Document ID: FDA-2015-N-0002-0020
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Approval of New Animal Drug Applications
Posted Date: 2015-09-04T04:00Z

[Federal Register Volume 80, Number 172 (Friday, September 4, 2015)]
[Rules and Regulations]
[Pages 53458-53463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21905]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 524, and 558

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

New Animal Drugs; Approval of New Animal Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect application-related actions for new animal 
drug applications (NADAs) and abbreviated new animal drug applications 
(ANADAs) during May and June 2015. FDA is also informing the public of 
the availability of summaries of the basis of approval and of 
environmental review documents, where applicable. The animal drug 
regulations are also being amended to reflect a nonsubstantive change. 
This technical amendment is being made to improve the accuracy of the 
regulations.

DATES: This rule is effective September 4, 2015.

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

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations 
to reflect approval actions for NADAs and ANADAs during May and June 
2015, as listed in table 1. In addition, FDA is informing the public of 
the availability, where applicable, of documentation of environmental 
review required under the National Environmental Policy Act (NEPA) and, 
for actions requiring review of safety or effectiveness data, summaries 
of the basis of approval (FOI Summaries) under the Freedom of 
Information Act (FOIA). These public documents may be seen in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 
p.m., Monday through Friday. Persons with access to the Internet may 
obtain these documents at the 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 May and June 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              New animal drug                               21 CFR
            NADA/ANADA                     Sponsor              product name             Action            sections       FOIA summary     NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-417...........................  Bayer HealthCare LLC,  CORAXIS (moxidectin)   Original approval           524.1450  yes............  CE.\1\ \2\
                                     Animal Health          Topical Solution for   for the prevention
                                     Division, P.O. Box     Dogs.                  of heartworm
                                     390, Shawnee                                  disease, and for
                                     Mission, KS 66201.                            the treatment and
                                                                                   control of
                                                                                   intestinal
                                                                                   hookworm, roundworm
                                                                                   and whipworm
                                                                                   infections in dogs.
141-188...........................  Merial Inc., 3239      MARQUIS (ponazuril)    Supplemental                520.1855  yes............  CE.\1\ \2\
                                     Satellite Blvd.,       Oral Paste.            approval of a
                                     Bldg. 500, Duluth,                            revised dosage that
                                     GA 30096-4640.                                includes a loading
                                                                                   dose on the first
                                                                                   day of treatment.
141-262...........................  Zoetis Inc., 333       CERENIA (maropitant    Supplemental                520.1315  yes............  CE.\1\ \2\
                                     Portage St.,           citrate) Tablets.      approval extending
                                     Kalamazoo, MI 49007.                          duration of daily
                                                                                   administration
                                                                                   until resolution of
                                                                                   acute vomiting.

[[Page 53459]]

