[Federal Register Volume 89, Number 95 (Wednesday, May 15, 2024)]
[Rules and Regulations]
[Pages 42354-42361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10586]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 529, and 558

[Docket No. FDA-2024-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) and abbreviated new animal drug 
applications (ANADAs) during January, February, and March 2024. The 
animal drug regulations are also being amended to improve their 
accuracy and readability.

DATES: This rule is effective May 15, 2024.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-5689, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Approvals

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during January, February, and March 2024, 
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 Animal Drugs 
@FDA: https://animaldrugsatfda.fda.gov/adafda/views/#/search.

 Table 1--Original and Supplemental NADAs and ANADAs Approved During January, February, and March 2024 Requiring
                                     Evidence of Safety and/or Effectiveness
----------------------------------------------------------------------------------------------------------------
                                             Sponsor (drug                           Effect of the      21 CFR
      Date of approval         File No.      labeler code)       Product name           action          section
----------------------------------------------------------------------------------------------------------------
January 11, 2024............     200-766  Aurora              EQUICOXIB           Original approval      520.929
                                           Pharmaceutical,     (firocoxib) Oral    as a generic copy
                                           Inc., 1196          Solution.           of NADA 141-253.
                                           Highway 3 South,
                                           Northfield, MN
                                           55057-3009
                                           (051072).

[[Page 42355]]

 
January 12, 2024............     200-768  Huvepharma EOOD,    RAVANTAGE 9 and     Original approval      558.500
                                           5th Floor, 3A       RAVANTAGE 45        as a generic copy
                                           Nikolay Haytov      (ractopamine        of NADA 140-863.
                                           Str., 1113 Sofia,   hydrochloride)
                                           Bulgaria (016592).  Type A Medicated
                                                               Articles.
January 12, 2024............     200-767  Felix               Carprofen Tablets.  Original approval      520.304
                                           Pharmaceuticals                         as a generic copy
                                           Pvt. Ltd., 25-28                        of NADA 141-053.
                                           North Wall Quay,
                                           Dublin 1, Ireland
                                           (086101).
January 30, 2024............     200-769  ZyVet Animal        SELAMECTIN Topical  Original approval     524.2098
                                           Health, Inc., 73    Solution.           as a generic copy
                                           Route 31N,                              of NADA 141-152.
                                           Pennington, NJ
                                           08534 (086117).
February 13, 2024...........     141-575  Boehringer          VETMEDIN            Original approval     520.1782
                                           Ingelheim Animal    (pimobendan oral    for management of
                                           Health USA, Inc.,   solution)           the signs of
                                           3239 Satellite      Solution.           mild, moderate,
                                           Blvd., Duluth, GA                       or severe
                                           30096 (000010).                         congestive heart
                                                                                   failure in dogs.
February 22, 2024...........     200-749  Ceva Sante          KESIUM              Original approval      520.88g
                                           Animale, 10         (amoxicillin and    as a generic copy
                                           Avenue de la        clavulanate         of NADA 055-099.
                                           Ballasti[egrave]r   potassium
                                           e, 33500            tablets) Chewable
                                           Libourne, France    Tablets.
                                           (013744).
March 1, 2024...............     200-772  Parnell             CONTRASED           Original approval      522.147
                                           Technologies Pty.   (atipamezole        as a generic copy
                                           Ltd., unit 4, 476   hydrochloride)      of NADA 141-033.
                                           Gardeners Rd.,      Injectable
                                           Alexandria, New     Solution.
                                           South Wales 2015,
                                           Australia
                                           (068504).
March 15, 2024..............     141-579  Dechra Ltd.         DUOTIC              Original approval     524.2338
                                           Snaygill            (terbinafine and    for treatment of
                                           Industrial          betamethasone       otitis externa in
                                           Estate, Keighley    acetate otic gel)   dogs, associated
                                           Road, Skipton,      Otic Gel.           with susceptible
                                           North Yorkshire,                        strains of yeast
                                           BD23 2RW, United                        (Malassezia
                                           Kingdom (043264).                       pachydermatis).
----------------------------------------------------------------------------------------------------------------

II. Withdrawals of Approval

    Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., 
Duluth, GA 30096 (drug labeler code 000010) requested that FDA withdraw 
approval of the five NADAs 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 January, February, and March 2024
------------------------------------------------------------------------
    Date of withdrawal of                                       21 CFR
          approval             File No.      Product name       section
------------------------------------------------------------------------
March 4, 2024...............     141-015  ENACARD (enalapril     520.804
                                           maleate) Tablets.
Do..........................     141-096  DICURAL                520.645
                                           (difloxacin
                                           hydrochloride)
                                           Tablets.
Do..........................     141-108  ETOGESIC               520.870
                                           (etodolac)
                                           Tablets.
Do..........................     141-274  ETOGESIC               522.870
                                           (etodolac)
                                           Injectable
                                           Solution.
Do..........................     141-421  DUOCARE               520.1198
                                           (ivermectin and
                                           praziquantel)
                                           Paste.
------------------------------------------------------------------------

III. Changes 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. The regulations 
cited in table 3 are amended to reflect these actions.

