Preparation for International Conference on Harmonization Meetings in Chicago, Illinois; Public Meeting, 55908-55909 [05-19017]
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55908
Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Notices
Estimated Total Annual Burden
Hours: 1,155
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded 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. E-mail address:
grjohnson@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: September 16, 2005.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 05–19012 Filed 9–22–05; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
OMB No.: New Collection.
Description: This survey for the Child
Care and Development Fund (CCDF)
program will request that States
Voluntarily provide information
including how they define improper
payments in their State, the process
used to identify such payments and
what actions are taken in the State to
reduce or eliminate improper payments.
HHS/ACF intends to establish a
repository for the State submissions,
which will be available to all States for
viewing on an HHS/ACF Web site. This
Web site will provide information that
will help States improve their program
integrity systems so that improper
payments in the program can be
reduced.
Respondents: The 50 States of the
United States, the District of Columbia,
and the Territories of Guam, Puerto Rico
and the Virgin Islands.
Title: Improper Payments Information
Survey for the CCDF Program.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Improper Payments Information Survey for the CCDF Program ....................
54
1
24
1,296
Estimated Total Annual Burden
Hours: 1,296 hours.
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:
grjohnson@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 received 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, Attn: Desk Officer for
ACF, E-mail address:
Katherine_T._Astrich_@omb.eop.gov.
VerDate Aug<31>2005
15:21 Sep 22, 2005
Jkt 205001
Dated: September 16, 2005.
Robert Sargin,
Reports Clearance Officer.
[FR Doc. 05–19013 Filed 9–22–05; 8:45am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0363]
Preparation for International
Conference on Harmonization
Meetings in Chicago, Illinois; 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 Chicago, Illinois’’ to
provide information and receive
comments on the International
Conference on Harmonization (ICH) as
well as the upcoming meetings in
Chicago, IL. The topics to be discussed
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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 Chicago, IL,
November 7 through 10, 2005, at which
discussion of the topics underway and
the future of ICH will continue.
Date and Time: The meeting will be
held on October 20, 2005, from 1:30
p.m. to 4 p.m.
Location: The meeting will be held at
5600 Fishers Lane, 3rd Fl., Maryland
Conference Room, Rockville, MD 20857.
For security reasons, all attendees are
asked to arrive no later than 1:25 p.m.,
as you will be escorted from the front
entrance of 5600 Fishers Lane to the
Maryland Conference Room.
Contact: Sema Hashemi, Office of the
Commissioner (HFG–1), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–3050,
FAX: 301–480–0716, e-mail:
Sema.Hashemi@fda.hhs.gov.
Registration and Requests for Oral
Presentations: Send registration
information (including name, title, firm
name, address, telephone, and fax
E:\FR\FM\23SEN1.SGM
23SEN1
Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Notices
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:
https://www.ich.org.
Interested persons may present data,
information, or views orally or in
VerDate Aug<31>2005
15:21 Sep 22, 2005
Jkt 205001
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 https://
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).
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
DATES:
PO 00000
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55909
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 https://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,
E:\FR\FM\23SEN1.SGM
23SEN1
]]>Agencies
[Federal Register Volume 70, Number 184 (Friday, September 23, 2005)]
[Notices]
[Pages 55908-55909]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-19017]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0363]
Preparation for International Conference on Harmonization
Meetings in Chicago, Illinois; 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 Chicago, Illinois''
to provide information and receive comments on the International
Conference on Harmonization (ICH) as well as the upcoming meetings in
Chicago, IL. 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 Chicago, IL, November 7 through
10, 2005, at which discussion of the topics underway and the future of
ICH will continue.
Date and Time: The meeting will be held on October 20, 2005, from
1:30 p.m. to 4 p.m.
Location: The meeting will be held at 5600 Fishers Lane, 3rd Fl.,
Maryland Conference Room, Rockville, MD 20857. For security reasons,
all attendees are asked to arrive no later than 1:25 p.m., as you will
be escorted from the front entrance of 5600 Fishers Lane to the
Maryland Conference Room.
Contact: Sema Hashemi, Office of the Commissioner (HFG-1), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
3050, FAX: 301-480-0716, e-mail: Sema.Hashemi@fda.hhs.gov.
Registration and Requests for Oral Presentations: Send registration
information (including name, title, firm name, address, telephone, and
fax
[[Page 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: https://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 https://www.fda.gov/cder/meeting/ICH/ICH_
fall2005.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
