Federal Register / Vol. 62, No. 171 / Thursday, September 4, 1997 / Rules and Regulations 46669

basis for approval is discussed in the

freedom of information summary.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

9 a.m. and 4 p.m., Monday to Friday.

The agency has determined under 21

CFR 25.24(d)(1)(i) that this action is of

a type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

List of Subjects in 21 CFR Part 520

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 part 520 is amended as follows:

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

2. Section 520.447 is amended by

revising paragraph (b) to read as follows:

§ 520.447 Clindamycin hydrochloride

liquid.

* * * * *

(b) Sponsor. See No. 000009 in

§ 510.600(c) of this chapter for use as in

paragraphs (c) and (d) of this section.

See No. 059130 for use as in paragraph

(c) of this section.

* * * * *

Dated: August 22, 1997.

Michael J. Blackwell,

Deputy Director, Center for Veterinary

Medicine.

[FR Doc. 97–23450 Filed 9–3–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 100

[CGD 05–97–007]

RIN 2115–AE46

Special Local Regulations for Marine

Events; Norfolk Harbor, Elizabeth

River, Norfolk, Virginia and

Portsmouth, Virginia

AGENCY: Coast Guard, DOT.

ACTION: Final rule.

SUMMARY: The Coast Guard is amending

permanent special local regulations

established for marine events held in

the Norfolk Harbor, Elizabeth River,

between Norfolk and Portsmouth,

Virginia, by identifying specific annual

events for which the regulated area will

be in effect. This rule updates the

regulation in order to enhance the safety

of life and property during the events.

EFFECTIVE DATE: This final rule is

effective on June 6, 1997.

FOR FURTHER INFORMATION CONTACT: S.L.

Phillips, Project Manager, Search and

Rescue Branch, at (757) 398–6204.

SUPPLEMENTARY INFORMATION:

Regulatory History

On February 21, 1997, the Coast

Guard published a notice of proposed

rulemaking entitled Special Local

Regulations for Marine Events; Norfolk

Harbor, Elizabeth River, Norfolk,

Virginia and Portsmouth, Virginia, in

the Federal Register (62 FR 7969). The

Coast Guard received no comments on

the proposed rulemaking. No public

hearing was requested, and none was

held. The final rule was inadvertently

published as a quarterly on 8 August

1997 (62 FR 42671).

Background and Purpose

33 CFR 100.501 established special

local regulations for marine events held

in the Norfolk Harbor, Elizabeth River,

between Norfolk and Portsmouth,

Virginia. The effect of these regulations

is the control of vessel traffic during

marine events to enhance the safety of

participants, spectators, and transiting

vessels. The regulations are

implemented at various times, for

various events throughout the year by

publishing notice in the Federal

Register and the Fifth Coast Guard

District Local Notice to Mariners. This

rule updates the regulations to reflect

specific events for which the regulated

area will be in effect.

Discussion of Comments and Changes

The Coast Guard received no

comments on the proposed rulemaking;

however, the Coast Guard has learned

that the sponsoring organization for the

Harborfest event will be Festevents, Ltd.

Therefore, Table 1 of the proposed rule

has been amended to reflect this change.

Good Cause Statement

This final rule is effective in less than

30 days because it is contrary to the

public interest to delay the effective

date because timely action is required to

protect vessel traffic and event

participants during these events.

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

final rule to be so minimal that a full

Regulatory Evaluation under paragraph

10e of the regulatory policies and

procedures of DOT is unnecessary. This

rule merely changes the effective period

of an existing regulation and does not

impose any new restrictions on vessel

traffic.

Small Entities

Under the Regulatory Flexibility Act

(5 U.S.C. 601 et seq.), 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).

This rule does not impose any new

restrictions on vessel traffic, but merely

changes the effective period of the

regulation. Therefore, the Coast Guard

certifies under Section 605(b) of the

Regulatory Flexibility Act ( 5 U.S.C. 601

et seq.) that this final rule will not have

a significant economic impact on a

substantial number of small entities.

Collection of Information

This final rule contains no collection

of information requirement under the

Paperwork Reduction Act of 1995 (44

U.S.C. 3501 et seq.).
46670 Federal Register / Vol. 62, No. 171 / Thursday, September 4, 1997 / Rules and Regulations

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 section

2.b.2.e(34)(h) of Commandant

Instruction M16475.1b (as amended, 61

FR 13564; 27 March 1996), this rule is

categorically excluded from further

environmental documentation.

List of Subjects in 33 CFR Part 100

Marine safety, Navigation (water),

Reporting and recordkeeping

requirements, Waterways.

For the reasons set out in the

preamble, the Coast Guard amends 33

CFR part 100 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.

