39624 Federal Register / Vol. 65, No. 124 / Tuesday, June 27, 2000 / Notices

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: Antiviral Drugs

Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on July 25, 2000, 8:30 a.m. to 5

p.m. and on July 26, 2000, 8:30 a.m. to

5 p.m.

Location: Holiday Inn, The Ballrooms,

Two Montgomery Village Ave.,

Gaithersburg, MD.

Contact Person: Nancy Chamberlin or

Beverly O’Neil, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 5600

Fishers Lane, (for express delivery, 5630

Fishers Lane, rm. 1093) Rockville, MD

20857, 301–827–7001, or by e-mail:

CHAMBERLINN@CDER.FDA.GOV, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12531. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On July 25, 2000, the

committee will discuss scientific data

characterizing relationships of

pharmacokinetic parameters and

virologic response to approved

antiretroviral drugs used in the

treatment of human immunodeficiency

virus (HIV) infection. The primary

objectives for the committee

deliberations are to explore the use of

pharmacokinetic data to improve the

evaluation of new formulations,

alternative dosing regimens, and choice

of dosing in the setting of drug-drug

interactions for approved antiretroviral

drugs. Additionally, other issues to be

discussed include: the relationship

between pharmacokinetic parameters

and drug toxicity, and safety

requirements and pediatric

considerations for alternative dosing

regimens.

Procedure: On July 25, 2000, from

8:30 a.m. to 5 p.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 July 11, 2000. Oral

presentations from the public will be

scheduled between approximately 1

p.m. to 2 p.m. on July 25, 2000. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before July 11, 2000, 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

July 26, 2000, from 8:30 a.m. to 5 p.m.,

the meeting will be closed to permit

discussion and review of trade secret

and/or confidential information (5

U.S.C. 552b(c)(4)). Pending

investigational new drug applications

and drug development plans will be

presented, and recent action on selected

new drug applications will be

discussed. This portion of the meeting

will be closed to permit discussion of

this information.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 19, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–16196 Filed 6–26–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Orthopaedic and Rehabilitation

Devices Panel of the Medical Devices

Advisory Committee; 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). The meeting will be open to the

public.

Name of Committee: Orthopaedic and

Rehabilitation Devices Panel of the

Medical Devices Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on July 20, 2000, 9:30 a.m. to 5

p.m.

Location: Holiday Inn, Walker and

Whetstone Rooms, Two Montgomery

Village Ave., Gaithersburg, MD.

Contact Person: Hany W. Demian,

Center for Devices and Radiological

Health (HFZ–410), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–594–2036, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12521. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The committee will discuss,

make recommendations, and vote on

premarket approval application (PMA)

for a shock wave lithotriptor used for

the treatment of heel pain and a PMA

for a ceramic on ceramic total hip

arthroplasty.

Procedure: 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 July 13, 2000. Oral

presentations from the public will be

scheduled between approximately 9:30

a.m. and 10 a.m. on July 20, 2000. Near

the end of the committee deliberations

for both PMA’s, a 30-minute open

public session will be conducted for

interested persons to address issues

specific to the submission before the

committee. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before July 13, 2000, 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.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 20, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–16195 Filed 6–26–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4564–N–05]

Notice of Proposed Information

Collection: National Survey of Lead

Hazards in Child Care Facilities

AGENCY: Office of Lead Hazard Control,

HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement concerning a

National Survey to Assess Lead Hazards

in child care facilities across the country

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.

Federal Register / Vol. 65, No. 124 / Tuesday, June 27, 2000 / Notices 39625

DATES: Comments Due Date: August 28,

2000.

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:

Gail N. Ward, Reports Liaison Officer,

Department of Housing and Urban

Development, 451 7th Street, SW.,

Room P3206, Washington, DC 20410.

FOR FURTHER INFORMATION CONTACT: Joey

Y. Zhou, (202) 755–1758 ext. 153 (this

is not a toll-free number), for copies of

the proposed forms and other available

documents.