 
141-291...........................  Dechra, Ltd.,          VETORYL (trilostane)   Supplemental                520.2598  no.............  CE.\1\ \2\
                                     Snaygill Industrial    Capsules.              approval of a 5-
                                     Estate, Keighley                              milligram capsule
                                     Rd., Skipton, North                           size.
                                     Yorkshire, BD23 2RW,
                                     United Kingdom.
141-278...........................  Intervet, Inc., 2      ZILMAX (zilpaterol     Supplemental                 558.665  yes............  CE.\1\ \3\
                                     Giralda Farms,         hydrochloride) plus    approval to provide
                                     Madison, NJ 07940.     RUMENSIN (monensin).   for component
                                                           Type A medicated        feeding of
                                                            articles.              combination drug
                                                                                   Type C medicated
                                                                                   feeds to cattle fed
                                                                                   in confinement for
                                                                                   slaughter.
141-282...........................  Intervet, Inc., 2      ZILMAX (zilpaterol     Supplemental                 558.665  yes............  CE.\1\ \3\
                                     Giralda Farms,         hydrochloride) plus    approval to provide
                                     Madison, NJ 07940.     RUMENSIN (monensin)    for component
                                                            plus MGA               feeding of
                                                            (melengestrol          combination drug
                                                            acetate).              Type C medicated
                                                           Type A medicated        feeds to heifers
                                                            articles.              fed in confinement
                                                                                   for slaughter.
141-284...........................  Intervet, Inc., 2      ZILMAX (zilpaterol     Supplemental                 558.665  yes............  CE.\1\ \3\
                                     Giralda Farms,         hydrochloride) plus    approval to provide
                                     Madison, NJ 07940.     MGA (melengestrol      for component
                                                            acetate).              feeding of
                                                           Type A medicated        combination drug
                                                            articles.              Type C medicated
                                                                                   feeds to heifers
                                                                                   fed in confinement
                                                                                   for slaughter.
200-497...........................  Norbrook               LOXICOM (meloxicam)    Original approval as        520.1367  yes............  CE.\1\ \3\
                                     Laboratories, Ltd.,    1.5 mg/mL Oral         a generic copy of
                                     Station Works, Newry   Suspension.            NADA 141-213.
                                     BT35 6JP, Northern
                                     Ireland.
200-580...........................  Huvepharma AD, 5th     TYLOVET (tylosin       Original approval as     \4\ 558.550  yes............  CE.\1\ \3\
                                     Floor, 3A Nikolay      phosphate) plus        a generic copy of
                                     Haytov Str., 1113      SACOX (salinomycin     NADA 141-198.
                                     Sophia, Bulgaria.      sodium)
                                                           Type C medicated
                                                            feeds.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an
  environmental impact statement because it is of a type that does not have a significant effect on the human environment.
\2\ CE granted under 21 CFR 25.33(d)(1).
\3\ CE granted under 21 CFR 25.33(a)(1).
\4\ The regulation does not require amendment.

    Also, the animal drug regulations are being amended to reflect 
approved labeling for hand feeding bambermycins medicated cattle feed. 
This technical amendment is being made 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 Parts 520 and 524

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR parts 520, 
524, and 558 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
2. In Sec.  520.1315, revise paragraph (c)(1) to read as follows:

Sec.  520.1315  Maropitant.

* * * * *
    (c) * * *
    (1) Indications for use and amount. (i) For prevention of acute 
vomiting in dogs 2 to 7 months of age, administer a minimum dose of 2.0 
mg per kilogram (/kg) body weight once daily for up to 5 consecutive 
days.
    (ii) For prevention of acute vomiting in dogs 7 months of age and 
older, administer a minimum dose of 2.0 mg/kg body weight once daily 
until resolution of acute vomiting.
    (iii) For prevention of vomiting due to motion sickness in dogs 4 
months of age and older, administer a minimum of 8.0 mg/kg body weight 
once daily for up to 2 consecutive days.
* * * * *

Sec.  520.1367  [Amended]

0
3. In Sec.  520.1367, in paragraph (b)(2), remove ``No. 013744'' and in 
its place add ``Nos. 013744 and 055529''.

0
4. In Sec.  520.1855, revise paragraph (c)(1) to read as follows:

Sec.  520.1855  Ponazuril.

* * * * *
    (c) * * *

[[Page 53460]]

    (1) Amount. Administer orally 15 mg per kilogram (kg) (6.81 mg per 
pound (lb)) body weight as the first dose, followed by 5 mg/kg (2.27 
mg/lb) body weight once daily for a period of 27 additional days.
* * * * *

Sec.  520.2598  [Amended]

0
5. In Sec.  520.2598, in paragraph (a), remove ``10, 30, or 60 
milligrams'' and in its place add ``5, 10, 30, 60, or 120 milligrams''.

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

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

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

0
7. In Sec.  524.1450, and revise paragraphs (a), (b), and (d), and 
remove paragraph (e).
    The revisions read as follows:

Sec.  524.1450  Moxidectin.

