Rules and Regulations. Final rule; technical amendments

4,897 words·~22 min read·/register/2025/08/22/2025-16079·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 528, and 558 [Docket No. FDA-2025-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 April, May, and June 2025.

The animal drug regulations are also being amended to improve their accuracy and readability. DATES: This rule is effective August 22, 2025. FOR FURTHER INFORMATION CONTACT: Cathie Marshall, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5693, *cathie.marshall@fda.hhs.gov.* SUPPLEMENTARY INFORMATION: I. Approval of Applications FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during April, May, and June 2025, as listed in table 1.

Documentation of environmental review required under the National Environmental Policy Act, summaries of the basis of approval under the Freedom of Information Act (FOIA summaries), and marketing exclusivity and patent information are available at Animal Drugs @FDA: *https://animaldrugsatfda.fda.gov/adafda/views/#/search.* Table 1—Original And Supplemental Applications Approved During April, May, and June 2025 Date of approval Application No. Sponsor (drug labeler code 1 ) Product name Effect of the action 21 CFR sections March 24, 2025 2 200-811 Bimeda Animal Health Ltd.

(061133) MOXICLOPRID for Cats (imidacloprid and moxidectin) Topical Solution Original approval as a generic copy of NADA 141-254 524.1146 March 24, 2025 3 200-810 Hikma Pharmaceuticals USA, Inc. (086194) Enrofloxacin Flavored Tablets (enrofloxacin flavored tablets) Original approval as a generic copy of NADA 140-441 520.812 April 3, 2025 200-791 Cronus Pharmaceuticals Specialities India Private Ltd. (069043) FLUNINE-S (flunixin meglumine injection) Injectable Solution Original approval as a generic copy of NADA 101-479 522.970 April 7, 2025 141-586 Phibro Animal Health Corp.

(066104) V-MAX (virginiamycin), RUMENSIN (monensin), and EXPERIOR (lubabegron) Type A medicated articles to be used in the manufacture of Type B and Type C medicated cattle feed Original approval 558.635 April 7, 2025 141-588 Phibro Animal Health Corp. (066104) V-MAX (virginiamycin) and RUMENSIN (monensin) Type A medicated articles to be used in the manufacture of Type B/C medicated cattle feeds Original approval 558.635 April 8, 2025 141-587 Phibro Animal Health Corp. (066104) V-MAX (virginiamycin), RUMENSIN (monensin), and OPTAFLEXX (ractopamine hydrochloride) Type A medicated articles to be used in the manufacture of Type B/C medicated cattle feeds Original approval 558.635 April 8, 2025 141-521 Zoetis Inc (054771) SIMPARICA TRIO (sarolaner, moxidectin, and pyrantel chewable tablets) Chewable Tablets Supplemental approval 520.2090 April 10, 2025 141-598 Dechra Ltd.

(043264) OTISERENE (marbofloxacin terbinafine dexamethasone otic suspension) Original approval 524.1312 April 23, 2025 141-554 Boehringer Ingelheim Animal Health USA, Inc.(000010) NEXGARD PLUS (afoxolaner, moxidectin, and pyrantel chewable tablets) Supplemental approval 520.35 April 24, 2025 200-797 Huvepharma EOOD (016592) COXIDIN (monensin) and BMD (bacitracin methylenedisalicylate) Type A medicated articles to be used in the manufacture of Type C medicated broiler feeds Original approval as a generic copy of NADA 049-463 558.355 April 24, 2025 200-798 Huvepharma EOOD (016592) COXIDIN (monensin) and FLAVOMYCIN (bambermycins) Type A medicated articles to be used in the manufacture of Type C medicated broiler feeds Original approval as a generic copy of NADA 098-340 558.355 April 24, 2025 200-799 Huvepharma EOOD (016592) COXIDIN (monensin) and BMD (bacitracin methylenedisalicylate) Type A medicated articles to be used in the manufacture of Type C medicated turkey feeds Original approval as a generic copy of NADA 140-937 558.355 April 24, 2025 200-800 Huvepharma EOOD (016592) COXIDIN (monensin) and FLAVOMYCIN (bambermycins) Type A medicated articles to be used in the manufacture of Type C medicated turkey feeds Original approval as a generic copy of NADA 140-955 558.355 April 24, 2025 200-801 Huvepharma EOOD (016592) COXIDIN (monensin) and INTEPRITY (avilamycin) Type A medicated articles to be used in the manufacture of Type C medicated broiler feeds Original approval as a generic copy of NADA 141-465 558.68 April 24, 2025 200-802 Huvepharma EOOD (016592) COXIDIN (monensin) and PENNITRACIN MD (bacitracin methylenedisalicylate) Type A medicated articles to be used in the manufacture of Type C medicated turkey feeds Original approval as a generic copy of NADA 141-540 558.355 April 29, 2025 141-609 Genus plc (086205) DELETION OF EXON 7 OF CD163 GENE IN DOMESTIC PIGS (Deletion of exon 7 of CD163 gene in domestic pigs) Original approval 528.2000 April 29, 2025 141-600 Intervet (000061) MOMETAMAX SINGLE (gentamicin, posaconazole, and mometasone furoate otic suspension) Original approval 524.1044j May 21, 2025 141-581 Elanco US Inc.

