Preparation for International Conference on Harmonisation Steering Committee and Expert Working Group Meetings in Fukuoka, Japan; Regional Public Meeting, 57803-57804 [2010-23642]
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57803
Federal Register / Vol. 75, No. 183 / Wednesday, September 22, 2010 / Notices
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[FR Doc. 2010–23562 Filed 9–21–10; 8:45 am]
BILLING CODE 4184–01–M
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17:32 Sep 21, 2010
[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.
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.
SUMMARY:
OMB Comment
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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
E:\FR\FM\22SEN1.SGM
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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:
https://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: https://www.fda.gov/Drugs/
NewsEvents/ucm225322.htm.
emcdonald on DSK2BSOYB1PROD with NOTICES
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.
Notice of public workshop;
request for comments.
ACTION:
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 https://
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.
SUMMARY:
SUPPLEMENTARY INFORMATION:
I. Background
The mission of the Safe Use Initiative
is to reduce preventable harm from
FDA-regulated medications. The Safe
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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
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[Federal Register Volume 75, Number 183 (Wednesday, September 22, 2010)]
[Notices]
[Pages 57803-57804]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-23642]
-----------------------------------------------------------------------
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
[[Page 57804]]
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: https://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: https://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
