[Federal Register Volume 77, Number 88 (Monday, May 7, 2012)]
[Rules and Regulations]
[Page 26697]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10892]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
[Docket No. FDA-2012-N-0002]
New Animal Drugs; Change of Sponsor; Change of Sponsor Address;
Change of Sponsor Name and Address; Fomepizole
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 name from Bioniche
Teoranta to Mylan Institutional, LLC; a change of sponsor for
fomepizole injectable solution from Synerx Pharma, LLC, to Mylan
Institutional, LLC; and a change of sponsor address for Modern
Veterinary Therapeutics, LLC.
DATES: This rule is effective May 7, 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: Bioniche Teoranta, Inverin, County Galway,
Ireland, has informed FDA that it has changed its name and address to
Mylan Institutional, LLC, 4901 Hiawatha Dr., Rockford, IL 61103. Synerx
Pharma, LLC, 100 N. State St., Newton, PA 18940, has informed FDA that
it has transferred ownership of, and all rights and interest in,
abbreviated new animal drug application (ANADA) 200-472 for Fomepizole
for Injection to Mylan Institutional, LLC. Modern Veterinary
Therapeutics, LLC, 1550 Madruga Ave., suite 329, Coral Gables, FL
33146, has informed FDA that it has changed its address to 18001 Old
Cutler Rd., suite 317, Miami, FL 33157. Accordingly, the Agency is
amending the regulations in parts 510 and 522 (21 CFR parts 510 and
522) to reflect these changes.
Following this change of sponsorship, Synerx Pharma, LLC, is no
longer the sponsor of an approved application. Accordingly, Sec.
510.600 (21 CFR 510.600) is being amended to remove the entries for
this firm.
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 522
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 and
522 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
entries for ``Bioniche Teoranta'' and ``Synerx Pharma, LLC''; revise
the entry for ``Modern Veterinary Therapeutics, LLC''; and
alphabetically add a new entry for ``Mylan Institutional, LLC''; and in
the table in paragraph (c)(2), remove the entry for ``068882'' and
revise the entries for ``015914'' and ``063286'' 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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* * * * *
Modern Veterinary Therapeutics, LLC, 18001 Old Cutler Rd., 015914
suite 317, Miami, FL 33157..................................
* * * * *
Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 063286
61103.......................................................
* * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * *
015914................................. Modern Veterinary Therapeutics,
LLC, 18001 Old Cutler Rd.,
suite 317, Miami, FL 33157.
* * * * *
063286................................. Mylan Institutional, LLC, 4901
Hiawatha Dr., Rockford, IL
61103.
* * * * *
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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.
0
4. In Sec. 522.1004, revise paragraph (b) to read as follows:
Sec. 522.1004 Fomepizole.
* * * * *
(b) Sponsors. See Nos. 046129 and 063286 in Sec. 510.600(c) of
this chapter.
* * * * *
Dated: April 30, 2012.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2012-10892 Filed 5-4-12; 8:45 am]
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