Document ID: FDA-2023-N-0002-0031
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: 2023-12-06T05:00Z

[Federal Register Volume 88, Number 233 (Wednesday, December 6, 2023)]
[Rules and Regulations]
[Pages 84696-84704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26545]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 516, 520, 522, 524, 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 July, August, and September 2023. The 
animal drug regulations are also being amended to improve their 
accuracy and readability.

DATES: This rule is effective December 6, 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 July, August, and 
September 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 (FOIA Summaries) under the 
Freedom of Information Act (FOIA). These documents, along with 
marketing exclusivity and patent information, may be obtained at 
AnimalDrugs@FDA: https://animaldrugsatfda.fda.gov/adafda/views/#/search.

  Table 1--Original and Supplemental NADAs, ANADAs, and CNADAs Approved During July, August, and September 2023
                                Requiring Evidence of Safety and/or Effectiveness
----------------------------------------------------------------------------------------------------------------
                                                                                  Effect of the
        Approval date             File No.         Sponsor        Product name        action      21 CFR section
----------------------------------------------------------------------------------------------------------------
July 6, 2023.................         200-752  Cronus Pharma    DEXMEDVET        Original                522.558
                                                Specialties      (dexmedetomidi   approval as a
                                                India Private    ne               sedative,
                                                Ltd., Sy No-99/  hydrochloride)   analgesic, and
                                                1, M/s GMR       Injectable       preanesthetic
                                                Hyderabad        Solution.        in dogs and
                                                Aviation SEZ                      cats as a
                                                Ltd.,                             generic copy
                                                Mamidipalli                       of NADA 141-
                                                Village,                          267.
                                                Shamshabad
                                                Mandal, Ranga
                                                Reddy,
                                                Hyderabad,
                                                Telangana,
                                                501218, India.
July 11, 2023................         200-753  Do.............  CROPAMEZOLE      Original                522.147
                                                                 (atipamezole     approval for
                                                                 hydrochloride)   reversal of
                                                                 Injectable       sedation and
                                                                 Solution.        analgesia in
                                                                                  dogs as a
                                                                                  generic copy
                                                                                  of NADA 141-
                                                                                  033.
July 19, 2023................         141-554  Boehringer       NEXGARD PLUS     Original                 520.35
                                                Ingelheim        (afoxolaner,     approval for
                                                Animal Health    moxidectin,      the
                                                USA, Inc.,       and pyrantel     prevention,
                                                3239 Satellite   chewable         treatment, and
                                                Blvd., Duluth,   tablets).        control of
                                                GA30096.                          internal and
                                                                                  external
                                                                                  parasites in
                                                                                  dogs.
August 3, 2023...............         200-755  Felix            Firocoxib        Original                520.928
                                                Pharmaceutical   Chewable         approval for
                                                s Pvt. Ltd.,     Tablets.         the control of
                                                25-28 North                       pain and
                                                Wall Quay,                        inflammation
                                                Dublin 1,                         associated
                                                Ireland.                          with
                                                                                  osteoarthritis
                                                                                  and for the
                                                                                  control of
                                                                                  postoperative
                                                                                  pain and
                                                                                  inflammation
                                                                                  associated
                                                                                  with soft-
                                                                                  tissue and
                                                                                  orthopedic
                                                                                  surgery as a
                                                                                  generic copy
                                                                                  of NADA 141-
                                                                                  230.

[[Page 84697]]

