11332 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations 

direct final rule would be on March 30, 

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: 21 U.S.C. 360ccc–1, 360ccc–2, 

371. Accordingly, the amendments issued 

thereby are effective. 

Dated: February 24, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–4593 Filed 3–1–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2010–1030] 

RIN 1625–AA09 

Drawbridge Operation Regulation; 

Duluth Ship Canal, Duluth-Superior 

Harbor, MN 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is 

establishing a drawbridge opening 

schedule for the Duluth Aerial Lift 

Bridge for vessels under 300 gross tons. 

Scheduled drawbridge openings will 

improve traffic congestion in the area 

and enhance safety for all modes of 

transportation. 

DATES: This rule is effective April 1, 

2011. 

ADDRESSES: Comments and related 

materials received from the public, as 

well as documents mentioned in this 

preamble as being available in the 

docket, are part of docket USCG–2010– 

1030 and are available online by going 

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

USCG–2010–1030 in the ‘‘Keyword’’ 

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

material is 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 rule, call or 

e-mail Mr. Lee Soule, Bridge 

Management Specialist, Ninth Coast 

Guard District; telephone (216) 902– 

6085, e-mail lee.d.soule@uscg.mil. If you 

have questions on viewing material in 

the docket, call Renee V. Wright, 

Program Manager, Docket Operations, 

telephone 202–366–9826. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

Commander, Ninth Coast Guard 

District, published a temporary 

deviation from these regulations, with 

request for comments, on April 22, 

2010, in the Federal Register (75 FR 

20918). The temporary deviation was 

used to test a new bridge schedule 

during the 2010 navigation and tourist 

season. On December 8, 2010, we 

published a notice of proposed 

rulemaking (NPRM) entitled Drawbridge 

Operation Regulation; Duluth Ship 

Canal, Duluth-Superior Harbor, MN. in 

the Federal Register (75 FR 76324). We 

received two comments in response to 

the proposed rule. No public meeting 

was requested, and none was held. 

Basis and Purpose 

The Duluth Aerial Bridge is located 

0.25 miles from Duluth Harbor North 

Pier Light at the lakeward end of the 

Duluth Ship Canal. It is a vertical lift 

type bridge that provides 15 feet of 

vertical clearance in the down position 

and up to 141 feet in the open position. 

The bridge currently opens on signal for 

all vessel traffic that requires a bridge 

opening. Marine traffic on the waterway 

consists of both large and smaller 

commercial vessels, as well as both 

power and sail recreational vessels. 

Pursuant to 33 CFR 117.8 various 

entities in Duluth requested scheduled 

openings instead of opening on signal. 

The requesting entities included the 

City of Duluth, the Duluth Fire 

Department-Emergency Management, 

the Duluth Police Department, the Park 

Point Community Association, and the 

Canal Park Business Association. The 

scheduled drawbridge openings were 

requested during the peak navigation 

and tourist season to improve the flow 

of vehicular traffic over the bridge, 

relieve vehicular traffic congestion near 

the bridge and on city streets on both 

sides of the bridge (Park Point and Canal 

Park), improve access and response 

times for emergency response entities, 

and enhance pedestrian safety in the 

vicinity of the bridge. The test schedule 

allowed for scheduled bridge openings 

on the hour and half-hour for all vessels 

under 300 gross tons between the hours 

of 6 a.m. and 9 p.m., seven days per 

week, and on signal between 9 p.m. and 

6 a.m., from May 3 to October 29, 2010. 

The bridge continued to open on signal 

at all times for all vessels over 300 gross 

tons and Federal, state, and local 

government vessels, vessels in distress, 

commercial vessels engaged in rescue or 

emergency salvage operations, vessels 

engaged in pilot duties, and vessels 

seeking shelter from severe weather. 

