`[Federal Register Volume 90, Number 12 (Tuesday, January 21, 2025)]
[Rules and Regulations]
[Pages 6797-6804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-01226]



[[Page 6797]]

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

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 October, November, and December 2024. The 
animal drug regulations are also being amended to improve their 
accuracy and readability.

DATES: This rule is effective January 21, 2025.

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. Approval of New Animal Drug Applications

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during October, November, and December 
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 October, November, and December 2024 Requiring Evidence of Safety and/or
                                                                      Effectiveness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       Sponsor  (drug labeler                                                                 21 CFR
          Date of approval               File No.            code \1\)                 Product name              Effect of the action         section
--------------------------------------------------------------------------------------------------------------------------------------------------------
October 7, 2024.....................         141-554  Boehringer Ingelheim     NEXGARD PLUS (afoxolaner,     Supplemental approval for            520.35
                                                       Animal Health USA,       moxidectin, and pyrantel      the treatment and control
                                                       Inc. (000010)            chewable tablets).            of Asian longhorned tick
                                                                                                              infestations for 1 month
                                                                                                              in dogs and puppies.
October 7, 2024.....................         141-581  Elanco US Inc. (058198)  CREDELIO QUATTRO (lotilaner,  Original approval for the          520.1287
                                                                                moxidectin, praziquantel,     prevention of heartworm
                                                                                and pyrantel chewable         disease and for the
                                                                                tablets.                      treatment and control of
                                                                                                              roundworm, hookworm, and
                                                                                                              tapeworm infections. Kills
                                                                                                              adult fleas and is
                                                                                                              indicated for the
                                                                                                              treatment and prevention
                                                                                                              of flea infestations and
                                                                                                              the treatment and control
                                                                                                              of tick infestations for 1
                                                                                                              month in dogs and puppies.
October 18, 2024....................         200-748  Huvepharma EOOD          PENNCHLOR (chlortetracycline  Original approval as a              558.128
                                                       (016592)                 Type A medicated article)     generic copy of NADA 141-
                                                                                and MONOVET (monensin) Type   564.
                                                                                A medicated article) to be
                                                                                used in the manufacture of
                                                                                Type B and Type C medicated
                                                                                feeds.
October 23, 2024....................         141-589  Elanco US Inc. (058198)  EXPERIOR (lubabegron Type A   Original approval for               558.330
                                                                                medicated article) and MGA    increased rate of weight
                                                                                (melengestrol acetate Type    gain, improved feed
                                                                                A medicated article) to be    efficiency, suppression of
                                                                                used in the manufacture of    estrus (heat), and for
                                                                                Type C medicated feeds.       reduction of ammonia gas
                                                                                                              emissions per pound of
                                                                                                              live weight and hot
                                                                                                              carcass weight in growing
                                                                                                              beef heifers fed in
                                                                                                              confinement for slaughter
                                                                                                              during the last 14 to 91
                                                                                                              days on feed.
October 25, 2024....................         141-590  Do.                      EXPERIOR (lubabegron Type A   Original approval for               558.330
                                                                                medicated article),           increased rate of weight
                                                                                RUMENSIN (monensin Type A     gain, improved feed
                                                                                medicated article), and MGA   efficiency, suppression of
                                                                                (melengestrol acetate Type    estrus (heat), for
                                                                                A medicated article) to be    reduction of ammonia gas
                                                                                used in the manufacture of    emissions per pound of
                                                                                Type C medicated feeds.       live weight and hot
                                                                                                              carcass weight, and for
                                                                                                              the prevention and control
                                                                                                              of coccidiosis caused by
                                                                                                              Eimeria bovis and Eimeria
                                                                                                              zuernii in growing beef
                                                                                                              heifers fed in confinement
                                                                                                              for slaughter during the
                                                                                                              last 14 to 91 days on feed.

[[Page 6798]]

