Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Rules and Regulations 41329

7587; telephone number (907) 271–

5898; fax: (907) 271–2850; email:

Bob.Durand@faa.gov. Internet address:

http://www.alaska.faa.gov/at or at

address http://162.58.28.41/at.

SUPPLEMENTARY INFORMATION:

History

On April 24, 2000, a proposal to

amend part 71 of the Federal Aviation

Regulations (14 CFR part 71) to revise

the Class E airspace at Barrow, AK, was

published in the Federal Register (65

FR 21681). The proposal was necessary

due to revisions to the instrument

approaches to runway (RWY) 06 and

RWY 24 at Wiley Post—Will Rogers

Memorial Airport, Barrow, AK.

Interested parties were invited to

participate in this rulemaking

proceeding by submitting written

comments on the proposal to the FAA.

No public comments to the proposal

were received, thus, the rule is adopted

as written.

The area will be depicted on

aeronautical charts for pilot reference.

The coordinates for this airspace docket

are based on North American Datum 83.

The Class E airspace areas designated as

700/1200 foot transition areas are

published in paragraph 6005 of FAA

Order 7400.9G, Airspace Designations

and Reporting Points, dated September

1, 1999, and effective September 16,

1999, which is incorporated by

reference in 14 CFR 71.1. The Class E

airspace designations listed in this

document will be revised and published

subsequently in the Order.

The Rule

This amendment to 14 CFR part 71

revises the Class E airspace at Barrow,

AK, through the revisions of instrument

approaches to the Wiley Post—Will

Rogers Memorial Airport, Barrow, AK.

The area will be depicted on

aeronautical charts for pilot reference.

The intended effect of this proposal is

to provide adequate controlled airspace

for IFR operations at Wiley Post—Will

Rogers Memorial Airport, Barrow, AK.

The FAA has determined that these

proposed regulations only involve 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,

when promulgated, 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; 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 7400.9G,

Airspace Designations and Reporting

Points, dated September 1, 1999, and

effective September 16, 1999, is

amended as follows:

Paragraph 6005 Class E airspace areas

extending upward from 700 feet or more

above the surface of the earth.

* * * * *

AAL AK E5 Barrow, AK [Revised]

Barrow/Wiley Post—Will Rogers Memorial

Airport, AK

(Lat. 71°17′08′′ N, long. 156°45′58′′ W)

Barrow VORTAC

(Lat. 71°16′24′′ N, long. 156°47′18′′ W)

Barrow Localizer

(Lat. 71°17′08′′ N, long. 156°44′07′′ W)

That airspace extending upward from 700

feet above the surface within a 6.6-mile

radius of Barrow/Wiley Post—Will Rogers

Memorial Airport and within 4 miles north

and 6 miles south of the Barrow Localizer

back course extending from the 6.6-mile

radius to 14.6 miles east of the airport; and

that airspace extending upward from 1,200

feet above the surface within a 77-mile radius

of the airport extending clockwise from the

Barrow VORTAC 101° radial to the 240°

radial and within the area bounded by a line

beginning at the Barrow VORTAC 240° radial

20 miles west to lat. 71°13′ N long. 158° W,

to lat. 71°23′ N long. 157°48′ W to lat. 71°25′

N long. 156°55′ W to lat. 71°20′ N long.

155°40′ W to lat. 71°14′ N 155°40′ W.

* * * * *

Issued in Anchorage, AK, on June 27, 2000.

Willis C. Nelson,

Manager, Air Traffic Division, Alaskan

Region.

[FR Doc. 00–16918 Filed 7–3–00; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 99–ASW–33]

RIN 2120–AA66

Realignment of Jet Route; TX

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Final rule; correction.

SUMMARY: This action corrects a final

rule published in the Federal Register

on June 14, 2000 (Airspace Docket No.

99–ASW–33). The legal description of

Jet Route 25 (J–25) contained an

inadvertent error between the Corpus

Christi, TX, Very High Frequency

Omnidirectional Range/Tactical Air

Navigation (VORTAC) and the San

Antonio, TX, VORTAC. This action

corrects that error.

EFFECTIVE DATE: July 5, 2000.

FOR FURTHER INFORMATION CONTACT: Bil

Nelson, 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: On June

14, 2000, Airspace Docket No. 99–

ASW–33, FR Doc. 00–14909, was

published amending the legal

description of J–25 between the Corpus

Christi, TX, VORTAC and the San

Antonio, TX, VORTAC (65 FR 37277).

This rule inadvertently listed the true

bearing between Corpus Christi, TX, and

San Antonio, TX, as ‘‘166° .’’ The correct

true bearing is ‘‘174°.’’ The correct true

bearing was listed in the Notice of

Proposed Rulemaking for this matter.

