Document ID: FDA-2013-N-0002-0018
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs; Nicarbazin; Oclacitinib; Zilpaterol
Posted Date: 2013-07-15T04:00Z

[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Rules and Regulations]
[Pages 42006-42008]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16258]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 558

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

Oral Dosage Form New Animal Drugs; Nicarbazin; Oclacitinib; 
Zilpaterol

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 approval actions for new animal drug 
applications (NADAs) and abbreviated new animal drug applications 
(ANADAs) during May 2013. FDA is also informing the public of the 
availability of summaries the basis of approval and of environmental 
review documents, where applicable.

DATES: This rule is effective July 15, 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, ghaibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations 
to reflect approval actions for NADAs and ANADAs during May 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 May 2013
----------------------------------------------------------------------------------------------------------------
                                     New animal drug                       21 CFR
   NADA/ANADA         Sponsor          product name         Action        section    FOIA summary   NEPA  review
----------------------------------------------------------------------------------------------------------------
141-279........  Zoetis Inc., 333   NICARB 25%         Supplement          558.366  No...........  CE \1\
                  Portage St.,       (nicarbazin) and   revising
                  Kalamazoo, MI      BMD (bacitracin    nicarbazin
                  49007.             methylene          dosage to a
                                     disalicylate)      range
                                     Type A medicated   consistent with
                                     articles.          dosage approved
                                                        for use in
                                                        combination
                                                        feeds.

[[Page 42007]]

 
141-345........  Zoetis Inc., 333   APOQUEL            Original           520.1604  Yes..........  CE \1\
                  Portage St.,       (oclacitinib       approval for
                  Kalamazoo, MI      tablet).           control of
                  49007.                                pruritus
                                                        associated with
                                                        allergic
                                                        dermatitis and
                                                        control of
                                                        atopic
                                                        dermatitis in
                                                        dogs at least
                                                        12 months of
                                                        age.
200-544........  Huvepharma AD,     ZILMAX             Original            528.665  Yes..........  CE \1\
                  5th Floor, 3A      (zilpaterol        aapproval as a
                  Nikolay Haytov     hydrochloride)     generic copy of
                  Str., 1113         plus RUMENSIN      NADA 141-280).
                  Sophia, Bulgaria.  (monensin) plus
                                     TYLOVET 100
                                     (tylosin
                                     phosphate) plus
                                     MGA
                                     (melengestrol
                                     acetate) Type A
                                     medicated
                                     articles.
----------------------------------------------------------------------------------------------------------------
\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.

List of Subjects

21 CFR Part 520

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

    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 520 and 
558 are 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. Add Sec.  520.1604 to read as follows:

Sec.  520.1604  Oclacitinib.

    (a) Specifications. Each tablet contains 3.6, 5.4, or 16 milligrams 
(mg) of oclacitinib as oclacitinib maleate.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer orally 0.18 to 0.27 
mg/per pound of body weight (0.4 to 0.6 mg/kg body weight) twice daily 
for up to 14 days; then administered once daily for maintenance 
therapy.
    (2) Indications for use. For control of pruritus associated with 
allergic dermatitis and control of atopic dermatitis in dogs at least 
12 months of age.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
3. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority:  21 U.S.C. 360b, 371.

0
4. In Sec.  558.366, in paragraph (d), amend the table by:
0
a. Revising the entry for ``90.8 to 181.6 (0.01 to 0.02 pct)'', and
0
b. Removing the entry for ``Bacitracin methylene disalicylate 4 to 50'' 
under the heading ``113.5 (0.0125 pct)''; and
0
c. Removing the entry for ``Bacitracin methylene disalicylate 50'' 
under the heading ``113.5 (0.0125 pct)''.
    The additions and revisions read as follows:

Sec.  558.366  Nicarbazin.

* * * * *
    (d) * * *

----------------------------------------------------------------------------------------------------------------
 Nicarbazin in grams   Combination in grams
       per ton                per ton         Indications for use              Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
90.8 to 181.6 (0.01    ....................  Broiler chickens: As  Feed continuously as sole ration       066104
 to 0.02 pct).                                an aid in             from time chicks are placed on
                                              preventing            litter until past the time when
                                              outbreaks of cecal    coccidiosis is ordinarily a
                                              (Eimeria tenella)     hazard. Do not use as a treatment
                                              and intestinal (E.    for coccidiosis. Do not feed to
                                              acervulina, E.        laying hens. Withdraw 4 days
                                              maxima, E.            before slaughter for use levels
                                              necatrix, and E.      at or below 113.5 g/ton. Withdraw
                                              brunetti)             5 days before slaughter for use
                                              coccidiosis.          levels above 113.5 g/ton.
                       Bacitracin methylene  Broiler chickens: As  Feed continuously as sole ration       054771
                        disalicylate 4 to     an aid in             from time chicks are placed on
                        50.                   preventing            litter until past the time when
                                              outbreaks of cecal    coccidiosis is ordinarily a
                                              (Eimeria tenella)     hazard. Do not use as a treatment
                                              and intestinal (E.    for coccidiosis. Do not feed to
                                              acervulina, E.        laying hens. Withdraw 4 days
                                              maxima, E.            before slaughter for use levels
                                              necatrix, and E.      at or below 113.5 g/ton. Withdraw
                                              brunetti)             5 days before slaughter for use
                                              coccidiosis; for      levels above 113.5 g/ton.
                                              increased rate of     Bacitracin methylene disalicylate
                                              weight gain and       as provided by No. 054771 in Sec.
                                              improved feed           510.600(c) of this chapter.
                                              efficiency.

