45250 Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Notices 

Lane, Rockville, MD 20857, 301–827–

1482. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of May 25, 2006 (71 FR 

30142), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0445. The 

approval expires on January 31, 2010. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.fda.gov/ 

ohrms/dockets. 

Dated: August 6, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–15740 Filed 8–10–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0304] 

Preparation for International 

Conference on Harmonization 

Meetings in Yokohama, Japan; Public 

Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting entitled ‘‘Preparation for 

ICH meetings in Yokohama, Japan’’ to 

provide information and receive 

comments on the International 

Conference on Harmonization (ICH) as 

well as the upcoming meetings in 

Yokohama, Japan. 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 Groups meetings in 

Yokohama, Japan, October 27 through 

November 1, 2007, at which discussion 

of the topics underway and the future of 

ICH will continue. 

Date and Time: The meeting will be 

held on Wednesday, October 10, 2007, 

from 12:30p.m. to 3 p.m. 

Location: The meeting will be held at 

5600 Fishers Lane, 3rd floor, Conference 

Room D and E, Rockville, MD 20857. 

For security reasons, all attendees are 

asked to arrive no later than 12:20 p.m., 

as you will be escorted from the front 

entrance of 5600 Fishers Lane to 

Conference Room D and E. 

Contact Person: All participants must 

register with Tammie Bell, Office of the 

Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, by e-mail: 

Tammie.Bell2@fda.hhs.gov or fax: 301–

827–0003. 

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 by October 8, 2007. 

If you need special accommodations 

due to a disability, please contact 

Tammie Bell at least 7 days in advance. 

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. 

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 (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. 

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 4:30 p.m. and 5 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 April 2, 2007, 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 email 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 via the internet 

at http://www.fda.gov/cder/meeting/ 

ICH_20060508.htm. 

Dated: August 7, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–15803 Filed 8–10–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0313] 

Preparation for International 

Cooperation on Cosmetics 

Regulations Meeting in Brussels, 

Belgium; Notice of Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting entitled ‘‘Preparation for 

International Cooperation on Cosmetics 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Notices 45251 

Regulations (ICCR) Meeting in Brussels, 

Belgium’’ to provide information on the 

process and receive comments on issues 

that may be relevant to discussions 

being held at the ICCR meeting in 

Brussels, Belgium. The purpose of the 

meeting is to solicit public input prior 

to the first meeting of this group in 

Brussels on September 27, 2007. 

Date and Time: The meeting will be 

held on Tuesday, August 28, 2007, from 

2 p.m. to 3:30 p.m. 

Location: The meeting will be held at 

5600 Fishers Lane, 3rd fl., Chesapeake 

Conference Room, Rockville, MD 20857. 

For security reasons, all attendees must 

preregister and are asked to arrive no 

later than 1:50 p.m., as you will be 

escorted from the front entrance of 5600 

Fishers Lane to the Chesapeake 

Conference Room. 

Contact Person: All participants must 

register with Michelle Limoli, Office of 

the Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, by e-mail: 

michelle.limoli@fda.hhs.gov or FAX: 

301–827–0003. 

Registration and Requests for Oral 

Presentations: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number), and written material and 

requests to make oral presentations, to 

the contact person by August 21, 2007. 

If you need special accommodations 

due to a disability, please contact 

Michelle Limoli at least 7 days in 

advance. 

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. 

6–30, Rockville, MD 20857, 

approximately 15 working days after the 

meeting at a cost of 10 cents per page. 

SUPPLEMENTARY INFORMATION: The ICCR 

is a voluntary international group of 

cosmetics regulatory authorities from 

the United States, Japan, the European 

Union, and Canada. It should be noted 

that the definition and regulatory 

classification of ‘‘cosmetics’’ in the 

different countries/regions is not 

identical. For this reason, the ICCR will 

consider some U.S. over-the-counter 

drugs that are regulated as ‘‘cosmetics’’

outside the United States. ICCR 

members are: the Food and Drug 

Administration of the United States of 

America; the Ministry of Health, Labour, 

and Welfare of Japan; the European 

Commission Directorate General 

Enterprise; and Health Canada. This 

multilateral framework was created to 

identify ways to remove regulatory 

obstacles among the regions, while 

maintaining the highest level of global 

consumer protection. The first meeting 

of the group will occur in Brussels, 

Belgium, September 27, 2007. 

The ICCR will operate on a consensus 

basis whereby all decisions of the 

representatives of the regulatory 

members and subsequent actions must 

be taken by consensus. Members agree 

to take steps as appropriate to 

implement the items that have reached 

consensus within the boundaries of 

their legal and institutional constraints. 

In this respect, they agree to promote 

the documents reflecting the consensus 

within their own jurisdictions and to 

seek convergence of regulatory policies 

and practices. 

The members’ responsibilities will 

include providing overall strategic 

guidance and direction to activities of 

ICCR; defining subject areas for ICCR 

activities and deciding on future topics 

for activity; exchanging information on 

regulatory, trade, and market 

developments of interest; determining 

policies related to the ICCR process, 

administration, and external 

communications; appointing ad-hoc 

working groups to carry out technical 

work as needed; adopting guidelines 

and policy statements, including those 

developed by the ad-hoc working 

groups; and taking on any other 

initiatives that contribute to achieving 

ICCR objectives. 

It is recognized that successful 

implementation requires the input of a 

constructive dialogue with the 

cosmetics’ industry trade associations 

and other relevant stakeholders, hence 

the scheduling of this public meeting. 

The industry trade associations of 

each region will gather input in order to 

represent all affected industry sectors on 

specific issues at ICCR meetings. Prior 

to ICCR meetings, well in advance to 

allow adequate time for preparation, 

industry will suggest items for priority 

actions to be consider by ICCR 

members. During the ICCR meeting, 

industry trade associations will enter in 

a constructive dialogue with the 

members and give their opinion and 

directions for future work. 

According to specific needs, ICCR 

working groups may be established with 

a precise mandate on an ad-hoc and 

temporary basis by the members. 

Working groups are created primarily 

for the purpose of developing proposed 

guidelines and policy statements for 

adoption by the members. The working 

group participants are appointed by 

consensus of the members. Outside 

technical experts may be invited on an 

as-needed basis. 

The ICCR will meet at least once per 

year, but may alter the frequency of 

meetings if considered necessary to 

ensure progress. The venue of meetings 

rotates among the territory of the four 

members. 

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 p.m. and 3:30 p.m. 

Time allotted for oral presentations may 

be limited by the numbers requesting to 

speak; however no more than 10 

minutes will be allotted per speaker. 

Those desiring to make oral 

presentations should notify the contact 

person by August 24, 2007, and submit 

a brief statement of the general nature of 

the evidence or arguments they wish 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. 

Dated: August 8, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–3954 Filed 8–9–07; 1:38 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission of OMB Review; Comment 

Request; Drug Accountability Record 

Summary: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Cancer Institute, the National 

Cancer Institute (NIH) will publish 

periodic summaries to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection 

Title: Drug Accountability Record 

(Form NIH 2564). 

Type of Information Collection 

Request: Extension, with no Changes 

OMB No. 0925–0240, Expiration Date 

11/30/07. 

Need and Use of Information 

Collection: Food and Drug 

Administration (FDA) regulations 

require investigators to establish a 

record of the receipt, use and 

disposition of all investigational agents. 

The National Cancer Institute, (NCI) as 

a sponsor investigational drug trials, has 

the responsibility to assure the FDA that 

investigators in its clinical trials 

program are maintaining systems for 

drug accountability. In order to fulfill 


jlentini on PROD1PC65 with NOTICES