The City of Duluth collected data 

throughout the test period related to 

vehicular and vessel traffic counts, and 

the number of bridge openings. In 

addition to the data collected, each 

stakeholder had the opportunity to 

amplify their written comments and 

provide additional direct input to the 

Coast Guard during the October 20, 

2010 meeting. During the stakeholder 

meeting it was generally agreed by all 

parties that the scheduled bridge 

openings appeared to improve the 

general flow of vehicular traffic on both 

sides of the bridge and reduced 

vehicular traffic congestion. Regarding 

the time of year and hours each day that 

the scheduled openings would apply, it 

was generally agreed during the 

stakeholders meeting that the scheduled 

openings would be beneficial and 

effective between Memorial Day and 

Labor Day each year between the hours 

of 7 a.m. and 9 p.m. The data below 

collected by the City of Duluth 

illustrates support for the times and 

dates: 

May June July Aug Sep Oct 

TOTAL VESSELS UNDER 300 GROSS TONS 

2009 383 1287 2015 1974 1331 212 

2010 528 1066 2088 1430 1016 380 

TOTAL BRIDGE OPENINGS 

2009 320 841 1097 1184 800 350 

2010 300 576 860 630 752 429 

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Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations 11333 

May June July Aug Sep Oct 

TOTAL VEHICLES (BOTH DIRECTIONS) 

(Vehicular counts were not collected in 2009) 

2010 102,564 210,539 266,000 230,668 160,591 163,110 

6 a.m.–7 a.m. 7 a.m.–8 a.m. 

TOTAL AVERAGE VEHICLES FOR EACH HOUR 

June ......................................................................................................................................... 68.20 97.53 

July ........................................................................................................................................... 58.77 87.80 

August ...................................................................................................................................... 50.04 84.09 

In addition to the two scheduled 

openings per hour, vessels will continue 

to have access to the harbor through the 

alternate Superior, Wisconsin, Entry 

Channel, as well as passage thru the 

Aerial Bridge during unscheduled 

openings for commercial vessels. This 

rule will provide for the reasonable 

balance of all modes of transportation 

and effectively accomplish the 

requested goal of improving traffic 

congestion and safety in the area of the 

Duluth Aerial Bridge. This final rule 

also adjusts the current required 

advance notice requirement for vessels 

from 24-hours to 12-hours vessels 

between January 1 and March 15. 

Discussion of Comments and Changes 

The Coast Guard received two 

comments regarding the NPRM, one that 

was successfully received by the Docket 

Management Facility, and the second by 

direct email. Both comments were from 

private citizens. The first comment cited 

that members of the Park Point 

Community Association were invited to 

the stakeholder meeting on October 20, 

2010 described in the NPRM, however 

no representative from Park Point 

Community Association attended, that 

there was no provision in the proposed 

rule providing priority for emergency 

vehicles to cross the bridge, and that the 

proposed schedule should be extended 

to twelve months instead of providing 

only for the peak tourist season. 

The October 20, 2010 stakeholders 

meeting was attended by a Duluth City 

Councilwoman, who stated at the 

meeting she was representing Park Point 

residents. Additionally, all Park Point 

residents had the opportunity to provide 

comments during the test deviation as 

well as during the comment period for 

the NPRM. Regarding priority for 

emergency vehicles, 33 CFR 117.31(a) 

states that upon receiving notification 

that an emergency vehicle is responding 

to an emergency situation, a drawtender 

must make all reasonable efforts to have 

the drawspan closed at the time the 

emergency vehicle arrives. 

As described in the Basis and Purpose 

section above, all data, and all other 

comments, indicate that the dates and 

times in this final rule are the 

appropriate dates and times for 

scheduled drawbridge openings, and 

not throughout the whole year. 

The second comment, received by 

direct email, was from a local 

recreational vessel operator. The 

comment stated no general objection to 

the schedule, but he also stated the 

schedule did not appear to improve 

general vehicular and pedestrian traffic 

congestion. All other accounts of the 

scheduled openings indicate that the 

schedule has helped reduce traffic 

congestion and improved safety for all 

modes of transportation. 

