13326 Federal Register / Vol. 66, No. 43 / Monday, March 5, 2001 / Notices

Recommendation

Although GHB is an endogenous

compound that exists in the human

body, GHB has psychoactive and toxic

effects when administered. The pattern

and consequences of its abuse in a

number of countries in Europe and the

USA seem to suggest that its liability to

abuse constitutes a significant risk to

public health. The current easy

availability of GHB and some of its

precursors has contributed to its recent

abuse. The wide availability is likely to

be reduced once GHB is placed under

international control. On these bases, it

is recommended that GHB be placed in

Schedule IV of the 1971 Convention on

Psychotropic Substances.

Zolpidem (INN) Substance

Identification

Zolpidem is chemically N,N,6-

trimethyl-2-p-tolylimidazo [1,2-

a]pyridine-3-acetamide; N,N,6-

trimethyl-2-(4-

methylphenyl)imidazo[1,2-a]pyridine-3-

acetamide (CAS 82626–48–0). Trade

names include: Ambien, Bikalm, Niotal,

Stilnoct, Stilnox.

Similarity to Known Substances and

Effects on the Central Nervous System

Though chemically different from

benzodiazepines, zolpidem produces

benzodiazepine-like effects. It acts as an

agonist binding with high and low

affinity to BZ1 and BZ2 receptor

subtypes, respectively. It is generally

believed to produce relatively greater

hypnotic effects than other

benzodiazepine-like effects.

Dependence Potential

The results of human laboratory

studies suggest that zolpidem and

triazolam are generally similar in terms

of producing subjective reinforcing

effects. As with many of the

benzodiazepines, there have been a

number of case reports describing

withdrawal symptoms after cessation of

zolpidem administration. Though

withdrawal discomfort does not

necessarily lead to compulsory drug

taking (drug dependence) in humans,

there are reports of clinically diagnosed

cases of drug dependence resulting from

a prolonged use of zolpidem.

Actual Abuse and/or Evidence of

Likelihood of Abuse

Epidemiological studies indicate that

zolpidem is associated with relatively

low incidence of abuse. Sporadic case

reports in the scientific literature have

indicated that zolpidem is abused, but

these cases usually involved patients

with histories of drug abuse or chronic

psychiatric disorders. Cases of zolpidem

overdose requiring emergency treatment

have been reported. Death due to

zolpidem overdose is rare. Rates of

actual abuse and dependence of

zolpidem appear to be similar to other

hypnotic benzodiazepines in Schedule

IV. In terms of the numbers of cases of

abuse, dependence and withdrawal

reported as adverse drug reactions to the

WHO adverse drug reaction database,

less than ten benzodiazepines are

ranked higher than zolpidem.

Therapeutic Usefulness

Zolpidem is used for treatment of

insomnia in more than 80 countries.

Recommendation

Although zolpidem has a somewhat

novel neuropharmacological profile

relative to classic benzodiazepines,

studies of its abuse potential suggest

that it may be comparable to that of

many benzodiazepines. Furthermore,

rates of actual abuse and dependence of

zolpidem in medical use, as well as the

risk to public health of its abuse, appear

to be similar to hypnotic

benzodiazepines presently placed in

Schedule IV. On these bases, it is

recommended that zolpidem be placed

in Schedule IV of the 1971 Convention

on Psychotropic Substances.

I. Discussion

Although WHO has made specific

scheduling recommendations for each of

the drug substances, the CND is not

obliged to follow the WHO

recommendations. Options available to

the CND for substances considered for

control under the Psychotropic

Convention include: (1) Acceptance of

the WHO recommendations; (2)

acceptance of the recommendations to

control, but control the drug substance

in a schedule other than that

recommended; or (3) rejection of the

recommendations entirely.

4-Bromo-2,5-

dimethoxyphenethylamine (2C-B) is a

Schedule I controlled substance in the

United States. The U.S. Drug

Enforcement Administration (DEA)

placed 2C-B (including salts, isomers,

and salts of isomers: isomers include

optical, positional, and geometric) in

Schedule I of the Controlled Substance

Act (CSA) in June 1995. 4-

methylthioamphetamine (4-MTA) is not

marketed in the United States and is not

currently a controlled substance in the

United States. Gamma hydroxybutyric

acid (GHB) is a Schedule I controlled

substance in the United States. GHB,

including its salts, optical isomers, and

salts of optical isomers, became a

Schedule I controlled substance in

March 2000. Registered manufacturers

and distributors of GHB when it is

manufactured, distributed, or possessed

in accordance with an FDA authorized

investigational new drug exemption

under Section 505(i) of the Federal

Food, Drug, and Cosmetic Act (21 USC

355(i)) are subject to Schedule III

security requirements. If FDA approves

a drug product containing GHB for

marketing, the approved product will be

placed into Schedule III under Public

Law 106–172. Zolpidem, its salts,

isomers, and salts of isomers, is a

Schedule IV controlled substance in the

United States. The DEA placed

zolpidem in Schedule IV in February

1993. With the exception of 4-MTA,

current controls in the United States on

the substances under consideration for

international control appear to meet the

requirements of the recommended

Psychotropic Convention schedules.

