id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id FDA-1998-P-0032-0044,FDA,FDA-1998-P-0032,"Tab C Changes made at the Suggestion of OIRA re: Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration",Supporting & Related Material,Background Material,2016-03-21T04:00:00Z,2016,3,,,2016-03-21T17:09:03Z,,0,0,0900006480565450 FDA-1998-P-0032-0041,FDA,FDA-1998-P-0032,"Memorandum from OMB Review re: Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration",Supporting & Related Material,Background Material,2016-03-21T04:00:00Z,2016,3,,,2016-03-21T16:54:03Z,,0,0,090000648056544d FDA-1998-P-0032-0043,FDA,FDA-1998-P-0032,"Tab B Substantive Changes between Draft Submitted to OIRA for Review and Action Subsequently Announced, including changes in Regulatory Action re: Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration",Supporting & Related Material,Background Material,2016-03-21T04:00:00Z,2016,3,,,2016-03-21T17:03:23Z,,0,0,0900006480565452 FDA-1998-P-0032-0042,FDA,FDA-1998-P-0032,"Tab A Draft Regulatory Action as submitted to OMB OIRA for review re: Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration",Supporting & Related Material,Background Material,2016-03-21T04:00:00Z,2016,3,,,2016-03-21T16:57:40Z,,0,0,0900006480565456 FDA-1998-P-0032-0019,FDA,FDA-1998-P-0032,"List of References re: Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration; Proposed Rule",Supporting & Related Material,Background Material,2016-03-08T05:00:00Z,2016,3,,,2016-03-08T15:40:18Z,,0,0,0900006480565271 FDA-1998-P-0032-0016,FDA,FDA-1998-P-0032,"Reference 19 Letter from FDA CFSAN to Elf Sanofi, Inc. re: Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration; Proposed Rule",Supporting & Related Material,Background Material,2016-03-08T05:00:00Z,2016,3,,,2016-03-08T15:24:41Z,,0,0,090000648056526b FDA-1998-P-0032-0025,FDA,FDA-1998-P-0032,"Reference 26 Goldman et al The Clinical Impact of Adverse Event Reporting, MedWatch Continuing Education Article, pp. 1-11, 1996 re: Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration; Proposed Rule",Supporting & Related Material,Background Material,2016-03-08T05:00:00Z,2016,3,,,2016-03-08T19:43:00Z,,0,0,0900006480565295 FDA-1998-P-0032-0026,FDA,FDA-1998-P-0032,"Reference 29 Research Triangle Institute Estimating the Value of Consumers’ Loss From Foods Violating the FD&C Act, vol. II, Final Report, pp. G-11, G-22, September 1998. re: Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration; Proposed Rule",Supporting & Related Material,Background Material,2016-03-08T05:00:00Z,2016,3,,,2016-03-08T19:43:32Z,,0,0,090000648056529d FDA-1998-P-0032-0022,FDA,FDA-1998-P-0032,"Reference 23 US Census Bureau Distilleries 1997 Economic Census re: Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration; Proposed Rule",Supporting & Related Material,Background Material,2016-03-08T05:00:00Z,2016,3,,,2016-03-08T19:40:00Z,,0,0,090000648056528d FDA-1998-P-0032-0018,FDA,FDA-1998-P-0032,"Reference 21 US Census Bureau Fresh and Frozen Seafood 1997 Economic Census re: Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration; Proposed Rule",Supporting & Related Material,Background Material,2016-03-08T05:00:00Z,2016,3,,,2016-03-08T15:36:11Z,,0,0,090000648056526f FDA-1998-P-0032-0017,FDA,FDA-1998-P-0032,"Reference 20 US Census Bureau Seafood Canning 1997 Economic Census re: Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration; Proposed Rule",Supporting & Related Material,Background Material,2016-03-08T05:00:00Z,2016,3,,,2016-03-08T15:28:17Z,,0,0,090000648056526d FDA-1998-P-0032-0027,FDA,FDA-1998-P-0032,"Reference 30 Weighted National Estimates From