Document ID: FDA-2023-N-0002-0020
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 Address
Posted Date: 2023-08-16T04:00Z

[Federal Register Volume 88, Number 157 (Wednesday, August 16, 2023)]
[Rules and Regulations]
[Pages 55559-55571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17454]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 500, 510, 516, 520, 522, 524, 526, 529, 556 and 558

[Docket No. FDA-2023-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 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), abbreviated new animal drug 
applications (ANADAs), and conditionally approved new animal drug 
applications (cNADAs) during April, May, and June 2023. 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 their 
accuracy and readability.

DATES: This rule is effective August 16, 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, ANADAs, and cNADAs during April, May, and June 2023, 
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 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.

Table 1--Original and Supplemental NADAs, ANADAs, and cNADAs Approved During April, May, and June 2023 Requiring Evidence of Safety and/or Effectiveness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                21 CFR
          Approval date            File No.           Sponsor               Product name        Effect of the action      Public documents      section
--------------------------------------------------------------------------------------------------------------------------------------------------------
April 5, 2023...................     200-612  Bimeda Animal Health     BIMASONE                Original approval for   FOI Summary              522.960c
                                               Ltd., 1B The Herbert     (flumethasone)          the treatment of
                                               Building, The Park,      Injectable Solution.    various inflammatory
                                               Carrickmines, Dublin                             conditions in horses,
                                               18, Ireland.                                     dogs, and cats as a
                                                                                                generic copy of NADA
                                                                                                030-414.
April 10, 2023..................     038-439  Phibro Animal Health     TERRAMYCIN for Fish     Supplemental approval   FOI Summary               558.450
                                               Corp., GlenPointe        (oxytetracycline)       for the control of
                                               Centre East, 3d Floor,   Type A Medicated        mortality due to
                                               300 Frank W. Burr        Article.                columnaris disease in
                                               Blvd., Suite 21,                                 catfish and
                                               Teaneck, NJ 07666.                               freshwater-reared
                                                                                                salmonids.

[[Page 55560]]

 
April 20, 2023..................     141-570  Boehringer Ingelheim     NEXGARD COMBO           Original approval for   FOI Summary               524.838
                                               Animal Health USA,       (esafoxolaner,          prevention of
                                               Inc., 3239 Satellite     eprinomectin, and       heartworm disease;
                                               Blvd., Duluth, GA        praziquantel) Topical   for treatment and
                                               30096.                   Solution.               prevention of flea
                                                                                                infestations,
                                                                                                treatment and control
                                                                                                of tick infestations,
                                                                                                roundworms,
                                                                                                hookworms, and
                                                                                                tapeworms in cats and
                                                                                                kittens.
May 1, 2023.....................     141-571  Elanco US Inc., 2500     VARENZIN-CA1            Conditional approval    FOI Summary              516.1449
                                               Innovation Way,          (molidustat oral        for the control of
                                               Greenfield, IN 46140.    suspension).            nonregenerative
                                                                                                anemia associated
                                                                                                with chronic kidney
                                                                                                disease (CKD) in cats.
May 5, 2023.....................     141-562  Zoetis Inc., 333         LIBRELA (bedinvetmab    Original approval for   FOI Summary               522.158
                                               Portage St.,             injection) Injectable   the control of pain
                                               Kalamazoo, MI 49007.     Solution.               associated with
                                                                                                osteoarthritis in
                                                                                                dogs.
May 10, 2023....................     200-748  Huvepharma EOOD, 5th     PENNCHLOR               Original approval for   FOI Summary               558.128
                                               Floor, 3A Nikolay        (chlortetracycline      multiple indications
                                               Haytov Str., 1113        Type A medicated        in beef calves 2
                                               Sofia, Bulgaria.         article) and MONOVET    months of age and
                                                                        (monensin Type A        older and in growing
                                                                        medicated article) to   beef steers and
                                                                        be used in the          heifers fed in
                                                                        manufacture of Type B   confinement for
                                                                        and Type C medicated    slaughter as a
                                                                        feeds.                  generic copy of NADA
                                                                                                141-564.
May 25, 2023....................     200-750  Cronus Pharma            DORAJECT (doramectin    Original approval for   FOI Summary               522.770
                                               Specialities India       injection) Injectable   treatment and control
                                               Private Ltd., Sy No-99/  Solution.               of internal and
                                               1, M/s GMR Hyderabad                             external parasites of
                                               Aviation SEZ Ltd.,                               cattle and swine as a
                                               Mamidipalli Village,                             generic copy of NADA
                                               Shamshabad Mandal,                               141-061.
                                               Ranga Reddy,
                                               Hyderabad, Telangana,
                                               501218, India.
June 9, 2023....................     141-555  Zoetis Inc., 333         APOQUEL CHEWABLE        Original approval for   FOI Summary              520.1604
                                               Portage St.,             (oclacitinib tablet)    control of pruritus
                                               Kalamazoo, MI 49007.     Tablets.                associated with
                                                                                                allergic dermatitis
                                                                                                and control of atopic
                                                                                                dermatitis in dogs at
                                                                                                least 12 months of
                                                                                                age.
June 21, 2023...................     141-406  Boehringer Ingelheim     NEXGARD (afoxolaner)    Supplemental approval   FOI Summary                520.43
                                               Animal Health USA,       Chewable Tablet.        for Asian longhorned
                                               Inc., 3239 Satellite                             tick.
                                               Blvd., Duluth, GA
                                               30096.
June 22, 2023...................     200-751  Pegasus Laboratories,    Firocoxib Chewable      Original approval for   FOI Summary               520.928
                                               Inc., 8809 Ely Rd.,      Tablets for Dogs        the control of pain
                                               Pensacola, FL 32514.     (firocoxib).            and inflammation
                                                                                                associated with
                                                                                                osteoarthritis and
                                                                                                for the control of
                                                                                                postoperative pain
                                                                                                and inflammation
                                                                                                associated with soft-
                                                                                                tissue and orthopedic
                                                                                                surgery in dogs as a
                                                                                                generic copy of NADA
                                                                                                141-230.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 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 April, May, and June 2023 To Change the Marketing Status of
                                Antimicrobial Animal Drug Products From OTC to Rx
----------------------------------------------------------------------------------------------------------------
                                                                                                        21 CFR
           Approval date             File No.            Sponsor                  Product name          section
----------------------------------------------------------------------------------------------------------------
April 14, 2023....................     200-147  Huvepharma EOOD, 5th       GENTAPOULT (gentamicin)      522.1044
                                                 Floor, 3A Nikolay Haytov   Injectable Solution.
                                                 Str., 1113 Sofia,
                                                 Bulgaria.
April 24, 2023....................     065-481  Cronus Pharma              Chlortetracycline             520.443
                                                 Specialities India         Pneumonia/Calf Scour
                                                 Private Ltd., Sy No-99/    Bolus.
                                                 1, M/s GMR Hyderabad
                                                 Aviation SEZ Ltd.,
                                                 Mamidipalli Village,
                                                 Shamshabad Mandal, Ranga
                                                 Reddy, Hyderabad,
                                                 Telangana, 501218, India.
April 24, 2023....................     200-128  Huvepharma EOOD, 5th       AGRIMYCIN 200               522.1660a
                                                 Floor, 3A Nikolay Haytov   (oxytetracycline HCl)
                                                 Str., 1113 Sofia,          Injectable Solution.
                                                 Bulgaria.