(058198) CREDELIO QUATTRO (lotilaner, moxidectin, praziquantel, and pyrantel) Supplemental approval 520.1287 June 24, 2025 200-812 Qilu Animal Health Products Co., Ltd. (086163) Cefovecin Sodium for Injection (cefovecin sodium) Original approval as a generic copy of NADA 141-285 522.311 June 27, 2025 200-813 Felix Pharmaceuticals Pvt. Ltd. (086101) Clindamycin Hydrochloride Tablets (clindamycin hydrochloride) Original approval as a generic copy of NADA 120-161 520.446 June 27, 2025 200-814 Felix Pharmaceuticals Pvt.

Ltd. (086101) Methimazole Coated Tablets (methimazole tablets) Original approval as a generic copy of NADA 141-292 520.1375 1 See 21 CFR 510.600(c) for sponsor addresses. 2 Approved in the first quarter of 2025. 3 Ibid. II. Withdrawal of Approval of Applications Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom (drug labeler code 043264) requested that FDA withdraw approval of one NADA listed in table 2 because the product was never manufactured or marketed.

Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211 (drug labeler code 017033) requested that FDA withdraw approval of two ANADAs listed in table 2 because the products are no longer manufactured or marketed. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions. Table 2—Applications for Which Approval Was Voluntarily Withdrawn During April, May, and June 2025 Date of withdrawal of approval Application No.

Product name 21 CFR section May 27, 2025 008-760 ADRENOMONE (corticotropin) Injectable Solution 522.480 Do 200-366 Carprofen Caplets (carprofen) 520.304 Do 200-575 Carprofen Chewable Tablets (carprofen) 520.304 III. Changes of Sponsor The sponsor of the approved application listed in table 3 has informed FDA that they have transferred ownership of, and all rights and interest in, this application to another sponsor. The regulation cited in table 3 is amended to reflect this action.

Table 3—Applications for Which Ownership Was Transferred to Another Sponsor During April, May, and June 2025 Application No. Product name Transferring sponsor (drug labeler code) New sponsor (drug labeler code) 21 CFR section 200-512 TRIAMULOX (tiamulin hydrogen fumarate) Zoetis Inc. (054771) Phibro Animal Health Corp. (066104) 520.2455 IV. Change of Sponsor Address Elanco US Inc., (drug labeler code 058198 in 21 CFR 510.600(c)) has informed FDA that it has changed its address.

ECO LLC, (drug labeler code 066916 in 21 CFR 510.600(c)) also has informed FDA that it has changed its address. The entries in § 510.600(c) are amended to reflect these actions. V. Technical Amendments FDA is making the following amendments to improve the accuracy and readability of the animal drug regulations. • 21 CFR 510.600(c) is amended to revise the entries for Elanco US Inc., and ECO, LLC in the lists of sponsors of approved applications, and to add entries for Genus plc. and Qilu Animal Health Products Co., Ltd. • 21 CFR 510.600(c) is amended to change the name of “Sergeant's Pet Care Products, Inc.” to “Sergeant's Pet Care Products LLC” in the lists of sponsors of approved applications. • 21 CFR 522.1260(e)(2)(iii) is amended to clarify that the statement “Federal law restricts this drug to use by or on the order of a licensed veterinarian” applies to all drug products in that paragraph.

