61710 Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Proposed Rules

decisions on the proposal. Comments

are specifically invited on the overall

regulatory, aeronautical, economic,

environmental, and energy-related

aspects of the proposal.

Communications should identify the

airspace docket 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. 97–ASO–25.’’ The

postcard will be date/time stamped and

returned to the commenter. All

communications received before the

specified 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 the comments received. All

comments submitted will be available

for examination in the Office of the

Assistant Chief Counsel for Southern

Region, Room 550, 1701 Columbia

Avenue, College Park, Georgia 30337,

both before and after the closing date for

comments. A report summarizing each

substantive public contact with 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 Federal

Aviation Administration, Manager,

Airspace Branch, ASO–520, Air Traffic

Division, P.O. Box 20636, Atlanta,

Georgia 30320. Communications must

identify the 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 14 CFR part 71 to amend

the Class E airspace areas at Owensboro,

KY. A VOR RWY 5 SIAP has been

developed for Owensboro-Daviess

County Airport. Additional controlled

airspace is needed to accommodate the

SIAP and for IFR operations at the

airport. This proposal would provide a

southwest extension to the existing

Class D surface area and increase the

radius of the Class E airspace that

extends upward from 700 feet above the

surface of the earth. Class E airspace

areas designated as an extension to a

Class D or Class E surface area, and

Class E airspace areas extending upward

from 700 feet or more above the surface

of the earth are published in Paragraphs

6004 and 6005, respectively, 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 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 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 7400.9E, Airspace

Designations and Reporting Points,

dated September 10, 1997, and effective

September 16, 1997, is amended as

follows:

Paragraph 6004 Class E airspace areas

designated as an extension to a Class D or

Class E surface area.

* * * * *

ASO KY E4 Owensboro, KY [Revised]

Owensboro-Daviess County Airport, KY

(Lat. 37°44′25′′ N, long. 87°10′23′′ W)

Owensboro VOR/DME

(Lat. 37°44′37′′ N, long. 87°09′57′′ W)

That airspace extending upward from the

surface within 3 miles each side of

Owensboro VOR/DME 351°, 177°, and 223°

radials, extending from the 4.1-mile radius of

Owensboro-Daviess County Airport to 7

miles north, south and southwest of the

Owensboro VOR/DME. This Class E airspace

area is effective during the specific days and

times established in advance by a Notice to

Airmen. The effective days and times will

thereafter be continuously published in the

Airport/Facility Directory.

* * * * *

Paragraph 6005 Class E airspace areas

extending upward from 700 feet or more

above the surface of the earth.

* * * * *

ASO KY E5 Owensboro, KY [Revised]

Owensboro-Daviess County Airport, KY

(Lat. 37°44′25′′ N, long. 87°10′23′′ W)

That airspace extending upward from 700

feet or more above the surface within a 7.2-

mile radius of Owensboro-Daviess County

Airport.

* * * * *

Issued in College Park, Georgia, on

November 7, 1997.

Nancy B. Shelton,

Acting Manager, Air Traffic Division,

Southern Region.

[FR Doc. 97–30356 Filed 11–18–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 333, 347, and 348

[Docket Nos. 80N–0476, 78N–0301, 78N–

0021, and 75N–0183]

RIN 0910–AA01

Antifungal Drug Products for Over-theCounter Human Use; External

Analgesic Drug Products for Over-theCounter Human Use; Skin Protectant

Drug Products for Over-the-Counter

Human Use; and Topical Antimicrobial

Drug Products for Over-the-Counter

Human Use; Reopening of

Administrative Records

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule; reopening of

administrative records.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

reopening of the administrative records

for four rulemakings to include safety

and effectiveness data on over-thecounter (OTC) vaginal douche drug

product ingredients that were

previously considered in the advance
Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Proposed Rules 61711

notice of proposed rulemaking for OTC

vaginal drug products. The agency is

reopening the following rulemakings for

consideration of data on vaginal douche

drug products: (1) Antifungal drug

products, (2) OTC external analgesic

drug products (3) OTC skin protectant

drug products and (4) OTC topical

antimicrobial drug products. This action

is part of the ongoing review of OTC

drug products conducted by FDA.

DATES: Submit written comments by

February 17, 1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Helen Cothran, 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 October 13,

1983 (48 FR 46694), FDA published

under 21 CFR 330.10(a)(6), an advance

notice of proposed rulemaking to

establish a monograph for OTC vaginal

drug products, together with the

recommendations of the Advisory

Review Panel on OTC Contraceptives

and Other Vaginal Drug Products (the

Panel), which was the advisory review

panel responsible for evaluating data on

the active ingredients in OTC vaginal

drug products. In its report, the Panel

recommended Category I (i.e., safe and

effective) status for 1 to 3 percent

potassium sorbate and 0.15 to 0.3

percent povidone-iodine as a douche for

the relief of minor vaginal itching,

irritation, and soreness (48 FR 46694 at

46704 to 46706). The Panel also

recommended the following ingredients

as Category I in a douche formulation to

remove vaginal discharge and vaginal

secretions, for a mild detergent action,

and to thin out vaginal mucus

discharge: 0.002 percent dioctyl sodium

sulfosuccinate (docusate sodium),

0.0176 percent nonoxynol 9, 0.088

percent octoxynol 9, and 0.01 to 0.02

percent sodium lauryl sulfate (48 FR

46706 to 46707). In the preamble to the

Panel’s report (48 FR 46694 to 46695),

the agency did not allow the marketing

of potassium sorbate for relief of minor

vaginal irritation because it was

considered a new drug (had not been

marketed for a material time and

extent).

In the Federal Register of February 3,

1994 (59 FR 5226), the agency issued a

notice to withdraw the advance notice

of proposed rulemaking of October 13,

1983. This action was taken in part

because the agency determined that

some of the Panel’s recommended

labeling indications related to cosmetic

claims and not drug claims. The agency

also stated that the intended use of a

product will be considered in

determining whether it is a cosmetic, a

drug, or both (59 FR 5226 at 5231). In

addition, recommended labeling

indications and ingredients used for

minor irritation, itching, or soreness are

not unique to the vaginal area and are

already being considered in other OTC

drug rulemakings (e.g., antifungal,

antimicrobial, and external analgesic).

Therefore, the agency stated that those

ingredients and claims would be

considered in those other rulemakings,

as appropriate.

II. Recent Developments

In the Federal Register of March 27,

1997 (62 FR 14683), the agency

announced that its Nonprescription

Drugs Advisory Committee (NDAC)

would hold a public meeting on April

15, 1997, to discuss a possible

association between vaginal douching

and adverse consequences. The notice

stated that FDA is aware of a number of

case-control epidemiologic studies in

the literature that suggest a possible

association between vaginal douching

and several conditions, such as pelvic

inflammatory disease, ectopic

pregnancy , and cervical cancer (Ref. 1).

At the April 15, 1997, meeting, NDAC

members were joined by representatives

from two other FDA advisory

committees, Reproductive Health Drugs

and Anti-infective Drugs, as well as

representatives from the Center for Food

Safety and Applied Nutrition and the

Center for Devices and Radiological

Health. The Committees discussed

issues relating to behavioral,

epidemiological, and microbiological

aspects of vaginal douching. Committee

members felt that there was a suggestive

association between vaginal douching

and ectopic pregnancy and pelvic

inflammatory disease, but that more

data and further research were needed

to support such an association. Some

members stated that a possible

association between douching and tubal

infertility also needed more

investigation. The Committees did not

find any evidence of a relationship

between vaginal douching and cervical

carcinoma. Some members expressed

concern that certain individuals who

douche, e.g., those with sexually

transmitted diseases or multiple sexual

partners, may be at increased risk for

ectopic pregnancy, tubal disease, or

tubal infertility. The Committees were

also concerned about the risks and

benefits/efficacy of vaginal douche

products. The Committee members

stressed that labeling for these products

should be easy to read and understand,

and should provide consistent

information across the broad product

class. The Committees encouraged the

use of educational programs for both

consumers and health care providers as

a way to expand the public’s knowledge

about use of these products (Ref. 2).

III. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday

through Friday.

1. Letter from D. Bowen, FDA, to R.W.

Soller, Nonprescription Drug Manufacturers

Association, coded LET 105, Docket No.

75N–0183, Dockets Management Branch.

2. Comment No. TR1, Docket No. 80N–

0476, Dockets Management Branch.

IV. Reopening of the Administrative

Records

Because the issues concerning the

safety of vaginal douching also have an

impact on the agency’s review of the

safety and effectiveness of all OTC

vaginal douche drug products, the

agency is reopening the administrative

records for the rulemakings for OTC

antifungal drug products (Docket No.

80N–0476), (2) OTC external analgesic

drug products (Docket No. 78N–0301),

(3) OTC skin protectant drug products

(Docket No. 78N–0021), and (4) OTC

topical antimicrobial drug products

(Docket No. 75N–0183). This action is to

specifically allow for submission of data

on the issues raised at the April 15,

1997, meeting. The agency also requests

safety and effectiveness data on the

vaginal douche drug product

ingredients that were discussed at that

meeting.

Interested persons may submit

comments on OTC vaginal douche drug

products to the applicable docket

number(s) based on the ingredient’s

labeling claim(s), intended use, or

mechanism/mode of action. For

example, data on povidone-iodine for

the relief of minor vaginal itching and

irritation may be submitted to the

external analgesic rulemaking, but if

relief of itching is due to an antifungal

effect, i.e., killing the fungus, data

should be submitted to the antifungal

rulemaking . Likewise, if data support

the use of nonoxynol 9 for the relief of

minor vaginal itching and irritation

because of an antimicrobial action, data

should be submitted to the

antimicrobial rulemaking. Interested
61712 Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Proposed Rules

persons should determine the

appropriate rulemaking to which data

should be submitted. Comments on

other vaginal drug products or issues

should not be submitted at this time.

Submit written comments on or

before February 17, 1998 to the Dockets

Management Branch (address above).

Three copies of any comments are to be

submitted, except that individuals may

submit one copy. If comments could be

submitted to several dockets, they may

be submitted to one docket and crossreferenced in the other docket(s). All

comments are to be identified with the

appropriate docket number(s) found in

brackets in the heading of this

document and may be accompanied by

a supporting memorandum or brief.

Received comments may be seen in the

office above between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: November 12, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–30410 Filed 11–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 918

[SPATS No. LA–017–FOR]

Louisiana Regulatory Program

AGENCY: Office of Surface Mining

Reclamation and Enforcement (OSM),

Interior.

ACTION: Proposed rule; public comment

period and opportunity for public

hearing.

SUMMARY: OSM is announcing receipt of

a proposed amendment to the Louisiana

regulatory program (hererinfafter the

‘‘Louisiana program’’) under the Surface

Mining Control and Reclamation Act of

1977 (SMCRA). The proposed

amendment consists of revisions to and/

or additions of regulations pertaining to

definitions, request for hearing,

permitting requirements, small operator

assistance program, bond release

requirements, performance standards,

and enforcement procedures/civil

penalties. The amendment is intended

to revise the Louisiana program to be

consistent with the corresponding

Federal regulations.

This document sets forth the times

and locations that the Louisiana

program and proposed amendment to

that program are available for public

inspection, the comment period during

which interested persons may submit

written comments on the proposed

amendment, and the procedures that

will be followed regarding the public

hearing, if one is requested.

DATES: Written comments must be

received by 4:00 p.m., c.s.t., December

19, 1997. If requested, a public hearing

on the proposed amendment will be

held on December 15, 1997. Requests to

speak at the hearing must be received by

4:00 p.m., c.s.t. on December 4, 1997.