[[Page 55561]]

 
April 28, 2023....................     108-963  Cronus Pharma              MEDAMYCIN 100                522.1662
                                                 Specialities India         (oxytetracycline HCl)
                                                 Private Ltd., Sy No-99/    Injectable Solution.
                                                 1, M/s GMR Hyderabad
                                                 Aviation SEZ Ltd.,
                                                 Mamidipalli Village,
                                                 Shamshabad Mandal, Ranga
                                                 Reddy, Hyderabad,
                                                 Telangana, 501218, India.
April 28, 2023....................     097-452  Do.......................  OXYJECT 100                  522.1662
                                                                            (oxytetracycline HCl)
                                                                            Injectable Solution.
April 28, 2023....................     047-278  Do.......................  OXY-TET 50                   522.1662
                                                                            (oxytetracycline HCl)
                                                                            Injectable Solution.
April 28, 2023....................     045-143  Do.......................  OXYJECT 50                   522.1662
                                                                            (oxytetracycline HCl)
                                                                            Injectable Solution.
May 15, 2023......................     140-270  Huvepharma EOOD, 5th       SULFATECH SR                520.2260b
                                                 Floor, 3A Nikolay Haytov   (sulfamethazine
                                                 Str., 1113 Sofia,          sustained release bolus).
                                                 Bulgaria.
May 15, 2023......................     200-306  Norbrook Laboratories      Oxytetracycline Injection   522.1660a
                                                 Ltd., Carnbane             200.
                                                 Industrial Estate,
                                                 Newry, County Down, BT35
                                                 6QQ, United Kingdom.
May 16, 2023......................     120-615  Bimeda Animal Health       SUSTAIN III                 520.2260b
                                                 Ltd., 1B The Herbert       (sulfamethazine) Calf
                                                 Building, The Park,        Bolus.
                                                 Carrickmines, Dublin 18,
                                                 Ireland.
May 17, 2023......................     200-224  Elanco US Inc., 2500       COMPONENT T-S with TYLAN;    522.2476
                                                 Innovation Way,            COMPONENT T-H with TYLAN
                                                 Greenfield, IN 46140.      (trenbolone acetate and
                                                                            tylosin tartrate)
                                                                            Implants.
May 19, 2023......................     200-364  Bimeda Animal Health       SPECTOGARD Scour-Chek       520.2123c
                                                 Ltd., 1B The Herbert       (spectinomycin
                                                 Building, The Park,        dihydrochloride
                                                 Carrickmines, Dublin 18,   pentahydrate) Oral
                                                 Ireland.                   Solution.
May 22, 2023......................     035-455  Do.......................  ERYTHRO-36 Dry                526.820
                                                                            (erythromycin) IMM
                                                                            Infusion.
May 22, 2023......................     200-452  Norbrook Laboratories      OXYTET 100                   522.1662
                                                 Ltd., Carnbane             (oxytetracycline HCl)
                                                 Industrial Estate,         Injectable Solution.
                                                 Newry, County Down, BT35
                                                 6QQ, United Kingdom.
May 26, 2023......................     200-068  Huvepharma EOOD, 5th       Oxytetracycline              522.1662
                                                 Floor, 3A Nikolay Haytov   Hydrochloride Injection,
                                                 Str., 1113 Sofia,          100 mg/mL.
                                                 Bulgaria.
May 30, 2023......................     055-097  HQ Specialty Pharma        DRY-MAST                     526.1697
                                                 Corp., 120 Rte. 17         (dihydrostreptomycin
                                                 North, Suite 130,          sulfate and penicillin G
                                                 Paramus, NJ 07652.         procaine).
May 31, 2023......................     200-008  Boehringer Ingelheim       BIO-MYCIN 200               522.1660a
                                                 Animal Health USA, Inc.,   (oxytetracycline HCl)
                                                 3239 Satellite Blvd.,      Injectable Solution.
                                                 Duluth, GA 30096.
June 2, 2023......................     065-383  Bimeda Animal Health       FORMULA A-34; UNI BIOTIC     526.1696
                                                 Ltd., 1B The Herbert       (penicillin G procaine)
                                                 Building, The Park,        4 DOSE.
                                                 Carrickmines, Dublin 18,
                                                 Ireland.
June 2, 2023......................     200-537  Do.......................  TETROXY-LA                  522.1660a
                                                                            (oxytetracycline HCl)
                                                                            Injectable Solution.
June 7, 2023......................     200-154  Pharmgate Inc., 1800 Sir   PENNOX 200                  522.1660a
                                                 Tyler Dr., Wilmington,     (oxytetracycline HCl)
                                                 NC 28405.                  Injectable Solution.
June 8, 2023......................     200-123  Huvepharma EOOD, 5th       MAXIM-200 Injection         522.1660a
                                                 Floor, 3A Nikolay Haytov   (oxytetracycline HCl).
                                                 Str., 1113 Sofia,
                                                 Bulgaria.
June 9, 2023......................     200-117  Bimeda Animal Health       OXYSHOT LA                  522.1660a
                                                 Ltd., 1B The Herbert       (oxytetracycline HCl)
                                                 Building, The Park,        Injectable Solution.
                                                 Carrickmines, Dublin 18,
                                                 Ireland.
June 15, 2023.....................     135-906  Elanco US Inc., 2500       COMPONENT E-H with TYLAN     522.2343
                                                 Innovation Way,            (testosterone propionate
                                                 Greenfield, IN 46140.      and estradiol benzoate
                                                                            with tylosin tartrate)
                                                                            Implant.
June 22, 2023.....................     200-221  Do.......................  COMPONENT TE-G with          522.2477
                                                                            TYLAN; COMPONENT TE-ID
                                                                            with TYLAN; COMPONENT TE-
                                                                            IS with TYLAN; COMPONENT
                                                                            TE-S with TYLAN
                                                                            (trenbolone acetate,
                                                                            estradiol, and tylosin
                                                                            tartrate) Implants.
June 30, 2023.....................     200-346  Do.......................  COMPONENT TE-200 with        522.2477
                                                                            TYLAN; COMPONENT TE-H
                                                                            with TYLAN; COMPONENT TE-
                                                                            IH with TYLAN;
                                                                            (trenbolone acetate,
                                                                            estradiol, and tylosin
                                                                            tartrate) Implants.
June 30, 2023.....................     110-315  Do.......................  COMPONENT E-C with TYLAN;    522.1940
                                                                            COMPONENT E-S with TYLAN
                                                                            (progesterone, estradiol
                                                                            benzoate, and tylosin
                                                                            tartrate) Implants.
----------------------------------------------------------------------------------------------------------------

II. Withdrawals of Approval

    The sponsors of the following files have requested that FDA 
withdraw approval of the applications listed in table 3 because the 
products are no longer manufactured or marketed. As provided in the 
regulatory text of this document, the cited animal drug regulations are 
amended to reflect these actions.

   Table 3--Applications for Which Approval Was Voluntarily Withdrawn
                    During April, May, and June 2023
------------------------------------------------------------------------
                                                                21 CFR
         File No.              Sponsor        Product name     section
------------------------------------------------------------------------
140-954..................  Intervet, Inc.,  Type C               558.325
                            2 Giralda        medicated
                            Farms,           swine feed
                            Madison, NJ      containing
                            07940.           fenbendazole
                                             and lincomycin.
141-002..................  Boehringer       OXY 1000           520.1660c
                            Ingelheim        (oxytetracycli
                            Animal Health    ne HCl) Calf
                            USA, Inc.,       Bolus; OXY 500
                            3239 Satellite   (oxytetracycli
                            Blvd., Duluth,   ne HCl) Calf
                            GA 30096.        Bolus.
200-191..................  Med-Pharmex,     GENTASOL           529.1044b
                            Inc., 2727       (gentamicin
                            Thompson Creek   sulfate
                            Rd., Pomona,     solution).
                            CA 91767-1861.
------------------------------------------------------------------------

[[Page 55562]]

III. Change of Sponsor

    Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140 has 
informed FDA that it has transferred ownership of, and all rights and 
interest in, NADA 135-468 for CARBIGRAN 25 (nicarbazin) Type A 
Medicated Article to Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 
28405. As provided in the regulatory text of this document, 21 CFR 
558.366 is amended to reflect this action.

