Document ID: FDA-2012-N-0002-0024
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Enrofloxacin; Tylvalosin
Posted Date: 2012-09-10T04:00Z

[Federal Register Volume 77, Number 175 (Monday, September 10, 2012)]
[Rules and Regulations]
[Pages 55414-55415]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22194]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 522, and 556

[Docket No. FDA-2012-N-0002]

New Animal Drugs; Enrofloxacin; Tylvalosin

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 July 2012. 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 10, 2012.

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 original and supplemental approval actions during July 2012, 
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 FOIA 
Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.

                                      Table 1--Original and Supplemental NADAs and ANADAs Approved During July 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               New animal drug
       NADA/ANADA              Sponsor          product name              Action            21 CFR section        FOIA summary           NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-336................  ECO LLC, 8209       AIVLOSIN            Original approval for             520.2645  yes..................  CE \1\
                          Hollister Ave.,     (tylvalosin         control of porcine                556.748
                          Las Vegas, NV       tartrate) Water     proliferative
                          89131.              Soluble Granules.   enteropathy (PPE)
                                                                  associated with
                                                                  Lawsonia
                                                                  intracellularis
                                                                  infection in groups of
                                                                  swine in buildings
                                                                  experiencing an
                                                                  outbreak of PPE.
141-068................  Bayer HealthCare    BAYTRIL 100         Supplement adding                  522.812  yes..................  CE \1\
                          LLC, Animal         (enrofloxacin)      control of bovine
                          Health Division,    Injectable          respiratory disease
                          P.O. Box 390,       Solution.           (BRD) in beef and non-
                          Shawnee Mission,                        lactating dairy cattle
                          KS 66201.                               at high risk of
                                                                  developing BRD
                                                                  associated with
                                                                  Mannheimia
                                                                  haemolytica,
                                                                  Pasteurella multocida,
                                                                  Histophilus somni and
                                                                  Mycoplasma bovis; and
                                                                  revising a food safety
                                                                  warning statement.

[[Page 55415]]

 
200-482................  Cross VetPharm      AMPROMED for        Original approval as a             520.100  yes..................  CE \1\
                          Group, Ltd.,        Calves              generic copy of NADA
                          Broomhill Rd.,      (amprolium) 9.6%    13-149.
                          Tallaght, Dublin    Oral Solution.
                          24, Ireland.
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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.

    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.

List of Subjects

21 CFR Parts 520 and 522

    Animal drugs.

21 CFR Part 556

    Animal drugs, Food.

    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, 
522, and 556 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. In Sec.  520.100, revise paragraph (b)(4) to read as follows:

Sec.  520.100  Amprolium.

* * * * *
    (b) * * *
    (4) No. 061623 for use of product described in paragraph (a)(1) of 
this section as in paragraph (d)(2); and for use of product described 
in paragraph (a)(2) of this section as in paragraphs (d)(1) and (d)(2) 
of this section.
* * * * *

0
3. Add Sec.  520.2645 to read as follows:

Sec.  520.2645  Tylvalosin.

    (a) Specifications. Granules containing 62.5 percent tylvalosin (w/
w) as tylvalosin tartrate.
    (b) Sponsor. See No. 066916 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.748 of this chapter.
    (d) Conditions of use in swine--(1) Amount. Administer 50 parts per 
million tylvalosin in drinking water for 5 consecutive days.
    (2) Indications for use. For the control of porcine proliferative 
enteropathy (PPE) associated with Lawsonia intracellularis infection in 
groups of swine in buildings experiencing an outbreak of PPE.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

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

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

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

0
5. In 522.812, revise paragraphs (e)(2)(i), (e)(2)(ii)(A), and 
(e)(2)(iii) to read as follows:

Sec.  522.812  Enrofloxacin.

* * * * *
    (e) * * *
    (2) * * *
    (i) Amount--(A) Single-dose therapy: For treatment of bovine 
respiratory disease (BRD), administer 7.5 to 12.5 mg/kg of body weight 
(3.4 to 5.7 mL per 100 pounds (/100 lb)) once by subcutaneous 
injection. For control of BRD, administer 7.5 mg/kg of body weight (3.4 
mL/100 lb) once by subcutaneous injection.
    (B) Multiple-day therapy: For treatment of BRD, administer 2.5 to 
5.0 mg/kg of body weight (1.1 to 2.3 mL/100 lb) by subcutaneous 
injection. Treatment should be repeated at 24-hour intervals for 3 
days. Additional treatments may be given on days 4 and 5 to animals 
that have shown clinical improvement but not total recovery.
    (ii) Indications for use--(A) Single-dose therapy: For the 
treatment of BRD associated with Mannheimia haemolytica, Pasteurella 
multocida, Histophilus somni, and Mycoplasma bovis in beef and non-
lactating dairy cattle; for the control of BRD in beef and non-
lactating dairy cattle at high risk of developing BRD associated with 
M. haemolytica, P. multocida, H. somni and M. bovis.
* * * * *
    (iii) Limitations. Animals intended for human consumption must not 
be slaughtered within 28 days from the last treatment. This product is 
not approved for female dairy cattle 20 months of age or older, 
including dry dairy cows. Use in these cattle may cause drug residues 
in milk and/or in calves born to these cows. A withdrawal period has 
not been established for this product in preruminating calves. Do not 
use in calves to be processed for veal.
* * * * *

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

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

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

0
7. Add Sec.  556.748 to read as follows:

Sec.  556.748  Tylvalosin.

    (a) Acceptable Daily Intake (ADI). The ADI for total residues of 
tylvalosin is 47.7 micrograms per kilogram of body weight per day.
    (b) Tolerances. A tolerance for tylvalosin in edible tissues of 
swine is not required.
    (c) Related conditions of use. See Sec.  520.2645 of this chapter.

    Dated: September 5, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-22194 Filed 9-7-12; 8:45 am]
BILLING CODE 4160-01-P