Table 3--Applications for Which Ownership Was Transferred to Another Sponsor During January, February, and March
                                                      2024
----------------------------------------------------------------------------------------------------------------
                                                         Transferring sponsor    New sponsor (drug      21 CFR
            File No.                  Product name       (drug labeler code)       labeler code)        section
----------------------------------------------------------------------------------------------------------------
200-141........................  ATTANE (isoflurane)..  Piramal Critical       Piramal Pharma Ltd.,     529.1186
                                                         Care, Inc., 3850       Ground floor,
                                                         Schelden Circle,       Piramal Ananta,
                                                         Bethlehem, PA 18017    Agastya Corporate
                                                         (066794).              Park, Mumbai,
                                                                                Maharashtra--400070,
                                                                                India (065085).
200-237........................  Isoflurane, USP......  Do...................  Do...................         Do.
200-338........................  TRI-HEART (ivermectin  Heska Corp., 3760      Diamond Animal            510.600
                                  and pyrantel           Rocky Mountain Ave.,   Health, Inc., 2538      520.1196
                                  pamoate) Tablets.      Loveland, CO 80538-    SE 43rd St., Des
                                                         7084 (063604).         Moines, IA 50327
                                                                                (053701).
200-438........................  PETREM (sevoflurane).  Piramal Critical       Piramal Pharma Ltd.,     529.2110
                                                         Care, Inc., 3850       Ground floor,
                                                         Schelden Circle,       Piramal Ananta,
                                                         Bethlehem, PA 18017    Agastya Corporate
                                                         (066794).              Park, Mumbai,
                                                                                Maharashtra--400070,
                                                                                India (065085).
----------------------------------------------------------------------------------------------------------------


[[Page 42356]]

IV. Change of Sponsor Address

    ECO LLC, 344 Nassau St., Princeton, NJ 08540 (drug labeler code 
066916 in 21 CFR 510.600(c)) has informed FDA that it has changed its 
address to 11224 Aurora Ave., Urbandale, IA 50322. 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 and 
readability of the animal drug regulations.
     21 CFR 510.600 is amended to remove entries for Heska 
Corp. and Piramal Critical Care, Inc. from the lists of sponsors of 
approved applications, to revise the entries for Cronus Pharma 
Specialities India Private Ltd. and ECO LLC; and to add entries for 
Diamond Animal Health, Inc.
     21 CFR 522.840 is amended to reflect revisions to approved 
labeling for cattle implants containing estradiol.
     21 CFR 522.1940 is amended to reflect the current format 
for regulations and revisions to approved labeling for cattle implants 
containing progesterone and estradiol benzoate.
     21 CFR 522.2343 is amended to reflect revisions to 
approved labeling for cattle implants containing testosterone 
propionate and estradiol benzoate.
     21 CFR 522.2477 is amended to reflect revisions to 
approved labeling for cattle implants containing trenbolone acetate and 
estradiol.
     21 CFR 524.1193 is amended to reflect periods of 
persistent activity for an approved generic ivermectin topical solution 
used in cattle.
     21 CFR 558.485 is amended to reflect an inclusion rate for 
pyrantel tartrate in medicated horse feeds.

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 Parts 520, 522, 524, and 529

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
510, 520, 522, 524, 529, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

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

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


0
2. In Sec.  510.600:
0
a. In the table in paragraph (c)(1):
0
i. Add in alphabetical order an entry for ``Diamond Animal Health, 
Inc.'';
0
ii. Revise the entries for ``Cronus Pharma Specialities India Private 
Ltd.''; and ``ECO LLC''; and
0
iii. Remove the entries for ``Heska Corp.'' and ``Piramal Critical 
Care, Inc.'';
0
b. In the table in paragraph (c)(2), add an entry for ``053701''; 
remove the entries for ``063604'' and ``066794''; and revise the 
entries for ``066916'' and ``069043''.
    The revisions and additions 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
------------------------------------------------------------------------
 
                              * * * * * * *
Cronus Pharma Specialities India Private Ltd.,                    069043
 Plot No.9(B), Survey No. 99/1, GMR Hyderabad
 Aviation SEZ Ltd., Mamidipalle Village, Balapur
 Mandal, Shamshabad, Rangareddy, Hyderabad,
 Telangana, 500108, India.........................
 
                              * * * * * * *
Diamond Animal Health, Inc., 2538 SE 43rd St., Des                053701
 Moines, IA 50327.................................
 
                              * * * * * * *
ECO LLC, 11224 Aurora Ave., Urbandale, IA 50322...                066916
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
053701......................  Diamond Animal Health, Inc., 2538 SE 43rd
                               St., Des Moines, IA 50327.
 
                              * * * * * * *
066916......................  ECO LLC, 11224 Aurora Ave., Urbandale, IA
                               50322.
 
                              * * * * * * *
069043......................  Cronus Pharma Specialities India Private
                               Ltd., Plot No.9(B), Survey No. 99/1, GMR
                               Hyderabad Aviation SEZ Ltd., Mamidipalle
                               Village, Balapur Mandal, Shamshabad,
                               Rangareddy, Hyderabad, Telangana, 500108,
                               India.
 
                              * * * * * * *
------------------------------------------------------------------------


[[Page 42357]]

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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


0
4. In Sec.  520.88g, revise the section heading and paragraph (a), and 
add paragraph (b)(3) to read as follows:


Sec.  520.88g  Amoxicillin and clavulanate potassium tablets.

    (a) Specifications. Each tablet or chewable tablet contains 
amoxicillin and clavulanate potassium equivalent to 50 milligrams (mg) 
amoxicillin and 12.5 mg clavulanic acid, 100 mg amoxicillin and 25 mg 
clavulanic acid, 200 mg amoxicillin and 50 mg clavulanic acid, or 300 
mg amoxicillin and 75 mg clavulanic acid.
    (b) * * *
    (3) No. 013744 for use of chewable tablets as in paragraph (c) of 
this section.
* * * * *

0
5. In Sec.  520.304:
0
i. Add paragraph (a)(4);
0
ii. Revise paragraph (b)(1); and
0
iii. Add paragraph (b)(4).
    The additions and revision read as follows:


Sec.  520.304  Carprofen.

    (a) * * *
    (4) Each flavored tablet contains 25, 75, or 100 mg carprofen.
    (b) * * *
    (1) Nos. 017033, 054771, 055529, and 062250 for use of products 
described in paragraphs (a)(1) and (a)(2) of this section as in 
paragraph (c) of this section.
* * * * *
    (4) No. 086101 for use of product described in paragraphs (a)(1), 
(a)(2), and (a)(4) of this section as in paragraph (c) of this section.
* * * * *


Sec.  520.645  [Removed]

0
6. Remove Sec.  520.645.


Sec.  520.804  [Removed]

0
7. Remove Sec.  520.804.


Sec.  520.870  [Removed]

0
8. Remove Sec.  520.870.

0
9. Amend Sec.  520.928 by revising the section heading to read as 
follows:


Sec.  520.928  Firocoxib tablets.

0
10. Add Sec.  520.929 to read as follows:


Sec.  520.929  Firocoxib solution.

    (a) Specifications. Each milliliter of solution contains 9 
milligram (mg) firocoxib.
    (b) Sponsors. See No. 051072 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 0.1 mg per 
kilogram (0.045 mg per pound) of body weight once daily for up to 14 
days.
    (2) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

0
11. In Sec.  520.1196, revise paragraph (b) to read as follows:


Sec.  520.1196  Ivermectin and pyrantel tablets.

* * * * *
    (b) Sponsors. See Nos. 000010, 051311, and 053701 in Sec.  
510.600(c) of this chapter.
* * * * *


Sec.  520.1198  [Amended]

0
12. In Sec.  520.1198, remove paragraphs (a)(3) and (b)(3).

0
13. Amend Sec.  520.1780 by revising the section heading to read as 
follows:


Sec.  520.1780  Pimobendan tablets.

0
14. Add Sec.  520.1782 to read as follows:


Sec.  520.1782  Pimobendan solution.

    (a) Specifications. Each milliliter of solution contains 1.5 
milligrams (mg) pimobendan.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally at a 
total daily dose of 0.23 mg/lb (0.5 mg/kg) body weight. The total daily 
dose should be divided into two equal portions administered 
approximately 12 hours apart (i.e., morning and evening).
    (2) Indications for use. For the management of the signs of mild, 
moderate, or severe congestive heart failure in dogs due to clinical 
myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM); 
for use with concurrent therapy for congestive heart failure (e.g., 
furosemide, etc.) as appropriate on a case-by-case basis.
    (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.

0
16. In Sec.  522.147, revise paragraph (b) to read as follows:


Sec.  522.147  Atipamezole.

* * * * *
    (b) Sponsors. See Nos. 015914, 052483, 068504, and 069043 in Sec.  
510.600(c) of this chapter.
* * * * *

0
17. In Sec.  522.840, revise paragraph (d) to read as follows:


Sec.  522.840  Estradiol.

