Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 48539-48541 [2020-17533]
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Federal Register / Vol. 85, No. 155 / Tuesday, August 11, 2020 / Notices
Reserve Bank(s) indicated below and at
the offices of the Board of Governors.
This information may also be obtained
on an expedited basis, upon request, by
contacting the appropriate Federal
Reserve Bank and from the Board’s
Freedom of Information Office at
https://www.federalreserve.gov/foia/
request.htm. Interested persons may
express their views in writing on the
question whether the proposal complies
with the standards of section 4 of the
BHC Act.
Unless otherwise noted, comments
regarding the applications must be
received at the Reserve Bank indicated
or the offices of the Board of Governors,
Ann E. Misback, Secretary of the Board,
20th Street and Constitution Avenue
NW, Washington, DC 20551–0001, not
later than August 26, 2020.
A. Federal Reserve Bank of
Minneapolis (Chris P. Wangen,
Assistant Vice President), 90 Hennepin
Avenue, Minneapolis, Minnesota
55480–0291:
1. First Holding Company of Park
River, Inc., Park River, North Dakota; to
indirectly retain voting shares of
AccuData Services, Inc., through its
subsidiary bank, First United Bank, both
of Park River, North Dakota, pursuant to
section 225.28(b)(14)(i) of Regulation Y.
Board of Governors of the Federal Reserve
System, August 6, 2020.
Yao-Chin Chao,
Assistant Secretary of the Board.
[FR Doc. 2020–17530 Filed 8–10–20; 8:45 am]
BILLING CODE P
GENERAL SERVICES
ADMINISTRATION
[OMB Control No. 3090–0118; Docket No.
2020–0001; Sequence No. 4]
Submission for OMB Review; Federal
Management Regulation; Standard
Form 94, Statement of Witness
Office of Government-wide
Policy (OGP), General Services
Administration (GSA).
ACTION: Notice; request for comments.
AGENCY:
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collection should be sent within 30 days
of publication of this notice to
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. If your
comment cannot be submitted using
www.reginfo.gov/public/do/PRAMain,
call or email the points of contact in the
Control No. 3090–0118, Standard Form
94, Statement of Witness, in all
correspondence.
FOR FURTHER INFORMATION CONTACT
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
section of this document for alternate
instructions.
FOR FURTHER INFORMATION CONTACT:
Mr.
Ray Wynter, GSA, Office of
Government-wide Policy (MAG), Office
of Asset and Transportation
Management, at telephone 202–501–
3802 or via email to ray.wynter@gsa.gov.
SUPPLEMENTARY INFORMATION:
Respondents: 290.
Responses per Respondent: 1.
Total Annual Responses: 290.
Hours Per Response: 0.333.
Total Burden Hours: 97.
C. Public Comments
A 60-day notice was published in the
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Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
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GSARegSec@gsa.gov. Please cite OMB
Frm 00040
[FR Doc. 2020–17474 Filed 8–10–20; 8:45 am]
BILLING CODE 6820–14–P
Food and Drug Administration
[Docket No. FDA–2020–N–0626]
Pulmonary-Allergy Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
Food and Drug Administration,
HHS.
GSA’s Office of Government-wide
Policy is announcing the availability of
Standard Form 94, Statement of Witness
that is publicly available on https://
www.gsa.gov/forms. This form will be
used to collect information from
witnesses reporting accidents and/or
damage to Federal Fleet Vehicles.
Standard Form (SF) 94 provides
additional accounts of motor vehicle
accidents that supplement statements
made by a motor vehicle operator. Use
of the SF 94 is prescribed in Federal
Management Regulation, 41 CFR 102–
34.290(b) and Federal Property
Management Regulations, 41 CFR 101–
39.401(b). The SF 94 is usually
completed at the time of an accident
involving a motor vehicle owned or
leased by the Government.
The SF 94 is an essential part of the
investigation of motor vehicle accidents,
especially those involving the public
with a potential for claims against the
United States. It is a vital piece of
information in lawsuits and provides
the Assistant United States Attorneys
with a written statement to refresh
recollection of accidents, as necessary.
PO 00000
Beth Anne Killoran,
Deputy Chief Information Officer.
AGENCY:
A. Purpose
B. Annual Reporting Burden
Under the provisions of the
Paperwork Reduction Act, the
Regulatory Secretariat Division will be
submitting to the Office of Management
and Budget (OMB) a request to review
and approve an existing information
collection requirement regarding OMB
Control No: 3090–0118; Standard Form
94, Statement of Witness.
DATES: Submit comments on or before
September 10, 2020.
ADDRESSES: Written comments and
recommendations for this information
SUMMARY:
48539
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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 Pulmonary-Allergy Drugs
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.
SUMMARY:
The meeting will take place
virtually on August 31, 2020, from 10
a.m. Eastern Time to 4 p.m. Eastern
Time.
DATES:
Please note that due to the
impact of this COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
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–2020–N–0626.
