International Conference on Harmonisation Workshop on Oncolytic Viruses; Public Workshop, 56471-56472 [05-19195]

Download as PDF Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices HHS will publish a notice in the Federal Register reporting the addition of this class to the SEC or the result of any provision by Congress regarding the decision by HHS to add the class to the SEC. FOR FURTHER INFORMATION CONTACT: Larry Elliott, Director, Office of Compensation Analysis and Support, National Institute for Occupational Safety and Health, 4676 Columbia Parkway, MS C–46, Cincinnati, OH 45226, Telephone 513–533–6800 (this is not a toll-free number). Information requests can also be submitted by e-mail to OCAS@CDC.GOV. Dated: September 20, 2005. John Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. [FR Doc. 05–19225 Filed 9–26–05; 8:45 am] BILLING CODE 4160–17–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects Title: ACF–196 State Temporary Assistance for Needy Families Financial Report. OMB No.: 0970–0247. Description: This information collection is authorized under the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA). The request is for renewal of approval to use the Administration for Children and Families (ACF) 196 form for periodic financial reporting under the Temporary Assistance for Needy Families (TANF) program. 56471 Current approval expires on September 30, 2005. States participating in the TANF program are required by statute to report financial data on a quarterly basis. This form meets the legal standard and provides essential data on the use of Federal funds. Failure to collect the data would seriously compromise ACF’s ability to monitor program expenditures, estimate funding needs and prepare budget submissions required by Congress. Financial reporting under the TANF program is governed by 45 CFR Part 265. Respondents: State TANF Agencies. ANNUAL BURDEN ESTIMATES Instrument Number of respondents Number of responses per respondent Average burden hours per response Total burden hours ACF–196 .......................................................................................................... 54 4 8 1,728 Estimated Total Annual Burden Hours: 1,728. Additional Information: In compliance with the requirements of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use VerDate Aug<31>2005 14:52 Sep 26, 2005 Jkt 205001 of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: September 20, 2005. Robert Sargis, Reports Clearance Officer. [FR Doc. 05–19271 Filed 9–26–05; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration International Conference on Harmonisation Workshop on Oncolytic Viruses; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA) is announcing a public workshop entitled ‘‘ICH Workshop on Oncolytic Viruses.’’ The workshop will be held in conjunction with the International Conference on Harmonisation (ICH) expert working group and steering committee meetings in Chicago, IL. The objective of the workshop is to identify and discuss issues relevant to clinical development PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 of oncolytic viruses including safety. The following viruses will be covered: Adenovirus, herpes simplex virus, reovirus, Newcastle disease virus, measles virus, and Sendai virus. Speakers will address selectivity, attenuation modes, shedding, clinical and viral safety, and proof of concept in support of the approach in animal and human setting. Date and Time: The workshop will be held on November 7, 2005, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Westin Michigan Avenue, 909 North Michigan Ave., Chicago, IL 60611. Contact Person: Daniel Takefman, Center for Biologics Evaluation and Research (HFM–720), Food and Drug Administration, Rockville, MD 20852, 301–827–5102, e-mail: daniel.takefman@fda.hhs.gov. Registration: Registrations are being collected by the Pharmaceutical Research and Manufacturers of America (PhRMA). Send registration information (including name, title, firm name, address, telephone, and fax number) to Liz Cross at PhRMA by FAX: 202–572– 7797, or e-mail: lcross@phrma.org, no later than Friday, October 14, 2005. The registration fee for this workshop is $450 for industry; $175 for academia and government participants. To register via the Internet go to https:// E:\FR\FM\27SEN1.SGM 27SEN1 56472 Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices www.ich.org/cache/html/2238-2721.html. The registration fee will be used to offset some expenses of hosting the workshop including speakers, meeting rooms, coffee breaks, and materials. If you need special accommodations due to a disability, please contact Liz Cross at least 7 days in advance of the workshop. DEPARTMENT OF HEALTH AND HUMAN SERVICES 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 the European Union (EU), Japan, and the United States without compromising the regulatory obligations of safety and effectiveness. ICH’s steering committee recognized that in the rapidly evolving area of gene therapy medicinal products, there is a need to continue to foster the exchange of information that may impact the regulation of such products. The Gene Therapy Discussion Group (GTDG) is leading these activities within ICH. Regulatory and industry representatives from the three ICH regions (EU, Japan, and the United States), and experts from the European Free Trade Association, Health Canada, and the World Health Organization participate in this group. The objectives of GTDG are to monitor emerging scientific issues and proactively set out principles that may have a beneficial impact on harmonizing regulation of gene therapy products. The current ICH process and structure can be found on the Internet at https:// 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). The agenda and registration form for the public workshop are available on the Internet at https://www.ich.org/ cache/html/2238-272-1.html (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). The workshop agenda includes panel discussions in addition to invited presentations. A summary of the workshop will be available through ICH after the meeting. ACTION: SUPPLEMENTARY INFORMATION: Dated: September 20, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–19195 Filed 9–26–05; 8:45 am] BILLING CODE 4160–01–S VerDate Aug<31>2005 14:52 Sep 26, 2005 Jkt 205001 Food and Drug Administration Advisory Committee for Pharmaceutical Science; Notice of Meeting AGENCY: Food and Drug Administration, HHS. Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Advisory Committee for Pharmaceutical Science. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on October 25 and 26, 2005, from 8:30 a.m. to 5 p.m. Location: Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD. Contact Person: Igor Cerny, Center for Drug Evaluation and Research (HFD– 21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301–827–7001, e-mail: cerny@cder.fda.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572) in the Washington, DC area), code 3014512539. Please call the Information Line for up-to-date information on this meeting. The background material will become available no later than the day before the meeting and will be posted on FDA’s Web site at https:// www.fda.gov/ohrms/dockets/ac/ acmenu.htm under the heading ‘‘Advisory Committee for Pharmaceutical Science (ACPS).’’ (Click on the year 2005 and scroll down to ACPS meetings.) Agenda: On October 25, 2005, the committee will do the following: (1) Receive an update on current activities of the Parametric Tolerance Interval Test Workgroup; (2) receive and discuss presentations from the Pharmaceutical Research and Manufacturing Association, the Generic Pharmaceutical Association, and the U.S. Pharmacopeia pertaining to their perspectives on the general topic of Quality-By-Design (QBD) and drug release or dissolution specification setting; and (3) discuss and provide comments on the updated tactical plan under development for the PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 establishment of drug release or dissolution specifications. On October 26, 2005, the committee will do the following: (1) Discuss and provide comments on the general QBD topics of question-based review and alcoholinduced dose dumping and (2) receive and discuss an update on the establishment of a workgroup for the review and assessment of Office of Pharmaceutical Science research programs. Following those items, an awareness topic will be introduced concerning the need to enhance the pharmaceutical education system in the United States. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by October 17, 2005. Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 noon on October 25, 2005, and between approximately 1 p.m. and 2 p.m. on October 26, 2005. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before October 17, 2005, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Igor Cerny at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 19, 2005. Scott Gottlieb, Deputy Commissioner for Policy. [FR Doc. 05–19193 Filed 9–26–05; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\27SEN1.SGM 27SEN1

