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: http://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: http://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 http://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: http://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: http://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