Health Canada and United States Food and Drug Administration Joint Public Consultation on International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; Public Webinar; Request for Comments, 67764-67766 [2015-27953]
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67764
Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2012–N–0115]
[Docket No. FDA–2014–N–2076]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry and Food and
Drug Administration Staff—Class II
Special Controls Automated Blood Cell
Separator Device Operating by
Centrifugal or Filtration Separation
Principle
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Survey on Occurrence of Foodborne
Illness Risk Factors in Selected Retail
and Foodservice Facility Types
[Docket No. FDA–2015–N–3921]
AGENCY:
Food and Drug Administration,
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry and Food and
Drug Administration Staff—Class II
Special Controls Automated Blood Cell
Separator Device Operating by
Centrifugal or Filtration Separation
Principle’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
On June
29, 2015, the Agency submitted a
proposed collection of information
entitled ‘‘Guidance for Industry and
Food and Drug Administration Staff—
Class II Special Controls Automated
Blood Cell Separator Device Operating
by Centrifugal or Filtration Separation
Principle’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0594. The
approval expires on September 30,
2018. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Notice of public webinar;
request for comments.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Survey on Occurrence of Foodborne
Illness Risk Factors in Selected Retail
and Foodservice Facility Types’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
On August
18, 2015, the Agency submitted a
proposed collection of information
entitled ‘‘Survey on Occurrence of
Foodborne Illness Risk Factors in
Selected Retail and Foodservice Facility
Types’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0744. The
approval expires on September 30,
2018. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: October 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–27944 Filed 11–2–15; 8:45 am]
BILLING CODE 4164–01–P
Dated: October 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–27970 Filed 11–2–15; 8:45 am]
BILLING CODE 4164–01–P
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Food and Drug Administration,
ACTION:
Notice.
SUMMARY:
Notice.
AGENCY:
HHS.
HHS.
ACTION:
Health Canada and United States Food
and Drug Administration Joint Public
Consultation on International
Conference on Harmonisation of
Technical Requirements for
Registration of Pharmaceuticals for
Human Use; Public Webinar; Request
for Comments
Frm 00067
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA or Agency) is
announcing a regional public webinar
entitled ‘‘Health Canada and U.S. Food
and Drug Administration Joint Public
Consultation on International
Conference on Harmonisation of
Technical Requirements for Registration
of Pharmaceuticals for Human Use
(ICH).’’ The goal of this webinar is to
provide information and receive
comments on the ICH, as well as the
upcoming ICH meetings in Jacksonville,
FL, in December 2015. The topics to be
discussed are the topics for discussion
at the forthcoming ICH Management
Steering Meeting. The purpose of the
webinar is to solicit public input prior
to the next Steering Committee and
Expert Working Group meetings in
Jacksonville, FL, scheduled for
December 5 to 10, 2015, at which the
discussion of the topics underway and
ICH reforms will continue.
DATES: The public webinar will be held
on November 12, 2015, from 1 p.m. to
4 p.m., Eastern Standard Time.
Registration to attend the webinar and
requests for online presentations must
be received by November 6, 2015. See
the SUPPLEMENTARY INFORMATION section
for information on how to register for
the webinar. Interested persons may
submit either electronic or written
comments to the public docket (see
ADDRESSES) by December 12, 2015.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
E:\FR\FM\03NON1.SGM
03NON1
Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2015–N–3921 for ‘‘Health Canada and
U.S. Food and Drug Administration
Joint Public Consultation on
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use; Public
Webinar.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
VerDate Sep<11>2014
18:04 Nov 02, 2015
Jkt 238001
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Amanda Roache, Food and Drug
Administration, Center for Drug
Evaluation and Research, Office of
Strategic Programs, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1128,
Silver Spring, MD 20993, 301–796–
4548, email:
Amanda.Roache@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
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
PO 00000
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Fmt 4703
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67765
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. Members of the ICH
Steering Committee include the
European Union; the European
Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of
Health, Labor, and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; FDA; the Pharmaceutical
Research and Manufacturers of America;
Health Canada; Swissmedic; and the
World Health Organization (as an
Observer). The ICH process has
achieved significant harmonization of
the technical requirements for the
approval of pharmaceuticals for human
use in the ICH regions over the past two
decades. 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 as of the
date this document publishes in the
Federal Register, but Web sites are
subject to change over time.)
