[Federal Register Volume 77, Number 93 (Monday, May 14, 2012)]
[Rules and Regulations]
[Pages 28252-28253]
From the Federal Register Online via the Government Publishing 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,
[email protected].
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
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1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.1100 [Amended]
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2. In paragraph (b)(2) of Sec. 520.1100, remove ``059130'' and in its
place add ``061623''.
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3. In Sec. 520.1242, revise the section heading to read as follows:
Sec. 520.1242 Levamisole.
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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]
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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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