[Federal Register Volume 91, Number 73 (Thursday, April 16, 2026)] [Rules and Regulations] [Pages 20337-20348] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2026-07500] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 516, 520, 522, 524, and 558 [Docket No. FDA-2025-N-0002] New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; 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), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during October, November, and December 2025. The animal drug regulations are also being amended to improve their accuracy and readability. DATES: This rule is effective April 16, 2026. FOR FURTHER INFORMATION CONTACT: James Delaney, Center for Veterinary Medicine, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. james.delaney@fda.hhs.gov, 240-402-5677. SUPPLEMENTARY INFORMATION: I. Approval of Applications FDA is amending the animal drug regulations to reflect approval actions for NADAs, ANADAs, and CNADAs during October, November, and December 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, Conditional, and Supplemental Applications Approved During October, November, and December 2025 ---------------------------------------------------------------------------------------------------------------- Application Sponsor (drug Effect of the 21 CFR Date of approval No. labeler code \1\) Product name action sections ---------------------------------------------------------------------------------------------------------------- October 20, 2025........... 141-581 Elanco US Inc. CREDELIO QUATTRO Supplemental 520.1287 (058198). (lotilaner, Approval. moxidectin, praziquantel, and pyrantel chewable tablets). October 21, 2025........... 200-825 Felix Clomipramine Original approval 520.455 Pharmaceuticals Hydrochloride as a generic copy Pvt. Ltd. Tablets. of NADA 141-120. (086101). October 21, 2025........... 141-574 Pharmgate Inc. PENNITRACIN MD 50G Original approval. 558.363 (069254). (bacitracin methylenedisalicy late Type A medicated article) and MONTEBAN (narasin Type A medicated article). October 24, 2025........... 141-494 Elanco US Inc. CREDELIO Supplemental 520.1286 (058198). (lotilaner). approval. December 5, 2025........... 200-710 Dechra Veterinary Maropitant Citrate Original approval 522.1315 Products LLC (maropitant as a generic copy (017033). citrate) of NADA 141-263. injectable solution. December 17, 2025.......... 141-619 Elanco US Inc. CREDELIO QUATTRO Conditional 516.1287 (058198). CA1 (lotilaner, approval. moxidectin, praziquantel, and pyrantel chewable tablets). December 18, 2025.......... 141-614 Anivive LAVERDIA Original approval 520.2700 Lifesciences, (verdinexor from conditional 516.2980 Inc. (086121). tablets). approval. December 19, 2025.......... 141-576 Dechra, Ltd. COSACTHEN Original approval. 522.500 (043264). (cosyntropin injection). December 19, 2025.......... 141-273 Boehringer VETMEDIN Supplemental 520.1780 Ingelheim Animal (pimobendan). approval. Health USA, Inc. (000010). [[Page 20338]] December 19, 2025.......... 200-823 Dechra Veterinary Zygolide Original approval 520.1705 Products LLC (pergolide as a generic copy (017033). tablets). of NADA 141-331. December 22, 2025.......... 200-832 ZyVet Animal Robenacoxib Original approval 520.2075 Health, Inc. (robenacoxib). as a generic copy (086117). of NADA 141-320. December 22, 2025.......... 200-834 Felix Praziquantel Original approval 520.1870 Pharmaceuticals Tablets as a generic copy Pvt. Ltd. (praziquantel of NADA 111-798. (086101). tablets). December 22, 2025.......... 200-829 Aurora Klentz Original approval 524.957 Pharmaceutical, (florfenicol, as a generic copy Inc. (051072). terbinafine, of NADA 141-440. mometasone furoate) otic solution. ---------------------------------------------------------------------------------------------------------------- \1\ See 21 CFR 510.600(c) for sponsor addresses. II. 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 3 are amended to reflect these actions. Table 2--Applications for Which Ownership Was Transferred to Another Sponsor During October, November, and December 2025 ---------------------------------------------------------------------------------------------------------------- Transferring sponsor New sponsor (drug 21 CFR Application No. Product name (drug labeler code) labeler code) section ---------------------------------------------------------------------------------------------------------------- 039-417................... DECCOX ((decoquinate Zoetis (054771)........ Phibro (066104)....... 558.195 Type A medicated article). 040-209................... ROFENAID 40 Do..................... Do.................... 558.575 (sulfadimethoxine and ormetoprim Type A medicated article). 045-348................... DECCOX and ALBAC Do..................... Do.................... 558.195 (decoquinate Type A medicated article and bacitracin zinc Type A medicated article). 097-505................... LINCOMIX 20 and Do..................... Do.................... 558.325 LINCOMIX 50 (lincomycin Type A medicated article). 111-636................... LINCOMIX Soluble Powder Do..................... Do.................... 520.1263b (lincomycin hydrochloride soluble powder). 138-941................... LINCOMIX and BANMINTH Do..................... Do.................... 558.325 (lincomycin Type A medicated article and pyrantel tartrate Type A medicated article). 140.853................... BMD and MONTEBAN Do..................... Do.................... 558.363 (bacitracin methylenedisalicylate Type A medicated article and narasin Type A medicated article). 140-865................... MONTEBAN and BACIFERM Do..................... Do.................... 558.363 or MONTEBAN and ALBAC (narasin Type A medicated article and bacitracin zinc Type A medicated article). 141-025................... CATTLYST (laidlomycin Do..................... Do.................... 558.305 propionate potassium Type A medicated article). 141-102................... DECCOX and BMD Do..................... Do.................... 558.1951 (decoquinate Type A medicated article and bacitracin methylenedisalicylate Type A medicated article). 141-148................... DECCOX and Rumensin Do..................... Do.................... 558.1951 (decoquinate Type A medicated article and monensin Type A medicated article). 