81 FR 36787 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 110 (June 8, 2016)

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 March and April 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 applications and the voluntary withdrawals of approval of applications that occurred in January and February.

[Federal Register Volume 81, Number 110 (Wednesday, June 8, 2016)]
[Rules and Regulations]
[Pages 36787-36790]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13517]



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Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Rules 
and Regulations

[[Page 36787]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 556, and 558

[Docket No. FDA-2016-N-0002]


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

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 March and April 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 applications and the voluntary withdrawals of approval 
of applications that occurred in January and February.

DATES: This rule is effective June 8, 2016 except for the amendments to 
21 CFR 520.1696b, 520.2325a, 520.2261a, 558.248, and 558.625, which are 
effective June 20, 2016.

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 March and April 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., 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 March and April 2016
----------------------------------------------------------------------------------------------------------------
                                                                           21 CFR
     File No.           Sponsor        Product name         Action        section    FOIA summary   NEPA review
----------------------------------------------------------------------------------------------------------------
141-392..........  Elanco Animal     IMRESTOR          Original           522.1684  yes..........  EA/FONSI \1\
                    Health, a         (pegbovigrastim   approval for
                    Division of Eli   injection).       the reduction
                    Lilly & Co.,                        in the
                    Lilly Corporate                     incidence of
                    Center,                             clinical
                    Indianapolis,                       mastitis in the
                    IN 46285.                           first 30 days
                                                        of lactation in
                                                        periparturient
                                                        dairy cows and
                                                        periparturient
                                                        replacement
                                                        dairy heifers.
141-455..........  Aratana           GALLIPRANT        Original            510.600  yes..........  CE \2\ \3\
                    Therapeutics,     (grapiprant       approval for      520.1084
                    Inc., 11400       tablets).         the control of
                    Tomahawk Creek                      pain and
                    Pkwy., Leawood,                     inflammation
                    KS 66211.                           associated with
                                                        osteoarthritis
                                                        in dogs.
141-460..........  ECO LLC, 344      AIVLOSIN 17%      Original            558.633  yes..........  CE \2\ \4\
                    Nassau St.,       (tylvalosin       approval for
                    Princeton, NJ     tartrate) Type    control of
                    08540.            A Medicated       porcine
                                      Article.          proliferative
                                                        enteropathy
                                                        (PPE)
                                                        associated with
                                                        Lawsonia
                                                        intracellularis
                                                        infection in
                                                        groups of swine
                                                        in buildings
                                                        experiencing an
                                                        outbreak of PPE.
----------------------------------------------------------------------------------------------------------------
\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact
  of this action and has made a finding of no significant impact (FONSI).
\2\ The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an
  environmental assessment or an environmental impact statement because it is of a type that does not have a
  significant effect on the human environment.
\3\ CE granted under 21 CFR 25.33(d)(1).
\4\ CE granted under 21 CFR 25.33(d)(5).


[[Page 36788]]

II. Changes of Sponsorship

    Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee 
Mission, KS 66201 (Bayer) has informed FDA that it has transferred 
ownership of, and all rights and interest in, the following approved 
applications to Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, 
Dublin 24, Ireland:

----------------------------------------------------------------------------------------------------------------
                   File No.                                       Product name                    21 CFR section
----------------------------------------------------------------------------------------------------------------
099-169.......................................  Oxytocin Injection..............................        522.1680
124-241.......................................  PVL Oxytocin Injectable Solution................        522.1680
200-069.......................................  OvaCyst (gonadorelin diacetate tetrahydrate)            522.1077
                                                 Injection.
200-253.......................................  ProstaMate (dinoprost tromethamine) Injectable           522.690
                                                 Solution.
----------------------------------------------------------------------------------------------------------------

    Bayer has also transferred sponsorship of NADA 141-070 for 
RAPINOVET (propofol) Injectable Emulsion to iVaoes Animal Health, 4300 
SW 73rd Ave., suite 110, Miami, FL 33155. As provided in the regulatory 
text of this document, the animal drug regulations are amended to 
reflect these changes of sponsorship.

