66112 Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Notices

Head Start Program and the expansion

of services by other agencies providing

child care and early childhood

education, it is estimated that

approximately 8,000 CDA candidates

will require assessment and a credential

award during each of the next four

years.

In the face of these challenges, the

Department seeks to ensure the

continuity of the administration of this

unique national credentialing program,

which provides affordable credentialing

award services which are nationally

recognized, cost effective, represent

quality standards for staff working with

children ages birth to five years, and

enjoy the confidence of the States,

institutions of higher learning, and the

field of early childhood.

(Catalog of Federal Domestic Assistance

Program Number 93.600, Project Head Start)

Dated: December 11, 1997.

James A. Harrell,

Deputy Commissioner, Administration on

Children, Youth and Families.

[FR Doc. 97–32954 Filed 12–16–97; 8:45 am]

BILLING CODE 4184–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0430]

Medical Devices; Guidance Document

for the Submission of Tumor

Associated Antigen Premarket

Notifications, [510(k)], to FDA;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance entitled

‘‘Guidance Document for the

Submission of Tumor Associated

Antigen Premarket Notifications,

[510(k)], to FDA.’’ The guidance

document provides suggestions for the

nonclinical laboratory studies and the

design, conduct, and analysis of

appropriate clinical studies that the

Center for Devices and Radiological

Health (CDRH), FDA, believes will

provide reasonable assurance of the

safety and effectiveness of these devices.

The guidance document also sets forth

the review criteria and describes the

data to support a 510(k) submission.

The guidance accompanies a final rule,

which appears elsewhere in this issue of

the Federal Register, announcing the

reclassification of tumor associated

antigen immunological test systems

from class III (premarket approval) to

class II (special controls).

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written comments

concerning this guidance document to

the contact person listed below. Submit

written requests for single copies of

‘‘Guidance Document for the

Submission of Tumor Associated

Antigen Premarket Notifications,

[510(k)], to FDA’’ to the Division of

Small Manufacturers Assistance

(DSMA), Center for Devices and

Radiological Health (HFZ–220), Food

and Drug Administration, 1350 Piccard

Dr., Rockville, MD 20850. Send two selfaddressed adhesive labels to assist the

office in processing your request, or fax

your request to 301–443–8818. See the

SUPPLEMENTARY INFORMATION

section for electronic access to the

guidance document.

FOR FURTHER INFORMATION CONTACT:

Peter E. Maxim, Center for Devices and

Radiological Health (HFZ–440), Food

and Drug Administration, 2098 Gaither

Rd., Rockville, MD 20850, 301–594–

1293.

SUPPLEMENTARY INFORMATION:

I. Background

FDA issued an order (September 19,

1996) in the form of a letter reclassifying

tumor associated antigen immunological

test systems from class III to class II. The

order identified the premarket

notification guidance document for

tumor associated antigens as one of the

designated special controls. The

guidance document contains general

information on the definition of

qualifying devices and the

administrative requirements for

submitting a 510(k) to FDA. The

document also lists the types of

nonclinical (analytical) studies to be

included in the submission. These

studies include reagent characterization,

assay specificity, and device

performance characteristics to include

precision, linearity, interfering

substances, analytical sensitivity and

methods of comparison to another

device. Finally, the document provides

guidance on the design of clinical

studies to support a submission for a

new tumor marker intended to monitor

previously treated patients.

This guidance document represents

the agency’s current thinking on the

design of clinical studies expected to

support a 510(k) submission for new

tumor markers intended to monitor

previously treated patients. It does not

create or confer any rights for or on any

person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the requirements of the

applicable statute, regulation, or both.

II. Requests for Comments

Interested persons may, at any time,

submit to the contact person listed

above written comments regarding this

guidance document. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document.

III. Electronic Access

In order to receive the ‘‘Guidance

Document for the Submission of Tumor

Associated Antigen Premarket

Notifications, [510(k)], to FDA’’ via your

fax machine, call the CDRH Facts-OnDemand system at 1–800–899–0381 or

301–827–0111 from a touch-tone

telephone. At the first voice prompt

press 1 to access DSMA Facts, at second

voice prompt press 2, and then enter the

document number (957) followed by the

pound sign (#). Follow the remaining

voice prompts to complete your request.

Persons interested in obtaining a copy

of the guidance may also do so using the

World Wide Web (WWW). The CDRH

maintains an entry on the WWW for

easy access to the Web. Updated on a

regular basis, the CDRH home page

includes ‘‘Guidance Document for the

Submission of Tumor Associated

Antigen Premarket Notifications,

[510(k)], to FDA,’’ device safety alerts,

Federal Register reprints, information

on premarket submissions (including

lists of approved applications and

manufacturers’ addresses), small

manufacturers’ assistance, information

on video conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh. ‘‘Guidance

Document for the Submission of Tumor

Associated Antigen Premarket

Notifications, [510(k)], to FDA’’ will be

available at http://www.fda.gov/cdrh/

ode/ed—cl.html.

A text-only version of the CDRH Web

site is also available from a computer or

VT–100 compatible terminal by dialing

1–800–222–0185 (terminal settings are

8/1/N). Once the modem answers, press

Enter several times and select menu

choice 1: FDA BULLETIN BOARD

SERVICE. From there follow

instructions for logging in, and at the

BBS TOPICS PAGE, arrow down to the

FDA home page (do not select the first

CDRH entry). Then select Medical

Devices and Radiological Health. From

there select CENTER FOR DEVICES
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).