New Animal Drugs; Approval of New Animal Drug Applications, 53458-53463 [2015-21905]

Download as PDF 53458 Federal Register / Vol. 80, No. 172 / Friday, September 4, 2015 / Rules and Regulations a street address, to the Branch Chief, Regulations and Paperwork Management Branch, U.S. Department of Agriculture, 300 7th Street SW., 7th Floor, Washington, DC 20024. All written comments will be available for public inspection during regular work hours at the 300 7th Street, SW., 7th Floor address listed above. Dated: August 26, 2015. Lisa Mensah, Under Secretary, Rural Development. Dated: August 27, 2015. Michael Scuse, Under Secretary, Farm and Foreign Agricultural Services. [FR Doc. 2015–21898 Filed 9–3–15; 8:45 am] BILLING CODE 3410–XY–P FOR FURTHER INFORMATION CONTACT: Farah Ahmad, Rural BusinessCooperative Service, U.S. Department of Agriculture, Stop 3254, 1400 Independence Avenue SW., Washington, DC 20250–0783, Telephone: 202–245–1169. Email: Farah.Ahmad@wdc.usda.gov. On July 20, 2015, the Rural Housing Service, the Rural Business-Cooperative Service, the Rural Utilities Service, and the Farm Service Agency published an interim rule with comment in the Federal Register (80 FR 28807), ‘‘Strategic Economic and Community Development.’’ The interim rule identified that public comments were to be submitted by August 18, 2015. Unfortunately, the Web site Regulations.gov inadvertently closed the comment period on July 20, 2015, which was the closing date for comments on the information collection request. To compensate for closing the comment period early via the Regulations.gov Web site, this action provides commenters additional time to submit comments on the interim rule. SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520, 524, and 558 [Docket No. FDA–2015–N–0002] New Animal Drugs; Approval of New Animal Drug Applications AGENCY: This rule is effective September 4, 2015. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV–6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–5689, george.haibel@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during May and June 2015, 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 Division of Dockets Management (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. Persons with access to the Internet may obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/ AboutFDA/CentersOffices/ OfficeofFoods/CVM/ CVMFOIAElectronicReadingRoom/ default.htm. Marketing exclusivity and patent information may be accessed in FDA’s publication, Approved Animal Drug Products Online (Green Book) at: https://www.fda.gov/AnimalVeterinary/ Products/ ApprovedAnimalDrugProducts/ default.htm. DATES: Food and Drug Administration, HHS. Final rule; technical amendments. ACTION: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May and June 2015. FDA is also 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 reflect a nonsubstantive change. This technical amendment is being made to improve the accuracy of the regulations. SUMMARY: TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MAY AND JUNE 2015 Sponsor New animal drug product name Action 141–417 ......................... Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201. CORAXIS (moxidectin) Topical Solution for Dogs. 141–188 ......................... rmajette on DSK2VPTVN1PROD with RULES NADA/ANADA Merial Inc., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096– 4640. MARQUIS (ponazuril) Oral Paste. 141–262 ......................... Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. CERENIA (maropitant citrate) Tablets. Original approval for the prevention of heartworm disease, and for the treatment and control of intestinal hookworm, roundworm and whipworm infections in dogs. Supplemental approval of a revised dosage that includes a loading dose on the first day of treatment. Supplemental approval extending duration of daily administration until resolution of acute vomiting. VerDate Sep<11>2014 13:57 Sep 03, 2015 Jkt 235001 PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 E:\FR\FM\04SER1.SGM 21 CFR sections FOIA summary NEPA review 524.1450 CE.1 2 520.1855 yes ....... CE.1 2 520.1315 04SER1 yes ....... yes ....... CE.1 2 Federal Register / Vol. 80, No. 172 / Friday, September 4, 2015 / Rules and Regulations 53459 TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MAY AND JUNE 2015—Continued New animal drug product name FOIA summary 21 CFR sections Sponsor 141–291 ......................... Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom. Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940. VETORYL (trilostane) Capsules. Supplemental approval of a 5-milligram capsule size. 520.2598 no ......... CE.1 2 ZILMAX (zilpaterol hydrochloride) plus RUMENSIN (monensin). Type A medicated articles. 558.665 yes ....... CE.1 3 141–282 ......................... Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940. 558.665 yes ....... CE.1 3 141–284 ......................... Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940. ZILMAX (zilpaterol hydrochloride) plus RUMENSIN (monensin) plus MGA (melengestrol acetate). Type A medicated articles. ZILMAX (zilpaterol hydrochloride) plus MGA (melengestrol acetate). Type A medicated articles. Supplemental approval to provide for component feeding of combination drug Type C medicated feeds to cattle fed in confinement for slaughter. Supplemental approval to provide for component feeding of combination drug Type C medicated feeds to heifers fed in confinement for slaughter. 558.665 yes ....... CE.1 3 200–497 ......................... Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland. Huvepharma AD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. Supplemental approval to provide for component feeding of combination drug Type C medicated feeds to heifers fed in confinement for slaughter. Original approval as a generic copy of NADA 141–213. 520.1367 yes ....... CE.1 3 4 558.550 yes ....... CE.1 3 141–278 ......................... 200–580 ......................... LOXICOM (meloxicam) 1.5 mg/mL Oral Suspension. TYLOVET (tylosin phosphate) plus SACOX (salinomycin sodium) Type C medicated feeds. Action NEPA review NADA/ANADA Original approval as a generic copy of NADA 141–198. 