[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will support development of a draft guidance on benefit-risk assessment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