30464 Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Rules and Regulations 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8337, 

e-mail: melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Dechra, 

Ltd., Dechra House, Jamage Industrial 

Estate, Talke Pits, Stoke-on-Trent, 

Staffordshire, ST7 1XW, United 

Kingdom, filed a supplement to NADA 

141–291 that provides for use of 

VETORYL (trilostane) Capsules in dogs 

for treatment of pituitary-dependent 

hyperadrenocorticism and for treatment 

of hyperadrenocorticism due to 

adrenocortical tumors. The supplement 

provides for the use of a 10-milligram 

capsule size. The supplemental NADA 

is approved as of June 5, 2009, and the 

regulations are amended in 21 CFR 

520.2598 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. 

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 520 

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 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. 

§ 520.2598 [Amended] 

■ 2. In paragraph (a) of § 520.2598 

remove ‘‘30 or 60 milligrams’’ and in its 

place add ‘‘10, 30, or 60 milligrams’’. 

Dated: June 19, 2009. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. E9–15152 Filed 6–25–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2009–0405] 

RIN 1625–AA00 

Safety Zone; Harborfest 2009, Parade 

of Sail, Elizabeth River, Norfolk, VA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a mobile safety zone on the 

Elizabeth River in the vicinity of 

Sewell’s Point, Virginia, to Town Point 

Park, Norfolk, Virginia, in support of the 

Parade of Sail event taking place in 

conjunction with Harborfest 2009. This 

action is intended to restrict vessel 

traffic on the Elizabeth River to protect 

mariners from the hazards associated 

with marine parade events. 

DATES: This rule is effective from 10 

a.m. July 3, 2009 through 3 p.m. on July 

5, 2009. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket USCG–2009– 

0405 and are available online by going 

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

the Advanced Docket Search option on 

the right side of the screen, inserting 

USCG–2009–0405 in the Docket ID box, 

pressing Enter, and then clicking on the 

item in the Docket ID column. They are 

also available for inspection or copying 

at the following location: 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 LT Tiffany Duffy, 

Chief, Waterways Management Division, 

Coast Guard; telephone 757–668–5580, 

e-mail Tiffany.A.Duffy@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 any 

delay encountered in this regulation’s 

effective date by publishing a NPRM 

would be contrary to public interest 

since immediate action is needed to 

provide for the safety of life and 

property on navigable waters. 

Additionally, this temporary safety zone 

will be enforced for approximately 4 

hours on Friday, July 3, 2009 and for 

approximately 4 hours on Sunday, July 

5, 2009 while the Parade of Sail arrives 

at and departs Town Point Park. This 

safety zone should have a minimal 

impact on vessel transits because 

mariners are not precluded from using 

any portion of the waterway except the 

safety zone area. 

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 as any delay encountered in 

this regulation’s effective date by 

publishing a NPRM would be contrary 

to public interest since immediate 

action is needed to provide for the 

safety of life and property on navigable 

waters. 

Background and Purpose 

During the period of July 3 through 

July 5, 2009, the City of Norfolk and 

Norfolk Festevents Ltd. will sponsor 

Harborfest 2009, which includes the 

Parade of Sail event. This event will 

include a parade of more than twenty 

ships from around the world departing 

from Sewell’s Point, Virginia enroute to 

Town Point Park, Norfolk, Virginia on 

July 3, 2009. Due to the need for vessel 

control during the event, vessel traffic 

will be temporarily restricted to provide 

for the safety of spectators and transiting 

vessels. The Coast Guard anticipates 

numerous spectator craft for these 

scheduled events. Operators should 

expect significant vessel congestion 

along the parade route and viewing 

areas. The purpose of this regulation is 

to promote maritime safety and protect 

participants and the boating public in 

Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Rules and Regulations 30465 

the Port of Hampton Roads during the 

Parade of Sail event. For the safety 

concerns noted and to address the need 

for vessel control and vessel safety, all 

vessel traffic will be temporarily 

restricted in the vicinity of the parade 

route to provide for the safety of 

participants, spectators and transiting 

vessels. 

Discussion of Rule 

The Coast Guard is establishing a 

safety zone on specified waters of the 

Elizabeth River from Sewell’s Point, 

Virginia to Town Point Park, Norfolk, 

Virginia. This safety zone will 

encompass all navigable waters within 

300 yards ahead of, 100 yards abeam of, 

and all waters between participating 

vessels transiting from Sewell’s Point 

enroute to Town Point Park, Norfolk, 

VA. This regulated area will be 

established in the interest of public 

safety during the Parade of Sail and will 

be enforced during the Parade of Sail on 

July 3, 2009, from approximately 11 

a.m. until 3 p.m. and from 

approximately 11 a.m. until 3 p.m. on 

July 5, 2009 as the Parade of Sail departs 

Town Point Park, Norfolk, Virginia. 

Access to the safety zone will be 

restricted during the specified date and 

times. Except for participants and 

vessels authorized by the Captain of the 

Port or his Representative, no person or 

vessel may enter or remain in the 

regulated area. 

