New Animal Drugs: Gentamicin and Betamethasone Spray

Federal Register: May 15, 2009 (Volume 74, Number 93)

Rules and Regulations

Page 22821-22822

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr15my09-5

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 21 CFR Parts 510 and 524

Docket No. FDA-2009-N-0665

New Animal Drugs; Gentamicin and Betamethasone Spray

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 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.

DATES: This rule is effective May 15, 2009.

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: john.harshman@fda.hhs.gov.

SUPPLEMENTARY 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

Page 22822

approved 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.

List of Subjects 21 CFR Part 510

Administrative practice and procedure, Animal drugs, Labeling,

Reporting and recordkeeping requirements. 21 CFR Part 524

Animal drugs. 0

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 and 524 are amended as follows:

PART 510--NEW ANIMAL DRUGS 0 1. The authority citation for 21 CFR part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 0 2. In Sec. 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:

Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.

* * * * *

(c) * * *

(1) * * *

Firm name and address

Drug labeler code

* * * * *

American Pharmaceuticals and Cosmetics,

065531

Inc., 1401 Joel East Rd., Fort Worth, TX 76140

* * * * *

(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 DRUGS 0 3. The authority citation for 21 CFR part 524 continues to read as follows:

Authority: 21 U.S.C. 360b.

Sec. 524.1044f [Amended] 0 4. In Sec. 524.1044f, in paragraph (b), remove ``and 058829'' and in its place add ``058829, and 065531''.

Dated: May 8, 2009.

William T. Flynn,

Acting Director, Center for Veterinary Medicine.

FR Doc. E9-11368 Filed 5-14-09; 8:45 am

BILLING CODE 4160-01-S