 
August 3, 2023...............         200-756  Ceva Sante       FIRODYL          Original                520.928
                                                Animale, 10      (firocoxib)      approval for
                                                Avenue de la     Chewable         the control of
                                                Ballasti[egrav   Tablets.         pain and
                                                e]re, 33500                       inflammation
                                                Libourne,                         associated
                                                France.                           with
                                                                                  osteoarthritis
                                                                                  and for the
                                                                                  control of
                                                                                  postoperative
                                                                                  pain and
                                                                                  inflammation
                                                                                  associated
                                                                                  with soft-
                                                                                  tissue and
                                                                                  orthopedic
                                                                                  surgery as a
                                                                                  generic copy
                                                                                  of NADA 141-
                                                                                  230.
August 10, 2023..............         141-568  Boehringer       SENVELGO         Original               520.2654
                                                Ingelheim        (velagliflozin   approval to
                                                Animal Health    oral solution).  improve
                                                USA, Inc.,                        glycemic
                                                3239 Satellite                    control in
                                                Blvd., Duluth,                    otherwise
                                                GA30096.                          healthy cats
                                                                                  with diabetes
                                                                                  mellitus not
                                                                                  previously
                                                                                  treated with
                                                                                  insulin.
August 31, 2023..............         200-757  ZyVet Animal     Acepromazine     Original                 520.23
                                                Health, Inc.,    Maleate          approval as an
                                                73 Route 31N,    Tablets          aid in
                                                Pennington, NJ   (acepromazine    tranquilizatio
                                                08534.           maleate          n and as a
                                                                 tablets).        preanesthetic
                                                                                  agent in dogs
                                                                                  as a generic
                                                                                  copy of NADA
                                                                                  117-532.
September 6, 2023............         141-578  Genus            FIDOQUEL-CA1     Conditional            516.1760
                                                Lifesciences     (phenobarbital   approval for
                                                Inc., 700 N      tablets).        the control of
                                                Fenwick St.,                      seizures
                                                Allentown, PA                     associated
                                                18109.                            with
                                                                                  idiopathic
                                                                                  epilepsy in
                                                                                  dogs.
September 20, 2023...........         200-310  Parnell          ESTROPLAN        Supplemental            522.460
                                                Technologies     (cloprostenol    approval for
                                                Pty. Ltd.,       injection)       use with
                                                Unit 4, 476      Injectable       gonadorelin to
                                                Gardeners Rd.,   Solution.        synchronize
                                                Alexandria,                       estrous cycles
                                                New South                         to allow for
                                                Wales 2015,                       fixed time
                                                Australia.                        artificial
                                                                                  insemination
                                                                                  (FTAI) in
                                                                                  lactating
                                                                                  dairy cows as
                                                                                  a generic copy
                                                                                  of NADA 113-
                                                                                  645.
----------------------------------------------------------------------------------------------------------------

II. Withdrawals of Approval

    Oasmia Pharmaceutical AB, Vallongatan 1, Uppsala, 75228 Sweden 
requested that FDA withdraw conditional approval of CNADA 141-422 for 
PACCAL VET-CA1 (paclitaxel for injection) because the product is no 
longer manufactured or marketed. Also, Med-Pharmex, Inc., 2727 Thompson 
Creek Rd., Pomona, CA 91767-1861 requested that FDA withdraw approval 
of the eight abbreviated applications listed in table 2 because the 
products are no longer manufactured or marketed. As provided in the 
regulatory text of this document, the animal drug regulations are 
amended to reflect these actions.

   Table 2--Applications for Which Approval Was Voluntarily Withdrawn During July, August, and September 2023
----------------------------------------------------------------------------------------------------------------
                   File No.                                    New animal drug                   21 CFR section
----------------------------------------------------------------------------------------------------------------
200-190......................................  GENTORAL (gentamicin sulfate) Concentrate               520.1044a
                                                Solution.
200-241......................................  LINCOSOL (lincomycin hydrochloride) Soluble             520.1263b
                                                Powder.
200-245......................................  DERMA-VET (neomycin sulfate, nystatin,                  524.1600a
                                                thiostrepton, triamcinolone acetonide) Cream.
200-275......................................  MEDALONE (triamcinolone acetonide) Cream......           524.2483
200-289......................................  NEOSOL-ORAL (neomycin sulfate) Concentrate               520.1484
                                                Solution.
200-292......................................  IVERSOL (ivermectin) Liquid for Horses........           520.1195
200-299......................................  IVER-ON (ivermectin) Topical Solution.........           524.1193
200-456......................................  Dexamethasone Solution........................            522.540
----------------------------------------------------------------------------------------------------------------

III. Change of Sponsor

    The sponsors of the approved applications listed in table 3 have 
informed FDA that they have transferred ownership of, and all rights 
and interest in, these applications to another sponsor. As provided in 
the regulatory text of this document, the animal drug regulations are 
amended to reflect these actions.

 Table 3--Applications for Which Ownership Was Transferred to Another Sponsor During July, August, and September
                                                      2023
----------------------------------------------------------------------------------------------------------------
        File No.              Product name        Transferring sponsor       New sponsor         21 CFR section
----------------------------------------------------------------------------------------------------------------
141-342................  ALFAXAN Multidose       Jurox Pty. Ltd., 85    Zoetis Inc., 333                  522.52
                          (alfaxalone)            Gardiner St.,          Portage St.,
                          injectable solution.    Rutherford, NSW        Kalamazoo, MI 49007.
                                                  2320, Australia.

