[Federal Register Volume 86, Number 200 (Wednesday, October 20, 2021)] [Rules and Regulations] [Pages 57992-58016] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2021-22604] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 516, 520, 522, 526, 556 and 558 [Docket No. FDA-2021-N-0002] New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship 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 conditional new animal drug applications (cNADAs) during January, February, and March 2021. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations. DATES: This rule is effective October 20, 2021. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected]. SUPPLEMENTARY INFORMATION: I. Approvals FDA is amending the animal drug regulations to reflect approval actions for NADAs, ANADAs, and conditional approval actions for cNADAs during January, February, and March 2021, 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 (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the office of the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. Persons with access to the internet may obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book. FDA has verified the website addresses as of the date this document publishes in the Federal Register, but websites are subject to change over time. Table 1--Original and Supplemental NADAs and ANADAs Approved During January, February, and March 2021 -------------------------------------------------------------------------------------------------------------------------------------------------------- Approval date File No. Sponsor Product name Species Effect of the action Public documents -------------------------------------------------------------------------------------------------------------------------------------------------------- January 8, 2021.............. 141-336 ECO LLC, 344 Nassau AIVLOSIN (62.5% w/w Swine.............. Supplemental FOI Summary. St., Princeton, NJ tylvalosin as approval for the 08540. tylvalosin tartrate) addition of Water Soluble Mycoplasma Granules. hyopneumoniae to the list of pathogens for the control of swine respiratory disease indication. January 11, 2021............. 141-526 Anivive Lifesciences, LAVERDIA-CA1 Dogs............... Conditional approval FOI Summary. Inc., 3250 Airflite (verdinexor tablets). for the treatment Way, Suite 400, Long of lymphoma in dogs. Beach, CA 90807. January 12, 2021............. 200-675 Huvepharma EOOD, 5th Ractopamine Cattle............. Original approval as FOI Summary. Floor, 3A Nikolay hydrochloride and a generic copy of Haytov Str., 1113 monensin Type B and NADA 141-225. Sofia, Bulgaria. Type C medicated feeds. January 12, 2021............. 200-676 Do................... Ractopamine Cattle............. Original approval as FOI Summary. hydrochloride, a generic copy of monensin, and NADA 141-224. tylosin phosphate Type B and Type C medicated feeds. [[Page 57993]] January 12, 2021............. 200-677 Do................... Ractopamine Cattle............. Original approval as FOI Summary. hydrochloride, a generic copy of monensin, and NADA 141-234. melengestrol acetate Type C medicated feeds. January 12, 2021............. 200-678 Do................... Ractopamine Cattle............. Original approval as FOI Summary. hydrochloride, a generic copy of monensin, tylosin NADA 141-233. phosphate, and melengestrol acetate Type C medicated feeds. January 14, 2021............. 141-544 Pegasus Laboratories, KBROVET-CA1 Dogs............... Conditional approval FOI Summary. Inc., 8809 Ely Rd., (potassium bromide for the control of Pensacola, FL 32514. chewable tablets) seizures associated Chewable Tablet. with idiopathic epilepsy in dogs. January 15, 2021............. 141-539 Neogen Corp., 944 THYROKARE Dogs............... Original approval FOI Summary. Nandino Blvd., (levothyroxine for replacement Lexington, KY 40511. sodium tablets). therapy for diminished thyroid function in dogs. February 1, 2021............. 200-683 Huvepharma EOOD, 5th Melengestrol acetate Cattle............. Original approval as FOI Summary. Floor, 3A Nikolay and monensin Type C a generic copy of Haytov Str., 1113 medicated feeds. NADA 125-476. Sofia, Bulgaria. February 1, 2021............. 200-684 Do................... Ractopamine Cattle............. Original approval as FOI Summary. hydrochloride, a generic copy of monensin, and NADA 141-234. melengestrol acetate Type C medicated feeds. February 1, 2021............. 200-685 Do................... Melengestrol acetate, Cattle............. Original approval as FOI Summary. monensin, and a generic copy of tylosin phosphate NADA 138-870. Type C medicated feeds. February 1, 2021............. 200-686 Do................... Monensin, ractopamine Cattle............. Original approval as FOI Summary. hydrochloride, a generic copy of tylosin phosphate, NADA 141-233. and melengestrol acetate Type C medicated feeds. February 8, 2021............. 200-466 Sparhawk SPARMECTIN Plus Cattle............. Supplemental FOI Summary. Laboratories, Inc., Clorsulon approval reducing 12340 Santa Fe Trail (ivermectin and preslaughter Dr., Lenexa, KS clorsulon) Injection. withdrawal period 66215. to 21 days. February 16, 2021............ 200-506 Chanelle ANIMEC PLUS Cattle............. Original approval as FOI Summary. Pharmaceuticals (ivermectin and a generic copy of Manufacturing Ltd., clorsulon) Injection. NADA 140-833. Loughrea, County Galway, Ireland. February 18, 2021............ 200-657 Bimeda Animal Health MACROSYN Cattle............. Original approval as FOI Summary. Ltd., 1B The Herbert (tulathromycin a generic copy of Building, The Park, injection) NADA 141-244. Carrickmines, Dublin Injectable Solution. 18, Ireland. February 18, 2021............ 200-666 Elanco US Inc., 2500 INCREXXA Cattle............. Original approval as FOI Summary. Innovation Way, (tulathromycin a generic copy of Greenfield, IN 46140. injection) NADA 141-244. Injectable Solution. February 26, 2021............ 141-540 Pharmgate, Inc., 1800 PENNITRACIN MD Turkeys............ Original approval FOI Summary. Sir Tyler Dr., (bacitracin Type A for the prevention Wilmington, NC 28405. medicated article) of coccidiosis and COBAN (monensin caused by Eimeria Type A medicated adenoeides, E. article) to be used meleagrimitis and in the manufacture E. gallopavonis, of Type C medicated and for increased feeds. rate of weight gain and improved feed efficiency in growing turkeys. March 11, 2021............... 200-699 Akorn Animal Health, Dexmedetomidine Dogs and cats...... Original approval as FOI Summary. Inc., 1925 West Hydrochloride a generic copy of Field Ct., Suite Injection NADA 141-267. 300, Lake Forest, IL (dexmedetomidine 60045. hydrochloride). [[Page 57994]] March 15, 2021............... 141-530 Zoetis Inc., 333 MGA (melengestrol Cattle............. Original approval FOI Summary. Portage St., acetate Type A for increased rate Kalamazoo, MI 49007. medicated article) of weight gain, and AUREOMYCIN improved feed (chlortetracycline efficiency, and Type A medicated suppression of article) to be used estrus (heat) in in the manufacture replacement dairy of Type C medicated and beef heifers, feeds. or growing beef heifers fed in confinement for slaughter receiving medicated feed containing chlortetracycline for the treatment of bacterial enteritis or pneumonia, control of bacterial pneumonia associated with shipping fever complex, reduction of incidence of liver abscesses, and control of active infection of anaplasmosis. March 19, 2021............... 141-531 Do................... MGA (melengestrol Cattle............. Original approval FOI Summary. acetate Type A for suppression of medicated article), estrus (heat) in AUREOMYCIN replacement dairy (chlortetracycline and beef heifers, Type A medicated or growing beef article), and heifers fed in BOVATEC (lasalocid confinement for Type A medicated slaughter receiving article) to be used medicated feed in the manufacture containing of Type C medicated chlortetracycline feeds. for the treatment of bacterial enteritis or pneumonia, control of bacterial pneumonia associated with shipping fever complex, or control of active infection of anaplasmosis; and lasalocid for control of coccidiosis, increased rate of weight gain, and improved feed efficiency. March 22, 2021............... 200-625 Bimeda Animal Health KETOMED (ketoprofen) Horses............. Original approval as FOI Summary. Ltd., 1B The Herbert Sterile Solution. a generic copy of Building, The Park, NADA 140-269. Carrickmines, Dublin 18, Ireland. March 24, 2021............... 132-872 Intervet, Inc., 2 SAFE-GUARD Cattle............. Supplemental FOI Summary. Giralda Farms, (fenbendazole) Paste approval providing Madison, NJ 07940. 10%. for tolerances, a tissue withdrawal period, and a milk discard time in accordance with a repartitioning of the acceptable daily intake; and the addition of indications for fourth[dash]stage larvae of certain endoparasites. -------------------------------------------------------------------------------------------------------------------------------------------------------- II. Changes of Sponsor The sponsors of the following approved applications have informed FDA that they have transferred ownership of, and all rights and interest in, these applications to another sponsor: ---------------------------------------------------------------------------------------------------------------- File No. Product name Transferring sponsor New sponsor 21 CFR section ---------------------------------------------------------------------------------------------------------------- 141-175.................. CAPSTAR (nitenpyram) Elanco US Inc., 2500 Sergeant's Pet Care 520.1510. Tablets. Innovation Way, Products, Inc., Greenfield, IN 10077 S 134th St., 46140. Omaha, NE 68138. 141-120.................. CLOMICALM Do.................. Virbac AH, Inc., 520.455. (clomipramine P.O. Box 162059, hydrochloride) Fort Worth, TX Tablets. 76161. 141-474.................. ITRAFUNGOL Do.................. Do.................. 520.1189. (itraconazole oral solution). 065-081.................. GO-DRY (penicillin G G. C. Hanford Mfg. HQ Specialty Pharma 526.1696. procaine) Co., P.O. Box 1017, Corp., 120 Rte. 17 Intramammary Syracuse, NY 13201. North, Suite 130, Infusion. Paramus, NJ 07652. 200-335.................. Ampicillin Sodium Do.................. Do.................. 522.90c. Powder for Injection. 200-372.................. HAN-PEN (penicillin Do.................. Do.................. 520.1696a. G potassium) Soluble Powder. 065-071.................. Chlortetracycline Huvepharma EOOD, 5th Pharmgate Inc., 1800 520.441. (chlortetracycline Floor, 3A Nikolay Sir Tyler Dr., hydrochloride) Haytov Str., 1113 Wilmington, NC Soluble Powder. Sofia, Bulgaria. 28405. 065-440.................. CHLORONEX Do.................. Do.................. Do. (chlortetracycline hydrochloride) Soluble Powder. 200-441.................. A[dash]MYCIN Do.................. Do.................. Do. (chlortetracycline hydrochloride) Soluble Powder. 200-528.................. SAVALAN 60 Pharmgate Inc., 1800 Huvepharma EOOD, 5th 558.550. (salinomycin Sir Tyler Dr., Floor, 3A Nikolay sodium) Type A Wilmington, NC Haytov Str., 1113 medicated article. 