1892 Federal Register / Vol. 62, No. 9 / Tuesday, January 14, 1997 / Notices

hearing concerning the action proposed

and a waiver of any contentions

concerning the legal status of that

person’s drug products. Any new drug

product marketed without an approved

new drug application is subject to

regulatory action at any time.

III. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

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

through Friday.

1. Thompson, D., and G. Oster, ‘‘Use of

Terfenadine and Contraindicated Drugs,’’

Journal of the American Medical Association,

275(17):1339–1341, 1996.

2. Cavuto, N. J., R. L. Woosley, and M. Sale,

‘‘Pharmacies and Prevention of Potentially

Fatal Drug Interactions’’ (letter), Journal of

the American Medical Association,

275(14):1086–1087, 1996.

3. Carlson, A. M., and L. S. Morris,

‘‘Coprescription of Terfenadine and

Erythromycin and Ketoconazole: An

Assessment of Potential Harm,’’ Journal of

the American Pharmaceutical Association,

NS36(4):263–269, 1996.

A request for a hearing may not rest

upon mere allegations or denials, but

must present specific facts showing that

there is a genuine and substantial issue

of fact that requires a hearing. If it

conclusively appears from the face of

the data, information, and factual

analyses in the request for a hearing that

there is no genuine and substantial issue

of fact that precludes the withdrawal of

approval of the applications, or when a

request for hearing is not made in the

required format or with the required

analyses, the Commissioner of Food and

Drugs will enter summary judgment

against the person who requests the

hearing, making findings and

conclusions, and denying a hearing.

All submissions pursuant to this

notice of opportunity for a hearing are

to be filed in four copies. Except for data

and information prohibited from public

disclosure under 21 U.S.C. 331(j) or 18

U.S.C. 1905, the submissions may be

seen in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(sec. 505 (21 U.S.C. 355)) and under

authority delegated to the Director of the

Center for Drug Evaluation and Research

(21 CFR 5.82).

Dated: January 7, 1997.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 97–714 Filed 1–10–97; 8:45 am]

BILLING CODE 4160–01–F

National Institutes of Health

Consensus Development Conference

on Breast Cancer Screening For

Women Ages 40–49

Notice is hereby given of the NIH

Consensus Development Conference on

‘‘Breast Cancer Screening For Women

Ages 40–49,’’ which will be held

January 21–23, 1997, in the Natcher

Conference Center of the National

Institutes of Health, 9000 Rockville

Pike, Bethesda, Maryland 20892. The

conference begins at 8:30 a.m. on

January 21, at 8 a.m. on January 22, and

at 9 a.m. on January 23.

A number of randomized clinical

trials have shown clearly that early

detection of breast cancer by

mammography, with and without

clinical breast examination at regular

intervals ranging from 1 year to 33

months, reduces breast cancer mortality

in women ages 50–69 by about a third.

However, the picture is not as clear for

women 40–49 years of age, and

worldwide experts continue to examine

the data regarding the use of

mammography in this age group.

Follow-up data from the Swedish,

Canadian, Edinburgh (U.K.), and health

Insurance Plan of New York clinical

trials will be presented at the conference

in an attempt to help clarify these

issues.

This conference will bring together

the investigators who have conducted

the randomized clinical trials,

epidemiologists, statisticians,

radiologists, oncologists, and other

experts, as well as representatives of the

public, to present and discuss the latest

data and data analyses.

After 11⁄2 days of presentations and

audience discussion, an independent,

no-Federal consensus panel will weigh

the scientific evidence and write a draft

statement that it will present to the

audience on the third day. The

consensus statement will address the

following key questions:

—Is there a reduction in mortality from

breast cancer due to screening women

ages 40 to 49 with mammography,

with or without physical

examination? If so, how large is the

benefit? How does it change with age?

—What are the risks associated with

screening women ages 40–49 with

mammography and with physical

examination?

Are there other benefits? If so, what are

they? How do they change with age?

—What is known about how the benefits

and risks of breast cancer screening

differ based on known risk factors for

breast cancer?

—What are the directions for future

research?

The primary sponsors of this

conference are the National Cancer

Institute and the NIH Office of Medical

Applications Research. The conference

is cosponsored by the National Institute

on Aging, the NIH Office of Research on

Women’s Health, and the Centers for

Disease Control and Prevention.

Advance information on the

conference program and conference

registration materials may be obtained

from Hope Levy Cott, Technical

Resources International, Inc., 3202

Tower Oaks Blvd., Suite 200, Rockville,

Maryland 20852, (301) 770–3153, or by

sending e-mail to confdept@techres.com.

The consensus statement will be

submitted for publication in

professional journals and other

publications. In addition, the statement

will be available beginning January 23,

1997, from the NIH Consensus Program

Information Center, P.O. Box 2577,

Kensington, Maryland 20891, phone 1–

888–NIH–CONSENSUS (1–888–644–

2667), and from the NIH Consensus

Development Program site on the World

Wide Web at http://consensus.nih.gov.

Dated: January 7, 1997.

Ruth L. Kirschstein,

Deputy Director, NIH.

[FR Doc. 97–850 Filed 1–13–97; 8:45 am]

BILLING CODE 4140–01–M

John E. Fogarty International Center

for Advanced Study in the Health

Sciences; Notice of Meeting of the

Fogarty International Center Advisory

Board

Pursuant to Public Law 92–463, as

amended, notice is hereby given of the

thirty-fifth meeting of the Fogarty

International Center (FIC) Advisory

Board, February 4, 1997, in the Lawton

Chiles International House (Building 16)

at the National Institute of Health.

The meeting will be open to the

public from 8:30 a.m. to 12:00 p.m.

The agenda will include a report by

the Director, FIC; a report on the

Recommendations of the External

Advisory Panel to Review NIH/FIC

International Programs followed by a

discussion of the recommendations led

by the Director, NIH; a report on the

December Meeting of the Advisory

Committee to the Director, NIH; a

presentation on the recommendations of

a review panel on the FIC AIDS

International Training and Research

Program; and a report on the

International Conference on Malaria that