Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of eight supplemental new animal drug applications (NADAs). The effect of these supplemental applications will be to change the marketing status from over-the- counter (OTC) use to use by veterinary feed directive (VFD) for these antimicrobial drugs of importance to human medicine, administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for production indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and abbreviated new animal drug applications (ANADAs) that were affected by this initiative.
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 558 [Docket No. FDA-2016-N-0002] AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of eight supplemental new animal drug applications (NADAs). The effect of these supplemental applications will be to change the marketing status from over-the-counter (OTC) use to use by veterinary feed directive (VFD) for these antimicrobial drugs of importance to human medicine, administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for production indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and abbreviated new animal drug applications (ANADAs) that were affected by this initiative. DATES: This rule is effective February 24, 2017. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl…
Other Federal Register documents from the same docket.
Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications; Correction
Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications; Correction
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Name
New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Address
Citation: 82 FR 11510
