Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Notices 66113

AND RADIOLOGICAL HEALTH for

general information, or arrow down for

specific topics.

Dated: October 7, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–32875 Filed 12–16–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Cardiovascular and Renal Drugs

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

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: Cardiovascular

and Renal 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 January 27, 1998, 8:30 a.m. to

5:30 p.m.; and January 28, 1998, 9 a.m.

to 4 p.m.

Location: National Institutes of

Health, Natcher Conference Center, 45

Center Dr., Bethesda, MD 20892.

Contact Person: Joan C. Standaert,

Center for Drug Evaluation and Research

(HFD–110), 419–259–6211, or Danyiel

A. D’Antonio (HFD–21), 301–443–5455,

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12533. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On January 27, 1998, the

committee will review and discuss: (1)

New drug application (NDA) 20–736,

VerdiaTM (tasosartan, Wyeth-Ayerst

Research), as a therapy for hypertension;

and (2) the unapproved outpatient use

of intermittent intravenous positive

inotropic agents. On January 28, 1998,

the committee will review and discuss

NDA 20–718, IntegrilinTM (eptifibatide,

Cor Therapeutics, Inc.), for use in the

settings of percutaneous transluminal

angioplasty and acute coronary

syndrome.

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 January 20, 1998. Oral

presentations from the public will be

scheduled between approximately 8:30

a.m. and 9:30 a.m. on January 27, 1998.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before January 20,

1998, 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: December 11, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–32874 Filed 12–16–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0188]

International Conference on

Harmonisation; Guidance on General

Considerations for Clinical Trials

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is publishing a

guidance entitled ‘‘E8 General

Considerations for Clinical Trials.’’ The

guidance was prepared under the

auspices of the International Conference

on Harmonisation of Technical

Requirements for Registration of

Pharmaceuticals for Human Use (ICH).

The guidance sets forth general

scientific principles for the conduct,

performance, and control of clinical

trials.

DATES: Effective December 17, 1997.

Submit written comments at any time.

ADDRESSES: Submit written comments

on the guidance to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. Copies of the guidance are

available from the Drug Information

Branch (HFD–210), Center for Drug

Evaluation and Research, Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

4573. Single copies of the guidance may

be obtained by mail from the Office of

Communication, Training and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, or by calling

the CBER Voice Information System at

1–800–835–4709 or 301–827–1800.

Copies may be obtained from CBER’s

FAX Information System at 1–888–

CBER–FAX or 301–827–3844.

FOR FURTHER INFORMATION CONTACT:

Regarding the guidance: G. Alexander

Fleming, Center for Drug Evaluation

and Research (HFD–510), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–

827–6391.

Regarding ICH: Janet J. Showalter,

Office of Health Affairs (HFY–20),

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–827–0864.

SUPPLEMENTARY INFORMATION: In recent

years, many important initiatives have

been undertaken by regulatory

authorities and industry associations to

promote international harmonization of

regulatory requirements. FDA has

participated in many meetings designed

to enhance harmonization and is

committed to seeking scientifically

based harmonized technical procedures

for pharmaceutical development. One of

the goals of harmonization is to identify

and then reduce differences in technical

requirements for drug development

among regulatory agencies.

ICH was organized to provide an

opportunity for tripartite harmonization

initiatives to be developed with input

from both regulatory and industry

representatives. FDA also seeks input

from consumer representatives and

others. ICH is concerned with

harmonization of technical

requirements for the registration of

pharmaceutical products among three

regions: The European Union, Japan,

and the United States. The six ICH

sponsors are the European Commission,

the European Federation of

Pharmaceutical Industries Associations,

the Japanese Ministry of Health and

Welfare, the Japanese Pharmaceutical

Manufacturers Association, the Centers

for Drug Evaluation and Research

(CDER) and CBER, FDA, and the

Pharmaceutical Research and

Manufacturers of America. The ICH

Secretariat, which coordinates the

preparation of documentation, is

provided by the International

Federation of Pharmaceutical

Manufacturers Associations (IFPMA).