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 regulation restricts 

access to the safety zone, the effect of 

this rule will not be significant because: 

(i) The safety zone will be in effect for 

a limited duration; (ii) the zone is of 

limited size; and (iii) the Coast Guard 

will make notifications via maritime 

advisories so mariners can adjust their 

plans accordingly. 

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 rule will affect the following 

entities, some of which may be small 

entities: The owners or operators of 

vessels intending to transit the specified 

portion of the Elizabeth River from 11 

a.m. to 3 p.m. on July 3, 2009 and July 

5, 2009. 

This safety zone will not have a 

significant economic impact on a 

substantial number of small entities for 

the following reasons. This rule will be 

enforced for only about 4 hours on July 

3 and July 5, 2009, and vessel traffic 

will be able to navigate safely around 

the zone. In addition, before the 

effective period begins, the Coast Guard 

will make notifications via maritime 

advisories so mariners can adjust their 

plans accordingly. 

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 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. 

Taking of Private Property 

This rule will not effect 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 

30466 Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Rules and Regulations 

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 which 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 

involves establishing a mobile safety 

zone around a parade of vessels and is 

expected to have no impact on the 

water. This zone is designed to protect 

mariners from the hazards associated 

with vessel parades. 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 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, and 

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. 

Chapter 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.T05–0405 to read as 

follows: 

§ 165.T05–0405 Safety Zone: Harborfest 

2009, Parade of Sail, Elizabeth River, 

Norfolk, VA. 

(a) Regulated Area: The following area 

is a safety zone: specified waters of the 

Elizabeth River 300 yards ahead of, 100 

yards abeam of, and all waters between 

all vessels participating in the Parade of 

Sail, transiting from Sewell’s Point, 

Virginia enroute to Town Point Park, 

Norfolk, Virginia. 

(b) Definition: For the purposes of this 

part, Captain of the Port Representative 

means any U.S. Coast Guard 

commissioned, warrant or petty officer 

who has been authorized by the Captain 

of the Port, Hampton Roads, Virginia to 

act on his behalf. 

(c) Regulations: (1) In accordance with 

the general regulations in 165.23 of this 

part, entry into this zone is prohibited 

unless authorized by the Captain of the 

Port, Hampton Roads or his designated 

representatives. 

(2) The operator of any vessel in the 

immediate vicinity of this safety zone 

shall: 

(i) Stop the vessel immediately upon 

being directed to do so by any 

commissioned, warrant or petty officer 

on shore or on board a vessel that is 

displaying a U.S. Coast Guard Ensign. 

(ii) Proceed as directed by any 

commissioned, warrant or petty officer 

on shore or on board a vessel that is 

displaying a U.S. Coast Guard Ensign. 

(3) The Captain of the Port, Hampton 

Roads can be reached through the Sector 

Duty Officer at Sector Hampton Roads 

in Portsmouth, Virginia at telephone 

number (757) 638–6641. 

(4) The Coast Guard Representatives 

enforcing the safety zone can be 

contacted on VHF–FM marine band 

radio channel 13 (165.65Mhz) and 

channel 16 (156.8 Mhz). 

(d) Enforcement Period: This 

regulation will be in effect from 10 a.m. 

July 3, 2009 to 3 p.m. on July 5, 2009. 

Dated: June 16, 2009. 

M.S. Ogle, 

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

Port Hampton Roads. 

[FR Doc. E9–15191 Filed 6–25–09; 8:45 am] 

BILLING CODE 4910–15–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R05–OAR–2007–1131; FRL–8921–5] 

Approval and Promulgation of Air 

Quality Implementation Plans; Illinois; 

Oxides of Nitrogen Regulations, Phase 

II 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: EPA is approving a request 

submitted by the Illinois Environmental 

Protection Agency (Illinois EPA) on 

October 23, 2007, to revise the Illinois 

State Implementation Plan (SIP). The 

State has submitted revisions to 35 

Illinois Administrative Code (Ill. Adm. 

Code) parts 211 and 217. The submitted 

revisions are final and adopted in the 

Ill. Adm. Code, and pertain to 

definitions and general provisions, and 

control of Nitrogen Oxides (NOX). The 

rules satisfy the requirements of EPA’s 

NOX SIP Call Phase II Rule (the Phase 

II Rule). We are approving these 

regulations based on Illinois’ 

demonstration that the State will meet 

the emissions targets set forth in the 

Phase II Rule through reductions from 

stationary internal combustion (IC) 

engines and turbines which are 

identified in the NOX plan submittal. 

Limiting NOX emissions from IC engines 

and turbines will enable the State to 

meet the 7,055 ton reduction 

requirement contained in the Phase II 

Rule, thereby improving air quality and 

protecting the health of Illinois citizens. 

DATES: This direct final will be effective 

August 25, 2009, unless EPA receives 

adverse comments by July 27, 2009. If 

adverse comments are received, EPA 

will publish a timely withdrawal of the 

direct final rule in the Federal Register 

informing the public that the rule will 

not take effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R05– 

OAR–2007–1131, by one of the 

following methods: 

1. http://www.regulations.gov: Follow 

the on-line instructions for submitting 

comments. 

2. E-mail: mooney.john@epa.gov. 

3. Fax: (312) 692–2551.