Document ID: FDA-2018-N-0002-0003
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor’s Name and Address
Posted Date: 2018-12-18T05:00Z

[Federal Register Volume 83, Number 242 (Tuesday, December 18, 2018)]
[Rules and Regulations]
[Pages 64738-64744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27238]

[[Page 64738]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 556, and 558

[Docket No. FDA-2018-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications; 
Changes of Sponsorship; Change of a Sponsor's Name and Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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

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 April, May, and June 2018. FDA is 
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 make technical 
amendments to improve the accuracy and readability of the regulations.

DATES: This rule is effective December 18, 2018.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-5689, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during April, May, and June 2018, 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 
office of the Dockets Management Staff (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: https://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: 
https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

                              Table 1--Original and Supplemental NADAs and ANADAs Approved During April, May, and June 2018
--------------------------------------------------------------------------------------------------------------------------------------------------------
      Approval date       File  No.         Sponsor            Product name           Species          Effect of the action        Public  documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
May 4, 2018.............    141-481  Kindred Biosciences,  MIRATAZ (mirtazapine  Cats.............  Original approval for the  FOI Summary.
                                      Inc., 1555 Bayshore   transdermal                              management of weight
                                      Hwy., Suite 200,      ointment).                               loss in cats.
                                      Burlingame, CA
                                      94010.
May 15, 2018............    141-501  Boehringer Ingelheim  SEMINTRA              Cats.............  Original approval for the  FOI Summary.
                                      Vetmedica, Inc.,      (telmisartan oral                        control of systemic
                                      2621 North Belt       solution).                               hypertension in cats.
                                      Hwy., St. Joseph,
                                      MO 64506-2002.
May 25, 2018............    141-063  Intervet, Inc., 2     NUFLOR                Cattle...........  Supplemental approval to   FOI Summary.
                                      Giralda Farms,        (florfenicol),                           provide human food
                                      Madison, NJ 07940.    Injectable Solution.                     safety information for
                                                                                                     the use of the inactive
                                                                                                     ingredient n[dash]methyl-
                                                                                                     2-pyrrolidone (NMP).
May 31, 2018............    141-495  Elanco US Inc., 2500  INTEPRITY             Chickens.........  Original approval for the  FOI Summary.
                                      Innovation Way,       (avilamycin) and                         prevention of mortality
                                      Greenfield, IN        BIO-COX                                  caused by necrotic
                                      46140.                (salinomycin                             enteritis and for the
                                                            sodium) Type C                           prevention of
                                                            medicated feeds.                         coccidiosis in broiler
                                                                                                     chickens.
June 6, 2018............    141-342  Jurox Pty. Ltd., 85   ALFAXAN               Dogs and cats....  Supplemental approval      FOI Summary.
                                      Gardiner Rd.,         (alfaxalone),                            providing for addition
                                      Rutherford, NSW       Injectable Solution.                     of preservatives and use
                                      2320, Australia.                                               of a multidose vial.
June 14, 2018...........    098-379  Merial, Inc., 3239    CYSTORELIN            Cattle...........  Supplemental approval for  FOI Summary, EA/FONSI.\1\
                                      Satellite Blvd.,      (gonadorelin),                           use with cloprostenol
                                      Bldg. 500, Duluth,    Injectable Solution.                     sodium to synchronize
                                      GA 30096-4640.                                                 estrous cycles to allow
                                                                                                     for fixed-time
                                                                                                     artificial insemination
                                                                                                     (FTAI) in lactating
                                                                                                     dairy cows and beef cows.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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).

II. Technical Amendments

    With the approval of NADA 141-481, Kindred Biosciences, Inc. is now 
the sponsor of an approved application. Accordingly, we are amending 
Sec.  510.600(c) to add the name, address, and drug labeler code of 
this sponsor.
    Piramal Healthcare Ltd., Piramal Tower, Ganpatrao Kadam Marg, Lower 
Parel, Mumbai-400 013, India, has informed FDA that it has changed its 
name and address to Piramal Enterprises Ltd., Ananta, Agastya Corporate 
Park, Opp Fire Brigade, Kamani Junction, LBS Mag Kurla (West), Mumbai, 
400070, India. We are amending Sec.  510.600(c) to reflect this change.
    We are also making technical amendments to update the scientific 
name of a pathogenic bacterium and to accurately list the 
concentrations of active ingredients in an otic dosage form new animal 
drug. We are also making a technical amendment to correct the sponsor 
of epsiprantel tablets. These actions are being taken to improve the 
accuracy of the regulations.
    In addition, we are reformatting the regulations to create a 
tabular display of

[[Page 64739]]

the approved uses of narasin and a separate section for uses of a 
fixed-ratio, combination drug Type A medicated article containing 
narasin and nicarbazin. These actions are being taken to improve the 
readability, consistency, and accuracy of the regulations.

III. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)), which requires 
Federal Register publication of ``notice[s] . . . effective as a 
regulation,'' of the conditions of use of approved new animal drugs. 
This rule sets forth technical amendments to the regulations to codify 
recent actions on approved new animal drug applications and corrections 
to improve the accuracy of the regulations, and as such does not impose 
any burden on regulated entities.
    Although denominated a rule pursuant to the FD&C Act, this document 
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. 
Likewise, this is not a rule subject to Executive Order 12866, which 
defines a rule as ``an agency statement of general applicability and 
future effect, which the agency intends to have the force and effect of 
law, that is designed to implement, interpret, or prescribe law or 
policy or to describe the procedure or practice requirements of an 
agency.''

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 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, 21 CFR parts 
510, 520, 522, 524, 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.

0
2. In Sec.  510.600, in the table in paragraph (c)(1), alphabetically 
add an entry for ``Kindred Biosciences, Inc.'' and remove the entry for 
``Piramal Healthcare Ltd.'' and add an entry for ``Piramal Enterprises 
Ltd.'' in its place; and in the table in paragraph (c)(2), revise the 
entry for ``065085'' and numerically add an entry for ``086078'' to 
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
------------------------------------------------------------------------
 
                              * * * * * * *
Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite              086078
 200, Burlingame, CA 94010..............................
 
                              * * * * * * *
Piramal Enterprises Ltd., Ananta, Agastya Corporate               065085
 Park, Opp Fire Brigade, Kamani Junction, LBS Mag Kurla
 (West), Mumbai, 400070, India..........................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
   Drug labeler  code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
065085..................  Piramal Enterprises Ltd., Ananta, Agastya
                           Corporate Park, Opp Fire Brigade, Kamani
                           Junction, LBS Mag Kurla (West), Mumbai,
                           400070, India.
 
                              * * * * * * *
086078..................  Kindred Biosciences, Inc., 1555 Bayshore Hwy.,
                           Suite 200, Burlingame, CA 94010.
 
                              * * * * * * *
------------------------------------------------------------------------

[[Page 64740]]

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.  520.88f   [Amended]

0
4. In Sec.  520.88f, in paragraph (c)(2), remove ``lacerations) due to 
S. aureus, Streptococcus spp., E. coli'' and in its place add 
``lacerations) due to S. aureus, Enterococcus faecalis, E. coli''.

Sec.  520.816   [Amended]

0
5. In Sec.  520.816, in paragraph (b), remove ``050604'' and in its 
place add ``054771''.

0
6. Add Sec.  520.2335 to read as follows:

Sec.  520.2335  Telmisartan.

    (a) Specifications. Each milliliter of solution contains 10 
milligrams (mg) telmisartan.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer 1.5 mg/kilogram (kg) 
(0.68 mg/pound (lb)) orally twice daily for 14 days, followed by 2 mg/
kg (0.91 mg/lb) orally once daily.
    (2) Indications for use. For the control of systemic hypertension 
in cats.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

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

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

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

0
8. Revise Sec.  522.1077 to read as follows:

Sec.  522.1077   Gonadorelin.