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 under 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 528 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, 528, 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): i. Revise the entries for “ECO LLC”, “Elanco US Inc.”; ii. Add in alphabetical order entries for “Genus plc” and “Qilu Animal Health Products Co., Ltd.”; and iii.

Revise the entry for “Sergeant's Pet Care Products, Inc”; b. In the table in paragraph (c)(2), add entries in numerical order for “086163” and “086205”; and revise the entries for “021091”; “058198”, and “066916”. The revisions and additions read as follows: § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.

(c)* * *

(1)* * * Firm name and address Drug labeler code * * * * * * * ECO LLC, 506 Carnegie Centre, Suite 400, Princeton, NJ 08540 066916 Elanco US Inc., 450 Elanco Circle, Indianapolis, IN 46221 058198 * * * * * * * Genus plc, 1525 River Road, Deforest, WI 53532 086205 * * * * * * * Qilu Animal Health Products Co., Ltd., No. 10688, Wenliang Road, Dongjia Town, Licheng District Jinan, Shandong, 250100, China 086163 * * * * * * * Sergeant's Pet Care Products LLC, 10077 S. 134th St., Omaha, NE 68138 021091 * * * * * * *

(2)* * * Drug labeler code Firm name and address * * * * * * * 021091 Sergeant's Pet Care Products LLC, 10077 S. 134th St., Omaha, NE 68138 * * * * * * * 058198 Elanco US Inc., 450 Elanco Circle, Indianapolis, IN 46221 * * * * * * * 066916 ECO LLC, 506 Carnegie Centre, Suite 400, Princeton, NJ 08540 * * * * * * * 086163 Qilu Animal Health Products Co., Ltd., No. 10688, Wenliang Road, Dongjia Town, Licheng District Jinan, Shandong, 250100, China * * * * * * * 086205 Genus plc, 1525 River Road, Deforest, WI 53532 * * * * * * * 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 paragraph (c)(2) by adding a sentence at the end of the paragraph to read as follows: § 520.35 Afoxolaner, moxidectin, and pyrantel.

(c)* * *

(2)** * ** For the prevention of *Borrelia burgdorferi* infections as a direct result of killing *Ixodes scapularis* vector ticks. § 520.304 [Amended] 5. In § 520.304, in paragraph (b)(1), remove the text “Nos. 017033, 054771, 055529, and 082983” and in its place add the text “Nos. 054771, 055529, and 082983”. § 520.446 [Amended] 6. In § 520.446, in paragraph (b)(2), remove the text “No. 051311” and in its place add the text “Nos. 051311 and 086101”. § 520.812 [Amended] 7. In § 520.812, in paragraph (b)(2), remove the text “Nos. 017033 and 086117” and in its place add the text “Nos. 017033, 086117, and 086194”. 8. In § 520.1287, revise the first sentence in paragraph (c)(2) to read as follows: § 520.1287 Lotilaner, moxidectin, praziquantel, and pyrantel.

(c)* * *

(b)and (c)(1) to read as follows: § 520.1375 Methimazole tablets.

(b)*Sponsors,* See Nos. 043264 and 086101in § 510.600 of this chapter.

(c)* * *

(1)*Amount.* The starting dose is 2.5 mg every 12 hours. Following 3 weeks of treatment, the dose should be titrated to effect based on individual serum total T4

(TT4)levels and clinical response. Dose adjustments should be made in 2.5 mg increments. The maximum total dosage is 20 mg per day divided, not to exceed 10 mg as a single administration. 10. 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, the prevention of *Dipylidium caninum* (tapeworm) infections as a direct result of killing *Ctenocephalides felis* vector fleas on the treated dog, 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 one 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. 11. In § 520.2455: a. Revise paragraph (b)(2); and b. Remove paragraph (b)(4). The revision reads as follows: § 520.2455 Tiamulin.

(b)* * *

(2)No. 066104 for products described in paragraphs (a)(1) and

(3)of this section.

(3)* * *

(c)* * * PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 12. The authority citation for part 522 continues to read as follows: Authority: 21 U.S.C. 360b. § 522.311 [Amended] 13. In § 522.311, in paragraph (b), remove the text “ *Sponsor.* See No. 054771 in § 510.600(c) of this chapter” and in its place add the text “ *Sponsors.* See Nos. 054771 and 086163 in § 510.600(c) of this chapter”. 14. In § 522.480: a. Revise paragraph (b); and b. Remove paragraph (c)(3). The revision reads as follows: § 522.480 Corticotropin.

