[Federal Register Volume 85, Number 99 (Thursday, May 21, 2020)]
[Notices]
[Pages 30965-30966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10975]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1291]


Stakeholder Engagement on ICH E6: Guideline for Good Clinical 
Practice; Public Web Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public web conference.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing a free public web conference for discussion of the 
International Council for Harmonisation's (ICH's) good clinical 
practice guidelines, ICH E6. This public web conference, ``Stakeholder 
Engagement on ICH E6: Guideline for Good Clinical Practice,'' is being 
convened and supported by a cooperative agreement between the Clinical 
Trials Transformation Initiative (CTTI) and FDA. The purpose of the web 
conference is to capture stakeholder experiences with current ICH E6 
guidelines for good clinical practice (GCP) and to gather stakeholder 
input to further inform the development of an updated guideline, ICH 
E6(R3).

DATES: The public web conference will be held on Thursday and Friday, 
June 4 and 5, 2020, from 10 a.m. to 1 p.m. Eastern Time. Further 
details on the web conference (including times) are available at the 
website provided under ADDRESSES. See the SUPPLEMENTARY INFORMATION 
section for details.

ADDRESSES: The web conference will be held online. Meeting details and 
background materials, including the web conference link, are available 
at the following website: https://www.ctti-clinicaltrials.org/briefing-room/meetings/ich-e6-guideline-good-clinical-practice-stakeholder-engagement.

FOR FURTHER INFORMATION CONTACT: Suzanne Pattee, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3328, Silver Spring, MD 20993, 301-796-
1706, Suzanne.Pattee@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    To support GCP renovation, FDA and ICH are seeking stakeholder 
input to develop a new ICH guideline, ``ICH E6(R3): Guideline for Good 
Clinical Practice,'' to enable flexible application of those guidelines 
to interventional clinical trials, including innovative clinical trial 
designs and data sources. ICH E6(R3) materials, including the ICH 
Reflection Paper on ``GCP Renovation,'' concept paper, business plan, 
work plan, and an expert list, as well as the current guideline, ``ICH 
E6(R2): Guideline for Good Clinical Practice,'' are available on the 
ICH website: https://www.ich.org/page/efficacy-guidelines.
    The purpose of the public web conference announced in this notice 
is to obtain input on stakeholder experiences with the current GCP 
guideline (ICH E6(R2)) and suggested changes to improve the guideline's 
applicability to the changing clinical trial landscape.

II. Topics for Discussion at the Public Web Conference

    During the public web conference, speakers and participants will 
cover a range of GCP issues to inform revisions to the current GCP 
guidelines. Topics for discussion will include and are not limited to: 
(1) Issues with application of current guidelines to traditional 
interventional clinical trials, (2) ways to modify the guideline to 
address innovative trial designs, (3) use of digital technology tools, 
(4) new data sources, and (5) other topics relating to GCPs.

[[Page 30966]]

III. Participating in the Public Web Conference

    Registration: To register for the free public web conference, 
complete the registration form at https://www.ctti-clinicaltrials.org/briefing-room/meetings/ich-e6-guideline-good-clinical-practice-stakeholder-engagement. Please provide complete contact information for 
each attendee, including name, title, affiliation, address, email, and 
telephone number.
    Streaming Public Web Conference: This live web conference will be 
recorded and archived and will be available after the event at the 
event website. Persons interested in participating in the live web 
conference are encouraged to register in advance (see Registration). 
The live web conference will also be available at the website above on 
the day of the event without preregistration. Detailed information is 
available at the following website: https://www.ctti-clinicaltrials.org/briefing-room/meetings/ich-e6-guideline-good-clinical-practice-stakeholder-engagement.
    Registered web conference participants will be sent technical 
system requirements in advance of the event. It is recommended that you 
review these technical system requirements prior to joining the 
streaming web conference of the public event.
    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.
    Meeting Materials: All event materials will be provided to 
registered attendees via email prior to the web conference and will be 
publicly available at the https://www.ctti-clinicaltrials.org/briefing-room/meetings/ich-e6-guideline-good-clinical-practice-stakeholder-engagement.
    Transcripts: Please be advised that transcripts of the public web 
conference will not be available.

    Dated: May 15, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10975 Filed 5-20-20; 8:45 am]
 BILLING CODE 4164-01-P


