[Federal Register Volume 84, Number 79 (Wednesday, April 24, 2019)]
[Notices]
[Pages 17176-17177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08219]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1468]


Characterizing the Food and Drug Administration's Approach to 
Benefit-Risk Assessment Throughout the Medical Product Life Cycle; 
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 ``Characterizing FDA's 
Approach to Benefit-Risk Assessment Throughout the Medical Product Life 
Cycle'' and an opportunity for public comment. The meeting will be 
convened by Duke University's Robert J. Margolis, MD, Center for Health 
Policy (Duke-Margolis) and supported by a cooperative agreement with 
FDA. The meeting is intended to gather industry, patient, researcher, 
and other stakeholder input on applying FDA's Benefit-Risk Framework 
throughout the human drug lifecycle and best approaches to 
communicating FDA's benefit-risk assessment. Input from this meeting 
will support development of a draft guidance on benefit-risk assessment 
for new drugs and biologics and result in a publicly available summary 
report from Duke-Margolis. This meeting 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 meeting will be held on May 16, 2019, from 9 a.m. to 
5 p.m. Submit either electronic or written comments on this public 
meeting by June 17, 2019. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public meeting will be held at the Tommy Douglas 
Conference Center, 10000 New Hampshire Ave., Silver Spring, MD 20903. 
For information on the public meeting location please see https://www.tommydouglascenter.com/.
    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 June 17, 2019. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of June 17, 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-2019-N-1468 for ``Characterizing FDA's Approach to Benefit-Risk 
Assessment Throughout the Medical Product Life Cycle; 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

[[Page 17177]]

Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug 
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, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    This public meeting is intended to satisfy a commitment 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, healthcare professionals, and other public stakeholders as 
part of negotiations with industry. Section I.J.2 of the Goals Letter, 
``Enhancing Benefit-Risk Assessment in Regulatory Decision-Making,'' 
outlines the commitment for FDA to convene and/or participate in a 
public meeting to gather stakeholder input on key topics relating to 
FDA's benefit-risk assessment.

II. Topics for Discussion at the Public Meeting

    This meeting will provide FDA the opportunity to gather input from 
stakeholders on their experiences and perspectives regarding FDA's 
benefit-risk assessment. Input from this meeting will support 
development of the draft guidance on benefit-risk assessment for new 
drugs and biologics as outlined in Section I.J.2 of the Goals Letter, 
which FDA intends to issue by the end of June 2020. The meeting will 
allow participants (including industry, patients, researchers, and 
other stakeholders) to provide input on key topics, including the 
application of FDA's Benefit-Risk Framework throughout the human drug 
lifecycle and information that sponsors may develop or collect at the 
various stages of drug development that can inform the benefit-risk 
assessment and related regulatory decisions. This includes 
consideration of how relevant patient experience data and related 
information may inform the benefit-risk assessment. In addition, the 
meeting will consider appropriate approaches to communicate to the 
public FDA's thinking regarding a product's benefit-risk assessment.
    For more information on meeting topics and discussion questions, 
visit https://healthpolicy.duke.edu/events/benefit-risk-framework-public-workshop. FDA will publish a background document outlining the 
topic areas that FDA plans to address in the draft guidance to this 
site approximately 2 weeks before the meeting date. FDA will also post 
the agenda and other meeting materials to this site approximately 5 
business days before the meeting.
    The format of the meeting will consist of a series of 
presentations, panel discussions, and audience Q&As. In addition to 
input generated through this public meeting, FDA is interested in 
receiving input on the planned draft guidance through written comments, 
which can be submitted to the public docket (see ADDRESSES).

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the 
following website: https://events.r20.constantcontact.com/register/eventReg?oeidk=a07eg01qxxd45281872&oseq=&c=&ch. Please register by May 
10, 2019. 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. 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 
meeting must register by May 10, 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 
meeting will be provided beginning at 8 a.m. We will let registrants 
know if registration closes before the day of the public meeting.
    If you need special accommodations due to a disability, please 
contact Graham Thompson no later than May 10, 2019, 11:59 p.m. Eastern 
Time.
    Open Public Comment: There will be time allotted during the meeting 
for open public comment. Sign-up for this session will be on a first-
come, first-served basis on the day of the meeting. Individuals and 
organizations with common interests are urged to consolidate or 
coordinate and request time for a joint presentation. No commercial or 
promotional material will be permitted to be presented or distributed 
at the public meeting.
    Streaming Webcast of the Public Meeting: This public meeting will 
also be webcast. Please register for the webcast by visiting https://events.r20.constantcontact.com/register/eventReg?oeidk=a07eg01qxxd45281872&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.
    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 also may be viewed at the Dockets Management 
Staff (see ADDRESSES).

    Dated: April 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08219 Filed 4-23-19; 8:45 am]
 BILLING CODE 4164-01-P