70304 Federal Register / Vol. 65, No. 226 / Wednesday, November 22, 2000 / Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 00–ASO–41]

Amendment of Class E Airspace; New

Bern, NC

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Final rule.

SUMMARY: This action amends the Class

E2 airspace at New Bern, NC, from

continuous to part time. A Federal

Contract Tower is operational at Craven

County Regional Airport, NC. Class D

airspace has been established for the

airport during the tower hours of

operation. Therefore, the Class E2

airspace is amended from continuous to

part time.

EFFECTIVE DATE: 0901 UTC, January 25,

2001.

FOR FURTHER INFORMATION CONTACT:

Wade T. Carpenter, Jr., Manager,

Airspace Branch, Air Traffic Division,

Federal Aviation Administration, P.O.

Box 20636, Atlanta, Georgia 30320;

telephone (404) 305–5627.

SUPPLEMENTARY INFORMATION:

History

On August 28, 2000, the FAA

proposed to amend part 71 of the

Federal Aviation Regulations (14 CFR

part 71) by establishing Class D airspace

at New Bern, NC, (65 FR 52375) as a

Federal Contract Tower has opened.

This action will provide Class D

airspace designated as surface area to

accommodate IFR operations at Craven

County Regional Airport when the

control tower is open. Therefore, the

Class E2 airspace at New Bern, NC, must

be amended from continuous to part

time. Class E airspace designations are

published in Paragraph 6002 of FAA

Order 7400.9H, dated September 1,

2000, and effective September 16, 2000,

which is incorporated by reference in 14

CFR 71.1, dated September 1, 1999. The

Class E airspace designations listed in

this document will be published

subsequently in the Order.

The Rule

This amendment to Part 71 of the

Federal Aviation Regulations (14 CFR

part 71) amends Class E2 airspace at

New Bern, NC.

The FAA has determined that this

regulation only involves an established

body of technical regulations for which

frequent and routine amendments are

necessary to keep them operationally

current. It, therefore, (1) Is not a

‘‘significant regulatory action’’ under

Executive Order 12866; (2) is not a

‘‘significant rule’’ under DOT

Regulatory Policies and Procedures (44

FR 11034; February 26, 1979); and (3)

does not warrant preparation of a

regulatory evaluation as the anticipated

impact is so minimal. Since this is a

routine matter that will only affect air

traffic procedures and air navigation, it

is certified that this rule will not have

a significant economic impact on a

substantial number of small entities

under the criteria of the Regulatory

Flexibility Act.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference,

Navigation (air).

Adoption of the Amendment

In consideration of the foregoing, the

Federal Aviation Administration

amends 14 CFR Part 71 as follows:

PART 71—DESIGNATION OF CLASS A,

CLASS B, CLASS C, CLASS D AND

CLASS E AIRSPACE AREAS;

AIRWAYS; ROUTES; AND REPORTING

POINTS

1. The authority citation for 14 CFR

Part 71 continues to read as follows:

Authority: 49 U.S.C. 106(g); 40103, 40113,

40120; EO 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389; 14 CFR 11.69.

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of Federal Aviation

Administration Order 7400.9H,

Airspace Designations and Reporting

Points, dated September 1, 2000, and

effective September 16, 2000, is

amended as follows:

Paragraph 6002 Class E Airspace

Designated as Surface Areas.

* * * * *

ASO NC E2 New Bern, NC [Revised]

Craven County Regional Airport, NC

(Lat. 35°04′23′′N, long. 77°02′35′′W)

New Bern, VOR/DME

(Lat. 35°04′23′′N, long. 77°02′42′′W)

Within a 4-mile radius of Craven County

Regional Airport and within 2.4-miles each

side of New Bern VOR/DME 038° and 210°

radials, extending from the 4-mile radius to

7 miles northeast and southwest of the VOR/

DME. This Class E airspace area is effective

during the specific dates and times

established in advance by a Notice to

Airmen. The effective date and time will

thereafter be continuously published in the

Airport/Facility Directory.

* * * * *

Issued in College Park, Georgia, on

November 16, 2000.

Wade T. Carpenter,

Acting Manager, Air Traffic Division,

Southern Region.

[FR Doc. 00–29908 Filed 11–21–00; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 00–AAL–02]

RIN: 2120–AA66

Establishment of VOR Federal Airway;

AK

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Final rule.

SUMMARY: This action establishes a Very

High Frequency Omnidirectional Range

(VOR) Federal airway (V–457) in

Alaska. The FAA is establishing this

Federal airway for the following

reasons: (1) The conversion of this

uncharted nonregulatory route to a VOR

Federal airway will add to the

instrument flight rules (IFR) airway and

route infrastructure in Alaska; (2) pilots

will be provided with minimum en

route altitudes and minimum

obstruction clearance altitudes

information; (3) this amendment

establishes controlled airspace, thus

eliminating some of the commercial IFR

operations in uncontrolled airspace; and

(4) the addition of this route improves

the management of air traffic operations

and thereby enhances safety.

EFFECTIVE DATE: 0901 UTC, January 25,

2001.

FOR FURTHER INFORMATION CONTACT: Ken

McElroy, Airspace and Rules Division,

ATA–400, Office of Air Traffic Airspace

Management, Federal Aviation

Administration, 800 Independence

Avenue, SW., Washington, DC 20591;

telephone: (202) 267–8783.

SUPPLEMENTARY INFORMATION:

Background

On June 28, 2000, the FAA proposed

to amend Title 14 of the Code of Federal

Regulations part 71 (part 71) to establish

VOR Federal Airway, V–457, in Alaska

(65 FR 39834). Interested parties were

invited to participate in this rulemaking

proceeding by submitting written

comments on the proposal to the FAA.