HCUP Nationwide Inpatient Sample (NIS) 1997, Agency for Healthcare Research and Quality [AHRQ) re: Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration; Proposed Rule",Supporting & Related Material,Background Material,2016-03-08T05:00:00Z,2016,3,,,2016-03-08T19:44:08Z,,0,0,0900006480565251 FDA-1998-P-0032-0021,FDA,FDA-1998-P-0032,"Reference 22 US Census Bureau Meat Processed from Carcasses 1997 Economic Census re: Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration; Proposed Rule",Supporting & Related Material,Background Material,2016-03-08T05:00:00Z,2016,3,,,2016-03-08T19:02:49Z,,0,0,090000648056528a FDA-1998-P-0032-0024,FDA,FDA-1998-P-0032,"Reference 25 US Census Bureau Retail Bakeries 1997 Economic Census re: Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration; Proposed Rule",Supporting & Related Material,Background Material,2016-03-08T05:00:00Z,2016,3,,,2016-03-08T19:42:33Z,,0,0,0900006480565293 FDA-1998-P-0032-0020,FDA,FDA-1998-P-0032,"Reference 7 Sarkany, Meara, and Everall, Cheilitis Due to Carmine in Lip Slave Transactions and Annual Report of he St. John’s Hospital Dermatological Society, vol. 46, p. 39, 1961. re: Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration; Proposed Rule",Supporting & Related Material,Background Material,2016-03-08T05:00:00Z,2016,3,,,2016-03-08T16:43:45Z,,0,0,0900006480565283 FDA-1998-P-0032-0023,FDA,FDA-1998-P-0032,"Reference 24 US Census Bureau Toilet Preparation Manufacturing 1997 Economic Census re: Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration; Proposed Rule",Supporting & Related Material,Background Material,2016-03-08T05:00:00Z,2016,3,,,2016-03-08T19:41:36Z,,0,0,090000648056528f FDA-1998-P-0032-0009,FDA,FDA-1998-P-0032,"Exhibit 5 Quirce et al Occupational asthma and immunologic responses induced by inhaled carmine among employees at a factory making natural dyes. 93 J, Allergy Clinmmunol 44, 1994. re: Citizen Petition from Center for Science in the Public Interest (CSPI)",Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:40:16Z,,0,0,0900006481ea580d FDA-1998-P-0032-0011,FDA,FDA-1998-P-0032,Acknowledgment Letter from FDA DDM to Center for Science in the Public Interest,Other,Letter(s),2016-03-07T05:00:00Z,2016,3,2016-03-07T05:00:00Z,,2016-03-07T16:53:53Z,,0,0,0900006480565247 FDA-1998-P-0032-0010,FDA,FDA-1998-P-0032,"Exhibit 6 Burge et al Occupational asthma due to inhaled carmine. 9 Clin Allergy 185, 1979. re: Citizen Petition from Center for Science in the Public Interest (CSPI)",Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:44:05Z,,0,0,0900006481ea580e FDA-1998-P-0032-0014,FDA,FDA-1998-P-0032,Interim Response Letter from FDA CFSAN to Center for Science in the Public Interest,Other,Letter(s),2016-03-07T05:00:00Z,2016,3,2016-03-07T05:00:00Z,,2016-03-07T17:27:42Z,,0,0,090000648056524f FDA-1998-P-0032-0015,FDA,FDA-1998-P-0032,"Exhibit 17 Christiansen et al Extrinsic Allergic Alveolitis caused by Occupational Inhalation of Carmine European Journal of Respiratory Diseases, vol. 62 (suppl 113), pp 82-83,1981. re: Citizen Petition from Center for Science in the Public Interest (CSPI)",Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T20:05:32Z,,0,0,0900006480565266 FDA-1998-P-0032-0013,FDA,FDA-1998-P-0032,Answer from FDA CFSAN to Joe M Regenstein,Other,Answer,2016-03-07T05:00:00Z,2016,3,2016-03-07T05:00:00Z,,2016-03-07T17:20:17Z,,0,0,090000648056524c FDA-1998-P-0032-0008,FDA,FDA-1998-P-0032,Citizen Petition from Center for Science in the Public Interest (CSPI),Other,Citizen Petition,2016-03-07T05:00:00Z,2016,3,2016-03-07T05:00:00Z,,2016-03-07T17:00:35Z,,0,0,0900006480565233