    (a) Specifications. Each milliliter (mL) of solution contains:
    (1) 43 micrograms ([mu]g) of gonadorelin as gonadorelin acetate;
    (2) 100 [mu]g of gonadorelin as gonadorelin acetate;
    (3) 43 [mu]g of gonadorelin as gonadorelin diacetate tetrahydrate; 
or
    (4) 50 [mu]g of gonadorelin as gonadorelin hydrochloride.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter.
    (1) No. 000061 for use of the 43-[mu]g/mL product described in 
paragraph (a)(1) as in paragraphs (d)(1)(i), (d)(1)(iv), and (d)(2) of 
this section.
    (2) No. 068504 for use of the 100-[mu]g/mL product described in 
paragraph (a)(2) as in paragraphs (d)(1)(ii), (d)(1)(v), and (d)(2) of 
this section.
    (3) No. 061623 for use of the 43-[mu]g/mL product described in 
paragraph (a)(3) as in paragraphs (d)(1)(i) and (d)(2) of this section.
    (4) No. 050604 for use of the 43-[mu]g/mL product described in 
paragraph (a)(3) as in paragraphs (d)(1)(i), (d)(1)(vi), and (d)(2) of 
this section.
    (5) No. 054771 for use of the 50-[mu]g/mL product described in 
paragraph (a)(4) as in paragraphs (d)(1)(iii), (d)(1)(vii), and (d)(2) 
of this section.
    (c) Special considerations. Concurrent luteolytic drug use is 
approved as follows:
    (1) Cloprostenol injection for use as in paragraph (d)(1)(iv) of 
this section as provided by No. 000061 in Sec.  510.600(c) of this 
chapter.
    (2) Cloprostenol injection for use as in paragraph (d)(1)(v) and 
(d)(1)(vi) of this section as provided by No. 000061 or No. 068504 in 
Sec.  510.600(c) of this chapter.
    (3) Dinoprost injection for use as in paragraph (d)(1)(vii) of this 
section as provided by No. 054771 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use in cattle--(1) Indications for use and 
amounts--(i) For the treatment of ovarian follicular cysts in dairy 
cattle: Administer 86 [mu]g gonadorelin (No. 000061) or 100 [mu]g 
gonadorelin diacetate tetrahydrate (Nos. 061623 and 050604) by 
intramuscular or intravenous injection.
    (ii) For the treatment of ovarian follicular cysts in dairy cattle: 
Administer 100 [mu]g gonadorelin by intramuscular or intravenous 
injection.
    (iii) For the treatment of ovarian follicular cysts in cattle: 
Administer 100 [mu]g gonadorelin by intramuscular injection.
    (iv) For use with cloprostenol injection to synchronize estrous 
cycles to allow for fixed-time artificial insemination (FTAI) in 
lactating dairy cows: Administer to each cow 86 [mu]g gonadorelin by 
intramuscular injection, followed 6 to 8 days later by 500 [mu]g 
cloprostenol by intramuscular injection, followed 30 to 72 hours later 
by 86 [mu]g gonadorelin by intramuscular injection.
    (v) For use with cloprostenol sodium to synchronize estrous cycles 
to allow for fixed-time artificial insemination (FTAI) in lactating 
dairy cows and beef cows: Administer to each cow 100 [mu]g gonadorelin 
by intramuscular injection, followed 6 to 8 days later by 500 [mu]g 
cloprostenol by intramuscular injection, followed 30 to 72 hours later 
by 100 [mu]g gonadorelin by intramuscular injection.
    (vi) For use with cloprostenol sodium to synchronize estrous cycles 
to allow for fixed-time artificial insemination (FTAI) in lactating 
dairy cows and beef cows: Administer to each cow 100 [mu]g gonadorelin 
diacetate tetrahydrate by intramuscular injection, followed 6 to 8 days 
later by 500 [mu]g cloprostenol by intramuscular injection, followed 30 
to 72 hours later by 100 [mu]g gonadorelin diacetate tetrahydrate by 
intramuscular injection.
    (vii) For use with dinoprost injection to synchronize estrous 
cycles to allow fixed-time artificial insemination (FTAI) in lactating 
dairy cows: Administer to each cow 100 to 200 [mu]g gonadorelin by 
intramuscular injection, followed 6 to 8 days later by 25 mg dinoprost 
by intramuscular injection, followed 30 to 72 hours later by 100 to 200 
[mu]g gonadorelin by intramuscular injection.
    (2) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

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

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

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

0
10. In Sec.  524.957, revise paragraph (a) to read as follows:

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

    (a) Specifications. Each single-dose, prefilled dropperette 
contains 1 milliliter (mL) of a solution containing 16.6 milligrams 
(mg) florfenicol, 14.8 mg terbinafine (equivalent to 16.6 mg 
terbinafine hydrochloride), and 2.2 mg mometasone furoate.
* * * * *

0
11. Add Sec.  524.1448 to read as follows:

Sec.  524.1448   Mirtazapine transdermal ointment.

    (a) Specifications. Each gram of ointment contains 20 milligrams 
(mg) mirtazapine.
    (b) Sponsor. See No. 086078 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer topically by applying 
a 1.5 inch ribbon of ointment (approximately 2 mg) on the inner pinna 
of the cat's ear once daily for 14 days. Alternate the daily 
application of ointment between the left and right inner pinna of the 
ears.
    (2) Indications for use. For the management of weight loss in cats.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

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

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

[[Page 64741]]

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

0
13. In Sec.  556.428, add paragraph (c) to read as follows:

Sec.  556.428  Narasin.

* * * * *
    (c) Related conditions of use. See Sec. Sec.  558.363 and 558.364 
of this chapter.

0
14. Revise Sec.  556.445 to read as follows:

Sec.  556.445  Nicarbazin.

    (a) [Reserved]
    (b) Tolerances. A tolerance of 4 parts per million is established 
for residues of nicarbazin in uncooked chicken muscle, liver, skin, and 
kidney.
    (c) Related conditions of use. See Sec. Sec.  558.364 and 558.366 
of this chapter.

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.

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

Sec.  558.68   Avilamycin.

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

----------------------------------------------------------------------------------------------------------------
                            Combination  in     Indications for
Avilamycin in  grams/ton       grams/ton              use                    Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ii) 13.6 to 40.9.......  Monensin, 90 to     Broiler chickens:   Feed as the sole ration for 21          058198
                           110.                For the             consecutive days. To assure
                                               prevention of       responsible antimicrobial drug
                                               mortality caused    use in broiler chickens,
                                               by necrotic         treatment administration must
                                               enteritis           begin on or before 10 days of
                                               associated with     age. See Sec.   558.355(d) of
                                               Clostridium         this chapter. Monensin as
                                               perfringens; and    provided by No. 058198 in Sec.
                                               as an aid in the    510.600(c) of this chapter.
                                               prevention of
                                               coccidiosis
                                               caused by Eimeria
                                               necatrix, E.
                                               tenella, E.
                                               acervulina, E.
                                               brunetti, E.
                                               mivati, and E.
                                               maxima.
 
