[Federal Register Volume 78, Number 180 (Tuesday, September 17, 2013)]
[Rules and Regulations]
[Pages 57057-57058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22523]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2013-N-0002]


Oral Dosage Form New Animal Drugs; Amprolium; Meloxicam

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval actions for new animal drug 
applications (NADAs) and abbreviated new animal drug applications 
(ANADAs) during August 2013. 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 September 17, 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, 
[email protected].

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations 
to reflect approval actions for NADAs and ANADAs during August 2013, 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 CVM FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.
    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.

                 Table 1--Original and Supplemental NADAs and ANADAs Approved During August 2013
----------------------------------------------------------------------------------------------------------------
                                     New Animal Drug                          21 CFR         FOIA        NEPA
   NADA/ANADA         Sponsor          Product Name          Action           Section       Summary     Review
----------------------------------------------------------------------------------------------------------------
200-514........  Phibro Animal      BOVIPROL           Original approval         520.100  Yes.......  CE \1\.
                  Health Corp.,      (amprolium) 9.6%   as a generic
                  GlenPointe         Oral Solution.     copy of NADA 13-
                  Centre East, 3d                       149.
                  floor, 300 Frank
                  W. Burr Blvd.,
                  Suite 21,
                  Teaneck, NJ
                  07666.
200-550........  Ceva Sante         MELOXIDYL          Original approval        520.1350  Yes.......  CE \1\.
                  Animale, 10        (meloxicam) Oral   as a generic
                  Avenue de la       Suspension.        copy of NADA 141-
                  Ballasti[eacute]                      213.
                  re 33500
                  Libourne, France.
----------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined under 21 CFR 25.33(a)(1) 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.


[[Page 57058]]

List of Subjects in 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 part 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


0
2. In Sec.  520.100, revise paragraph (b)(2) to read as follows:


Sec.  520.100  Amprolium.

* * * * *
    (b) * * *
    (2) No. 066104 for use of product described in paragraph (a)(1) of 
this section as in paragraph (d) of this section.
* * * * *


Sec.  520.1350  [Redesignated as Sec.  520.1367]

0
3. Redesignate Sec.  520.1350 as Sec.  520.1367.

0
4. Amend newly redesignated Sec.  520.1367 by revising paragraphs (a) 
and (b) to read as follows:


Sec.  520.1367  Meloxicam.

    (a) Specifications--(1) Each milliliter of suspension contains 0.5 
milligrams (mg) meloxicam.
    (2) Each milliliter of suspension contains 1.5 mg meloxicam.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
uses as in paragraph (c) of this section:
    (1) No. 000010 for use of the products described in paragraph (a) 
of this section; and
    (2) No. 013744 for use of the product described in paragraph (a)(2) 
of this section.
* * * * *

    Dated: September 11, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-22523 Filed 9-16-13; 8:45 am]
BILLING CODE 4160-01-P