(b)*Sponsor.* See No. 061133 in § 510.600(c) of this chapter.

(c)*Conditions of use* —

(1)* * *

(2)* * * § 522.970 [Amended] 15. In § 522.970, in paragraph (b)(1), remove the text “Nos. 000061, 055529, and 061133” and in its place add the text “Nos. 000061, 055529, 061133, and 069043”; and in paragraph (b)(3), remove the text “Nos. 016592, 058198, and 069043” and in its place add the text “Nos. 016592 and 058198”. 16. In § 522.1260, revise paragraph (e)(2)(iii) to read as follows: § 522.1260 Lincomycin.

(e)* * *

(2)* * *

(iii)*Limitations.* Do not treat within 48 hours of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 17. The authority citation for part 524 continues to read as follows: Authority: 21 U.S.C360b. 18. In Part 524, add § 524.1144j to read as follows: § 524.1144j Gentamicin, posaconazole, and mometasone furoate otic suspension.

(a)*Sponsor.* See No. 000061 in § 510.600(c) of this chapter

(b)*Specifications.* A 0.8 milliliters

(mL)dose delivers 6.88 milligrams

(mg)gentamicin, 2.08 mg posaconazole, and 1.68 mg mometasone furoate.

(c)*Conditions of use* —This product should be administered by a veterinary professional.

(1)*Amount.* The dose volume is 0.8 mL per affected ear. Verify the tympanic membrane is intact prior to administration.

(2)*Indications for use.* For the treatment of otitis externa associated with susceptible strains of yeast *(Malassezia pachydermatis)* and bacteria *(Staphylococcus pseudintermedius and Pseudomonas aeruginosa))* in dogs.

(3)*Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian. § 524.1146 [Amended] 19. In § 524.1146, in paragraph (b)(2), remove the text “and 058198” and in its place add the text “058198, and 061133”; and in paragraph (b)(3), remove the text “058198, and” and in its place add the text “058198, 061133, and”. 20. Add § 524.1312 to read as follows: § 524.1312 Marbofloxacin, terbinafine, and dexamethasone otic suspension.

(a)*Specifications.* Each single-use tube contains 15.1 milligrams

(mg)marbofloxacin, 22.7 mg terbinafine, and 2.01 mg dexamethasone.

(b)*Sponsor.* See No. 043264 in § 510.600(c) of this chapter.

(c)*Conditions of use* —(1) *Amount.* Administer one dose (1 tube) per affected ear once. Do not clean the ear canal for 30 days after administration.

(2)*Indications for use.* For the treatment of otitis externa associated with susceptible strains of yeast *(Malassezia pachydermatis)* and bacteria *(Staphylococcus pseudintermedius)* in dogs.

(3)*Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian. PART 528—INTENTIONAL GENOMIC ALTERATIONS IN ANIMALS 21. The authority citation for part 528 continues to read as follows: Authority: 21 U.S.C. 360b. 22. Add § 528.2000 to read as follows: § 528.2000 Deletion of exon 7 of CD163 gene in domestic pigs.

(a)*Specifications.* Deletion of one (heterozygous) or two (homozygous) copies of exon 7 of *CD163* gene1(abbreviated CD163ΔE7) in domestic pigs ( *Sus scrofa domesticus* ).

(b)*Sponsor.* See No. 086205 in § 510.600(c) of this chapter.

(c)*Conditions of use* —(1) *Intended use.* Deletion of exon 7 of the *CD163* gene in domestic pigs ( *Sus scrofa domesticus)* is intended to confer resistance to porcine reproductive and respiratory syndrome virus (PRRSV) in homozygous pigs. Pigs carrying one or two copies of CD163 D E7 , and their offspring, are intended for breeding or to be used as sources of food. PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 23. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 24. In § 558.68, revise paragraphs (e)(1)(ii) and

(vii)to read as follows: § 558.68 Avilamycin.