1 The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an environmental impact statement because it is of a type that does not have a significant effect on the human environment. 2 CE granted under 21 CFR 25.33(d)(1). 3 CE granted under 21 CFR 25.33(a)(1). 4 The regulation does not require amendment. Also, the animal drug regulations are being amended to reflect approved labeling for hand feeding bambermycins medicated cattle feed. This technical amendment is being made to improve the accuracy of the regulations. This rule 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. rmajette on DSK2VPTVN1PROD with RULES 21 CFR Parts 520 and 524 Animal drugs. 1. The authority citation for 21 CFR part 520 continues to read as follows: ■ Authority: 21 U.S.C. 360b. 2. In § 520.1315, revise paragraph (c)(1) to read as follows: § 520.1367 ■ ■ Maropitant. * 21 CFR Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to 16:40 Sep 03, 2015 PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS (ii) For prevention of acute vomiting in dogs 7 months of age and older, administer a minimum dose of 2.0 mg/ kg body weight once daily until resolution of acute vomiting. (iii) For prevention of vomiting due to motion sickness in dogs 4 months of age and older, administer a minimum of 8.0 mg/kg body weight once daily for up to 2 consecutive days. * * * * * § 520.1315 List of Subjects VerDate Sep<11>2014 the Center for Veterinary Medicine, 21 CFR parts 520, 524, and 558 are amended as follows: Jkt 235001 * * * * (c) * * * (1) Indications for use and amount. (i) For prevention of acute vomiting in dogs 2 to 7 months of age, administer a minimum dose of 2.0 mg per kilogram (/kg) body weight once daily for up to 5 consecutive days. PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 [Amended] 3. In § 520.1367, in paragraph (b)(2), remove ‘‘No. 013744’’ and in its place add ‘‘Nos. 013744 and 055529’’. 4. In § 520.1855, revise paragraph (c)(1) to read as follows: ■ § 520.1855 * Ponazuril. * * (c) * * * E:\FR\FM\04SER1.SGM 04SER1 * * 53460 Federal Register / Vol. 80, No. 172 / Friday, September 4, 2015 / Rules and Regulations (1) Amount. Administer orally 15 mg per kilogram (kg) (6.81 mg per pound (lb)) body weight as the first dose, followed by 5 mg/kg (2.27 mg/lb) body weight once daily for a period of 27 additional days. * * * * * § 520.2598 [Amended] 5. In § 520.2598, in paragraph (a), remove ‘‘10, 30, or 60 milligrams’’ and in its place add ‘‘5, 10, 30, 60, or 120 milligrams’’. ■ PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 6. The authority citation for 21 CFR part 524 continues to read as follows: ■ Authority: 21 U.S.C. 360b. 7. In § 524.1450, and revise paragraphs (a), (b), and (d), and remove paragraph (e). The revisions read as follows: ■ § 524.1450 Moxidectin. (a) Specifications. Each milliliter of solution contains: (1) 5 milligrams (mg) moxidectin (0.5 percent solution). (2) 25 mg moxidectin (2.5 percent solution). (b) Sponsors. See sponsor numbers in § 510.600 of this chapter: (1) No. 000010 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section; (2) No. 000859 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section. * * * * * (d) Conditions of use—(1) Cattle—(i) Amount. Administer topically 0.5 mg per kilogram (kg) of body weight. (ii) Indications for use. Beef and dairy cattle: For treatment and control of internal and external parasites: gastrointestinal roundworms (Ostertagia ostertagi (adult and L4, including inhibited larvae), Haemonchus placei (adult and L4), Trichostrongylus axei (adult and L4), T. colubriformis (adult and L4), Cooperia oncophora (adult and L4), C. pectinata (adult), C. punctata (adult and L4), C. spatulata (adult), C. surnabada (adult and L4), Bunostomum phlebotomum (adult), Oesophagostomum radiatum (adult and L4), Nematodirus helvetianus (adult and L4)); lungworms (Dictyocaulus viviparus (adult and L4)); cattle grubs (Hypoderma bovis, H. lineatum); mites (Chorioptes bovis, Psoroptes ovis (P. communis var. bovis)); lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus, Bovicola (Damalinia) bovis); and horn flies (Haematobia irritans). To control infections and to protect from reinfection with H. placei for 14 days after treatment, O. radiatum and O. ostertagi for 28 days after treatment, and D. viviparus for 42 days after treatment. (iii) Limitations. A withdrawal period has not been established for this product on preruminating calves. Do not use on calves to be processed for veal. See § 500.25 of this chapter. (2) Dogs—(i) Amount. Administer topically a minimum of 1.1 mg per pound (lb) (2.5 mg/kg) of body weight, once monthly using the appropriate preloaded applicator tube. (ii) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis, as well as the treatment and control of intestinal hookworm (Ancylostoma caninum (adult, immature adult, and L4 larvae) and Uncinaria stenocephala (adult, immature adult, and L4 larvae)), roundworm (Toxocara canis (adult and L4 larvae) and Toxascaris leonina (adult)), and whipworm (Trichuris vulpis (adult)) infections in dogs and puppies that are at least 7 weeks of age and that weigh at least 3 lbs. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 8. The authority citation for 21 CFR part 558 continues to read as follows: ■ Authority: 21 U.S.C. 360b, 371. § 558.95 [Amended] 9. In § 558.95, in the table in paragraph (d)(4)(ii), in the ‘‘Bambermycins in grams/ton’’ column, remove ‘‘2 to 40’’ and in its place add ‘‘2 to 80’’; and in the ‘‘Limitations’’ column, remove the first sentence and in its place add ‘‘Feed continuously on a hand-fed basis at a rate of 10 to 40 milligrams per head per day in 1 to 10 pounds of supplemental Type C medicated feed.’’. ■ 10. In § 558.665, revise paragraphs (d)(2) and (e) to read as follows: ■ § 558.665 Zilpaterol. * * * * * (d) * * * (2) Labeling of Type A medicated articles and Type B medicated feeds used to manufacture complete Type C medicated feeds shall bear the caution statement in paragraph (d)(3) of this section. * * * * * (e) Conditions of use in cattle. It is administered in feed as follows: Combination in grams/ton Indications for use Limitations (1) 6.8 ........... ................................... 000061 Monensin 10 to 40 ... Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed. Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii. Feed continuously as the sole ration during the last 20 to 40 days on feed to provide 60 to 90 mg zilpaterol hydrochloride per head per day. Withdrawal period: 3 days. See paragraph (d) of this section. (2) 6.8 ........... rmajette on DSK2VPTVN1PROD with RULES Zilpaterol hydrochloride in grams/ton Feed continuously as the sole ration during the last 20 to 40 days on feed to provide 60 to 90 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/ head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraph § 558.355(d) of this chapter Monensin as provided by No. 000986 in § 510.600(c) of this chapter. 000061 000986 VerDate Sep<11>2014 13:57 Sep 03, 2015 Jkt 235001 PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 E:\FR\FM\04SER1.SGM 04SER1 Sponsor Federal Register / Vol. 80, No. 172 / Friday, September 4, 2015 / Rules and Regulations Combination in grams/ton Indications for use Limitations (3) 6.8 ........... Melengestrol acetate to provide 0.25 to 0.5 mg/head/day. Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; and for suppression of estrus (heat). (4) 6.8 ........... Monensin 10 to 40 plus melengestrol acetate to provide 0.25 to 0.5 mg/ head/day. Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for suppression of estrus (heat). (5) 6.8 ........... Monensin 10 to 40, plus tylosin 8 to 10. For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes. (6) 6.8 ........... Monensin 10 to 40, plus tylosin 8 to 10, plus melengestrol acetate to provide 0.25 to 0.5 mg/ head/day. Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; and for suppression of estrus (heat). (7) 6.8 to 24 .. rmajette on DSK2VPTVN1PROD with RULES Zilpaterol hydrochloride in grams/ton ................................... Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed. Feed continuously as the sole ration during the last 20 to 40 days on feed to provide 60 to 90 mg zilpaterol hydrochloride per head per day. Withdrawal period: 3 days. See paragraph (d) of this section. Melengestrol acetate as provided by Nos. 000986 or 054771 in § 510.600(c) of this chapter. Feed continuously as the sole ration during the last 20 to 40 days on feed to provide 60 to 90 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/ head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraphs §§ 558.342(d) and 558.355(d) of this chapter. Monensin as provided by No. 000986; melengestrol acetate as provided by Nos. 000986 or 054771 in § 510.600(c) of this chapter. Feed continuously as the sole ration during the last 20 to 40 days on feed to provide 60 to 90 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/ head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraphs §§ 558.355(d) and 558.625(c) of this chapter. Monensin as provided by No. 000986; tylosin as provided by Nos. 000986 or 016592 in § 510.600(c) of this chapter. Feed continuously as the sole ration during the last 20 to 40 days on feed to provide 60 to 90 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/ head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraphs §§ 558.342(d), 558.355(d), and 558.625(c) of this chapter. Monensin as provided by No. 000986; tylosin as provided by Nos. 000986 or 016592; and melengestrol acetate as provided by Nos. 000986 or 054771 in § 510.600(c) of this chapter. Feed continuously during the last 20 to 40 days on feed to provide 60 mg zilpaterol hydrochloride per head per day. Withdrawal period: 3 days. See paragraph (d) of this section. VerDate Sep<11>2014 13:57 Sep 03, 2015 Jkt 235001 PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 E:\FR\FM\04SER1.SGM 04SER1 53461 Sponsor 000061 000986 000061 000986 000061 016592 000061 000986 016592 000061 53462 Federal Register / Vol. 80, No. 172 / Friday, September 4, 2015 / Rules and Regulations Combination in grams/ton Indications for use Limitations (8) 6.8 to 24 .. Monensin 10 to 40 ... Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii. (9) 6.8 to 24 .. Melengestrol acetate to provide 0.25 to 0.5 mg/head/day. Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; and for suppression of estrus (heat). (10) 6.8 to 24 Monensin 10 to 40, plus melengestrol acetate to provide 0.25 to 0.5 mg/ head/day. Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for suppression of estrus (heat). (11) 6.8 to 24 Monensin 10 to 40, plus tylosin 8 to 10. (12) 6.8 to 24 rmajette on DSK2VPTVN1PROD with RULES Zilpaterol hydrochloride in grams/ton Monensin 10 to 40, plus tylosin 8 to 10, plus melengestrol acetate to provide 0.25 to 0.5 mg/ head/day. Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes. Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; and for suppression of estrus (heat). Feed continuously during the last 20 to 40 days on feed to provide 60 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraph § 558.355(d) of this chapter. Monensin as provided by No. 000986 in § 510.600(c) of this chapter. Feed continuously during the last 20 to 40 days on feed to provide 60 mg zilpaterol hydrochloride per head per day. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraph § 558.342(d) of this part. Melengestrol acetate as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously during the last 20 to 40 days on feed to provide 60 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraphs §§ 558.342(d) and 558.355(d) of this chapter. Monensin as provided by No. 000986; melengestrol acetate as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously during the last 20 to 40 days on feed to provide 60 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraphs §§ 558.355(d) and 558.625(c) of this chapter. Monensin and tylosin as provided by No. 000986 in § 510.600(c) of this chapter. Feed continuously during the last 20 to 40 days on feed to provide 60 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraphs §§ 558.342(d), 558.355(d), and 558.625(c) of this chapter. Monensin and tylosin as provided by No. 000986; melengestrol acetate as provided by No. 054771 in § 510.600(c) of this chapter. Dated: August 31, 2015. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2015–21905 Filed 9–3–15; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 16:40 Sep 03, 2015 Jkt 235001 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 E:\FR\FM\04SER1.SGM 04SER1 Sponsor 000061 000061 000061 000061 000061 Federal Register / Vol. 80, No. 172 / Friday, September 4, 2015 / Rules and Regulations DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. USCG–2010–1024] Olympia Harbor Days Tug Boat Races, Budd Inlet, WA Coast Guard, DHS. Notice of enforcement of regulation. AGENCY: ACTION: The Coast Guard will enforce the Special Local Regulation, Olympia Harbor Days Tug Boat Races, Budd Inlet, WA from 11:00 a.m. through 8:00 p.m. on September 6, 2015. This action is necessary to restrict vessel movement within the specified race area immediately prior to, during, and immediately after racing activity in order to ensure the safety of participants, spectators and the maritime public. Entry into, transit through, mooring or anchoring within the specified race area is prohibited unless authorized by the Captain of the Port, Puget Sound or Designated Representatives. SUMMARY: The regulations in 33 CFR 100.1309 will be enforced from 11:00 a.m. through 8:00 p.m. on September 6, 2015. FOR FURTHER INFORMATION CONTACT: If you have questions on this document, call or email Petty Officer Ryan Griffin, Sector Puget Sound Waterways Management Division, Coast Guard; telephone 206–510–7888, email SectorPugetSoundWWM@uscg.mil. SUPPLEMENTARY INFORMATION: The Coast Guard is providing notice of enforcement of the Special Local Regulation for Olympia Harbor Days Tug Boat Races, Budd Inlet, WA in 33 CFR 100.1309 on September 6, 2015, from 11:00 a.m. to 8:00 p.m. The following area is specified as a race area: All waters of Budd Inlet, WA the width of the navigation channel south of a line connecting the following points: 47°05.530′ N. 122°55.844′ W. and 47°05.528′ N. 122°55.680′ W. until reaching the northernmost end of the navigation channel at a line connecting the following points: 47°05.108′ N. 122°55.799′ ″ W. and 47°05.131′ N. 122°55.659′ W. then southeasterly until reaching the southernmost entrance of the navigation channel at a line connecting the following points: 47°03.946′ N. 122°54.577′ W., 47°04.004′ N. 122°54.471′ W. Under the provisions of 33 CFR 100.1309, the regulated area shall be closed immediately prior to, during and immediately after the event to all persons and vessels not participating in the event and authorized by the event sponsor. This document is issued under authority of 33 CFR 100.1309 and 5 U.S.C. 552(a). In addition to this document in the Federal Register, the Coast Guard will provide the maritime community with advance notification of this enforcement period via the Local Notice to Mariners. If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this document, he may use a Broadcast Notice to Mariners to grant general permission to enter the regulated area. Dated: August 25, 2015. M.W. Raymond, Captain, U.S. Coast Guard, Captain of the Port, Puget Sound. [FR Doc. 2015–22024 Filed 9–3–15; 8:45 am] BILLING CODE 9110–04–P DEPARTMENT OF HOMELAND SECURITY Coast Guard rmajette on DSK2VPTVN1PROD with RULES DATES: VerDate Sep<11>2014 16:40 Sep 03, 2015 Jkt 235001 33 CFR Part 117 [Docket No. USCG–2015–0708] Drawbridge Operation Regulation; Petaluma River, Petaluma, CA Coast Guard, DHS. Notice of deviation from drawbridge regulation. AGENCY: ACTION: The Coast Guard has issued a temporary deviation from the operating schedule that governs the Haystack Landing Drawbridge across the Petaluma River, mile 12.4, at Petaluma, CA. The deviation is necessary to allow the bridge owner to replace the bridge. This deviation allows the bridge to remain in the closed-to-navigation position during the deviation period. DATES: This deviation is effective without actual notice from September 4, 2015 to 6 p.m. on October 19, 2015. For the purposes of enforcement, actual notice will be used from 6 a.m. on August 31, 2015, until September 4, 2015. SUMMARY: The docket for this deviation, [USCG–2015–0708], is available at https://www.regulations.gov. Type the docket number in the ‘‘SEARCH’’ box and click ‘‘SEARCH.’’ Click on Open Docket Folder on the line ADDRESSES: PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 53463 associated with this deviation. You may also visit the Docket Management Facility in Room W12–140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. If you have questions on this temporary deviation, call or email David H. Sulouff, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510– 437–3516, email David.H.Sulouff@ uscg.mil. If you have questions on viewing the docket, call Cheryl Collins, Program Manager, Docket Operations, telephone 202–366–9826. FOR FURTHER INFORMATION CONTACT: Sonoma Marin Area Rail Transit has requested a temporary change to the operation of the Haystack Landing Drawbridge across the Petaluma River, mile 12.4, at Petaluma, CA. The drawbridge navigation span provides approximately 3 feet vertical clearance above Mean High Water in the closed-to-navigation position. In accordance with 33 CFR 117.187(a), the draw is maintained in the fully open position, except for the crossing of trains or for maintenance. Navigation on the waterway is commercial and recreational. SUPPLEMENTARY INFORMATION: The drawspan will be periodically secured in the closed-to-navigation position, during daylight hours from 6 a.m. on August 31, 2015 to 6 p.m. on October 19, 2015, due to bridge replacement construction. During daylight hours, the bridge will be secured in the closed to navigation position for construction, and will require four hours advance notice for bridge openings for commercial vessels moving on the tide. Scheduled 30-minute bridge openings will be provided at midday for the passage of accumulated, small vessels. The bridge will be secured in the opento-navigation position nights and weekends, when no work is in progress. This temporary deviation has been coordinated with the waterway users. Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will be able to open for emergencies upon two hours advance notice. There is no alternative route available for vessel traffic. The Coast Guard will inform waterway users of this temporary deviation via our Local and Broadcast Notices to Mariners E:\FR\FM\04SER1.SGM 04SER1

