Federal Register / Vol. 66, No. 43 / Monday, March 5, 2001 / Notices 13323

publication of this document in the

Federal Register. Therefore, a comment

is best assured of having its full effect

if OMB receives it within 30 days of

publication. Written comments and

recommendations for the proposed

information collection should be sent

directly to the following: Office of

Management and Budget, Paperwork

Reduction Project, 725 17th Street, NW.,

Washington, DC 20503, Attn: Desk

Officer for ACF.

Dated: February 27, 2001.

Bob Sargis,

Reports Clearance Officer.

[FR Doc. 01–5234 Filed 3–2–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1441]

Agency Information Collection

Activities; Announcement of OMB

Approval; Infant Formula

Requirements

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Infant Formula Requirements’’ has

been approved by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of November 9, 2000

(65 FR 67388), the agency announced

that the proposed information collection

had been submitted to OMB for review

and clearance under 44 U.S.C. 3507. An

agency may not conduct or sponsor, and

a person is not required to respond to,

a collection of information unless it

displays a currently valid OMB control

number. OMB has now approved the

information collection and has assigned

OMB control number 0910–0256. The

approval expires on February 29, 2004.

A copy of the supporting statement for

this information collection is available

on the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: February 23, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–5158 Filed 3–2–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1257]

International Drug Scheduling;

Convention on Psychotropic

Substances; Single Convention on

Narcotic Drugs; World Health

Organization Scheduling

Recommendations for 4-Bromo-2,5-

dimethoxyphenethylamine (2C–B);

Gamma-hydroxybutyric acid (GHB); 4-

Methylthioamphetamine (4-MTA);

Zolpidem (INN)

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is providing

interested persons with the opportunity

to submit written comments concerning

recommendations by the World Health

Organization (WHO) to impose

international manufacturing and

distribution restrictions, under

international treaties, on certain drug

substances. The comments received in

response to this notice will be

considered in preparing the U.S.

position on these proposals for a

meeting of the United Nations

Commission on Narcotic Drugs (CND) in

Vienna, Austria, March 20 to 29, 2001.

This notice is issued under the

Controlled Substances Act.

DATES: Submit written comments by

March 15, 2001.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. To ensure

expeditious review of written

comments, send a copy by facsimile or

e-mail to: James R. Hunter (address

below).

FOR FURTHER INFORMATION CONTACT:

James R. Hunter, Controlled Substances

Staff (HFD–9), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–2098,

Fax: 301–443–9222, e-mail:

hunterj@cder.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

The United States is a party to the

1971 Convention on Psychotropic

Substances (the Convention). Section

201(d)(2)(B) of the Controlled

Substances Act (the CSA) (21 U.S.C.

811(d)(2)(B)) provides that when the

United States is notified under Article 2

of the Convention that CND proposes to

decide whether to add a drug or other

substance to one of the schedules of the

Convention, transfer a drug or substance

from one schedule to another, or delete

it from the schedules, the Secretary of

State must transmit notice of such

information to the Secretary of Health

and Human Services (HHS). The

Secretary of HHS must then publish a

summary of such information in the

Federal Register and provide

opportunity for interested persons to

submit comments. The Secretary of HHS

must then evaluate the proposal and

furnish a recommendation to the

Secretary of State that shall be binding

on the representative of the United

States in discussions and negotiations

relating to the proposal.

As detailed below, the Secretary of

State has received notification from the

Secretary-General of the United Nations

(the Secretary-General) regarding

substances to be considered for control

under the Convention. The notification

reflects the recommendations from the

31st WHO Expert Committee for Drug

Dependence (ECDD), which met in June

1998. In the Federal Register of April

28, 2000 (65 FR 24969), FDA announced

the WHO ECDD review, and the agency

invited interested persons to submit

information for WHO’s consideration.

The full text of the notification from

the Secretary-General is provided in

section II of this document. Section

201(d)(2)(B) of the CSA requires the

Secretary of HHS, after receiving a

notification proposing scheduling, to

publish a notice in the Federal Register

to provide the opportunity for interested

persons to submit information and

comments on the proposed scheduling

action.

II. United Nations Notification

The formal United Nations

notification that identifies the drug

substances and explains the basis for the

recommendations is reproduced below.

Notification on 2C-B, 4-MTA, GHB

and Zolpidem: Reference: NAR/CL.26/

2000 CU 2000/240.

C1971/WHO

UNDCP 42nd CND

TLACSB/CNDS–40/00

The Secretary-General of the United

Nations presents his compliments to the

Secretary of State of the United States of