[Federal Register Volume 84, Number 194 (Monday, October 7, 2019)]
[Rules and Regulations]
[Pages 53309-53313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21514]



[[Page 53309]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 526, 529, 556, and 558

[Docket No. FDA-2019-N-0002]


New Animal Drugs; Approval of New Animal Drug Applications; 
Change of 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 2019. 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 of the regulations.

DATES: This rule is effective October 7, 2019.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (CVM) (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 2019, 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 2019
--------------------------------------------------------------------------------------------------------------------------------------------------------
     Approval date        File No.          Sponsor            Product name             Species            Effect of the action       Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
April 11, 2019........      140-989  Syndel USA, 1441 W.   PARASITE-S            Freshwater-reared      Supplemental approval for  FOI Summary.
                                      Smith Rd.,            (formalin) Aqueous    finfish.               the control of mortality
                                      Ferndale, WA 98248.   Formaldehyde                                 in freshwater-reared
                                                            Solution.                                    finfish due to
                                                                                                         saprolegniasis
                                                                                                         associated with fungi in
                                                                                                         the family
                                                                                                         Saprolegniaceae.
May 6, 2019...........      141-288  Zoetis Inc., 333      EXCENEL RTU EZ        Cattle and swine.....  Supplemental approval      FOI Summary.
                                      Portage St.,          (ceftiofur                                   providing for an
                                      Kalamazoo, MI 49007.  hydrochloride)                               increase in the maximum
                                                            Sterile Suspension.                          injection site volume in
                                                                                                         swine.
May 7, 2019...........      200-633  Pharmgate LLC, 1800   DERACIN               Swine................  Original approval as a     FOI Summary.
                                      Sir Tyler Dr.,        (chlortetracycline)                          generic copy of NADA 141-
                                      Wilmington, NC        plus DENAGARD                                011.
                                      28405.                (tiamulin hydrogen
                                                            fumarate) Type C
                                                            medicated swine
                                                            feeds.
May 16, 2019..........      200-598  Bimeda Animal Health  ENROMED 100           Cattle and swine.....  Original approval as a     FOI Summary.
                                      Ltd., 1B The          (enrofloxacin)                               generic copy of NADA 141-
                                      Herbert Building,     Antimicrobial                                068.
                                      The Park,             Injectable Solution.
                                      Carrickmines,
                                      Dublin, 18, Ireland.
May 21, 2019..........      141-512  Elanco US Inc. 2500   EXPERIOR              Cattle...............  Original approval for      FOI Summary.
                                      Innovation Way,       (lubabegron),                                beef steers and heifers
                                      Greenfield, IN        RUMENSIN                                     fed in confinement for
                                      46140.                (monensin), and                              slaughter during the
                                                            TYLAN (tylosin                               last 14 to 91 days on
                                                            phosphate) Type C                            feed for reduction of
                                                            medicated feeds.                             ammonia gas emissions
                                                                                                         per pound of live weight
                                                                                                         and hot carcass weight;
                                                                                                         for reduction of
                                                                                                         incidence of liver
                                                                                                         abscesses associated
                                                                                                         with Fusobacterium
                                                                                                         necrophorum and
                                                                                                         Arcanobacterium
                                                                                                         pyogenes; and for either
                                                                                                         improved feed efficiency
                                                                                                         or prevention and
                                                                                                         control of coccidiosis
                                                                                                         due to Eimeria bovis and
                                                                                                         E. zuernii.
May 21, 2019..........      141-514  Elanco US Inc. 2500   EXPERIOR              Cattle...............  Original approval for      FOI Summary.
                                      Innovation Way,       (lubabegron) and                             beef steers and heifers
                                      Greenfield, IN        RUMENSIN (monensin)                          fed in confinement for
                                      46140.                Type C medicated                             slaughter during the
                                                            feeds.                                       last 14 to 91 days on
                                                                                                         feed for reduction of
                                                                                                         ammonia gas emissions
                                                                                                         per pound of live weight
                                                                                                         and hot carcass weight;
                                                                                                         and for either improved
                                                                                                         feed efficiency or
                                                                                                         prevention and control
                                                                                                         of coccidiosis due to
                                                                                                         Eimeria bovis and E.
                                                                                                         zuernii.
May 30, 2019..........      200-573  Bimeda Animal Health  OXYMED LA             Cattle and swine.....  Original approval as a     FOI Summary.
                                      Ltd., 1B The          (oxytetracycline                             generic copy of NADA 113-
                                      Herbert Building,     injection).                                  232.
                                      The Park,
                                      Carrickmines,
                                      Dublin, 18, Ireland.
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 53310]]

II. Change of Sponsor's Names and Addresses

    Medicis Dermatologics, Inc., 8125 North Hayden Rd., Scottsdale, AZ 
85258 has informed FDA that it has changed its name and address to 
Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 
08807. Accordingly, we are amending Sec.  510.600(c) to reflect these 
changes.

