[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Rules and Regulations]
[Pages 14893-14908]
[FR Doc No: 2023-03649]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 526, 528, and 558

[Docket No. FDA-2022-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications; Change of
Sponsor; Change of Sponsor Name and Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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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 July, August, and September 2022. 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 improve the accuracy
and readability of the regulations.

DATES: This rule is effective March 10, 2023.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Approvals

    FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during July, August, and September 2022,
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,<PHONE_NUMBER>. Persons
with access to the internet may obtain these documents at the CVM

FOIA Electronic Reading Room: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. Marketing
exclusivity and patent information may be accessed in FDA's
publication, Approved Animal Drug Products Online (Green Book) at:
https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book.
    FDA has verified the website addresses as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.

 Table 1--Original and Supplemental NADAs and ANADAs Approved During July, August, and September 2022 Requiring Evidence of Safety and/or Effectiveness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                21 CFR
         Approval date            File No.          Sponsor              Product name        Effect of the action       Public documents        section
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 18, 2022..................    141-043  Zoetis Inc., 333        SYNOVEX Choice and      Supplemental approval  FOI Summary, EA, FONSI....   522.2478
                                             Portage St.,            SYNOVEX Plus            of a reimplantation
                                             Kalamazoo, MI 49007.    (trenbolone acetate     program for growing
                                                                     and estradiol           beef steers and
                                                                     benzoate implants)      heifers fed in
                                                                     Implants.               confinement for
                                                                                slaughter for
                                                                                increased rate of
                                                                                weight gain for up
                                                                                to 200 days.
July 18, 2022..................    141-348  Zoetis Inc., 333        SYNOVEX ONE Feedlot     Supplemental approval  FOI Summary, EA, FONSI....   522.2478
                                             Portage St.,            (trenbolone acetate     of a reimplantation
                                             Kalamazoo, MI 49007.    and estradiol           program for growing
                                                                     benzoate extended-      beef steers and
                                                                     release implants)       heifers fed in
                                                                     Implants.               confinement for
                                                                                slaughter for
                                                                                increased rate of
                                                                                weight gain for up
                                                                                to 200 days.
July 19, 2022..................    200-724  Huvepharma EOOD, 5th    Lubabegron, monensin,   Original approval for  FOI Summary...............    558.625
                                             Floor, 3A Nikolay       and tylosin Type C      use of EXPERIOR
                                             Haytov Str., 1113       medicated feeds.        (lubabegron Type A
                                             Sofia, Bulgaria.                                medicated article)
                                                                                with MONOVET
                                                                                (monensin Type A
                                                                                medicated article)
                                                                                and TYLOVET (tylosin
                                                                                phosphate Type A
                                                                                medicated article)
                                                                                in the manufacture
                                                                                of Type C medicated
                                                                                cattle feeds as a
                                                                                generic copy of NADA
                                                                                141-512.
July 19, 2022..................    200-725  Huvepharma EOOD, 5th    Lubabegron and          Original approval for  FOI Summary...............    558.330
                                             Floor, 3A Nikolay       monensin Type C         use of EXPERIOR
                                             Haytov Str., 1113       medicated feeds.        (lubabegron Type A
                                             Sofia, Bulgaria.                                medicated article)
                                                                                with MONOVET
                                                                                (monensin Type A
                                                                                medicated article)
                                                                                in the manufacture
                                                                                of Type C medicated
                                                                                cattle feeds as a
                                                                                generic copy of NADA
                                                                                141-514.
July 28, 2022..................    141-564  Pharmgate, Inc., 1800   Chlortetracycline and   Original approval for  FOI Summary...............    558.128
                                             Sir Tyler Dr.,          monensin Type C         use of PENNCHLOR
                                             Wilmington, NC 28405.   medicated feeds.        (chlortetracycline
                                                                                Type A medicated
                                                                                article) and
                                                                                RUMENSIN (monensin
                                                                                Type A medicated
                                                                                article) in the
                                                                                manufacture of Type
                                                                                C medicated cattle
                                                                                feeds.
July 29, 2022..................    200-726  Pegasus Laboratories,   Firocoxib Tablets for   Original approval for  FOI Summary...............    520.928
                                             Inc., 8809 Ely Rd.,     Horses (firocoxib       the control of pain
                                             Pensacola, FL 32514.    tablets).               and inflammation
                                                                                associated with
                                                                                osteoarthritis in
                                                                                horses as a generic
                                                                                copy of NADA 141-458.
July 29, 2022..................    200-727  Felix Pharmaceuticals   Meloxicam 5 mg/mL       Original approval for  FOI Summary...............   522.1367
                                             Pvt. Ltd., 25-28        Solution for            the control of pain
                                             North Wall Quay,        Injection.              and inflammation in
                                             Dublin, 1, Ireland.                             dogs and cats as a
                                                                                generic copy of NADA
                                                                                141-219.
August 9, 2022.................    141-459  Intervet, Inc., 2       BRAVECTO (fluralaner    Supplemental approval  FOI Summary...............    524.998
                                             Giralda Farms,          topical solution) for   for the treatment
                                             Madison, NJ 07940.      Cats.                   and control of Asian
                                                                                longhorned tick
                                                                                infestations for 12
                                                                                weeks in cats and
                                                                                kittens.
August 9, 2022.................    141-518  Intervet, Inc., 2       BRAVECTO PLUS           Supplemental approval  FOI Summary...............   524.1001
                                             Giralda Farms,          (fluralaner and         for the treatment
                                             Madison, NJ 07940.      moxidectin topical      and control of Asian
                                                                     solution) for Cats.     longhorned tick
                                                                                infestations for 2
                                                                                months in cats and
                                                                                kittens.
August 11, 2022................    141-565  Pharmgate, Inc., 1800   Bacitracin and          Original approval of   FOI Summary...............    558.355
                                             Sir Tyler Dr.,          monensin Type C         PENNITRACIN MD
                                             Wilmington, NC 28405.   medicated feeds.        (bacitracin Type A
                                                                                medicated article)
                                                                                and COBAN (monensin
                                                                                Type A medicated
                                                                                article) to be used
                                                                                in the manufacture
                                                                                of Type C medicated
                                                                                feeds for the
                                                                                prevention of
                                                                                mortality caused by
                                                                                necrotic enteritis,
                                                                                or for increased
                                                                                rate of weight gain
                                                                                and improved feed
                                                                                efficiency, and as
                                                                                an aid in the
                                                                                prevention of
                                                                                coccidiosis in
                                                                                broiler chickens,
                                                                                laying hen
                                                                                replacement
                                                                                chickens, and layer
                                                                                breeder replacement
                                                                                chickens.
September 6, 2022..............    141-462  Phibro Animal Health    Virginiamycin and       Original approval of   FOI Summary...............    558.635
                                             Corp., GlenPointe       narasin Type C          STAFAC
                                             Centre East, 3d         medicated feeds.        (virginiamycin Type
                                             Floor, 300 Frank W                              A medicated article)
                                             Burr Blvd., Suite 21,                           and MONTEBAN
                                             Teaneck, NJ 07666.                              (narasin Type A
                                                                                medicated article)
                                                                                to be used in the
                                                                                manufacture of Type
                                                                                C medicated feeds
                                                                                for the prevention
                                                                                of necrotic
                                                                                enteritis and
                                                                                coccidiosis in
                                                                                broiler chickens.