SUPPLEMENTARY INFORMATION: The

Department is submitting 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 affected

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.

Title of Proposal: National Survey of

Lead Hazards in Child Care Facilities.

OMB Control Number: To be assigned.

Need for the Information and

Proposed Use: Lead is a highly toxic

heavy metal that adversely affects

virtually every organ system in the

body. Young children are particularly

susceptible to the effects of lead. Lead

poisoning remains one of the top

childhood environmental health

problems today. The most current

national survey (1991–1994) shows that

nearly 900,000 children are lead

poisoned. A large body of evidence

shows that the most common source of

lead exposure for children today is lead

paint in older housing and the

contaminated dust and soil it generates.

The Department of Housing and Urban

Development (HUD) conducted a

National Survey of Lead Hazards in

Housing in 1999. This proposed survey

on child care facilities is required to

supplement the National Survey in

residential homes. Young children may

spend a significant portion of their time

in child care facilities. Although child

care facilities have the same painting

history as does housing across the

Nation, the environmental conditions

and exposure characteristics maybe

different. There is no systematic

national survey previously done for lead

hazards in child care facilities, and the

extent of lead hazards in child care

facilities is unknown. Results from this

survey will provide current information

needed for regulatory and policy

decisions and enables an assessment of

progress in making the U.S. housing

stock lead-safe.

Agency Form Numbers: None.

Members of Affected Public:

Operators of licensed child care

facilities.

Total Burden Estimate (first Year):

Task Number of

respondents × Frequency ofresponses × Hours perresponse = Burdenhours

Respondents ............................................................................................... 220 1 3 660

Total Estimated Burden Hours: 660.

Status of the Proposed Information

Collection: New request.

Authority: The Paperwork Reduction Act

of 1995, 44 U.S.C. Chapter 35, as amended.

Dated: June 20, 2000.

David E. Jacobs,

Director, Office of Lead Hazard Control.

[FR Doc. 00–16189 Filed 6–26–00; 8:45 am]

BILLING CODE 4210–01–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4561–N–39]

Notice of Submission of Proposed

Information Collection to OMB;

Reporting Requirements Associated

With 24 CFR 203.508b and 24 CFR

235.1001

AGENCY: Office of the Chief Information

Officer, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

has been 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: July 27,

2000.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

approval number (2502–0235) and

should be sent to: Joseph F. Lackey, Jr.,

OMB Desk Officer, Office of

Management and Budget, Room 10235,

New Executive Office Building,

Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT:

Wayne Eddins, Reports Management

Officer, Q, Department of Housing and

Urban Development, 451 Seventh Street,

SW., Washington, DC 20410; e-mail

Wayne_Eddins@HUD.gov; telephone

(202) 708–2374. This is not a toll-free

number. Copies of the proposed forms

and other available documents

submitted to OMB may be obtained

from Mr. Eddins.

SUPPLEMENTARY INFORMATION: The

Department has submitted the proposal

for the collection of information, as

described below, to OMB or review, as

required by the Paperwork Reduction

Act (44 U.S.C. chapter 35). The Notice

lists the following information: (1) The

title of the information collection

proposal; (2) the office of the agency to

collect the information; (3) the OMB

approval number, if applicable; (4) the

description of the need for the

information and its proposed use; (5)

the agency form number, if applicable;

(6) what members of the public will be

affected by the proposal; (7) how

frequently information submissions will

be required; (8) an estimate of the total

number of hours needed to prepare the

information submission including

number of respondents, frequency of

response, and hours of response; (9)

whether the proposal is new, an

extension, reinstatement, or revision of

an information collection requirement;

and (10) the name and telephone

number of an agency official familiar

with the proposal and of the OMB Desk

Officer for the Department.

This notice also lists the following

information.

Title of Proposal: Reporting

Requirements Associated with 24 CFR