Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 40522-40524 [2018-17524]
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40522
Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices
of the FD&C Act (21 U.S.C. 379aa(b)(1)),
including followup reports under
760(c)(2) of the FD&C Act (21 U.S.C.
379aa(c)(2)), and how to submit these
reports. The estimates for the annual
reporting and recordkeeping burdens
are based on FDA data on the number
of adverse drug experience reports
submitted for nonprescription drug
products marketed without an approved
application and on prior input from
comments received from prior Federal
Register publications.
Based on FDA records, we received
194,449 total annual responses from
approximately 283 respondents for
nonprescription drugs marketed without
an approved application. We estimate
that each submission will take
approximately 6 hours to prepare and
submit.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
Reports of serious adverse drug events (21 U.S.C.
379aa((b) and (c)) ............................................................
283
687.099
194,449
6
1,166,694
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Section 760(e) of the FD&C Act (21
U.S.C. 379aa(e)) also requires that
responsible persons maintain records of
nonprescription adverse event reports,
whether or not the event is serious, for
a period of 6 years. The guidance
recommends that respondents maintain
records of efforts to obtain the minimum
data elements for a report of a serious
adverse drug event and any followup
reports. We estimate that there are
approximately 265,700 records per year
maintained by approximately 300
respondents, and that it takes
approximately 8 hours to maintain each
record.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total hours
Recordkeeping (21 U.S.C. 379aa(e)(1)) ..............................
300
885.6667
265,700
8
2,125,600
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
[FR Doc. 2018–17526 Filed 8–14–18; 8:45 am]
and Clinical Pharmacology Advisory
Committee. The general function of the
committee is to provide advice and
recommendations to FDA on regulatory
issues. The meeting will be open to the
public. FDA is establishing a docket for
public comment on this document.
DATES: The meeting will be held on
September 20, 2018, from 8 a.m. to 5
p.m.
BILLING CODE 4164–01–P
ADDRESSES:
Our estimated burden for the
information collection reflects an
overall increase. We attribute this
adjustment to an increase in the number
of submissions we received in the last
few years.
Dated: August 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2944]
Pharmaceutical Science and Clinical
Pharmacology Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments
daltland on DSKBBV9HB2PROD with NOTICES
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 Pharmaceutical Science
SUMMARY:
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FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
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/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2018–N–2944.
The docket will close on September 19,
2018. Submit either electronic or
written comments on this public
meeting by September 19, 2018. Please
note that late, untimely filed comments
will not be considered. Electronic
comments must be submitted on or
before September 19, 2018. The https://
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www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of
September 19, 2018. 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 5, 2018, will be provided to
the committee. Comments received after
that date will be taken into
consideration by FDA.
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,
E:\FR\FM\15AUN1.SGM
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Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
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–
2018–N–2944 for ‘‘Pharmaceutical
Science and Clinical Pharmacology
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.’’ FDA
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
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Jkt 244001
contact information 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 the 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: Jay
R. Fajiculay, 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: ACPS-CP@
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
FDA’s website 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 meeting will focus on
two topics related to the Office of
Pharmaceutical Quality’s priority of
promoting the availability of better
medicine. During the morning session,
the committee will discuss the
modernization of assessing drug
applications through a KnowledgeAided Assessment and Structured
Application (KASA) initiative. FDA will
seek input on the potential
enhancement of a submission format
consistent with KASA to improve the
efficiency and consistency of regulatory
quality assessment. During the
afternoon session, the committee will
discuss in-vitro/in-vivo relationship
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40523
standards, and will seek input on
establishing patient-focused dissolution
standards for oral solid modified-release
dosage forms.
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 website 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 website 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 5, 2018, will be provided to
the committee. Oral presentations from
the public will be scheduled between
approximately 10:40 a.m. to 11:10 a.m.
and 3:20 p.m. to 3:50 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 August 28, 2018. 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 August 29, 2018.