Agencies

[Federal Register Volume 80, Number 172 (Friday, September 4, 2015)]
[Rules and Regulations]
[Pages 53458-53463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21905]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 524, and 558

[Docket No. FDA-2015-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect application-related actions for new animal
drug applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during May and June 2015. FDA is also 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 reflect a nonsubstantive change.
This technical amendment is being made to improve the accuracy of the
regulations.

DATES: This rule is effective September 4, 2015.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-402-5689,
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect approval actions for NADAs and ANADAs during May and June
2015, 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
Division of Dockets Management (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. Persons with access to the Internet may
obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and
patent information may be accessed in FDA's publication, Approved
Animal Drug Products Online (Green Book) at: https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

Table 1--Original and Supplemental NADAs and ANADAs Approved During May and June 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
New animal drug 21 CFR
NADA/ANADA Sponsor product name Action sections FOIA summary NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-417........................... Bayer HealthCare LLC, CORAXIS (moxidectin) Original approval 524.1450 yes............ CE.\1\ \2\
Animal Health Topical Solution for for the prevention
Division, P.O. Box Dogs. of heartworm
390, Shawnee disease, and for
Mission, KS 66201. the treatment and
control of
intestinal
hookworm, roundworm
and whipworm
infections in dogs.
141-188........................... Merial Inc., 3239 MARQUIS (ponazuril) Supplemental 520.1855 yes............ CE.\1\ \2\
Satellite Blvd., Oral Paste. approval of a
Bldg. 500, Duluth, revised dosage that
GA 30096-4640. includes a loading
dose on the first
day of treatment.
141-262........................... Zoetis Inc., 333 CERENIA (maropitant Supplemental 520.1315 yes............ CE.\1\ \2\
Portage St., citrate) Tablets. approval extending
Kalamazoo, MI 49007. duration of daily
administration
until resolution of
acute vomiting.

[[Page 53459]]

141-291........................... Dechra, Ltd., VETORYL (trilostane) Supplemental 520.2598 no............. CE.\1\ \2\
Snaygill Industrial Capsules. approval of a 5-
Estate, Keighley milligram capsule
Rd., Skipton, North size.
Yorkshire, BD23 2RW,
United Kingdom.
141-278........................... Intervet, Inc., 2 ZILMAX (zilpaterol Supplemental 558.665 yes............ CE.\1\ \3\
Giralda Farms, hydrochloride) plus approval to provide
Madison, NJ 07940. RUMENSIN (monensin). for component
Type A medicated feeding of
articles. combination drug
Type C medicated
feeds to cattle fed
in confinement for
slaughter.
141-282........................... Intervet, Inc., 2 ZILMAX (zilpaterol Supplemental 558.665 yes............ CE.\1\ \3\
Giralda Farms, hydrochloride) plus approval to provide
Madison, NJ 07940. RUMENSIN (monensin) for component
plus MGA feeding of
(melengestrol combination drug
acetate). Type C medicated
Type A medicated feeds to heifers
articles. fed in confinement
for slaughter.
141-284........................... Intervet, Inc., 2 ZILMAX (zilpaterol Supplemental 558.665 yes............ CE.\1\ \3\
Giralda Farms, hydrochloride) plus approval to provide
Madison, NJ 07940. MGA (melengestrol for component
acetate). feeding of
Type A medicated combination drug
articles. Type C medicated
feeds to heifers
fed in confinement
for slaughter.
200-497........................... Norbrook LOXICOM (meloxicam) Original approval as 520.1367 yes............ CE.\1\ \3\
Laboratories, Ltd., 1.5 mg/mL Oral a generic copy of
Station Works, Newry Suspension. NADA 141-213.
BT35 6JP, Northern
Ireland.
200-580........................... Huvepharma AD, 5th TYLOVET (tylosin Original approval as \4\ 558.550 yes............ CE.\1\ \3\
Floor, 3A Nikolay phosphate) plus a generic copy of
Haytov Str., 1113 SACOX (salinomycin NADA 141-198.
Sophia, Bulgaria. sodium)
Type C medicated
feeds.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an
environmental impact statement because it is of a type that does not have a significant effect on the human environment.
\2\ CE granted under 21 CFR 25.33(d)(1).
\3\ CE granted under 21 CFR 25.33(a)(1).
\4\ The regulation does not require amendment.

Also, the animal drug regulations are being amended to reflect
approved labeling for hand feeding bambermycins medicated cattle feed.
This technical amendment is being made to improve the accuracy of the
regulations.
This rule 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.

List of Subjects

21 CFR Parts 520 and 524

Animal drugs.

21 CFR Part 558

Animal drugs, Animal feeds.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 520,
524, and 558 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as
follows:

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

0
2. In Sec. 520.1315, revise paragraph (c)(1) to read as follows:

Sec. 520.1315 Maropitant.