141-149................... DECCOX and RUMENSIN and Do..................... Do.................... 558.625 TYLAN (decoquinate Type A medicated article and monensin Type A medicated article and tylosin phosphate Type A medicated article). 141-191................... COBAN and LINCOMIX Do..................... Do.................... 558.325 (monensin Type A medicated article and lincomycin Type A medicated article). 141-483................... DECCOX and LINCOMIX Do..................... Do.................... 558.325 decoquinate Type A medicated article and lincomycin Type A medicated articles to be used in the manufacture of Type C medicated feeds. 141-484................... BIO-COX and LINCOMIX Do..................... Do.................... 558.325 (salinomycin sodium Type A medicated article and lincomycin Type A medicated article). 141-485................... COYDEN and LINCOMIX Do..................... Do.................... 558.325 (clopidol Type A medicated article and lincomycin Type A medicated article). [[Page 20339]] 141-489................... ZOAMIX and LINCOMIX Do..................... Do.................... 558.325 (zoalene Type A medicated article and lincomycin Type A medicated article). 200-218................... COYDEN and ALBAC Do..................... Do.................... 558.175 (clopidol Type A medicated article and bacitracin zinc Type A medicated article). 200-548................... Actogain (ractopamine Do..................... Do.................... 558.500 hydrochloride). 200-579................... Altrenogest Solution Ceva Sante Animale Diamond Animal Health, 520.48 (altrenogest). (013744). Inc. (053701). ---------------------------------------------------------------------------------------------------------------- III. Change of Sponsor Address Ivaoes Animal Health (drug labeler code 086064 in 21 CFR 510.600(c)), Kinetic Technologies, LLC, (drug labeler code 051031 in 21 CFR 510.600(c)), and Qbiotics Group Ltd., (drug labeler code 086132 in 21 CFR 510.600(c)) have informed FDA that they have changed their address. The entries in Sec. 510.600(c) are amended to reflect these actions. IV. 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 remove the entries for Agri Laboratories, Ltd., as the firm is no longer the sponsor of approved applications, and to add an entry for TriviumVet. • 21 CFR 520.1660d is amended to reflect a 2016 and 2018 change of sponsorship for oxytetracycline powder that did not get recorded in the CFR. • 21 CFR 520.2345d is amended to reflect a 2018 change of sponsorship for tetracycline powder. • 21 CFR 522.2100 is revised to clarify the dosage is in pounds of body weight for all species listed. • 21 CFR 524.1055h is amended to add clarity to the dosage directions for dogs. • 21 CFR 558.78 is amended to remove inadvertent text. • 21 CFR 558.500 is amended to present additional language for labeling and to add clarity to indications for use and limitations. V. 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 Part 516 Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements. 21 CFR Parts 520, 522, and 524 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, 516, 520, 522, 524, and 558 are amended as follows: PART 510--NEW ANIMAL DRUGS 0 1. The authority citation for part 510 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 0 2. In Sec. 510.600: 0 a. In the table in paragraph (c)(1): 0 i. Revise the entries for Ivaoes Animal Health, Kinetic Technologies, LLC, and Qbiotics Group Ltd., 0 ii Add in alphabetical order an entry for TriviumVet, and 0 iii. Remove the entry for Agri Laboratories, Ltd. 0 b. In the table in paragraph (c)(2), add an entry in numerical order for 086169; remove the entry for 057561, and revise the entries for 051031, 086064, and 086132. The revisions and additions read 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 ------------------------------------------------------------------------ * * * * * * * Ivaoes Animal Health, 1200 NW 78th, Suite 200-D, Doral, 086064 FL 33126............................................... * * * * * * * Kinetic Technologies, LLC, 1700 Albany Pl SE, Orange 051031 City, IA 51041......................................... * * * * * * * Qbiotics Group Ltd., Level 14, 15 Lakes Street, Cairns, 086132 Queensland, QLD4870, Australia......................... * * * * * * * TriviumVet, Unit 3A, Cleaboy Business Park, Old 086169 Kilmeaden Road, Waterford, Waterford, X91 H5FE, Ireland [[Page 20340]] * * * * * * * ------------------------------------------------------------------------ (2) * * * ------------------------------------------------------------------------ Drug labeler code Firm name and address ------------------------------------------------------------------------ * * * * * * * 051031................... Kinetic Technologies, LLC, 1700 Albany Pl SE, Orange City, IA 51041. * * * * * * * 086064................... Ivaoes Animal Health, 1200 NW 78th, Suite 200- D, Doral, FL 33126. * * * * * * * 086132................... Qbiotics Group Ltd., Level 14, 15 Lakes Street, Cairns, Queensland, QLD4870, Australia. * * * * * * * 086169................... TriviumVet, Unit 3A, Cleaboy Business Park, Old Kilmeaden Road, Waterford, Waterford, X91 H5FE, Ireland. * * * * * * * ------------------------------------------------------------------------ PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES 0 3. The authority citation for part 516 continues to read as follows: Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371. 0 4. Add Sec. 516.1287 to read as follows: Sec. 516.1287 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 at the minimum dosage of 9 mg/pound (mg/lb) (20 mg/kilogram (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 treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) 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. It is a violation of Federal law to use this product other than as directed in the labeling. Sec. 516.2980 [Removed] 0 5. Remove Sec. 516.2980. PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 0 6. The authority citation for part 520 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 520.48 [Amended] 0 7. In Sec. 520.48, in paragraph (b)(3), remove the text ``No. 013744'' and in its place add the text ``No. 053701''. Sec. 520.455 [Amended] 0 8. In Sec. 520.455, in paragraph (a), remove the text ``Specifications'' and in its place add the text ``Specifications'', and in paragraph (b), remove the text ``Nos. 051311 and 086039'' and in its place add the text ``Nos. 051311, 086039, and 086101''. 