IV. Change of Sponsor Address

    Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 has informed FDA 
that it has changed its address to 126 E. Lincoln Ave., Rahway, NJ 
07065. As provided in the regulatory text of this document, the tabular 
listings in 21 CFR 510.600(c) are amended to reflect this action.

V. Technical Amendments

    FDA is making the following amendments to improve the accuracy of 
the animal drug regulations.
     21 CFR 500.1410 and 522.1660a are amended to reflect the 
use of N-methyl-2-pyrrolidone as an excipient in a formulation of 
oxytetracycline injectable solution.
     21 CFR 520.1484 is being revised to include use of 
neomycin administered in drinking water of turkeys.
     21 CFR 520.1660a is being redesignated as 21 CFR 520.1664 
to reflect the drug as a fixed-ratio combination of oxytetracycline and 
carbomycin.
     21 CFR 520.1660b is being revised to reflect the format 
and content of a prescription drug.
     21 CFR 520.2220b is amended to reflect revised conditions 
of use for sulfadimethoxine oral suspension in dogs and cats.
     21 CFR 520.2220c is amended to reflect revised conditions 
of use for sulfadimethoxine tablets in dogs and cats.
     21 CFR 520.2260b is amended to reflect current sponsors of 
sulfamethazine sustained-release boluses for use in cattle.
     21 CFR 522.2680 is amended to reflect revised conditions 
of use for zeranol implants in beef cattle.
     21 CFR 529.1044a is amended to reflect sponsors of 
approved applications for use of gentamicin solution for uterine 
infusion in mares.
     21 CFR 556.110 and 556.500 are being revised to reflect 
redesignation of a combination drug containing oxytetracycline and 
carbomycin used in the drinking water of chickens.
     21 CFR 558.68 is being revised to reflect approved feeding 
instructions for avilamycin and monensin two-way, combination drug Type 
C medicated chicken feed.

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 500

    Animal drugs, Animal feeds, Cancer, Labeling, Packaging and 
containers, Polychlorinated biphenyls (PCBs).

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 516

    Administrative practice and procedure, Animal drugs, Confidential 
business information, Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, 524, 526, and 529

    Animal drugs.

21 CFR Part 556

    Animal drugs, Dairy products, Foods, Meat and meat products.

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 
500, 510, 516, 520, 522, 524, 526, 529, 556, and 558 are amended as 
follows:

PART 500--GENERAL

0
1. The authority citation for part 500 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 
360b, 371, 379e.

0
2. In Sec.  500.1410, revise paragraph (c) to read as follows:

Sec.  500.1410  N-methyl-2-pyrrolidone.

* * * * *
    (c) Related conditions of use. See Sec. Sec.  522.814, 522.955, and 
522.1660a of this chapter.

PART 510--NEW ANIMAL DRUGS

0
3. 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
4. In Sec.  510.600, in the table in paragraph (c)(1), revise the entry 
for ``Intervet, Inc.'' and in the table in paragraph (c)(2), revise the 
entry for ``000061'' to read as follows:

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

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

[[Page 55563]]

------------------------------------------------------------------------
               Firm name and address                  Drug labeler code
------------------------------------------------------------------------
 
                              * * * * * * *
Intervet, Inc., 126 E Lincoln Ave., Rahway, NJ                    000061
 07065............................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
000061......................  Intervet, Inc., 126 E Lincoln Ave.,
                               Rahway, NJ 07065
 
                              * * * * * * *
------------------------------------------------------------------------

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
5. The authority citation for part 516 continues to read as follows:

    Authority:  21 U.S.C. 360ccc-1, 360ccc-2, 371.

0
6. Add Sec.  516.1449 to read as follows:

Sec.  516.1449  Molidustat oral suspension.

    (a) Specifications. Each milliliter (mL) of suspension contains 25 
milligrams (mg) molidustat sodium.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer orally at a dosage of 
5 mg/kg of body weight (2.3 mg/lb) daily for up to 28 consecutive days.
    (2) Indications for use. For the control of nonregenerative anemia 
associated with chronic kidney disease in cats.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. It is a violation of Federal law 
to use this product other than as directed in the labeling.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
8. In Sec.  520.43, revise paragraphs (c)(1) and (2) to read as 
follows:

Sec.  520.43  Afoxolaner.

* * * * *
    (c) * * *
    (1) Amount. Administer orally once a month at a minimum dosage of 
1.14 mg/pound (2.5 mg/kilogram).
    (2) Indications for use. Kills adult fleas and for the treatment 
and prevention of flea infestations (Ctenocephalides felis); and the 
treatment and control of Ixodes scapularis (black-legged tick), 
Dermacentor variabilis (American dog tick), Amblyomma americanum (lone 
star tick), Rhipicephalus sanguineus (brown dog tick), and 
Haemaphysalis longicornis (longhorned tick) infestations in dogs and 
puppies 8 weeks of age and older, weighing 4 pounds of body weight or 
greater, for 1 month; and for the prevention of Borrelia burgdorferi 
infections as a direct result of killing Ixodes scapularis vector 
ticks.
* * * * *

0
9. In Sec.  520.443, revise paragraph (d)(1)(ii) to read as follows:

Sec.  520.443  Chlortetracycline tablets and boluses.

* * * * *
    (d) * * *
    (1) * * *
    (ii) Limitations. Administer bolus directly by mouth or crush and 
dissolve in milk or water for drenching or bucket feeding. Do not use 
for more than 5 days. Do not administer within 24 hours of slaughter. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
* * * * *

Sec.  520.928  [Amended]

0
10. In Sec.  520.928, in paragraph (b)(1), remove ``Nos. 000010 and 
055529'' and add in its place ``Nos. 000010, 055246, and 055529''.

0
11. In Sec.  520.1484, revise paragraph (b)(3) and add paragraph (b)(4) 
to read as follows:

Sec.  520.1484  Neomycin.

* * * * *
    (b) * * *
    (3) Nos. 016592, 054771, and 058005 for use of product described in 
paragraph (a)(2) as in paragraph (e)(1) of this section.
    (4) No. 054925 for use of product described in paragraph (a)(2) as 
in paragraphs (e)(1) and (2) of this section.
* * * * *

Sec.  520.1604  [Amended]

0
12. In Sec.  520.1604, in paragraph (a), remove ``Each tablet 
contains'' and add in its place ``Each tablet or chewable tablet 
contains''.

Sec.  520.1660a  [Redesignated as Sec.  520.1664]

0
13. Redesignate Sec.  520.1660a as Sec.  520.1664.

Sec.  520.1660a  [Reserved]

0
14. Add reserved Sec.  520.1660a.

0
15. In Sec.  520.1660b, revise the section heading and paragraphs (a) 
and (c) to read as follows:

Sec.  520.1660b  Oxytetracycline capsules.