28405. Sofia, Bulgaria. [[Page 57995]] 200-237.................. Isoflurane, U.S.P... Piramal Enterprises Piramal Pharma Ltd., N/A. Ltd., Ananta, Ground Floor, Agastya Corporate Piramal Ananta, Park, Opp Fire Agastya Corporate Brigade, Kamani Park, Mumbai, Junction, LBS Mag Maharashtra, Kurla (West), 400070, India. Mumbai, 400070, India. ---------------------------------------------------------------------------------------------------------------- Following these changes of sponsorship, G. C. Hanford Manufacturing Co. and Piramal Enterprises Ltd. are no longer the sponsor of an approved application. Accordingly, the regulations in 21 CFR 510.600(c) are being amended to reflect these changes. III. Technical Amendments FDA is making the following amendments to improve the accuracy, consistency, and readability of the animal drug regulations:21 CFR 510.600 is amended by revising the entries for Cronus Pharma Specialities India Private Ltd. to reflect the correct address for the firm. 21 CFR 520.2090 is amended to reflect the current approved indications for use for sarolaner, moxidectin, and pyrantel tablets. 21 CFR 522.970 is amended to reflect the approved species for a flunixin injectable solution. 21 CFR 558.76 for use of bacitracin methylenedisalicylate in medicated feed is amended to reflect a current tabular format organized by species. 21 CFR 558.128 is amended to reflect sponsors of combination medicated feeds containing chlortetracycline for which there is no preslaughter withdrawal period. 21 CFR 558.355 for use of monensin in medicated feeds is amended to reflect the sponsor of an approved generic product and to remove a redundant condition of use. IV. 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)), which requires Federal Register publication of ``notice[s] . . . effective as a regulation,'' of the conditions of use of approved new animal drugs. This rule sets forth technical amendments to the regulations to codify recent actions on approved new animal drug applications and corrections to improve the accuracy of the regulations, and as such does not impose any burden on regulated entities. Although denominated 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.'' Therefore, it 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, which defines a rule as ``an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.'' 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 526 Animal drugs. 21 CFR Part 556 Animal drugs, Food. 21 CFR Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act, 21 CFR parts 510, 516, 520, 522, 526, 556, 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. Add in alphabetical order an entry for ``Anivive Lifesciences, Inc.''; 0 ii. Revise the entry for ``Cronus Pharma Specialities India Private Ltd.''; 0 iii. Remove the entries for ``G. C. Hanford Manufacturing Co.'' and ``Piramal Enterprises Ltd.''; and 0 iv. Add in alphabetical order an entry for ``Piramal Pharma Ltd.''; and 0 b. In the table in paragraph (c)(2): 0 i. Remove the entry for ``010515''; 0 ii. Revise the entries for ``065085'' and ``069043''; and 0 iii. Add in numerical order an entry for ``086121''. 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 ------------------------------------------------------------------------ * * * * * * * Anivive Lifesciences, Inc., 3250 Airflite Way, Suite 086121 400, Long Beach, CA 90807.............................. * * * * * * * Cronus Pharma Specialities India Private Ltd., Sy No-99/ 069043 1, M/s GMR Hyderabad Aviation SEZ Ltd., Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, India............................... * * * * * * * Piramal Pharma Ltd., Ground Floor, Piramal Ananta, 065085 Agastya Corporate Park, Mumbai, Maharashtra, 400070, India.................................................. [[Page 57996]] * * * * * * * ------------------------------------------------------------------------ (2) * * * ------------------------------------------------------------------------ Drug labeler code Firm name and address ------------------------------------------------------------------------ * * * * * * * 065085.................. Piramal Pharma Ltd., Ground Floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra, 400070, India * * * * * * * 069043.................. Cronus Pharma Specialities India Private Ltd., Sy No-99/1, M/s GMR Hyderabad Aviation SEZ Ltd., Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, India * * * * * * * 086121.................. Anivive Lifesciences, Inc., 3250 Airflite Way, Suite 400, Long Beach, CA 90807 * * * * * * * ------------------------------------------------------------------------ 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, 360ccc-2, 371. 0 4. Add Sec. 516.1858 to subpart E to read as follows: Sec. 516.1858 Potassium bromide. (a) Specifications. Each chewable tablet contains 250 or 500 milligrams (mg) potassium bromide. (b) Sponsor. See No. 055246 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Amount. Administer 25 to 68 mg per kilogram (11 to 31 mg per pound) of body weight once daily. The dosage can be divided and should be adjusted to clinical response. (2) Indications for use. For the control of seizures associated with idiopathic epilepsy 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. 0 5. Add Sec. 516.2980 to subpart E to read as follows: Sec. 516.2980 Verdinexor. (a) Specifications. Each tablet contains 2.5, 10, 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 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. 0 7. In Sec. 520.441, revise paragraph (b)(1) to read as follows: Sec. 520.441 Chlortetracycline powder. * * * * * (b) * * * (1) Nos. 000010, 054771, and 069254 for use as in paragraph (d) of this section. * * * * * 0 8. In Sec. 520.455, revise the section heading and paragraph (b) to read as follows: Sec. 520. 455 Clomipramine. * * * * * (b) Sponsors. See Nos. 051311 and 086039 in Sec. 510.600(c) of this chapter. * * * * * 0 9. In Sec. 520.905c, revise paragraph (e)(2) to read as follows: Sec. 520.905c Fenbendazole paste. * * * * * (e) * * * (2) Beef and dairy cattle--(i) Amount. Administer orally 2.3 mg/lb (5 mg/kg) body weight. (ii) Indications for use. For the treatment and control of: Lungworms: Adult (Dictyocaulus viviparus); Stomach worms: Adult brown stomach worms (Ostertagia ostertagi), adult and fourth-stage larvae barberpole worms (Haemonchus contortus), fourth-stage larvae barberpole worms (H. placei), and adult and fourth-stage larvae small stomach worms (Trichostrongylus axei); Intestinal worms (adult and fourth-stage larvae): Hookworms (Bunostomum phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata and C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum). (iii) Limitations. Milk taken during treatment and for 96 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 8 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in preruminating calves. 0 10. In Sec. 520.1189, revise paragraph (b) to read as follows: Sec. 520.1189 Itraconazole. * * * * * (b) Sponsor. See No. 051311 in Sec. 510.600(c) of this chapter. * * * * * 0 11. In Sec. 520.1248, revise paragraphs (b) and (c)(1) to read as follows: Sec. 520.1248 Levothyroxine. * * * * * [[Page 57997]] (b) Sponsors. See Nos. 059051 and 061690 in Sec. 510.600(c) of this chapter. (c) * * * (1) Amount. Administer by mouth as follows: (i) No. 061690: 0.1 mg/10 pounds (lb) body weight (0.022 mg/ kilogram (kg)) as a single dose every 24 hours or as a divided dose every 12 hours. (ii) No. 059051: 0.1 mg/10 lb (0.01 mg/lb, 0.022 mg/kg) body weight twice daily. * * * * * 0 12. In Sec. 520.1510, revise paragraph (b)(1) to read as follows: Sec. 520. 1510 Nitenpyram. * * * * * (b) * * * (1) No. 021091 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii)(A), and (d)(2) of this section. * * * * * 0 13. In Sec. 520.1696a, revise paragraph (b) to read as follows: Sec. 520.1696a Penicillin G powder. * * * * * (b) Sponsors. See Nos. 016592, 042791, 054771, 061133, and 076475 in Sec. 510.600(c) of this chapter. * * * * * 0 14. In Sec. 520.2090, revise paragraph (c)(2) to read as follows: Sec. 520.2090 Sarolaner, moxidectin, and pyrantel. * * * * * (c) * * * (2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina) and adult hookworm (Ancylostoma caninum and Uncinaria stenocephala) infections. Kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black- legged tick), and Rhipicephalus sanguineus (brown dog tick) for 1 month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater. * * * * * 0 15. In Sec. 520.2645, revise paragraph (d)(2) to read as follows: Sec. 520.2645 Tylvalosin. * * * * * (d) * * * (2) Indications for use. For control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine intended for slaughter in buildings experiencing an outbreak of PPE; and for control of swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Haemophilus parasuis, Pasteurella multocida, Streptococcus suis, and Mycoplasma hyopneumoniae in groups of swine intended for slaughter in buildings experiencing an outbreak of SRD. * * * * * PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 16. The authority citation for part 522 continues to read as follows: Authority: 21 U.S.C. 360b. 0 17. In Sec. 522.90c, revise paragraph (b) to read as follows: Sec. 522.90c Ampicillin sodium. * * * * * (b) See Nos. 042791 and 054771 in Sec. 510.600(c) of this chapter. * * * * * 0 18. In Sec. 522.558, revise paragraphs (b)(1) and to read as follows: Sec. 522.558 Dexmedetomidine. * * * * * (b) * * * (1) Nos. 026637 and 059399 for use of product described in paragraph (a)(2) of this section. * * * * * 0 19. In Sec. 522.970, revise paragraph (b)(1) and add paragraph (b)(3) to read as follows: Sec. 522.970 Flunixin. * * * * * (b) * * * (1) See Nos. 000061, 055529, 058198, and 061133 for use as in paragraph (e) of this section. * * * * * (3) See No. 016592 for use as in paragraphs (e)(1) and (e)(2) of this section. * * * * * 0 20. In Sec. 522.1193, revise paragraphs (b) and (e)(2) and (3) to read as follows: Sec. 522.1193 Ivermectin and clorsulon. * * * * * (b) Sponsors. See Nos. 000010, 055529, 058005, 061133, and 061651 in Sec. 510.600(c) of this chapter. * * * * * (e) * * * (2) Indications for use. For the treatment and control of gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus helvetianus (adults only), N. spathiger (adults only), Bunostomum phlebotomum; lungworms (adults and fourth-stage larvae) (Dictyocaulus viviparus); liver flukes (adults only) (Fasciola hepatica); cattle grubs (parasitic stages) (Hypoderma bovis, H. lineatum); sucking lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus); mange mites (cattle scab) (Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var. bovis); and for control of infections of D. viviparus and O. radiatum for 28 days after treatment; O. ostertagi, T. axei, and C. punctata for 21 days after treatment; and H. placei and C. oncophora for 14 days after treatment. (3) Limitations. Do not treat cattle within 21 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. 