This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

33591

Vol. 63, No. 118

Friday, June 19, 1998

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 98–ASO–9]

Proposed Establishment of Class E

Airspace; Villa Rica, GA

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

SUMMARY: This notice proposes to

establish Class E airspace at Villa Rica,

GA. A Global Positioning System (GPS)

Runway (RWY) 10 Standard Instrument

Approach Procedure (SIAP) has been

developed for Stockmar Airport. As a

result, controlled airspace extending

upward from 700 feet Above Ground

Level (AGL) is needed to accommodate

the SIAP and for Instrument Flight

Rules (IFR) operations at Stockmar

Airport. The operating status of the

airport will change from Visual Flight

Rules (VFR) to include IFR operations

concurrent with the publication of the

SIAP.

DATES: Comments must be received on

or before July 20, 1998.

ADDRESSES: Send comments on the

proposal in triplicate to: Federal

Aviation Administration, Docket No.

98–ASO–9, Manager, Airspace Branch,

ASO–520, P.O. Box 20636, Atlanta,

Georgia 30320.

The official docket may be examined

in the Office of the Regional Counsel for

Southern Region, Room 550, 1701

Columbia Avenue, College Park, Georgia

30337, telephone (404) 305–5586.

FOR FURTHER INFORMATION CONTACT:

Nancy B. Shelton, Manager, Airspace

Branch, Air Traffic Division, Federal

Aviation Administration, P.O. Box

20636, Atlanta, Georgia 30320;

telephone (404) 305–5586.

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, aeronautical, 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. 98–

ASO–9.’’ 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

Regional 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 part 71 of the Federal

Aviation Regulations (14 CFR Part 71) to

establish Class E airspace at Villa Rica,

GA. A GPS RWY 10 SIAP has been

developed for Stockmar Airport. As a

result, controlled airspace extending

upward from 700 feet AGL is needed to

accommodate the SIAP and for IFR

operations at Stockmar Airport. The

operating status of the airport will

change from VFR to include IFR

operations concurrent with the

publication of the SIAP. Class E airspace

designations for airspace areas

extending upward from 700 feet or more

above the surface are published in

Paragraph 6005 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 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. 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.
33592 Federal Register / Vol. 63, No. 118 / Friday, June 19, 1998 / Proposed Rules

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of Federal Aviation

Administration Order 7400.9D, Airspace

Designations and Reporting Points,

dated September 10, 1997, and effective

September 16, 1997, is amended as

follows:

Paragraph 6005 Class E airspace areas

extending upward from 700 feet or more

above the surface of the earth.

Spruce Creek Airport

(Lat. 29°04′49′′ N, long. 81°03′27′′ W)

Ormond Beach Municipal Airport

(Lat. 29°18′04′′ N, long. 81°06′50′′ W)

That airspace extending upward from 700

feet or more above the surface of the earth

within a 10-mile radius of Daytona Beach

International Airport, within a 6.4-mile

radius of Spruce creek Airport and within a

7.3-mile radius of Ormond Beach Municipal

Airport.

* * * * *

Issued in College Park, Georgia, on June 10,

1998.

Nancy B. Shelton,

Acting Manager, Air Traffic Division,

Southern Region.

[FR Doc. 98–16354 Filed 6–18–98; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 310 and 334

[Docket No. 78N–036L]

RIN 0910–AA01

Laxative Drug Products for Over-theCounter Human Use; Proposed

Amendment to the Tentative Final

Monograph

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Food and Drug

Administration (FDA) is reopening the

administrative record and proposing to

amend the tentative final monograph

(proposed rule) for over-the-counter

(OTC) laxative drug products to

reclassify the stimulant laxative

ingredients aloe, bisacodyl, cascara

sagrada, and senna (including

sennosides A and B) from Category I

(generally recognized as safe and

effective and not misbranded) to

Category III (further testing is required).

FDA is issuing this proposed

rulemaking after considering data and

information on the safety of bisacodyl,

senna, and two related stimulant

laxative ingredients, danthron and

phenolphthalein. This proposal is part

of the ongoing review of OTC drug

products conducted by FDA.

DATES: Submit written comments by

September 17, 1998. Written comments

on the agency’s economic impact

determination by September 17, 1998.

New data by June 21, 1999. Comments

on the new data by August 19, 1999.

ADDRESSES: Submit written comments

and new data to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

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 March 21,

1975 (40 FR 12902), FDA published,

under § 330.10(a)(6) (21 CFR

330.10(a)(6)), an advance notice of

proposed rulemaking to establish a

monograph for OTC laxative,

antidiarrheal, emetic, and antiemetic

drug products, together with the

recommendations of the Advisory

Review Panel on OTC Laxative,

Antidiarrheal, Emetic, and Antiemetic

Drug Products (the Panel), which was

the advisory review panel responsible

for evaluating data on the active

ingredients in these classes. In the

advance notice of proposed rulemaking,

the Panel recommended Category I

status for the OTC stimulant laxative

ingredients aloe, bisacodyl, cascara

sagrada preparations, danthron,

phenolphthalein, and senna

preparations (40 FR 12902 at 12908 to

12910). The agency concurred with the

Panel’s Category I classification of these

ingredients in the tentative final

monograph published in the Federal

Register of January 15, 1985 (50 FR 2124

at 2152 to 2156).

II. Danthron and Phenolphthalein

In the Federal Register of September

2, 1997 (62 FR 46223), the agency

reopened the administrative record for

this rulemaking, discussed the

carcinogenic risk of danthron and

phenolphthalein, and proposed to

reclassify these two anthraquinone

laxative ingredients from Category I to

Category II (not generally recognized as

safe and effective or misbranded). The

agency is evaluating the data and

comments submitted in response to that

proposal and will discuss this subject

further in a future issue of the Federal

Register.

III. Bisacodyl

The FDA Center for Drug Evaluation

and Research (CDER) Carcinogenicity

Assessment Committee (CAC) has

recommended that the anthraquinone

laxatives (aloe, cascara sagrada, and

senna) and bisacodyl be tested in the

standard battery of genotoxicity tests

and under the test conditions by which

phenolphthalein was found to be

positive (Ref. 1). Phenolphthalein and

bisacodyl are diphenylmethane

derivatives with a similar chemical

structure and pharmacological

characteristics. The CAC recommended

the Syrian Hamster Embryo (SHE) cell

transformation assay as an early screen

for bisacodyl and, based on its results,

either the p53 transgenic mouse assay or

another in vivo alternative assay, as

appropriate, follow. Two-year

carcinogenicity studies would then be

contingent upon the results of these

assays.

The agency has informed industry

that additional testing for bisacodyl will

be necessary (Ref. 2). Subsequently,

industry submitted data from two

mutagenicity studies (Ames test and rat

bone marrow micronucleus assay) and a

chromosomal aberration study in

Chinese hamster ovary cells. The agency

has reviewed these studies and

determined that the results of all of the

tests were negative (Ref. 3).

Phenolphthalein was tested in two of

these tests and was found negative in

one (Ames test). However, findings from

further studies indicated that

phenolphthalein presents a potential

carcinogenic risk. Thus, because of the

chemical similarity of bisacodyl to

phenolphthalein and the lack of

previous carcinogenicity testing of

bisacodyl, the agency is requesting that

bisacodyl undergo further testing to

assess its carcinogenic potential.

Industry has completed dose range

finding studies intended to select

bisacodyl doses for a 6-month oral

gavage carcinogenicity study in the p53

transgenic mouse (Ref. 4).

IV. Senna

The agency has reviewed metabolic,

genotoxicity, and carcinogenicity data

on senna and its components (Ref. 5).

Senna contains a number of

components, including but not limited

to: Sennosides A and B, sennosides C

and D, rhein (including rhein anthrone8-monoglucoside and rhein-8-

monoglucoside), chrysophanol, emodin,

and aloe-emodin. The metabolic studies

show that varying amounts of senna and

its metabolites are absorbed into the