[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Notices]
[Page 49243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20129]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2735]


Scientific Inquiry Into How Mobile Health and Social Data Sources 
May Inform Medical Product Safety and Efficacy; Public Workshop; 
Request for Comments

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), in collaboration with 
the University of Maryland's Center of Excellence in Regulatory Science 
and Innovation (M-CERSI) is announcing a public workshop entitled 
``Scientific Inquiry Into How Mobile Health and Social Data Sources May 
Inform Medical Product Safety and Efficacy.'' The purpose of the public 
workshop is to discuss important scientific questions about using two 
of the most ubiquitous and fastest growing data sources, mobile health 
data and social computing data, focusing especially on the implications 
for product safety.

DATES: The public workshop will be held on September 11, 2015, from 
12:30 p.m. to 5:30 p.m.

ADDRESSES: The public workshop will be held at the Adele H. Stamp 
Student Union, University of Maryland, 1021A Adele H. Stamp Student 
Union, College Park, MD. For additional travel and hotel information, 
please refer to: http://go.umd.edu/mobilesocialanalytics.
    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. All comments should be identified with the docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Regarding this notice: Leslie D. 
Wheelock, Food and Drug Administration, Office of the Commissioner, 
10903 New Hampshire Ave., Bldg. 1, Rm. 4345, Silver Spring, MD 20993, 
301-796-8450, FAX: 301-847-8106; email: [email protected].
    Regarding registration: Ann Anonsen, University of Maryland, 
Fischell Dept. of Bioengineering, 2207 Jeong H. Kim Bldg., College 
Park, MD 20742, 301-405-0285, FAX: 301-405-9953, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Mobile health and social computing data sources create unique and 
hitherto unavailable opportunities, but there are important questions 
that need to be answered. This workshop will bring together thought 
leaders from industry, academia, and the regulatory communities to 
reflect on the opportunities and challenges that these new data sources 
create.

II. Attendance and Registration

    There is a registration fee to attend this public workshop. The 
registration fee is charged to help defray the costs for facilities, 
materials, and food. Seats are limited, and registration will be on a 
first-come, first-served basis. The costs of registration for the 
different categories of attendees are as follows:

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                            Category                               Cost
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Industry Representatives........................................     $50
Charitable Nonprofit/Academic...................................      50
Government/Students.............................................       0
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    Persons interested in attending this public workshop must register 
online at http://go.umd.edu/mobilesocialanalytics by September 1, 2015. 
To register, please refer to: http://www.rhsmith.umd.edu/centers-excellence/center-health-information-decision-systems/events/m-cersi-workshop. Early registration is recommended because space is limited. 
Those without Internet access should contact Ann Anonsen to register 
(see FOR FURTHER INFORMATION CONTACT regarding registration).
    Attendees are responsible for their own hotel accommodations. If 
you need special accommodations due to a disability, please contact Ann 
Anonsen, at 301-405-0285 or email: [email protected].

III. Comments

    Regardless of attendance at the public workshop, interested persons 
may submit either electronic comments to http://www.regulations.gov or 
written comments to the Division of Dockets Management (see ADDRESSES). 
The deadline for submitting comments related to this public workshop is 
August 28, 2015. It is only necessary to send one set of comments. 
Identify comments with the docket number found in brackets in the 
heading of this document. 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: August 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20129 Filed 8-14-15; 8:45 am]
 BILLING CODE 4164-01-P