[Federal Register Volume 66, Number 178 (Thursday, September 13, 2001)]
[Notices]
[Pages 47676-47677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22941]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0384]


Preparation for Global Harmonization Task Force Conference in 
Barcelona, Spain, Including a Discussion of Guidance Proposed for 
Comment and Currently Under Development and Possibilities for New 
Topics; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting entitled ``Preparation for Global Harmonization Task Force 
Conference in Barcelona, Spain, Including a Discussion of Guidance 
Proposed for Comment and Currently Under Development and Possibilities 
for New Topics.'' The purpose of this meeting is to solicit information 
and receive comments on FDA's future participation in the Global 
Harmonization Task Force (GHTF) as well as the upcoming meetings in 
Barcelona, Spain. The topics to be discussed are an overview of GHTF, 
guidance proposed for comment and currently under development, and 
possibilities for new topics. This meeting is being held to solicit 
public input prior to the next meeting of the GHTF Steering Committee 
and Study Groups in Barcelona, Spain, from October 11 to 16, 2001, at 
which discussion of the guidance proposed for comment and under 
development and possible new topics will be continued.
    Comments: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Comments are to be identified with the docket number 
found in brackets in the heading of this document.
    Date and Time: The public meeting will be held on October 1, 2001, 
from 1:30 p.m. to 4:30 p.m.
    Location: The public meeting will be held at 5630 Fishers Lane, rm. 
1056, Rockville, MD.
    Contact: Kimberly Topper, Center for Drug Evaluation and Research, 
Food and Drug Administration, 5630 Fishers Lane, Rockville, MD 20852, 
301-827-7001, FAX 301-827-6801, or e-mail: [email protected].
    Registration and Requests for Oral Presentations: Send registration 
information (including name, title, firm or organization name, address, 
telephone, and fax number), and written material and requests to make 
oral presentations to the contact person by September 26, 2001.
    If you need special accommodations due to a disability, please 
contact Kimberly Topper at least 7 days in advance.

SUPPLEMENTARY INFORMATION:

I. Background

    The GHTF was established in 1992 as a joint regulatory/industry 
project to encourage convergence in regulatory practices related to 
ensuring the safety, effectiveness/performance and quality of medical 
devices; promote technological innovation; and facilitate international 
trade. The GHTF works to achieve these objectives by disseminating 
guidance documents on basic regulatory practices. These documents, 
which are developed by four different GHTF Study Groups, can be 
adopted/implemented by member national regulatory authorities. Other 
national regulatory authorities that are not GHTF members also are 
encouraged to adopt and implement GHTF guidance documents.

[[Page 47677]]

    In recent years, regulatory authorities and industry associations 
have undertaken many important initiatives to promote international 
harmonization of regulatory requirements. FDA has participated in many 
meetings designed to enhance harmonization. FDA is committed to seeking 
scientifically based harmonized technical procedures for medical device 
regulation. One of the goals of harmonization is to identify 
similarities and differences in technical requirements for medical 
devices, increase the similarities, and reduce the differences. The 
GHTF was organized to provide an opportunity for harmonization 
initiatives to be developed with input from both regulatory and 
industry representatives.
    The GHTF is concerned with harmonization among three regions: the 
European Union, Asia-Pacific, and North America. The members of the 
GHTF are the European Union, Australia, Japan, Canada, and the United 
States. The GHTF Steering Committee is composed of four regulatory and 
four industry representatives from each region for a total of 12 
regulatory and 12 industry representatives. The secretariat rotates 
from one region to another every 3 years. The Therapeutic Goods 
Administration of Australia currently serves as the secretariat for 
GHTF. Health Canada previously served as the secretariat. The Ministry 
of Health and Welfare of Japan will serve as the next secretariat.
    GHTF study groups develop guidance documents on device regulation. 
There are currently four study groups: Study Group 1--premarket issues; 
Study Group 2--postmarket vigilance; Study Group 3--quality systems; 
and Study Group 4--auditing of quality systems.
    The GHTF process is intended to achieve harmonization of the 
technical requirements for approval or clearance of medical devices, 
quality system requirements, procedures for auditing quality systems, 
and postmarket vigilance in the three regions. Information about the 
GHTF, its structure, proposed and final study group guidance documents, 
and the upcoming conference in Barcelona, Spain, can be found on the 
Internet at http://www.ghtf.org.

II. Issues To Be Discussed at the Public Meeting

    The issues to be discussed include the following: (1) GHTF overview 
and procedures, (2) overview of GHTF Study Group work, (3) medical 
device nomenclature, and (4) possibilities for new topics.
    Interested persons may present data, information, or views orally 
or in writing, on issues pending at the public meeting. Oral 
presentations from the public will be scheduled. Time allotted for oral 
presentations may be limited to 10 minutes. Anyone desiring to make an 
oral presentation should notify the contact person by September 20, 
2001, and submit a brief statement of the general nature of the 
evidence or arguments they wish to present, the name and address, phone 
number, fax and e-mail of the proposed participant, and an indication 
of the approximate time requested to make the presentation.
    The agenda for the public meeting will be available on September 
17, 2001, at the Dockets Management Branch (address above) under Docket 
No. 01N-0384.
    Transcripts: A transcript of the meeting will be posted on the 
Internet at: http://www.fda.gov/ohrms/dockets/dockets/docwhatsnew.htm 
under Docket No. 01N-0384. A transcript of the meeting also may be 
requested in writing from the Freedom of Information Office (HFI-35), 
Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, 
MD 20857, approximately 15 working days after the meeting at a cost of 
10 cents per page.

    Dated: September 6, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-22941 Filed 9-12-01; 8:45 am]
BILLING CODE 4160-01-S