Federal Register / Vol. 62, No. 9 / Tuesday, January 14, 1997 / Notices 1889

and the final decision of the

Commission shall be issued by May 8,

1998.

By the Commission.

Joseph C. Polking,

Secretary.

[FR Doc. 97–829 Filed 1–13–97; 8:45 am]

BILLING CODE 6730–01–M

FEDERAL RESERVE SYSTEM

Notice of Proposals To Engage in

Permissible Nonbanking Activities or

To Acquire Companies That Are

Engaged in Permissible Nonbanking

Activities

The companies listed in this notice

have given notice under section 4 of the

Bank Holding Company Act (12 U.S.C.

1843) (BHC Act) and Regulation

Y, (12 CFR Part 225) to engage de novo,

or to acquire or control voting securities

or assets of a company that engages

either directly or through a subsidiary or

other company, in a nonbanking activity

that is listed in § 225.25 of Regulation

Y (12 CFR 225.25) or that the Board has

determined by Order to be closely

related to banking and permissible for

bank holding companies. Unless

otherwise noted, these activities will be

conducted throughout the United States.

Each notice is available for inspection

at the Federal Reserve Bank indicated.

Once the notice has been accepted for

processing, it will also be available for

inspection at the offices of the Board of

Governors. Interested persons may

express their views in writing on the

question whether the proposal complies

with the standards of section 4 of the

BHC Act, including whether

consummation of the proposal can

‘‘reasonably be expected to produce

benefits to the public, such as greater

convenience, increased competition, or

gains in efficiency, that outweigh

possible adverse effects, such as undue

concentration of resources, decreased or

unfair competition, conflicts of

interests, or unsound banking practices’’

(12 U.S.C. 1843). Any request for a

hearing on this question must be

accompanied by a statement of the

reasons a written presentation would

not suffice in lieu of a hearing,

identifying specifically any questions of

fact that are in dispute, summarizing the

evidence that would be presented at a

hearing, and indicating how the party

commenting would be aggrieved by

approval of the proposal.

Unless otherwise noted, comments

regarding the applications must be

received at the Reserve Bank indicated

or the offices of the Board of Governors

not later than January 29, 1997.

A. Federal Reserve Bank of New

York (Christopher J. McCurdy, Senior

Vice President) 33 Liberty Street, New

York, New York 10045:

1. Canadian Imperial Bank of

Commerce, Toronto, Canada; to engage

de novo, through its wholly owned

subsidiary, CIBC Investment

Corporation, New York, New York

(‘‘Company’’), in trading for its own

account, for purposes other than

hedging, in futures, options, and options

on futures contracts based on certain

securities indices and money market

instruments. Canadian Imperial

proposes that Company would conduct

these activities throughout the world.

See Swiss Bank Corporation, 81 Fed.

Res. Bull. 185 (1995).

Board of Governors of the Federal Reserve

System, January 8, 1997.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 97–828 Filed 1–13–97; 8:45 am]

BILLING CODE 6210–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96N–0512]

Hoechst Marion Roussel, Inc., and

Baker Norton Pharmaceuticals, Inc.;

Terfenadine; Proposal To Withdraw

Approval of Two New Drug

Applications and One Abbreviated New

Drug Application; Opportunity for a

Hearing

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

withdraw approval of two new drug

applications (NDA’s) and one

abbreviated new drug application

(ANDA) for drug products containing

terfenadine. NDA 18–949 (Seldane) and

NDA 19–664 (Seldane-D) are held by

Hoechst Marion Roussel (HMR), Inc.,

P.O. Box 9627, Kansas City, MO 64134–

0627. ANDA 74-475 is held by Baker

Norton Pharmaceuticals, Inc., 4400

Biscayne Blvd., Miami, FL 33137. On

July 25, 1996, FDA approved HMR’s

NDA 20–625 for fexofenadine

hydrochloride (Allegra). Fexofenadine is

the active metabolite of terfenadine that

is responsible for the desired beneficial

properties of terfenadine. When patients

take terfenadine, parent terfenadine is

ordinarily present in their blood at very

low concentrations, because the

terfenadine molecule is metabolized to

form fexofenadine. Fexofenadine is

responsible for providing patients with

essentially all the clinical benefits of

taking terfenadine. If terfenadine’s

metabolism is inhibited, either by

another drug or by intrinsic liver

disease, the level of parent terfenadine

can rise to levels that can cause serious

side effects in people as a result of the

effect of parent terfenadine on cardiac

potassium channels. Inhibition of these

channels causes delayed cardiac

repolarization (prolonged

electrocardiographic QT interval) and

increases the risk of a characteristic

kind of ventricular tachycardia called

torsades de pointes and possibly the risk

of other rhythm abnormalities.

Fexofenadine hydrochloride, however,

has not been shown to affect cardiac

potassium channels and has been

shown not to cause prolongation of the

electrocardiographic QT interval, even

at larger-than-recommended doses.

Based on all data to date, fexofenadine

hydrochloride appears to lack parent

terfenadine’s risk of serious

cardiovascular adverse events. The basis

for the proposed withdrawal of the

applications is a finding that the

availability of fexofenadine

hydrochloride provides patients with an

alternative that can provide essentially

all the benefits of terfenadine, because

it is identical in molecular structure to

the metabolized (active) form of

terfenadine, without the serious and

potentially fatal risks associated with

terfenadine when terfenadine’s

metabolism is inhibited either by

another drug or by intrinsic liver

disease. Because of the availability of

fexofenadine hydrochloride, terfenadine

is not shown to be safe for use under the

conditions of use that formed the basis

upon which the applications were

approved.

DATES: A hearing request is due on

February 13, 1997; data and information

in support of the hearing request are due

on March 17, 1997.

ADDRESSES: A request for hearing,

supporting data, and other comments

are to be identified with docket no.

96N–0512 and submitted to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

For information on medical/scientific

issues: John K. Jenkins, Center for

Drug Evaluation and Research

(HFD–570), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–
1890 Federal Register / Vol. 62, No. 9 / Tuesday, January 14, 1997 / Notices

1050.

For general information concerning

this notice: David T. Read, Center

for Drug Evaluation and Research

(HFD–7), Food and Drug

Administration, 7520 Standish Pl.,

Rockville, MD 20855, 301–594–

2041.

SUPPLEMENTARY INFORMATION:

I. Background

Terfenadine is an antihistamine,

indicated for the relief of symptoms

associated with seasonal allergic rhinitis

such as sneezing, rhinorrhea, pruritus,

and lacrimation. Terfenadine was the

first antihistamine approved in the

United States that was not associated

with more somnolence than placebo in

clinical trials. The absence of an

increased risk of somnolence over

placebo is an important safety advantage

to many people who use antihistamines.

NDA 18–949 for Seldane tablets

(terfenadine 60 milligrams (mg)) was

approved by FDA on May 8, 1985. NDA

19–664 for Seldane-D tablets

(terfenadine 60 mg and the decongestant

pseudoephedrine hydrochloride 120

mg) was approved by FDA on August

19, 1991.

Other antihistamines now available in

the United States that were not

associated with more somnolence than

placebo in clinical trials are astemizole

(Hismanal) and loratadine (Claritin),

approved on December 29, 1988, and

April 12, 1993, respectively. Most

significant to this proceeding, on July

25, 1996, FDA approved HMR’s NDA

20–625 for fexofenadine hydrochloride

60 mg capsules (Allegra). Fexofenadine

is the metabolite of terfenadine

responsible for its desired

antihistaminic efficacy. Fexofenadine

hydrochloride was also not associated

with more somnolence than placebo in

clinical trials.

