Safety Assessment for Investigational New Drug Safety Reporting; Public Workshop, 56036-56037 [2017-25454]
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56036
Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
responses
Total hours
11.10 ....................................................................................
11.30 ....................................................................................
11.50 ....................................................................................
11.300 ..................................................................................
2,500
2,500
4,500
4,500
1
1
1
1
2,500
2,500
4,500
4,500
20
20
20
20
50,000
50,000
90,000
90,000
Total ..............................................................................
........................
........................
........................
........................
280,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–25453 Filed 11–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–4562]
Safety Assessment for Investigational
New Drug Safety Reporting; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the public workshop
entitled ‘‘Safety Assessment for IND
Safety Reporting.’’ Convened by the
Duke-Robert J. Margolis, MD, Center for
Health Policy at Duke University and
supported by a cooperative agreement
with FDA, the purpose of the public
workshop is to bring the stakeholder
community together to discuss a variety
of topics related to ‘‘Safety Assessment
for Investigational New Drug (IND)
Safety Reporting.’’ This public
workshop is organized in response to
public comments received to Docket No.
FDA–2015–D–4562 for the draft
guidance ‘‘Safety Assessment for IND
Safety Reporting’’ issued in December
2015 requesting a public meeting to
discuss the draft guidance and its
implications. The public workshop is
intended to engage external
stakeholders in discussions related to
finalizing the draft guidance entitled
‘‘Safety Assessment for IND Safety
Reporting.’’
I. Background
The IND safety reporting requirements
for human drugs and biological
products being studied under an IND
are stated in § 312.32 (21 CFR 312.32).
In 2012, FDA published final guidance
for industry and investigators regarding
implementation of these requirements
entitled ‘‘Safety Reporting Requirements
for INDs and BA/BE Studies.1 ’’ During
the evaluation of comments to the draft
guidance for industry and investigators
entitled ‘‘Safety Reporting Requirements
for INDs and BA/BE Studies’’ (Docket
No. FDA–2010–D–0482) and at meetings
with stakeholders, FDA identified the
need for additional guidance on IND
safety reporting. The draft guidance for
industry entitled ‘‘Safety Assessment for
IND Safety Reporting’’ was issued in
December 2015 2 as a follow-on to the
guidance for industry and investigators
entitled ‘‘Safety Reporting Requirements
for INDs and BA/BE Studies’’ and
provides recommendations for how
sponsors of INDs can identify and
evaluate important safety information
The public workshop will be
held on January 11, 2018, from 9 a.m.
to 4 p.m., Eastern Time. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
1 Available at: https://www.fda.gov/downloads/
Drugs/Guidances/UCM227351.pdf.
2 https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/
Guidances/UCM477584.pdf.
SUMMARY:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
The public workshop will
be held at the Conference Center at 1777
F Street NW., Washington, DC 20006.
For additional travel and hotel
information, please refer to the
following Web site: https://
healthpolicy.duke.edu/events/fda-indsafety-reporting-meeting. There will also
be a live webcast for those unable to
attend the meeting in person (see
Streaming Webcast of Public
Workshop).
FOR FURTHER INFORMATION CONTACT:
Lauren Wedlake, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6362,
Silver Spring, MD 20993, 301–796–
2728, Lauren.Wedlake@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
DATES:
VerDate Sep<11>2014
16:59 Nov 24, 2017
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Frm 00052
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that must be submitted to FDA and all
participating investigators under the
IND safety reporting regulations at
§ 312.32. The focus of this draft
guidance is on safety information that is
only interpretable in the aggregate and
therefore, this guidance is most
applicable to late-stage studies and drug
development programs that have
multiple studies. This guidance
contains recommendations on the
following matters that are most relevant
to sponsors’ review of aggregate data for
IND safety reporting: (1) The entity that
reviews aggregate data, (2) methods for
aggregate analyses of safety data, (3)
maintaining trial integrity while
reviewing unblinded data, and (4)
reporting criteria. This guidance also
contains recommendations regarding
the development of a plan for safety
surveillance, and includes
considerations and recommendations.
