Document ID: FDA-2016-N-0002-0039
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor’s Address
Posted Date: 2017-02-24T05:00Z

[Federal Register Volume 82, Number 36 (Friday, February 24, 2017)]
[Rules and Regulations]
[Pages 11506-11509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03677]

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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-2016-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications; 
Withdrawal of Approval of a New Animal Drug Application; Change of 
Sponsor; Change of Sponsor's Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA or we) 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 2016. 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 several applications and a change of a sponsor's 
address.

DATES: This rule is effective February 24, 2017, except for the 
amendment to 21 CFR 524.1465, which is effective March 6, 2017.

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: 

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during September and October 2016, 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.,

[[Page 11507]]

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. 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 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Effect of the action/
          Approval date            File No.        Sponsor            Product name           Species          indications for use      Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
October 26, 2016................    141-465  Elanco US Inc, 2500  INTEPRITY            Chickens...........  Original approval for    FOI Summary.
                                              Innovation Way,      (avilamycin) and                          the prevention of
                                              Greenfield, IN       COBAN (monensin)                          mortality caused by
                                              46140.               Type C medicated                          necrotic enteritis
                                                                   feeds.                                    associated with
                                                                                                             Clostridium
                                                                                                             perfringens in broiler
                                                                                                             chickens; and as an
                                                                                                             aid in the prevention
                                                                                                             of coccidiosis caused
                                                                                                             by Eimeria necatrix,
                                                                                                             E. tenella, E.
                                                                                                             acervulina, E.
                                                                                                             brunetti, E. mivati,
                                                                                                             and E. maxima.
September 8, 2016...............    200-592  Putney, Inc., One    Amoxicillin          Dogs...............  Original approval of a   FOI Summary.
                                              Monument Sq.,        Trihydrate and                            generic copy of NADA
                                              Suite 400,           Clavulanate                               055-099.
                                              Portland, ME 04101.  Potassium Tablets.
--------------------------------------------------------------------------------------------------------------------------------------------------------

II. Change of Sponsorship

    Sogeval S. A., 200 Avenue de Mayenne, 53000 Laval, France has 
informed FDA that it has transferred ownership of, and all rights and 
interest in, the following applications to Ceva Sante Animale, 10 
Avenue de la Ballasti[egrave]re, 33500 Libourne, France:

------------------------------------------------------------------------
           File No.                  Product name        21 CFR section
------------------------------------------------------------------------
099-667.......................  IMPOSIL (iron                   522.1182
                                 heptomer) Injection.
110-399.......................  GLEPTOSIL                       522.1055
                                 (gleptoferron)
                                 Injection.
------------------------------------------------------------------------

    Following these changes of sponsorship, Sogeval S. A. is no longer 
the sponsor of an approved NADA. Accordingly, the firm's name, address, 
and drug labeler code are being removed from Sec.  510.600(c) (21 CFR 
510.600(c)).
    In addition, Zoetis, Inc., 333 Portage St., Kalamazoo, MI 49007 has 
informed FDA that it has transferred ownership of, and all rights and 
interest in, the following applications to Kinetic Technologies, LLC, 
961 Beasley St., Suite 270, Lexington, KY 40509:

------------------------------------------------------------------------
           File No.                  Product name        21 CFR section
------------------------------------------------------------------------
006-417.......................  RECOVR                          522.2615
                                 (tripelennamine
                                 hydrochloride)
                                 Injection.
032-319.......................  FUROX (furazolidone)            524.1005
                                 Aerosol Powder.
038-838.......................  ROBAXIN-V                       522.1380
                                 (methocarbamol)
                                 Injection.
108-687.......................  PET DERM III                    520.540c
                                 (dexamethasone)
                                 Tablets.
111-369.......................  Dexamethasone Sterile            522.540
                                 Solution.
------------------------------------------------------------------------

    Following these changes of sponsorship, Kinetic Technologies, LLC 
is now the sponsor of an approved NADA. Accordingly, the firm's name, 
address, and drug labeler code are being added to Sec.  510.600(c).

III. Withdrawals of Approval

    In addition, Putney, Inc., One Monument Square, Suite 400, 
Portland, ME 04101 has requested that FDA withdraw approval of ANADA 
200-524 for Mupirocin Ointment 2% because the product is no longer 
manufactured or marketed.
    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of ANADA 200-524, and all supplements and amendments 
thereto, is withdrawn, effective March 6, 2017. As provided in the 
regulatory text of this document, the animal drug regulations are 
amended to reflect this voluntary withdrawal of approval.

