Federal Register / Vol. 75, No. 183 / Wednesday, September 22, 2010 / Notices 57803 

enter the terms of the order into the 

automated system for use in issuing 

income withholding orders. Copies of 

the income withholding order are made 

for all necessary parties, and copies are 

transmitted to the employer/income 

withholder by mail or through the OCSE 

electronic income withholding order (eIWO) portal. 

The Income Withholding for Support 

form and instructions were updated for 

consistency and clarity in light of 

numerous comments suggesting 

changes, based on comments received 

during the 60-day comment period of 

the 1st Federal Register Notice 

publication. 

Respondents: State Child Support 

Agencies and Tribes. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total burden 

hours 

Income Withholding for Support (Form) .................................................. 58 0 0 0 

e-IWO Record Layouts ............................................................................ 58 0 0 0 

Estimated Total Annual Burden 

Hours: 0. 

Additional Information 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: 

Office of Management and Budget, 

Paperwork Reduction Project. Fax: 202– 

395–6974. Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: September 15, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–23562 Filed 9–21–10; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0490] 

Preparation for International 

Conference on Harmonisation Steering 

Committee and Expert Working Group 

Meetings in Fukuoka, Japan; Regional 

Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting entitled ‘‘Preparation for 

ICH Steering Committee and Expert 

Working Group Meetings in Fukuoka, 

Japan’’ to provide information and 

receive comments on the International 

Conference on Harmonisation (ICH) as 

well as the upcoming meetings in 

Fukuoka, 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 Group meetings in 

Fukuoka, Japan, November 6 through 

11, 2010, at which discussion of the 

topics underway and the future of ICH 

will continue. 

Date and Time: The public meeting 

will be held on October 13, 2010, from 

2:30 p.m. to 4:30 p.m. 

Location: The public meeting will be 

held at the Washington Theater at the 

Hilton Washington DC/Rockville Hotel 

& Executive Meeting Center, 1750 

Rockville Pike, Rockville, MD 20852. 

Contact Person: All participants must 

register with Jennifer Haggerty, Office of 

the Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

email: jennifer.haggerty@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 Jennifer 

Haggerty (see Contact Person) by 5 p.m. 

e.s.t. on October 11, 2010. 

If you need special accommodations 

due to a disability, please contact 

Jennifer Haggerty (see Contact Person) at 

least 7 days in advance. 

Transcripts: Please be advised that as 

soon as a transcript is available, it can 

be obtained 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 (HFI–35), Office 

of Management Programs, Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, 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 


emcdonald on DSK2BSOYB1PROD with NOTICES
57804 Federal Register / Vol. 75, No. 183 / Wednesday, September 22, 2010 / Notices 

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. 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. Public oral presentations will 

be scheduled between approximately 4 

p.m. and 4:30 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 5 p.m. e.s.t. on October 11, 

2010, 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. 

The agenda for the public meeting 

will be made available on the Internet 

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

NewsEvents/ucm225322.htm. 

Dated: September 16, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–23642 Filed 9–21–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0486] 

Safe Use Initiative; Public Workshop; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public workshop entitled ‘‘Safe Use 

Initiative.’’ This public workshop, 

organized and hosted by FDA’s Safe Use 

Initiative Team, will communicate the 

status of ongoing activities and the 

future vision for Safe Use Initiative 

projects. The workshop will also offer 

an opportunity for the Safe Use 

Initiative Team to gather input and 

perspectives for future directions and 

develop collaborative, cross-sector safe 

medication use activities with health 

care stakeholders. 

DATES: The public workshop will be 

held on November 16, 2010, from 8:30 

a.m. to 4:45 p.m., and November 17, 

2010, from 8:30 a.m. to 12 noon. 

Suggestions for safe use topics received 

by October 15, 2010, may become the 

focus for indepth discussions during the 

workshop breakout sessions held the 

afternoon of November 16, 2010 (see 

section II of this document). Electronic 

or written comments will be accepted 

until January 31, 2011 (see section IV of 

this document). 

ADDRESSES: The public workshop will 

be held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

rm. 1503, Silver Spring, MD 20993– 

0002. 

Submit electronic comments on this 

document to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Sharon Bakayoko, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 1353, 

Silver Spring, MD 20993–0002, 301– 

796–7600, 

CDERSafeUseInitia@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The mission of the Safe Use Initiative 

is to reduce preventable harm from 

FDA-regulated medications. The Safe 

Use Initiative seeks to create and 

facilitate public and private 

collaborations aimed at reduction of 

preventable harm. 

FDA announced the ‘‘FDA’s Safe Use 

Initiative—Collaborating to Reduce 

Preventable Harm From Medications’’ 

(the Safe Use Report) on November 5, 

2009 (74 FR 57319). The Safe Use 

Report calls for an open and transparent 

process with health care stakeholders to 

identify candidate drug/drug classes or 

therapeutic areas that could benefit from 

a collaborative approach to harm 

reduction. 

The first steps in public engagement 

involved outreach to the health care 

community—through public meetings, 

teleconferences, and listening sessions 

with stakeholder groups (e.g., health 

care professionals, consumer groups, 

insurers, and industry). The goals were 

to inform organizations about the Safe 

Use Initiative, to obtain feedback about 

medication safety and preventable 

medication harm, and to seek 

opportunities for collaboration. The 

suggestions that emerged from the safe 

use outreach activities ranged from 

preventing a specific drug-related 

adverse event to broad and overarching 

themes in health care. 

II. Scope of the Public Workshop 

This public workshop expands the 

Safe Use Initiative outreach efforts. It 

will provide a forum to engage the 

health care community about 

collaborations, interventions, and 

metrics for ongoing and future projects 

to make medications safer. 

We are soliciting input in advance of 

the public workshop about topics for 

potential safe use collaborations. FDA 

will consider all topics. However, if 

submitted by October 15, 2010, some 

topics may become the focus for more 

indepth discussions and partnership 

development during the public 

workshop. Please submit topic 

suggestions (identified with the docket 

number found in brackets in the 

heading of this document) to the 

Division of Dockets Management (see 

ADDRESSES). When submitting a topic 

for consideration, please suggest how it 

could become a safe use project, e.g., 

other health care partners who might 

have an interest in the issue, kinds of 

interventions to reduce preventable 

harm, metrics, etc. 

III. Attendance and Registration to 

Speak 

The FDA Conference Center at the 

White Oak location is a Federal facility 

with security procedures. There is no 

fee to attend the workshop, and 

attendees who do not wish to make an 


emcdonald on DSK2BSOYB1PROD with NOTICES