Oral Dosage Form New Animal Drugs; Spinosad and Milbemycin Oxime, 12563-12564 [2011-5144]

Download as PDF Federal Register / Vol. 76, No. 45 / Tuesday, March 8, 2011 / Rules and Regulations not have a significant economic impact. Therefore the FAA preliminarily certifies that this rule will not have a significant economic impact on a substantial number of small entities. The FAA solicits comments regarding this determination on this supplemental regulatory flexibility analysis. Please provide detailed economic analysis to support the position of higher cost. The FAA also invites comments regarding other small entity concerns with respect to the final rule. Nan Shellabarger, Director, Office of Aviation Policy and Plans. [FR Doc. 2011–5257 Filed 3–7–11; 8:45 am] BILLING CODE P day period ending February 14, 2011. FDA stated that the effective date of the direct final rule would be on April 14, 2011, 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the comment period. FDA did not receive any significant adverse comments. Authority: Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 1, 14, and 17 are amended. Accordingly, the amendments issued thereby are effective. Dated: March 2, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–5147 Filed 3–7–11; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4160–01–P Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 CFR Parts 1, 14, and 17 Food and Drug Administration [Docket No. FDA–2010–N–0560] 21 CFR Part 520 RIN 0910–AG55 Amendments to General Regulations of the Food and Drug Administration; Confirmation of Effective Date AGENCY: Food and Drug Administration, [Docket No. FDA–2011–N–0003] Oral Dosage Form New Animal Drugs; Spinosad and Milbemycin Oxime AGENCY: HHS. Direct final rule; confirmation of effective date. ACTION: ACTION: The Food and Drug Administration (FDA) is confirming the effective date of April 14, 2011, for the final rule that appeared in the Federal Register of November 30, 2010 (75 FR 73951). The direct final rule amends certain general regulations of FDA to include tobacco products, where appropriate, in light of FDA’s authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act, by revising the Agency’s regulations to require tobacco products to be subject to the same general requirements that apply to other FDA-regulated products. This document confirms the effective date of the direct final rule. DATES: Effective date confirmed: April 14, 2011. FOR FURTHER INFORMATION CONTACT: Gerie A. Voss, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., rm. 204G, Rockville, MD 20850, 1–877– CTP–1373. SUPPLEMENTARY INFORMATION: In the Federal Register of November 30, 2010 (75 FR 73951), FDA solicited comments concerning the direct final rule for a 75SUMMARY: emcdonald on DSK2BSOYB1PROD with RULES Food and Drug Administration, HHS. VerDate Mar<15>2010 18:59 Mar 07, 2011 Jkt 223001 Final rule. The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Elanco Animal Health. The NADA provides for veterinary prescription use of chewable tablets containing spinosad and milbemycin oxime in dogs for the treatment and prevention of flea infestations and for the prevention and control of various internal parasites. DATES: This rule is effective March 8, 2011. FOR FURTHER INFORMATION CONTACT: Angela Clarke, Center for Veterinary Medicine (HFV–112), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8318, email: angela.clarke@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA 141–321 that provides for veterinary prescription use of TRIFEXIS (spinosad and milbemycin oxime) Chewable Tablets in dogs for the treatment and prevention of flea infestations and for the prevention and control of various internal parasites. The NADA is SUMMARY: PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 12563 approved as of January 4, 2011, and the regulations in part 520 (21 CFR part 520) are amended by adding § 520.2134 to reflect the approval. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application 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. Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning on the date of approval. FDA has determined under 21 CFR 25.33 that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. 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 in 21 CFR Part 520 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows: PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: ■ Authority: 21 U.S.C. 360b. ■ 2. Add § 520.2134 to read as follows: § 520.2134 Spinosad and milbemycin. (a) Specifications. Each chewable tablet contains 140 milligrams (mg) spinosad and 2.3 mg milbemycin oxime, 270 mg spinosad and 4.5 mg milbemycin oxime, 560 mg spinosad and 9.3 mg milbemycin oxime, 810 mg spinosad and 13.5 mg milbemycin oxime, or 1,620 mg spinosad and 27 mg milbemycin oxime. (b) Sponsor. See No. 000986 in § 510.600 of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer once a month at a E:\FR\FM\08MRR1.SGM 08MRR1 12564 Federal Register / Vol. 76, No. 45 / Tuesday, March 8, 2011 / Rules and Regulations minimum dosage of 13.5 mg/pound (lb) (30 mg/kilogram (kg)) of body weight spinosad and 0.2 mg/lb (0.5 mg/kg) of body weight milbemycin oxime. (2) Indications for use. To kill fleas; for the prevention and treatment of flea infestations (Ctenocephalides felis); for the prevention of heartworm disease (Dirofilaria immitis); and for the treatment and control of adult hookworm (Ancylostoma caninum), adult roundworm (Toxocara canis and Toxascaris leonina), and adult whipworm (Trichuris vulpis) infections in dogs and puppies 8 weeks of age or older and 5 lbs of body weight or greater. