[Federal Register Volume 88, Number 85 (Wednesday, May 3, 2023)]
[Rules and Regulations]
[Pages 27693-27701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09212]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 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

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 January, February, and March 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 May 3, 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 January, February, and 
March 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.

[[Page 27694]]



   Table 1--Original and Supplemental NADAs, ANADAs, and cNADAs Approved During January, February, and March 2023 Requiring Evidence of Safety and/or
                                                                      Effectiveness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                 21 CFR
         Approval date            File No.          Sponsor              Product name        Effect of the action        Public documents       section
--------------------------------------------------------------------------------------------------------------------------------------------------------
January 5, 2023................    200-732  Felix Pharmaceuticals   Carprofen Tablets       Original approval for   FOI Summary..............    520.304
                                             Pvt. Ltd., 25-28        (carprofen tablets)     the relief of pain
                                             North Wall Quay,        Caplets.                and inflammation
                                             Dublin 1, Ireland.                              associated with
                                                                                             osteoarthritis and
                                                                                             for the control of
                                                                                             postoperative pain
                                                                                             associated with soft
                                                                                             tissue and orthopedic
                                                                                             surgeries in dogs as
                                                                                             a generic copy of
                                                                                             NADA 141-053.
January 11, 2023...............    200-611  Akorn Operating         DETOMISED (detomidine   Original approval as a  FOI Summary..............    522.536
                                             Company LLC, 5605       hydrochloride)          sedative and
                                             Centerpoint Ct.,        Injectable Solution.    analgesic to
                                             Suite A, Gurnee, IL                             facilitate minor
                                             60031.                                          surgical and
                                                                                             diagnostic procedures
                                                                                             in horses as a
                                                                                             generic copy of NADA
                                                                                             140-862.
January 11, 2023...............    200-738  Aurora Pharmaceutical,  DECTOGARD (doramectin   Original approval for   FOI Summary..............    524.770
                                             Inc., 1196 Highway 3    topical solution)       treatment and control
                                             South, Northfield, MN   Topical Solution.       of internal and
                                             55057-3009.                                     external parasites of
                                                                                             cattle as a generic
                                                                                             copy of NADA 141-095.
January 12, 2023...............    141-426  Intervet, Inc., 2       BRAVECTO (fluralaner)   Supplemental approval   FOI Summary..............    520.998
                                             Giralda Farms,          Chewable tablets.       for the treatment and
                                             Madison, NJ 07940.                              control of Asian long
                                                                                             horned tick
                                                                                             infestations for 12
                                                                                             weeks in dogs and
                                                                                             puppies.
January 12, 2023...............    200-721  Norbrook Laboratories   MIDAMOX for Cats        Supplemental approval   FOI Summary..............   524.1146
                                             Ltd., Carnbane          (imidacloprid and       for prevention of
                                             Industrial Estate,      moxidectin) Topical     heartworm disease and
                                             Newry, County Down,     Solution.               treatment of flea
                                             BT35 6QQ, United                                infestations in
                                             Kingdom.                                        ferrets as a generic
                                                                                             copy of NADA 141-254.
January 12, 2023...............    200-733  Felix Pharmaceuticals   Marbofloxacin Chewable  Original approval for   FOI Summary..............   520.1310
                                             Pvt. Ltd., 25-28        Tablets                 treatment of
                                             North Wall Quay,        (marbofloxacin).        infections in dogs
                                             Dublin 1, Ireland.                              and cats associated
                                                                                             with bacteria
                                                                                             susceptible to
                                                                                             marbofloxacin as a
                                                                                             generic copy of NADA
                                                                                             141-151.
January 12, 2023...............    200-734  Do....................  Praziquantel Tablets    Original approval for   FOI Summary..............   520.1870
                                                                     (praziquantel).         removal or removal
                                                                                             and control of
                                                                                             certain canine
                                                                                             tapeworms as a
                                                                                             generic copy of NADA
                                                                                             111-798.
January 13, 2023...............    200-735  ZyVet Animal Health,    Dexmedetomidine         Original approval for   FOI Summary..............    522.558
                                             Inc., 73 Route 31N,     Hydrochloride           use as a sedative,
                                             Pennington, NJ 08534.   (dexmedetomidine        analgesic, and
                                                                     hydrochloride)          preanesthetic in dogs
                                                                     Injectable Solution.    and cats as a generic
                                                                                             copy of NADA 141-267.
January 13, 2023...............    200-736  Do....................  Marbofloxacin Tablets   Original approval for   FOI Summary..............   520.1310
                                                                     (marbofloxacin).        treatment of
                                                                                             infections in dogs
                                                                                             and cats associated
                                                                                             with bacteria
                                                                                             susceptible to
                                                                                             marbofloxacin as a
                                                                                             generic copy of NADA
                                                                                             141-151.
February 2, 2023...............    200-737  Do....................  Enrofloxacin            Original approval for   FOI Summary..............    520.812
                                                                     (enrofloxacin)          the management of
                                                                     Flavored                diseases associated
                                                                     Antimicrobial Tablets.  with bacteria
                                                                                             susceptible to
                                                                                             enrofloxacin in dogs
                                                                                             and cats as a generic
                                                                                             copy of NADA 140-441.
February 2, 2023...............    200-739  Do....................  Carprofen (carprofen)   Original approval for   FOI Summary..............    520.304
                                                                     Chewable Tablets.       the relief of pain
                                                                                             and inflammation
                                                                                             associated with
                                                                                             osteoarthritis and
                                                                                             for the control of
                                                                                             postoperative pain
                                                                                             associated with soft
                                                                                             tissue and orthopedic
                                                                                             surgeries in dogs as
                                                                                             a generic copy of
                                                                                             NADA 141-111.
February 9, 2023...............    200-701  Chanelle                PARASEDGE Multi for     Supplemental approval   FOI Summary..............   524.1146
                                             Pharmaceuticals         Cats (imidacloprid      for prevention of
                                             Manufacturing Ltd.,     and moxidectin)         heartworm disease and
                                             Loughrea, County        Topical Solution.       treatment of flea
                                             Galway, Ireland.                                infestations in
                                                                                             ferrets as a generic
                                                                                             copy of NADA 141-254.

