Document ID: FDA-2012-N-0002-0043
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Cefpodoxime; Meloxicam
Posted Date: 2013-01-28T05:00Z

[Federal Register Volume 78, Number 18 (Monday, January 28, 2013)]
[Rules and Regulations]
[Pages 5713-5715]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01647]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, and 522

[Docket No. FDA-2012-N-0002]

New Animal Drugs; Cefpodoxime; Meloxicam

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval actions for new animal drug

[[Page 5714]]

applications (NADAs) and abbreviated new animal drug applications 
(ANADAs) during December 2012. FDA is also informing the public of the 
availability of summaries of the basis of approval and of environmental 
review documents, where applicable.

DATES: This rule is effective January 28, 2013.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9019, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations 
to reflect approval actions for several original ANADAs during December 
2012, as listed in table 1. In addition, FDA is informing the public of 
the availability, where applicable, of documentation of environmental 
review required under the National Environmental Policy Act (NEPA) and, 
for actions requiring review of safety or effectiveness data, summaries 
of the basis of approval (FOI Summaries) under the Freedom of 
Information Act (FOIA). These public documents may be seen in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 
p.m., Monday through Friday. Persons with access to the Internet may 
obtain these documents at the Center for Veterinary Medicine FOIA 
Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.

                             Table 1--Original ANADAs Approved During December 2012
----------------------------------------------------------------------------------------------------------------
                                        New animal drug                       21 CFR
    NADA/ANADA           Sponsor          product name         Action        section   FOIA summary  NEPA review
----------------------------------------------------------------------------------------------------------------
200-485...........  Accord             Meloxicam          Original           522.1367  yes.........  CE\1\
                     Healthcare,        Injection.         approval as a
                     Inc., 1009                            generic copy of
                     Slater Rd.,                           NADA 141-219.
                     suite 210-B,
                     Durham, NC 27703.
200-491...........  Norbrook           LOXICOM            Original           522.1367  yes.........  CE\1\
                     Laboratories,      (meloxicam)        approval as a
                     Ltd., Station      Solution for       generic copy of
                     Works, Newry       Injection.         NADA 141-219.
                     BT35 6JP,
                     Northern Ireland.
200-543...........  Putney, Inc., 400  Cefpodoxime        Original            520.370  yes.........  CE\1\
                     Congress St.,      Proxetil Tablets.  approval as a
                     suite 200,                            generic copy of
                     Portland, ME                          NADA 141-232.
                     04101.
----------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the
  requirement to submit an environmental assessment or an environmental impact statement because it is of a type
  that does not individually or cumulatively have a significant effect on the human environment.

    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 Parts 520 and 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, 
520, 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.

Sec.  510.600  [Amended]

    2. In Sec.  510.600, in the table in paragraph (c)(1), 
alphabetically add an entry for ``Accord Healthcare, Inc.'' and revise 
the entry for ``Jurox Pty. Ltd.''; and in the table in paragraph 
(c)(2), numerically add an entry for ``016729'' and revise the entry 
for ``049480'' to read as follows:
    (1) * * *

------------------------------------------------------------------------
                                                           Drug  labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                                * * * * *
Accord Healthcare, Inc., 1009 Slater Rd., suite 210-B,            016729
 Durham, NC 27703.......................................
 
                                * * * * *
Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320,           049480
 Australia..............................................
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
          Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
016729..............................  Accord Healthcare, Inc., 1009
                                       Slater Rd., suite 210-B, Durham,
                                       NC 27703
 
                                * * * * *
049480..............................  Jurox Pty. Ltd., 85 Gardiner St.,
                                       Rutherford, NSW 2320, Australia
 
                                * * * * *
------------------------------------------------------------------------

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.  520.370  [Amended]

0
4. In paragraph (b) of Sec.  520.370, remove ``No. 000009'' and in its 
place add ``Nos. 000009 and 026637''.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
5. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority:  21 U.S.C. 360b.

[[Page 5715]]

Sec.  522.1367  [Amended]

0
6. In paragraph (b) of Sec.  522.1367, remove ``No. 000010'' and in its 
place add ``Nos. 000010, 016729, and 055529''.

    Dated: January 22, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-01647 Filed 1-25-13; 8:45 am]
BILLING CODE 4160-01-P