III. Withdrawals of Approval

    In addition, during March and April 2016, the following two 
sponsors have requested that FDA withdraw approval of the NADAs and 
ANADAs listed in the following table because the products are no longer 
manufactured or marketed:

----------------------------------------------------------------------------------------------------------------
           File No.                       Sponsor                    Product name              21 CFR section
----------------------------------------------------------------------------------------------------------------
007-076 \1\..................  Cross Vetpharm Group Ltd.,    SULFA-NOX Liquid              520.2325a
                                Broomhill Rd., Tallaght,      (sulfaquinoxaline) 3.44%
                                Dublin 24, Ireland.           Solution.
008-244 \1\..................  Cross Vetpharm Group Ltd.,    SULFA-NOX Concentrate         520.2325a
                                Broomhill Rd., Tallaght,      (sulfaquinoxaline) 12.85%
                                Dublin 24, Ireland.           Solution.
041-955 \1\..................  Cross Vetpharm Group Ltd.,    Erythromycin Medicated        558.248
                                Broomhill Rd., Tallaght,      Premix.
                                Dublin 24, Ireland.
049-729 \1\..................  Cross Vetpharm Group Ltd.,    PURINA Sulfa                  520.2261a
                                Broomhill Rd., Tallaght,      (sulfamethazine) 12.5%
                                Dublin 24, Ireland.           Solution.
100-128 \1\..................  Cross Vetpharm Group Ltd.,    Supersweet Medipak TYLAN 10.  558.625
                                Broomhill Rd., Tallaght,
                                Dublin 24, Ireland.
200-307 \1\..................  Vetoquinol N.-A., Inc., 2000  Penicillin G Potassium        520.1696b
                                chemin Georges, Lavaltrie     Soluble Powder.
                                (PQ), Canada J5T 3S5.
----------------------------------------------------------------------------------------------------------------
\1\ These NADAs were identified as being affected by guidance for industry #213, ``New Animal Drugs and New
  Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing
  Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,''
  December 2013.

    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADAs 007-076, 008-244, 041-955, 049-729, 100-128, and 
ANADA 200-307, and all supplements and amendments thereto, is 
withdrawn, effective June 20, 2016. As provided in the regulatory text 
of this document, the animal drug regulations are amended to reflect 
these voluntary withdrawals of approval.

IV. Technical Amendments

    FDA has noticed that the section heading for 21 CFR 520.1430 does 
not accurately reflect the new animal drug for which approved 
conditions of use are codified. At this time, we are amending the 
section heading to read ``Mibolerone'' rather than ``Megestrol acetate 
tablets.'' This action is being taken to improve the accuracy of the 
regulations.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

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

21 CFR Parts 520 and 522

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

21 CFR Part 558

    Animal drugs, Animal feeds.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, parts 510, 520, 522, 
556, 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. In Sec.  510.600:
0
a. In the table in paragraph (c)(1), alphabetically add entries for 
``Aratana Therapeutics, Inc.'' and ``iVaoes Animal Health'' and revise 
entry for ``Huvepharma AD;'' and
0
b. In the table in paragraph (c)(2), revise the entry for ``016592'' 
and numerically add entries for ``086026'' and ``086064.''
    The additions and revisions read as follows:


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

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

[[Page 36789]]



------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                              * * * * * * *
Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy.,           086026
 Leawood, KS 66211......................................
 
                              * * * * * * *
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113          016592
 Sofia, Bulgaria........................................
 
                              * * * * * * *
iVaoes Animal Health, 4300 SW 73rd Ave., suite 110,               086064
 Miami, FL 33155........................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
016592......................  Huvepharma EOOD, 5th Floor, 3A Nikolay
                               Haytov Str., 1113 Sofia, Bulgaria
 
                              * * * * * * *
086026......................  Aratana Therapeutics, Inc., 11400 Tomahawk
                               Creek Pkwy., Leawood, KS 66211
 
                              * * * * * * *
086064......................  iVaoes Animal Health, 4300 SW 73rd Ave.,
                               suite 110, Miami, FL 33155
 
                              * * * * * * *
------------------------------------------------------------------------

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.


0
4. Add Sec.  520.1084 to read as follows:


Sec.  520.1084  Grapiprant.

    (a) Specifications. Each tablet contains 20, 60, or 100 milligrams 
(mg) grapiprant.
    (b) Sponsor. See No. 086026 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 0.9 mg/lb (2 
mg/kg) once daily by mouth.
    (2) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
5. Revise the heading of Sec.  520.1430 to read as follows:


Sec.  520.1430  Mibolerone.

* * * * *


Sec.  520.1696b  [Amended]

0
6. Effective June 20, 2016, in Sec.  520.1696b, in paragraph (b), 
remove ``059320,''.


Sec.  520.2261a  [Amended]

0
7. Effective June 20, 2016, in Sec.  520.2261a, in paragraph (b), 
remove ``Nos. 016592 and 061623'' and in its place add ``No. 016592''.