ADDRESSES: Written comments and

requests to speak at the hearing should

be mailed or hand delivered to Michael

C. Wolfrom, Director, Tulsa Field Office,

at the address listed below.

Copies of the Louisiana program, the

proposed amendment, a listing of any

scheduled public hearings, and all

written comments received in response

to this document will be available for

public review at the addresses listed

below during normal business hours,

Monday through Friday, excluding

holidays. Each requester may receive

one free copy of the proposed

amendment by contacting OSM’s Tulsa

Field Office.

Michael C. Wolfrom, Director, Tulsa

Field Office, Office of Surface Mining

Reclamation and Enforcement, 5100

East Skelly Drive, Suite 470, Tulsa,

Oklahoma 74135–6547, Telephone (918)

581–6430.

Department of Natural Resources,

Office of Conservation, Injection and

Mining Division, 625 N. 4th Street, P.O.

Box 94275, Baton Rouge, LA 70804,

Telephone: (504) 342–5540.

FOR FURTHER INFORMATION CONTACT:

Michael C. Wolfrom, Director, Tulsa

Field Office, Telephone (918) 581–6430.

SUPPLEMENTARY INFORMATION:

I. Background on the Louisiana

Program

On October 10, 1980, the Secretary of

the Interior conditionally approved the

Louisiana program. General background

information on the Louisiana program,

including the Secretary’s findings, the

disposition of comments, and the

conditions of approval of the Louisiana

program can be found in the October 10,

1980, Federal Register (45 FR 67340).

Subsequent actions concerning the

Louisiana program and program

amendments can be found at 30 CFR

918.15 and 918.16.

II. Description of the Proposed

Amendment

By letter dated October 24, 1997

(Administrative Record No. LA–362),

Louisiana submitted a proposed

amendment to its program pursuant to

SMCRA. Louisiana submitted the

proposed amendment in response to a

June 17, 1997, letter (Administrative

Record No. LA–361) that OSM sent to

Louisiana in accordance with 30 CFR

732.17(c). Louisiana proposes to amend

the Louisiana Surface Mining

Regulations. The full text of the

proposed program amendment

submitted by Louisiana is available for

public inspection at the locations listed

above under ADDRESSES. A brief

discussion of the proposed amendment

is presented below.

A. Section 105. Definitions

1. Louisiana proposes to revise its

definition for ‘‘other treatment

facilities.’’

2. Louisiana proposes to add a

definition for ‘‘previously mined area.’’

3. Louisiana proposes to add a

definition for ‘‘qualified laboratory.’’

B. Section 2537. Cross-Sections, Maps

and Plans

Louisiana proposes to delete

paragraph 2537.11. that requires crosssections, maps and plans in the permit

applications to show sufficient slope

measurements to adequately represent

the existing land surface configuration

of the proposed permit area.

C. Section 2725. Reclamation Plan:

Ponds, Impoundments, Banks, Dams

and Embankments

1. Louisiana proposes to revise

paragraph 2725.A. by adding ‘‘siltation

structure’’ to the types of ponds,

impoundments, banks, dams and

embankments requiring a general

reclamation plan, and by adding a

provision that requires each application

to include a detailed reclamation plan

for each proposed containment

structure.

2. At paragraph 2725.A.2., Louisiana

proposes to delete the existing language

and to replace it with language that adds

specific references to the U.S.

Department of Agriculture, Soil

Conservation Service Technical Release

No. 60 criteria for dam classification

and requires compliance with this

technical release if structures meet or

exceed the size or other criteria of the

Mine Safety and Health Administration.

3. Louisiana proposes to revise

paragraph 2725.A.3. to refer to

structures that are not included in

paragraph 2725.A.2.

4. At paragraph 2725.A.3.a., Louisiana

proposes to require qualified, registered,

professional engineers to certify all coal

processing waste dams and

embankments covered by sections 5375

through 5395.