82_FR_11542 82 FR 11506 - 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

82 FR 11506 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 36 (February 24, 2017)

Page Range11506-11509
FR Document2017-03677

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.

Federal Register, Volume 82 Issue 36 (Friday, February 24, 2017)
[Federal Register Volume 82, Number 36 (Friday, February 24, 2017)]
[Rules and Regulations]
[Pages 11506-11509]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-03677]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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, 
[email protected].

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



                                             11506             Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations

                                             Powers Act. BIS continues to carry out                  comment and a delay in effective date,                DEPARTMENT OF HEALTH AND
                                             the provisions of the Export                            then the national security and foreign                HUMAN SERVICES
                                             Administration Act, as appropriate and                  policy objectives of this rule would be
                                             to the extent permitted by law, pursuant                harmed. Because a notice of proposed                  Food and Drug Administration
                                             to Executive Order 13222, as amended                    rulemaking and an opportunity for
                                             by Executive Order 13637.                               public comment are not required to be                 21 CFR Parts 510, 520, 522, 524, and
                                                                                                     given for this rule by 5 U.S.C. 553, or               558
                                             Rulemaking Requirements
                                                                                                     by any other law, the analytical                      [Docket No. FDA–2016–N–0002]
                                                1. Executive Orders 13563 and 12866
                                             direct agencies to assess all costs and                 requirements of the Regulatory
                                                                                                     Flexibility Act, 5 U.S.C. 601 et seq., are            New Animal Drugs; Approval of New
                                             benefits of available regulatory                                                                              Animal Drug Applications; Withdrawal
                                             alternatives and, if regulation is                      not applicable. Accordingly, no
                                                                                                     regulatory flexibility analysis is required           of Approval of a New Animal Drug
                                             necessary, to select regulatory
                                                                                                     and none has been prepared.                           Application; Change of Sponsor;
                                             approaches that maximize net benefits
                                                                                                                                                           Change of Sponsor’s Address
                                             (including potential economic,                          List of Subject in 15 CFR Part 744
                                             environmental, public health and safety                                                                       AGENCY:    Food and Drug Administration,
                                             effects, distributive impacts, and                        Exports, Reporting and recordkeeping                HHS.
                                             equity). Executive Order 13563                          requirements, Terrorism.                                    Final rule; technical
                                                                                                                                                           ACTION:
                                             emphasizes the importance of                                                                                  amendment.
                                             quantifying both costs and benefits, of                   Accordingly, part 744 of the Export
                                             reducing costs, of harmonizing rules,                   Administration Regulations (15 CFR                    SUMMARY:   The Food and Drug
                                             and of promoting flexibility. This rule                 parts 730 through 774) is amended as                  Administration (FDA or we) is
                                             has been determined to be not                           follows:                                              amending the animal drug regulations to
                                             significant for purposes of Executive                                                                         reflect application-related actions for
                                             Order 12866.                                            PART 744—[AMENDED]                                    new animal drug applications (NADAs)
                                                2. Notwithstanding any other                                                                               and abbreviated new animal drug
                                             provision of law, no person is required                 ■ 1. The authority citation for 15 CFR                applications (ANADAs) during
                                             to respond to or be subject to a penalty                part 744 continues to read as follows:                September and October 2016. FDA is
                                             for failure to comply with a collection                                                                       also informing the public of the
                                             of information, subject to the                             Authority: 50 U.S.C. 4601 et seq.; 50
                                                                                                     U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.;          availability of summaries of the basis of
                                             requirements of the Paperwork                                                                                 approval and of environmental review
                                                                                                     42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22
                                             Reduction Act of 1995 (44 U.S.C. 3501                                                                         documents, where applicable. The
                                                                                                     U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR,
                                             et seq.) (PRA), unless that collection of                                                                     animal drug regulations are also being
                                                                                                     1978 Comp., p. 179; E.O. 12851, 58 FR 33181,
                                             information displays a currently valid                                                                        amended to reflect changes of
                                                                                                     3 CFR, 1993 Comp., p. 608; E.O. 12938, 59
                                             Office of Management and Budget                                                                               sponsorship of several applications and
                                                                                                     FR 59099, 3 CFR, 1994 Comp., p. 950; E.O.
                                             (OMB) Control Number. This regulation                                                                         a change of a sponsor’s address.
                                                                                                     12947, 60 FR 5079, 3 CFR, 1995 Comp., p.
                                             involves collections previously
                                                                                                     356; E.O. 13026, 61 FR 58767, 3 CFR, 1996             DATES: This rule is effective February
                                             approved by OMB under control
                                                                                                     Comp., p. 228; E.O. 13099, 63 FR 45167, 3             24, 2017, except for the amendment to
                                             number 0694–0088, Simplified Network
                                                                                                     CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR            21 CFR 524.1465, which is effective
                                             Application Processing System, which
                                                                                                     44025, 3 CFR, 2001 Comp., p. 783; E.O.                March 6, 2017.
                                             includes, among other things, license
                                                                                                     13224, 66 FR 49079, 3 CFR, 2001 Comp., p.             FOR FURTHER INFORMATION CONTACT:
                                             applications and carries a burden
                                                                                                     786; Notice of January 20, 2016, 81 FR 3937           George K. Haibel, Center for Veterinary
                                             estimate of 43.8 minutes for a manual or                (January 22, 2016); Notice of August 4, 2016,
                                             electronic submission. Total burden                                                                           Medicine (HFV–6), Food and Drug
                                                                                                     81 FR 52587 (August 8, 2016); Notice of               Administration, 7519 Standish Pl.,
                                             hours associated with the PRA and                       September 15, 2016, 81 FR 64343 (September
                                             OMB control number 0694–0088 are not                                                                          Rockville, MD 20855, 240–402–5689,
                                                                                                     19, 2016); Notice of November 8, 2016, 81 FR          george.haibel@fda.hhs.gov.
                                             expected to increase as a result of this                79379 (November 10, 2016).
                                             rule. You may send comments regarding                                                                         SUPPLEMENTARY INFORMATION:
                                             the collection of information associated                Supplement No. 7 to Part 744—
                                                                                                                                                           I. Approval Actions
                                             with this rule, including suggestions for               [AMENDED]
                                             reducing the burden, to Jasmeet K.                                                                              FDA is amending the animal drug
                                             Seehra, Office of Management and                        ■  2. In Supplement No. 7 to part 744,                regulations to reflect approval actions
                                             Budget (OMB), by email to Jasmeet_K._                   remove ‘‘February 27, 2017’’ and add in               for NADAs and ANADAs during
                                             Seehra@omb.eop.gov, or by fax to (202)                  its place ‘‘March 29, 2017’’.                         September and October 2016, as listed
                                             395–7285.                                                                                                     in table 1. In addition, FDA is informing
                                                                                                       Dated: February 21, 2017.
                                                3. This rule does not contain policies                                                                     the public of the availability, where
                                             with Federalism implications as that                    Matthew S. Borman,                                    applicable, of documentation of
                                             term is defined in Executive Order                      Deputy Assistant Secretary for Export                 environmental review required under
                                             13132.                                                  Administration.                                       the National Environmental Policy Act
                                                4. The provisions of the                             [FR Doc. 2017–03664 Filed 2–23–17; 8:45 am]           (NEPA) and, for actions requiring
                                             Administrative Procedure Act (5 U.S.C.                  BILLING CODE 3510–33–P                                review of safety or effectiveness data,
                                             553) requiring notice of proposed                                                                             summaries of the basis of approval (FOI
pmangrum on DSK3GDR082PROD with RULES




