Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Rules and Regulations 9767 

List of Subjects 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

21 CFR Part 529 

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 parts 510 and 529 are amended as 

follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 510 continues to read as follows: 

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

353, 360b, 371, 379e. 

■ 2. In § 510.600, in the table in 

paragraph (c)(1) alphabetically add an 

entry for ‘‘Medical Developments 

International, Ltd.’’; and in the table in 

paragraph (c)(2) numerically add an 

entry for ‘‘025245’’ 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 

* * * * * 

Medical Developments 

International, Ltd.,P.O. 

Box 21, Sandown Village, 3171 VIC Australia 

025245 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

025245 ......... Medical Developments 

International, Ltd.,P.O. 

Box 21, Sandown Village, 3171 VIC Australia 

* * * * * 

* * * * * 

PART 529—CERTAIN OTHER DOSAGE 

FORM NEW ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 529 continues to read as follows: 

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

■ 4. Add § 529.1455 to read as follows: 

§ 529.1455 Methoxyflurane. 

(a) Specifications. Methoxyflurane 

liquid. 

(b) Sponsor. See No. 025245 in 

§ 510.600 of this chapter. 

(c) Conditions of use—(1) Amount. 

The amount of methoxyflurane used 

depends on the weight of the patient, 

the depth of anesthesia, and the type of 

equipment used. Anesthesia may be 

induced with methoxyflurane alone, or 

by the intravenous administration of a 

short-acting general anesthetic or by 

inhalation of another anesthetic agent. 

(2) Indications for use. For the 

induction and maintenance of general 

anesthesia. 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

Dated: March 3, 2009. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. E9–4758 Filed 3–5–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2009–0026] 

Drawbridge Operation Regulation; 

Park Street Drawbridge, Oakland Inner 

Harbor, Alameda, CA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: The Commander, Eleventh 

Coast Guard District, has issued a 

temporary deviation from the regulation 

governing the operation of the Park 

Street drawbridge across the Oakland 

Inner Harbor, mile 5.2, at Alameda, CA. 

The deviation is necessary to allow 

seismic retrofitting of the bridge. This 

deviation allows single leaf operation of 

the double leaf, bascule style 

drawbridge, during the deviation 

period. 

DATES: This deviation is effective from 

12:01 a.m. on February 1, 2009 until 

11:59 p.m. on May 31, 2009. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of the docket USCG– 

2009–0026 and are available online at 

http://www.regulations.gov. They are 

also available for inspection or copying 

at two locations: 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, and the 

Commander (dpw), Eleventh Coast 

Guard District, Building 50–2, Coast 

Guard Island, Alameda, CA 94501– 

5100, between 8 a.m. and 4 p.m., 

Monday through Friday, except Federal 

holidays. 

FOR FURTHER INFORMATION CONTACT: 

David H. Sulouff, Chief, Bridge Section, 

Eleventh Coast Guard District, 

telephone (510) 437–3516. If you have 

questions on viewing the docket, call 

Renee Wright, Program Manager, Docket 

Operations, telephone (202) 366–9826. 

SUPPLEMENTARY INFORMATION: The 

County of Alameda requested a 

temporary change to the operation of the 

Park Street drawbridge across the 

Oakland Inner Harbor, mile 5.2, at 

Alameda, CA. The Park Street 

drawbridge navigation span provides a 

horizontal clearance of 241 feet between 

pier fenders. During single leaf 

operation, horizontal clearance is 

reduced to approximately 100 feet. The 

drawbridge provides a vertical clearance 

of 15 feet above Mean High Water in the 

closed-to-navigation position and 

unlimited vertical clearance in the 

open-to-navigation position. As required 

by 33 CFR 117.181, the draw shall open 

on signal; except that, from 8 a.m. to 9 

a.m. and 4:30 p.m. to 6:30 p.m. Monday 

through Friday except Federal holidays, 

the draw need not be opened for the 

passage of vessels. However, the draw 

shall open during the above closed 

periods for vessels which must, for 

reasons of safety, move on a tide or 

slack water, if at least two hours notice 

is given. The waterway is navigated by 

commercial, recreational, emergency 

and law enforcement vessels. 