    (a) Specifications. Each capsule contains 125 or 250 milligrams 
(mg) oxytetracycline hydrochloride.
* * * * *
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 
orally 25 to 50 mg per pound of body weight per day in divided doses at 
12-hour intervals.
    (2) Indications for use. For the treatment of bacterial pneumonia 
caused by Brucella bronchiseptica, tonsilitis caused by Streptococcus 
hemolyticus, bacterial enteritis caused by Escherichia coli, urinary 
tract infections caused by Escherichia coli, and wound infections 
caused by Staphylococcus aureus.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
16. In Sec.  520.1660c, revise the section heading and paragraphs (a), 
(b), and (d) to read as follows:

[[Page 55564]]

Sec.  520.1660c  Oxytetracycline tablets.

    (a) Specifications. Each tablet contains 250 or 500 milligrams (mg) 
oxytetracycline hydrochloride.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *
    (d) Conditions of use in beef and dairy cattle--(1) Amounts. 10 mg 
per pound of body weight every 12 hours for treatment; 5 mg per pound 
of body weight every 12 hours for control.
    (2) Indications for use. For treatment and control of bacterial 
enteritis caused by Salmonella typhimurium and Escherichia coli 
(colibacillosis) and bacterial pneumonia (shipping fever complex, 
pasteurellosis) caused by Pasteurella multocida.
    (3) Limitations. 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
17. In Sec.  520.2220b, revise paragraphs (c)(1) and (2) to read as 
follows:

Sec.  520.2220b  Sulfadimethoxine suspension.

* * * * *
    (c) * * *
    (1) Amount. Administer orally 25 mg per pound of body weight, 
followed by 12.5 mg per pound of body weight daily until the animal is 
free of clinical signs for 48 hours.
    (2) Indications for use. For the treatment of sulfadimethoxine-
susceptible bacterial infections in dogs and cats and enteritis 
associated with coccidiosis in dogs.
* * * * *

0
18. In Sec.  520.2220c, revise paragraphs (d)(1) and (2) to read as 
follows:

Sec.  520.2220c  Sulfadimethoxine tablet.

* * * * *
    (d) * * *
    (1) Amount. Administer orally 25 mg per pound of body weight, 
followed by 12.5 mg per pound of body weight daily until the animal is 
free of clinical signs for 48 hours.
    (2) Indications for use. For the treatment of sulfadimethoxine-
susceptible bacterial infections in dogs and cats and enteritis 
associated with coccidiosis in dogs.
* * * * *

0
19. In Sec.  520.2260b, revise paragraphs (d)(2)(iii), (f)(2)(iii), and 
(g)(2)(iii) and remove paragraph (h).
    The revisions read as follows:

Sec.  520.2260b  Sulfamethazine sustained-release boluses.

* * * * *
    (d) * * *
    (2) * * *
    (iii) Limitations. Do not use in female dairy cattle 20 months of 
age or older. Use of sulfamethazine in this class of cattle may cause 
milk residues. Do not treat animals within 12 days of slaughter. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
* * * * *
    (f) * * *
    (2) * * *
    (iii) Limitations. For use in ruminating replacement calves only. 
Do not slaughter animals for food for at least 12 days after the last 
dose. Exceeding two consecutive doses may cause violative tissue 
residue to remain beyond the withdrawal time. Do not use in calves 
under 1 month of age or calves being fed an all milk diet. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (g) * * *
    (2) * * *
    (iii) Limitations. For use in beef cattle and nonlactating dairy 
cattle only. Do not slaughter animals for food for at least 8 days 
after the last dose. Do not use in lactating dairy cattle. Do not 
administer more than two consecutive doses. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.

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

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

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

0
21. Add Sec.  522.158 to read as follows:

Sec.  522.158  Bedinvetmab.

    (a) Specifications. Each single-use vial contains 5, 10, 15, 20, or 
30 milligrams (mg) bedinvetmab in an extractable volume of 1 
milliliter.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer 0.23 mg/pound (0.5 
mg/kilogram) body weight monthly by subcutaneous injection.
    (2) Indications for use. For the control of pain associated with 
osteoarthritis in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
22. In Sec.  522.770, revise paragraphs (b), (d)(1)(iii), and 
(d)(2)(iii) to read as follows:

Sec.  522.770  Doramectin.

* * * * *
    (b) Sponsors. See Nos. 054771 and 069043 in Sec.  510.600(c) of 
this chapter.
* * * * *
    (d) * * *
    (1) * * *
    (iii) Limitations. Consult your veterinarian for assistance in the 
diagnosis, treatment, and control of parasitism. Administer as a single 
subcutaneous or intramuscular injection. Do not slaughter cattle for 
human consumption within 35 days of treatment. Not for use in female 
dairy cattle 20 months of age or older. A withdrawal period has not 
been established for this product in preruminating calves. Do not use 
in calves to be processed for veal.
    (2) * * *
    (iii) Limitations. Consult your veterinarian for assistance in the 
diagnosis, treatment, and control of parasitism. Administer as a single 
intramuscular injection. Do not slaughter swine for human consumption 
within 24 days of treatment.

0
23. In Sec.  522.960c, revise paragraphs (b) and (c)(1)(iii) to read as 
follows:

Sec.  522.960c  Flumethasone solution.

* * * * *
    (b) Sponsors. See Nos. 054771 and 061133 in Sec.  510.600(c) of 
this chapter.
    (c) * * *
    (1) * * *
    (iii) Limitations. Not for use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
* * * * *

Sec.  522.1222  [Amended]

0
24. In Sec.  522.1222, in paragraph (b), remove ``063286,''.

0
25. In Sec.  522.1660a:
0
a. Revise paragraph (c);
0
b. Remove paragraph (d);
0
c. Redesignate paragraph (e) as paragraph (d); and
0
d. Revise newly redesignated paragraphs (d)(1)(ii) and (d)(2)(ii).
    The revisions read as follows:

Sec.  522.1660a  Oxytetracycline solution, 200 milligrams/milliliter.

* * * * *
    (c) Related tolerances. See Sec.  556.500 of this chapter; and for 
No. 061133, see also Sec.  500.1410 of this chapter.
    (d) * * *
    (1) * * *
    (ii) Limitations. Discontinue treatment at least 28 days prior to 
slaughter. Milk taken from animals during treatment and for 96 hours 
after the last treatment

[[Page 55565]]

must not be used for food. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.
    (2) * * *
    (ii) Limitations. Administer intramuscularly. Do not inject more 
than 5 mL per site in adult swine. Discontinue treatment at least 28 
days prior to slaughter. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.

0
26. In Sec.  522.1662, revise paragraphs (b), (c), (g), (h), and (j) to 
read as follows:

Sec.  522.1662  Oxytetracycline.

