Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 / Notices 34433

Paces Ferry Road, NE., Room 300, Mail

Stop E–18, Atlanta, GA 30305,

telephone (404) 842–6593, by fax (404)

842–6513, or by the Internet address:

gld1@cdc.gov.

Programmatic technical assistance

and information about studies cited in

this announcement may be obtained

from Leah Robin, Ph.D., Division of

Adolescent and School Health, National

Center for Chronic Disease Prevention

and Health Promotion, Centers for

Disease Control and Prevention (CDC),

4700 Buford Highway, NE., Mail Stop

K–33, Atlanta, GA 30341-3717;

telephone (770) 488–3210, or by the

Internet address: ler7@cdc.gov.

You may obtain this announcement,

and other CDC announcements, from

one of two Internet sites on the actual

publication date: CDC’s homepage at

http://www.cdc.gov or at the

Government Printing Office homepage

(including free on-line access to the

Federal Register at http://

www.access.gpo.gov).

Please refer to Announcement

Number 98085 when requesting

information and submitting an

application.

Potential applicants may obtain a

copy of:

1. ‘‘Healthy People 2000’’ (Full

Report, Stock No. 017–001-00474–0), or

‘‘Healthy People 2000’’ (Summary

Report, Stock No. 017–001–00473–1),

referenced in the ‘‘Introduction’’

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

2. ‘‘Reaching Out to Youth Out of the

Education Mainstream’’ (NCJ 163920),

referenced in the section entitled

‘‘Background,’’ through the Office of

Juvenile Justice and Delinquency

Prevention’s Juvenile Justice

Clearinghouse, P.O. Box 6000,

Rockville, MD 20849–6000; telephone

(800) 638–8736; E-mail:

aksncirs@ncirs.org.

Dated: June 18, 1998.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

Attachment 1

Youth in High-Risk Situations

The following is the Centers for Disease

Control and Prevention’s definition of youth

in high-risk situations. (From CDC, ‘‘Report

of the Fourth Meeting of the CDC Advisory

Committee on the Prevention of HIV

Infection,’’ November 7–8, 1990.)

Young people between the ages of 10 and

24 who fit at least one of the following

categories are considered at high risk for HIV

infection:

1. Homeless youth

2. Runaway youth

3. Youth not in school and unemployed

4. Youth requiring drug or alcohol

rehabilitation

5. Youth who interface with the juvenile

corrections system

6. Medically indigent youth

7. Youth requiring mental health services

8. Youth in foster homes

9. Migrant farm worker youth

10. Gay or lesbian youth

11. Youth with STDs, especially genital ulcer

disease

12. Sexually abused youth

13. Sexually active youth

14. Pregnant youth

15. Youth seeking counseling and testing for

HIV infection

16. Youth with signs and symptoms of HIV

infection or AIDS without alternative

diagnosis

17. Youth who barter or sell sex

18. Youth who use illegal injected drugs

(including crack cocaine)

Some characteristics of youth who fit the

definition of youth at high risk for HIV

infection pose barriers to effective

intervention. Those characteristics include:

1. feeling invulnerable to disease;

2. having little adult supervision, whether at

home, having run away from home, or

having been asked to leave home;

3. a history of emotional, sexual, and/or

physical abuse;

4. distrust of adults;

5. serious emotional and personal problems;

6. disenfranchised from institutions that

normally provide structure and support;

and

7. difficulty filling basic human needs for

food, shelter, money, and safety—

consequently placing prevention of HIV

infection a low priority.

[FR Doc. 98–16766 Filed 6–23–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0376]

Guidance on FDA’s Expectations of

Medical Device Manufacturers

Concerning the Year 2000 Date

Problem

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the guidance entitled

‘‘Guidance on FDA’s Expectations of

Medical Device Manufacturers

Concerning the Year 2000 Date

Problem.’’ The guidance, which is

included in this notice, is a Level 1

guidance that is immediately effective

in accordance with FDA’s good

guidance practices (GGP’s) criteria,

which allow immediate implementation

of guidance that is necessary for public

health reasons. FDA will receive

comments on the guidance at any time

and consider them in determining

whether to amend the current guidance.

