70 FR 66 pgs. 17698-17699 - Preparation for the International Conference on HarmonizationMeetings in Brussels, Belgium; Public Meeting
Type: NOTICEVolume: 70Number: 66Pages: 17698 - 17699
Docket number: [Docket No. 2005N-0119]
FR document: [FR Doc. 05-7020 Filed 4-5-05; 11:53 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0119]
Preparation for the International Conference on HarmonizationMeetings in Brussels, Belgium; Public Meeting
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice of meeting.
SUMMARY:
The Food and Drug Administration (FDA) isannouncing a public meeting to provide information and receive comments onthe International Conference on Harmonization (ICH) in advance of its nextnext Steering Committee and Expert Working Group meetings in Brussels,Belgium, May 9 through 12, 2005. Scheduled for the ICH meetings is anEfficacy Brainstorming Session focusing on the review of the existingefficacy guidelines and their need for updating as well as potential newtopics for consideration. To promote a fuller discussion of this topic thepublic meeting will be expanded to include public input on initiativesrelated to current ICH efficacy guidelines and consider needs for furtherinformation both within and between existing guidances. These initiativesinclude electronic source data, clinical development plan summaries, HealthLevel 7 structured product labeling, and other initiatives includinginformation 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 DoubleTreeHotel and Executive Meeting Center, 1750 Rockville Pike, Rockville, MD. Ablock of rooms for those wishing to attend the meeting have been set asideat the government rate. Please contact the hotel directly for yourreservation: 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 : Sendregistration information (including name, title, firm name, address,telephone, and FAX number), and written material and requests to make oralpresentations, to the contact person by April 14, 2005.
Transcripts : Transcripts of the meeting may be requestedin writing from the Freedom of Information Office (HFI-35), Food andDrug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD20857, approximately 15 working days after the meeting at a cost of 10cents per page.
If you need special accommodations due to a disability, please contactSema Hashemi at least 7 days in advance.
SUPPLEMENTARY INFORMATION:
The ICH was established in 1990 as a joint regulatory/industry projectto improve, through harmonization, the efficiency of the process fordeveloping and registering new medicinal products in Europe, Japan, and theUnited States without compromising the regulatory obligations of safety andeffectiveness.
In recent years, many important initiatives have been undertaken byregulatory authorities and industry associations to promote internationalharmonization of regulatory requirements. FDA has participated in manymeetings designed to enhance harmonization and is committed to seekingscientifically based harmonized technical procedures for pharmaceuticaldevelopment. One of the goals of harmonization is to identify and thenreduce differences in technical requirements for medical productdevelopment among regulatory agencies. ICH was organized to provide anopportunity for harmonization initiatives to be developed with input fromboth regulatory and industry representatives. ICH is concerned withharmonization among the following three regions: The European Union,Japan, and the United States. The six ICH sponsors are the EuropeanCommission; the European Federation of Pharmaceutical IndustriesAssociations; the Japanese Ministry of Health, Labor, and Welfare; theJapanese Pharmaceutical Manufacturers Association; the Centers for DrugEvaluation and Research and Biologics Evaluation and Research, FDA; and thePharmaceutical Research and Manufacturers of America. The ICH Secretariat,which coordinates the preparation of documentation, is provided by theInternational Federation of Pharmaceutical Manufacturers Associations. TheICH Steering Committee includes representatives from each of the ICHsponsors and Health Canada, the European Free Trade Area and the WorldHealth Organization. The ICH process has achieved significantharmonization of the technical requirements for the approval ofpharmaceuticals for human use in the three ICH regions.
The current ICH process and structure can be found at the following Website: http://www.ich.org . (FDA has verified the Web siteaddress, but we are not responsible for subsequent changes to the Web siteafter this document publishes in the Federal Register .)
Interested persons may present data, information, or views orally or inwriting, on issues pending at the public meeting. Oral presentations fromthe public will be scheduled between approximately 1 p.m. and 2 p.m. Timeallotted for oral presentations may be limited to 10 minutes. Thosedesiring to make oral presentations should notify the contact person byApril 14, 2005, and submit a brief statement of the general nature of theevidence or arguments they which to present, the names and addresses, phonenumber, FAX, and e-mail of proposed participants, and an indication of theapproximate time requested to make their presentation.
The topics to be discussed are the topics for discussion at theforthcoming ICH Steering Committee Meeting and ICH Expert Working Groups.One of the topics for the upcoming ICH meeting is an Efficacy BrainstormingSession focusing on the review of the existing efficacy guidelines andtheir 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 afuller discussion of this topic the public meeting will be expanded toinclude public input on initiatives related to current ICH efficacyguidelines and consider needs for further information both within andbetween existing guidances. These initiatives include electronic sourcedata, clinical development plan summaries, Health Level 7 structuredproduct labeling, and other initiatives including information exchangestandards (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]
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