 
October 25, 2024....................         141-591  Do.                      EXPERIOR (lubabegron Type A   Original approval for               558.625
                                                                                medicated article),           increased rate of weight
                                                                                RUMENSIN (monensin Type A     gain, improved feed
                                                                                medicated article), TYLAN     efficiency, suppression of
                                                                                (tylosin Type A medicated     estrus (heat), for
                                                                                article), and MGA             reduction of ammonia gas
                                                                                (melengestrol acetate Type    emissions per pound of
                                                                                A medicated article) to be    live weight and hot
                                                                                used in the manufacture of    carcass weight, and for
                                                                                Type C medicated feeds.       the prevention and control
                                                                                                              of coccidiosis caused by
                                                                                                              Eimeria bovis and Eimeria
                                                                                                              zuernii and for reduction
                                                                                                              of incidence of liver
                                                                                                              abscesses associated with
                                                                                                              Fusobacterium necrophorum
                                                                                                              and Arcanobacterium
                                                                                                              pyogenes in growing beef
                                                                                                              heifers fed in confinement
                                                                                                              for slaughter during the
                                                                                                              last 14 to 91 days on feed.
November 6, 2024....................         141-521  Zoetis Inc. (054771)     SIMPARICA TRIO (sarolaner,    Supplemental approval for          520.2090
                                                                                moxidectin, and pyrantel      the treatment and control
                                                                                chewable tablets).            of tick infestations with
                                                                                                              Asian longhorned tick for
                                                                                                              1 month in dogs and
                                                                                                              puppies.
November 13, 2024...................         141-502  Do.....................  REVOLUTION PLUS (selamectin   Supplemental approval for          524.2099
                                                                                and sarolaner topical         the prevention of tapeworm
                                                                                solution).                    infections as a direct
                                                                                                              result of killing vector
                                                                                                              fleas on the treated cat
                                                                                                              for 1 month in cats and
                                                                                                              kittens.
November 14, 2024...................         200-803  Phibro Animal Health     PAQFLOR (florfenicol) Type A  Original approval as a              558.261
                                                       Corp. (066104)           Medicated Article to be       generic copy of NADA 141-
                                                                                used in the manufacture of    246.
                                                                                Type C medicated feeds.
November 18, 2024...................         200-793  Parnell Technologies,    PROPOFOLVET MULTIDOSE         Original approval as a             522.2005
                                                       Pty., Ltd. (068504)      (propofol injectable          generic copy of NADA 141-
                                                                                emulsion).                    098.
November 18, 2024...................         200-805  Virbac AH, Inc.          MEL 500 (melengestrol         Original approval as a              558.342
                                                       (051311)                 acetate Type A liquid         generic copy of NADA 039-
                                                                                medicated article) to be      402.
                                                                                used in the manufacture of
                                                                                Type C medicated feeds.
November 20, 2024...................         200-636  Bimeda Animal Health,    DORACIDE (doramectin topical  Original approval as a              524.770
                                                       Ltd. (061133)            solution).                    generic copy of NADA 141-
                                                                                                              095.
November 22, 2024...................         141-452  Zoetis Inc. (054771)     SIMPARICA (sarolaner)         Supplemental approval for          520.2086
                                                                                Chewable Tablet.              the treatment and control
                                                                                                              of tick infestations with
                                                                                                              Asian longhorned tick for
                                                                                                              1 month in dogs and
                                                                                                              puppies.
November 25, 2024...................         141-532  Intervet, Inc. (000061)  BRAVECTO 1-MONTH              Supplemental approval for           520.998
                                                                                (fluralaner) Chewable         the treatment and control
                                                                                Tablet.                       of Asian longhorned tick
                                                                                                              infestations for 1 month
                                                                                                              in dogs and puppies.
December 19, 2024...................         141-043  Zoetis Inc. (054771)     SYNOVEX CHOICE and SYNOVEX    Supplemental approval of           522.2478
                                                                                PRIMER (trenbolone acetate    both products for
                                                                                and estradiol benzoate        increased rate of weight
                                                                                implants) Implants.           gain in growing beef
                                                                                                              steers and heifers on
                                                                                                              pasture (stocker, feeder,
                                                                                                              and slaughter).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ See Sec.   510.600(c) (21 CFR 510.600(c)) for sponsor addresses.

II. Withdrawal of Approval of New Animal Drug Applications

    Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861 
(drug labeler code (054925) requested that FDA withdraw approval of 
NADA 140-810 for DERMA-VET (nystatin, neomycin sulfate, thiostrepton, 
triamcinolone acetonide) Ointment because the product is no longer 
manufactured or marketed. Accordingly, approval of NADA 140-810 was 
withdrawn effective December 23, 2024. The animal drug regulations do 
not require amendment as the sponsor's drug labeler code is not 
codified in 21 CFR 524.1600a.
    Mylan Institutional LLC, a Viatris Company, 3711 Collins Ferry Rd., 
Morgantown, WV 26505 (drug labeler code 063286) requested that FDA 
withdraw approval of ANADA 200-257 for Ketamine HCL (ketamine 
hydrochloride injection, USP) Injectable Solution because the product 
is no longer manufactured or marketed. Accordingly, approval of ANADA 
200-257 was withdrawn effective June 29, 2023. The animal drug 
regulations do not require amendment as the sponsor's drug labeler code 
was removed from 21 CFR 522.1222 in a rule that published August 16, 
2023 (88 FR 55559 at 55564).

III. Changes of Sponsor

    The sponsors of the approved applications listed in table 2 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 2 are amended to reflect these actions.

[[Page 6799]]



                Table 2--Applications for Which Ownership was Transferred to Another Sponsor During October, November, and December 2024
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          Transferring sponsor  (drug     New sponsor  (drug labeler
               File No.                          Product name                    labeler code)                      code)                21 CFR section
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-339...............................  OVUGEL (triptorelin acetate)    United-AH II LLC (051233)       Aurora Pharmaceutical, Inc.             529.2620
                                         Gel.                                                            (051072)
200-233...............................  SUPERIORBUTE (phenylbutazone)   Superior Equine                 Noble Pharma, LLC (086119)             520.1720e
                                         Powder.                         Pharmaceuticals, Inc.
                                                                         (027053)
--------------------------------------------------------------------------------------------------------------------------------------------------------

IV. Change of Sponsor Address

    Pharmacosmos, Inc. (drug labeler code 042552 in Sec.  510.600(c)) 
has informed FDA that it has changed its address to 120 Headquarters 
Plz., Morristown, NJ 07960. 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.
     Sec.  510.600(c) is amended to remove entries for Superior 
Equine Pharmaceuticals, Inc. and United-AH II, LLC from the lists of 
sponsors of approved applications as these firms are no longer sponsors 
of an approved application.
     21 CFR 522.2630(b) is amended to present the sequence of 
drug labeler codes for tulathromycin injectable solutions.