0 9. In Sec. 520.1263b, 0 a. Retitle the section, 0 b. In paragraph (b)(1), remove the text ``Nos. 054771 and 061133'' and in its place add the text ``Nos. 061133 and 066104'', and 0 c. Revise paragraph (d), to read as follows: Sec. 520.1263b Lincomycin hydrochloride soluble powder. * * * * * (b) * * * (1) Nos. 061133 and 066104 for use as in paragraph (d) of this section. * * * * * (d) * * * (1) Swine-- (i) Amount. Administer at a dose rate of 250 milligrams (mg) of lincomycin per gallon of drinking water. In clinical studies, this dose rate provided an average of 3.8 mg of lincomycin per pound of body weight per day. The drug should be administered for a minimum of 5 consecutive days beyond the disappearance of symptoms (bloody stools) up to a maximum of 10 consecutive days. If water treatment is discontinued prior to this time, a lincomycin treatment program may be continued with lincomycin Type A medicated article at 100 grams lincomycin per ton of complete feed as the sole ration according to label directions. A dose of 3.8 mg lincomycin per pound of body weight may be maintained by medicating the drinking water at a concentration of 250 mg per gallon of drinking water when pigs are consuming 1.5 gallons per 100 lb of body weight per day. Under these circumstances the concentration of lincomycin required in medicated water may be adjusted to compensate for variations in age and weight of animals, the nature and severity of disease symptoms, environmental temperature and humidity, each of which affects water consumption. For use in automatic water proportioner to deliver 1 ounce of stock solution per gallon of drinking water. NOTE: After a treatment program is discontinued, a control program for swine dysentery may be followed by feeding lincomycin Type A [[Page 20341]] medicated article at 40 grams lincomycin per ton of complete feed as the sole ration. (ii) Indications for use. For the treatment of swine dysentery (bloody scours) in swine. Not for use in pregnant swine or swine intended for breeding. (iii) Limitations. Discard medicated drinking water if not used within 2 days. Fresh stock should be prepared daily. Do not use the water treatment and the feed treatment simultaneously. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to water containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. If clinical signs of bloody scours (watery, mucoid, or bloody stools) have not improved during the first 6 days of medication, discontinue treatment and redetermine the diagnosis. On rare occasions, some pigs may show reddening of the skin, swelling of the anus, and irritable behavior. These conditions have been self- correcting within five to seven days without discontinuing the lincomycin treatment. The safety of lincomycin has not been demonstrated for pregnant swine or swine intended for breeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Broiler Chickens-- (i) Amount. Administer at a dose rate of 64 mg of lincomycin per gallon of drinking water. Start medication as soon as the diagnosis of necrotic enteritis is determined. The drug should be administered for 7 consecutive days. NOTE: After water medication is discontinued, a control program for necrotic enteritis may be followed by feeding lincomycin Type A medicated article at 2 grams lincomycin per ton of complete feed. (ii) * * * (iii) Limitations. Not for use in laying hens or breeder chickens. Discard medicated drinking water if not used within 2 days. Fresh stock should be prepared daily. Do not use the water treatment and the feed treatment simultaneously. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to water containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (3) Honey bees-- (i) Amount. Administer 100 mg lincomycin per hive once weekly for 3 weeks. Mix 250 mg LINCOMIX Soluble Powder (100 mg lincomycin) with 20 g confectioners'/powder sugar and dust over the top bars of the brood chamber. (ii) Indications for use. For the control of American foulbrood (Paenibacillus larvae) in honey bees. * * * * * 0 10. In Sec. 520.1286, revise paragraph (c)(1)(ii) to read as follow: Sec. 520.1286 Lotilaner. * * * * * (c) * * * (1) * * * (i) * * * (ii) Indications for use. Kills adult fleas, and 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), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick)) for one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater. For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. * * * * * 0 11. In Sec. 520.1287, revise paragraph (c)(2) to read as follows: Sec. 520.1287 Lotilaner, moxidectin, praziquantel, and pyrantel. * * * * * (c) * * * (1) * * * (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 (fourth stage larvae, immature adult, and adult Ancylostoma caninum and 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), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick)) for one month in dogs and puppies 8 weeks of age and older, and weighing 3.3 pounds or greater. For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. * * * * * 0 12. In Sec. 520.1660d, 0 a. Revise paragraph (d)(1)(ii)(A)(3), and 0 b. Revise paragraph (d)(1)(ii)(B)(3) to read as follows: Sec. 520.1660d Oxytetracycline powder. * * * * * (d) * * * (1) * * * (ii) Turkeys-- (A) * * * (3) Do not use in birds producing eggs for human consumption. Withdraw 5 days prior to slaughter those products sponsored by Nos. 054771 and 061133 in Sec. 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 016592. Zero-day withdrawal for those products sponsored by Nos. 016592 and 069254. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (B) * * * (3) Do not use in birds producing eggs for human consumption. Withdraw 5 days prior to slaughter those products sponsored by Nos. 054771 and 061133 in Sec. 