Federal Register / Vol. 74, No. 141 / Friday, July 24, 2009 / Rules and Regulations 36605 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 314 is 

amended as follows: 

PART 314—APPLICATIONS FOR FDA 

APPROVAL TO MARKET A NEW DRUG 

■ 1. The authority citation for 21 CFR 

part 314 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 355, 356, 356a, 356b, 356c, 371, 374, 

379e. 

§ 314.52 [Amended] 

■ 2. Section 314.52 is amended in 

paragraph (a)(2) by removing ‘‘at the 

address identified on FDA’s Web site 

(http://www.fda.gov/cder/ogd)’’ and by 

adding in its place ‘‘7500 Standish Pl., 

Rockville, MD 20855’’. 

§ 314.53 [Amended] 

■ 3. Section 314.53 is amended in 

paragraph (f) by removing ‘‘at the 

address identified on FDA’s Web site 

(http://www.fda.gov/cder/ogd)’’ and by 

adding in its place ‘‘7500 Standish Pl., 

Rockville, MD 20855’’. 

§ 314.95 [Amended] 

■ 4. Section 314.95 is amended in 

paragraph (a)(2) by removing ‘‘at the 

address identified on FDA’s Web site 

(http://www.fda.gov/cder/ogd)’’ and by 

adding in its place ‘‘7500 Standish Pl., 

Rockville, MD 20855’’. 

Dated: July 17, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–17680 Filed 7–23–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket No. USCG–2009–0659] 

RIN 1625–AA08 

Special Local Regulations for Marine 

Events; Port Huron to Mackinac Island 

Sail Race 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard will enforce 

a special local regulation for the annual 

Port Huron to Mackinac Island Sail 

Race. This action is necessary to safely 

control vessel movements in the vicinity 

of the race starting point and provide for 

the safety of the general boating public 

and commercial shipping. During this 

period, no person or vessel may enter 

the regulated area without the 

permission of the Coast Guard Patrol 

Commander (‘‘PATCOM’’). 

DATES: This rule is effective from 9 a.m. 

through 4 p.m. on July 25, 2009. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket USCG–2009– 

0659 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–2009–0659 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 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 concerning this 

temporary rule, call or e-mail Mr. Frank 

Jennings, Jr., Enforcement Branch, Ninth 

Coast Guard District, 1240 East 9th 

Street, Cleveland, OH, via e-mail at: 

frank.t.jennings@uscg.mil or by phone 

at: (216) 902–6094. 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 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 the 

special local regulation pertaining to 

this annual race was previously 

published in the Code of Federal 

Regulations, but inadvertently removed 

during the most recent revision to 33 

CFR 100.901. Because this is an annual 

race, held in the same location, local 

maritime interests are already familiar 

with the provisions of these regulations. 

Based on the late discovery of the 

missing permanent rule, the hazards 

associated with marine regattas within 

Port Huron and the short amount of 

time until the event, delaying 

publication of this regulation would be 

contrary to the public interest. 

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. The special local regulation 

pertaining to this annual race was 

previously published in the Code of 

Federal Regulations, but inadvertently 

removed during the most recent revision 

to 33 CFR 100.901. Because this is an 

annual race, held in the same location, 

local maritime interests are already 

familiar with the provisions of these 

regulations. Delaying this rule would be 

contrary to the public interest of 

ensuring the safety of spectators and 

vessels during this operation and 

immediate action is necessary to 

prevent possible loss of life or property. 

Background and Purpose 

Special local regulations are necessary 

to safely control vessel movements in 

the vicinity of the race starting point 

and provide for the safety of the general 

boating public and commercial 

shipping. The Captain of the Port 

Detroit has determined that the start of 

the Port Huron to Mackinac Island Sail 

Race does pose significant risks to 

public safety and property. The likely 

combination of congested waterways, 

vessels engaged in a regatta, and fast 

currents could easily result in serious 

injuries or fatalities. 

