Document ID: FDA-2012-N-0002-0009
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs: Change of Sponsor; Griseofulvin Powder; Levamisole Hydrochloride Powder; Oxytetracycline Powder
Posted Date: 2012-05-14T04:00Z

[Federal Register Volume 77, Number 93 (Monday, May 14, 2012)]
[Rules and Regulations]
[Pages 28252-28253]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11382]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

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

Oral Dosage Form New Animal Drugs; Change of Sponsor; 
Griseofulvin Powder; Levamisole Hydrochloride Powder; Oxytetracycline 
Powder

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 five abbreviated 
new animal drug applications (ANADAs) for griseofulvin powder, 
levamisole hydrochloride soluble powder, and oxytetracycline 
hydrochloride soluble powder from Teva Animal Health, Inc., to Cross 
Vetpharm Group, Ltd.

DATES: This rule is effective May 14, 2012.

[[Page 28253]]

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, 
steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Teva Animal Health, Inc., 3915 South 48th 
St. Ter., St. Joseph, MO 64503, has informed FDA that it has 
transferred ownership of, and all rights and interest in, ANADA 200-391 
for Griseofulvin Powder, ANADAs 200-146 and 200-247 for Oxytetracycline 
Hydrochloride Soluble Powder, and ANADAs 200-313 and 200-386 for 
Levamisole Hydrochloride Soluble Pig Wormer and Drench Powder to Cross 
Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland. 
Accordingly, the agency is amending the regulations in part 520 (21 CFR 
part 520) to reflect the transfer of ownership and a current format.
    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 in 21 CFR Part 520

    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 part 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

Sec.  520.1100  [Amended]

0
2. In paragraph (b)(2) of Sec.  520.1100, remove ``059130'' and in its 
place add ``061623''.

0
3. In Sec.  520.1242, revise the section heading to read as follows:

Sec.  520.1242  Levamisole.

0
4. In Sec.  520.1242a, revise the section heading to read as set forth 
below, and in paragraph (b)(4) remove ``059130'' and in its place add 
``061623''.

Sec.  520.1242a  Levamisole powder.

* * * * *

Sec.  520.1660d  [Amended]

0
5. In Sec.  520.1660d, in paragraphs (b)(5), (d)(1)(ii)(A)(3), 
(d)(1)(ii)(B)(3), (d)(1)(ii)(C)(3), and (d)(1)(iii)(C), remove 
``059130'' and in its place add ``061623''.

    Dated: May 7, 2012.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2012-11382 Filed 5-11-12; 8:45 am]
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