III. Technical Amendments

    A section describing tolerances of hetacillin residues (21 CFR 
556.316) has been added to subpart B of part 556. This section cross-
references the sole hetacillin product approved for use in food-
producing animals, an intramammary infusion for use in lactating dairy 
cows (21 CFR 526.1130). This new section codifies FDA's finding at the 
time of product approval that, because hetacillin is rapidly hydrolyzed 
to ampicillin, existing ampicillin tolerances provide appropriate 
tolerances for hetacillin in edible tissues of cattle (38 FR 31172, 
November 12, 1973). This amendment is being made to make the 
regulations more comprehensive.
    FDA is also revising the regulations to reflect the approved 
conditions of use of sulfaquinoxaline soluble powder as a veterinary 
prescription product for oral administration to cattle as a drench. 
Finally, we are also revising the regulations for use of monensin in 
medicated goat feed to reflect the approved incorporation level. These 
actions are being taken to improve the accuracy of the regulations.

IV. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food, 
Drug, and Cosmetic Act (the 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, 526, and 529

    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, 526, 529, 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), remove the entry 
for ``Medicis Dermatologics, Inc.'' and add an entry in alphabetic 
order for ``Bausch Health US, LLC''; and in the table in paragraph 
(c)(2), revise the entry for ``099207''.
    The addition and revision 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
------------------------------------------------------------------------
 
                              * * * * * * *
Bausch Health US, LLC, 400 Somerset Corporate Blvd.,              099207
 Bridgewater, NJ 08807..................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
099207.......................  Bausch Health US, LLC, 400 Somerset
                                Corporate Blvd., Bridgewater, NJ 08807.
------------------------------------------------------------------------

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.  520.812  [Amended]

0
4. In Sec.  520.812, in paragraph (a)(1)(i), remove ``2.7'' and in its 
place add ``22.7''.

0
5. In Sec.  520.2325b, revise paragraph (d)(3) to read as follows:


Sec.  520.2325b  Sulfaquinoxaline drench.

* * * * *
    (d) * * *
    (3) Limitations. Not for use in lactating dairy cattle. A 
withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal.

[[Page 53311]]

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

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

0
7. In Sec.  522.313b, revise paragraphs (a)(2) and (e)(1)(iii) to read 
as follows:


Sec.  522.313b  Ceftiofur hydrochloride.

    (a) * * *
    (2) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur 
equivalents in the inactive vehicles polyoxyethylene sorbitan 
monooleate (polysorbate 80) in a caprylic/capric triglyceride 
suspension; or
* * * * *
    (e) * * *
    (1) * * *
    (iii) Limitations. For products described in paragraphs (a)(1) and 
(3) of this section: Treated swine must not be slaughtered for 4 days 
following the last treatment. For products described in paragraph 
(a)(2) of this section: Treated swine must not be slaughtered for 6 
days following the last treatment when injection site volumes are 
greater than 5 mL up to the maximum injection site volume of 15 mL. 
Treated swine must not be slaughtered for 4 days when injection site 
volumes are less than or equal to 5 mL.
* * * * *

0
8. In Sec.  522.812, revise paragraphs (b)(1) and (2) to read as 
follows:


Sec.  522.812  Enrofloxacin.

* * * * *
    (b) * * *
    (1) Nos. 000859, 026637, and 055529 for use of product described in 
paragraph (a)(1) as in paragraph (e)(1); and
    (2) Nos. 000859, 055529, and 061133 for use of product described in 
paragraph (a)(2) as in paragraphs (e)(2) and (3) of this section.
* * * * *

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

0
9. The authority citation for part 526 continues to read as follows:

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

0
10. In Sec.  526.1130, revise the section heading, redesignate 
paragraph (c) as paragraph (d), and add new paragraph (c).
    The revision and addition read as follows:


Sec.  526.1130  Hetacillin.

