Federal Register / Vol. 63, No. 96 /Tuesday, May 19, 1998 / Notices 27583

tobacco and the FDA Modernization

Act.

DATES: The meeting will be held on

Thursday, May 28, 1998, from 2 p.m. to

4 p.m.

ADDRESSES: The meeting will be held at

the Bethesda Holiday Inn, 8120

Wisconsin Ave., Bethesda, MD.

FOR FURTHER INFORMATION CONTACT:

Peter H. Rheinstein, Office of Health

Affairs (HFY–40), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–6630.

Registration: There is no registration fee,

however, space is limited. Persons will

be registered in the order in which calls

are received. Please call Betty Palsgrove

at 301–827–6618 to register.

Registrations also may be transmitted by

FAX to 1–800–344–3332 or 301–443–

2446. Please include the name and title

of the person attending and the name of

the organization.

SUPPLEMENTARY INFORMATION: The

purpose of the meeting is to provide an

opportunity for representatives of health

professional organizations and other

interested persons to be briefed by

senior FDA staff. It will also provide an

opportunity for informal discussion on

these topics of particular interest to

health professional organizations.

This public meeting is free of charge;

however, space is limited. Registration

for the meeting will be accepted in the

order received and should be sent to the

contact person. Registration should

include the name and title of the person

attending and the name of the

organization being represented, if any.

Dated: May 13, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–13410 Filed 5–15–98; 2:58 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

First Party Audit Program

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of industry exchange

meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

industry exchange meeting to discuss

with the regulated industry a new

initiative being considered by the

agency. The First Party Audit Program

(FPAP) is intended to gather

information from selected human use

pharmaceutical manufacturers regarding

their quality assurance measures. This

information would be submitted to FDA

by those firms and would substitute, in

some measure, for information the

agency would otherwise obtain from its

direct inspectional activities. The

industry exchange meeting is intended

to present the broad concepts of this

initiative, discuss attendant issues, and

obtain feedback from all interested

parties as to the merits of proceeding

with the project. This meeting is

cosponsored by the Center for Drug

Evaluation and Research’s (CDER’s)

Office of Compliance and the Office of

the Commissioner’s Industry Small

Business and Community Affairs Staff.

DATES: The industry exchange meeting

will be held on June 23, 1998, from 9

a.m. to 4 p.m. Registration is required by

June 12, 1998.

ADDRESSES: The industry exchange

meeting will be held at the Hyatt

Regency Bethesda Hotel, One Bethesda

Metro Center, Bethesda, MD.

FOR FURTHER INFORMATION CONTACT: C.

Russ Rutledge, Center for Drug

Evaluation and Research (HFD–325),

Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 301–

594–2455.

Those persons interested in attending

this meeting should FAX or e-mail their

registration to C. Russ Rutledge (FAX

301–594–2202 or e-mail via the Internet

at ‘‘rutledgec@cder.fda.gov’’), including

name of attendee(s), title, affiliation,

mailing address, phone number, fax

number, and e-mail address. There is no

registration fee for this meeting, but

advance registration is required.

Interested parties are encouraged to

register early because space is limited.

SUPPLEMENTARY INFORMATION: FDA relies

in large part on information acquired

during inspections of manufacturing

facilities, conducted by the agency’s

investigators, to ensure that firms are

meeting the minimum levels of product

quality assurance for human drug

products. Although the agency believes

that full inspection by its investigators

is the ideal situation, FDA is evaluating

alternative methods of acquiring

information it would otherwise directly

obtain from traditional onsite

inspections. One approach the agency is

considering is the FPAP. The first party

is the manufacturing firm itself. The

concept is to limit program participation

to those manufacturers FDA recognizes

as having both a quality assurance

program that is effective and a record of

substantial compliance with FDA

requirements. Program participation

would be strictly voluntary. Firms the

agency selects for the program would

supply FDA with information from its

self-audits apart from FDA onsite

inspections. The agency would use this

information along with modified

inspections to document minimum

levels of assurance of manufacturing

quality of the pharmaceuticals produced

in that site.

FDA is holding this industry

exchange meeting to present the core

concepts of FPAP, discuss the relevant

issues, and afford interested parties the

opportunity to pose questions and

provide comments. The agency will

consider this public input in deciding

on whether and how to proceed with

the program, initially on a pilot basis.

The agenda and any other relevant

information will be available

electronically via the Internet at ‘‘http:/

/www.fda.gov/cder/dmpq/fpap.htm’’

beginning Monday, May 18, 1998.

Dated: May 8, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–13163 Filed 5–18–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee for

Pharmaceutical Science; 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: Advisory

Committee for Pharmaceutical Science.

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 June 23, 1998, 8 a.m. to 5 p.m.,

and on June 24, 1998, 8:30 a.m. to 5:30

p.m.

Location: Holiday Inn, The Ballrooms,

Two Montgomery Village Ave.,

Gaithersburg, MD.

Contact Person: Kimberly L. Topper,

Center for Drug Evaluation and Research

(HFD–21), Food and Drug

Administration 5600 Fishers Lane,

Rockville, MD 20857, 301–443–5455,

(For Federal Express Deliveries—

Chapman Bldg., 801 Thompson Ave.,

rm. 200, Rockville, MD 20857) or FDA

Advisory Committee Information Line,