After the approval of terfenadine in

1985, there began to be reports of certain

serious cardiac adverse events

associated with terfenadine use in

patients taking certain antimicrobials or

with significant liver dysfunction. Very

little parent terfenadine normally

circulates in the plasma because orally

administered terfenadine undergoes

extensive first pass metabolism by a

specific cytochrome P–450 isoenzyme

(CYP3A4). This metabolic pathway may

be impaired in patients with liver

dysfunction (e.g., alcoholic cirrhosis) or

who are taking drugs such as

ketoconazole, itraconazole, or macrolide

antimicrobials (e.g., clarithromycin,

erythromycin, or troleandomycin).

These drugs are all inhibitors of the

cytochrome P–450 isoenzyme.

Interference with the normal

metabolism of terfenadine can lead to

elevated plasma terfenadine levels. At

these elevated levels, terfenadine can

delay cardiac repolarization (prolong

the electrocardiographic QT interval)

because of its effects on cardiac

potassium channels. The delayed

cardiac repolarization increases the risk

of serious ventricular tachyarrhythmias,

most characteristically a kind of

ventricular tachycardia called torsades

de pointes. This arrhythmia can cause

dizziness and syncope when it is shortlived, but it may persist and degenerate

into unstable ventricular tachycardia or

ventricular fibrillation. Ventricular

fibrillation is fatal if not promptly

reversed. These serious and possibly

fatal events can occur at the

recommended dose of terfenadine if it is

taken along with other medications that

interfere with its metabolism or if it is

administered to someone with

significant hepatic dysfunction.

In an effort to inform the medical and

patient communities about the serious

and potentially fatal cardiac adverse

effects associated with inappropriate

use of terfenadine, the labeling for

Seldane and Seldane-D have been

revised many times. In 1992,

terfenadine labeling was revised to

include a prominent boxed warning

cautioning against its use in certain

settings, particularly with the drugs that

inhibit its metabolism. In addition,

‘‘Dear Health Care Professional’’ letters

warning health care practitioners of the

serious risk of inappropriate use of

terfenadine were issued by the sponsor

in 1990, 1992, and 1996.

Although the revised labeling and

‘‘Dear Health Care Professional’’ letters

have significantly reduced the

inappropriate prescribing of terfenadine

together with the drugs that block its

metabolism, such prescribing and

dispensing has not been eliminated and

almost certainly cannot be. Three

recently published studies indicate that

coprescription and codispensing of

medications contraindicated with

terfenadine continues to occur (Refs. 1,

2, and 3). The Cavuto study also

demonstrates that the computerized

drug-interaction screening programs

used by many pharmacists, who are the

last line of defense against prescribing

errors, do not completely prevent

prescribing and filling of prescriptions

for potentially dangerous combinations

of terfenadine and contraindicated

drugs.

Terfenadine is an antihistamine that

is intended to be used when symptoms

of seasonal allergic rhinitis occur.

Patients often do not consume all of the

pills they receive in a prescription of

terfenadine for a single episode of

seasonal allergic rhinitis, and may keep

the remaining pills for later use when

needed, as patients often do with overthe-counter antihistamines. Because of

the nature of seasonal allergies, a long

period of time (e.g., from early fall to

spring) can elapse between the time the

drug and any associated warning from a

health care practitioner or pharmacist is

received and the time terfenadine is

used. Such intermittent dosing of

terfenadine increases the probability

that some patients may be taking one of

the contraindicated medications, such

as one of the frequently prescribed

antimicrobials listed above, at the same

time the patient self-diagnoses his or her

seasonal allergy symptoms and takes the

remaining terfenadine from the pill

container in the medicine chest.

This problem of concomitant use is

further compounded by the growing list

of medications known to inhibit the

metabolism of terfenadine, many of

which are taken for chronic medical

conditions and may be prescribed by

health care practitioners other than the

practitioner who prescribed the

terfenadine. Labeling changes and even

perfect performance by prescribers and

close attention by pharmacists,

therefore, cannot completely eliminate

the risks of serious cardiac adverse

events associated with the inappropriate

use of terfenadine.

