Document ID: FDA-2011-N-0003-0075
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Change of Sponsor; Chlortetracycline Powder
Posted Date: 2012-02-06T05:00Z

[Federal Register Volume 77, Number 24 (Monday, February 6, 2012)]
[Rules and Regulations]
[Page 5700]
From the Federal Register Online via the Government Printing 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: 
steven.vaughn@fda.hhs.gov.

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) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                                * * * * *
Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville,            076475
 NC 28349...............................................
 
                                * * * * *
------------------------------------------------------------------------

     (2) * * *

------------------------------------------------------------------------
          Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
076475..............................  Quo Vademus, LLC, 277 Faison
                                       McGowan Rd., Kenansville, NC
                                       28349
 
                                * * * * *
------------------------------------------------------------------------

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