[[Page 84698]]

 
200-699................  Dexmedetomidine         Akorn Operating Co.    Parnell Technologies             522.558
                          hydrochloride           LLC, 5605              Pty. Ltd., Unit 4,
                          injection.              Centerpoint Ct.,       476 Gardeners Rd.,
                                                  Suite A, Gurnee, IL    Alexandria, New
                                                  60031.                 South Wales 2015,
                                                                         Australia.
200-614................  Pentobarbital sodium    Do...................  Noble Pharma, LLC,              522.1700
                          and phenytoin sodium                           4602 Domain Dr.,
                          injectable solution.                           Menomonie, WI 54751.
141-559................  Pentosan polysulfate    Anzac Animal Health,   Dechra, Ltd.,                   522.1704
                          sodium injectable       LLC, 218 Millwell      Snaygill Industrial
                          solution.               Dr., Suite B,          Estate, Keighley
                                                  Maryland Heights, MO   Rd., Skipton, North
                                                  63043.                 Yorkshire, BD23 2RW,
                                                                         United Kingdom.
200-553................  Bacitracin, neomycin,   Akorn Operating Co.    Domes Pharma S.A.,               524.154
                          polymyxin B             LLC, 5605              ZAC de Champ Lamet,
                          ophthalmic ointment.    Centerpoint Ct.,       3 rue Andre Citroen,
                                                  Suite A, Gurnee, IL    Pont-du-Chateau,
                                                  60031.                 Auvergne-Rh[ocirc]ne-
                                                                         Alpes, 63430, FRANCE.
----------------------------------------------------------------------------------------------------------------

    As provided in the regulatory text of this document, the animal 
drug regulations cited in table 3 are amended to reflect these actions.

IV. Change of Sponsor Address

    Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525 has 
informed FDA that it has changed its address to 3760 Rocky Mountain 
Ave., Loveland, CO 80538-7084. The entries in Sec.  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 510.600 is amended to reflect sponsors of approved 
applications by adding entries for Domes Pharma S.A., Genus 
Lifesciences, Inc., and Noble Pharma, LLC, by revising the entry for 
Heska Corp., and by removing the entries for Jurox Pty. Ltd. and Oasmia 
Pharmaceutical AB.
     21 CFR 520.23 is amended to reflect approved strengths of 
acepromazine maleate tablets for dogs and cats.
     21 CFR 522.460 is amended to reflect current labeling for 
cloprostenol injectable solution for use in cattle.
     21 CFR 522.2640 is amended to reflect the approved 
strengths of generic tylosin injectable solutions.
     21 CFR 558.330 is amended to reflect the sponsors of drugs 
approved for use in combination medicated feeds containing lubebegron 
and monensin.
     21 CFR 558.355 is amended to reflect the classes of 
pasture cattle approved for use of a monensin free-choice block.
     21 CFR 558.625 is amended to reflect the sponsors of drugs 
approved for use in combination medicated feeds containing lubebegron, 
monensin, and tylosin.

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)). Although deemed 
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'' and 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.

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, and 524

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
510, 516, 520, 522, 524, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

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

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

0
2. In Sec.  510.600, in the table in paragraph (c)(1), add entries for 
``Domes Pharma S.A.'', ``Genus Lifesciences, Inc.'', and ``Noble 
Pharma, LLC''; revise the entry for ``Heska Corp.''; and remove the 
entries for ``Jurox Pty. Ltd.'' and ``Oasmia Pharmaceutical AB''.

0
3. In the table in paragraph (c)(2), remove the entries for ``049480'' 
and ``052818'', revise the entry for ``063604'', and add entries for 
``064950'', ``086119'', and ``086189''.
    The revisions read as follows:

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

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

------------------------------------------------------------------------
                Firm name and address                  Drug labeler code
------------------------------------------------------------------------
 
                              * * * * * * *
Domes Pharma S.A., ZAC de Champ Lamet, 3 rue Andre                086189
 Citroen, Pont-du-Chateau, Auvergne-Rh[ocirc]ne-
 Alpes, 63430, FRANCE................................
 

[[Page 84699]]

 
                              * * * * * * *
Genus Lifesciences Inc., 700 N Fenwick St.,                       064950
 Allentown, PA 18109.................................
 
                              * * * * * * *
Heska Corp., 3760 Rocky Mountain Ave., Loveland, CO               063604
 80538-7084..........................................
 
                              * * * * * * *
Noble Pharma, LLC, 4602 Domain Dr., Menomonie, WI                 086119
 54751...............................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
       Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
063604........................  Heska Corp., 3760 Rocky Mountain Ave.,
                                 Loveland, CO 80538-7084.
 
                              * * * * * * *
064950........................  Genus Lifesciences Inc., 700 N Fenwick
                                 St., Allentown, PA 18109.
 
                              * * * * * * *
086119........................  Noble Pharma, LLC, 4602 Domain Dr.,
                                 Menomonie, WI 54751.
 
                              * * * * * * *
086189........................  Domes Pharma S.A., ZAC de Champ Lamet, 3
                                 rue Andre Citroen, Pont-du-Chateau,
                                 Auvergne-Rh[ocirc]ne-Alpes, 63430,
                                 FRANCE.
 
