Document ID: FDA-2013-N-0002-0034
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Afoxolaner, Carprofen, Ceftiofur Hydrochloride, Monensin
Posted Date: 2013-11-05T05:00Z

[Federal Register Volume 78, Number 214 (Tuesday, November 5, 2013)]
[Rules and Regulations]
[Pages 66263-66265]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26473]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, and 558

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

New Animal Drugs; Afoxolaner; Carprofen; Ceftiofur Hydrochloride; 
Monensin

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 September 2013. FDA is also informing the public of the 
availability of summaries on the basis of approval and of environmental 
review documents, where applicable. The animal drug regulations are 
also being amended to reflect a change of sponsorship for an ANADA.

DATES: This rule is effective November 5, 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 September 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 FOIA 
Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.
    In addition, Piedmont Animal Health, 204 Muirs Chapel Rd., suite 
200, Greensboro, NC 27410 has informed FDA that it has transferred 
ownership of, and all rights and interest in, ANADA 200-555 for 
LIBREVIA (carprofen) Soft Chewable Tablets to Bayer HealthCare LLC, 
Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201. 
Accordingly, the Agency is amending the regulations to reflect this 
change of sponsorship.
    Following this change of sponsorship, Piedmont Animal Health is no 
longer a sponsor of an approved NADA. Accordingly, FDA is amending 21 
CFR 510.600 to remove the entries for this firm.
    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 66264]]

               Table 1--Original and Supplemental NADAs and ANADAs Approved During September 2013
----------------------------------------------------------------------------------------------------------------
                                     New animal drug                           21 CFR       FOIA
   NADA/ANADA         Sponsor         product name            Action          Section     Summary    NEPA Review
----------------------------------------------------------------------------------------------------------------
141-406........  Merial Ltd., 3239  NEXGARD           Original approval for     520.43  yes........  CE 1 2.
                  Satellite Blvd.,   (afoxolaner),     the treatment and
                  Bldg. 500,         Chewable          prevention of flea
                  Duluth, GA 30096-  Tablets.          infestations, and
                  4640.                                the treatment and
                                                       control of American
                                                       dog tick
                                                       infestations in
                                                       dogs.
095-735........  Elanco Animal      RUMENSIN          Supplement extending     558.355  yes........  CE 1 3.
                  Health, A          (monensin).       the lower dose limit
                  Division of Eli   Type A medicated   of monensin
                  Lilly & Co.,       article.          medicated feed for
                  Lilly Corporate                      pasture cattle from
                  Center,                              25 grams per ton (g/
                  Indianapolis, IN                     ton) to 15 g/ton.
                  46285.
141-288........  Zoetis Inc., 333   EXCENEL RTU EZ    Supplemental approval   522.313b  yes........  CE 1 4.
                  Portage St.,       (ceftiofur        of a reformulated
                  Kalamazoo, MI      hydrochloride),   product for use in
                  49007.             Injectable        cattle and swine,
                                     Suspension.       addition of an
                                                       intramuscular route
                                                       of injection in
                                                       cattle, change in
                                                       withdrawal period
                                                       for cattle, and
                                                       addition of a
                                                       warning statement.
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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.
2 CE granted under 21 CFR 25.33(d)(1).
3 CE granted under 21 CFR 25.33(a)(1).
4 CE granted under 21 CFR 25.33(a)(3).

List of Subjects

21 CFR Part 510

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

21 CFR Parts 520 and 522

    Animal drugs.

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, 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), remove the entry 
for ``Piedmont Animal Health''; and in the table in paragraph (c)(2), 
remove the entry for ``058147''.

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. Sec.  520.44, 520.45, 520.45a, and 520.45b   [Redesignated as 
Sec. Sec.  520.28, 520.38, 520.38a, and 520.38b]

0
4. Redesignate Sec. Sec.  520.44, 520.45, 520.45a, and 520.45b as 
Sec. Sec.  520.28, 520.38, 520.38a, and 520.38b, respectively.

0
5. Add Sec.  520.43 to read as follows:

Sec.  520.43  Afoxolaner.

    (a) Specifications. Each chewable tablet contains 11.3, 28.3, 68, 
or 136 milligrams (mg) afoxolaner.
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer orally once a month 
at a minimum dosage of 1.14 mg/pound (lb) (2.5 mg/kilogram (kg)).
    (2) Indications for use. For the treatment and prevention of flea 
infestations (Ctenocephalides felis), and the treatment and control of 
American dog tick (Dermacentor variabilis) infestations in dogs and 
puppies 8 weeks of age and older, weighing 4 pounds of body weight or 
greater, for 1 month.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

Sec.  520.309  [Amended]

0
6. In paragraph (b)(2) of Sec.  520.309, remove ``Nos. 000115, 055529, 
058147, and 062250'' and in its place add ``Nos. 000115, 000859, 
055529, and 062250''.

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

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

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

0
8. In 522.313b, revise paragraphs (b), (d), (e)(2)(i), and (e)(2)(iii) 
to read as follows:

Sec.  522.313b  Ceftiofur hydrochloride.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *
    (d) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian. Federal law prohibits 
extra-label use of this drug in cattle and swine for disease prevention 
purposes; at unapproved doses, frequencies, durations, or routes of 
administration; and in unapproved major food-producing species/
production classes.
    (e) * * *
    (2) * * *
    (i) Amount. Administer by subcutaneous or intramuscular injection 
as follows:
    (A) For bovine respiratory disease and acute bovine interdigital 
necrobacillosis: 1.1 to 2.2 mg/kg of body weight at 24-hour intervals 
for 3 to 5 consecutive days.
    (B) For bovine respiratory disease: 2.2 mg/kg of body weight 
administered twice at a 48 hour interval.
    (C) For acute metritis: 2.2 mg/kg of body weight at 24-hour 
intervals for 5 consecutive days.
* * * * *
    (iii) Limitations. Treated cattle must not be slaughtered for 4 
days following the last treatment. A withdrawal period has not been 
established in preruminating calves. Do not use in calves to be 
processed for veal.

[[Page 66265]]

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

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

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

Sec.  558.355  [Amended]

0
10. In Sec.  558.355, in the introductory text in paragraph 
(f)(3)(iii), remove ``Monensin, 25 to 400 grams'' and in its place add 
``Monensin, 15 to 400 grams''.

    Dated: October 31, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-26473 Filed 11-4-13; 8:45 am]
BILLING CODE 4160-01-P