Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 40003-40005 [2017-17856]
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Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices
40003
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Jeffrey A. Koses,
Director, Office of Acquisition Policy, Office
of Government-wide Policy.
cdc.gov), National Institute for
Occupational Safety and Health, Centers
for Disease Control and Prevention,
Mailstop E–20, 1600 Clifton Road NE.,
Atlanta, GA 30329.
[FR Doc. 2017–17831 Filed 8–22–17; 8:45 am]
SUPPLEMENTARY INFORMATION:
The
National Occupational Research Agenda
(NORA) is a partnership program
created to stimulate innovative research
and improved workplace practices. The
national agenda is developed and
implemented through the NORA sector
and cross-sector councils. Each council
develops and maintains an agenda for
its sector or cross-sector.
The National Occupational Research
Agenda for Manufacturing is intended
to identify the research, information,
and actions most urgently needed to
prevent occupational injuries and
illnesses in the manufacturing sector.
The National Occupational Research
Agenda for Manufacturing provides a
vehicle for industry stakeholders to
describe the most relevant issues, gaps,
and safety and health needs for the
sector. Each NORA research agenda is
meant to guide or promote high priority
research efforts on a national level,
conducted by various entities,
including: Government, higher
education, and the private sector. The
first National Occupational Research
Agenda for Manufacturing was
published in 2010 for the second decade
of NORA (2006–2016). This draft is an
updated agenda for the third decade of
NORA (2016–2026). The revised agenda
was developed considering new
information about injuries and illnesses,
the state of the science, and the
probability that new information and
approaches will make a difference.
As the steward of the NORA process,
NIOSH invites comments on the draft
National Occupational Research Agenda
for Manufacturing. A copy of the draft
Agenda is available at https://
www.regulations.gov (see Docket
Number CDC–2017–0072, NIOSH–300).
Peripheral and Central Nervous
System Drugs Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments
Burden Information Collection Reports,
in all correspondence.
BILLING CODE 6820–61–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2017–0072, NIOSH–300]
Draft—National Occupational Research
Agenda for Manufacturing
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Request for comments.
AGENCY:
As steward of the National
Occupational Research Agenda (NORA),
the National Institute for Occupational
Safety and Health of the Centers for
Disease Control and Prevention
announces the availability of the draft
National Occupational Research Agenda
for Manufacturing for public comment.
Written by the NORA Manufacturing
Sector Council, the Agenda identifies
the most important occupational safety
and health research needs for the next
decade, 2016–2026. A copy of the draft
Agenda is available at https://
www.regulations.gov (search Docket
Number CDC–2017–0072).
DATES: Electronic or written comments
must be received by October 23, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2017–
0072 and docket number NIOSH–300,
by any of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: National Institute for
Occupational Safety and Health, NIOSH
Docket Office, 1090 Tusculum Avenue,
MS C–34, Cincinnati, Ohio 45226–1998.
Instructions: All submissions received
must include the agency name and
Docket Number [CDC–2017–0072;
NIOSH–300]. All relevant comments
received will be posted without change
to https://www.regulations.gov, including
any personal information provided. For
access to the docket to read background
documents or comments received, go to
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Emily Novicki (NORACoordinator@
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
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Dated: August 17, 2017.
Frank Hearl,
Chief of Staff, National Institute for
Occupational Safety and Health, Centers for
Disease Control and Prevention.
[FR Doc. 2017–17786 Filed 8–22–17; 8:45 am]
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Food and Drug Administration
[Docket No. FDA–2017–N–4835]
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Peripheral and Central
Nervous System Drugs Advisory
Committee. The general function of the
committee is to provide advice and
recommendations to the Agency on
FDA’s regulatory issues. The meeting
will be open to the public. FDA is
establishing a docket for public
comment on this document.
DATES: The public meeting will be held
on September 28, 2017, from 9 a.m. to
4:30 p.m.
ADDRESSES: Tommy Douglas Conference
Center, The Ballroom, 10000 New
Hampshire Ave., Silver Spring, MD
20903. Answers to commonly asked
questions about FDA Advisory
Committee meetings may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm. Information about the
Tommy Douglas Conference Center may
be accessed at: https://
www.tommydouglascenter.com/.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2017–N–4835.