The Coast Guard decided not to make 

any changes to the proposed rule. 

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. The rule will establish 

permanent scheduled openings and 

revise the advance notice time during 

winter seasons from twenty-four hours 

to twelve hours. The scheduled bridge 

openings are expected to improve 

vehicular traffic congestion and safety 

near the bridge while still providing for 

reasonable openings for vessel traffic. 

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 would not 

have a significant economic impact on 

a substantial number of small entities. 

This rule continues to provide at least 

two drawbridge openings per hour 

between 7:00 a.m. and 9 p.m. each day, 

and openings at any time during all 

other hours, as well as during 

unscheduled transits of commercial 

vessels. The test schedule implemented 

this year resulted in only minor 

adjustments in schedules or operations 

for all entities. Additionally, all vessels 

that do not require bridge openings may 

transit the drawbridge at any time, and 

the alternate Superior, Wisconsin, Entry 

Channel may be used by all vessels at 

any time. 

Assistance for Small Entities 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

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

in the NPRM 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. 

Collection of Information 

This rule would call 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 

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11334 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations 

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. 

Taking of Private Property 

This rule would 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 

would not create an environmental risk 

to health or risk to safety that might 

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 guides the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have concluded that 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 

(32(e), of the Instruction. 

Under figure 2–1, paragraph (32)(e), of 

the instruction, an environmental 

analysis checklist and a categorical 

exclusion determination are not 

required for this rule. 

List of Subjects in 33 CFR Part 117 

Bridges. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 117 as follows: 

PART 117—DRAWBRIDGE 

OPERATION REGULATIONS 

■ 1. The authority citation for part 117 

continues to read as follows: 

Authority: 33 U.S.C. 499; 33 CFR 1.05–1; 

Department of Homeland Security Delegation 

No. 0170.1. 

■ 2. Revise § 117.661 to read as follow: 

§ 117.661 Duluth Ship Canal (DuluthSuperior Harbor). 

The draw of the Duluth Ship Canal 

Aerial bridge, mile 0.25 at Duluth, shall 

open on signal; except that, from the 

Friday before Memorial Day through the 

Tuesday after Labor Day each year, 

between the hours of 7 a.m. and 9 p.m., 

seven days a week, the drawbridge shall 

open on the hour and half-hour for 

vessels under 300 gross tons, if needed; 

and the bridge will open on signal for 

all vessels from 9 p.m. to 7 a.m., seven 

days a week, and at all times for 

Federal, state, and local government 

vessels, vessels in distress, commercial 

vessels engaged in rescue or emergency 

salvage operations, commercial-assist 

towing vessels engaged in towing or 

port operations, vessels engaged in pilot 

duties, vessels seeking shelter from 

severe weather, and all commercial 

vessels 300 gross tons or greater. From 

January 1 through March 15, the draw 

shall open on signal if at least 12 hours 

notice is given. The opening signal is 

one prolonged blast, one short blast, one 

prolonged blast, one short blast. If the 

drawbridge is disabled, the bridge 

authorities shall give incoming and 

outgoing vessels timely and dependable 

notice, by tug service if necessary, so 

that the vessels do not attempt to enter 

the canal. 

Dated: February 7, 2011. 

M.N. Parks, 

Rear Admiral, U. S. Coast Guard, 

Commander, Ninth Coast Guard District. 

[FR Doc. 2011–4591 Filed 3–1–11; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR part 165 

[Docket No. USCG–2011–0086] 

RIN 1625–AA00 

Safety Zone; Soil Sampling; Chicago 

River, Chicago, IL 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone on 

the North Branch of the Chicago River 

near Chicago, Illinois. This zone is 

intended to restrict vessels from a 

portion of the North Branch of the 

Chicago River due to soil sampling in 

this area. This temporary safety zone is 

necessary to protect the surrounding 

public and vessels from the hazards 

WReier-Aviles on DSKGBLS3C1PROD with RULES