September 6, 2022..............    141-429  Phibro Animal Health    Virginiamycin,          Original approval of   FOI Summary...............    558.635
                                             Corp., GlenPointe       narasin, and            STAFAC
                                             Centre East, 3d         nicarbazin Type C       (virginiamycin Type
                                             Floor, 300 Frank W      medicated feeds.        A medicated article)
                                             Burr Blvd., Suite 21,                           and MAXIBAN (narasin
                                             Teaneck, NJ 07666.                              and nicarbazin Type
                                                                                A medicated article)
                                                                                to be used in the
                                                                                manufacture of Type
                                                                                C medicated feeds
                                                                                for the prevention
                                                                                of necrotic
                                                                                enteritis and
                                                                                coccidiosis in
                                                                                broiler chickens.
September 9, 2022..............    141-553  Zoetis Inc, 333         VALCOR (doramectin and  Original approval for  FOI Summary...............    522.772
                                             Portage St.,            levamisole injection)   the treatment and
                                             Kalamazoo, MI 49007.    Injectable Solution.    control of certain
                                                                                gastrointestinal
                                                                                roundworms,
                                                                                lungworms, eyeworms,
                                                                                grubs, sucking lice,
                                                                                and mange mites in
                                                                                cattle; and for
                                                                                revising the
                                                                                tolerance for
                                                                                residues of
                                                                                doramectin in the
                                                                                target tissue,
                                                                                cattle liver.
September 28, 2022.............    200-719  Vetoquinol USA, Inc.,   SIMPLERA (florfenicol,  Original approval for  FOI Summary...............    524.957
                                             4250 N Sylvania Ave.,   terbinafine,            the treatment of
                                             Fort Worth, TX 76137.   mometasone furoate)     otitis externa in
                                                                     Otic Solution.          dogs as a generic
                                                                                copy of NADA 141-440.
September 29, 2022.............    200-694  Bimeda Animal Health    SPECTOGARD              Original approval for  FOI Summary...............   522.2121
                                             Ltd., 1B The Herbert    (spectinomycin          the treatment of
                                             Building, The Park,     sulfate) Injectable     bovine respiratory
                                             Carrickmines, Dublin    Solution.               disease as a generic
                                             18, Ireland.                                    copy of NADA 141-077.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Also, FDA is amending the animal drug regulations to reflect
approval of supplemental applications, as listed in table 2, to change
the marketing status of dosage form antimicrobial animal drug products
from over-the-counter (OTC) to by veterinary prescription (Rx). These
applications were submitted in voluntary compliance with the goals of
the FDA Center for Veterinary Medicine's (CVM's) Judicious Use
Initiative as identified by guidance for industry #263,
``Recommendations for Sponsors of Medically Important Antimicrobial
Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary
Oversight All Products That Continue to be Available Over-the-
Counter,'' June 11, 2021 (https://www.fda.gov/media/130610/download).

  Table 2--Supplemental Applications Approved During July, August, and September 2022, To Change the Marketing
                           Status of Antimicrobial Animal Drug Products From OTC to Rx
----------------------------------------------------------------------------------------------------------------
         Approval date           File No.         Sponsor            Product name           21 CFR  section
----------------------------------------------------------------------------------------------------------------
July 7, 2022..................    041-629  Zoetis Inc., 333      SPECTOGARD            520.2123c.
                                            Portage St.,          (spectinomycin)
                                            Kalamazoo, MI 49007.  Solution.
July 7, 2022..................    055-072  Do..................  ALBACILLIN            526.1698.
                                                                  (penicillin G
                                                                  procaine and
                                                                  novobiocin sodium)
                                                                  Intramammary
                                                                  Infusion.
July 19, 2022.................    041-245  Do..................  ALBON                 522.2220.
                                                                  (sulfadimethoxine)
                                                                  Injection 40%.
July 29, 2022.................    055-098  Do..................  ALBADRY PLUS          526.1698.
                                                                  (penicillin G
                                                                  procaine and
                                                                  novobiocin sodium)
                                                                  Intramammary
                                                                  Infusion.
July 29, 2022.................    012-965  Elanco US Inc., 2500  TYLAN 50 (tylosin)    522.2640.
                                            Innovation Way,       Injection and TYLAN
                                            Greenfield, IN        200 (tylosin)
                                            46140.                Injection.
July 29, 2022.................    011-060  Zoetis Inc., 333      TERRAMYCIN            520.1660c.
                                            Portage St.,          (oxytetracycline
                                            Kalamazoo, MI 49007.  HCl) Tablets.
July 29, 2022.................    140-909  Do..................  SULKA-S               520.2260a.
                                                                  (sulfamethazine)
                                                                  Bolus.
July 29, 2022.................    094-114  Do..................  TERRAMYCIN<PHONE_NUMBER>a.
                                                                  (oxytetracycline
                                                                  HCl) Injectable
                                                                  Solution; and
                                                                  LIQUAMYCIN 100
                                                                  (oxytetracycline
                                                                  HCl) Injectable
                                                                  Solution.
August 3, 2022................    037-586  Do..................  ERYTHROMAST 36        526.820.
                                                                  (erythromycin)
                                                                  Intramammary
                                                                  Infusion.
August 5, 2022................    065-124  Do..................  Tetracycline          Not codified.
                                                                  Intramuscular Vet
                                                                  (tetracycline)
                                                                  Injection.
August 11, 2022...............    031-944  Do..................  DYNAMXYIN             522.2340.
                                                                  (sulfomyxin)
                                                                  Injectable.
August 16, 2022...............    065-130  Do..................  CRYSTALLINE PRO       522.1696b.
                                                                  PENICILLIN G
                                                                  (penicillin G
                                                                  procaine)
                                                                  Injectable
                                                                  Suspension.
August 30, 2022...............    099-402  Do..................  OXYVET and AQUACHEL   522.1662a.
                                                                  (oxytetracycline
                                                                  hydrochloride)
                                                                  Injectable Solution.
September 22, 2022............    008-763  Do..................  TERRAMYCIN            524.1662b.
                                                                  (oxytetracycline
                                                                  hydrochloride and
                                                                  polymyxin B
                                                                  sulfate) Ophthalmic
                                                                  Ointment.
September 23, 2022............    091-127  Do..................  OXYVET Injection      522.1662a.
                                                                  (oxytetracycline
                                                                  hydrochloride)
                                                                  Injectable Solution.
September 23, 2022............    048-287  Huvepharma EEOD, 5th  Oxytetracycline 50    522.1662a.
                                            Floor, 3A Nikolay     (oxytetracycline
                                            Haytov Str., 1113     hydrochloride)
                                            Sofia, Bulgaria.      Injectable Solution.
----------------------------------------------------------------------------------------------------------------

II. Changes of Sponsorship

    The sponsors of the following approved applications have informed
FDA that they have transferred ownership of, and all rights and
interest in, the applications to another sponsor, as listed in table 3.

                     Table 3--Changes of Sponsorship During July, August, and September 2022
----------------------------------------------------------------------------------------------------------------
                                                                                21 CFR
            File No.                  Product name        Transferring sponsor       New sponsor        section
----------------------------------------------------------------------------------------------------------------
039-583........................  GRANULEX V (balsam      Mylan Institutional,   Cronus Pharma          524.2620.
                                  Peru oil, castor oil,   Inc., 12720 Dairy      Specialities India
                                  trypsin).               Ashford Rd., Sugar     Private Ltd., Sy No-
                                                          Land, TX 77478.        99/1, M/s GMR
                                                                                Hyderabad Aviation
                                                                                SEZ Ltd.,
                                                                                Mamidipalli Village,
                                                                                Shamshabad Mandal,
                                                                                Ranga Reddy,
                                                                                Hyderabad,
                                                                                Telangana, 501218,
                                                                                India.
141-513........................  ZIMETA (dipyrone)       Kindred Biosciences,   Dechra, Ltd.,           522.728.
                                  Injectable Solution.    Inc., 1555 Bayshore    Snaygill Industrial
                                                          Hwy., Suite 200,       Estate, Keighley
                                                          Burlingame, CA 94010.  Rd., Skipton, North
                                                                                Yorkshire, BD23 2RW,
                                                                                United Kingdom.
----------------------------------------------------------------------------------------------------------------

    Following these changes of sponsorship, Kindred Biosciences, Inc.
is no longer the sponsor of an approved application. Accordingly, the
drug labeler code for this firm will be removed from Sec.  510.600(c)
(21 CFR 510.600(c)).

III. Withdrawals of Approval

    LFB USA, Inc., 175 Crossing Blvd., Framingham, MA 01702 has
requested that FDA withdraw approval of NADA 141-294 for a Bc6 rDNA
construct in GTC 155-92 Goats because the product is no longer
manufactured or marketed. As provided in the regulatory text of this
document, the animal drug regulations in 21 CFR 528.1070 are amended to
reflect this action and in Sec.  510.600(c) to reflect that LFB USA,
Inc. is no longer the sponsor of an approved application.

IV. Change of Sponsor Name and Address

    Akorn Animal Health, Inc., 1925 West Field Ct., Suite 300, Lake
Forest, IL 60045 has informed FDA that it has changed its name and
address to Akorn Operating Co. LLC, 5605 Centerpoint Ct., Suite A,
Gurnee, IL 60031. As provided in the regulatory text, Sec.  510.600(c)
is amended to reflect this change.