Very low to undetectable blood levels

of parent terfenadine are found in

patients taking the recommended dose

of terfenadine. For this reason, parent

terfenadine appears to have very little,

if any, impact on the therapeutic

efficacy that is associated with

terfenadine use.

The discovery of terfenadine’s ability

to delay cardiac repolarization and its

associations with serious and sometimes

fatal cardiac adverse events when used

inappropriately led to evaluation of its

principal active metabolite as a

potentially safer alternative

antihistamine. It was discovered that the

metabolite that is responsible for the

desired therapeutic effect of terfenadine,

fexofenadine, does not affect cardiac

potassium channels. The agency,

therefore, encouraged HMR to initiate

the development of a drug product with

only the active metabolite fexofenadine

as the active antihistamine. Even at

doses considerably in excess of those

recommended for use, fexofenadine

hydrochloride has not been shown to

prolong the QT interval. It therefore

should not have, and has not been

shown to have, the serious

cardiovascular adverse events

potentially associated with

unmetabolized terfenadine. No new
Federal Register / Vol. 62, No. 9 / Tuesday, January 14, 1997 / Notices 1891

adverse reaction, not already associated

with terfenadine, would be expected

because the many people who have

taken terfenadine have been, in fact,

exposed primarily to fexofenadine

manufactured by their body.

An NDA for fexofenadine

hydrochloride was approved by FDA on

July 25, 1996. Nearly 5 months of

marketing of this product in the United

States have not resulted in any reports

of serious cardiac arrhythmias.

Prior to the approval of fexofenadine

hydrochloride, the agency considered

terfenadine to be safe (i.e., its benefits

outweighed its risks) despite

terfenadine’s known serious adverse

effects when its metabolism was

blocked and despite the availability of

alternative antihistamines that, like

terfenadine, were not associated with

greater somnolence than placebo in

clinical trials. This is because the

agency recognizes that responses to

drugs are not uniform among

individuals and, for reasons that are

often unclear and difficult to discover,

some patients may respond better, with

respect to therapeutic effectiveness or

tolerance, to one drug than to another.

Terfenadine certainly provided a unique

therapeutic benefit when it was the only

available antihistamine that was not

associated with more somnolence than

placebo in clinical trials, and it

continued to provide a benefit and

choice to patients even after the

approval of astemizole and loratadine

(e.g., some patients may have found that

terfenadine provided some advantage

over either of the other two products or

may have been unable to tolerate the

alternative medications for a variety of

medical reasons, including drug

allergy). So long as terfenadine

represented a unique molecule, the

agency concluded that terfenadine’s

risks, which had been greatly reduced

by labeling changes and public

awareness, were acceptable in light of

its benefits. It is only now, when there

is an alternative that is identical to the

molecule that provides the therapeutic

benefits of terfenadine, that

terfenadine’s benefits do not outweigh

its risks. This is because essentially all

of its benefits can be obtained with

fexofenadine hydrochloride without the

cardiovascular risk caused by QT

prolongation.

Currently, there is no combination of

fexofenadine hydrochloride and

pseudoephedrine approved for

marketing in the United States.

Although the absence of a fexofenadine

hydrochloride/pseudoephedrine

combination product may be

inconvenient for patients currently

taking Seldane-D, there are available

over-the-counter extended-release

pseudoephedrine 120 mg products that

could be taken with fexofenadine

hydrochloride to provide symptomatic

relief comparable to that provided by

Seldane-D for the treatment of seasonal

allergic rhinitis. The minor

inconvenience to patients of having to

take separate fexofenadine

hydrochloride and extended-release

pseudoephedrine doses is more than

offset by the cardiac safety advantage of

fexofenadine hydrochloride over

terfenadine.

