New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship, 57992-58016 [2021-22604]

Download as PDF 57992 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations for a ‘‘significant regulatory action’’ as specified in Executive Order 12866. Paperwork Reduction Act There is no new collection of information required in this document; therefore, the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507) are inapplicable. Dated: October 15, 2021. Robert F. Altneu, Director, Regulations & Disclosure Law Division, Regulations & Rulings, Office of Trade, U.S. Customs and Border Protection. BILLING CODE 9111–14–P I. Approvals Signing Authority This document is limited to a technical correction of CBP regulations. Accordingly, it is being signed under the authority of 19 CFR 0.1(b). Acting Commissioner Troy A. Miller, having reviewed and approved this document, is delegating the authority to electronically sign this document to Robert F. Altneu, who is the Director of the Regulations and Disclosure Law Division for CBP, for purposes of publication in the Federal Register. List of Subjects in 19 CFR Part 122 Air carriers, Aircraft, Airports, Customs duties and inspection, Freight. HHS. PART 122—AIR COMMERCE REGULATIONS 1. The general authority citation for part 122 continues to read as follows: ■ Authority: 5 U.S.C. 301; 19 U.S.C. 58b, 66, 1415, 1431, 1433, 1436, 1448, 1459, 1590, 1594, 1623, 1624, 1644, 1644a, 2071 note. * * § 122.15 * * * [Amended] 2. In § 122.15, amend the table in paragraph (b) by removing the entry for ‘‘Monroe, North Carolina’’. ■ George K. Haibel, Center for Veterinary Medicine (HFV–6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–5689, george.haibel@fda.hhs.gov. SUPPLEMENTARY INFORMATION: [FR Doc. 2021–22880 Filed 10–19–21; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Amendments to Regulations Part 122, of title 19 of the Code of Federal Regulations (19 CFR part 122) is amended as set forth below: FOR FURTHER INFORMATION CONTACT: 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, Final rule; technical amendments. ACTION: 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. SUMMARY: 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/centerveterinary-medicine/cvm-foiaelectronic-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/approvedanimal-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 lotter on DSK11XQN23PROD with RULES1 Approval date File No. Sponsor Product name Species Effect of the action Public documents Supplemental approval for the addition of Mycoplasma hyopneumoniae to the list of pathogens for the control of swine respiratory disease indication. Conditional approval for the treatment of lymphoma in dogs. FOI Summary. January 8, 2021 ......... 141–336 ECO LLC, 344 Nassau St., Princeton, NJ 08540. AIVLOSIN (62.5% w/w tylvalosin as tylvalosin tartrate) Water Soluble Granules. Swine ......... January 11, 2021 ....... 141–526 LAVERDIA–CA1 (verdinexor tablets). Dogs ........... January 12, 2021 ....... 200–675 Original approval as a generic copy of NADA 141–225. FOI Summary. 200–676 Ractopamine hydrochloride and monensin Type B and Type C medicated feeds. Ractopamine hydrochloride, monensin, and tylosin phosphate Type B and Type C medicated feeds. Cattle .......... January 12, 2021 ....... Anivive Lifesciences, Inc., 3250 Airflite Way, Suite 400, Long Beach, CA 90807. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria. Do .................................... Cattle .......... Original approval as a generic copy of NADA 141–224. FOI Summary. VerDate Sep<11>2014 16:22 Oct 19, 2021 Jkt 256001 PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 E:\FR\FM\20OCR1.SGM 20OCR1 FOI Summary. Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations 57993 TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY, FEBRUARY, AND MARCH 2021—Continued lotter on DSK11XQN23PROD with RULES1 Approval date File No. Sponsor Product name Species Effect of the action Public documents Ractopamine hydrochloride, monensin, and melengestrol acetate Type C medicated feeds. Ractopamine hydrochloride, monensin, tylosin phosphate, and melengestrol acetate Type C medicated feeds. KBROVET–CA1 (potassium bromide chewable tablets) Chewable Tablet. THYROKARE (levothyroxine sodium tablets). Melengestrol acetate and monensin Type C medicated feeds. Cattle .......... Original approval as a generic copy of NADA 141–234. FOI Summary. Cattle .......... Original approval as a generic copy of NADA 141–233. FOI Summary. Dogs ........... Conditional approval for the control of seizures associated with idiopathic epilepsy in dogs. FOI Summary. Dogs ........... Original approval for replacement therapy for diminished thyroid function in dogs. Original approval as a generic copy of NADA 125–476. FOI Summary. Ractopamine hydrochloride, monensin, and melengestrol acetate Type C medicated feeds. Melengestrol acetate, monensin, and tylosin phosphate Type C medicated feeds. Monensin, ractopamine hydrochloride, tylosin phosphate, and melengestrol acetate Type C medicated feeds. SPARMECTIN Plus Clorsulon (ivermectin and clorsulon) Injection. Cattle .......... Original approval as a generic copy of NADA 141–234. FOI Summary. Cattle .......... Original approval as a generic copy of NADA 138–870. FOI Summary. Cattle .......... Original approval as a generic copy of NADA 141–233. FOI Summary. Cattle .......... Supplemental approval reducing preslaughter withdrawal period to 21 days. FOI Summary. ANIMEC PLUS (ivermectin and clorsulon) Injection. Cattle .......... Original approval as a generic copy of NADA 140–833. FOI Summary. MACROSYN (tulathromycin injection) Injectable Solution. Cattle .......... Original approval as a generic copy of NADA 141–244. FOI Summary. INCREXXA (tulathromycin injection) Injectable Solution. PENNITRACIN MD (bacitracin Type A medicated article) and COBAN (monensin Type A medicated article) to be used in the manufacture of Type C medicated feeds. Dexmedetomidine Hydrochloride Injection (dexmedetomidine hydrochloride). Cattle .......... Original approval as a generic copy of NADA 141–244. FOI Summary. Turkeys ...... Original approval for the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis and E. gallopavonis, and for increased rate of weight gain and improved feed efficiency in growing turkeys. FOI Summary. Dogs and cats. Original approval as a generic copy of NADA 141–267. FOI Summary. January 12, 2021 ....... 200–677 Do .................................... January 12, 2021 ....... 200–678 Do .................................... January 14, 2021 ....... 141–544 Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514. January 15, 2021 ....... 141–539 February 1, 2021 ........ 200–683 February 1, 2021 ........ 200–684 Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria. Do .................................... February 1, 2021 ........ 200–685 Do .................................... February 1, 2021 ........ 200–686 Do .................................... February 8, 2021 ........ 200–466 February 16, 2021 ...... 200–506 February 18, 2021 ...... 200–657 February 18, 2021 ...... 200–666 February 26, 2021 ...... 141–540 Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215. Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland. Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland. Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140. Pharmgate, Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405. March 11, 2021 .......... 200–699 VerDate Sep<11>2014 16:22 Oct 19, 2021 Akorn Animal Health, Inc., 1925 West Field Ct., Suite 300, Lake Forest, IL 60045. Jkt 256001 PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 Cattle .......... E:\FR\FM\20OCR1.SGM 20OCR1 FOI Summary. 57994 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY, FEBRUARY, AND MARCH 2021—Continued Approval date File No. Sponsor Species Effect of the action Public documents Original approval for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) in replacement dairy and beef heifers, 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. Original approval for suppression of estrus (heat) in replacement dairy and beef heifers, 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, or control of active infection of anaplasmosis; and lasalocid for control of coccidiosis, increased rate of weight gain, and improved feed efficiency. Original approval as a generic copy of NADA 140–269. FOI Summary. March 15, 2021 .......... 141–530 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. MGA (melengestrol acetate Type A medicated article) and AUREOMYCIN (chlortetracycline Type A medicated article) to be used in the manufacture of Type C medicated feeds. Cattle .......... March 19, 2021 .......... 141–531 Do .................................... MGA (melengestrol acetate Type A medicated article), AUREOMYCIN (chlortetracycline Type A medicated article), and BOVATEC (lasalocid Type A medicated article) to be used in the manufacture of Type C medicated feeds. Cattle .......... March 22, 2021 .......... 