20690 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or http:// 

www.regulations.gov. 

Dated: April 7, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8817 Filed 4–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Preparation for International 

Conference on Harmonization Steering 

Committee and Expert Working Group 

Meetings in Cincinnati, OH; Regional 

Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

The Food and Drug Administration 

(FDA) is announcing a public meeting 

entitled ‘‘Preparation for ICH Steering 

Committee and Expert Working Group 

Meetings in Cincinnati, Ohio’’ to 

provide information and receive 

comments on the International 

Conference on Harmonization (ICH) as 

well as the upcoming meetings in 

Cincinnati, OH. 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 Group meetings in 

Cincinnati, OH, scheduled on June 11 

through 17, 2011, at which discussion of 

the topics underway and the future of 

ICH will continue. 

Date and Time: The public meeting 

will be held on May 19, 2011, from 2 

p.m. to 4 p.m. 

Location: The public meeting will be 

held at the Washington Theater room at 

the Hilton Washington DC/Rockville 

Hotel & Executive Meeting Center, 1750 

Rockville Pike, Rockville, MD 20852. 

Contact Person: All participants must 

register with Kimberly Franklin, Office 

of the Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, email: Kimberly.Franklin@fda.hhs.gov, or 

FAX: 301–595–7937. 

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 presentations to the contact 

person (see Contact Person) by May 16, 

2011. 

Interested persons may present data, 

information, or views orally or in 

writing, on issues pending at the public 

meeting. Public oral presentations 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 (see Contact Person) by May 16, 

2011, 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 email of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation. 

If you need special accommodations 

due to a disability, please contact 

Kimberly Franklin (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 http:// 

www.regulations.gov. 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, 12420 

Parklawn Dr., 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 

Associations; 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 

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. (FDA has verified 

the Web site addresses in this 

document, but FDA is not responsible 

for any subsequent changes to the Web 

sites after this document publishes in 

the Federal Register.) 

The agenda for the public meeting 

will be made available on the Internet 

at http://www.fda.gov/Drugs/ 

NewsEvents/ucm248489.htm. 

Dated: April 8, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8816 Filed 4–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

International Consortium of 

Orthopedic Registries; Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled ‘‘International Consortium of 

Orthopedic Registries (ICOR).’’ The 

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