                                             rulemaking, the opportunity for public                                                                        Summaries) under the Freedom of
                                             comment, and a delay in effective date                                                                        Information Act (FOIA). These public
                                             are inapplicable because this regulation                                                                      documents may be seen in the Division
                                             involves a military or foreign affairs                                                                        of Dockets Management (HFA–305),
                                             function of the United States. (See 5                                                                         Food and Drug Administration, 5630
                                             U.S.C. 553(a)(1)). If this rule were                                                                          Fishers Lane, Rm. 1061, Rockville, MD
                                             delayed to allow for notice and                                                                               20852, between 9 a.m. and 4 p.m.,


                                        VerDate Sep<11>2014   14:13 Feb 23, 2017   Jkt 241001   PO 00000   Frm 00006   Fmt 4700   Sfmt 4700   E:\FR\FM\24FER1.SGM   24FER1


                                                                      Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations                                                                          11507

                                             Monday through Friday. Persons with                                       OfficeofFoods/CVM/                                                Drug Products Online (Green Book) at:
                                             access to the Internet may obtain these                                   CVMFOIAElectronicReadingRoom/                                     http://www.fda.gov/AnimalVeterinary/
                                             documents at the CVM FOIA Electronic                                      default.htm. Marketing exclusivity and                            Products/
                                             Reading Room: http://www.fda.gov/                                         patent information may be accessed in                             ApprovedAnimalDrugProducts/
                                             AboutFDA/CentersOffices/                                                  FDA’s publication, Approved Animal                                default.htm.

