Document ID: FDA-2022-N-0002-0039
Agency: fda
Document Type: Rule
Title: 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
Posted Date: 2023-03-10T05:00Z

[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Rules and Regulations]
[Pages 14893-14908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03649]

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

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.

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

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, 240-402-5689, 
[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, 240-402-7500. Persons 
with access to the internet may obtain these documents at the CVM

[[Page 14894]]

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.

[[Page 14895]]

 
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 100        522.1662a.
                                                                  (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.
----------------------------------------------------------------------------------------------------------------

[[Page 14896]]

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:

[[Page 14897]]

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.

[[Page 14898]]

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

[[Page 14899]]

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''.

[[Page 14900]]

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

[[Page 14901]]

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) * * *

[[Page 14902]]

--------------------------------------------------------------------------------------------------------------------------------------------------------
    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.

[[Page 14903]]

 
(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.
 

[[Page 14904]]

 
                                                                      * * * * * * *
(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) * * *

[[Page 14905]]

----------------------------------------------------------------------------------------------------------------
  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.

[[Page 14906]]

 
(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.
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

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) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
      Monensin in grams/ton          Combination in grams/ton      Indications for use                         Limitations                       Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
(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,
                                                                 E. brunetti, E. mivati,   bacitracin methylenedisalicylate provided by No.
                                                                 and E. maxima, and for    069254 in Sec.   510.600(c) of this chapter.
                                                                 increased rate of
                                                                 weight gain and
                                                                 improved feed
                                                                 efficiency.
 
                                                                      * * * * * * *
(viii) 90 to 110.................  Bacitracin                   Broiler chickens: As an   Feed as the sole ration for 28 to 35 days, starting     069254
                                    methylenedisalicylate, 50.   aid in the prevention     from the time chicks are placed for brooding. Do
                                                                 of coccidiosis caused     not feed to laying chickens. Do not feed to
                                                                 by Eimeria necatrix, E.   chickens over 16 weeks of age. Do not allow horses,
                                                                 tenella, E. acervulina,   other equines, mature turkeys, or guinea fowl
                                                                 E. brunetti, E. mivati,   access to feed containing monensin. Ingestion of
                                                                 and E. maxima, and for    monensin by horses and guinea fowl has been fatal.
                                                                 the prevention of         In the absence of coccidiosis in broiler chickens,
                                                                 mortality caused by       the use of monensin with no withdrawal period may
                                                                 necrotic enteritis        limit feed intake resulting in reduced weight gain.
                                                                 associated with           Not for broiler breeder replacement chickens.
                                                                 Clostridium perfringens.  Monensin provided by No. 058198, bacitracin
                                                                                           methylenedisalicylate provided by No. 069254 in
                                                                                           Sec.   510.600(c) of this chapter.
(ix) 90 to 110...................  Bacitracin                   Laying hen replacement    Feed as the sole ration for 28 to 35 days, starting     069254
                                    methylenedisalicylate, 50.   chickens and layer        from the time chicks are placed for brooding. Do
                                                                 breeder replacement       not feed to laying chickens. Do not feed to
                                                                 chickens: As an aid in    chickens over 16 weeks of age. Do not allow horses,
                                                                 the prevention of         other equines, mature turkeys, or guinea fowl
                                                                 coccidiosis caused by     access to feed containing monensin. Ingestion of
                                                                 Eimeria necatrix, E.      monensin by horses and guinea fowl has been fatal.
                                                                 tenella, E. acervulina,   Not for broiler breeder replacement chickens.
                                                                 E. brunetti, E. mivati,   Monensin provided by No. 058198, bacitracin
                                                                 and E. maxima, and for    methylenedisalicylate provided by No. 069254 in
                                                                 the prevention of         Sec.   510.600(c) of this chapter.
                                                                 mortality caused by
                                                                 necrotic enteritis
                                                                 associated with
                                                                 Clostridium perfringens.

[[Page 14907]]

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

* * * * *

0
40. In Sec.  558.364, add paragraph (d)(2)(ii) to read as follows:

Sec.  558.364  Naracin and nicarbazin.

* * * * *
    (d) * * *
    (2) * * *
    (ii) Virginiamycin as in Sec.  558.635.

0
41. In Sec.  558.366, revise paragraph (d)(1)(i) and add paragraph 
(d)(2) to read as follows:

Sec.  558.366  Nicarbazin.

