26648 Federal Register / Vol. 75, No. 91 / Wednesday, May 12, 2010 / Rules and Regulations 

adds claims for persistent effectiveness 

against various species of external and 

internal parasites that were approved for 

the pioneer product with 3 years of 

marketing exclusivity (69 FR 501, 

January 6, 2004). The supplemental 

ANADA is approved as of March 26, 

2010, and 21 CFR 524.1193 is amended 

to reflect the approval. 

In addition, FDA has noticed the 

regulations do not accurately reflect 

approved indications for generic 

products. At this time, the regulations 

are being revised to reflect which 

generic products have approved labeling 

for the durations of persistent 

effectiveness approved for the pioneer 

product. FDA is also adding a parasite 

species that was inadvertently omitted 

in the previously cited January 6, 2004, 

final rule. These actions are being taken 

to improve the accuracy of the 

regulations. 

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. 

The agency 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 524 

Animal drugs. 

■ 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 part 524 is amended as follows: 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 524 continues to read as follows: 

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

■ 2. In § 524.1193, revise paragraphs (b) 

and (e)(2) to read as follows: 

§ 524.1193 Ivermectin topical solution. 

* * * * * 

(b) Sponsors. See sponsors in 

§ 510.600(c) of this chapter for use as in 

paragraph (e) of this section. 

(1) Nos. 050604, 055529, 058829 for 

use as in paragraphs (e)(1), (e)(2)(i), 

(e)(2)(iii), and (e)(3) of this section. 

(2) Nos. 054925, 059130, 061623, and 

066916 for use as in paragraphs (e)(1), 

(e)(2)(i), (e)(2)(ii), and (e)(3) of this 

section. 

* * * * * 

(e) * * * 

(2) Indications for use—(i) It is used 

for the treatment and control of: 

Gastrointestinal roundworms (adults 

and fourth-stage larvae) Ostertagia 

ostertagi (including inhibited stage), 

Haemonchus placei, Trichostrongylus 

axei, T. colubriformis, Cooperia 

oncophora, C. punctata, C. surnabada, 

Oesophagostomum radiatum; (adults) 

Strongyloides papillosus, Trichuris spp.; 

lungworms (adults and fourth-stage 

larvae) Dictyocaulus viviparus; cattle 

grubs (parasitic stages) Hypoderma 

bovis, H. lineatum; mites Sarcoptes 

scabiei var. bovis; lice Linognathus 

vituli, Haematopinus eurysternus, 

Damalinia bovis, Solenoptes capillatus; 

and horn flies Haematobia irritans. 

(ii) It controls infections and prevents 

reinfection with O. ostertagi, O. 

radiatum, H. placei, T. axei, C. 

punctata, and C. oncophora for 14 days 

after treatment. 

(iii) It controls infections and prevents 

reinfection with O. radiatum and D. 

viviparus for 28 days after treatment, C. 

punctata and T. axei for 21 days after 

treatment, O. ostertagi, H. placei, C. 

oncophora, and C. surnabada for 14 

days after treatment, and D. bovis for 56 

days after treatment. 

* * * * * 

Dated: May 6, 2010. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2010–11244 Filed 5–11–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2010–0285] 

RIN 1625–AA00 

Safety Zones; May Fireworks Displays 

Within the Captain of the Port Puget 

Sound Area of Responsibility (AOR) 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The U.S Coast Guard is 

establishing two safety zones on the 

waters of Puget Sound, WA for two 

fireworks displays. This action is 

necessary to provide for the safety of life 

on navigable waters during the 

fireworks displays. Entry into, transit 

through, mooring, or anchoring within 

these zones is prohibited unless 

authorized by the Captain of the Port, 

Puget Sound or Designated 

Representative. 

DATES: This rule is effective from 12:01 

a.m. May 14, 2010 through 11:59 p.m. 

May 23, 2010 unless canceled sooner by 

the Captain of the Port. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket USCG–2010– 

0285 and are available online by going 

to http://www.regulations.gov, inserting 

USCG–2010–0285 in the ‘‘Keyword’’ 

box, and then clicking ‘‘Search.’’ They 

are also available for inspection or 

copying at the Docket Management 

Facility (M–30), U.S. Department of 

Transportation, West Building Ground 

Floor, Room W12–140, 1200 New Jersey 

Avenue SE., Washington, DC 20590, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

rule, call or e-mail Ensign Rebecca E. 

