Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of an abbreviated new animal drug application (ANADA) filed by American Pharmaceuticals and Cosmetics, Inc. The ANADA provides for the veterinary prescription use of gentamicin sulfate and betamethasone valerate topical spray in dogs.
This rule is effective May 15, 2009.Start Further Info
FOR FURTHER INFORMATION CONTACT:
John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: email@example.com.End Further Info End Preamble Start Supplemental Information
American Pharmaceuticals and Cosmetics, Inc., 1401 Joel East Rd., Fort Worth, TX 76140, filed ANADA 200-388 that provides for veterinary prescription use of GB (gentamicin sulfate and betamethasone valerate) Topical Spray in dogs. American Pharmaceuticals and Cosmetics, Inc.'s GB Topical Spray is Start Printed Page 22822approved as a generic copy of Schering-Plough Animal Health Corp.'s GENTOCIN Topical Spray, approved under NADA 132-338. The ANADA is approved as of April 7, 2009, and the regulations are amended in 21 CFR 524.1044f to reflect the approval.
In addition, American Pharmaceuticals and Cosmetics, Inc., is not currently listed in the animal drug regulations as a sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to add entries for this sponsor.
In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
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,End Amendment Part Start Part
PART 510—NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part Start Amendment Part
2. In § 510.600, in the table in paragraph (c)(1), alphabetically add an entry for “American Pharmaceuticals and Cosmetics, Inc.”; and in the table in paragraph (c)(2), numerically add an entry for “065531” to read as follows:End Amendment Part
(c) * * *
(1) * * *
|Firm name and address||Drug labeler code|
|* * * * *|
|American Pharmaceuticals and Cosmetics, Inc., 1401 Joel East Rd., Fort Worth, TX 76140||065531|
|* * * * *|
(2) * * *
|Drug labeler code||Firm name and address|
|* * * * *|
|065531||American Pharmaceuticals and Cosmetics, Inc., 1401 Joel East Rd., Fort Worth, TX 76140|
|* * * * *|
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
3. The authority citation forEnd Amendment Part
4. In § 524.1044f, in paragraph (b), remove “and 058829” and in its place add “058829, and 065531”.End Amendment Part Start Signature
Dated: May 8, 2009.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. E9-11368 Filed 5-14-09; 8:45 am]
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