Department of Health and Human Services April 7, 2005 – Federal Register Recent Federal Regulation Documents

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 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.

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