Document ID: FDA-2012-N-0002-0019
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Change of Sponsor; Change of Sponsor Address: Azaperone; Miconazole, Polymyxin B, and Prednisolone Suspension
Posted Date: 2012-08-06T04:00Z

[Federal Register Volume 77, Number 151 (Monday, August 6, 2012)]
[Rules and Regulations]
[Pages 46612-46613]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19147]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 522, and 524

[Docket No. FDA-2012-N-0002]

New Animal Drugs; Change of Sponsor; Change of Sponsor Address; 
Azaperone; Miconazole, Polymyxin B, and Prednisolone Suspension

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for two new animal drug 
applications (NADAs) from Janssen Pharmaceutica NV, to Elanco Animal 
Health, a Division of Eli Lilly & Co. FDA is also amending the animal 
drug regulations to reflect a change of sponsor's address for 
Veterinary Service, Inc.

DATES: This rule is effective August 6, 2012.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 240-276-8300, email: 
steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Janssen Pharmaceutica NV, Turnhoutseweg 30, 
B-2340 Beerse, Belgium, has informed FDA that it has transferred 
ownership of, and all rights and interest in, NADA 115-732 for STRESNIL 
(azaperone) Injection and NADA 141-298 for SUROLAN (miconazole nitrate, 
polymyxin B sulfate, prednisolone acetate) Otic Suspension to Elanco 
Animal Health, a Division of Eli Lilly & Co., Lilly Corporate Center, 
Indianapolis, IN 46285. Following these changes of sponsorship, Janssen 
Pharmaceutica NV will no longer be the sponsor of an approved 
application. Accordingly, the Agency is amending the regulations in 21 
CFR 510.600, 522.150, and 524.1445 to reflect the transfer of 
ownership.
    In addition, Veterinary Service, Inc., 416 North Jefferson St., 
P.O. Box 2467,

[[Page 46613]]

Modesto, CA 95354 has informed FDA of a change of address to 4100 Bangs 
Ave., Modesto, CA 95356. Accordingly, the Agency is amending the 
regulations in 21 CFR 510.600 to reflect these changes.
    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 Parts 520 and 524

    Animal drugs.

    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, 
522, 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), remove the entry 
for ``Janssen Pharmaceutica NV'' and revise the entry for ``Veterinary 
Service, Inc.''; and in the table in paragraph (c)(2), remove the entry 
for ``012758'' and revise the entry for ``033008'' to read as follows:

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

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
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                                * * * * *
Veterinary Service, Inc., 4100 Bangs Ave., Modesto, CA            033008
 95356..................................................
 
                                * * * * *
------------------------------------------------------------------------

     (2) * * *

------------------------------------------------------------------------
          Drug labeler code                  Firm name and address
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                                * * * * *
033008..............................  Veterinary Service, Inc., 4100
                                       Bangs Ave., Modesto, CA 95356.
 
                                * * * * *
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PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

Sec.  522.150  [Amended]

0
4. In paragraph (b) of Sec.  522.150, remove ``012578'' and in its 
place add ``000986''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
6. In Sec.  524.1445, revise paragraph (b) to read as follows:

Sec.  524.1445  Miconazole, polymixin B, and prednisolone suspension.

* * * * *
    (b) Sponsor. See No. 000986 in Sec.  510.600(c) of this chapter.
* * * * *

    Dated: August 1, 2012.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2012-19147 Filed 8-3-12; 8:45 am]
BILLING CODE 4160-01-P