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