2019 Public Meeting on Center for Drug Evaluation and Research Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program; Public Meeting; Request for Comments, 64083-64085 [2019-25160]
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Federal Register / Vol. 84, No. 224 / Wednesday, November 20, 2019 / Notices
statement that the nominated substance
meets the definition of bulk drug
substance.
2. Description of the Bulk Drug
Substance:
(a) Chemical name(s);
(b) common name(s);
(c) chemical grade (e.g., USP–NF,
ACS, etc.);
(d) description of the strength,
stability, purity; and
(e) how the bulk drug substance is
supplied (e.g., powder, liquid).
3. Description of the Animal Drugs
That Will be Compounded With the
Bulk Drug Substance:
(a) dosage form(s) into which the bulk
drug substance will be compounded
(e.g., capsule, tablet, suspension);
(b) strength(s) of the compounded
drug(s); and
(c) intended route(s) of administration
of the compounded drug(s).
4. Information Requested for FDA to
Evaluate Bulk Drug Substances for
Inclusion on the List:
(a) the species and condition(s) that
the drug to be compounded with the
nominated bulk drug substance is
intended to treat;
(b) a bibliography of scientific
literature containing safety and
effectiveness data for the drug
compounded using the nominated
substance;
(c) a list of animal drugs, if any, that
are FDA-approved, conditionally
approved, or indexed for the
condition(s) in the species that the drug
compounded with the nominated
substance is intended to address;
(d) if there are marketed FDAapproved, conditionally approved, or
indexed drugs that address the same
condition(s) in the same species, an
explanation, supported by relevant
scientific literature or other evidence, of
why a compounded drug is necessary
(e.g., why the FDA-approved,
conditionally approved, or indexed drug
is not suitable for a particular animal
population);
(e) confirmation, using supporting
evidence, that there are no marketed
FDA-approved animal or human drugs
that could be prescribed in an extralabel
manner under section 512(a)(4) and
(a)(5) of the FD&C Act and 21 CFR part
530 to treat the condition(s) in the
species that the drug compounded with
the nominated substance is intended to
address;
(f) If the bulk drug substance is an
active ingredient in a marketed FDAapproved, conditionally approved, or
indexed animal or human drug, an
explanation, supported by appropriate
scientific data or information, of why
the animal drug cannot be compounded
VerDate Sep<11>2014
17:21 Nov 19, 2019
Jkt 250001
from the marketed FDA-approved,
conditionally approved, or indexed
animal or human drug.
(g) An explanation, supported by
relevant scientific literature or other
evidence, of why the animal drug to be
compounded with the nominated bulk
drug substance must be available to the
veterinarian for immediate treatment to
avoid animal suffering or death.
Nominations should include specific
information documenting that animal
suffering or death will result if
treatment is delayed until a
compounded animal drug can be
obtained pursuant to a prescription for
an individually identified animal; and
(h) A description of any human user
or animal safety concerns associated
with use of the nominated bulk drug
substance or finished compounded drug
for the condition(s) in the species that
the compounded drug is intended to
address. If there are concerns, an
explanation, supported by scientific
literature or other evidence, of why the
concerns should not preclude inclusion
of that bulk drug substance on the List.
(i) For compounded drugs intended
for use as antidotes to treat toxicoses in
food-producing animals, relevant
scientific literature or other evidence
that demonstrates that the prescribing
veterinarian has a basis for determining
appropriate withdrawal, withholding, or
discard time(s) for meat, milk, eggs, or
any food which might be derived from
the treated animal(s).
Dated: November 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25140 Filed 11–19–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–5157]
2019 Public Meeting on Center for
Drug Evaluation and Research
Standard Core Sets: Clinical Outcome
Assessments and Endpoints Grant
Program; 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 public
meeting entitled ‘‘2019 Public Meeting
on CDER Standard Core Sets: Clinical
SUMMARY:
PO 00000
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Fmt 4703
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64083
Outcome Assessments and Endpoints
Grant Program.’’ The purpose of the
public meeting is to help 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, 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 December 5, 2019, from 8:30 a.m. to
12 p.m. Submit either electronic or
written comments on this public
meeting by January 6, 2020. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting will be
held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
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 January 6, 2020. The
https://www.regulations.gov electronic
filing system will accept comments
until 11:59 p.m. Eastern Time at the end
of January 6, 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
E:\FR\FM\20NON1.SGM
20NON1
64084
Federal Register / Vol. 84, No. 224 / Wednesday, November 20, 2019 / Notices
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–
2019–N–5157 for ‘‘2019 Public Meeting
on CDER Standard Core Sets: Clinical
Outcome Assessments and Endpoints
Grant Program.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ 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
VerDate Sep<11>2014
17:21 Nov 19, 2019
Jkt 250001
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.
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:
Meena Savani, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6306,
Silver Spring, MD 20993–0002, 240–
402–1348, CDER_StandardCoreCOAs@
fda.hhs.gov.
benefit to patients. 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.
SUPPLEMENTARY INFORMATION:
III. Participating in the Public Meeting
Registration: Persons interested in
attending this public meeting in person
or via webcast must register online at
https://standard_core_coa_grant_
program.eventbrite.com by December 2,
2019, at 11:59 p.m. Eastern Time.
Registration is free and based on space
availability, with priority given to early
registrants. Early registration for in
person attendance is recommended
because seating is limited; therefore,
FDA may limit the number of
participants from each organization.