                              * * * * * * *
------------------------------------------------------------------------

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.  516.1684   [Removed]

0
4. Remove Sec.  516.1684.

0
5. Add Sec.  516.1760 to subchapter E to read as follows:

Sec.  516.1760   Phenobarbital.

    (a) Specifications. Each tablet contains 16.2, 32.4, 64.8, or 97.2 
milligrams (mg) phenobarbital.
    (b) Sponsor. See No. 064950 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer phenobarbital as 
tablets given orally twice a day at the minimum dosage of 2.5 mg per 
kilogram of body weight (mg/kg) and may be titrated to effect to a 
maximum dosage of 5 mg/kg. The dosage of phenobarbital tablets should 
be adjusted based on monitoring the clinical response of the individual 
patient.
    (2) Indications for use. For the control of seizures associated 
with idiopathic epilepsy in dogs.
    (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
6. The authority citation for part 520 continues to read as follows:

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

0
7. In Sec.  520.23, revise paragraphs (a) and (b) to read as follows:

Sec.  520.23   Acepromazine.

    (a) Specifications. Each tablet contains 10 or 25 milligrams (mg) 
acepromazine maleate.
    (b) Sponsors. See Nos. 000010 and 086117 in Sec.  510.600(c) of 
this chapter.
* * * * *

0
8. Add Sec.  520.35 to read as follows:

Sec.  520.35   Afoxolaner, moxidectin, and pyrantel.

    (a) Specifications. Each chewable tablet contains 9.375 milligrams 
(mg) afoxolaner, 45 micrograms (mcg) moxidectin, and 18.75 mg pyrantel; 
18.75 mg afoxolaner, 90 mcg moxidectin, and 37.5 mg pyrantel; 37.5 mg 
afoxolaner, 180 mcg moxidectin, and 75 mg pyrantel; 75 mg afoxolaner, 
360 mcg moxidectin, and 150 mg pyrantel; or 150 mg afoxolaner, 720 mcg 
moxidectin, and 300 mg pyrantel.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer orally once a month 
at the minimum dose of 1.14 mg/lb (2.5 mg/kg) afoxolaner, 5.45 mcg/lb 
(12 mcg/kg) moxidectin, and 2.27 mg/lb (5.0 mg/kg) pyrantel. For 
heartworm disease prevention, give once monthly for at least 6 months 
after last exposure to mosquitoes.
    (2) Indications for use in dogs. For the prevention of heartworm 
disease caused by Dirofilaria immitis and for the treatment and control 
of adult hookworm (Ancylostoma caninum, Ancylostoma braziliense, and 
Uncinaria stenocephala) and roundworm (Toxocara canis and Toxascaris 
leonina) infections. Kills adult fleas and is indicated for the 
treatment and prevention of flea infestations (Ctenocephalides felis) 
and the treatment and control of Ixodes scapularis (black-legged tick), 
Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis 
(American dog tick), and Amblyomma americanum (lone star tick) 
infestations for 1 month in dogs and puppies 8 weeks of age and older, 
weighing 4 pounds of body weight or greater.

[[Page 84700]]

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

Sec.  520.928   [Amended]

0
9. In Sec.  520.928, in paragraph (b)(1), remove ``Nos. 000010, 055246, 
and 055529'' and in its place add ``Nos. 000010, 013744, 055246, 
055529, and 086101''.

Sec.  520.1044a   [Amended]

0
10. In Sec.  520.1044a, in paragraph (b), remove ``Nos. 000061 and 
054925'' and in its place add ``No. 000061''.

0
11. In Sec.  520.1195, revise paragraph (b)(1) to read as follows:

Sec.  520.1195   Ivermectin liquid.

* * * * *
    (b) * * *
    (1) Nos. 058005 and 058198 for use of product described in 
paragraph (a)(1) of this section as in paragraphs (e)(1)(i), 
(e)(1)(ii)(A), and (e)(1)(iii) of this section.
* * * * *

0
12. In Sec.  520.1263b, revise paragraphs (b)(2) and (d)(1)(iii) to 
read as follows:

Sec.  520.1263b   Lincomycin powder.

* * * * *
    (b) * * *
    (2) Nos. 016592 and 076475 for use as in paragraphs (d)(1) and (2) 
of this section.
* * * * *
    (d) * * *
    (1) * * *
    (iii) Limitations. Discard medicated drinking water if not used 
within 2 days. Prepare fresh stock solution daily. Do not use for more 
than 10 days. If clinical signs of disease have not improved within 6 
days, discontinue treatment and reevaluate diagnosis. The safety of 
lincomycin has not been demonstrated in pregnant swine or swine 
intended for breeding. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
* * * * *

Sec.  520.1484   [Amended]

0
13. In Sec.  520.1484, in paragraph (b)(1), remove ``Nos. 054771 and 
054925'' and in its place add ``No. 054771''; and remove paragraph 
(b)(4).