McCann, Waterways Management, 

Sector Seattle, Coast Guard; telephone 

206–217–6088, email 

SectorSeattleWWM@uscg.mil. If you 

have questions on viewing the docket, 

call Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

The Coast Guard is issuing this 

temporary final rule without prior 

notice and opportunity to comment 

pursuant to authority under section 4(a) 

of the Administrative Procedure Act 

(APA) (5 U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b)(B), the Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule because it is 

contrary to public interest to delay the 

effective date of this rule. Delaying the 

effective date by first publishing an 

NPRM would be contrary to the safety 

zone’s intended objectives since 

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Federal Register / Vol. 75, No. 91 / Wednesday, May 12, 2010 / Rules and Regulations 26649 

immediate action is needed to protect 

persons and vessels against the hazards 

associated with fireworks displays on 

navigable waters. Such hazards include 

premature detonations, dangerous 

projectiles and falling or burning debris. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register. Due to the need for immediate 

action, the restriction of vessel traffic is 

necessary to protect life, property and 

the environment; therefore, a 30-day 

notice is impracticable. Delaying the 

effective date would be contrary to the 

safety zone’s intended objectives of 

protecting persons and vessels involved 

in the event, and enhancing public and 

maritime safety. 

Basis and Purpose 

Fireworks displays are frequently 

held from locations on or near the 

navigable waters of the United States. 

The potential hazards associated with 

fireworks displays are a safety concern 

during such events. The purpose of this 

rule is to promote public and maritime 

safety during fireworks displays, and to 

protect mariners transiting the area from 

the potential hazards associated with 

the fireworks displays, such as the 

accidental discharge of fireworks, 

dangerous projectiles, and falling hot 

embers or other debris. This rule is 

needed to ensure safety on the waterway 

during the scheduled events. 

This rule will restrict access to the 

specified waters surrounding the 

fireworks events indicated in the 

temporary final rule. The restriction of 

vessel traffic is necessary to protect life, 

property and the environment. 

Discussion of Rule 

The U.S. Coast Guard is establishing 

temporary safety zones to allow for safe 

fireworks displays. A safety zone for the 

Viking Fest will be enforced from 6:30 

p.m. to 11:30 p.m. on May 14, 2010 at 

47°43′55′′ N, 122°39′08′′ W (NAD 83) 

extending to a 1000 foot radius from the 

launch site. A safety zone for a Private 

Party fireworks display North of 

Meadow Point in Central Puget Sound 

will be enforced from 8:30 p.m. until 11 

p.m. on May 22, 2010 at 47°43′42′′ N, 

122°24′26′′ W (NAD 83) extending to a 

1500 foot radius from the launch site. 

These safety zones do not extend onto 

land. 

These events may result in a number 

of vessels congregating near fireworks 

launching barges. These safety zones are 

needed to protect watercraft and their 

occupants from safety hazards 

associated with fireworks displays. The 

Captain of the Port, Puget Sound may be 

assisted by other federal and local 

agencies in the enforcement of these 

safety zones. Vessels will be allowed to 

transit the waters of the Puget Sound 

outside the safety zones. Notification of 

the temporary safety zones will be 

provided to the public via marine 

information broadcasts. 

Entry into these zones by all vessel 

operators or persons will be prohibited 

unless authorized by the Captain of the 

Port or Designated Representative. The 

Captain of the Port may be assisted by 

other federal, state, or local agencies as 

needed. 

Regulatory Analyses 

We developed this rule after 

considering numerous statutes and 

executive orders related to rulemaking. 

Below we summarize our analyses 

based on 13 of these statutes or 

executive orders. 

