30142 Federal Register / Vol. 63, No. 106 /Wednesday, June 3, 1998 /Rules and Regulations

§ 864.1860 Immunohistochemistry

reagents and kits.

(a) Identification.

Immunohistochemistry test systems

(IHC’s) are in vitro diagnostic devices

consisting of polyclonal or monoclonal

antibodies labeled with directions for

use and performance claims, which may

be packaged with ancillary reagents in

kits. Their intended use is to identify,

by immunological techniques, antigens

in tissues or cytologic specimens.

Similar devices intended for use with

flow cytometry devices are not

considered IHC’s.

(b) Classification of

immunohistochemistry devices—(1)

Class I (general controls). Except as

described in paragraphs (b)(2) and (b)(3)

of this section, these devices are exempt

from the premarket notification

requirements in part 807, subpart E of

this chapter. This exemption applies to

IHC’s that provide the pathologist with

adjunctive diagnostic information that

may be incorporated into the

pathologist’s report, but that is not

ordinarily reported to the clinician as an

independent finding. These IHC’s are

used after the primary diagnosis of

tumor (neoplasm) has been made by

conventional histopathology using

nonimmunologic histochemical stains,

such as hematoxylin and eosin.

Examples of class I IHC’s are

differentiation markers that are used as

adjunctive tests to subclassify tumors,

such as keratin.

(2) Class II (special control, guidance

document: ‘‘FDA Guidance for

Submission of Immunohistochemistry

Applications to the FDA,’’ Center for

Devices and Radiologic Health, 1998).

These IHC’s are intended for the

detection and/or measurement of certain

target analytes in order to provide

prognostic or predictive data that are

not directly confirmed by routine

histopathologic internal and external

control specimens. These IHC’s provide

the pathologist with information that is

ordinarily reported as independent

diagnostic information to the ordering

clinician, and the claims associated

with these data are widely accepted and

supported by valid scientific evidence.

Examples of class II IHC’s are those

intended for semiquantitative

measurement of an analyte, such as

hormone receptors in breast cancer.

(3) Class III (premarket approval).

IHC’s intended for any use not

described in paragraphs (b)(1) or (b)(2)

of this section.

(c) Date of PMA or notice of

completion of a PDP is required. As of

May 28, 1976, an approval under

section 515 of the Federal Food, Drug,

and Cosmetic Act is required for any

device described in paragraph (b)(3) of

this section before this device may be

commercially distributed. See § 864.3.

Dated: February 6, 1998.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 98–14605 Filed 6–2–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 100

[CGD 05–98–035]

RIN 2115–AE46

Special Local Regulations for Marine

Events; The Great Chesapeake Bay

Swim Event, Chesapeake Bay, MD

AGENCY: Coast Guard, DOT.

ACTION: Notice of implementation.

SUMMARY: This notice implements 33

CFR 100.507 for the Great Chesapeake

Bay Swim Event to be held on June 14,

1998. These special local regulations are

needed to provide for the safety of

participants and spectators on the

navigable waters during this event. The

effect will be to restrict general

navigation in the regulated area for the

safety of participants in the swim and

their attending personnel.

EFFECTIVE DATE: 33 CFR 100.507 is

effective from 10 a.m. until 4 p.m., on

June 14, 1998.

FOR FURTHER INFORMATION CONTACT:

LT J. Driscoll, Marine Events

Coordinator, Commander, Coast Guard

Activities Baltimore, 2401 Hawkins

Point Rd., Baltimore, MD 21226–1797,

(410) 576–2676.

SUPPLEMENTARY INFORMATION: The

March of Dimes will sponsor the Great

Chesapeake Bay Swim Event on

Chesapeake Bay in the vicinity of the

William P. Lane Jr. Memorial Twin

Bridges. Approximately 600 swimmers

will start from Sandy Point State Park

and swim between the William P. Lane

Jr. Memorial Twin Bridges to the

Eastern Shore. A large fleet of support

vessels will be accompanying the

swimmers. Therefore, to ensure the

safety of the participants and support

vessels, 33 CFR 100.507 will be in effect

for the duration of the event. Under

provisions of 33 CFR 100.507, no

vessels may enter the regulated area

without permission of the Coast Guard

patrol commander. Vessel traffic will be

permitted to transit the regulated area as

the swim progresses. As a result,

maritime traffic should not be

significantly disrupted.

Dated: May 20, 1998.

Roger T. Rufe, Jr.

Vice Admiral, U.S. Coast Guard Commander,

Fifth Coast Guard District.

[FR Doc. 98–14705 Filed 6–2–98; 8:45 am]

BILLING CODE 4910–15–M

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 100

[CGD01–98–057]

RIN 2115–AE46

Special Local Regulation: Fireworks

Displays Within the First Coast Guard

District

AGENCY: Coast Guard, DOT.

ACTION: Notice of Implementation.

SUMMARY: This document provides

notice of the dates and times of the

special local regulations contained in 33

CFR 100.114, Fireworks Displays

Within the First Coast Guard District.

All vessels will be restricted from

entering the area of navigable water

within a 500-yard radius of the

fireworks launch platform for each

event listed in the table below.

Implementation of these regulations is

necessary to control vessel traffic within

the regulated area to ensure the safety of

spectators.

EFFECTIVE DATE: The regulations in 33

CFR 100.114 are effective from one hour

before the scheduled start of the event

until thirty minutes after the last

firework is exploded for each event

listed in the table below. The events are

listed chronologically by month with

their corresponding number listed in the

special local regulations, 33 CFR

100.114.

ADDRESSES: Comments should be

mailed to Commander (osr), First Coast

Guard District, Captain John Foster

Williams Federal Building, 408 Atlantic

Ave., Boston, MA 02110–3350, or may

be hand delivered to Room 734 at the

same address, between 8 a.m. and 4

p.m., Monday through Friday, except

federal holidays. Comments will

become part of this docket and will be

available for inspection or copying at

the above address.