Sec.  520.2325a  [Amended]

0
8. Effective June 20, 2016, in Sec.  520.2325a, remove paragraph (a)(2) 
and redesignate paragraphs (a)(3) and (4) as paragraphs (a)(2) and (3).

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

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

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


Sec.  522.690  [Amended]

0
10. In Sec.  522.690, in paragraph (b)(3), remove ``000859'' and in its 
place add ``061623''.


Sec.  522.1077  [Amended]

0
11. In Sec.  522.1077, in paragraph (b)(3), remove ``000859 and 
050604'' and in its place add ``050604 and 061623''.


Sec.  522.1680  [Amended]

0
12. In Sec.  522.1680, in paragraph (b), remove ``000859''.
0
13. Add Sec.  522.1684 to read as follows:


Sec.  522.1684  Pegbovigrastim.

    (a) Specifications. Each pre-filled, single-dose syringe contains 
15 milligrams of pegbovigrastim.
    (b) Sponsor. See No. 000986 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in cattle--(1) Amount. Administer the first 
dose (syringe) by subcutaneous injection 7 days prior to the cow's or 
heifer's anticipated calving date. If necessary, the first dose may be 
administered within a range of 4 to 10 days prior to the anticipated 
calving date to accommodate management schedules. Administer the second 
dose (syringe) by subcutaneous injection within 24 hours after calving.
    (2) Indications for use. For the reduction in the incidence of 
clinical mastitis in the first 30 days of lactation in periparturient 
dairy cows and periparturient replacement dairy heifers.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.


Sec.  522.2005  [Amended]

0
14. In Sec.  522.2005, in paragraph (b)(1), remove ``000859'' and in 
its place add ``086064''.

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

0
15. The authority citation for part 556 continues to read as follows:

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


0
16. In Sec.  556.748, revise paragraph (c) to read as follows:

[[Page 36790]]

Sec.  556.748  Tylvalosin.

* * * * *
    (c) Related conditions of use. See Sec. Sec.  520.2645 and 558.633 
of this chapter.

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

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

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


0
18. In Sec.  558.4, in paragraph (d), in the ``Category I'' table, add 
an entry in alphabetical order for ``Tylvalosin'' to read as follows:


Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   Category I
----------------------------------------------------------------------------------------------------------------
                                        Assay limits percent Type                                Assay limits
                 Drug                               A                Type B maximum (200x)     percent Type B/C
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Tylvalosin............................  90-110...................  3.86 g/lb................             85-115
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *


Sec.  558.248  [Amended]

0
19. Effective June 20, 2016, in Sec.  558.248, revise paragraphs (a) 
and (b) and remove and reserve paragraph (d)(1)(iii).
    The revisions read as follows:


Sec.  558.248  Erythromycin.

    (a) Specifications. Type A medicated articles containing 5 or 10 
percent erythromycin thiocyanate.
    (b) Sponsor. See No. 061623 in Sec.  510.600(c) of this chapter.
* * * * *


Sec.  558.625  [Amended]

0
20. Effective June 20, 2016, in Sec.  558.625, remove paragraph (b)(3) 
and redesignate paragraphs (b)(4) and (5) as paragraphs (b)(3) and (4).
0
21. Add Sec.  558.633 to read as follows:


Sec.  558.633  Tylvalosin.

    (a) Specifications. Type A medicated articles containing 77.12 
grams tylvalosin per pound as tylvalosin tartrate.
    (b) Sponsor. See No. 066916 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.748 of this chapter.
    (d) Special considerations--(1) Federal law restricts tylvalosin 
medicated feeds to use under a veterinary feed directive (VFD) and the 
professional supervision of a licensed veterinarian. See Sec.  558.6 of 
this chapter for additional requirements.
    (2) VFDs for tylvalosin shall not be refilled.
    (3) An expiration date of 1 week is required for tylvalosin Type C 
medicated swine feeds in pelleted or crumbled form.
    (e) Conditions of use in swine--(1) Amount. Administer 38.6 grams 
tylvalosin per ton of Type C medicated feed (42.5 ppm) as the sole 
ration for 14 consecutive days.
    (2) Indications for use. For the control of porcine proliferative 
enteropathy (PPE) associated with Lawsonia intracellularis infection in 
groups of swine in buildings experiencing an outbreak of PPE.

    Dated: May 31, 2016.
Tracey Forfa,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2016-13517 Filed 6-7-16; 8:45 am]
 BILLING CODE 4164-01-P