[Federal Register: April 7, 2005 (Volume 70, Number 66)]
[Notices]
[Page 17698-17699]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ap05-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0119]
Preparation for the International Conference on Harmonization
Meetings in Brussels, Belgium; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meeting.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to provide information and receive comments on the
International Conference on Harmonization (ICH) in advance of its next
next Steering Committee and Expert Working Group meetings in Brussels,
Belgium, May 9 through 12, 2005. Scheduled for the ICH meetings is an
Efficacy Brainstorming Session focusing on the review of the existing
efficacy guidelines and their need for updating as well as potential
new topics for consideration. To promote a fuller discussion of this
topic the public meeting will be expanded to include public input on
initiatives related to current ICH efficacy guidelines and consider
needs for further information both within and between existing
guidances. These initiatives include electronic source data, clinical
development plan summaries, Health Level 7 structured product labeling,
and other initiatives including information exchange standards (e.g.,
Electronic Common Technical Document (eCTD) and terminology standards).
Date and Time: The meeting will be held on April 20, 2005, from 9
a.m. to 5:30 p.m.
Location: The meeting will be held at The DoubleTree Hotel and
Executive Meeting Center, 1750 Rockville Pike, Rockville, MD. A block
of rooms for those wishing to attend the meeting have been set aside at
the government rate. Please contact the hotel directly for your
reservation: DoubleTree Hotel and Executive Meeting Center, 301-468-
1100, FAX: 301-468-0308.
Contact Person: Sema Hashemi, Office of the Commissioner, Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
3050, FAX: 301-480-0716, e-mail: Sema.Hashemi@fda.hhs.gov.
Registration and Requests for Oral Presentations: Send registration
information (including name, title, firm name, address, telephone, and
FAX number), and written material and
[[Page 17699]]
requests to make oral presentations, to the contact person by April 14,
2005.
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.
If you need special accommodations due to a disability, please
contact Sema Hashemi at least 7 days in advance.
SUPPLEMENTARY INFORMATION: The ICH was established in 1990 as a joint
regulatory/industry project to improve, through harmonization, the
efficiency of the process for developing and registering new medicinal
products in Europe, Japan, and the United States without compromising
the regulatory obligations of safety and effectiveness.
In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for medical product development among regulatory agencies.
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 the
following 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 Centers for Drug Evaluation and Research
and 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 Health Canada, the European Free Trade Area and the
World Health Organization. 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 at the following
Web site: http://www.ich.org. (FDA has verified the Web site address,
but we are not responsible for subsequent changes to the Web site after
this document publishes in the Federal Register.)
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 between approximately 1
p.m. and 2 p.m. Time allotted for oral presentations may be limited to
10 minutes. Those desiring to make oral presentations should notify the
contact person by April 14, 2005, and submit a brief statement of the
general nature of the evidence or arguments they which to present, the
names and addresses, phone number, FAX, and e-mail of proposed
participants, and an indication of the approximate time requested to
make their presentation.
The topics to be discussed are the topics for discussion at the
forthcoming ICH Steering Committee Meeting and ICH Expert Working
Groups. One of the topics for the upcoming ICH meeting is an Efficacy
Brainstorming Session focusing on the review of the existing efficacy
guidelines and their need for updating as well as potential new topics
for consideration. The complete set of ICH Efficacy Guidelines may be
found at http://www.ich.org/ or http://www.fda.gov/cder/guidance/index.htm.
To promote a fuller discussion of this topic the public
meeting will be expanded to include public input on initiatives related
to current ICH efficacy guidelines and consider needs for further
information both within and between existing guidances. These
initiatives include electronic source data, clinical development plan
summaries, Health Level 7 structured product labeling, and other
initiatives including information exchange standards (e.g., eCTD and
terminology standards).
The agenda for the public meeting will be made available on April
15, 2005, via the internet at http://www.fda.gov/cder/meeting/ICH_Spring2005.htm
.
Dated: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7020 Filed 4-5-05; 11:53 am]
BILLING CODE 4160-01-S