V. Technical Amendments

    FDA is making the following amendments to improve the accuracy of
the animal drug regulations:
     21 CFR 510.600(c) is amended to revise the names and
addresses of Akorn Animal Health, Inc.; Mylan Institutional, Inc.; and
Mylan Institutional LLC in the list of sponsors of approved
applications and to remove Kindred Biosciences, Inc.
     21 CFR 520.154a is amended to add instructions for
administration of bacitracin methylenedisalicylate soluble powder in
drinking water of chickens, turkeys, and swine.
     21 CFR 522.840 is amended to reflect revised conditions of
use for estradiol sustained-release implants in beef steers and
heifers.
     21 CFR 522.1372 is amended to reflect the correct volume
of mepivacaine solution for nerve blocks used in horses.
     21 CFR 522.1702 is redesignated to list it in a correct
alphabetical sequence.
     21 CFR 558.128 is amended to reflect the correct
terminology for chlortetracycline Type C free-choice cattle feeds used
for control of anaplasmosis.
     21 CFR 558.258 is amended to reflect approved conditions
of use for free-choice fenbendazole protein and mineral blocks in beef
cattle.
     21 CFR 558.330 is amended to add a previously uncodified
concentration of lubabegron Type A medicated article for use in the
manufacture of Type C feeds for beef steers and heifers fed in
confinement for slaughter.
     21 CFR 558.366 is amended to correctly describe the target
class for nicarbazin medicated chicken feeds.
     21 CFR 558.450 is amended to revise the instructions for
use of oxytetracycline medicated feeds in breeding swine.

VI. 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, 524, 526, and 528

    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, 21 CFR parts
510, 520, 522, 524, 526, 528, 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:
0
a. In the table in paragraph (c)(1), revise the entry for ``Akorn
Animal Health, Inc.'', remove the entries for ``Kindred Biosciences,
Inc.'' and ``LFB USA, Inc.'', and revise the entries for ``Mylan
Institutional, Inc.'' and ``Mylan Institutional LLC''; and
0
b. In the table in paragraph (c)(2), revise the entries for ``051079'',
``059399'', and ``063286'' and remove the entries for ``086047'' and
``086078''.
    The revisions read as follows:

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

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

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------

                              * * * * * * *
Akorn Operating Co. LLC, 5605 Centerpoint Ct., Suite A,           059399
 Gurnee, IL 60031.......................................

                              * * * * * * *
Mylan Institutional, Inc., 12720 Dairy Ashford Rd.,               051079
 Sugar Land, TX 77478...................................
Mylan Institutional LLC, a Viatris Company, 3711 Collins          063286
 Ferry Rd., Morgantown, WV 26505........................

                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------

                              * * * * * * *
051079.......................  Mylan Institutional, Inc., 12720 Dairy
                                Ashford Rd., Sugar Land, TX 77478.

                              * * * * * * *
059399.......................  Akorn Operating Co. LLC, 5605 Centerpoint
                                Ct., Suite A, Gurnee, IL 60031.

                              * * * * * * *
063286.......................  Mylan Institutional LLC, a Viatris
                                Company, 3711 Collins Ferry Rd.,
                                Morgantown, WV 26505

                              * * * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for part 520 continues to read as follows:

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

0
4. In Sec.  520.154a:
0
a. Redesignate paragraphs (d)(1) and (2) as paragraphs (d)(2) and (1),
respectively;
0
b. In newly redesignated paragraphs (d)(1)(i)(B), (d)(1)(ii)(B), and
(d)(2)(iii), add a sentence to the end of the paragraph; and
0
c. Revise paragraph (d)(3)(iii).
    The additions and revision read as follows:

Sec.  520.154a  Bacitracin methylenedisalicylate.

* * * * *
    (d) * * *
    (1) * * *
    (i) * * *
    (B) * * * Use as the sole source of drinking water.
    (ii) * * *
    (B) * * * Use as the sole source of drinking water.
    (2) * * *
    (iii) * * * Use as the sole source of drinking water.
    (3) * * *
    (iii) Limitations. Prepare a fresh solution daily. Use as the sole
source of drinking water. Treatment not to exceed 14 days. Not to be
given to swine that weigh more than 250 pounds.
* * * * *

Sec.  520.928  [Amended]

0
5. In Sec.  520.928, in paragraph (b)(2), remove ``No. 000010'' and in
its place add ``Nos. 000010 and 055246''.

0
6. In Sec.  520.1660c, revise the section heading and paragraph (d)(3)
to read as follows:

Sec.  520.1660c  Oxytetracycline hydrochloride tablets and boluses.

* * * * *
    (d) * * *
    (3) Limitations--(i) For No. 000010: Dosage should continue until
the animal returns to normal and for 24 hours to 48 hours after
symptoms have subsided. Treatment should not exceed 4 consecutive days.
Do not exceed 500 milligrams per 100 pounds of body weight every 12
hours (10 milligrams per pound daily).
    (ii) For No. 054771: Discontinue treatment 7 days prior to
slaughter. 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. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.

0
7. In Sec.  520.2123c, revise paragraph (d)(3) to read as follows:

Sec.  520.2123c  Spectinomycin solution.

* * * * *
    (d) * * *
    (3) Limitations. Do not administer to pigs over 15 lb body weight
or over 4 weeks of age. Do not administer within 21 days of slaughter.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.

0
8. In Sec.  520.2260a, revise paragraph (d)(2)(iii) to read as follows:

Sec.  520.2260a  Sulfamethazine oblets and boluses.

* * * * *
    (d) * * *
    (2) * * *
    (iii) Limitations. Do not administer for more than 5 consecutive
days. Do not treat calves within 11 days of slaughter. Do not use in
calves to be slaughtered under 1 month of age or in calves being fed an
all milk diet. Do not use in female dairy cattle 20 months of age or
older; such use may cause drug residues in milk. 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
9. The authority citation for part 522 continues to read as follows:

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

Sec.  522.728  [Amended]

0
10. In 522.728, in paragraph (b), remove ``086078'' and in its place
add ``043264''.

0
11. Add Sec.  522.772 to read as follows:

Sec.  522.772  Doramectin and levamisole.

    (a) Specifications. Each milliliter of solution contains 5
milligrams (mg) of doramectin and 150 mg levamisole hydrochloride.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec.  556.222 and 556.350 of this
chapter.
    (d) Conditions of use--(1) Cattle--(i) Amount. Inject
subcutaneously in the neck as a single dose at a dosage of 0.2 mg
doramectin (0.91 mg/lb) and 6 mg of levamisole hydrochloride per kg
(2.72 mg/lb) of body weight.
    (ii) Indications for use. For treatment and control of
gastrointestinal roundworms (adults and fourth stage larvae):
Ostertagia ostertagi (including inhibited larvae), O. lyrata,
Haemonchus placei, Trichostrongylus axei, T. colubriformis, T.
longispicularis, Cooperia oncophora, C. pectinata, C. punctata, C.
surnabada, Bunostomum phlebotomum (adults only), Strongyloides
papillosus (adults only), Oesophagostomum radiatum, Trichuris spp.
(adults only) and Nematodirus helvetianus (adults only); lungworms
(adults and fourth stage larvae): Dictyocaulus viviparus; eyeworms
(adults): Thelazia spp.; grubs (parasitic stages): Hypoderma bovis and
H. lineatum; sucking lice: Haematopinus eurysternus, Linognathus
vituli, and Solenopotes capillatus; mange mites: Psoroptes bovis and
Sarcoptes scabiei in beef cattle 2 months of age and older and
replacement dairy heifers less than 20 months of age. Not for use in
beef bulls intended for breeding over 1 year of age, dairy calves, and
veal calves.
    (iii) Limitations. Cattle must not be slaughtered for human
consumption within 15 days following last treatment with this drug
product. Not for use in female dairy cattle 20 months of age or older,
including dry dairy cows; use in these cattle may cause drug residues
in milk and/or in calves born to these cows or heifers. Not for use in
beef calves less than 2 months of age, dairy calves, and veal calves. A
withdrawal period has not been established for this product in pre-
ruminating calves.
    (2) [Reserved]

0
12. In Sec.  522.840, revise paragraphs (d)(1) and (2) and remove
paragraph (d)(3).
    The revisions read as follows:

Sec.  522.840  Estradiol.

* * * * *
    (d) * * *
    (1) Amounts and indications for use--(i) 25.7-mg extended-release
implant. Insert one implant for increased rate of weight gain for up to
200 days in beef steer calves 2 months of age and older; for increased
rate of weight gain for up to 200 days in growing beef steers and
heifers on pasture (stocker, feeder, and slaughter); and for increased
rate of weight gain and improved feed efficiency for up to 200 days in
growing beef steers and heifers fed in confinement for slaughter.
    (ii) 43.9-mg extended-release implant. Insert one implant for
increased rate of weight gain for up to 400 days in beef steer calves 2
months of age and older; for increased rate of weight gain for up to
400 days in growing beef steers and heifers on pasture (stocker,
feeder, and slaughter); and for increased rate of weight gain and
improved feed efficiency for up to 400 days in growing beef steers and
heifers fed in confinement for slaughter.
    (2) Limitations. For subcutaneous ear implantation only. Not
approved for repeated implantation (reimplantation) with this or any
other cattle ear implant within each separate production phase (beef
steer calves 2 months of age and older, growing beef steers on pasture
(stocker, feeder, and slaughter), growing beef steers and heifers fed
in confinement for slaughter). Safety and effectiveness following
reimplantation have not been evaluated. Do not use in beef calves less
than 2 months of age, dairy calves, and veal calves. A withdrawal
period has not been established for this product in pre-ruminating
calves. Do not use in dairy cows or in animals intended for subsequent
breeding. Use in these cattle may cause drug residues in milk and/or in
calves born to these cows.