Registrants will receive confirmation
when they have been accepted. If time
and space permit, onsite registration on
the day of the public meeting/public
workshop will be provided beginning at
8 a.m.
If you need special accommodations
due to a disability, please contact Meena
Savani no later than November 29, 2019.
Streaming Webcast of the Public
Meeting: This public meeting will also
be webcast. Webcast information will be
provided upon completion of
registration.
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
I. Background
As part of our Patient Focused Drug
Development efforts, FDA developed a
pilot grant program to support the
development of publicly available
standard core set(s) of COAs and their
related endpoints for specific disease
indications. On September 11, 2019, the
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
PO 00000
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Fmt 4703
Sfmt 4703
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 development plans for the
standard core COA sets and to receive
feedback from stakeholders. FDA will
provide an introduction and discuss
plans for the pilot grant program
including future public meetings.
E:\FR\FM\20NON1.SGM
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Federal Register / Vol. 84, No. 224 / Wednesday, November 20, 2019 / Notices
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the website addresses in this
document, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
Transcripts: Please be advised that as
soon as a transcript of the public
meeting is available, it will be accessible
at https://www.regulations.gov. It may
be viewed at the Dockets Management
Staff (see ADDRESSES). A link to the
transcript will also be available on the
internet at https://www.fda.gov/drugs/
news-events-human-drugs/publicmeeting-cder-standard-core-setsclinical-outcome-assessments-andendpoints-grant-program.
Dated: November 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25160 Filed 11–19–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–4533]
Compounding Animal Drugs From
Bulk Drug Substances; Draft 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 draft
guidance for industry (GFI) #256
entitled ‘‘Compounding Animal Drugs
from Bulk Drug Substances.’’ The draft
guidance, if finalized, will describe
FDA’s current thinking about
compounding animal drugs from bulk
drug substances. FDA has generally
exercised enforcement discretion with
regard to animal drug compounding
from bulk drug substances under certain
circumstances when no other medically
appropriate treatment options exist.
This draft guidance, a continuation of
this practice, is intended to provide
additional information and clarity to
veterinarians and pharmacists about
FDA’s current thinking with respect to
animal drug compounding from bulk
drug substances. FDA previously
published draft guidance on this issue
for public comment in May 2015 (Draft
GFI #230, ‘‘Compounding Animal Drugs
from Bulk Drug Substances’’). We
received over 150 comments on that
draft guidance. Based on those
comments, we decided to withdraw the
SUMMARY:
VerDate Sep<11>2014
17:21 Nov 19, 2019
Jkt 250001
May 2015 draft guidance and publish
this draft guidance for public comment.
DATES: Submit either electronic or
written comments on the draft guidance
by February 18, 2020 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
Submit either electronic or written
comments on the proposed collection of
information by February 18, 2020.
ADDRESSES: You may submit comments
on any guidance at any time 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–D–4533 for ‘‘Compounding
Animal Drugs From Bulk Drug
Substances.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
64085
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.
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
With regard to this draft guidance: Eric
E:\FR\FM\20NON1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 224 (Wednesday, November 20, 2019)]
[Notices]
[Pages 64083-64085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25160]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5157]
2019 Public Meeting on Center for Drug Evaluation and Research
Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant
Program; 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 public meeting entitled ``2019 Public Meeting
on CDER Standard Core Sets: Clinical Outcome Assessments and Endpoints
Grant Program.'' The purpose of the public meeting is to help 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, 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 December 5, 2019, from 8:30
a.m. to 12 p.m. Submit either electronic or written comments on this
public meeting by January 6, 2020. See the SUPPLEMENTARY INFORMATION
section for registration date and information.
ADDRESSES: The public meeting will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
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 January 6, 2020. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of January 6, 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
[[Page 64084]]
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-2019-N-5157 for ``2019 Public Meeting on CDER Standard Core Sets:
Clinical Outcome Assessments and Endpoints Grant Program.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' 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/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: Meena Savani, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6306, Silver Spring, MD 20993-0002, 240-
402-1348, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
As part of our Patient Focused Drug Development efforts, FDA
developed a pilot grant program to support the development of publicly
available standard core set(s) of COAs and their related endpoints for
specific disease indications. On September 11, 2019, the 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. 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 development plans for the standard core COA sets and to
receive feedback from stakeholders. FDA will provide an introduction
and discuss plans for the pilot grant program including future public
meetings.
III. Participating in the Public Meeting
Registration: Persons interested in attending this public meeting
in person or via webcast must register online at https://standard_core_coa_grant_program.eventbrite.com by December 2, 2019, at
11:59 p.m. Eastern Time. Registration is free and based on space
availability, with priority given to early registrants. Early
registration for in person attendance is recommended because seating is
limited; therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
accepted. If time and space permit, onsite registration on the day of
the public meeting/public workshop will be provided beginning at 8 a.m.
If you need special accommodations due to a disability, please
contact Meena Savani no later than November 29, 2019.
Streaming Webcast of the Public Meeting: This public meeting will
also be webcast. Webcast information will be provided upon completion
of registration.
If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro
[[Page 64085]]
program, visit https://www.adobe.com/go/connectpro_overview. FDA has
verified the website addresses in this document, as of the date this
document publishes in the Federal Register, but websites are subject to
change over time.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-cder-standard-core-sets-clinical-outcome-assessments-and-endpoints-grant-program.
Dated: November 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25160 Filed 11-19-19; 8:45 am]
BILLING CODE 4164-01-P
