United States Food and Drug Administration and Health Canada Joint Regional Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting and Webcast; Request for Comments, 13458-13459 [2017-04839]
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13458
Federal Register / Vol. 82, No. 47 / Monday, March 13, 2017 / Notices
ACL estimates the burden of this
collection of information as follows:
Number of
respondents
Respondent/data collection activity
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Hours per response
Annual
burden
hours
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Service Recipients (i.e., Congregate and Home-delivered meal nutrition
programs; Case Management, Homemaker, and Transportation Services).
National Family Caregiver Support Program Clients ...................................
250
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1
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6,250
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Daniel Berger,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2017–04843 Filed 3–10–17; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1112]
United States Food and Drug
Administration and Health Canada
Joint Regional Consultation on
International Council for
Harmonisation of Technical
Requirements for Pharmaceuticals for
Human Use; Public Meeting and
Webcast; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing a regional public meeting
entitled ‘‘U.S. Food and Drug
Administration and Health Canada Joint
Regional Consultation on International
Council for Harmonisation of Technical
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 Montreal.
The topics to be covered in the public
meeting are the topics for discussion at
the forthcoming ICH Assembly Meeting
in Montreal. The purpose of this public
meeting is also to solicit public input
prior to the ICH Assembly meeting and
the Expert Working Group meetings in
Montreal, Canada, scheduled for May 28
through June 1, 2017.
DATES: The public meeting will be held
on April 24, 2017, from 11 a.m. to 2
p.m., Eastern Time. Submit either
electronic or written comments on this
public meeting by May 12, 2017. Late,
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:49 Mar 10, 2017
Jkt 241001
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before May 12, 2017.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of May 12, 2017. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date. See the SUPPLEMENTARY
INFORMATION section for registration date
and information. Registration to attend
the meeting and requests for oral
presentations must be received by April
19, 2017; see the SUPPLEMENTARY
INFORMATION section for information on
how to register for the meeting.
ADDRESSES: The public meeting will be
held at 10903 New Hampshire Ave.,
Bldg. 31, Rm. 1503 Section A, Silver
Spring, MD 20993. It will also be
broadcast on the Web allowing
participants to join in person OR via the
Web. Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://www.
fda.gov/AboutFDA/WorkingatFDA/
BuildingsandFacilities/WhiteOak
CampusInformation/ucm241740.htm.
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
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
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 the U.S. Food and
Drug Administration and Health Canada
Joint Public Consultation on
International Council on Harmonisation
of Technical Requirements for
Pharmaceuticals for Human Use; Public
Meeting. Received comments, those
filed in a timely manner (see DATES),
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
E:\FR\FM\13MRN1.SGM
13MRN1
Federal Register / Vol. 82, No. 47 / Monday, March 13, 2017 / Notices
mstockstill on DSK3G9T082PROD with NOTICES
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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
VerDate Sep<11>2014
17:49 Mar 10, 2017
Jkt 241001
members. More involvement from
regulators around the world is expected,
as they will join their counterparts from
Europe, Japan, USA, 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
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://ich_regional_consultation.
eventbrite.com. 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
meeting.
B. Requests for Oral Presentations
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
PO 00000
Frm 00032
Fmt 4703
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13459
1:30 p.m. and 2 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 April 19, 2017, 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/
ucm536015.htm.
Dated: March 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–04839 Filed 3–10–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; AREA:
Immunology.
Date: March 9, 2017.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Alok Mulky, Ph.D.,
Scientific Review Officer, Center for
Scientific Review (CSR), National Institutes
of Health (NIH), 6701 Rockledge Dr, Room
4203, Bethesda, MD 20817, (301) 435–3566,
alok.mulky@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Neuropharmacology.
Date: March 28, 2017.
Time: 2:00 p.m. to 5:30 p.m.
E:\FR\FM\13MRN1.SGM
13MRN1
]]>Agencies
[Federal Register Volume 82, Number 47 (Monday, March 13, 2017)]
[Notices]
[Pages 13458-13459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04839]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-1112]
United States Food and Drug Administration and Health Canada
Joint Regional Consultation on International Council for Harmonisation
of Technical Requirements for Pharmaceuticals for Human Use; Public
Meeting and Webcast; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing a regional public meeting entitled ``U.S. Food and Drug
Administration and Health Canada Joint Regional Consultation on
International Council for Harmonisation of Technical 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 Montreal. The topics to be
covered in the public meeting are the topics for discussion at the
forthcoming ICH Assembly Meeting in Montreal. The purpose of this
public meeting is also to solicit public input prior to the ICH
Assembly meeting and the Expert Working Group meetings in Montreal,
Canada, scheduled for May 28 through June 1, 2017.
DATES: The public meeting will be held on April 24, 2017, from 11 a.m.
to 2 p.m., Eastern Time. Submit either electronic or written comments
on this public meeting by May 12, 2017. Late, untimely filed comments
will not be considered. Electronic comments must be submitted on or
before May 12, 2017. The https://www.regulations.gov electronic filing
system will accept comments until midnight Eastern Time at the end of
May 12, 2017. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date. See the SUPPLEMENTARY INFORMATION section for registration
date and information. Registration to attend the meeting and requests
for oral presentations must be received by April 19, 2017; see the
SUPPLEMENTARY INFORMATION section for information on how to register
for the meeting.
ADDRESSES: The public meeting will be held at 10903 New Hampshire Ave.,
Bldg. 31, Rm. 1503 Section A, Silver Spring, MD 20993. It will also be
broadcast on the Web allowing participants to join in person OR via the
Web. Entrance for the public meeting participants (non-FDA employees)
is through Building 1 where routine security check procedures will be
performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
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 the U.S. Food and Drug Administration and Health
Canada Joint Public Consultation on International Council on
Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use; Public Meeting. Received comments, those filed in a timely manner
(see DATES), 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
[[Page 13459]]
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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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, USA, 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 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://ich_regional_consultation.eventbrite.com.
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
meeting.
B. Requests for Oral Presentations
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 1:30 p.m. and 2
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 April 19, 2017, 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/ucm536015.htm.
Dated: March 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-04839 Filed 3-10-17; 8:45 am]
BILLING CODE 4164-01-P
