Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Notices 55909 

number), written material and requests 

to make oral presentations, to the 

contact person by October 14, 2005. If 

you need special accommodations due 

to a disability, please contact Sema 

Hashemi at least 7 days in advance. 

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 

Associations; the Japanese Ministry of 

Health, Labor and Welfare; the Japanese 

Pharmaceutical Manufacturers 

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. The ICH 

Steering Committee includes 

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: 

http://www.ich.org. 

Interested persons may present data, 

information, or views orally or in 

writing, on issues pending at the public 

meeting. Oral presentations from the 

public will be scheduled between 

approximately 3:30 p.m. and 4 p.m. 

Time allotted for oral presentations may 

be limited to 10 minutes. Those desiring 

to make oral presentations should notify 

the contact person by October 14, 2005, 

and submit a brief statement of the 

general nature of the evidence or 

arguments they which to present, the 

names and addresses, phone 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 October 7, 

2005, via the Internet at http:// 

www.fda.gov/cder/meeting/ICH/ 

ICHlfall2005.htm. 

Transcripts: Transcripts of the 

meeting may be requested in writing 

from the Freedom of Information Office 

(HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

12A–16, Rockville, MD 20857, 

approximately 15 working days after the 

meeting at a cost of 10 cents per page. 

Dated: September 16, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–19017 Filed 9–22–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0375] 

Stakeholder Meeting on the 

Implementation of A New Direction for 

the Food and Drug Administration’s 

Radiological Health Program; Public 

Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

following public meeting: A New 

Direction for FDA’s Radiological Health 

Program. The topics of discussion are 

the agency’s activities to implement its 

radiological health program (the 

program). 

DATES: The public meeting will be held 

on October 31 and November 1, 2005, 

from 8:30 a.m. to 5 p.m. The agency is 

requiring registration by October 17, 

2005. 

All parties wishing to make a 

presentation or to speak on an issue 

specific to the topics of the meeting 

should indicate their intent, the topics 

to be addressed, and provide an abstract 

of their comments to be presented by 

October 17, 2005. FDA will limit the 

time for presentations to the public 

comment periods; the number of parties 

requesting to participate will determine 

the amount of time allotted to each 

presentation. 

ADDRESSES: The public meeting will be 

held at the Hilton Washington DC 

North/Gaithersburg, 620 Perry Pkwy., 

Gaithersburg, MD 20877. 

Submit written requests to make an 

oral presentation to Kaye Chesemore 

(see FOR FURTHER INFORMATION CONTACT). 

Include your name, title, firm or 

organization name (if representing 

such), address, telephone, and fax 

number with your request. All requests 

and presentation materials should 

include the docket number found in 

brackets in the heading of this 

document. Submit all requests for 

suggestions and recommendations to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kaye Chesemore, Center for Devices and 

Radiological Health (HFZ–240), Food 

and Drug Administration, 1350 Piccard 

Dr., Rockville, MD 20850, 301–594–

3309, FAX: 301–594–3306, e-mail: 

kfc@cdrh.fda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In May 2004, FDA’s Center for 

Devices and Radiological Health (CDRH) 

began an effort to examine how the 

program could best adapt to current 

public health needs. This effort 

culminated in a report that outlines key 

elements of the program and states how 

the new direction will impact the most 

pressing public health problems in the 

radiological health area. A copy of the 

report is available on CDRH’s Web site 

at http://www.fda.gov/cdrh/radhlth/ 

initiative.html. 

The agency has determined that it 

must shift the focus of resources to the 

products and procedures with the 

highest risks to the public, including 

those that affect the greatest number of 

people or present the potential for the 

greatest harm. 

The benefits that FDA expects from 

this focus are that the new program will: 

(1) Align CDRH efforts with current 

and evolving public health needs, 

(2) Expand focus on patient and 

consumer protection, 

(3) Allow for a more targeted 

approach to FDA’s programs and 

activities, 

55910 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Notices 

(4) Increase information 

dissemination and training, and 

(5) Improve coordination across the 

radiological health community. 