Persons attending FDA’s advisory
committee meetings are advised that
FDA is not responsible for providing
access to electrical outlets.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
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 Jay Fajiculay
(see FOR FURTHER INFORMATION CONTACT)
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
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Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices
meetings. Please visit our website 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: August 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–17524 Filed 8–14–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Dated: August 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[Docket No. FDA–2017–N–0809]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
FDA has determined that CRYSVITA
(burosamab-twza), manufactured by
Ultragenyx Pharmaceutical, Inc., meets
the criteria for a priority review
voucher.
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, Fax: 301–796–9856,
email: althea.cuff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that CRYSVITA
(burosamab-twza), manufactured by
Ultragenyx Pharmaceutical, Inc., meets
SUMMARY:
daltland on DSKBBV9HB2PROD with NOTICES
[FR Doc. 2018–17527 Filed 8–14–18; 8:45 am]
Food and Drug Administration,
HHS.
ACTION:
the criteria for a priority review
voucher. CRYSVITA (burosamab-twza)
is indicated for the treatment of Xlinked hypophosphatemia in adult and
pediatric patients 1 year of age and
older.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about CRYSVITA
(burosumab-twza), go to the ‘‘Drugs@
FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
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Food and Drug Administration
[Docket No. FDA–2018–D–0943]
Elemental Impurities in Animal Drug
Products—Questions and Answers;
Draft Guidance for Industry;
Availability; Reopening of the
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; reopening
of the comment period.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
reopening the comment period for the
notice of availability that published in
the Federal Register on March 27, 2018.
In that document, FDA requested
comments on the draft guidance for
industry (GFI) #255 entitled ‘‘Elemental
Impurities in Animal Drug Products—
Questions and Answers.’’ The Agency is
taking this action in response to
requests for an extension to allow
interested parties additional time to
develop and submit comments.
DATES: FDA is reopening the comment
period on the notice of availability
published March 27, 2018 (83 FR
13134). Submit either electronic or
written comments on the draft guidance
by October 15, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
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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–
2018–D–0943 for ‘‘Elemental Impurities
in Animal Drug Products—Questions
and Answers.’’ 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
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
E:\FR\FM\15AUN1.SGM
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Agencies
[Federal Register Volume 83, Number 158 (Wednesday, August 15, 2018)]
[Notices]
[Pages 40522-40524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17524]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-2944]
Pharmaceutical Science and Clinical Pharmacology 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 Pharmaceutical Science and
Clinical Pharmacology Advisory Committee. The general function of the
committee is to provide advice and recommendations to FDA on regulatory
issues. The meeting will be open to the public. FDA is establishing a
docket for public comment on this document.
DATES: The meeting will be held on September 20, 2018, from 8 a.m. to 5
p.m.
ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. 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/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2018-N-2944. The docket will close on
September 19, 2018. Submit either electronic or written comments on
this public meeting by September 19, 2018. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before September 19, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of September 19, 2018. 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 5, 2018, will be provided
to the committee. Comments received after that date will be taken into
consideration by FDA.
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,
[[Page 40523]]
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-2018-N-2944 for ``Pharmaceutical Science and Clinical Pharmacology
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.'' FDA 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 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 the 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: Jay R. Fajiculay, 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: [email protected], 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 FDA's website 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 meeting will focus on two topics related to the Office
of Pharmaceutical Quality's priority of promoting the availability of
better medicine. During the morning session, the committee will discuss
the modernization of assessing drug applications through a Knowledge-
Aided Assessment and Structured Application (KASA) initiative. FDA will
seek input on the potential enhancement of a submission format
consistent with KASA to improve the efficiency and consistency of
regulatory quality assessment. During the afternoon session, the
committee will discuss in-vitro/in-vivo relationship standards, and
will seek input on establishing patient-focused dissolution standards
for oral solid modified-release dosage forms.
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 website 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 website 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 5, 2018, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 10:40 a.m. to 11:10 a.m. and 3:20 p.m. to 3:50 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
August 28, 2018. 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 August 29, 2018.
Persons attending FDA's advisory committee meetings are advised
that FDA is not responsible for providing access to electrical outlets.
For press inquiries, please contact the Office of Media Affairs at
[email protected] or 301-796-4540.
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 Jay Fajiculay (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
[[Page 40524]]
meetings. Please visit our website 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 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17524 Filed 8-14-18; 8:45 am]
BILLING CODE 4164-01-P