* * * * *
    (c) Related tolerances. See Sec.  556.316 of this chapter.
* * * * *

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
11. The authority citation for part 529 continues to read as follows:

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

0
12. In Sec.  529.1030, revise paragraph (b) and add paragraphs 
(d)(1)(iv) and (d)(2)(iv) to read as follows:


Sec.  529.1030  Formalin.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
uses as in paragraph (d) of this section.
    (1) No. 050378 for use as in paragraph (d) of this section.
    (2) Nos. 049968 and 067188 for use as in paragraphs (d)(1)(i), 
(ii), and (iii), (d)(2)(i), (ii), and (iii), and (d)(3) of this 
section.
    (d) * * *
    (1) * * *
    (iv) Freshwater-reared finfish. For the control of mortality due to 
saprolegniasis associated with fungi in the family Saprolegniaceae.
    (2) * * *
    (iv) For the control of mortality in freshwater-reared finfish due 
to saprolegniasis associated with fungi in the family Saprolegniaceae: 
In tanks and raceways, administer 150 [mu]L/L (ppm) for 60 minutes per 
day on alternate days for three treatments.
* * * * *

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

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

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


0
14. Add Sec.  556.316 to read as follows:


Sec.  556.316  Hetacillin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for ampicillin (marker residue for 
hetacillin) are:
    (1) Cattle. Edible tissues: 0.01 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  526.1130 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.  558.4, in paragraph (d), in the ``Category II'' table, 
revise the row entry for ``Tilmicosin'' to read as follows:


Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   Category II
----------------------------------------------------------------------------------------------------------------
                                       Assay limits
                Drug                    percent \1\       Type B maximum (100x)       Assay limits percent \1\
                                          Type A                                            Type B/C \2\
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Tilmicosin..........................          90-110  37.9 g/lb (8.35%)...........  Swine Type B/C feed: 85-115
                                                                                    Cattle Type B feed: 85-115
                                                                                    Cattle Type C feed: 80-110
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
17. In Sec.  558.330, revise paragraph (d) to read as follows:


Sec.  558.330  Lubabegron.

* * * * *
    (d) Conditions of use--(1) It is used in cattle feed as follows:

[[Page 53312]]



