49610 Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Rules and Regulations 

(6) For purposes of paragraph (f)(2) of 

this section, information will be 

considered newly acquired if it consists 

of data, analyses, or other information 

not previously submitted to the agency, 

which may include (but are not limited 

to) data derived from new clinical 

studies, reports of adverse events, or 

new analyses of previously submitted 

data (e.g., meta-analyses) if the studies, 

events or analyses reveal risks of a 

different type or greater severity or 

frequency than previously included in 

submissions to FDA. 

* * * * * 

PART 814—PREMARKET APPROVAL 

OF MEDICAL DEVICES 

■ 6. The authority citation for 21 CFR 

part 814 continues to read as follows: 

Authority: 21 U.S.C. 351, 352, 353, 360, 

360c–360j, 371, 372, 373, 374, 375, 379, 379e, 

381. 

■ 7. Section 814.3 is amended by adding 

paragraph (o) to read as follows: 

§ 814.3 Definitions. 

* * * * * 

(o) Newly acquired information means 

data, analyses, or other information not 

previously submitted to the agency, 

which may include (but are not limited 

to) data derived from new clinical 

studies, reports of adverse events, or 

new analyses of previously submitted 

data (e.g., meta-analyses) if the studies, 

events or analyses reveal risks of a 

different type or greater severity or 

frequency than previously included in 

submissions to FDA. 

■ 8. Section 814.39 is amended by 

revising paragraphs (d)(1) introductory 

text and (d)(2)(i) to read as follows: 

§ 814.39 PMA supplements. 

* * * * * 

(d)(1) After FDA approves a PMA, any 

change described in paragraph (d)(2) of 

this section to reflect newly acquired 

information that enhances the safety of 

the device or the safety in the use of the 

device may be placed into effect by the 

applicant prior to the receipt under 

§ 814.17 of a written FDA order 

approving the PMA supplement 

provided that: 

* * * * * 

(2) * * * 

(i) Labeling changes that add or 

strengthen a contraindication, warning, 

precaution, or information about an 

adverse reaction for which there is 

reasonable evidence of a causal 

association. 

* * * * * 

Dated: August 19, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–19572 Filed 8–21–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket No. USCG–2008–0424] 

Special Local Regulation; U.S. 

Nationals Waterski Racing 

Championship; Mission Bay, San 

Diego, CA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

the U.S. Nationals Waterski Racing 

Championship special local regulation 

on Mission Bay from 8 a.m. on October 

10, 2008 through 5 p.m. on October 12, 

2008. This action is necessary to 

provide for the safety of the 

participants, crew, spectators, 

participating vessels, and other vessels 

and users of the waterway. During the 

enforcement period, no person or vessel 

may enter the special local regulation 

without permission of the Captain of the 

Port. 

DATES: The regulations in 33 CFR 

100.1101 will be enforced from 8 a.m. 

on October 10, 2008 through 5 p.m. on 

October 12, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Petty Officer Kristen Beer, USCG, 

Waterways Management, U.S. Coast 

Guard Sector San Diego at (619) 278–

7233. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the special local 

regulation for the U.S. Nationals 

Waterski Racing Championship in 33 

CFR 100.1101 on October 10, 2008, from 

8 a.m. to 7 p.m., October 11, 2008, from 

8 a.m. to 7 p.m., and October 12, 2008, 

from 8 a.m. to 7 p.m. 

Under the provisions of 33 CFR 

100.1101, a vessel may not enter the 

regulated area, unless it receives 

permission from the COTP. Spectator 

vessels may safely transit outside the 

regulated area but may not anchor, 

block, loiter in, or impede the transit of 

participants or official patrol vessels. 

The Coast Guard may be assisted by 

other Federal, State, or local law 

enforcement agencies in enforcing this 

regulation. 

This notice is issued under authority 

of 33 CFR 100.1101(a) and 5 U.S.C. 

552(a). In addition to this notice in the 

Federal Register, the Coast Guard will 

provide the maritime community with 

extensive advance notification of this 

enforcement period via the Local Notice 

to Mariners, marine information 

broadcasts, local radio stations and area 

newspapers. If the COTP or his 

designated representative determines 

that the regulated area need not be 

enforced for the full duration stated in 

this notice, he or she may use a 

Broadcast Notice to Mariners to grant 

general permission to enter the 

regulated area. 

Dated: August 8, 2008. 

T.H. Farris, 

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

Port Sector San Diego. 