Regulatory Planning and Review 

This rule is not a significant 

regulatory action under section 3(f) of 

Executive Order 12866, Regulatory 

Planning and Review, and does not 

require an assessment of potential costs 

and benefits under section 6(a)(3) of that 

Order. The Office of Management and 

Budget has not reviewed it under that 

Order. Although this rule will restrict 

access to the areas, the effect of this rule 

will not be significant because: (1) The 

safety zones will be in effect for a 

limited duration of time, (ii) the safety 

zones are limited in size, and (iii) 

vessels may be granted permission to 

transit the area by the Captain of the 

Port or a designated representative. 

Small Entities 

Under the Regulatory Flexibility Act 

(5 U.S.C. 601–612), we have considered 

whether this rule would have a 

significant economic impact on a 

substantial number of small entities. 

The term ‘‘small entities’’ comprises 

small businesses, not-for-profit 

organizations that are independently 

owned and operated and are not 

dominant in their fields, and 

governmental jurisdictions with 

populations of less than 50,000. 

The Coast Guard certifies under 5 

U.S.C. 605(b) that this rule will not have 

a significant economic impact on a 

substantial number of small entities. 

This temporary rule will affect the 

following entities, some of which may 

be small entities: The owners or 

operators of vessels intending to transit 

the specified waters of Puget Sound 

while this rule is enforced. These safety 

zones will not have significant 

economic impact on a substantial 

number of small entities for the 

following reasons. This temporary rule 

will be in effect for short periods of 

time, when vessel traffic volume is low 

and is comprised of mostly small 

pleasure craft. If safe to do so, traffic 

will be allowed to pass through these 

safety zones with the permission of the 

Captain of the Port or Designated 

Representative. 

Assistance for Small Entities 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Pub. L. 104–121), 

we offer to assist small entities in 

understanding the rule so that they can 

better evaluate its effects on them and 

participate in the rulemaking process. 

Small businesses may send comments 

on the actions of Federal employees 

who enforce, or otherwise determine 

compliance with, Federal regulations to 

the Small Business and Agriculture 

Regulatory Enforcement Ombudsman 

and the Regional Small Business 

Regulatory Fairness Boards. The 

Ombudsman evaluates these actions 

annually and rates each agency’s 

responsiveness to small business. If you 

wish to comment on actions by 

employees of the Coast Guard, call 1– 

888–REG–FAIR (1–888–734–3247). The 

Coast Guard will not retaliate against 

small entities that question or complain 

about this rule or any policy or action 

of the Coast Guard. 

Collection of Information 

This rule calls for no new collection 

of information under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). 

Federalism 

A rule has implications for federalism 

under Executive Order 13132, 

Federalism, if it has a substantial direct 

effect on State or local governments and 

would either preempt State law or 

impose a substantial direct cost of 

compliance on them. We have analyzed 

this rule under that Order and have 

determined that it does not have 

implications for federalism. 

Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 (adjusted for inflation) or 

more in any one year. Though this rule 

will not result in such an expenditure, 

we do discuss the effects of this rule 

elsewhere in this preamble. 

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26650 Federal Register / Vol. 75, No. 91 / Wednesday, May 12, 2010 / Rules and Regulations 

Taking of Private Property 

This rule will not cause a taking of 

private property or otherwise have 

taking implications under Executive 

Order 12630, Governmental Actions and 

Interference with Constitutionally 

Protected Property Rights. 

Civil Justice Reform 

This rule meets applicable standards 

in sections 3(a) and 3(b)(2) of Executive 

Order 12988, Civil Justice Reform, to 

minimize litigation, eliminate 

ambiguity, and reduce burden. 

Protection of Children 

We have analyzed this rule under 

Executive Order 13045, Protection of 

Children from Environmental Health 

Risks and Safety Risks. This rule is not 

an economically significant rule and 

does not create an environmental risk to 

health or risk to safety that may 

disproportionately affect children. 

Indian Tribal Governments 

This rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not have a substantial 

direct effect on one or more Indian 

tribes, on the relationship between the 

Federal Government and Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

Energy Effects 

We have analyzed this rule under 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use. We have 

determined that it is not a ‘‘significant 

energy action’’ under that order because 

it is not a ‘‘significant regulatory action’’ 

under Executive Order 12866 and is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. The Administrator of the Office 

of Information and Regulatory Affairs 

has not designated it as a significant 

energy action. Therefore, it does not 

require a Statement of Energy Effects 

under Executive Order 13211. 

