Preparation for International Conference on Harmonization Steering Committee and Expert Working Group Meetings in Seville, Spain; Regional Public Meeting, 61368-61369 [2011-25480]
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Federal Register / Vol. 76, No. 192 / Tuesday, October 4, 2011 / Notices
a list of guidance documents that CDRH
is considering for development and
providing stakeholders an opportunity
to provide comments and/or draft
language for those topics, or suggestions
for new or different guidances. This
notice announces the Web site location
of the list of guidances on which CDRH
is intending to work over the next fiscal
year (FY). We note that the Agency is
not required to issue every guidance on
the list, nor is it precluded from issuing
guidance documents that are not on the
list. The list includes topics that
currently have no guidance associated
with them, topics where updated
guidance may be helpful, and topics for
which CDRH has already issued level 1
drafts that may be finalized following
review of public comments. We will
consider stakeholder comments as we
prioritize our guidance efforts.
FDA and CDRH priorities are subject
to change at any time. Topics on this
and past guidance priority lists may be
removed or modified based on current
priorities. We also note that CDRH’s
experience over the years has shown
that there are many reasons CDRH staff
does not complete the entire annual
agenda of guidances it undertakes. Staff
are frequently diverted from guidance
development to other activities,
including review of premarket
submissions or postmarket problems. In
addition, the center is required each
year to issue a number of guidances that
it cannot anticipate at the time the
annual list is generated. These may
involve newly identified public health
issues as well as special control
guidance documents for de novo
classifications of devices. It will be
helpful, therefore, to receive comments
that indicate the relative priority of
different guidance topics to interested
stakeholders.
Through feedback from stakeholders,
including draft language for guidance
documents, CDRH expects to be able to
better prioritize and more efficiently
draft guidances that will be useful to
industry and other stakeholders. This
will be the fifth annual list CDRH has
posted. FDA intends to update the list
each year.
FDA invites interested persons to
submit comments on any or all of the
guidance documents on the list. FDA
has established a docket where
comments about the FY 2012 list, draft
language for guidance documents on
those topics, and suggestions for new or
different guidances may be submitted
(see ADDRESSES). FDA believes this
docket is an important tool for receiving
information from interested parties and
for sharing this information with the
public. Similar information about
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15:03 Oct 03, 2011
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planned guidance development is
included in the annual Agency-wide
notice issued by FDA under its good
guidance practices (21 CFR 10.115(f)(5)).
This CDRH list, however, will be
focused exclusively on device-related
guidances and will be made available on
FDA’s Web site prior to the beginning of
each FY from 2008 to 2012. To access
the list of the guidance documents
CDRH is considering for development in
FY 2012, visit FDA’s Web site https://
www.fda.gov/MedicalDevices/Device
RegulationandGuidance/Overview/
MedicalDeviceUserFeeand
ModernizationActMDUFMA/
ucm109196.htm.
II. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: September 29, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–25507 Filed 10–3–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Preparation for International
Conference on Harmonization Steering
Committee and Expert Working Group
Meetings in Seville, Spain; 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 Seville, Spain’’ to provide
information and receive comments on
the International Conference on
Harmonization (ICH) as well as the
upcoming meetings in Seville, Spain.
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
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public input prior to the next Steering
Committee and Expert Working Group
meetings in Seville, Spain, scheduled
on November 5 through 10, 2011, 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 25, 2011, from
2 p.m. to 4 p.m.
Location: The public meeting will be
held at the Washington Theater room at
the Hilton Washington DC/Rockville
Hotel & Executive Meeting Center, 1750
Rockville Pike, Rockville, MD 20852.
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, email: Kimberly.Franklin@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 the contact
person (see Contact Person) by October
21, 2011.
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 October
21, 2011, 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 e-mail 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),
12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.
SUPPLEMENTARY INFORMATION: The ICH
was established in 1990 as a joint
E:\FR\FM\04OCN1.SGM
04OCN1
pmangrum on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 192 / Tuesday, October 4, 2011 / Notices
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 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. (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/ucm248489.htm.
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Dated: September 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–25480 Filed 10–3–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[USCG–2011–0914]
Information Collection Request to
Office of Management and Budget
Coast Guard, DHS.
Sixty-day notice requesting
comments.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an
Information Collection Request (ICR) to
the Office of Management and Budget
(OMB), Office of Information and
Regulatory Affairs (OIRA), requesting
approval of revisions to the following
collection of information: 1625–0015,
Bridge Permit Application Guide. Our
ICR describes the information we seek
to collect from the public. Before
submitting this ICR to OIRA, the Coast
Guard is inviting comments as
described below.