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dated: March 2, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. DEPARTMENT OF AGRICULTURE Forest Service 36 CFR Part 242 50 CFR Part 100 [Docket No. FWS–R7–SM–2009–0061; 70101–1261–0000L6] RIN 1018–AW71 Subsistence Management Regulations for Public Lands in Alaska—2011–12 and 2012–13 Subsistence Taking of Fish and Shellfish Regulations Forest Service, Agriculture; Fish and Wildlife Service, Interior. ACTION: Final rule. AGENCIES: This final rule establishes regulations for seasons, harvest limits, methods, and means related to taking of fish and shellfish for subsistence uses in Alaska during the 2011–12 and 2012–13 regulatory years. The Federal Subsistence Board (Board) completes the biennial process of revising subsistence hunting and trapping regulations in even-numbered years and subsistence fishing and shellfish regulations in odd-numbered years; public proposal and review processes take place during the preceding year. SUMMARY: Jkt 223001 • A Chair appointed by the Secretary of the Interior with concurrence of the Secretary of Agriculture; The Board meeting transcripts are available for review at the Office of Subsistence Management, 1011 East Tudor Road, Mail Stop 121, Anchorage, Alaska 99503, or on the Office of Subsistence Management Web site (https://alaska.fws.gov/asm/ index.cfml). • The Alaska Regional Director, U.S. National Park Service; ADDRESSES: Background Fish and Wildlife Service Consistent with subpart B of these regulations, the Secretaries established a Federal Subsistence Board to administer the Federal Subsistence Management Program. The Board is currently made up of: • The Alaska Regional Director, U.S. Fish and Wildlife Service; SUPPLEMENTARY INFORMATION: DEPARTMENT OF THE INTERIOR emcdonald on DSK2BSOYB1PROD with RULES This rule is effective April 1, Determinations; and Subpart D, Subsistence Taking of Fish and Wildlife. 2011. Chair, Federal Subsistence Board, c/o U.S. Fish and Wildlife Service, Attention: Peter J. Probasco, Office of Subsistence Management; (907) 786– 3888 or subsistence@fws.gov. For questions specific to National Forest System lands, contact Steve Kessler, Subsistence Program Leader, USDA, Forest Service, Alaska Region, (907) 743–9461 or skessler@fs.fed.us. BILLING CODE 4160–01–P 18:59 Mar 07, 2011 DATES: FOR FURTHER INFORMATION CONTACT: [FR Doc. 2011–5144 Filed 3–7–11; 8:45 am] VerDate Mar<15>2010 The Board also addresses customary and traditional use determinations during the applicable biennial cycle. This rulemaking replaces the fish and shellfish taking regulations that expire on March 31, 2011. This rule also revises the address of the Office of Subsistence Management; the new address should be used to obtain maps delineating the boundaries of the subsistence resource regions. Under Title VIII of the Alaska National Interest Lands Conservation Act (ANILCA) (16 U.S.C. 3111–3126), the Secretary of the Interior and the Secretary of Agriculture (Secretaries) jointly implement the Federal Subsistence Management Program. This program provides a preference for take of fish and wildlife resources for subsistence uses on Federal public lands and waters in Alaska. The Secretaries published temporary regulations to carry out this program in the Federal Register on June 29, 1990 (55 FR 27114), and final regulations were published in the Federal Register on May 29, 1992 (57 FR 22940). The Program has subsequently amended these regulations a number of times. Because this program is a joint effort between Interior and Agriculture, these regulations are located in two titles of the Code of Federal Regulations (CFR): Title 36, ‘‘Parks, Forests, and Public Property,’’ and Title 50, ‘‘Wildlife and Fisheries,’’ at 36 CFR 242.1–28 and 50 CFR 100.1–28, respectively. The regulations contain subparts as follows: Subpart A, General Provisions; Subpart B, Program Structure; Subpart C, Board PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 • The Alaska State Director, U.S. Bureau of Land Management; • The Alaska Regional Director, U.S. Bureau of Indian Affairs; and • The Alaska Regional Forester, U.S. Forest Service. Through the Board, these agencies participate in the development of regulations for subparts C and D, which, among other things, set forth program eligibility and specific harvest seasons and limits. In administering the program, the Secretaries divided Alaska into 10 subsistence resource regions, each of which is represented by a Regional Advisory Council. The Regional Advisory Councils provide a forum for rural residents with personal knowledge of local conditions and resource requirements to have a meaningful role in the subsistence management of fish and wildlife on Federal public lands in Alaska. The Regional Advisory Council members represent varied geographical, cultural, and user interests within each region. The Board addresses customary and traditional use determinations during the applicable biennial cycle. Section ___.24 (customary and traditional use determinations) was originally published in the Federal Register on May 29, 1992 (57 FR 22940). The regulations at 36 CFR 242.4 and 50 CFR 100.4 define ‘‘customary and traditional use’’ as ‘‘a long-established, consistent pattern of use, incorporating beliefs and customs which have been transmitted from generation to generation. * * *’’ Since 1992, the Board has made a number of customary and traditional use determinations at the request of affected subsistence users. Those modifications, along with some administrative corrections, were published in the Federal Register as follows: E:\FR\FM\08MRR1.SGM 08MRR1