0 21. In Sec. 522.1225, revise paragraph (b) to read as follows: Sec. 522.1225 Ketoprofen. * * * * * (b) Sponsors. See Nos. 054771 and 061133 in Sec. 510.600(c) of this chapter. * * * * * 0 22. In Sec. 522.1696a, revise paragraph (d)(2)(iii) to read as follows: Sec. 522.1696a Penicillin G benzathine and penicillin G procaine suspension. * * * * * (d) * * * (2) * * * (iii) Limitations. Not for use within 30 days of slaughter. For No. 016592: A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. 0 23. In Sec. 522.2630, revise paragraphs (b) and (d)(1)(iii)(A) to read as follows: Sec. 522.2630 Tulathromycin. * * * * * (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this chapter. (1) Nos. 054771, 058198, and 061133 for use of product described in paragraph (a)(1) as in paragraphs (d)(1)(i), (d)(1)(ii), (d)(1)(iii)(A), and (d)(2) of this section. (2) No. 054771 for use of product described in paragraph (a)(2) as in [[Page 57998]] paragraphs (d)(1)(i), (d)(1)(ii)(B), (d)(1)(iii)(B), and (d)(2) of this section. * * * * * (d) * * * (1) * * * (iii) * * * (A) Cattle intended for human consumption must not be slaughtered within 18 days from the last treatment. 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian. * * * * * PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS 0 24. The authority citation for part 526 continues to read as follows: Authority: 21 U.S.C. 360b. 0 25. In Sec. 526.1696, revise paragraph (b) to read as follows: Sec. 526.1696 Penicillin G procaine. * * * * * (b) See Nos. 042791 and 061133 in Sec. 510.600(c) of this chapter. * * * * * PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 0 26. The authority citation for part 556 continues to read as follows: Authority: 21 U.S.C. 342, 360b, 371. 0 27. In Sec. 556.275: 0 a. Revise paragraph (b)(1)(ii); 0 b. Remove paragraph (b)(1)(iii); and 0 c. Remove and reserve paragraphs (b)(3)(ii), (b)(4)(ii), and (b)(5)(ii). The revision reads as follows: Sec. 556.275 Fenbendazole. * * * * * (b) * * * (1) * * * (ii) Milk: 0.22 ppm fenbendazole sulfoxide (marker residue). * * * * * PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 28. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 0 29. In Sec. 558.76: 0 a. Revise paragraphs (a)(1) and (2) and (d)(1); 0 b. Redesignate paragraph (d)(2) as paragraph (d)(6); and 0 c. Add new paragraph (d)(2) and paragraphs (d)(3) through (5). The revisions and additions read as follows: Sec. 558.76 Bacitracin methylenedisalicylate. (a) * * * (1) Type A medicated articles containing feed grade bacitracin methylenedisalicylate equivalent to 10, 25, 30, 40, 50, 60, or 75 grams bacitracin per pound. (2) Type A medicated article containing feed grade bacitracin methylenedisalicylate equivalent to 50 grams bacitracin per pound. * * * * * (d) * * * (1) Chickens-- ------------------------------------------------------------------------ Bacitracin in grams per Indications for ton use Limitations Sponsor ------------------------------------------------------------------------ (i) 4 to 50............ Broiler and Feed 054771 replacement continuously as 069254 chickens: For sole ration. increased rate of weight gain and improved feed efficiency. (ii) 10 to 25.......... Laying hens: For Feed 054771 increased egg continuously as production and sole ration for improved feed the first 7 efficiency. months of egg production. (iii) 50............... Broiler and Feed 054771 replacement continuously as chickens: As an sole ration. aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. (iv) 100 to 200........ Broiler and Feed 054771 replacement continuously as chickens: As an sole ration. aid in the Start at first control of clinical signs necrotic of disease. enteritis Vary dosage caused or based on complicated by severity of Clostridium infection. spp. or other Administer organisms continuously susceptible to for 5 to 7 days bacitracin. or as long as clinical signs persist, then reduce medication to prevention level (50 grams/ ton). ------------------------------------------------------------------------ (2) Turkeys-- ------------------------------------------------------------------------ Bacitracin in grams per Indications for ton use Limitations Sponsor ------------------------------------------------------------------------ (i) 4 to 50............ Growing turkeys: Feed 054771 For increased continuously as 069254 rate of weight sole ration. gain and improved feed efficiency. (ii) 200............... Growing turkeys: Feed 054771 As an aid in continuously as the control of the sole ration. transmissible enteritis complicated by organisms susceptible to bacitracin methylenedisali cylate. ------------------------------------------------------------------------ (3) Swine-- ------------------------------------------------------------------------ Bacitracin in grams per Indications for ton use Limitations Sponsor ------------------------------------------------------------------------ (i) 10 to 30........... Growing and ................ 054771 finishing swine: For increased rate of weight gain and improved feed efficiency. [[Page 57999]] (ii) 250............... Growing and Feed as the sole 054771 finishing ration. Feed swine: For 250 grams per control of ton of complete swine dysentery feed on (bloody scours) premises with a associated with history of Brachyspira swine hyodysenteriae dysentery, but in pigs up to where signs of 250 lbs body the disease weight. have not yet occurred or following an approved treatment of the disease condition. Diagnosis should be confirmed by a veterinarian a when results are not satisfactory. (iii) 250.............. Pregnant sows: As the sole 054771 For control of ration. Feed to clostridial sows from 14 enteritis days before caused by through 21 days Clostridium after farrowing perfringens in on premises suckling with a history piglets. of clostridial scours. Diagnosis should be confirmed by a veterinarian when results are not satisfactory. ------------------------------------------------------------------------ (4) Cattle-- ------------------------------------------------------------------------ Indications for Bacitracin amount use Limitations Sponsor ------------------------------------------------------------------------ (i) 70 mg per head per Beef steers and Administer 054771 day. heifers fed in continuously 069254 confinement for throughout the slaughter: For feeding period. reduction in the number of liver condemnations due to abscesses. (ii) 250 mg per head Beef steers and Administer 054771 per day. heifers fed in continuously 069254 confinement for for 5 days then slaughter: For discontinue for reduction in subsequent 25 the number of days, repeat liver the pattern condemnations during the due to feeding period. abscesses. ------------------------------------------------------------------------ (5) Game birds-- ------------------------------------------------------------------------ Bacitracin in grams per Indications for ton use Limitations Sponsor ------------------------------------------------------------------------ (i) 4 to 50............ Growing Feed 054771 pheasants: For continuously as 069254 increased rate sole ration. of weight gain and improved feed efficiency. (ii) 5 to 20........... Growing quail: Feed 054771 For increased continuously as 069254 rate of weight sole ration to gain and quail not over improved feed 5 weeks of age. efficiency in quail not over 5 weeks of age. (iii) 200.............. Growing quail: Feed 054771 For the continuously as prevention of the sole ration. ulcerative enteritis in growing quail due to Clostridium colinum susceptible to bacitracin methylenedisali cylate. ------------------------------------------------------------------------ * * * * * 0 30. In Sec. 558.128, revise paragraphs (d)(4) and (e)(4) to read as follows: Sec. 558.128 Chlortetracycline. * * * * * (d) * * * (4) Manufacture for use in free-choice feeds as in paragraph (e)(4)(vi) of this section must conform to Sec. 510.455 of this chapter. * * * * * (e) * * * (4) * * * ---------------------------------------------------------------------------------------------------------------- Indications for Chlortetracycline amount Combination in grams/ton use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) to provide 70 mg/head/day... ............................... Growing cattle Feed to provide 054771 (over 400 lb): chlortetracycli 066104 For reduction ne at the rate 069254 of liver of 70 mg per condemnation animal daily. A due to liver withdrawal abscesses. period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal. (ii) 5.83 to 14 g/ton to provide Melengestrol acetate, 0.25 to 2 Growing beef Melengestrol 054771 70 mg/head/day. g/ton to provide 0.25 to 0.5 heifers fed in acetate Type C mg melengestrol acetate per confinement for top-dress head per day. slaughter (over medicated feed 400 lb): For must be top reduction of dressed onto or the incidence mixed at of liver feeding with abscesses, the Type C increased rate medicated feed of weight gain, containing 5.83 improved feed to 14 g/ton efficiency, and chlortetracycli suppression of ne. estrus (heat). Chlortetracycli ne and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. [[Page 58000]] (iii) to provide 0.5 mg/lb of ............................... Beef cattle Feed to provide 054771 body weight daily. (over 700 lb): chlortetracycli 066104 For control of ne at the rate 069254 active of 0.5 mg per infection of pound of body anaplasmosis weight daily in caused by beef cattle Anaplasma under 700 marginale pounds. susceptible to Withdraw 48 chlortetracycli hours prior to ne. slaughter. To sponsor Nos. 054771 and 069254: Zero withdrawal time. (iv) 33.33 to 50 g/ton to Melengestrol acetate, 0.5 to 2 Replacement beef Melengestrol 054771 provide 0.5 mg/lb of body g/ton to provide 0.5 mg heifers over acetate Type C weight per day. melengestrol acetate per head 700 lb: For top-dress per day. control of medicated feed active must be top infection of dressed onto or anaplasmosis mixed at caused by feeding with a Anaplasma Type C marginale medicated feed susceptible to containing chlortetracycli 33.33 to 50 g/ ne and for ton suppression of chlortetracycli estrus (heat). ne. Feeding a Type C top- dress medicated feed containing melengestrol acetate shall not exceed 24 days. Chlortetracycli ne and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. (v) 25 to 1,100 g/ton to provide Lasalocid, 30 to 600........... Pasture cattle Feed 054771 0.5 mg/lb of body weight daily. (slaughter, continuously on 069254 stocker, feeder a hand-fed cattle, beef basis 0.5 mg replacement chlortetracycli heifers) over ne per lb. body 700 pounds: For weight per day control of and not less active than 60 mg or infection of more than 300 anaplasmosis mg lasalocid caused by per head daily Anaplasma in at least 1 marginale pound of feed. susceptible to Daily lasalocid chlortetracycli intakes in ne; and for excess of 200 increased rate mg/head/day in of weight gain. pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/ day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See Sec. 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in Sec. 510.600(c) of this chapter. (vi) 25 to 1,100 g/ton to Lasalocid, 30 to 600; Replacement beef The melengestrol 054771 provide 0.5 mg/lb of body melengestrol acetate, 0.5 to 2 heifers on acetate Type C weight daily. g/ton to provide 0.5 mg/head/ pasture over top-dress day melengestrol acetate. 