35772 Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices

the applicant from the Director of the

office of Device Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act (21 U.S.C.

360e(d)(3)) authorizes any interested

person to petition, under section 515(g)

of the act, for administrative review of

CDRH’s decision to approve this

application. A petitioner may request

either a formal hearing under part 12 (21

CFR part 12) of FDA’s administrative

practices and regulations or a review of

the application and CDRH’s action by an

independent advisory committee of

experts. A petition is to be in the form

of a petition for reconsideration under

§ 10.33(b) (21 CFR 10.33(b)). A

petitioner shall identify the form of

review requested (hearing or

independent advisory committee) and

shall submit with the petition

supporting data and information

showing that there is a genuine and

substantial issue of material fact for

resolution through administrative

review. After reviewing the petition,

FDA will decide whether to grant or

deny the petition and will publish a

notice of its decision in the Federal

Register. If FDA grants the petition, the

notice will state the issue to be

reviewed, the form of the review to be

used, the persons who may participate

in the review, the time and place where

the review will occur, and other details.

Petitioners may, at any time on or

before August 7, 1996, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: June 21, 1996.

Joesph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 96–17235 Filed 7–5–96; 8:45 am]

BILLING CODE 4160–01–F

National Institutes of Health

National Cancer Institute; Notice of

Meeting

Pursuant to Public Law 92–463,

notice is hereby given of a meeting of

the President’s Cancer Panel.

The meeting will be open to the

public as indicated below, with

attendance by the public limited to

space available. Individuals who plan to

attend and need special assistance, such

as sign language interpretation or other

reasonable accommodations, should

notify the Contact Person listed below.

The meeting will be closed in

accordance with the provisions set forth

in sec. 552b(c)(9), Title 5, U.S.C. for

discussion of future meetings and

preparation of the annual report to the

President. These discussions could

disclose information, the premature

disclosure of which would be likely to

significantly frustrate implementation of

proposed action the Panel may plan to

take.

Carole Frank, the Committee

Management Officer, National Cancer

Institute, Executive Plaza North, Room

630M, 6130 Executive Blvd., MSC 7405,

Bethesda, MD 20891–7405 (301–496–

5708) will provide a summary of the

meeting and the roster of committee

members upon request. Other

information pertaining to the meetings

may be obtained from the contact

person indicated below.

Committee Name: President’s Cancer

Panel.

Date: July 29–30, 1996.

Place: Fred Hutchinson Cancer Center,

Stuart Auditorium, First Hill, 1124 Columbia

Street, Seattle, WA 98104.

Closed: July 29, 1996—7 p.m. to 10 p.m.

Agenda: Planning session to discuss future

meetings and preparation of the mandatory

annual report of the Chairman to the

President.

Open: July 30, 1996—8:30 a.m. to 5:00 p.m.

Agenda: Managed Care’s Role in the War

on Cancer. Where are we today? Existing

problems for cutting edge clinical research in

today’s environment.

Contact Person: Dr. Maureen O. Wilson,

Executive Secretary, National Cancer

Institute, NIH, Building 31, Room 4B43,

Bethesda, MD 20892, (301) 496–1148.

(Catalog of Federal Domestic Assistance

Program Numbers: 93:393, Cancer Cause and

Prevention Research; 93.394, Cancer

Detection and Diagnosis Research; 93.395,

Cancer Treatment Research; 93.396, Cancer

Biology Research; 93.397, Cancer Centers

Support; 93.398, Cancer Research Manpower;

93.399, Cancer Control.)

Dated: July 1, 1996.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 96–17209 Filed 7–5–96; 8:45 am]

BILLING CODE 4140–01–M

National Institute of Allergy and

Infectious Diseases; Notice of Closed

Meeting

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

National Institute of Allergy and

Infectious Diseases Special Emphasis

Panel (SEP) meeting:

Name of SEP: Unsolicited AIDS Related

Career Award, Conference and Supplement

Applications

Date: July 26, 1996

Time: 8:30 a.m.

Place: Doubletree Hotel, Rockville Room,

1750 Rockville Pike, Rockville, MD 20852,

(301) 468–1100.

Contact Person: Dr. Paula Strickland,

Scientific Review Adm., 6003 Executive

Boulevard, Solar Bldg., Room 4C02,

Bethesda, MD 20892–7610, (301) 402–0643.

Purpose/Agenda: To evaluate grant

applications.

The meeting 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

Programs Nos. 93.855, Immunology, Allergic

and Immunologic Diseases Research; 93.856,

Microbiology and Infectious Diseases

Research, National Institutes of Health.)

Dated: July 1, 1996.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 96–17210 Filed 7–5–96; 8:45 am]

BILLING CODE 4140–01–M

National Institute of Environmental

Health Sciences; Notice of a Closed

Meeting

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

National Institute of Environmental

Health Sciences Special Emphasis Panel

(SEP) meeting:

Name of SEP: The Use of Transgenic

Model Systems in Molecular Toxicology.