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

[[Page 42358]]

extended-release implant containing 25.7 mg estradiol for increased 
rate of weight gain and improved feed efficiency for up to 200 days.
    (B) An extended-release implant containing 43.9 mg estradiol for 
increased rate of weight gain and improved feed efficiency for up to 
400 days.
    (ii) Limitations. For subcutaneous ear implantation only. Not 
approved for repeated implantation (reimplantation) with this or any 
other cattle ear implant in growing beef steers and heifers fed in 
confinement for slaughter. Safety and effectiveness following 
reimplantation have not been evaluated. Do not use in beef calves less 
than 2 months of age, dairy calves, and veal calves. A withdrawal 
period has not been established for this product in pre-ruminating 
calves. Do not use in dairy cows or in animals intended for subsequent 
breeding. Use in these cattle may cause drug residues in milk and/or in 
calves born to these cows.


Sec.  522.870  [Removed]

0
18. Remove Sec.  522.870.

0
19. Revise Sec.  522.1940 to read as follows:


Sec.  522.1940  Progesterone and estradiol benzoate.

    (a) Specifications--(1) Each implant consists of progesterone and 
estradiol benzoate. (i) 100 mg progesterone and 10 mg estradiol 
benzoate (one implant consisting of four pellets, each containing 25 mg 
progesterone and 2.5 mg estradiol benzoate).
    (ii) 200 mg progesterone and 20 mg estradiol benzoate (one implant 
consisting of eight pellets, each containing 25 mg progesterone and 2.5 
mg estradiol benzoate).
    (2) Each implant consists of progesterone and estradiol benzoate 
and tylosin tartrate. (i) 100 mg progesterone, 10 mg estradiol 
benzoate, and 29 mg tylosin tartrate (one implant consisting of four 
pellets, each containing 25 mg progesterone and 2.5 mg estradiol 
benzoate, and one pellet containing 29 mg tylosin tartrate).
    (ii) 200 mg progesterone, 20 mg estradiol benzoate, and 29 mg 
tylosin tartrate (one implant consisting of eight pellets, each 
containing 25 mg progesterone and 2.5 mg estradiol benzoate, and one 
pellet containing 29 mg tylosin tartrate).
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (c) of this section:
    (1) No. 054771 for use as in paragraphs (e)(1)(i)(A), (e)(1)(ii), 
(e)(2)(i)(A), (B), (C), and (e)(2)(ii) of this section.
    (2) No. 058198 for use as in paragraphs (e)(1)(i)(A), (e)(1)(i)(B), 
(e)(1)(ii), and (e)(3) of this section.
    (c) Related tolerances. See Sec. Sec.  556.240 and 556.540 of this 
chapter.
    (d) Special considerations. Labeling of implants described in 
paragraphs (a)(2)(i) and (a)(2)(ii) for use in paragraphs (e)(1)(i)(B), 
(e)(1)(ii), (e)(3)(i), and (e)(3)(ii) of this section shall bear the 
following: ``Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.''
    (e) Conditions of use--(1) Beef calves 45 days of age and older and 
weighing up to 400 lbs--(i) Amounts and indications for use. (A) An 
implant containing 100 mg progesterone and 10 mg estradiol benzoate as 
described in paragraph (a)(1)(i) of this section for increased rate of 
weight gain.
    (B) An implant containing 100 mg progesterone, 10 mg estradiol 
benzoate, and 29 mg tylosin tartrate as described in paragraph 
(a)(2)(i) of this section for increased rate of weight gain.
    (ii) Limitations. Implant pellets subcutaneously in ear only. Other 
than when used as described in (e)(2)(i)(B) of this section, the 
implant as described in paragraph (a)(1)(i) of this section is not 
approved for repeated implantation (reimplantation). The implant as 
described in paragraph (a)(2)(i) of this section is not approved for 
repeated implantation (reimplantation) with this or any other cattle 
ear implant. Do not use in beef calves less than 45 days of age, dairy 
calves, and veal calves because effectiveness and safety have not been 
evaluated. Do not use in dairy cows or in animals intended for 
subsequent breeding. Use in these cattle may cause drug residues in 
milk and/or calves born to these cows.
    (2) Growing beef steers fed in confinement for slaughter--(i) 
Amounts and indications for use. (A) An implant containing 200 mg 
progesterone and 20 mg estradiol benzoate as described in paragraph 
(a)(1)(ii) of this section for increased rate of weight gain and 
improved feed efficiency.
    (B) An implant containing 200 mg progesterone and 20 mg estradiol 
benzoate as described in paragraph (a)(1)(ii) of this section for 
increased rate of weight gain in a reimplantation program where an 
implant as described in paragraph (a)(1)(i) of this section is the 
first implant and an implant as described in paragraph (a)(1)(ii) of 
this section is administered approximately 70 days later.
    (C) An implant containing 200 mg progesterone and 20 mg estradiol 
benzoate as described in paragraph (a)(1)(ii) of this section for 
increased rate of weight gain in a reimplantation program where an 
implant as described in paragraph (a)(1)(ii) of this section is the 
first implant and an implant as described in paragraph (a)(1)(ii) of 
this section is administered approximately 70 days later.
    (ii) Limitations. Implant pellets subcutaneously in ear only. Other 
than when used as described in paragraphs (e)(2)(i)(B) or (C) of this 
section, the implant described in paragraph (a)(1)(ii) of this section 
is not approved for repeated implantation (reimplantation) with any 
other cattle ear implant in growing beef steers and heifers fed in 
confinement for slaughter as safety and effectiveness have not been 
evaluated. Do not use in beef calves less than 2 months of age, dairy 
calves, and veal calves because effectiveness and safety have not been 
evaluated. Do not use in dairy cows or in animals intended for 
subsequent breeding. Use in these cattle may cause drug residues in 
milk and/or calves born to these cows.
    (3) Growing beef steers weighing 400 lbs or more--(i) Amounts and 
indications for use. An implant containing 200 mg progesterone, 20 mg 
estradiol benzoate, and 29 mg tylosin tartrate as described in 
paragraph (a)(2)(ii) of this section for increased rate of weight gain 
and improved feed efficiency.
    (ii) Limitations. The implant as described in paragraph (a)(2)(ii) 
of this section is not approved for repeated implantation 
(reimplantation) with this or any other cattle ear implant. Do not use 
in beef calves less than 2 months of age, dairy calves, and veal calves 
because effectiveness and safety have not been evaluated. Do not use in 
dairy cows or in animals intended for subsequent breeding. Use in these 
cattle may cause drug residues in milk and/or calves born to these 
cows.

