[Federal Register Volume 84, Number 187 (Thursday, September 26, 2019)]
[Notices]
[Pages 50848-50849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20935]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3935]


International Council for Harmonisation of Technical Requirements 
for Pharmaceuticals for Human Use Global Meeting on E8(R1) Guideline on 
General Considerations for Clinical Trials; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
a public meeting entitled ``International Council on Harmonisation 
(ICH) Global Meeting on E8(R1) Guideline on General Considerations for 
Clinical Trials.'' The purpose of the public meeting is to provide 
information on the draft revised E8(R1) Guideline ``General 
Considerations for Clinical Trials'' (ICH E8 Guideline) following the 
closing of the FDA comment period and closing of the regional 
consultations conducted in other ICH regions. The ICH E8 Guideline is 
being revised to provide updated guidance that is both appropriate and 
flexible enough to address the increasing diversity of clinical trial 
designs and data sources being employed to support regulatory and other 
health policy decisions, while retaining the underlying principles of 
human subject protection and data quality.

DATES: The public meeting will be held on Thursday, October 31, 2019, 
from 8:30 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public meeting will be held at FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503 (the 
Great Room), Silver Spring, MD 20993-0002. The meeting will also be 
broadcast on the web, allowing participants to join in person or via 
the web. For those who will attend in person, the 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. For those who register to attend the public meeting 
remotely via the webcast, a link to access the webcast will be emailed 
in advance of the meeting.

FOR FURTHER INFORMATION CONTACT: Amanda Roache, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6364, Silver Spring, MD 20993-0002, 301-
796-4548, Amanda.Roache@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    The ICH was established in 1990 as a joint regulatory/industry 
project to improve, through harmonization, the efficiency of the 
process for developing and registering new medicinal products in 
Europe, Japan, and the United States without compromising the 
regulatory requirements for safety and effectiveness. One of the goals 
of harmonization is to identify and then reduce regional differences in 
technical regulatory requirements for pharmaceutical products while 
preserving a consistently high standard for drug efficacy, safety, and 
quality. This is accomplished through the development of 
internationally harmonized guidelines developed through a process of 
scientific consensus with regulatory and industry experts. FDA 
participates in ICH as a founding member and implements all ICH 
guidelines as FDA guidance.
    In 2015, ICH was reformed to establish it as a true global 
initiative and to expand beyond the previous ICH members. More 
involvement from regulators around the world is expected, as they join 
counterparts from Europe, Japan, the United States, Canada, and 
Switzerland as ICH regulatory members and observers. Expanded 
involvement is also anticipated from global regulated pharmaceutical 
industry parties, joining as ICH industry members and observers. The 
reforms built on a 25-year track record and have allowed ICH to 
continue its successful delivery of harmonized guidelines for global 
pharmaceutical development and their regulation.
    The ICH E8 Guideline sets out general principles on the conduct of 
clinical trials, was adopted in 1997, and has not undergone revision. 
Since its adoption, clinical trial design and conduct have become more 
complex, impacting the time and cost required to develop drugs. A wide 
range of both trial designs and data sources play a role in drug 
development and are not adequately addressed in the original ICH E8 
Guideline. Approaches are needed for

[[Page 50849]]

optimizing trial quality, which promote the reliability, efficiency, 
and patient focus of clinical trials. This involves identifying the 
factors that are critical to the quality of a clinical trial at the 
design stage and planning the trial conduct proportionate to the risks 
to these quality factors, thereby protecting human subjects and 
ensuring the reliability of trial results. To resolve these issues, the 
ICH Assembly initiated a revision of the ICH E8 Guideline in November 
2017 to provide updated guidance that is both appropriate and flexible 
enough to address the increasing diversity of clinical trial designs 
and data sources being employed to support regulatory and other health 
policy decisions, while retaining the underlying principles of human 
subject protection and data quality.

II. Topics for Discussion at the Public Meeting

    The draft revised ICH E8 Guideline was endorsed by the ICH Assembly 
in May 2019 and made available for public comment. In the Federal 
Register of August 1, 2019 (84 FR 37649), FDA published a notice 
announcing the availability of a draft guidance entitled ``E8(R1) 
General Considerations for Clinical Studies'' (ICH E8(R1) Guideline) 
(available at https://www.fda.gov/media/129527/download). The notice 
gave interested persons an opportunity to submit comments by September 
30, 2019. As part of a broader outreach process, ICH is holding public 
meetings before the finalization of the revised ICH E8(R1) Guideline. 
One of these public meetings will be hosted by FDA in Silver Spring, 
MD, on October 31, 2019 (see DATES and ADDRESSES). The purpose of the 
public meeting is to provide an overview of the new concepts presented 
in the revised ICH E8(R1) Guideline, allow for stakeholders who will be 
affected by the revised guideline to share their perspective, and allow 
for public input.
    Public consultation is a standard part of all ICH guideline 
development, and it is conducted within each region of ICH Regulatory 
Members who commit to adoption of the finalized ICH guideline. This 
meeting is part of the ICH ``Good Clinical Practice (GCP) Renovation'' 
strategy to update the ICH guidelines related to clinical trial design, 
planning, management, and conduct, starting with the revision of the 
ICH E8 Guideline and followed by the revision of the ICH E6 Guideline 
for Good Clinical Practice. For more information, see the document 
``ICH Reflection on `GCP Renovation': Modernization of ICH E8 and 
Subsequent Renovation of ICH E6,'' available at https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Reflection_Papers/ICH_Reflection_paper_GCP_Renovation_Jan_2017_Final.pdf.

III. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting 
must register online by October 25, 2019, 11:59 p.m. Eastern Time. To 
register for the public meeting, please visit the following website: 
https://globalichmeeting_e8r1_2019_americas.eventbrite.com. 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. Early registration is recommended because 
seating is limited; therefore, FDA may limit the number of participants 
from each organization.
    The agenda for the public meeting is available on the internet and 
can be viewed at the following link: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/ich-global-meeting-ich-e8r1-guideline-general-considerations-clinical-trials-10312019-10312019.
    If you need special accommodations due to a disability, please 
contact Amanda Roache (see FOR FURTHER INFORMATION CONTACT) no later 
than October 18, 2019.
    Requests for Oral Presentations: If you wish to make a presentation 
during the public comment session, please contact Amanda Roache (see 
FOR FURTHER INFORMATION CONTACT) no later than October 18, 2019. 
Presentation slots may be limited and will be granted on a first-come, 
first-served basis. Any public presentations should be limited to 5 
minutes or less. Individuals and organizations with common interests 
are urged to consolidate or coordinate their presentations and request 
time for a joint presentation. If selected for presentation, any 
presentation materials must be emailed to Amanda Roache (see FOR 
FURTHER INFORMATION CONTACT) no later than October 24, 2019. No 
commercial or promotional material will be permitted to be presented or 
distributed at the public meeting. Signup for making a public comment 
during the meeting will also be available between 8 a.m. and 8:30 a.m. 
on the day of the meeting.
    Streaming Webcast of the Public Meeting: This public meeting will 
also be webcast through the following link: https://collaboration.fda.gov/ich103119/. To register to attend via webcast, 
please visit the following website: https://globalichmeeting_e8r1_2019_americas.eventbrite.com.
    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 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.

    Dated: September 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20935 Filed 9-25-19; 8:45 am]
 BILLING CODE 4164-01-P


