Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or we) is amending the final rule that published in the Federal Register of April 16, 2026. That final rule updated regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during October, November, and December of 2025. The final rule published with some inadvertent errors in the instructions for technical amendments. This document corrects those errors.
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 Parts 520 and 558 [Docket No. FDA-2025-N-0002] ( printed page 33071) AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment; correcting amendment. SUMMARY: The Food and Drug Administration (FDA or we) is amending the final rule that published in the Federal Register of April 16, 2026. That final rule updated regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during October, November, and December of 2025. The final rule published with some inadvertent errors in the instructions for technical amendments. This document corrects those errors. DATES: This rule is effective June 3, 2026. FOR FURTHER INFORMATION CONTACT: James Delaney, Center for Veterinary Medicine, Food and Drug Administration, 5001 Campus Drive, College Park, MD 20740, 240-402-5677, james.delaney@fda.hhs.gov . SUPPLEMENTARY INFORMATION: In the Federal Register of April 16, 2026 ( 91 FR 20337 ), FDA published the final rule “New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address” with errors. On page 20340, amendatory language in instruction 9 for § 520.1263b Lincomycin hydrochloride soluble powder, did not properly provide instructions to revise paragraphs (d)(1), (d)(2) heading, (d)(2)(i), (d)(2)(iii), an…
Other Federal Register documents from the same docket.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address; Correction
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
Citation: 91 FR 33071