[[Page 27695]]

 
February 24, 2023..............    200-741  Aurora Pharmaceutical,  EPRIGARD                Original approval for   FOI Summary..............    524.814
                                             Inc., 1196 Highway 3    (eprinomectin)          treatment and control
                                             South, Northfield, MN   Topical Solution.       of internal and
                                             55057-3009.                                     external parasites in
                                                                                             cattle as a generic
                                                                                             copy of NADA 141-079.
March 21, 2023.................    200-743  Provetica LLC, 8735     MODULIS for Dogs        Original approval for   FOI Summary..............    520.522
                                             Rosehill Rd., Suite     (cyclosporine oral      the control of atopic
                                             300, Lenexa, KS 66215.  solution) USP           dermatitis in dogs as
                                                                     MODIFIED.               a generic copy of
                                                                                             NADA 141-218.
March 21, 2023.................    200-745  Parnell Technologies    RESPIRMYCIN 25          Original approval for   FOI Summary..............   522.2630
                                             Pty. Ltd., Unit 4,      (tulathromycin          the treatment of
                                             476 Gardeners Rd.,      injection) Injectable   respiratory disease
                                             Alexandria, New South   Solution.               in swine and calves
                                             Wales 2015, Australia.                          as a generic copy of
                                                                                             NADA 141-349.
March 29, 2023.................    200-744  Provetica LLC, 8735     MODULIS for Cats        Original approval for   FOI Summary..............    520.522
                                             Rosehill Rd., Suite     (cyclosporine oral      the control of feline
                                             300, Lenexa, KS 66215.  solution) USP           allergic dermatitis
                                                                     MODIFIED.               in cats as a generic
                                                                                             copy of NADA 141-329.
March 30, 2023.................    200-746  Norbrook Laboratories   TAURAMOX (moxidectin)   Original approval for   FOI Summary..............   522.1450
                                             Ltd., Carnbane          Injectable Solution.    treatment and control
                                             Industrial Estate,                              of internal and
                                             Newry, County Down,                             external parasites in
                                             BT35 6QQ, United                                beef and nonlactating
                                             Kingdom.                                        dairy cattle as a
                                                                                             generic copy of NADA
                                                                                             141-220.
March 31, 2023.................    200-747  ZyVet Animal Health,    Maropitant Citrate      Original approval for   FOI Summary..............   520.1315
                                             Inc., 73 Route 31N,     (maropitant citrate)    the prevention of
                                             Pennington, NJ 08534.   Tablets.                acute vomiting and
                                                                                             the prevention of
                                                                                             vomiting due to
                                                                                             motion sickness in
                                                                                             dogs as a generic
                                                                                             copy of NADA 141-262.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