                                                TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING SEPTEMBER AND OCTOBER 2016
                                                                                                                                                                                                                                     Public
                                                 Approval date                   File No.                   Sponsor                   Product name              Species         Effect of the action/indications for use           documents

                                             October 26, 2016 ....                141–465           Elanco US Inc,                INTEPRITY                    Chickens        Original approval for the prevention of            FOI Sum-
                                                                                                      2500 Innovation               (avilamycin) and                             mortality caused by necrotic enter-                mary.
                                                                                                      Way, Greenfield,              COBAN                                        itis associated with Clostridium
                                                                                                      IN 46140.                     (monensin) Type                              perfringens in broiler chickens; and
                                                                                                                                    C medicated                                  as an aid in the prevention of coc-
                                                                                                                                    feeds.                                       cidiosis caused by Eimeria necatrix,
                                                                                                                                                                                 E. tenella, E. acervulina, E. brunetti,
                                                                                                                                                                                 E. mivati, and E. maxima.
                                             September 8, 2016                    200–592           Putney, Inc., One             Amoxicillin Tri-             Dogs ......     Original approval of a generic copy of             FOI Sum-
                                                                                                      Monument Sq.,                hydrate and                                   NADA 055–099.                                      mary.
                                                                                                      Suite 400, Port-             Clavulanate Po-
                                                                                                      land, ME 04101.              tassium Tablets.



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

                                                                     File No.                                                                               Product name                                                       21 CFR section

                                             099–667 ...................................................        IMPOSIL (iron heptomer) Injection ..........................................................................          522.1182
                                             110–399 ...................................................        GLEPTOSIL (gleptoferron) Injection ........................................................................           522.1055



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

                                                                     File No.                                                                               Product name                                                       21 CFR section

                                             006–417      ...................................................   RECOVR (tripelennamine hydrochloride) Injection .................................................                     522.2615
                                             032–319      ...................................................   FUROX (furazolidone) Aerosol Powder ..................................................................                524.1005
                                             038–838      ...................................................   ROBAXIN–V (methocarbamol) Injection .................................................................                 522.1380
                                             108–687      ...................................................   PET DERM III (dexamethasone) Tablets ................................................................                 520.540c
                                             111–369      ...................................................   Dexamethasone Sterile Solution .............................................................................           522.540



                                                Following these changes of                                             As provided in the regulatory text of                                This rule does not meet the definition
                                             sponsorship, Kinetic Technologies, LLC                                    this document, the animal drug                                    of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
                                             is now the sponsor of an approved                                         regulations are amended to reflect this                           it is a rule of ‘‘particular applicability.’’
                                             NADA. Accordingly, the firm’s name,                                       voluntary withdrawal of approval.                                 Therefore, it is not subject to the
                                             address, and drug labeler code are being                                                                                                    congressional review requirements in 5
                                                                                                                       IV. Technical Amendments
                                             added to § 510.600(c).                                                                                                                      U.S.C. 801–808.
                                             III. Withdrawals of Approval                                                 Wildlife Laboratories, Inc., 1401 Duff                         List of Subjects
                                                                                                                       Dr., Suite 600, Fort Collins, CO 80524
                                                In addition, Putney, Inc., One                                         has informed FDA that it has changed                              21 CFR Part 510
                                             Monument Square, Suite 400, Portland,                                     its address to 1230 W. Ash St., Suite D,
                                             ME 04101 has requested that FDA                                           Windsor, CO 80550. In addition, FDA                                 Administrative practice and
                                             withdraw approval of ANADA 200–524                                        has noticed that a sponsor name in                                procedure, Animal drugs, Labeling,
                                             for Mupirocin Ointment 2% because the                                     § 510.600 does not reflect the particular                         Reporting and recordkeeping
pmangrum on DSK3GDR082PROD with RULES




                                             product is no longer manufactured or                                      punctuation used in this sponsor’s                                requirements.
                                             marketed.                                                                 applications and other correspondence.                            21 CFR Parts 520, 522, and 524
                                                Elsewhere in this issue of the Federal                                 At this time, we are amending the list
                                             Register, FDA gave notice that approval                                   of sponsors of approved applications in                              Animal drugs.
                                             of ANADA 200–524, and all                                                 § 510.600(c) to reflect this change of                            21 CFR Part 558
                                             supplements and amendments thereto,                                       sponsor address and sponsor’s
                                             is withdrawn, effective March 6, 2017.                                    punctuation.                                                         Animal drugs, Animal feeds.


