Federal Register / Vol. 90, No. 12 / Tuesday, January 21, 2025 / Rules and Regulations 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, 

george.haibel@fda.hhs.gov. 

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

Date of approval File No. Sponsor 

(drug labeler code 1) Product name Effect of the action 21 CFR section 

October 7, 2024 ........ 141–554 Boehringer 

Ingelheim Animal 

Health USA, Inc. 

(000010) 

NEXGARD PLUS (afoxolaner, 

moxidectin, and pyrantel chewable 

tablets).

Supplemental approval for the treatment 

and control of Asian longhorned tick 

infestations for 1 month in dogs and 

puppies.

520.35 

October 7, 2024 ........ 141–581 Elanco US Inc. 

(058198) 

CREDELIO QUATTRO (lotilaner, 

moxidectin, praziquantel, and pyrantel 

chewable tablets.

Original approval for the prevention of 

heartworm disease and for the 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.

520.1287 

October 18, 2024 ...... 200–748 Huvepharma EOOD 

(016592) 

PENNCHLOR (chlortetracycline Type A 

medicated article) and MONOVET 

(monensin) Type A medicated article) 

to be used in the manufacture of Type 

B and Type C medicated feeds.

Original approval as a generic copy of 

NADA 141–564.

558.128 

October 23, 2024 ...... 141–589 Elanco US Inc. 

(058198) 

EXPERIOR (lubabegron Type A medicated article) and MGA (melengestrol 

acetate Type A medicated article) to 

be used in the manufacture of Type C 

medicated feeds.

Original approval for increased rate of 

weight gain, improved feed efficiency, 

suppression of estrus (heat), and for 

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.

558.330 

October 25, 2024 ...... 141–590 Do. EXPERIOR (lubabegron Type A medicated article), RUMENSIN (monensin 

Type A medicated article), and MGA 

(melengestrol acetate Type A medicated article) to be used in the manufacture of Type C medicated feeds.

Original approval for increased rate of 

weight gain, improved feed efficiency, 

suppression of estrus (heat), for reduction of ammonia gas emissions per 

pound of 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.

558.330 


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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING OCTOBER, NOVEMBER, AND

DECEMBER 2024 REQUIRING EVIDENCE OF SAFETY AND/OR EFFECTIVENESS—Continued 

Date of approval File No. Sponsor 

(drug labeler code 1) Product name Effect of the action 21 CFR 

section 

October 25, 2024 ...... 141–591 Do. EXPERIOR (lubabegron Type A medicated article), RUMENSIN (monensin 

Type A medicated article), TYLAN 

(tylosin Type A medicated article), and 

MGA (melengestrol acetate Type A 

medicated article) to be used in the 

manufacture of Type C medicated 

feeds.

Original approval for increased rate of 

weight gain, improved feed efficiency, 

suppression of estrus (heat), for reduction of ammonia gas emissions per 

pound of live weight and hot carcass 

weight, and for 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.

558.625 

November 6, 2024 .... 141–521 Zoetis Inc. (054771) SIMPARICA TRIO (sarolaner, 

moxidectin, and pyrantel chewable 

tablets).

Supplemental approval for the treatment 

and control of tick infestations with 

Asian longhorned tick for 1 month in 

dogs and puppies.

520.2090 

November 13, 2024 .. 141–502 Do. .......................... REVOLUTION PLUS (selamectin and 

sarolaner topical solution).

Supplemental approval for the prevention of tapeworm infections as a direct 

result of killing vector fleas on the 

treated cat for 1 month in cats and kittens.

524.2099 

November 14, 2024 .. 200–803 Phibro Animal 

Health Corp. 

(066104) 

PAQFLOR (florfenicol) Type A Medicated Article to be used in the manufacture of Type C medicated feeds.Original approval as a generic copy of 

NADA 141–246.

558.261 

November 18, 2024 .. 200–793 Parnell Technologies, Pty., 

Ltd. (068504) 

PROPOFOLVET MULTIDOSE (propofol 

injectable emulsion).

Original approval as a generic copy of 

NADA 141–098.

522.2005 

November 18, 2024 .. 200–805 Virbac AH, Inc. 

(051311) 

MEL 500 (melengestrol acetate Type A 

liquid medicated article) to be used in 

the manufacture of Type C medicated 

feeds.

Original approval as a generic copy of 

NADA 039–402.

558.342 

November 20, 2024 .. 200–636 Bimeda Animal 

Health, Ltd. 

(061133) 

DORACIDE (doramectin topical solution) Original approval as a generic copy of 

NADA 141–095.

524.770 

November 22, 2024 .. 141–452 Zoetis Inc. (054771) SIMPARICA (sarolaner) Chewable Tablet.Supplemental approval for the treatment 

and control of tick infestations with 

Asian longhorned tick for 1 month in 

dogs and puppies.