  Table 2--Supplemental Applications Approved During January, February, and March 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
----------------------------------------------------------------------------------------------------------------
January 3, 2022.......................      200-274  Zoetis Inc., 333        LINCOMIX (lincomycin       522.1260
                                                      Portage St.,            hydrochloride)
                                                      Kalamazoo, MI 49007.    Injectable Solution.
January 12, 2022......................      012-123  Bimeda Animal Health    GALLIMYCIN 100              522.820
                                                      Ltd., 1B The Herbert    Injection
                                                      Building, The Park,     (erythromycin)
                                                      Carrickmines, Dublin    Injectable Solution.
                                                      18, Ireland.
January 12, 2022......................      130-952  Intervet, Inc., 2       GENTOCIN Pinkeye Spray    524.1044e
                                                      Giralda Farms,          (gentamicin) Topical
                                                      Madison, NJ 07940.      Spray.
January 13, 2022......................      008-774  Huvepharma EEOD, 5th    SULMET (sodium             522.2260
                                                      Floor, 3A Nikolay       sulfamethazine)
                                                      Haytov Str., 1113       Injectable Solution.
                                                      Sofia, Bulgaria.
February 10, 2023.....................      065-506  Bimeda Animal Health    COMBI-PEN-48              522.1696a
                                                      Ltd., 1B The Herbert    (penicillin G
                                                      Building, The Park,     benzathine and
                                                      Carrickmines, Dublin    penicillin G
                                                      18, Ireland.            procaine) Injectable
                                                                              Suspension.
February 14, 2023.....................      055-018  Huvepharma EOOD, 5th    Chlortetracycline           520.443
                                                      Floor, 3A Nikolay       (chlortetracycline
                                                      Haytov Str., 1113       hydrochloride)
                                                      Sofia, Bulgaria.        Tablets, 25 mg.
February 15, 2023.....................      033-157  Do....................  SPECTAM Scour-Halt        520.2123c
                                                                              (spectinomycin) Oral
                                                                              Solution.
February 15, 2023.....................      040-040  Do....................  SPECTAM                    522.2120
                                                                              (spectinomycin)
                                                                              Injectable Solution.
February 24, 2023.....................      065-010  Do....................  NOROCILLIN (penicillin    522.1696b
                                                                              G procaine)
                                                                              Injectable Suspension.
March 1, 2023.........................      200-351  Do....................  Lincomycin Injectable,     522.1260
                                                                              USP.
March 1, 2023.........................      200-368  Do....................  Lincomycin Injectable,     522.1260
                                                                              USP.
March 1, 2023.........................      130-464  Intervet, Inc., 2       GARACIN Pig Pump          520.1044b
                                                      Giralda Farms,          (gentamicin) Oral
                                                      Madison, NJ 07940.      Solution.

[[Page 27696]]

 
March 9, 2023.........................      035-456  Bimeda Animal Health    GALLIMYCIN-36               526.820
                                                      Ltd., 1B The Herbert    (erythromycin)
                                                      Building, The Park,     Intramammary Solution.
                                                      Carrickmines, Dublin
                                                      18, Ireland.
March 13, 2023........................      200-315  Sparhawk Laboratories,  LINCOMYCIN 300             522.1260
                                                      Inc., 12340 Santa Fe    (lincomycin
                                                      Trail Dr., Lenexa, KS   hydrochloride)
                                                      66215.                  Injectable Solution.
March 16, 2023........................      065-505  Bimeda Animal Health    PRO-PEN-G (penicillin     522.1696b
                                                      Ltd., 1B The Herbert    G procaine)
                                                      Building, The Park,     Injectable Suspension.
                                                      Carrickmines, Dublin
                                                      18, Ireland.
March 20, 2023........................      200-127  Zoetis Inc., 333        PROSPEC (spectinomycin     522.2120
                                                      Portage St.,            hydrochloride)
                                                      Kalamazoo, MI 49007.    Injectable Solution.
March 25, 2023........................      040-181  Huvepharma EOOD, 5th    VETSULID                   520.2200
                                                      Floor, 3A Nikolay       (sulfachlorpyridazine
                                                      Haytov Str., 1113       ) Oral Suspension.
                                                      Sofia, Bulgaria.
March 28, 2023........................      065-081  HQ Specialty Pharma     MASTI-CLEAR                526.1696
                                                      Corp., 120 Rte. 17      (penicillin G
                                                      North, Suite 130,       procaine) Suspension
                                                      Paramus, NJ 07652.      and GO-DRY
                                                                              (penicillin G
                                                                              procaine) Suspension.
----------------------------------------------------------------------------------------------------------------

II. Withdrawals of Approval

    Elanco US Inc. (Elanco), 2500 Innovation Way, Greenfield, IN 46140 
has requested that FDA withdraw approval of conditionally approved NADA 
141-527 for BAYTRIL 100-CA1 (enrofloxacin) Injectable Solution. 
Pursuant to Elanco's request, approval of their application was 
withdrawn on March 31, 2023. As provided in the regulatory text of this 
document, the animal drug regulations in 21 CFR 516.812 are removed to 
reflect this action.
    Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., 
Duluth, GA 30096 has requested that FDA withdraw approval of the 49 
applications listed in table 3 because the products are no longer 
manufactured or marketed. As provided in the regulatory text of this 
document, the animal drug regulations are amended where appropriate to 
reflect this action.