--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Combination in grams/
  Lubabegron fumarate in grams/ton             ton               Indications for use                        Limitations                       Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 1.25 to 4.54...................  ......................  Beef steers and heifers fed  Feed continuously as the sole ration to                 058198
                                                              in confinement for           provide 13 to 90 mg lubabegron/head/day
                                                              slaughter: For reduction     during the last 14 to 91 days on feed. A
                                                              of ammonia gas emissions     decrease in dry matter intake may be noticed
                                                              per pound of live weight     in some animals receiving lubabegron. Not
                                                              and hot carcass weight       approved for use in breeding animals because
                                                              during the last 14 to 91     safety and effectiveness have not been
                                                              days on feed.                evaluated in these animals. Do not allow
                                                                                           horses or other equines access to feed
                                                                                           containing lubabegron.
(ii) 1.25 to 4.54..................  Monensin, 5 to 40.....  Beef steers and heifers fed  Feed continuously as the sole ration to                 058198
                                                              in confinement for           provide 13 to 90 mg lubabegron/head/day and
                                                              slaughter: For reduction     50 to 480 mg monensin/head/day during the
                                                              of ammonia gas emissions     last 14 to 91 days on feed. No additional
                                                              per pound of live weight     improvement in feed efficiency has been shown
                                                              and hot carcass weight and   from feeding monensin at levels greater than
                                                              for improved feed            30 g/ton (360 mg monensin/head/day. A
                                                              efficiency during the last   decrease in dry matter intake may be noticed
                                                              14 to 91 days on feed.       in some animals receiving lubabegron.
                                                                                           Lubabegron has not been approved for use in
                                                                                           breeding animals because safety and
                                                                                           effectiveness have not been evaluated in
                                                                                           these animals. Do not allow horses or other
                                                                                           equines access to feed containing lubabegron
                                                                                           and monensin. Ingestion of monensin by horses
                                                                                           has been fatal. Monensin medicated cattle and
                                                                                           goat feeds are safe for use in cattle and
                                                                                           goats only. Consumption by unapproved species
                                                                                           may result in toxic reactions. Feeding
                                                                                           undiluted or mixing errors resulting in high
                                                                                           concentrations of monensin has been fatal to
                                                                                           cattle and could be fatal to goats. Must be
                                                                                           thoroughly mixed in feeds before use. Do not
                                                                                           exceed the levels of monensin recommended in
                                                                                           the feeding directions, as reduced average
                                                                                           daily gains may result. If feed refusals
                                                                                           containing monensin are fed to other groups
                                                                                           of cattle, the concentration of monensin in
                                                                                           the refusals and amount of refusals fed
                                                                                           should be taken into consideration to prevent
                                                                                           monensin overdosing. A withdrawal period has
                                                                                           not been established for this product for
                                                                                           preruminating calves. Do not use in calves to
                                                                                           be processed for veal.
(iii) 1.25 to 4.54.................  Monensin, 10 to 40....  Beef steers and heifers fed  Feed continuously as the sole ration to                 058198
                                                              in confinement for           provide 13 to 90 mg lubabegron/head/day and
                                                              slaughter: For reduction     0.14 to 0.42 mg monensin/lb body weight per
                                                              of ammonia gas emissions     day, depending upon severity of coccidiosis
                                                              per pound of live weight     challenge, during the last 14 to 91 days on
                                                              and hot carcass weight;      feed. A decrease in dry matter intake may be
                                                              and for prevention and       noticed in some animals receiving lubabegron.
                                                              control of coccidiosis due   Lubabegron has not been approved for use in
                                                              to Eimeria bovis and E.      breeding animals because safety and
                                                              zuernii during the last 14   effectiveness have not been evaluated in
                                                              to 91 days on feed.          these animals. Do not allow horses or other
                                                                                           equines access to feed containing lubabegron
                                                                                           and monensin. Ingestion of monensin by horses
                                                                                           has been fatal. Monensin medicated cattle and
                                                                                           goat feeds are safe for use in cattle and
                                                                                           goats only. Consumption by unapproved species
                                                                                           may result in toxic reactions. Feeding
                                                                                           undiluted or mixing errors resulting in high
                                                                                           concentrations of monensin has been fatal to
                                                                                           cattle and could be fatal to goats. Must be
                                                                                           thoroughly mixed in feeds before use. Do not
                                                                                           exceed the levels of monensin recommended in
                                                                                           the feeding directions, as reduced average
                                                                                           daily gains may result. If feed refusals
                                                                                           containing monensin are fed to other groups
                                                                                           of cattle, the concentration of monensin in
                                                                                           the refusals and amount of refusals fed
                                                                                           should be taken into consideration to prevent
                                                                                           monensin overdosing. A withdrawal period has
                                                                                           not been established for this product for
                                                                                           preruminating calves. Do not use in calves to
                                                                                           be processed for veal.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (2) Lubabegron may also be used in combination with:
    (i) Tylosin as in Sec.  558.625.
    (ii) [Reserved]

0
18. In Sec.  558.355, in paragraph (f)(6)(i), in the ``Monensin in 
grams/ton'' column, remove ``5 to 40'' and in its place add ``20''; and 
redesignate paragraphs (f)(7)(iv) through (xi) as paragraphs (f)(7)(v) 
through (xii) and add new paragraph (f)(7)(iv).
    The addition reads as follows:


Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (7) * * *
    (iv) Lubabegron as in Sec.  558.330.
* * * * *

0
19. In Sec.  558.625, redesignate paragraphs (e)(2)(vii) through (xv) 
as paragraphs (e)(2)(ix) through (xvii), and add new paragraphs 
(e)(2)(vii) and (viii).
    The additions read as follows:

[[Page 53313]]

Sec.  558.625  Tylosin.