DATES: This guidance is effective June

24, 1998. Submit written comments by

September 22, 1998. After the close of

the comment period, written comments

may be submitted at any time to Thomas

B. Shope (address below).

ADDRESSES: See the SUPPLEMENTARY

INFORMATION section for information on

electronic access to the guidance in this

notice.

Submit comments during the

comment period to: Dockets

Management Branch (HFA–305),

Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. Such

comments will be considered when

determining whether to amend the

current guidance. Comments should

be identified with the docket

number found in brackets in the

heading of this document.

Submit comments at any time after

the close of the comment period to:

Thomas B. Shope (address below).

Comments may not be acted upon

by the agency until the document is

next revised or updated.

FOR FURTHER INFORMATION CONTACT:

Thomas B. Shope, Center for Devices

and Radiological Health (HFZ–140),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–3314, ext. 32.

SUPPLEMENTARY INFORMATION:

I. Background

The guidance entitled ‘‘Guidance on

FDA’s Expectations of Medical Device

Manufacturers Concerning the Year

2000 Date Problem’’ reviews the legal

responsibilities of device manufacturers

under the Federal Food, Drug, and

Cosmetic Act in ensuring the

uninterrupted functioning of any

medical device that might be impacted

by the Year 2000 date problem. It also

reviews legislative and regulatory

requirements applicable to device

manufacturers with regard to correcting

potential Year 2000 problems, to

indicate when corrective action is or is

not required, to present

recommendations for device

assessment, and to encourage reporting

on the status of devices that are

adversely affected by the Year 2000 date

problem.

II. Significance of Guidance

This guidance document represents

the agency’s current thinking on FDA’s
34434 Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 / Notices

expectations of medical device

manufacturers concerning the Year 2000

date problem. It does not create or

confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

applicable statute, regulations, or both.

The agency has adopted GGP’s that

set forth the agency’s policies and

procedures for the development,

issuance, and use of guidance

documents (62 FR 8961, February 27,

1997). This guidance document is

issued as a Level 1 guidance consistent

with GGP’s.

III. Electronic Access

In order to receive the guidance

entitled ‘‘Guidance on FDA’s

Expectations of Medical Device

Manufacturers Concerning the Year

2000 Date Problem’’ via your fax

machine, call the CDRH Facts-OnDemand (FOD) system at 800–899–0381

or 301–827–0111 from a touch-tone

telephone. At the first voice prompt

press 1 to access DSMA Facts, at the

second voice prompt press 2, and then

enter the document number 2000

followed by the pound sign (#). Then

follow the remaining voice prompts to

complete your request.

Persons interested in obtaining a copy

of the guidance may also use the World

Wide Web (WWW). CDRH maintains an

entry on the WWW for easy access to

information including text, graphics,

and files that may be downloaded to a

personal computer with access to the

Web. Updated on a regular basis, the

CDRH home page includes guidances,

device safety alerts, Federal Register

reprints, information on premarket

submissions (including lists of approved

applications and manufacturers’

addresses), small manufacturers’

assistance, information on video

conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh. The

guidance entitled ‘‘Guidance on FDA’s

Expectations of Medical Device

Manufacturers Concerning the Year

2000 Date Problem’’ will be available at

http://www.fda.gov/cdrh/yr2000/

y2kguide.html.

A text-only version of the CDRH web

site is also available from a computer or

VT–100 compatible terminal by dialing

800–222–0185 (terminal settings are 8/

1/N). Once the modem answers, press

Enter several times and then select

menu choice 1: FDA BULLETIN BOARD

SERVICE. From there follow

instructions for logging in, and at the

BBS TOPICS PAGE, arrow down to the

FDA home page (do not select the first

CDRH entry). Then select Medical

Devices and Radiological Health. From

there select CENTER FOR DEVICES

AND RADIOLOGICAL HEALTH for

general information, or arrow down for

specific topics.

