Document ID: FDA-2013-N-0002-0004
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Enrofloxacin; Tilmicosin; Tylosin
Posted Date: 2013-04-03T04:00Z

[Federal Register Volume 78, Number 64 (Wednesday, April 3, 2013)]
[Rules and Regulations]
[Pages 19986-19987]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07571]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 522, and 558

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

New Animal Drugs; Enrofloxacin; Tilmicosin; Tylosin

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 and abbreviated new animal drug applications during 
February 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 April 3, 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 new animal drug applications (NADAs) 
and abbreviated new animal drug applications (ANADAs) during February 
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 Center for Veterinary Medicine (CVM) 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 the spelling of a street name in the sponsor's 
address, and at 21 CFR 558.618 to clarify the dosage of tilmicosin 
phosphate in medicated feeds for beef and non-lactating dairy cattle.
    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.

[[Page 19987]]

                Table 1--Original and Supplemental NADAs and ANADAs Approved During February 2013
----------------------------------------------------------------------------------------------------------------
                                        New animal drug                        21 CFR       FOIA         NEPA
    NADA/ANADA           Sponsor          product name          Action        section      Summary      Review
----------------------------------------------------------------------------------------------------------------
200-495...........  Norbrook           ENROFLOX 100       Original approval    522.812  yes.........  CE \1\
                     Laboratories,      (enrofloxacin)     as a generic
                     Ltd., Station      Injectable         copy of NADA 141-
                     Works, Newry       Solution.          068.
                     BT35 6JP,
                     Northern Ireland.
200-509...........  Huvepharma AD,     TILMOVET 90        Original approval    558.618  yes.........  CE \1\
                     5th Floor, 3A      (tilmicosin        as a generic
                     Nikolay Haytov     phosphate) Type    copy of NADA 141-
                     Str., 1113         A medicated        064.
                     Sophia, Bulgaria.  article.
200-531...........  Huvepharma AD,     TYLOVET 100        Original approval    558.355  yes.........  CE \1\
                     5th Floor, 3A      (tylosin           as a generic
                     Nikolay Haytov     phosphate) and     copy of NADA 104-
                     Str., 1113         RUMENSIN           646.
                     Sophia, Bulgaria.  (monensin) Type
                                        A medicated
                                        articles.
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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 Part 522

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feed.

    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, 
522, 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.

Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), in the entry for 
``Huvepharma AD'', remove ``Haitov'' and in its place add ``Haytov''; 
and in the table in paragraph (c)(2), in the entry for ``016592'', 
remove ``Haitov'' and in its place add ``Haytov''.

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

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

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

0
4. In Sec.  522.812, revise paragraphs (b) and (e)(3)(ii); and add 
introductory text to paragraph (e)(2) to read as follows:

Sec.  522.812  Enrofloxacin.

* * * * *
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter:
    (1) No. 000859 for use of products described in paragraph (a) as in 
paragraph (e) of this section; and
    (2) No. 055529 for use of product described in paragraph (a)(2) as 
in paragraphs (e)(2)(i)(B), (e)(2)(ii)(B), (e)(2)(iii), (e)(3)(i), and 
(e)(3)(iii) of this section.
* * * * *
    (e) * * *
    (2) Cattle. Use the product described in paragraph (a)(2) of this 
section as follows:
* * * * *
    (3) * * *
    (ii) Indications for use--(A) For the treatment and control of 
swine respiratory disease (SRD) associated with Actinobacillus 
pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, 
Streptococcus suis, Bordetella bronchiseptica, and Mycoplasma 
hyopneumoniae.
    (B) For the treatment and control of swine respiratory disease 
(SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella 
multocida, Haemophilus parasuis, and Streptococcus suis.
* * * * *

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

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

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

0
6. In Sec.  558.355, remove and reserve paragraph (f)(3)(ix); and in 
paragraphs (f)(3)(ii)(b) and (f)(3)(xii)(b), add a new last sentence to 
read as follows:

Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (3) * * *
    (ii) * * *
    (b) * * * Tylosin provided by Nos. 000986 and 016592 in Sec.  
510.600(c) of this chapter.
* * * * *
    (xii) * * *
    (b) * * * Tylosin provided by Nos. 000986 and 016592 in Sec.  
510.600(c) of this chapter.
* * * * *

Sec.  558.618  [Amended]

0
7. Amend Sec.  558.618 as follows:
0
a. In paragraph (b), remove ``No. 000986'' and in its place add ``Nos. 
000986 and 016592'';
0
b. In the table in paragraph (e)(1)(i), in the ``Sponsor'' column, add 
``, 016592'' after ``000986'';
0
c. In the table in paragraph (e)(1)(ii), in the ``Sponsor'' column, 
remove ``000986'';
0
d. In the table in paragraph (e)(2)(i), in the ``Limitations'' column, 
in the first sentence, remove ``12.5 milligrams/kilogram/head/day'' and 
in its place add ``12.5 mg tilmicosin/kg of bodyweight/day''; and
0
e. In the table in paragraphs (e)(2)(ii) and (e)(2)(iii), in the 
``Limitations'' column, in the first sentence, remove ``12.5 milligrams 
tilmicosin/kilogram/head/day'' and in its place add ``12.5 mg 
tilmicosin/kg of bodyweight/day''.

    Dated: March 26, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-07571 Filed 4-2-13; 8:45 am]
BILLING CODE 4160-01-P