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 016592. Zero-day withdrawal for those products sponsored by Nos. 016592 and 069254. Federal law restricts this drug to use by or on the order of a licensed veterinarian. * * * * * Sec. 520.1705 [Amended] 0 13. In Sec. 520.1705, in paragraph (a), remove the text ``peroglide (as pergolide mesylate)'' and in its place add the text ``pergolide (as pergolide mesylate)'', and in paragraph (b), remove the text ``No. 000010'' and in its place add the text ``Nos. 000010 and 017033''. 0 14. In Sec. 520.1780, revise paragraph (c)(2) to read as follows: Sec. 520.1780 Pimobendan tablets. * * * * * (c) * * * (2) Indications for use. For the delay of onset of congestive heart failure in dogs with Stage B2 preclinical myxomatous mitral valve disease. Stage B2 preclinical myxomatous mitral valve disease (MMVD) refers to dogs with asymptomatic MMVD that have a moderate or loud mitral murmur due to mitral regurgitation and cardiomegaly. For the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical MMVD or dilated cardiomyopathy (DCM); for use with concurrent therapy for congestive heart failure (e.g., [[Page 20342]] furosemide, etc.,) as appropriate on a case-by-case basis. * * * * * 0 15. In Sec. 520.1870: 0 a. Revise paragraphs (a) introductory text, revise paragraphs (a)(1) and (2), and add paragraph (a)(3); and 0 b. Add paragraph (b)(3). The revisions and additions read as follows: Sec. 520.1870 Praziquantel tablets. (a) Specifications. (1) Each tablet contains 34 milligrams (mg) praziquantel. (2) Each tablet contains 11.5 or 23 mg praziquantel. (3) Each chewable tablet contains 23 mg praziquantel. (b) * * * (3) No. 086101 for use of product as described in paragraph (a)(3) of this section as in paragraph (c)(2) of this section. * * * * * 0 16. In Sec. 520.2075, revise paragraphs (a) and (b) to read as follows: Sec. 520.2075 Robenacoxib. (a) Specifications. Each tablet contains: (1) 10, 20, or 40 milligrams (mg) robenacoxib for use in dogs; or (2) 6 mg robenacoxib for use in cats. (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter. (1) No. 058198 for use of product described in paragraph (a)(1) and (a)(2) of this section as in paragraph (c)(1) and (c)(2) of this section. (2) No. 086117 for use of product described in paragraph (a)(2) of this section as in paragraph (c)(2) of this section. * * * * * Sec. 520.2345d [Amended] 0 17. In Sec. 520.2345d, in paragraph (d)(1)(iii), remove the text ``for Nos. 016592, 054771, 054925, 057561, and 061133'' and in its place add the text ``for Nos. 016592, 054771, 054925, and 061133'', and in paragraph (d)(2)(iii), remove the text ``for Nos. 016592, 054771, 054925, 057561, and 061133'' and in its place add the text ``for Nos. 016592, 054771, 054925, and 061133''. 0 18. Add Sec. 520.2700 to read as follows: Sec. 520.2700 Verdinexor tablets. (a) Specifications. Each tablet contains 2.5, 10, 22.5, or 50 milligrams (mg) verdinexor. (b) Sponsor. See No. 086121 in Sec. 510.600(c) of this chapter. (c) Conditions of use-- (1) Amount. Administer verdinexor tablets orally at an initial dose of 1.25 mg per kilogram (mg/kg) of body weight twice per week with at least 72 hours between doses. If tolerated after 2 weeks, increase the dose to 1.5 mg/kg twice per week with at least 72 hours between doses. (2) Indications for use. For the treatment of lymphoma in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling. PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 19. The authority citation for part 522 continues to read as follows: Authority: 21 U.S.C. 360b. 0 20. Add Sec. 522.500 to read as follows: Sec. 522.500 Cosyntropin injection. (a) Sponsor. See No. 043264 in Sec. 510.600(c) of this chapter. (b) Specifications. Each milliliter (mL) contains 0.25 milligrams (mg) cosyntropin, 1 mg glacial acetic acid, 0.82 mg sodium acetate trihydrate, 8.1 mg sodium chloride, and water for injection (to 100%). (c) Conditions of use-- (1) Amount. Administer 0.25 mg (1 mL) per dog weighing 10-110 pounds (4.5-50 kilograms) by intravenous or intramuscular injection. (2) Indications for use. For the evaluation of adrenal function in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling. Sec. 522.1315 [Amended] 0 21. In Sec. 522.1315, in paragraph (b), remove the text ``No. 054771'' and in its place add the text ``Nos. 054771 and 017033''. 0 22. In Sec. 522.2100, revise paragraph (c)(3)(i) to read as follows: Sec. 522.2100 Selenium and vitamin E. * * * * * (c) * * * (3) * * * (i) Dosage. Calves: 2.5 to 3.75 milliliters per 100 pounds of body weight. Lambs 2 weeks of age and older: 1 milliliter per 40 pounds of body weight, minimum 1 milliliter. Ewes: 2.5 milliliters per 100 pounds of body weight. Sows: 1 milliliter per 40 pounds of body weight. Weanling pigs: 1 milliliter per 40 pounds of body weight, minimum 1 milliliter. * * * * * PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0 23. The authority citation for part 524 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 524.957 [Amended] 0 24. In Sec. 524.957, in paragraph (b), remove the text ``Nos. 017030 and 058198'' and in its place add the text ``Nos. 017030, 051072, and 058198''. 0 25. In Sec. 524.1044h, revise paragraph (c)(1) to read as follows: Sec. 524.1044h Gentamicin, mometasone, and clotrimazole otic suspension. * * * * * (c) * * * (1) Amount. For dogs weighing less than 30 pounds (lb), instill 4 drops from the 7.5 gram (g), 15 g, or 30 g bottles (2 drops from the 215 g bottle) once daily into the ear canal. For dogs weighing 30 lb or more, instill 8 drops from the 7.5 g, 15 g, or 30 g bottles (4 drops from the 215 g bottle) once daily into the ear canal. Therapy should continue for 7 consecutive days. * * * * * PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 26. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 0 27. In Sec. 558.78, revise paragraph (d)(1)(vii) to read as follows: Sec. 558.78 Bacitracin zinc. * * * * * (d) * * * (1) * * * ---------------------------------------------------------------------------------------------------------------- Combination in Bacitracin zinc in grams per ton grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (vii) 20 to 40.................... ................... Growing-finishing ....................... 054771 swine; improved feed efficiency. [[Page 20343]] * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * Sec. 558.175 [Amended] 0 28. In Sec. 558.175, in the table in paragraph (d)(1)(iii), in the Sponsors column, replace the text ``054771'' and in its place add the text ``066104''. 