Preparation for International Conference on Harmonization Steering Committee and Expert Working Group Meetings in Fukuoka, Japan; Regional Public Meeting, 14528-14529 [2012-5857]
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Federal Register / Vol. 77, No. 48 / Monday, March 12, 2012 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Average
burden hours
per
response
Number of
responses per
respondent
Total annual
burden hours
Performance measure reporting form (for private sector affected public) ......
Performance measure reporting form (for State, local, and tribal government
affected public) .............................................................................................
103
2
0.8
165
15
2
0.8
30
Estimated Total Annual Burden Hours .....................................................
........................
........................
........................
195
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Attn: ACF Reports Clearance Officer.
Email address:
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Robert Sargis,
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[FR Doc. 2012–5835 Filed 3–9–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Preparation for International
Conference on Harmonization 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
Harmonization (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, scheduled
on June 2 through 7, 2012, at which
discussion of the topics underway and
the future of ICH will continue.
DATES: Date and Time: The public
meeting will be held on May 14, 2012,
from 2 p.m. to 4 p.m.
Location: The public meeting will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993.
Information regarding visitor parking
and transportation may be accessed at:
https://www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm; under the heading
‘‘Public Meetings at the White Oak
Campus.’’ Please note that visitors to the
White Oak Campus must enter through
Building 1.
Contact Person: All participants must
register with Kimberly Franklin, Office
of the Commissioner, Food and Drug
PO 00000
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Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
FAX: 301–595–7937, email: Kimberly.
Franklin@fda.hhs.gov.
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 9,
2012.
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 9,
2012, 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 https://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
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg., 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
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Federal Register / Vol. 77, No. 48 / Monday, March 12, 2012 / Notices
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. (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 https://www.fda.gov/Drugs/
NewsEvents/ucm291624.htm.
Dated: March 6, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–5857 Filed 3–9–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Arthritis Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Arthritis
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 9, 2012, from 8 a.m. to 5
p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm. 1503), Silver Spring, MD 20993–
0002. Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Philip Bautista,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Avenue, Bldg. 31, rm. 2417, Silver
Spring, MD 20993–0002, 301–796–9001,
FAX: (301) 847–8533, email:
AAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301) 443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: The committee will discuss
new drug application (NDA) 203214,
tofacitinib tablets, Pfizer Inc., for the
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14529
treatment of adult patients with
moderately to severely active
rheumatoid arthritis who have had an
inadequate response to one or more
disease-modifying anti-rheumatic drugs.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before April 25, 2012. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before April 17,
2012. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by April 18, 2012.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Philip
Bautista at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
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[Federal Register Volume 77, Number 48 (Monday, March 12, 2012)]
[Notices]
[Pages 14528-14529]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5857]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Preparation for International Conference on Harmonization
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 Harmonization (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, scheduled on June 2 through 7, 2012, at
which discussion of the topics underway and the future of ICH will
continue.
DATES: Date and Time: The public meeting will be held on May 14, 2012,
from 2 p.m. to 4 p.m.
Location: The public meeting will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31, Conference Center, the
Great Room (rm. 1503), Silver Spring, MD 20993. Information regarding
visitor parking and transportation may be accessed at: https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm; under the heading ``Public
Meetings at the White Oak Campus.'' Please note that visitors to the
White Oak Campus must enter through Building 1.
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, FAX: 301-595-
7937, email: Kimberly.Franklin@fda.hhs.gov.
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 9, 2012.
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 9, 2012, 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 https://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 (ELEM-1029), Food
and Drug Administration, 12420 Parklawn Dr., Element Bldg., 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
[[Page 14529]]
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. (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 https://www.fda.gov/Drugs/NewsEvents/ucm291624.htm.
Dated: March 6, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-5857 Filed 3-9-12; 8:45 am]
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