Timely reporting of meaningful safety
information allows FDA to consider
whether any changes in study conduct
should be made beyond those initiated
by the sponsor and allows investigators
to make any needed changes to protect
subjects. Simply reporting all serious
adverse events, however, including
those where there is little reason to
consider them suspected adverse
reactions (suspected adverse reactions
being those with a reasonable possibility
of having been caused by the drug), does
not serve this purpose because it may
obscure safety information that is
relevant to the investigational drug.
Sponsors’ effective processes for a
systematic approach to safety
surveillance, coupled with IND safety
reporting of suspected adverse reactions
to FDA and all participating
investigators (and subsequent reporting
to involved institutional review boards),
allows all parties to focus on important
safety issues and to take actions to
minimize the risks of participation in a
clinical trial. Sponsors are encouraged
to have internal processes for governing
the safety surveillance and safety
reporting for their development
programs. Such process may include
E:\FR\FM\27NON1.SGM
27NON1
Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices
documenting which adverse events are
anticipated in the population under
study and would not likely be reported
as a single occurrence, but instead
would be evaluated by assessing
whether there are differences in the rate
of occurrence of such events between
those receiving the intervention and the
concurrent or historical control.
This public workshop is being held in
response to public comments received
to Docket No. FDA–2015–D–4562 for
the draft guidance entitled ‘‘Safety
Assessment for IND Safety Reporting’’
issued in December 2015 requesting a
public meeting to discuss the draft
guidance recommendations and their
implications, including the new
recommendations regarding the
formation of a safety assessment
committee and the submission of a
portion of the safety surveillance plan to
the IND before initiating phase 2 or 3
studies. The public workshop is
intended to engage external
stakeholders in discussions related to
finalizing the draft guidance entitled
‘‘Safety Assessment for IND Safety
Reporting.’’
asabaliauskas on DSKBBXCHB2PROD with NOTICES
II. Topics for Discussion at the Public
Workshop
During the public workshop, speakers
and participants will address a range of
issues related to the draft guidance
‘‘Safety Assessment for IND Safety
Reporting’’, issued in December 2015.
Items for discussion will include topics
raised in public comments submitted to
the draft guidance docket, including but
not limited to: The entity that conducts
aggregate analysis of safety data for IND
safety reporting, concerns with
unblinding of data and trial integrity,
methods for determining the threshold
for reporting, and developing and
documenting a plan for safety
surveillance. Furthermore, input will be
sought on other factors that drive overreporting of safety events that do not
meet the definition of a suspected
unexpected serious adverse reaction.
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit the following
Web site: https://healthpolicy.duke.edu/
events/fda-ind-safety-reporting-meeting
and register online by January 8, 2018,
midnight Eastern Time. There will be no
onsite registration. Please provide
complete contact information for each
attendee, including name, title,
affiliation, address, email, and
telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
VerDate Sep<11>2014
16:59 Nov 24, 2017
Jkt 244001
attending this public workshop must
register online by January 8, 2018,
midnight Eastern Time. Early
registration 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. Duke-Margolis will post
on its Web site if registration closes
before the day of the public workshop.
If you need special accommodations
due to a disability, please contact Sarah
Supsiri at the Duke-Margolis Center for
Health Policy, 202–791–9561,
sarah.supsiri@duke.edu, no later than
January 4, 2018.
Streaming Webcast of the Public
Workshop: This public workshop will
also be webcast; archived video footage
will be available at the Duke-Margolis
Web site (https://healthpolicy.duke.edu/
events/fda-ind-safety-reporting-meeting)
following the workshop. Organizations
are requested to register all participants,
but to view using one connection per
location whenever possible. Webcast
participants will be sent technical
system requirements in advance of the
event. Prior to joining the streaming
webcast of the public workshop, we
recommend that you review these
technical system requirements in
advance.
Transcripts: Please be advised that
transcripts will not be available.
FDA has verified the Web site
addresses in this document, as of the
date this document publishes in the
Federal Register, but Web sites are
subject to change over time.
Meeting Materials: All event materials
will be provided to registered attendees
via email prior to the workshop and
publicly available at the Duke-Margolis
Web site: https://healthpolicy.duke.edu/
events/fda-ind-safety-reporting-meeting.
