Public reporting burden for this collection of information is estimated to average 4.6 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. 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 OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Food and Drug Administration, CDER HFD 94, 12229 Wilkins Ave., Rockville, MD 20852, ATTN: PRA 0915-0459. Do not return the completed form to this address.