Public Meeting on the Center for Drug Evaluation and Research Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program-Summer 2020; Public Meeting; Request for Comments, 51445-51446 [2020-18238]
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Federal Register / Vol. 85, No. 162 / Thursday, August 20, 2020 / Notices
Dated: August 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–18254 Filed 8–19–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1727]
Public Meeting on the Center for Drug
Evaluation and Research Standard
Core Sets: Clinical Outcome
Assessments and Endpoints Grant
Program—Summer 2020; Public
Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following virtual
public meeting entitled ‘‘Public Meeting
on CDER Standard Core Sets: Clinical
Outcome Assessments and Endpoints
Grant Program—Summer 2020.’’ The
purpose of the public meeting is to
ensure that as standard core sets of
clinical outcome assessments (COAs)
are developed as part of the FDA pilot
grant program, the identified concepts,
COAs, and endpoints reflect what is
most important to patients and relevant
to regulatory and potentially other
stakeholder decision making. To
facilitate this, stakeholders including
patients, care partners, FDA reviewers,
drug developers, as well as other
government and academic researchers,
health care providers, health technology
assessors and health payers are
encouraged to attend the meeting.
DATES: The public meeting will be held
on Friday, August 28, 2020, from 8:30
a.m. to 12:30 p.m. Eastern Time. Submit
either electronic or written comments
on this public meeting by Wednesday,
October 28, 2020. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: Please note that due to the
impact of the COVID–19 pandemic, all
meeting participants will be joining this
public meeting via an online
teleconferencing platform.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2020–N–1727.
The docket will close on October 28,
2020. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:01 Aug 19, 2020
Jkt 250001
on or before Wednesday, October 28,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of Wednesday, October 28,
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.
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–1727 for ‘‘Public Meeting on
CDER Standard Core Sets Clinical
Outcome Assessments and Endpoints
Grant Program—Summer 2020.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
51445
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, 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.’’ 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.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:
Lyna Merzoug, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6308,
Silver Spring, MD 20993–0002, 301–
796–6001, CDER_StandardCoreCOAs@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
As part of our Patient Focused Drug
Development (PFDD) efforts, FDA
developed a pilot grant program to
support the development of publicly
available standard core set(s) of COAs
E:\FR\FM\20AUN1.SGM
20AUN1
51446
Federal Register / Vol. 85, No. 162 / Thursday, August 20, 2020 / Notices
and their related endpoints for specific
disease indications. On September 11,
2019, FDA made three awards under
this grant program in the areas of: (1)
Migraine, (2) acute pain in infants and
young children, and (3) physical
function across a range of chronic
conditions.
The purpose of this public meeting is
to ensure that, as these standard core
sets of clinical outcome assessments are
developed, the identified concepts,
COAs, and endpoints reflect what is
most important and relevant to patients
and support regulatory and potentially
other stakeholder decision making.
COAs are often endpoints in clinical
trials used to support drug approval and
labeling claims or other
communications regarding clinical
benefit. Clinical benefit is defined as a
positive clinically meaningful effect of
an intervention on how an individual
feels, functions, or survives. FDA uses
COAs primarily to determine whether a
drug has been shown to provide clinical
benefit to patients. The severity of side
effects or treatment burden can also be
measured by COAs.
A standard core set of COAs can
include different types of COAs such as
patient-reported outcome (PRO),
clinician-reported outcome (ClinRO),
observer-reported outcome (ObsRO),
and performance outcome (PerfO)
instruments and their related endpoints.
These sets should assess a minimum list
of impacts that matter most to patients,
are likely to demonstrate change
(including differences in trial arms
related to disease burden, treatment
burden, and if applicable, physical
function), and should be assessed
during a clinical trial. A standard core
set might be relevant across several
disease populations or subgroups or be
focused on attributes of a specific
disease.
jbell on DSKJLSW7X2PROD with NOTICES
II. Topics for Discussion at the Public
Meeting
This meeting will provide an
opportunity for grantees funded as part
of the FDA Standard Core COAs and
Endpoints Pilot Grant Program to share
their progress on the standard core COA
sets and to receive feedback from
stakeholders.
III. Participating in the Public Meeting
Registration: Persons interested in
attending this public meeting via
webcast must register online at https://
www.eventbrite.com/e/public-meetingon-cder-standard-core-sets-clinicaloutcome-assessments-registration108754210772 by August 28, 2020, at 12
p.m. Eastern Daylight Time. Registration
is free and based on availability, with
VerDate Sep<11>2014
18:01 Aug 19, 2020
Jkt 250001
priority given to early registrants. FDA
may limit the number of participants
from each organization. Registrants will
receive confirmation when they have
been accepted. Webcast information
will be provided upon completion of
registration. Closed captioning will be
provided.
Streaming webcast of the public
meeting: This public meeting will be
streamed via a webcast only. To register
for the webcast, please visit https://
www.eventbrite.com/e/public-meetingon-cder-standard-core-sets-clinicaloutcome-assessments-registration108754210772. The webcast can be
accessed via: https://fda.yorkcast.com/
webcast/Play/
50353b66f81e463ea7c0df6e31e225a11d.
Click on the link and hit the ‘‘play’’
button and it will start. The webcast
link will be activated 30 minutes prior
to the start of the meeting.
Transcripts: Please be advised that as
soon as a transcript of the public
meeting is available, it will be accessible
on the meeting website at https://
www.fda.gov/drugs/news-eventshuman-drugs/public-meeting-cderstandard-core-sets-clinical-outcomeassessments-and-endpoints-grantprogram-0.