0
13. In Sec.  522.1367, revise paragraph (b) to read as follows:

Sec.  522.1367  Meloxicam.

* * * * *
    (b) Sponsors. See Nos. 000010, 016729, 017033, 055529, and 086101
in Sec.  510.600(c) of this chapter.
* * * * *

Sec.  522.1372  [Amended]

0
14. In Sec.  522.1372, in paragraph (c)(1), remove ``3 to 5 mL'' and in
its place add ``3 to 15 mL''.

Sec. Sec.  522.1662a and 522.1662b  [Redesignated as Sec.  522.1662 and
Sec.  522.1663]

0
15. Redesignate Sec. Sec.  522.1662a and 522.1662b as Sec. Sec.
522.1662 and 522.1663, respectively.

0
16. In newly redesignated Sec.  522.1662:
0
a. Revise the section heading;
0
b. Add headings to paragraphs (b)(3)(i) through (iii);
0
c. Remove paragraph (b)(3)(iv); and
0
d. Revise paragraphs (d), (e), (f), and (i)(1) through (3).
    The revisions and additions read as follows:

Sec.  522.1662  Oxytetracycline.

* * * * *
    (b) * * *
    (3) * * *
    (i) Amount. * * *
    (ii) Indications for use. * * *
    (iii) Limitations. * * *
* * * * *
    (d)(1) Specifications. Each milliliter of solution contains 100 mg
of oxytetracycline hydrochloride.
    (2) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use in beef cattle and nonlactating dairy
cattle--(i) Amount. Administer 3 to 5 mg of oxytetracycline per pound
of body weight per day by intramuscular injection, not to exceed a
total of 4 consecutive days. Administer 5 mg/lb of body weight per day
for treatment of anaplasmosis, severe foot-rot, or severe cases of
other indicated diseases, not to exceed a total of 4 consecutive days.
    (ii) Indications for use. For treatment of diseases due to
oxytetracycline-susceptible organisms as follows: Pneumonia and
shipping fever complex associated with Pasteurella spp. and Haemophilus
spp., foot-rot and diphtheria caused by Fusobacterium necrophorum,
bacterial enteritis (scours) caused by Escherichia coli, wooden tongue
caused by Actinobacillus lignieresii, leptospirosis caused by
Leptospira pomona, and wound infections and acute metritis caused by
Staphylococcus spp. and Streptococcus spp. For treatment of
anaplasmosis caused by Anaplasma marginale and anthrax caused by
Bacillus anthracis.
    (iii) Limitations. This drug product is not approved for use in
female dairy cattle 20 months of age or older, including dry dairy
cows. Use in these cattle may cause drug residues in milk and/or in
calves born to these cows. Discontinue treatment at least 15 days

prior to slaughter. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
    (e)(1) Specifications. Each milliliter of solution contains 50 mg
of oxytetracycline hydrochloride.
    (2) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use in beef cattle and nonlactating dairy cattle.
It is used as follows:
    (i) Amount. Administer by intravenous or intramuscular injection at
3 to 5 mg/lb of body weight per day, not exceed a total of 4
consecutive days.
    (ii) Indications for use. For treatment of pneumonia and shipping
fever complex associated with Pasteurella spp. and Haemophilus spp.;
foot-rot and diphtheria caused by Spherophorus necrophorus; bacterial
enteritis (scours) caused by Escherichia coli; wooden tongue caused by
Actinobacillus lignieresii; leptospirosis caused by Leptospira pomona;
wound infections and acute metritis caused by staphylococcal and
streptococcal organisms; and treatment of anaplasmosis caused by
Anaplasma marginale and anthrax caused by Bacillus anthracis.
    (iii) Limitations. This drug product is not approved for use in
female dairy cattle 20 months of age or older, including dry dairy
cows. Use in these cattle may cause drug residues in milk and/or in
calves born to these cows. Discontinue treatment at least 22 days prior
to slaughter. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
    (4) Conditions of use in swine. It is used in swine as follows:
    (i) Amount. Administer by intramuscular injection at 3 to 5 mg/lb
of body weight per day to swine, not to exceed a total of 4 consecutive
days. Administered to sows at 3 mg/lb of body weight approximately 8
hours before farrowing or immediately after farrowing.
    (ii) Indications for use. It is used for the treatment of bacterial
enteritis (scours, colibacillosis) caused by Escherichia coli;
pneumonia caused by Pasteurella multocida; and leptospirosis caused by
Leptospira pomona. Administered to sows as an aid in the control of
infectious enteritis (baby pig scours, colibacillosis) in suckling pigs
caused by Escherichia coli.
    (iii) Limitations. Discontinue treatment at least 22 days prior to
slaughter. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
    (5) Poultry (broilers, turkeys, and breeding chickens). It is used
as follows:
    (i) Amount. Administer subcutaneously to chickens and turkeys
according to age as directed on labeling.
    (ii) Indications for use. For the treatment of air sacculitis (air-
sac disease, chronic respiratory disease) caused by Mycoplasma
gallisepticum and Escherichia coli; fowl cholera caused by Pasteurella
multocida; infectious sinusitis caused by Mycoplasma gallisepticum; and
infectious synovitis caused by Mycoplasma synoviae.
    (iii) Limitations. Do not administer to laying hens unless the eggs
are used for hatching only. Discontinue treatment at least 5 days prior
to slaughter. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
    (f)(1) Specifications. Each milliliter of solution contains 100 mg
of oxytetracycline hydrochloride.
    (2) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use in beef cattle and nonlactating dairy
cattle--(i) Amount. Administer 3 to 5 mg of oxytetracycline per pound
of body weight per day by intramuscular injection, not to exceed a
total of 4 consecutive days. Administer 5 mg/lb of body weight per day
for treatment of anaplasmosis, severe foot-rot, or severe cases of
other indicated diseases, not to exceed a total of 4 consecutive days.
    (ii) Indications for use. For treatment of diseases due to
oxytetracycline-susceptible organisms as follows: Pneumonia and
shipping fever complex associated with Pasteurella spp. and Haemophilus
spp., foot-rot and diphtheria caused by Fusobacterium necrophorum,
bacterial enteritis (scours) caused by Escherichia coli, wooden tongue
caused by Actinobacillus lignieresii, leptospirosis caused by
Leptospira pomona, and wound infections and acute metritis caused by
Staphylococcus spp. and Streptococcus spp. For treatment of
anaplasmosis caused by Anaplasma marginale and anthrax caused by
Bacillus anthracis.
    (iii) Limitations. This drug product is not approved for use in
female dairy cattle 20 months of age or older, including dry dairy
cows. Use in these cattle may cause drug residues in milk and/or in
calves born to these cows. Discontinue treatment at least 15 days prior
to slaughter. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
* * * * *
    (i) * * *
    (1) Specifications. Each milliliter of solution contains 50
milligrams (mg) of oxytetracycline hydrochloride.
    (2) Sponsor. See No. 016592 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use in beef cattle, beef calves, nonlactating
dairy cattle, and dairy calves--(i) Amount. Administer 3 to 5 mg/lb
body weight per day by intramuscular injection not to exceed a total of
4 consecutive days.
    (ii) Indications for use. For treatment of bacterial pneumonia and
shipping fever complex associated with Pasteurella spp.; foot-rot and
diphtheria caused by Spherophorus necrophorus; bacterial enteritis
(scours) caused by Escherichia coli; wooden tongue caused by
Actinobacillus lignieresii; wound infections and acute metritis caused
by staphylococcal and streptococcal organisms susceptible to
oxytetracycline.
    (iii) Limitations. This drug product is not approved for use in
female dairy cattle 20 months of age or older, including dry dairy
cows. Use in these cattle may cause drug residues in milk and/or in
calves born to these cows. Discontinue treatment at least 18 days
before slaughter. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
* * * * *

0
17. In Sec.  522.1696b, revise paragraphs (b)(2), (d)(1)(i), and
(d)(2)(iii)(B) and add paragraph (d)(2)(iii)(C) to read as follows:

Sec.  522.1696b  Penicillin G procaine aqueous suspension.