II. Webinar Attendance and
Participation
A. Registration
If you wish to attend the webinar,
submit a request in writing via email to
HPFB_ICH_DGPSA@hc-sc.gc.ca by
November 6, 2015. Registrations may be
limited, so early registration is
recommended. Registration is free and
will be on a first-come, first-served
basis. However, the number of
participants from each organization may
be limited based on space limitations.
Registrants will receive confirmation
once they have been accepted. If you
need special accommodations because
of a disability, please contact Amanda
Roache (see FOR FURTHER INFORMATION
CONTACT) at least 7 days before the
webinar.
B. Requests for Online Presentations
Interested persons may present data,
information, or views orally or in
writing on issues pending at the public
webinar. Online presentations made by
the public will be scheduled between
approximately 3:30 p.m. and 4 p.m.
Time allotted for online presentations
may be limited to 5 minutes. Those
desiring to make online presentations
should notify Amanda Roache (see FOR
FURTHER INFORMATION CONTACT) by
November 6, 2015, 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
E:\FR\FM\03NON1.SGM
03NON1
67766
Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Notices
indication of the approximate time
requested to make their presentation.
The agenda for the public webinar will
be made available on the Internet at
https://www.fda.gov/Drugs/NewsEvents/
ucm466461.htm.
III. Transcripts
Please be advised that as soon as a
webinar transcript is available, FDA will
post it at https://www.fda.gov/Drugs/
NewsEvents/ucm466461.htm.
Dated: October 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–27953 Filed 11–2–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Science Board to the Food and Drug
Administration Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
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: Science Board to
the Food and Drug Administration
(Science Board).
General Function of the Committee:
The Science Board provides advice to
the Commissioner of Food and Drugs
and other appropriate officials on
specific, complex scientific and
technical issues important to the FDA
and its mission, including emerging
issues within the scientific community.
Additionally, the Science Board
provides advice to the Agency on
keeping pace with technical and
scientific developments including in
regulatory science, input into the
Agency’s research agenda and on
upgrading its scientific and research
facilities and training opportunities. It
will also provide, where requested,
expert review of Agency sponsored
intramural and extramural scientific
research programs.
Date and Time: The meeting will be
held on November 18, 2015, from 9 a.m.
until 4 p.m.
Location: Food and Drug
Administration, White Oak 31, Rm.
1503, Section A, 10903 New Hampshire
VerDate Sep<11>2014
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Ave., Silver Spring, MD 20993. For
those unable to attend in person, the
meeting will also be webcast. The link
for the webcast is available at https://
collaboration.fda.gov/science
board1115/. Answers to commonly
asked questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: Rakesh Raghuwanshi,
Office of the Chief Scientist, Office of
the Commissioner, Food and Drug
Administration, White Oak Bldg. 1 Rm.
3309, 10903 New Hampshire Ave.,
Silver Spring, MD 20993, 301–796–
4769, rakesh.raghuwanshi@fda.hhs.gov,
or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area). 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 at https://www.fda.gov/Advisory
Committees/default.htm and scroll
down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
Agenda: The Science Board will be
provided with updates from the Center
for Food Safety and Applied Nutrition,
Centers for Excellence in Regulatory
Science and Innovation, Evaluation
Subcommittee and the ORA Food
Emergency Response Network
Evaluation Subcommittee. The Board
will hear about the scope of FDA’s
involvement in precision medicine, as
well as an overview of specific health
informatics initiatives including
precision FDA, Open FDA, and Chillax.
The Board will also hear about FDA’s
laboratory safety initiative. A recipient
of one of the FY 2014 Scientific
Achievement Awards (selected by the
Board) will provide an overview of the
activities for which the award was
given.
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
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available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
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 November 11, 2015.
Oral presentations from the public will
be scheduled between approximately 3
and 4 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 November 11, 2015. 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 November 13,
2015.
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 disabilities.
