43534 Federal Register / Vol. 62, No. 157 / Thursday, August 14, 1997 / Notices

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of

responses

per respondent

Average

burden

hours per

response

Total burden hours

ACF–196 ........................................................................................................................... 54 4 8 1,728

Estimated Total Annual Burden

Hours: 1,728.

In compliance with the requirements

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

Paperwork Reduction Act of 1995, the

Administration for Children and

Families is soliciting public comment

on the specific aspects of the

information collection described above.

Copies of the proposed collection of

information can be obtained and

comments may be forwarded by writing

to the Administration for Children and

Families, Office of Information Services,

Division of Information Resource

Management Services, 270 L’Enfant

Promenade, S.W., Washington, D.C.

20447, Attn: ACF Reports Clearance

Officer. All requests should be

identified by the title of the information

collection.

The Department specifically requests

comments on: (a) Whether the proposed

collection of information is necessary

for the proper performance of the

functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

the quality, utility, and clarity of the

information to be collected; and (d)

ways to minimize the burden of the

collection of information on

respondents, including through the use

of automated collection techniques or

other forms of information technology.

Consideration will be given to

comments and suggestions submitted

within 60 days of this publication.

Dated: August 11, 1997.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 97–21535 Filed 8–13–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0321]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by September

15, 1997.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane, rm.

16B–19, Rockville, MD 20857, 301–827–

4659.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed

collection of information to OMB for

review and clearance:

Advisory Opinions—21 CFR 10.85

(OMB Control No. 0910–0193—

Reinstatement)

Section 10.85 (21 CFR 10.85), issued

under section 701(a) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

371(a)), provides that an interested

person may request an advisory opinion

from the Commissioner of Food and

Drugs (the Commissioner) on a matter of

general applicability. Section 10.85 sets

forth the format and instructions for

making an advisory opinion request.

When making a request, the petitioner

must provide a concise statement of the

issues and questions on which an

opinion is requested and a full

statement of the facts and legal points

relevant to the request. An advisory

opinion represents the formal position

of FDA on a matter of general

applicability.

Respondents to this collection of

information are parties seeking an

advisory opinion from the

Commissioner on the agency’s formal

position for matters of general

applicability.

FDA estimates the burden of the

collection of information provisions for

these regulations as follows:

ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

10.85 8 1 8 16 128

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

The burden estimate for this

collection of information is based on

agency data received on this

administrative procedure for the past 3

years. Agency personnel responsible for

the processing of requests for an

advisory opinion estimate

approximately eight requests are

received annually by the agency, each

requiring an estimated 16 hours of

preparation time.

Dated: August 8, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–21586 Filed 8–13–97; 8:45 am]

BILLING CODE 4160–01–F