    (a) Specifications. Each milliliter of solution contains:
    (1) 5 milligrams (mg) moxidectin (0.5 percent solution).
    (2) 25 mg moxidectin (2.5 percent solution).
    (b) Sponsors. See sponsor numbers in Sec.  510.600 of this chapter:
    (1) No. 000010 for use of product described in paragraph (a)(1) of 
this section as in paragraph (d)(1) of this section;
    (2) No. 000859 for use of product described in paragraph (a)(2) of 
this section as in paragraph (d)(2) of this section.
* * * * *
    (d) Conditions of use--(1) Cattle--(i) Amount. Administer topically 
0.5 mg per kilogram (kg) of body weight.
    (ii) Indications for use. Beef and dairy cattle: For treatment and 
control of internal and external parasites: gastrointestinal roundworms 
(Ostertagia ostertagi (adult and L4, including inhibited larvae), 
Haemonchus placei (adult and L4), Trichostrongylus axei (adult and L4), 
T. colubriformis (adult and L4), Cooperia oncophora (adult and L4), C. 
pectinata (adult), C. punctata (adult and L4), C. spatulata (adult), C. 
surnabada (adult and L4), Bunostomum phlebotomum (adult), 
Oesophagostomum radiatum (adult and L4), Nematodirus helvetianus (adult 
and L4)); lungworms (Dictyocaulus viviparus (adult and L4)); cattle 
grubs (Hypoderma bovis, H. lineatum); mites (Chorioptes bovis, 
Psoroptes ovis (P. communis var. bovis)); lice (Linognathus vituli, 
Haematopinus eurysternus, Solenopotes capillatus, Bovicola (Damalinia) 
bovis); and horn flies (Haematobia irritans). To control infections and 
to protect from reinfection with H. placei for 14 days after treatment, 
O. radiatum and O. ostertagi for 28 days after treatment, and D. 
viviparus for 42 days after treatment.
    (iii) Limitations. A withdrawal period has not been established for 
this product on preruminating calves. Do not use on calves to be 
processed for veal. See Sec.  500.25 of this chapter.
    (2) Dogs--(i) Amount. Administer topically a minimum of 1.1 mg per 
pound (lb) (2.5 mg/kg) of body weight, once monthly using the 
appropriate preloaded applicator tube.
    (ii) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis, as well as the treatment and control of 
intestinal hookworm (Ancylostoma caninum (adult, immature adult, and L4 
larvae) and Uncinaria stenocephala (adult, immature adult, and L4 
larvae)), roundworm (Toxocara canis (adult and L4 larvae) and 
Toxascaris leonina (adult)), and whipworm (Trichuris vulpis (adult)) 
infections in dogs and puppies that are at least 7 weeks of age and 
that weigh at least 3 lbs.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

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

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

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

Sec.  558.95  [Amended]

0
9. In Sec.  558.95, in the table in paragraph (d)(4)(ii), in the 
``Bambermycins in grams/ton'' column, remove ``2 to 40'' and in its 
place add ``2 to 80''; and in the ``Limitations'' column, remove the 
first sentence and in its place add ``Feed continuously on a hand-fed 
basis at a rate of 10 to 40 milligrams per head per day in 1 to 10 
pounds of supplemental Type C medicated feed.''.
0
10. In Sec.  558.665, revise paragraphs (d)(2) and (e) to read as 
follows:

Sec.  558.665  Zilpaterol.

* * * * *
    (d) * * *
    (2) Labeling of Type A medicated articles and Type B medicated 
feeds used to manufacture complete Type C medicated feeds shall bear 
the caution statement in paragraph (d)(3) of this section.
* * * * *
    (e) Conditions of use in cattle. It is administered in feed as 
follows:

----------------------------------------------------------------------------------------------------------------
      Zilpaterol
hydrochloride in grams/ Combination in grams/     Indications for use            Limitations           Sponsor
          ton                    ton
----------------------------------------------------------------------------------------------------------------
(1) 6.8...............  .....................  Cattle fed in confinement  Feed continuously as the        000061
                                                for slaughter: For         sole ration during the
                                                increased rate of weight   last 20 to 40 days on
                                                gain, improved feed        feed to provide 60 to 90
                                                efficiency, and            mg zilpaterol
                                                increased carcass          hydrochloride per head
                                                leanness in cattle fed     per day. Withdrawal
                                                in confinement for         period: 3 days. See
                                                slaughter during the       paragraph (d) of this
                                                last 20 to 40 days on      section.
                                                feed.
(2) 6.8...............  Monensin 10 to 40....  Cattle fed in confinement  Feed continuously as the        000061
                                                for slaughter: For         sole ration during the         000986
                                                increased rate of weight   last 20 to 40 days on
                                                gain, improved feed        feed to provide 60 to 90
                                                efficiency, and            mg zilpaterol
                                                increased carcass          hydrochloride per head
                                                leanness in cattle fed     per day and 0.14 to 0.42
                                                in confinement for         mg monensin per pound of
                                                slaughter during the       body weight per day
                                                last 20 to 40 days on      depending on the
                                                feed; for prevention and   severity of the
                                                control of coccidiosis     coccidiosis challenge,
                                                due to Eimeria bovis and   up to 480 mg/head/day
                                                E. zuernii.                monensin. Withdrawal
                                                                           period: 3 days. See
                                                                           paragraph (d) of this
                                                                           section. See paragraph
                                                                           Sec.   558.355(d) of
                                                                           this chapter Monensin as
                                                                           provided by No. 000986
                                                                           in Sec.   510.600(c) of
                                                                           this chapter.

