2015-31827. New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of New Animal Drug Applications; Nitarsone
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Start Preamble
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule.
SUMMARY:
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of three new animal drug applications (NADAs) providing for the use of nitarsone in medicated feed for chickens and turkeys. This action is being taken at the sponsor's request because these products are no longer manufactured or marketed.
DATES:
This rule is effective December 31, 2015.
Start Further InfoFOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, sujaya.dessai@fda.hhs.gov.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY INFORMATION:
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 has requested that FDA withdraw approval of the following NADAs that provide for the use of nitarsone in medicated feed for chickens and turkeys because the products are no longer manufactured or marketed:
File No. Product name 21 CFR Section 007-616 HISTOSTAT 50 (nitarsone) Type A Medicated Article 558.369 141-088 HISTOSTAT 50 (nitarsone)/BMD (bacitracin methylene disalicylate) 558.369 141-132 HISTOSTAT 50/ALBAC (bacitracin zinc) 558.369 Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADAs 007-616, 141-088, and 141-132, and all supplements and amendments thereto, is withdrawn, effective December 31, 2015. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these voluntary withdrawals of approval.
This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.
Start List of SubjectsList of Subjects
21 CFR Parts 556
- Animal drugs
- Food
21 CFR Parts 558
- Animal drugs
- Animal feeds
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 556 and 558 are amended as follows:
Start PartPART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
End Part Start Amendment Part1. The authority citation for 21 CFR part 556 continues to read as follows:
End Amendment Part[Removed]2. Remove § 556.60.
End Amendment Part Start PartPART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
End Part Start Amendment Part3. The authority citation for 21 CFR part 558 continues to read as follows:
End Amendment Part[Amended]4. In § 558.4(d), in the “Category II” table, remove the entry for “Nitarsone”.
End Amendment Part[Amended]5. In § 558.76, remove and reserve paragraph (d)(3)(xiii).
End Amendment Part[Amended]6. In § 558.78, remove and reserve paragraph (d)(3)(vii).
End Amendment Part[Removed]7. Remove § 558.369.
End Amendment Part Start SignatureDated: December 11, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-31827 Filed 12-17-15; 8:45 am]
BILLING CODE 4164-01-P
Document Information
- Effective Date:
- 12/31/2015
- Published:
- 12/18/2015
- Department:
- Food and Drug Administration
- Entry Type:
- Rule
- Action:
- Final rule.
- Document Number:
- 2015-31827
- Dates:
- This rule is effective December 31, 2015.
- Pages:
- 78970-78970 (1 pages)
- Docket Numbers:
- Docket No. FDA-2015-N-0002
- PDF File:
- 2015-31827.pdf
- Supporting Documents:
- » FONSI for sN 141-361, approved December 7, 2015
- » FONSI for oN 141-453, approved December 8, 2015
- » FOI Summary for sN 141-361, approved December 7, 2015
- » FOI Summary for sN 141-258, approved December 2, 2015
- » FOI Summary for oN 141-453, approved December 8, 2015
- » EA for sN 141-361, approved December 7, 2015
- » EA for oN 141-453, approved December 8, 2015
- » Finding of No Significant Impact (FONSI) for SAFE-GUARD AQUASOL (fenbendazole oral suspension) in Chickens
- » FREEDOM OF INFORMATION SUMMARY NADA 141-442 LUTALYSE HighCon Injection Dinoprost Tromethamine Injection Lactating dairy cows, beef cows, beef heifers, and replacement dairy heifers
- » FREEDOM OF INFORMATION SUMMARY NADA 141-449 SAFE-GUARD AquaSol Fenbendazole oral suspension Broiler chickens, replacement chickens intended to become breeding chickens, and breeding chickens