II. Agenda 

On October 31, 2005, FDA is 

providing the opportunity for a number 

of stakeholder organizations to discuss 

how they can assist FDA in 

implementing the program and in 

addressing important public health 

problems. FDA and its stakeholders will 

discuss the following aspects of the 

radiological health plan overview: 

• Standards—Discussion will 

consider the following topics: Increased 

reliance by FDA on consensus radiation 

safety performance standards, the role of 

national and international standards, 

and the role of State regulations in 

assuring product safety and proper use. 

• Monitoring the Use of Radiation—

Discussion will consider the following 

topics: The shift of CDRH’s focus from 

products to users, patients, and 

consumers; adverse event reporting; 

State program roles in ensuring 

appropriate use of radiation; facility 

quality assurance programs; and the 

establishment of a voluntary patient 

radiation dose reporting system for 

diagnostic imaging procedures that use 

ionizing radiation. This system could be 

used to monitor national exposure 

trends and provide a basis for 

establishing diagnostic reference levels 

of patient dose for use in facility quality 

improvement programs. 

• Monitoring the Industry—

Discussion will consider the following 

topics: The shift of FDA emphasis from 

testing products, to inspecting 

manufacturers to assure quality 

manufacturing and products; the 

reduction of reporting requirements; 

and the development of electronic 

reporting methods. 

• Education—Discussion will 

consider education and training for 

manufacturers, regulators, and users. 

On November 1, 2005, FDA will hold 

concurrent discussion sessions 

throughout the day on the Standards, 

Monitoring, and Education topics to 

provide further opportunity for 

stakeholder comment and discussion. 

FDA will provide an opportunity for 

comment during the public comment 

period for individuals and/or 

organizations on October 31, 2005. In 

addition, the agency will provide an 

opportunity to present individual 

viewpoints during the concurrent 

discussion sessions on November 1, 

2005. FDA reserves the right to limit the 

time of speakers during the public 

comment periods. 

III. Registration 

Participants must register for the 

meeting by October 17, 2005. 

Acceptance will be on a first-come, firstserved basis. There will be no onsite 

registration and unregistered 

participants will not be added to the 

program. Please register online at http:// 

www.fda.gov/cdrh/meetings/ 

120303.html. Persons without Internet 

access may register for the onsite 

meeting by calling 301–594–3309 by 

October 17, 2005. 

If you need special accommodations 

due to a disability, please fax 

information regarding those needs to 

Kaye Chesemore at 301–594–3306, at 

least 7 days in advance of the meeting. 

IV. Request for Suggestions, 

Recommendations, and Materials 

FDA is particularly interested in 

receiving suggestions from stakeholders 

related to the topics listed previously in 

this document. Send suggestions or 

recommendations to the Division of 

Dockets Management (see ADDRESSES). 

FDA will place an additional copy of 

any material it receives in the docket for 

this document (2005N–0375). 

Suggestions, recommendations, and 

materials may be seen at the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday (see 

ADDRESSES). 

V. Transcripts 

Following the meeting, transcripts 

will be available for review at the 

Division of Dockets Management (see 

ADDRESSES). 

Dated: September 19, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–19077 Filed 9–20–05; 3:31 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[FDA 225–04–8000] 

Memorandum of Understanding 

Between the Food and Drug 

Administration and the Food and Drug 

Administration Alumni Association 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

notice of a memorandum of 

understanding (MOU) between FDA and 

the Food and Drug Administration 

Alumni Association, Inc. The purpose 

of this MOU is to establish a greater 

collaboration between FDA and the 

Food and Drug Administration Alumni 

Association, Inc., regarding FDAs 2006 

Centennial Observance. 

DATES: The agreement became effective 

July 28, 2004. 

FOR FURTHER INFORMATION CONTACT: 

Mary Hitch, Senior Advisor, Office of 

External Relations (HF–10), 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–4406. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 20.108(c), 

which states that all written agreements 

and MOUs between FDA and others 

shall be published in the Federal 

Register, the agency is publishing notice 

of this MOU. 

Dated: September 8, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

BILLING CODE 4160–01–S