[Federal Register Volume 83, Number 38 (Monday, February 26, 2018)]
[Notices]
[Pages 8281-8283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03804]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0049]


Promoting the Use of Complex Innovative Designs in Clinical 
Trials; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public meeting entitled ``Promoting the Use of 
Complex Innovative Designs in Clinical Trials.'' The topic to be 
discussed is the use of complex innovative designs (CID) in clinical 
trials of drugs and biological products to inform regulatory decision 
making. This meeting will inform development of a guidance document as 
required by the 21st Century Cures Act (Cures Act) and is being 
conducted to meet the performance goal of convening a public workshop 
on CID included in the sixth authorization of the Prescription Drug 
User Fee Act (PDUFA VI), part of the FDA Reauthorization Act of 2017 
(FDARA). This meeting will also inform the development of a CID pilot 
program. FDA is seeking comments on the use of CID to inform regulatory 
decision making and is also seeking input on the CID pilot program.

DATES: The public meeting will be held on March 20, 2018, from 8:30 
a.m. to 5 p.m. Submit either electronic or written comments on this 
public meeting by April 20, 2018. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503, Section A), Silver Spring, MD 20993-0002. 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.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before April 20, 2018. The https://www.regulations.gov 
electronic filing system will accept comments until midnight Eastern 
Time at the end of April 20, 2018. Comments received by mail/hand 
delivery/courier (for written/paper submissions) will be considered 
timely if they are postmarked or the delivery service acceptance 
receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

[[Page 8282]]

     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-0049 for ``Promoting the Use of Complex Innovative Designs 
in Clinical Trials; Public Meeting; Request for Comments.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Robyn Bent, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 21, Rm. 3541, Silver Spring, MD 20993-0002, 240-402-2572, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    This public meeting is intended to support FDA guidance development 
as required under section 3021 of the Cures Act. Section 3021 of the 
Cures Act directs FDA to develop a guidance document to address several 
areas related to CID, including the use of complex innovative clinical 
trial designs, ways sponsors may obtain feedback on technical issues 
related to simulations, the submission of resulting information, the 
types of quantitative information that should be submitted for review, 
and recommended analysis methodologies. Before issuing the guidance, 
FDA is required to conduct a public meeting to gather input from the 
wider community of stakeholders, including academic and medical 
researchers, expert practitioners, drug developers, and other 
interested persons.
    The public meeting is also intended to meet a performance goal FDA 
agreed to under FDARA, in accordance with the PDUFA Reauthorization 
Performance Goals and Procedures Fiscal Years 2018 Through 2022 letter 
(PDUFA VI letter), which is available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf. 
Specifically, Section J.4 of the PDUFA VI letter, ``Enhancing Capacity 
to Review Complex Innovative Designs,'' (https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf) outlines 
commitments, including a public workshop to discuss various CIDs and a 
CID pilot program. The meeting will focus on clinical trial designs for 
which simulations are necessary to evaluate the operating 
characteristics of the trial and the acceptability of those designs in 
regulatory decision making.

II. Topics for Discussion at the Public Meeting

    The purpose of this public meeting is to (1) facilitate discussion 
and information sharing about the use of CID in drug development and 
regulatory decision making and (2) obtain input from stakeholders about 
the CID pilot program.
    The meeting will consist of four sessions. The sessions will focus 
on (1) complex adaptive designs; (2) other innovative designs such as 
use of external/historical control subjects, Bayesian designs, and 
master protocols; (3) clinical trial simulations for confirmatory trial 
design and planning; and (4) the CID pilot program. Following each 
session there will be an opportunity for public comment.
    After this public meeting, FDA will consider the stakeholder input 
from the meeting and the public docket, launch the pilot program by the 
end of fiscal year 2018, and publish a draft guidance within 18 months 
of the meeting.
    Meeting updates, the agenda, and background materials (if any) will 
be made available at: https://www.fda.gov/Drugs/NewsEvents/ucm587344.htm prior to the workshop.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, visit https://ComplexInnovativeDesigns.eventbrite.com by March 13, 2018. Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone. If you are unable to 
attend the meeting in person, you can register to view a live webcast 
of the meeting. You will be asked to indicate in your registration if 
you plan to attend in person or via the webcast.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
meeting must register by March 13, 2018. Early registration is 
recommended because seating is limited; therefore, FDA may limit the 
number of participants from each organization. Onsite registration on 
the day of the meeting will be based on space availability. If you need 
special accommodations because of a disability, please contact Robyn 
Bent (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the 
meeting.
    FDA will also hold an open public comment period at the meeting to 
give the public an opportunity to present their comments. Registration 
for open public comment will occur at the registration desk on the day 
of the meeting on a first-come, first-served basis.
    Streaming Webcast of the Public Meeting: This public meeting will 
also be webcast. To register for the webcast of this public meeting, 
visit https://ComplexInnovativeDesigns.eventbrite.com by March 13, 
2018. Please provide complete contact information for each attendee, 
including name, title, affiliation, address, email, and telephone. A 
link to the webcast will be provided following registration.

[[Page 8283]]

    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.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
internet at https://www.fda.gov/Drugs/NewsEvents/ucm587344.htm.

    Dated: February 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03804 Filed 2-23-18; 8:45 am]
 BILLING CODE 4164-01-P