0
20. Revise Sec.  522.2343 to read as follows:


Sec.  522.2343  Testosterone propionate and estradiol benzoate.

    (a) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 054771 for use as in paragraph (d)(1) of this section.
    (2) No. 058198 for use as in paragraph (d)(2) of this section.
    (b) Related tolerances. See Sec. Sec.  556.240 and 556.710 of this 
chapter.
    (c) Special considerations. Labeling of the implants described in 
paragraph (d)(2) of this section shall bear the following: ``Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.''
    (d) Conditions of use--(1) Growing beef heifers fed in confinement 
for

[[Page 42359]]

slaughter--(i) Amounts and indications for use. An implant containing 
200 mg testosterone propionate and 20 mg estradiol benzoate (one 
implant consisting of eight pellets, each containing 25 mg testosterone 
propionate and 2.5 mg estradiol benzoate) for increased rate of weight 
gain and improved feed efficiency.
    (ii) Limitations. Implant pellets subcutaneously in ear only. Not 
approved for repeated implantation (reimplantation) with this or any 
other cattle ear implant. Do not use in beef calves less than 2 months 
of age, dairy calves, and veal calves because safety and effectiveness 
have not been evaluated. Do not use in dairy cows or in animals 
intended for subsequent breeding. Use in these cattle may cause drug 
residues in milk and/or in calves born to these cows.
    (2) Growing beef heifers weighing 400 lbs or more--(i) Amounts and 
indications for use. An implant containing 200 mg testosterone 
propionate, 20 mg estradiol benzoate, and 29 mg tylosin tartrate (one 
implant consisting of eight pellets, each containing 25 mg testosterone 
propionate and 2.5 mg estradiol benzoate, and one pellet containing 29 
mg tylosin tartrate) for increased rate of weight gain and improved 
feed efficiency.
    (ii) Limitations. Implant pellets subcutaneously in ear only. Not 
approved for repeated implantation (reimplantation) with this or any 
other cattle ear implant. Do not use in beef calves less than 2 months 
of age, dairy calves, and veal calves because safety and effectiveness 
have not been evaluated. Do not use in dairy cows or in animals 
intended for subsequent breeding. Use in these cattle may cause drug 
residues in milk and/or in calves born to these cows.

0
21. Revise Sec.  522.2477 to read as follows:


Sec.  522.2477  Trenbolone acetate and estradiol.

