80_FR_49401 80 FR 49243 - Scientific Inquiry Into How Mobile Health and Social Data Sources May Inform Medical Product Safety and Efficacy; Public Workshop; Request for Comments

80 FR 49243 - Scientific Inquiry Into How Mobile Health and Social Data Sources May Inform Medical Product Safety and Efficacy; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 158 (August 17, 2015)

Page Range49243-49243
FR Document2015-20129

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.

Federal Register, Volume 80 Issue 158 (Monday, August 17, 2015) 
[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Notices]
[Page 49243]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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: leslie.wheelock@fda.hhs.gov.
    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: 
aanonsen@umd.edu.

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:

------------------------------------------------------------------------
                            Category                               Cost
------------------------------------------------------------------------
Industry Representatives........................................     $50
Charitable Nonprofit/Academic...................................      50
Government/Students.............................................       0
------------------------------------------------------------------------

    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: aanonsen@umd.edu.

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

Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Notices 49243 exceed $250,000 in total costs (direct Science and Innovation (M–CERSI) is a first-come, first-served basis. The costs plus indirect). announcing a public workshop entitled of registration for the different ‘‘Scientific Inquiry Into How Mobile categories of attendees are as follows: B. Length of Support Health and Social Data Sources May The maximum project period is 1 Inform Medical Product Safety and Category Cost year. Efficacy.’’ The purpose of the public workshop is to discuss important Industry Representatives .................... $50 III. Electronic Application, scientific questions about using two of Charitable Nonprofit/Academic ........... 50 Registration, and Submission the most ubiquitous and fastest growing Government/Students ......................... 0 Only electronic applications will be data sources, mobile health data and accepted. To submit an electronic social computing data, focusing Persons interested in attending this application in response to this FOA, especially on the implications for public workshop must register online at applicants should first review the full product safety. http://go.umd.edu/ announcement located at DATES: The public workshop will be mobilesocialanalytics by September 1, www.grants.gov. Search by Funding held on September 11, 2015, from 12:30 2015. To register, please refer to: Opportunity Number: RFA–FD–15–038. p.m. to 5:30 p.m. http://www.rhsmith.umd.edu/centers- For all electronically submitted ADDRESSES: The public workshop will excellence/center-health-information- applications, the following steps are required. be held at the Adele H. Stamp Student decision-systems/events/m-cersi- • Step 1: Obtain a Dun and Bradstreet Union, University of Maryland, 1021A workshop. Early registration is (DUNS) Number Adele H. Stamp Student Union, College recommended because space is limited. • Step 2: Register With System for Park, MD. For additional travel and Those without Internet access should Award Management (SAM) hotel information, please refer to: contact Ann Anonsen to register (see • Step 3: Obtain Username & http://go.umd.edu/ FOR FURTHER INFORMATION CONTACT Password mobilesocialanalytics. regarding registration). • Step 4: Authorized Organization Submit electronic comments to http://www.regulations.gov. Submit Attendees are responsible for their Representative (AOR) Authorization • Step 5: Track AOR Status written comments to the Division of own hotel accommodations. If you need • Step 6: Register With Electronic Dockets Management (HFA–305), Food special accommodations due to a Research Administration (eRA) and Drug Administration, 5630 Fishers disability, please contact Ann Anonsen, Commons Lane, Rm. 1061, Rockville, MD 20852. at 301–405–0285 or email: aanonsen@ Steps 1 through 5, in detail, can be All comments should be identified with umd.edu. found at http://www07.grants.gov/ the docket number found in brackets in III. Comments applicants/organization_ the heading of this document. registration.jsp. Step 6, in detail, can be FOR FURTHER INFORMATION CONTACT: Regardless of attendance at the public found at https://commons.era.nih.gov/ Regarding this notice: Leslie D. workshop, interested persons may commons/registration/ Wheelock, Food and Drug submit either electronic comments to registrationInstructions.jsp. After you Administration, Office of the http://www.regulations.gov or written have followed these steps, submit Commissioner, 10903 New Hampshire comments to the Division of Dockets electronic applications to http:// Ave., Bldg. 1, Rm. 4345, Silver Spring, Management (see ADDRESSES). The www.grants.gov. MD 20993, 301–796–8450, FAX: 301– deadline for submitting comments Dated: August 10, 2015. 847–8106; email: leslie.wheelock@ related to this public workshop is Leslie Kux, fda.hhs.gov. August 28, 2015. It is only necessary to Regarding registration: Ann Anonsen, Associate Commissioner for Policy. send one set of comments. Identify University of Maryland, Fischell Dept. [FR Doc. 2015–20130 Filed 8–14–15; 8:45 am] comments with the docket number of Bioengineering, 2207 Jeong H. Kim BILLING CODE 4164–01–P found in brackets in the heading of this Bldg., College Park, MD 20742, 301– 405–0285, FAX: 301–405–9953, email: document. Received comments may be aanonsen@umd.edu. seen in the Division of Dockets DEPARTMENT OF HEALTH AND Management between 9 a.m. and 4 p.m., HUMAN SERVICES SUPPLEMENTARY INFORMATION: Monday through Friday, and will be I. Background posted to the docket at http:// Food and Drug Administration Mobile health and social computing www.regulations.gov. [Docket No. FDA–2015–N–2735] data sources create unique and hitherto Dated: August 10, 2015. unavailable opportunities, but there are Leslie Kux, Scientific Inquiry Into How Mobile important questions that need to be Health and Social Data Sources May Associate Commissioner for Policy. answered. This workshop will bring Inform Medical Product Safety and [FR Doc. 2015–20129 Filed 8–14–15; 8:45 am] together thought leaders from industry, Efficacy; Public Workshop; Request academia, and the regulatory BILLING CODE 4164–01–P for Comments communities to reflect on the AGENCY: Food and Drug Administration, opportunities and challenges that these mstockstill on DSK4VPTVN1PROD with NOTICES HHS. new data sources create. ACTION: Notice of public workshop; II. Attendance and Registration request for comments. There is a registration fee to attend SUMMARY: The Food and Drug this public workshop. The registration Administration (FDA), in collaboration fee is charged to help defray the costs with the University of Maryland’s for facilities, materials, and food. Seats Center of Excellence in Regulatory are limited, and registration will be on VerDate Sep<11>2014 16:57 Aug 14, 2015 Jkt 235001 PO 00000 Frm 00046 Fmt 4703 Sfmt 9990 E:\FR\FM\17AUN1.SGM 17AUN1


Document Created: 2015-12-15 11:06:46
Document Modified: 2015-12-15 11:06:46
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public workshop; request for comments.
DatesThe public workshop will be held on September 11, 2015, from 12:30 p.m. to 5:30 p.m.
ContactRegarding 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]
FR Citation80 FR 49243 
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