82 FR 56036 - Safety Assessment for Investigational New Drug Safety Reporting; Public Workshop
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 226 (November 27, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 226 (November 27, 2017)
| Page Range | 56036-56037 | |
| FR Document | 2017-25454 |
[Federal Register Volume 82, Number 226 (Monday, November 27, 2017)] [Notices] [Pages 56036-56037] From the Federal Register Online [www.thefederalregister.org] [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 This public workshop is organized in response to public comments received to Docket No. FDA-2015-D-4562 for the draft guidance ``Safety Assessment for IND Safety Reporting'' issued in December 2015 requesting a public meeting to discuss the draft guidance and its implications. The public workshop is intended to engage external stakeholders in discussions related to finalizing the draft guidance entitled ``Safety Assessment for IND Safety Reporting.''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, [email protected]. 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, [email protected], 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
![56036 Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Average
Number of
Number of Total annual burden per
21 CFR section responses per Total hours
respondents responses response
respondent (in hours)
11.10 .................................................................................... 2,500 1 2,500 20 50,000
11.30 .................................................................................... 2,500 1 2,500 20 50,000
11.50 .................................................................................... 4,500 1 4,500 20 90,000
11.300 .................................................................................. 4,500 1 4,500 20 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. ADDRESSES: The public workshop will that must be submitted to FDA and all
Leslie Kux, be held at the Conference Center at 1777 participating investigators under the
Associate Commissioner for Policy. F Street NW., Washington, DC 20006. IND safety reporting regulations at
[FR Doc. 2017–25453 Filed 11–24–17; 8:45 am] For additional travel and hotel § 312.32. The focus of this draft
BILLING CODE 4164–01–P
information, please refer to the guidance is on safety information that is
following Web site: https:// only interpretable in the aggregate and
healthpolicy.duke.edu/events/fda-ind- therefore, this guidance is most
DEPARTMENT OF HEALTH AND safety-reporting-meeting. There will also applicable to late-stage studies and drug
HUMAN SERVICES be a live webcast for those unable to development programs that have
attend the meeting in person (see multiple studies. This guidance
Food and Drug Administration Streaming Webcast of Public contains recommendations on the
Workshop). following matters that are most relevant
[Docket No. FDA–2015–D–4562] to sponsors’ review of aggregate data for
FOR FURTHER INFORMATION CONTACT:
Lauren Wedlake, Center for Drug IND safety reporting: (1) The entity that
Safety Assessment for Investigational reviews aggregate data, (2) methods for
New Drug Safety Reporting; Public Evaluation and Research, Food and
Drug Administration, 10903 New aggregate analyses of safety data, (3)
Workshop maintaining trial integrity while
Hampshire Ave., Bldg. 51, Rm. 6362,
AGENCY: Food and Drug Administration, Silver Spring, MD 20993, 301–796– reviewing unblinded data, and (4)
HHS. 2728, Lauren.Wedlake@fda.hhs.gov. reporting criteria. This guidance also
contains recommendations regarding
ACTION: Notice of public workshop. SUPPLEMENTARY INFORMATION:
the development of a plan for safety
SUMMARY: The Food and Drug I. Background surveillance, and includes
Administration (FDA, the Agency, or The IND safety reporting requirements considerations and recommendations.
we) is announcing the public workshop Timely reporting of meaningful safety
for human drugs and biological
entitled ‘‘Safety Assessment for IND information allows FDA to consider
products being studied under an IND
Safety Reporting.’’ Convened by the whether any changes in study conduct
are stated in § 312.32 (21 CFR 312.32).