* * * * *
(c) * * *
(1) Indications for use and amount. (i) For prevention of acute
vomiting in dogs 2 to 7 months of age, administer a minimum dose of 2.0
mg per kilogram (/kg) body weight once daily for up to 5 consecutive
days.
(ii) For prevention of acute vomiting in dogs 7 months of age and
older, administer a minimum dose of 2.0 mg/kg body weight once daily
until resolution of acute vomiting.
(iii) For prevention of vomiting due to motion sickness in dogs 4
months of age and older, administer a minimum of 8.0 mg/kg body weight
once daily for up to 2 consecutive days.
* * * * *

Sec. 520.1367 [Amended]

0
3. In Sec. 520.1367, in paragraph (b)(2), remove ``No. 013744'' and in
its place add ``Nos. 013744 and 055529''.

0
4. In Sec. 520.1855, revise paragraph (c)(1) to read as follows:

Sec. 520.1855 Ponazuril.

* * * * *
(c) * * *

[[Page 53460]]

(1) Amount. Administer orally 15 mg per kilogram (kg) (6.81 mg per
pound (lb)) body weight as the first dose, followed by 5 mg/kg (2.27
mg/lb) body weight once daily for a period of 27 additional days.
* * * * *

Sec. 520.2598 [Amended]

0
5. In Sec. 520.2598, in paragraph (a), remove ``10, 30, or 60
milligrams'' and in its place add ``5, 10, 30, 60, or 120 milligrams''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
6. The authority citation for 21 CFR part 524 continues to read as
follows:

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

0
7. In Sec. 524.1450, and revise paragraphs (a), (b), and (d), and
remove paragraph (e).
The revisions read as follows:

Sec. 524.1450 Moxidectin.

(a) Specifications. Each milliliter of solution contains:
(1) 5 milligrams (mg) moxidectin (0.5 percent solution).
(2) 25 mg moxidectin (2.5 percent solution).
(b) Sponsors. See sponsor numbers in Sec. 510.600 of this chapter:
(1) No. 000010 for use of product described in paragraph (a)(1) of
this section as in paragraph (d)(1) of this section;
(2) No. 000859 for use of product described in paragraph (a)(2) of
this section as in paragraph (d)(2) of this section.
* * * * *
(d) Conditions of use--(1) Cattle--(i) Amount. Administer topically
0.5 mg per kilogram (kg) of body weight.
(ii) Indications for use. Beef and dairy cattle: For treatment and
control of internal and external parasites: gastrointestinal roundworms
(Ostertagia ostertagi (adult and L4, including inhibited larvae),
Haemonchus placei (adult and L4), Trichostrongylus axei (adult and L4),
T. colubriformis (adult and L4), Cooperia oncophora (adult and L4), C.
pectinata (adult), C. punctata (adult and L4), C. spatulata (adult), C.
surnabada (adult and L4), Bunostomum phlebotomum (adult),
Oesophagostomum radiatum (adult and L4), Nematodirus helvetianus (adult
and L4)); lungworms (Dictyocaulus viviparus (adult and L4)); cattle
grubs (Hypoderma bovis, H. lineatum); mites (Chorioptes bovis,
Psoroptes ovis (P. communis var. bovis)); lice (Linognathus vituli,
Haematopinus eurysternus, Solenopotes capillatus, Bovicola (Damalinia)
bovis); and horn flies (Haematobia irritans). To control infections and
to protect from reinfection with H. placei for 14 days after treatment,
O. radiatum and O. ostertagi for 28 days after treatment, and D.
viviparus for 42 days after treatment.
(iii) Limitations. A withdrawal period has not been established for
this product on preruminating calves. Do not use on calves to be
processed for veal. See Sec. 500.25 of this chapter.
(2) Dogs--(i) Amount. Administer topically a minimum of 1.1 mg per
pound (lb) (2.5 mg/kg) of body weight, once monthly using the
appropriate preloaded applicator tube.
(ii) Indications for use. For the prevention of heartworm disease
caused by Dirofilaria immitis, as well as the treatment and control of
intestinal hookworm (Ancylostoma caninum (adult, immature adult, and L4
larvae) and Uncinaria stenocephala (adult, immature adult, and L4
larvae)), roundworm (Toxocara canis (adult and L4 larvae) and
Toxascaris leonina (adult)), and whipworm (Trichuris vulpis (adult))
infections in dogs and puppies that are at least 7 weeks of age and
that weigh at least 3 lbs.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
8. The authority citation for 21 CFR part 558 continues to read as
follows:

Authority: 21 U.S.C. 360b, 371.

Sec. 558.95 [Amended]

0
9. In Sec. 558.95, in the table in paragraph (d)(4)(ii), in the
``Bambermycins in grams/ton'' column, remove ``2 to 40'' and in its
place add ``2 to 80''; and in the ``Limitations'' column, remove the
first sentence and in its place add ``Feed continuously on a hand-fed
basis at a rate of 10 to 40 milligrams per head per day in 1 to 10
pounds of supplemental Type C medicated feed.''.
0
10. In Sec. 558.665, revise paragraphs (d)(2) and (e) to read as
follows:

Sec. 558.665 Zilpaterol.

