
[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