* * * * *
    (b)(1) Specifications. Each milliliter (mL) of solution contains 50 
milligrams (mg) oxytetracycline hydrochloride.
    (2) Sponsor. See No. 069043 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use--(i) Amount. Administer 3 to 5 mg per pound 
of body weight (mg/lb) per day by intramuscular injection. 
Leptospirosis, severe foot-rot, and severe forms of the indicated 
diseases should be treated with 5 mg/lb per day. Treatment should be 
continued for 24 to 48 hours following remission of clinical signs of 
disease, not to exceed 4 consecutive days. Not more than 10 mL should 
be injected per injection site in adult cattle, and only 2 mL per 
injection site in calves weighing 100 pounds or less.
    (ii) Indications for use. Beef cattle, beef calves, nonlactating 
dairy cattle, and dairy calves; for treatment of diseases due to 
oxytetracycline-susceptible organisms as follows: Pneumonia and 
shipping fever complex (Pasteurella spp., Haemophilus spp., Klebsiella 
spp.), bacterial enteritis (scours) (Escherichia coli), foot-rot 
(Spherophorus necrophorus), diphtheria (Spherophorus necrophorus), 
wooden tongue (Actinobacillus lignieresii), leptospirosis (Leptospira 
pomona), and wound infections and acute metritis caused by 
Staphylococcus spp. and Streptococcus spp.
    (iii) Limitations. Discontinue treatment at least 20 days prior to 
slaughter. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.
    (c)(1) Specifications. Each milliliter (mL) of solution contains 50 
or 100 milligrams (mg) oxytetracycline hydrochloride.
    (2) Sponsor. See No. 069043 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use--(i) Beef cattle and nonlactating dairy 
cattle--(A) Amount. Administer 3 to 5 mg per pound of body weight (mg/
lb) per day; 5 mg/lb per day for the treatment of anaplasmosis, severe 
foot-rot, and severe cases of other indicated diseases. For 50-mg/mL 
solution, administer intramuscularly or intravenously; for 100-mg/mL 
solution, administer intramuscularly only. Treatment should be 
continued for 24 to 48 hours following remission of clinical signs of 
disease, not to exceed 4 consecutive days.
    (B) Indications for use. For treatment of diseases due to 
oxytetracycline-susceptible organisms as follows: Pneumonia and 
shipping fever complex associated with Pasteurella spp., Haemophilus 
spp., and Klebsiella 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, anaplasmosis caused by 
Anaplasma marginale; and wound infections and acute metritis caused by 
Staphylococcus spp. and Streptococcus spp.
    (C) Limitations. Exceeding the highest recommended dose of 5 mg/lb, 
administering at recommended levels for more than 4 consecutive days, 
and/or exceeding 10 mL intramuscularly per injection site may result in 
antibiotic residues beyond the withdrawal time. Discontinue treatment 
at least 18 days prior to slaughter. Not for use in lactating dairy 
cattle. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (ii) Swine--(A) Amount. Administer 3 to 5 mg/lb per day by 
intramuscular injection. Sows: Administer 3 mg/lb by intramuscular 
injection approximately 8 hours before farrowing or immediately after 
completion of farrowing.
    (B) Indications for use. For treatment of bacterial enteritis 
(scours, colibacillosis) caused by Escherichia coli, pneumonia caused 
by Pasteurella multocida, and leptospirosis caused by Leptospira 
pomona. Sows: as an aid in control of infectious enteritis (baby pig 
scours, colibacillosis) in suckling pigs caused by Escherichia coli.
    (C) Limitations. Do not inject more than 5 mL per injection site. 
Do not use for more than 4 consecutive days. Discontinue treatment at 
least 26 days before slaughter. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
* * * * *
    (g)(1) Specifications. Each milliliter (mL) of solution contains 
100 milligrams (mg) oxytetracycline hydrochloride.
    (2) Sponsor. See No. 069043 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use. For the treatment of diseases due to 
oxytetracycline-susceptible organisms as follows:
    (i) Beef cattle, beef calves, nonlactating dairy cattle, and dairy 
calves--(A) Amount. Administer 3 to 5 mg/lb body weight per day by 
intramuscular, intravenous, or subcutaneous injection. In severe forms 
of the indicated diseases, administer 5 mg/lb body weight per day. 
Continue treatment 24 to 48 hours following remission of clinical signs 
of disease, not to exceed 4 consecutive days.
    (B) Indications for use. For the treatment of pneumonia and 
shipping fever complex associated with Pasteurella spp., Haemophilus 
spp., or Klebsiella spp.
    (C) Limitations. Do not inject more than 10 mL per intramuscular 
injection site in adult cattle, and no more than 1 mL per site in 
calves weighing 100 pounds or less. Do not slaughter cattle for 13 days 
after intramuscular or intravenous treatment, or 2 days after 
subcutaneous treatment. Exceeding the highest recommended dosage or 
duration of treatment (not more than 4 consecutive days) may result in 
residues beyond the withdrawal period. A withdrawal period has not been 
established for use of 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.
    (ii) Swine--(A) Amount. Administer 3 to 5 mg/lb body weight per day 
by intramuscular injection. Sows: Administer 3 mg/lb body weight once, 
by intramuscular injection, approximately 8 hours before farrowing or 
immediately after completion of farrowing.
    (B) Indications for use. For treatment of bacterial enteritis 
(scours, colibacillosis) caused by Escherichia coli, pneumonia caused 
by Pasteurella multocida, and leptospirosis caused by Leptospira 
pomona. Sows: As an aid in control of infectious enteritis (baby pig 
scours, colibacillosis) in suckling pigs caused by Escherichia coli.
    (C) Limitations. Do not inject more than 5 mL per site. Discontinue 
treatment at least 20 days prior to slaughter. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.
    (h)(1) Specifications. Each milliliter (mL) of solution contains 50 
or 100 milligrams (mg) oxytetracycline hydrochloride.
    (2) Sponsors. See No. 069043 in Sec.  510.600(c) of this chapter 
for use of 50- and 100-mg/mL solution and Nos. 016592 and 055529 in 
Sec.  510.600(c) of this chapter for use of 100-mg/mL solution.
    (3) Conditions of use in beef cattle, beef calves, nonlactating 
dairy cattle,

[[Page 55566]]

and dairy calves--(i) Amount. Administer 3 to 5 mg/lb body weight per 
day by intramuscular injection; 5 mg/lb body weight per day for 
treatment of severe forms of the indicated diseases.
    (ii) Indications for use. For treatment of bacterial pneumonia and 
shipping fever complex associated with Pasteurella spp., foot-rot and 
calf diphtheria caused by Fusobacterium necrophorum, bacterial 
enteritis (scours) caused by Escherichia coli, wooden tongue caused by 
Actinobacillus lignieresii; and wound infections and acute metritis 
caused by Staphylococcus spp. and Streptococcus spp.
    (iii) Limitations. Do not inject more than 10 mL per site in adult 
cattle. Reduce the volume administered per injection site according to 
age and body size. In calves weighing 100 pounds or less, do not inject 
more than 2 mL per site. Discontinue treatment at least 22 days before 
slaughter. Not for use in lactating dairy animals. 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.
* * * * *
    (j)(1) Specifications. Each milliliter (mL) of solution contains 
either 50 or 100 milligrams (mg) of oxytetracycline hydrochloride.
    (2) Sponsor. See No. 061133 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/lb body weight daily by 
intravenous injection. Administer 5 mg/lb for anaplasmosis, severe foot 
rot, and severe forms of other diseases. Treatment should be continued 
24 to 48 hours following remission of clinical signs of disease, but 
not to exceed 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, anaplasmosis caused by Anaplasma marginale and 
anthrax caused by Bacillus anthracis; and acute metritis and wound 
infections caused by staphylococcal and streptococcal organisms.
    (iii) Limitations. Not for use in lactating dairy cattle. 
Discontinue use at least 19 days prior to slaughter. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

0
27. In Sec.  522.1940, revise paragraph (a), redesignate paragraph (c) 
as paragraph (d), and add new paragraph (c).
    The revision and addition read as follows:

Sec.  522.1940  Progesterone and estradiol benzoate.

    (a) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 054771 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii) 
and (iii), (d)(2)(i)(A), (d)(2)(ii) and (iii), and (d)(3) of this 
section.
    (2) No. 058198 for use as in paragraphs (d)(1) and (2) of this 
section.
* * * * *
    (c) Special considerations. Labeling of implants described in 
paragraphs (d)(1)(i)(B) and (d)(2)(i)(B) of this section shall bear the 
following: ``Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.''.
* * * * *

0
28. In Sec.  522.2343, revise paragraph (a), redesignate paragraph (c) 
as paragraph (d), and add new paragraph (c).
    The revision and addition read as follows:

Sec.  522.2343  Testosterone propionate and estradiol benzoate.