FOR FURTHER INFORMATION CONTACT:

Lieutenant Commander Mark A.

Cawthorn, Office of Search and Rescue

Branch, First Coast Guard District at

(617) 223–8460.

SUPPLEMENTARY INFORMATION: This

notice implements the special local
Federal Register / Vol. 63, No. 106 /Wednesday, June 3, 1998 /Rules and Regulations 30143

regulations in 33 CFR 100.114 (62 FR

30988; June 6, 1997). All vessels are

prohibited from entering a 500-yard

radius of navigable water surrounding

the launch platform used in each

fireworks display listed below.

Table 1—Fireworks Displays

May

1. Hull Memorial Day Festival, Date:

May 30, 1998, Time: 8 p.m. to 10 p.m.

Location: Off Nantasket Beach, Lat:

42°16.6′ N., Long: 070°51.5′ W. (NAD

1983)

June

2. Barnum Festival Fireworks, Date:

June 26, 1998, Time: 9 p.m. to 9:30

p.m., Location: Seaside Park,

Bridgeport Harbor, Lat: 43°11.5′ N.,

Long: 073°.09.5′ W. (NAD 1983)

Dated: May 24, 1998.

James D. Garrison,

Captain, U.S. Coast Guard, Acting

Commander, First Coast Guard District.

[FR Doc. 98–14703 Filed 6–2–98; 8:45 am]

BILLING CODE 4910–15–M

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 165

[CGD01–98–009]

RIN 2121–AA97

Safety Zone; Coney Island Air Show

Days, Coney Island Channel, Brooklyn,

New York

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is

establishing a temporary safety zone in

the vicinity of Coney Island Channel for

the Coney Island Air Show Days. The

safety zone is in effect from 10:30 a.m.

until 2:00 p.m. on June 5, 6, and 7, 1998.

This action is necessary to provide for

the safety of life on navigable waters

during the event. It is intended to

restrict vessel traffic approximately 1⁄2

mile from the beach at Coney Island,

NY.

DATES: This rule is effective from 10:30

a.m. until 2:00 p.m. on June 5, 6, and

7, 1998.

ADDRESSES: Comments may be mailed to

Commander (wob) (CGD01–98–009),

Coast Guard Activities New York, 212

Coast Guard Drive, Staten Island, New

York 10305–5005, or deliver them to

room 205 at the same address between

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

Friday, except Federal holidays.

The Waterways Oversight Branch of

Coast Guard Activities New York

maintains the public docket for this

rulemaking. Comments, and documents

as indicated in this preamble, will

become part of this docket and will be

available for inspection or copying in

room 205 at the same address between

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

Friday, except federal holidays.

FOR FURTHER INFORMATION CONTACT:

Lieutenant (Junior Grade) A. Kenneally,

Waterways Oversight Branch, Coast

Guard Activities New York, at (718)

354–4195.

SUPPLEMENTARY INFORMATION:

Regulatory History

Pursuant to 5 U.S.C. 553, a notice of

proposed rulemaking (NPRM) was not

published for this regulation. Good

cause exists for not publishing an NPRM

and for making this regulation effective

less than 30 days after Federal Register

publication. Due to the date this

application was received, there was

insufficient time to draft and publish an

NPRM. Any delay encountered in this

regulation’s effective date would be

contrary to public interest. Immediate

action is needed to close a portion of the

waterway and protect the maritime

public from the hazards associated with

this airshow, which is intended for

public entertainment.

Background and Purpose

Astroland Amusement Park has

submitted an Application for Approval

of Marine Event to hold the Coney

Island Air Show Days over the waters in

the vicinity of Coney Island Channel.

This regulation establishes a safety

zone, rectangular in shape; the borders

of which are marked by buoys in the

following positions:

Latitude Longitude

40° 34.03′ N 073° 59.81′ W, then

south to

40° 33.69′ N 073° 59.75′ W, then

east to

40° 33.94′ N 073° 57.19′ W, then

north to

40° 34.30′ N 073° 57.25′ W, then

west to the starting

point.

The safety zone is in effect from 10:30

a.m. until 2 p.m. June 5, 6, and 7, 1998.

The safety zone prevents vessels from

transiting an area adjacent to Coney

Island. This safety zone is needed to

provide unobstructed flight lines for the

U.S. Navy Blue Angels Jet

Demonstration Team and to protect

mariners from the hazards associated

with military aircraft flying high speed

maneuvers at low altitudes. No more

than 100 spectator crafts are expected

for the event.

Regulatory Evaluation

This 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 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 finding is

based on the following: pleasure craft

desiring to view the event will be able

to do so outside the safety zone;

commercial and recreational vessels

navigating Coney Island Channel can

alter their route south of the affected

area; the minimal time that vessels will

be restricted from the zone, and the

extensive advance notifications which

will be made.

Small Entities

Under the Regulatory Flexibility Act

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

considered whether this rule 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 governmental jurisdictions

with populations of less than 50,000.

For the reasons discussed in the

Regulatory Evaluation section above, the

Coast Guard certifies under section

605(b) of the Regulatory Flexibility Act

(5 U.S.C. 601 et seq.) that this rule will

not have a significant economic impact

on a substantial number of small

entities.

Collection of Information

This final rule does not provide for a

collection of information under the

Paperwork Reduction Act of 1995 (44

U.S.C. 3501 et seq.).

Federalism

The Coast Guard has analyzed this

final rule under the principles and

criteria contained in Executive Order

12612, and has determined that this

final rule does not have sufficient

implications for federalism to warrant

the preparation of a Federalism

Assessment.