200–625 KETOMED (ketoprofen) Sterile Solution. Horses ........ March 24, 2021 .......... 132–872 Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland. Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940. SAFE–GUARD (fenbendazole) Paste 10%. Cattle .......... II. Changes of Sponsor FDA that they have transferred ownership of, and all rights and interest The sponsors of the following approved applications have informed File No. Product name 141–175 ........... CAPSTAR (nitenpyram) Tablets ..... Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140. 141–120 ........... CLOMICALM (clomipramine hydrochloride) Tablets. ITRAFUNGOL (itraconazole oral solution). GO–DRY (penicillin G procaine) Intramammary Infusion. Do ................................................... Ampicillin Sodium Powder for Injection. HAN–PEN (penicillin G potassium) Soluble Powder. Chlortetracycline (chlortetracycline hydrochloride) Soluble Powder. 141–474 ........... 065–081 ........... 200–335 ........... 200–372 ........... 065–071 ........... lotter on DSK11XQN23PROD with RULES1 Product name 065–440 ........... 200–441 ........... 200–528 ........... VerDate Sep<11>2014 Jkt 256001 PO 00000 FOI Summary. FOI Summary. in, these applications to another sponsor: Transferring sponsor CHLORONEX (chlortetracycline hydrochloride) Soluble Powder. A-MYCIN (chlortetracycline hydrochloride) Soluble Powder. SAVALAN 60 (salinomycin sodium) Type A medicated article. 16:22 Oct 19, 2021 Supplemental approval providing 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-stage larvae of certain endoparasites. FOI Summary. New sponsor 21 CFR section Sergeant’s Pet Care Products, Inc., 10077 S 134th St., Omaha, NE 68138. Virbac AH, Inc., P.O. Box 162059, Fort Worth, TX 76161. Do ................................................... 520.1510. 526.1696. Do ................................................... HQ Specialty Pharma Corp., 120 Rte. 17 North, Suite 130, Paramus, NJ 07652. Do ................................................... Do ................................................... Do ................................................... 520.1696a. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria. Do ................................................... Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405. 520.441. Do ................................................... Do. Do ................................................... Do ................................................... Do. Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria. 558.550. Do ................................................... G. C. Hanford Mfg. Co., P.O. Box 1017, Syracuse, NY 13201. Frm 00010 Fmt 4700 Sfmt 4700 E:\FR\FM\20OCR1.SGM 20OCR1 520.455. 520.1189. 522.90c. 57995 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations 21 CFR section File No. Product name Transferring sponsor New sponsor 200–237 ........... Isoflurane, U.S.P ............................. Piramal Enterprises Ltd., Ananta, Agastya Corporate Park, Opp Fire Brigade, Kamani Junction, LBS Mag Kurla (West), Mumbai, 400070, India. Piramal Pharma Ltd., Ground Floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra, 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 1. The authority citation for part 510 continues to read as follows: ■ Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 2. In § 510.600: a. In the table in paragraph (c)(1): ■ i. Add in alphabetical order an entry for ‘‘Anivive Lifesciences, Inc.’’; ■ ii. Revise the entry for ‘‘Cronus Pharma Specialities India Private Ltd.’’; ■ iii. Remove the entries for ‘‘G. C. Hanford Manufacturing Co.’’ and ‘‘Piramal Enterprises Ltd.’’; and ■ iv. Add in alphabetical order an entry for ‘‘Piramal Pharma Ltd.’’; and ■ b. In the table in paragraph (c)(2): ■ i. Remove the entry for ‘‘010515’’; ■ ii. Revise the entries for ‘‘065085’’ and ‘‘069043’’; and ■ iii. Add in numerical order an entry for ‘‘086121’’. The revisions and additions read as follows: ■ ■ § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * (c) * * * (1) * * * * * Drug labeler code Firm name and address lotter on DSK11XQN23PROD with RULES1 N/A. * * * * * * Anivive Lifesciences, Inc., 3250 Airflite Way, Suite 400, Long Beach, CA 90807 ............................................................................. * * * * * * * 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 ................................................................................ * * * * * * * Piramal Pharma Ltd., Ground Floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra, 400070, India ................... . * VerDate Sep<11>2014 16:22 Oct 19, 2021 Jkt 256001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\20OCR1.SGM 20OCR1 086121 069043 065085 57996 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations Drug labeler code Firm name and address * * * * * * * (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 3. The authority citation for part 516 continues to read as follows: ■ Authority: 21 U.S.C. 360ccc, 360ccc–2, 371. 4. Add § 516.1858 to subpart E to read as follows: ■ § 516.1858 Potassium bromide. (a) Specifications. Each chewable tablet contains 250 or 500 milligrams (mg) potassium bromide. (b) Sponsor. See No. 055246 in § 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. ■ 5. Add § 516.2980 to subpart E to read as follows: lotter on DSK11XQN23PROD with RULES1 § 516.2980 Verdinexor. (a) Specifications. Each tablet contains 2.5, 10, or 50 milligrams (mg) verdinexor. (b) Sponsor. See No. 086121 in § 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 VerDate Sep<11>2014 16:22 Oct 19, 2021 Jkt 256001 * * 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 6. The authority citation for part 520 continues to read as follows: ■ Authority: 21 U.S.C. 360b. 7. In § 520.441, revise paragraph (b)(1) to read as follows: ■ § 520.441 Chlortetracycline powder. * * * * * (b) * * * (1) Nos. 000010, 054771, and 069254 for use as in paragraph (d) of this section. * * * * * ■ 8. In § 520.455, revise the section heading and paragraph (b) to read as follows: § 520. 455 Clomipramine. * * * * * (b) Sponsors. See Nos. 051311 and 086039 in § 510.600(c) of this chapter. * * * * * ■ 9. In § 520.905c, revise paragraph (e)(2) to read as follows: § 520.905c Fenbendazole paste. * * * * * (e) * * * (2) Beef and dairy cattle—(i) Amount. Administer orally 2.3 mg/lb (5 mg/kg) body weight. PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 * * * * (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. ■ 10. In § 520.1189, revise paragraph (b) to read as follows: § 520.1189 Itraconazole. * * * * * (b) Sponsor. See No. 051311 in § 510.600(c) of this chapter. * * * * * ■ 11. In § 520.1248, revise paragraphs (b) and (c)(1) to read as follows: § 520.1248 Levothyroxine. * * E:\FR\FM\20OCR1.SGM * 20OCR1 * * Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations (b) Sponsors. See Nos. 059051 and 061690 in § 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. * * * * * ■ 12. In § 520.1510, revise paragraph (b)(1) to read as follows: (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. * * * * * § 520. 1510 PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS Nitenpyram. * * * * * (b) * * * (1) No. 021091 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii)(A), and (d)(2) of this section. * * * * * ■ 13. In § 520.1696a, revise paragraph (b) to read as follows: § 520.1696a Penicillin G powder. Authority: 21 U.S.C. 360b. 17. In § 522.90c, revise paragraph (b) to read as follows: ■ § 522.90c * * * * * (b) Sponsors. See Nos. 016592, 042791, 054771, 061133, and 076475 in § 510.600(c) of this chapter. * * * * * ■ 14. In § 520.2090, revise paragraph (c)(2) to read as follows: * § 520.2090 pyrantel. * Sarolaner, moxidectin, and * lotter on DSK11XQN23PROD with RULES1 16. The authority citation for part 522 continues to read as follows: ■ * * * * (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 (blacklegged 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. * * * * * ■ 15. In § 520.2645, revise paragraph (d)(2) to read as follows: § 520.2645 * Tylvalosin. * * (d) * * * VerDate Sep<11>2014 * * 16:22 Oct 19, 2021 Jkt 256001 Ampicillin sodium. * * * * (b) See Nos. 042791 and 054771 in § 510.600(c) of this chapter. * * * * * ■ 18. In § 522.558, revise paragraphs (b)(1) and to read as follows: § 522.558 Dexmedetomidine. * * * * (b) * * * (1) Nos. 026637 and 059399 for use of product described in paragraph (a)(2) of this section. * * * * * ■ 19. In § 522.970, revise paragraph (b)(1) and add paragraph (b)(3) to read as follows: § 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. * * * * * ■ 20. In § 522.1193, revise paragraphs (b) and (e)(2) and (3) to read as follows: § 522.1193 Ivermectin and