* * * * *
    (b) * * *
    (2) Nos. 055529 and 061133 for use as in paragraph (d)(2) of this
section.
* * * * *
    (d) * * *
    (1) * * *
    (i) Amount. 10,000 units per pound body weight daily by
intramuscular injection.
* * * * *
    (2) * * *
    (iii) * * *
    (B) For Nos. 016592 and 055529: Treatment should not exceed 4
consecutive days. A withdrawal period has not been established for this
product in pre-ruminating calves. Discontinue treatment for the
following number of days before slaughter: Cattle--10; sheep--9; and
swine--7.
    (C) For No. 054771: Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

Sec.  522.1702  [Redesignated as Sec.  522.1698]

0
18. Redesignate Sec.  522.1702 as Sec.  522.1698.

Sec.  522.2121   [Amended]

0
19. In Sec.  522.2121, in paragraph (b), remove ``No. 054771'' and in
its place add ``Nos. 054771 and 061133''.

0
20. In Sec.  522.2220, revise paragraph (d)(4)(iii) to read as follows:

Sec.  522.2220  Sulfadimethoxine.

* * * * *
    (d) * * *
    (4) * * *
    (iii) Limitations. Milk taken from animals during treatment and for
60 hours (5 milkings) after the latest treatment must not be used for
food. Do not administer within 5 days of slaughter. A withdrawal period
has not been established for this product in preruminating calves. Do
not use in calves to be processed for veal. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.

0
21. In Sec.  522.2340, revise paragraph (e)(4) to read as follows:

Sec.  522.2340  Sulfomyxin.

* * * * *
    (e) * * *
    (4) Not for use in laying hens; do not treat chickens within 5 days
of slaughter. Do not treat turkeys within 7 days of slaughter. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.

0
22. Revise Sec.  522.2478 to read as follows:

Sec.  522.2478  Trenbolone acetate and estradiol benzoate.

    (a) Specifications. (1) Each implant consists of:
    (i) 100 milligrams (mg) trenbolone acetate and 14 mg estradiol
benzoate (one implant consisting of four pellets, each pellet
containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate) per
implant dose.
    (ii) 200 mg trenbolone acetate and 28 mg estradiol benzoate (one
implant consisting of eight pellets, each pellet containing 25 mg
trenbolone acetate and 3.5 mg estradiol benzoate) per implant dose.
    (2) Each extended-release implant consists of:
    (i) 150 mg trenbolone acetate and 21 mg estradiol benzoate (one
implant consisting of six pellets with a porous polymer film coating,
each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol
benzoate) per implant dose.
    (ii) 200 mg trenbolone acetate and 28 mg estradiol benzoate (one
implant consisting of eight pellets with a porous polymer film coating,
each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol
benzoate) per implant dose.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec.  556.240 and 556.739 of this
chapter.
    (d) Conditions of use--(1) Growing beef steers and heifers fed in
confinement for slaughter--(i) Amounts and indications for use--(A) An
implant containing 100 mg trenbolone acetate and 14 mg estradiol
benzoate as described in paragraph (a)(1)(i) of this section for
increased rate of weight gain in growing beef steers fed in confinement
for slaughter and for increased rate of weight gain and improved feed
efficiency in growing beef heifers fed in confinement for slaughter.
For increased rate of weight gain for up to 200 days in a
reimplantation program where an implant as described in paragraph
(a)(1)(i) of this section is the first implant and an implant as
described in paragraph (a)(1)(i) or (ii) or (a)(2)(ii) of this section
is administered 60 to 120 days later.
    (B) An implant containing 200 mg trenbolone acetate and 28 mg
estradiol benzoate as described in paragraph (a)(1)(ii) of this section
for increased rate of weight gain and improved feed efficiency in
growing beef steers fed in confinement for slaughter and for increased
rate of weight gain in growing beef heifers fed in confinement for
slaughter. For increased rate of weight gain for up to 200 days in a
reimplantation program where an implant as described in paragraph
(a)(1)(i) of this section is the first implant and an implant as
described in paragraph (a)(1)(ii) of this section is administered 60 to
120 days later.
    (C) An extended-release implant containing 150 mg trenbolone
acetate and 21 mg estradiol benzoate as described in paragraph
(a)(2)(i) of this section for increased rate of weight gain for up to
200 days.
    (D) An extended-release implant containing 200 mg trenbolone
acetate and 28 mg estradiol benzoate as described in paragraph
(a)(2)(ii) of this section for increased rate of weight gain and
improved feed efficiency for up to 200 days. For increased rate of
weight gain for up to 200 days in a reimplantation program where an
implant as described in paragraph (a)(1)(i) of this section is the
first implant and an implant as described in paragraph (a)(2)(ii) of
this section is administered 60 to 120 days later.
    (ii) Limitations. Implant pellets subcutaneously in ear only. Other
than as described on the labeling, this implant is not approved for
repeated implantation (reimplantation) with any other cattle ear
implant in growing beef steers and heifers fed in confinement for
slaughter as safety and effectiveness have not been evaluated. Do not
use in beef calves less than 2 months of age, dairy calves, and veal
calves because effectiveness and safety have not been established. A
withdrawal period has not been established for this product in pre-
ruminating calves. Do not use in dairy cows or in animals intended for
subsequent breeding. Use in these cattle may cause drug residues in
milk and/or in calves born to these cows. The extended-release implant
described in paragraph (a)(2)(i) of this section, used as described in
paragraph (d)(1)(i)(C) of this section, is not approved for repeated
implantation (reimplantation) with this or any other cattle ear
implant.
    (2) Growing beef steers and heifers on pasture (stocker, feeder,
and slaughter)--(i) Amounts and indications for use. An extended-
release implant containing 150 mg trenbolone acetate and 21 mg
estradiol benzoate as described in paragraph (a)(2)(i) of this section
for increased rate of weight gain for up to 200 days.
    (ii) Limitations. Implant pellets subcutaneously in ear only. Not
approved for repeated implantation (reimplantation) with this or any
other cattle ear implant. Safety and effectiveness following
reimplantation have not been evaluated. Do not use in beef calves less
than 2 months of age, dairy calves, and veal calves because
effectiveness and safety have not been established. A withdrawal period
has not been established for this product in pre-ruminating calves. Do
not use in dairy cows or in animals intended for subsequent breeding.
Use in these cattle may cause drug residues in milk and/or in calves
born to these cows.

0
23. In Sec.  522.2640, revise paragraphs (b)(1), (e)(1)(iii), and
(e)(2)(iii) to read as follows:

Sec.  522.2640  Tylosin.

* * * * *
    (b) * * *
    (1) No. 058198 for use of 50- or 200-mg/mL solutions as in
paragraph (e) of this section.
* * * * *
    (e) * * *
    (1) * * *
    (iii) Limitations. Cattle intended for human consumption must not
be slaughtered within 21 days of the last use of this drug product.
This drug product is not approved for use in female dairy cattle 20
months of age or older, including dry dairy cows. Use in these cattle
may cause drug residues in milk and/or in calves born to these cows.
This product is not approved for use in calves intended to be processed
for veal. A withdrawal period has not been established in preruminating
calves. For No. 058198: Federal law

restricts this drug to use by or on the order of a licensed
veterinarian.
    (2) * * *
    (iii) Limitations. Swine intended for human consumption must not be
slaughtered within 14 days of the last use of this drug product. For
No. 058198: 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
24. The authority citation for part 524 continues to read as follows:

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

Sec.  524.957  [Amended]

0
25. In Sec.  524.957, in paragraph (b), remove ``No. 058198'' and in
its place add ``Nos. 017030 and 058198''.

0
26. In Sec.  524.998, revise paragraph (c)(2)(ii) to read as follows:

Sec.  524.998  Fluralaner.

* * * * *
    (c) * * *
    (2) * * *
    (ii) Indications for use. Kills adult fleas; for the treatment and
prevention of flea infestations (C. felis) and the treatment and
control of I. scapularis (black-legged tick) and Haemaphysalis
longicornis (Asian longhorned tick) infestations for 12 weeks in cats
and kittens 6 months of age and older, and weighing 2.6 lb or greater;
for the treatment and control of D. variabilis (American dog tick)
infestations for 8 weeks in cats and kittens 6 months of age and older,
and weighing 2.6 lb or greater.
* * * * *

0
27. In Sec.  524.1001, revise paragraph (c)(2) to read as follows:

Sec.  524.1001  Fluralaner and moxidectin.