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), revise the entry for 
``Pharmacosmos, Inc.'' and remove the entries for ``Superior Equine 
Pharmaceuticals, Inc.'' and ``United-AH II, LLC''; and
0
b. In the table in paragraph (c)(2):
0
i. Remove the entry for ``027053'';
0
ii. Revise the entry for ``042552''; and
0
iii. Remove the entry for ``051233''.
    The revision reads as follows:


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

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

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                              * * * * * * *
Pharmacosmos, Inc., 120 Headquarters Plz., Morristown,            042552
 NJ 07960...............................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
          Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
042552...............................  Pharmacosmos, Inc., 120
                                        Headquarters Plz., Morristown,
                                        NJ 07960.
 
                              * * * * * * *
------------------------------------------------------------------------

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.  520.35, revise paragraphs (a) and (c)(2) to read as 
follows:


Sec.  520.35  Afoxolaner, moxidectin, and pyrantel.

    (a) Specifications. Each chewable tablet contains:
    (1) 9.375 milligrams (mg) afoxolaner, 45 micrograms (mcg) 
moxidectin, and 18.75 mg pyrantel (as pamoate salt);
    (2) 18.75 mg afoxolaner, 90 mcg moxidectin, and 37.5 mg pyrantel 
(as pamoate salt);

[[Page 6800]]

    (3) 37.5 mg afoxolaner, 180 mcg moxidectin, and 75 mg pyrantel (as 
pamoate salt);
    (4) 75 mg afoxolaner, 360 mcg moxidectin, and 150 mg pyrantel (as 
pamoate salt); or
    (5) 150 mg afoxolaner, 720 mcg moxidectin, and 300 mg pyrantel (as 
pamoate salt).
* * * * *
    (c) * * *
    (2) Indications for use. 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), Amblyomma americanum (lone star tick), and 
Haemaphysalis longicornis (longhorned tick) infestations for 1 month in 
dogs and puppies 8 weeks of age and older, weighing 4 pounds of body 
weight or greater.
* * * * *


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


Sec.  520.998  Fluralaner.

* * * * *
    (c) * * *
    (2) * * *
    (ii) Chewable tablets described in paragraph (a)(2) of this 
section. Kills adult fleas; for the treatment and prevention of flea 
infestations (C. felis), and the treatment and control of tick 
infestations (I. scapularis (black-legged tick), D. variabilis 
(American dog tick), R. sanguineus (brown dog tick), and H. longicornis 
(Asian longhorned tick)) for 1 month in dogs and puppies 8 weeks of age 
and older, and weighing 4.4 lb or greater; and for the treatment and 
control of A. americanum (lone star tick) infestations for 1 month in 
dogs and puppies 6 months of age and older, and weighing 4.4 lb or 
greater.
* * * * *


0
6. Add Sec.  520.1287 to read as follows:


Sec.  520.1287  Lotilaner, moxidectin, praziquantel, and pyrantel.

    (a) Specifications. Each chewable tablet contains:
    (1) 56.25 milligrams (mg) lotilaner, 0.056 mg moxidectin, 14.25 mg 
praziquantel, and 14.25 mg pyrantel (as pamoate salt);
    (2) 112.5 mg lotilaner, 0.113 mg moxidectin, 28.5 mg praziquantel, 
and 28.5 mg pyrantel (as pamoate salt);
    (3) 225 mg lotilaner, 0.225 mg moxidectin, 57 mg praziquantel, and 
57 mg pyrantel (as pamoate salt);
    (4) 450 mg lotilaner, 0.45 mg moxidectin, 114 mg praziquantel, and 
114 mg pyrantel (as pamoate salt); or
    (5) 900 mg lotilaner, 0.9 mg moxidectin, 228 mg praziquantel, and 
228 mg pyrantel (as pamoate salt).
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer orally once a month, 
at the minimum dosage of 9 mg/lb (20 mg/kg) lotilaner, 0.009 mg/lb 
(0.02 mg/kg) moxidectin, 2.28 mg/lb (5 mg/kg) praziquantel, and 2.28 
mg/lb (5 mg/kg) pyrantel (as pamoate salt).
    (2) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis and for the treatment and control of 
roundworm (immature adult and adult Toxocara canis and adult Toxascaris 
leonina), hookworm (adult Uncinaria stenocephala), and tapeworm 
(Dipylidium caninum, Taenia pisiformis and Echinococcus granulosus) 
infections. Kills adult fleas and is indicated for the treatment and 
prevention of flea infestations (Ctenocephalides felis) and the 
treatment and control of tick infestations (Amblyomma americanum (lone 
star tick), Dermacentor variabilis (American dog tick), Ixodes 
scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog 
tick)) for 1 month in dogs and puppies 8 weeks of age and older, and 
weighing 3.3 pounds or greater.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.