The docket will close on September 27,
2017. Submit either electronic or
written comments on this public
meeting by September 27, 2017. Late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before September 27,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of September 27, 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.
Comments received on or before
September 14, 2017, will be provided to
the committee. Comments received after
that date will be taken into
consideration by the Agency.
SUMMARY:
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Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices
You may submit comments as
follows:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2017–N–4835 for ‘‘Peripheral and
Central Nervous System Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff 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
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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 Dockets Management
Staff. 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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Moon Hee V. Choi, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, Fax: 301–847–8533, email:
PCNS@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/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
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modifications before coming to the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The committee will discuss
new drug application (NDA) 200896,
ataluren for oral suspension, sponsored
by PTC Therapeutics, Inc., for the
treatment of patients with
dystrophinopathy due to a nonsense
mutation in the dystrophin gene.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
written submissions submitted to the
docket (see ADDRESSES) on or before
September 14, 2017, will be provided to
the committee. Oral presentations from
the public will be scheduled between
approximately 1:15 p.m. and 2:15 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 September 6, 2017. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
September 7, 2017.
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 special accommodations
due to a disability, please contact Moon
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Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices
Hee V. Choi at least 7 days in advance
of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
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: August 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–17856 Filed 8–22–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2017–N–2464]
Advancing the Development of
Pediatric Therapeutics: Application of
‘‘Big Data’’ to Pediatric Safety Studies;
Public Workshop
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Office of Pediatric
Therapeutics, Food and Drug
Administration (FDA), is announcing a
public workshop entitled ‘‘Advancing
the Development of Pediatric
Therapeutics (ADEPT): Application of
‘‘Big Data’’ to Pediatric Safety Studies.’’
The purpose of this 2-day workshop is
to understand how to access and
analyze ‘‘Big Data’’ associated with
safety information in the health care
setting, and the utility and challenges
associated with the use of ‘‘Big Data’’ to
study the safety of therapeutics in
children.
DATES: The public workshop will be
held on September 18 and 19, 2017,
from 8:30 a.m. to 5 p.m. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will
be held at the DoubleTree by Hilton
Hotel, 8727 Colesville Rd. (Route 29),
Silver Spring, MD 20910.
FOR FURTHER INFORMATION CONTACT:
Renan A. Bonnel, Office of Pediatric
Therapeutics, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–8654, Fax: 301–847–8640,
renan.bonnel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
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Large volumes of data in the context
of the health care industry have the
potential to provide additional
information related to medication use,
which may affect the benefit-risk
assessment of medicines in general and
pediatric medicines in particular. Since
pediatric pharmacoepidemiologic
studies tend to enroll fewer patients
than adult studies, additional
information may be needed to better
understand the safety and efficacy of
use of these drugs in children. ‘‘Big
Data’’, including forms of real world
evidence that may involve large and
complex data sets, may be particularly
useful as a supplement to traditional
studies. Supplementary information
may include additional clinical trial
data, registry data, and electronic health
record information.
II. Topics for Discussion at the Public
Workshop
Food and Drug Administration
AGENCY:
I. Background
In this workshop, FDA will gather
information on the latest developments
in ‘‘Big Data’’ from the perspective of a
number of stakeholders and expand the
conversation to include the utility and
challenges associated with the use of
‘‘Big Data’’ in the pediatric setting. Day
1 will focus on national and
international uses of ‘‘Big Data’’ in
health care. Day 2 will focus on ‘‘Big
Data’’ utility in the pediatric setting,
including specific challenges associated
with pediatric data.
III. Participation in the Public
Workshop
Registration: Persons interested in
attending this workshop must register
online at: https://www.eventbrite.com/e/
public-workshop-advancing-thedevelopment-of-pediatric-therapeuticsadept-application-of-big-data-tickets32470264435 by August 22, 2017. For
those without internet access, please
contact Renan A. Bonnel (see FOR
FURTHER INFORMATION CONTACT) to
register.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register by August 22, 2017. Early
registration is recommended because
seating is limited; therefore, FDA may
limit the number of participants.