Technical Standards 

The National Technology Transfer 

and Advancement Act (NTTAA) (15 

U.S.C. 272 note) directs agencies to use 

voluntary consensus standards in their 

regulatory activities unless the agency 

provides Congress, through the Office of 

Management and Budget, with an 

explanation of why using these 

standards would be inconsistent with 

applicable law or otherwise impractical. 

Voluntary consensus standards are 

technical standards (e.g., specifications 

of materials, performance, design, or 

operation; test methods; sampling 

procedures; and related management 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This rule does not use technical 

standards. Therefore, we did not 

consider the use of voluntary consensus 

standards. 

Environment 

We have analyzed this rule under 

Department of Homeland Security 

Management Directive 023–01 and 

Commandant Instruction M16475.lD, 

which guide the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 

(NEPA)(42 U.S.C. 4321–4370f), and 

have concluded this action is one of a 

category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule is categorically 

excluded, under figure 2–1, paragraph 

(34)(g), of the Instruction. This rule 

establishes temporary safety zones to 

protect the public from dangers 

associated with fireworks displays. 

An environmental analysis checklist 

and a categorical exclusion 

determination are available in the 

docket where indicated under 

ADDRESSES. 

List of Subjects in 33 CFR Part 165 

Harbor, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

■ For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR Part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. 

Chapters 701, 3306, 3703; 50 U.S.C. 191, 195; 

33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; 

Pub. L. 107–295, 116 Stat. 2064; Department 

of Homeland Security Delegation No. 0170.1 

■ 2. Add § 165.T13–140 to read as 

follows: 

§ 165.T13–140 Safety Zones; May 

Fireworks displays within the Captain of the 

Port Puget Sound Area of Responsibility 

(AOR) 

(a) Safety Zones. The following areas 

are designated safety zones: 

(1) Viking Fest, Liberty Bay, WA 

(i) Location. Liberty Bay, WA 

extending out to a 1000 foot radius from 

the launch site at 47°43′55′′ N 

122°39′08′′ W. 

(ii) Enforcement. 6:30 p.m. until 11:30 

p.m. on May 14, 2010. 

(2) Private Party, North of 

Meadowpoint in Central Puget Sound, 

WA 

(i) Location. Two miles north of 

Meadowpoint in Central Puget Sound, 

WA extending out to 1500 foot radius 

from the launch site at 47°43′42′′ N 

122°24′26′′ W. 

(i) Enforcement. 8:30 p.m. until 11 

p.m. on May 22, 2010. 

(b) Regulations. In accordance with 

the general regulations in 33 CFR Part 

165, Subpart C, no vessel operator may 

enter, transit, moor, or anchor within 

these safety zones, except for vessels 

authorized by the Captain of the Port or 

Designated Representative. 

(c) Authorization. All vessel operators 

who desire to enter these safety zones 

must obtain permission from the 

Captain of the Port or Designated 

Representative by contacting either the 

on-scene patrol craft on VHF Ch 13 or 

Ch 16 or the Coast Guard Sector Seattle 

Joint Harbor Operations Center (JHOC) 

via telephone at 206–217–6002. 

(d) Effective Period. This rule is 

effective from 12:01 a.m. May 14, 2010 

through 11:59 p.m. May 23, 2010 unless 

canceled sooner by the Captain of the 

Port. 

Dated: April 15, 2010. 

S.W. Bornemann, 

Captain, U.S. Coast Guard, Captain of the 

Port, Puget Sound. 

[FR Doc. 2010–11300 Filed 5–11–10; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2010–0129] 

RIN 1625–AA00 

Safety Zones; Annual Events 

Requiring Safety Zones in the Captain 

of the Port Lake Michigan Zone 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is amending 

the regulations establishing permanent 

safety zones in the Captain of the Port 

Lake Michigan zone during annual 

events. When these safety zones are 

activated, and thus subject to 

enforcement, this rule would restrict 

vessels from portions of water areas 

during annual events that pose a hazard 

to public safety. The safety zones 

established by this rule are necessary to 

WReier-Aviles on DSKGBLS3C1PROD with RULES