520.2086 

November 25, 2024 .. 141–532 Intervet, Inc. 

(000061) 

BRAVECTO 1–MONTH (fluralaner) 

Chewable Tablet.

Supplemental approval for the treatment 

and control of Asian longhorned tick 

infestations for 1 month in dogs and 

puppies.

520.998 

December 19, 2024 .. 141–043 Zoetis Inc. (054771) SYNOVEX CHOICE and SYNOVEX 

PRIMER (trenbolone acetate and estradiol benzoate implants) Implants.

Supplemental approval of both products 

for increased rate of weight gain in 

growing beef steers and heifers on 

pasture (stocker, feeder, and slaughter).

522.2478 

1See § 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. 


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TABLE 2—APPLICATIONS FOR WHICH OWNERSHIP WAS TRANSFERRED TO ANOTHER SPONSOR DURING OCTOBER, 

NOVEMBER, AND DECEMBER 2024 

File No. Product name Transferring sponsor 

(drug labeler code) 

New sponsor 

(drug labeler code) 21 CFR section 

141–339 .............. OVUGEL (triptorelin acetate) Gel United-AH II LLC (051233) Aurora Pharmaceutical, Inc. 

(051072) 

529.2620 

200–233 .............. SUPERIORBUTE 

(phenylbutazone) Powder.

Superior Equine Pharmaceuticals, Inc. (027053) Noble Pharma, LLC (086119) 520.1720e 

IV. Change of Sponsor Address 

Pharmacosmos, Inc. (drug labeler 

code 042552 in § 510.600(c)) has 

informed FDA that it has changed its 

address to 120 Headquarters Plz., 

Morristown, NJ 07960. The entries in 

§ 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. 

• § 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 

■ 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. 

■ 2. In § 510.600: 

■ 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 

■ b. In the table in paragraph (c)(2): 

■ i. Remove the entry for ‘‘027053’’; 

■ ii. Revise the entry for ‘‘042552’’; and 

■ iii. Remove the entry for ‘‘051233’’. 

The revision reads as follows: 

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address Drug labeler 

code 

*******

Pharmacosmos, Inc., 120 Headquarters Plz., Morristown, NJ 07960 ................................................................................................ 042552 

* * * * * * * 

(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 

■ 3. The authority citation for part 520 

continues to read as follows: 

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

■ 4. In § 520.35, revise paragraphs (a) 

and (c)(2) to read as follows: 

§ 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); 


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(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. 

* * * * * 

■ 5. In § 520.998, revise paragraph 

(c)(2)(ii) to read as follows: 

§ 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. 

* * * * * 

■ 6. Add § 520.1287 to read as follows: 

§ 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 

§ 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. 

§ 520.1720e [Amended] 

■ 7. In § 520.1720e, in paragraph (b)(1), 

remove the text ‘‘027053’’ and in its 

place add the text ‘‘086119’’. 

■ 8. In § 520.2086, revise paragraphs 

(c)(1) and (2) to read as follows: 

§ 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. 

* * * * * 

■ 9. In § 520.2090, revise paragraph 

(c)(2) to read as follows: 

§ 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 (blacklegged 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 

■ 10. The authority citation for part 522 

continues to read as follows: 

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

■ 11. In § 522.2005: 

■ a. Revise paragraph (b); 

■ b. Revise the heading for paragraph 

(c); 

■ c. Revise paragraph (c)(2); and 

■ d. Add paragraph (d). 

The revisions and addition read as 

follows: 

§ 522.2005 Propofol. 

* * * * * 


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(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. 

■ 12. In § 522.2478, revise paragraph 

(d)(2) to read as follows: 

§ 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 preruminating 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. 

* * * * * 

§ 522.2630 [Amended] 

■ 13. In § 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 

■ 14. The authority citation for part 524 

continues to read as follows: 

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

■ 15. In § 524.770, revise paragraph (b) 

to read as follows: 

§ 524.770 Doramectin. 

* * * * * 

(b) Sponsors. See Nos. 051072, 

054771, and 061133 in § 510.600(c) of 

this chapter. 

* * * * * 

■ 16. In § 524.2099, revise paragraph 

(c)(2) to read as follows: 

§ 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 (blacklegged 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 

■ 17. The authority citation for part 529 

continues to read as follows: 

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

§ 529.2620 [Amended] 

■ 18. In § 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 

■ 19. The authority citation for part 558 

continues to read as follows: 

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

360ccc-1, 371. 

■ 20. In § 558.128, revise paragraphs 

(e)(4)(xxi) and (xxii) to read as follows: 

§ 558.128 Chlortetracycline. 