[[Page 53461]]

 
(3) 6.8...............  Melengestrol acetate   Heifers fed in             Feed continuously as the        000061
                         to provide 0.25 to     confinement for            sole ration during the         000986
                         0.5 mg/head/day.       slaughter: For increased   last 20 to 40 days on
                                                rate of weight gain,       feed to provide 60 to 90
                                                improved feed              mg zilpaterol
                                                efficiency, and            hydrochloride per head
                                                increased carcass          per day. Withdrawal
                                                leanness in cattle fed     period: 3 days. See
                                                in confinement for         paragraph (d) of this
                                                slaughter during the       section.
                                                last 20 to 40 days on     Melengestrol acetate as
                                                feed; and for              provided by Nos. 000986
                                                suppression of estrus      or 054771 in Sec.
                                                (heat).                    510.600(c) of this
                                                                           chapter.
(4) 6.8...............  Monensin 10 to 40      Heifers fed in             Feed continuously as the        000061
                         plus melengestrol      confinement for            sole ration during the         000986
                         acetate to provide     slaughter: For increased   last 20 to 40 days on
                         0.25 to 0.5 mg/head/   rate of weight gain,       feed to provide 60 to 90
                         day.                   improved feed              mg zilpaterol
                                                efficiency, and            hydrochloride per head
                                                increased carcass          per day and 0.14 to 0.42
                                                leanness in cattle fed     mg monensin per pound of
                                                in confinement for         body weight per day
                                                slaughter during the       depending on the
                                                last 20 to 40 days on      severity of the
                                                feed; for prevention and   coccidiosis challenge,
                                                control of coccidiosis     up to 480 mg/head/day
                                                due to Eimeria bovis and   monensin. Withdrawal
                                                E. zuernii; and for        period: 3 days. See
                                                suppression of estrus      paragraph (d) of this
                                                (heat).                    section. See paragraphs
                                                                           Sec.  Sec.   558.342(d)
                                                                           and 558.355(d) of this
                                                                           chapter.
                                                                          Monensin as provided by
                                                                           No. 000986; melengestrol
                                                                           acetate as provided by
                                                                           Nos. 000986 or 054771 in
                                                                           Sec.   510.600(c) of
                                                                           this chapter.
(5) 6.8...............  Monensin 10 to 40,     For increased rate of      Feed continuously as the        000061
                         plus tylosin 8 to 10.  weight gain, improved      sole ration during the         016592
                                                feed efficiency, and       last 20 to 40 days on
                                                increased carcass          feed to provide 60 to 90
                                                leanness in cattle fed     mg zilpaterol
                                                in confinement for         hydrochloride per head
                                                slaughter during the       per day and 0.14 to 0.42
                                                last 20 to 40 days on      mg monensin per pound of
                                                feed; for prevention and   body weight per day
                                                control of coccidiosis     depending on the
                                                due to Eimeria bovis and   severity of the
                                                E. zuernii; and for        coccidiosis challenge,
                                                reduction of incidence     up to 480 mg/head/day
                                                of liver abscesses         monensin. Withdrawal
                                                caused by Fusobacterium    period: 3 days. See
                                                necrophorum and            paragraph (d) of this
                                                Arcanobacterium            section. See paragraphs
                                                (Actinomyces) pyogenes.    Sec.  Sec.   558.355(d)
                                                                           and 558.625(c) of this
                                                                           chapter.
                                                                          Monensin as provided by
                                                                           No. 000986; tylosin as
                                                                           provided by Nos. 000986
                                                                           or 016592 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(6) 6.8...............  Monensin 10 to 40,     Heifers fed in             Feed continuously as the        000061
                         plus tylosin 8 to      confinement for            sole ration during the         000986
                         10, plus               slaughter: For increased   last 20 to 40 days on          016592
                         melengestrol acetate   rate of weight gain,       feed to provide 60 to 90
                         to provide 0.25 to     improved feed              mg zilpaterol
                         0.5 mg/head/day.       efficiency, and            hydrochloride per head
                                                increased carcass          per day and 0.14 to 0.42
                                                leanness in cattle fed     mg monensin per pound of
                                                in confinement for         body weight per day
                                                slaughter during the       depending on the
                                                last 20 to 40 days on      severity of the
                                                feed; for prevention and   coccidiosis challenge,
                                                control of coccidiosis     up to 480 mg/head/day
                                                due to Eimeria bovis and   monensin. Withdrawal
                                                E. zuernii; for            period: 3 days. See
                                                reduction of incidence     paragraph (d) of this
                                                of liver abscesses         section. See paragraphs
                                                caused by Fusobacterium    Sec.  Sec.   558.342(d),
                                                necrophorum and            558.355(d), and
                                                Arcanobacterium            558.625(c) of this
                                                (Actinomyces) pyogenes;    chapter.
                                                and for suppression of    Monensin as provided by
                                                estrus (heat).             No. 000986; tylosin as
                                                                           provided by Nos. 000986
                                                                           or 016592; and
                                                                           melengestrol acetate as
                                                                           provided by Nos. 000986
                                                                           or 054771 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(7) 6.8 to 24.........  .....................  Cattle fed in confinement  Feed continuously during        000061
                                                for slaughter: For         the last 20 to 40 days
                                                increased rate of weight   on feed to provide 60 mg
                                                gain, improved feed        zilpaterol hydrochloride
                                                efficiency, and            per head per day.
                                                increased carcass          Withdrawal period: 3
                                                leanness in cattle fed     days. See paragraph (d)
                                                in confinement for         of this section.
                                                slaughter during the
                                                last 20 to 40 days on
                                                feed.