0 29. In Sec. 558.195, 0 a. In the tables in (e)(1), (e)(2), and (e)(3), in the ``Sponsor'' column, remove ``054771'' where it occurs, and in its place add ``066104''. 0 b. Revise paragraphs (e)(1)(ii), (e)(1)(iii), and (e)(2)(ii) to read as follows: Sec. 558.195 Decoquinate. * * * * * (e) * * * (1) Chickens-- ---------------------------------------------------------------------------------------------------------------- Combination in Decoquinate in grams/ton grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (ii) 27.2......................... Bacitracin (as Broiler chickens: Feed as the sole 066104 bacitracin For the prevention ration. Do not feed to methylenedisalicyl of coccidiosis chickens producing ate), 4 to 50. caused by Eimeria eggs for human tenella, E. consumption. Do not necatrix, E. use in feeds acervulina, E. containing bentonite. mivati, E. maxima, Bacitracin and E. brunetti, methylenedisalicylate and for increased as provided by No. rate of weight 066104 in Sec. gain and improved 510.600(c) of this feed efficiency. chapter. (iii) 27.2........................ Bacitracin zinc, 10 Broiler chickens: Feed as the sole 066104 to 50. For the prevention ration. Do not feed to of coccidiosis chickens producing caused by Eimeria eggs for human tenella, E. consumption. necatrix, E. Bacitracin zinc as acervulina, E. provided by No. 054771 mivati, E. maxima, in Sec. 510.600(c) and E. brunetti; of this chapter. and for increased rate of weight gain and improved feed efficiency. ---------------------------------------------------------------------------------------------------------------- (2) Cattle-- ---------------------------------------------------------------------------------------------------------------- Combination in Decoquinate in grams/ton grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (ii) 12.9 to 90.8................. Monensin, 5 to 30.. Growing beef steers Feed as the sole ration 066104 and heifers fed in to provide 22.7 mg of confinement for decoquinate per 100 lb slaughter: For of body weight per day prevention of and 50 to 360 mg of coccidiosis caused monensin per head per by Eimeria bovis day. Feed at least 28 and E. zuernii; days during periods of and for improved coccidiosis exposure feed efficiency. or when experience indicates that coccidiosis is likely to be a hazard. Do not feed to cows producing milk for human consumption. A withdrawal period has not been established for this product in pre-ruminant calves. Do not use in calves to be processed for veal. Also see paragraph (d)(1) of this section and Sec. 558.355(d)(9)(i). Monensin as provided by No. 016592 or 058198 in Sec. 510.600(c) of this chapter. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * 0 30. In Sec. 558.305, 0 a. Retitle the section, and 0 b. Revise paragraphs (d)(1) through (d)(3), (e)(1), (e)(2), and (f), to read as follows: Sec. 558.305 Laidlomycin propionate potassium. * * * * * (d) * * * (1) Laidlomycin propionate potassium Type B liquid medicated feeds may be manufactured from dry laidlomycin propionate potassium Type A medicated articles. The Type B liquid medicated feeds must have a pH of 6.0 to 8.0, dry matter of 62 to 75 percent, and bear appropriate mixing directions as follows: * * * * * (2) The expiration date of the Type B liquid medicated feed is 21 days after date of manufacture. The expiration date for the dry Type C medicated feed made from the Type B liquid medicated feed is 7 days after date of manufacture. (3) Labeling for all Type B medicated feeds (liquid and dry) and Type C medicated feeds containing laidlomycin propionate potassium shall bear the following statements: * * * * * (e) Conditions of use. It is used in growing beef steers and heifers fed in confinement for slaughter as follows: [[Page 20344]] ---------------------------------------------------------------------------------------------------------------- Laidlomycin propionate potassium Combination in in grams per ton grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (1) 5............................. ................... For increased rate Feed as the sole ration 066104 of weight gain and Type C medicated feeds improved feed to provide 30 to 75 mg efficiency. laidlomycin propionate potassium per head per day. (2) 5-10.......................... ................... For improved feed Feed as the sole ration 066104 efficiency. Type C medicated feeds to provide 30 to 150 mg laidlomycin propionate potassium per head per day. ---------------------------------------------------------------------------------------------------------------- (f) Laidlomycin propionate potassium may also be used in combination with chlortetracycline as in Sec. 558.128. 0 31. In Sec. 558.325, revise paragraphs (a), (b), (d)(3)(i), (d)(4)(i), (d)(4)(ii), (e)(1)(i), (e)(1)(iii), (e)(1)(iv), (e)(1)(vii), (e)(1)(ix), (e)(1)(x), (e)(2)(i), (e)(2)(vii), (e)(2)(xii), and (e)(2)(xiv) to read as follows: Sec. 558.325 Lincomycin. (a) Specifications. Type A medicated articles containing 20 or 50 grams of lincomycin (as lincomycin hydrochloride agricultural grade) per pound. (b) Sponsor. See No. 066104 in Sec. 510.600(c) of this chapter. * * * * * (d) * * * (3) * * * (i) ``Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.'' * * * * * (4) * * * (i) ``Occasionally, swine fed lincomycin may within the first 2 days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within 5 to 8 days without discontinuing the lincomycin treatment.'' (ii) ``The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined.'' (e) * * * (1) Chickens-- ---------------------------------------------------------------------------------------------------------------- Lincomycin (as lincomycin hydrochloride agricultural grade) Combination in Indications for use Limitations Sponsor grams/ton grams/ton ---------------------------------------------------------------------------------------------------------------- (i) 2............................. ................... Broiler chickens: Feed as the sole 066104 For the control of ration. Not for use in necrotic enteritis laying hens, breeder caused or chickens, or turkeys. complicated