                                                  * * * * * * *
(v) 13.6 to 40.9........  Salinomycin         Broiler chickens:   Feed as the sole ration for 21          058198
                           sodium, 40 to 60.   For the             consecutive days. Feed to
                                               prevention of       chickens that are at risk of
                                               mortality caused    developing, but not yet showing
                                               by necrotic         clinical signs of, necrotic
                                               enteritis           enteritis associated with
                                               associated with     Clostridium perfringens. Not
                                               Clostridium         approved for use with pellet
                                               perfringens; and    binders. To assure responsible
                                               for the             antimicrobial drug use in
                                               prevention of       broiler chickens, treatment
                                               coccidiosis         administration must begin on or
                                               caused by Eimeria   before 10 days of age. The
                                               tenella, E.         safety of avilamycin has not
                                               necatrix, E.        been established in chickens
                                               acervulina, E.      intended for breeding purposes.
                                               maxima, E.          Avilamycin has not been
                                               brunetti, and E.    demonstrated to be effective in
                                               mivati.             broiler chickens showing
                                                                   clinical signs of necrotic
                                                                   enteritis prior to the start of
                                                                   medication. Do not feed to
                                                                   laying hens producing eggs for
                                                                   human consumption. May be fatal
                                                                   if fed to adult turkeys or to
                                                                   horses. Salinomycin as provided
                                                                   by No. 016592 in Sec.
                                                                   510.600(c) of this chapter.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
17. In Sec.  558.76, remove and reserve paragraph (e)(1)(viii); 
redesignate paragraphs (e)(2)(xiii) through (xvii) as paragraphs 
(e)(2)(xiv) through (xviii); add new paragraph (e)(2)(xiii); and revise 
newly redesignated paragraph (e)(2)(xiv).
    The addition and revision read as follows:

Sec.  558.76   Bacitracin methylendisalicylate.

* * * * *
    (e) * * *
    (2) * * *
    (xiii) Narasin and nicarbazin as in Sec.  558.364.
    (xiv) Nicarbazin as in Sec.  558.366.
* * * * *

0
18. In Sec.  558.78, add paragraph (d)(3)(vii) to read as follows:

Sec.  558.78  Bacitracin zinc.

* * * * *
    (d) * * *
    (3) * * *
    (vii) Nicarbazin as in Sec.  558.366.
* * * * *

0
19. In Sec.  558.95, revise paragraph (d)(5)(viii); redesignate 
paragraphs (d)(5)(ix) through (xi) as paragraphs (d)(5)(x) through 
(xii); and add new paragraph (d)(5)(ix).
    The revision and addition read as follows:

Sec.  558.95   Bambermycins.

* * * * *
    (d) * * *
    (5) * * *
    (viii) Narasin as in Sec.  558.363.
    (ix) Narasin and nicarbazin as in Sec.  558.364.
* * * * *

Sec.  558.128   [Amended]

0
20. In Sec.  558.128, in paragraph (e)(3)(iv), in the ``Limitations'' 
column, at the end of the second sentence, add ``Chlortetracycline and 
bacitracin methylenedisalicylate as provided by No. 054771 in Sec.  
510.600(c) of this chapter.''

Sec.  558.325   [Amended]

0
21. In Sec.  558.325, in paragraph (e)(1)(iv), in the ``Combination in 
grams/ton'' column, remove ``Decoquinate, 2.72'' and in its place add 
``Decoquinate, 27.2''.

0
22. Revise Sec.  558.363 to read as follows:

Sec.  558.363   Narasin.

    (a) Specifications. Type A medicated articles containing 36, 45, 
54, 72, and 90 grams narasin per pound.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Tolerances. See Sec.  556.428 of this chapter.
    (d) Special considerations. An expiration date of 2 months (8 
weeks) is required for narasin Type C medicated swine feeds.
    (e) Conditions of use. It is used as follows:
    (1) Chickens--

[[Page 64742]]

