26192 Federal Register / Vol. 61, No. 102 / Friday, May 24, 1996 / Notices

each age category; a summary of the

information submitted to support the

pediatric labeling statements and an

integrated summary of the pediatric

safety data with a risk/benefit

assessment; and presentation of the

data.

Although this guidance does not

create or confer any rights for or on any

person and does not operate to bind

FDA, it does represent the agency’s

current thinking on how to prepare

‘‘pediatric use’’ labeling supplements

for submission to FDA.

Interested persons may, at any time,

submit to the Dockets Management

Branch (address above) written

comments on the guidance. 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. The guidance and received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday. If written

comments demonstrate that changes to

the guidance are appropriate, such

changes to the guidance will be made.

Dated: May 17, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–13175 Filed 5–23–96; 8:45 am]

BILLING CODE 4160–01–F

National Institutes of Health

Division of Research Grants; Notice of

Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following Division

of Research Grants Special Emphasis

Panel (SEP) meetings:

Purpose/Agenda: To review individual

grant applications.

Name of SEP: Clinical Sciences.

Date: May 30, 1996.

Time: 8:30 a.m.

Place: NIH, Natcher Bldg., Bethesda, MD.

Contact Person: Dr. Ronald Suddendorf,

Scientific Review Administrator, 6000

Executive Blvd., Room 409, Bethesda,

Maryland 20892, (301) 443–2926.

This notice is being published less

than 15 days prior to the above meeting

due to the urgent need to meet timing

limitations imposed by the review and

funding cycle.

Name of SEP: Biological and Physiological

Sciences.

Date: June 4, 1996.

Time: 1:00 p.m.

Place: NIH, Rockledge 2, Room 5146,

Telephone Conference.

Contact Person: Dr. Ramesh Nayak,

Scientific Review Administrator, 6701

Rockledge Drive, Room 5146, Bethesda,

Maryland 20892, (301) 435–1026.

Name of SEP: Biological and Physiological

Sciences.

Date: June 17, 1996.

Time: 8:00 a.m.

Place: Bethesda Marriott Hotel, Bethesda,

MD.

Contact Person: Dr. Nabeeh Mourad,

Scientific Review Administrator, 6701

Rockledge Drive, Room 5110, Bethesda,

Maryland 20892, (301) 435–1168.

Name of SEP: Clinical Sciences.

Date: June 19–20, 1996.

Time: 8:00 a.m.

Place: Residence Inn, Bethesda, MD.

Contact Person: Dr. Josephine Pelham,

Scientific Review Administrator, 6701

Rockledge Drive, Room 4106, Bethesda,

Maryland 20892, (301) 435–1786.

Name of SEP: Behavioral and

Neurosciences.

Date: July 10, 1996.

Time: 8:30 a.m.

Place: Holiday Inn, Bethesda, MD.

Contact Person: Dr. Carl Banner, Scientific

Review Administrator, 6701 Rockledge Drive,

Room 5182, Bethesda, Maryland 20892, (301)

435–1251.

Name of SEP: Clinical Sciences.

Date: October 23–24, 1996.

Time: 8:00 a.m.

Place: Residence Inn, Bethesda, MD.

Contact Person: Dr. Josephine Pelham,

Scientific Review Administrator, 6701

Rockledge Drive, Room 4106, Bethesda,

Maryland 20892, (301) 435–1786.

Purpose/Agenda: To review Small

Business Innovation Research.

Name of SEP: Multidisciplinary Sciences.

Date: June 5, 1996.

Time: 1:00 p.m.

Place: Rosslyn Westpark Holiday Inn,

Arlington, VA.

Contact Person: Dr. Lee Rosen, Scientific

Review Administrator, 6701 Rockledge Drive,

Room 5116, Bethesda, Maryland 20892, (301)

435–1171.

The meetings will be closed in accordance

with the provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5, U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Program Nos. 93.306, 93.333, 93.337, 93.393–

93.396, 93.837–93.844, 93.846–93.878,

93.892, 93.893, National Institutes of Health,

HHS)

Dated: May 14, 1996.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 96–13166 Filed 5–23–96; 8:45 am]

BILLING CODE 4140–01–M

Substance Abuse and Mental Health

Services Administration

Special Emphasis Panel II

Pursuant to Pub. L. 92–463, notice is

hereby given of the following meeting of

the SAMHSA Special Emphasis Panel II

in June.

A summary of the meeting may be

obtained from: Ms. Dee Herman,

Committee Management Liaison,

SAMHSA Office of Extramural

Activities Review, 5600 Fishers Lane,

Room 17–89, Rockville, Maryland

20857. Telephone: (301) 443–4783.

Substantive program information may

be obtained from the individual named

as Contact for the meeting listed below.

The meeting will include the review,

discussion and evaluation of individual

contract proposals. These discussions

could reveal personal information

concerning individuals associated with

the proposals and confidential and

financial information about an

individual’s proposal. The discussion

may also reveal information about

procurement activities exempt from

disclosure by statute and trade secrets

and commercial or financial information

obtained from a person and privileged

and confidential. Accordingly, the

meeting is concerned with matters

exempt from mandatory disclosure in

Title 5 U.S.C. 552b(c) (3), (4), and (6)

and 5 U.S.C. App. 2, section 10(d).

Committee Name: SAMHSA Special

Emphasis Panel II.

Meeting Date: June 3, 1996.

Place: Parklawn Building—Conference

Room ‘‘O’’, 5600 Fishers Lane, Rockville,

Maryland 20852.

Closed: June 3, 1996, 10:30 a.m.–12:30 p.m.

Contact: Ferdinand W. Hui, Ph.D., Room

17–89, Parklawn Building, Telephone: (301)

443–9912 and FAX: (301) 443–3437.

This notice is being published less

than 15 days prior to the meeting due

to the urgent need to meet timing

limitations imposed by the review and

funding cycle.

Dated: May 20, 1996.

Jeri Lipov,

Committee Management Officer, Substance

Abuse and Mental Health Services

Administration.

[FR Doc. 96–13103 Filed 5–23–96; 8:45 am]

BILLING CODE 4162–20–M