Federal Register / Vol. 66, No. 127 / Monday, July 2, 2001 / Notices 34945

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Workshop on Preclinical Testing for

Endovascular Grafts

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of meeting.

This notice announces the

forthcoming workshop on preclinical

testing for endovascular grafts,

sponsored by the Food and Drug

Administration (FDA). The meeting will

be open to the public.

Date and Time: The meeting will be

held on July 31, 2001, 9 a.m. to 6 p.m.,

and August 1, 2001, 9 a.m. to 5 p.m.

Location: Gaithersburg Holiday Inn,

Walker-Whetstone Room, Two

Montgomery Village Ave., Gaithersburg,

MD.

Contact: The workshop organizers are

Megan Moynahan, 301–443–8517, ext.

171, mbm@cdrh.fda.gov, and Dorothy

Abel, 301–443–8262, ext. 165,

dba@cdrh.fda.gov, Center for Devices

and Radiological Health (HFZ–450),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850.

Agenda: The workshop will concern

endovascular grafts used in the

treatment of abdominal aortic

aneurysms. The goal of the workshop is

to find ways to improve how these grafts

are tested. Participants of the workshop

will first be asked to describe the

environment to which these grafts are

exposed. Then they will identify the

failure modes of the grafts and examine

how the devices have been tested to

date. Finally, the participants will be

asked to suggest ways to modify the

testing of these devices by taking into

consideration the graft environment.

Workshop participation is by

invitation only and is therefore limited.

However, the public may observe as

audience members. Background

information for the workshop will be

available to the public on the Internet at

http://www.fda.gov/cdrh/meetings/

073101workshop.html.

Procedure: Members of the public

who are interested in attending as

audience members should contact the

workshop organizers by July 13, 2001.

If you need special accommodations

due to a disability, please contact either

one of the contact persons listed above

at least 7 days in advance.

Dated: June 25, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–16471 Filed 6–29–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D–0239]

Medical Devices; Guidance on

Resolving Scientific Disputes

Concerning the Regulation of Medical

Devices; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the guidance entitled

‘‘Resolving Scientific Disputes

Concerning the Regulation of Medical

Devices.’’ The guidance describes the

role and operation of the Medical

Devices Dispute Resolution Panel of the

Medical Devices Advisory Committee

(the Dispute Resolution Panel), the

types of controversies eligible for review

by the Dispute Resolution Panel, and

recommendations for submitting a

request for review.

DATES: Submit written comments at any

time.

ADDRESSES: Submit written requests for

single copies on a 3.5′′ diskette of the

guidance document entitled ‘‘Resolving

Scientific Disputes Concerning the

Regulation of Medical Devices’’ to the

Division of Small Manufacturers

Assistance (HFZ–220), Center for

Devices and Radiological Health, Food

and Drug Administration, 1350 Piccard

Dr., Rockville, MD 20850. Send two selfaddressed labels to assist that office in

processing your request, or fax your

request to 301–443–8818. Submit

written comments concerning this

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Comments

should be identified with the docket

number found in brackets in the

heading of this document. See the

SUPPLEMENTARY INFORMATION section for

information on electronic access to the

guidance.

FOR FURTHER INFORMATION CONTACT: Les

S. Weinstein, Center for Devices and

Radiological Health (HFZ–5), Food and

Drug Administration, 9200 Corporate

Blvd., Rockville, MD 20850, 301–443–

6220, ext. 119.

SUPPLEMENTARY INFORMATION:

I. Background

Section 404 of the Food and Drug

Administration Modernization Act

(FDAMA) of 1997 (section 562 of the

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360bbb-1)) requires FDA to

establish procedures for the review of

scientific controversies where there is

not already an existing right of review.

Although FDA believes existing

procedures, such as internal agency

review of decisions under § 10.75 (21

CFR 10.75), provide for an appropriate

review of most, if not all, disputes, the

Center for Devices and Radiological

Health (CDRH) is developing new

procedures to ensure effective and

timely review of scientific disputes. In

fact, CDRH has recently taken

significant steps to achieve this

objective, including the appointment of

its first CDRH Ombudsman and the

establishment of an advisory Dispute

Resolution Panel. CDRH is now

announcing a final guidance document

on the use of this new Dispute

Resolution Panel to facilitate the fair

and rapid resolution of scientific

disputes.

This guidance supersedes the April

27, 1999 (64 FR 22617), draft guidance

document entitled ‘‘Resolving Scientific

Disputes Concerning the Regulation of

Medical Devices: An Administrative

Procedures Guide to Use of the Medical

Devices Dispute Resolution Panel.’’

The Dispute Resolution Panel,

chartered on August 18, 1999, has five

standing members (including a

nonvoting industry representative and a

nonvoting consumer representative),

and three additional temporary voting

members appointed for each particular

dispute. Standing members will have

broad, crosscutting scientific, clinical,

analytical, or mediation skills.

Temporary members will be chosen

based on their experience, expertise, or

analytical skills relevant to the review of

each particular dispute. FDA published

a notice in the Federal Register of

November 10, 1999 (64 FR 61352),

requesting nominations for the Dispute

Resolution Panel members. The five

standing members have since been

appointed, and the first meeting of the

Dispute Resolution Panel, an open

public session, was held on October 31,

2000; the Dispute Resolution Panel

members heard presentations from FDA

and the device industry on the role of

this panel in dispute resolution.

A. Response to Comments on the Draft

Guidance

Three comments were submitted

concerning the April 27, 1999, draft

guidance, two from medical device

industry associations—Health Industry

Manufacturers Association (now

AdvaMed) and the Medical Device

Manufacturers Association, and one

from a device firm. CDRH’s response to

the significant comments follows: