43540 Federal Register / Vol. 62, No. 157 / Thursday, August 14, 1997 / Notices

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: Oncologic Drugs

Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on September 18 and 19, 1997, 8

a.m. to 5:30 p.m.

Location: Holiday Inn, Versailles

Ballrooms II and III, 8120 Wisconsin

Ave., Bethesda, MD.

Contact Person: Jannette O’NeillGonzalez, Center for Drug Evaluation

and Research (HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–5455, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12542. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On September 18, 1997, the

committee will discuss: (1) New drug

application (NDA) 20–817, RivizorTM

Tablets (vorozole, Janssen Research

Foundation), indicated for ‘‘the

treatment of advanced breast cancer in

postmenopausal women (natural or

artificially-induced menopause) with

disease progression following

antiestrogen therapy’’; and (2) NDA

Supplement 20–451/S002, Photofrin

(porfimer sodium, QLT Photo

Therapeutics Inc.), indicated for: ‘‘a)

reduction of obstruction and palliation

of symptoms in patients with

completely or partially obstructing

endobronchial nonsmall cell lung

cancer (NSCLC), and b) treatment of

endobronchial carcinoma in situ or

microinvasive NSCLC in patients for

whom surgery and radiotherapy are not

indicated.’’ On September 19, 1997, the

committee will discuss: (1) NDA 20–

826, Paxene (paclitaxel, Baker-Norton

Pharmaceuticals, Inc.), ‘‘indicated after

failure of first line or subsequent

systemic chemotherapy for the

treatment of advanced AIDS-related

Kaposi’s Sarcoma’’; and (2) NDA

Supplement 16–295/S029, Droxia

(hydroxyurea, Bristol-Myers Squibb),

‘‘indicated in the treatment of sickle cell

anemia in adult patients to prevent

painful crises and to reduce the need for

blood transfusions.’’

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 September 4, 1997. Oral

presentations from the public will be

scheduled between approximately 8:05

a.m. and 9:05 a.m. on both days. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before September 4,

1997, 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: August 7, 1997.

William B. Schultz,

Acting Lead Deputy Commissioner for the

Food and Drug Administration.

[FR Doc. 97–21572 Filed 8–13–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0158]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Petition for Generally Recognized As

Safe Affirmation’’ has been approved by

the Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Wolff, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of May 9, 1997 (61 FR

25632), the agency announced that the

proposed information collection had

been submitted to OMB for review and

clearance under section 3507 of the

Paperwork Reduction Act of 1995 (44

U.S.C. 3507). OMB has now approved

the information collection and has

assigned OMB control number 0910–

0132. The approval expires on July 31,

2000. An agency may not conduct or

sponsor, and a person is not required to

respond to, a collection of information

unless it displays a currently valid OMB

control number.

Dated: August 7, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–21435 Filed 8–13–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96N–0135]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Animal Proteins Prohibited in

Ruminant Feed’’ has been approved by

the Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–1472.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 5, 1997 (62 FR

30936), the agency announced that the

proposed information collection had

been submitted to OMB for review and

clearance under section 3507 of the

Paperwork Reduction Act of 1995 (44

U.S.C. 3507). OMB has now approved

the information collection and has

assigned OMB control number 0910–

0339. The approval expires on July 31,

2000. An agency may not conduct or

sponsor, and a person is not required to

respond to, a collection of information

unless it displays a currently valid OMB

control number.

Dated: August 8, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–21563 Filed 8–13–97; 8:45 am]

BILLING CODE 4160–01–F