Sec.  520.1720e  [Amended]

0
7. In Sec.  520.1720e, in paragraph (b)(1), remove the text ``027053'' 
and in its place add the text ``086119''.


0
8. In Sec.  520.2086, revise paragraphs (c)(1) and (2) to read as 
follows:


Sec.  520.2086  Sarolaner.

* * * * *
    (c) * * *
    (1) Amount. Administer orally once a month at the recommended 
minimum dosage of 0.91 mg/lb (2 mg/kg).
    (2) Indications for use. Kills adult fleas, and is indicated for 
the treatment and prevention of flea infestations (Ctenocephalides 
felis), and the treatment and control of tick infestations (Amblyomma 
americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), 
Dermacentor variabilis (American dog tick), Ixodes scapularis (black-
legged tick), Rhipicephalus sanguineus (brown dog tick), and 
Haemaphysalis longicornis (Asian longhorned tick)) for 1 month in dogs 
6 months of age or older and weighing 2.8 pounds or greater. For the 
prevention of Borrelia burgdorferi infections as a direct result of 
killing Ixodes scapularis vector ticks.
* * * * *


0
9. In Sec.  520.2090, revise paragraph (c)(2) to read as follows:


Sec.  520.2090  Sarolaner, moxidectin, and pyrantel.

* * * * *
    (c) * * *
    (2) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis and for the treatment and control of 
roundworm (immature adult and adult Toxocara canis and adult Toxascaris 
leonina) and hookworm (L4, immature adult, and adult Ancylostoma 
caninum and adult Uncinaria stenocephala) infections. Kills adult fleas 
(Ctenocephalides felis) and is indicated for the treatment and 
prevention of flea infestations, and the treatment and control of tick 
infestations with Amblyomma americanum (lone star tick), Amblyomma 
maculatum (Gulf Coast tick), Dermacentor variabilis (American dog 
tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus 
(brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick) 
for 1 month in dogs and puppies 8 weeks of age and older, and weighing 
2.8 pounds or greater. For the prevention of Borrelia burgdorferi 
infections as a direct result of killing Ixodes scapularis vector 
ticks.
* * * * *

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

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

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


0
11. In Sec.  522.2005:
0
a. Revise paragraph (b);
0
b. Revise the heading for paragraph (c);
0
c. Revise paragraph (c)(2); and
0
d. Add paragraph (d).
    The revisions and addition read as follows:


Sec.  522.2005  Propofol.

* * * * *

[[Page 6801]]

    (b) * * *
    (1) No. 086064 for use as in paragraphs (c)(1), (c)(2)(i), (c)(3), 
(d)(1), (d)(2)(i), and (d)(3) of this section.
    (2) No. 054771 for use as in paragraphs (c)(1), (c)(2)(ii), (c)(3), 
(d)(1), (d)(2)(ii), and (d)(3) of this section.
    (3) Nos. 054771 and 068504 for use as in paragraphs (c)(1), 
(c)(2)(iii), and (c)(3) of this section.
* * * * *
    (c) Conditions of use in dogs--
* * * * *
    (2) Indications for use. (i) As a single injection to provide 
general anesthesia for short procedures; for induction and maintenance 
of general anesthesia using incremental doses to effect; and for 
induction of general anesthesia where maintenance is provided by 
inhalant anesthetics.
    (ii) For induction of general anesthesia; for maintenance of 
anesthesia for up to 20 minutes; and for induction of general 
anesthesia followed by maintenance with an inhalant anesthetic.
    (iii) For induction and maintenance of general anesthesia; and for 
induction of general anesthesia followed by maintenance with an 
inhalant anesthetic.
* * * * *
    (d) Conditions of use in cats--(1) Amount. Administer by 
intravenous injection according to label directions. The use of 
preanesthetic medication reduces propofol dose requirements.
    (2) Indications for use. (i) As a single injection to provide 
general anesthesia for short procedures; for induction and maintenance 
of general anesthesia using incremental doses to effect; and for 
induction of general anesthesia where maintenance is provided by 
inhalant anesthetics.
    (ii) For induction and maintenance of general anesthesia; and for 
induction of general anesthesia followed by maintenance with an 
inhalant anesthetic.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.


0
12. In Sec.  522.2478, revise paragraph (d)(2) to read as follows:


Sec.  522.2478  Trenbolone acetate and estradiol benzoate.