----------------------------------------------------------------------------------------------------------------
                            Combination in grams/
     Narasin grams/ton               ton            Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 54 to 90..............  .....................  Broiler chickens: For  For broiler chickens            058198
                                                    prevention of          only. Feed continuously
                                                    coccidiosis caused     as sole ration. Do not
                                                    by Eimeria necatrix,   allow adult turkeys,
                                                    E. tenella, E.         horses, or other equines
                                                    acervulina, E.         access to narasin
                                                    brunetti, E. mivati,   formulations. Ingestion
                                                    and E. maxima.         of narasin by these
                                                                           species has been fatal.
(ii) 54 to 72.............  Bacitracin             Broiler chickens: For  For broiler chickens            054771
                             methylenedisalicylat   prevention of          only. Feed continuously
                             e, 10 to 50.           coccidiosis caused     as sole ration. Do not
                                                    by Eimeria necatrix,   feed to laying hens. Do
                                                    E. tenella, E.         not allow adult turkeys,
                                                    acervulina, E.         horses, or other equines
                                                    brunetti, E. mivati,   access to narasin
                                                    and E. maxima, and     formulations. Ingestion
                                                    for increased rate     of narasin by these
                                                    of weight gain and     species has been fatal.
                                                    improved feed          Bacitracin
                                                    efficiency.            methylenedisalicylate as
                                                                           provided by No. 054771
                                                                           in Sec.   510.600(c) of
                                                                           this chapter.
(iii) 54 to 72............  Bacitracin zinc, 4 to  Broiler chickens: For  For broiler chickens            054771
                             50.                    prevention of          only. Feed continuously
                                                    coccidiosis caused     as sole ration. Do not
                                                    by Eimeria necatrix,   allow adult turkeys,
                                                    E. tenella, E.         horses, or other equines
                                                    acervulina, E.         access to narasin
                                                    brunetti, E. mivati,   formulations. Ingestion
                                                    and E. maxima, and     of narasin by these
                                                    for increased rate     species has been fatal.
                                                    of weight gain and     Bacitracin zinc as
                                                    improved feed          provided by No. 054771
                                                    efficiency.            in Sec.   510.600(c) of
                                                                           this chapter.
(iv) 54 to 72.............  Bambermycins, 1 to 2.  Broiler chickens: For  For broiler chickens            016592
                                                    prevention of          only. Feed continuously
                                                    coccidiosis caused     as sole ration. Do not
                                                    by Eimeria necatrix,   allow adult turkeys,
                                                    E. tenella, E.         horses, or other equines
                                                    acervulina, E.         access to narasin
                                                    brunetti, E. mivati,   formulations. Ingestion
                                                    and E. maxima, and     of narasin by these
                                                    for increased rate     species has been fatal.
                                                    of weight gain and     Bambermycins as provided
                                                    improved feed          by No. 016592 in Sec.
                                                    efficiency.            510.600(c) of this
                                                                           chapter.
----------------------------------------------------------------------------------------------------------------

    (2) Swine--

----------------------------------------------------------------------------------------------------------------
                            Combination in grams/
     Narasin grams/ton               ton            Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 13.6 to 27.2..........  .....................  Growing-finishing      Feed continuously for at        058198
                                                    swine: For increased   least 4 weeks to swine
                                                    rate of weight gain    during the growing-
                                                    when fed for at        finishing period as the
                                                    least 4 weeks.         sole ration. No
                                                                           increased benefit in
                                                                           rate of weight gain has
                                                                           been shown when narasin
                                                                           concentrations in the
                                                                           diet are greater than
                                                                           13.6 g/ton.
                                                                           Effectiveness has not
                                                                           been demonstrated when
                                                                           fed for durations less
                                                                           than 4 weeks. Do not
                                                                           allow adult turkeys,
                                                                           horses, or other equines
                                                                           access to narasin
                                                                           formulations. Ingestion
                                                                           of narasin by these
                                                                           species has been fatal.
                                                                           Not approved for use in
                                                                           breeding animals because
                                                                           safety and effectiveness
                                                                           have not been evaluated
                                                                           in these animals. Swine
                                                                           being fed with narasin
                                                                           should not have access
                                                                           to feeds containing
                                                                           pleuromutilins (e.g.,
                                                                           tiamulin) as adverse
                                                                           reactions may occur. If
                                                                           signs of toxicity occur,
                                                                           discontinue use.
(ii) 18.1 to 27.2.........  .....................  Growing-finishing      Feed continuously for at        058198
                                                    swine: For increased   least 4 weeks to swine
                                                    rate of weight gain    during the growing-
                                                    and improved feed      finishing period as the
                                                    efficiency when fed    sole ration. No
                                                    for at least 4 weeks.  increased benefit in
                                                                           rate of weight gain has
                                                                           been shown when narasin
                                                                           concentrations in the
                                                                           diet are greater than
                                                                           13.6 g/ton.
                                                                           Effectiveness has not
                                                                           been demonstrated when
                                                                           fed for durations less
                                                                           than 4 weeks. Do not
                                                                           allow adult turkeys,
                                                                           horses, or other equines
                                                                           access to narasin
                                                                           formulations. Ingestion
                                                                           of narasin by these
                                                                           species has been fatal.
                                                                           Not approved for use in
                                                                           breeding animals because
                                                                           safety and effectiveness
                                                                           have not been evaluated
                                                                           in these animals. Swine
                                                                           being fed with narasin
                                                                           should not have access
                                                                           to feeds containing
                                                                           pleuromutilins (e.g.,
                                                                           tiamulin) as adverse
                                                                           reactions may occur. If
                                                                           signs of toxicity occur,
                                                                           discontinue use.
----------------------------------------------------------------------------------------------------------------

    (3) Narasin single-ingredient Type A medicated articles may also be 
used in combination with:
    (i) Avilamycin as in Sec.  558.68.
    (ii) [Reserved]

Sec.  558.364   [Redesignated as Sec.  558.365]

0
23. Redesignate Sec.  558.364 as Sec.  558.365.

