Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 26483-26485 [2018-12226]
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Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
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information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Requests for
Feedback and Meetings for Medical
Device Submissions: The Q-Submission
Program; Draft Guidance for Industry
and Food and Drug Administration
Staff’’ to the Office of the Center
Director, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002 or the Office of
Communication, Outreach, and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request.
FOR FURTHER INFORMATION CONTACT: J.
Allen Hill, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5627, Silver Spring,
MD 20993–0002, 301–796–7086; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993, 240–402–
7911.
SUPPLEMENTARY INFORMATION:
I. Background
The pre-IDE program was established
in 1995, to provide applicants a
mechanism to obtain FDA feedback on
future IDE applications prior to their
submission. Over time, the pre-IDE
program evolved to include feedback on
PMA applications, HDE applications, de
novo requests, and 510(k) submissions,
as well as to address whether a clinical
study requires submission of an IDE.
To capture this evolution, the
Secretary of Health and Human
Services’ 2012 Commitment Letter to
Congress regarding the Medical Device
User Fee Amendments of 2012 (MDUFA
III) included FDA’s commitment to
institute a structured process for
managing these interactions, referring to
them as ‘‘Pre-Submissions.’’ The PreSubmission Guidance, published
February 18, 2014, implemented the
broader Q-Submission (Q-Sub) Program,
which includes Pre-Submissions (PreSubs), as well as additional
opportunities to engage with FDA.
As part of the Medical Device User
Fee Amendments of 2017 (MDUFA IV),
industry and the Agency agreed to
refine the Q-Sub Program with changes
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related to the scheduling of Pre-Sub
meetings and a new performance goal
on the timing of FDA feedback on PreSubs. This guidance reflects those
changes and clarifies other elements of
the Q-Sub program.
This draft guidance document
provides an overview of the
mechanisms available to applicants
through which they can request
feedback from or a meeting with FDA
regarding potential or planned medical
device IDE applications, PMA
applications, HDE applications, de novo
requests, 510(k) Submissions, CLIA
Waiver by Application, Accessory
Classification Requests, and certain
INDs and BLAs.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Requests for Feedback and Meetings
for Medical Device Submissions: The QSubmission Program; Draft Guidance for
Industry and Food and Drug
Administration Staff.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. This
draft guidance is also available at
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/default.htm or
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Requests for Feedback and Meetings
for Medical Device Submissions: The QSubmission Program; Draft Guidance for
Industry and Food and Drug
Administration Staff’’ may send an
email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number 1677 to identify the
guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance also refers to
previously approved information
collections found in FDA regulations.
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These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 803 are
approved under OMB control number
0910–0437; the collections of
information in 21 CFR part 807, subpart
E are approved under OMB control
number 0910–0120; the collections of
information in 21 CFR part 812 are
approved under OMB control number
0910–0078; the collections of
information in 21 CFR part 814 are
approved under OMB control number
0910–0231; and the collections of
information for ‘‘Request for Feedback
on Medical Device Submissions’’ are
approved under OMB control number
0910–0756.
Dated: June 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12223 Filed 6–6–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1823]
Pulmonary-Allergy Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
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 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 be held on July
25, 2018, from 8 a.m. to 4 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/AboutAdvisory
Committees/ucm408555.htm.
SUMMARY:
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Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2018–N–1823.
The docket will close on July 24, 2018.
Submit either electronic or written
comments on this public meeting by
July 24, 2018. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 24, 2018.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of July 24, 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 July
11, 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
sradovich on DSK3GMQ082PROD with NOTICES
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.
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• 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–1823, 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 ADDRESSSES), 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/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.
PO 00000
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FOR FURTHER INFORMATION CONTACT:
Jennifer Shepherd, 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
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 committee will discuss
supplemental biologics license
application (sBLA) 125526 for
mepolizumab for injection, submitted
by GlaxoSmithKline for add-on
treatment to inhaled corticosteroidbased maintenance treatment for the
reduction of exacerbations in patients
with chronic obstructive pulmonary
disease (COPD) guided by blood
eosinophil counts.
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. Written
submissions may be made to the contact
person on or before July 11, 2018. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 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
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Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
approximate time requested to make
their presentation on or before July 2,
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 July 3, 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 Jennifer
Shepherd (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: June 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12226 Filed 6–6–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Facilitation of Public-Private Dialogue
to Increase Innovation and Investment
in the Healthcare Sector
Immediate Office of the
Secretary, HHS.
ACTION: Request for information.
AGENCY:
This request for information
solicits public comment on a planned
initiative of the Office of the Deputy
Secretary of HHS to develop a
workgroup to facilitate constructive,
high-level dialogue between HHS
leadership and those focused on
innovating and investing in the
healthcare industry. HHS seeks
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SUMMARY:
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comment on how to structure a
workgroup, or other form of interaction
between the Department and such
participants in the healthcare industry,
in order to best support communication
and understanding between these
parties that will spur investment,
increase competition, accelerate
innovation, and allow capital
investment in the healthcare sector to
have a more significant impact on the
health and wellbeing of Americans.
