26952 Federal Register / Vol. 74, No. 107 / Friday, June 5, 2009 / Rules and Regulations 

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

353, 360b, 371, 379e. 

■ 2. In § 510.600, in the table in 

paragraph (c)(1) remove the entry for 

‘‘Jazz Pharmaceuticals, Inc.’’ and 

alphabetically add a new entry for 

‘‘Paladin Labs, Inc.’’; and in the table in 

paragraph (c)(2) remove the entry for 

‘‘068727’’ and numerically add a new 

entry for ‘‘046129’’ to read as follows: 

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address Drug labeler 

code 

* * * * * 

Paladin Labs (USA), Inc., 

160 Greentree Dr., suite 

101, Dover, DE 19904 

046129 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

046129 Paladin Labs (USA), Inc., 

160 Greentree Dr., suite 

101, Dover, DE 19904 

* * * * * 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

§ 522.1004 [Amended] 

■ 4. In paragraph (b) of § 522.1004, 

remove ‘‘068727’’ and add in its place 

‘‘046129’’. 

Dated: June 1, 2009. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E9–13126 Filed 6–4–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2009–0385] 

RIN 1625–AA09 

Drawbridge Operation Regulation; 

Sturgeon Bay Ship Canal, Sturgeon 

Bay, WI 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard proposes to 

temporarily revise the operating 

regulations for the Maple-Oregon Bridge 

at Mile 4.17 over the Sturgeon Bay Ship 

Canal in Sturgeon Bay, WI. This action 

was requested by the Wisconsin 

Department of Transportation 

(Wisconsin DOT) to facilitate vehicular 

traffic in downtown Sturgeon Bay 

during the rehabilitation of the 

Michigan Street Bridge at Mile 4.30 over 

the Sturgeon Bay Ship Canal. This final 

rule is expected to reflect the need for 

bridge openings for the Maple-Oregon 

Bridge during the Michigan Street 

Bridge rehabilitation and still provide 

for the reasonable needs of navigation. 

DATES: This temporary final rule is 

effective from 6 a.m. on June 1, 2009 to 

6 p.m. on November 15, 2010. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket, are part of docket USCG–2009– 

0385 and are available by going to 

http://www.regulations.gov, selecting 

the Advanced Docket Search option on 

the right side of the screen, inserting 

USCG–2009–0385 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 

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 Blair Stanifer, Bridge 

Management Specialist, Coast Guard 

Ninth District; telephone 216–902–6086, 

e-mail: William.B.Stanifer@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 the 

request to revise the operating schedule 

for this temporary final rule included 

extensive preliminary coordination with 

known affected marine entities, 

Wisconsin DOT, and the City of 

Sturgeon Bay, WI, and resulted in a 

temporary drawbridge schedule that 

would not significantly impact either 

vehicular traffic or known navigation. 

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

Guard finds that good cause exists for 

making this rule effective in less than 30 

days after publication in the Federal 

Register. As noted above the Coast 

Guard has conducted extensive 

preliminary coordination with known 

affected marine entities, the Wisconsin 

DOT and the City of Sturgeon Bay, WI 

and determined that the impact on 

navigation will be minimal as the bridge 

will continue to open on demand for 

commercial vessels and public vessels 

and on the hour for recreational vessels 

from March 15 through December 31, 

and from January 1 through March 14, 

for any vessel provided at least notice is 

given at least 12 hours advance. This is 

the same schedule under which the 

Michigan Street Bridge currently 

operates under 33 CFR 117.1101. During 

renovation the Michigan Street Bridge 

will remain in the open position and 

vehicular traffic is expected to use the 

Maple-Oregon Bridge as an alternate 

route. Repeated openings would likely 

cause significant congestion on the 

vehicular approaches to the bridge. 

Hourly openings will allow vehicular 

traffic to plan accordingly and will 

minimally affect recreational vessels. 

Background and Purpose 

Wisconsin DOT requested a 

temporary change to the operating 

schedule of the Maple-Oregon Bridge at 

Mile 4.17 over the Sturgeon Bay Ship 

Canal to facilitate the rehabilitation of 

the Michigan Street Bridge. The MapleOregon Double-Leaf Bascule Bridge 

navigation span provides for a design 

clearance of 25 feet above Mean Low 


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Federal Register / Vol. 74, No. 107 / Friday, June 5, 2009 / Rules and Regulations 26953 