IV. Technical Amendments

    Wildlife Laboratories, Inc., 1401 Duff Dr., Suite 600, Fort 
Collins, CO 80524 has informed FDA that it has changed its address to 
1230 W. Ash St., Suite D, Windsor, CO 80550. In addition, FDA has 
noticed that a sponsor name in Sec.  510.600 does not reflect the 
particular punctuation used in this sponsor's applications and other 
correspondence. At this time, we are amending the list of sponsors of 
approved applications in Sec.  510.600(c) to reflect this change of 
sponsor address and sponsor's punctuation.
    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.

[[Page 11508]]

    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 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. Revise Sec.  510.600 as follows:
0
a. In the table in paragraph (c)(1):
0
i. In the entry for ``Elanco US, Inc.'', remove ``Elanco US, Inc.'' and 
in its place add ``Elanco US Inc.'';
0
ii. Alphabetically add an entry for ``Kinetic Technologies, LLC'';
0
iii. Remove the entry for ``Sogeval S. A.''; and
0
iv. Revise the entry for ``Wildlife Laboratories, Inc.''
0
b. In the table in paragraph (c)(2):
0
i. Numerically add an entry for ``051031'';
0
ii. Revise the entry for ``053923''
0
iii. In the entry for ``058198'', remove ``Elanco US, Inc.'' and in its 
place add ``Elanco US Inc.''; and
0
iv. Remove the entry for ``059120''.
    The additions and revisions read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                              * * * * * * *
Kinetic Technologies, LLC, 961 Beasley St., Suite 270,            051031
 Lexington, KY 40509....................................
 
                              * * * * * * *
Wildlife Laboratories, Inc., 1230 W. Ash St., Suite D,            053923
 Windsor, CO 80550......................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
             Drug labeler code                                                          Firm name and address
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
051031.....................................  Kinetic Technologies, LLC, 961 Beasley St., Suite 270, Lexington, KY 40509.
 
                                                                      * * * * * * *
053923.....................................  Wildlife Laboratories, Inc., 1230 W. Ash St., Suite D, Windsor, CO 80550.
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for part 520 continues to read as follows:

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

Sec.  520.88g  [Amended]

0
4. In Sec.  520.88g, in paragraph (b), remove ``No. 054771'' and in its 
place add ``Nos. 026637 and 054771''.

Sec.  520.540c  [Amended]

0
5. In Sec.  520.540c, in paragraph (b), remove ``054771'' and in its 
place add ``051031''.

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

0
6. The authority citation for part 522 continues to read as follows:

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

Sec.  522.540  [Amended]

0
7. In Sec.  522.540, in paragraph (d)(2)(i), remove ``054771'' and in 
its place add ``051031''.

Sec.  522.1055  [Amended]

0
8. In Sec.  522.1055, in paragraph (b), remove ``059120'' and in its 
place add ``013744''.

Sec.  522.1182  [Amended]

0
9. In Sec.  522.1182, in paragraph (b)(3), remove ``059120'' and in its 
place add ``013744''.

Sec.  522.1380  [Amended]

0
10. In Sec.  522.1380, in paragraph (b), remove ``054771'' and in its 
place add ``051031''.

Sec.  522.2615  [Amended]

0
11. In Sec.  522.2615, in paragraph (b), remove ``054771'' and in its 
place add ``051031''.

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

0
12. The authority citation for part 524 continues to read as follows:

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

Sec.  524.1005  [Amended]

0
13. In Sec.  524.1005, in paragraph (b)(1), remove ``054771'' and in 
its place add ``051031''.

Sec.  524.1465  [Amended]

0
14. Effective March 6, 2017, in Sec.  524.1465, in paragraph (b), 
remove ``026637''.

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

0
15. The authority citation for part 558 continues to read as follows:

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

[[Page 11509]]

0
16. In Sec.  558.68, revise paragraph (e)(1)(ii) to read as follows:

Sec.  558.68  Avilamycin.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                                   Combination in
    Avilamycin in grams/ton           grams/ton        Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ii) 13.6 to 40.9..............  Monensin 90 to      Broiler chickens: For    Feed as the sole ration     058198
                                  110; as provided    the prevention of        for 21 consecutive
                                  by No. 058198 in    mortality caused by      days. To assure
                                  Sec.   510.600(c)   necrotic enteritis       responsible
                                  of this chapter.    associated with          antimicrobial drug use
                                                      Clostridium              in broiler chickens,
                                                      perfringens in broiler   treatment
                                                      chickens; and as an      administration must
                                                      aid in the prevention    begin on or before 10
                                                      of coccidiosis caused    days of age. See Sec.
                                                      by Eimeria necatrix,      558.355(d) of this
                                                      E. tenella, E.           chapter for additional
                                                      acervulina, E.           required labeling.
                                                      brunetti, E. mivati,
                                                      and E. maxima.
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: February 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03677 Filed 2-23-17; 8:45 am]
 BILLING CODE 4164-01-P