40646 Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 /Rules and Regulations

a notice of proposed rulemaking may be

published with a new comment period.

Comments Invited

Although this action is in the form of

a final rule and was not preceded by a

notice of proposed rulemaking,

comments are invited on this rule.

Interested persons are invited to

comment on this rule by submitting

such written data, views, or arguments

as they may desire. Communications

should identify the Rules Docket

number and be submitted in triplicate to

the address specified under the caption

ADDRESSES. All communications

received on or before the specified

closing date for comments will be

considered, and this rule may be

amended or withdrawn in light of

comments received. Factual information

that supports the commenter’s ideas and

suggestions is extremely helpful in

evaluating the effectiveness of this

action and determining whether

additional rulemaking action would be

needed.

Comments are specifically invited on

the overall regulatory, aeronautical,

economic, environmental, and energyrelated aspects of the rule that might

suggest a need to modify the rule. All

comments submitted will be available

for examination in the Rules Docket

both before and after the closing date for

comments. A report that summarizes

each FAA-public contact concerned

with the substance of this action will be

filed in the Rules Docket.

Commenters wishing the FAA to

acknowledge receipt of their comments

submitted in response to this rule must

submit a self-addressed, stamped

postcard on which the following

statement is made: ‘‘Comments to

Airspace Docket No. 98–ASW–40.’’ The

postcard will be date stamped and

returned to the commenter.

The Rule

This amendment to 14 CFR part 71

realigns V–369 located in the Dallas/

Fort Worth area. Due to the

decommissioning of the Dallas/Fort

Worth VORTAC, V–369 is being

realigned to the newly commissioned

Maverick VOR/DME, which is located

.66 nautical miles west of the former

Dallas/Fort Worth VORTAC. Realigning

V–369 will ensure that air traffic

operations are not interrupted by virtue

of the decommissioning of the Dallas/

Fort Worth VORTAC and the

commissioning of the Maverick VOR/

DME. The effective date of this direct

final rule will coincide with the

effective date of the commissioning of

the Maverick VOR/DME. The FAA is

taking this action to improve the

management of air traffic operations in

the vicinity of Dallas/Fort Worth area.

Domestic VOR Federal Airways are

published in paragraph 6010(a) of FAA

Order 7400.9E, dated September 10,

1997, and effective September 16, 1997,

which is incorporated by reference in 14

CFR 71.1. The airways listed in this

document will be published

subsequently in the Order.

Agency Findings

The regulations adopted herein will

not have substantial direct effects on the

States, on the relationship between the

national government and the States, or

on the distribution of power and

responsibilities among the various

levels of government. Therefore, in

accordance with Executive Order 12612,

it is determined that this final rule does

not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

The FAA has determined that this

regulation is not controversial and

unlikely to result in adverse or negative

comments. For the reasons discussed in

the preamble, I certify that 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, positive or

negative, 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).

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 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 the Federal Aviation

Administration Order 7400.9E, Airspace

Designations and Reporting Points,

dated September 10, 1997, and effective

September 16, 1997, is amended as

follows:

Paragraph 6010(a)—Domestic VOR Federal

Airways

* * * * *

V–369 [Revised]

From Navasota, TX; Groesbeck, TX; to

Maverick, TX.

* * * * *

Issued in Washington, DC, on July 23,

1998.

Reginald C. Matthews,

Acting Program Director for Air Traffic

Airspace Management.

[FR Doc. 98–20346 Filed 7–29–98; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 96–ANM–15]

RIN 2120–AA66

Modification of VOR Federal Airway V–

465

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Final rule.

SUMMARY: This action modifies Very

High Frequency Omnidirectional Range

(VOR) Federal Airway V–465 (V–465)

by lowering the floor of a portion of the

airway from 12,400 mean sea level

(MSL) to 1,200 feet above the surface.

This action also establishes a new

segment of V–465 between Billings,

Montana (MT), and Miles City, MT. The

FAA is taking this action to support an

instrument approach procedure into the

Jackson Hole Airport, Wyoming (WY),

and enhance the management of air

traffic operations in the Jackson Hole,

WY, area.

EFFECTIVE DATE: 0901 UTC October 8,

1998.

FOR FURTHER INFORMATION CONTACT:

Joseph White, 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:

History

On December 15, 1997, the FAA

proposed to amend 14 CFR part 71 (part

71) to modify a portion of V–465 (62 FR

65631). Interested parties were invited
Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 /Rules and Regulations 40647

to participate in this rulemaking

proceeding by submitting written

comments on the proposal to the FAA.