                                        VerDate Sep<11>2014        14:13 Feb 23, 2017          Jkt 241001       PO 00000      Frm 00007     Fmt 4700     Sfmt 4700    E:\FR\FM\24FER1.SGM          24FER1


                                             11508                    Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations

                                               Therefore, under the Federal Food,                                      § 510.600         [Amended]                                   ■  ii. Revise the entry for ‘‘053923’’
                                             Drug, and Cosmetic Act and under                                          ■  2. Revise § 510.600 as follows:                            ■  iii. In the entry for ‘‘058198’’, remove
                                             authority delegated to the Commissioner                                   ■  a. In the table in paragraph (c)(1):                       ‘‘Elanco US, Inc.’’ and in its place add
                                             of Food and Drugs and redelegated to                                      ■  i. In the entry for ‘‘Elanco US, Inc.’’,                   ‘‘Elanco US Inc.’’; and
                                             the Center for Veterinary Medicine, 21                                    remove ‘‘Elanco US, Inc.’’ and in its                         ■ iv. Remove the entry for ‘‘059120’’.
                                             CFR parts 510, 520, 522, 524, and 558                                     place add ‘‘Elanco US Inc.’’;
                                                                                                                       ■ ii. Alphabetically add an entry for                            The additions and revisions read as
                                             are amended as follows:                                                                                                                 follows:
                                                                                                                       ‘‘Kinetic Technologies, LLC’’;
                                             PART 510—NEW ANIMAL DRUGS                                                 ■ iii. Remove the entry for ‘‘Sogeval S.
                                                                                                                                                                                     § 510.600 Names, addresses, and drug
                                                                                                                       A.’’; and                                                     labeler codes of sponsors of approved
                                                                                                                       ■ iv. Revise the entry for ‘‘Wildlife                         applications.
                                             ■ 1. The authority citation for part 510
                                                                                                                       Laboratories, Inc.’’                                          *       *    *       *    *
                                             continues to read as follows:                                             ■ b. In the table in paragraph (c)(2):
                                               Authority: 21 U.S.C. 321, 331, 351, 352,                                ■ i. Numerically add an entry for                                 (c) * * *
                                             353, 360b, 371, 379e.                                                     ‘‘051031’’;                                                       (1) * * *

                                                                                                                                                                                                                      Drug labeler
                                                                                                                           Firm name and address                                                                         code


                                                       *                  *                     *                  *                              *                                *                                     *
                                             Kinetic Technologies, LLC, 961 Beasley St., Suite 270, Lexington, KY 40509 ..................................................................................                   051031

                                                       *                     *                    *                 *                                *                                *                                  *
                                             Wildlife Laboratories, Inc., 1230 W. Ash St., Suite D, Windsor, CO 80550 .......................................................................................                053923

                                                           *                              *                                *                          *                       *                       *                  *



                                                 (2) * * *

                                                                                    Drug labeler                                                                                  Firm name and address
                                                                                       code


                                                     *                                 *                                 *                             *                   *                   *                     *
                                             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                                                 § 522.540         [Amended]                                   PART 524—OPHTHALMIC AND
                                             NEW ANIMAL DRUGS                                                                                                                        TOPICAL DOSAGE FORM NEW
                                                                                                                       ■  7. In § 522.540, in paragraph (d)(2)(i),
                                                                                                                                                                                     ANIMAL DRUGS
                                                                                                                       remove ‘‘054771’’ and in its place add
                                             ■ 3. The authority citation for part 520                                  ‘‘051031’’.
                                             continues to read as follows:                                                                                                           ■ 12. The authority citation for part 524
                                                                                                                       § 522.1055          [Amended]                                 continues to read as follows:
                                                 Authority: 21 U.S.C. 360b.
                                                                                                                                                                                         Authority: 21 U.S.C. 360b.
                                             § 520.88g         [Amended]                                               ■  8. In § 522.1055, in paragraph (b),
                                                                                                                       remove ‘‘059120’’ and in its place add                        § 524.1005    [Amended]
                                             ■ 4. In § 520.88g, in paragraph (b),                                      ‘‘013744’’.
                                             remove ‘‘No. 054771’’ and in its place                                                                                                  ■  13. In § 524.1005, in paragraph (b)(1),
                                             add ‘‘Nos. 026637 and 054771’’.                                           § 522.1182          [Amended]                                 remove ‘‘054771’’ and in its place add
                                                                                                                                                                                     ‘‘051031’’.
                                             § 520.540c         [Amended]                                              ■  9. In § 522.1182, in paragraph (b)(3),
                                                                                                                       remove ‘‘059120’’ and in its place add                        § 524.1465    [Amended]
                                             ■  5. In § 520.540c, in paragraph (b),                                    ‘‘013744’’.
                                             remove ‘‘054771’’ and in its place add                                                                                                  ■  14. Effective March 6, 2017, in
                                             ‘‘051031’’.                                                               § 522.1380          [Amended]                                 § 524.1465, in paragraph (b), remove
                                                                                                                                                                                     ‘‘026637’’.
                                                                                                                       ■  10. In § 522.1380, in paragraph (b),
                                             PART 522—IMPLANTATION OR
pmangrum on DSK3GDR082PROD with RULES