IV. Comments

Interested persons may, on or before

September 22, 1998, submit to the

Dockets Management Branch (address

above) written comments regarding the

guidance for medical devices. After the

close of the comment period, comments

may be submitted at any time to Thomas

B. Shope (address above). Two copies of

any comments are to be submitted,

except that individuals may submit one

copy. Comments are to be identified

with the docket number found in

brackets in the heading of this

document. A copy of the guidance and

received comments may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: June 11, 1998.

Linda S. Kahan,

Acting Deputy Director for Regulations Policy,

Center for Devices and Radiological Health.

The text of the guidance is set forth

below:

BILLING CODE 4160–01–P
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[FR Doc. 98–16736 Filed 6–23–98; 8:45 am]

BILLING CODE 4160–01–C

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–320]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

In compliance with the requirement

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

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the burden estimate or any

other aspect of this collection of

information, including any of the

following subjects: (1) the necessity and

utility of the proposed information

collection for the proper performance of

the agency’s functions; (2) the accuracy

of the estimated burden; (3) ways to

enhance the quality, utility, and clarity

of the information to be collected; and

(4) the use of automated collection

techniques or other forms of information

technology to minimize the information

collection burden.

Type of Information Collection

Request: Reinstatement, with change, of

a previously approved collection for

which approval has expired; Title of

Information Collection: Corrective

Action Plan (Medicaid Eligibility

Quality Control) and Supporting

Regulations 42 CFR 431.; Form No.:

HCFA–320; Use: Medicaid eligibility

quality control (MEQC) is a Stateadministered system designed to

improve the management of the

Medicaid program. States are required

to submit a corrective action plan

annually. The plan must detail the

initiatives the State will implement in

order to reduce the type of errors

occurring in the Medicaid eligibility

determination process. Frequency:

Annually; Affected Public: State, Local

or Tribal Government; Number of

Respondents: 21; Total Annual

Responses: 21; Total Annual Hours:

8,400.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, E-mail

your request, including your address

and phone number, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, DC 20503.

Dated: June 16, 1998.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Information

Technology Investment Management Group,

Division of HCFA Enterprise Standards.

[FR Doc. 98–16794 Filed 6–23–98; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR 4352–N–03]

Notice of Proposed Information

Collection: Comment Request

AGENCY: Office of the Assistant

Secretary for Public and Indian

Housing, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

will be submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments due date: August 24,

1998.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

Control Number and should be sent to:

Mildred M. Hamman, Reports Liaison

Officer, Department of Housing and

Urban Development, 451 Seventh Street,

SW, Room 4238, Washington, DC 20410.

FOR FURTHER INFORMATION CONTACT:

Mildred M. Hamman, (202) 708–3642,

extension 4128, for copies of other

available documents. (This is not a tollfree number).

SUPPLEMENTARY INFORMATION: The

Department will submit the proposed

information collection to OMB for

review, as required by the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35, as amended).

This Notice is soliciting comments

from members of the public and

affecting agencies concerning the

proposed collection of information to:

(1) Evaluate whether the proposed

collection of information is necessary

for the proper performance of the

functions of the agency, including

whether the information will have

practical utility; (2) Evaluate the

accuracy of the agency’s estimate of the

burden of the proposed collection of

information; (3) Enhance the quality,

utility, and clarity of the information to

be collected; and (4) Minimize the

burden of the collection of information

on those who are to respond; including

through the use of appropriate

automated collection techniques or

other forms of information technology,

e.g., permitting electronic submission of

responses.

This notice also lists the following

information:

Title of Proposal: Comprehensive

Grant Program (CGP) Reporting

Requirements.

OMB Control Number if applicable:

2577–0157.

Description of the need for the

information and proposed use: Public

Housing Agencies (PHAs) with 250