                    Table 3--Applications for Which Approval Was Voluntarily Withdrawn by FDA
----------------------------------------------------------------------------------------------------------------
                    File No.                                         Product name                    21 CFR cite
----------------------------------------------------------------------------------------------------------------
006-623.........................................  CAPARSOLATE (arsenamide sodium) Injectable                 Not
                                                   Solution.                                            codified
008-422.........................................  SELEEN (selenium disulfide) Topical Suspension...     524.2101
010-424.........................................  NALLINE (nalorphine hydrochloride) Injectable         522.1452
                                                   Solution.
011-080.........................................  HYDELTRONE-TBA (prednisolone tertiary                 522.1885
                                                   butylacetate) Injectable Suspension.
011-437.........................................  HYDELTRONE (neomycin sulfate and prednisolone        524.1484j
                                                   sodium phosphate) Ointment.
011-532.........................................  SULFABROM (sulfabromomethazine sodium) Bolus.....     520.2170
011-678.........................................  DIURIL (chlorothiazide) Tablets..................      520.420
012-734.........................................  DIURIL (chlorothiazide) Bolus....................      520.420
013-022.........................................  THIBENZOLE (thiabendazole) Sheep & Goat Wormer...    520.2380c
013-407.........................................  EQUIZOLE (thiabendazole) Horse Wormer Top Dress..    520.2380a
013-624.........................................  Triamcinolone Acetonide Tablets..................     520.2483
013-674.........................................  HYDROZIDE (hydrochlorothiazide) Injectable            522.1150
                                                   Solution.
013-954.........................................  THIBENZOLE (thiabendazole) 20% Swine Premix......      558.600
014-350.........................................  OMNIZOLE (thiabendazole) Oral Liquid.............    520.2380b
015-123.........................................  TBZ (thiabendazole) Cattle Wormer Oral Liquid....    520.2380b
015-875.........................................  TBZ 200 (thiabendazole) Medicated Feed Premix....      558.600
030-103.........................................  THIBENZOLE (thiabendazole) Oral Liquid...........    520.2380b
032-702.........................................  PROM ACE (acepromazine maleate) Tablets..........       520.23
033-127.........................................  VETISULID (sulfachlorpyridazine) Bolus...........     520.2200
033-318.........................................  VETISULID (sulfachlorpyridazine) Injectable           520.2200
                                                   Solution.
033-319.........................................  VETISULID (sulfachlorpyridazine) Tablets.........     520.2200
034-114.........................................  EQUIZOLE (thiabendazole) Oral Liquid.............    520.2380b
034-879.........................................  DOPRAM-V (doxapram hydrochloride) Injectable           522.775
                                                   Solution.
035-631.........................................  THIBENZOLE (thiabendazole) Pig Wormer............    520.2380b
037-410.........................................  EQUIZOLE A (thiabendazole and piperazine             520.2380e
                                                   phosphate) Oral Liquid.
043-141.........................................  THIBENZOLE 300 (thiabendazole) Medicated.........      558.600
044-654.........................................  EQUIZOLE (thiabendazole) Horse Wormer Pellets....    520.2380a
046-146.........................................  VETALOG (triamcinolone acetonide) Cream..........     524.2483
047-333.........................................  EQUIZOLE A (thiabendazole and piperazine citrate)    520.2380d
                                                   Oral Liquid.
048-487.........................................  TBZ (thiabendazole) Wormer Paste 50%.............    520.2380b
049-461.........................................  TBZ (thiabendazole) Wormer Paste 43%.............    520.2380b
055-021.........................................  HETACIN K (hetacillin potassium) Capsules Vet....     520.1130
055-022.........................................  HETACIN K (hetacillin potassium) Tablets.........     520.1130
055-048.........................................  HETACIN K (hetacillin potassium) Oral Liquid.....     520.1130
065-275.........................................  Penicillin VK (penicillin V potassium) Filmtab       520.1696c
                                                   Tablets 250 mg.
065-276.........................................  VEESYN (penicillin V potassium) Granules for Oral    520.1696b
                                                   Solution.
093-600.........................................  VOREN (dexamethasone-21-isonicotinate) Suspension      522.542

[[Page 27697]]

 
094-642.........................................  CAMVET (cambendazole) Suspension Horse Wormer....     520.284a
095-642.........................................  OXY-TET (oxytetracycline hydrochloride)              522.1662a
                                                   Injectable Solution.
096-506.........................................  CAMVET (cambendazole) Horse Wormer Pellets.......     520.284b
096-731.........................................  CAMVET (cambendazole) Horse Wormer Paste 45%.....     520.284c
098-689.........................................  EQUIZOLE (thiabendazole) 50% Wormer Paste........    520.2380b
099-388.........................................  VETALOG (triamcinolone acetonide) Oral Powder....     520.2483
117-531.........................................  Acepromazine Maleate Injection...................       522.23
127-443.........................................  EQVALAN (ivermectin) Injectable Solution.........     522.1192
140-439.........................................  EQVALAN (ivermectin) Oral Liquid For Horses......     522.1195
141-180.........................................  TORPEX (albuterol sulfate).......................       529.40
200-361.........................................  Acepromazine Maleate Injection...................       522.23
200-564.........................................  Ivermectin Paste 1.87%...........................     520.1192
----------------------------------------------------------------------------------------------------------------

III. Technical Amendments

    FDA is making the following amendments to improve the accuracy of 
the animal drug regulations.
     21 CFR 520.48 is amended to reflect the sponsors of 
products containing altrenogest for use in horses and swine.
     21 CFR 520.2380 is removed and 21 CFR 558.600 revised to 
characterize a free-choice block containing thiabendazole as a new 
animal drug for use in cattle feed.
     21 CFR 522.1077 is amended to reflect indications for use 
of gonadorelin in cattle.
     21 CFR 522.1222 is amended to reflect sponsors of approved 
applications for use of ketamine in cats and subhuman primates.
     21 CFR 556.620 is removed because there are no longer any 
approved products containing sulfabromomethazine for use in food-
producing animals.
     21 CFR 556.730 is revised to reflect the removal of 
products containing thiabendazole for use in food-producing animals 
other than cattle.
     21 CFR 558.311 is amended to reflect approved classes of 
pasture cattle for use of lasalocid medicated feeds.
     21 CFR 558.455 is amended to reflect the approved 
conditions of use of medicated feeds containing oxytetracycline and 
neomycin in sheep.

