Federal Register / Vol. 62, No. 243 / Thursday, December 18, 1997 / Notices 66373

Integrity, 5515 Security Lane, Suite 700,

Rockville, MD 20852, (301) 443–5330.

Chris B. Pascal, J.D.,

Acting Director, Office of Research Integrity.

[FR Doc. 97–33035 Filed 12–17–97; 8:45 am]

BILLING CODE 4160–17–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Proposed Information Collection

Activity; Comment Request, Proposed

Projects

Title: IRS Project 1099.

OMB No.: New Collection.

Description: A voluntary program

which provides States’ Child Support

Enforcement agencies upon there

request access to all of the earned and

unearned income information reported

to IRS by employers and financial

institutions. The IRS 1099 information

is used to locate noncustodial parents

and to verify income and employment,

which has proven essential to accurately

establishing and enforcing child support

obligations.

Respondents: State, Local, or Tribal

Govt.

ANNUAL BURDEN ESTIMATES

Instrument Number of respondents

Number of responses per

respondent

Average burden hours per

response

Total burden

hours

OCSE 1099 Request Records ......................................................................... 43 12 1 1,032

Estimated Total Annual Burden

Hours: 1,032.

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, 370 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: December 15, 1997.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 97–33083 Filed 12–17–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0517]

Changes in Medical Device Tracking

and Postmarket Surveillance Authority

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of meeting.

The Food and Drug Administration

(FDA) is announcing the following

meeting: Changes in medical device

tracking and postmarket surveillance

authority under the Food and Drug

Administration Modernization Act of

1997. The topic to be discussed is

postmarket controls, including tracking

and/or surveillance of devices.

Date and Time: The meeting will be

held on January 15, 1998, 9 a.m. to 3

p.m.

Location: The meeting will be held at

the University of Maryland Auditorium,

9640 Gudelsky Dr., Rockville, MD.

Contact: Casper E. Uldriks, Center for

Devices and Radiological Health (HFZ–

300), Food and Drug Administration,

2098 Gaither Rd., Rockville, MD 20850,

301–594–4692, FAX 301–594–4610.

Registration and Requests for Oral

Presentations: Send registration

information (including name, title, firm

name, address, telephone, and fax

number) and written material and

requests to make oral presentations to

the contact person by January 5, 1998.

Written comments may be submitted to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857, by January 5,

1998.

If you need special accommodations

due to a disability, please contact

Casper E. Uldriks at least 7 days in

advance of the meeting.

Transcripts: Transcripts of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, 5600 Fishers Lane, rm.

12A–16, Rockville, MD 20857,

approximately 15 working days after the

meeting at a cost of 10 cents per page.

The agency is interested in discussing

the statutory changes concerning

tracking and postmarket surveillance

under the Food and Drug

Administration Modernization Act of

1997 and whether the agency should

develop additional criteria to use to

determine whether tracking or

postmarket surveillance requirements

should be ordered by FDA. The agency

would like to supplement the statutory

criteria with additional nonbinding

criteria to help determine which devices

may need to be added or removed from

the list of devices subject to tracking

and/or postmarket surveillance

requirements. FDA intends to publish

its revised lists by February 19, 1998,

the effective date of the new law.

By way of example, additional criteria

that would support a tracking order

might include the likelihood of a recall,

or the likelihood of irreversible clinical

outcomes. Additional criteria that might

not support a tracking order, for

example, might include current,

standard clinical practices that mitigate

risk. Additional criteria that would

support a postmarket surveillance order

might include, for example, the use of

a new technology or the need to assess

a new public health issue based on

measurable outcomes. Additional

criteria that would not support a