    * * *
    (d) * * *
    (2) Growing beef steers and heifers on pasture (stocker, feeder, 
and slaughter)--(i) Amounts and indications for use. (A) An implant 
containing 50 mg trenbolone acetate and 7 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 trenbolone acetate and 14 mg 
estradiol benzoate as described in paragraph (a)(1)(ii) of this section 
for increased rate of weight gain.
    (C) An extended-release implant containing 150 mg trenbolone 
acetate and 21 mg estradiol benzoate as described in paragraph 
(a)(2)(i) of this section for increased rate of weight gain for up to 
200 days.
    (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). Safety and effectiveness following 
reimplantation have not been evaluated. Do not use in beef calves less 
than 2 months of age, dairy calves, and veal calves because 
effectiveness and safety have not been established. A withdrawal period 
has not been established for this product in pre-ruminating calves. Do 
not use in dairy cows or in animals intended for subsequent breeding. 
Use in these cattle may cause drug residues in milk and/or in calves 
born to these cows.
* * * * *


Sec.  522.2630  [Amended]

0
13. In Sec.  522.2630, in paragraphs (b)(1) and (2), remove the text 
``and 068504, 069043'' and add in its place the text ``068504, and 
069043''.

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

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

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


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


Sec.  524.770  Doramectin.

* * * * *
    (b) Sponsors. See Nos. 051072, 054771, and 061133 in Sec.  
510.600(c) of this chapter.
* * * * *


0
16. In Sec.  524.2099, revise paragraph (c)(2) to read as follows:


Sec.  524.2099  Selamectin and sarolaner.

* * * * *
    (c) * * *
    (2) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis, the treatment and control of roundworm 
(Toxocara cati) and intestinal hookworm (Ancylostoma tubaeforme) 
infections, and the treatment and control of ear mite (Otodectes 
cynotis) infestations. Kills adult fleas (Ctenocephalides felis) and is 
indicated for the treatment and prevention of flea infestations, the 
prevention of Dipylidium caninum (tapeworm) infections as a direct 
result of killing Ctenocephalides felis vector fleas on the treated 
cat, and the treatment and control of tick infestations with Amblyomma 
americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), 
Dermacentor variabilis (American dog tick), and Ixodes scapularis 
(black-legged tick) for 1 month in cats and kittens 8 weeks and older, 
and weighing 2.8 pounds or greater.
* * * * *

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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


Sec.  529.2620  [Amended]

0
18. In Sec.  529.2620, in paragraph (b), remove the text ``051233'' and 
in its place add the text ``051072''.

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

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

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


0
20. In Sec.  558.128, revise paragraphs (e)(4)(xxi) and (xxii) to read 
as follows:


Sec.  558.128  Chlortetracycline.

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

[[Page 6802]]



----------------------------------------------------------------------------------------------------------------
                                     Combination in      Indications for
    Chlortetracycline amount           grams/ton               use             Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(xxi) 400 to 2,000 g/ton........  Monensin, 15 to 84.  Replacement beef    For replacement        069254, 016592
                                                        and dairy           beef and dairy
                                                        heifers: For        heifers not
                                                        treatment of        currently being
                                                        bacterial           fed monensin:
                                                        enteritis caused    Feed as the sole
                                                        by Escherichia      ration for not
                                                        coli and            more than 5 days
                                                        bacterial           to provide 10 mg
                                                        pneumonia caused    chlortetracycline
                                                        by Pasteurella      per pound of body
                                                        multocida           weight per day
                                                        susceptible to      and 0.14 to 0.42
                                                        chlortetracycline   mg monensin per
                                                        ; and for the       pound of body
                                                        prevention and      weight per day,
                                                        control of          depending upon
                                                        coccidiosis         severity of
                                                        caused by Eimeria   challenge, to
                                                        bovis and Eimeria   provide 50 to 100
                                                        zuernii.            mg monensin per
                                                                            head per day in a
                                                                            minimum of 1
                                                                            pound of Type C
                                                                            medicated feed.
                                                                            After 5 days,
                                                                            continue to feed
                                                                            monensin Type C
                                                                            medicated feed
                                                                            alone to provide
                                                                            50 to 200 mg
                                                                            monensin per head
                                                                            per day in a
                                                                            minimum of 1
                                                                            pound of Type C
                                                                            medicated feed..
                                                                           For replacement
                                                                            beef and dairy
                                                                            heifers currently
                                                                            being fed
                                                                            monensin: Feed as
                                                                            the sole ration
                                                                            for not more than
                                                                            5 days to provide
                                                                            10 mg
                                                                            chlortetracycline
                                                                            per pound of body
                                                                            weight per day
                                                                            and 0.14 to 0.42
                                                                            mg monensin per
                                                                            pound of body
                                                                            weight per day,
                                                                            depending upon
                                                                            severity of
                                                                            challenge, to
                                                                            provide 50 to 200
                                                                            mg monensin per
                                                                            head per day in a
                                                                            minimum of 1
