
[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)]
[Notices]
[Pages 78607-78608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26934]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3631]


Ninth Annual Sentinel Initiative; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Ninth Annual Sentinel Initiative Public Workshop.'' 
Convened by the Duke-Margolis Center for Health Policy at Duke 
University 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 update on the state of FDA's Sentinel Initiative, including 
an overview of the current state of Sentinel System safety surveillance 
activities, and uses of the Sentinel System accomplished in 2016. In 
addition, panelists will discuss the future of the Sentinel System and 
opportunities to expand its medical product surveillance capabilities. 
This workshop will also engage stakeholders to discuss current and 
emerging Sentinel Initiative projects.

DATES: The public workshop will be held on February 2, 2017, from 9 
a.m. to 4:30 p.m., Eastern Standard Time (EST). Submit either 
electronic or written comments by March 2, 2017.

ADDRESSES: Location: The public workshop will be held at the Barbara 
Jordan Conference Center at the Kaiser Family Foundation, 1330 G St. 
NW., Washington, DC 20005. For additional travel and hotel information, 
please refer to https://healthpolicy.duke.edu/events/ninth-annual-sentinel-initiative-public-workshop. FDA has verified the meeting 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. There will also be a live Webcast for those 
unable to attend the meeting in person (see Streaming Webcast of the 
Public Workshop).
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2016-N-3631 for ``Ninth Annual Sentinel Initiative; Public 
Workshop.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Carlos Bell, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 4343, Silver Spring, MD 20993-0002, 301-
796-3714, FAX: 301-796-9832, email: SentinelInitiative@fda.hhs.gov.

[[Page 78608]]


SUPPLEMENTARY INFORMATION:
    Registration: To attend the public workshop, you must register 
before February 2, 2017, by visiting https://healthpolicy.duke.edu/events/ninth-annual-sentinel-initiative-public-workshop. You may also 
register for the live Webcast by visiting this Web page. 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. Those without 
Internet access should contact Carlos Bell to register (See FOR FURTHER 
INFORMATION CONTACT). There is no registration fee for the public 
workshop. However, registration will be on a first-come, first-served 
basis because seating is limited. Therefore, early registration is 
recommended. Upon registering, attendees will receive an confirmatory 
email, containing event materials. A 1-hour lunch break is scheduled, 
but food will not be provided. There are multiple restaurants within 
walking distance of the Barbara Jordan Conference Center at the Kaiser 
Family Foundation.
    If you need special accommodations due to a disability, please 
contact Joanna Higgison at the Duke-Margolis Center for Health Policy 
(phone: 908-432-4872, email: joanna.higgison@duke.edu) at least 7 days 
in advance.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be Webcast (archived video footage will be available following the 
workshop at https://healthpolicy.duke.edu/events/ninth-annual-sentinel-initiative-public-workshop). Persons interested in viewing the live 
Webcast must register online by February 1, 2017, at 5 p.m. EST. Early 
registration is recommended because Webcast connections are limited. 
Organizations are requested to register all participants, and view the 
workshop using one connection per location whenever possible. Webcast 
participants will be sent technical system requirements upon 
registering. Prior to joining the streaming Webcast of the public 
workshop, it is recommended that you review these technical system 
requirements.
    Meeting Materials: All event materials will be sent to registered 
attendees via email before the workshop. The event materials will also 
be available to view on the Duke-Margolis Web site at https://healthpolicy.duke.edu/events/ninth-annual-sentinel-initiative-public-workshop.
    Transcripts: Please be advised that transcripts will not be 
available.

    Dated: November 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26934 Filed 11-7-16; 8:45 am]
 BILLING CODE 4164-01-P