0
14. Add Sec.  520.2654 to read as follows:

Sec.  520.2654   Velagliflozin.

    (a) Specifications. Each milliliter of solution contains 15 
milligrams (mg) velagliflozin.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer orally 0.45 mg per 
pound of body weight (1 mg per kilogram) velagliflozin once daily.
    (2) Indications for use. To improve glycemic control in otherwise 
healthy cats with diabetes mellitus not previously treated with 
insulin.
    (3) Limitations. 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
15. The authority citation for part 522 continues to read as follows:

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

Sec.  522.52   [Amended]

0
16. In Sec.  522.52, in paragraph (b), remove ``049480'' and in its 
place add ``054771''.

0
17. In Sec.  522.147, revise paragraphs (b), (c)(1), and (2) to read as 
follows:

Sec.  522.147   Atipamezole.

* * * * *
    (b) Sponsors. See Nos. 015914, 052483, and 069043 in Sec.  
510.600(c) of this chapter.
    (c) * * *
    (1) Amount. Administer 3,750 mcg/m\2\ intramuscularly for the 
reversal of intravenous dexmedetomidine hydrochloride or medetomidine 
hydrochloride and 5,000 mcg/m\2\ intramuscularly for the reversal of 
intramuscular dexmedetomidine hydrochloride or medetomidine 
hydrochloride.
    (2) Indications for use. For the reversal of the sedative and 
analgesic effects of dexmedetomidine hydrochloride and medetomidine 
hydrochloride.
* * * * *

0
18. In Sec.  522.460, revise paragraphs (b) and (c) to read as follows:

Sec.  522.460   Cloprostenol.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter.
    (1) No. 000061 for use of product described in paragraph (a)(1) of 
this section as in paragraphs (c)(1)(i) and (c)(2) of this section.
    (2) No. 000061 for use of product described in paragraph (a)(2) as 
in paragraphs (c)(1)(ii) through (viii) and (c)(2) of this section.
    (3) No. 068504 for use of product described in paragraph (a)(2) as 
in paragraphs (c)(1)(ii) through (vii), (c)(1)(ix), and (c)(2) of this 
section.
    (c) Conditions of use in cattle--(1) Amount and indications for 
use.
    (i) Administer 375 [micro]g by intramuscular injection to induce 
abortion in pregnant feedlot heifers from 1 week after mating until 
4\1/2\ months of gestation.
    (ii) Administer 500 [micro]g by intramuscular injection for 
unobserved or non-detected estrus in beef cows, lactating dairy cows, 
and replacement beef and dairy heifers.
    (iii) Administer 500 [micro]g by intramuscular injection for 
treatment of pyometra or chronic endometritis in beef cows, lactating 
dairy cows, and replacement beef and dairy heifers.
    (iv) Administer 500 [micro]g by intramuscular injection for 
treatment of mummified fetus in beef cows, lactating dairy cows, and 
replacement beef and dairy heifers.
    (v) Administer 500 [micro]g by intramuscular injection for 
treatment of luteal cysts in beef cows, lactating dairy cows, and 
replacement beef and dairy heifers.
    (vi) Administer 500 [micro]g by intramuscular injection for 
abortion of beef cows, lactating dairy cows, and replacement beef and 
dairy heifers from 1 week after mating until 5 months of gestation. Not 
for use in heifers placed in feedlots.
    (vii) Administer 500 [micro]g by intramuscular injection as a 
single injection regimen or double injection regimen with a second 
injection 11 days after the first injection, for estrus synchronization 
in beef cows, lactating dairy cows, and replacement beef and dairy 
heifers.
    (viii) For use with gonadorelin acetate to synchronize estrous 
cycles to allow for fixed time artificial insemination (FTAI) in 
lactating dairy cows: administer to each cow 86 [micro]g gonadorelin by 
intramuscular injection, followed 6 to 8 days later by 500 [micro]g 
cloprostenol by intramuscular injection, followed 30 to 72 hours later 
by 86 [micro]g gonadorelin by intramuscular injection. Gonadorelin 
acetate as provided in Sec.  522.1077(a)(1) of this chapter.
    (ix) For use with gonadorelin to synchronize estrous cycles to 
allow for FTAI in lactating dairy cows: administer to each cow by 
intramuscular injection, followed 6 to 8 days later by 500 [micro]g 
cloprostenol by intramuscular injection, followed 30 to 72 hours later 
by gonadorelin by intramuscular injection. Gonadorelin as provided in 
Sec.  522.1077(a)(1) through (3) of this chapter.
    (2) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

Sec.  522.540   [Amended]

0
19. In Sec.  522.540, in paragraph (a)(2)(ii), remove ``Sponsors. See 
Nos.

