[Federal Register Volume 84, Number 28 (Monday, February 11, 2019)]
[Notices]
[Pages 3190-3191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01826]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4731]


Enhancing the Incorporation of Patient Perspectives on Clinical 
Trials; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public workshop entitled ``Enhancing the 
Incorporation of Patient Perspectives on Clinical Trials'' and an 
opportunity for public comment. The workshop will be convened by the 
Clinical Trials Transformation Initiative (CTTI). The topic to be 
discussed is stakeholders' (including patients, caregivers, industry, 
academic researchers, and expert practitioners) perspectives on 
challenges and barriers to patients participating in clinical trials 
and best practices and key considerations for enhancing the 
incorporation of patient perspectives on clinical trial access, design, 
conduct, and post-trial followup. The workshop will result in a 
publicly available report from CTTI on proceedings and recommendations 
from discussions at the workshop. This workshop is intended to meet an 
FDA commitment included in the sixth authorization of the Prescription 
Drug User Fee Amendments of 2017 (PDUFA VI).

DATES: The public workshop will be held on March 18, 2019, from 9 a.m. 
to 5 p.m. Submit either electronic or written comments on this public 
workshop by May 20, 2019. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public workshop will be held at the Tommy Douglas 
Conference Center, 10000 New Hampshire Ave., Silver Spring, MD 20903.
    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 May 20, 2019. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of May 20, 2019. 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.
     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-4731 for ``Patient Engagement on Clinical Trials; Public 
Workshop; 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: Graham Thompson, Center for Drug

[[Page 3191]]

Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 301-
796-5003, Fax: 301-847-8443, [email protected]; or Stephen 
Ripley, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    This public workshop is intended to meet one of the performance 
goals included in PDUFA VI. This PDUFA reauthorization is part of the 
FDA Reauthorization Act of 2017 signed by the President on August 18, 
2017. The complete set of performance goals and procedures documented 
in the PDUFA Reauthorization Performance Goals And Procedures Fiscal 
Years 2018 Through 2022 (Goals Letter) is available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf. These goals were developed in consultation with patient 
and consumer advocates, health care professionals, and other public 
stakeholders, as part of negotiations with regulated industry. Section 
I.J.1 of the Goals Letter, ``Enhancing the Incorporation of the 
Patient's Voice in Drug Development and Decision-Making,'' outlines the 
requirement for FDA to conduct a public workshop.

II. Topics for Discussion at the Public Workshop

    This workshop will provide FDA the opportunity to better understand 
patients' perspectives on current barriers to participating in clinical 
trials and will discuss best practices and key considerations for 
enhancing the incorporation of patient perspectives into clinical trial 
development. At the workshop, patients (including patients with 
experience in participating in clinical trials and patients who have 
not participated in clinical trials but who are interested in doing 
so), caregivers, and other patient representatives will provide 
perspectives on several key topics related to clinical trials. These 
topics will include challenges and barriers patients face with access 
to trials, trial design, trial conduct, and trial followup. The meeting 
will also gather input from patients, caregivers, industry experts, 
academic researchers, and other external stakeholders on approaches and 
best practices to address these challenges and barriers. For more 
information on meeting topics and discussion questions, visit http://events.r20.constantcontact.com/register/event?llr=w8jl4kkab&oeidk=a07efuk61xm39d90653. FDA will also post the 
agenda and other workshop materials to this site approximately 5 
business days before the workshop.
    The format of the meeting will consist of a series of 
presentations, panel discussions, and audience Q&A. In addition to 
input generated through this public workshop, FDA is interested in 
receiving input through written comments, which can be submitted to the 
public docket (see ADDRESSES).

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following website https://events.r20.constantcontact.com/register/eventReg?oeidk=a07efuk61xm39d90653&oseq=&c=&ch. Please register by 
March 11, 2019. Persons without access to the internet can call 919-
668-5938 to register. If you are unable to attend the workshop in 
person, you can register to view a live webcast of the workshop. You 
will be asked to indicate in your registration if you plan to attend in 
person or via the webcast. 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 by March 11, 2019, 11:59 p.m. 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 once they have been 
accepted. If time and space permit, onsite registration on the day of 
the public workshop will be provided beginning at 8 a.m. We will let 
registrants know if registration closes before the day of the public 
workshop.
    If you need special accommodations due to a disability, please 
contact Graham Thompson (see FOR FURTHER INFORMATION CONTACT) no later 
than March 11, 2019, 11:59 p.m. Eastern Time.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be webcast. Please register for the webcast by visiting https://events.r20.constantcontact.com/register/eventReg?oeidk=a07efuk61xm39d90653&oseq=&c=&ch=.
    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.
    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.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It also may be viewed at the Dockets Management 
Staff (see ADDRESSES).

    Dated: January 24, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-01826 Filed 2-8-19; 8:45 am]
 BILLING CODE 4164-01-P