29058 Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Proposed Rules

the surface of the earth are published in

Paragraphs 5000 and 6002 respectively,

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 Class D

and Class E airspace designations listed

in this document would be published

subsequently in the Order.

The FAA has determined that this

proposed 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,

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).

The Proposed Amendment

In consideration of the foregoing, the

Federal Aviation Administration

proposes to amend 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 5000 Class D Airspace.

* * * * *

ASO GA D Augusta, GA [Revised]

Augusta, Bush Field, GA

(Lat. 33°22′12′′ N, long. 81°57′52′′ W)

That airspace extending upward from the

surface to an including 2,600 feet MSL

within a 5.3-mile radius of Bush Field

Airport. This Class D 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.

* * * * *

Paragraph 6002 Class E2 Airspace

Designated as Surface Areas.

* * * * *

ASO GA E2 Augusta, GA [Revised]

Augusta, Bush Field, GA

(Lat. 33°22′12′′ N, long. 81°57′52′′ W)

Within a 5.3-mile radius of Bush Field

Airport. 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 May 16,

2001.

Walter R. Cochran,

Acting Manager, Air Traffic Division,

Southern Region.

[FR Doc. 01–13310 Filed 5–25–01; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 01–AEA–16]

Establishment of Class E Airspace;

Couldersport, PA

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

SUMMARY: This document proposes to

establish Class E airspace at Charles

Cole Memorial Hospital Heliport,

Couldersport, PA. Development of an

Area Navigation (RNAV) Standard

Instrument Approach (SIAP), Helicopter

RNAV 343 approach for the Charles

Cole Memorial Hospital Heliport has

made this action necessary. Controlled

airspace extending upward from 700

feet Above Ground Level (AGL) is

needed to contain aircraft executing the

approach. The area would be depicted

on aeronautical charts for pilot

reference.

DATES: Comments must be received on

or before June 28, 2001.

ADDRESSES: Send comments on the

proposal in triplicate to: Manager,

Airspace Branch, AEA–520, Docket No.

01–AEA16, F.A.A. Eastern Region, 1

Aviation Plaza, Jamaica, NY, 11434–

4809.

The official docket may be examined

in the Office of the Regional Counsel,

AEA–7, F.A.A. Eastern Region, 1

Aviation Plaza, Jamaica, NY, 11434–

4809.

An informal docket may also be

examined during normal business hours

in the Airspace Branch, AEA–520,

F.A.A. Eastern Region, 1 Aviation Plaza,

Jamaica, NY, 11434–4809.

FOR FURTHER INFORMATION CONTACT: Mr.

Francis T. Jordan, Jr., Airspace

Specialist, Airspace Branch, AEA–520,

F.A.A. Eastern Region, 1 Aviation Plaza,

Jamaica, NY, 11434–4809: telephone:

(718) 553–4521.

SUPPLEMENTARY INFORMATION:

Comments Invited

Interested parties are invited to

participate in this proposed rulemaking

by submitting such written data, views,

or arguments as they may desire.

Comments that provide the factual basis

supporting the views and suggestions

presented are particularly helpful in

developing reasoned regulatory

decisions on the proposal. Comments

are specifically invited on the overall

regulatory, economic, environmental,

and energy-related aspects of the

proposal. Communications should

identify the airspace docket number and

be submitted in triplicate to the address

listed above. Commenters wishing the

FAA to acknowledge receipt of their

comments on this notice must submit

with those comments a self-addressed,

stamped postcard on which the

following statement is made:

‘‘Comments to Airspace Docket No. 01–

AEA–16’’. The postcard will be date/

time stamped and returned to the

commenter. All communications

received on or before the closing date

for comments will be considered before

taking action on the proposed rule. The

proposal contained in this notice may

be changed in light of comments

received. All comments submitted will

be available for examination in the

Rules Docket closing both before and

after the closing date for comments. A

report summarizing each substantive

public contact with the FAA personnel

concerned with this rulemaking will be

filed in the docket.

Availability of NPRMs

Any person may obtain a copy of this

Notice of Proposed Rulemaking (NPRM)

by submitting a request to the Office of

the Regional Counsel, AEA–7, F.A.A.

Eastern Region, 1 Aviation Plaza,

Jamaica, NY 11434–4809.

Communications must identify the

Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Proposed Rules 29059

notice number of this NPRM. Persons

interested in being placed on a mailing

list for future NPRMs should also

request a copy of Advisory Circular No.

11–2A, which describes the application

procedure.

