40652 Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 /Rules and Regulations

purposes to apply pressure to prominent

regions of an infant’s cranium in order

to improve cranial symmetry and/or

shape in infants from 3 to 18 months of

age, with moderate to severe

nonsynostotic positional plagiocephaly,

including infants with plagiocephalic-,

brachycephalic-, and scaphocephalicshaped heads.

(b) Classification. Class II (special

controls) (prescription use in

accordance with § 801.109 of this

chapter, biocompatibility testing, and

labeling (contraindications, warnings,

precautions, adverse events,

instructions for physicians and

parents)).

Dated: July 21, 1998.

Elizabeth D. Jacobson,

Deputy Director for Science, Center for

Devices and Radiological Health.

[FR Doc. 98–20308 Filed 7–29–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 100

[CGD 05–98–063]

RIN 2115–AE 46

Special Local Regulations for Marine

Events; Prospect Bay, Maryland

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: Temporary special local

regulations are being adopted for the

‘‘Thunder on the Narrows’’ hydroplane

races to be held on the waters of

Prospect Bay near Kent Narrows,

Maryland. These regulations are needed

to protect boaters, spectators and

participants from the dangers associated

with the event. This action is intended

to enhance the safety of life and

property during the event.

DATES: This temporary final rule is

effective from 12 p.m. EDT (Eastern

Daylight Time) to 6 p.m. EDT on August

1 and August 2, 1998.

FOR FURTHER INFORMATION CONTACT:

Chief Warrant Officer R. Houck, Marine

Events Coordinator, Commander, Coast

Guard Activities Baltimore, 2401

Hawkins Point Road, Baltimore

Maryland, 21226–1791, telephone

number (410) 576–2674.

SUPPLEMENTARY INFORMATION:

Regulatory History

In accordance with 5 U.S.C. 553, a

notice of proposed rulemaking was not

published for this regulation and good

cause exists for making it effective less

than 30 days after Federal Register

publication. The application for this

event was not received until June 24,

1998. Following normal rulemaking

procedures would have been

impractical since there is not sufficient

time remaining to publish a proposed

rule in advance of the event or to

provide for a delayed effective date.

Immediate action is needed to protect

vessel traffic from the potential hazards

associated with congested waterways.

Background and Purpose

The Kent Narrows Racing Association

has submitted a marine event

application to the U.S. Coast Guard for

the ‘‘Thunder on the Narrows’’

hydroplane races, to be held on the

waters of Prospect Bay on August 1 and

2, 1998. The event will consist of 75

hydroplanes racing in heats counterclockwise around an oval race course. A

large fleet of spectator vessels is

anticipated. Due to the need for vessel

control during the races, vessel traffic

will be temporarily restricted to provide

for the safety of spectators, participants

and transiting vessels.

Discussion of Regulations

The Coast Guard will establish

temporary special local regulations on

specified waters of Prospect Bay. The

temporary special local regulations will

be in effect from 12 p.m. EDT (Eastern

Daylight Time) to 6 p.m. EDT on August

1 and 2, 1998, and will restrict general

navigation in the regulated area during

the event. Except for persons or vessels

authorized by the Coast Guard Patrol

Commander, no person or vessel may

enter or remain in the regulated area.

These regulations are needed to control

vessel traffic during the marine event to

enhance the safety of participants,

spectators, and transiting vessels.

Regulatory Evaluation

This rule is not a significant

regulatory action under section 3(f) of

Executive Order 12866 and does not

require an assessment of potential costs

and benefits under section 6(a)(3) of that

order. It has been exempted from review

by the office of Management and Budget

under that order. It is not significant

under the regulatory policies and

procedures of the Department of

Transportation (DOT) (44 FR 11040;

February 26, 1979). The Coast Guard

expects the economic impact of this rule

to be so minimal that a full Regulatory

Evaluation under paragraph 10e of the

regulatory policies and procedures of

DOT is unnecessary. This conclusion is

based on the fact that the regulated areas

will only be in effect for a limited

amount of time, and extensive

advisories have been and will be made

to the affected Maritime Community so

that they may adjust their schedules

accordingly.