0
24. Add new Sec.  558.364 to read as follows:

Sec.  558.364   Narasin and nicarbazin.

    (a) Specifications. A fixed-ratio, combination drug Type A 
medicated article containing 36 grams narasin and 36 grams nicarbazin 
per pound.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Tolerances. See Sec. Sec.  556.428 and 556.445 of this chapter.
    (d) Conditions of use. It is used as follows:
    (1) Chickens--

[[Page 64743]]

----------------------------------------------------------------------------------------------------------------
  Narasin and nicarbazin    Combination in grams/
         grams/ton                   ton            Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 27 to 45 of each drug.  .....................  Broiler chickens: For  Feed continuously as sole       058198
                                                    prevention of          ration. Do not feed to
                                                    coccidiosis caused     laying hens. Withdraw 5
                                                    by Eimeria tenella,    days before slaughter.
                                                    E. necatrix, E.        Do not allow adult
                                                    acervulina, E.         turkeys, horses, or
                                                    maxima, E. brunetti,   other equines access to
                                                    and E. mivati.         narasin formulations.
                                                                           Ingestion of narasin by
                                                                           these species has been
                                                                           fatal.
(ii) 27 to 45 of each drug  Bacitracin             Broiler chickens: For  Feed continuously as sole       058198
                             methylenedisalicylat   prevention of          ration. Do not feed to
                             e, 4 to 50.            coccidiosis caused     laying hens. Withdraw 5
                                                    by Eimeria tenella,    days before slaughter.
                                                    E. necatrix, E.        Do not allow turkeys,
                                                    acervulina, E.         horses, or other equines
                                                    maxima, E. brunetti,   access to formulations
                                                    and E. mivati, and     containing narasin.
                                                    for increased rate     Ingestion of narasin by
                                                    of weight gain and     these species has been
                                                    improved feed          fatal. Bacitracin
                                                    efficiency.            methylenedisalicylate as
                                                                           provided by No. 054771
                                                                           in Sec.   510.600(c) of
                                                                           this chapter.
(iii) 27 to 45 of each      Bacitracin             Broiler chickens: For  Feed continuously as sole       054771
 drug.                       methylenedisalicylat   prevention of          ration. Withdraw 5 days
                             e, 50.                 coccidiosis caused     before slaughter. Do not
                                                    by Eimeria tenella,    feed to laying hens. Do
                                                    E. necatrix, E.        not allow turkeys,
                                                    acervulina, E.         horses, or other equines
                                                    maxima, E. brunetti,   access to formulations
                                                    and E. mivati, and     containing narasin.
                                                    as an aid in the       Ingestion of narasin by
                                                    prevention of          these species has been
                                                    necrotic enteritis     fatal. Bacitracin
                                                    caused or              methylenedisalicylate as
                                                    complicated by         provided by No. 054771
                                                    Clostridium spp. or    in Sec.   510.600(c) of
                                                    other organisms        this chapter.
                                                    susceptible to
                                                    bacitracin.
(iv) 27 to 45 of each drug  Bacitracin             Broiler chickens: For  To control necrotic             054771
                             methylenedisalicylat   prevention of          enteritis, start
                             e, 100 to 200.         coccidiosis caused     medication at first
                                                    by Eimeria tenella,    clinical signs of
                                                    E. necatrix, E.        disease; vary dosage
                                                    acervulina, E.         based on the severity of
                                                    maxima, E. brunetti,   infection; administer
                                                    and E. mivati, and     continuously for 5 to 7
                                                    as an aid in the       days or as long as
                                                    control of necrotic    clinical signs persist,
                                                    enteritis caused or    then reduce bacitracin
                                                    complicated by         to prevention level (50
                                                    Clostridium spp. or    g/ton). Do not feed to
                                                    other organisms        laying hens. Withdraw 5
                                                    susceptible to         days before slaughter.
                                                    bacitracin.            Do not allow turkeys,
                                                                           horses, or other equines
                                                                           access to formulations
                                                                           containing narasin.
                                                                           Ingestion of narasin by
                                                                           these species has been
                                                                           fatal. Bacitracin
                                                                           methylenedisalicylate as
                                                                           provided by No. 054771
                                                                           in Sec.   510.600(c) of
                                                                           this chapter.
(v) 27 to 45 of each drug.  Bambermycins, 1 to 2.  Broiler chickens: As   Feed continuously as sole       058198
                                                    an aid in preventing   ration from time chicks
                                                    outbreaks of cecal     are placed on litter
                                                    (Eimeria tenella)      until past the time when
                                                    and intestinal (E.     coccidiosis is
                                                    acervulina, E.         ordinarily a hazard. Do
                                                    maxima, E. necatrix,   not use as a treatment
                                                    and E. brunetti)       for coccidiosis. Do not
                                                    coccidiosis, and for   feed to laying hens.
                                                    increased rate of      Withdraw 5 days before
                                                    weight gain and        slaughter. Do not allow
                                                    improved feed          turkeys, horses, or
                                                    efficiency.            other equines access to
                                                                           formulations containing
                                                                           narasin. Ingestion of
                                                                           narasin by these species
                                                                           has been fatal.
                                                                           Bambermycins as provided
                                                                           by No. 016592 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
----------------------------------------------------------------------------------------------------------------