IV. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)), which requires 
Federal Register publication of ``notice[s] . . . effective as a 
regulation,'' of the conditions of use of approved new animal drugs. 
This rule sets forth technical amendments to the regulations to codify 
recent actions on approved new animal drug applications and corrections 
to improve the accuracy of the regulations, and as such does not impose 
any burden on regulated entities.
    Although denominated a rule pursuant to the FD&C Act, this document 
does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because 
it is a ``rule of particular applicability.'' Therefore, it is not 
subject to the congressional review requirements in 5 U.S.C. 801-808. 
Likewise, this is not a rule subject to Executive Order 12866, which 
defines a rule as ``an agency statement of general applicability and 
future effect, which the agency intends to have the force and effect of 
law, that is designed to implement, interpret, or prescribe law or 
policy or to describe the procedure or practice requirements of an 
agency.''

List of Subjects

21 CFR Part 510

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

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

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for part 510 continues to read as follows:

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


0
2. In Sec.  510.600:
0
a. In paragraph (c)(1), amend the table by adding an entry for 
``Provetica LLC''; and
0
b. In paragraph (c)(2), amend the table by adding add an entry for 
``086097''.
    The additions read as follows:


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

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

[[Page 27698]]



------------------------------------------------------------------------
               Firm name and address                  Drug labeler code
------------------------------------------------------------------------
 
                              * * * * * * *
Provetica LLC, 8735 Rosehill Rd., Suite 300,                      086097
 Lenexa, KS 66215.................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
086097......................  Provetica LLC, 8735 Rosehill Rd., Suite
                               300, Lenexa, KS 66215.
 
                              * * * * * * *
------------------------------------------------------------------------

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

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

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


Sec.  516.812  [Removed]

0
4. Remove Sec.  516.812.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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


0
6. In Sec.  520.48, revise paragraph (b) to read as follows:


Sec.  520.48  Altrenogest.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter:
    (1) Nos. 000061 and 051072 for use as in paragraph (d) of this 
section.
    (2) No. 061133 for use as in paragraph (d)(1) of this section.
    (3) No. 013744 for use as in paragraph (d)(2) of this section.
* * * * *


Sec. Sec.  520.284, 520.284a, 520.284b, and 520.284c  [Removed]

0
7. Remove Sec. Sec.  520.284, 520.284a, 520.284b, and 520.284c.

0
8. In Sec.  520.304, revise paragraphs (b)(1) and (2) to read as 
follows:


Sec.  520.304  Carprofen.

* * * * *
    (b) * * *
    (1) Nos. 017033, 054771, 055529, 062250, and 086101 for use of 
products described in paragraph (a)(1) and (2) of this section as in 
paragraph (c) of this section.
    (2) Nos. 058198 and 086117 for use of product described in 
paragraph (a)(2) as in paragraph (c) of this section.
* * * * *


Sec. Sec.  520.420  [Removed]

0
9. Remove Sec.  520.420.

0
10. In Sec.  520.443, amend paragraph (d)(2)(ii) by adding a sentence 
at the end of the paragraph to read as follows:


Sec.  520.443  Chlortetracycline tablets and boluses.

* * * * *
    (d) * * *
    (2) * * *
    (ii) * * * Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.
* * * * *

0
11. In Sec.  520.522, add paragraph (b)(4) and revise (d)(2)(ii) to 
read as follows:


Sec.  520.522  Cyclosporine.

* * * * *
    (b) * * *
    (4) No. 086097 for use of product described in paragraph (a)(2) as 
in paragraph (d) of this section.
* * * * *
    (d) * * *
    (2) * * *
    (ii) Indications for use. For the control of feline allergic 
dermatitis as manifested by excoriations (including facial and neck), 
miliary dermatitis, eosinophilic plaques, and self-induced alopecia in 
cats at least 6 months of age and at least 3 lbs (1.4 kg) in body 
weight.
* * * * *


Sec.  520.812  [Amended]

0
12. Amend Sec.  520.812 by:
0
a. In paragraph (b)(2), removing ``No. 017033'' and in its place adding 
``Nos. 017033 and 086117''; and
0
b. Removing paragraph (b)(4).

0
13. In Sec.  520.998, revise paragraph (c)(2)(i) to read as follows:


Sec.  520.998  Fluralaner.