* * * * * 

(e) * * * 

(4) * * * 


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Chlortetracycline 

amount 

Combination in 

grams/ton Indications for use Limitations Sponsor 

*******

(xxi) 400 to 2,000 g/ton Monensin, 15 to 84 .... Replacement beef and dairy heifers: For 

treatment of bacterial enteritis caused by 

Escherichia coli and bacterial pneumonia 

caused by Pasteurella multocida susceptible to chlortetracycline; and for the prevention and control of coccidiosis caused 

by Eimeria bovis and Eimeria zuernii.

For replacement beef and dairy heifers not 

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 100 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 

§ 510.600(c) of this chapter.

069254, 016592 

(xxii) 400 to 2,000 g/ 

ton.

Monensin, 15 to 400 .. Replacement beef and dairy heifers: For 

treatment of bacterial enteritis caused by 

Escherichia coli and bacterial pneumonia 

caused by Pasteurella multocida susceptible to chlortetracycline; and for increased 

rate of weight gain.

For replacement beef and dairy heifers not 

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 100 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 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 § 510.600(c) of this chapter.

0692544, 0165924 

*******

* * * * * 

■ 21. In § 558.261, revise paragraph (b) 

to read as follows: 

§ 558.261 Florfenicol. 

* * * * * 

(b) Sponsors. See sponsor numbers as 

in § 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. 

* * * * * 

■ 22. In § 558.330: 

■ a. Redesignate paragraph (d) as 

paragraph (e); 

■ b. Add new paragraph (d); and 

■ c. Revise newly redesignated 

paragraph (e). 

The addition and revision read as 

follows: 

§ 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 


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Federal Register / Vol. 90, No. 12 / Tuesday, January 21, 2025 / Rules and Regulations 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 fumarate) in 

grams/ton 

Combination in 

grams/ton Indications for use Limitations Sponsors 

(i) 1.25 to 4.54 ................. .................................... Beef steers and heifers fed in confinement 

for slaughter: For reduction of ammonia 

gas emissions per pound of live weight 

and hot carcass weight during the last 14 

to 91 days on feed.

Feed continuously as the sole ration to provide 13 to 90 mg lubabegron/head/day 

during the last 14 to 91 days on feed. See 

special labeling considerations in paragraph (d) of this section..

058198 

(ii) 1.25 to 4.54 ................. Melengestrol acetate, 

0.25 to 2 g/ton.

Growing beef heifers fed in confinement for 

slaughter: For increased rate of weight 

gain, improved feed efficiency, suppression of estrus (heat), and for reduction of 

ammonia gas emissions per pound of live 

weight and hot carcass weight during the 

last 14 to 91 days on feed.

Melengestrol acetate Type C top-dress 

medicated feed (0.5 to 2 lb(s) per head 

per day) must be top dressed onto or 

mixed at feeding with a Type C medicated 

feed containing 1.25 to 4.54 g/ton 

lubabegron to provide 0.25 to 0.5 mg 

melengestrol acetate and 13 to 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 § 558.342(d). Lubabegron fumarate 

as provided by No. 058198; melengestrol 

acetate as provided by No. 054771 in 

§ 510.600(c) of this chapter..

058198 

(iii) 1.25 to 4.54 ................ Monensin, 5 to 40 ..... Beef steers and heifers fed in confinement 

for slaughter: For reduction of ammonia 

gas emissions per pound of live weight 

and hot carcass weight and for improved 

feed efficiency during the last 14 to 91 

days on feed.

Feed continuously as sole ration to provide 

13 to 90 mg lubabegron/head/day and 50 

to 480 mg monensin/head/day during the 

last 14 to 91 days on feed. No additional 

improvement in feed efficiency has been 

shown 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 § 558.355(d). Lubabegron fumarate as 

provided by No. 058198; monensin as 

provided by No. 016592 or 058198 in 

§ 510.600(c) of this chapter..

016592, 058198 

(iv) 1.25 to 4.54 ................ Monensin, 10 to 40 ... Beef steers and heifers fed in confinement 

for slaughter: For reduction of ammonia 

gas emissions per pound of live weight 

and hot carcass weight; and for prevention and control of coccidiosis due to 

Eimeria bovis and E. zuernii during the 

last 14 to 91 days on feed.

Feed continuously as the sole ration to provide 13 to 90 mg lubabegron/head/day 

and 0.14 to 0.42 mg monensin/lb body 

weight per day, depending upon severity 

of coccidiosis challenge, during the last 

14 to 91 days on feed. See special labeling considerations in paragraph (d) of this 

section and in § 558.355(d). Lubabegron 

fumarate as provided by No. 058198; 

monensin as provided by No. 016592 or 

058198 in § 510.600(c) of this chapter..

016592, 058198 

(v) 1.25 to 4.54 ................ Monensin, 10 to 40 

and melengestrol 

acetate, 0.25 to 2.

Growing beef heifers fed in confinement for 

slaughter: For increased rate of weight 

gain, improved feed efficiency, suppression of estrus (heat), for reduction of ammonia gas emissions per pound of live 

weight and hot carcass weight, and for 

the prevention and control of coccidiosis 

caused by Eimeria bovis and Eimeria 

zuernii during the last 14 to 91 days on 

feed.

