Federal Register / Vol. 76, No. 45 / Tuesday, March 8, 2011 / Rules and Regulations 12563 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 1, 14, and 17 

[Docket No. FDA–2010–N–0560] 

RIN 0910–AG55 

Amendments to General Regulations 

of the Food and Drug Administration; 

Confirmation of Effective Date 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule; confirmation of 

effective date. 

SUMMARY: 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 75- 

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] 

BILLING CODE 4160–01–P 

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, 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 

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 


emcdonald on DSK2BSOYB1PROD with RULES
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. 

[FR Doc. 2011–5144 Filed 3–7–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF AGRICULTURE 

Forest Service 

36 CFR Part 242 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

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 

AGENCIES: Forest Service, Agriculture; 

Fish and Wildlife Service, Interior. 

ACTION: Final rule. 

SUMMARY: 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. 

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. 

DATES: This rule is effective April 1, 

2011. 

ADDRESSES: 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 (http://alaska.fws.gov/asm/ 

index.cfml). 

FOR FURTHER INFORMATION CONTACT: 

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. 

SUPPLEMENTARY INFORMATION: 

Background 

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 

Determinations; and Subpart D, 

Subsistence Taking of Fish and Wildlife. 

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: 

• A Chair appointed by the Secretary 

of the Interior with concurrence of the 

Secretary of Agriculture; 

• The Alaska Regional Director, U.S. 

Fish and Wildlife Service; 

• The Alaska Regional Director, U.S. 

National Park Service; 

• 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: 


emcdonald on DSK2BSOYB1PROD with RULES