[[Page 84701]]

054925 and 058005'' and in its place add ``No. 058005''.

Sec.  522.558   [Amended]

0
20. In Sec.  522.558, in paragraph (b)(1), remove ``Nos. 017033, 
059399, and 086117'' and in its place add ``Nos. 017033, 068504, 
069043, and 086117''.

Sec.  522.1700   [Amended]

0
21. In Sec.  522.1700, in paragraph (b), remove ``059399'' and in its 
place add ``086119''.

Sec.  522.1704   [Amended]

0
22. In Sec.  522.1704, in paragraph (b), remove ``086073'' and in its 
place add ``043264''.

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

Sec.  522.2640   Tylosin.

* * * * *
    (b) * * *
    (1) Nos. 016592 and 058198 for use of 50- or 200-mg/mL solutions as 
in paragraph (e) of this section.
    (2) No. 061133 for use of a 200-mg/mL solution as in paragraphs 
(e)(1) and (2) of this section.
* * * * *

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

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

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

Sec.  524.154   [Amended]

0
25. In Sec.  524.154, in paragraph (b)(2), remove ``059399'' and in its 
place add ``086189''.

Sec.  524.1193   [Amended]

0
26. In Sec.  524.1193, in paragraph (b)(2), remove ``Nos. 016592 and 
054925'' and in its place add ``No. 016592''.

0
27. In Sec.  524.1600a, revise paragraph (b) to read as follows:

Sec.  524.1600a  Nystatin, neomycin, thiostrepton, and triamcinolone 
ointment.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter:
    (1) For petrolatum base ointments: Nos. 025463 and 054771; or
    (2) For vanishing cream base ointments: Nos. 025463 and 054771.
* * * * *

Sec.  524.2483  [Removed]

0
28. Remove Sec.  524.2483.

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

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

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

0
30. In Sec.  558.330, revise paragraphs (d)(1)(ii) and (iii) and 
(d)(2)(i) and (ii) to read as follows:

Sec.  558.330  Lubabegron.

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

--------------------------------------------------------------------------------------------------------------------------------------------------------
   Lubabegron fumarate in grams/ton      Combination in grams/ton     Indications for use                   Limitations                     Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
(ii) 1.25 to 4.54.....................  Monensin, 5 to 40........  Beef steers and heifers    Feed continuously as the sole ration to     016592, 058198
                                                                    fed in confinement for     provide 13 to 90 mg lubabegron/head/
                                                                    slaughter: for reduction   day and 50 to 480 mg monensin/head/day
                                                                    of ammonia gas emissions   during the last 14 to 91 days on feed.
                                                                    per pound of live weight   No additional improvement in feed
                                                                    and hot carcass weight     efficiency has been shown from feeding
                                                                    and for improved feed      monensin at levels greater than 30 g/
                                                                    efficiency during the      ton (360 mg monensin/head/day). A
                                                                    last 14 to 91 days on      decrease in dry matter intake may be
                                                                    feed.                      noticed in some animals receiving
                                                                                               lubabegron. Lubabegron has not been
                                                                                               approved for use in breeding animals
                                                                                               because safety and effectiveness have
                                                                                               not been evaluated in these animals.
                                                                                               Do not allow horses or other equines
                                                                                               access to feed containing lubabegron
                                                                                               and monensin. Ingestion of monensin by
                                                                                               horses has been fatal. Monensin
                                                                                               medicated cattle and goat feeds are
                                                                                               safe for use in cattle and goats only.
                                                                                               Consumption by unapproved species may
                                                                                               result in toxic reactions. Feeding
                                                                                               undiluted or mixing errors resulting
                                                                                               in high concentrations of monensin has
                                                                                               been fatal to cattle and could be
                                                                                               fatal to goats. Must be thoroughly
                                                                                               mixed in feeds before use. Do not
                                                                                               exceed the levels of monensin
                                                                                               recommended in the feeding directions,
                                                                                               as reduced average daily gains may
                                                                                               result. If feed refusals containing
                                                                                               monensin are fed to other groups of
                                                                                               cattle, the concentration of monensin
                                                                                               in the refusals and amount of refusals
                                                                                               fed should be taken into consideration
                                                                                               to prevent monensin overdosing. A
                                                                                               withdrawal period has not been
                                                                                               established for this product for
                                                                                               preruminating calves. Do not use in
                                                                                               calves to be processed for veal. See
                                                                                               special labeling considerations in
                                                                                               Sec.   558.355(d) of this chapter.
                                                                                               Lubabegron fumarate as provided by No.
                                                                                               058198, monensin as provided by No.
                                                                                               016592 or 058198 in Sec.   510.600(c)
                                                                                               of this chapter.

