[Federal Register Volume 67, Number 150 (Monday, August 5, 2002)]
[Notices]
[Page 50678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19728]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0330]


International Conference on Harmonisation Workshop on Gene 
Therapy; Public Meeting

AGENCY: Food and Drug Administration, HHS

ACTION: Notice of public meeting.

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    The Food and Drug Administration (FDA) is announcing a public 
meeting entitled ``Public Meeting: ICH Workshop on Gene Therapy.'' The 
purpose of the meeting is to solicit input and conduct discussion on 
gene therapy issues regarding the development of viral vector reference 
materials, adenovirus shedding, and the safe use of Lentivirus vectors 
in clinical trials.
    Date and Time: The meeting will be held on September 9, 2002, from 
8 a.m. to 5 p.m.
    Location: The meeting will be held at the Sheraton Premiere Tysons 
Corner, McLean, VA.
    Contact: Stephanie Simek, Division of Cellular and Gene Therapies 
(HFM-591), Food and Drug Administration, Woodmont Office Complex One, 
1401 Rockville Pike, suite 380 North, Rockville, MD 20852, 301-827-
5102, FAX 301-827-5397.
    Registration and Request for Oral Representations: Send 
registration information (including name, title, firm name, address, 
telephone, and fax number), and written material and requests to make 
oral presentations, to the contact person by August 26, 2002. To 
register electronically, please see the Pharmaceutical Research and 
Manufacturers of America at http://www.phrma.org/meetings/ and register 
by August 16, 2002.
    If you need special accommodations due to a disability, please 
contact Stephanie Simek at least 7 days in advance.

SUPPLEMENTARY INFORMATION:

I. Background

    The International Conference on Harmonisation (ICH) was organized 
to provide an opportunity for harmonization initiatives to be developed 
with input from both regulatory and industry representatives. ICH is 
concerned with harmonization among three regions: The European Union, 
Japan, and the United States. The six ICH sponsors are the European 
Commission; the European Federation of Pharmaceutical Industries 
Associations; the Japanese Ministry of Health, Labor and Welfare; the 
Japanese Pharmaceutical Manufacturers Association; the Center for Drug 
Evaluation and Research and the Center for Biologics Evaluation and 
Research, FDA; and the Pharmaceutical Research and Manufacturers of 
America. The ICH Secretariat, which coordinates the preparation of 
documentation, is provided by the International Federation of 
Pharmaceutical Manufacturers Associations. The ICH Steering Committee 
includes representatives from each of the ICH sponsors and Canadian 
Therapeutics Programme, and the European Free Trade Area. The ICH 
process has achieved significant harmonization of the technical 
requirements for the approval of pharmaceuticals for human use in the 
three ICH regions. The current ICH process and structure can be found 
on the Internet at http://www.ifpma.org/ich1.html.
    In recent years, many important initiatives have been undertaken by 
regulatory authorities and industry associations to promote 
international harmonization of gene therapy regulatory requirements. 
FDA has participated in many meetings designed to enhance harmonization 
and is committed to participating with the international community in 
the development and clinical use of safer and more effective gene 
therapy products.
    The ICH held its first workshop on Gene Therapy in Chiba Japan, May 
21 through 24, 2001. The workshop was held as a joint regulatory/
industry project to improve, through harmonization, the efficiency of 
the process for sharing information on the development of gene therapy 
products in Europe, Japan, and the United States without compromising 
the regulatory obligations of safety and effectiveness.
    At this workshop, it was agreed that the scientific principles for 
the regulation of gene therapy or gene therapy products are currently 
harmonized in the three ICH regions. Because the field of gene therapy 
is extremely complex and rapidly evolving, the group suggested that an 
exchange of scientific expertise and experience among the ICH partners 
could foster prospective harmonization of technical requirements.
    It was then agreed that an ICH scientific workshop would be held in 
conjunction with the Spring ICH Steering Committee and Expert Working 
Group meetings in Washington, DC.

II. Issues To Be Discussed at the Public Meeting

    The issues to be discussed include the following: (1) Development 
of viral vector reference standards, and (2) safe use of Lentivirus 
vectors in gene therapy clinical trials.
    Interested persons may take part in an open discussion at two 
sessions during the September 9, 2002, meeting. The morning panel 
discussion will be between approximately 9:45 a.m. and 10:45 a.m. and 
will be focused on the development of viral vector reference standards. 
The afternoon discussion panel will be scheduled between approximately 
3:40 p.m. and 4:40 p.m. and will focus on the safe use of Lentivirus 
vectors in gene therapy clinical trials.
    The agenda for the public meeting will be made available on August 
26, 2002, at the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, under 
docket number 02N-0330.
    Transcripts: Transcripts of the meeting 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: July 29, 2002.
 Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-19728 Filed 8-2-02; 8:45 am]
BILLING CODE 4160-01-S