Between the hours of 7 a.m. and 9 

p.m. Monday through Thursday, and 

between the hours of 7 a.m. and 3:30 

p.m. on Friday, the drawspan will be 

operated, one leaf at a time, while the 

opposite leaf, counterweight and hinges 

are seismically retrofitted. The 

drawbridge will be operated in the 

normal double leaf operation mode at 

night and on weekends, when work is 

not actually being performed on the 

bridge. The starting and ending dates for 

the project are from 12:01 a.m. on 

February 1, 2009 until 11:59 p.m. on 

May 31, 2009. This temporary deviation 

has been coordinated with the waterway 

users. The largest tug and barge 

combination on the waterway will be 

able to continue navigating safely 

through the bridge. Recreational and 

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9768 Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Rules and Regulations 

other waterway traffic will not be 

negatively impacted by the project. 

Vessels that can transit the bridge, 

while in the closed-to-navigation 

position, may continue to do so at any 

time. 

In accordance with 33 CFR 117.35(e), 

the drawbridge must return to its regular 

operating schedule immediately at the 

end of the designated time period. This 

deviation from the operating regulations 

is authorized under 33 CFR 117.35. 

Dated: January 30, 2009. 

P.F. Zukunft, 

Rear Admiral, U.S. Coast Guard, Commander, 

Eleventh Coast Guard District. 

[FR Doc. E9–4811 Filed 3–5–09; 8:45 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2008–0440] 

RIN 1625–AA87 

Security Zone; Coast Guard Base San 

Juan, San Juan Harbor, PR 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is 

establishing a permanent security zone 

of 100 yards around the Coast Guard 

Base in San Juan, Puerto Rico. The 

security zone is needed for national 

security reasons to protect the public 

and the Coast Guard base from potential 

subversive acts. This rule would 

exclude entry into the security zone by 

all vessels and personnel without 

permission of the U.S. Coast Guard 

Captain of the Port San Juan (COTP). 

DATES: This rule is effective April 6, 

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–2008–0440 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– 

2008–0440 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 two locations: 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 and the USCG 

Sector San Juan, Prevention Operations 

Department, 5 Calle La Puntilla, San 

Juan, Puerto Rico 00901 between 7:30 

a.m. and 3 p.m., Monday through 

Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call 

Lieutenant Junior Grade Rachael Love of 

Sector San Juan, Prevention Operations 

Department at (787) 289–2071. 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 September 30, 2008, we published 

a notice of proposed rulemaking 

(NPRM) entitled Security Zone; Coast 

Guard Base San Juan, San Juan Harbor, 

Puerto Rico in the Federal Register (73 

FR 56773). We received no letters 

commenting on the proposed rule. No 

public meeting was requested, and none 

was held. 

Background and Purpose 

The Coast Guard docking facilities at 

La Puntilla in Old San Juan are home to 

six Coast Guard cutters and six Coast 

Guard small boats. Incidents of 

unknown vessels mooring up to the 

Coast Guard piers have occurred twice 

in the past year. In addition, suspected 

surveillance in the form of photography 

has been performed by unknown 

individuals located in close proximity 

to the Coast Guard base on more than 

one occasion. These incidents pose a 

potential threat to national security and 

may lead to subversive acts against the 

personnel or equipment located at the 

Coast Guard base. 

This rulemaking attempts to solve the 

problem by prohibiting all persons and 

vessels from entering in, transiting 

through or remaining in a security zone 

extending 100 yards seaward from the 

water’s edge of the Coast Guard La 

Puntilla facility. 

Discussion of Comments and Changes 

No comments were received as a 

result of publishing the NPRM; therefore 

no changes have been made to the 

regulatory text. 

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 a significant 

regulatory action because the security 

zone only extends 100 yards from Base 

San Juan and does not impede any 

regular vessel traffic (i.e., cruise ships, 

ferries, small passenger vessels, etc.). 

Vessels will be able to transit safely 

around the zone. In the event that a 

vessel or person feels the need to 

temporarily transit through the 

proposed security zone, the COTP will 

handle the requests on a case-by-case 

basis. 

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 would affect the following 

entities, some of which might be small 

entities: The owners or operators of 

vessels intending to transit or anchor in 

the proposed zone. The impact would 

not be economically significant because 

vessels would be able to transit around 

the zone. The zone does not encompass 

any portions of any shipping channels 

and would only affect those vessels 

transiting the area adjacent to the Coast 

Guard facility. 

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. 

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 

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