(e)* * *

(1)* * * Avilamycin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor * * * * * * *

(ii)13.6 to 40.9 Monensin, 90 to 110 Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with *Clostridium perfringens,* and as an aid in the prevention of coccidiosis caused by E *imeria necatrix, E. tenella,* *E. acervulina, E. brunetti,* *E. mivati,* and *E. maxima* Feed as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with *Clostridium perfringens.* To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. Monensin as provided by Nos. 016592 or 058198 in § 510.600(c) of this chapter. See § 558.355(d) 016592 058198 * * * * * * * * * * * * * *

(vii)100 For the treatment of swine dysentery and the control of porcine proliferative enteropathies (ileitis) caused by *Lawsonia intracellularis* Feed as a sole ration for 3 weeks or until signs of disease (watery, mucoid, or bloody stools) disappear 066104 * * * * * * * 25. In § 558.355, revise paragraphs (b)(2), (e)(1)(vii) and (xiv), and (e)(2)(ii) through

(v)to read as follows: § 558.355 Monensin.

(b)* * *

(2)No. 016592 for use of a Type A medicated article containing 90.7 grams monensin, USP, per pound as in paragraphs (e)(1)(i), (e)(1)(ii), (e)(1)(vii), (e)(1)(xiv), (e)(2), (e)(3), (e)(4)(v), and (e)(5) of this section.

(e)* * *

(1)* * * Monensin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor * * * * * * *

(vii)90 to 110 Bacitracin methylenedisalicylate, 5 to 25 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, * E. acervulina, E. brunetti,* *E. mivati,* and *E. maxima,* and for increase in rate of weight gain and improved feed efficiency Feed as the sole ration. Monensin as provided by Nos. 016592 or 058198; bacitracin methylenedisalicylate as provided by No. 066104 in § 510.600(c) of this chapter. See special labeling considerations in paragraph

(d)of this section. 016592 058198 * * * * * * *

(xiv)90 to 110 Bambermycins, 1 to 2 Broiler chickens: As an aid in the prevention of coccidiosis caused by *Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati,* and *E. maxima,* and for increase in rate of weight gain and improved feed efficiency Feed as the sole ration. Monensin as provided by Nos. 016592 or 058198; bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. See special labeling considerations in paragraph

(d)of this section. 016592 058198 * * * * * * *

(2)* * * Monensin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor * * * * * * *

(ii)54 to 90 Bacitracin methylenedisalicylate, 4 to 50 Growing turkeys: For the prevention of coccidiosis caused by *Eimeria adenoeides, E. meleagrimitis,* and *E. gallopavonis,* and for increased rate of weight gain and improved feed efficiency Feed continuously as the sole ration. The optimum level depends upon the severity of coccidiosis exposure. Monensin as provided by Nos. 016592 or 058198; bacitracin methylenedisalicylate as provided by Nos. 066104 or 069254 in § 510.600(c) of this chapter. See special labeling considerations in paragraph

(d)of this section 016592 058198 069254

(iii)54 to 90 Bacitracin methylenedisalicycate, 200 Growing turkeys: For the prevention of coccidiosis caused by *Eimeria adenoeides, E. meleagrimitis,* and *E. gallopavonis,* and as an aid in the control of transmissible enteritis complicated by organisms susceptible to bacitracin methylenedisalicylate Feed continuously as the sole ration. Monensin as provided by Nos. 016592 or 058198; bacitracin methylenedisalicylate as provided by No. 066104 in § 510.600(c) * of this chapter.* See special labeling considerations in paragraph

(d)of this section 016592 058198

(iv)54 to 90 Bambermycins, 1 to 2 Growing turkeys: For the prevention of coccidiosis caused by *Eimeria adenoeides, E. meleagrimitis,* and *E. gallopavonis,* and for improved feed efficiency Feed continuously as the sole ration. Monensin as provided by Nos. 016592 or 058198; bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. See special labeling considerations in paragraph

(d)of this section 016592 058198

(v)54 to 90 Bambermycins, 2 Growing turkeys: For the prevention of coccidiosis caused by *Eimeria adenoeides, E. meleagrimitis,* and *E. gallopavonis,* and for increased rate of weight gain and improved feed efficiency Feed continuously as sole ration. Monensin as provided by Nos. 016592 or 058198; bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. See special labeling considerations in paragraph

(d)of this section 016592 058198 26. In § 558.635, add paragraphs (e)(3)(ii) through

(viii)to read as follows: § 558.635 Virginiamycin.