[[Page 84702]]

 
(iii) 1.25 to 4.54....................  Monensin, 10 to 40.......  Beef steers and heifers    Feed continuously as the sole ration to     016592, 058198
                                                                    fed in confinement for     provide 13 to 90 mg lubabegron/head/
                                                                    slaughter: for reduction   day and 0.14 to 0.42 mg monensin/lb
                                                                    of ammonia gas emissions   body weight per day, depending upon
                                                                    per pound of live weight   severity of coccidiosis challenge,
                                                                    and hot carcass weight;    during the last 14 to 91 days on feed.
                                                                    and for prevention and     A decrease in dry matter intake may be
                                                                    control of coccidiosis     noticed in some animals receiving
                                                                    due to Eimeria bovis and   lubabegron. Lubabegron has not been
                                                                    E. zuernii during the      approved for use in breeding animals
                                                                    last 14 to 91 days on      because safety and effectiveness have
                                                                    feed.                      not been evaluated in these animals.
                                                                                               Do not allow horses or other equines
                                                                                               access to feed containing lubabegron
                                                                                               and monensin. Ingestion of monensin by
                                                                                               horses has been fatal. Monensin
                                                                                               medicated cattle and goat feeds are
                                                                                               safe for use in cattle and goats only.
                                                                                               Consumption by unapproved species may
                                                                                               result in toxic reactions. Feeding
                                                                                               undiluted or mixing errors resulting
                                                                                               in high concentrations of monensin has
                                                                                               been fatal to cattle and could be
                                                                                               fatal to goats. Must be thoroughly
                                                                                               mixed in feeds before use. Do not
                                                                                               exceed the levels of monensin
                                                                                               recommended in the feeding directions,
                                                                                               as reduced average daily gains may
                                                                                               result. If feed refusals containing
                                                                                               monensin are fed to other groups of
                                                                                               cattle, the concentration of monensin
                                                                                               in the refusals and amount of refusals
                                                                                               fed should be taken into consideration
                                                                                               to prevent monensin overdosing. A
                                                                                               withdrawal period has not been
                                                                                               established for this product for
                                                                                               preruminating calves. Do not use in
                                                                                               calves to be processed for veal. See
                                                                                               special labeling considerations in
                                                                                               Sec.   558.355(d) of this chapter.
                                                                                               Lubabegron fumarate as provided by No.
                                                                                               058198, monensin as provided by No.
                                                                                               016592 or 058198 in Sec.   510.600(c)
                                                                                               of this chapter.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (2) * * *
    (i) Monensin as in Sec.  558.355.
    (ii) Tylosin in Sec.  558.625.

0
31. In Sec.  558.355, revise paragraph (f)(4)(iv) to read as follows:

Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
            Monensin amount                Indications for use              Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(iv) 400 mg per pound of block........  Growing beef steers and    Provide 50 to 200 mg of                086113
                                         heifers on pasture         monensin (2 to 8 ounces of
                                         (stocker, feeder, and      block) per head per day, in
                                         slaughter) and beef        at least one block per five
                                         replacement heifers):      head of cattle. Feed blocks
                                         for increased rate of      continuously. Do not feed
                                         weight gain.               salt of mineral supplements
                                                                    in addition to this block.
                                                                    Discontinue feeding if block
                                                                    consumption falls below 2
                                                                    ounces or rises above 8
                                                                    ounces daily. See paragraph
                                                                    (d)(10)(i) of this section..
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

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

Sec.  558.625   Tylosin.

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

[[Page 84703]]