Accordingly, the Director of the

Center for Drug Evaluation and Research

concludes with respect to NDA 18–949

(terfenadine 60 mg) that: (1) Prior to the

approval of fexofenadine hydrochloride,

terfenadine provided a unique

therapeutic alternative for which the

risks associated with the use of

terfenadine were acceptable; (2)

terfenadine provides no therapeutic

benefit to any patient population that is

not also provided by fexofenadine

hydrochloride, because fexofenadine

hydrochloride is identical in molecular

structure to terfenadine’s

therapeutically active metabolite; (3)

current data demonstrate that

fexofenadine hydrochloride lacks the

serious cardiovascular risks associated

with misuse of terfenadine, and

approximately 5 months of marketing

experience with fexofenadine

hydrochloride in the United States has

not resulted in any reports of serious

cardiac arrythmias; (4) despite the many

interventions undertaken by the agency

and by HMR (three ‘‘Dear Health Care

Professional’’ letters, multiple labeling

changes, and extensive education

campaigns), residual coprescribing,

codispensing, and concomitant use of

terfenadine with a growing list of

medications that inhibit its metabolism

continues and cannot be expected to be

completely eliminated; and (5)

terfenadine, therefore, is no longer

shown to be safe for use under the

conditions that formed the basis upon

which the application was initially

approved. The Director also finds that

ANDA 74–475 refers to NDA 18–949

(Seldane, 60 mg terfenadine oral tablets)

as the listed drug. The Director further

finds that the conclusions set out above

for NDA 18–949 apply with respect to

NDA 19–664 (terfenadine 60 mg and

pseudoephedrine 120 mg), and that the

inconvenience to patients of taking

separate doses of fexofenadine

hydrochloride and extended-release

pseudoephedrine is more than offset by

the cardiac safety advantage of

fexofenadine hydrochloride over

terfenadine. The Director is proposing to

withdraw approval of NDA 18–949 and

NDA 19–664 in accordance with section

505(e)(2) of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C.

355(e)(2)). The Director is proposing to

withdraw approval of ANDA 74–475 in

accordance with section 505(j)(5) of the

act.

II. Notice of Opportunity for a Hearing

The Director has evaluated the

information discussed above and, on the

grounds stated, is proposing to

withdraw approval of NDA 18–949,

NDA 19–664, and ANDA 74–475.

Therefore, notice is given to HMR and

Baker Norton Pharmaceuticals, Inc. that

the Director proposes to issue an order

under section 505(e)(2) of the act,

withdrawing approval of NDA 18–949

and NDA 19–664, and all amendments

and supplements thereto, and under

section 505(j)(5) of the act, withdrawing

approval of ANDA 74–475, and all

amendments and supplements thereto.

The Director finds that new evidence of

clinical experience, not contained in

NDA 18–949 and NDA 19–664 or not

available to the Director until after the

applications were approved, evaluated

together with the evidence available to

the Director when the applications were

approved, shows that terfenadine is not

shown to be safe for use under the

conditions which formed the basis upon

which the applications were approved.

The Director also finds that ANDA 74–

475 refers to the drug that is the subject

of NDA 18–949.

In accordance with section 505 of the

act and part 314 (21 CFR part 314), HMR

and Baker Norton Pharmaceuticals, Inc.

are hereby given an opportunity for a

hearing to show why approval of the

NDA’s should not be withdrawn.

An applicant who decides to seek a

hearing shall file: (1) On or before

February 13, 1997, a written notice of

appearance and request for hearing, and

(2) on or before March 17, 1997, the

data, information, and analyses relied

on to demonstrate that there is a

genuine issue of material fact to justify

a hearing, as specified in § 314.200. Any

other interested person may also submit

comments on this notice. The

procedures and requirements governing

this notice of opportunity for a hearing,

a notice of appearance and request for

a hearing, information and analyses to

justify a hearing, other comments, and

a grant or denial of a hearing are

contained in §§ 314.151 and 314.200,

and in 21 CFR part 12.

The failure of an applicant to file a

timely written notice of appearance and

request for hearing, as required by

§ 314.200, constitutes an election by that

person not to use the opportunity for a
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