Preparation for International Conference on Harmonisation Meetings in Yokohama, Japan; Public Meeting, 17500-17501 [E9-8679]

Download as PDF 17500 Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices Dated: April 8, 2009. Carlton Duncan, Deputy Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. E9–8632 Filed 4–14–09; 8:45 am] Dated: April 8, 2009. Carlton Duncan, Deputy Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. E9–8631 Filed 4–14–09; 8:45 am] BILLING CODE 3410–16–P BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Food and Drug Administration [Docket No. FDA–2009–N–0178] Notice of Annual Meeting The Vessel Sanitation Program, National Center for Environmental Health, Centers for Disease Control and Prevention (CDC), announces the following meeting: Name: Vessel Sanitation Program: Annual Program Status Update and Experience to Date with Program Operations. Time and Date: 9 a.m. to 4 p.m., June 12, 2009. Location: Auditorium, Port Everglades Administration Building, 1850 Eller Drive, Fort Lauderdale, Florida 33316. Status: The meeting is open to the public, but space is limited. The meeting room can accommodate approximately 100 persons. Annual attendees normally include cruise ship industry officials, private sanitation consultants, and other interested parties. rwilkins on PROD1PC63 with PROPOSALS Meeting Objectives CDC staff will update attendees on the current status of program topics, including but not limited to the following: • 2008 Program Review. • Proposed revisions to the Vessel Sanitation Program Operations Manual 2005. • Proposed revisions to the Vessel Sanitation Program Construction Guidelines 2005. • Updates on cruise ship outbreaks. An official record of this meeting will remain open for 15 days (through June 27, 2009) so that additional materials or comments may be submitted and made part of the record. Advanced registration is encouraged. You may contact Stephanie Lawrence to register in advance or to receive additional information about the meeting. Ms. Lawrence can be reached by phone (770–488–3141), fax (770– 488–4127), or e-mail (slawrence@cdc.gov). Please provide your name, title, company name, mailing address, telephone number, fax number, and e-mail address when contacting Ms. Lawrence. VerDate Nov<24>2008 16:44 Apr 14, 2009 Jkt 217001 Preparation for International Conference on Harmonisation Meetings in Yokohama, Japan; 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 ICH meetings in Yokohama, Japan’’ to provide information and receive comments on the International Conference on Harmonisation (ICH) as well as the upcoming meetings in Yokohama, Japan. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Yokohama, Japan, scheduled for June 6 through 11, 2009, at which discussion of the topics underway and the future of ICH will continue, as well as provide comprehensive updates of the various ICH topics. Date and Time: The meeting will be held on May 6, 2009, from 2:30 p.m. to 5 p.m. Location: The meeting will be held in the Washington Room at the Hilton Washington DC/Rockville Hotel & Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852. For security reasons, all attendees are asked to arrive no later than 2:15 p.m. Contact Person: All participants must register with Tammie Jo Bell, Office of the Commissioner (HFG–1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, e-mail: Tammie.Bell2@fda.hhs.gov, or FAX: 301–827–0003. Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number), written material and requests to make oral presentation, to the contact person by April 29, 2009. PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 If you need special accommodations due to a disability, please contact Tammie Jo Bell (see Contact Person) at least 7 days in advance. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https://www.fda.gov/ ohrms/dockets/ac/acmenu.htm. It may be viewed at the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI–35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6–30, Rockville, MD 20857. 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 three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Association; the Japanese Ministry of Health, Labor and Welfare; the Japanese Pharmaceutical Manufactures 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 (IFPMA). The ICH Steering Committee includes E:\FR\FM\15APN1.SGM 15APN1 Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices 17501 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: https://www.ich.org. Interested persons may present data, information, or views orally or in writing, on issues pending at the public meeting. Time allotted for oral presentations may be limited to 10 minutes. Those desiring to make oral presentations should notify the contact person by April 29, 2009, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses, telephone number, fax, and e-mail of proposed participants, and an indication of the approximate time requested to make their presentation. The agenda for the public meeting will be made available on the Internet at https://www.fda.gov/cder/meeting/ ICH_20090506.htm. Time: 10 a.m. to 3 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, 6700B Rockledge Drive, Bethesda, MD 20817. (Telephone Conference Call) Contact Person: Kenneth E. Santora, PhD, Scientific Review Officer, Scientific Review Program, NIH/NIAID/DHHS, Room 3146, 6700B Rockledge Drive, MSC 7616, Bethesda, MD 20892, 301–451–2605, ks216i@nih.gov. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, Genetic Control of Autoimmunity. Date: May 6, 2009. Time: 11 a.m. to 3 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6700B Rockledge Drive, Bethesda, MD 20817. (Telephone Conference Call) Contact Person: Thames E. Pickett, PhD, Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institutes of Health/NIAID/DHHS, 6700B Rockledge Drive, MSC 7616, Bethesda, MD 20892–7616, 301–496–2550, pickettte@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Place: National Institutes of Health, 6100 Executive Boulevard, Room 2A03, Rockville, MD 20852. (Telephone Conference Call) Contact Person: Ralph M. Nitkin, PhD, Director, B.S.C.D. Biological Sciences and Career Development, NCMRR, Eunice Kennedy Shriver National Institute of Child Health & Human Development, NIH, DHHS, 6100 Executive Boulevard, Room 2A03, Bethesda, MD 20892–7510, (301) 402–4206, nitkinr@mail.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute’s/Center’s home page: https:// www.nichd.nih.gov/about/ncmrr.htm, where an agenda and any additional information for the meeting will be posted when available. To attend the meeting virtually, please click on the https://www.nichd.nih.gov/about/ overview/advisory/nmrrab/minutes/ 2009may.cfm. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: April 9, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–8679 Filed 4–14–09; 8:45 am] Dated: April 9, 2009. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–8682 Filed 4–14–09; 8:45 am] Dated: April 9, 2009. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–8681 Filed 4–14–09; 8:45 am] BILLING CODE 4140–01–P BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health rwilkins on PROD1PC63 with PROPOSALS National Institute of Allergy And Infectious Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, Asthma Consortium. Date: May 6, 2009. VerDate Nov<24>2008 16:44 Apr 14, 2009 Jkt 217001 BILLING CODE 4140–01–P National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Board on Medical Rehabilitation Research. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. Name of Committee: National Advisory Board on Medical Rehabilitation Research. Date: May 7, 2009. Time: 1 p.m. to 4 p.m. Agenda: NICHD Director’s Report presentation, NCMRR Director’s Report presentation and various reports on Medical Research Initiatives. PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute of Dental & Craniofacial Research; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: NIDCR Special Grants Review Committee, NIDCR Special Grants Review Committee: Review of F, K, and R03 Applications. E:\FR\FM\15APN1.SGM 15APN1

