Federal Register / Vol. 65, No. 83 / Friday, April 28, 2000 / Notices 24969

1 If the reply to the questionnaire confirms a

medical use of 4-MTA recognized by any Member

State, the substance will be subjected to a prereview

instead of a critical review.

2For Ministries of Health only.

Name: Board of Scientific Counselors,

National Center for Infectious Diseases

(NCID).

Times and Dates: 9 a.m.–5:30 p.m.,

May 4, 2000. 8:30 a.m.–2:30 p.m., May

5, 2000.

Place: CDC, Conference Room

Building 17, 1600 Clifton Road, Atlanta,

Georgia 30333.

Status: Open to the public, limited

only by the space available.

Purpose: The Board of Scientific

Counselors, NCID, provides advice and

guidance to the Director, CDC, and

Director, NCID, in the following areas:

Program goals and objectives; strategies;

program organization and resources for

infectious disease prevention and

control; and program priorities.

Matters To Be Discussed: Agenda

items will include:

1. NCID Update.

2. CDC Facilities Master Plan.

3. Laboratory Response Capacity.

4. Integrating Surveillance Systems—

NEDSS.

5. Current Issues in Vaccine

Development.

6. Tour of New Facility: Building 17.

7. Discussions.

8. Improving Communications.

9. Program Update: Mycotic Diseases.

10. Transfer of Interstate Quarantine

Authority.

11. Late Breaker: Current Scientific

Issues/Events.

12. Discussions and

Recommendations.

Other agenda items include

announcements/introductions; followup on actions recommended by the

Board December 1999; consideration of

future directions, goals, and

recommendations.

Agenda items are subject to change as

priorities dictate.

Written comments are welcome and

should be received by the contact

person listed below prior to the opening

of the meeting.

Contact Person for More Information:

Diane S. Holley, Office of the Director,

NCID, CDC, M/S C–20, 1600 Clifton

Road, NE, Atlanta, Georgia 30333,

telephone 404/639–0078.

The Director, Management Analysis

and Services office has been delegated

the authority to sign Federal Register

notices pertaining to announcements of

meetings and other committee

management activities, for both the

Centers for Disease Control and

Prevention and the Agency for Toxic

Substances and Disease Registry.

Dated: April 24, 2000.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention.

[FR Doc. 00–10681 Filed 4–27–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1257]

International Drug Scheduling;

Convention on Psychotropic

Substances; 4-Bromo-2,5-

dimethoxyphenethylamine (2C-B);

Gamma-hydroxybutyric acid (GHB); 4-

Methylthioamphetamine (4-MTA); NMethyl-1-(3,4-methylenedioxyphenyl)-

2-butanamine (MBDB); Diazepam

(INN); Zolpidem (INN)

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

interested persons to submit comments

concerning abuse potential, actual

abuse, medical usefulness, and

trafficking of six drug substances. These

comments will be considered in

preparing a response from the United

States to the World Health Organization

(WHO) regarding the abuse liability and

diversion of these drugs. WHO will use

this information to consider whether to

recommend that certain international

restrictions be placed on these drugs.

This notice requesting comments is

required by the Controlled Substances

Act (CSA).

DATES: Submit written comments by

May 15, 2000.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Corinne P. Moody, Center for Drug

Evaluation and Research (HFD–009),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1999, e-mail:

Moody@cder.FDA.gov.

SUPPLEMENTARY INFORMATION: The

United States is a party to the 1971

Convention on Psychotropic

Substances. Article 2 of the Convention

on Psychotropic Substances provides

that if a party to the convention or WHO

has information about a substance,

which in its opinion may require

international control or change in such

control, it shall so notify the Secretary

General of the United Nations and

provide the Secretary General of the

United Nations with information in

support of its opinion.

