Document ID: FDA-2015-N-0002-0050
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawals of Approval of New Animal Drug Applications; Changes of
Sponsorship
Posted Date: 2015-12-09T05:00Z

[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Rules and Regulations]
[Pages 76384-76387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31042]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, and 558

[Docket No. FDA-2015-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications; 
Withdrawals of Approval of New Animal Drug Applications; Changes of 
Sponsorship

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect application-related actions for new animal 
drug applications (NADAs) and abbreviated new animal drug applications 
(ANADAs) during September and October 2015. FDA is also informing the 
public of the availability of summaries of the basis of approval and of 
environmental review documents, where applicable. The animal drug 
regulations are also being amended to reflect changes of sponsorship of 
applications and the voluntary withdrawals of approval of applications 
that occurred in September and October 2015.

DATES: This rule is effective December 9, 2015, except for the 
amendments to 21 CFR 520.446, 520.2043, 558.625, and 558.630, which are 
effective December 21, 2015.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-402-5689, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

[[Page 76385]]

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during September and October 2015, 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. Marketing 
exclusivity and patent information may be accessed in FDA's 
publication, Approved Animal Drug Products Online (Green Book) at: 
http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

                             Table 1--Original and Supplemental NADAs and ANADAs Approved During September and October 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                          21 CFR
            File No.                     Sponsor            Product name               Action            section       FOIA  summary      NEPA  review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-440.........................  Piedmont Animal       CLARO (florfenicol,   Original approval for        524.957  yes...............  CE.1 2
                                   Health, 204 Muirs     terbinafine,          the treatment of
                                   Chapel Rd., suite     mometasone furoate)   otitis externa in dogs.
                                   200, Greensboro, NC   Otic Solution.
                                   27410.
141-449.........................  Intervet, Inc., 2     SAFE-GUARD AquaSol    Original approval for       520.905a  yes...............  EA/
                                   Giralda Farms,        (fenbendazole oral    the treatment and                                        FONSI.\3\
                                   Madison, NJ 07940.    suspension)           control of certain
                                                         Suspension            nematode worms in
                                                         Concentrate.          broiler chickens,
                                                                               replacement chickens
                                                                               intended to become
                                                                               breeding chickens, and
                                                                               breeding chickens.
141-442.........................  Zoetis Inc., 333      LUTALYSE HighCon      Supplemental approval        522.690  yes...............  CE.1 4
                                   Portage St.,          (dinoprost            of subcutaneous route
                                   Kalamazoo, MI 49007.  tromethamine          of administration.
                                                         injection)
                                                         Injection.
108-901.........................  Zoetis Inc. 333       LUTALYSE (dinoprost   Supplemental approval        522.690  no................  CE.1 4
                                   Portage St.,          tromethamine          of revised indications
                                   Kalamazoo, MI 49007.  injection)            for uses in cattle.
                                                         Injection.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined 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 have a significant effect on the human environment.
\2\ CE granted under 21 CFR 25.33(d)(1).
\3\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
  no significant impact (FONSI).
\4\ CE granted under 21 CFR 25.33(a)(1).

II. Changes of Sponsorship

    During September and October 2015, ownership of, and all rights and 
interest in, the following approved applications have been transferred 
as follows:

----------------------------------------------------------------------------------------------------------------
                                                                                                      21 CFR
           File No.               Previous sponsor        Product name           New sponsor          section
----------------------------------------------------------------------------------------------------------------
141-440......................  Piedmont Animal        CLARO (florfenicol,   Bayer HealthCare             524.957
                                Health, 204 Muirs      terbinafine,          LLC, Animal Health
                                Chapel Rd., suite      mometasone furoate)   Division, P.O. Box
                                200, Greensboro, NC    Otic Solution.        390, Shawnee
                                27410.                                       Mission, KS 66201.
200-582......................  Orkeo USA, Inc., 77    LONCOR 300            Bayer HealthCare             522.955
                                Water St., New York,   (florfenicol)         LLC, Animal Health
                                NY 10005.              Injectable Solution.  Division, P.O. Box
                                                                             390, Shawnee
                                                                             Mission, KS 66201.
----------------------------------------------------------------------------------------------------------------

As provided in the regulatory text of this document, the animal drug 
regulations are amended to reflect these changes of sponsorship. 
Following the change of sponsorship of ANADA 200-582, Orkeo USA, Inc., 
is no longer the sponsor of an approved application.

