Document ID: FDA-2013-N-0002-0024
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Carprofen; Enrofloxacin; Florfenicol; Tildipirosin; Zilpaterol
Posted Date: 2013-08-27T04:00Z

[Federal Register Volume 78, Number 166 (Tuesday, August 27, 2013)]
[Rules and Regulations]
[Pages 52852-52854]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20538]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 524, 556, and 558

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

New Animal Drugs; Carprofen; Enrofloxacin; Florfenicol; 
Tildipirosin; Zilpaterol

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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 June 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 August 27, 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 NADAs and ANADAs during June 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 (Freedom of Information 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.
    In addition, the animal drug regulations are being amended at 21 
CFR 510.600 to correct a sponsor's name and at 21 CFR 556.733 to 
correct the acceptable daily intake of total residues of tildipirosin. 
This is being done to improve the accuracy of the regulations.
    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 June 2013
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                                     New animal drug                      21 CFR
    NADA/ANADA          Sponsor        product name        Action        section    FOIA  summary   NEPA  review
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200-524..........  Putney, Inc.,     Mupirocin        Original            524.1465  yes..........  CE.\1\
                    400 Congress      Ointment 2%.     approval as a
                    St., suite 200,                    generic copy
                    Portland, ME                       of NADA 140-
                    04101.                             839.
200-517..........  Novartis Animal   ZOBUXA           Original             520.812  yes..........  CE.\1\
                    Health US,        (enrofloxacin)   approval as a
                    Inc., 3200        Flavored         generic copy
                    Northline Ave.,   Antibacterial    of NADA 140-
                    suite 300,        Tablets.         441.
                    Greensboro, NC
                    27408.
200-519..........  Novartis Animal   FLORVIO          Original             520.995  yes..........  CE.\1\
                    Health US,        (florfenicol)    approval as a
                    Inc., 3200        2.3%             generic copy
                    Northline Ave.,   Concentrate      of NADA 141-
                    suite 300,        Solution.        206.
                    Greensboro, NC
                    27408.
200-547..........  Huvepharma AD,    ZILMAX           Original             558.665  yes..........  CE.\1\
                    5th Floor, 3A     (zilpaterol      approval as a
                    Nikolay Haytov    hydrochloride)   generic copy
                    Str., 1113        plus RUMENSIN    of NADA 141-
                    Sophia,           (monensin USP)   276.
                    Bulgaria.         plus TYLOVET
                                      100 (tylosin
                                      phosphate)
                                      Type A
                                      medicated
                                      articles.

[[Page 52853]]

 
200-555..........  Piedmont Animal   LIBREVIA         Original             520.309  yes..........  CE.\1\
                    Health, 204       (carprofen)      approval as a
                    Muirs Chapel      Soft Chewable    generic copy
                    Rd., suite 200,   Tablets.         of NADA 141-
                    Greensboro, NC                     111.
                    27410.
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\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 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Parts 520 and 524

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

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 510, 
520, 524, 556, and 558 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), remove the entry 
for ``Purina Nutrition LLC'', and alphabetically add entries for 
``Piedmont Animal Health'' and ``Purina Animal Nutrition LLC''; and in 
the table in paragraph (c)(2), in the entry for ``017800'', remove 
``Purina Nutrition'' and in its place add ``Purina Animal Nutrition'', 
and numerically add an entry for ``058147'' 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
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                              * * * * * * *
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Piedmont Animal Health, 204 Muirs Chapel Rd., suite               058147
 200, Greensboro, NC 27410............................
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                              * * * * * * *
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Purina Animal Nutrition LLC, 1080 County Road F West,             017800
 Shoreview, MN 55126-2910.............................
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                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------
058147.......................  Piedmont Animal Health, 204 Muirs Chapel
                                Rd., suite 200, Greensboro, NC 27410
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------

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.  520.309  [Amended]

0
4. In paragraph (b)(2) of Sec.  520.309, remove ``Nos. 000115, 055529, 
and 062250'' and in its place add ``Nos. 000115, 055529, 058147, and 
062250''.
0
5. In Sec.  520.812, revise paragraphs (a) and (b) to read as follows:

Sec.  520.812  Enrofloxacin.

    (a) Specifications. Each tablet contains:
    (1) 22.7, 68.0, or 136.0 milligrams (mg) enrofloxacin; or
    (2) 22.7, 68.0, 136.0, or 272 mg enrofloxacin.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter for use as in paragraph (c) of this section.
    (1) Nos. 000859 and 026637 for use of product described in 
paragraph (a)(1) of this section.

[[Page 52854]]

    (2) No. 058198 for use of product described in paragraph (a)(2) of 
this section.
* * * * *

Sec.  520.955  [Amended]

0
6. In paragraph (b) of Sec.  520.955, remove ``No. 000061'' and in its 
place add ``Nos. 000061 and 058198''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
7. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

Sec.  524.1465  [Amended]

0
8. In paragraph (b) of Sec.  524.1465, add ``026637,'' after 
``025463,''.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
9. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority:  21 U.S.C. 342, 360b, 371.

Sec.  556.733  [Amended]

0
10. In paragraph (a) of Sec.  556.733, remove ``10 micrograms'' and in 
its place add ``50 micrograms''.

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

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

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

0
12. In Sec.  558.665, in the table, revise paragraph (e)(5) to read as 
follows:

Sec.  558.665  Zilpaterol.

* * * * *
    (e) * * *

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                                  Combination in
    Zilpaterol in grams/ton         grams/ton        Indications for use        Limitations           Sponsor
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                                                  * * * * * * *
(5) 6.8 to provide 60 to 90 mg/ Monensin 10 to     Cattle fed in           As in paragraph         000061 016592
 head/day.                       40, plus tylosin   confinement for         (e)(1) of this
                                 8 to 10.           slaughter: As in        section; see Sec.
                                                    paragraph (e)(1) of     Sec.   558.355(d)
                                                    this section; for       and 558.625(c) of
                                                    prevention and          this chapter.
                                                    control of              Monensin as provided
                                                    coccidiosis due to      by No. 000986;
                                                    Eimeria bovis and E.    tylosin as provided
                                                    zuernii; and for        by Nos. 000986 or
                                                    reduction of            016592 in Sec.
                                                    incidence of liver      510.600(c) of this
                                                    abscesses caused by     chapter.
                                                    Fusobacterium
                                                    necrophorum and
                                                    Arcanobacterum
                                                    (Actinomyces)
                                                    pyogenes.
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    Dated: August 19, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-20538 Filed 8-26-13; 8:45 am]
BILLING CODE 4160-01-P