0910-AF12 200410 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Cochineal Extract and Carmine Label Declaration The purpose of this proposed rule is to protect consumers who have allergies to the color additives carmine and cochineal extract by requiring label declaration on products under FDA jurisdiction. This action responds to adverse event reports received by FDA and to a citizen petition submitted to FDA. Other Significant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined No 21 CFR 73.100(d) 21 CFR 73.1100(c) 21 CFR 73.2087(c) 21 CFR 101.22(k) 21 CFR 201.100(b) 21 CFR 201.324 21 USC 379e(b) No NPRM 09/00/2005 Yes Businesses None NA Not Collected Mical Honigfort E. 0910 Food and Drug Administration FDA 301 436-1278 301 436-2972 mical.honigfort@fda.hhs.gov HFS-265, 5100 Paint Branch Parkway, College Park MD 20740