by Clostridium spp. or other organisms susceptible to lincomycin. * * * * * * * (iii) 2........................... Clopidol, 113.5.... Broiler chickens: Feed as the sole ration 066104 As an aid in the to broiler chickens. prevention of Do not feed to coccidiosis caused chickens over 16 weeks by Eimeria of age. Not for use in tenella, E. laying hens, breeder necatrix, E. chickens, or turkeys. acervulina, E. Consult a veterinarian maxima, E. or poultry pathologist brunetti, and E. if losses exceed 0.5% mivati, and for in a two-day period. the control of Do not allow rabbits, necrotic enteritis hamsters, guinea pigs, caused or horses, or ruminants complicated by access to feeds Clostridium spp. containing lincomycin. or other organisms Ingestion by these susceptible to species may result in lincomycin. severe gastrointestinal effects. Clopidol as provided by No. 016592 in Sec. 510.600 of this chapter. (iv) 2............................ Decoquinate, 27.2.. Broiler chickens: Feed as the sole 066104 For the prevention ration. Do not feed to of coccidiosis chickens producing caused by Eimeria eggs for human tenella, E. consumption. Do not necatrix, E. use in feeds acervulina, E. containing bentonite. mivati, E. maxima, Not for use in laying and E. brunetti, hens, breeding and for the chickens, or turkeys. control of Do not allow rabbits, necrotic enteritis hamsters, guinea pigs, caused or horses, or ruminants complicated by access to feeds Clostridium spp. containing lincomycin. or other organisms Ingestion by these susceptible to species may result in lincomycin. severe gastrointestinal effects. Decoquinate as provided by No. 066104 in Sec. 510.600 of this chapter. * * * * * * * (vii) 2........................... Monensin, 90 to 110 Broiler chickens: Feed as the sole 066104 As an aid in the ration. Do not feed to prevention of chickens producing coccidiosis caused eggs for human by Eimeria consumption. Do not necatrix, E. feed to chickens over tenella, E. 16 weeks of age. Not acervulina, E. for use in laying brunetti, E. hens, breeding mivati, and E. chickens, or turkeys. maxima, and for Do not allow horses, the control of other equines, mature necrotic enteritis turkeys, or guinea caused or fowl access to feed complicated by containing monensin. Clostridium spp. Ingestion of monensin or other organisms by horses and guinea susceptible to fowl has been fatal. lincomycin in Do not allow rabbits, broiler chickens hamsters, guinea pigs, up to 16 weeks of horses, or ruminants age. access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Not for broiler breeder replacement chickens. In the absence of coccidiosis in broiler chickens, the use of monensin with no withdrawal period may limit feed intake, resulting in reduced weight gain. Do not use this medicated feed after 90 days from the date of manufacture. Monensin as provided by No. 058198 in Sec. 510.600 of this chapter. [[Page 20345]] * * * * * * * (ix) 2............................ Salinomycin sodium Broiler chickens: Feed as the sole ration 066104 activity, 40 to 60. For the prevention to broiler chickens. of coccidiosis Do not feed to caused by Eimeria chickens producing tenella, E. eggs for human necatrix, E. consumption. Not for acervulina, E use in laying hens, maxima, E. breeding chickens, or brunetti, and E. turkeys. May be fatal mivati, and for if accidentally fed to the control of adult turkeys or necrotic enteritis horses. Do not allow caused or rabbits, hamsters, complicated by guinea pigs, horses, Clostridium spp. or ruminants access to or other organisms feeds containing susceptible to lincomycin. Ingestion lincomycin. by these species may result in severe gastrointestinal effects. Do not use in Type C medicated feeds containing pellet binders. Salinomycin sodium activity as provided by No. 016592 in Sec. 510.600 of this chapter. (x) 2............................. Zoalene, 113.5..... Broiler chickens: Feed as the sole ration 066104 For prevention and from the time chicks control of are placed in floor coccidiosis and pens until slaughtered for the control of for meat. Not for use necrotic enteritis in laying hens, caused or breeding chickens, or complicated by turkeys. Consult a Clostridium spp. veterinarian or or other organisms poultry pathologist if susceptible to losses exceed 0.5% in lincomycin in a two-day period. Do broiler chickens. not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Zoalene as provided by No. 066104 in Sec. 510.600 of this chapter. ---------------------------------------------------------------------------------------------------------------- (2) Swine-- ---------------------------------------------------------------------------------------------------------------- Lincomycin (as lincomycin hydrochloride agricultural grade) Combination in Indications for use Limitations Sponsor grams/ton grams/ton ---------------------------------------------------------------------------------------------------------------- (i) 40............................ ................... For the control of Feed as sole ration. 066104 swine dysentery For use in swine on and the control of premises with a porcine history of swine proliferative dysentery but where enteropathies symptoms have not yet (ileitis) caused occurred, or following by Lawsonia use of lincomycin at intracellularis. 100 grams (g)/ton for the treatment of swine dysentery and the control of porcine proliferative enteropathies (ileitis). * * * * * * * (vii) 100......................... ................... For the treatment Feed as a sole ration 066104 of swine dysentery for 3 weeks or until and the control of signs of disease porcine (watery, mucoid, or proliferative bloody stools) enteropathies disappear. (ileitis) caused by Lawsonia intracellularis. * * * * * * * (xii) 100 to 200.................. ................... For reduction in Feed as sole ration for 066104 the severity of 21 days. the effects of respiratory disease associated with Mycoplasma hyopneumoniae. * * * * * * * (xiv) 200......................... Pyrantel tartrate, For reduction in Feed as the sole ration 066104 96. the severity of for 21 days. Not for the effects of use in swine that respiratory weigh more than 250 disease associated pounds. Withdraw 6 with Mycoplasma days before