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 a supplemental new animal drug application (NADA) filed by Pharmgate LLC for the use of a Type A medicated article containing bacitracin methylenedisalicylate to manufacture Type B and Type C medicated feeds for chickens, turkeys, pheasants, quail, and feedlot cattle. This supplemental approval reflects FDA's effectiveness conclusions that relied on the National Academy of Sciences/National Research Council Drug Efficacy Study Group's evaluation of the effectiveness of this drug as well indications for use not subject to this review.
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-2015-N-0002] AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmgate LLC for the use of a Type A medicated article containing bacitracin methylenedisalicylate to manufacture Type B and Type C medicated feeds for chickens, turkeys, pheasants, quail, and feedlot cattle. This supplemental approval reflects FDA's effectiveness conclusions that relied on the National Academy of Sciences/National Research Council Drug Efficacy Study Group's evaluation of the effectiveness of this drug as well indications for use not subject to this review. DATES: This rule is effective December 22, 2015. FOR FURTHER INFORMATION CONTACT: Matthew Lucia, Center for Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0589, email: matthew.lucia@fda.hhs.gov . SUPPLEMENTARY INFORMATION: In the Federal Register of August 8, 2003 ( 68 FR 47332 ), as corrected October 7, 2003 ( 68 FR 57911 ), as part of the Drug Efficacy Study Implementation (DESI) program, the Center for Veterinary Medicine (CVM) announced the effective conditions of use for several drug products and use combinations that were listed in 21 CFR 558.15 . CVM proposed to withdraw the NADAs for those produ…
Other Federal Register documents from the same docket.
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
Conditional Approval of a New Animal Drug No Longer In Effect; Masitinib Mesylate Tablets
Conditional Approval of a New Animal Drug No Longer in Effect; Masitinib
New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of New Animal Drug Applications; Nitarsone
Citation: 80 FR 79474
