OMB Burden Statement FDA Form 3800

Public reporting burden for this collection of information is estimated to average 0.60 hours per response for a voluntary report and 1.0 hours per response for a mandatory report, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information

Send comments regarding this burden estimate or another aspect of this collection of information, including suggestions for reducing this burden to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer (HFA-710)
5600 Fishers Lane
Rockville, MD 20857

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number.