                                                                            pound of Type C
                                                                            medicated feed.
                                                                            After 5 days,
                                                                            continue to feed
                                                                            monensin Type C
                                                                            medicated feed
                                                                            alone. This drug
                                                                            is not approved
                                                                            for use in female
                                                                            dairy cattle 20
                                                                            months of age or
                                                                            older, including
                                                                            dry dairy cows.
                                                                            Use in these
                                                                            cattle may cause
                                                                            drug residues in
                                                                            milk and/or in
                                                                            calves born to
                                                                            these cows.
                                                                            Monensin as
                                                                            provided by No.
                                                                            058198 or 016592;
                                                                            chlortetracycline
                                                                            by No. 069254 in
                                                                            Sec.   510.600(c)
                                                                            of this chapter.
(xxii) 400 to 2,000 g/ton.......  Monensin, 15 to 400  Replacement beef    For replacement      0692544, 0165924
                                                        and dairy           beef and dairy
                                                        heifers: For        heifers not
                                                        treatment of        currently being
                                                        bacterial           fed monensin:
                                                        enteritis caused    Feed as the sole
                                                        by Escherichia      ration for not
                                                        coli and            more than 5 days
                                                        bacterial           to provide 10 mg
                                                        pneumonia caused    chlortetracycline
                                                        by Pasteurella      per pound of body
                                                        multocida           weight per day
                                                        susceptible to      and 50 to 100 mg
                                                        chlortetracycline   monensin per head
                                                        ; and for           per day in a
                                                        increased rate of   minimum of 1
                                                        weight gain.        pound of Type C
                                                                            medicated feed.
                                                                            After 5 days,
                                                                            continue to feed
                                                                            monensin Type C
                                                                            medicated feed
                                                                            alone to provide
                                                                            50 to 200 mg
                                                                            monensin per head
                                                                            per day in a
                                                                            minimum of 1
                                                                            pound of Type C
                                                                            medicated feed..
                                                                           For replacement
                                                                            beef and dairy
                                                                            heifers currently
                                                                            being fed
                                                                            monensin: Feed as
                                                                            the sole ration
                                                                            for not more than
                                                                            5 days to provide
                                                                            10 mg
                                                                            chlortetracycline
                                                                            per pound of body
                                                                            weight per day
                                                                            and 50 to 200 mg
                                                                            monensin per head
                                                                            per day in a
                                                                            minimum of 1
                                                                            pound of Type C
                                                                            medicated feed.
                                                                            After 5 days,
                                                                            continue to feed
                                                                            monensin Type C
                                                                            medicated feed
                                                                            alone. This drug
                                                                            is not approved
                                                                            for use in female
                                                                            dairy cattle 20
                                                                            months of age or
                                                                            older, including
                                                                            dry dairy cows.
                                                                            Use in these
                                                                            cattle may cause
                                                                            drug residues in
                                                                            milk and/or in
                                                                            calves born to
                                                                            these cows.
                                                                            Monensin as
                                                                            provided by No.
                                                                            058198 or 016592;
                                                                            chlortetracycline
                                                                            by No. 069254 in
                                                                            Sec.   510.600(c)
                                                                            of this chapter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *


0
21. In Sec.  558.261, revise paragraph (b) to read as follows:


Sec.  558.261  Florfenicol.

* * * * *
    (b) Sponsors. See sponsor numbers as in Sec.  510.600(c) of this 
chapter.
    (1) No. 000061 for use of products described in paragraph (a) of 
this section as in paragraph (e) of this section.
    (2) No. 066104 for use of product described in paragraph (a)(2) of 
this section as in paragraph (e)(2) of this section.
* * * * *


0
22. In Sec.  558.330:
0
a. Redesignate paragraph (d) as paragraph (e);
0
b. Add new paragraph (d); and
0
c. Revise newly redesignated paragraph (e).
    The addition and revision read as follows:


Sec.  558.330  Lubabegron.

* * * * *
    (d) Special considerations. Labeling shall bear the following 
caution statements:
    (1) Lubabegron has not been approved for use in breeding animals 
because

[[Page 6803]]

safety and effectiveness have not been evaluated in these animals.
    (2) Do not allow horses or other equines access to feed containing 
lubabegron.
    (3) A decrease in dry matter intake may be noticed in some animals 
receiving lubabegron.
    (e) Conditions of use. (1) It is used in cattle feed as follows:

----------------------------------------------------------------------------------------------------------------
    Lubabegron (as lubabegron        Combination in      Indications for
     fumarate) in grams/ton            grams/ton               use             Limitations          Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 1.25 to 4.54................  ...................  Beef steers and     Feed continuously              058198
                                                        heifers fed in      as the sole
                                                        confinement for     ration to provide
                                                        slaughter: For      13 to 90 mg
                                                        reduction of        lubabegron/head/
                                                        ammonia gas         day during the
                                                        emissions per       last 14 to 91
                                                        pound of live       days on feed. See
                                                        weight and hot      special labeling
                                                        carcass weight      considerations in
                                                        during the last     paragraph (d) of
                                                        14 to 91 days on    this section..
                                                        feed.
(ii) 1.25 to 4.54...............  Melengestrol         Growing beef        Melengestrol                   058198
                                   acetate, 0.25 to 2   heifers fed in      acetate Type C
                                   g/ton.               confinement for     top-dress
                                                        slaughter: For      medicated feed
                                                        increased rate of   (0.5 to 2 lb(s)
                                                        weight gain,        per head per day)
                                                        improved feed       must be top
                                                        efficiency,         dressed onto or
                                                        suppression of      mixed at feeding
                                                        estrus (heat),      with a Type C
                                                        and for reduction   medicated feed
                                                        of ammonia gas      containing 1.25
                                                        emissions per       to 4.54 g/ton
                                                        pound of live       lubabegron to
                                                        weight and hot      provide 0.25 to
                                                        carcass weight      0.5 mg
                                                        during the last     melengestrol
                                                        14 to 91 days on    acetate and 13 to
                                                        feed.               90 mg lubabegron
                                                                            per head per day.
                                                                            Feed as the sole
                                                                            ration during the
                                                                            last 14 to 91
                                                                            days on feed. See
                                                                            special labeling
                                                                            considerations in
                                                                            paragraph (d) of
                                                                            this section and
                                                                            in Sec.
                                                                            558.342(d).
                                                                            Lubabegron
                                                                            fumarate as
                                                                            provided by No.
                                                                            058198;
                                                                            melengestrol
                                                                            acetate as
                                                                            provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of
                                                                            this chapter..
(iii) 1.25 to 4.54..............  Monensin, 5 to 40..  Beef steers and     Feed continuously      016592, 058198
                                                        heifers fed in      as sole ration to
                                                        confinement for     provide 13 to 90
                                                        slaughter: For      mg lubabegron/
                                                        reduction of        head/day and 50
                                                        ammonia gas         to 480 mg
                                                        emissions per       monensin/head/day
                                                        pound of live       during the last
                                                        weight and hot      14 to 91 days on
                                                        carcass weight      feed. No
                                                        and for improved    additional
                                                        feed efficiency     improvement in
                                                        during the last     feed efficiency
                                                        14 to 91 days on    has been shown
                                                        feed.               from feeding
                                                                            monensin at
                                                                            levels greater
                                                                            than 30 g/ton
                                                                            (360 mg monensin/
                                                                            head/day). See
                                                                            special labeling
                                                                            considerations in
                                                                            paragraph (d) of
                                                                            this section and
                                                                            in Sec.
                                                                            558.355(d).
                                                                            Lubabegron
                                                                            fumarate as
                                                                            provided by No.
                                                                            058198; monensin
                                                                            as provided by
                                                                            No. 016592 or
                                                                            058198 in Sec.
                                                                            510.600(c) of
                                                                            this chapter..
(iv) 1.25 to 4.54...............  Monensin, 10 to 40.  Beef steers and     Feed continuously      016592, 058198
                                                        heifers fed in      as the sole
                                                        confinement for     ration to provide
                                                        slaughter: For      13 to 90 mg
                                                        reduction of        lubabegron/head/
                                                        ammonia gas         day and 0.14 to
                                                        emissions per       0.42 mg monensin/
                                                        pound of live       lb body weight
                                                        weight and hot      per day,
                                                        carcass weight;     depending upon
                                                        and for             severity of
                                                        prevention and      coccidiosis
                                                        control of          challenge, during
                                                        coccidiosis due     the last 14 to 91
                                                        to Eimeria bovis    days on feed. See
                                                        and E. zuernii      special labeling
                                                        during the last     considerations in
                                                        14 to 91 days on    paragraph (d) of
                                                        feed.               this section and
                                                                            in Sec.
                                                                            558.355(d).
                                                                            Lubabegron
                                                                            fumarate as
                                                                            provided by No.
                                                                            058198; monensin
                                                                            as provided by
                                                                            No. 016592 or
                                                                            058198 in Sec.
                                                                            510.600(c) of
                                                                            this chapter..
(v) 1.25 to 4.54................  Monensin, 10 to 40   Growing beef        Melengestrol                   058198
                                   and melengestrol     heifers fed in      acetate Type C
                                   acetate, 0.25 to 2.  confinement for     top-dress
                                                        slaughter: For      medicated feed
                                                        increased rate of   (0.5 to 2 lb(s)
                                                        weight gain,        per head per day)
                                                        improved feed       must be top
                                                        efficiency,         dressed onto or
                                                        suppression of      mixed at feeding
                                                        estrus (heat),      with a Type C
                                                        for reduction of    medicated feed
                                                        ammonia gas         containing 1.25
                                                        emissions per       to 4.54 g/ton
                                                        pound of live       lubabegron and 10
                                                        weight and hot      to 40 g/ton
                                                        carcass weight,     monensin, to
                                                        and for the         provide 0.25 to
                                                        prevention and      0.5 mg
                                                        control of          melengestrol
                                                        coccidiosis         acetate and 13 to
                                                        caused by Eimeria   90 mg lubabegron
                                                        bovis and Eimeria   per head per day,
                                                        zuernii during      and 0.14 to 0.42
                                                        the last 14 to 91   mg monensin per
                                                        days on feed.       pound of body
                                                                            weight per day,
                                                                            depending upon
                                                                            severity of
                                                                            challenge, up to
                                                                            a maximum of 480
                                                                            mg monensin per
                                                                            head per day.
                                                                            Feed as the sole
                                                                            ration during the
                                                                            last 14 to 91
                                                                            days on feed. See
                                                                            special labeling
                                                                            considerations in
                                                                            paragraph (d) of
                                                                            this section, and
                                                                            in Sec.  Sec.
                                                                            558.342(d) and
                                                                            558.355(d).
                                                                            Lubabegron
                                                                            fumarate and
                                                                            monensin as
                                                                            provided by No.
                                                                            058198;
                                                                            melengestrol
                                                                            acetate as
                                                                            provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of
                                                                            this chapter..
----------------------------------------------------------------------------------------------------------------

    (2) Lubabegron may also be used in combination with:
    (i) [Reserved]
    (ii) Tylosin as in Sec.  558.625.


