Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 33686-33687 [2020-11883]
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Federal Register / Vol. 85, No. 106 / Tuesday, June 2, 2020 / Notices
III. Electronic Access
An electronic version of this
document and the full text of the
Authorizations are available on the
internet at https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/emergency-useauthorization.
IV. Process for Publishing EUAs for
Medical Devices During COVID–19
Dated: May 28, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
khammond on DSKJM1Z7X2PROD with NOTICES
BILLING CODE 4164–01–P
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Jkt 250001
Food and Drug Administration
[Docket No. FDA–2020–N–1302]
Pediatric Oncology Subcommittee of
the Oncologic Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
To facilitate publication of each EUA,
and each termination or revocation of an
EUA under section 564, in accordance
with section 564(h)(1) of the FD&C Act,
the Agency intends to use the following
process:
• Rather than publishing a separate
Notice of Availability (NOA) for each
COVID–19 related EUA for a medical
device, FDA intends to publish
periodically a consolidated NOA. This
periodic NOA will announce the
availability of all the COVID–19 related
EUAs for medical devices that issued
during the relevant period. The
consolidated NOA will provide
instructions to the public on how to
view the EUAs, and instructions for
persons interested in obtaining a copy of
the COVID–19 related EUAs.
• COVID–19 related EUAs for
medical devices will be accessible on
the internet at the FDA web page
entitled ‘‘Emergency Use
Authorization,’’ available at https://
www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization.
• COVID–19 related EUAs for
medical devices are also currently
accessible on the internet from the FDA
web page entitled ‘‘Emergency Use
Authorizations,’’ available at https://
www.fda.gov/medical-devices/
emergency-situations-medical-devices/
emergency-useauthorizations#covid19ivd.
[FR Doc. 2020–11898 Filed 6–1–20; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 Pediatric Oncology
Subcommittee of the Oncologic 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 be held on June
17, 2020, from 10 a.m. to 3:30 p.m. and
June 18, 2020, from 10 a.m. to 3:30 p.m.
ADDRESSES: Please note that due to the
impact of this COVID–19 public health
emergency, 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/AboutAdvisory
Committees/ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2020–N–1302.
The docket will close on June 16, 2020.
Submit either electronic or written
comments on this public meeting by
June 16, 2020. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before June 16, 2020.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 16, 2020. 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 June
10, 2020, will be provided to the
subcommittee. Comments received after
that date will be taken into
consideration by FDA. In the event that
DATES:
PO 00000
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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–1302 for ‘‘Pediatric Oncology
Subcommittee of the Oncologic 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
E:\FR\FM\02JNN1.SGM
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khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 85, No. 106 / Tuesday, June 2, 2020 / Notices
a.m. and 4 p.m., Monday through
Friday. Please call 240–402–7500 ahead
of the meeting time to verify access.
• 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:
LaToya Bonner, 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:
ODAC@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.
VerDate Sep<11>2014
20:46 Jun 01, 2020
Jkt 250001
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 presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform. On June 17,
2020, information will be presented
regarding pediatric development plans
for two products that are in
development for an adult oncology
indication. The subcommittee will
consider and discuss issues relating to
the development of each product for
pediatric use and provide guidance to
facilitate the formulation of written
requests for pediatric studies, if
appropriate. The two products under
consideration are: (1) SP 2577
presentation by Salarius
Pharmaceuticals, Inc. and (2)
Marizomib, presentation by Celgene
International II Sa`rl, a wholly owned
subsidiary of Bristol-Myers Squibb.
On June 18, 2020, information will be
presented regarding pediatric
development plans for two products
that are in development for an adult
oncology indication. The subcommittee
will consider and discuss issues relating
to the development of each product for
pediatric use and provide guidance to
facilitate the formulation of written
requests for pediatric studies, if
appropriate. The two products under
consideration are: (1) CD30.CAR–T,
presentation by Tessa Therapeutics and
(2) SNDX–5613, presentation by Syndax
Pharmaceuticals, Inc.
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 on FDA’s
website at the time of the advisory
committee meeting. Background
material and the link to the online
teleconferencing platform will be
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link. The meeting will include slide
presentations with audio components to
allow the presentation of materials in a
manner that most closely resembles an
in-person advisory committee meeting.
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33687
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the subcommittee. All electronic
and written submissions submitted to
the Docket (see ADDRESSES) on or before
June 10, 2020, will be provided to the
subcommittee. Oral presentations from
the public will be scheduled between
approximately 10:50 a.m. to 11:20 a.m.
and 1:55 p.m. to 2:25 p.m. on June 17,
2020. Oral presentations from the public
will also be scheduled between
approximately 10:50 a.m. to 11:20 a.m.
and 1:55 p.m. to 2:25 p.m. on June 18,
2020. 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 June 5, 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 June 8, 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 LaToya Bonner
(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/AboutAdvisory
Committees/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: May 28, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–11883 Filed 6–1–20; 8:45 am]
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]]>Agencies
[Federal Register Volume 85, Number 106 (Tuesday, June 2, 2020)]
[Notices]
[Pages 33686-33687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11883]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1302]
Pediatric Oncology Subcommittee of the Oncologic 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 Pediatric Oncology
Subcommittee of the Oncologic 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 June 17, 2020, from 10 a.m. to 3:30
p.m. and June 18, 2020, from 10 a.m. to 3:30 p.m.
ADDRESSES: Please note that due to the impact of this COVID-19 public
health emergency, 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-1302. The docket will close on June 16,
2020. Submit either electronic or written comments on this public
meeting by June 16, 2020. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before June 16, 2020. The https://www.regulations.gov electronic
filing system will accept comments until 11:59 p.m. Eastern Time at the
end of June 16, 2020. 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 June 10, 2020, will be provided to
the subcommittee. 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-1302 for ``Pediatric Oncology Subcommittee of the Oncologic
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
[[Page 33687]]
a.m. and 4 p.m., Monday through Friday. Please call 240-402-7500 ahead
of the meeting time to verify access.
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: LaToya Bonner, 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 presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. On June 17,
2020, information will be presented regarding pediatric development
plans for two products that are in development for an adult oncology
indication. The subcommittee will consider and discuss issues relating
to the development of each product for pediatric use and provide
guidance to facilitate the formulation of written requests for
pediatric studies, if appropriate. The two products under consideration
are: (1) SP 2577 presentation by Salarius Pharmaceuticals, Inc. and (2)
Marizomib, presentation by Celgene International II S[agrave]rl, a
wholly owned subsidiary of Bristol-Myers Squibb.
On June 18, 2020, information will be presented regarding pediatric
development plans for two products that are in development for an adult
oncology indication. The subcommittee will consider and discuss issues
relating to the development of each product for pediatric use and
provide guidance to facilitate the formulation of written requests for
pediatric studies, if appropriate. The two products under consideration
are: (1) CD30.CAR-T, presentation by Tessa Therapeutics and (2) SNDX-
5613, presentation by Syndax Pharmaceuticals, Inc.
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 on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconferencing platform will be available at
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide presentations with audio components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the subcommittee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before June 10, 2020, will be provided to the
subcommittee. Oral presentations from the public will be scheduled
between approximately 10:50 a.m. to 11:20 a.m. and 1:55 p.m. to 2:25
p.m. on June 17, 2020. Oral presentations from the public will also be
scheduled between approximately 10:50 a.m. to 11:20 a.m. and 1:55 p.m.
to 2:25 p.m. on June 18, 2020. 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 June 5, 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 June 8, 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 LaToya Bonner (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: May 28, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-11883 Filed 6-1-20; 8:45 am]
BILLING CODE 4164-01-P