slaughter. hyopneumoniae; to Lincomycin as provided aid in the by No. 066104; prevention of pyrantel tartrate as migration and provided by No. 066104 establishment of in Sec. 510.600(c) large roundworm of this chapter. (Ascaris suum) infections; and to aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections in swine. ---------------------------------------------------------------------------------------------------------------- 0 32. In Sec. 558.363, 0 a. Revise paragraph (e)(1)(ii); 0 b. Redesignate paragraphs (e)(1)(iii) and (e)(1)(iv) as (e)(1)(v) and (e)(1)(vi) respectively; 0 c. Add new paragraphs (e)(1)(iii) and (e)(1)(iv); and 0 d. Revise newly redesignated paragraph (e)(1)(v). The revision and addition read as follows: Sec. 558.363 Narasin. * * * * * (e) * * * (1) Chickens-- [[Page 20346]] ---------------------------------------------------------------------------------------------------------------- Combination in Narasin grams/ton grams/ton Indications for use Limitations Sponsors ---------------------------------------------------------------------------------------------------------------- * * * * * * * (ii) 54 to 72..................... Bacitracin (as feed Broiler chickens: Feed as the sole 066104 grade bacitracin For the prevention ration. The narasin methylenedisalicyl of coccidiosis concentration should ate), 10 to 50. caused by Eimeria be adjusted to meet necatrix, E. the severity of the tenella, E. coccidial challenge, acervulina, E. which varies with brunetti, E. environmental and mivati, and E. management conditions. maxima, and for Do not allow adult increased rate of turkeys, horses, or weight gain and other equines access improved feed to narasin efficiency. formulations. Ingestion of narasin by these species has been fatal. Bacitracin methylenedisalicylate as provided by No. 066104 in Sec. 510.600(c) of this chapter. (iii) 54 to 90.................... Bacitracin (as feed Broiler chickens: Feed as the sole ration 069254 grade bacitracin For increased rate throughout the feeding methylenedisalicyl of weight gain and period. The narasin ate), 4 to 50. improved feed concentration should efficiency, and be adjusted to meet for the prevention the severity of the of coccidiosis coccidial challenge, caused by Eimeria which varies with necatrix, E. environmental and tenella, E. management conditions. acervulina, E. Do not allow adult brunetti, E. turkeys, horses, or mivati, and E. other equines access maxima. to narasin formulations. Ingestion of narasin by these species has been fatal. Bacitracin methylenedisalicylate as provided by No. 069254 in Sec. 510.600(c) of this chapter. (iv) 54 to 90..................... Bacitracin (as feed Broiler chickens: Feed as the sole ration 069254 grade bacitracin For the prevention for 28 to 35 days, methylenedisalicyl of mortality starting from the time ate), 50. caused by necrotic chicks are placed for enteritis brooding. The narasin associated with concentration should Clostridium be adjusted to meet perfringens, and the severity of the for the prevention coccidial challenge, of coccidiosis which varies with caused by Eimeria environmental and necatrix, E. management conditions. tenella, E. Do not allow adult acervulina, E. turkeys, horses, or brunetti, E. other equines access mivati, and E. to narasin maxima. formulations. Ingestion of narasin by these species has been fatal. Bacitracin methylenedisalicylate as provided by No. 069254 in Sec. 510.600(c) of this chapter. (v) 54 to 72...................... Bacitracin (as feed Broiler chickens: Feed as the sole 066104 grade bacitracin For the prevention ration. The narasin zinc), 4 to 50. of coccidiosis concentration should caused by Eimeria be adjusted to meet necatrix, E. the severity of the tenella, E. coccidial challenge, acervulina, E. which varies with brunetti, E. environmental and mivati, and E. management conditions. maxima, and for Do not allow adult increased rate of turkeys, horses, or weight gain and other equines access improved feed to narasin efficiency. formulations. Ingestion of narasin by these species has been fatal. Bacitracin zinc as provided by No. 054771 in Sec. 510.600(c) of this chapter. (vi) 54 to 72..................... Bambermycins, 1 to Broiler chickens: For broiler chickens 016592 2. For prevention of only. Feed coccidiosis caused continuously as sole by Eimeria ration. Do not allow necatrix, E. adult turkeys, horses, tenella, E. or other equines acervulina, E. access to narasin brunetti, E. formulations. mivati, and E. Ingestion of narasin maxima, and for by these species has increased rate of been fatal. weight gain and Bambermycins as improved feed provided by No. 016592 efficiency. in Sec. 510.600(c) of this chapter. ---------------------------------------------------------------------------------------------------------------- * * * * * 0 33. In Sec. 558.500, 0 a. Revise paragraphs (b)(2), (d)(1), and (d)(2)(i) and (ii), 0 b. Add new paragraphs (d)(2)(iii) and (d)(6), 0 c. Revise the heading in the first column in (e)(1) through (3), 0 d. In the tables in (e)(1) and (e)(2), in the ``Sponsor'' column, remove ``054771'' where it occurs, and in its place add ``066104'', and 0 e. Revise paragraphs (e)(1)(i), (e)(2)(i), (e)(2)(iii), (e)(2)(vi), and (e)(3). The revisions and additions read as follows: Sec. 558.500 Ractopamine. * * * * * (b) * * * (1) * * * (2) Nos. 051311 and 066104: Type A medicated articles containing 45.4 g/lb ractopamine hydrochloride. * * * * * (d) Special considerations. (1) Labeling of Type A medicated articles and Type B and Type C feeds shall bear the following: ``Not for use in animals intended for breeding.'' (2) Labeling of Type A medicated articles and Type B and Type C medicated feeds intended for swine shall bear the following: (i) ``No increased benefit has been shown when ractopamine hydrochloride concentrations in the diet are greater than 4.5 g/ton (5 ppm).'' (ii) ``Ractopamine hydrochloride use may increase the number of injured, lame, and/or fatigued pigs during marketing. Behavioral signs such as hyperactivity, anxiety, and aggression have been reported in pigs fed ractopamine hydrochloride.'' (iii) ``Additional Recommendations: To help mitigate the signs identified in the Animal Safety Warnings section, see