* * * * *
    (c) * * *
    (2) Indications for use. For the prevention of heartworm disease
caused by Dirofilaria immitis and for the treatment of infections with
intestinal roundworm (Toxocara cati, fourth-stage larvae, immature
adults, and adults) and hookworm (Ancylostoma tubaeforme, fourth-stage
larvae, immature adults, and adults); kills adult fleas and is
indicated for the treatment and prevention of flea infestations
(Ctenocephalides felis) and the treatment and control of tick
infestations (Ixodes scapularis (black-legged tick), Dermacentor
variabilis (American dog tick), and Haemaphysalis longicornis (Asian
longhorned tick)) for 2 months in cats and kittens 6 months of age and
older and weighing 2.6 lb or greater.
* * * * *

0
28. In Sec.  524.1662b, revise paragraph (c)(3) to read as follows:

Sec.  524.1662b  Oxytetracycline and polymyxin B ophthalmic ointment.

* * * * *
    (c) * * *
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

Sec.  524.2620  [Amended]

0
29. In Sec.  524.2620, in paragraph (b)(1), remove ``051079'' and in
its place add ``069043''.

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
31. In Sec.  526.820, revise paragraphs (d)(3) and (e)(3) to read as
follows:

Sec.  526.820  Erythromycin.

* * * * *
    (d) * * *
    (3) Limitations. Milk taken from animals during treatment and for
36 hours (3 milkings) after the latest treatment must not be used for
food. Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
    (e) * * *
    (3) Limitations. For use in dry cows only. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.

0
32. In Sec.  526.1698, revise paragraphs (d)(3) and (e)(3) to read as
follows:

Sec.  526.1698  Penicillin G procaine and novobiocin.

* * * * *
    (d) * * *
    (3) Limitations. For udder instillation in lactating cows only. Do
not milk for at least 6 hours after treatment; thereafter, milk at
regular intervals. Milk taken from treated animals within 72 hours (6
milkings) after the latest treatment must not be used for food. Treated
animals must not be slaughtered for food for 15 days following the
latest treatment. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
    (e) * * *
    (3) Limitations. For udder instillation in dry cows only. Do not
use less than 30 days prior to calving. Milk from treated cows must not
be used for food during the first 72 hours after calving. Treated
animals must not be slaughtered for food for 30 days following udder
infusion. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.

PART 528--INTENTIONAL GENOMIC ALTERATIONS IN ANIMALS

0
33. The authority citation for part 528 continues to read as follows:

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

Sec.  528.1070  [Removed]

0
34. Remove Sec.  528.1070.

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

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

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

0
36. In Sec.  558.128:
0
a. Redesignate paragraphs (e)(4)(x) through (xlvii) as paragraphs
(e)(4)(xxi) through (lviii);
0
b. Redesignate paragraphs (e)(4)(vii) through (ix) as paragraphs
(e)(4)(xv) through (xvii);
0
c. Redesignate paragraphs (e)(4)(iii) through (vi) as paragraphs
(e)(4)(v) through (viii);
0
d. Revise newly redesignated paragraph (e)(4)(xv); and
0
e. Add new paragraphs (e)(4)(iii) and (iv), (ix) through (xiv), and
(xviii) through (xx).
    The revision and additions read as follows:

Sec.  558.128  Chlortetracycline.

* * * * *
    (e) * * *
    (4) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
    Chlortetracycline  amount       Combination  in grams/ton      Indications for use                         Limitations                       Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
(iii) 7 to 17.5 g/ton............  Monensin, 5 to 40..........  Growing beef steers and   Feed as the sole ration to provide 70 mg                069254
                                                                 heifers fed in            chlortetracycline per head per day and 50 to 480 mg
                                                                 confinement for           monensin per head per day. No additional
                                                                 slaughter over 400 lb:    improvement in feed efficiency has been shown from
                                                                 For reduction of the      feeding monensin at levels greater than 30 grams
                                                                 incidence of liver        per ton (360 mg monensin per head per day). For use
                                                                 abscesses and for         in dry feeds only. Not for use in liquid feed
                                                                 improved feed             supplements. Do not allow horses or other equines
                                                                 efficiency.               access to feed containing 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. 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 in pre-ruminating calves. Do not use in
                                                                                calves to be processed for veal. Monensin as
                                                                                provided by No. 058198, chlortetracycline by No.
                                                                                069254 in Sec.   510.600(c) of this chapter.
(iv) 7 to 17.5 g/ton.............  Monensin, 10 to 40.........  Growing beef steers and   Feed as the sole ration to provide 70 mg                069254
                                                                 heifers fed in            chlortetracycline per head per day and 0.14 to 0.42
                                                                 confinement for           mg monensin per lb. body weight per day to provide,
                                                                 slaughter over 400 lb:    depending upon severity of coccidiosis challenge,
                                                                 For reduction of the      up to 480 mg monensin per head per day. For use in
                                                                 incidence of liver        dry feeds only. Not for use in liquid feed
                                                                 abscesses and for         supplements. Do not allow horses or other equines
                                                                 prevention and control    access to feed containing monensin. Ingestion of
                                                                 of coccidiosis due to     monensin by horses has been fatal. Monensin
                                                                 Eimeria bovis and         medicated cattle and goat feeds are safe for use in
                                                                 Eimeria zuernii.          cattle and goats only. Consumption by unapproved
                                                                                species may result in toxic reactions. 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 in pre-ruminating calves. Do not use in
                                                                                calves to be processed for veal. Monensin as
                                                                                provided by No. 058198, chlortetracycline by No.
                                                                                069254 in Sec.   510.600(c) of this chapter.

                                                                      * * * * * * *
(ix) 33.33 to 66.67 g/ton........  Monensin, 5 to 40..........  Growing beef steers and   Feed as the sole ration to provide 0.5 mg               069254
                                                                 heifers fed in            chlortetracycline per lb. body weight per day and
                                                                 confinement for           50 to 480 mg monensin per head per day. No
                                                                 slaughter over 700 lb:    additional improvement in feed efficiency has been
                                                                 For control of active     shown from feeding monensin at levels greater than
                                                                 infection of              30 grams per ton (360 mg monensin per head per
                                                                 anaplasmosis caused by    day). For use in dry feeds only. Not for use in
                                                                 Anaplasma marginale       liquid feed supplements. Do not allow horses or
                                                                 susceptible to            other equines access to feed containing monensin.
                                                                 chlortetracycline and     Ingestion of monensin by horses has been fatal.
                                                                 for improved feed         Monensin medicated cattle and goat feeds are safe
                                                                 efficiency.               for use in cattle and goats only. Consumption by
                                                                                unapproved species may result in toxic reactions.
                                                                                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 in pre-ruminating calves. Do not use in
                                                                                calves to be processed for veal. Monensin as
                                                                                provided by No. 058198, chlortetracycline by No.
                                                                                069254 in Sec.   510.600(c) of this chapter.
(x) 33.33 to 66.67 g/ton.........  Monensin, 10 to 40.........  Growing beef steers and   Feed as the sole ration to provide 0.5 mg               069254
                                                                 heifers fed in            chlortetracycline per lb. body weight per day and
                                                                 confinement for           0.14 to 0.42 mg monensin per lb. body weight per
                                                                 slaughter over 700 lb:    day to provide, depending upon severity of
                                                                 For control of active     coccidiosis challenge, up to 480 mg monensin per
                                                                 infection of              head per day. For use in dry feeds only. Not for
                                                                 anaplasmosis caused by    use in liquid feed supplements. Do not allow horses
                                                                 Anaplasma marginale       or other equines access to feed containing
                                                                 susceptible to            monensin. Ingestion of monensin by horses has been
                                                                 chlortetracycline and     fatal. Monensin medicated cattle and goat feeds are
                                                                 for the prevention and    safe for use in cattle and goats only. Consumption
                                                                 control of coccidiosis    by unapproved species may result in toxic
                                                                 due to Eimeria bovis      reactions. Do not exceed the levels of monensin
                                                                 and Eimeria zuernii.      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 in pre-ruminating calves. Do not use
                                                                                in calves to be processed for veal. Monensin as
                                                                                provided by No. 058198, chlortetracycline by No.
                                                                                069254 in Sec.   510.600(c) of this chapter.