0
23. In Sec.  558.342:
0
a. Add paragraphs (b)(1) and (2); and
0
b. Revise paragraphs (e)(1)(i) and (ii).
    The addition and revision read as follows:


Sec.  558.342  Melengestrol.

* * * * *
    (b) * * *

[[Page 6804]]

    (1) No. 054771 for use of products described in paragraph (a)(1) of 
this section:
    (2) Nos. 016592, 051311, 054771, and 058198 for use of product 
described in paragraph (a)(2) of this section.
* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
Melengestrol acetate in mg/head/    Combination  in      Indications for
               day                     grams/ton               use             Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(i) 0.25 to 0.5.................  ...................  Heifers fed in      Administer 0.5 to     016592, 051311,
                                                        confinement for     2.0 pounds (lb)/      054771, 058198
                                                        slaughter: For      head/day of
                                                        increased rate of   medicated feed
                                                        weight gain,        containing 0.125
                                                        improved feed       to 1.0 mg
                                                        efficiency, and     melengestrol
                                                        suppression of      acetate/lb to
                                                        estrus (heat)..     provide 0.25 to
                                                                            0.5 mg
                                                                            melengestrol
                                                                            acetate/head/day..
(ii) 0.5........................  ...................  Heifers intended    Administer 0.5 to     016592, 051311,
                                                        for breeding: For   2.0 lb/head/day       054771, 058198
                                                        suppression of      of Type C feed
                                                        estrus (heat).      containing 0.25
                                                                            to 1.0 mg
                                                                            melengestrol
                                                                            acetate/lb to
                                                                            provide 0.5 mg
                                                                            melengestrol
                                                                            acetate/head/day.
                                                                            Do not exceed 24
                                                                            days of feeding.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *


0
24. In Sec.  558.625:
0
a. Redesignate paragraphs (e)(2)(ix) through (xvii) as paragraphs 
(e)(2)(x) through (xviii); and
0
b. Add new paragraph (e)(2)(ix).
    The addition reads as follows:


Sec.  558.625  Tylosin.

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

----------------------------------------------------------------------------------------------------------------
                                     Combination in      Indications for
        Tylosin grams/ton              grams/ton               use             Limitations          Sponsors
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ix) 8 to 10....................  Monensin, 10 to 40   Growing beef        Feed as the sole               058198
                                   plus lubabegron      heifers fed in      ration during the
                                   (as lubebegron       confinement for     last 14 to 91
                                   fumarate), 1.25 to   slaughter: For      days on feed.
                                   4.54, plus           increased rate of   Melengestrol
                                   melengestrol         weight gain,        acetate Type C
                                   acetate, 0.25 to     improved feed       top-dress
                                   2.0.                 efficiency,         medicated feed
                                                        suppression of      (0.5 to 2.0 lb
                                                        estrus (heat),      per head per day)
                                                        for reduction of    must be top
                                                        ammonia gas         dressed onto or
                                                        emissions per       mixed at feeding
                                                        pound of live       with a Type C
                                                        weight and hot      medicated feed
                                                        carcass weight,     containing 8 to
                                                        for the             10 g/ton tylosin,
                                                        prevention and      1.25 to 4.54 g/
                                                        control of          ton lubabegron,
                                                        coccidiosis         and 10 to 40 g/
                                                        caused by Eimeria   ton monensin, to
                                                        bovis and Eimeria   provide 0.25 to
                                                        zuernii, and for    0.5 mg
                                                        reduction of        melengestrol
                                                        incidence of        acetate, 60 to 90
                                                        liver abscesses     mg tylosin per
                                                        associated with     head per day, 13
                                                        Fusobacterium       to 90 mg
                                                        necrophorum and     lubabegron per
                                                        Arcanobacterium     head per day, and
                                                        pyogenes during     0.14 to 0.42 mg
                                                        the last 14 to 91   monensin per
                                                        days on feed.       pound of body
                                                                            weight per day,
                                                                            depending on
                                                                            severity of
                                                                            challenge, up to
                                                                            480 mg monensin
                                                                            per head per day.
                                                                            See special
                                                                            labeling
                                                                            considerations in
                                                                            Sec.  Sec.
                                                                            558.330(d),
                                                                            558.342(d), and
                                                                            558.355(d).
                                                                            Tylosin as
                                                                            provided by No.
                                                                            016592 or 058198;
                                                                            lubabegron
                                                                            fumarate and
                                                                            monensin as
                                                                            provided by No.
                                                                            058198;
                                                                            melengestrol
                                                                            acetate as
                                                                            provided in No.
                                                                            054771 in Sec.
                                                                            510.600(c) of
                                                                            this chapter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------


    Dated: January 14, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-01226 Filed 1-17-25; 8:45 am]
BILLING CODE 4164-01-P`