Dated: November 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–25454 Filed 11–24–17; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
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56037
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Rural Health
Care Services Outreach Program
Performance Improvement and
Measurement Systems (PIMS)
Measures, OMB No. 0906–0009—
Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR must be
received no later than January 26, 2018.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Rural Health Care Services Outreach
Program Performance Improvement and
Measurement Systems (PIMS) Measures
OMB No. 0906–0009 Revision.
Abstract: The Rural Health Care
Services Outreach (Outreach) Program is
authorized by Section 330A(e) of the
Public Health Service (PHS) Act (42
U.S.C. 254c(e)), as amended, to
‘‘promote rural health care services
outreach by expanding the delivery of
health care services to include new and
enhanced services in rural areas.’’ The
goals for the Outreach Program are as
follows: (1) Expand the delivery of
SUMMARY:
E:\FR\FM\27NON1.SGM
27NON1
]]>Agencies
[Federal Register Volume 82, Number 226 (Monday, November 27, 2017)]
[Notices]
[Pages 56036-56037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25454]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-4562]
Safety Assessment for Investigational New Drug Safety Reporting;
Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the public workshop entitled ``Safety Assessment for IND
Safety Reporting.'' Convened by the Duke-Robert J. Margolis, MD, Center
for Health Policy at Duke University and supported by a cooperative
agreement with FDA, the purpose of the public workshop is to bring the
stakeholder community together to discuss a variety of topics related
to ``Safety Assessment for Investigational New Drug (IND) Safety
Reporting.'' This public workshop is organized in response to public
comments received to Docket No. FDA-2015-D-4562 for the draft guidance
``Safety Assessment for IND Safety Reporting'' issued in December 2015
requesting a public meeting to discuss the draft guidance and its
implications. The public workshop is intended to engage external
stakeholders in discussions related to finalizing the draft guidance
entitled ``Safety Assessment for IND Safety Reporting.''
DATES: The public workshop will be held on January 11, 2018, from 9
a.m. to 4 p.m., Eastern Time. See the SUPPLEMENTARY INFORMATION section
for registration date and information.
ADDRESSES: The public workshop will be held at the Conference Center at
1777 F Street NW., Washington, DC 20006. For additional travel and
hotel information, please refer to the following Web site: https://healthpolicy.duke.edu/events/fda-ind-safety-reporting-meeting. There
will also be a live webcast for those unable to attend the meeting in
person (see Streaming Webcast of Public Workshop).
FOR FURTHER INFORMATION CONTACT: Lauren Wedlake, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6362, Silver Spring, MD 20993, 301-796-
2728, Lauren.Wedlake@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The IND safety reporting requirements for human drugs and
biological products being studied under an IND are stated in Sec.
312.32 (21 CFR 312.32). In 2012, FDA published final guidance for
industry and investigators regarding implementation of these
requirements entitled ``Safety Reporting Requirements for INDs and BA/
BE Studies.\1\ '' During the evaluation of comments to the draft
guidance for industry and investigators entitled ``Safety Reporting
Requirements for INDs and BA/BE Studies'' (Docket No. FDA-2010-D-0482)
and at meetings with stakeholders, FDA identified the need for
additional guidance on IND safety reporting. The draft guidance for
industry entitled ``Safety Assessment for IND Safety Reporting'' was
issued in December 2015 \2\ as a follow-on to the guidance for industry
and investigators entitled ``Safety Reporting Requirements for INDs and
BA/BE Studies'' and provides recommendations for how sponsors of INDs
can identify and evaluate important safety information that must be
submitted to FDA and all participating investigators under the IND
safety reporting regulations at Sec. 312.32. The focus of this draft
guidance is on safety information that is only interpretable in the
aggregate and therefore, this guidance is most applicable to late-stage
studies and drug development programs that have multiple studies. This
guidance contains recommendations on the following matters that are
most relevant to sponsors' review of aggregate data for IND safety
reporting: (1) The entity that reviews aggregate data, (2) methods for
aggregate analyses of safety data, (3) maintaining trial integrity
while reviewing unblinded data, and (4) reporting criteria. This
guidance also contains recommendations regarding the development of a
plan for safety surveillance, and includes considerations and
recommendations.