The docket will close on August 28,
2020. Submit either electronic or
written comments on this public
meeting by August 28, 2020. Please note
that late, untimely filed comments will
not be considered. Electronic comments
must be submitted on or before August
28, 2020. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
August 28, 2020. Comments received by
mail/hand delivery/courier (for written/
ADDRESSES:
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48540
Federal Register / Vol. 85, No. 155 / Tuesday, August 11, 2020 / Notices
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
August 17, 2020, will be provided to the
committee. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
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–
2020–N–0626 for ‘‘Pulmonary-Allergy
Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public
VerDate Sep<11>2014
17:02 Aug 10, 2020
Jkt 250001
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. Eastern Time and 4 p.m. Eastern
Time, Monday through Friday, 240–
402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Philip Bautista, 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:
PADAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
PO 00000
Frm 00041
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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
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 be heard,
viewed, captioned, and recorded
through an online teleconferencing
platform. On August 31, 2020, the
committee will discuss supplemental
new drug application 209482/S–008, for
TRELEGY ELLIPTA, a fixed-dose
combination (fluticasone furoate,
umeclidinium, and vilanterol inhalation
powder oral inhalation), submitted by
GlaxoSmithKline, for the following
proposed labeling claim: Reduction in
all-cause mortality in patients with
chronic obstructive pulmonary disease
(COPD). The focus of the discussion will
be on the efficacy data submitted to
support the proposed labeling claim,
including the results from the Informing
the Pathway of COPD Treatment trial
and the influence of inhaled
corticosteroids withdrawal on the
results.
FDA intends to make the meeting’s
background material and pre-recorded
presentations available to the public no
later than 2 business days before the
meeting. The pre-recorded presentations
will be viewed by the committee prior
to the meeting and will not be replayed
on meeting day. If FDA is unable to post
the background material and/or prerecorded presentations on its website
prior to the meeting, the background
material and/or pre-recorded
presentations will be made publicly
available on FDA’s website at the time
of the advisory committee meeting. The
meeting will include brief summaries of
the pre-recorded presentations.
Background material and the link to the
online teleconference meeting room will
be 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
August 17, 2020, will be provided to the
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Federal Register / Vol. 85, No. 155 / Tuesday, August 11, 2020 / Notices
committee. Oral presentations from the
public will be scheduled on August 31,
2020, between approximately 12:50 p.m.
Eastern Time and 1:50 p.m. Eastern
Time. Those individuals interested in
making formal oral presentations should
notify the contact person (see FOR
FURTHER INFORMATION CONTACT). The
notification should include 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 14, 2020. 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 17, 2020.
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 Philip Bautista
(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
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 5, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–17533 Filed 8–10–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–4615]
Marketing Status Notifications Under
Section 506I of the Federal Food, Drug,
and Cosmetic Act; Content and
Format; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Marketing Status Notifications Under
Section 506I of the Federal Food, Drug,
and Cosmetic Act; Content and Format.’’
This guidance is intended to assist
holders of new drug applications
(NDAs) and abbreviated new drug
applications (ANDAs) approved under
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) with their submission of
required marketing status notifications.
This guidance finalizes the draft
guidance of the same title issued on
January 31, 2019.
DATES: The announcement of the
guidance is published in the Federal
Register on August 11, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time 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
PO 00000
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Fmt 4703
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48541
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–4615 for ‘‘Marketing Status
Notifications Under Section 506I of the
Federal Food, Drug, and Cosmetic Act;
Content and Format.’’ 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
‘‘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.
E:\FR\FM\11AUN1.SGM
11AUN1
Agencies
[Federal Register Volume 85, Number 155 (Tuesday, August 11, 2020)]
[Notices]
[Pages 48539-48541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17533]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0626]
Pulmonary-Allergy 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 Pulmonary-Allergy Drugs
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 take place virtually on August 31, 2020, from
10 a.m. Eastern Time to 4 p.m. Eastern Time.
ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings 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-2020-N-0626. The docket will close on August
28, 2020. Submit either electronic or written comments on this public
meeting by August 28, 2020. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before August 28, 2020. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of August 28, 2020. Comments received by mail/hand
delivery/courier (for written/
[[Page 48540]]
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 August 17, 2020, will be provided to
the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
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-2020-N-0626 for ``Pulmonary-Allergy 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.
Eastern Time and 4 p.m. Eastern Time, Monday through Friday, 240-402-
7500.
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.govinfo.gov/content/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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Philip Bautista, 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 the 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 be heard, viewed, captioned, and recorded
through an online teleconferencing platform. On August 31, 2020, the
committee will discuss supplemental new drug application 209482/S-008,
for TRELEGY ELLIPTA, a fixed-dose combination (fluticasone furoate,
umeclidinium, and vilanterol inhalation powder oral inhalation),
submitted by GlaxoSmithKline, for the following proposed labeling
claim: Reduction in all-cause mortality in patients with chronic
obstructive pulmonary disease (COPD). The focus of the discussion will
be on the efficacy data submitted to support the proposed labeling
claim, including the results from the Informing the Pathway of COPD
Treatment trial and the influence of inhaled corticosteroids withdrawal
on the results.
FDA intends to make the meeting's background material and pre-
recorded presentations available to the public no later than 2 business
days before the meeting. The pre-recorded presentations will be viewed
by the committee prior to the meeting and will not be replayed on
meeting day. If FDA is unable to post the background material and/or
pre-recorded presentations on its website prior to the meeting, the
background material and/or pre-recorded presentations will be made
publicly available on FDA's website at the time of the advisory
committee meeting. The meeting will include brief summaries of the pre-
recorded presentations. Background material and the link to the online
teleconference meeting room will be 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 August 17, 2020, will be provided to the
[[Page 48541]]
committee. Oral presentations from the public will be scheduled on
August 31, 2020, between approximately 12:50 p.m. Eastern Time and 1:50
p.m. Eastern Time. Those individuals interested in making formal oral
presentations should notify the contact person (see FOR FURTHER
INFORMATION CONTACT). The notification should include 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 14, 2020. 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 17, 2020.
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 Philip Bautista (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
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 5, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-17533 Filed 8-10-20; 8:45 am]
BILLING CODE 4164-01-P