* * * * *
(d) * * *
(2) Labeling of Type A medicated articles and Type B medicated
feeds used to manufacture complete Type C medicated feeds shall bear
the caution statement in paragraph (d)(3) of this section.
* * * * *
(e) Conditions of use in cattle. It is administered in feed as
follows:

----------------------------------------------------------------------------------------------------------------
Zilpaterol
hydrochloride in grams/ Combination in grams/ Indications for use Limitations Sponsor
ton ton
----------------------------------------------------------------------------------------------------------------
(1) 6.8............... ..................... Cattle fed in confinement Feed continuously as the 000061
for slaughter: For sole ration during the
increased rate of weight last 20 to 40 days on
gain, improved feed feed to provide 60 to 90
efficiency, and mg zilpaterol
increased carcass hydrochloride per head
leanness in cattle fed per day. Withdrawal
in confinement for period: 3 days. See
slaughter during the paragraph (d) of this
last 20 to 40 days on section.
feed.
(2) 6.8............... Monensin 10 to 40.... Cattle fed in confinement Feed continuously as the 000061
for slaughter: For sole ration during the 000986
increased rate of weight last 20 to 40 days on
gain, improved feed feed to provide 60 to 90
efficiency, and mg zilpaterol
increased carcass hydrochloride per head
leanness in cattle fed per day and 0.14 to 0.42
in confinement for mg monensin per pound of
slaughter during the body weight per day
last 20 to 40 days on depending on the
feed; for prevention and severity of the
control of coccidiosis coccidiosis challenge,
due to Eimeria bovis and up to 480 mg/head/day
E. zuernii. monensin. Withdrawal
period: 3 days. See
paragraph (d) of this
section. See paragraph
Sec. 558.355(d) of
this chapter Monensin as
provided by No. 000986
in Sec. 510.600(c) of
this chapter.

[[Page 53461]]

(3) 6.8............... Melengestrol acetate Heifers fed in Feed continuously as the 000061
to provide 0.25 to confinement for sole ration during the 000986
0.5 mg/head/day. slaughter: For increased last 20 to 40 days on
rate of weight gain, feed to provide 60 to 90
improved feed mg zilpaterol
efficiency, and hydrochloride per head
increased carcass per day. Withdrawal
leanness in cattle fed period: 3 days. See
in confinement for paragraph (d) of this
slaughter during the section.
last 20 to 40 days on Melengestrol acetate as
feed; and for provided by Nos. 000986
suppression of estrus or 054771 in Sec.
(heat). 510.600(c) of this
chapter.
(4) 6.8............... Monensin 10 to 40 Heifers fed in Feed continuously as the 000061
plus melengestrol confinement for sole ration during the 000986
acetate to provide slaughter: For increased last 20 to 40 days on
0.25 to 0.5 mg/head/ rate of weight gain, feed to provide 60 to 90
day. improved feed mg zilpaterol
efficiency, and hydrochloride per head
increased carcass per day and 0.14 to 0.42
leanness in cattle fed mg monensin per pound of
in confinement for body weight per day
slaughter during the depending on the
last 20 to 40 days on severity of the
feed; for prevention and coccidiosis challenge,
control of coccidiosis up to 480 mg/head/day
due to Eimeria bovis and monensin. Withdrawal
E. zuernii; and for period: 3 days. See
suppression of estrus paragraph (d) of this
(heat). section. See paragraphs
Sec. Sec. 558.342(d)
and 558.355(d) of this
chapter.
Monensin as provided by
No. 000986; melengestrol
acetate as provided by
Nos. 000986 or 054771 in
Sec. 510.600(c) of
this chapter.
(5) 6.8............... Monensin 10 to 40, For increased rate of Feed continuously as the 000061
plus tylosin 8 to 10. weight gain, improved sole ration during the 016592
feed efficiency, and last 20 to 40 days on
increased carcass feed to provide 60 to 90
leanness in cattle fed mg zilpaterol
in confinement for hydrochloride per head
slaughter during the per day and 0.14 to 0.42
last 20 to 40 days on mg monensin per pound of
feed; for prevention and body weight per day
control of coccidiosis depending on the
due to Eimeria bovis and severity of the
E. zuernii; and for coccidiosis challenge,
reduction of incidence up to 480 mg/head/day
of liver abscesses monensin. Withdrawal
caused by Fusobacterium period: 3 days. See
necrophorum and paragraph (d) of this
Arcanobacterium section. See paragraphs
(Actinomyces) pyogenes. Sec. Sec. 558.355(d)
and 558.625(c) of this
chapter.
Monensin as provided by
No. 000986; tylosin as
provided by Nos. 000986
or 016592 in Sec.
510.600(c) of this
chapter.
(6) 6.8............... Monensin 10 to 40, Heifers fed in Feed continuously as the 000061
plus tylosin 8 to confinement for sole ration during the 000986
10, plus slaughter: For increased last 20 to 40 days on 016592
melengestrol acetate rate of weight gain, feed to provide 60 to 90
to provide 0.25 to improved feed mg zilpaterol
0.5 mg/head/day. efficiency, and hydrochloride per head
increased carcass per day and 0.14 to 0.42
leanness in cattle fed mg monensin per pound of
in confinement for body weight per day
slaughter during the depending on the
last 20 to 40 days on severity of the
feed; for prevention and coccidiosis challenge,
control of coccidiosis up to 480 mg/head/day
due to Eimeria bovis and monensin. Withdrawal
E. zuernii; for period: 3 days. See
reduction of incidence paragraph (d) of this
of liver abscesses section. See paragraphs
caused by Fusobacterium Sec. Sec. 558.342(d),
necrophorum and 558.355(d), and
Arcanobacterium 558.625(c) of this
(Actinomyces) pyogenes; chapter.
and for suppression of Monensin as provided by
estrus (heat). No. 000986; tylosin as
provided by Nos. 000986
or 016592; and
melengestrol acetate as
provided by Nos. 000986
or 054771 in Sec.
510.600(c) of this
chapter.
(7) 6.8 to 24......... ..................... Cattle fed in confinement Feed continuously during 000061
for slaughter: For the last 20 to 40 days
increased rate of weight on feed to provide 60 mg
gain, improved feed zilpaterol hydrochloride
efficiency, and per head per day.
increased carcass Withdrawal period: 3
leanness in cattle fed days. See paragraph (d)
in confinement for of this section.
slaughter during the
last 20 to 40 days on
feed.