--------------------------------------------------------------------------------------------------------------------------------------------------------
           Tylosin grams/ton             Combination in grams/ton     Indications for use                   Limitations                     Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
(vii) 8 to 10.........................  Monensin, 5 to 40 plus     Beef steers and heifers    Feed continuously as sole ration to         016592, 058198
                                         lubabegron fumarate,       fed in confinement for     provide 13 to 90 mg lubabegron/head/
                                         1.25 to 4.54.              slaughter: for reduction   day, 50 to 480 mg monensin/head/day,
                                                                    of ammonia gas emissions   and 60 to 90 mg tylosin/head/day
                                                                    per pound of live weight   during the last 14 to 91 days on feed.
                                                                    and hot carcass weight;    No additional improvement in feed
                                                                    for reduction of           efficiency has been shown from feeding
                                                                    incidence of liver         monensin at levels greater than 30 g/
                                                                    abscesses associated       ton (360 mg monensin/head/day). A
                                                                    with Fusobacterium         decrease in dry matter intake may be
                                                                    necrophorum and            noticed in some animals receiving
                                                                    Arcanobacterium pyogenes   lubabegron. Lubabegron has not been
                                                                    and for improved feed      approved for use in breeding animals
                                                                    efficiency during the      because safety and effectiveness have
                                                                    last 14 to 91 days on      not been evaluated in these animals.
                                                                    feed.                      Do not allow horses or other equines
                                                                                               access to feed containing lubabegron
                                                                                               and monensin. Ingestion of monensin by
                                                                                               horses has been fatal. Monensin
                                                                                               medicated cattle and goat feeds are
                                                                                               safe for use in cattle and goats only.
                                                                                               Consumption by unapproved species may
                                                                                               result in toxic reactions. Feeding
                                                                                               undiluted or mixing errors resulting
                                                                                               in high concentrations of monensin has
                                                                                               been fatal to cattle and could be
                                                                                               fatal to goats. Must be thoroughly
                                                                                               mixed in feeds before use. Do not
                                                                                               exceed the levels of monensin
                                                                                               recommended in the feeding directions,
                                                                                               as reduced average daily gains may
                                                                                               result. If feed refusals containing
                                                                                               monensin are fed to other groups of
                                                                                               cattle, the concentration of monensin
                                                                                               in the refusals and amount of refusals
                                                                                               fed should be taken into consideration
                                                                                               to prevent monensin overdosing. A
                                                                                               withdrawal period has not been
                                                                                               established for this product for
                                                                                               preruminating calves. Do not use in
                                                                                               calves to be processed for veal. See
                                                                                               special labeling considerations in
                                                                                               Sec.   558.355(d) of this chapter.
                                                                                               Tylosin as provided by No. 016592 or
                                                                                               058198, monensin as provided by No.
                                                                                               016592 or 058198, lubabegron fumarate
                                                                                               as provided by No. 058198 in Sec.
                                                                                               510.600(c) of this chapter.
(viii) 8 to 10........................  Monensin, 10 to 40 plus    Beef steers and heifers    Feed continuously as sole ration to         016592, 058198
                                         lubabegron fumarate,       fed in confinement for     provide 13 to 90 mg lubabegron/head/
                                         1.25 to 4.54.              slaughter: for reduction   day, 0.14 to 0.42 mg monensin/lb body
                                                                    of ammonia gas emissions   weight per day, depending upon
                                                                    per pound of live weight   severity of coccidiosis challenge, up
                                                                    and hot carcass weight,    to 480 mg/head/day, and 60 to 90 mg
                                                                    for reduction of           tylosin/head/day during the last 14 to
                                                                    incidence of liver         91 days on feed. A decrease in dry
                                                                    abscesses associated       matter intake may be noticed in some
                                                                    with Fusobacterium         animals receiving lubabegron.
                                                                    necrophorum and            Lubabegron has not been approved for
                                                                    Arcanobacterium pyogenes   use in breeding animals because safety
                                                                    and for prevention and     and effectiveness have not been
                                                                    control of coccidiosis     evaluated in these animals. Do not
                                                                    due to Eimeria bovis and   allow horses or other equines access
                                                                    E. zuernii during the      to feed containing lubabegron and
                                                                    last 14 to 91 days on      monensin. Ingestion of monensin by
                                                                    feed.                      horses has been fatal. Monensin
                                                                                               medicated cattle and goat feeds are
                                                                                               safe for use in cattle and goats only.
                                                                                               Consumption by unapproved species may
                                                                                               result in toxic reactions. Feeding
                                                                                               undiluted or mixing errors resulting
                                                                                               in high concentrations of monensin has
                                                                                               been fatal to cattle and could be
                                                                                               fatal to goats. Must be thoroughly
                                                                                               mixed in feeds before use. Do not
                                                                                               exceed the levels of monensin
                                                                                               recommended in the feeding directions,
                                                                                               as reduced average daily gains may
                                                                                               result. If feed refusals containing
                                                                                               monensin are fed to other groups of
                                                                                               cattle, the concentration of monensin
                                                                                               in the refusals and amount of refusals
                                                                                               fed should be taken into consideration
                                                                                               to prevent monensin overdosing. A
                                                                                               withdrawal period has not been
                                                                                               established for this product for
                                                                                               preruminating calves. Do not use in
                                                                                               calves to be processed for veal. See
                                                                                               special labeling considerations in
                                                                                               Sec.   558.355(d) of this chapter.
                                                                                               Tylosin as provided by No. 016592 or
                                                                                               058198, monensin as provided by No.
                                                                                               016592 or 058198, lubabegron fumarate
                                                                                               as provided by No. 058198 in Sec.
                                                                                               510.600(c) of this chapter.
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 84704]]

* * * * *

    Dated: November 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26545 Filed 12-5-23; 8:45 am]
BILLING CODE 4164-01-P