[FR Doc. E8–19532 Filed 8–21–08; 8:45 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2008–0769] 

Oregon Symphony Celebration 

Fireworks Display, Portland, OR 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

the ‘‘Oregon Symphony Celebration 

Fireworks Display safety zone on the 

Willamette River’’; from 8:30 p.m. 

through 11:30 p.m. on August 28, 2008. 

This action is necessary to provide a 

safe display for the public and to keep 

them clear of the fall out area of the 

fireworks. During the enforcement 

period, no person or vessel may enter 

the safety zone without permission of 

the Captain of the Port Portland or his 

designated representative. 

DATES: The regulations in 33 CFR 

165.1315(a)(7) will be enforced from 

8:30 p.m. through 11:30 p.m. on August 

28, 2008. 

FOR FURTHER INFORMATION CONTACT: BM2 

Joshua Lehner, Sector Portland 

Waterways Management at (503) 247–

4015. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the safety zone for 

the Oregon Symphony Celebration 

Fireworks Display in 33 CFR 

165.1315(a)(7) on August 28, 2008 from 

8:30 p.m. to 11:30 p.m. 


yshivers on PROD1PC62 with RULES
Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Rules and Regulations 49611 

Under the provisions of 33 CFR 

165.1315, a vessel may not enter the 

regulated area, unless it receives 

permission from the Captain of the Port 

(COTP) or his designated representative. 

The Coast Guard may be assisted by 

other Federal, state, or local law 

enforcement agencies in enforcing this 

regulation. 

This notice is issued under authority 

of 33 CFR 165.1315 and 5 U.S.C. 552(a). 

In addition to this notice in the Federal 

Register, the Coast Guard will provide 

the maritime community with advance 

notification of this enforcement period 

via the Local Notice to Mariners and a 

marine information broadcast. If the 

COTP determines that the regulated area 

need not be enforced for the full 

duration stated in this notice, he may 

use a Broadcast Notice to Mariners to 

grant general permission to enter the 

regulated area. 

Dated: August 13, 2008. 

F.G. Myer, 

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

Port Portland. 

[FR Doc. E8–19531 Filed 8–21–08; 8:45 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[USCG–2008–0759] 

RIN 1625–AA00 

Safety Zone; American Music Festival; 

Chesapeake Bay, Virginia Beach, VA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a 420-foot radius safety 

zone on the Chesapeake Bay in the 

vicinity of the Virginia Beach 

Oceanfront, Virginia Beach, VA in 

support of the American Music Festival 

Fireworks event. This action is intended 

to protect mariners from the hazards 

associated with fireworks displays by 

restricting vessel traffic movement in 

the vicinity of the event. 

DATES: This rule is effective from 

August 29, 2008 at 10 p.m. until August 

31, 2008 at 11 p.m. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket USCG–2008–

0759 and are available online at 

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

also available for inspection or copying 

in 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 Sector 

Hampton Roads, Norfolk Federal 

Building, 200 Granby St., 7th Floor, 

Norfolk, VA 23510 between 9 a.m. and 

2 p.m., Monday through Friday, except 

Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

rule, call LT Tiffany Duffy, Chief 

Waterways Management Division, 

Sector Hampton Roads at (757) 668–

5580. 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 only be enforced for 1 hour on 

August 29, 2008 and for 1 hour on 

August 31, 2008 and should have 

minimal impact on vessel transits due to 

the fact that vessels can safely transit 

through the zone when authorized by 

the Captain of the Port or his 

Representative and that they are not 

precluded from using any portion of the 

waterway except the safety zone area 

itself. For the same reasons above, 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. 

Background and Purpose 

On August 29 and August 31, 2008, 

Dominion Fireworks will sponsor a 

fireworks display on the Chesapeake 

Bay shoreline centered on position 

36°49′58′′ N/75°57′57′′ W (NAD 1983). 

Due to the need to protect mariners and 

spectators from the hazards associated 

with the fireworks display, access will 

be temporarily restricted within 420 feet 

of the fireworks launch site. 

Discussion of Rule 

The Coast Guard is establishing a 

safety zone on the navigable waters of 

the Chesapeake Bay within 420 feet of 

position 36°49′58′′ N/075°57′57′′ W 

(NAD 1983). This safety zone will be 

established in the vicinity of Virginia 

Beach, VA on August 29, 2008 at 10 

p.m. to August 31, 2008 at 11 p.m. In 

the interest of public safety, access to 

the safety zone will be restricted from 

10 p.m. to 11 p.m. on August 29, 2008 

and from 10 p.m. to 11 p.m. on August 

31, 2008. Except for participants and 

vessels authorized by the Coast Guard 

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. 


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