Docket: For access to the docket to read background documents or comments and scientific data and information received, go to http://www.regulations.gov and insert the docket number found in brackets in the heading of this document into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852.