clorsulon. * * * * * (b) Sponsors. See Nos. 000010, 055529, 058005, 061133, and 061651 in § 510.600(c) of this chapter. * * * * * (e) * * * (2) Indications for use. For the treatment and control of gastrointestinal PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 57997 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. ■ 21. In § 522.1225, revise paragraph (b) to read as follows: § 522.1225 Ketoprofen. * * * * * (b) Sponsors. See Nos. 054771 and 061133 in § 510.600(c) of this chapter. * * * * * ■ 22. In § 522.1696a, revise paragraph (d)(2)(iii) to read as follows: § 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 preruminating calves. Do not use in calves to be processed for veal. ■ 23. In § 522.2630, revise paragraphs (b) and (d)(1)(iii)(A) to read as follows: § 522.2630 Tulathromycin. * * * * * (b) Sponsors. See sponsor numbers in § 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 E:\FR\FM\20OCR1.SGM 20OCR1 57998 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations 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 24. The authority citation for part 526 continues to read as follows: ■ Authority: 21 U.S.C. 360b. (b) See Nos. 042791 and 061133 in § 510.600(c) of this chapter. * * * * * Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc–1, 371. PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD ■ 26. The authority citation for part 556 continues to read as follows: ■ Authority: 21 U.S.C. 342, 360b, 371. 27. In § 556.275: a. Revise paragraph (b)(1)(ii); b. Remove paragraph (b)(1)(iii); and c. Remove and reserve paragraphs (b)(3)(ii), (b)(4)(ii), and (b)(5)(ii). The revision reads as follows: ■ ■ ■ ■ § 556.275 Fenbendazole. * * * * * (b) * * * (1) * * * (ii) Milk: 0.22 ppm fenbendazole sulfoxide (marker residue). * * * * * 25. In § 526.1696, revise paragraph (b) to read as follows: PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS § 526.1696 Penicillin G procaine. ■ * * ■ * * 28. The authority citation for part 558 continues to read as follows: * 29. In § 558.76: a. Revise paragraphs (a)(1) and (2) and (d)(1); ■ b. Redesignate paragraph (d)(2) as paragraph (d)(6); and ■ c. Add new paragraph (d)(2) and paragraphs (d)(3) through (5). The revisions and additions read as follows: ■ § 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 ton Indications for use Limitations (i) 4 to 50 ............. Broiler and replacement chickens: For increased rate of weight gain and improved feed efficiency. Laying hens: For increased egg production and improved feed efficiency. Broiler and replacement chickens: As an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Broiler and replacement chickens: As an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Feed continuously as sole ration ................................ Indications for use Limitations (ii) 10 to 25 .......... (iii) 50 .................. (iv) 100 to 200 ..... Feed continuously as sole ration for the first 7 months of egg production. Feed continuously as sole ration ................................ Feed continuously as sole ration. Start at first clinical signs of disease. Vary dosage based on severity of infection. Administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce medication to prevention level (50 grams/ton). Sponsor 054771 069254 054771 054771 054771 (2) Turkeys— Bacitracin in grams per ton (i) 4 to 50 ............. (ii) 200 ................. Growing turkeys: For increased rate of weight gain and improved feed efficiency. Growing turkeys: As an aid in the control of transmissible enteritis complicated by organisms susceptible to bacitracin methylenedisalicylate. Feed continuously as sole ration ................................ Feed continuously as the sole ration .......................... Sponsor 054771 069254 054771 lotter on DSK11XQN23PROD with RULES1 (3) Swine— Bacitracin in grams per ton (i) 10 to 30 ........... VerDate Sep<11>2014 Indications for use Limitations Growing and finishing swine: For increased rate of weight gain and improved feed efficiency. 16:22 Oct 19, 2021 Jkt 256001 PO 00000 Frm 00014 Fmt 4700 ...................................................................................... Sfmt 4700 E:\FR\FM\20OCR1.SGM 20OCR1 Sponsor 054771 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations Bacitracin in grams per ton Indications for use Limitations (ii) 250 ................. Growing and finishing swine: For control of swine dysentery (bloody scours) associated with Brachyspira hyodysenteriae in pigs up to 250 lbs body weight. (iii) 250 ................ Pregnant sows: For control of clostridial enteritis caused by Clostridium perfringens in suckling piglets. Feed as the sole ration. Feed 250 grams per ton of complete feed on premises with a history of swine dysentery, but where signs of the disease 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. As the sole ration. Feed to sows from 14 days before through 21 days after farrowing on premises with a history of clostridial scours. Diagnosis should be confirmed by a veterinarian when results are not satisfactory. 57999 Sponsor 054771 054771 (4) Cattle— Bacitracin amount Indications for use (i) 70 mg per head per day. Limitations Beef steers and heifers fed in confinement for slaughter: For reduction in the number of liver condemnations due to abscesses. Beef steers and heifers fed in confinement for slaughter: For reduction in the number of liver condemnations due to abscesses. (ii) 250 mg per head per day. Sponsor Administer continuously throughout the feeding period. 054771 069254 Administer continuously for 5 days then discontinue for subsequent 25 days, repeat the pattern during the feeding period. 054771 069254 (5) Game birds— Bacitracin in grams per ton Indications for use Limitations (i) 4 to 50 ............. Growing pheasants: For increased rate of weight gain and improved feed efficiency. Growing quail: For increased rate of weight gain and improved feed efficiency in quail not over 5 weeks of age. Growing quail: For the prevention of ulcerative enteritis in growing quail due to Clostridium colinum susceptible to bacitracin methylenedisalicylate. Feed continuously as sole ration ................................ (ii) 5 to 20 ............ (iii) 200 ................ * * * * § 558.128 * 30. In § 558.128, revise paragraphs (d)(4) and (e)(4) to read as follows: ■ lotter on DSK11XQN23PROD with RULES1 Chlortetracycline amount Feed continuously as sole ration to quail not over 5 weeks of age. 054771 069254 054771 069254 Feed continuously as the sole ration .......................... 054771 Chlortetracycline. * * * * * (d) * * * (4) Manufacture for use in free-choice feeds as in paragraph (e)(4)(vi) of this Combination in grams/ ton Limitations ........................................ Growing cattle (over 400 lb): For reduction of liver condemnation due to liver abscesses. (ii) 5.83 to 14 g/ton to provide 70 mg/head/ day. Melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg melengestrol acetate per head per day. Growing beef heifers fed in confinement for slaughter (over 400 lb): For reduction of the incidence of liver abscesses, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). 16:22 Oct 19, 2021 Jkt 256001 PO 00000 section must conform to § 510.455 of this chapter. * * * * * (e) * * * (4) * * * Indications for use (i) to provide 70 mg/ head/day. VerDate Sep<11>2014 Frm 00015 Fmt 4700 Sponsor Sfmt 4700 Feed to provide chlortetracycline at the rate of 70 mg per animal daily. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal. Melengestrol acetate Type C topdress medicated feed must be top dressed onto or mixed at feeding with the Type C medicated feed containing 5.83 to 14 g/ton chlortetracycline. Chlortetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. E:\FR\FM\20OCR1.SGM 20OCR1 Sponsor 054771 066104 069254 054771 58000 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations Combination in grams/ ton Indications for use Limitations (iii) to provide 0.5 mg/lb of body weight daily. ........................................ Beef cattle (over 700 lb): For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline. (iv) 33.33 to 50 g/ton to provide 0.5 mg/lb of body weight per day. Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg melengestrol acetate per head per day. Replacement beef heifers over 700 lb: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline and for suppression of estrus (heat). (v) 25 to 1,100 g/ton to provide 0.5 mg/lb of body weight daily. Lasalocid, 30 to 600 ...... Pasture cattle (slaughter, stocker, feeder cattle, beef replacement heifers) over 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline; and for increased rate of weight gain. (vi) 25 to 1,100 g/ton to provide 0.5 mg/lb of body weight daily. Lasalocid, 30 to 600; melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate. Replacement beef heifers on pasture over 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline, increased rate of weight gain, and suppression of estrus (heat). (vii) to provide 0.5 to 2.0 mg/lb of body weight daily. ........................................ Beef cattle and nonlactating dairy cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline. Feed to provide chlortetracycline at the rate of 0.5 mg per pound of body weight daily in beef cattle under 700 pounds. Withdraw 48 hours prior to slaughter. To sponsor Nos. 054771 and 069254: Zero withdrawal time. Melengestrol acetate Type C topdress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 33.33 to 50 g/ton chlortetracycline. Feeding a Type C topdress medicated feed containing melengestrol acetate shall not exceed 24 days. Chlortetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously on a hand-fed basis 0.5 mg chlortetracycline per lb. body weight per day and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in 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 § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 1,100 g/ton of chlortetracycline and 30 to 600 g/ ton lasalocid to provide 0.5 mg chlortetracycline 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 § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. In free-choice cattle feeds such as feed blocks or salt-mineral mixes manufactured from approved Type A articles. See paragraph (d)(4) of this section. lotter on DSK11XQN23PROD with RULES1 Chlortetracycline amount VerDate Sep<11>2014 16:22 Oct 19, 2021 Jkt 256001 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:\FR\FM\20OCR1.SGM 20OCR1 Sponsor 054771 066104 069254 054771 054771 069254 054771 054771 069254 lotter on DSK11XQN23PROD with RULES1 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations Chlortetracycline amount Combination in grams/ ton Indications for use Limitations (viii) to provide 10 mg/lb of body weight daily. ........................................ Calves, beef and nonlactating dairy cattle: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline. (ix) to provide 10 mg/lb of body weight daily. ........................................ (x) to provide 10 mg/lb of body weight daily. Laidlomycin, 5 ................ Calves (up to 250 lb): For the treatment of bacterial enteritis caused by Escherichia coli susceptible to chlortetracycline. Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for increased rate of weight and improved feed efficiency. (xi) to provide 10 mg/lb of body weight daily. Laidlomycin, 5 to 10 ...... Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for improved feed efficiency. (xii) 500 to 2,000 to provide 10 mg/lb of body weight daily. Lasalocid, 10 to 30 ........ Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for improved feed efficiency. Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Treat for not more than 5 days. To sponsor No. 054771 (NADAs 048–761 and 046–699) and to sponsor No. 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. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day for not more than 5 days. 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 § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day for not more than 5 days. 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 § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously in complete feed for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 100 mg or more than 360 mg lasalocid per head per 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 § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. VerDate Sep<11>2014 16:22 Oct 19, 2021 Jkt 256001 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\FR\FM\20OCR1.SGM 20OCR1 58001 Sponsor 054771 066104 069254 054771 066104 069254 054771 054771 054771 069254 lotter on DSK11XQN23PROD with RULES1 58002 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations Chlortetracycline amount Combination in grams/ ton Indications for use Limitations (xiii) to provide 10 mg/lb of body weight daily. Lasalocid, 25 to 30 ........ Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency. (xiv) 500 to 4,000 to provide 10 mg/lb of body weight daily. Lasalocid, 30 to 600 ...... Pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heifers): For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain. (xv) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily. Lasalocid, 30 to 600: Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate. Replacement dairy heifers on pasture less than 20 months of age and replacement beef heifers on pasture: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, increased rate of weight gain, and suppression of estrus (heat). Feed continuously in complete feed for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 250 mg or more than 360 mg lasalocid per head per 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 § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously on a hand-fed basis for not more than 5 days to provide 10 mg chlortetracycline 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. Daily lasalocid intakes in excess of 200 mg/head/day in 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 § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton of chlortetracycline and 30 to 600 g/ ton lasalocid to provide 10 mg chlortetracycline 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 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 § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. VerDate Sep<11>2014 16:22 Oct 19, 2021 Jkt 256001 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 E:\FR\FM\20OCR1.SGM 20OCR1 Sponsor 054771 069254 054771 069254 054771 lotter on DSK11XQN23PROD with RULES1 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations Chlortetracycline amount Combination in grams/ ton Indications for use Limitations (xvi) 500 to 4,000 g/ton .. ........................................ Calves, beef and nonlactating dairy cattle: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline. (xvii) 500 to 4,000 g/ton Decoquinate, 12.9 to 90.8. Calves, beef and non-lactating dairy cattle: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for the prevention of coccidiosis caused by Eimeria bovis and E. zuernii. (xviii) 500 to 4,000 to provide 10 mg per pound of body weight. Melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg melengestrol acetate per head per day. Growing beef heifers fed in confinement for slaughter: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). (xix) 500 to 4,000 to provide 10 mg per pound of body weight. Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg melengestrol acetate per head per day. Replacement dairy heifers less than 20 months of age and replacement beef heifers: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, and for suppression of estrus (heat). Hand feed continuously for not more than 5 days to provide 10 mg/lb body weight per day. 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 046–699: 24hour withdrawal period. To sponsor No. 054771 under NADA 048–761 and No. 069254 under ANADA 200–510: Zero withdrawal period. Feed at a rate of 1g chlortetracycline per 100 lb body weight/day and 22.7 mg decoquinate per 100 lb of body weight/day for not more than 5 days. When it is fully consumed, resume feeding 22.7 mg decoquinate per 100 lb of body weight/day for a total of 28 days to prevent coccidiosis. A withdrawal period has not 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 § 510.600(c) of this chapter. Melengestrol acetate Type C topdress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton chlortetracycline 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. Chlortetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. Melengestrol acetate Type C topdress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton chlortetracycline 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. 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. Chlortetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. VerDate Sep<11>2014 16:22 Oct 19, 2021 Jkt 256001 PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 E:\FR\FM\20OCR1.SGM 20OCR1 58003 Sponsor 054771 069254 054771 069254 054771 054771 58004 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations Combination in grams/ ton Indications for use Limitations (xx) 4,000 to 20,000 g/ ton. ........................................ Calves, beef and nonlactating dairy cattle: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline. (xxi) 4,000 to 20,000 g/ ton. Decoquinate, 90.8 to 535.7. Calves, beef and non-lactating dairy cattle: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for the prevention of coccidiosis caused by Eimeria bovis and E. zuernii. (xxii) 4,000 to 20,000 g/ ton to provide 10 mg/ lb of body weight per day. Melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg melengestrol acetate per head per day. Growing beef heifers fed in confinement for slaughter: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). (xxiii) 4,000 to 20,000 g/ ton to provide 10 mg/ lb of body weight per day. Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg melengestrol acetate per head per day. Replacement dairy heifers less than 20 months of age and replacement beef heifers: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, and for suppression of estrus (heat). Administer as a top dress, varying with body weight and feed consumption, to provide 10 mg/lb per day. Treat for not more than 5 days. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Feed at a rate of 1g chlortetracycline per 100 lb body weight/day and 22.7 mg decoquinate per 100 lb of body weight/day for not more than 5 days. When it is fully consumed, resume feeding 22.7 mg decoquinate per 100 lb of body weight/day for a total of 28 days to prevent coccidiosis. A withdrawal period has not 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 § 510.600(c) of this chapter. Top dress 0.5 to 2 pounds of this medicated feed containing both drugs onto or mix at feeding with a non-medicated 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. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Chlortetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. Top dress 0.5 to 2 pounds of this medicated feed containing both drugs onto or mix at feeding with a non-medicated 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. 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. Chlortetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. lotter on DSK11XQN23PROD with RULES1 Chlortetracycline amount VerDate Sep<11>2014 16:22 Oct 19, 2021 Jkt 256001 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 E:\FR\FM\20OCR1.SGM 20OCR1 Sponsor 054771 069254 054771 069254 054771 054771 lotter on DSK11XQN23PROD with RULES1 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations Chlortetracycline amount Combination in grams/ ton (xxiv) to provide 350 mg/ head/day. ........................................ Beef cattle: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline. (xxv) to provide 350 mg/ head/day. ........................................ Beef cattle (under 700 lb): For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline. (xxvi) 50 to 350 g/ton to provide 350 mg/head/ day. Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg melengestrol acetate per head per day. Replacement beef heifers under 700 lb: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline and for suppression of estrus (heat). (xxvii) 20 to 350 g/ton .... ........................................ Beef cattle and replacement dairy heifers: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline. (xxviii) 20 to 350 g/ton to provide 350 mg/head/ day. Melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg melengestrol acetate per head per day. Growing beef heifers fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). VerDate Sep<11>2014 16:22 Oct 19, 2021 Jkt 256001 PO 00000 Indications for use Frm 00021 Fmt 4700 Sfmt 4700 Limitations Feed to provide chlortetracycline at the rate of 350 mg per animal daily. A withdrawal period has not been established for this product in pre-ruminating 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. Feed to provide chlortetracycline at the rate of 350 mg per animal daily. A withdrawal period has not been established for this product in pre-ruminating 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. Melengestrol acetate Type C topdress medicated feed must be top dressed or mixed at feeding with the Type C medicated feed containing 50 to 350 g/ton chlortetracycline for up to 24 days of feeding. Do not exceed 24 days of feeding. Chlortetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. Feed to provide chlortetracycline at the rate of 350 mg per head per day. 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. 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. Melengestrol acetate Type C topdress medicated feed must be top dressed onto or mixed at feeding with the Type C medicated feed containing 20 to 350 g/ton chlortetracycline. Chlortetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. E:\FR\FM\20OCR1.SGM 20OCR1 58005 Sponsor 054771 066104 069254 054771 066104 069254 054771 054771 069254 054771 58006 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations lotter on DSK11XQN23PROD with RULES1 Chlortetracycline amount Combination in grams/ ton Indications for use Limitations Melengestrol acetate Type C topdress medicated feed must be top dressed or mixed at feeding with the Type C medicated feed containing 20 to 350 g/ton chlortetracycline. 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. Chlortetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day. 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 § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day. 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 § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 250 mg nor more than 360 mg lasalocid per head daily. 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 § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 250 mg nor more than 360 mg lasalocid per head daily. 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 § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. (xxix) 20 to 350 g/ton to provide 350 mg/head/ day. Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg melengestrol acetate per head per day. Replacement dairy heifers less than 20 months of age and replacement beef heifers: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline and suppression of estrus (heat). (xxx) to provide 350 mg/ head/day. Laidlomycin, 5 ................ Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for increased rate of weight and improved feed efficiency. (xxxi) to provide 350 mg/ head/day. Laidlomycin, 5 to 10 ...... Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for improved feed efficiency. (xxxii) 25 to 42.2 g/ton to provide 350 mg/head/ day. Lasalocid, 25 to 30 ........ Cattle under 700 pounds fed in confinement for slaughter: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency. (xxxiii) 25 to 42.2 g/ton to provide 350 mg/ head/day. Lasalocid, 25 to 30 ........ Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency. VerDate Sep<11>2014 16:22 Oct 19, 2021 Jkt 256001 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 E:\FR\FM\20OCR1.SGM 20OCR1 Sponsor 054771 054771 054771 054771 069254 054771 069254 lotter on DSK11XQN23PROD with RULES1 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations Chlortetracycline amount Combination in grams/ ton Indications for use Limitations (xxxiv) 25 to 100 g/ton to provide 350 mg/head/ day. Lasalocid, 10 to 30 ........ Cattle under 700 pounds fed in confinement for slaughter: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline; and for improved feed efficiency. (xxxv) 25 to 100 g/ton to provide 350 mg/head/ day. Lasalocid, 10 to 30 ........ Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for improved feed efficiency. (xxxvi) 25 to 700 to provide 350 g/head/day. Lasalocid, 30 to 600 ...... Pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heifers): For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain. (xxxvii) 25 to 700 g/ton to provide 350 mg/ head/day. Lasalocid, 30 to 600; melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate. Replacement beef heifers on pasture: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline, increased rate of weight gain, and suppression of estrus (heat). Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 100 mg nor more than 360 mg lasalocid per head daily. 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 § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 100 mg nor more than 360 mg lasalocid per head daily. 