The Proposal

The FAA is considering an

amendment to Part 71 of the Federal

Aviaiton Regulations (14 CFR part 71) to

establish Class E airspace area at

Couldersport, PA. An RNAV Approach,

Helicopter RNAV 343, has been

developed for Charles Cole Memorial

Hospital Heliport, Couldersport, PA.

Controlled airspace extending upward

from 700 feet AGL is needed to

accommodate the SIAP. Class E airspace

designations for airspace areas

extending upward from 700 feet from or

above the surface are published in

Paragraph 6005 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 Class E airspace designation

listed in this document would be

published subsequently in the Order.

The FAA has determined that this

proposed regulation only involves an

established body of technical

regulations for which frequent and

routine amendments are necessary to

keep them operationally current.

Therefore, this proposed 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 would only affect air

traffic procedures and air navigation, it

is certified that this proposed rule

would not have 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).

The Proposed Amendment

In consideration of the foregoing, the

Federal Aviation Administration

proposes to amend 14 CFR part 71 as

follows:

PART 71—[AMENDED]

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 7400.9H dated

September 1, 2000, and effective

September 16, 2000, is proposed to be

amended as follows:

Paragraph 6005 Class E airspace areas

extending upward from 700 feet or more

above the surface of the earth.

* * * * *

AEA PA E5 Couldersport, PA (New)

Charles Cole Memorial Hospital Heliport

Lat. 41°46′16.14′′ N/long. 77°58′28′′ W)

That airspace extending upward from 700

feet above the surface within a 6 mile radius

of the Charles Cole Memorial Hospital

Heliport.

* * * * *

Issued in Jamaica, New York, on May 15,

2001.

F.D. Hatfield,

Manager, Air Traffic Division, Eastern Region.

[FR Doc. 01–13311 Filed 5–25–01; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 333

[Docket No. 96P–0460]

RIN 0910–AA01

Topical Antifungal Drug Products for

Over-the-Counter Human Use;

Proposed Amendment of Final

Monograph

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a

proposed rule that would amend the

final monograph for over-the-counter

(OTC) topical antifungal drug products

to add the ingredient clotrimazole as

generally recognized as safe and

effective for the treatment of athlete’s

foot, jock itch, and ringworm. This

proposal is part of FDA’s ongoing

review of OTC drug products.

DATES: Submit written comments by

August 27, 2001. Submit written

comments on the agency’s economic

impact determination by August 27,

2001. See section IX of this document

for the effective date of any final rule

that may publish based on this proposal.

ADDRESSES: Submit written comments

to the Docket Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Gerald M. Rachanow, Center for Drug

Evaluation and Research (HFD–560),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2307.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of September

23, 1993 (58 FR 49890), FDA published

a final monograph for OTC topical

antifungal drug products in part 333 (21

CFR part 333), subpart C. That

monograph includes six antifungal

active ingredients used for the treatment

of athlete’s foot, jock itch, and ringworm

and one ingredient used for the

prevention of athlete’s foot. The

monograph provides that two

ingredients may contain professional

labeling (may be provided to health

professionals but not to the general

public) for the treatment of superficial

infections caused by yeast (Candida

albicans). A manufacturer submitted a

citizen petition (Refs. 1 through 4) to

include the antifungal ingredient

clotrimazole in the monograph for both

the OTC and professional labeling

treatment claims. Subsequently, the

manufacturer withdrew its request to

include clotrimazole in the monograph

for the professional labeling treatment

claim (Ref. 5).

II. The Agency’s Evaluation of the

Citizen Petition

A. General Background

Clotrimazole is a member of the

imidazole class of antifungal drugs and

is recognized in the U.S. Pharmacopeia

(Ref. 6). Clotrimazole has been marketed

as a topical antifungal at a 1-percent

concentration in the United States as a

prescription product since 1975 and as

an OTC product since 1989 under new

drug applications (NDAs) in cream,

lotion, and solution dosage forms. The

agency notes that clotrimazole has also

been marketed OTC in a number of

other countries, the first marketing

occurring in 1980. Distribution figures

(Ref. 1) indicate a significant amount of

the drug has been marketed OTC in the

United States and other countries since

1990. Miconazole nitrate, a related

member of the imidazole class of

antifungal drugs, is currently included

as an active ingredient in § 333.210(c) of

the final monograph for OTC topical

antifungal drug products.

B. Safety

The toxicity of clotrimazole has been

well-studied (Refs. 1 and 2). Acute