III. Withdrawals of Approval

    In addition, during September and October 2015, the following three 
sponsors have requested that FDA withdraw approval of the NADAs and 
ANADAs listed in the following table because the products are no longer 
manufactured or marketed:

----------------------------------------------------------------------------------------------------------------
                                                                                                      21 CFR
              File No.                           Sponsor                    Product name              section
----------------------------------------------------------------------------------------------------------------
140-680 \1\.........................  Pharmgate LLC, 1015 Ashes     TYLAN (tylosin phosphate)            558.625
                                       Dr., suite 102, Wilmington,   Premix.
                                       NC 28405.

[[Page 76386]]

 
140-681 \1\.........................  Pharmgate LLC, 1015 Ashes     TYLAN SULFA G (tylosin               558.630
                                       Dr., suite 102, Wilmington,   phosphate and
                                       NC 28405.                     sulfamethazine) Premix.
200-028.............................  Pegasus Laboratories, Inc.,   EVICT 300 (pyrantel pamoate)        520.2043
                                       8809 Ely Rd., Pensacola, FL   Suspension.
                                       32514.
200-383.............................  Bayer HealthCare LLC, Animal  CLINDAROBE (clindamycin)             520.446
                                       Health Division, P.O. Box     Capsules.
                                       390, Shawnee Mission, KS
                                       66201.
----------------------------------------------------------------------------------------------------------------
\1\ These NADAs were identified as being affected by guidance for industry #213, ``New Animal Drugs and New
  Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing
  Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,''
  December 2013.

    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADA 140-680, NADA 140-681, ANADA 200-028, and ANADA 
200-383, and all supplements and amendments thereto, is withdrawn, 
effective December 21, 2015. As provided in the regulatory text of this 
document, the animal drug regulations are amended to reflect these 
voluntary withdrawals of approval.

IV. Technical Amendments

    FDA has noticed that a previous sponsor of ANADA 200-383, Teva 
Canada Ltd., was no longer the sponsor of an approved application 
following a prior change of sponsorship. At this time, FDA is amending 
the regulation to remove the firm from the listings of sponsors of 
approved applications in 21 CFR 510.600. This action is being taken to 
improve the accuracy of the regulations.
    FDA is also revising the special considerations for medicated feeds 
containing veterinary feed directive drugs to align with 21 CFR 
558.6(a)(6), which was recently amended (80 FR 31708, June 3, 2015). 
This action is being taken to improve the consistency of the 
regulations.
    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 Part 510

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

21 CFR Parts 520, 522, and 524

    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, 524, 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:
0
a. In the table in paragraph (c)(1), remove the entries for ``Orkeo 
USA, Inc.'' and ``Teva Canada Ltd.''; and
0
b. In the table in paragraph (c)(2), remove the entries for ``043806'' 
and ``086050''.

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.  520.446  [Amended]

0
4. Effective December 21, 2015, in Sec.  520.446, in paragraph (b)(1), 
remove ``Nos. 000859 and 054771'' and in its place add ``No. 054771''.
0
5. In Sec.  520.905a:
0
a. Revise paragraphs (a) and (e)(4)(i);
0
b. In paragraph (e)(4)(iii), remove the first sentence; and
0
c. Add paragraph (e)(5).
    The revisions and addition read as follows:

Sec.  520.905a  Fenbendazole suspension.