    (a) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 054771 for use as in paragraphs (d)(1)(i) and (d)(2) and 
(3) of this section.
    (2) No. 058198 for use as in paragraph (d) of this section.
* * * * *
    (c) Special considerations. Labeling of implants described in 
paragraph (d)(1)(ii) of this section shall bear the following: 
``Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.''
* * * * *

0
29. In Sec.  522.2476, revise paragraph (a), redesignate paragraph (c) 
as paragraph (d), and add new paragraph (c).
    The revision and addition read as follows:

Sec.  522.2476  Trenbolone acetate.

    (a) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 000061 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii) 
and (iii), (d)(2)(i)(A), and (d)(2)(ii) and (iii) of this section.
    (2) No. 058198 for use as in paragraph (d) of this section.
* * * * *
    (c) Special considerations. Labeling of implants described in 
paragraph (d)(1)(i)(B) and (d)(2)(i)(B) of this section shall bear the 
following: ``Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.''.
* * * * *

0
30. In Sec.  522.2477, redesignate paragraphs (b) and (c) as paragraphs 
(a) and (b) and add new paragraph (c) to read as follows:

Sec.  522.2477  Trenbolone acetate and estradiol.

* * * * *
    (c) Special considerations. Labeling of implants described in 
paragraphs (d)(1)(i)(B), (E), and (F), (d)(2)(i)(B), (E), and (F), and 
(d)(3)(i)(B) of this section shall bear the following: ``Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.''.
* * * * *

0
31. In Sec.  522.2680, revise paragraphs (d)(1)(ii)(A) and (B) and 
(d)(1)(iii) to read as follows:

Sec.  522.2680  Zeranol.

* * * * *
    (d) * * *
    (1) * * *
    (ii) * * *
    (A) Weaned beef calves, growing beef cattle, feedlot steers, and 
feedlot heifers: For increased rate of weight gain and improved feed 
conversion.
    (B) Suckling calves: For increased rate of weight gain.
    (iii) Limitations. Implant pellets subcutaneously only. Not 
approved for repeated implantation (reimplantation) with this or any 
other cattle ear implant within a single production phase 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 evaluated. A withdrawal period 
has not been established for this product in preruminating calves. Do 
not use in replacement beef heifers after weaning or in bulls, dairy 
cows, or replacement dairy heifers.
* * * * *

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

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

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

0
33. Add Sec.  524.838 to read as follows:

Sec.  524.838  Esafoxolaner, eprinomectin, and praziquantel.

    (a) Specifications. Each milliliter (mL) of topical solution 
contains 12

[[Page 55567]]

milligrams (mg) esafoxolaner, 4 mg eprinomectin, and 83 mg 
praziquantel.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer the entire contents 
of a provided unit applicator topically once a month at a minimum dose 
of 0.055 mL/lb (0.12 mL/kg), which delivers a minimum dose of 0.66 mg/
lb (1.45 mg/kg) esafoxolaner, 0.23 mg/lb (0.51 mg/kg) eprinomectin, and 
4.55 mg/lb (10.0 mg/kg) praziquantel.
    (2) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis. Kills adult fleas (Ctenocephalides 
felis) and is indicated for the treatment and prevention of flea 
infestations, the treatment and control of Ixodes scapularis (black-
legged tick) and Amblyomma americanum (lone star tick) infestations, 
and the treatment and control of roundworms (fourth-stage larval and 
adult Toxocara cati), hookworms (fourth-stage larval and adult 
Ancylostoma tubaeforme; adult Ancylostoma braziliense), and tapeworms 
(Dipylidium caninum) in cats and kittens 8 weeks of age and older, and 
weighing 1.8 lbs or greater.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

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

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

Sec.  526.1696  [Amended]

0
35. In Sec.  526.1696, in paragraphs (d)(3) and (e)(3), in the last 
sentence, remove ``For No. 042791:''.

0
36. In Sec.  526.1697, add a sentence to the end of paragraph (d)(3) to 
read as follows:

Sec.  526.1697  Penicillin G procaine and dihydrostreptomycin.

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

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
38. In Sec.  529.1044a, revise paragraph (b) to read as follows:

Sec.  529.1044a  Gentamicin solution for infusion.

* * * * *
    (b) Sponsors. See Nos. 000061, 016592, 054771, 058005, 058198, 
061133, and 069043 in Sec.  510.600(c) of this chapter.
* * * * *

0
39. In 529.1044b, revise paragraph (c)(3) to read as follows:

Sec.  529.1044b  Gentamicin solution for dipping eggs.

* * * * *
    (c) * * *
    (3) Limitations. Eggs which have been dipped in the drug shall not 
be used for food. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

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

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

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

0
41. In Sec.  556.110, revise paragraph (c) to read as follows:

Sec.  556.110  Carbomycin.

* * * * *
    (c) Related conditions of use. See Sec.  520.1664 of this chapter.

0
42. In Sec.  556.500, revise paragraph (c) to read as follows:

Sec.  556.500  Oxytetracycline.

* * * * *
    (c) Related conditions of use. See Sec. Sec.  520.1660c, 520.1660d, 
520.1664, 522.1660a, 522.1660b, 522.1662, 522.1664, 529.1660, 558.450, 
and 558.455 of this chapter.

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

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

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

0
44. In Sec.  558.68, revise paragraph (e)(1)(ii) to read as follows:

Sec.  558.68  Avilamycin.

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

----------------------------------------------------------------------------------------------------------------
   Avilamycin in grams/ton       Combination in grams/ton    Indications for use      Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ii) 13.6 to 40.9............  Monensin, 90 to 110.........  Broiler chickens:    Feed this complete      058198
                                                              For the prevention   Type C medicated
                                                              of mortality         feed as the sole
                                                              caused by necrotic   ration for 21
                                                              enteritis            consecutive days.
                                                              associated with      To assure
                                                              Clostridium          responsible
                                                              perfringens; and     antimicrobial drug
                                                              as an aid in the     use in broiler
                                                              prevention of        chickens,
                                                              coccidiosis caused   treatment
                                                              by Eimeria           administration
                                                              necatrix, E.         must begin on or
                                                              tenella, E.          before 18 days of
                                                              acervulina, E.       age. See Sec.
                                                              brunetti, E.         558.355(d) of this
                                                              mivati, and E.       chapter. Monensin
                                                              maxima.              as provided by No.
                                                                                   058198 in Sec.
                                                                                   510.600(c) of this
                                                                                   chapter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
45. In Sec.  558.128, revise paragraphs (e)(4)(iii) and (iv), 
(e)(4)(ix) through (xiv), and (e)(4)(xviii) through (xx) to read as 
follows:

Sec.  558.128  Chlortetracycline.