The CSA (21 U.S.C. 811 et seq.) (Title

II of the Comprehensive Drug Abuse

Prevention and Control Act of 1970)

provides that when WHO notifies the

United States under Article 2 of the

Convention on Psychotropic Substances

that it has information that may justify

adding a drug or other substances to one

of the schedules of the convention,

transferring a drug or substance from

one schedule to another, or deleting it

from the schedules, the Secretary of

State must transmit the notice to the

Secretary of Health and Human Services

(the Secretary of HHS). The Secretary of

HHS must then publish the notice in the

Federal Register and provide

opportunity for interested persons to

submit comments that will be

considered by HHS in its preparation of

the scientific and medical evaluations of

the drug or substance. The Secretary of

HHS received the following notices

from WHO:

I. WHO Notification

Ref.: C.L.1.2000

WHO questionnaire for collection of

information for review of dependenceproducing psychoactive substances.

The Director-General of the World Health

Organization presents her compliments and

has the pleasure of informing Member States

that the Thirty-second Expert Committee on

Drug Dependence (ECDD) will meet from 11

to 14 September 2000 to review the following

substances:

1. 4-Bromo-2,5-dimethoxyphenethylamine

(2C-B)

2. Gamma-hydroxybutyric acid (GHB)

3. 4-Methylthioamphetamine (4-MTA)1

4. N-Methyl-l-(3,4-methylenedioxyphenyl)-

2-butanamine (MBDB)

5. Diazepam (INN)

6. Zolpidem (INN)

One of the essential elements of the

established review procedure is for the

Secretariat to collect relevant information

from Member States to prepare a Critical

Review document for submission to the

Expert Committee on Drug Dependence. The

World Health Organization invites Member

States to collaborate, as in the past, in this

process by providing pertinent information

mentioned in the attached questionnaire2

concerning the substances listed above.

Further clarification on any of the above

items can be obtained from Quality

Assurance and Safety: Medicines (QSM),

Essential Drugs and Medicines Policy (EDM),

WHO, Geneva, to which replies should be

sent not later than 1 May 2000.

24970 Federal Register / Vol. 65, No. 83 / Friday, April 28, 2000 / Notices

3 In this questionnaire, ‘‘abuse or misuse’’ refers

to use of the substance other than for medical or

scientific purposes.

GENEVA, 12 January 2000

WHO Questionnaire for review of

dependence-producing psychoactive

substances by the Thirty-second Expert

Committee on Drug Dependence.

Substance reported on:

1. Availability of the substance (registered,

marketed, dispensed, etc.);

2. Extent of the abuse or misuse3 of the

substance;

3. Degree of seriousness of the public

health and social problems associated with

the abuse of the substance (statistics on cases

of overdose deaths, dependence, etc.); and

4. Any information on the nature and

extent of illicit activities involving the

substance (clandestine manufacture,

smuggling, diversion, seizure, etc.).

In addition to the above, with regard to

Diazepam (INN) report on:

5. The impact of transferring diazepam

from Schedule IV to Schedule III of the

Convention on Psychotropic Substances,

1971, and its effect on availability for

medical use.

In addition to items 1 to 4 above, with

regard to Zolpidem (INN) report on:

6. The impact of placing zolpidem in

Schedule IV of the Convention on

Psychotropic Substances, 1971, and its effect

on availability for medical use.

II. Background

The substance 4-Bromo-2,5-

dimethoxyphenethylamine (2C-B) is a

structural analogue of the

phenethylamine hallucinogens. In

various preclinical and clinical studies,

it has been described as a stimulant,

depressant, and hallucinogen, but

appears to more closely fit the profile of

the latter. It is not marketed in the

United States, however, it is controlled

domestically in Schedule I of the CSA.

Gamma-hydroxybutyric acid (GHB) is

a substance classified as a central

nervous system depressant. It is not

marketed in the United States. The Drug

Enforcement Administration published

a final rule on March 13, 2000 (65 FR

13235), placing gamma-hydroxybutyric

acid and its salts, isomers, and salts of

isomers into Schedule I of the CSA

under Public Law 106–172. The final

rule imposes Schedule III security

requirements for registered

manufacturers and distributors of GHB

when it is manufactured, distributed, or

possessed in accordance with FDA

authorized investigational new drug

exemptions under section 505(i) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 355(i)). If drug products

containing GHB are approved by FDA,

the final rule places FDA approved

products containing GHB into Schedule

III of the CSA under Public Law 106–

172.