[[Page 53462]]

(8) 6.8 to 24......... Monensin 10 to 40.... Cattle fed in confinement Feed continuously during 000061
for slaughter: For the last 20 to 40 days
increased rate of weight on feed to provide 60 mg
gain, improved feed zilpaterol hydrochloride
efficiency, and per head per day and
increased carcass 0.14 to 0.42 mg monensin
leanness in cattle fed per pound of body weight
in confinement for per day depending on the
slaughter during the severity of the
last 20 to 40 days on coccidiosis challenge,
feed; and for prevention up to 480 mg/head/day
and control of monensin. Withdrawal
coccidiosis due to period: 3 days. See
Eimeria bovis and E. paragraph (d) of this
zuernii. section. See paragraph
Sec. 558.355(d) of
this chapter.
Monensin as provided by
No. 000986 in Sec.
510.600(c) of this
chapter.
(9) 6.8 to 24......... Melengestrol acetate Heifers fed in Feed continuously during 000061
to provide 0.25 to confinement for the last 20 to 40 days
0.5 mg/head/day. slaughter: For increased on feed to provide 60 mg
rate of weight gain, zilpaterol hydrochloride
improved feed per head per day.
efficiency, and Withdrawal period: 3
increased carcass days. See paragraph (d)
leanness in cattle fed of this section. See
in confinement for paragraph Sec.
slaughter during the 558.342(d) of this part.
last 20 to 40 days on Melengestrol acetate as
feed; and for provided by No. 054771
suppression of estrus in Sec. 510.600(c) of
(heat). this chapter.
(10) 6.8 to 24........ Monensin 10 to 40, Heifers fed in Feed continuously during 000061
plus melengestrol confinement for the last 20 to 40 days
acetate to provide slaughter: For increased on feed to provide 60 mg
0.25 to 0.5 mg/head/ rate of weight gain, zilpaterol hydrochloride
day. improved feed per head per day and
efficiency, and 0.14 to 0.42 mg monensin
increased carcass per pound of body weight
leanness in cattle fed per day depending on the
in confinement for severity of the
slaughter during the coccidiosis challenge,
last 20 to 40 days on up to 480 mg/head/day
feed; for prevention and monensin. Withdrawal
control of coccidiosis period: 3 days. See
due to Eimeria bovis and paragraph (d) of this
E. zuernii; and for section. See paragraphs
suppression of estrus Sec. Sec. 558.342(d)
(heat). and 558.355(d) of this
chapter.
Monensin as provided by
No. 000986; melengestrol
acetate as provided by
No. 054771 in Sec.
510.600(c) of this
chapter.
(11) 6.8 to 24........ Monensin 10 to 40, Cattle fed in confinement Feed continuously during 000061
plus tylosin 8 to 10. for slaughter: For the last 20 to 40 days
increased rate of weight on feed to provide 60 mg
gain, improved feed zilpaterol hydrochloride
efficiency, and per head per day and
increased carcass 0.14 to 0.42 mg monensin
leanness in cattle fed per pound of body weight
in confinement for per day depending on the
slaughter during the severity of the
last 20 to 40 days on coccidiosis challenge,
feed; for prevention and up to 480 mg/head/day
control of coccidiosis monensin. Withdrawal
due to Eimeria bovis and period: 3 days. See
E. zuernii; and for paragraph (d) of this
reduction of incidence section. See paragraphs
of liver abscesses Sec. Sec. 558.355(d)
caused by Fusobacterium and 558.625(c) of this
necrophorum and chapter.
Arcanobacterium Monensin and tylosin as
(Actinomyces) pyogenes. provided by No. 000986
in Sec. 510.600(c) of
this chapter.
(12) 6.8 to 24........ Monensin 10 to 40, Heifers fed in Feed continuously during 000061
plus tylosin 8 to confinement for the last 20 to 40 days
10, plus slaughter: For increased on feed to provide 60 mg
melengestrol acetate rate of weight gain, zilpaterol hydrochloride
to provide 0.25 to improved feed per head per day and
0.5 mg/head/day. efficiency, and 0.14 to 0.42 mg monensin
increased carcass per pound of body weight
leanness in cattle fed per day depending on the
in confinement for severity of the
slaughter during the coccidiosis challenge,
last 20 to 40 days on up to 480 mg/head/day
feed; for prevention and monensin. Withdrawal
control of coccidiosis period: 3 days. See
due to Eimeria bovis and paragraph (d) of this
E. zuernii; for section. See paragraphs
reduction of incidence Sec. Sec. 558.342(d),
of liver abscesses 558.355(d), and
caused by Fusobacterium 558.625(c) of this
necrophorum and chapter.
Arcanobacterium Monensin and tylosin as
(Actinomyces) pyogenes; provided by No. 000986;
and for suppression of melengestrol acetate as
estrus (heat). provided by No. 054771
in Sec. 510.600(c) of
this chapter.
----------------------------------------------------------------------------------------------------------------

Dated: August 31, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-21905 Filed 9-3-15; 8:45 am]
BILLING CODE 4164-01-P

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