Small Entities

Under the Regulatory Flexibility Act

(5 U.S.C. 601–612), the Coast Guard

must consider whether this rule will

have a significant economic impact on

a substantial number of small entities.

‘‘Small entities’’ include independently

owned and operated small businesses

that are not dominant in their field and

that otherwise qualify as ‘‘small

business concerns’’ under section 3 of

the Small Business Act (15 U.S.C. 632).

Because it expects the impact of this

rule to be minimal, the Coast Guard

certifies under 5 U.S.C. 605(b) that this

temporary final rule will not have a

significant economic impact on a

substantial number of small entities

because of the event’s short duration.

Collection of Information

These regulations contain no

Collection of Information requirements

under the Paperwork Reduction Act (44

U.S.C. 3501–3520).

Federalism

The Coast Guard has analyzed this

rule under the principles and criteria

contained in Executive Order 12612 and

has determined that this rule does not

have sufficient federalism implications

to warrant the preparation of a

Federalism Assessment.

Environment

The Coast Guard considered the

environmental impact of this rule and

concluded that, under figure 2–1,

paragraph (34)(h) of COMDTINST

M16475.1C, this rule is categorically

excluded from further environmental

documentation. Special local

regulations issued in conjunction with a

regatta or marine parade are excluded

under that authority.

List of Subjects in 33 CFR Part 100

Marine Safety, Navigation (water),

Reporting and recordkeeping

requirements, Waterways.

Temporary Regulations

In consideration of the foregoing, Part

100 of Title 33, Code of Federal

Regulations is amended as follows:

PART 100—[AMENDED]

1. The authority citation for Part 100

continues to read as follows:

Authority: 33 U.S.C. 1233; 49 CFR 1.46 and

33 CFR 100.35.
Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 /Rules and Regulations 40653

2. A temporary section, § 100.35–T05–

063 is added to read as follows:

§ 100.35–T05–063 Prospect Bay, Maryland.

(a) Definitions.

(1) Regulated area. The waters of

Prospect Bay, between Kent Island and

Hog Island enclosed by:

Latitude Longitude

38°57′52.0′′ North 76°14′48.0′′ West, to

38°58′02.0′′ North 76°15′05.0′′ West, to

38°57′38.0′′ North 76°15′29.0′′ West, to

38°57′28.0′′ North 76°15′23.0′′ West, to

38°57′52.0′′ North 76°14′48.0′′ West

[Datum: NAD 1983]

(2) Coast Guard Patrol Commander.

The Coast Guard Patrol Commander is

a commissioned, warrant, or petty

officer of the Coast Guard who has been

designated by the Commander, Coast

Guard Activities Baltimore.

(b) Special local regulations. (1) All

persons and/or vessels not authorized as

participants or official patrol vessels are

considered spectators. The ‘‘official

patrol’’ consists of any Coast Guard,

public, state, county or local law

enforcement vessels assigned and/or

approved by Commander, Coast Guard

Activities Baltimore.

(2) Except for persons or vessels

authorized by the Coast Guard Patrol

Commander, no person or vessel may

enter or remain in the regulated area.

(3) The operator of any vessel in this

area shall:

(i) Stop the vessel immediately when

directed to do so by any official patrol,

including any commissioned, warrant,

or petty officer on board a vessel

displaying a Coast Guard ensign.

(ii) Proceed as directed by any official

patrol, including any commissioned,

warrant, or petty officer on board a

vessel displaying a Coast Guard ensign.

(c) Effective dates. This section is

effective from 12 p.m. EDT (Eastern

Daylight Time) to 6 p.m. EDT on August

1 and 2, 1998.

Dated: July 14, 1998.

Roger T. Rufe, Jr.,

Vice Admiral, U.S. Coast Guard Commander,

Fifth Coast Guard District.

[FR Doc. 98–20418 Filed 7–29–98; 8:45 am]

BILLING CODE 4910–15–M

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 117

[CGD08–94–028]

RIN 2115–AE47

Drawbridge Operating Regulation;

Kelso Bayou, LA

AGENCY: Coast Guard, DOT.