No comments objecting to the proposal

were received.

Federal Register / Vol. 65, No. 226 / Wednesday, November 22, 2000 / Rules and Regulations 70305

The Rule

This action amends part 71 by

establishing VOR Federal Airway V–457

in Alaska. Presently, there is an

uncharted nonregulatory route using the

same routings as the V–457 which

becomes effective January 25, 2001. The

FAA is establishing V–457 for the

following reasons: (1) The conversion of

this uncharted nonregulatory route to a

VOR Federal airway adds to the IFR

airway and route infrastructure in

Alaska; (2) pilots will be provided with

minimum en route altitudes and

minimum obstruction clearance

altitudes information; (3) this

amendment establishes controlled

airspace, thus eliminating some of the

commercial IFR operations in

uncontrolled airspace; and (4) the

addition of this route improves the

management of air traffic operations and

thereby enhance safety.

The FAA has determined that this

regulation only involves an established

body of technical regulations for which

frequent and routine amendments are

necessary to keep them operationally

current. Therefore, this regulation: (1) Is

not a ‘‘significant regulatory action’’

under Executive Order 12866; (2) is not

a ‘‘significant rule’’ under DOT

Regulatory Policies and Procedures (44

FR 11034; February 26, 1979); and (3)

does not warrant preparation of a

regulatory evaluation as the anticipated

impact is so minimal. Since this is a

routine matter that will only affect air

traffic procedures and air navigation, it

is certified that this rule, when

promulgated, will not have a significant

economic impact on a substantial

number of small entities under the

criteria of the Regulatory Flexibility Act.

Alaskan VOR Federal airways are

published in paragraph 6010(b) of FAA

Order 7400.9H dated September 1, 2000,

and effective September 16, 2000, which

is incorporated by reference in 14 CFR

71.1. The Alaskan VOR Federal airway

listed in this document will be

published subsequently in the order.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference,

Navigation (air).

The Rule

In consideration of the foregoing, the

Federal Aviation Administration

amends 14 CFR part 71 as follows:

PART 71—DESIGNATION OF CLASS A,

CLASS B, CLASS C, CLASS D, AND

CLASS E AIRSPACE AREAS;

AIRWAYS; ROUTES; AND REPORTING

POINTS

1. The authority citation for part 71

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389.

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of Federal Aviation

Administration Order 7400.9H,

Airspace Designations and Reporting

Points, dated September 1, 2000, and

effective September 16, 2000, is

amended as follows:

Paragraph 6010(b) Alaskan VOR Federal

Airways

* * * * *

V–457 [New]

From Iliamna, AK, NDB; to Kenai, AK.

* * * * *

Issued in Washington, DC, on November

15, 2000.

Reginald C. Matthews,

Manager, Airspace and Rules Division.

[FR Doc. 00–29906 Filed 11–21–00; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. 00N–1565]

Immunology and Microbiology

Devices; Classification of AntiSaccharomyces cerevisiae (S.

cerevisiae) Antibody (ASCA) Test

Systems

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is classifying the

Anti-Saccharomyces cerevisiae (S.

cerevisiae) antibody (ASCA) test system

into class II (special controls). The

special control that will apply to this

device is a guidance document entitled

‘‘Guidance for Industry and FDA

Reviewers: Class II Special Control

Guidance Document for AntiSaccharomyces cerevisiae (S. cerevisiae)

Antibody (ASCA) Premarket

Notifications.’’ Elsewhere in this issue

of the Federal Register, FDA is

announcing the availability of this

guidance document. The agency is

taking this action in response to a

petition submitted under the Federal

Food, Drug, and Cosmetic Act (the act)

as amended by the Medical Device

Amendments of 1976, the Safe Medical

Devices Act of 1990, and the Food and

Drug Administration Modernization Act

of 1997. The agency is classifying these

devices into class II (special controls) in

order to provide a reasonable assurance

of the safety and effectiveness of the

devices.

DATES: This rule is effective December

22, 2000.

FOR FURTHER INFORMATION CONTACT:

Deborah M. Moore, Center for Devices

and Radiological Health (HFZ–440),

Food and Drug Administration, 2098

Gaither Rd., Rockville, MD 20850, 301–

594–1293.

SUPPLEMENTARY INFORMATION:

I. Background

In accordance with section 513(f)(1) of

the act (21 U.S.C. 360c(f)(1)), devices

that were not in commercial distribution

before May 28, 1976, the date of

enactment of the Medical Device

Amendments of 1976, generally referred

to as postamendments devices, are

classified automatically by statute into

class III without any FDA rulemaking

process. These devices remain in class

III and require premarket approval,

unless and until the device is classified

or reclassified into class I or II or FDA

issues an order finding the device to be

substantially equivalent, in accordance

with section 513(i) of the act, to a

predicate device that does not require

premarket approval. The agency

determines whether new devices are

substantially equivalent to previously

marketed devices by means of

premarket notification procedures in

section 510(k) of the act (21 U.S.C.

360(k)) and 21 CFR part 807 of the FDA

regulations.

Section 513(f)(2) of the act provides

that any person who submits a

premarket notification under section

510(k) of the act for a device that has not

previously been classified may, within

30 days after receiving an order

classifying the device in class III under

section 513(f)(1) of the act, request FDA

to classify the device under the criteria

set forth in section 513(a)(1) of the act.

FDA shall, within 60 days of receiving

such a request, classify the device by

written order. This classification shall

be the initial classification of the device.

Within 30 days after the issuance of an

order classifying the device, FDA must

publish a notice in the Federal Register

announcing such classification.