[Federal Register Volume 82, Number 152 (Wednesday, August 9, 2017)]
[Notices]
[Pages 37230-37232]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16720]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-4076]
Benefit-Risk Assessments in Drug Regulatory Decision-Making;
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 or the Agency) is
announcing a public meeting to convene a discussion of topics related
to the structured assessment of benefits and risks in drug regulatory
decision-making. This meeting will focus on regulatory and industry
experiences with approaches to structured benefit-risk assessments,
approaches to incorporating patient perspectives into structured
benefit-risk assessment, and exploration of methods to advance
structured benefit-risk assessment. The format of the meeting will
include a series of presentations on the above topics related to
structured assessment of benefits and risks, followed by a discussion
on those topics with invited panelists and audience members. This
meeting satisfies an FDA commitment that is part of the fifth
authorization of the Prescription Drug User Fee Act (PDUFA V).
DATES: The public meeting will be held on September 18, 2017, from 9
a.m. to 5 p.m. Registration to attend the meeting must be received by
September 11, 2017 (see the SUPPLEMENTARY INFORMATION section for
instructions). Public comments will be accepted through November 18,
2017. See the ADDRESSES section for information about submitting
comments to the public docket.
ADDRESSES: The public meeting will be held on September 18, 2017, at
the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference
Center (the Great Room), 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 more
information on parking and security procedures, 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 November 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 18, 2017. 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
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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-2017-N-4076 for ``Benefit-Risk Assessments in Drug Regulatory
Decision-Making; 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.
FDA will post the agenda approximately 5 days before the meeting
at: https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm378861.htm.
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].
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, the President signed into law the Food and Drug
Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144).
Title I of FDASIA reauthorizes PDUFA V and provides FDA with the user
fee resources necessary to maintain an efficient review process for
human drug and biological products. The reauthorization of PDUFA V
includes performance goals and procedures for the Agency that
represents FDA's commitments during fiscal years 2013-2017. These
commitments are fully described in the document entitled ``PDUFA
Reauthorization Performance Goals and Procedures Fiscal Years 2013
through 2017'' (PDUFA Goals Letter), available on FDA's Web site at
http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf.
Section X of the PDUFA Goals Letter, entitled ``Enhancing Benefit-
Risk Assessment in Regulatory Decision-Making,'' includes development
of a plan to further develop and implement a structured approach to
benefit-risk assessment in the human drug review process. As part of
this enhancement, FDA committed to holding two public workshops on
benefit-risk considerations from the regulator's perspective that will
begin by the first quarter of fiscal year 2014. The public workshop
held in 2014 fulfilled the first of the two workshop commitments. The
workshop announced by this notice will fulfill the second of the two
workshop commitments.
As part of its commitment, FDA has published the ``Structured
Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making:
Draft PDUFA V Implementation Plan,'' available on FDA's Web site at
http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf. In this Plan, FDA identified as
an area of further development the exploration of structured approaches
to evaluate and communicate the assessment of benefits and risks. FDA's
human drug regulatory decisions are informed by an extensive body of
evidence on the safety and efficacy of a drug product, as well as other
factors affecting the benefit-risk assessment, including the nature and
severity of the condition the drug is intended to treat or prevent, the
benefits and risks of other available therapies for the condition, and
any risk management tools that might be necessary to ensure that the
benefits outweigh the risks. A structured benefit-risk framework serves
as a foundational element to FDA's benefit-risk assessments.
II. Purpose and Scope of the Meeting
This public meeting will focus on: (1) Regulatory and industry
experiences with approaches to structured benefit-risk assessments, and
the results of implementing structured frameworks at regulatory
agencies both for premarket application review and postmarket safety
review, (2) approaches to incorporating patient perspectives into
structured benefit-risk assessment, and (3) exploration of methods to
advance structured benefit-risk assessment. This meeting will be an
opportunity to share any challenges and lessons learned in applying a
more structured approach to regulatory decision-making. The public
meeting will also explore more systematic and structured approaches to
evaluate and communicate methods of assessing benefits and risks; and
their implications on human drug regulatory decisions. Specifically,
the workshop will examine FDA, other regulatory
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agencies, industry, and external perspectives and experiences with
structured benefit-risk assessment. This public meeting will have
discussion sessions focusing on the entire drug development life cycle,
including premarket drug review and postmarket safety surveillance. The
format of the meeting consists of a series of presentations on topics
related to structured assessment of benefits and risks, followed by a
discussion on those topics with invited panelists and audience members.
III. Meeting Attendance and Participation
Registration: If you wish to attend this meeting, visit https://fdabenefitrisk.eventbrite.com. Please register by September 11, 2017.
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.
Seating will be limited, so early registration is recommended.
Registration is free and will be on a first-come, first-served
basis. However, FDA may limit the number of participants from each
organization based on space limitations. Registrants will receive
confirmation once they have been accepted. 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 Graham Thompson (see FOR FURTHER INFORMATION CONTACT) at least
7 days before the meeting.
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/forindustry/userfees/prescriptiondruguserfee/ucm378861.htm.
Dated: August 3, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16720 Filed 8-8-17; 8:45 am]
BILLING CODE 4164-01-P