the Pork Quality Assurance (PQA Plus) and Transport Quality Assurance (TQA) recommendations for best practices in swine care during handling, transport, and marketing.'' * * * * * (6) Labeling of Type A medicated articles and Type B and Type C medicated feeds intended for cattle feeds shall bear the following: (i) ``Behavioral signs such as agitation and decreased feed consumption have been reported in cattle fed ractopamine hydrochloride.'' [[Page 20347]] (ii) ``Additional Recommendations: See the Beef Quality Assurance (BQA) recommendations for best practices in cattle care and handling during ractopamine hydrochloride feeding, transport, and marketing to help mitigate the behavioral signs stated in the Animal Safety Warnings section above.'' (e) * * * (1) Swine-- ---------------------------------------------------------------------------------------------------------------- Ractopamine hydrochloride in grams/ Combination in ton grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 4.5 to 9.0.................... ................... For increased rate Not for use in swine 016592 of weight gain, intended for breeding. 066104 improved feed Feed as sole ration. 058198 efficiency, and increased carcass leanness in finishing swine, weighing at least 150 lb, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lb of gain prior to slaughter. (ii) Reserved..................... ---------------------------------------------------------------------------------------------------------------- (2) Cattle-- ---------------------------------------------------------------------------------------------------------------- Ractopamine hydrochloride in grams/ Combination in ton grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 8.2 to 24.6................... ................... For increased rate Feed as the sole ration 016592 of weight gain and to provide 70 to 430 051311 improved feed mg of ractopamine 066104 efficiency in hydrochloride per head 058198 growing beef per day during the steers and heifers last 28 to 42 days on fed in confinement feed. Not for use in for slaughter cattle intended for during the last 28 breeding. to 42 days on feed. * * * * * * * (iii) 9.8 to 24.6................. ................... For increased rate Feed as the sole ration 016592 of weight gain, to provide 90 to 430 051311 improved feed mg ractopamine 066104 efficiency, and hydrochloride per head 058198 increased carcass per day during the leanness in last 28 to 42 days on growing beef feed. Not for use in steers and heifers cattle intended for fed in confinement breeding. for slaughter during the last 28 to 42 days on feed. * * * * * * * (vi) 100 to 800................... ................... For increased rate Feed a minimum of 1 lb 016592 of weight gain and per head per day of 051311 improved feed Type C top-dress 066104 efficiency in medicated feed to 058198 growing beef provide 70 to 400 mg steers and heifers ractopamine fed in confinement hydrochloride per head for slaughter per day during the during the last 28 last 28 to 42 days on to 42 days on feed. feed. Not for use in cattle intended for breeding. * * * * * * * ---------------------------------------------------------------------------------------------------------------- (3) Turkeys-- ---------------------------------------------------------------------------------------------------------------- Ractopamine hydrochloride in grams/ Combination in ton grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * Sec. 558.575 [Amended] 0 34. In Sec. 558.575, 0 a. In paragraph (e)(1)(i) and (ii), in the column ``Indications for Use'', remove the text ``Heterakis gallinarum'' and in its place add the text ``Haemophilus gallinarum'', and 0 b. In paragraph (e)(1)(i) and (ii), in the column ``Sponsor'', remove the text ``054771'' and in its place add the text ``066104''. 0 35. In Sec. 558.625, revise paragraph (e)(2)(vi) to read as follows: Sec. 558.625 Tylosin. * * * * * (e) * * * (2) Cattle-- [[Page 20348]] ---------------------------------------------------------------------------------------------------------------- Combination in Tylosin grams/ton grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (vi) 8 to 10...................... Monensin, 5 to 30 Growing beef steers Feed as the sole ration 016592 plus decoquinate, and heifers fed in to provide 22.7 mg of 066104 13.6 to 27.2. confinement for decoquinate per 100 slaughter: For the lb. of body weight per prevention of day, 50 to 360 mg of coccidiosis caused monensin per head per by Eimeria bovis day, and 60 to 90 mg and E. zuernii, tylosin (as tylosin for improved feed phosphate). Feed for efficiency, and at least 28 days for the reduction during periods of of incidence of coccidiosis exposure liver abscesses or when experience associated with indicates that Fusobacterium coccidiosis is likely necrophorum and to be a hazard. Do not Arcanobacterium allow horses or other pyogenes. equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle feed is safe only for use in cattle. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. Do not use in feeds containing bentonite. Do not feed to cows producing milk for food. A withdrawal period has not been established for this product in pre- ruminating calves. Do not use in calves to be processed for veal. Tylosin as provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; decoquinate as provided by No. 058198 in Sec. 510.600(c) of this chapter. See Sec. Sec. 558.311(d) and 558.355(d). * * * * * * * ---------------------------------------------------------------------------------------------------------------- Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2026-07500 Filed 4-15-26; 8:45 am] BILLING CODE 4164-01-P
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New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
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), abbreviated...
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91 FR 20337
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“New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address,” thefederalregister.org (April 16, 2026), https://thefederalregister.org/documents/2026-07500/new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-new-animal-drug-application-change-o.