
- Regulation ID (RIN)
- 0910-AI43
- Code of Federal Regulations
- 21 CFR 201; 21 CFR 500; 21 CFR 501; 21 CFR 510; 21 CFR 514; 21 CFR 516
- Topics
- Administrative practice and procedure; Animal drugs; Cancer; Confidential business information; Drugs; Labeling; Packaging and containers; Polychlorinated biphenyls (PCB's); Reporting and recordkeeping requirements
- Pages
- 76
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