(e)* * *

(3)* * * Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations Sponsor * * * * * * *

(ii)13.5 to 16.0 Monensin, 5 to 40 Growing beef steers and heifers fed in confinement for slaughter: For improved feed efficiency and reduction of incidence of liver abscesses Feed at every feeding to provide 50 to 480 mg monensin/head/day and 85 to 240 mg virginiamycin/head/day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 g/ton (360 mg monensin/head/day). A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See § 558.355(d) 066104

(iii)13.5 to 16.0 Monensin, 10 to 40 Growing beef steers and heifers fed in confinement for slaughter: For the prevention and control of coccidiosis caused by *Eimeria bovis* and *Eimeria zuernii,* and reduction of incidence of liver abscesses Feed at every feeding to provide 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of coccidiosis challenge, up to a maximum of 480 mg monensin/head/day and 85 to 240 mg virginiamycin/head/day. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See § 558.355(d) 066104

(iv)13.5 to 16.0 Monensin, 5 to 40; and lubabegron, 1.25 to 4.54 Growing beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed: For reduction of ammonia gas emissions per pound of live weight and hot carcass weight, improved feed efficiency, and reduction of incidence of liver abscesses Feed at every feeding as sole ration to provide 13 to 90 mg lubabegron/head/day, 50 to 480 mg monensin/head/day and 85 to 240 mg virginiamycin/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). A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See § 558.355(d) 066104

(v)13.5 to 16.0 Monensin, 10 to 40; and lubabegron, 1.25 to 4.54 Growing beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed: For reduction of ammonia gas emissions per pound of live weight and hot carcass weight, the prevention and control of coccidiosis caused by *Eimeria bovis* and *Eimeria zuernii,* and reduction of incidence of liver abscesses Feed at every feeding as sole ration to provide 13 to 90 mg lubabegron/head/day, 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of coccidiosis challenge, up to a maximum of 480 mg monensin/head/day and 85 to 240 mg virginiamycin/head/day during the last 14 to 91 days on feed. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See § 558.355(d) 066104

(vi)13.5 to 16.0 Monensin, 10 to 40; and ractopamine hydrochloride, 8.2 to 24.6 Growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feed: For increased rate of weight gain, improved feed efficiency, the prevention and control of coccidiosis caused by *Eimeria bovis* and * Eimeria zuernii,* and reduction of incidence of liver abscesses Feed at every feeding as a sole ration to provide 70 to 430 mg ractopamine hydrochloride/head/day, 0.14 to 0.42 mg monensin/lb of body weight per day, depending upon severity of coccidiosis challenge, up to a maximum of 480 mg monensin/head/day and 85 to 240 mg virginiamycin/head/day during the last 28 to 42 days on feed. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See § 558.355(d) 066104

(vii)13.5 to 6.0 Monensin, 10 to 40; and ractopamine hydrochloride, 9.8 to 24.6 Growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feed: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, the prevention and control of coccidiosis caused by *Eimeria bovis* and * Eimeria zuernii,* and reduction of incidence of liver abscesses Feed at every feeding as a sole ration to provide 90 to 430 mg ractopamine hydrochloride/head/day, 0.14 to 0.42 mg monensin/lb of body weight per day, depending upon severity of coccidiosis challenge, up to a maximum of 480 mg monensin/head/day and 85 to 240 mg virginiamycin/head/day during the last 28 to 42 days on feed. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See § 558.355(d) 066104

(viii)13.5 to 16.0 Monensin, 10 to 40; and ractopamine hydrochloride, not to exceed 800 Growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feed: For increased rate of weight gain and improved feed efficiency, the prevention and control of coccidiosis caused by *Eimeria bovis* and * Eimeria zuernii,* and reduction of incidence of liver abscesses when ractopamine hydrochloride is used as a top dress with rations containing monensin and virginiamycin Feed a minimum of 1.0 lb per head per day of this Type C top-dress medicated feed to provide 70 to 400 mg/head/day ractopamine hydrochloride during the last 28 to 42 days on feed. Must be top dressed onto or mixed at feeding with a Type C medicated feed containing 10 to 40 g/ton monensin and 13.5 to 16 g/ton virginiamycin (90% dry matter basis), to provide 0.14 to 0.42 mg monensin/lb of body weight per day, depending upon severity of coccidiosis challenge, up to a maximum of 480 mg monensin/head/day and 85 to 240 mg virginiamycin/head/day. See § 558.355(d) 066104 Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2025-16079 Filed 8-21-25; 8:45 am]

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