700 pounds: For medicated feed control of must be top active dressed onto or infection of mixed at anaplasmosis feeding with a caused by Type C Anaplasma medicated feed marginale containing 25 susceptible to to 1,100 g/ton chlortetracycli of ne, increased chlortetracycli rate of weight ne and 30 to gain, and 600 g/ton suppression of lasalocid to estrus (heat). provide 0.5 mg chlortetracycli ne per lb body weight per day and not less than 60 mg or more than 300 mg lasalocid per head per day in at least 1 pound of feed. Do not exceed 24 days of feeding. See Sec. 558.311(d) of this chapter. Chlortetracycli ne, lasalocid, and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. (vii) to provide 0.5 to 2.0 mg/ ............................... Beef cattle and In free-choice 054771 lb of body weight daily. nonlactating cattle feeds 069254 dairy cattle: such as feed As an aid in blocks or salt- the control of mineral mixes active manufactured infection of from approved anaplasmosis Type A caused by articles. See Anaplasma paragraph marginale (d)(4) of this susceptible to section. chlortetracycli ne. [[Page 58001]] (viii) to provide 10 mg/lb of ............................... Calves, beef and Feed 054771 body weight daily. nonlactating approximately 066104 dairy cattle: 400 g/ton, 069254 For treatment varying with of bacterial body weight and enteritis feed caused by consumption to Escherichia provide 10 mg/ coli and lb per day. bacterial Treat for not pneumonia more than 5 caused by days. To Pasteurella sponsor No. multocida 054771 (NADAs organisms 048-761 and 046- susceptible to 699) and to chlortetracycli sponsor No. ne. 069254 (ANADA 200-510): May be mixed in the cattle's daily ration or administered as a top-dress. In feed including milk replacers withdraw 10 days prior to slaughter. To sponsor Nos. 054771 and 069254: Zero withdrawal time. See paragraph (d)(3) of this section. (ix) to provide 10 mg/lb of body ............................... Calves (up to A withdrawal 054771 weight daily. 250 lb): For period has not 066104 the treatment been 069254 of bacterial established for enteritis this product in caused by pre-ruminating Escherichia calves. Do not coli use in calves susceptible to to be processed chlortetracycli for veal. ne. (x) to provide 10 mg/lb of body Laidlomycin, 5................. Cattle fed in Feed 054771 weight daily. confinement for continuously at slaughter: For a rate of 30 to treatment of 75 mg bacterial laidlomycin enteritis propionate caused by potassium per Escherichia head per day coli and for not more bacterial than 5 days. A pneumonia withdrawal caused by period has not Pasteurella been multocida established for organisms this product in susceptible to pre-ruminating chlortetracycli calves. Do not ne; and for use in calves increased rate to be processed of weight and for veal. See improved feed Sec. efficiency. 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xi) to provide 10 mg/lb of body Laidlomycin, 5 to 10........... Cattle fed in Feed 054771 weight daily. confinement for continuously at slaughter: For a rate of 30 to treatment of 75 mg bacterial laidlomycin enteritis propionate caused by potassium per Escherichia head per day coli and for not more bacterial than 5 days. A pneumonia withdrawal caused by period has not Pasteurella been multocida established for organisms this product in susceptible to pre-ruminating chlortetracycli calves. Do not ne; and for use in calves improved feed to be processed efficiency. for veal. See Sec. 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xii) 500 to 2,000 to provide 10 Lasalocid, 10 to 30............ Cattle fed in Feed 054771 mg/lb of body weight daily. confinement for continuously in 069254 slaughter: For complete feed treatment of for not more bacterial than 5 days to enteritis provide 10 mg caused by chlortetracycli Escherichia ne per lb. body coli and weight per day bacterial and not less pneumonia than 100 mg or caused by more than 360 Pasteurella mg lasalocid multocida per head per organisms day. Do not susceptible to allow horses or chlortetracycli other equines ne; and for access to feeds improved feed containing efficiency. lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See Sec. 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in Sec. 510.600(c) of this chapter. [[Page 58002]] (xiii) to provide 10 mg/lb of Lasalocid, 25 to 30............ Cattle fed in Feed 054771 body weight daily. confinement for continuously in 069254 slaughter: For complete feed treatment of for not more bacterial than 5 days to enteritis provide 10 mg caused by chlortetracycli Escherichia ne per lb. body coli and weight per day bacterial and not less pneumonia than 250 mg or caused by more than 360 Pasteurella mg lasalocid multocida per head per organisms day. Do not susceptible to allow horses or chlortetracycli other equines ne; and for access to feeds increased rate containing of weight gain lasalocid. No and improved withdrawal feed efficiency. period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See Sec. 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xiv) 500 to 4,000 to provide 10 Lasalocid, 30 to 600........... Pasture cattle Feed 054771 mg/lb of body weight daily. (slaughter, continuously on 069254 stocker, feeder a hand-fed cattle, dairy basis for not and beef more than 5 replacement days to provide heifers): For 10 mg treatment of chlortetracycli bacterial ne per lb. body enteritis weight per day caused by and not less Escherichia than 60 mg or coli and more than 300 bacterial mg lasalocid pneumonia per head per caused by day in at least Pasteurella 1 pound of multocida feed. Daily organisms lasalocid susceptible to intakes in chlortetracycli excess of 200 ne; and for mg/head/day in increased rate pasture cattle of weight gain. have not been shown to be more effective than 200 mg lasalocid/head/ day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See Sec. 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xv) 500 to 4,000 g/ton to Lasalocid, 30 to 600: Replacement The melengestrol 054771 provide 10 mg/lb of body weight Melengestrol acetate, 0.5 to 2 dairy heifers acetate Type C daily. g/ton to provide 0.5 mg/head/ on pasture less top-dress day melengestrol acetate. than 20 months medicated feed of age and must be top replacement dressed onto or beef heifers on mixed at pasture: For feeding with a treatment of Type C bacterial medicated feed enteritis containing 500 caused by to 4,000 g/ton Escherichia of coli and chlortetracycli bacterial ne and 30 to pneumonia 600 g/ton caused by lasalocid to Pasteurella provide 10 mg multocida chlortetracycli organisms ne per lb body susceptible to weight per day chlortetracycli and not less ne, increased than 60 mg or rate of weight more than 300 gain, and mg lasalocid suppression of per head per estrus (heat). day in at least 1 pound of feed for not more than 5 days. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone for a total time not exceeding 24 days of feeding. See Sec. 558.311(d) of this chapter. Chlortetracycli ne, lasalocid, and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. [[Page 58003]] (xvi) 500 to 4,000 g/ton........ ............................... Calves, beef and Hand feed 054771 nonlactating continuously 069254 dairy cattle: for not more For the than 5 days to treatment of provide 10 mg/ bacterial lb body weight enteritis per day. A caused by withdrawal Escherichia period has not coli and been bacterial established for pneumonia this product in caused by pre-ruminating Pasteurella calves. Do not multocida use in calves susceptible to to be processed chlortetracycli for veal. To ne. sponsor No. 054771 under NADA 046-699: 24-hour withdrawal period. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200- 510: Zero withdrawal period. (xvii) 500 to 4,000 g/ton....... Decoquinate, 12.9 to 90.8...... Calves, beef and Feed at a rate 054771 non-lactating of 1g 069254 dairy cattle: chlortetracycli For the ne per 100 lb treatment of body weight/day bacterial and 22.7 mg enteritis decoquinate per caused by 100 lb of body Escherichia weight/day for coli and not more than 5 bacterial days. When it pneumonia is fully caused by consumed, Pasteurella resume feeding multocida 22.7 mg organisms decoquinate per susceptible to 100 lb of body chlortetracycli weight/day for ne; and for the a total of 28 prevention of days to prevent coccidiosis coccidiosis. A caused by withdrawal Eimeria bovis period has not and E. zuernii. been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xviii) 500 to 4,000 to provide Melengestrol acetate, 0.25 to 2 Growing beef Melengestrol 054771 10 mg per pound of body weight. g/ton to provide 0.25 to 0.5 heifers fed in acetate Type C mg melengestrol acetate per confinement for top-dress head per day. slaughter: For medicated feed the treatment must be top of bacterial dressed onto or enteritis mixed at caused by feeding with a Escherichia Type C coli and medicated feed bacterial containing 500 pneumonia to 4,000 g/ton caused by chlortetracycli Pasteurella ne for not more multocida than 5 days. organisms After susceptible to completing chlortetracycli feeding of this ne, increased combination, rate of weight continue gain, improved feeding a Type feed C top-dress efficiency, and medicated feed suppression of containing estrus (heat). melengestrol acetate alone. Chlortetracycli ne and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xix) 500 to 4,000 to provide 10 Melengestrol acetate, 0.5 to 2 Replacement Melengestrol 054771 mg per pound of body weight. g/ton to provide 0.5 mg dairy heifers acetate Type C melengestrol acetate per head less than 20 top-dress per day. months of age medicated feed and replacement must be top beef heifers: dressed onto or For the mixed at treatment of feeding with a bacterial Type C enteritis medicated feed caused by containing 500 Escherichia to 4,000 g/ton coli and chlortetracycli bacterial ne for not more pneumonia than 5 days. caused by After Pasteurella completing multocida feeding of this organisms combination, susceptible to continue chlortetracycli feeding a Type ne, and for C top-dress suppression of medicated feed estrus (heat). containing melengestrol acetate alone for a total time not exceeding 24 days. Use in dairy heifers less than 20 months of age may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Chlortetracycli ne and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. [[Page 58004]] (xx) 4,000 to 20,000 g/ton...... ............................... Calves, beef and Administer as a 054771 nonlactating top dress, 069254 dairy cattle: varying with For the body weight and treatment of feed bacterial consumption, to enteritis provide 10 mg/ caused by lb per day. Escherichia Treat for not coli and more than 5 bacterial days. A pneumonia withdrawal caused by period has not Pasteurella been multocida established for organisms this product in susceptible to pre-ruminating chlortetracycli calves. Do not ne. use in calves to be processed for veal. (xxi) 4,000 to 20,000 g/ton..... Decoquinate, 90.8 to 535.7..... Calves, beef and Feed at a rate 054771 non-lactating of 1g 