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 § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously on a hand-fed basis at a rate of 350 mg chlortetracycline and not less than 60 mg nor more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in 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 § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 700 g/ton of chlortetracycline and 30 to 600 g/ton lasalocid to provide 350 mg chlortetracycline 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 § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. VerDate Sep<11>2014 16:22 Oct 19, 2021 Jkt 256001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\FR\FM\20OCR1.SGM 20OCR1 58007 Sponsor 054771 069254 054771 069254 054771 069254 054771 lotter on DSK11XQN23PROD with RULES1 58008 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations Chlortetracycline amount Combination in grams/ ton (xxxviii) 25 to 700 to provide 350 mg/head/day. Lasalocid, 30 to 600 ...... Pasture cattle (slaughter, stocker, feeder cattle, beef replacement heifers) under 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline; and for increased rate of weight gain. (xxxix) 25 to 700 g/ton to provide 350 mg/head/ day. Lasalocid, 30 to 600; melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate. Replacement beef heifers on pasture under 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline, increased rate of weight gain, and suppression of estrus (heat). (xl) 25 to 2,800 to provide 350 mg/head/day. Lasalocid, 30 to 181.8 ... Beef cattle weighing under 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline; and for the control of coccidiosis caused by Eimeria bovis and E. zuernii. (xli) 25 to 2,80 g/ton to provide 350 mg/head/ day. Lasalocid, 30 to 181.8; melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg/ head/day melengestrol acetate. Growing beef heifers fed in confinement for slaughter under 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline, control of coccidiosis caused by Eimeria bovis and E. zuernii, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). VerDate Sep<11>2014 16:22 Oct 19, 2021 Jkt 256001 PO 00000 Indications for use Frm 00024 Fmt 4700 Sfmt 4700 Limitations Feed continuously on a hand-fed basis at a rate of 350 mg chlortetracycline and not less than 60 mg nor more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in 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 § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 700 g/ton of chlortetracycline and 30 to 600 g/ton lasalocid to provide 350 mg chlortetracycline 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 § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. Hand feed continuously at a rate of 350 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per 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 § 558.311(d) of this chapter. Chlortetracycline and lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 2,800 g/ton of chlortetracycline and 30 to 181.8 g/ ton lasalocid to provide 350 mg chlortetracycline per head per day and 1 mg lasalocid per 2.2 lb. of body weight daily with a maximum of 360 mg lasalocid per head per day. See § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. E:\FR\FM\20OCR1.SGM 20OCR1 Sponsor 054771 069254 054771 054771 069254 054771 lotter on DSK11XQN23PROD with RULES1 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations Chlortetracycline amount Combination in grams/ ton (xlii) 25 to 2,800 to provide 350 mg/head/day. Lasalocid, 30 to 181.8 ... Beef cattle weighing up to 800 pounds: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for the control of coccidiosis caused by Eimeria bovis and E. zuernii. (xliii) 25 to 2,800 g/ton to provide 350 mg/head/ day. Lasalocid, 30 to 181.8; melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg/ head/day melengestrol acetate. Growing beef heifers fed in confinement for slaughter up to 800 pounds: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline, control of coccidiosis caused by Eimeria bovis and E. zuernii, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). (xliv) 25 to 2,800 g/ton to provide 350 mg/head/ day. Lasalocid, 30 to 181.8; melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate. Replacement beef heifers up to 800 pounds: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline, control of coccidiosis caused by Eimeria bovis and E. zuernii, and suppression of estrus (heat). (xlv) 500 to 4,000 to provide 10 mg/head/day. Lasalocid, 30 to 181.8 ... Cattle weighing up to 800 pounds: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline; and for the control of coccidiosis caused by Eimeria bovis and E. zuernii. VerDate Sep<11>2014 16:22 Oct 19, 2021 Jkt 256001 PO 00000 Indications for use Frm 00025 Fmt 4700 Sfmt 4700 Limitations Hand feed continuously at a rate of 350 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per 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 § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 2,800 g/ton of chlortetracycline and 30 to 181.8 g/ ton lasalocid to provide 350 mg chlortetracycline per head daily and 1 mg lasalocid per 2.2 lb. of body weight daily with a maximum of 360 mg lasalocid per head per day. See § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 2,800 g/ton of chlortetracycline and 30 to 181.8 g/ ton lasalocid to provide 350 mg chlortetracycline per head 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 § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. Hand feed continuously for not more than 5 days at a rate of 10 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per 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 § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. E:\FR\FM\20OCR1.SGM 20OCR1 58009 Sponsor 054771 069254 054771 054771 054771 069254 58010 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations Chlortetracycline amount Combination in grams/ ton Indications for use Limitations (xlvi) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily. Lasalocid, 30 to 181.8; melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg/ head/day melengestrol acetate. Growing beef heifers fed in confinement for slaughter up to 800 pounds: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, control of coccidiosis caused by Eimeria bovis and E. zuernii, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). (xlvii) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily. Lasalocid, 30 to 181.8; melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate. Replacement dairy heifers up to 800 pounds and less than 20 months of age and replacement beef heifers up to 800 pounds: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, control of coccidiosis caused by Eimeria bovis and E. zuernii, and suppression of estrus (heat). The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton of chlortetracycline and 30 to 181.8 g/ ton lasalocid to provide 10 mg chlortetracycline per lb of body weight per day and 1 mg lasalocid per 2.2 lb of body weight per day with a maximum of 360 mg lasalocid per head per day 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 § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton of chlortetracycline and 30 to 181.8 g/ ton lasalocid to provide 10 mg chlortetracycline per lb of body weight per day and 1 mg lasalocid per 2.2 lb of body weight per day with a maximum of 360 mg lasalocid per head per day 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. See § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. * § 558.342 ■ * lotter on DSK11XQN23PROD with RULES1 * * * * 31. In § 558.342, revise paragraph (e)(1)(iv) to read as follows: Melengestrol. * * (e) * * * * Indications for use * (iv) 0.25 to 0.5 ..... * Monensin, 10 to 40 * * Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat); and for the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii. Jkt 256001 PO 00000 Frm 00026 Fmt 4700 054771 (1) * * * Combination in mg/head/day 16:22 Oct 19, 2021 054771 * Melengestrol acetate in mg/head/day VerDate Sep<11>2014 Sponsor Sfmt 4700 Limitations Sponsor * * * Add at the rate of 0.5 to 2.0 lb/head/day a 016592 medicated feed (liquid or dry) containing 045771 0.125 to 1.0 mg melengestrol acetate/lb 058198 to a feed containing 10 to 40 g of monensin per ton to provide 0.25 to 0.5 mg 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 § 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 § 510.600(c) of this chapter. E:\FR\FM\20OCR1.SGM 20OCR1 58011 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations Melengestrol acetate in mg/head/day Combination in mg/head/day * * Indications for use * * * * * 32. In § 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) Monensin in grams/ton * (ii) 54 to 90 .......... * * § 558.355 Monensin. * * * * * (b) * * * (2) No. 016592 for use of a Type A medicated article containing 90.7 grams Combination in grams/ton * * * Limitations * * Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain and improved feed efficiency. * Sponsor monensin, USP, per pound as in paragraphs (f)(3), (f)(4)(v), and (f)(6) of this section. * * * * * (f) * * * (2) * * * Indications for use * * Bacitracin methylenedisalicylate, 4 to 50. * * The revisions read as follows: * ■ Limitations Sponsor * * Feed continuously as the sole ra058198 tion. The optimum level depends 069254 upon the severity of coccidiosis exposure. Do not allow horses, other equines, mature turkeys, or guinea 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 methylene disalicylate as provided by No. 054771 or 069254 in § 510.600(c) of this chapter. * * * lotter on DSK11XQN23PROD with RULES1 (3) * * * Monensin in grams/ton Indications for use Limitations (i) 5 to 40 ............. Growing beef steers and heifers fed in confinement for slaughter: For improved feed efficiency. (ii) 10 to 40 .......... Growing beef steers and heifers fed in confinement for slaughter: For prevention and control of coccidiosis due to Eimeria bovis and E. zuernii. (iii) 10 to 200 ....... Calves excluding veal calves: For prevention and control of coccidiosis due to Eimeria bovis and E. zuernii. (iv) 11 to 22 ......... Dairy cows: For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake). Dairy cows: For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake). Feed continuously in complete feed at a rate of 50 to 480 milligrams of 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. Feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending upon the severity of challenge, up to maximum of 480 milligrams per head per day. See special labeling considerations in paragraph (d) of this section. Feed at a rate of 0.14 to 1.0 milligram monensin per pound of body weight per day, depending 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. Feed continuously to dry and lactating dairy cows in a total mixed ration (‘‘complete feed’’). See special labeling considerations in paragraph (d) of this section. Feed continuously to dry and lactating dairy cows in a component feeding system (including top dress). The 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. (v) 11 to 400 ........ VerDate Sep<11>2014 16:22 Oct 19, 2021 Jkt 256001 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 E:\FR\FM\20OCR1.SGM 20OCR1 Sponsor 016592 058198 016592 058198 016592 058198 016592 058198 016592 058198 58012 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations Monensin in grams/ton Indications for use Limitations (vi) 15 to 400 ....... Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) or in a dry lot and replacement beef and dairy heifers: For increased rate of weight gain, and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii. (vii) 25 to 400 ...... Beef cows: For improved feed efficiency when receiving supplemental feed, and for the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii. Sponsor For increased rate of weight gain, feed at a rate of 50 to 200 milligrams monensin per head per day in not less than 1 pound of feed or, after the 5th day, feed at a rate of 400 milligrams per head per day every other day in not less than 2 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. Feed as supplemental feed, either hand-fed in a minimum of 1 pound of feed or mixed in a total ration. For improved feed efficiency, 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. 016592 058198 016592 058198 (4) * * * Monensin amount (i) 150 milligrams per pound of protein-mineral block (0.033%). (ii) 175 milligrams per pound of protein-mineral block (0.038%). * (v) 1,620 grams per ton of mineral granules as specified in paragraph (f)(4)(v)(A) of this section. Indications for use Limitations Sponsor Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) and replacement beef heifers on pasture: For increased rate of weight gain, and for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii in pasture cattle which may require supplemental feed. Growing beef steers and heifers on pasture (stocker, feeder, and slaughter): For increased rate of weight gain. Provide 50 to 200 milligrams of monensin (0.34 to 1.33 pounds of block) per head per day, at least 1 block per 10 to 12 head of cattle. Roughage must be available at all times. Do not allow animals access to other protein blocks, salt or mineral, while being fed this product. See paragraph (d)(10)(i) of this section. Provide 40 to 200 milligrams of monensin (0.25 to 1.13 pounds or 4 to 18 ounces of block) per head per 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. * * * Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) or in a dry lot and replacement beef and dairy heifers: For increased rate of weight gain, and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii. * * * Feed at a rate of 50 to 200 milligrams per head per 016592 day. During the first 5 days of feeding, cattle 058198 should receive no more than 100 milligrams per day. Do not feed additional salt or minerals. Do not mix with grain or other 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. 012286 017800 lotter on DSK11XQN23PROD with RULES1 (A) Specifications. Use as free-choice Type C medicated feed formulated as mineral granules as follows: Ingredient Percent Monocalcium phosphate (21% phosphorus, 15% calcium) ............................................................................................ Sodium chloride (salt) ...................................................................................................................................................... Dried cane molasses ....................................................................................................................................................... Ground limestone (33% calcium) or calcium carbonate (38% calcium) ......................................................................... VerDate Sep<11>2014 16:22 Oct 19, 2021 Jkt 256001 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 E:\FR\FM\20OCR1.SGM 20OCR1 29.49 24.37 20.0 13.75 International feed No. 6–01–082 6–04–152 4–04–695 6–02–632 58013 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations Ingredient Percent Cane molasses ................................................................................................................................................................ Processed grain by-products (as approved by AAFCO) ................................................................................................. Vitamin/trace mineral premix 1 ......................................................................................................................................... Monensin Type A article, 90.7 grams per pound ............................................................................................................ Antidusting oil .................................................................................................................................................................. 3.0 5.0 2.5 0.89 1.0 International feed No. 4–04–696 ........................ ........................ ........................ ........................ 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) * * * * Monensin in grams/ton Indications for use (i) 20 .................... * Goats maintained in confinement: For the prevention of coccidiosis caused by Eimeria crandallis, E. christenseni, and E. ninakohlyakimovae. * * (7) * * * (viii) Ractopamine as in § 558.500. * * * * * Ractopamine in grams/ton lotter on DSK11XQN23PROD with RULES1 Limitations Feed continuously. Do not feed to lactating goats. See paragraph (d)(11) of this section for provisions for monensin liquid Type C goat feeds. * * 33. In § 558.500, revise paragraphs (e)(2)(ii), (iv), (v), and (vii) to read as follows: ■ Combination in grams/ton Sponsor * § 558.500 * * Ractopamine. * * (e) * * * (2) * * * Indications for use 016592 058198 * * Limitations Sponsor * * * (ii) 8.2 to 24.6 to provide Monensin 10 to 40 to 70 to 430 mg/head/day. provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day. * * * Cattle fed in confinement for slaughFeed continuously as sole ration durter: For increased rate of weight ing the last 28 to 42 days on feed. gain, improved feed efficiency, and Not for animals intended for breedprevention and control of coccidiing. See special labeling considerosis due to Eimeria bovis and E. ations in § 558.355(d) of this chapzuernii during the last 28 to 42 ter. Ractopamine as provided by days on feed. No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter. * 016592 054771 058198 * * * (iv) 9.8 to 24.6 to provide Monensin 10 to 40 to 90 to 430 mg/head/day. provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day. * * * Cattle fed in confinement for slaughFeed continuously as sole ration durter: For increased rate of weight ing the last 28 to 42 days on feed. gain, improved feed efficiency, inNot for animals intended for breedcreased carcass leanness, and ing. See special labeling considerprevention and control of coccidiations in § 558.355(d) of this chaposis due to Eimeria bovis and E. ter. Ractopamine as provided by zuernii during the last 28 to 42 No. 016592, 054771, or 058198; days on feed. monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter. Heifers fed in confinement for slaugh- Feed continuously as sole ration durter: For increased rate of weight ing the last 28 to 42 days on feed. gain, improved feed efficiency, inNot for animals intended for breedcreased carcass leanness, prevening. See special labeling considertion and control of coccidiosis due ations in §§ 558.342(d) and to Eimeria bovis and E. zuernii, 558.355(d) of this chapter. and suppression of estrus (heat) Ractopamine as provided by No. during the last 28 to 42 days on 016592, 054771, or 058198; feed. monensin as provided by No. 016592 or 058198; melengestrol acetate as provided by No. 016592, 054771 or 058198 in § 510.600(c) of this chapter. * 016592 054771 058198 (v) 9.8 to 24.6 to provide Monensin 10 to 40 to 90 to 430 mg/head/day. provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day, plus melengestrol acetate to provide 0.25 to 0.5 mg/head/day. VerDate Sep<11>2014 16:22 Oct 19, 2021 Jkt 256001 PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 E:\FR\FM\20OCR1.SGM 20OCR1 016592 054771 058198 58014 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations Ractopamine in grams/ton Combination in grams/ton * (vii) Not to exceed 800; to provide 70 to 400 mg/head/day. * * Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day. * * * Indications for use * * * * * * Cattle fed in confinement for slaughTop dress ractopamine at a minimum ter: For increased rate of weight of 1.0 lb/head/day of medicated gain, improved feed efficiency, and feed continuously during the last prevention and control of coccidi28 to 42 days on feed. Not for aniosis due to Eimeria bovis and E. mals intended for breeding. See zuernii during the last 28 to 42 special labeling considerations in days on feed. § 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter. * * § 558. 