* * * * *
    (e) * * *
    (2) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Combination in grams/
         Tylosin grams/ton                     ton               Indications for use                        Limitations                       Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
(vii) 8 to 10......................  Monensin, 5 to 40 plus  Beef steers and heifers fed  Feed continuously as sole ration to provide 13          058198
                                      lubabegron fumarate,    in confinement for           to 90 mg lubabegron/head/day, 50 to 480 mg
                                      1.25 to 4.54.           slaughter: For reduction     monensin/head/day, and 60 to 90 mg tylosin/
                                                              of ammonia gas emissions     head/day during the last 14 to 91 days on
                                                              per pound of live weight     feed. No additional improvement in feed
                                                              and hot carcass weight;      efficiency has been shown from feeding
                                                              for reduction of incidence   monensin at levels greater than 30 g/ton (360
                                                              of liver abscesses           mg monensin/head/day. A decrease in dry
                                                              associated with              matter intake may be noticed in some animals
                                                              Fusobacterium necrophorum    receiving lubabegron. Lubabegron has not been
                                                              and Arcanobacterium          approved for use in breeding animals because
                                                              pyogenes, and for improved   safety and effectiveness have not been
                                                              feed efficiency during the   evaluated in these animals. Do not allow
                                                              last 14 to 91 days on feed.  horses or other equines access to feed
                                                                                           containing lubabegron and monensin. Ingestion
                                                                                           of monensin by horses has been fatal.
                                                                                           Monensin medicated cattle and goat feeds are
                                                                                           safe for use in cattle and goats only.
                                                                                           Consumption by unapproved species may result
                                                                                           in toxic reactions. Feeding undiluted or
                                                                                           mixing errors resulting in high
                                                                                           concentrations of monensin has been fatal to
                                                                                           cattle and could be fatal to goats. Must be
                                                                                           thoroughly mixed in feeds before use. Do not
                                                                                           exceed the levels of monensin recommended in
                                                                                           the feeding directions, as reduced average
                                                                                           daily gains may result. If feed refusals
                                                                                           containing monensin are fed to other groups
                                                                                           of cattle, the concentration of monensin in
                                                                                           the refusals and amount of refusals fed
                                                                                           should be taken into consideration to prevent
                                                                                           monensin overdosing. A withdrawal period has
                                                                                           not been established for this product for
                                                                                           preruminating calves. Do not use in calves to
                                                                                           be processed for veal.
(viii) 8 to 10.....................  Monensin, 10 to 40      Beef steers and heifers fed  Feed continuously as sole ration to provide 13          058198
                                      plus lubabegron         in confinement for           to 90 mg lubabegron/head/day, 0.14 to 0.42 mg
                                      fumarate, 1.25 to       slaughter: For reduction     monensin/lb body weight per day, depending
                                      4.54.                   of ammonia gas emissions     upon severity of coccidiosis challenge, up to
                                                              per pound of live weight     480 mg/head/day, and 60 to 90 mg tylosin/head/
                                                              and hot carcass weight,      day during the last 14 to 91 days on feed. A
                                                              for reduction of incidence   decrease in dry matter intake may be noticed
                                                              of liver abscesses           in some animals receiving lubabegron.
                                                              associated with              Lubabegron has not been approved for use in
                                                              Fusobacterium necrophorum    breeding animals because safety and
                                                              and Arcanobacterium          effectiveness have not been evaluated in
                                                              pyogenes, and for            these animals. Do not allow horses or other
                                                              prevention and control of    equines access to feed containing lubabegron
                                                              coccidiosis due to Eimeria   and monensin. Ingestion of monensin by horses
                                                              bovis and E. zuernii         has been fatal. Monensin medicated cattle and
                                                              during the last 14 to 91     goat feeds are safe for use in cattle and
                                                              days on feed.                goats only. Consumption by unapproved species
                                                                                           may result in toxic reactions. Feeding
                                                                                           undiluted or mixing errors resulting in high
                                                                                           concentrations of monensin has been fatal to
                                                                                           cattle and could be fatal to goats. Must be
                                                                                           thoroughly mixed in feeds before use. Do not
                                                                                           exceed the levels of monensin recommended in
                                                                                           the feeding directions, as reduced average
                                                                                           daily gains may result. If feed refusals
                                                                                           containing monensin are fed to other groups
                                                                                           of cattle, the concentration of monensin in
                                                                                           the refusals and amount of refusals fed
                                                                                           should be taken into consideration to prevent
                                                                                           monensin overdosing. A withdrawal period has
                                                                                           not been established for this product for
                                                                                           preruminating calves. Do not use in calves to
                                                                                           be processed for veal.
 
                                                                      * * * * * * *
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    Dated: September 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21514 Filed 10-4-19; 8:45 am]
 BILLING CODE 4164-01-P