Duke-Robert J. Margolis, MD, Center for should be made beyond those initiated
In 2012, FDA published final guidance
Health Policy at Duke University and by the sponsor and allows investigators
for industry and investigators regarding
supported by a cooperative agreement to make any needed changes to protect
implementation of these requirements
with FDA, the purpose of the public subjects. Simply reporting all serious
entitled ‘‘Safety Reporting Requirements
workshop is to bring the stakeholder adverse events, however, including
for INDs and BA/BE Studies.1 ’’ During
community together to discuss a variety those where there is little reason to
the evaluation of comments to the draft consider them suspected adverse
of topics related to ‘‘Safety Assessment guidance for industry and investigators
for Investigational New Drug (IND) reactions (suspected adverse reactions
entitled ‘‘Safety Reporting Requirements being those with a reasonable possibility
Safety Reporting.’’ This public for INDs and BA/BE Studies’’ (Docket
workshop is organized in response to of having been caused by the drug), does
No. FDA–2010–D–0482) and at meetings not serve this purpose because it may
public comments received to Docket No. with stakeholders, FDA identified the obscure safety information that is
FDA–2015–D–4562 for the draft need for additional guidance on IND relevant to the investigational drug.
guidance ‘‘Safety Assessment for IND safety reporting. The draft guidance for Sponsors’ effective processes for a
Safety Reporting’’ issued in December industry entitled ‘‘Safety Assessment for systematic approach to safety
2015 requesting a public meeting to IND Safety Reporting’’ was issued in surveillance, coupled with IND safety
discuss the draft guidance and its December 2015 2 as a follow-on to the reporting of suspected adverse reactions
implications. The public workshop is guidance for industry and investigators to FDA and all participating
intended to engage external entitled ‘‘Safety Reporting Requirements investigators (and subsequent reporting
stakeholders in discussions related to for INDs and BA/BE Studies’’ and
asabaliauskas on DSKBBXCHB2PROD with NOTICES
to involved institutional review boards),
finalizing the draft guidance entitled provides recommendations for how allows all parties to focus on important
‘‘Safety Assessment for IND Safety sponsors of INDs can identify and safety issues and to take actions to
Reporting.’’ evaluate important safety information minimize the risks of participation in a
DATES: The public workshop will be clinical trial. Sponsors are encouraged
1 Available at: https://www.fda.gov/downloads/
held on January 11, 2018, from 9 a.m. to have internal processes for governing
Drugs/Guidances/UCM227351.pdf.
to 4 p.m., Eastern Time. See the 2 https://www.fda.gov/downloads/Drugs/ the safety surveillance and safety
SUPPLEMENTARY INFORMATION section for GuidanceComplianceRegulatoryInformation/ reporting for their development
registration date and information. Guidances/UCM477584.pdf. programs. Such process may include
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![Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices 56037
documenting which adverse events are attending this public workshop must DEPARTMENT OF HEALTH AND
anticipated in the population under register online by January 8, 2018, HUMAN SERVICES
study and would not likely be reported midnight Eastern Time. Early
as a single occurrence, but instead registration is recommended because Health Resources and Services
would be evaluated by assessing seating is limited; therefore, FDA may Administration
whether there are differences in the rate limit the number of participants from
of occurrence of such events between Agency Information Collection
each organization. Registrants will Activities: Proposed Collection: Public
those receiving the intervention and the receive confirmation when they have
concurrent or historical control. Comment Request; Information
been accepted. Duke-Margolis will post Collection Request Title: Rural Health
This public workshop is being held in
on its Web site if registration closes Care Services Outreach Program
response to public comments received
to Docket No. FDA–2015–D–4562 for before the day of the public workshop. Performance Improvement and
the draft guidance entitled ‘‘Safety If you need special accommodations Measurement Systems (PIMS)
Assessment for IND Safety Reporting’’ due to a disability, please contact Sarah Measures, OMB No. 0906–0009—
issued in December 2015 requesting a Supsiri at the Duke-Margolis Center for Revision
public meeting to discuss the draft Health Policy, 202–791–9561, AGENCY: Health Resources and Services
guidance recommendations and their sarah.supsiri@duke.edu, no later than Administration (HRSA), Department of
implications, including the new January 4, 2018. Health and Human Services.
recommendations regarding the
Streaming Webcast of the Public ACTION: Notice.