* * * * *
    (c) * * *
    (2) * * *
    (i) Chewable tablets described in paragraph (a)(1) of this section. 
Kills adult fleas; for the treatment and prevention of flea 
infestations (Ctenocephalides felis), and the treatment and control of 
tick infestations (Ixodes scapularis (black-legged tick), Dermacentor 
variabilis (American dog tick), Rhipicephalus sanguineus (brown dog 
tick), and Haemaphysalis longicornis (Asian longhorned tick)) for 12 
weeks in dogs and puppies 6 months of age and older, and weighing 4.4 
lbs or greater; and for the treatment and control of Amblyomma 
americanum (lone star tick) infestations for 8 weeks in dogs and 
puppies 6 months of age and older, and weighing 4.4 lbs or greater.
* * * * *

0
14. Amend Sec.  520.1044b by adding a sentence at the end of paragraph 
(d)(3) to read as follows:


Sec.  520.1044b  [Amended]

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


Sec.  520.1130  [Removed]

0
15. Remove Sec. Sec.  520.1130.


Sec.  520.1195  [Amended]

0
16. In Sec.  520.1195, in paragraph (b)(1), remove ``000010,''.

0
17. In Sec.  520.1310, revise paragraphs (a) and (b) to read as 
follows:

[[Page 27699]]

Sec.  520.1310  Marbofloxacin.

    (a) Specifications. Each tablet or chewable tablet contains 25, 50, 
100, or 200 milligrams (mg) marbofloxacin.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (d) of this section:
    (1) Nos. 017033, 054771, and 086117 for use of tablets.
    (2) No. 086101 for use of chewable tablets.
* * * * *

0
18. In Sec.  520.1315, revise paragraph (b) to read as follows:


Sec.  520.1315  Maropitant.

* * * * *
    (b) Sponsors. See Nos. 054771 and 086117 in Sec.  510.600(c) of 
this chapter.
* * * * *


Sec.  520.1696b  [Removed]

0
19. Remove Sec.  520.1696b.

0
20. In Sec.  520.1696c, revise paragraph (b) to read as follows:


Sec.  520.1696c  Penicillin V tablets.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *


Sec.  520.1870  [Amended]

0
21. In Sec.  520.1870, in paragraph (b)(2), remove ``No. 069043'' and 
in its place add ``Nos. 069043 and 086101''.

0
22. In Sec.  520.2200, revise paragraph (a)(2), remove paragraph 
(a)(3), revise paragraphs (d)(1)(i) and (d)(2)(i), and remove (d)(3) to 
read as follows:


Sec.  520.2200  Sulfachlorpyridazine.

    (a) * * *
    (2) Each milliliter (mL) of suspension contains 50 milligrams (mg) 
of sodium sulfachlorpyridazine.
* * * * *
    (d) * * *
    (1) * * *
    (i) Amount. Administer 30 to 45 mg sulfachlorpyridazine powder per 
pound (/lb) of body weight per day in milk or milk replacer in divided 
doses twice daily for 1 to 5 days.
* * * * *
    (2) * * *
    (i) Amount. Administer 20 to 35 mg/lb body weight per day in 
divided doses twice daily for 1 to 5 days in drinking water or an oral 
suspension containing 50 mg per mL.
* * * * *


Sec.  Sec.  520.1696b, 520.2170, 520.2380, 520.2380a, 520.2380b, 
520.2380c, 520.2380d and 520.2380e   [Removed]

0
23. Remove Sec. Sec.  520.1696b, 520.2170, 520.2380, 520.2380a, 
520.2380b, 520.2380c, 520.2380d and 520.2380e.


Sec.  520.2380f  [Redesignated]

0
24. Redesignate Sec.  520.2380f as Sec.  520.2382.


Sec.  520.2483  [Removed]

0
25. Remove Sec.  520.2483.

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

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

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


Sec.  522.536  [Amended]

0
27. In Sec.  522.536, in paragraph (b), remove ``Nos. 015914 and 
052483'' and in its place add ``Nos. 015914, 052483, and 059399''.


Sec.  522.542  [Removed]

0
28. Remove Sec.  522.542.


Sec.  522.558  [Amended]

0
29. In Sec.  522.558, in paragraph (b)(1), remove ``Nos. 017033 and 
059399'' and in its place add ``Nos. 017033, 059399, and 086117''.


Sec.  522.775  [Removed]

0
30. Remove Sec.  522.775.

0
31. Amend Sec.  522.820 by adding a sentence at the end of paragraph 
(d)(3)(iii) to read as follows:


Sec.  522.820  Erythromycin.

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

0
32. In Sec.  522.1077, revise paragraphs (b)(2), (d)(1)(iv), and 
(e)(1)(i) to read as follows:


Sec.  522.1077  Gonadorelin.

* * * * *
    (b) * * *
    (2) No. 068504 for use of the 100-[micro]g/mL product described in 
paragraph (a)(2) as in paragraphs (d)(1)(i) and (iv) of this section.
* * * * *
    (d) * * *
    (1) * * *
    (iv) Dinoprost injection for use as in paragraph (e)(1)(vi) of this 
section as provided by No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *
    (e) * * *
    (1) * * *
    (i) For the treatment of ovarian follicular cysts in dairy cattle: 
Administer 86 [micro]g gonadorelin (No. 000061), or 100 [micro]g 
gonadorelin diacetate tetrahydrate (Nos. 000010 and 061133), or 100 
[micro]g gonadorelin (as gonadorelin acetate; No. 068504) by 
intramuscular or intravenous injection.
* * * * *


Sec.  522.1150  [Removed]

0
33. Remove Sec.  522.1150.