---------------------------------------------------------------------------
\1\ Available at: https://www.fda.gov/downloads/Drugs/Guidances/UCM227351.pdf.
\2\ https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM477584.pdf.
---------------------------------------------------------------------------
Timely reporting of meaningful safety information allows FDA to
consider whether any changes in study conduct should be made beyond
those initiated by the sponsor and allows investigators to make any
needed changes to protect subjects. Simply reporting all serious
adverse events, however, including those where there is little reason
to consider them suspected adverse reactions (suspected adverse
reactions being those with a reasonable possibility of having been
caused by the drug), does not serve this purpose because it may obscure
safety information that is relevant to the investigational drug.
Sponsors' effective processes for a systematic approach to safety
surveillance, coupled with IND safety reporting of suspected adverse
reactions to FDA and all participating investigators (and subsequent
reporting to involved institutional review boards), allows all parties
to focus on important safety issues and to take actions to minimize the
risks of participation in a clinical trial. Sponsors are encouraged to
have internal processes for governing the safety surveillance and
safety reporting for their development programs. Such process may
include
[[Page 56037]]
documenting which adverse events are anticipated in the population
under study and would not likely be reported as a single occurrence,
but instead would be evaluated by assessing whether there are
differences in the rate of occurrence of such events between those
receiving the intervention and the concurrent or historical control.
This public workshop is being held in response to public comments
received to Docket No. FDA-2015-D-4562 for the draft guidance entitled
``Safety Assessment for IND Safety Reporting'' issued in December 2015
requesting a public meeting to discuss the draft guidance
recommendations and their implications, including the new
recommendations regarding the formation of a safety assessment
committee and the submission of a portion of the safety surveillance
plan to the IND before initiating phase 2 or 3 studies. The public
workshop is intended to engage external stakeholders in discussions
related to finalizing the draft guidance entitled ``Safety Assessment
for IND Safety Reporting.''
II. Topics for Discussion at the Public Workshop
During the public workshop, speakers and participants will address
a range of issues related to the draft guidance ``Safety Assessment for
IND Safety Reporting'', issued in December 2015. Items for discussion
will include topics raised in public comments submitted to the draft
guidance docket, including but not limited to: The entity that conducts
aggregate analysis of safety data for IND safety reporting, concerns
with unblinding of data and trial integrity, methods for determining
the threshold for reporting, and developing and documenting a plan for
safety surveillance. Furthermore, input will be sought on other factors
that drive over-reporting of safety events that do not meet the
definition of a suspected unexpected serious adverse reaction.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following Web site: https://healthpolicy.duke.edu/events/fda-ind-safety-reporting-meeting and register online by January 8, 2018,
midnight Eastern Time. There will be no onsite registration. Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register online by January 8, 2018, midnight Eastern
Time. Early registration 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. Duke-Margolis will post on its Web site if registration
closes before the day of the public workshop.
If you need special accommodations due to a disability, please
contact Sarah Supsiri at the Duke-Margolis Center for Health Policy,
202-791-9561, sarah.supsiri@duke.edu, no later than January 4, 2018.
Streaming Webcast of the Public Workshop: This public workshop will
also be webcast; archived video footage will be available at the Duke-
Margolis Web site (https://healthpolicy.duke.edu/events/fda-ind-safety-reporting-meeting) following the workshop. Organizations are requested
to register all participants, but to view using one connection per
location whenever possible. Webcast participants will be sent technical
system requirements in advance of the event. Prior to joining the
streaming webcast of the public workshop, we recommend that you review
these technical system requirements in advance.
Transcripts: Please be advised that transcripts will not be
available.
FDA has verified the Web site addresses in this document, as of the
date this document publishes in the Federal Register, but Web sites are
subject to change over time.
Meeting Materials: All event materials will be provided to
registered attendees via email prior to the workshop and publicly
available at the Duke-Margolis Web site: https://healthpolicy.duke.edu/events/fda-ind-safety-reporting-meeting.
Dated: November 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25454 Filed 11-24-17; 8:45 am]
BILLING CODE 4164-01-P
