Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting and Webcast, 64164-64166 [2016-22471]
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64164
Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices
ethylone has been sold as the street drug
‘‘Molly’’ and encountered as a
replacement for methylone. As a
positional isomer of the controlled drug
butylone, ethylone is considered a
Schedule I controlled substance under
the CSA.
Ethylphenidate (EPH) is structurally
related to methylphenidate.
Methylphenidate is controlled in
Schedule IV of the CSA, and an active
ingredient in drug products approved
for medical use and marketed in the
United States. Ethylphenidate is not
approved for medical use in the United
States. Ethylphenidate is structurally
related to methylphenidate are being
marketed as novel psychoactive
substances with psychoactive effects
similar to methylphenidate, therefore
posing similar health risks to the users.
Ethylphenidate is a controlled substance
in several European countries, and is
not a controlled substance in the United
States under the CSA.
Methiopropamine (MPA) is a
structural analogue of the Schedule II
controlled substance methamphetamine.
Pharmacologically, it functions as a
norepinephrine-dopamine reuptake
inhibitor and, secondarily, as a
serotonin reuptake inhibitor. MPA is a
thiophene based analog of
methamphetamine. It has stimulant
properties as an inhibitor of dopamine,
norepinephrine transporters in the
central nervous system. MPA was
critically reviewed by the WHO at its
36th meeting of the Expert Committee
on Drug Dependence in June 2014. It is
not approved for medical use or
controlled in the United States under
the CSA, but is a controlled substance
in the United Kingdom.
MDMB-CHMICA is an indole-based
synthetic cannabinoid that is a potent
full agonist at CB1 receptors and mimics
functionally (biologically) the effects of
the structurally unrelated delta-9tetrahydrocannabinol (THC), a Schedule
I substance, and the main active
ingredient of marijuana. Synthetic
cannabinoids are marketed under the
guise of ‘‘herbal incense,’’ and promoted
by drug traffickers as legal alternatives
to marijuana. MDMB-CHMICA use is
associated with serious adverse events
including death in several European
countries. There are no commercial or
approved medical uses for MDMBCHMICA. MDMB-CHMICA is not
controlled under the CSA, but may be
treated as a ‘‘controlled substance
analogue’’ under the CSA pursuant to 21
U.S.C 802(32)(A) and 813, and is a
controlled substance in the State of
Louisiana.
5F-APINACA (5F-AKB48) is a
synthetic cannabinoid belonging to a
VerDate Sep<11>2014
21:47 Sep 16, 2016
Jkt 238001
chemical structural class with an
indazole core. In vitro studies show that
it binds to the cannabinoid CB1
receptors and displays agonist
properties in functional assays,
suggesting that it would share in vivo
effects with delta-9-THC and various
synthetic cannabinoids. There are no
commercial or medical uses for 5FAPINACA. Synthetic cannabinoids are
marketed under the guise of ‘‘herbal
incense,’’ and promoted by drug
traffickers as legal alternatives to
marijuana. SF-APINACA is not a
controlled substance under the CSA, but
may be treated as a ‘‘controlled
substance analogue’’ under the CSA
pursuant to 21 U.S.C. 802(32)(A) and
813.
JWH-073 is an indole-based synthetic
cannabinoid agonist without the
classical cannabinoid chemical
structure. Pharmacology studies have
been conducted on this substance.
Behavioral pharmacology studies show
that JWH-073 has delta-9-THC-like
activity in animals. Synthetic
cannabinoids are marketed under the
guise of ‘‘herbal incense,’’ and promoted
by drug traffickers as legal alternatives
to marijuana. On March 1, 2011, JWH073 was temporarily controlled in
Schedule I and on July 9, 2012, JWH073 was permanently controlled as a
Schedule I substance under the CSA.
XLR-11 (5-Fluoro-UR-144, 5F-UR-144)
is an indole-based synthetic
cannabinoid and acts as an agonist at
cannabinoid CB1 receptors. Animal
studies indicate that it mimics
functionally (biologically) the effects of
the structurally unrelated delta-9-THC, a
Schedule I substance, and the main
active ingredient of marijuana and
numerous other Schedule I synthetic
cannabinoids. Synthetic cannabinoids
are marketed under the guise of ‘‘herbal
incense,’’ and promoted by drug
traffickers as legal alternatives to
marijuana. On May 16, 2013, XLR-11
was temporarily placed under Schedule
I and on May 11, 2016, XLR11 was
permanently controlled as a Schedule I
substance under the CSA.
