56472 Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices 

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 http:// 

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 http://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 

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. 

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 http:// 

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 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