Agencies

[Federal Register Volume 74, Number 71 (Wednesday, April 15, 2009)]
[Notices]
[Pages 17500-17501]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-8679]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0178]


Preparation for International Conference on Harmonisation 
Meetings in Yokohama, Japan; 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 ICH meetings in Yokohama, Japan'' to 
provide information and receive comments on the International 
Conference on Harmonisation (ICH) as well as the upcoming meetings in 
Yokohama, Japan. The topics to be discussed are the topics for 
discussion at the forthcoming ICH Steering Committee Meeting. The 
purpose of the meeting is to solicit public input prior to the next 
Steering Committee and Expert Working Groups meetings in Yokohama, 
Japan, scheduled for June 6 through 11, 2009, at which discussion of 
the topics underway and the future of ICH will continue, as well as 
provide comprehensive updates of the various ICH topics.
    Date and Time: The meeting will be held on May 6, 2009, from 2:30 
p.m. to 5 p.m.
    Location: The meeting will be held in the Washington Room at the 
Hilton Washington DC/Rockville Hotel & Executive Meeting Center, 1750 
Rockville Pike, Rockville, MD 20852. For security reasons, all 
attendees are asked to arrive no later than 2:15 p.m.
    Contact Person: All participants must register with Tammie Jo Bell, 
Office of the Commissioner (HFG-1), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, e-mail: Tammie.Bell2@fda.hhs.gov, or 
FAX: 301-827-0003.
    Registration and Requests for Oral Presentations: Send registration 
information (including name, title, firm name, address, telephone, and 
fax number), written material and requests to make oral presentation, 
to the contact person by April 29, 2009.
    If you need special accommodations due to a disability, please 
contact Tammie Jo Bell (see Contact Person) at least 7 days in advance.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at https://www.fda.gov/ohrms/dockets/ac/acmenu.htm. It may be viewed at the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD. A transcript will also be available in either hardcopy 
or on CD-ROM, after submission of a Freedom of Information request. 
Written requests are to be sent to Division of Freedom of Information 
(HFI-35), Office of Management Programs, Food and Drug Administration, 
5600 Fishers Lane, rm. 6-30, Rockville, MD 20857.

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 
three regions: The European Union, Japan, and the United States. The 
six ICH sponsors are the European Commission; the European Federation 
of Pharmaceutical Industries Association; the Japanese Ministry of 
Health, Labor and Welfare; the Japanese Pharmaceutical Manufactures 
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 (IFPMA). The 
ICH Steering Committee includes

[[Page 17501]]

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: https://www.ich.org.
    Interested persons may present data, information, or views orally 
or in writing, on issues pending at the public meeting. Time allotted 
for oral presentations may be limited to 10 minutes. Those desiring to 
make oral presentations should notify the contact person by April 29, 
2009, and submit a brief statement of the general nature of the 
evidence or arguments they wish to present, the names and addresses, 
telephone number, fax, and e-mail of proposed participants, and an 
indication of the approximate time requested to make their 
presentation.
    The agenda for the public meeting will be made available on the 
Internet at https://www.fda.gov/cder/meeting/ICH_20090506.htm.

    Dated: April 9, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-8679 Filed 4-14-09; 8:45 am]
BILLING CODE 4160-01-S
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