(xi) 50 to 117 g/ton.............  Monensin, 7.14 to 40.......  Growing beef steers and   Feed as the sole ration to provide 350 mg               069254
                                                                 heifers fed in            chlortetracycline per head per day and 50 to 480 mg
                                                                 confinement for           monensin per head per day. No additional
                                                                 slaughter under 700 lb:   improvement in feed efficiency has been shown from
                                                                 For control of active     feeding monensin at levels greater than 30 grams
                                                                 infection of              per ton (360 mg monensin per head per day). For use
                                                                 anaplasmosis caused by    in dry feeds only. Not for use in liquid feed
                                                                 Anaplasma marginale       supplements. Do not allow horses or other equines
                                                                 susceptible to            access to feed containing monensin. Ingestion of
                                                                 chlortetracycline and     monensin by horses has been fatal. Monensin
                                                                 for improved feed         medicated cattle and goat feeds are safe for use in
                                                                 efficiency.               cattle and goats only. Consumption by unapproved
                                                                                species may result in toxic reactions. 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 in pre-ruminating calves. Do not use in
                                                                                calves to be processed for veal. Monensin as
                                                                                provided by No. 058198, chlortetracycline by No.
                                                                                069254 in Sec.   510.600(c) of this chapter.
(xii) 50 to 117 g/ton............  Monensin, 10 to 40.........  Growing beef steers and   Feed as the sole ration to provide 350 mg               069254
                                                                 heifers fed in            chlortetracycline per head per day and 0.14 to 0.42
                                                                 confinement for           mg monensin per lb. body weight per day to provide,
                                                                 slaughter under 700 lb:   depending upon severity of coccidiosis challenge,
                                                                 For control of active     up to 480 mg monensin per head per day. For use in
                                                                 infection of              dry feeds only. Not for use in liquid feed
                                                                 anaplasmosis caused by    supplements. Do not allow horses or other equines
                                                                 Anaplasma marginale       access to feed containing monensin. Ingestion of
                                                                 susceptible to            monensin by horses has been fatal. Monensin
                                                                 chlortetracycline and     medicated cattle and goat feeds are safe for use in
                                                                 for the prevention and    cattle and goats only. Consumption by unapproved
                                                                 control of coccidiosis    species may result in toxic reactions. Do not
                                                                 due to Eimeria bovis      exceed the levels of monensin recommended in the
                                                                 and Eimeria zuernii.      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 in pre-ruminating calves. Do not use in
                                                                                calves to be processed for veal. Monensin as
                                                                                provided by No. 058198, chlortetracycline by No.
                                                                                069254 in Sec.   510.600(c) of this chapter.
(xiii) 50 to 117 g/ton...........  Monensin, 7.14 to 40.......  Growing beef steers and   Feed as the sole ration to provide 350 mg               069254
                                                                 heifers fed in            chlortetracycline per head per day and 50 to 480 mg
                                                                 confinement for           monensin per head per day. No additional
                                                                 slaughter: For the        improvement in feed efficiency has been shown from
                                                                 control of bacterial      feeding monensin at levels greater than 30 grams
                                                                 pneumonia associated      per ton (360 mg monensin per head per day). For use
                                                                 with shipping fever       in dry feeds only. Not for use in liquid feed
                                                                 complex caused by         supplements. Do not allow horses or other equines
                                                                 Pasteurella spp.          access to feed containing monensin. Ingestion of
                                                                 susceptible to            monensin by horses has been fatal. Monensin
                                                                 chlortetracycline and     medicated cattle and goat feeds are safe for use in
                                                                 for improved feed         cattle and goats only. Consumption by unapproved
                                                                 efficiency.               species may result in toxic reactions. 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 in pre-ruminating calves. Do not use in
                                                                                calves to be processed for veal. Monensin as
                                                                                provided by No. 058198, chlortetracycline by No.
                                                                                069254 in Sec.   510.600(c) of this chapter.
(xiv) 50 to 117 g/ton............  Monensin, 10 to 40.........  Growing beef steers and   Feed as the sole ration to provide 350 mg               069254
                                                                 heifers fed in            chlortetracycline per head per day and 0.14 to 0.42
                                                                 confinement for           mg monensin per lb. body weight per day to provide,
                                                                 slaughter: For the        depending upon severity of coccidiosis challenge,
                                                                 control of bacterial      up to 480 mg monensin per head per day. For use in
                                                                 pneumonia associated      dry feeds only. Not for use in liquid feed
                                                                 with shipping fever       supplements. Do not allow horses or other equines
                                                                 complex caused by         access to feed containing monensin. Ingestion of
                                                                 Pasteurella spp.          monensin by horses has been fatal. Monensin
                                                                 susceptible to            medicated cattle and goat feeds are safe for use in
                                                                 chlortetracycline and     cattle and goats only. Consumption by unapproved
                                                                 for the prevention and    species may result in toxic reactions. Do not
                                                                 control of coccidiosis    exceed the levels of monensin recommended in the
                                                                 due to Eimeria bovis      feeding directions, as reduced average daily gains
                                                                 and Eimeria zuernii.      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 in pre-ruminating calves. Do not use in
                                                                                calves to be processed for veal. Monensin as
                                                                                provided by No. 058198, chlortetracycline by No.
                                                                                069254 in Sec.   510.600(c) of this chapter.
(xv) to provide 0.5 to 2.0 mg/lb   ...........................  Beef cattle and           In Type C free-choice cattle feeds such as feed         054771
 of body weight daily.                                           nonlactating dairy        blocks or salt-mineral mixes manufactured from         069254
                                                                 cattle: As an aid in      approved Type A articles. See paragraph (d)(4) of
                                                                 the control of active     this section.
                                                                 infection of
                                                                 anaplasmosis caused by
                                                                 Anaplasma marginale
                                                                 susceptible to
                                                                 chlortetracycline.

                                                                      * * * * * * *
(xviii) 400 to 2,000 g/ton.......  Monensin, 5 to 40..........  Growing beef steers and   Feed as the sole ration to provide 10 mg                069254
                                                                 heifers fed in            chlortetracycline per lb. body weight per day.
                                                                 confinement for           Treat for not more than 5 days, then continue
                                                                 slaughter: For            feeding monensin Type C medicated feed alone. No
                                                                 treatment of bacterial    additional improvement in feed efficiency has been
                                                                 enteritis caused by       shown from feeding monensin at levels greater than
                                                                 Escherichia coli and      30 grams per ton (360 mg monensin per head per
                                                                 bacterial pneumonia       day). For use in dry feeds only. Not for use in
                                                                 caused by Pasteurella     liquid feed supplements. Do not allow horses or
                                                                 multocida susceptible     other equines access to feed containing monensin.
                                                                 to chlortetracycline;     Ingestion of monensin by horses has been fatal.
                                                                 for improved feed         Monensin medicated cattle and goat feeds are safe
                                                                 efficiency.               for use in cattle and goats only. Consumption by
                                                                                unapproved species may result in toxic reactions.
                                                                                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 in pre-ruminating calves. Do not use in
                                                                                calves to be processed for veal. Monensin as
                                                                                provided by No. 058198, chlortetracycline by No.
                                                                                069254 in Sec.   510.600(c) of this chapter.
(xix) 400 to 2,000 g/ton.........  Monensin, 5 to 40..........  Growing beef steers and   Feed as the sole ration to provide 10 mg                069254
                                                                 heifers: For treatment    chlortetracycline per lb. body weight per day and
                                                                 of bacterial enteritis    0.14 to 0.42 mg monensin per lb. body weight per
                                                                 caused by Escherichia     day to provide, depending upon severity of the
                                                                 coli and bacterial        coccidiosis challenge, up to 480 mg monensin per
                                                                 pneumonia caused by       head per day. Treat for not more than 5 days, then
                                                                 Pasteurella multocida     continue feeding monensin Type C medicated feed
                                                                 susceptible to            alone. For use in dry feeds only. Not for use in
                                                                 chlortetracycline; and    liquid feed supplements. Do not allow horses or
                                                                 for the prevention and    other equines access to feed containing monensin.
                                                                 control of coccidiosis    Ingestion of monensin by horses has been fatal.
                                                                 due to Eimeria bovis      Monensin medicated cattle and goat feeds are safe
                                                                 and Eimeria zuernii.      for use in cattle and goats only. Consumption by
                                                                                unapproved species may result in toxic reactions.
                                                                                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 in pre-ruminating calves. Do not use in
                                                                                calves to be processed for veal. Monensin as
                                                                                provided by No. 058198, chlortetracycline by No.
                                                                                069254 in Sec.   510.600(c) of this chapter.
(xx) 400 to 2,000 g/ton..........  Monensin, 10 to 200........  Beef calves 2 months of   Feed as the sole ration to provide 10 mg                069254
                                                                 age and older: For        chlortetracycline per lb. body weight per day and
                                                                 treatment of bacterial    0.14 to 1.00 mg monensin per lb. body weight per
                                                                 enteritis caused by       day to provide, depending upon severity of
                                                                 Escherichia coli and      coccidiosis challenge, up to 200 mg of monensin per
                                                                 bacterial pneumonia       head per day. Feed for not more than 5 days, then
                                                                 caused by Pasteurella     continue to feed monensin Type C medicated feed
                                                                 multocida susceptible     alone. For use in dry feeds only. Not for use in
                                                                 to chlortetracycline;     liquid feed supplements. Do not allow horses or
                                                                 and for the prevention    other equines access to feed containing monensin.
                                                                 and control of            Ingestion of monensin by horses has been fatal.
                                                                 coccidiosis due to        Monensin medicated cattle and goat feeds are safe
                                                                 Eimeria bovis and         for use in cattle and goats only. Consumption by
                                                                 Eimeria zuernii.          unapproved species may result in toxic reactions.
                                                                                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 in pre-ruminating calves. Do not use in
                                                                                calves to be processed for veal. Monensin as
                                                                                provided by No. 058198, chlortetracycline by No.
                                                                                069254 in Sec.   510.600(c) of this chapter.

