[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]


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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.

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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comments received to Docket No. FDA-2015-D-4562 for the draft guidance 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requesting a public meeting to discuss the draft guidance and its 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stakeholders in discussions related to finalizing the draft guidance 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.
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    \1\ Available at: https://www.fda.gov/downloads/Drugs/Guidances/UCM227351.pdf.
    \2\ https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM477584.pdf.
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    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