                                                                                                                       remove ‘‘054771’’ and in its place add                        PART 558—NEW ANIMAL DRUGS FOR
                                             INJECTABLE DOSAGE FORM NEW
                                                                                                                       ‘‘051031’’.                                                   USE IN ANIMAL FEEDS
                                             ANIMAL DRUGS
                                                                                                                       § 522.2615          [Amended]
                                                                                                                                                                                     ■ 15. The authority citation for part 558
                                             ■ 6. The authority citation for part 522
                                                                                                                       ■  11. In § 522.2615, in paragraph (b),                       continues to read as follows:
                                             continues to read as follows:
                                                                                                                       remove ‘‘054771’’ and in its place add                          Authority: 21 U.S.C. 354, 360b, 360ccc,
                                                 Authority: 21 U.S.C. 360b.                                            ‘‘051031’’.                                                   360ccc–1, 371.



                                        VerDate Sep<11>2014         14:13 Feb 23, 2017        Jkt 241001       PO 00000        Frm 00008      Fmt 4700    Sfmt 4700   E:\FR\FM\24FER1.SGM    24FER1


                                                                    Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations                                           11509

                                             ■ 16. In § 558.68, revise paragraph                            § 558.68    Avilamycin.                                  (e) * * *
                                             (e)(1)(ii) to read as follows:                                 *      *      *      *       *                           (1) * * *

                                                  Avilamycin in                    Combination in                      Indications for use                                 Limitations              Sponsor
                                                   grams/ton                         grams/ton