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

0
37. In Sec.  558.258, add paragraphs (e)(3)(iv)(A)(3) and (4) to read
as follows:

Sec.  558.258  Fenbendazole.

    (e) * * *
    (3) * * *
    (iv) * * *
    (A) * * *

----------------------------------------------------------------------------------------------------------------
  Fenbendazole concentration       Indications for use                     Limitations                   Sponsor
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(3) 750 mg/lb of protein       Beef cattle: For the        Feed free choice at a rate of 0.1 pound of     000061
 block (to provide 5 mg/kg      treatment and control of:   block per 100 pounds of body weight per
 body weight (2.27 mg/lb)).     Lungworms: adult            day for 3 days to deliver a total of 2.27
                                (Dictyocaulus viviparus);   mg fenbendazole per pound of body weight.
                                Stomach worms: adult        Cattle must not be slaughtered for human
                                brown stomach worms         consumption within 16 days following last
                                (Ostertagia ostertagi),     treatment with this drug product. Not for
                                adult and fourth-stage      use in female dairy cattle 20 months of
                                larvae barberpole worms     age or older, including dry dairy cows.
                                (Haemonchus contortus),     Use in these cattle may cause drug
                                fourth-stage larvae         residues in milk and/or in calves born to
                                barberpole worms (H.        these cows or heifers. Not for use in beef
                                placei), and adult and      calves less than 2 months of age, dairy
                                fourth-stage larvae small   calves, and veal calves. A withdrawal
                                stomach worms               period has not been established for this
                                (Trichostrongylus axei);    product in pre-ruminating calves.
                                Intestinal worms (adult
                                and fourth-stage larvae):
                                hookworms (Bunostomum
                                phlebotomum), thread-
                                necked intestinal worms
                                (Nematodirus
                                helvetianus), small
                                intestinal worms
                                (Cooperia punctata and C.
                                oncophora), bankrupt
                                worms (Trichostrongylus
                                colubriformis), and
                                nodular worms
                                (Oesophagostomum
                                radiatum).
(4) 750 mg/lb of molasses      Beef cattle: For the        Feed free choice at a rate of 0.1 pound of     000061
 block (to provide 5 mg/kg      treatment and control of:   block per 100 pounds of body weight per
 body weight (2.27 mg/lb)).     Lungworms: adult            day for 3 days to deliver a total of 2.27
                                (Dictyocaulus viviparus);   mg fenbendazole per pound of body weight.
                                Stomach worms: adult        Cattle must not be slaughtered for human
                                brown stomach worms         consumption within 11 days following last
                                (Ostertagia ostertagi),     treatment with this drug product. Not for
                                adult and fourth-stage      use in female dairy cattle 20 months of
                                larvae barberpole worms     age or older, including dry dairy cows.
                                (Haemonchus contortus),     Use in these cattle may cause drug
                                fourth-stage larvae         residues in milk and/or in calves born to
                                barberpole worms (H.        these cows or heifers. Not for use in beef
                                placei), and adult and      calves less than 2 months of age, dairy
                                fourth-stage larvae small   calves, and veal calves. A withdrawal
                                stomach worms               period has not been established for this
                                (Trichostrongylus axei);    product in pre-ruminating calves.
                                Intestinal worms (adult
                                and fourth-stage larvae):
                                hookworms (Bunostomum
                                phlebotomum), thread-
                                necked intestinal worms
                                (Nematodirus
                                helvetianus), small
                                intestinal worms
                                (Cooperia punctata and C.
                                oncophora), bankrupt
                                worms (Trichostrongylus
                                colubriformis), and
                                nodular worms
                                (Oesophagostomum
                                radiatum).
----------------------------------------------------------------------------------------------------------------

* * * * *

0
38. In Sec.  558.330, revise paragraphs (a) and (d)(1)(ii) and (iii) to
read as follows:

Sec.  558.330  Lubabegron.

    (a) Specifications. Each pound of Type A medicated article contains
4.54 grams (10 grams per kilogram) or 22.7 grams (50 grams per
kilogram) of lubabegron as lubabegron fumarate.
* * * * *
    (d) * * *
    (1) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
 Lubabegron fumarate in grams/ton    Combination in grams/ton      Indications for use                         Limitations                       Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
(ii) 1.25 to 4.54................  Monensin, 5 to 40..........  Beef steers and heifers   Feed continuously as the sole ration to provide 13      016592
                                                                 fed in confinement for    to 90 mg lubabegron/head/day and 50 to 480 mg          058198
                                                                 slaughter: For            monensin/head/day during the last 14 to 91 days on
                                                                 reduction of ammonia      feed. No additional improvement in feed efficiency
                                                                 gas emissions per pound   has been shown from feeding monensin at levels
                                                                 of live weight and hot    greater than 30 g/ton (360 mg monensin/head/day). A
                                                                 carcass weight and for    decrease in dry matter intake may be noticed in
                                                                 improved feed             some animals receiving lubabegron. Lubabegron has
                                                                 efficiency during the     not been approved for use in breeding animals
                                                                 last 14 to 91 days on     because safety and effectiveness have not been
                                                                 feed.                     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   Feed continuously as the sole ration to provide 13      016592
                                                                 fed in confinement for    to 90 mg lubabegron/head/day and 0.14 to 0.42 mg       058198
                                                                 slaughter: For            monensin/lb body weight per day, depending upon
                                                                 reduction of ammonia      severity of coccidiosis challenge, during the last
                                                                 gas emissions per pound   14 to 91 days on feed. A decrease in dry matter
                                                                 of live weight and hot    intake may be noticed in some animals receiving
                                                                 carcass weight; and for   lubabegron. Lubabegron has not been approved for
                                                                 prevention and control    use in breeding animals because safety and
                                                                 of coccidiosis due to     effectiveness have not been evaluated in these
                                                                 Eimeria bovis and E.      animals. Do not allow horses or other equines
                                                                 zuernii during the last   access to feed containing lubabegron and monensin.
                                                                 14 to 91 days on feed.    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.

                                                                      * * * * * * *
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0
39. In Sec.  558.355, redesignate paragraphs (f)(1)(iv), (v), and (vi)
through (x) as paragraphs (f)(1)(vi), (vii), and (x) through (xiv),
respectively, and add new paragraphs (f)(1)(iv), (v), (viii), and (ix)
to read as follows:

Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (1) * * *

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      Monensin in grams/ton          Combination in grams/ton      Indications for use                         Limitations                       Sponsor
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                                                                      * * * * * * *
(iv) 90 to 110...................  Bacitracin                   Broiler chickens: As an   Feed as the sole ration throughout the feeding          069254
                                    methylenedisalicylate, 4     aid in the prevention     period. Do not feed to laying chickens. Do not feed
                                    to 50.                       of coccidiosis caused     to chickens over 16 weeks of age. Do not allow
                                                                 by Eimeria necatrix, E.   horses, other equines, mature turkeys, or guinea
                                                                 tenella, E. acervulina,   fowl access to feed containing monensin. Ingestion
                                                                 E. brunetti, E. mivati,   of monensin by horses and guinea fowl has been
                                                                 and E. maxima, and for    fatal. In the absence of coccidiosis in broiler
                                                                 increased rate of         chickens, the use of monensin with no withdrawal
                                                                 weight gain and           period may limit feed intake resulting in reduced
                                                                 improved feed             weight gain. Not for broiler breeder replacement
                                                                 efficiency.               chickens. Monensin provided by No. 058198,
                                                                                bacitracin methylenedisalicylate provided by No.
                                                                                069254 in Sec.   510.600(c) of this chapter.
(v) 90 to 110....................  Bacitracin                   Laying hen replacement    Feed as the sole ration throughout the feeding          069254
                                    methylenedisalicylate, 4     chickens and layer        period. Do not feed to laying chickens. Do not feed
                                    to 50.                       breeder replacement       to chickens over 16 weeks of age. Do not allow
                                                                 chickens: As an aid in    horses, other equines, mature turkeys, or guinea
                                                                 the prevention of         fowl access to feed containing monensin. Ingestion
                                                                 coccidiosis caused by     of monensin by horses and guinea fowl has been
                                                                 Eimeria necatrix, E.      fatal. Not for broiler breeder replacement
                                                                 tenella, E. acervulina,   chickens. Monensin provided by No. 058198,