069254 dairy cattle: chlortetracycli For the ne per 100 lb treatment of body weight/day bacterial and 22.7 mg enteritis decoquinate per caused by 100 lb of body Escherichia weight/day for coli and not more than 5 bacterial days. When it pneumonia is fully caused by consumed, Pasteurella resume feeding multocida 22.7 mg organisms decoquinate per susceptible to 100 lb of body chlortetracycli weight/day for ne; and for the a total of 28 prevention of days to prevent coccidiosis coccidiosis. A caused by withdrawal Eimeria bovis period has not and E. zuernii. been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xxii) 4,000 to 20,000 g/ton to Melengestrol acetate, 0.25 to 2 Growing beef Top dress 0.5 to 054771 provide 10 mg/lb of body weight g/ton to provide 0.25 to 0.5 heifers fed in 2 pounds of per day. mg melengestrol acetate per confinement for this medicated head per day. slaughter: For feed containing the treatment both drugs onto of bacterial or mix at enteritis feeding with a caused by non-medicated Escherichia feed for not coli and more than 5 bacterial days. After pneumonia completing caused by feeding of this Pasteurella combination, multocida continue organisms feeding a Type susceptible to C top-dress chlortetracycli medicated feed ne, and for containing increased rate melengestrol of weight gain, acetate alone. improved feed A withdrawal efficiency, and period has not suppression of been estrus (heat). established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Chlortetracycli ne and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xxiii) 4,000 to 20,000 g/ton to Melengestrol acetate, 0.5 to 2 Replacement Top dress 0.5 to 054771 provide 10 mg/lb of body weight g/ton to provide 0.5 mg dairy heifers 2 pounds of per day. melengestrol acetate per head less than 20 this medicated per day. months of age feed containing and replacement both drugs onto beef heifers: or mix at For the feeding with a treatment of non-medicated bacterial feed for not enteritis more than 5 caused by days. After Escherichia completing coli and feeding of this bacterial combination, pneumonia continue caused by feeding a Type Pasteurella C top-dress multocida medicated feed organisms containing susceptible to melengestrol chlortetracycli acetate alone ne, and for for a total suppression of time not estrus (heat). exceeding 24 days. Use in dairy heifers less than 20 months of age may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Chlortetracycli ne and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. [[Page 58005]] (xxiv) to provide 350 mg/head/ ............................... Beef cattle: For Feed to provide 054771 day. control of chlortetracycli 066104 bacterial ne at the rate 069254 pneumonia of 350 mg per associated with animal daily. A shipping fever withdrawal complex caused period has not by Pasteurella been spp. established for susceptible to this product in chlortetracycli pre-ruminating ne. calves. Do not use in calves to be processed for veal. Withdrawal periods: To sponsor No. 054771 under NADAs 046-699 and 049-287, No. 066104 under NADA 092- 286, and No. 069254 under NADA 048-480: Withdraw 48 hours prior to slaughter. To sponsor No. 054771 under NADA 048-761 and No. 069254 under NADA 138- 935 and ANADA 200-510: Zero withdrawal period. (xxv) to provide 350 mg/head/day ............................... Beef cattle Feed to provide 054771 (under 700 lb): chlortetracycli 066104 For control of ne at the rate 069254 active of 350 mg per infection of animal daily. A anaplasmosis withdrawal caused by period has not Anaplasma been marginale established for susceptible to this product in chlortetracycli pre-ruminating ne. calves. Do not use in calves to be processed for veal. Withdrawal periods: To sponsor No. 054771 under NADAs 046-699 and 049-287, No. 066104 under NADA 092- 286, and No. 069254 under NADA 048-480: Withdraw 48 hours prior to slaughter. To sponsor No. 054771 under NADA 048-761 and No. 069254 under NADA 138- 935 and ANADA 200-510: Zero withdrawal period. (xxvi) 50 to 350 g/ton to Melengestrol acetate, 0.5 to 2 Replacement beef Melengestrol 054771 provide 350 mg/head/day. g/ton to provide 0.5 mg heifers under acetate Type C melengestrol acetate per head 700 lb: For top-dress per day. control of medicated feed active must be top infection of dressed or anaplasmosis mixed at caused by feeding with Anaplasma the Type C marginale medicated feed susceptible to containing 50 chlortetracycli to 350 g/ton ne and for chlortetracycli suppression of ne for up to 24 estrus (heat). days of feeding. Do not exceed 24 days of feeding. Chlortetracycli ne and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xxvii) 20 to 350 g/ton......... ............................... Beef cattle and Feed to provide 054771 replacement chlortetracycli 069254 dairy heifers: ne at the rate For control of of 350 mg per bacterial head per day. pneumonia This drug is associated with not approved shipping fever for use in complex caused female dairy by Pasteurella cattle 20 spp. months of age susceptible to or older, chlortetracycli including dry ne. dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200- 510: Zero withdrawal period. (xxviii) 20 to 350 g/ton to Melengestrol acetate, 0.25 to 2 Growing beef Melengestrol 054771 provide 350 mg/head/day. g/ton to provide 0.25 to 0.5 heifers fed in acetate Type C mg melengestrol acetate per confinement for top-dress head per day. slaughter: For medicated feed control of must be top bacterial dressed onto or pneumonia mixed at associated with feeding with shipping fever the Type C complex caused medicated feed by Pasteurella containing 20 spp. to 350 g/ton susceptible to chlortetracycli chlortetracycli ne. ne, increased Chlortetracycli rate of weight ne and gain, improved melengestrol as feed provided by No. efficiency, and 054771 in Sec. suppression of 510.600(c) of estrus (heat). this chapter. [[Page 58006]] (xxix) 20 to 350 g/ton to Melengestrol acetate, 0.5 to 2 Replacement Melengestrol 054771 provide 350 mg/head/day. g/ton to provide 0.5 mg dairy heifers acetate Type C melengestrol acetate per head less than 20 top-dress per day. months of age medicated feed and replacement must be top beef heifers: dressed or For control of mixed at bacterial feeding with pneumonia the Type C associated with medicated feed shipping fever containing 20 complex caused to 350 g/ton by Pasteurella chlortetracycli spp. ne. Use in susceptible to dairy heifers chlortetracycli less than 20 ne and months of age suppression of may cause drug estrus (heat). residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Chlortetracycli ne and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xxx) to provide 350 mg/head/day Laidlomycin, 5................. Cattle fed in Feed 054771 confinement for continuously at slaughter: For a rate of 30 to control of 75 mg bacterial laidlomycin pneumonia propionate associated with potassium per shipping fever head per day. A complex caused withdrawal by Pasteurella period has not spp. been susceptible to established for chlortetracycli this product in ne; and for pre-ruminating increased rate calves. Do not of weight and use in calves improved feed to be processed efficiency. for veal. See Sec. 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xxxi) to provide 350 mg/head/ Laidlomycin, 5 to 10........... Cattle fed in Feed 054771 day. confinement for continuously at slaughter: For a rate of 30 to control of 75 mg bacterial laidlomycin pneumonia propionate associated with potassium per shipping fever head per day. A complex caused withdrawal by Pasteurella period has not spp. been susceptible to established for chlortetracycli this product in ne; and for pre-ruminating improved feed calves. Do not efficiency. use in calves to be processed for veal. See Sec. 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xxxii) 25 to 42.2 g/ton to Lasalocid, 25 to 30............ Cattle under 700 Feed 054771 provide 350 mg/head/day. pounds fed in continuously in 069254 confinement for complete feed slaughter: For at a rate of control of 350 mg active chlortetracycli infection of ne and not less anaplasmosis than 250 mg nor caused by more than 360 Anaplasma mg lasalocid marginale per head daily. susceptible to Do not allow chlortetracycli horses or other ne; and for equines access increased rate to feeds of weight gain containing and improved lasalocid. No feed efficiency. withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See Sec. 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xxxiii) 25 to 42.2 g/ton to Lasalocid, 25 to 30............ Cattle fed in Feed 054771 provide 350 mg/head/day. confinement for continuously in 069254 slaughter: For complete feed control of at a rate of bacterial 350 mg pneumonia chlortetracycli associated with ne and not less shipping fever than 250 mg nor complex caused more than 360 by Pasteurella mg lasalocid multocida per head daily. organisms Do not allow susceptible to horses or other chlortetracycli equines access ne; and for to feeds increased rate containing of weight gain lasalocid. No and improved withdrawal feed efficiency. period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See Sec. 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in Sec. 510.600(c) of this chapter. [[Page 58007]] (xxxiv) 25 to 100 g/ton to Lasalocid, 10 to 30............ Cattle under 700 Feed 054771 provide 350 mg/head/day. pounds fed in continuously in 069254 confinement for complete feed slaughter: For at a rate of control of 350 mg active chlortetracycli infection of ne and not less anaplasmosis than 100 mg nor caused by more than 360 Anaplasma mg lasalocid marginale per head daily. susceptible to Do not allow chlortetracycli horses or other ne; and for equines access improved feed to feeds efficiency. containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See Sec. 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xxxv) 25 to 100 g/ton to Lasalocid, 10 to 30............ Cattle fed in Feed 054771 provide 350 mg/head/day. confinement for continuously in 069254 slaughter: For complete feed control of at a rate of bacterial 350 mg pneumonia chlortetracycli associated with ne and not less shipping fever than 100 mg nor complex caused more than 360 by Pasteurella mg lasalocid multocida per head daily. organisms Do not allow susceptible to horses or other chlortetracycli equines access ne; and for to feeds improved feed containing efficiency. lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See Sec. 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xxxvi) 25 to 700 to provide 350 Lasalocid, 30 to 600........... Pasture cattle Feed 054771 g/head/day. (slaughter, continuously on 069254 stocker, feeder a hand-fed cattle, dairy basis at a rate and beef of 350 mg replacement chlortetracycli heifers): For ne and not less control of than 60 mg nor bacterial more than 300 pneumonia mg lasalocid associated with per head per shipping fever day in at least complex caused 1 pound of by Pasteurella feed. Daily multocida lasalocid organisms intakes in susceptible to excess of 200 chlortetracycli mg/head/day in ne; and for pasture cattle increased rate have not been of weight gain. shown to be more effective than 200 mg lasalocid/head/ day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See Sec. 