Correction to Final Rule

Accordingly, pursuant to the

authority delegated to me, the legal

description for J–25 as published in the

Federal Register on June 24, 2000 (65

FR 37277), FR Doc. 00–14909, and

incorporated by reference in 14 CFR

71.1, is corrected as follows:

§ 71.1 [Corrected]

Paragraph 2004 Jet Routes

* * * * *

41330 Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Rules and Regulations

J–25 [Revised]

From the INT of the United States/Mexican

Border and the Brownsville, TX, INT 221°

radial via Brownsville; INT of the

Brownsville 358° and the Corpus Christi, TX,

178° radials; Corpus Christi; INT of the

Corpus Christi 311° and the San Antonio, TX,

174° radials; San Antonio; Centex, TX; Waco,

TX; Ranger, TX; Tulsa, OK; Kansas City, MO;

Des Moines, IA; Mason City, IA; Gopher, MN;

Brainerd, MN; to Winnipeg, MB, Canada. The

airspace within Canada is excluded. The

airspace within Mexico is excluded.

* * * * *

Issued in Washington, DC, on June 27,

2000.

Reginald C. Matthews,

Manager, Airspace and Rules Division

[FR Doc. 00–16915 Filed 7–3–00; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 97–ASO–18]

RIN 2120–AA66

Realignment and Establishment of

VOR Federal Airways; KY and TN

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Final rule; correction.

SUMMARY: This action corrects a final

rule published in the Federal Register

on June 2, 2000. The legal description

of Federal Airway V–384 inadvertently

listed incorrect radials. This action

corrects that error.

EFFECTIVE DATE: July 5, 2000.

FOR FURTHER INFORMATION CONTACT:

Terry Brown, 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: On June 2,

2000, Airspace Docket No. 97–ASO–18,

FR Doc. 00–13750, was published

establishing V–384 between Livingston,

TN, and Volunteer, TN. This rule

included a legal description for V–384,

which inadvertently listed incorrect

radials. This action corrects this

situation by omitting the radials in the

legal description for V–384, thereby

eliminating the error.

Correction to Final Rule

Accordingly, pursuant to the

authority delegated to me, the legal

description for V–384 as published in

the Federal Register on June 2, 2000 (65

FR 35272); FR Doc. 00–13750, and

incorporated by reference in 14 CFR

71.1, is corrected as follows:

§ 71.1 [Corrected]

On page 35273, the legal description

for V–384 is corrected as follows:

Paragraph 6010(a)—Domestic VOR Federal

Airways

* * * * *

V–384—[Revised]

From Livingston, TN; to Volunteer, TN.

* * * * *

Issued in Washington, DC, on June 27,

2000.

Reginald C. Matthews,

Manager, Airspace and Rules Division.

[FR Doc. 00–16914 Filed 7–3–00; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. 95N–0084]

Medical Devices; Effective Date of

Requirement for Premarket Approval

for a Class III Preamendments

Obstetrical and Gynecological Device

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a final

rule to require the filing of a premarket

approval application (PMA) or a notice

of completion of product development

protocol (PDP) for a Group 1

preamendments class III device, the

obstetric data analyzer intended to

analyze data from fetal and maternal

monitors during labor and to warn of

possible fetal distress. The agency has

summarized its findings regarding the

degree of risk of illness or injury

designed to be eliminated or reduced by

requiring the device to meet the statute’s

approval requirements and the benefits

to the public from the use of the

devices.

DATES: This rule is effective July 5,

2000.

FOR FURTHER INFORMATION CONTACT:

Colin M. Pollard, Center for Devices and

Radiological Health (HFZ–470), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1180.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of May 6, 1994

(59 FR 23731), FDA issued a notice of

availability of a preamendments class III

devices strategy document. The strategy

document set forth FDA’s plans for

implementing the provisions of section

515(i) of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C.

360e(i)) for preamendments class III

devices for which FDA had not yet

required premarket approval. FDA

divided this universe of devices into

three groups as referenced in the May 6,

1994, notice.

In the Federal Register of September

7, 1995 (60 FR 46718), FDA published

a proposed rule to require the filing

under section 515(b) of the act of a PMA

or a notice of completion of a PDP for

43 preamendment class III devices,

including the obstetric data analyzer. In

accordance with section 515(b)(A)(2) of

the act, FDA included in the preamble

to the proposal the agency’s tentative

findings with respect to the degree of

risk of illness or injury designed to be

eliminated or reduced by requiring the

device to meet the premarket approval

requirements of the act, and the benefits

to the public from use of the device. The

September 7, 1995, proposed rule also

provided an opportunity for interested

persons to submit comments on the

proposed rule and the agency’s findings.

Under section 515(b)(2)(B) of the act,

FDA provided an opportunity for

interested persons to request a change in

the classification of the device based on

new information relevant to its

classification. Any petition requesting a

change in the classification of the

devices was required to be submitted by

September 22, 1995. The comment

period closed January 5, 1996.

FDA received one citizen petition

requesting a change in the classification

of the obstetrical data analyzer. FDA

reviewed the petition, identified a

deficiency in the petition, and issued a

deficiency letter on March 7, 1996, to

the petitioner. From the petitioner’s

response to the deficiency letter, it was

apparent that the petitioner had

misinterpreted the September 7, 1995,

proposed rule because he believed that

it was about another device and not the

obstetrical data analyzer. In light of this

petition, FDA has amended the

identification of the device in

§ 884.2050(a) by changing the first two

sentences to read as follows: ‘‘An

obstetric data analyzer (fetal status data

analyzer) is a device used during labor

to analyze electronic signal data

obtained from fetal and maternal

monitors. The obstetric data analyzer

provides clinical diagnosis of fetal