[Federal Register Volume 77, Number 107 (Monday, June 4, 2012)]
[Rules and Regulations]
[Pages 32897-32898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-13409]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
[Docket No. FDA-2012-N-0002]
New Animal Drugs; Change of Sponsor's Name
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's name from Novopharm
Ltd. to Teva Canada Ltd.
DATES: This rule is effective June 4, 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:
[email protected].
SUPPLEMENTARY INFORMATION: Novopharm Ltd., 30 Novopharm Ct., Toronto,
Ontario, Canada M1B 2K9 has informed FDA of a change of name to Teva
Canada Ltd. Accordingly, the Agency is amending the regulations in 21
CFR 510.600(c) 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 in 21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 510 is
amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
[[Page 32898]]
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 ``Novopharm Ltd.'' and alphabetically add a new entry for ``Teva
Canada Ltd.''; and in the table in paragraph (c)(2), revise the entry
for ``043806'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
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Drug
Firm name and address labeler
code
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* * * * *
Teva Canada Ltd., 30 Novopharm Ct., Toronto, Ontario, Canada 043806
M1B 2K9.....................................................
* * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * *
043806.................................... Teva Canada Ltd., 30
Novopharm Ct., Toronto,
Ontario, Canada M1B 2K9.
* * * * *
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Dated: May 29, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-13409 Filed 6-1-12; 8:45 am]
BILLING CODE 4160-01-P