Advisory Committee for Pharmaceutical Science; Notice of Meeting, 56472 [05-19193]

Download as PDF 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]
[Page 56472]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-19193]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Advisory Committee for Pharmaceutical Science; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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 
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 
alcohol-induced 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

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