Agencies

[Federal Register Volume 70, Number 186 (Tuesday, September 27, 2005)]
[Notices]
[Pages 56471-56472]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-19195]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


International Conference on Harmonisation Workshop on Oncolytic 
Viruses; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``ICH Workshop on Oncolytic Viruses.'' The workshop 
will be held in conjunction with the International Conference on 
Harmonisation (ICH) expert working group and steering committee 
meetings in Chicago, IL. The objective of the workshop is to identify 
and discuss issues relevant to clinical development of oncolytic 
viruses including safety. The following viruses will be covered: 
Adenovirus, herpes simplex virus, reovirus, Newcastle disease virus, 
measles virus, and Sendai virus. Speakers will address selectivity, 
attenuation modes, shedding, clinical and viral safety, and proof of 
concept in support of the approach in animal and human setting.
    Date and Time: The workshop will be held on November 7, 2005, from 
8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Westin Michigan 
Avenue, 909 North Michigan Ave., Chicago, IL 60611.
    Contact Person: Daniel Takefman, Center for Biologics Evaluation 
and Research (HFM-720), Food and Drug Administration, Rockville, MD 
20852, 301-827-5102, e-mail: daniel.takefman@fda.hhs.gov.
    Registration: Registrations are being collected by the 
Pharmaceutical Research and Manufacturers of America (PhRMA). Send 
registration information (including name, title, firm name, address, 
telephone, and fax number) to Liz Cross at PhRMA by FAX: 202-572-7797, 
or e-mail: lcross@phrma.org, no later than Friday, October 14, 2005. 
The registration fee for this workshop is $450 for industry; $175 for 
academia and government participants. To register via the Internet go 
to https://

[[Page 56472]]

www.ich.org/cache/html/2238-272-1.html.
    The registration fee will be used to offset some expenses of 
hosting the workshop including speakers, meeting rooms, coffee breaks, 
and materials.
    If you need special accommodations due to a disability, please 
contact Liz Cross at least 7 days in advance of the workshop.

SUPPLEMENTARY INFORMATION: 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 the European Union (EU), Japan, and the United States 
without compromising the regulatory obligations of safety and 
effectiveness.
    ICH's steering committee recognized that in the rapidly evolving 
area of gene therapy medicinal products, there is a need to continue to 
foster the exchange of information that may impact the regulation of 
such products. The Gene Therapy Discussion Group (GTDG) is leading 
these activities within ICH.
    Regulatory and industry representatives from the three ICH regions 
(EU, Japan, and the United States), and experts from the European Free 
Trade Association, Health Canada, and the World Health Organization 
participate in this group.
    The objectives of GTDG are to monitor emerging scientific issues 
and proactively set out principles that may have a beneficial impact on 
harmonizing regulation of gene therapy products.
    The current ICH process and structure can be found on the Internet 
at https://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).
    The agenda and registration form for the public workshop are 
available on the Internet at https://www.ich.org/cache/html/2238-272-
1.html (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).
    The workshop agenda includes panel discussions in addition to 
invited presentations. A summary of the workshop will be available 
through ICH after the meeting.

    Dated: September 20, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-19195 Filed 9-26-05; 8:45 am]
BILLING CODE 4160-01-S

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