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xxxvii) 25 to 700 g/ton to Lasalocid, 30 to 600; Replacement beef The melengestrol 054771 provide 350 mg/head/day. melengestrol acetate, 0.5 to 2 heifers on acetate Type C g/ton to provide 0.5 mg/head/ pasture: For top-dress day melengestrol acetate. control of medicated feed bacterial must be top pneumonia dressed onto or associated with mixed at shipping fever feeding with a complex caused Type C by Pasteurella medicated feed spp. containing 25 susceptible to to 700 g/ton of chlortetracycli chlortetracycli ne, increased ne and 30 to rate of weight 600 g/ton gain, and lasalocid to suppression of provide 350 mg estrus (heat). chlortetracycli ne per head daily and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 pound of feed. Do not exceed 24 days of feeding. See Sec. 558.311(d) of this chapter. Chlortetracycli ne, lasalocid, and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. [[Page 58008]] (xxxviii) 25 to 700 to provide Lasalocid, 30 to 600........... Pasture cattle Feed 054771 350 mg/head/day. (slaughter, continuously on 069254 stocker, feeder a hand-fed cattle, beef basis at a rate replacement of 350 mg heifers) under chlortetracycli 700 pounds: For ne and not less control of than 60 mg nor active more than 300 infection of mg lasalocid anaplasmosis per head per caused by day in at least Anaplasma 1 pound of marginale feed. Daily susceptible to lasalocid chlortetracycli intakes in ne; and for excess of 200 increased rate mg/head/day in of weight gain. pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/ day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See Sec. 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xxxix) 25 to 700 g/ton to Lasalocid, 30 to 600; Replacement beef The melengestrol 054771 provide 350 mg/head/day. melengestrol acetate, 0.5 to 2 heifers on acetate Type C g/ton to provide 0.5 mg/head/ pasture under top-dress day melengestrol acetate. 700 pounds: For medicated feed control of must be top active dressed onto or infection of mixed at anaplasmosis feeding with a caused by Type C Anaplasma medicated feed marginale containing 25 susceptible to to 700 g/ton of chlortetracycli chlortetracycli ne, increased ne and 30 to rate of weight 600 g/ton gain, and lasalocid to suppression of provide 350 mg estrus (heat). chlortetracycli ne per head daily and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 pound of feed. Do not exceed 24 days of feeding. See Sec. 558.311(d) of this chapter. Chlortetracycli ne, lasalocid, and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xl) 25 to 2,800 to provide 350 Lasalocid, 30 to 181.8......... Beef cattle Hand feed 054771 mg/head/day. weighing under continuously at 069254 700 pounds: For a rate of 350 control of mg active chlortetracycli infection of ne and 1 mg anaplasmosis lasalocid per caused by 2.2 lb. body Anaplasma weight daily to marginale cattle with a susceptible to maximum of 360 chlortetracycli mg of lasalocid ne; and for the per head per control of day. Do not coccidiosis allow horses or caused by other equines Eimeria bovis access to feeds and E. zuernii. containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See Sec. 558.311(d) of this chapter. Chlortetracycli ne and lasalocid as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xli) 25 to 2,80 g/ton to Lasalocid, 30 to 181.8; Growing beef The melengestrol 054771 provide 350 mg/head/day. melengestrol acetate, 0.25 to heifers fed in acetate Type C 2 g/ton to provide 0.25 to 0.5 confinement for top-dress mg/head/day melengestrol slaughter under medicated feed acetate. 700 pounds: For must be top control of dressed onto or active mixed at infection of feeding with a anaplasmosis Type C caused by medicated feed Anaplasma containing 25 marginale to 2,800 g/ton susceptible to of chlortetracycli chlortetracycli ne, control of ne and 30 to coccidiosis 181.8 g/ton caused by lasalocid to Eimeria bovis provide 350 mg and E. zuernii, chlortetracycli increased rate ne per head per of weight gain, day and 1 mg improved feed lasalocid per efficiency, and 2.2 lb. of body suppression of weight daily estrus (heat). with a maximum of 360 mg lasalocid per head per day. See Sec. 558.311(d) of this chapter. Chlortetracycli ne, lasalocid, and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. [[Page 58009]] (xlii) 25 to 2,800 to provide Lasalocid, 30 to 181.8......... Beef cattle Hand feed 054771 350 mg/head/day. weighing up to continuously at 069254 800 pounds: For a rate of 350 control of mg bacterial chlortetracycli pneumonia ne and 1 mg associated with lasalocid per shipping fever 2.2 lb. body complex caused weight daily to by Pasteurella cattle with a spp. maximum of 360 susceptible to mg of lasalocid chlortetracycli per head per ne; and for the day. Do not control of allow horses or coccidiosis other equines caused by access to feeds Eimeria bovis containing and E. zuernii. lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See Sec. 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xliii) 25 to 2,800 g/ton to Lasalocid, 30 to 181.8; Growing beef The melengestrol 054771 provide 350 mg/head/day. melengestrol acetate, 0.25 to heifers fed in acetate Type C 2 g/ton to provide 0.25 to 0.5 confinement for top-dress mg/head/day melengestrol slaughter up to medicated feed acetate. 800 pounds: For must be top control of dressed onto or bacterial mixed at pneumonia feeding with a associated with Type C shipping fever medicated feed complex caused containing 25 by Pasteurella to 2,800 g/ton spp. of susceptible to chlortetracycli chlortetracycli ne and 30 to ne, control of 181.8 g/ton coccidiosis lasalocid to caused by provide 350 mg Eimeria bovis chlortetracycli and E. zuernii, ne per head increased rate daily and 1 mg of weight gain, lasalocid per improved feed 2.2 lb. of body efficiency, and weight daily suppression of with a maximum estrus (heat). of 360 mg lasalocid per head per day. See Sec. 558.311(d) of this chapter. Chlortetracycli ne, lasalocid, and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xliv) 25 to 2,800 g/ton to Lasalocid, 30 to 181.8; Replacement beef The melengestrol 054771 provide 350 mg/head/day. melengestrol acetate, 0.5 to 2 heifers up to acetate Type C g/ton to provide 0.5 mg/head/ 800 pounds: For top-dress day melengestrol acetate. control of medicated feed bacterial must be top pneumonia dressed onto or associated with mixed at shipping fever feeding with a complex caused Type C by Pasteurella medicated feed spp. containing 25 susceptible to to 2,800 g/ton chlortetracycli of ne, control of chlortetracycli coccidiosis ne and 30 to caused by 181.8 g/ton Eimeria bovis lasalocid to and E. zuernii, provide 350 mg and suppression chlortetracycli of estrus ne per head (heat). daily and 1 mg lasalocid per 2.2 lb. of body weight daily with a maximum of 360 mg lasalocid per head per day. Do not exceed 24 days of feeding. See Sec. 558.311(d) of this chapter. Chlortetracycli ne, lasalocid, and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xlv) 500 to 4,000 to provide 10 Lasalocid, 30 to 181.8......... Cattle weighing Hand feed 054771 mg/head/day. up to 800 continuously 069254 pounds: For the for not more treatment of than 5 days at bacterial a rate of 10 mg enteritis chlortetracycli caused by ne and 1 mg Escherichia lasalocid per coli and 2.2 lb. body bacterial weight daily to pneumonia cattle with a caused by maximum of 360 Pasteurella mg of lasalocid multocida per head per susceptible to day. Do not chlortetracycli allow horses or ne; and for the other equines control of access to feeds coccidiosis containing caused by lasalocid. No Eimeria bovis withdrawal and E. zuernii. period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See Sec. 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in Sec. 510.600(c) of this chapter. [[Page 58010]] (xlvi) 500 to 4,000 g/ton to Lasalocid, 30 to 181.8; Growing beef The melengestrol 054771 provide 10 mg/lb of body weight melengestrol acetate, 0.25 to heifers fed in acetate Type C daily. 2 g/ton to provide 0.25 to 0.5 confinement for top-dress mg/head/day melengestrol slaughter up to medicated feed acetate. 800 pounds: For must be top the treatment dressed onto or of bacterial mixed at enteritis feeding with a caused by Type C Escherichia medicated feed coli and containing 500 bacterial to 4,000 g/ton pneumonia of caused by chlortetracycli Pasteurella ne and 30 to multocida 181.8 g/ton organisms lasalocid to susceptible to provide 10 mg chlortetracycli chlortetracycli ne, control of ne per lb of coccidiosis body weight per caused by day and 1 mg Eimeria bovis lasalocid per and E. zuernii, 2.2 lb of body increased rate weight per day of weight gain, with a maximum improved feed of 360 mg efficiency, and lasalocid per suppression of head per day estrus (heat). for not more than 5 days of feeding. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone. See Sec. 558.311(d) of this chapter. Chlortetracycli ne, lasalocid, and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. (xlvii) 500 to 4,000 g/ton to Lasalocid, 30 to 181.8; Replacement The melengestrol 054771 provide 10 mg/lb of body weight melengestrol acetate, 0.5 to 2 dairy heifers acetate Type C daily. g/ton to provide 0.5 mg/head/ up to 800 top-dress day melengestrol acetate. pounds and less medicated feed than 20 months must be top of age and dressed onto or replacement mixed at beef heifers up feeding with a to 800 pounds: Type C For the medicated feed treatment of containing 500 bacterial to 4,000 g/ton enteritis of caused by chlortetracycli Escherichia ne and 30 to coli and 181.8 g/ton bacterial lasalocid to pneumonia provide 10 mg caused by chlortetracycli Pasteurella ne per lb of multocida body weight per organisms day and 1 mg susceptible to lasalocid per chlortetracycli 2.2 lb of body ne, control of weight per day coccidiosis with a maximum caused by of 360 mg Eimeria bovis lasalocid per and E. zuernii, head per day and suppression for not more of estrus than 5 days. (heat). After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone. See Sec. 558.311(d) of this chapter. Chlortetracycli ne, lasalocid, and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. ---------------------------------------------------------------------------------------------------------------- * * * * * 0 31. In Sec. 558.342, revise paragraph (e)(1)(iv) to read as follows: Sec. 558.342 Melengestrol. * * * * * (e) * * * (1) * * * ---------------------------------------------------------------------------------------------------------------- Melengestrol acetate in Indications for mg/head/day Combination in mg/head/day use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (iv) 0.25 to 0.5.......... Monensin, 10 to 40......... Heifers fed in Add at the rate of 016592 confinement for 0.5 to 2.0 lb/ 045771 slaughter: For head/day a 058198 increased rate of medicated feed weight gain, (liquid or dry) improved feed containing 0.125 efficiency, and to 1.0 mg suppression of melengestrol estrus (heat); acetate/lb to a and for the feed containing prevention and 10 to 40 g of control of monensin per ton coccidiosis due to provide 0.25 to Eimeria bovis to 0.5 mg and E. zuernii. melengestrol acetate/head/day and 0.14 to 0.42 mg monensin/lb body weight, depending on severity of coccidiosis challenge, up to 480 mg monensin/ head/day. See Sec. 558.355(d) of this chapter. Monensin as provided by No. 016592 or 058198; melengestrol acetate as provided by No. 016952, 054771, or 058198 in Sec. 510.600(c) of this chapter. [[Page 58011]] * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * 0 32. In Sec. 558.355, revise paragraphs (b)(2), (f)(2)(ii), (f)(3), and (f)(4)(i) and (ii), remove paragraph (f)(4)(v), redesignate paragraph (f)(4)(vi) as paragraph (f)(4)(v) and revise it, and revise paragraphs (f)(6)(i) and (f)(7)(viii) The revisions read as follows: Sec. 