Document ID: FDA-2012-N-0002-0016
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs: Maropitant; Tildipirosin
Posted Date: 2012-07-03T04:00Z

[Federal Register Volume 77, Number 128 (Tuesday, July 3, 2012)]
[Rules and Regulations]
[Pages 39390-39392]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-16203]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556

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

Implantation or Injectable Dosage Form New Animal Drugs; 
Maropitant; Tildipirosin

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 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 July 3, 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, 
email:george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA's Center for Veterinary Medicine (CVM) 
is adopting use of a monthly Federal Register document to codify 
approval actions for NADAs and ANADAs. CVM will no longer publish a 
separate rule for each action. This approach will allow a more 
efficient use of available resources.

[[Page 39391]]

    In this document, FDA is amending the animal drug regulations to 
reflect the original and supplemental approval actions during May 2012, 
as listed in table 1 of this document. 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 CVM FOIA 
Electronic Reading Room at 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 2012
----------------------------------------------------------------------------------------------------------------
                                   New animal drug                       21 CFR                          NEPA
   NADA/ANADA         Sponsor        product name        Action         Section       FOIA  Summary     Review
----------------------------------------------------------------------------------------------------------------
141-334.........  Intervet, Inc.,  ZUPREVO 18%      Original         522.2460       yes.............  CE \1\
                   556 Morris       (tildipirosin)   approval for    556.733
                   Ave., Summit,    Injectable       the treatment
                   NJ 07901.        Solution.        of bovine
                                                     respiratory
                                                     disease (BRD)
                                                     in beef and
                                                     non-lactating
                                                     dairy cattle;
                                                     and for the
                                                     control of
                                                     respiratory
                                                     disease in
                                                     beef and non-
                                                     lactating
                                                     dairy cattle
                                                     at high risk
                                                     of developing
                                                     BRD.
141-263.........  Pfizer, Inc.,    CERENIA          Supplemental     522.1315       yes.............  CE \1\
                   235 East 42d     (maropitant      approval
                   St., New York,   citrate)         adding
                   NY 10017.        Injectable       treatment of
                                    Solution.        vomiting in
                                                     cats.
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\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded 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 522

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

    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 522 and 
556 are amended as follows:

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

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

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

0
2. In Sec.  522.1315, revise paragraph (c) to read as follows:

Sec.  522.1315  Maropitant.

* * * * *
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 1.0 mg per 
kilogram (mg/kg) of body weight by subcutaneous injection once daily 
for up to 5 consecutive days.
    (ii) Indications for use. For the prevention and treatment of acute 
vomiting.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer 1.0 mg/kg of body weight by 
subcutaneous injection once daily for up to 5 consecutive days.
    (ii) Indications for use. For the treatment of vomiting.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
3. Section 522.2460 is added to read as follows:

Sec.  522.2460  Tildipirosin.

    (a) Specifications. Each milliliter of solution contains:
    (1) 180 milligrams (mg) tildipirosin.
    (2) [Reserved]
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.733 of this chapter.
    (d) Conditions of use--(1) Cattle--(i) Amount. Administer 4 mg/kg 
of bodyweight one time by subcutaneous injection in the neck.
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (BRD) associated with Mannheimia haemolytica, Pasteurella 
multocida, and Histophilus somni in beef and non-lactating dairy 
cattle; and for the control of respiratory disease in beef and non-
lactating dairy cattle at high risk of developing BRD associated with 
M. haemolytica, P. multocida, and H. somni.
    (iii) Limitations. Cattle intended for human consumption must not 
be slaughtered within 21 days from the last treatment. Do not use in 
female dairy cattle 20 months of age or older. A withdrawal period has 
not been established for this product in preruminating calves. Do not 
use in calves to be processed for veal. Federal law restricts this drug 
to use by or on the order of a licensed veterinarian.
    (2) [Reserved]

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

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

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

0
5. Add Sec.  556.733 to read as follows:

Sec.  556.733  Tildipirosin.

    (a) Acceptable Daily Intake (ADI). The ADI for total residues of 
tildipirosin is 10 micrograms per kilogram of body weight per day.
    (b) Tolerances. The tolerances for tildipirosin (the marker 
residue) are:
    (1) Cattle--(i) Liver (the target tissue): 10 parts per million.
    (ii) [Reserved]
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  522.2460 of this chapter.

[[Page 39392]]

    Dated: June 27, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-16203 Filed 7-2-12; 8:45 am]
BILLING CODE 4160-01-P