[[Page 42008]]

 
                       Bacitracin methylene  Broiler chickens: As  Feed continuously as sole ration       066104
                        disalicylate 4 to     an aid in             from time chicks are placed on
                        50 and roxarsone      preventing            litter until past the time when
                        22.7 to 45.4.         outbreaks of cecal    coccidiosis is ordinarily a
                                              (Eimeria tenella)     hazard. Do not use as a treatment
                                              and intestinal (E.    for coccidiosis. Discontinue
                                              acervulina, E.        medication 5 days before
                                              maxima, E.            marketing birds for human
                                              necatrix, and E.      consumption. Do not feed to
                                              brunetti)             laying hens. Nicarbazin as
                                              coccidiosis; for      provided by No. 066104;
                                              increased rate of     bacitracin methylene disalicylate
                                              weight gain and       and roxarsone as provided by No.
                                              improved feed         054771 in Sec.   510.600(c) of
                                              efficiency.           this chapter.
                       Bacitracin methylene  Broiler chickens: As  Feed continuously as sole ration       066104
                        disalicylate 30.      an aid in             from time chicks are placed on
                                              preventing            litter until past the time when
                                              outbreaks of cecal    coccidiosis is ordinarily a
                                              (Eimeria tenella)     hazard. Do not use as a treatment
                                              and intestinal (E.    for coccidiosis. Do not feed to
                                              acervulina, E.        laying hens. Withdraw 4 days
                                              maxima, E.            before slaughter for use levels
                                              necatrix, and E.      at or below 113.5 g/ton. Withdraw
                                              brunetti)             5 days before slaughter for use
                                              coccidiosis; for      levels above 113.5 g/ton.
                                              increased rate of     Bacitracin methylene disalicylate
                                              weight gain and       as provided by No. 054771 in Sec.
                                              improved feed           510.600(c) of this chapter.
                                              efficiency.
                       Bacitracin methylene  Broiler chickens: As  Feed continuously as sole ration       054771
                        disalicylate 50.      an aid in             from time chicks are placed on
                                              preventing            litter until past the time when
                                              outbreaks of cecal    coccidiosis is ordinarily a
                                              (Eimeria tenella)     hazard. Do not use as a treatment
                                              and intestinal (E.    for coccidiosis. Do not feed to
                                              acervulina, E.        laying hens. Withdraw 4 days
                                              maxima, E.            before slaughter for use levels
                                              necatrix, and E.      at or below 113.5 g/ton. Withdraw
                                              brunetti)             5 days before slaughter for use
                                              coccidiosis; as an    levels above 113.5 g/ton.
                                              aid in the            Bacitracin methylene disalicylate
                                              prevention of         as provided by No. 054771 in Sec.
                                              necrotic enteritis      510.600(c) of this chapter.
                                              caused or
                                              complicated by
                                              Clostridium spp. or
                                              other organisms
                                              susceptible to
                                              bacitracin.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
5. In Sec.  558.665, in the table, in paragraphs (e)(2), (e)(4), and 
(e)(6), revise the last sentence in the ``Limitations'' column and 
revise the ``Sponsor'' column to read as follows:

Sec.  558.665  Zilpaterol.

* * * * *
    (e) * * *

----------------------------------------------------------------------------------------------------------------
 Zilpaterol in grams/  Combination in grams/
         ton                    ton           Indications for use              Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(2)..................  ....................  ....................  * * * Melengestrol acetate as          000061
                                                                    provided by Nos. 000986 or 054771     000986
                                                                    in Sec.   510.600(c) of this
                                                                    chapter.
 
                                                  * * * * * * *
(4)..................  ....................  ....................  * * * Monensin as provided by No.      000061
                                                                    000986; and melengestrol acetate      000986
                                                                    as provided by Nos. 000986 or
                                                                    054771 in Sec.   510.600(c) of
                                                                    this chapter.
 
                                                  * * * * * * *
(6)..................  ....................  ....................  * * * Monensin as provided by No.      000061
                                                                    000986; tylosin as provided by        000986
                                                                    Nos. 000986 or 016592; and            016592
                                                                    melengestrol acetate as provided
                                                                    by Nos. 000986 or 054771 in Sec.
                                                                     510.600(c) of this chapter.
----------------------------------------------------------------------------------------------------------------

    Dated: July 1, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-16258 Filed 7-12-13; 8:45 am]
BILLING CODE 4160-01-P