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.

Federal Register / Vol. 65, No. 83 / Friday, April 28, 2000 / Notices 24971

ACTION: Notice of meeting.

SUMMARY: In accordance with section

10(a) of the Federal Advisory Committee

Act, this notice announces a meeting of

the Competitive Pricing Advisory

Committee (the CPAC) on May 23, 2000.

The Balanced Budget Act of 1997 (BBA)

requires the Secretary of the Department

of Health and Human Services (the

Secretary) to establish a demonstration

project under which payments to

Medicare+Choice organizations in

designated areas are determined in

accordance with a competitive pricing

methodology. The BBA requires the

Secretary to create the CPAC to make

recommendations on demonstration

area designation and appropriate

research designs for the project. The

CPAC meetings are open to the public.

DATES: The meeting is scheduled for

May 23, 2000, from 9 a.m. until 1 p.m.,

e.d.s.t.

ADDRESSES: The meeting will be held at

the Double Tree Hotel Park Terrace,

1515 Rhode Island Avenue, NW.,

Washington, D.C. 20005.

FOR FURTHER INFORMATION CONTACT:

Sharon Arnold, Ph.D., Executive

Director, Competitive Pricing Advisory

Committee, Health Care Financing

Administration, 7500 Security

Boulevard C4–14–17, Baltimore,

Maryland 21244–1850, (410) 786–6451.

Please refer to the HCFA Advisory

Committees Information Line (1–877–

449–5659 toll free)/(410–786–9379

local) or the Internet (http://www/

hcfa.gov/fac) for additional information

and updates on committee activities.

SUPPLEMENTARY INFORMATION:

Section 4011 of the Balanced Budget

Act of 1997 (BBA), Public Law 105–33,

requires the Secretary of the Department

of Health and Human Services (the

Secretary) to establish a demonstration

project under which payments to

Medicare+Choice organizations in

designated areas are determined in

accordance with a competitive pricing

methodology. Section 4012(a) of the

BBA requires the Secretary to appoint a

Competitive Pricing Advisory

Committee (the CPAC) to meet

periodically and make

recommendations to the Secretary

concerning the designation of areas for

inclusion in the project and appropriate

research design for implementing the

project. The CPAC has previously met

on May 7, 1998, June 24 and 25, 1998,

September 23 and 24, 1998, October 28,

1998, January 6, 1999, May 13, 1999,

July 22, 1999, September 16, 1999,

October 29, 1999, and January 12, 2000.

The CPAC consists of 15 individuals

who are independent actuaries; experts

in competitive pricing and the

administration of the Federal Employees

Health Benefit Program; and

representatives of health plans, insurers,

employers, unions, and beneficiaries.

The CPAC members are: James Cubbin,

Executive Director, General Motors

Health Care Initiative; Robert Berenson,

M.D., Director, Center for Health Plans

and Providers, HCFA; John Bertko,

Actuary Principal, Humana Inc.; David

Durenberger, Vice President, Public

Policy Partners; Gary Goldstein, M.D.,

Healthcare Consultant; Samuel Havens,

Healthcare Consultant; Margaret Jordan,

Executive Vice President, Texas Health

Resources; Chip Kahn, President, The

Health Insurance Association of

America; Cleve Killingsworth, President

and CEO, Health Alliance Plan; Nancy

Kichak, Director, Office of Actuaries,

Office of Personnel Management; Len

Nichols, Principal Research Associate,

The Urban Institute; Robert Reischauer,

President, The Urban Institute; John

Rother, Director, Legislation and Public

Policy, American Association of Retired

Persons; Andrew Stern, President,

Service Employees International Union,

AFL–CIO; and Jay Wolfson, Director,

The Florida Information Center,

University of South Florida. The

Chairperson is James Cubbin and the

Co-Chairperson is Robert Berenson,

M.D. In accordance with section

4012(a)(5) of the BBA, the CPAC will

terminate on December 31, 2004.

The agenda for the May 23, 2000,

meeting will include a discussion of the

components of a Report to Congress

being prepared by the CPAC. Section

533 of the Medicare, Medicaid, and

State Child Health Insurance Program

(SCHIP) Balanced Budget Refinement

Act of 1999, Public Law 106–113,

revised section 4011 of the BBA to

require the CPAC to submit a report on

the following topics:

• Incorporation of original Medicare

fee-for-service into the demonstration.

• Requirements of quality activities

under the demonstration.

• Inclusion of a rural area in the

demonstration.

sbull Requirements of a benefit

structure under the demonstration.

Individuals or organizations that wish

to make 5-minute oral presentations on

the agenda issues should contact the

Executive Director, by 12 noon, May 18,

2000, to be scheduled. The number of

oral presentations may be limited by the

time available. A written copy of the

oral remarks should be submitted to the

Executive Director, no later than 12

noon, May 22, 2000. Anyone who is not

scheduled to speak, may submit written

comments to the Executive Director, by

12 noon, May 22, 2000.

The meeting is open to the public, but

attendance is limited to the space

available. Individuals requiring sign

language interpretation for the hearing

impaired or other special

accommodation should contact the

Executive Director at least 10 days

before the meeting.

(Section 4012 of the Balanced Budget Act of

1997, Public Law 105–33 (42 U.S.C.1395w–

23 note) and section 10(a) of Public Law 92–

463 (5 U.S.C. App. 2, section 10(a))

(Catalog of Federal Domestic Assistance

Program No. 93.773, Medicare—Hospital

Insurance; and Program No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: April 18, 2000.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing

Administration.

[FR Doc. 00–10555 Filed 4–27–00; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–3053–N]

Medicare Program; Open Town Hall

Meeting To Promote and Establish

Partnerships Between the Medicare

Peer Review Organizations (PROs) and

Entities in the Health Care Community

To Foster Health Care Quality

Improvement—May 15, 2000

AGENCY: Health Care Financing

Administration (HCFA), DHHS.

ACTION: Notice of meeting.

SUMMARY: This notice announces the

second in a series of Partnership Open

Town Hall Meetings for the purpose of

exploring and exercising opportunities

for the entire health care community to

collaborate with the PROs on quality

improvement projects that will raise the

quality of care provided to Medicare

beneficiaries and to all patients. The

primary focus of the quality

improvement partnerships will be six

national clinical topics, including acute

myocardial infarction, breast cancer,

diabetes, heart failure, pneumonia, and

stroke. We view this meeting as an

opportunity to develop partnerships

with the provider, practitioner, plan,

purchaser and beneficiary communities.

The meeting is open to the public, but

attendance is limited to space available.

DATES The meeting: The meeting will be

held on Monday, May 15, 2000, from

9:00 a.m. until 4:00 p.m., EDT.