ACTION: Final rule.

SUMMARY: The Coast Guard is changing

the regulation governing the operation

of the State Route 27 swing span

drawbridge across Kelso Bayou, mile

0.7, at Hackberry, Cameron Parish,

Louisiana. The change requires four

hours advance notification at night from

May 20 through December 22. The

change will increase the advance

notification from four hours to 24 hours

from December 23 through May 19. This

action provides relief to the bridge

owner and still provides for the

reasonable needs of navigation.

DATES: This rule is effective August 31,

1998.

ADDRESSES: Unless otherwise indicated,

documents referred to in this notice are

available for inspection or copying at

the office of the Eighth Coast Guard

District, Bridge Administration Branch,

Hale Boggs Federal Building, room

1313, 501 Magazine Street, New

Orleans, Louisiana 70130–3396 between

7 a.m. and 4 p.m., Monday through

Friday, except Federal holidays. The

telephone number is (504) 589–2965.

Commander (ob) maintains the public

docket for this rulemaking.

FOR FURTHER INFORMATION CONTACT:

Mr. David Frank, Bridge Administration

Branch, telephone number 504–589–

2965.

SUPPLEMENTARY INFORMATION:

Regulatory History

On October 4, 1994, the Coast Guard

published a notice of proposed

rulemaking (NPRM) in the Federal

Register (59 FR 50528). The NPRM

proposed a change to the advance

notification required prior to opening

the bridge.

The Coast Guard received four letters

in response to the NPRM. One of the

letters was from a business owner

whose business was dependent upon

access by waterway users to deliver

their product to his facility. He stated

that the change would force a closure of

his business. The applicant and the

bridge owner began discussions to

attempt to resolve their differences, but

were unable to reach any agreement.

Since that time, the business owner has

sold his business. Subsequently, the

business closed completely. The

Louisiana Department of Transportation

and Development (LDOTD) resubmitted

a proposal requesting a new operating

schedule.

On April 15, 1998, the Coast Guard

published a Supplemental Notice of

Proposed Rulemaking entitled

Drawbridge Operation Regulation; Kelso

Bayou, LA in the Federal Register (63

FR 18350). The Coast Guard received

one letter commenting on the proposal.

A public hearing was not requested and

one was not held.

Background and Purpose

The Kelso Bayou bridge is a 406-foot

long structure. Navigational clearances

provided by the bridge are 9.1 feet

vertical above mean high water in the

closed position and unlimited in the

open position. Horizontal clearance is

50 feet. Navigation on the waterway

consists mainly of small and large

fishing boats and occasional small oil

field work boats.

LDOTD requested the new regulation

because of a decline in vessel traffic that

passes the Kelso Bayou bridge at

Hackberry during certain times of the

year. The rule allows the bridge owner

relief from having a person available at

the bridge site during the periods when

vessel traffic is less frequent. This rule

creates a saving to the taxpayer while

still serving the reasonable needs of

navigational interests.

The regulation requires that from May

20, through October 31, the draw opens

on signal from 7 a.m. until 7 p.m. From

7 p.m. until 7 a.m., the draw opens on

signal if at least four hours notice is

given. From November 1, through

December 22, the draw opens on signal

from 7 a.m. to 3 p.m. From 3 p.m. to 7

a.m., the draw opens on signal if at least

four hours notice is given. From

December 23, through May 19, the draw

opens on signal if at least 24 hours

notice is given. Alternate routes are

available.

Data provided by LDOTD show that

from January 1, through December 31,

1997, the number of vessels that passed

the bridge totaled 803. Between January

1, and May 20, the bridge opened a total

of 13 times for the passage of vessels.

Due to the limited number of openings,

LDOTD requested an increase in

notification from four hours to 24 hours

between December 23, and May 19.

Between May 20, and October 31, the

bridge open 682 times for the passage of

vessels. Between November 1, and

December 31, the bridge opened 108

times for the passage of vessels. Of the

803 openings, 579 occurred between the