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Public reporting burden for this collection of information is estimated to average 2 - 12 hours per response for form 3537 and 1 hour per response for form 3537a, 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
CFSAN/PRB Comments/HFS-24
5100 Paint Branch Parkway
College Park, MD 20740-3835

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.