    (a) Specifications. Each milliliter of suspension contains 100 
milligrams (mg) fenbendazole for use as in paragraphs (e)(1), (2), (3), 
and (4) of this section; or 200 mg fenbendazole for use as in paragraph 
(e)(5) of this section.
* * * * *
    (e) * * *
    (4) * * *
    (i) Amount. Administer orally 5 mg/kg of body weight (2.3 mg/lb). 
Retreatment may be needed after 4 to 6 weeks.
* * * * *
    (5) Chickens--(i) Amount. Administer orally via drinking water at a 
daily dose of 1 mg/kg body weight (0.454 mg/lb) for 5 consecutive days.
    (ii) Indications for use. For the treatment and control of adult 
Ascaridia galli in broiler chickens and replacement chickens intended 
to become breeding chickens, and for the treatment and control of adult 
A. galli and Heterakis gallinarum in breeding chickens.
    (iii) Limitations. Not for use in laying hens and replacement 
chickens intended to become laying hens.

Sec.  520.2043  [Amended]

0
6. Effective December 21, 2015, in Sec.  520.2043, in paragraph (b)(2), 
remove ``Nos. 054771, 055246, 058829, and 059130'' and in its place add 
``Nos. 000859, 054771, and 058829''.

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 Sec.  522.690, revise paragraphs (b)(2) and (d)(1)(i) and add 
paragraph (b)(3) to read as follows:

Sec.  522.690  Dinoprost.

* * * * *
    (b) * * *
    (2) No. 054771 for use of the 5 mg/mL product as in paragraphs 
(d)(1), (2), and (3) of this section.
    (3) No. 000859 for use of the 5 mg/mL product as in paragraphs 
(d)(2), (3), and (4) of this section.
* * * * *
    (d) * * *
    (1) * * *
    (i) Amount. 25 mg as a single intramuscular or subcutaneous 
injection.
* * * * *

Sec.  522.955  [Amended]

0
9. In Sec.  522.955(b)(2), remove ``086050'' and in its place add 
``000859''.

[[Page 76387]]

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
10. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

0
11. Add Sec.  524.957 to read as follows:

Sec.  524.957  Florfenicol, terbinafine, and mometasone otic solution.

    (a) Specifications. Each single-dose, prefilled dropperette 
contains 1 milliliter (mL) of a solution containing 15 milligrams (mg) 
florfenicol, 13.3 mg terbinafine, and 2 mg mometasone furoate.
    (b) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer one 
dropperette (1 mL) per affected ear(s).
    (2) Indications for use. For the treatment of otitis externa in 
dogs associated with susceptible strains of yeast (Malassezia 
pachydermatis) and bacteria (Staphylococcus pseudintermedius).
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

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

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

    Authority:  (P>21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

0
13. In Sec.  558.68, revise paragraph (c)(1) to read as follows:

Sec.  558.68  Avilamycin.

* * * * *
    (c) * * *
    (1) Federal law restricts medicated feed containing this veterinary 
feed directive (VFD) drug to use by or on the order of a licensed 
veterinarian. See Sec.  558.6 for additional requirements.
* * * * *
0
14. In Sec.  558.261, revise paragraphs (c)(1) and (2) introductory 
text to read as follows:

Sec.  558.261  Florfenicol.

* * * * *
    (c) * * *
    (1) Federal law restricts medicated feed containing this veterinary 
feed directive (VFD) drug to use by or on the order of a licensed 
veterinarian. See Sec.  558.6 for additional requirements.
    (2) The expiration date of VFDs for florfenicol medicated feeds:
* * * * *

0
15. In Sec.  558.618, revise paragraph (c)(1) to read as follows:

Sec.  558.618  Tilmicosin.

* * * * *
    (c) * * *
    (1) Federal law restricts medicated feed containing this veterinary 
feed directive (VFD) drug to use by or on the order of a licensed 
veterinarian. See Sec.  558.6 for additional requirements.
* * * * *

Sec.  558.625  [Amended]

0
16. Effective December 21, 2015, in Sec.  558.625, remove paragraph 
(b)(5) and redesignate paragraph (b)(6) as paragraph (b)(5).

Sec.  558.630  [Amended]

0
17. Effective December 21, 2015, in Sec.  558.630, in paragraph (b)(2), 
remove ``Nos. 054771 and 069254'' and in its place add ``No. 054771''.

    Dated: December 4, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-31042 Filed 12-8-15; 8:45 am]
 BILLING CODE 4164-01-P