[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Notices]
[Pages 1877-1879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00258]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1658]
Characterizing and Communicating Uncertainty in the Assessment of
Benefits and Risks in Drug Regulatory Decision-Making; Public Workshop;
Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of Public Workshop; request for public comments.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the following workshop convened by the Institute of Medicine
(IOM): ``Characterizing and Communicating Uncertainty in the Assessment
of Benefits and Risks in Drug Regulatory Decision-Making.'' The purpose
of the workshop is twofold: To explore potential approaches to
addressing and communicating uncertainty and to identify key
considerations on developing, evaluating, and incorporating potential
approaches for addressing uncertainty into the assessment of benefits
and risks in the human drug review process. The format of the meeting
consists of a series of presentations on topics related to uncertainty
in the assessment of benefits
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and risks, followed by a discussion on those topics with invited
panelists and audience members. This workshop satisfies an FDA
commitment that is part of the fifth authorization of the Prescription
Drug User Fee Act (PDUFA V).
DATES: The public workshop will be held on February 12, 2014, from 8:30
a.m. to 4:30 p.m. and February 13, 2014, from 8:30 a.m. to 3:30 p.m.
Registration to attend the public workshop must be received by January
31, 2014. See the SUPPLEMENTARY INFORMATION section for information on
how to register for the workshop. Submit either electronic or written
comments by March 14, 2014.
ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, Rm. 1503A,
Silver Spring, MD 20993-0002. Entrance for public workshop attendees
(non-FDA employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. Identify all comments with the docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Sara Eggers, Food and Drug
Administration, Center for Drug Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1166, Silver Spring, MD 20993-0002, 301-
796-4904, FAX: 301-847-8443, email: [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 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 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
announced in this notice will fulfill the first 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 uncertainty in 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. In many cases, this evidence is subject to uncertainty arising
from many sources. One example is the uncertainty in the degree to
which premarket clinical trial data translates to the postmarket
setting after the drug is approved and used in a much wider patient
population. Another example is uncertainty about a potential safety
signal that emerges in the postmarket setting, where the basis for the
finding comes from multiple evidence sources of varying levels of
rigor. Drawing conclusions in the face of uncertainty can be a complex
and challenging task. Furthermore, being explicit about the impact of
uncertainty on decision-making is an important part of communicating
regulatory decisions.
II. Purpose and Scope of the Workshop
This 2-day public workshop is being convened by IOM. The public
workshop will explore more systematic and structured approaches to
evaluate and communicate: (1) The sources of uncertainty in the
assessment of benefits and risks and (2) their implications on human
drug regulatory decisions. Specifically, the workshop will explore
potential analytical and communication approaches to addressing and
communicating uncertainty and identify key considerations on
developing, evaluating, and incorporating potential approaches for
addressing uncertainty into the assessment of benefits and risks in the
human drug review process. This public workshop will consider 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 uncertainty in the
assessment of benefits and risks, followed by a discussion on those
topics with invited panelists and audience members.
III. Attendance and Registration
FDA's Conference Center at the White Oak location is a Federal
facility with security procedures and limited seating. Persons
interested in attending the public workshop must register online by
January 31, 2014. To register for the public workshop, please visit
FDA's workshop Web site at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm378861.htm. Early registration is
recommended. Registration is free and will be on a first-come, first-
served basis. However, the number of participants from each
organization may be limited based on space limitations. Registrants
will receive confirmation once they have been accepted. Onsite
registration on the day of the workshop will be based on space
availability. If you need special accommodations because of disability,
please contact Sara Eggers (see FOR FURTHER INFORMATION CONTACT) at
least 7 days before the workshop. More information will be made
available on FDA's workshop Web site at least 5 days before the
workshop date.
A live Webcast of this workshop will be viewable on FDA's workshop
Web site at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm378861.htm on the day of the workshop. A
video recording of the workshop will be available on FDA's workshop Web
site approximately 1 week following the workshop. IOM will
independently prepare a summary of the workshop, and the summary will
be available on FDA's workshop Web site approximately 10 months
following the workshop.
IV. Comments
Regardless of attendance at the public workshop, interested persons
may submit either electronic comments or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of
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comments. Identify comments with the docket number found in brackets in
the heading of this document. To ensure consideration, submit comments
by March 14, 2014. Received comments may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday,
and will be posted to the docket at http://www.regulations.gov.
Dated: January 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00258 Filed 1-9-14; 8:45 am]
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