Water in the closed to navigation 

position. The waterway carries 

commercial, recreational and public 

vessel traffic. The bridge is normally 

required to open on signal for vessels 

year-round under the general provisions 

of 33 CFR 117.5. In order to perform the 

rehabilitation to the Michigan Street 

Bridge with a minimum of disruptions, 

Wisconsin DOT has requested that the 

Maple-Oregon Bridge be required to 

open for recreational vessels only on the 

hour, 24 hours a day, seven days a 

week, between March 15 and December 

31. The Maple-Oregon Bridge will 

continue to open on demand for 

commercial and public vessels during 

this period. Between January 1 and 

March 14, the Maple-Oregon Bridge will 

open if notice is provided at least 12 

hours in advance of a vessel’s time of 

intended passage. As the Michigan 

Street Bridge currently operates under 

this schedule as outlined in 33 CFR 

117.1101, Wisconsin DOT feels that 

operating the Maple-Oregon Bridge with 

this schedule will maintain the 

expectations of the waterway users and 

vehicular traffic while the Michigan 

Street Bridge is rehabilitated in the open 

to navigation position. The request from 

Wisconsin DOT also included 

undefined periods of time where the 

Maple-Oregon Bridge would not be 

required to open for any vessel as work 

being performed on the Michigan Street 

Bridge would necessitate the occasional, 

short-term closing of the waterway. The 

dates of these closure periods can not, 

and have not, been identified due to the 

nature of the work, but Wisconsin DOT 

is required to provide those dates to the 

Coast Guard 10–14 days in advance of 

anticipated closure periods. The Coast 

Guard will issue Broadcast and Local 

Notices to Mariners covering those dates 

when they have been finalized. 

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. This rule is not ‘‘significant’’ 

under the regulatory policies and 

procedures of the Department of 

Homeland Security. The temporary 

drawbridge schedule still provides for 

the passing of vessels throughout the 

entire proposed work period. The 

unspecified closure periods, which are 

necessary for a limited amount of 

rehabilitation work being performed on 

the Michigan Street Bridge, will be 

published as early as possible in the 

Ninth Coast Guard District Local and/or 

Broadcast Notice to Mariners prior to 

the work beginning. 

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 

recreational vessels intending to transit 

the bridge from 6 a.m. on June 1, 2009 

to 6 p.m. on November 15, 2010, and 

marine facilities that provide services 

for recreational vessels. However, this 

action will not have a significant 

economic impact on a substantial 

number of small entities for the 

following reasons. The Maple-Oregon 

Bridge was designed to pass a 

substantial amount of waterway users 

without the need for an opening. 

Vessels that can safely transit under the 

bridge may do so at any time. The 

remaining vessels will still be granted 

openings once an hour on the hour, 

twenty-four hours a day. Before the 

effective period, we will issue maritime 

advisories widely available 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 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 

would not create an environmental risk 

to health or risk to safety that might 

disproportionately affect children. 


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26954 Federal Register / Vol. 74, No. 107 / Friday, June 5, 2009 / Rules and Regulations 

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 0023.1 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. From 6 a.m. on June 1, 2009 to 6 

p.m. on November 15, 2010, temporarily 

add paragraph (c) to § 117.1101 to read 

as follows: 

§ 117.1101 Sturgeon Bay. 

* * * * * 

(c) The draw of the Maple-Oregon 

Bridge at Mile 4.17 at Sturgeon Bay, 

shall operate as follows: 

(1) From June 1 through December 31, 

2009, and from March 15 through 

November 15, 2010 the draw need open 

for recreational vessels only on the 

hour, 24 hours a day. 

(2) Commercial and Public vessels 

shall be passed at all times. 

(3) From January 1 through March 14, 

2010, the draw shall open on signal for 

all vessels if notice is given at least 12 

hours in advance of a vessel’s intended 

time of passage. 

Dated: May 18, 2009. 

D.R. Callahan, 

Captain, U.S. Coast Guard, Commander, 

Ninth Coast Guard District, Acting. 

[FR Doc. E9–13103 Filed 6–4–09; 8:45 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2009–0120] 

RIN 1625–AA00 

Safety Zone; Coronado Fourth of July 

Fireworks; San Diego Bay, San Diego, 

CA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone on 

the navigable waters of the San Diego 

Bay in support of the Coronado Fourth 

of July Fireworks. This temporary safety 

zone is necessary to provide for the 

safety of crew, spectators, and other 

users and vessels of the waterway. 

Persons and vessels are prohibited from 

entering into, transiting through, or 

anchoring within this temporary safety 

zone unless authorized by the Captain 

of the Port or his designated 

representative. 

DATES: This rule is effective from 8:45 

p.m. to 9:30 p.m. on July 4, 2009. 

ADDRESSES: Comments and material 

received from the public, as well as 

documents mentioned in this preamble 

as being available in the docket, are part 

of docket USCG–2009–0120 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– 

2009–0120 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 

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 Petty Officer Kristen 

Beer, Waterways Management, U.S. 

Coast Guard Sector San Diego, Coast 

Guard; telephone 619–278–7262, e-mail 

Kristen.A.Beer@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 

On April 27, 2009, we published a 

notice of proposed rulemaking (NPRM) 

entitled Safety Zone; Coronado Fourth 

of July Fireworks; San Diego Bay, San 

Diego, CA in the Federal Register (74 

FR 19034). We received no comments 

on the proposed rule. No public meeting 

was requested, and none was held. 

Background and Purpose 

Coronado 4th of July, Inc. is 

sponsoring the Coronado Fourth of July 

Fireworks, which will include a 

fireworks presentation originating from 

a barge located in Glorietta Bay at 

approximately 32°40.68′ N, 117°10.18′ 

W. The safety zone will encompass all 

navigable waters within 1200 feet of the 


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