Melengestrol acetate Type C top-dress 

medicated feed (0.5 to 2 lb(s) per head 

per day) must be top dressed onto or 

mixed at feeding with a Type C medicated 

feed containing 1.25 to 4.54 g/ton 

lubabegron and 10 to 40 g/ton monensin, 

to provide 0.25 to 0.5 mg melengestrol 

acetate and 13 to 90 mg lubabegron per 

head per day, and 0.14 to 0.42 mg 

monensin per 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 §§ 558.342(d) and 558.355(d). 

Lubabegron fumarate and monensin as 

provided by No. 058198; melengestrol acetate as provided by No. 054771 in 

§ 510.600(c) of this chapter..

058198 

(2) Lubabegron may also be used in 

combination with: 

(i) [Reserved] 

(ii) Tylosin as in § 558.625. 

■ 23. In § 558.342: 

■ a. Add paragraphs (b)(1) and (2); and 

■ b. Revise paragraphs (e)(1)(i) and (ii). 

The addition and revision read as 

follows: 

§ 558.342 Melengestrol. 

* * * * * 

(b) * * * 


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6804 Federal Register / Vol. 90, No. 12 / Tuesday, January 21, 2025 / Rules and Regulations 

(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/day 

Combination 

in grams/ton Indications for use Limitations Sponsor 

*******

(i) 0.25 to 0.5 ..................... ................................... Heifers fed in confinement for slaughter: For 

increased rate of weight gain, improved 

feed efficiency, and suppression of estrus 

(heat)..

Administer 0.5 to 2.0 pounds (lb)/head/day 

of medicated feed containing 0.125 to 1.0 

mg melengestrol acetate/lb to provide 

0.25 to 0.5 mg melengestrol acetate/ 

head/day..

016592, 051311, 

054771, 058198 

(ii) 0.5 ................................ ................................... Heifers intended for breeding: For suppression of estrus (heat).Administer 0.5 to 2.0 lb/head/day of Type C 

feed 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.

016592, 051311, 

054771, 058198 

* * * * * * * 

* * * * * 

■ 24. In § 558.625: 

■ a. Redesignate paragraphs (e)(2)(ix) 

through (xvii) as paragraphs (e)(2)(x) 

through (xviii); and 

■ b. Add new paragraph (e)(2)(ix). 

The addition reads as follows: 

§ 558.625 Tylosin. 

* * * * * 

(e) * * * 

(2) * * * 

Tylosin grams/ton Combination in grams/ 

ton Indications for use Limitations Sponsors 

*******

(ix) 8 to 10 .................. Monensin, 10 to 40 

plus lubabegron (as 

lubebegron fumarate), 1.25 to 4.54, 

plus melengestrol 

acetate, 0.25 to 2.0.

Growing beef heifers fed in confinement for 

slaughter: For increased rate of weight 

gain, improved feed efficiency, suppression 

of estrus (heat), for reduction of ammonia 

gas emissions per pound of live weight and 

hot carcass weight, for 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 during the last 

14 to 91 days on feed.

Feed as the sole ration during the last 14 to 

91 days on feed. Melengestrol acetate 

Type C top-dress medicated feed (0.5 to 

2.0 lb per head per day) must be top 

dressed onto or mixed at feeding with a 

Type C medicated feed containing 8 to 10 

g/ton tylosin, 1.25 to 4.54 g/ton lubabegron, 

and 10 to 40 g/ton monensin, to provide 

0.25 to 0.5 mg melengestrol acetate, 60 to 

90 mg tylosin per head per day, 13 to 90 

mg lubabegron per head per day, and 0.14 

to 0.42 mg monensin per 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 §§ 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 § 510.600(c) of this chapter.

058198 

* * * * * * * 

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 

DEPARTMENT OF JUSTICE 

Office of the Attorney General 

28 CFR Part 50 

[Docket No. OAG 174; AG Order No. 6148– 

2025] 

RIN 1105–AB61 

Processes and Procedures for 

Issuance and Use of Guidance 

Documents 

AGENCY: Office of the Attorney General, 

Department of Justice. 

ACTION: Final rule. 

SUMMARY: This rule finalizes without 

change an interim final rule by which 

the Department of Justice 

(‘‘Department’’) removed amendments 

to its regulations that were made during 

2020 pursuant to the now-revoked 

Executive Order 13891, which had 

imposed limitations on the use of 

Department guidance documents in 

criminal and civil enforcement actions 

brought by the Department. 

DATES: This rule is effective January 17, 

2025. 

FOR FURTHER INFORMATION CONTACT: 

Robert Hinchman, Senior Counsel, 

Office of Legal Policy, U.S. Department 


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