IV. Comments

Interested persons may, on or before

March 15, 2001, submit to the Dockets

Management Branch (address above)

written comments regarding this notice.

This abbreviated comment period is

necessary to allow HHS to furnish a

recommendation to the Secretary of

State in time for the March 2001

meeting of the United Nations

Commission on Narcotic Drugs.

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 (address above)

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

through Friday.

Dated: February 27, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–5218 Filed 2–28–01; 11:36 am]

BILLING CODE 4160–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Blood Products Advisory Committee;

Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Blood Products

Advisory Committee.

General Function of the Committee:

To provide advice and

Federal Register / Vol. 66, No. 43 / Monday, March 5, 2001 / Notices 13327

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on March 15, 2001, from 8:30 a.m.

to 6 p.m. and on March 16, 2001, from

8:30 a.m. to 12 noon.

Location: Hilton, 620 Perry Pkwy.,

Gaithersburg, MD.

Contact: Linda A. Smallwood, Center

for Biologics Evaluation and Research

(HFM–302), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

3514, or FDA Advisory Committee

Information Line, 1–800–741–8138

(301–443–0572 in the Washington, DC

area), code 19516. Please call the

Information Line for up-to-date

information on this meeting.

Agenda: On March 15, 2001, the

committee will hear presentations,

discuss and make recommendations on

the comparative sensitivity of Hepatitis

B Virus nucleic acid testing versus

Hepatitis B Surface Antigen testing. In

the afternoon, the committee will hear

presentations, discuss and make

recommendations on the

implementation of nucleic acid testing

for Hepatitis C Virus and human

immunodeficiency virus, testing donor

and product management, and blood

bags for diversion of the initial

collection. On March 16, 2001, the

committee will hear updates on the

following topics: (1) Summaries of the

Transmissible Spongiform

Encephalopathies Advisory Committee

Meeting and the Public Health Service

Advisory Committee Meeting on blood

safety and availability, and (2) The

Office of Inspector General’s report on

tissue and organ regulation. The

committee will additionally hear

presentations, discuss and make

recommendations on the topic of

guidance on malaria, applicability to

plasma.

Procedure: On March 15, 2001, from

8:30 a.m. to 6 p.m. and on March 16,

2001, from 8:30 a.m. to 12 noon, the

meeting is open to the public. Interested

persons may present data, information,

or views, orally or in writing, on issues

pending before the committee. Written

submissions may be made to the contact

person by March 9, 2001. Oral

presentations from the public will be

scheduled between approximately 9:30

a.m. and 10:30 a.m., 1:30 p.m. and 2:30

p.m., and 4:30 p.m. and 5:30 p.m. on

March 15, 2001, and 10:15 a.m. and

10:30 a.m. on March 16, 2001. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before March 9, 2001,

and submit a brief statement of the

general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time requested to make

their presentation.

FDA regrets that it was unable to

publish this notice 15 days prior to the

March 15 to 16, 2001, Blood Products

Advisory Committee meeting. Because

the agency believes there is some

urgency to bring these issues to public

discussion and qualified members of the

Blood Products Advisory Committee

were available at this time, the

Commissioner of Food and Drugs

concluded that it was in the public

interest to hold this meeting even if

there was not sufficient time for the

customary 15-day public notice.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: February 28, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–5375 Filed 3–1–01; 11:53 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–1728]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Revision of a currently

approved collection; Title of

Information Collection: Home Health

Agency Cost Report and Supporting

Regulations in 42 CFR 413.20, 413.24

and 413.106; Form No.: HCFA–1728

(OMB No. 0938–0022); Use:

Participating providers are required to

submit annual information to HCFA in

order to achieve settlement of costs for

health care services rendered to

Medicare beneficiaries. The HCFA–1728

is the form used by Home Health

Agencies to report their health care

costs to determine the amount

reimbursable for services furnished to

Medicare beneficiaries; Frequency:

Annually; Affected Public: Business or

other for profit, Not for profit

institutions, and State, Local or Tribal

Gov.; Number of Respondents: 7,310;

Total Annual Responses: 7,310; Total

Annual Hours Requested: 1,293,870.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB desk officer: OMB Human

Resources and Housing Branch,

Attention: Wendy Taylor, New

Executive Office Building, Room 10235,

Washington, D.C. 20503.

Dated: February 15, 2001.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–5181 Filed 3–2–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–108]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the