This PDF is the current document as it appeared on Public Inspection on 08/22/2013 at 08:45 am.
Food and Drug Administration, HHS.
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) at the sponsors' request because the products are no longer manufactured or marketed.
This rule is effective September 3, 2013.Start Further Info
FOR FURTHER INFORMATION CONTACT:
David Alterman, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6843, email: email@example.com.End Further Info End Preamble Start Supplemental Information
Phibro Animal Health Corp., 65 Challenger Rd., 3d Floor, Ridgefield Park, NJ 07660 has requested that FDA withdraw approval of NADA 098-371 for use of nicarbazin, penicillin, and roxarsone in 3-way, combination drug Type C medicated feeds for broiler chickens and NADA 098-374 for use of nicarbazin and penicillin in 2-way, combination drug Type C medicated feeds for broiler chickens because the products are no longer manufactured or marketed. Accordingly, 21 CFR 558.366 and 558.460 are being amended to reflect the withdrawal of approval.
R. P. Scherer North America, P.O. Box 5600, Clearwater, FL 33518 has requested that FDA withdraw approval of NADA 123-116 for Diethylcarbamazine Citrate Capsules used in dogs for the prevention of heartworm disease because the product is no longer manufactured or marketed. Accordingly, 21 CFR 520.622d is being amended to reflect the withdrawal of approval.
Following this withdrawal of approval, R. P. Scherer North America is no longer the sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for these firms.
Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADA 098-371, NADA 098-374, and NADA 123-116, and all supplements and amendments thereto, is withdrawn. 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 Subjects
List of Subjects
- Administrative practice and procedure
- Animal drugs
- Reporting and recordkeeping requirements
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 510, 520, and 558 are amended as follows:Start Part
PART 510—NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. In § 510.600, in the table in paragraph (c)(1), remove the entry for “R. P. Scherer North America”; and in the table in paragraph (c)(2), remove the entry for “011014”.End Amendment Part Start Part
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
3. The authority citation forEnd Amendment Part
4. Remove § 520.622d.End Amendment Part Start Part
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDSEnd Part Start Amendment Part
5. The authority citation forEnd Amendment Part
6. In § 558.366, in the table in paragraph (d), in the entry for “90.8 to 181.6 (0.01 to 0.02 pct)”, remove theEnd Amendment Part
7. In § 558.460, remove and reserve paragraph (d)(2)(iv).End Amendment Part Start Signature
Dated: August 19, 2013.
Director, Center for Veterinary Medicine.
[FR Doc. 2013-20540 Filed 8-22-13; 8:45 am]
BILLING CODE 4160-01-P