If you require accommodations due to a
disability, please contact Rakesh
Raghuwanshi 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/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: October 28, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–27957 Filed 11–2–15; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 80, Number 212 (Tuesday, November 3, 2015)]
[Notices]
[Pages 67764-67766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27953]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3921]
Health Canada and United States Food and Drug Administration
Joint Public Consultation on International Conference on Harmonisation
of Technical Requirements for Registration of Pharmaceuticals for Human
Use; Public Webinar; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public webinar; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a regional public webinar entitled ``Health Canada and U.S. Food and
Drug Administration Joint Public Consultation on International
Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use (ICH).'' The goal of this webinar is
to provide information and receive comments on the ICH, as well as the
upcoming ICH meetings in Jacksonville, FL, in December 2015. The topics
to be discussed are the topics for discussion at the forthcoming ICH
Management Steering Meeting. The purpose of the webinar is to solicit
public input prior to the next Steering Committee and Expert Working
Group meetings in Jacksonville, FL, scheduled for December 5 to 10,
2015, at which the discussion of the topics underway and ICH reforms
will continue.
DATES: The public webinar will be held on November 12, 2015, from 1
p.m. to 4 p.m., Eastern Standard Time. Registration to attend the
webinar and requests for online presentations must be received by
November 6, 2015. See the SUPPLEMENTARY INFORMATION section for
information on how to register for the webinar. Interested persons may
submit either electronic or written comments to the public docket (see
ADDRESSES) by December 12, 2015.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your
[[Page 67765]]
comment will be made public, you are solely responsible for ensuring
that your comment does not include any confidential information that
you or a third party may not wish to be posted, such as medical
information, your or anyone else's Social Security number, or
confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your comments,
that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2015-N-3921 for ``Health Canada and U.S. Food and Drug
Administration Joint Public Consultation on International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use; Public Webinar.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Amanda Roache, Food and Drug
Administration, Center for Drug Evaluation and Research, Office of
Strategic Programs, 10903 New Hampshire Ave., Bldg. 51, Rm. 1128,
Silver Spring, MD 20993, 301-796-4548, email:
Amanda.Roache@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
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. Members of the ICH
Steering Committee include the European Union; the European Federation
of Pharmaceutical Industries Associations; the Japanese Ministry of
Health, Labor, and Welfare; the Japanese Pharmaceutical Manufacturers
Association; FDA; the Pharmaceutical Research and Manufacturers of
America; Health Canada; Swissmedic; and the World Health Organization
(as an Observer). The ICH process has achieved significant
harmonization of the technical requirements for the approval of
pharmaceuticals for human use in the ICH regions over the past two
decades. 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 as of the date this document publishes in the Federal
Register, but Web sites are subject to change over time.)
II. Webinar Attendance and Participation
A. Registration
If you wish to attend the webinar, submit a request in writing via
email to sc.gc.ca">HPFB_ICH_DGPSA@hc-sc.gc.ca by November 6, 2015. Registrations
may be limited, so early registration is recommended. Registration is
free and will be on a first-come, first-served basis. However, the
number of participants from each organization may be limited based on
space limitations. Registrants will receive confirmation once they have
been accepted. If you need special accommodations because of a
disability, please contact Amanda Roache (see FOR FURTHER INFORMATION
CONTACT) at least 7 days before the webinar.
B. Requests for Online Presentations
Interested persons may present data, information, or views orally
or in writing on issues pending at the public webinar. Online
presentations made by the public will be scheduled between
approximately 3:30 p.m. and 4 p.m. Time allotted for online
presentations may be limited to 5 minutes. Those desiring to make
online presentations should notify Amanda Roache (see FOR FURTHER
INFORMATION CONTACT) by November 6, 2015, 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
[[Page 67766]]
indication of the approximate time requested to make their
presentation. The agenda for the public webinar will be made available
on the Internet at https://www.fda.gov/Drugs/NewsEvents/ucm466461.htm.
III. Transcripts
Please be advised that as soon as a webinar transcript is
available, FDA will post it at https://www.fda.gov/Drugs/NewsEvents/ucm466461.htm.
Dated: October 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27953 Filed 11-2-15; 8:45 am]
BILLING CODE 4164-01-P
