Benefit-Risk Assessments in Drug Regulatory Decision-Making; Public Meeting; Request for Comments, 37230-37232 [2017-16720]
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Federal Register / Vol. 82, No. 152 / Wednesday, August 9, 2017 / Notices
entitled ‘‘Expiration Dating of Unit-Dose
Repackaged Solid Oral Dosage Form
Drug Products.’’ FDA’s current good
manufacturing practice (CGMP)
regulations for finished pharmaceuticals
require that each drug product bear an
expiration date determined by
appropriate stability testing and that the
date must be related to any storage
conditions stated on the labeling, as
determined by stability studies (21 CFR
211.137(a) and (b)). Samples used for
stability testing must be in the same
container-closure system as that in
which the drug product is marketed (21
CFR 211.166(a)(4)). For unit-dose
repackaged products, U.S.
Pharmacopeial Convention (USP)
General Chapter <1178> recommends
that the expiration date ‘‘not exceed (1)
6 months from the date of repackaging;
or (2) the manufacturer’s expiration
date; or (3) 25% of the time between the
date of repackaging and the expiration
date shown on the manufacturer’s bulk
article container of the drug being
repackaged, whichever is earlier.’’
For solid oral dosage forms
repackaged in unit-dose containers, the
revised draft guidance states that FDA
does not intend to take action regarding
the requirements of §§ 211.137 and
211.166 (i.e., expiration dating
determined by stability studies) under
certain conditions. This revised draft
guidance describes these conditions.
This draft guidance revises an earlier
draft guidance for industry, ‘‘Expiration
Dating of Unit-Dose Repackaged Drugs:
Compliance Policy Guide.’’ Changes
include the following:
• Shortens the expiration date to be
used under certain conditions for solid
oral dosage forms repackaged in unitdose containers from 12 months to 6
months or 25 percent of the time
remaining until the expiration date on
the container of the original
manufacturer’s product, whichever time
period is shorter.
• Provides for an expiration date
exceeding 6 months if supportive data
from appropriate studies are available
and other conditions are met.
• Excludes from the scope of the
guidance products repackaged by Statelicensed pharmacies, Federal facilities,
and outsourcing facilities as defined
under section 503B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
353b).
• Excludes from the scope of the
guidance all dosage forms other than
solid oral dosage forms.
• Provides for the use of containers
meeting USP <671> Class B standards if
certain conditions are met.
This revised draft guidance is being
issued consistent with FDA’s good
VerDate Sep<11>2014
17:00 Aug 08, 2017
Jkt 241001
guidance practices regulation (21 CFR
10.115). The revised draft guidance,
when finalized, will represent the
current thinking of FDA on expiration
dating of unit-dose repackaged solid
oral dosage form drug products. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
The current Compliance Policy Guide
480.200, ‘‘Expiration Dating of UnitDose Repackaged Drugs,’’ issued
February 1, 1984, revised March 1995,
will be withdrawn when the revised
draft guidance is finalized.
II. The Paperwork Reduction Act of
1995
This revised draft guidance refers to
previously approved collections of
information that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
parts 210 and 211 have been approved
under OMB control number 0910–0139.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: August 3, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–16719 Filed 8–8–17; 8:45 am]
BILLING CODE 4164–01–P
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.
Notice of public meeting;
request for comments.
ACTION:
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 decisionmaking. This meeting will focus on
regulatory and industry experiences
with approaches to structured benefit-
SUMMARY:
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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
E:\FR\FM\09AUN1.SGM
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Federal Register / Vol. 82, No. 152 / Wednesday, August 9, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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
VerDate Sep<11>2014
17:00 Aug 08, 2017
Jkt 241001
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/201523389.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,
graham.thompson@fda.hhs.gov.
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 https://
www.fda.gov/downloads/ForIndustry/
UserFees/PrescriptionDrugUserFee/
UCM270412.pdf.
Section X of the PDUFA Goals Letter,
entitled ‘‘Enhancing Benefit-Risk
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37231
Assessment in Regulatory DecisionMaking,’’ 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 https://
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 benefitrisk 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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Federal Register / Vol. 82, No. 152 / Wednesday, August 9, 2017 / Notices
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
III. Meeting Attendance and
Participation
ACTION:
sradovich on DSK3GMQ082PROD with NOTICES
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
17:00 Aug 08, 2017
[Docket No. FDA–2017–D–2802]
Chemistry, Manufacturing, and
Controls Postapproval Manufacturing
Changes for Specified Biological
Products To Be Documented in Annual
Reports; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘CMC
Postapproval Manufacturing Changes
for Specified Biological Products To Be
Documented in Annual Reports.’’ This
draft guidance provides
recommendations to holders of biologics
license applications (BLAs) for specified
products regarding the types of changes
to be documented in annual reports.
Specifically, the draft guidance
describes chemistry, manufacturing, and
controls (CMC) postapproval
manufacturing changes that the Agency
generally considers to have a minimal
potential to have an adverse effect on
the identity, strength, quality, purity, or
potency of the product as they may
relate to the safety or effectiveness of the
product. Under FDA regulations, such
minor changes in the product,
production process, quality controls,
equipment, facilities, or responsible
personnel must be documented by
applicants in an annual report.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by October 10,
2017.
SUMMARY:
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/prescriptiondrug
userfee/ucm378861.htm.
VerDate Sep<11>2014
Food and Drug Administration
Jkt 241001
ADDRESSES:
You may submit comments
as follows:
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
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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–D–2802 for ‘‘CMC Postapproval
Manufacturing Changes for Specified
Biological Products To Be Documented
in Annual Reports.’’ Received
comments 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
E:\FR\FM\09AUN1.SGM
09AUN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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, graham.thompson@fda.hhs.gov.
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
https://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
https://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
[[Page 37232]]
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