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



                                             *       *        *        *       *                               Therefore, under authority delegated               approval of NADAs and ANADAs for
                                               Dated: February 21, 2017.                                    to the Commissioner of Food and Drugs                 antimicrobial drugs of importance to
                                             Leslie Kux,                                                    and redelegated to the Center for                     human medicine that are administered
                                                                                                            Veterinary Medicine, and in accordance                to food-producing animals in medicated
                                             Associate Commissioner for Policy.
                                                                                                            with § 514.116 Notice of withdrawal of                feed are being made because the
                                             [FR Doc. 2017–03677 Filed 2–23–17; 8:45 am]
                                                                                                            approval of application (21 CFR                       products are no longer manufactured or
                                             BILLING CODE 4164–01–P
                                                                                                            514.116), notice is given that approval               marketed. These actions are consistent
                                                                                                            of ANADA 200–524, and all                             with the FDA Center for Veterinary
                                                                                                            supplements and amendments thereto,                   Medicine’s initiative for the Judicious
                                             DEPARTMENT OF HEALTH AND
                                                                                                            is hereby withdrawn, effective March 6,               Use of Antimicrobials.
                                             HUMAN SERVICES
                                                                                                            2017.                                                 DATES:  Withdrawal of approval is
                                             Food and Drug Administration                                      Elsewhere in this issue of the Federal             effective February 24, 2017.
                                                                                                            Register, FDA is amending the animal
                                                                                                            drug regulations to reflect the voluntary             FOR FURTHER INFORMATION CONTACT:
                                             21 CFR Part 524                                                                                                      Sujaya Dessai, Center for Veterinary
                                                                                                            withdrawal of approval of this
                                             [Docket No. FDA–2016–N–0002]                                   application.                                          Medicine (HFV–212), Food and Drug
                                                                                                                                                                  Administration, 7519 Standish Pl.,
                                             New Animal Drugs; Withdrawal of                                  Dated: February 21, 2017.                           Rockville, MD 20855, 240–402–5761,
                                             Approval of a New Animal Drug                                  Leslie Kux,                                           sujaya.dessai@fda.hhs.gov.
                                             Application                                                    Associate Commissioner for Policy.
                                                                                                                                                                  SUPPLEMENTARY INFORMATION: FDA is
                                                                                                            [FR Doc. 2017–03678 Filed 2–23–17; 8:45 am]
                                             AGENCY:      Food and Drug Administration,                                                                           withdrawing approval of 18 NADAs and
                                                                                                            BILLING CODE 4164–01–P
                                             HHS.                                                                                                                 2 ANADAs. These applications were
                                             ACTION:     Notification of withdrawal.                                                                              identified as being affected by guidance
                                                                                                                                                                  for industry (GFI) #213, ‘‘New Animal
                                             SUMMARY:   The Food and Drug                                   DEPARTMENT OF HEALTH AND
                                                                                                                                                                  Drugs and New Animal Drug
                                             Administration (FDA) is withdrawing                            HUMAN SERVICES
                                                                                                                                                                  Combination Products Administered in
                                             approval of an abbreviated new animal                                                                                or on Medicated Feed or Drinking Water
                                                                                                            Food and Drug Administration
                                             drug application (ANADA) at the                                                                                      of Food-Producing Animals:
                                             sponsor’s request because the product is                                                                             Recommendations for Drug Sponsors for
                                                                                                            21 CFR Part 558
                                             no longer manufactured or marketed.                                                                                  Voluntarily Aligning Product Use
                                             DATES: Withdrawal of approval is                               [Docket No. FDA–2016–N–0002]                          Conditions With GFI #209,’’ December
                                             effective March 6, 2017.                                                                                             2013 (http://www.fda.gov/downloads/
                                             FOR FURTHER INFORMATION CONTACT:
                                                                                                            New Animal Drugs; Withdrawal of                       AnimalVeterinary/
                                             Sujaya Dessai, Center for Veterinary                           Approval of New Animal Drug                           GuidanceComplianceEnforcement/
                                             Medicine (HFV–212), Food and Drug                              Applications                                          GuidanceforIndustry/UCM299624.pdf).
                                             Administration, 7519 Standish Pl.,                             AGENCY:    Food and Drug Administration,              Their withdrawal of approval is
                                             Rockville, MD 20855, 240–402–5761,                             HHS.                                                  consistent with the FDA Center for
                                             sujaya.dessai@fda.hhs.gov.                                     ACTION:    Notification of withdrawal.                Veterinary Medicine’s initiative for the
                                             SUPPLEMENTARY INFORMATION: Putney,                                                                                   Judicious Use of Antimicrobials.
                                             Inc., One Monument Square, Suite 400,                          SUMMARY:  The Food and Drug                             Approval of the following
                                             Portland, ME 04101 has requested that                          Administration (FDA) is withdrawing                   applications for new animal drugs
                                             FDA withdraw approval of ANADA                                 approval of 18 new animal drug                        administered in medicated feed is being
                                             200–524 for Mupirocin Ointment 2%                              applications (NADAs) and 2 abbreviated                voluntarily withdrawn at the sponsors’
                                             because the product is no longer                               new animal drug applications                          requests because these products are no
pmangrum on DSK3GDR082PROD with RULES




                                             manufactured or marketed.                                      (ANADAs). These withdrawals of                        longer manufactured or marketed:

                                                              File No.                                             Product name                                                     Sponsor

                                             044–820 ......................................   LINCOMIX (lincomycin)/AMPROL PLUS (amprolium                  Zoetis Inc.
                                                                                                and ethopabate).                                            333 Portage St.
                                                                                                                                                            Kalamazoo, MI 49007 (Zoetis Inc.).



                                        VerDate Sep<11>2014       14:13 Feb 23, 2017      Jkt 241001   PO 00000   Frm 00009   Fmt 4700   Sfmt 4700   E:\FR\FM\24FER1.SGM   24FER1



Document Created: 2017-02-24 01:18:04
Document Modified: 2017-02-24 01:18:04
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule; technical amendment.
DatesThis rule is effective February 24, 2017, except for the amendment to 21 CFR 524.1465, which is effective March 6, 2017.
ContactGeorge K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected]
FR Citation82 FR 11506 
CFR Citation21 CFR 510
21 CFR 520
21 CFR 522
21 CFR 524
21 CFR 558
CFR AssociatedAdministrative Practice and Procedure; Animal Drugs; Labeling; Reporting and Recordkeeping Requirements and Animal Feeds

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR