64526 Federal Register / Vol. 62, No. 235 / Monday, December 8, 1997 / Proposed Rules

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 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–26.’’ 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 part 71 of the Federal

Aviation Regulations (14 CFR part 71) to

amend the Class E airspace area at New

Bern, NC. The required weather

observation information is available on

a continuous basis to the air traffic

control facility providing service to New

Bern, Craven County, NC, Airport.

Therefore, the Class E surface area

airspace at New Bern, NC, meets the

requirement for modification from part

time to continuous. Class E airspace

areas designated as a surface area for an

airport are published in Paragraph 6002

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 6002 Class E airspace areas

designated as a surface area for an

airport.

* * * * *

ASO NC E2—New Bern, NC [Revised]

New Bern, Craven County Regional Airport,

NC

(Lat 35°04′21′′ N, long. 77°02′37′′ W)

New Bern VOR/DME

(Lat 35°04′23′′ N, long 77°02′42′′ W)

Within a 4-mile radius of Craven County

Regional Airport and within 2.4 miles each

side of New Bern VOR/DME 038° and 210°

radials, extending from the 4-mile radius

northeast and southwest of the VOR/DME.

* * * * *

Issued in College Park, Georgia, on

November 24, 1997.

Nancy B. Shelton,

Acting Manager, Air Traffic Division,

Southern Region.

[FR Doc. 97–32035 Filed 12–5–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA No. 173P]

Schedules of Controlled Substances:

Proposed Placement of Sibutramine

Into Schedule IV

AGENCY: Drug Enforcement

Administration (DEA), Justice.

ACTION: Notice of proposed rulemaking.

SUMMARY: This proposed rule is issued

by the Acting Deputy Administrator of

the DEA to place the substance,

sibutramine, including its salts and

optical isomers into Schedule IV of the

Controlled Substances Act (CSA). This

proposed action is based on a

recommendation from the Assistant

Secretary for Health of the Department

of Health and Human Services (DHHS)

that sibutramine be added to Schedule

IV and on an evaluation of the relevant

data by the DEA. If finalized, this action

will impose the regulatory controls and

criminal sanctions of Schedule IV on

those who handle sibutramine and

products containing sibutramine.

DATES: Comments, objections, and

requests for a hearing must be received

on or before January 7, 1998.

ADDRESSES: Comments, objections and

requests for a hearing should be

submitted in quintuplicate to the Acting

Deputy Administrator, Drug

Enforcement Administration,

Washington, D.C. 20537, Attn.: DEA

Federal Register Representative/CCR.

FOR FURTHER INFORMATION CONTACT:

Frank Sapienza, Chief, Drug and

Chemical Evaluation Section, Drug

Enforcement Administration,

Washington, D.C. 20537, (202) 307–

7183.
Federal Register / Vol. 62, No. 235 / Monday, December 8, 1997 / Proposed Rules 64527

SUPPLEMENTARY INFORMATION:

Sibutramine is an amphetamine

analogue pharmacologically similar to

other anorectic agents that produce

central nervous system stimulation and

amphetamine-like effects in humans

and animals. Sibutramine hydrochloride

will be marketed under the trade name

of MERIDA as an oral anorectic for the

long term management of obesity.

The Acting Deputy Administrator of

the DEA received a letter dated

November 12, 1997 from the Acting

Assistant Secretary for Health, on behalf

of the Secretary of the DHHS,

recommending that the substance,

sibutramine, and salts and isomers

thereof, be placed into Schedule IV of

the CSA (21 U.S.C. 801 et seq.).

Enclosed with the letter from the

Assistant Secretary was a document

prepared by the Food and Drug

Administration (FDA) entitled ‘‘Basis

for the Recommendation for Control of

Sibutramine and its Salts in Schedule IV

of the Controlled Substances Act

(CSA).’’ The document contained a

review of the factors which the CSA

requires the Secretary to consider [21

U.S.C. 811(b)] and the summarized

recommendations regarding the

placement of sibutramine into Schedule

IV of the CSA.

The factors considered by the

Assistant Secretary for Health with

respect to the drug sibutramine were:

(1) Its actual or relative potential for

abuse.

(2) Scientific evidence of its

pharmacological effect, if known.

(3) The state of current scientific

knowledge regarding the drug or other

substance.

(4) Its history and current pattern of

abuse.

(5) The scope, duration, and

significance of abuse.

