
[Federal Register Volume 78, Number 217 (Friday, November 8, 2013)]
[Notices]
[Pages 67168-67169]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26855]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Sixth Annual Sentinel Initiative; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing the following 
public workshop entitled ``Sixth Annual Sentinel Initiative.'' Convened 
by the Engelberg Center for Health Care Reform at the Brookings 
Institution and supported by a cooperative agreement with FDA, this 1-
day workshop will bring the stakeholder community together to discuss a 
variety of topics on active medical product surveillance. Topics will 
include an overview of the status of FDA's Sentinel Initiative and 
future plans, highlights from key Mini-Sentinel and related activities, 
and an update on active surveillance collaborations and program 
extensions. In addition, this workshop will engage stakeholders to 
discuss current and emerging Sentinel projects and facilitate 
stakeholder feedback and input on Sentinel projects that would be 
appropriate to determine the feasibility of using Sentinel to evaluate 
drug safety issues that may require regulatory action (e.g., labeling 
changes, postmarketing requirements (PMRs), or postmarketing 
commitments (PMCs)). This workshop satisfies an FDA commitment that is 
part of the fifth authorization of the Prescription Drug User Fee Act 
(PDUFA V).
    Date and Time: The public workshop will be held on January 14, 
2014, from 9 a.m. to 4 p.m.
    Location: The public workshop will be held at the Washington 
Marriott at Metro Center, 775 12th Street NW., Washington, DC 20001. 
For additional travel and hotel information, please refer to http://www.cvent.com/d/jcqhyy. (FDA has verified the Web site addresses 
throughout this notice, but FDA is not responsible for subsequent 
changes to the Web sites after this document publishes in the Federal 
Register).
    Contact Person: Carlos Bell, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6358, Silver Spring, MD 20993, 301-796-3714, FAX: 301-847-3529, 
email: SentinelInitiative@fda.hhs.gov.
    Registration: To attend the public workshop, you must register 
before January 14, 2014, by visiting http://www.cvent.com/d/jcqhyy. 
Early registration is recommended. There will be no onsite 
registration. When registering, please provide the following 
information: Your name, title, company or organization (if applicable), 
postal address, telephone number, and email address. There is no 
registration fee for the public workshop; but because seating is 
limited, registration will be on a first-come, first-served basis. A 1-
hour lunch break is scheduled; however, food will not be provided. 
There are multiple restaurants within walking distance of the hotel.
    If you need special accommodations due to a disability, please 
contact Joanna Klatzman at the Brookings Institution (email: 
jKlatzman@brookings.edu) at least 7 days in advance.
    Meeting Materials: All event materials will be available to 
registered attendees via email prior to the workshop and will be posted 
after the event on the

[[Page 67169]]

Brookings Institution event Web site at http://www.brookings.edu//health/events.
    Transcripts: Please be advised that transcripts will not be 
available.

SUPPLEMENTARY INFORMATION: 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 represent FDA's commitments during fiscal years 2013-
2017 (PDUFA V). 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 XI of the PDUFA Goals 
Letter, entitled ``Enhancement and Modernization of the FDA Drug Safety 
System,'' includes Sentinel as a tool for evaluating drug safety issues 
that may require regulatory action. As part of this enhancement, FDA 
committed to hold a public meeting to engage stakeholders in a 
discussion of current and emerging Sentinel projects and facilitate 
stakeholder feedback and input to determine the feasibility of using 
Sentinel to evaluate drug safety issues that may require regulatory 
action, e.g., labeling changes, PMRs, or PMCs. The public workshop 
announced by this notice will fulfill this commitment.

    Dated: November 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26855 Filed 11-7-13; 8:45 am]
BILLING CODE 4160-01-P