    (2) Narasin and nicarbazin fixed-ratio, combination drug Type A 
medicated articles may also be used in combination with:
    (i) Avilamycin as in Sec.  558.68.
    (ii) [Reserved]

0
25. Revise Sec.  558.366 to read as follows:

Sec.  558.366  Nicarbazin.

    (a) Specifications. Type A medicated articles containing 25 percent 
nicarbazin.
    (b) Sponsors. See Nos. 058198, 060728, and 066104 in Sec.  
510.600(c) of this chapter for use as in paragraph (d) of this section.
    (c) Related tolerances. See Sec.  556.445 of this chapter.
    (d) Conditions of use. It is used as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
                              Combination in grams
Nicarbazin in grams per ton          per ton           Indications for use           Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 90.8 to 181.6..........  ......................  Broiler chickens: As    Feed continuously as sole    066104
                                                      an aid in preventing    ration from time chicks
                                                      outbreaks of cecal      are placed on litter
                                                      (Eimeria tenella) and   until past the time when
                                                      intestinal (E.          coccidiosis is ordinarily
                                                      acervulina, E.          a hazard. Do not use as a
                                                      maxima, E. necatrix,    treatment for outbreaks
                                                      and E. brunetti)        of coccidiosis. Do not
                                                      coccidiosis.            use in flushing mashes.
                                                                              Do not feed to laying
                                                                              hens. Withdraw 4 days
                                                                              before slaughter for use
                                                                              levels at or below 113.5
                                                                              g/ton. Withdraw 5 days
                                                                              before slaughter for use
                                                                              levels above 113.5 g/ton.
(ii) 90.8 to 181.6.........  Bacitracin              Broiler chickens: As    Feed continuously as sole    054771
                              methylenedisalicylate   an aid in preventing    ration from time chicks
                              , 4 to 50.              outbreaks of cecal      are placed on litter
                                                      (Eimeria tenella) and   until past the time when
                                                      intestinal (E.          coccidiosis is ordinarily
                                                      acervulina, E.          a hazard. Do not use as a
                                                      maxima, E. necatrix,    treatment for outbreaks
                                                      and E. brunetti)        of coccidiosis. Do not
                                                      coccidiosis, and for    use in flushing mashes.
                                                      increased rate of       Do not feed to laying
                                                      weight gain and         hens. Withdraw 4 days
                                                      improved feed           before slaughter for use
                                                      efficiency.             levels at or below 113.5
                                                                              g/ton. Withdraw 5 days
                                                                              before slaughter for use
                                                                              levels above 113.5 g/ton.
                                                                              Nicarbazin as provided by
                                                                              No. 066104; bacitracin
                                                                              methylenedisalicylate as
                                                                              provided by No. 054771 in
                                                                              Sec.   510.600(c) of this
                                                                              chapter.

[[Page 64744]]

