[Federal Register Volume 77, Number 24 (Monday, February 6, 2012)]
[Rules and Regulations]
[Page 5700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-2633]
[[Page 5700]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
[Docket No. FDA-2011-N-0003]
New Animal Drugs; Change of Sponsor; Chlortetracycline 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 an abbreviated new
animal drug application (ANADA) for chlortetracycline soluble powder
from Teva Animal Health, Inc., to Quo Vademus, LLC.
DATES: This rule is effective February 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:
[email protected].
SUPPLEMENTARY INFORMATION: Teva Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503, has informed FDA that it has
transferred ownership of, and all rights and interest in, ANADA 200-236
for Chlortetracycline HCL Soluble Powder to Quo Vademus, LLC, 277
Faison McGowan Rd., Kenansville, NC 28349. Accordingly, the Agency is
amending the regulations in 21 CFR 520.441 to reflect the transfer of
ownership.
Quo Vademus, LLC, is not currently listed in the animal drug
regulations as a sponsor of an approved application. Accordingly, 21
CFR 510.600 is being amended to add entries for this sponsor.
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 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 parts 510 and
520 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), alphabetically
add a new entry for ``Quo Vademus, LLC''; and in the table in paragraph
(c)(2), in numerical sequence add a new entry for ``076475'' 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 labeler
Firm name and address code
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* * * * *
Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, 076475
NC 28349...............................................
* * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * *
076475.............................. Quo Vademus, LLC, 277 Faison
McGowan Rd., Kenansville, NC
28349
* * * * *
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PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.441 [Amended]
0
4. In paragraph (b)(4) of Sec. 520.441, remove ``059130'' and in its
place add ``076475''.
Dated: February 1, 2012.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2012-2633 Filed 2-3-12; 8:45 am]
BILLING CODE 4160-01-P