Document ID: FDA-2013-N-0002-0014
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs; Clindamycin; Enrofloxacin
Posted Date: 2013-05-22T04:00Z

[Federal Register Volume 78, Number 99 (Wednesday, May 22, 2013)]
[Rules and Regulations]
[Page 30197]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12134]

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  Federal Register / Vol. 78, No. 99 / Wednesday, May 22, 2013 / Rules 
and Regulations  

[[Page 30197]]

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; Clindamycin; Enrofloxacin

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 April 2013. FDA is also informing the public of the 
availability of summaries for the basis of approval and of 
environmental review documents, where applicable.

DATES: This rule is effective May 22, 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 April 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 April 2013
----------------------------------------------------------------------------------------------------------------
                                     New animal drug                         21 CFR                       NEPA
  NADA/ ANADA         Sponsor          product name          Action         Section     FOIA summary     review
----------------------------------------------------------------------------------------------------------------
200-538........  Cross Vetpharm     CLINDAMED          Original approval      520.447  yes...........  CE \1\.
                  Group Ltd.,        (clindamycin       as a generic
                  Broomhill Rd.,     hydrochloride)     copy of NADA 135-
                  Tallaght, Dublin   Oral Drops.        940.
                  24, Ireland.
200-551........  Putney, Inc., 400  Enrofloxacin       Original approval      520.812  yes...........  CE \1\.
                  Congress St.,      Flavored Tablets.  as a generic
                  Suite 200,                            copy of NADA 140-
                  Portland, ME                          441.
                  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 (EA) or an environmental impact statement (EIS) because it
  is of a type that does not individually or cumulatively have a significant effect on the human environment.

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.

Sec.  520.447  [Amended]

0
2. In paragraph (b) of Sec.  520.447, remove ``and'' and add ``, and 
061623'' after ``058829''.

0
3. Revise Sec.  520.812 to read as follows:

Sec.  520.812  Enrofloxacin.

    (a) Specifications. Each tablet contains 22.7, 68.0, or 136.0 
milligrams (mg) of enrofloxacin.
    (b) Sponsors. See Nos. 000859 and 026637 in Sec.  510.600(c) of 
this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 
orally as a single, daily dose or divided into two equal doses at 12-
hour intervals.
    (i) Dogs. 5 to 20 mg per kilogram (/kg) (2.27 to 9.07 mg per pound 
(/lb)) of body weight.
    (ii) Cats. 5 mg/kg (2.27 mg/lb) of body weight.
    (2) Indications for use. For the management of diseases associated 
with bacteria susceptible to enrofloxacin.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. Federal law prohibits the 
extralabel use of this drug in food-producing animals.

    Dated: May 16, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-12134 Filed 5-21-13; 8:45 am]
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