Through this notice, we are establishing a docket to provide an opportunity for interested parties to provide comments and scientific data and information that will help us refine our draft approach to identifying high risk foods, as required by section 204(d)(2) of FSMA. Section I.B summarizes our tentative draft approach for the review and evaluation of data to designate high-risk foods. Attached as a reference to this notice is a draft approach document in which we describe the process and methodology we are considering using for designating high-risk foods. After reviewing comments received in response to this notice on the draft approach described here, we plan to further revise the approach as necessary. We also anticipate that the approach will be reviewed by scientific experts (‘‘peer reviewed’’).