 
(iii) 90.8 to 181.6........  Bacitracin              Broiler chickens; As    Feed continuously as sole    066104
                              methylenedisalicylate   an aid in preventing    ration from time chicks
                              , 30.                   outbreaks of cecal      are placed on litter
                                                      (Eimeria tenella) and   until past the time when
                                                      intestinal (E.          coccidiosis is ordinarily
                                                      acervulina, E.          a hazard. Do not use as a
                                                      maxima, E. necatrix,    treatment for
                                                      and E. brunetti)        coccidiosis. Do not use
                                                      coccidiosis, and for    in flushing mashes. Do
                                                      increased rate of       not feed to laying hens.
                                                      weight gain and         Withdraw 4 days before
                                                      improved feed           slaughter for use levels
                                                      efficiency.             at or below 113.5 g/ton.
                                                                              Withdraw 5 days before
                                                                              slaughter for use levels
                                                                              above 113.5 g/ton.
                                                                              Nicarbazin as provided by
                                                                              No. 066104; bacitracin
                                                                              methylenedisalicylate as
                                                                              provided by No. 054771 in
                                                                              Sec.   510.600(c) of this
                                                                              chapter.
(iv) 90.8 to 181.6.........  Bacitracin              Broiler chickens: As    Feed continuously as sole    054771
                              methylenedisalicylate   an aid in preventing    ration from time chicks
                              50.                     outbreaks of cecal      are placed on litter
                                                      (Eimeria tenella) and   until past the time when
                                                      intestinal (E.          coccidiosis is ordinarily
                                                      acervulina, E.          a hazard. Do not use as a
                                                      maxima, E. necatrix,    treatment for outbreaks
                                                      and E. brunetti)        of coccidiosis. Do not
                                                      coccidiosis, and as     use in flushing mashes.
                                                      an aid in the           Do not feed to laying
                                                      prevention of           hens. Withdraw 4 days
                                                      necrotic enteritis      before slaughter for use
                                                      caused or complicated   levels at or below 113.5
                                                      by Clostridium spp.     g/ton. Withdraw 5 days
                                                      or other organisms      before slaughter for use
                                                      susceptible to          levels above 113.5 g/ton.
                                                      bacitracin.             Nicarbazin as provided by
                                                                              No. 066104; bacitracin
                                                                              methylenedisalicylate as
                                                                              provided by No. 054771 in
                                                                              Sec.   510.600(c) of this
                                                                              chapter.
(v) 113.5..................  ......................  Chickens: As an aid in  Feed continuously as sole    058198
                                                      preventing outbreaks    ration from time chicks     060728
                                                      of cecal (Eimeria       are placed on litter
                                                      tenella) and            until past the time when
                                                      intestinal (E.          coccidiosis is ordinarily
                                                      acervulina, E.          a hazard. Do not use as a
                                                      maxima, E. necatrix,    treatment for
                                                      and E. brunetti)        coccidiosis. Do not use
                                                      coccidiosis.            in flushing mashes. Do
                                                                              not feed to laying hens.
                                                                              Withdraw 4 days before
                                                                              slaughter.
(vi) 113.5.................  Bacitracin              Broiler chickens; aid   Feed continuously as sole    060728
                              methylenedisalicylate   in preventing           ration from time chicks
                              , 30.                   outbreaks of cecal      are placed on litter
                                                      (Eimeria tenella) and   until past the time when
                                                      intestinal (E.          coccidiosis is ordinarily
                                                      acervulina, E.          a hazard. Do not use as a
                                                      maxima, E. necatrix,    treatment for
                                                      and E. brunetti)        coccidiosis. Do not use
                                                      coccidiosis, and for    in flushing mashes. Do
                                                      increased rate of       not feed to laying hens.
                                                      weight gain and         Withdraw 4 days before
                                                      improved feed           slaughter. Nicarbazin as
                                                      efficiency.             provided by No. 066104;
                                                                              bacitracin
                                                                              methylenedisalicylate as
                                                                              provided by No. 054771 in
                                                                              Sec.   510.600(c) of this
                                                                              chapter.
(vii) 113.5................  Bacitracin zinc, 4 to   Broiler chickens; aid   For broiler chickens only.   054771
                              50.                     in preventing           Feed continuously as sole   066104
                                                      outbreaks of cecal      ration from time chicks
                                                      (Eimeria tenella) and   are placed on litter
                                                      intestinal (E.          until past the time when
                                                      acervulina, E.          coccidiosis is ordinarily
                                                      maxima, E. necatrix,    a hazard. Do not use in
                                                      and E. brunetti)        flushing mashes. Do not
                                                      coccidiosis, and for    feed to laying hens.
                                                      increased rate of       Withdraw 4 days before
                                                      weight gain and         slaughter. Nicarbazin as
                                                      improved feed           provided by No. 066104,
                                                      efficiency.             bacitracin zinc as
                                                                              provided by No. 054771 in
                                                                              Sec.   510.600(c) of this
                                                                              chapter.
(viii) 113.5...............  Bambermycins, 1 to 2..  Broiler chickens: As    Feed continuously as sole    016592
                                                      an aid in preventing    ration from time chicks
                                                      outbreaks of cecal      are placed on litter
                                                      (Eimeria tenella) and   until past the time when
                                                      intestinal (E.          coccidiosis is ordinarily
                                                      acervulina, E.          a hazard; do not use as a
                                                      maxima, E. necatrix,    treatment for
                                                      and E. brunetti)        coccidiosis. Do not use
                                                      coccidiosis, and for    in flushing mashes. Do
                                                      increased rate of       not feed to laying hens.
                                                      weight gain and         Withdraw 4 days before
                                                      improved feed           slaughter. Nicarbazin as
                                                      efficiency.             provided by No. 066104;
                                                                              bambermycins as provided
                                                                              by No. 016592 in Sec.
                                                                              510.600(c) of this
                                                                              chapter.
----------------------------------------------------------------------------------------------------------------

    (2) [Reserved]

Sec.  558.485   [Amended]

0
26. In Sec.  558.485, in paragraph (e)(2), in the ``Limitations'' 
column, remove ``Not for use in horses intended for food.'' and in its 
place add ``Do not use in horses intended for human consumption.''

    Dated: December 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27238 Filed 12-17-18; 8:45 am]
 BILLING CODE 4164-01-P