Discussion of Rule 

The Coast Guard will enforce special 

local regulations for the annual Port 

Huron to Mackinac Sail Race from 9 

a.m. until 4 p.m. on July 25, 2009. The 

special local regulations apply to the 

waters of the Black River, St. Clair River 

and lower Lake Huron from: 

Latitude Longitude 

42°58.8′ N ............ 082°26′ W, to 

42°58.4′ N ............ 082°24.8′ W, thence 

northward along the 

International Boundary 

to 

43°02.8′ N ............ 082°23.8′ W, to 

43°02.8′ N ............ 082°26.8′ W, thence 

southward along the 

U.S. shoreline to 

42°58.9′ N ............ 082°26′ W, thence to 

42°58.8′ N ............ 082°26′ W. 

[DATUM: NAD 1983]. 

In order to ensure the safety of 

spectators and participating vessels, the 

special local regulations will be in effect 

for the day of the start of the event. The 

Coast Guard will patrol the race area 

under the direction of a designated 

Coast Guard Patrol Commander 


rmajette on DSK29S0YB1PROD with RULES
36606 Federal Register / Vol. 74, No. 141 / Friday, July 24, 2009 / Rules and Regulations 

(‘‘PATCOM’’). Vessels desiring to transit 

the regulated area may do so only with 

prior approval of the PATCOM and 

when so directed by that officer. The 

PATCOM may be contacted on Channel 

16 (156.8 MHZ) by the call sign ‘‘Coast 

Guard Patrol Commander.’’ Vessels will 

be operated at a no wake speed to 

reduce the wake to a minimum, and in 

a manner which will not endanger 

participants in the event or any other 

craft. The rules contained in the above 

two sentences shall not apply to 

participants in the event or vessels of 

the patrol operating in the performance 

of their assigned duties. 

In the event these special local 

regulations affect shipping, commercial 

vessels may request permission from the 

PATCOM to transit the area of the event 

by hailing call sign ‘‘Coast Guard Patrol 

Commander’’ on Channel 16 (156.8 

MHZ). 

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. 

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 or anchor in 

a portion of the Black River, St. Clair 

River and lower Lake Huron from 9 a.m. 

until 4 p.m. July 25, 2009. 

These special local regulations 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 7 hours on a 

weekend when the majority of vessel 

traffic transiting the area is recreational. 

Vessel traffic will be allowed to pass 

through the area of the race start with 

the permission of the Coast Guard patrol 

commander. Before the effective period, 

the Coast Guard will issue maritime 

advisories widely to users of the river. 

Assistance for Small Entities 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

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

we offered to assist small entities in 

understanding the rule so that they 

could 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 affect 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 

The Coast Guard recognizes the treaty 

rights of Native American Tribes. 

Moreover, the Coast Guard is committed 

to working with Tribal Governments to 

implement local policies and to mitigate 

Tribal concerns. We have determined 

that these regulations and fishing rights 

protection need not be incompatible. 

We have also determined that 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. 

Nevertheless, Indian Tribes that have 

questions concerning the provisions of 

this Rule or options for compliance are 

encouraged to contact the point of 

contact listed under FOR FURTHER

INFORMATION CONTACT. 

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 


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Federal Register / Vol. 74, No. 141 / Friday, July 24, 2009 / Rules and Regulations 36607 

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)(h), of the Instruction. This rule 

involves the enforcement of special 

local regulations, pursuant to 33 CFR 

100, for the annual Port Huron to 

Mackinac Island Sail Race, July 25, 2009 

at 9 a.m. to July 25, 2009 at 4 p.m. This 

action is necessary to safely control 

vessel movements in the vicinity of the 

start of the race and provide for the 

safety of the general boating public and 

commercial shipping. Regulations will 

be in effect for seven hours on the day 

the event starts. The Coast Guard will 

patrol the race area under the direction 

of a designated Coast Guard Patrol 

Commander. 

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 100 

Marine safety, Navigation (water), 

Reporting and recordkeeping 

requirements, Waterways. 