0
34. In Sec.  522.1192, remove and reserve paragraph (a)(1), and revise 
paragraphs (b)(1) and (2), remove and reserve paragraph (e)(1), and 
revise paragraph (e)(2)(i) to read as follows:


Sec.  522.1192  Ivermectin.

* * * * *
    (b) * * *
    (1) Nos. 000010, 016592, 055529, 058005, and 061133 for use of the 
product described in paragraph (a)(2) of this section as in paragraphs 
(e)(2) through (e)(5) of this section; and
    (2) No. 000010 for use of the product described in paragraph (a)(3) 
of this section as in paragraphs (e)(3) and (e)(6) of this section.
* * * * *
    (e) * * *
    (2) * * *
    (i) Amount. 200 micrograms per kilogram ([micro]g/kg) of body 
weight by subcutaneous injection.
* * * * *


Sec.  522.1222  [Amended]

0
35. In Sec.  522.1222, revise paragraph (b) by adding, in numeric 
sequence, ``00010,''.

0
36. In Sec.  522.1450, revise paragraphs (a), (b), and (e) to read as 
follows:


Sec.  522.1450  Moxidectin solution.

    (a) Specifications. Each milliliter (mL) of solution contains 10 
milligrams (mg) moxidectin.
    (b) Sponsors. See Nos. 055529 and 058198 in Sec.  510.600(c) of 
this chapter.
* * * * *
    (e) Conditions of use in cattle--(1) Amount. Administer by 
subcutaneous injection 1 mL for each 110 pounds (lb) (50 kilograms 
(kg)) body weight to provide 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body 
weight.
    (2) Indications for use. Beef and nonlactating dairy cattle: For 
treatment and control of Gastrointestinal roundworms: Ostertagia 
ostertagi (adults, fourth-stage larvae, and inhibited larvae), 
Haemonchus placei (adults), Trichostrongylus axei (adults and fourth-
stage larvae), Trichostrongylus colubriformis (adults and fourth-stage 
larvae), Cooperia oncophora (adults), Cooperia pectinata (adults), 
Cooperia punctata (adults and fourth-stage larvae), Cooperia spatulata 
(adults), Cooperia surnabada (adults

[[Page 27700]]

and fourth-stage larvae), Nematodirus helvetianus (adults), 
Oesophagostomum radiatum (adults and fourth-stage larvae), Trichuris 
spp. (adults); Lungworms: Dictyocaulus viviparus (adults and fourth-
stage larvae); Cattle grubs: Hypoderma bovis and Hypoderma lineatum; 
Mites: Psoroptes ovis (Psoroptes communis var. bovis); Lice: 
Linognathus vituli and Solenopotes capillatus. For protection from 
reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum 
for 42 days after treatment, with Haemonchus placei for 35 days after 
treatment, and with Ostertagia ostertagi and Trichostrongylus axei for 
14 days after treatment.
    (3) Limitations. Cattle must not be slaughtered for human 
consumption within 21 days of treatment. This drug product is not 
approved for use in female dairy cattle 20 months of age or older, 
including dry dairy cows. Use in these cattle may cause drug residues 
in milk and/or in calves born to these cows. A withdrawal period has 
not been established for preruminating calves. Do not use in calves to 
be processed for veal.


Sec.  522.1696b  [Amended]

0
37. In Sec.  522.1696b, amend paragraph (d)(2)(iii)(C), by removing 
``For Nos. 054771 and 055529:''.


Sec.  522.1885  [Removed]

0
38. Remove Sec.  522.1885.

0
39. Amend Sec.  522.2120 by adding a sentence at the end of paragraph 
(d)(1)(ii) to read follows:


Sec.  522.2120  Spectinomycin hydrochloride.

* * * * *
    (d) * * *
    (1) * * *
    (ii) * * * Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.
* * * * *


Sec.  522.2200  [Removed]

0
40. Remove Sec.  522.2200.

0
41. In 522.2630, revise paragraph (b)(2) to read as follows:


Sec.  522.2630  Tulathromycin.

* * * * *
    (b) * * *
    (2) Nos. 013744, 051311, 054771, 058198, and 068504 for use of 
product described in paragraph (a)(2) as in paragraphs (d)(1)(i), 
(d)(1)(ii)(B), (d)(1)(iii)(B), and (d)(2) of this section.
* * * * *

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

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

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


0
43. In Sec.  524.770, revise paragraph (b) to read as follows:


Sec.  524.770  Doramectin.

* * * * *
    (b) Sponsors. See Nos. 051072 and 054771 in Sec.  510.600(c) of 
this chapter.
* * * * *

0
44. In Sec.  524.814, revise paragraphs (b) and (e)(1) to read as 
follows:


Sec.  524.814  Eprinomectin.