[[Page 53462]]

 
(8) 6.8 to 24.........  Monensin 10 to 40....  Cattle fed in confinement  Feed continuously during        000061
                                                for slaughter: For         the last 20 to 40 days
                                                increased rate of weight   on feed to provide 60 mg
                                                gain, improved feed        zilpaterol hydrochloride
                                                efficiency, and            per head per day and
                                                increased carcass          0.14 to 0.42 mg monensin
                                                leanness in cattle fed     per pound of body weight
                                                in confinement for         per day depending on the
                                                slaughter during the       severity of the
                                                last 20 to 40 days on      coccidiosis challenge,
                                                feed; and for prevention   up to 480 mg/head/day
                                                and control of             monensin. Withdrawal
                                                coccidiosis due to         period: 3 days. See
                                                Eimeria bovis and E.       paragraph (d) of this
                                                zuernii.                   section. See paragraph
                                                                           Sec.   558.355(d) of
                                                                           this chapter.
                                                                          Monensin as provided by
                                                                           No. 000986 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(9) 6.8 to 24.........  Melengestrol acetate   Heifers fed in             Feed continuously during        000061
                         to provide 0.25 to     confinement for            the last 20 to 40 days
                         0.5 mg/head/day.       slaughter: For increased   on feed to provide 60 mg
                                                rate of weight gain,       zilpaterol hydrochloride
                                                improved feed              per head per day.
                                                efficiency, and            Withdrawal period: 3
                                                increased carcass          days. See paragraph (d)
                                                leanness in cattle fed     of this section. See
                                                in confinement for         paragraph Sec.
                                                slaughter during the       558.342(d) of this part.
                                                last 20 to 40 days on     Melengestrol acetate as
                                                feed; and for              provided by No. 054771
                                                suppression of estrus      in Sec.   510.600(c) of
                                                (heat).                    this chapter.
(10) 6.8 to 24........  Monensin 10 to 40,     Heifers fed in             Feed continuously during        000061
                         plus melengestrol      confinement for            the last 20 to 40 days
                         acetate to provide     slaughter: For increased   on feed to provide 60 mg
                         0.25 to 0.5 mg/head/   rate of weight gain,       zilpaterol hydrochloride
                         day.                   improved feed              per head per day and
                                                efficiency, and            0.14 to 0.42 mg monensin
                                                increased carcass          per pound of body weight
                                                leanness in cattle fed     per day depending on the
                                                in confinement for         severity of the
                                                slaughter during the       coccidiosis challenge,
                                                last 20 to 40 days on      up to 480 mg/head/day
                                                feed; for prevention and   monensin. Withdrawal
                                                control of coccidiosis     period: 3 days. See
                                                due to Eimeria bovis and   paragraph (d) of this
                                                E. zuernii; and for        section. See paragraphs
                                                suppression of estrus      Sec.  Sec.   558.342(d)
                                                (heat).                    and 558.355(d) of this
                                                                           chapter.
                                                                          Monensin as provided by
