Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Notices 38293

(FDA). The meeting will be open to the

public.

Name of Committee: Biological

Response Modifiers 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 13, 2000, 8:30 a.m. to 6

p.m. and July 14, 2000, 8:30 a.m. to 3

p.m.

Location: Hilton Hotel, 620 Perry

Pkwy., Gaithersburg, MD.

Contact Person: Gail Dapolito or

Rosanna Harvey (HFM–71), Food and

Drug Administration, 1401 Rockville

Pike, Rockville, MD 20852, 301–827–

0314, or FDA Advisory Committee

Information Line, 1–800–741–8138

(301–443–0572 in the Washington, DC

area), code 12389. Please call the

Information Line for up-to-date

information on this meeting.

Agenda: On July 13 and 14, 2000, the

committee will discuss product

development issues related to human

stem cells as cellular replacement

therapies for neurological disorders.

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 June 30, 2000. Oral

presentations from the public will be

scheduled between approximately 9

a.m. and 10 a.m. on July 14, 2000. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before June 30, 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 9, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–15431 Filed 6–19–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Nonprescription Drugs 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: Nonprescription

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 12, 2000, 1 p.m. to 5:30

p.m.

Location: Holiday Inn, Versailles

Ballrooms, 8120 Wisconsin Ave.,

Bethesda, MD.

Contact Person: Sandra L. Titus,

Center for Drug Evaluation and Research

(HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–7001, or

e-mail: TitusS@cder.fda.gov, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12541.

Please call the Information Line for upto-date information on this meeting.

Agenda: The committee will discuss

the remarketing and labeling of the

Today Vaginal Contraceptive Sponge,

new drug application (NDA) 18–683,

Allendale Pharmaceuticals. This

product was approved by FDA in 1983,

but has not been marketed since January

1995.

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 6, 2000. Oral

presentations from the public will be

scheduled between approximately 1:15

p.m. and 2:15 p.m. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before July 6, 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 9, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–15428 Filed 6–19–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Substance Abuse and

Mental Health Services Administration

(SAMHSA) will publish a list of

information collection requests under

OMB review, in compliance with the

Paperwork Reduction Act (44 U.S.C.

Chapter 35). To request a copy of these

documents, call the SAMHSA Reports

Clearance Officer on (301) 443–7978.

Phase I of the National Evaluation of

the Comprehensive Community Mental

Health Services for Children and Their

Families Program (0930–0171—

Extension, revision)—The core and

comparison studies of the evaluation

collect information on child and family

demographics, child mental health

status, and service system development.

In the core study, data were collected

from children and families at intake into

services, 6 months later, and every 12

months thereafter while the children

remain in services. In the comparison

study component, information is

collected at intake, 6 months, 12

months, 24 months, and annually

thereafter. In both studies, data were

collected annually from grantees’

administrators and providers.

SAMHSA’s Center for Mental Health

Services (CMHS) is seeking OMB

approval for a 4-month extension of

approval for the comparison study of

this evaluation of integrated child

mental health service systems funded by

CMHS to allow sufficient follow-up data

to be collected. The comparison study of

the evaluation collects information on

child and family demographics, and

child mental health status and social

functioning. The table below

summarizes burden for this extension.