    (a) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
uses as in paragraph (d) of this section.
    (1) No. 058198 for use in paragraphs (d)(1)(i)(B), (d)(1)(ii), 
(d)(2)(i)(B), (d)(2)(i)(D), (d)(2)(ii), (d)(3)(i)(B), (d)(3)(i)(D), 
(d)(3)(ii), (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) of this section.
    (2) No. 000061 for use in paragraphs (d)(1)(i)(A), (d)(1)(i)(C), 
(d)(1)(ii), (d)(2)(i)(A), (d)(2)(i)(C), (d)(2)(i)(E), (d)(2)(ii), 
(d)(3)(i)(A), (d)(3)(i)(C), (d)(3)(i)(E), (d)(3)(ii), (d)(4)(i)(A), and 
(d)(4)(ii) of this section.
    (3) No. 054771 for use in paragraphs (d)(2)(i)(A), (C), (d)(2)(ii), 
(d)(4)(i)(A), and (d)(4)(ii) of this section.
    (b) Related tolerances. See Sec. Sec.  556.240 and 556.739 of this 
chapter.
    (c) Special considerations. Labeling of implants described in 
paragraphs (d)(1)(i)(B), (d)(2)(i)(B), (d)(2)(i)(D), (d)(3)(i)(B), 
(d)(3)(i)(D), and (d)(4)(i)(B) of this section shall bear the 
following: ``Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.''
    (d) Conditions of use--(1) Growing beef steers and heifers fed in 
confinement for slaughter--(i) Amounts and indications. (A) An implant 
containing 200 mg trenbolone acetate and 20 mg estradiol (one implant 
consisting of 10 pellets each containing 20 mg trenbolone acetate and 2 
mg estradiol) for increased rate of weight gain and improved feed 
efficiency.
    (B) An implant containing 200 mg trenbolone acetate, 20 mg 
estradiol, and 29 mg tylosin tartrate (one implant consisting of 10 
pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol, 
and 1 pellet containing 29 mg tylosin tartrate) for increased rate of 
weight gain and improved feed efficiency.
    (C) An extended- and delayed-release implant containing 200 mg 
trenbolone acetate and 20 mg estradiol (1 implant consisting of 10 
coated pellets, each containing 20 mg trenbolone acetate and 2 mg 
estradiol) for increased rate of weight gain and improved feed 
efficiency during 70 to 200 days after implantation.
    (ii) Limitations. Implant pellets subcutaneously in ear only. Not 
approved for repeated implantation (reimplantation) with this or any 
other cattle ear implant in growing beef steers and heifers fed in 
confinement for slaughter. Do not use in beef calves less than 2 months 
of age, dairy calves, and veal calves because safety and effectiveness 
have not been evaluated. Do not use in dairy cows or in animals 
intended for subsequent breeding. Use in these cattle may cause drug 
residues in milk and/or calves born to these cows.
    (2) Growing beef steers fed in confinement for slaughter--(i) 
Amounts and indications. (A) An implant containing 80 mg trenbolone 
acetate and 16 mg estradiol (one implant consisting of four pellets, 
each containing 20 mg trenbolone acetate and 4 mg estradiol) for 
increased rate of weight gain and improved feed efficiency.
    (B) An implant containing 80 mg trenbolone acetate, 16 mg 
estradiol, and 29 mg tylosin tartrate (one implant consisting of four 
pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol, 
and one pellet containing 29 mg tylosin tartrate) for increased rate of 
weight gain and improved feed efficiency.
    (C) An implant containing 120 mg trenbolone acetate and 24 mg 
estradiol (one implant consisting of six pellets, each containing 20 mg 
trenbolone acetate and 4 mg estradiol) for increased rate of weight 
gain and improved feed efficiency.
    (D) An implant containing 120 mg trenbolone acetate, 24 mg 
estradiol, and 29 mg tylosin tartrate (one implant consisting of six 
pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol, 
and one pellet containing 29 mg tylosin tartrate) for increased rate of 
weight gain and improved feed efficiency.
    (E) An extended-release implant containing 200 mg trenbolone 
acetate and 40 mg estradiol (one implant consisting of six coated 
pellets and four uncoated pellets, each containing 20 mg trenbolone 
acetate and 4 mg estradiol) for increased rate of weight gain and 
improved feed efficiency for up to 200 days after implantation.
    (ii) Limitations. Implant pellets subcutaneously in ear only. Not 
approved for repeated implantation (reimplantation) with this or any 
other cattle ear implant in growing beef steers fed in confinement for 
slaughter. Do not use in beef calves less than 2 months of age, dairy 
calves, and veal calves because safety and effectiveness have not been 
evaluated. Do not use in dairy cows or in animals intended for 
subsequent breeding. Use in these cattle may cause drug residues in 
milk and/or calves born to these cows.
    (3) Growing beef heifers fed in confinement for slaughter--(i) 
Amounts and indications. (A) An implant containing 80 mg trenbolone 
acetate and 8 mg estradiol (one implant consisting of four pellets, 
each containing 20 mg trenbolone acetate and 2 mg estradiol) for 
increased rate of weight gain.
    (B) An implant containing 80 mg trenbolone acetate, 8 mg estradiol, 
and 29 mg tylosin tartrate (one implant consisting of four pellets, 
each containing 20 mg trenbolone acetate and 2 mg estradiol, and one 
pellet containing 29 mg tylosin tartrate) for increased rate of weight 
gain and improved feed efficiency.
    (C) An implant containing 140 mg trenbolone acetate and 14 mg 
estradiol (one implant consisting of seven pellets, each containing 20 
mg trenbolone acetate and 2 mg estradiol) for increased rate of weight 
gain and improved feed efficiency.