                                                                           No. 000986; melengestrol
                                                                           acetate as provided by
                                                                           No. 054771 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(11) 6.8 to 24........  Monensin 10 to 40,     Cattle fed in confinement  Feed continuously during        000061
                         plus tylosin 8 to 10.  for slaughter: For         the last 20 to 40 days
                                                increased rate of weight   on feed to provide 60 mg
                                                gain, improved feed        zilpaterol hydrochloride
                                                efficiency, and            per head per day and
                                                increased carcass          0.14 to 0.42 mg monensin
                                                leanness in cattle fed     per pound of body weight
                                                in confinement for         per day depending on the
                                                slaughter during the       severity of the
                                                last 20 to 40 days on      coccidiosis challenge,
                                                feed; for prevention and   up to 480 mg/head/day
                                                control of coccidiosis     monensin. Withdrawal
                                                due to Eimeria bovis and   period: 3 days. See
                                                E. zuernii; and for        paragraph (d) of this
                                                reduction of incidence     section. See paragraphs
                                                of liver abscesses         Sec.  Sec.   558.355(d)
                                                caused by Fusobacterium    and 558.625(c) of this
                                                necrophorum and            chapter.
                                                Arcanobacterium           Monensin and tylosin as
                                                (Actinomyces) pyogenes.    provided by No. 000986
                                                                           in Sec.   510.600(c) of
                                                                           this chapter.
(12) 6.8 to 24........  Monensin 10 to 40,     Heifers fed in             Feed continuously during        000061
                         plus tylosin 8 to      confinement for            the last 20 to 40 days
                         10, plus               slaughter: For increased   on feed to provide 60 mg
                         melengestrol acetate   rate of weight gain,       zilpaterol hydrochloride
                         to provide 0.25 to     improved feed              per head per day and
                         0.5 mg/head/day.       efficiency, and            0.14 to 0.42 mg monensin
                                                increased carcass          per pound of body weight
                                                leanness in cattle fed     per day depending on the
                                                in confinement for         severity of the
                                                slaughter during the       coccidiosis challenge,
                                                last 20 to 40 days on      up to 480 mg/head/day
                                                feed; for prevention and   monensin. Withdrawal
                                                control of coccidiosis     period: 3 days. See
                                                due to Eimeria bovis and   paragraph (d) of this
                                                E. zuernii; for            section. See paragraphs
                                                reduction of incidence     Sec.  Sec.   558.342(d),
                                                of liver abscesses         558.355(d), and
                                                caused by Fusobacterium    558.625(c) of this
                                                necrophorum and            chapter.
                                                Arcanobacterium           Monensin and tylosin as
                                                (Actinomyces) pyogenes;    provided by No. 000986;
                                                and for suppression of     melengestrol acetate as
                                                estrus (heat).             provided by No. 054771
                                                                           in Sec.   510.600(c) of
                                                                           this chapter.
----------------------------------------------------------------------------------------------------------------

    Dated: August 31, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-21905 Filed 9-3-15; 8:45 am]
 BILLING CODE 4164-01-P