[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

[[Page 37231]]

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