The substance 4-

Methylthioamphetamine (4-MTA) is a

compound structurally similar to

amphetamine. 4-MTA is reported to

have physiological effects similar to that

of 3,4-methylenedioxyamphetamine

(MDA) and 3,4-

methylenedioxymethamphetamine

(MDMA/ecstasy). The substance is not

marketed in the United States. It is not

specifically listed as a controlled

substance in the United States.

However, it is considered a Schedule I

controlled substance as an analogue of

either MDA or MDMA under the

analogue provisions of the CSA.

N-Methyl-l-(3,4-

methylenedioxyphenyl)-2-butanamine

(MBDB) is a positional isomer of MDE

(3,4-methylenedioxy-Nethylamphetamine) which is controlled

domestically in Schedule I. The

psychoactive effects of MBDB have been

described as hallucinogenic. It is not

marketed in the United States. As an

isomer of MDE, MBDB is a Schedule I

substance in the United States.

Diazepam (INN) is a benzodiazepine

derivative. It is marketed in the United

States for the management of anxiety

disorders or for the short-term relief of

the symptoms of anxiety; in acute

alcohol withdrawal, it is used in the

symptomatic relief of acute agitation,

tremor, impending or acute delirium

tremens, and hallucinosis; as an adjunct

for the relief of skeletal muscle spasm;

spasticity caused by upper motor

neuron disorders; athetosis; stiff-man

syndrome; tetanus; as an adjunct in

convulsive disorders; and as a

premedication for relief of anxiety and

tension in patients who are to undergo

surgical procedures. Domestically, it is

controlled in Schedule IV of the CSA.

Diazepam is controlled internationally

in Schedule IV of the Psychotropic

Convention.

Zolpidem (INN) is a hypnotic agent

with a chemical structure unrelated to

benzodiazepines, barbiturates, or other

drugs with known hypnotic properties.

It interacts with a GABA–BZ receptor

complex and shares some of the

pharmacological properties of the

benzodiazepines. It is marketed in the

United States for the short-term

treatment of insomnia. Domestically, it

is controlled in Schedule IV of the CSA.

III. Opportunity to Submit Domestic

Information

As required by section 201(d)(2)(A) of

the CSA (21 U.S.C. 811 (d)(2)(A)), FDA,

on behalf of the Department of Health

and Human Services (DHHS), invites

interested persons to submit comments

regarding the six named drugs. Any

comments received will be considered

by DHHS when it prepares a scientific

and medical evaluation of these drugs.

DHHS will forward a scientific and

medical evaluation of these drugs to

WHO, through the Secretary of State, for

WHO’s consideration in deciding

whether to recommend international

control/decontrol of any of these drugs.

Such control could limit, among other

things, the manufacture and distribution

(import/export) of these drugs and could

impose certain recordkeeping

requirements on them.

DHHS will not now make any

recommendations to WHO regarding

whether any of these drugs should be

subjected to international controls.

Instead, DHHS will defer such

consideration until WHO has made

official recommendations to the

Commission on Narcotic Drugs, which

are expected to be made in late 2000.

Any DHHS position regarding

international control of these drugs will

be preceded by another Federal Register

notice soliciting public comments as

required by 201(d)(2)(B) of the CSA.

IV. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding the

drugs by May 15, 2000. This abbreviated

comment period is necessary to allow

sufficient time to prepare and submit

the domestic information package by the

deadline imposed by WHO. Two copies

of any comments are to be submitted,

except that individuals may submit one

copy. Comments are to be identified

with the docket number found in

brackets in the heading of this

document. Received comments may be

seen in the Dockets Management Branch

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

through Friday.

Dated: April 24, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–10631 Filed 4–27–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–1132–N]

Medicare Program; May 23, 2000,

Meeting of the Competitive Pricing

Advisory Committee

AGENCY: Health Care Financing

Administration (HCFA), HHS.