2. Section 100.501 is amended by

revising paragraph (c) and adding Table

1 to read as follows:

§ 100.501 Norfolk Harbor, Elizabeth River,

Norfolk, Virginia and Portsmouth, Virginia.

* * * * *

(c) Effective periods. This section is

effective annually for the duration of

each marine event listed in Table 1, or

as otherwise specified in the Coast

Guard Local Notice to Mariners and a

Federal Register notice. The Coast

Guard Patrol Commander will announce

by Broadcast Notice to Mariners the

specific time periods during which the

regulations will be enforced.

TABLE 1 OF § 100.501

Harborfest:

Sponsor: Festevents, Ltd.

Date: First Friday, Saturday, and Sunday

in June

Great American Picnic:

Sponsor: Festevents, Ltd.

Date: July 4

Cock Island Race:

Sponsor: Ports Events, Inc.

Date: Third Saturday in July

Rendezvous at Zero Mile Marker:

Sponsor: Ports Events, Inc.

Date: Third Saturday in August

US Navy Fleet Week Celebration:

Sponsor: U.S. Navy

Date: Second Friday in October

Holidays in the City:

TABLE 1 OF § 100.501—Continued

Sponsor: Festevents, Ltd.

Date: Fourth Saturday in November

New Years Eve Fireworks Display:

Sponsor: Festevents, Ltd.

Date: December 31

Dated: May 30, 1997.

Roger T. Rufe, Jr.,

Vice Admiral, U.S. Coast Guard Commander,

Fifth Coast Guard District.

[FR Doc. 97–23445 Filed 9–3–97; 8:45 am]

BILLING CODE 4910–14–M

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 165

[CGD01–97–089]

RIN 2115–AA97

Safety Zone: Harbor Festival Fireworks

Display, Greenport, NY

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is

establishing a temporary safety zone,

September 27, 1997, for the Harbor

Festival Fireworks Display to be held in

Greenport Harbor, Greenport, NY. This

temporary safety zone is needed to

protect persons, facilities, vessels and

others in the maritime community from

the safety hazards associated with this

fireworks display. Entry into this safety

zone is prohibited unless authorized by

the Capital of the Port or the Coast

Guard Patrol Commander.

EFFECTIVE DATE: This regulation is

effective September 27, 1997, from 8:45

p.m. until 10:15 p.m.

ADDRESSES: Documents relating to this

temporary final rule are available for

inspection and copying at U.S. Coast

Guard Group Long Island Sound, 120

Woodward Ave., New Haven, CT 06512.

Normal office hours are between 8:00

a.m. and 4:00 p.m., Monday through

Friday, except holidays. Comments may

also be faxed to this address. Our fax

number is (203) 468–4445.

FOR FURTHER INFORMATION CONTACT:

Lieutenant Commander T.J. Walker,

Chief of Port Operations, Captain of the

Port, Long Island Sound at (203) 468–

4444.

SUPPLEMENTARY INFORMATION:

Regulatory History

Pursuant to 5 U.S.C. 553, good cause

exists for not publishing a notice of

proposed rulemaking (NPRM) and for

making this rule effective in less than 30

days after Federal Register publication.

The sponsor of the event did not

provide the Coast Guard with the final

details for the event in sufficient time to

publish a NPRM or a final rule 30 days

in advance. The delay encountered if

normal rulemaking procedures were

followed would effectively cancel the

event. Cancellation of this event is

contrary to the public interest since the

fireworks display is for the benefit of the

public.

Background and Purpose

The sponsor, East End Maritime

Museum, of Greenport, NY, requested

that a fireworks display be permitted in

Greenport Harbor, Greenport, NY. This

regulation establishes a temporary safety

zone in all waters of Greenport Harbor

within a 600 foot radius of the fireworks

barges. The safety zone is in effect on

September 27, 1997, from 8:45 p.m.

until 10:15 p.m. and is necessary to

protect the maritime community from

the safety hazards associated with this

fireworks display. Entry into or

movement within this zone will be

prohibited unless authorized by the

Captain of the Port or the Coast Guard

Patrol Commander.

Regulatory Evaluation

This temporary final 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 not been reviewed 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.

Entry into this zone will be restricted for

a brief period of time on September 27,

1997, the effect of this regulation will

not be significant for several reasons:

the duration of the event is limited; the

event is at a late hour; and extensive,

advance maritime advisories will be

made.

Small Entities

Under the Regulatory Flexibility Act

(5 U.S.C. 601 et seq.), the Coast Guard

considers whether this proposal will

have a significant economic impact on

a substantial number of small entities.

Small entities include small businesses,

not-for-profit organizations that are

independently owned and operated and

are not dominant in their fields, and