[[Page 42360]]

    (D) An implant containing 140 mg trenbolone acetate, 14 mg 
estradiol, and 29 mg tylosin tartrate (one implant consisting of seven 
pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol, 
and one pellet containing 29 mg tylosin tartrate) for increased rate of 
weight gain and improved feed efficiency.
    (E) An extended-release implant containing 200 mg trenbolone 
acetate and 20 mg estradiol (one implant consisting of six coated 
pellets and four uncoated pellets, each containing 20 mg trenbolone 
acetate and 2 mg estradiol) for increased rate of weight gain and 
improved feed efficiency for up to 200 days after implantation.
    (ii) Limitations. Implant pellets subcutaneously in ear only. Not 
approved for repeated implantation (reimplantation) with this or any 
other cattle ear implant in growing beef heifers fed in confinement for 
slaughter. Do not use in beef calves less than 2 months of age, dairy 
calves, and veal calves because safety and effectiveness have not been 
evaluated. Do not use in dairy cows or in animals intended for 
subsequent breeding. Use in these cattle may cause drug residues in 
milk and/or calves born to these cows.
    (4) Growing beef steers and heifers on pasture (stocker, feeder, 
and slaughter)--(i) Amounts and indications for use. (A) An implant 
containing 40 mg trenbolone acetate and 8 mg estradiol (one implant 
consisting of two pellets, each containing 20 mg trenbolone acetate and 
4 mg estradiol) for increased rate of weight gain.
    (B) An implant containing 40 mg trenbolone acetate, 8 mg estradiol, 
and 29 mg tylosin tartrate (one implant consisting of two pellets, each 
containing 20 mg trenbolone acetate and 4 mg estradiol, and one pellet 
containing 29 mg tylosin tartrate) for increased rate of weight gain.
    (ii) Limitations. Implant pellets subcutaneously in ear only. Not 
approved for repeated implantation (reimplantation) with this or any 
other cattle ear implant in growing beef steers and heifers on pasture 
(stocker, feeder, and slaughter). Do not use in beef calves less than 2 
months of age, dairy calves, and veal calves because safety and 
effectiveness have not been evaluated. Do not use in dairy cows or in 
animals intended for subsequent breeding. Use in these cattle may cause 
drug residues in milk and/or calves born to these cows.

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

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

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


0
23. In Sec.  524.1193:
0
a. Revise paragraph (b);
0
b. Remove paragraph (d);
0
c. Redesignate paragraph (e) as paragraph (d) and revise newly 
redesignated paragraphs (d)(2) and (d)(3).
    The revisions read as follows:


Sec.  524.1193  Ivermectin topical solution.

* * * * *
    (b) Sponsors. See Nos. 000010, 016592, 055529, 058829, and 061133 
in Sec.  510.600(c) of this chapter for use as in paragraph (d) of this 
section.
* * * * *
    (d) * * *
    (2) Indications for use. It is used for the treatment and control 
of: Gastrointestinal roundworms (adults and fourth-stage larvae) 
Ostertagia ostertagi (including inhibited stage), Haemonchus placei, 
Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. 
punctata, C. surnabada, Oesophagostomum radiatum (adults); 
Strongyloides papillosus, Trichuris spp.; lungworms (adults and fourth-
stage larvae) Dictyocaulus viviparus; cattle grubs (parasitic stages) 
Hypoderma bovis, H. lineatum; mites Sarcoptes scabiei var. bovis; lice 
Linognathus vituli, Haematopinus eurysternus, Damalinia bovis, 
Solenoptes capillatus; and horn flies Haematobia irritans. It controls 
infections and prevents reinfection with O. radiatum and D. viviparus 
for 28 days after treatment, C. punctata and T. axei for 21 days after 
treatment, O. ostertagi, H. placei, C. oncophora, and C. surnabada for 
14 days after treatment, and D. bovis for 56 days after treatment.
    (3) Limitations. Do not treat cattle within 48 days of slaughter. 
Do not use on female dairy cattle of breeding age or on calves to be 
processed for veal. Consult your veterinarian for assistance in the 
diagnosis, treatment, and control of parasitism.

0
24. In Sec.  524.2098, revise paragraph (b) to read as follows:


Sec.  524.2098  Selamectin.

* * * * *
    (b) Sponsors. See Nos. 051072, 051311, 054771, 055529, 061133, and 
086117 of this chapter.
* * * * *

0
25. Add Sec.  524.2338 to read as follows:


Sec.  524.2338  Terbinafine and betamethasone acetate.

    (a) Specifications. Each milliliter of gel contains 10 milligrams 
(mg) terbinafine and 1 mg betamethasone acetate.
    (b) Sponsor. See No. 043264 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer one dose (1 
tube) per affected ear(s) and repeat administration in 7 days.
    (2) Indications for use. For the treatment of otitis externa in 
dogs, associated with susceptible strains of yeast (Malassezia 
pachydermatis).
    (3) Limitations. 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
26. The authority citation for part 529 continues to read as follows:

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


0
27. In Sec.  529.1186, revise paragraph (b) to read as follows:


Sec.  529.1186  Isoflurane.

