Department of Health and Human Services
Food and Drug Administration
- [Docket No. FDA-2015-N-2735]
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.