550 * 34. In § 558. 550, revise paragraphs (a), (b), (e)(1)(i), and (e)(2)(i) to read as follows: ■ Limitations * Salinomycin. (a) Specifications. Type A medicated articles containing 30 or 60 grams of salinomycin sodium activity per pound. Salinomycin in grams/ton Combination in grams/ton Indications for use (i) 40 to 60 ........... ........................... Broiler, roaster, and replacement (breeder and layer) chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati. * * * * Sponsor * 016592 054771 058198 * (b) Sponsor. See No. 016592 in § 510.600(c) of this chapter for use as in paragraph (e) of this section. * * * * * (e) * * * (1) * * * Limitations * Feed continuously as sole ration. Do not feed to birds producing eggs for human consumption. May be fatal if accidentally fed to adult turkeys or horses. * * Sponsor 016592 * (2) * * * Salinomycin in grams/ton Combination in grams per ton Indications for use (i) 50 .................... ........................... Quail: For the prevention of coccidiosis caused by Eimeria dispersa and E. lettyae. * * * lotter on DSK11XQN23PROD with RULES1 * * § 558.625 ■ * * * * * 35. In § 558.625, revise paragraphs (e)(2)(i) and (e)(2)(ix) through (xiii) to read as follows: Limitations * * Indications for use (i) 8 to 10 ................. ................................. Beef cattle: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes. Jkt 256001 PO 00000 * * Combination in grams/ton 16:22 Oct 19, 2021 * 016592 Tylosin. * * (e) * * * (2) * * * Tylosin grams/ton VerDate Sep<11>2014 Feed continuously as sole ration. Do not feed to birds producing eggs for human consumption. May be fatal if accidentally fed to adult turkeys or horses. Sponsor Frm 00030 Fmt 4700 Sfmt 4700 Limitations Feed continuously as the sole ration to provide 60 to 90 mg/head/day tylosin. E:\FR\FM\20OCR1.SGM 20OCR1 Sponsor 016592 054771 058198 066104 lotter on DSK11XQN23PROD with RULES1 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations Tylosin grams/ton Combination in grams/ton Indications for use * (ix) 8 to 10 ............... * Monensin 10 to 40 plus melengestrol 0.25 to 2.0. * * Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii; and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). (x) 8 to 10 ................ Monensin 10 to 40 plus ractopamine 8.2 to 24.6. Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii; and for increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter for the last 28 to 42 days on feed. (xi) 8 to 10 ............... Monensin 10 to 40 plus ractopamine, not to exceed 800. Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii; and for increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter for the last 28 to 42 days on feed. VerDate Sep<11>2014 16:22 Oct 19, 2021 Jkt 256001 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 Limitations 58015 Sponsor * * * Feed continuously as sole ration to heif016592 ers at a rate of 0.5 to 2 pounds per 054771 head per day to provide 0.25 to 0.5 058198 mg/head/day melengestrol acetate and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/ head/day tylosin. The melengestrol 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 §§ 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 § 510.600(c) of this chapter. Feed continuously as sole ration to pro016592 vide 70 to 430 mg/head/day 054771 ractopamine and 0.14 to 0.42 mg 058198 monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin for the last 28 to 42 days on feed. 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 §§ 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 § 510.600(c) of this chapter. Feed a minimum of 1.0 lb/head/day 016592 ractopamine Type C top dress feed 054771 continuously to cattle fed in confine058198 ment for slaughter, to provide 70 to 400 mg/head/day ractopamine for the last 28 to 42 days on feed. Feed on top of a ration containing 10 to 40 g/ton monensin and 8 to 10 g/ton tylosin phosphate, to provide 0.14 to 0.42 mg monensin/lb body weight/day, depending on the severity of 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 §§ 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 § 510.600(c) of this chapter. E:\FR\FM\20OCR1.SGM 20OCR1 58016 Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations Tylosin grams/ton Combination in grams/ton Limitations Feed continuously as sole ration to provide 90 to 430 mg/head/day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin for the last 28 to 42 days on feed. 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 §§ 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 § 510.600(c) of this chapter. Feed continuously as sole ration to provide 90 to 430 mg/head/day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin for the last 28 to 42 days on feed. Feed melengestrol as a top dress or mixed with a complete ration at the rate of 0.5 to 2.0 pound/head/day (specify one level) to provide 0.25 to 0.5 mg melengestrol 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 §§ 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 § 510.600(c) of this chapter. (xii) 8 to 10 .............. Monensin 10 to 40 plus ractopamine 9.8 to 24.6. Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 28 to 42 days on feed. (xiii) 8 to 10 .............. Monensin, 10 to 40 plus ractopamine, 9.8 to 24.6, plus melengestrol, 0.125 to 1 mg/lb. Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii; for increased rate of weight gain, improved feed efficiency, and increased carcass leanness; and suppression of estrus (heat) in heifers fed in confinement for slaughter for the last 28 to 42 days on feed. * * * * * * * * DEPARTMENT OF THE TREASURY Office of Foreign Assets Control 31 CFR Part 591 Publication of Venezuela Web General License 7 and Subsequent Iterations Office of Foreign Assets Control, Treasury. AGENCY: Jkt 256001 The Department of the Treasury’s Office of Foreign Assets Control (OFAC) is publishing four Venezuela-related web general licenses (GLs) in the Federal Register: GL 7, GL 7A, and GL 7B, each of which is now expired and was previously issued on OFAC’s website, as well as GL 7C, which was also previously issued on OFAC’s website. DATES: GL 7C was issued on August 5, 2019. See SUPPLEMENTARY INFORMATION of this document for additional relevant dates. FOR FURTHER INFORMATION CONTACT: OFAC: Assistant Director for Licensing, 202–622–2480; Assistant Director for SUMMARY: BILLING CODE 4164–01–P 16:22 Oct 19, 2021 * Publication of web general licenses. [FR Doc. 2021–22604 Filed 10–19–21; 8:45 am] VerDate Sep<11>2014 * ACTION: Dated: October 12, 2021. Lauren K. Roth, Associate Commissioner for Policy. lotter on DSK11XQN23PROD with RULES1 Indications for use PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 * Sponsor 016592 054771 058198 016592 054771 058198 * Regulatory Affairs, 202–622–4855; or Assistant Director for Sanctions Compliance & Evaluation, 202–622– 2490. SUPPLEMENTARY INFORMATION: Electronic Availability This document and additional information concerning OFAC are available on OFAC’s website: www.treasury.gov/ofac. Background On March 8, 2015, the President, invoking the authority of, inter alia, the International Emergency Economic Powers Act (50 U.S.C. 1701–1706), issued Executive Order (E.O.) 13692, ‘‘Blocking Property and Suspending Entry of Persons Contributing to the E:\FR\FM\20OCR1.SGM 20OCR1

Agencies

[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]


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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.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
animal drug regulations to reflect application-related actions for new 
animal drug applications (NADAs), 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

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