Federal Register / Vol. 63, No. 97 /Wednesday, May 20, 1998 / Notices 27733

applications, but also indicates

procedural and other information about

the meeting.

Dated: May 15, 1998.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 98–13478 Filed 5–15–98; 4:22 pm]

BILLING CODE 6210–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Agency for Health Care Policy and

Research

Meeting of the National Advisory

Council for Health Care Policy,

Research, and Evaluation

AGENCY: Agency for Health Care Policy

and Research, HHS.

ACTION: Notice of public meeting.

SUMMARY: In accordance with section

10(a) of the Federal Advisory Committee

Act, this notice announces a meeting of

the National Advisory Council for

Health Care Policy, Research, and

Evaluation.

DATES: The meeting will be held on

Friday, June 5, 1998 from 8:30 a.m. to

4 p.m.

ADDRESSES: The meeting will be held at

the DoubleTree Hotel, 1750 Rockville

Pike, Rockville, Maryland 20852.

FOR FURTHER INFORMATION CONTACT:

Nancy Foster, Coordinator of the

Advisory Council at the Agency for

Health Care Policy and Research 2101

East Jefferson Street, Suite 502,

Rockville, Maryland 20852, (301) 594–

1349 ext. 1307.

If sign language interpretation or other

reasonable accommodation for a

disability is needed, please contact

Linda Reeves, Assistance Administrator

for Equal Opportunity, AHCPR, on (301)

594–6665 ext. 1055 no later than May

22, 1998.

SUPPLEMENTARY INFORMATION:

I. Purpose

The Council provides advice to the

Secretary and the Administrator,

Agency for Health Care Policy and

Research (AHCPR), on matters related to

AHCPR activities to enhance the

quality, appropriateness, and

effectiveness of health care services and

access to such services through

scientific research and the promotion of

improvements in clinical practice and

in the organization, financing, and

delivery of health care services. The

Council is composed of members of the

public appointed by the Secretary and

Federal ex-officio members. The

Council will be chaired by Harold S.

Luft, Ph.D.

II. Agenda

On Friday, June 5, 1998, the meeting

will begin at 8:30 a.m., with the call to

order by the Council Chairman. The

Administrator, AHCPR, will update the

status of current Agency programs and

initiatives. The Council will then

discuss key issues in dissemination of

research findings to promote their use,

ethical aspects of using public funds for

the development of products that will

be marketed commercially, and future

directions for research on quality, health

economics, and primary care.

The meeting will adjourn at 4:00 p.m.

Agenda items are subject to change as

priorities dictate.

Dated: May 14, 1998.

John M. Eisenberg,

Administrator.

[FR Doc. 98–13396 Filed 5–19–98; 8:45 am]

BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0056]

List of Drugs for Which Additional

Pediatric Information May Produce

Health Benefits in the Pediatric

Population; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a list entitled ‘‘List of

Drugs for Which Additional Pediatric

Information May Produce Health

Benefits in the Pediatric Population’’

(hereinafter referred to as ‘‘the list’’).

This is a list of approved drugs for

which additional pediatric information

may produce health benefits in the

pediatric population. The list is being

published under new statutory

requirements of the Food and Drug

Administration Modernization Act of

1997 (Modernization Act). The purpose

of the list is to identify certain drugs for

which certain information is necessary

to determine if an approved drug can be

used safely and effectively in the

pediatric population.

DATES: Submit written comments on the

procedure and criteria used to develop

the list at any time.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. Submit

written requests for single copies of the

list to 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.

Send one self-addressed adhesive label

to assist that office in processing your

request. Single copies of the list may

also be obtained by mail from the Office

of Communication, Training and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), or by calling the CBER

Voice Information System at 1–800–

835–4709, or 301–827–1800. Copies of

the list may be obtained from CBER’s

FAX Information System at 1–888–

CBER–FAX or 301–827–3844. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the list.

FOR FURTHER INFORMATION CONTACT:

Khyati N. Roberts, Center for Drug

Evaluation and Research (HFD–6),

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–594–6779, FAX 301–

594–5493, e-mail

robertsk@cder.fda.gov, or

David W. Feigal, Center for Biologics

Evaluation and Research (HFM–6),

Food and Drug Administration,

1401 Rockville Pike, Rockville, MD

20852, 301–827–0376, FAX 301–

827–0440, e-mail

feigal@cber.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

On November 21, 1997, President

Clinton signed into law the

Modernization Act (Pub. L. 105–115).

Section 111 of the Modernization Act

(21 U.S.C. 355A(b)) requires FDA, after

consultation with experts in pediatric

research, to develop, prioritize, and

publish a list of approved drugs for

which additional pediatric information

may produce health benefits in the

pediatric population. Inclusion of a drug

on the list does not necessarily mean

that the drug is entitled to pediatric

exclusivity.

FDA developed a draft list in

consultation with experts in pediatric

research, trade organizations, and other

interested persons, and made the draft

list available for public comment (see 63

FR 12815, March 16, 1998). After

consideration of comments on the draft

list, FDA is publishing the list of

approved drugs for which additional

pediatric information may produce

health benefits in the pediatric

population and announcing its

availability through this notice.