Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA, the Agency, or we) is amending the animal drug regulations for labeling of new animal drugs included on FDA's Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (indexed products) to reflect the 2018 statutory changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This amendment is intended to ensure accuracy and clarity in the Agency's regulations. This amendment is nonsubstantive.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 516 [Docket No. FDA-2006-N-0239] AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is amending the animal drug regulations for labeling of new animal drugs included on FDA's Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (indexed products) to reflect the 2018 statutory changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This amendment is intended to ensure accuracy and clarity in the Agency's regulations. This amendment is nonsubstantive. DATES: This rule is effective May 15, 2024. FOR FURTHER INFORMATION CONTACT: Lucy Lee, Center for Veterinary Medicine (HFV-50), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0563, lucy.lee@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. Background The Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act of 2004) ( Pub. L. 108-282 ) amended the FD&C Act to establish regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. In 2007, FDA issued final regulations ( 72 FR 69108 , December 6, 2007) to implement section 572 of the MUMS Act entitled “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.&rdquo…
Citation: 89 FR 42361