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

[[Page 55568]]

--------------------------------------------------------------------------------------------------------------------------------------------------------
     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       016592
                                                                             heifers fed in            mg chlortetracycline per head per day      069254
                                                                             confinement for           and 50 to 480 mg monensin per head per
                                                                             slaughter over 400 lb:    day. No additional improvement in feed
                                                                             For reduction of the      efficiency has been shown from feeding
                                                                             incidence of liver        monensin at levels greater than 30
                                                                             abscesses and for         grams per ton (360 mg monensin per
                                                                             improved feed             head per day). For use in dry feeds
                                                                             efficiency.               only. Not for use in liquid feed
                                                                                                       supplements. Do not allow horses or
                                                                                                       other equines 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
                                                                                                       preruminating calves. Do not use in
                                                                                                       calves to be processed for veal.
                                                                                                       Monensin as provided by Nos. 016592
                                                                                                       and 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       016592
                                                                             heifers fed in            mg chlortetracycline per head per day      069254
                                                                             confinement for           and 0.14 to 0.42 mg monensin per lb.
                                                                             slaughter over 400 lb:    body weight per day to provide,
                                                                             For reduction of the      depending upon severity of coccidiosis
                                                                             incidence of liver        challenge, up to 480 mg monensin per
                                                                             abscesses and for         head per day. For use in dry feeds
                                                                             prevention and control    only. Not for use in liquid feed
                                                                             of coccidiosis due to     supplements. Do not allow horses or
                                                                             Eimeria bovis and         other equines access to feed
                                                                             Eimeria zuernii.          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
                                                                                                       preruminating calves. Do not use in
                                                                                                       calves to be processed for veal.
                                                                                                       Monensin as provided by Nos. 016592
                                                                                                       and 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      016592
                                                                             heifers fed in            mg chlortetracycline per lb. body          069254
                                                                             confinement for           weight per day and 50 to 480 mg
                                                                             slaughter over 700 lbs:   monensin per head per day. No
                                                                             For control of active     additional improvement in feed
                                                                             infection of              efficiency has been shown from feeding
                                                                             anaplasmosis caused by    monensin at levels greater than 30
                                                                             Anaplasma marginale       grams per ton (360 mg monensin per
                                                                             susceptible to            head per day). For use in dry feeds
                                                                             chlortetracycline and     only. Not for use in liquid feed
                                                                             for improved feed         supplements. Do not allow horses or
                                                                             efficiency.               other equines 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
                                                                                                       preruminating calves. Do not use in
                                                                                                       calves to be processed for veal.
                                                                                                       Monensin as provided by Nos. 016592
                                                                                                       and 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      016592
                                                                             heifers fed in            mg chlortetracycline per lb. body          069254
                                                                             confinement for           weight per day and 0.14 to 0.42 mg
                                                                             slaughter over 700 lbs:   monensin per lb. body weight per day
                                                                             For control of active     to provide, depending upon severity of
                                                                             infection of              coccidiosis challenge, up to 480 mg
                                                                             anaplasmosis caused by    monensin per head per day. For use in
                                                                             Anaplasma marginale       dry feeds only. Not for use in liquid
                                                                             susceptible to            feed supplements. Do not allow horses
                                                                             chlortetracycline and     or other equines access to feed
                                                                             for the prevention and    containing monensin. Ingestion of
                                                                             control of coccidiosis    monensin by horses has been fatal.
                                                                             due to Eimeria bovis      Monensin medicated cattle and goat
                                                                             and Eimeria zuernii.      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
                                                                                                       preruminating calves. Do not use in
                                                                                                       calves to be processed for veal.
                                                                                                       Monensin as provided by Nos. 016592
                                                                                                       and 058198, chlortetracycline by No.
                                                                                                       069254 in Sec.   510.600(c) of this
                                                                                                       chapter.

[[Page 55569]]

 
(xi) 50 to 117 g/ton.............  Monensin, 7.14 to 40...................  Growing beef steers and   Feed as the sole ration to provide 350      016592
                                                                             heifers fed in            mg chlortetracycline per head per day      069254
                                                                             confinement for           and 50 to 480 mg monensin per head per
                                                                             slaughter under 700       day. No additional improvement in feed
                                                                             lbs: For control of       efficiency has been shown from feeding
                                                                             active infection of       monensin at levels greater than 30
                                                                             anaplasmosis caused by    grams per ton (360 mg monensin per
                                                                             Anaplasma marginale       head per day). For use in dry feeds
                                                                             susceptible to            only. Not for use in liquid feed
                                                                             chlortetracycline and     supplements. Do not allow horses or
                                                                             for improved feed         other equines access to feed
                                                                             efficiency.               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
                                                                                                       preruminating calves. Do not use in
                                                                                                       calves to be processed for veal.
                                                                                                       Monensin as provided by Nos. 016592
                                                                                                       and 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      016592
                                                                             heifers fed in            mg chlortetracycline per head per day      069254
                                                                             confinement for           and 0.14 to 0.42 mg monensin per lb.
                                                                             slaughter under 700       body weight per day to provide,
                                                                             lbs: For control of       depending upon severity of coccidiosis
                                                                             active infection of       challenge, up to 480 mg monensin per
                                                                             anaplasmosis caused by    head per day. For use in dry feeds
                                                                             Anaplasma marginale       only. Not for use in liquid feed
                                                                             susceptible to            supplements. Do not allow horses or
                                                                             chlortetracycline and     other equines access to feed
                                                                             for the prevention and    containing monensin. Ingestion of
                                                                             control of coccidiosis    monensin by horses has been fatal.
                                                                             due to Eimeria bovis      Monensin medicated cattle and goat
                                                                             and Eimeria zuernii.      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
                                                                                                       preruminating calves. Do not use in
                                                                                                       calves to be processed for veal.
                                                                                                       Monensin as provided by Nos. 016592
                                                                                                       and 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      016592
                                                                             heifers fed in            mg chlortetracycline per head per day      069254
                                                                             confinement for           and 50 to 480 mg monensin per head per
                                                                             slaughter: For the        day. No additional improvement in feed
                                                                             control of bacterial      efficiency has been shown from feeding
                                                                             pneumonia associated      monensin at levels greater than 30
                                                                             with shipping fever       grams per ton (360 mg monensin per
                                                                             complex caused by         head per day). For use in dry feeds
                                                                             Pasteurella spp.          only. Not for use in liquid feed
                                                                             susceptible to            supplements. Do not allow horses or
                                                                             chlortetracycline and     other equines access to feed
                                                                             for improved feed         containing monensin. Ingestion of
                                                                             efficiency.               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
                                                                                                       preruminating calves. Do not use in
                                                                                                       calves to be processed for veal.
                                                                                                       Monensin as provided by Nos. 016592
                                                                                                       and 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      016592
                                                                             heifers fed in            mg chlortetracycline per head per day      069254
                                                                             confinement for           and 0.14 to 0.42 mg monensin per lb.
                                                                             slaughter: For the        body weight per day to provide,
                                                                             control of bacterial      depending upon severity of coccidiosis
                                                                             pneumonia associated      challenge, up to 480 mg monensin per
                                                                             with shipping fever       head per day. For use in dry feeds
                                                                             complex caused by         only. Not for use in liquid feed
                                                                             Pasteurella spp.          supplements. Do not allow horses or
                                                                             susceptible to            other equines access to feed
                                                                             chlortetracycline and     containing monensin. Ingestion of
                                                                             for the prevention and    monensin by horses has been fatal.
                                                                             control of coccidiosis    Monensin medicated cattle and goat
                                                                             due to Eimeria bovis      feeds are safe for use in cattle and
                                                                             and Eimeria zuernii.      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
                                                                                                       preruminating calves. Do not use in
                                                                                                       calves to be processed for veal.
                                                                                                       Monensin as provided by Nos. 016592
                                                                                                       and 058198, chlortetracycline by No.
                                                                                                       069254 in Sec.   510.600(c) of this
                                                                                                       chapter.
 

