19734 Federal Register / Vol. 63, No. 76 /Tuesday, April 21, 1998 / Notices

Respondents: States.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of responses per

respondent

Average burden hours per

response

Total burden

hours

Survey ............................................................................................................... 51 1 3.75 191.25

Estimated Total Annual Burden

Hours: 191.25.

Additional Information: Copies of the

proposed collection may be obtained by

writing to The Administration for

Children and Families, Office of

Information Services, 370 L’Enfant

Promenade, SW., Washington, DC

20447, Attn: ACF Reports Clearance

Officer.

OMB Comment: OMB is required to

make a decision concerning the

collection of information between 30

and 60 days after 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: Ms.

Wendy Taylor.

Dated: April 14, 1998.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 98–10444 Filed 4–20–98; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0194]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

the voluntary registration of cosmetic

product establishments with FDA.

DATES: Submit written comments on the

collection of information by June 22,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. All comments

should be identified with the docket

number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

including each proposed extension of an

existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information listed below.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Registration of Cosmetic Product

Establishment—21 CFR Part 710 (OMB

Control Number 0910–0027—Extension)

Under the Federal Food, Drug, and

Cosmetic Act (the act), cosmetic

products that are adulterated under

section 601 of the act (21 U.S.C. 361) or

misbranded under section 602 of the act

(21 U.S.C. 362) may not be distributed

in interstate commerce. To assist FDA in

carrying out its responsibility to regulate

cosmetics, FDA requests that

establishments that manufacture or

package cosmetic products register with

the agency on Form FDA 2511

‘‘Registration of Cosmetic Product

Establishment.’’ Regulations providing

procedures for the voluntary registration

of cosmetic product establishments are

found in 21 CFR part 710.

Because mandatory registration of

cosmetic establishments is not

authorized by statute, voluntary

registration provides FDA with the best

information available about the location,

business trading names used, and the

type of activity (manufacturing or

packaging) of cosmetic product

establishments that participate in this

program. In addition, the registration

information is an essential part of

planning onsite inspections to

determine the scope and extent of

noncompliance with applicable

provisions of the act. The registration

information is used to estimate the size

of the cosmetic industry regulated.

Registration is permanent, although

FDA requests that firms submit an

amended registration on Form FDA

2511 if any of the information originally

submitted changes.

FDA uses registration information as

input for a computer data base of

cosmetic product establishments. This

data base is used for mailing lists to

distribute regulatory information or to

invite firms to participate in workshops

on topics they may be interested in.
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.