formation of a safety assessment
Workshop: This public workshop will
committee and the submission of a SUMMARY: In compliance with the
portion of the safety surveillance plan to also be webcast; archived video footage
requirement for opportunity for public
the IND before initiating phase 2 or 3 will be available at the Duke-Margolis
comment on proposed data collection
studies. The public workshop is Web site (https://healthpolicy.duke.edu/
projects of the Paperwork Reduction Act
intended to engage external events/fda-ind-safety-reporting-meeting) of 1995, HRSA announces plans to
stakeholders in discussions related to following the workshop. Organizations submit an Information Collection
finalizing the draft guidance entitled are requested to register all participants, Request (ICR), described below, to the
‘‘Safety Assessment for IND Safety but to view using one connection per Office of Management and Budget
Reporting.’’ location whenever possible. Webcast (OMB). Prior to submitting the ICR to
participants will be sent technical OMB, HRSA seeks comments from the
II. Topics for Discussion at the Public
system requirements in advance of the public regarding the burden estimate,
Workshop
event. Prior to joining the streaming below, or any other aspect of the ICR.
During the public workshop, speakers webcast of the public workshop, we DATES: Comments on this ICR must be
and participants will address a range of recommend that you review these received no later than January 26, 2018.
issues related to the draft guidance technical system requirements in
‘‘Safety Assessment for IND Safety ADDRESSES: Submit your comments to
advance. paperwork@hrsa.gov or mail the HRSA
Reporting’’, issued in December 2015.
Items for discussion will include topics Transcripts: Please be advised that Information Collection Clearance
raised in public comments submitted to transcripts will not be available. Officer, Room 14N39, 5600 Fishers
the draft guidance docket, including but FDA has verified the Web site Lane, Rockville, MD 20857.
not limited to: The entity that conducts addresses in this document, as of the FOR FURTHER INFORMATION CONTACT: To
aggregate analysis of safety data for IND date this document publishes in the request more information on the
safety reporting, concerns with Federal Register, but Web sites are proposed project or to obtain a copy of
unblinding of data and trial integrity, the data collection plans and draft
subject to change over time.
methods for determining the threshold instruments, email paperwork@hrsa.gov
for reporting, and developing and Meeting Materials: All event materials or call Lisa Wright-Solomon, the HRSA
documenting a plan for safety will be provided to registered attendees Information Collection Clearance Officer
surveillance. Furthermore, input will be via email prior to the workshop and at (301) 443–1984.
sought on other factors that drive over- publicly available at the Duke-Margolis SUPPLEMENTARY INFORMATION: When
reporting of safety events that do not Web site: https://healthpolicy.duke.edu/ submitting comments or requesting
meet the definition of a suspected events/fda-ind-safety-reporting-meeting. information, please include the
unexpected serious adverse reaction. Dated: November 20, 2017. information request collection title for
Leslie Kux,
reference.
III. Participating in the Public Information Collection Request Title:
Workshop Associate Commissioner for Policy. Rural Health Care Services Outreach
Registration: To register for the public [FR Doc. 2017–25454 Filed 11–24–17; 8:45 am] Program Performance Improvement and
workshop, please visit the following BILLING CODE 4164–01–P Measurement Systems (PIMS) Measures
Web site: https://healthpolicy.duke.edu/ OMB No. 0906–0009 Revision.
events/fda-ind-safety-reporting-meeting Abstract: The Rural Health Care
and register online by January 8, 2018, Services Outreach (Outreach) Program is
asabaliauskas on DSKBBXCHB2PROD with NOTICES
midnight Eastern Time. There will be no authorized by Section 330A(e) of the
onsite registration. Please provide Public Health Service (PHS) Act (42
complete contact information for each U.S.C. 254c(e)), as amended, to
attendee, including name, title, ‘‘promote rural health care services
affiliation, address, email, and outreach by expanding the delivery of
telephone. health care services to include new and
Registration is free and based on enhanced services in rural areas.’’ The
space availability, with priority given to goals for the Outreach Program are as
early registrants. Persons interested in follows: (1) Expand the delivery of
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Document Created: 2017-11-25 01:09:11
Document Modified: 2017-11-25 01:09:11
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public workshop. | |
| 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. | |
| 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, [email protected] | |
| FR Citation | 82 FR 56036 |
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