* * * * *
    (b) Sponsors. See Nos. 017033, 054771, and 065085 in Sec.  
510.600(c) of this chapter.
* * * * *

0
28. In Sec.  529.2110, revise paragraph (b) to read as follows:


Sec.  529.2110  Sevoflurane.

* * * * *
    (b) Sponsors. See Nos. 017033, 054771, and 065085 in Sec.  
510.600(c) of this chapter.
* * * * *

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.  558.485, revise (e)(2) to read as follows:


Sec.  558.485  Pyrantel.

* * * * *
    (e) * * *
    (2) Horses--

[[Page 42361]]



------------------------------------------------------------------------
                             Indications for
  Pyrantel tartrate g/ton          use           Limitation     Sponsor
------------------------------------------------------------------------
(i) 120 to 1,200 to provide  For prevention   Feed                017135
 1.2 mg/lb body weight.       of Strongylus    continuously       054771
                              vulgaris         as the horse's
                              larval           daily grain
                              infections;      ration during
                              control of       the time that
                              adult large      the animal is
                              strongyles (S.   at risk of
                              vulgaris, and    exposure to
                              S. edentatus),   internal
                              adult and 4th    parasites. Do
                              stage larvae     not use in
                              small            horses
                              strongyles       intended for
                              (Cyathostomum    human
                              spp.,            consumption.
                              Cylicocyclus     Consult your
                              spp.,            veterinarian
                              Cylicostephanu   before using
                              s spp.,          in severely
                              Cylicodontopho   debilitated
                              rus spp.,        animals and
                              Poteriostomum    for assistance
                              spp., and        in the
                              Triodontophoru   diagnosis,
                              s spp.), adult   treatment, and
                              and 4th stage    control of
                              larvae           parasitism.
                              pinworms
                              (Oxyuris
                              equi), and
                              adult and 4th
                              stage larvae
                              ascarids
                              (Parascaris
                              equorum).
------------------------------------------------------------------------

    (ii) Top dress medicated feed--(A) Proprietary Formulas. The 
following feed can be manufactured only per an approved proprietary 
formula and specifications:

------------------------------------------------------------------------
                             Indications for
  Pyrantel tartrate amount         use          Limitations     Sponsor
------------------------------------------------------------------------
(1) 9.6 g/lb to provide 1.2  Prevention of    Feed                017135
 mg/lb body weight.           Strongylus       continuously       054771
                              vulgaris         as a top dress
                              larval           during the
                              infections;      time that the
                              control of       animal is at
                              adult large      risk of
                              strongyles (S.   exposure to
                              vulgaris, and    internal
                              S. edentatus),   parasites. Do
                              adult and 4th    not use in
                              stage larvae     horses
                              small            intended for
                              strongyles       human
                              (Cyathostomum    consumption.
                              spp.,            Consult your
                              Cylicocyclus     veterinarian
                              spp.,            before using
                              Cylicostephanu   in severely
                              s spp.,          debilitated
                              Cylicodontopho   animals and
                              rus spp.,        for assistance
                              Poteriostomum    in the
                              spp., and        diagnosis,
                              Triodontophoru   treatment, and
                              s spp.), adult   control of
                              and 4th stage    parasitism.
                              larvae
                              pinworms
                              (Oxyuris
                              equi), and
                              adult and 4th
                              stage larvae
                              ascarids
                              (Parascaris
                              equorum).
(2) [Reserved].              ...............  ...............  .........
------------------------------------------------------------------------

    (B) [Reserved]
* * * * *

0
31. In Sec.  558.500, revise (b)(1), (b)(2), and (e)(1)(i) to read as 
follows:


Sec.  558.500  Ractopamine.

* * * * *
    (b) * * *
    (1) Nos. 016592 and 058198: Type A medicated articles containing 9 
or 45.4 grams per pound (g/lb) ractopamine hydrochloride.
    (2) Nos. 051311 and 054771: Type A medicated articles containing 
45.4 g/lb ractopamine hydrochloride.
* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                                      Combination in
     Ractopamine in grams/ton           grams/ton          Indications for use        Limitations       Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 4.5 to 9.0...................  ...................  For increased rate of     Feed continuously       016592
                                                         weight gain, improved     as sole ration.        054771
                                                         feed efficiency, and                             058198
                                                         increased carcass
                                                         leanness in finishing
                                                         swine, weighing not
                                                         less than 150 lb, fed a
                                                         complete ration
                                                         containing at least 16%
                                                         crude protein for the
                                                         last 45 to 90 lb of
                                                         gain prior to slaughter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: May 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-10586 Filed 5-14-24; 8:45 am]
BILLING CODE 4164-01-P