* * * * *
    (b) Sponsors. See Nos. 000010, 051072, and 055529 in Sec.  
510.600(c) of this chapter.
* * * * *
    (e) * * *
    (1) Amount. Apply 5 mg (1 mL) per 10 kilograms (kg) of body weight 
(500 micrograms/kg) topically along backbone from withers to tailhead.
* * * * *


Sec.  524.1044e  [Amended]

0
45. Amend Sec.  524.1044e by adding a sentence at the end of paragraph 
(d)(3) to read as follows:


Sec.  524.1044e  Gentamicin spray.

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


Sec.  524.1146  [Amended]

0
46. In Sec.  524.1146, in paragraph (b)(3), remove ``Nos. 051072 and 
058198'' and in its place add ``Nos. 051072, 055529, 058198, and 
061651''.


Sec.  524.1484j  [Removed]

0
47. Remove Sec.  524.1484j.


Sec.  524.2101  [Amended]

0
48. In Sec.  524.2101, in paragraph (b), remove ``000010, 000061,'' and 
in its place add ``000061''.


Sec.  524.2483  [Amended]

0
49. In Sec.  524.2483, in paragraph (b), remove ``Nos. 000010 and 
054925'' and in its place add ``No. 054925''.

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

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

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


0
51. Amend Sec.  526.1696 by adding a sentence at the end of paragraph 
(d)(3) and paragraph (e)(3) to read as follows:


Sec.  526.1696  Penicillin G procaine.

* * * * *
    (d) * * *
    (3) * * * For No. 042791: Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.
    (e)
    (3) * * * For No. 042791: 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
52. The authority citation for part 529 continues to read as follows:

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


Sec.  529.40  [Removed]

0
53. Remove Sec.  529.40.

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

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

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


Sec.  556.620  [Removed]

0
55. Remove Sec.  556.620.

0
56. Revise Sec.  556.730 to read as follows:


Sec.  556.730  Thiabendazole.

    (a) [Reserved]
    (b) Tolerances. The tolerances for thiabendazole are:
    (1) Cattle--(i) Edible tissues (excluding milk): 0.1 ppm.
    (ii) Milk: 0.05 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.600.

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

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

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


0
58. In Sec.  558.311, revise paragraph (e)(3)(iii) to read as follows:


Sec.  558.311  Lasalocid.

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

[[Page 27701]]



----------------------------------------------------------------------------------------------------------------
             Lasalocid amount                  Indications for use              Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(iii) Not less than 60 mg or more than     Pasture cattle (slaughter,   Feed continuously at a rate       054771
 300 mg of lasalocid per head per day.      stocker, feeder cattle,      of not less than 60 mg or
                                            and beef replacement         more than 300 mg of
                                            heifers): For increased      lasalocid per head per day
                                            rate of weight gain.         when on pasture. The drug
                                                                         must be contained in at
                                                                         least 1 pound of feed.
                                                                         Daily intakes of lasalocid
                                                                         in excess of 200 mg/head/
                                                                         day have not been shown to
                                                                         be more effective than 200
                                                                         mg/head/day.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
50. In Sec.  558.455, revise paragraph (e)(5) to read as follows:


Sec.  558.455  Oxytetracycline and neomycin.

* * * * *
    (e) * * *
    (5) Sheep. It is used in feed as follows:

----------------------------------------------------------------------------------------------------------------
   Oxytetracycline and neomycin sulfate
                  amount                       Indications for use              Limitations            Sponsors
----------------------------------------------------------------------------------------------------------------
(i) To provide 10 mg/lb of body weight     Sheep: For treatment of      Feed continuously for 7 to        066104
 daily.                                     bacterial enteritis caused   14 days. Treatment should        069254
                                            by Escherichia coli and      continue 24 to 48 hours
                                            bacterial pneumonia caused   beyond remission of
                                            by Pasteurella multocida     clinical signs of disease.
                                            susceptible to               Withdraw 5 days before
                                            oxytetracycline; treatment   slaughter.
                                            and control of
                                            colibacillosis (bacterial
                                            enteritis) caused by E.
                                            coli susceptible to
                                            neomycin.
----------------------------------------------------------------------------------------------------------------

    (ii) [Reserved]

0
59. Revise Sec.  558.600 to read as follows:


Sec.  558.600  Thiabendazole.

    (a) Specifications. Mineral protein block containing 3.3 percent 
thiabendazole.
    (b) Sponsor. See No. 012286 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.730 of this chapter.
    (d) Special considerations. See Sec.  500.25 of this chapter.
    (e) Conditions of use in cattle--(1) Amount. Provide free-choice to 
cattle on pasture or range accustomed to mineral protein block feeding 
for 3 days. Cattle should consume at a recommended level of 0.11 pound 
per 100 pounds of body weight per day. Animals maintained under 
conditions of constant worm exposure may require re-treatment within 2 
to 3 weeks.
    (2) Indications for use. For control of infections of 
gastrointestinal roundworms (Trichostrongylus, Haemonchus, Ostertagia, 
and Cooperia).
    (3) Limitations. Milk taken from animals during treatment and 
within 96 hours (8 milkings) after the latest treatment must not be 
used for food. Do not treat cattle within 3 days of slaughter.

    Dated: April 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09212 Filed 5-2-23; 8:45 am]
BILLING CODE 4164-01-P