No comments were received. Except for

editorial changes this amendment is the

same as that proposed in the notice.

The Rule

This action amends part 71 by

lowering the floor of a portion of V–465

from 12,400 MSL to 1,200 feet above the

surface. This action supports the

instrument approach procedure

requirements into the Jackson Hole

Airport, Jackson, WY.

This action also establishes a new

segment of V–465 between Billings, MT,

and Miles City, MT. When V–465 was

established, the FAA intended that the

airway include a segment between

Billings, MT, and Miles City, MT;

however, the airway segment was

omitted due to a typographical error.

This action properly defines that

portion of V–465 between Billings, MT,

and Miles City, MT, that was omitted in

previous publications. This new

segment does not result in any

additional controlled airspace because

the segment is co-located with a

segment of V–2.

The FAA is taking this action to

enhance the management of air traffic

operations in the Jackson Hole, WY,

area.

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.

Domestic VOR Federal airways are

published in paragraph 6010(a) of FAA

Order 7400.9E, dated September 10,

1997, and effective September 16, 1997,

which is incorporated by reference in 14

CFR 71.1. The airways 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).

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 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 [Revised]

2. The incorporation by reference in

14 CFR 71.1 of the Federal Aviation

Administration Order 7400.9E, Airspace

Designations and Reporting Points,

dated September 10, 1997, and effective

September 16, 1997, is amended as

follows:

Paragraph 6010(a)—Domestic VOR Federal

Airways

* * * * *

V–465 [Revised]

From Bullion, NV, Wells, NV; 12 miles; 30

miles, 115 MSL, 20 miles, 90 MSL, 36 miles,

115 MSL, 24 miles, 95 MSL, Malad City, ID;

Jackson, WY; Dunoir, WY; 14 miles, 45 miles,

137 MSL, Billings, MT; Miles City, MT;

Williston, ND.

* * * * *

Issued in Washington, DC, on July 24,

1998.

Reginald C. Matthews,

Acting Program Director for Air Traffic

Airspace Management.

[FR Doc. 98–20341 Filed 7–29–98; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 310 and 341

[Docket No. 76N–052N]

RIN 0910–AA01

Cold, Cough, Allergy, Bronchodilator,

and Antiasthmatic Drug Products for

Over-the-Counter Human Use;

Amendment of Monograph for OTC

Nasal Decongestant Drug Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

final monograph for over-the-counter

(OTC) nasal decongestant drug products

(drug products used to relieve nasal

congestion caused by acute or chronic

rhinitis) to add the ingredient

levmetamfetamine (formerly ldesoxyephedrine) and to classify this

ingredient as generally recognized as

safe and effective for OTC use. The

agency is also removing ldesoxyephedrine from the list of

nonmonograph active ingredients. This

final rule is part of the ongoing review

of OTC drug products conducted by

FDA.

EFFECTIVE DATE: July 30, 1999.

FOR FURTHER INFORMATION CONTACT:

Cazemiro R. Martin, Center for Drug

Evaluation and Research (HFD–560),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2222.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of August 23,

1994 (59 FR 43386), the agency

published a final rule in the form of a

final monograph establishing conditions

under which OTC nasal decongestant

drug products are generally recognized

as safe and effective. The final

monograph did not include ldesoxyephedrine as a nasal

decongestant active ingredient because

it was not currently standardized and

characterized for quality and purity in

an official compendium, i.e., the United

States Pharmacopeia (USP)/National

Formulary (59 FR 43386 at 43408).

Instead, the final rule listed ldesoxyephedrine in

§ 310.545(a)(6)(ii)(B) (21 CFR

310.545(a)(6)(ii)(B)) as not generally

recognized as safe and effective. The

agency stated in the final rule that OTC

drug products containing ldesoxyephedrine as a topical nasal

decongestant active ingredient were

new drugs under section 201(p) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 321(p)). The effective date of

the final rule was August 23, 1995.

In the Federal Register of March 8,

1996 (61 FR 9570), the agency stayed

the entry for ‘‘l-desoxyephedrine

(topical)’’ in § 310.545(a)(6)(ii)(B) until

further notice. The agency explained

that a citizen petition submitted in

response to the OTC nasal decongestant

final rule requested that the agency

defer the effective date of

§ 310.545(a)(6)(ii)(B) as it applies to ldesoxyephedrine (topical) until

December 31, 1996. The petitioner

stated that it had forwarded a draft

compendial monograph for ldesoxyephedrine to the USP in late July

1995. The agency added that when ldesoxyephedrine becomes official in the