Dated: August 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–18238 Filed 8–19–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–E–1945]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; OXERVATE
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for OXERVATE and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human
biological product.
DATES: Anyone with knowledge that any
of the dates as published (see
SUMMARY:
PO 00000
Frm 00044
Fmt 4703
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SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by October 19, 2020.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
February 16, 2021. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before October 19,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of October 19, 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.
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.
E:\FR\FM\20AUN1.SGM
20AUN1
]]>Agencies
[Federal Register Volume 85, Number 162 (Thursday, August 20, 2020)]
[Notices]
[Pages 51445-51446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18238]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1727]
Public Meeting on the Center for Drug Evaluation and Research
Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant
Program--Summer 2020; Public Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following virtual public meeting entitled ``Public
Meeting on CDER Standard Core Sets: Clinical Outcome Assessments and
Endpoints Grant Program--Summer 2020.'' The purpose of the public
meeting is to ensure that as standard core sets of clinical outcome
assessments (COAs) are developed as part of the FDA pilot grant
program, the identified concepts, COAs, and endpoints reflect what is
most important to patients and relevant to regulatory and potentially
other stakeholder decision making. To facilitate this, stakeholders
including patients, care partners, FDA reviewers, drug developers, as
well as other government and academic researchers, health care
providers, health technology assessors and health payers are encouraged
to attend the meeting.
DATES: The public meeting will be held on Friday, August 28, 2020, from
8:30 a.m. to 12:30 p.m. Eastern Time. Submit either electronic or
written comments on this public meeting by Wednesday, October 28, 2020.
See the SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: Please note that due to the impact of the COVID-19 pandemic,
all meeting participants will be joining this public meeting via an
online teleconferencing platform.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2020-N-1727. The docket will close on October
28, 2020. Please note that late, untimely filed comments will not be
considered. Electronic comments must be submitted on or before
Wednesday, October 28, 2020. The https://www.regulations.gov electronic
filing system will accept comments until 11:59 p.m. Eastern Time at the
end of Wednesday, October 28, 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.
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-1727 for ``Public Meeting on CDER Standard Core Sets
Clinical Outcome Assessments and Endpoints Grant Program--Summer
2020.'' 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, 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.'' 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.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: Lyna Merzoug, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6308, Silver Spring, MD 20993-0002, 301-
796-6001, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
As part of our Patient Focused Drug Development (PFDD) efforts, FDA
developed a pilot grant program to support the development of publicly
available standard core set(s) of COAs
[[Page 51446]]
and their related endpoints for specific disease indications. On
September 11, 2019, FDA made three awards under this grant program in
the areas of: (1) Migraine, (2) acute pain in infants and young
children, and (3) physical function across a range of chronic
conditions.
The purpose of this public meeting is to ensure that, as these
standard core sets of clinical outcome assessments are developed, the
identified concepts, COAs, and endpoints reflect what is most important
and relevant to patients and support regulatory and potentially other
stakeholder decision making.
COAs are often endpoints in clinical trials used to support drug
approval and labeling claims or other communications regarding clinical
benefit. Clinical benefit is defined as a positive clinically
meaningful effect of an intervention on how an individual feels,
functions, or survives. FDA uses COAs primarily to determine whether a
drug has been shown to provide clinical benefit to patients. The
severity of side effects or treatment burden can also be measured by
COAs.
A standard core set of COAs can include different types of COAs
such as patient-reported outcome (PRO), clinician-reported outcome
(ClinRO), observer-reported outcome (ObsRO), and performance outcome
(PerfO) instruments and their related endpoints. These sets should
assess a minimum list of impacts that matter most to patients, are
likely to demonstrate change (including differences in trial arms
related to disease burden, treatment burden, and if applicable,
physical function), and should be assessed during a clinical trial. A
standard core set might be relevant across several disease populations
or subgroups or be focused on attributes of a specific disease.
II. Topics for Discussion at the Public Meeting
This meeting will provide an opportunity for grantees funded as
part of the FDA Standard Core COAs and Endpoints Pilot Grant Program to
share their progress on the standard core COA sets and to receive
feedback from stakeholders.
III. Participating in the Public Meeting
Registration: Persons interested in attending this public meeting
via webcast must register online at https://www.eventbrite.com/e/public-meeting-on-cder-standard-core-sets-clinical-outcome-assessments-registration-108754210772 by August 28, 2020, at 12 p.m. Eastern
Daylight Time. Registration is free and based on availability, with
priority given to early registrants. FDA may limit the number of
participants from each organization. Registrants will receive
confirmation when they have been accepted. Webcast information will be
provided upon completion of registration. Closed captioning will be
provided.
Streaming webcast of the public meeting: This public meeting will
be streamed via a webcast only. To register for the webcast, please
visit https://www.eventbrite.com/e/public-meeting-on-cder-standard-core-sets-clinical-outcome-assessments-registration-108754210772. The
webcast can be accessed via: https://fda.yorkcast.com/webcast/Play/50353b66f81e463ea7c0df6e31e225a11d. Click on the link and hit the
``play'' button and it will start. The webcast link will be activated
30 minutes prior to the start of the meeting.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible on the meeting
website at https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-cder-standard-core-sets-clinical-outcome-assessments-and-endpoints-grant-program-0.
Dated: August 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-18238 Filed 8-19-20; 8:45 am]
BILLING CODE 4164-01-P