HHS also seeks comment more broadly
on opportunities for increased
engagement and dialogue between HHS
and those focused on innovating and
investing in the healthcare industry.
DATES: Comments must be submitted
within 30 days after the date of
publication in the Federal Register.
ADDRESSES: You may submit comments
in one of three ways (please choose only
one of the ways listed):
1. Electronically. You may submit
electronic comments through https://
www.regulations.gov.
2. By regular mail. You may mail
written comments to the following
address ONLY: Immediate Office of the
Secretary, Office of the Deputy
Secretary, U.S. Department of Health
and Human Services, Attention: RFI
Regarding Healthcare Sector Innovation
and Investment Workgroup, 200
Independence Avenue SW, Washington,
DC 20201.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may mail written comments to the
following address ONLY: Immediate
Office of the Secretary, Office of the
Deputy Secretary, U.S. Department of
Health and Human Services, Attention:
RFI Regarding Healthcare Sector
Innovation and Investment Workgroup,
200 Independence Avenue SW,
Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT:
William Brady, (202) 690–6133.
SUPPLEMENTARY INFORMATION:
I. Background
The healthcare industry is a complex
and highly regulated industry, and
although significant investment occurs
within the industry, innovation and
investment in the healthcare industry
must increase to produce more
significant impact on the health and
wellbeing of the American people.
Through this effort, the Department
intends to provide a forum for HHS
leadership to engage in a dialogue with
those focused on innovating and
investing in the healthcare industry,
such as healthcare innovation-focused
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companies, healthcare startup
incubators and accelerators, healthcare
investment professionals, healthcarefocused private equity firms, healthcarefocused venture capital firms, and
lenders to healthcare investors and
innovators. While HHS seeks comment
on the structure and focus of the
workgroup, as well as other
opportunities for engagement, the
Department envisions the workgroup as
a forum to hear the individual
perspectives of attendees and foster new
and innovative approaches to tackle the
complicated challenges facing the
healthcare industry. The Department
intends for non-HHS attendees to be
diverse across the subsectors of the
healthcare industry and the investment
and innovation lifecycles, and for HHS
attendees to be diverse across the
Department in senior leadership
positions. Workgroup members will not
be asked to provide any reports or
collaborative work product. No travel
expenses, per diem, or compensation of
any type will be provided to attendees.
II. Solicitation of Comments
HHS seeks comment on how to
structure the workgroup in order to best
support communication and
understanding between these parties
that will spur investment in the
healthcare industry, increase
competition, improve innovation, and
allow capital investment in the
healthcare sector to have a more
significant impact on the health and
wellbeing of Americans. HHS also seeks
comment more broadly on opportunities
for increased engagement and dialogue
between HHS and those focused on
innovating and investing in the
healthcare industry. Specifically, HHS
seeks comments addressing the
following topics:
1. Specific areas of inquiry or focus
for the workgroup. Should the
workgroup review recent developments
in health innovation and investing?
Should the workgroup examine
perceived barriers to innovation and
competition in the healthcare industry?
Should the workgroup encourage
outside parties to provide HHS with
information about how they are affected
by HHS programs or regulatory
requirements? Should the workgroup
provide a forum for attendees to share
their perspectives as to how the
Department may improve relevant
regulations, guidance, or other
documents? Should the workgroup
examine ways to encourage private
sector investment to help combat health
crises? What other areas of focus would
best help the Department engage with
diverse subsectors of the healthcare
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]]>Agencies
[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Pages 26483-26485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12226]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1823]
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 be held on July 25, 2018, from 8 a.m. to 4 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.
[[Page 26484]]
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2018-N-1823. The docket will close on July 24,
2018. Submit either electronic or written comments on this public
meeting by July 24, 2018. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before July 24, 2018. The https://www.regulations.gov electronic
filing system will accept comments until midnight Eastern Time at the
end of July 24, 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 July 11, 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, 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-1823, 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
ADDRESSSES), 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: Jennifer Shepherd, 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 committee will discuss supplemental biologics license
application (sBLA) 125526 for mepolizumab for injection, submitted by
GlaxoSmithKline for add-on treatment to inhaled corticosteroid-based
maintenance treatment for the reduction of exacerbations in patients
with chronic obstructive pulmonary disease (COPD) guided by blood
eosinophil counts.
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.
Written submissions may be made to the contact person on or before July
11, 2018. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 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
[[Page 26485]]
approximate time requested to make their presentation on or before July
2, 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 July 3, 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 Jennifer Shepherd (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: June 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12226 Filed 6-6-18; 8:45 am]
BILLING CODE 4164-01-P
