Federal Register / Vol. 62, No. 166 / Wednesday, August 27, 1997 / Notices 45425

Attendees requiring overnight

accommodations may contact the hotel

at 770–394–5000.

FOR FURTHER INFORMATION CONTACT:

For information regarding this notice:

JoAnn Pittman, Food and Drug

Administration, Atlanta District

Office, 60 Eighth St. NE., Atlanta,

GA 30309, 404–347–7355.

For information regarding registration

and the workshop: Denise Rooney,

AFDO, P.O. Box 3425, York, PA

17402, 717–757–2888, FAX 717–

755–8089.

SUPPLEMENTARY INFORMATION: This

workshop is cosponsored with AFDO.

AFDO will be assisting with the agenda

and administrative functions for the

meeting. Representatives from FDA’s

Center for Devices and Radiological

Health and ORA Southeast Region and

other FDA representatives will be

participating.

AFDO is charging a registration fee of

$200 for the public workshop that

includes training materials, breaks, and

lunch for 2 days. Those persons

interested in attending this public

workshop should send their registration

fee including name(s), firm name,

address, telephone number, and FAX

number to Denise Rooney (address

above) by September 5, 1997. Make

checks payable to AFDO. Space is

limited and all interested parties are

encouraged to register early.

Dated: August 21, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–22791 Filed 8–26–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Regulatory Partnership Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

The Food and Drug Administration

(FDA) is announcing the following

public workshop: Regulatory

Partnership Workshop. The topic to be

discussed is medical device reporting

for user facilities. FDA is holding this

public workshop to promote the

President’s initiative for a partnership

approach between front-line regulators

and the people affected by the work of

this agency, and specifically to develop

a device reporting partnership among

the Federal, manufacturing, and medical

communities.

Date and Time: The public workshop

will be held on Thursday, September

11, 1997, 9 a.m. to 12 m.

Location: The public workshop will

be held at Cavanaugh’s Inn at the Park,

303 West North River Dr., Spokane, WA

99201, 509–326–8000.

Contact:

In Seattle: Sue J. Hutchcroft, Food and

Drug Administration (HFR–PA

300), P.O. Box 3012, Bothell, WA

98041–3012, 425–483–4953, FAX

425–483–4996.

In Spokane: Dolores E. Price, Food

and Drug Administration (HFR–PA

3520), 1000 North Argonne, suite

105, Spokane, WA 99212, 509–353–

2470, FAX 509–353–2746.

In Oakland: Mark S. Roh, Food and

Drug Administration, 1301 Clay St.,

suite 1180N, Oakland, CA 94612–

5217, 510–637–3980, FAX 510–

637–3977.

Registration: Send registration

information (including name, title, firm

name, address, telephone, and fax

number) to one of the contact persons

by Thursday, September 4, 1997. There

is no registration fee for this public

workshop. Space is limited, therefore

interested parties are encouraged to

register early.

If you need special accommodations

due to a disability, please contact one of

the listed contact persons at least 7 days

in advance.

Dated: August 21, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–22792 Filed 8–26–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee Meeting;

Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

notice that published in the Federal

Register of August 22, 1997 (62 FR

44700). The notice announced a meeting

of the General Hospital and Personal

Use Devices Panel of the Medical

Devices Advisory Committee, which is

scheduled for September 15 and 16,

1997. The notice published with an

error. This document corrects that error.

FOR FURTHER INFORMATION CONTACT:

LaJuana D. Caldwell, Office of Policy

(HF–27), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–2994.

SUPPLEMENTARY INFORMATION: In the

Federal Register of August 22, 1997 (62

FR 44700), in FR Doc. 97–22556, FDA

announced that a meeting of the General

Hospital and Personal Use Devices

Panel of the Medical Devices Advisory

Committee would be held on September

15 and 16, 1997. The notice incorrectly

published the dates for submissions to

the contact person as August 9, 1997.

The correct date should be August 29,

1997.

Beginning on page 44700, in column

3, under the ‘‘Procedure:’’ portion of the

meeting, the date ‘‘August 9, 1997’’

should be corrected to read ‘‘August 29,

1997’’ both places that it appears.

Dated: August 22, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–22858 Filed 8-22-97; 4:20 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0345]

Guidance for Industry on

Postmarketing Adverse Experience

Reporting for Human Drug and

Licensed Biological Products:

Clarification of What to Report;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance for industry

entitled ‘‘Postmarketing Adverse

Experience Reporting for Human Drug

and Licensed Biological Products:

Clarification of What to Report.’’ The

purpose of this guidance document is to

clarify requirements for postmarketing

safety reporting. This guidance

document is intended to improve the

quality of safety reports submitted to

FDA while streamlining the

postmarketing surveillance of human

drug and licensed biological products.

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written requests for

single copies of the guidance for

industry ‘‘Postmarketing Adverse

Experience Reporting for Human Drug

and Licensed Biological Products:

Clarification of What to Report’’ to the