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 (f)(3), (f)(4)(v), and (f)(6) of this section. * * * * * (f) * * * (2) * * * ---------------------------------------------------------------------------------------------------------------- Combination in grams/ Monensin in grams/ton ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (ii) 54 to 90.............. Bacitracin Growing turkeys: For Feed continuously as 058198 methylenedisalicyla the prevention of the sole ration. 069254 te, 4 to 50. coccidiosis caused The optimum level by Eimeria depends upon the adenoeides, E. severity of meleagrimitis, and coccidiosis E. gallopavonis, exposure. Do not and for increased allow horses, other rate of weight gain equines, mature and improved feed turkeys, or guinea efficiency. fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Bacitracin methylenedisalicyla te as provided by No. 054771 or 069254 in Sec. 510.600(c) of this chapter. * * * * * * * ---------------------------------------------------------------------------------------------------------------- (3) * * * ------------------------------------------------------------------------ Indications for Monensin in grams/ton use Limitations Sponsor ------------------------------------------------------------------------ (i) 5 to 40............ Growing beef Feed 016592 steers and continuously 058198 heifers fed in in complete confinement for feed at a rate slaughter: For of 50 to 480 improved feed milligrams of efficiency. monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day). See special labeling considerations in paragraph (d) of this section. (ii) 10 to 40.......... Growing beef Feed at a rate 016592 steers and of 0.14 to 058198 heifers fed in 0.42 milligram confinement for per pound of slaughter: For body weight prevention and per day, control of depending upon coccidiosis due the severity to Eimeria of challenge, bovis and E. up to maximum zuernii. of 480 milligrams per head per day. See special labeling considerations in paragraph (d) of this section. (iii) 10 to 200........ Calves excluding Feed at a rate 016592 veal calves: of 0.14 to 1.0 058198 For prevention milligram and control of monensin per coccidiosis due pound of body to Eimeria weight per bovis and E. day, depending zuernii. upon the severity of challenge, up to maximum of 200 milligrams per head per day. See special labeling considerations in paragraph (d) of this section. (iv) 11 to 22.......... Dairy cows: For Feed 016592 increased milk continuously 058198 production to dry and efficiency lactating (production of dairy cows in marketable a total mixed solids- ration corrected milk (``complete per unit of feed''). See feed intake). special labeling considerations in paragraph (d) of this section. (v) 11 to 400.......... Dairy cows: For Feed 016592 increased milk continuously 058198 production to dry and efficiency lactating (production of dairy cows in marketable a component solids- feeding system corrected milk (including top per unit of dress). The feed intake). Type C medicated feed must be fed in a minimum of 1 lb of feed to provide 185 to 660 mg/head/ day monensin to lactating cows or 115 to 410 mg/head/ day monensin to dry cows. See special labeling considerations in paragraph (d) of this section. [[Page 58012]] (vi) 15 to 400......... Growing beef For increased 016592 steers and rate of weight 058198 heifers on gain, feed at pasture a rate of 50 (stocker, to 200 feeder, and milligrams slaughter) or monensin per in a dry lot head per day and replacement in not less beef and dairy than 1 pound heifers: For of feed or, increased rate after the 5th of weight gain, day, feed at a and for rate of 400 prevention and milligrams per control of head per day coccidiosis due every other to Eimeria day in not bovis and E. less than 2 zuernii. pounds of feed. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending on severity of challenge, up to 200 milligrams per head per day. During first 5 days of feeding, cattle should receive no more than 100 milligrams per day in not less than 1 pound of feed. See special labeling considerations in paragraph (d) of this section. (vii) 25 to 400........ Beef cows: For Feed as 016592 improved feed supplemental 058198 efficiency when feed, either receiving hand-fed in a supplemental minimum of 1 feed, and for pound of feed the prevention or mixed in a and control of total ration. coccidiosis due For improved to Eimeria feed bovis and E. efficiency, zuernii. feed continuously at a rate of 50 to 200 milligrams monensin per head per day. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending upon severity of challenge, up to a maximum of 200 milligrams per head per day. During first 5 days of feeding, cattle should receive no more than 100 milligrams per head per day in not less than 1 pound of feed. See special labeling considerations in paragraph (d) of this section. ------------------------------------------------------------------------ (4) * * * ---------------------------------------------------------------------------------------------------------------- Monensin amount Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 150 milligrams per pound of protein- Growing beef steers and Provide 50 to 200 012286 mineral block (0.033%). heifers on pasture milligrams of monensin (stocker, feeder, and (0.34 to 1.33 pounds slaughter) and of block) per head per replacement beef day, at least 1 block heifers on pasture: For per 10 to 12 head of increased rate of cattle. Roughage must weight gain, and for be available at all prevention and control times. Do not allow of coccidiosis caused animals access to by Eimeria bovis and E. other protein blocks, zuernii in pasture salt or mineral, while cattle which may being fed this require supplemental product. See paragraph feed. (d)(10)(i) of this section. (ii) 175 milligrams per pound of Growing beef steers and Provide 40 to 200 017800 protein-mineral block (0.038%). heifers on pasture milligrams of monensin (stocker, feeder, and (0.25 to 1.13 pounds slaughter): For or 4 to 18 ounces of increased rate of block) per head per weight gain. day, at least 1 block per 4 head of cattle. Do not allow cattle access to salt or mineral while being fed this product. Ingestion by cattle of monensin at levels of 600 milligrams per head per day and higher has been fatal. See paragraph (d)(10)(i) of this section. * * * * * * * (v) 1,620 grams per ton of mineral Growing beef steers and Feed at a rate of 50 to 016592 granules as specified in paragraph heifers on pasture 200 milligrams per 058198 (f)(4)(v)(A) of this section. (stocker, feeder, and head per day. During slaughter) or in a dry the first 5 days of lot and replacement feeding, cattle should beef and dairy heifers: receive no more than For increased rate of 100 milligrams per weight gain, and for day. Do not feed prevention and control additional salt or of coccidiosis due to minerals. Do not mix Eimeria bovis and E. with grain or other zuernii. feeds. Monensin is toxic to cattle when consumed at higher than approved levels. Stressed and/or feed- and/or water-deprived cattle should be adapted to the pasture and to unmedicated mineral supplement before using the monensin mineral supplement. ---------------------------------------------------------------------------------------------------------------- (A) Specifications. Use as free-choice Type C medicated feed formulated as mineral granules as follows: ------------------------------------------------------------------------ International Ingredient Percent feed No. ------------------------------------------------------------------------ Monocalcium phosphate (21% phosphorus, 15% 29.49 6-01-082 calcium).................................... Sodium chloride (salt)....................... 24.37 6-04-152 Dried cane molasses.......................... 20.0 4-04-695 Ground limestone (33% calcium) or calcium 13.75 6-02-632 carbonate (38% calcium)..................... [[Page 58013]] Cane molasses................................ 3.0 4-04-696 Processed grain by-products (as approved by 5.0 .............. AAFCO)...................................... Vitamin/trace mineral premix \1\............. 2.5 .............. Monensin Type A article, 90.7 grams per pound 0.89 .............. Antidusting oil.............................. 1.0 .............. ------------------------------------------------------------------------ \1\ Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide should comply with FDA Compliance Policy Guide Sec. 651.100 (CPG 7125.18). (B) [Reserved] * * * * * (6) * * * ------------------------------------------------------------------------ Indications for Monensin in grams/ton use Limitations Sponsor ------------------------------------------------------------------------ (i) 20................. Goats maintained Feed 016592 in confinement: continuously. 058198 For the Do not feed to prevention of lactating coccidiosis goats. See caused by paragraph Eimeria (d)(11) of crandallis, E. this section christenseni, for provisions and E. for monensin ninakohlyakimov liquid Type C ae. goat feeds. * * * * * * * ------------------------------------------------------------------------ (7) * * * (viii) Ractopamine as in Sec. 558.500. * * * * * 0 33. In Sec. 558.500, revise paragraphs (e)(2)(ii), (iv), (v), and (vii) to read as follows: Sec. 558.500 Ractopamine. * * * * * (e) * * * (2) * * * ---------------------------------------------------------------------------------------------------------------- Indications for Ractopamine in grams/ton Combination in grams/ton use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (ii) 8.2 to 24.6 to provide 70 Monensin 10 to 40 to provide Cattle fed in Feed 016592 to 430 mg/head/day. 0.14 to 0.42 mg monensin/lb of confinement continuously 054771 body weight, depending on for slaughter: as sole ration 058198 severity of coccidiosis For increased during the challenge, up to 480 mg/head/ rate of weight last 28 to 42 day. gain, improved days on feed. feed Not for efficiency, animals and prevention intended for and control of breeding. See coccidiosis special due to Eimeria labeling bovis and E. considerations zuernii during in Sec. the last 28 to 558.355(d) of 42 days on this chapter. feed. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198 in Sec. 510.600(c) of this chapter. * * * * * * * (iv) 9.8 to 24.6 to provide 90 Monensin 10 to 40 to provide Cattle fed in Feed 016592 to 430 mg/head/day. 0.14 to 0.42 mg monensin/lb of confinement continuously 054771 body weight, depending on for slaughter: as sole ration 058198 severity of coccidiosis For increased during the challenge, up to 480 mg/head/ rate of weight last 28 to 42 day. gain, improved days on feed. feed Not for efficiency, animals increased intended for carcass breeding. See leanness, and special prevention and labeling control of considerations coccidiosis in Sec. due to Eimeria 558.355(d) of bovis and E. this chapter. zuernii during Ractopamine as the last 28 to provided by 42 days on No. 016592, feed. 054771, or 058198; monensin as provided by No. 016592 or 058198 in Sec. 510.600(c) of this chapter. (v) 9.8 to 24.6 to provide 90 Monensin 10 to 40 to provide Heifers fed in Feed 016592 to 430 mg/head/day. 0.14 to 0.42 mg monensin/lb of confinement continuously 054771 body weight, depending on for slaughter: as sole ration 058198 severity of coccidiosis For increased during the challenge, up to 480 mg/head/ rate of weight last 28 to 42 day, plus melengestrol acetate gain, improved days on feed. to provide 0.25 to 0.5 mg/head/ feed Not for day. efficiency, animals increased intended for carcass breeding. See leanness, special prevention and labeling control of considerations coccidiosis in Sec. Sec. due to Eimeria 558.342(d) bovis and E. and 558.355(d) zuernii, and of this suppression of chapter. estrus (heat) Ractopamine as during the provided by last 28 to 42 No. 016592, days on feed. 054771, or 058198; monensin as provided by No. 016592 or 058198; melengestrol acetate as provided by No. 016592, 054771 or 058198 in Sec. 510.600(c) of this chapter. [[Page 58014]] * * * * * * * (vii) Not to exceed 800; to Monensin 10 to 40 to provide Cattle fed in Top dress 016592 provide 70 to 400 mg/head/day. 0.14 to 0.42 mg monensin/lb of confinement ractopamine at 054771 body weight, depending on for slaughter: a minimum of 058198 severity of coccidiosis For increased 1.0 lb/head/ challenge, up to 480 mg/head/ rate of weight day of day. gain, improved medicated feed feed continuously efficiency, during the and prevention last 28 to 42 and control of days on feed. coccidiosis Not for due to Eimeria animals bovis and E. intended for zuernii during breeding. See the last 28 to special 42 days on labeling feed. considerations in Sec. 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198 in Sec. 510.600(c) of this chapter. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * 0 34. In Sec. 558. 550, revise paragraphs (a), (b), (e)(1)(i), and (e)(2)(i) to read as follows: Sec. 558. 550 Salinomycin. (a) Specifications. Type A medicated articles containing 30 or 60 grams of salinomycin sodium activity per pound. (b) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter for use as in paragraph (e) of this section. * * * * * (e) * * * (1) * * * ---------------------------------------------------------------------------------------------------------------- Salinomycin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 40 to 60.............. ........................ Broiler, roaster, Feed continuously 016592 and replacement as sole ration. Do (breeder and not feed to birds layer) chickens: producing eggs for For the prevention human consumption. of coccidiosis May be fatal if caused by Eimeria accidentally fed tenella, E. to adult turkeys necatrix, E. or horses. acervulina, E. maxima, E. brunetti, and E. mivati. * * * * * * * ---------------------------------------------------------------------------------------------------------------- (2) * * * ---------------------------------------------------------------------------------------------------------------- Combination in grams per Salinomycin in grams/ton ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 50.................... ........................ Quail: For the Feed continuously 016592 prevention of as sole ration. Do coccidiosis caused not feed to birds by Eimeria producing eggs for dispersa and E. human consumption. lettyae. May be fatal if accidentally fed to adult turkeys or horses. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * 0 35. In Sec. 558.625, revise paragraphs (e)(2)(i) and (e)(2)(ix) through (xiii) to read as follows: Sec. 558.625 Tylosin. * * * * * (e) * * * (2) * * * ---------------------------------------------------------------------------------------------------------------- Combination in Tylosin grams/ton grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 8 to 10..................... ................... Beef cattle: For Feed continuously 016592 reduction of as the sole ration 054771 incidence of liver to provide 60 to 058198 abscesses caused 90 mg/head/day 066104 by Fusobacterium tylosin. necrophorum and Arcanobacterium pyogenes. [[Page 58015]] * * * * * * * (ix) 8 to 10.................... Monensin 10 to 40 Heifers fed in Feed continuously 016592 plus melengestrol confinement for as sole ration to 054771 0.25 to 2.0. slaughter: For heifers at a rate 058198 reduction of of 0.5 to 2 pounds incidence of liver per head per day abscesses caused to provide 0.25 to by Fusobacterium 0.5 mg/head/day necrophorum and melengestrol Arcanobacterium acetate and 0.14 pyogenes; for to 0.42 mg prevention and monensin/lb body control of weight per day, coccidiosis caused depending on the by Eimeria bovis severity of the and E. zuernii; coccidiosis and for increased challenge, up to rate of weight 480 mg/head/day gain, improved and 60 to 90 mg/ feed efficiency, head/day tylosin. and suppression of The melengestrol estrus (heat). acetate portion of this Type C medicated feed must be mixed into the complete feed containing 10 to 40 g/ton monensin and 8 to 10 g/ton tylosin at feeding into the amount of complete feed consumed by an animal per day. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. See Sec. Sec. 558.342(d) and 558.355(d) of this chapter. Tylosin provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; melengestrol provided by No. 016592, 054771, or 058198 in Sec. 510.600(c) of this chapter. (x) 8 to 10..................... Monensin 10 to 40 Cattle fed in Feed continuously 016592 plus ractopamine confinement for as sole ration to 054771 8.2 to 24.6. slaughter: For provide 70 to 430 058198 reduction of mg/head/day incidence of liver ractopamine and abscesses caused 0.14 to 0.42 mg by Fusobacterium monensin/lb body necrophorum and weight per day, Arcanobacterium depending on the pyogenes; for severity of the prevention and coccidiosis control of challenge, up to coccidiosis caused 480 mg/head/day by Eimeria bovis and 60 to 90 mg/ and E. zuernii; head/day tylosin and for increased for the last 28 to rate of weight 42 days on feed. A gain and improved withdrawal time feed efficiency in has not been cattle fed in established for confinement for pre-ruminating slaughter for the calves. Do not use last 28 to 42 days in calves to be on feed. processed for veal. See special labeling considerations in Sec. Sec. 558.355(d) and 558.500(d) of this chapter. Tylosin provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; ractopamine provided by No. 016592, 054771, or 058198 in Sec. 510.600(c) of this chapter. (xi) 8 to 10.................... Monensin 10 to 40 Cattle fed in Feed a minimum of 016592 plus ractopamine, confinement for 1.0 lb/head/day 054771 not to exceed 800. slaughter: For ractopamine Type C 058198 reduction of top dress feed incidence of liver continuously to abscesses caused cattle fed in by Fusobacterium confinement for necrophorum and slaughter, to Arcanobacterium provide 70 to 400 pyogenes; for mg/head/day prevention and ractopamine for control of the last 28 to 42 coccidiosis caused days on feed. Feed by Eimeria bovis on top of a ration and E. zuernii; containing 10 to and for increased 40 g/ton monensin rate of weight and 8 to 10 g/ton gain and improved tylosin phosphate, feed efficiency in to provide 0.14 to cattle fed in 0.42 mg monensin/ confinement for lb body weight/ slaughter for the day, depending on last 28 to 42 days the severity of on feed. the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/ head/day tylosin. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. See special labeling considerations in Sec. Sec. 558.355(d) and 558.500(d) of this chapter. Tylosin provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; ractopamine provided by No. 016592, 054771, or 058198 in Sec. 510.600(c) of this chapter. [[Page 58016]] (xii) 8 to 10................... Monensin 10 to 40 Cattle fed in Feed continuously 016592 plus ractopamine confinement for as sole ration to 054771 9.8 to 24.6. slaughter: For provide 90 to 430 058198 reduction of mg/head/day incidence of liver ractopamine and abscesses caused 0.14 to 0.42 mg by Fusobacterium monensin/lb body necrophorum and weight per day, Arcanobacterium depending on the pyogenes; for severity of the prevention and coccidiosis control of challenge, up to coccidiosis caused 480 mg/head/day by Eimeria bovis and 60 to 90 mg/ and E. zuernii; head/day tylosin and for increased for the last 28 to rate of weight 42 days on feed. A gain, improved withdrawal time feed efficiency, has not been and increased established for carcass leanness pre-ruminating in cattle fed in calves. Do not use confinement for in calves to be slaughter for the processed for last 28 to 42 days veal. See special on feed. labeling considerations in Sec. Sec. 558.355(d) and 558.500(d) of this chapter. Tylosin as provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; ractopamine as provided by No. 016592, 054771, or 058198 in Sec. 510.600(c) of this chapter. (xiii) 8 to 10.................. Monensin, 10 to 40 Heifers fed in Feed continuously 016592 plus ractopamine, confinement for as sole ration to 054771 9.8 to 24.6, plus slaughter: For provide 90 to 430 058198 melengestrol, reduction of mg/head/day 0.125 to 1 mg/lb. incidence of liver ractopamine and abscesses caused 0.14 to 0.42 mg by Fusobacterium monensin/lb body necrophorum and weight per day, Arcanobacterium depending on the pyogenes; for severity of the prevention and coccidiosis control of challenge, up to coccidiosis caused 480 mg/head/day by Eimeria bovis and 60 to 90 mg/ and E. zuernii; head/day tylosin for increased rate for the last 28 to of weight gain, 42 days on feed. improved feed Feed melengestrol efficiency, and as a top dress or increased carcass mixed with a leanness; and complete ration at suppression of the rate of 0.5 to estrus (heat) in 2.0 pound/head/day heifers fed in (specify one confinement for level) to provide slaughter for the 0.25 to 0.5 mg last 28 to 42 days melengestrol on feed. acetate/head/day (specify one level). A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. See special labeling considerations in Sec. Sec. 558.342(d), 558.355(d), and 558.500(d) of this chapter. Tylosin provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; ractopamine as provided by No. 016592, 054771, or 058198; melengestrol acetate as provided by No. 016592 or 054771 in Sec. 510.600(c) of this chapter. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * Dated: October 12, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021-22604 Filed 10-19-21; 8:45 am] BILLING CODE 4164-01-P