* * * * *
    (d) * * *
    (1) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
   Nicarbazin in grams per ton       Combination in grams/ton      Indications for use                         Limitations                       Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 90.8 to 181.6................  ...........................  Chickens: As an aid in    Feed continuously as sole ration from time chicks       066104
                                                                 preventing outbreaks of   are placed on litter until past the time when
                                                                 cecal (Eimeria tenella)   coccidiosis is ordinarily a hazard. Do not use as a
                                                                 and intestinal (E.        treatment for outbreaks of coccidiosis. Do not use
                                                                 acervulina, E. maxima,    in flushing mashes. Do not feed to laying hens.
                                                                 E. necatrix, and E.       Withdraw 4 days before slaughter for use levels at
                                                                 brunetti) coccidiosis.    or below 113.5 g/ton. Withdraw 5 days before
                                                                                           slaughter for use levels above 113.5 g/ton.
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (2) Nicarbazin single-ingredient Type A medicated articles may also 
be used in combination with:
    (i) [Reserved]
    (ii) Virginiamycin as in Sec.  558.635.

0
42. In Sec.  558.450:
0
a. Revise paragraph (e)(3)(i);
0
b. Redesignate paragraph (e)(3)(ii) as paragraph (e)(3)(iii); and
0
c. Add new paragraph (e)(3)(ii).
    The revision and addition read as follows:

Sec.  558.450  Oxytetracycline.

* * * * *
    (e) * * *
    (3) * * *

----------------------------------------------------------------------------------------------------------------
                              Combination in grams/
   Oxytetracycline amount              ton                Indications for use           Limitations      Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 mg/lb of body weight   .....................  Swine: For treatment of        Feed continuously     066104
 daily.                                               bacterial enteritis caused     for 7 to 14 days.    069254
                                                      by E. coli and Salmonella
                                                      choleraesuis susceptible to
                                                      oxytetracycline and
                                                      treatment of bacterial
                                                      pneumonia caused by
                                                      Pasteurella multocida
                                                      susceptible to
                                                      oxytetracycline.
(ii) 10 mg/lb of body weight  .....................  Breeding swine: For control    Feed continuously     066104
 daily.                                               and treatment of               for not more than    069254
                                                      leptospirosis (reducing the    14 days.
                                                      incidence of abortion and
                                                      shedding of leptospirae)
                                                      caused by Leptospira pomona
                                                      susceptible to
                                                      oxytetracycline.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
43. In Sec.  558.625, revise paragraphs (e)(2)(vii) and (viii) to read 
as follows:

Sec.  558.625  Tylosin.

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

--------------------------------------------------------------------------------------------------------------------------------------------------------
        Tylosin grams/ton             Combination in grams/ton       Indications for use                       Limitations                      Sponsors
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
(vii) 8 to 10...................  Monensin, 5 to 40 plus           Beef steers and         Feed continuously as sole ration to provide 13 to      016592
                                   lubabegron fumarate, 1.25 to     heifers fed in          90 mg lubabegron/head/day, 50 to 480 mg monensin/     058198
                                   4.54.                            confinement for         head/day, and 60 to 90 mg tylosin/head/day during
                                                                    slaughter: For          the last 14 to 91 days on feed. No additional
                                                                    reduction of ammonia    improvement in feed efficiency has been shown
                                                                    gas emissions per       from feeding monensin at levels greater than 30 g/
                                                                    pound of live weight    ton (360 mg monensin/head/day). A decrease in dry
                                                                    and hot carcass         matter intake may be noticed in some animals
                                                                    weight; for reduction   receiving lubabegron. Lubabegron has not been
                                                                    of incidence of liver   approved for use in breeding animals because
                                                                    abscesses associated    safety and effectiveness have not been evaluated
                                                                    with Fusobacterium      in these animals. Do not allow horses or other
                                                                    necrophorum and         equines access to feed containing lubabegron and
                                                                    Arcanobacterium         monensin. Ingestion of monensin by horses has
                                                                    pyogenes, and for       been fatal. Monensin medicated cattle and goat
                                                                    improved feed           feeds are safe for use in cattle and goats only.
                                                                    efficiency during the   Consumption by unapproved species may result in
                                                                    last 14 to 91 days on   toxic reactions. Feeding undiluted or mixing
                                                                    feed.                   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.

