Paperwork Reduction Act Statement: According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-0345. The time required to complete this information collection is estimated to average 15-20 minutes per response. Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden, to PRAStaff@fda.hhs.gov.