■ For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR Part 100 as follows: 

PART 100—SAFETY OF LIFE ON 

NAVIGABLE WATERS 

■ 1. The authority citation for part 100 

continues to read as follows: 

Authority: 33 U.S.C. 1233. 

■ 2. A new temporary § 100.35T09–0659 

is added as follows: 

§ 100.35T09–0659 Special Local 

Regulations for Marine Events; Port Huron 

to Mackinac Island Sail Race. 

(a) Location. The special local 

regulations apply to the waters of the 

Black River, St. Clair River and lower 

Lake Huron from: 

Latitude Longitude 

42°58.8′ N ............ 082°26′ W, to 

42°58.4′ N ............ 082°24.8′ W, thence 

northward along the 

International Boundary 

to 

43°02.8′ N ............ 082°23.8′ W, to 

43°02.8′ N ............ 082°26.8′ W, thence 

southward along the 

U.S. shoreline to 

42°58.9′ N ............ 082°26′ W, thence to 

42°58.8′ N ............ 082°26′ W. 

[DATUM: NAD 1983]. 

(b) Effective period. This rule is 

effective from 9 a.m. to 4 p.m. on July 

25, 2009. 

(c) Regulations. 

(1) In accordance with the general 

regulations in section 100.35 of this 

part, the Coast Guard will patrol the 

regatta area under the direction of a 

designated Coast Guard Patrol 

Commander (‘‘PATCOM’’). The 

PATCOM may be contacted on Channel 

16 (156.8 MHz) by the call sign ‘‘Coast 

Guard Patrol Commander.’’ Vessels 

desiring to transit the regulated area 

may do so only with prior approval of 

the PATCOM and when so directed by 

that officer. 

(2) Vessels will be operated at a no 

wake speed to reduce the wake to a 

minimum, and in a manner which will 

not endanger participants in the even or 

any other craft. The rules in this 

subparagraph shall not apply to 

participants in the event or vessels of 

the patrol operating in the performance 

of their assigned duties. 

(3) The PATCOM may direct the 

anchoring, mooring or movement of any 

boat or vessel within the regatta area. A 

succession of sharp, short signals by 

whistle or horn from vessels patrolling 

the area under the direction of the U.S. 

Coast Guard PATCOM shall serve as a 

signal to stop. Vessels so signaled shall 

stop and shall comply with the orders 

of the PATCOM. Failure to do so may 

result in expulsion from the area, 

citation for failure to comply, or both. 

(4) The PATCOM may establish vessel 

size and speed limitations and operating 

conditions. The PATCOM may restrict 

vessel operation within the regatta area 

to vessels having particular operating 

characteristics. The PATCOM may 

terminate the marine event or the 

operation of vessel at any time it is 

deemed necessary for the protection of 

life and property. 

Dated: July 10, 2009. 

F.M. Midgette, 

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

Port Detroit. 

[FR Doc. E9–17748 Filed 7–23–09; 8:45 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2009–0578] 

Drawbridge Operation Regulations; 

East River, New York City, NY, 

Maintenance 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: The Commander, First Coast 

Guard District, has issued a temporary 

deviation from the regulation governing 

the operation of the Roosevelt Island 

Bridge across the East River, mile 6.4, at 

New York City, New York. Under this 

temporary deviation the bridge may 

remain in the closed position for one 

month to facilitate completion of 

ongoing bridge maintenance. Vessels 

that can pass under the draw without a 

bridge opening may do so at all times. 

DATES: This deviation is effective from 

July 24, 2009 through August 15, 2009. 

ADDRESSES: Documents mentioned in 

this preamble as being available in the 

docket are part of docket USCG–2009– 

0578 and are available online at 

http://www.regulations.gov, selecting 

the Advanced Docket Search option on 

the right side of the screen, inserting 

USCG–2009–0578 in the docket ID box, 

pressing enter, and then clicking on the 

item in the Docket ID column. This 

material is also available for inspection 

or copying at the Docket Management 


rmajette on DSK29S0YB1PROD with RULES