[[Page 14908]]

 
(viii) 8 to 10..................  Monensin, 10 to 40 plus          Beef steers and         Feed continuously as sole ration to provide 13 to      016592
                                   lubabegron fumarate, 1.25 to     heifers fed in          90 mg lubabegron/head/day, 0.14 to 0.42 mg            058198
                                   4.54.                            confinement for         monensin/lb body weight per day, depending upon
                                                                    slaughter: For          severity of coccidiosis challenge, up to 480 mg/
                                                                    reduction of ammonia    head/day, and 60 to 90 mg tylosin/head/day during
                                                                    gas emissions per       the last 14 to 91 days on feed. A decrease in dry
                                                                    pound of live weight    matter intake may be noticed in some animals
                                                                    and hot carcass         receiving lubabegron. Lubabegron has not been
                                                                    weight, for reduction   approved for use in breeding animals because
                                                                    of incidence of liver   safety and effectiveness have not been evaluated
                                                                    abscesses associated    in these animals. Do not allow horses or other
                                                                    with Fusobacterium      equines access to feed containing lubabegron and
                                                                    necrophorum and         monensin. Ingestion of monensin by horses has
                                                                    Arcanobacterium         been fatal. Monensin medicated cattle and goat
                                                                    pyogenes, and for       feeds are safe for use in cattle and goats only.
                                                                    prevention and          Consumption by unapproved species may result in
                                                                    control of              toxic reactions. Feeding undiluted or mixing
                                                                    coccidiosis due to      errors resulting in high concentrations of
                                                                    Eimeria bovis and E.    monensin has been fatal to cattle and could be
                                                                    zuernii during the      fatal to goats. Must be thoroughly mixed in feeds
                                                                    last 14 to 91 days on   before use. Do not exceed the levels of monensin
                                                                    feed.                   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.
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

0
44. In Sec.  558.635, redesignate paragraphs (e)(1)(vii) through (ix) 
as paragraphs (e)(1)(ix) through (xi), respectively, and add new 
paragraphs (e)(1)(vii) and (viii) to read as follows:

Sec.  558.635  Virginiamycin.

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

----------------------------------------------------------------------------------------------------------------
   Virginiamycin grams/ton       Combination in grams/ton    Indications for use      Limitations       Sponsors
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(vii) 20.....................  Narasin, 54 to 90...........  Broiler chickens:    Feed as the sole        066104
                                                              For prevention of    ration for broiler
                                                              necrotic enteritis   chickens. Do not
                                                              caused by            feed to chickens
                                                              Clostridium          producing eggs for
                                                              perfringens          human consumption.
                                                              susceptible to       Do not allow adult
                                                              virginiamycin and    turkeys, horses,
                                                              for the prevention   or other equines
                                                              of coccidiosis       access to narasin
                                                              caused by Eimeria    formulations.
                                                              necatrix, E.         Ingestion of
                                                              tenella, E.          narasin by these
                                                              acervulina, E.       species has been
                                                              brunetti, E.         fatal. Naracin as
                                                              mivati, and E.       provided by No.
                                                              maxima.              066104 in Sec.
                                                                                   510.600(c) of this
                                                                                   chapter.
(viii) 20....................  Narasin, 27 to 54 plus        Broiler chickens:    Feed as the sole        066104
                                nicarbazin, 27 to 54.         For prevention of    ration for broiler
                                                              necrotic enteritis   chickens. Do not
                                                              caused by            feed to chickens
                                                              Clostridium          producing eggs for
                                                              perfringens          human consumption.
                                                              susceptible to       Nicarbazin
                                                              virginiamycin and    medicated broilers
                                                              for the prevention   may show reduced
                                                              of coccidiosis       heat tolerance if
                                                              caused by Eimeria    exposed to high
                                                              necatrix, E.         temperature and
                                                              tenella, E.          high humidity.
                                                              acervulina, E.       Provide adequate
                                                              brunetti, E.         drinking water and
                                                              mivati, and E.       ventilation during
                                                              maxima.              these periods. Do
                                                                                   not allow adult
                                                                                   turkeys, horses,
                                                                                   or other equines
                                                                                   access to narasin
                                                                                   formulations.
                                                                                   Ingestion of
                                                                                   narasin by these
                                                                                   species has been
                                                                                   fatal. Naracin as
                                                                                   provided by No.
                                                                                   066104 in Sec.
                                                                                   510.600(c) of this
                                                                                   chapter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: February 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03649 Filed 3-9-23; 8:45 am]
 BILLING CODE 4164-01-P