Agencies

[Federal Register Volume 76, Number 45 (Tuesday, March 8, 2011)]
[Rules and Regulations]
[Pages 12563-12564]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5144]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2011-N-0003]


Oral Dosage Form New Animal Drugs; Spinosad and Milbemycin Oxime

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a new animal drug application 
(NADA) filed by Elanco Animal Health. The NADA provides for veterinary 
prescription use of chewable tablets containing spinosad and milbemycin 
oxime in dogs for the treatment and prevention of flea infestations and 
for the prevention and control of various internal parasites.

DATES: This rule is effective March 8, 2011.

FOR FURTHER INFORMATION CONTACT: Angela Clarke, Center for Veterinary 
Medicine (HFV-112), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8318, e-mail: angela.clarke@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA 
141-321 that provides for veterinary prescription use of TRIFEXIS 
(spinosad and milbemycin oxime) Chewable Tablets in dogs for the 
treatment and prevention of flea infestations and for the prevention 
and control of various internal parasites. The NADA is approved as of 
January 4, 2011, and the regulations in part 520 (21 CFR part 520) are 
amended by adding Sec.  520.2134 to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this application 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.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning on the date of approval.
    FDA has determined under 21 CFR 25.33 that this action is of a type 
that does not individually or cumulatively have a significant effect on 
the human environment. Therefore, neither an environmental assessment 
nor an environmental impact statement is required.
    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 in 21 CFR Part 520

    Animal drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is 
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. Add Sec.  520.2134 to read as follows:


Sec.  520.2134  Spinosad and milbemycin.

    (a) Specifications. Each chewable tablet contains 140 milligrams 
(mg) spinosad and 2.3 mg milbemycin oxime, 270 mg spinosad and 4.5 mg 
milbemycin oxime, 560 mg spinosad and 9.3 mg milbemycin oxime, 810 mg 
spinosad and 13.5 mg milbemycin oxime, or 1,620 mg spinosad and 27 mg 
milbemycin oxime.
    (b) Sponsor. See No. 000986 in Sec.  510.600 of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer once a month 
at a

[[Page 12564]]

minimum dosage of 13.5 mg/pound (lb) (30 mg/kilogram (kg)) of body 
weight spinosad and 0.2 mg/lb (0.5 mg/kg) of body weight milbemycin 
oxime.
    (2) Indications for use. To kill fleas; for the prevention and 
treatment of flea infestations (Ctenocephalides felis); for the 
prevention of heartworm disease (Dirofilaria immitis); and for the 
treatment and control of adult hookworm (Ancylostoma caninum), adult 
roundworm (Toxocara canis and Toxascaris leonina), and adult whipworm 
(Trichuris vulpis) infections in dogs and puppies 8 weeks of age or 
older and 5 lbs of body weight or greater.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: March 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5144 Filed 3-7-11; 8:45 am]
BILLING CODE 4160-01-P

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