Registration information, the agenda,
and additional background materials
can be found at https://www.fda.gov/
NewsEvents/
MeetingsConferencesWorkshops/
ucm545847.htm.
If you need special accommodations
due to a disability, please contact Renan
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40005
A. Bonnel (see FOR FURTHER INFORMATION
at least 7 days in advance.
Persons attending the meeting are
advised that FDA is not responsible for
providing access to electrical outlets.
Streaming Webcast of the Public
Workshop: This public workshop will
also be webcast.
September 18: Login URL: https://
event.webcasts.com/
starthere.jsp?ei=1144352 (morning
session).
After the morning session, users will
be automatically redirected to the
afternoon link. Should you lose
connection over lunch, please use the
following link for the afternoon session
(Note: the link for the afternoon session
is different from the morning session):
Login URL: https://event.webcasts.com/
starthere.jsp?ei=1144354 (afternoon
session).
September 19: Login URL: https://
event.webcasts.com/
starthere.jsp?ei=1144356 (morning
session).
After the morning session, users will
be automatically redirected to the
afternoon link. Should you lose
connection over lunch, please use the
following link for the afternoon session
(Note: the link for the afternoon session
is different from the morning session):
Login URL: https://event.webcasts.com/
starthere.jsp?ei=1144357 (afternoon
session).
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the Web site addresses in this
document, as of the date this document
publishes in the Federal Register, but
Web sites are subject to change over
time.
Transcripts: Please be advised that as
soon as a transcript of the public
workshop is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Dockets Management Staff office
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. A link to
the transcript will be available on the
internet at https://www.fda.gov/
NewsEvents/
MeetingsConferencesWorkshops/
ucm545847.htm.
CONTACT)
Dated: August 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–17783 Filed 8–22–17; 8:45 am]
BILLING CODE 4164–01–P
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Agencies
[Federal Register Volume 82, Number 162 (Wednesday, August 23, 2017)]
[Notices]
[Pages 40003-40005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17856]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-4835]
Peripheral and Central Nervous System Drugs Advisory Committee;
Notice of Meeting; Establishment of a Public Docket; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Peripheral and Central Nervous
System Drugs Advisory Committee. The general function of the committee
is to provide advice and recommendations to the Agency on FDA's
regulatory issues. The meeting will be open to the public. FDA is
establishing a docket for public comment on this document.
DATES: The public meeting will be held on September 28, 2017, from 9
a.m. to 4:30 p.m.
ADDRESSES: Tommy Douglas Conference Center, The Ballroom, 10000 New
Hampshire Ave., Silver Spring, MD 20903. Answers to commonly asked
questions about FDA Advisory Committee meetings may be accessed at:
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. Information about the Tommy Douglas Conference Center
may be accessed at: https://www.tommydouglascenter.com/.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2017-N-4835. The docket will close on
September 27, 2017. Submit either electronic or written comments on
this public meeting by September 27, 2017. Late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before September 27, 2017. The https://www.regulations.gov
electronic filing system will accept comments until midnight Eastern
Time at the end of September 27, 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.
Comments received on or before September 14, 2017, will be provided
to the committee. Comments received after that date will be taken into
consideration by the Agency.
[[Page 40004]]
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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2017-N-4835 for ``Peripheral and Central Nervous System Drugs
Advisory Committee; Notice of Meeting; Establishment of a Public
Docket; Request for Comments.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
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 Dockets Management Staff. 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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Moon Hee V. Choi, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax: 301-847-8533, email: PCNS@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/AdvisoryCommittees/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.
SUPPLEMENTARY INFORMATION:
Agenda: The committee will discuss new drug application (NDA)
200896, ataluren for oral suspension, sponsored by PTC Therapeutics,
Inc., for the treatment of patients with dystrophinopathy due to a
nonsense mutation in the dystrophin gene.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the docket (see
ADDRESSES) on or before September 14, 2017, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 1:15 p.m. and 2:15 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 September 6, 2017. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by September 7, 2017.
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 special accommodations due to a
disability, please contact Moon
[[Page 40005]]
Hee V. Choi at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on 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: August 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17856 Filed 8-22-17; 8:45 am]
BILLING CODE 4164-01-P