(6) What, if any, risk there is to the

public health.

(7) Its psychic or physiological

dependence liability.

(8) Whether the substance is an

immediate precursor of a substance

already controlled under the CSA.

Relying on the scientific and medical

evaluation and the recommendation of

the Assistant Secretary of Health, the

FDA New Drug Application (NDA)

approval on November 22, 1997, and a

DEA review, the Acting Deputy

Administrator of the DEA, pursuant to

sections 201(a) and 201(b) of the Act (21

U.S.C. 811(a) and 811(b)), finds that:

(1) Sibutramine has a low potential

for abuse relative to the drugs or other

substances in Schedule III.

(2) Sibutramine has a currently

accepted medical use in treatment in the

United States.

(3) Abuse of sibutramine may lead to

limited physical dependence and

psychological dependence relative to

the drugs or other substances in

Schedule III.

Interested persons are invited to

submit their comments, objections or

requests for a hearing, in writing, with

regard to this proposal. Requests for a

hearing should state, with particularity,

the issues concerning which the person

desires to be heard. All correspondence

regarding this matter should be

submitted to the Acting Deputy

Administrator, Drug Enforcement

Administration, Washington, D.C.

20537. Attention: DEA Federal Register

Representative/CCR. In the event that

comments, objections or requests for a

hearing raise one or more issues which

the Acting Deputy Administrator finds

warrants a hearing, the Acting Deputy

Administrator shall order a public

hearing by notice in the Federal

Register, summarizing the issues to be

heard and setting the time for the

hearing.

In accordance with the provisions of

the CSA (21 U.S.C. 811(a)), this action

is a formal rulemaking on the record

after opportunity for a hearing. Such

proceedings are conducted pursuant to

the provisions of 5 U.S.C. 556 and 557

and, as such, are exempt from review by

the Office of Management and Budget

pursuant to Executive Order (E.O.)

12866, Section 3(d)(1).

The Acting Deputy Administrator, in

accordance with the Regulatory

Flexibility Act (5 U.S.C. 605(b)), has

reviewed this proposed rule and by

approving it certifies that it will not

have a significant economic impact on

a substantial number of small-business

entities. Sibutramine is a new drug in

the United States; recent approval of the

product and its labeling by the FDA will

allow it to be marked once it is placed

into Schedule IV of the CSA. This

proposed rule, if finalized, will allow

these entities to have access to a new

pharmaceutical product.

This rule will not result in the

expenditure by State, local and tribal

governments, in the aggregate, or by the

private sector, of $100,000,000 or more

in any one year, and it will not

significantly or uniquely affect small

governments. Therefore, no actions were

deemed necessary under provisions of

the Unfunded Mandates Reform Act of

1995.

This rule is not a major rule as

defined by section 804 of the Small

Business Regulatory Enforcement

Fairness Act of 1996. This rule will not

result in an annual effect on the

economy of $100,000,000 or more; a

major increase in costs or prices; or

significant adverse effects on

competition, employment, investment,

productivity, innovation, or on the

ability of the United States-based

companies to compete with foreignbased companies in domestic and

export markets.

This rule 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 E.O. 12612, it is

determined that this rule, if finalized,

does not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

List of Subjects in 21 CFR Part 1308

Administrative practice and

procedure, drug traffic control,

narcotics, prescription drugs.

Under the authority vested in the

Attorney General by section 201(a) of

the CSA (21 U.S.C. 811(a)), and

delegated to the Administrator of the

DEA by the Department of Justice

regulations (28 CFR 0.100) and

redelegated to the Deputy Administrator

pursuant to 28 CFR 0.104, the Acting

Deputy Administrator hereby proposes

that 21 CFR part 1308 be amended as

follows:

PART 1308—[AMENDED]

1. The authority citation for 21 CFR

part 1308 continues to read as follows:

Authority: 21 U.S.C. 811, 812, 871(b)

unless otherwise noted.

§ 1308.14 [Amended]

2. Section 1308.14 is proposed to be

amended by redesignating the existing

paragraph (e)(10) as (e)(11) and adding

a new paragraph (e)(10) to read as

follows:

§ 1308.14 Schedule IV

* * * * *

(10) Sibutramine .......................................1675

* * * * *

Dated: December 2, 1997.

James S. Milford,

Acting Deputy Administrator.

[FR Doc. 97–31951 Filed 12–5–97; 8:45 am]

BILLING CODE 4410–09–M