[[Page 55570]]

 
                                                                      * * * * * * *
(xviii) 400 to 2,000 g/ton.......  Monensin, 5 to 40......................  Growing beef steers and   Feed as the sole ration to provide 10       016592
                                                                             heifers fed in            mg chlortetracycline per lb. body          069254
                                                                             confinement for           weight per day and 50 to 480 mg
                                                                             slaughter: For            monensin per head per day. Feed for
                                                                             treatment of bacterial    not more than 5 days, then continue
                                                                             enteritis caused by       feeding monensin Type C medicated feed
                                                                             Escherichia coli and      alone. No additional improvement in
                                                                             bacterial pneumonia       feed efficiency has been shown from
                                                                             caused by Pasteurella     feeding monensin at levels greater
                                                                             multocida susceptible     than 30 grams per ton (360 mg monensin
                                                                             to chlortetracycline;     per head per day). For use in dry
                                                                             for improved feed         feeds only. Not for use in liquid feed
                                                                             efficiency.               supplements. Do not allow horses or
                                                                                                       other equines 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
                                                                                                       preruminating calves. Do not use in
                                                                                                       calves to be processed for veal.
                                                                                                       Monensin as provided by Nos. 016592
                                                                                                       and 058198, chlortetracycline by No.
                                                                                                       069254 in Sec.   510.600(c) of this
                                                                                                       chapter.
(xix) 400 to 2,000 g/ton.........  Monensin, 10 to 40.....................  Growing beef steers and   Feed as the sole ration to provide 10       016592
                                                                             heifers: For treatment    mg chlortetracycline per lb. body          069254
                                                                             of bacterial enteritis    weight per day and 0.14 to 0.42 mg
                                                                             caused by Escherichia     monensin per lb. body weight per day
                                                                             coli and bacterial        to provide, depending upon severity of
                                                                             pneumonia caused by       the coccidiosis challenge, up to 480
                                                                             Pasteurella multocida     mg monensin per head per day. Feed for
                                                                             susceptible to            not more than 5 days, then continue
                                                                             chlortetracycline; and    feeding monensin Type C medicated feed
                                                                             for the prevention and    alone. For use in dry feeds only. Not
                                                                             control of coccidiosis    for use in liquid feed supplements. Do
                                                                             due to Eimeria bovis      not allow horses or other equines
                                                                             and Eimeria zuernii.      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 preruminating calves. Do not use in
                                                                                                       calves to be processed for veal.
                                                                                                       Monensin as provided by Nos. 016592
                                                                                                       and 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       016592
                                                                             age and older: For        mg chlortetracycline per lb. body          069254
                                                                             treatment of bacterial    weight per day and 0.14 to 1.00 mg
                                                                             enteritis caused by       monensin per lb. body weight per day
                                                                             Escherichia coli and      to provide, depending upon severity of
                                                                             bacterial pneumonia       coccidiosis challenge, up to 200 mg of
                                                                             caused by Pasteurella     monensin per head per day. Feed for
                                                                             multocida susceptible     not more than 5 days, then continue to
                                                                             to chlortetracycline;     feed monensin Type C medicated feed
                                                                             and for the prevention    alone. For use in dry feeds only. Not
                                                                             and control of            for use in liquid feed supplements. Do
                                                                             coccidiosis due to        not allow horses or other equines
                                                                             Eimeria bovis and         access to feed containing monensin.
                                                                             Eimeria zuernii.          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 preruminating calves. Do not use in
                                                                                                       calves to be processed for veal.
                                                                                                       Monensin as provided by Nos. 016592
                                                                                                       and 058198, chlortetracycline by No.
                                                                                                       069254 in Sec.   510.600(c) of this
                                                                                                       chapter.
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

Sec.  558.325  [Amended]

0
46. In Sec.  558.325, remove and reserve paragraphs (e)(2)(ii), (viii), 
and (xiii).

0
47. In Sec.  558.366, revise paragraphs (b) and (d)(1)(v) to read as 
follows:

Sec.  558.366  Nicarbazin.

* * * * *
    (b) Sponsors. See Nos. 060728, 066104, and 069254 in Sec.  
510.600(c) of this chapter.
* * * * *
    (d) * * *
    (1) * * *

[[Page 55571]]

----------------------------------------------------------------------------------------------------------------
                                Combination  in grams per
  Nicarbazin in grams per ton              ton              Indications for use       Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(v) 113.5.....................  .........................  Chickens: As an aid   Feed continuously as     060728
                                                            in preventing         sole ration from        069254
                                                            outbreaks of cecal    time chicks are
                                                            (Eimeria tenella)     placed on litter
                                                            and intestinal (E.    until past the time
                                                            acervulina, E.        when coccidiosis is
                                                            maxima, E.            ordinarily a
                                                            necatrix, and E.      hazard. Do not use
                                                            brunetti)             as a treatment for
                                                            coccidiosis.          coccidiosis. Do not
                                                                                  use in flushing
                                                                                  mashes. Do not feed
                                                                                  to laying hens.
                                                                                  Withdraw 4 days
                                                                                  before slaughter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
48. In Sec.  558.450, revise paragraphs (e)(5)(iv) and (v) to read as 
follows:

Sec.  558.450  Oxytetracycline.

* * * * *
    (e) * * *
    (5) * * *

 
------------------------------------------------------------------------
                             Indications for
   Oxytetracycline amount          use          Limitations     Sponsor
------------------------------------------------------------------------
 
                              * * * * * * *
(iv) 2.5 to 3.75 g/100 lb    1. Freshwater-   Administer in       066104
 of fish/day.                 reared           mixed ration
                              salmonids: For   for 10 days.
                              control of       Do not
                              ulcer disease    liberate fish
                              caused by        or slaughter
                              Haemophilus      fish for food
                              piscium,         for 21 days
                              furunculosis     following the
                              caused by        last
                              Aeromonas        administration
                              salmonicida,     of medicated
                              bacterial        feed.
                              hemorrhagic
                              septicemia
                              caused by A.
                              hydrophila,
                              and
                              pseudomonas
                              disease.
                             2. Catfish: For  Administer in       066104
                              control of       mixed ration
                              bacterial        for 10 days.
                              hemorrhagic      Do not
                              septicemia       liberate fish
                              caused by A.     or slaughter
                              hydrophila and   fish for food
                              pseudomonas      for 21 days
                              disease.         following the
                                               last
                                               administration
                                               of medicated
                                               feed. Do not
                                               administer
                                               when water
                                               temperature is
                                               below 16.7
                                               [deg]C (62 F).
(v) 3.75 g/100 lb of fish/   1. Freshwater-   Administer in       066104
 day.                         reared           mixed ration
                              salmonids: For   for 10 days.
                              control of       Do not
                              mortality due    liberate fish
                              to coldwater     or slaughter
                              disease          fish for food
                              associated       for 21 days
                              with             following the
                              Flavobacterium   last
                              psychrophilum    administration
                              or for control   of medicated
                              of mortality     feed.
                              due to
                              columnaris
                              disease
                              associated
                              with
                              Flavobacterium
                              columnare.
                             2. Freshwater-   Feed for 10         066104
                              reared           days.
                              salmonids        Immediate
                              weighing up to   release is
                              55 grams: For    permitted
                              marking the      following last
                              skeletal         feeding of
                              tissue.          medicated feed.
                             3. Catfish: For  Administer in       066104
                              control of       mixed ration
                              mortality due    for 10 days.
                              to columnaris    Do not
                              disease          liberate fish
                              associated       or slaughter
                              with             fish for food
                              Flavobacterium   for 21 days
                              columnare.       following the
                                               last
                                               administration
                                               of medicated
                                               feed. Do not
                                               administer
                                               when water
                                               temperature is
                                               below 16.7
                                               [deg]C (62 F).
 
                              * * * * * * *
------------------------------------------------------------------------

    Dated: August 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17454 Filed 8-15-23; 8:45 am]
BILLING CODE 4164-01-P