DATES: Comments must reach the Coast
Guard on or before December 5, 2011.
ADDRESSES: You may submit comments
identified by Coast Guard docket
number [USCG–2011–0914] to the
Docket Management Facility (DMF) at
the U.S. Department of Transportation
(DOT). To avoid duplicate submissions,
please use only one of the following
means:
(1) Online: https://
www.regulations.gov.
(2) Mail: DMF (M–30), DOT, West
Building Ground Floor, Room W12–140,
1200 New Jersey Avenue, SE.,
Washington, DC 20590–0001.
(3) Hand delivery: Same as mail
address above, between 9 a.m. and 5
p.m., Monday through Friday, except
Federal holidays. The telephone number
is 202–366–9329.
(4) Fax: 202–493–2251. To ensure
your comments are received in a timely
manner, mark the fax, to attention Desk
Officer for the Coast Guard.
The DMF maintains the public docket
for this Notice. Comments and material
received from the public, as well as
documents mentioned in this Notice as
being available in the docket, will
become part of the docket and will be
available for inspection or copying at
room W12–140 on the West Building
SUMMARY:
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61369
Ground Floor, 1200 New Jersey Avenue,
SE., Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays. You may also
find the docket on the Internet at
https://www.regulations.gov.
A copy of the ICR is available through
the docket on the Internet at https://
www.regulations.gov. Additionally,
copies are available from: Commandant
(CG–611), Attn: Paperwork Reduction
Act Manager, U.S. Coast Guard, 2100
2nd Street, SW., Stop 7101, Washington,
DC 20593–7101.
FOR FURTHER INFORMATION CONTACT: Ms.
Kenlinishia Tyler, Office of Information
Management, telephone 202–475–3652,
or fax 202–475–3929, for questions on
these documents. Contact Ms. Renee V.
Wright, Program Manager, Docket
Operations, 202–366–9826, for
questions on the docket.
SUPPLEMENTARY INFORMATION:
Public Participation and Request for
Comments
This Notice relies on the authority of
the Paperwork Reduction Act of 1995;
44 U.S.C. Chapter 35, as amended. An
ICR is an application to OIRA seeking
the approval, extension, or renewal of a
Coast Guard collection of information
(Collection). The ICR contains
information describing the Collection’s
purpose, the Collection’s likely burden
on the affected public, an explanation of
the necessity of the Collection, and
other important information describing
the Collection. There is one ICR for each
Collection.
The Coast Guard invites comments on
whether this ICR should be granted
based on the Collection being necessary
for the proper performance of
Departmental functions. In particular,
the Coast Guard would appreciate
comments addressing: (1) The practical
utility of the Collection; (2) the accuracy
of the estimated burden of the
Collection; (3) ways to enhance the
quality, utility, and clarity of
information subject to the Collection;
and (4) ways to minimize the burden of
the Collection on respondents,
including the use of automated
collection techniques or other forms of
information technology. In response to
your comments, we may revise this ICR
or decide not to seek approval of
revisions of the Collection. We will
consider all comments and material
received during the comment period.
We encourage you to respond to this
request by submitting comments and
related materials. Comments must
contain the OMB Control Number of the
ICR and the docket number of this
request, [USCG–2011–0914], and must
E:\FR\FM\04OCN1.SGM
04OCN1
]]>Agencies
[Federal Register Volume 76, Number 192 (Tuesday, October 4, 2011)]
[Notices]
[Pages 61368-61369]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25480]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Preparation for International Conference on Harmonization
Steering Committee and Expert Working Group Meetings in Seville, Spain;
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 Seville, Spain'' to provide information and
receive comments on the International Conference on Harmonization (ICH)
as well as the upcoming meetings in Seville, Spain. 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 Seville, Spain, scheduled on November 5 through 10, 2011,
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 25, 2011,
from 2 p.m. to 4 p.m.
Location: The public meeting will be held at the Washington Theater
room at the Hilton Washington DC/Rockville Hotel & Executive Meeting
Center, 1750 Rockville Pike, Rockville, MD 20852.
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, e-mail:
Kimberly.Franklin@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 the contact person (see Contact Person) by October 21, 2011.
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 October 21, 2011, 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 e-mail
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), 12420
Parklawn Dr., Element Bldg., Rockville, MD 20857.
SUPPLEMENTARY INFORMATION: The ICH was established in 1990 as a joint
[[Page 61369]]
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 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. (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/ucm248489.htm.
Dated: September 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-25480 Filed 10-3-11; 8:45 am]
BILLING CODE 4160-01-P