IV. Opportunity To Submit Domestic
Information
As required by section 201(d)(2)(A) of
the CSA, FDA, on behalf of the
Department of Health and Human
Services (HHS), invites interested
persons to submit comments regarding
the 12 named drugs. Any comments
received will be considered by HHS
when it prepares a scientific and
medical evaluation of these drugs. HHS
will forward a scientific and medical
evaluation of these drugs to WHO,
through the Secretary of State, for
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WHO’s consideration in deciding
whether to recommend international
control/decontrol of any of these drugs.
Such control could limit, among other
things, the manufacture and distribution
(import/export) of these drugs and could
impose certain recordkeeping
requirements on them.
Although FDA is, through this notice,
requesting comments from interested
persons which will be considered by
HHS when it prepares an evaluation of
these drugs, HHS will not now make
any recommendations to WHO
regarding whether any of these drugs
should be subjected to international
controls. Instead, HHS will defer such
consideration until WHO has made
official recommendations to the
Commission on Narcotic Drugs, which
are expected to be made in early 2017.
Any HHS position regarding
international control of these drugs will
be preceded by another Federal Register
notice soliciting public comments, as
required by section 201(d)(2)(B) of the
CSA.
V. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: September 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–22472 Filed 9–16–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1112]
Health Canada and United States Food
and Drug Administration Joint Public
Consultation on International Council
for Harmonisation of Technical
Requirements for Pharmaceuticals for
Human Use; Public Meeting and
Webcast
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting and
Webcast; request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing a regional public meeting
(which will also be Webcast) entitled
‘‘Health Canada and U.S. Food and Drug
Administration Joint Public
Consultation on International Council
for Harmonisation of Technical
SUMMARY:
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Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices
mstockstill on DSK3G9T082PROD with NOTICES
Requirements for Pharmaceuticals for
Human Use (ICH).’’ The goal of this
meeting is to provide information and
receive comments on the current
activities of ICH, as well as the
upcoming ICH meetings in Osaka,
Japan, in November 2016. The topics to
be discussed are the topics for
discussion at the forthcoming ICH
Assembly Meeting in Osaka. The
purpose of this public meeting is to
solicit public input prior to the next ICH
Assembly meeting and the Expert
Working Group meetings in Osaka,
Japan, scheduled for November 6
through November 11, 2015.
DATES: The public meeting will be held
on October 24, 2016, from 1 p.m. to 3
p.m., EST. Registration to attend the
meeting and requests for oral
presentations must be received by
October 21, 2016; see the
SUPPLEMENTARY INFORMATION section for
information on how to register for the
meeting. Interested persons may submit
either electronic or written comments to
the public docket (see ADDRESSES) by
October 19, 2016.
ADDRESSES: The meeting will be held at
Sir Frederick G. Banting Research
Centre, 251 Sir Frederick Banting
Driveway, Ottawa, ON K1Y 0M1,
Canada. It will also be broadcast on the
Web allowing participants to join in
person or via the Web.
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
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’’).
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21:47 Sep 16, 2016
Jkt 238001
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–
2016–N–1112 for ‘‘Health Canada and
U.S. Food and Drug Administration
Joint Public Consultation on
International Council on Harmonisation
of Technical Requirements for
Pharmaceuticals for Human Use; Public
Meeting.’’ 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/
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64165
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. 1176,
Silver Spring, MD 20993, 301–796–
4548, email: Amanda.Roache@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The ICH, formerly known as the
International Conference on
Harmonisation 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 2015 the ICH was reformed to make
the ICH a true global initiative that
expands beyond the previous ICH
members. More involvement from
regulators around the world is expected,
as they will join their counterparts from
Europe, Japan, the United States,
Canada, and Switzerland as ICH
regulatory members. The reforms build
on a 25-year track record of successful
delivery of harmonized guidelines for
global pharmaceutical development,
and their regulation. 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. The ICH process has
achieved significant harmonization of
E:\FR\FM\19SEN1.SGM
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Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices
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
B. Requests for Oral Presentations
Interested persons may present data,
information, or views orally or in
writing on issues pending at the public
Webinar. Public oral presentations will
be scheduled between approximately
2:30 p.m. and 3 p.m. Time allotted for
oral presentations may be limited to 5
minutes. Those desiring to make oral
presentations should notify Amanda
Roache (see FOR FURTHER INFORMATION
CONTACT) by October 19, 2016, 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 Webinar will
be made available on the Internet at
https://www.fda.gov/Drugs/NewsEvents/
ucm516166.htm.
mstockstill on DSK3G9T082PROD with NOTICES
[Docket No. FDA–2016–N–2683]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Data To Support
Social and Behavioral Research as
Used by the Food and Drug
Administration
Food and Drug Administration,
HHS.
