Federal Register / Vol. 63, No. 76 /Tuesday, April 21, 1998 / Notices 19735

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Part Form No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

710 FDA 2511 50 1 50 0.4 20

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The burden estimates are based on

past experience and on discussions with

registrants during routine

communications. FDA receives an

average of 50 registration submissions

annually. There has been no change

over the past 13 years in the number of

submissions of Form FDA 2511 or in the

time it takes to complete this form.

Dated: April 14, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–10405 Filed 4–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0148]

International Drug Scheduling;

Convention on Psychotropic

Substances; Dihydroetorphine,

Ephedrine, and Remifentanil; Isomers

of Psychotropic Substances

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; correction.

The Food and Drug Administration

(FDA) is correcting a notice that

appeared in the Federal Register of

March 18, 1998 (63 FR 13258). The

document announced an upcoming

World Health Organization review of

three substances. The document was

published with an error. This document

corrects that error.

FOR FURTHER INFORMATION CONTACT:

Nicholas P. Reuter, Office of Health

Affairs (HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1696, Email: NReuter@bangate.fda.gov.

In FR Doc. 98–6910, beginning on

page 13258 in the Federal Register of

Wednesday, March 18, 1998, the

following correction is made:

1. On page 13259, in the first column,

in the fourth full paragraph, the second

sentence ‘‘Remifentanil is approved in

the United States as an anesthetic for

use in animals and is controlled

domestically as a narcotic in schedule II

of the CSA.’’ is corrected to read as

follows: ‘‘Remifentanil is approved in

the United States as an anesthetic and

is controlled domestically as a narcotic

in schedule II of the CSA.’’

Dated: April 14, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–10404 Filed 4–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Science Advisory Board to the

National Center for Toxicological

Research; 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). At least one portion of the

meeting will be closed to the public.

Name of Committee: Science

Advisory Board to the National Center

for Toxicological Research (NCTR).

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on May 6, 1998, 9 a.m. to 5 p.m.,

and May 7, 1998, 9 a.m. to 11 a.m.

Location: NCTR, Jefferson, AR.

Contact Person: Ronald F. Coene,

NCTR (HFT–10), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–6696, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12559. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The board will be presented

with draft reports on evaluations of

three of NCTR’s programs in

Information Technology, Biometry and

Risk Assessment, and Neurotoxicology

for their review, discussion, and

approval. The draft reports are the

products of three site visit teams who

conducted onsite reviews over the last

9 months. The staff from these programs

will provide a preliminary response to

the issues raised and recommendations

made. A progress report will be

presented to the board on the

recommendations it made at its last

meeting on NCTR’s Estrogen Knowledge

Base project. Also, there will be a Center

Director’s update.

Procedure: On May 6, 1998, from 9

a.m. to 5 p.m., and May 7, 1998, from

9 a.m. to 11 a.m., 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 April 17, 1998. Oral

presentations from the public will be

scheduled between approximately 11

a.m. and 12 m., on May 7, 1998. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before April 17, 1998,

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.

Closed Committee Deliberations. On

May 7, 1998, from 1 p.m. to 2:30 p.m.,

the meeting will be closed to permit

discussion where disclosure would

constitute a clearly unwarranted

invasion of personal privacy (5 U.S.C.

552b(c)(6)). This portion of the meeting

will be closed to permit discussion of

information concerning individuals

associated with the research programs at

NCTR.

The Commissioner approves the

scheduling of meetings at locations

outside of the Washington, DC, area on

the basis of the criteria of 21 CFR 14.22

of FDA’s regulations relating to public

advisory committees.