Rule2025-01226
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 21, 2025
Effective
January 21, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 90 Issue 12 (Tuesday, January 21, 2025)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-01226]
[[Page 6797]]
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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.
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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, <a href="/cdn-cgi/l/email-protection#2344464c5144460d4b424a41464f634547420d4b4b500d444c55"><span class="__cf_email__" data-cfemail="c9aeaca6bbaeace7a1a8a0abaca589afada8e7a1a1bae7aea6bf">[email protected]</span></a>.
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: <a href="https://animaldrugsatfda.fda.gov/adafda/views/#/search">https://animaldrugsatfda.fda.gov/adafda/views/#/search</a>.
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.
<bullet> 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.
<bullet> 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
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