If you wish to attend the meeting,
please register at the following Web site:
https://healthcanada-usfda_ich_
consultation.eventbrite.ca. 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.
Dated: September 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–22471 Filed 9–16–16; 8:45 am]
BILLING CODE 4164–01–P
21:47 Sep 16, 2016
Food and Drug Administration
AGENCY:
A. Registration
VerDate Sep<11>2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Jkt 238001
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a generic clearance to collect
information to support social and
behavioral research used by FDA about
drug products.
DATES: Submit either electronic or
written comments on the collection of
information by November 18, 2016.
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
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
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
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–
2016–N–2683 for ‘‘Data To Support
Social and Behavioral Research as Used
by the Food and Drug Administration.’’
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.
E:\FR\FM\19SEN1.SGM
19SEN1
]]>Agencies
[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)]
[Notices]
[Pages 64164-64166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22471]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-1112]
Health Canada and United States Food and Drug Administration
Joint Public Consultation on International Council for Harmonisation of
Technical Requirements for Pharmaceuticals for Human Use; Public
Meeting and Webcast
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting and Webcast; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a regional public meeting (which will also be Webcast) entitled
``Health Canada and U.S. Food and Drug Administration Joint Public
Consultation on International Council for Harmonisation of Technical
[[Page 64165]]
Requirements for Pharmaceuticals for Human Use (ICH).'' The goal of
this meeting is to provide information and receive comments on the
current activities of ICH, as well as the upcoming ICH meetings in
Osaka, Japan, in November 2016. The topics to be discussed are the
topics for discussion at the forthcoming ICH Assembly Meeting in Osaka.
The purpose of this public meeting is to solicit public input prior to
the next ICH Assembly meeting and the Expert Working Group meetings in
Osaka, Japan, scheduled for November 6 through November 11, 2015.
DATES: The public meeting will be held on October 24, 2016, from 1 p.m.
to 3 p.m., EST. Registration to attend the meeting and requests for
oral presentations must be received by October 21, 2016; see the
SUPPLEMENTARY INFORMATION section for information on how to register
for the meeting. Interested persons may submit either electronic or
written comments to the public docket (see ADDRESSES) by October 19,
2016.
ADDRESSES: The meeting will be held at Sir Frederick G. Banting
Research Centre, 251 Sir Frederick Banting Driveway, Ottawa, ON K1Y
0M1, Canada. It will also be broadcast on the Web allowing participants
to join in person or via the Web.
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 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-2016-N-1112 for ``Health Canada and U.S. Food and Drug
Administration Joint Public Consultation on International Council on
Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use; Public Meeting.'' 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. 1176,
Silver Spring, MD 20993, 301-796-4548, email:
Amanda.Roache@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The ICH, formerly known as the International Conference on
Harmonisation 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 2015 the ICH was
reformed to make the ICH a true global initiative that expands beyond
the previous ICH members. More involvement from regulators around the
world is expected, as they will join their counterparts from Europe,
Japan, the United States, Canada, and Switzerland as ICH regulatory
members. The reforms build on a 25-year track record of successful
delivery of harmonized guidelines for global pharmaceutical
development, and their regulation. 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. The ICH process has achieved
significant harmonization of
[[Page 64166]]
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 meeting, please register at the following
Web site: https://healthcanada-usfda_ich_consultation.eventbrite.ca.
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 Oral Presentations
Interested persons may present data, information, or views orally
or in writing on issues pending at the public Webinar. Public oral
presentations will be scheduled between approximately 2:30 p.m. and 3
p.m. Time allotted for oral presentations may be limited to 5 minutes.
Those desiring to make oral presentations should notify Amanda Roache
(see FOR FURTHER INFORMATION CONTACT) by October 19, 2016, 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
Webinar will be made available on the Internet at https://www.fda.gov/Drugs/NewsEvents/ucm516166.htm.
Dated: September 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22471 Filed 9-16-16; 8:45 am]
BILLING CODE 4164-01-P
