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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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49 rows where docket_id = "FDA-2005-N-0453" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2005-N-0453-0055 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 DSM Nutritional Products June 7 2019 Meeting Minutes Other Minutes 2019-08-28T04:00:00Z 2019 8 2019-08-28T04:00:00Z   2019-08-28T18:40:49Z   0 0 0900006483ed5517
FDA-2005-N-0453-0054 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Letter from FDA CDER to DSM Nutritional Products LLC Other Letter(s) 2019-06-05T04:00:00Z 2019 6 2019-06-05T04:00:00Z   2019-06-05T15:49:14Z   0 0 0900006483ced582
FDA-2005-N-0453-0053 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Request for Type C Meeting from DSM Other Request 2019-05-01T04:00:00Z 2019 5 2019-05-01T04:00:00Z   2019-05-01T18:52:26Z   0 0 0900006483c25323
FDA-2005-N-0453-0052 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Request for Non Public Meeting from DSM Nutritional Products Other Request 2019-01-29T05:00:00Z 2019 1 2019-01-29T05:00:00Z   2019-01-29T18:45:00Z   0 0 0900006483a2238b
FDA-2005-N-0453-0051 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 MEMORANDUM OF MEETING MINUTES - BASF Bemotrizinol and Bisoctrizole October 12, 2017 Other Memorandum 2017-11-15T05:00:00Z 2017 11 2017-11-15T05:00:00Z   2017-11-15T17:48:04Z   0 0 0900006482c7b23a
FDA-2005-N-0453-0050 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Revision from BASF (Morgan, Lewis & Bockius LLP) Other Correction(s) 2017-09-29T04:00:00Z 2017 9 2017-09-29T04:00:00Z   2017-09-29T20:24:09Z   0 0 0900006482b8cb9f
FDA-2005-N-0453-0049 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Meeting Granted Letter BASF August 28 2017 Meeting Request Other Memorandum 2017-09-19T04:00:00Z 2017 9 2017-09-19T04:00:00Z   2017-09-19T18:12:14Z   0 0 0900006482b4f4e1
FDA-2005-N-0453-0048 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Meeting Materials from BASF (Morgan, Lewis & Bockius LLP) Other Meeting Exhibits 2017-09-12T04:00:00Z 2017 9 2017-09-12T04:00:00Z   2017-09-29T20:24:44Z   0 0 0900006482b2bf58
FDA-2005-N-0453-0047 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Request for Meeting from BASF (Morgan, Lewis & Bockius LLP) Other Request 2017-09-01T04:00:00Z 2017 9 2017-09-01T04:00:00Z   2017-09-01T18:56:18Z   0 0 0900006482b03dc4
FDA-2005-N-0453-0045 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Letter from BASF SE (Morgan, Lewis & Bockius LLP) Other Letter(s) 2015-10-15T04:00:00Z 2015 10 2015-10-15T04:00:00Z   2015-10-15T14:41:58Z   0 0 0900006481ccce50
FDA-2005-N-0453-0046 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Advice Letter from FDA CDER to Morgan, Lewis & Bockius LLP Other Letter(s) 2015-10-15T04:00:00Z 2015 10 2015-10-15T04:00:00Z   2015-10-15T14:42:13Z   0 0 0900006481ccce52
FDA-2005-N-0453-0042 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Memorandum of Meeting Minutes between FDA CDER and BASF regarding Octyl Triazone and Bemotrizinol March 19, 2015 Other Memorandum 2015-06-15T04:00:00Z 2015 6 2015-06-15T04:00:00Z   2015-06-15T17:13:28Z   0 0 0900006481b37e78
FDA-2005-N-0453-0043 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Memorandum of Meeting Minutes between FDA CDER and BASF Corporation regarding bisoctrizole March 20, 2015 Other Memorandum 2015-06-15T04:00:00Z 2015 6 2015-06-15T04:00:00Z   2015-06-15T17:13:48Z   0 0 0900006481b37e79
FDA-2005-N-0453-0041 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Letter from FDA/CDER to Morgan, Lewis & Bockius, LLP (BASF SE) Granting Meeting Request Regarding GRASE Status of Octyl Triazone and Bemotrizinol Other Letter(s) 2015-03-09T04:00:00Z 2015 3 2015-03-09T04:00:00Z   2015-03-09T13:44:40Z   0 0 0900006481a33de1
FDA-2005-N-0453-0040 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Letter from FDA/CDER to Morgan, Lewis & Bockius, LLP (BASF SE) Granting Meeting Request Regarding GRASE Status of Bisoctrizole Other Letter(s) 2015-03-09T04:00:00Z 2015 3 2015-03-09T04:00:00Z   2015-03-09T13:40:04Z   0 0 0900006481a33ddd
FDA-2005-N-0453-0036 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Sunscreen Feedback Letters; Notice of Availability Under the Sunscreen Innovation Act Notice Request for Comments 2015-01-07T05:00:00Z 2015 1 2015-01-07T05:00:00Z 2015-02-24T04:59:59Z 2015-02-24T03:08:50Z 2015-00002 0 0 09000064819a9732
FDA-2005-N-0453-0035 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Determination and Feedback Letter from FDA/CDER to Ciba Specialty Chemicals Corporation (Ciba) (Morgan, Lewis & Bockius LLP) re Time and Extent Application (TEA) Bemotrizinol for use in Over-the-Counter (OTC) Sunscreen Other Letter(s) 2014-11-14T05:00:00Z 2014 11 2014-11-14T05:00:00Z   2014-11-14T20:28:13Z   0 0 090000648192f333
FDA-2005-N-0453-0034 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Initial Determination and Feedback Letter from FDA/CDER to Ciba Specialty Chemicals Corporation (Ciba) (Morgan, Lewis & Bockius LLP) re Time and Extent Application (TEA) Bemotrizinol for use in Over-the-Counter (OTC) Sunscreens Other   2014-11-13T00:00:00Z 2014 11     2014-11-14T16:27:35Z   0 1 090000648192d191
FDA-2005-N-0453-0028 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 8 of 12 re Supplement from Ciba Specialty Chemicals Corporation Supporting & Related Material Background Material 2014-11-10T05:00:00Z 2014 11     2014-11-10T16:28:36Z   0 0 0900006481902a13
FDA-2005-N-0453-0022 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 2 of 12 re Supplement from Ciba Specialty Chemicals Corporation Supporting & Related Material Background Material 2014-11-10T05:00:00Z 2014 11     2014-11-10T16:20:46Z   0 0 09000064819029b7
FDA-2005-N-0453-0025 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 5 of 12 re Supplement from Ciba Specialty Chemicals Corporation Supporting & Related Material Background Material 2014-11-10T05:00:00Z 2014 11     2014-11-10T16:22:33Z   0 0 09000064819029bf
FDA-2005-N-0453-0031 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 11 of 12 re Supplement from Ciba Specialty Chemicals Corporation Supporting & Related Material Background Material 2014-11-10T05:00:00Z 2014 11     2014-11-10T16:30:27Z   0 0 0900006481902a27
FDA-2005-N-0453-0021 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 1 of 12 re Supplement from Ciba Specialty Chemicals Corporation Supporting & Related Material Background Material 2014-11-10T05:00:00Z 2014 11     2014-11-10T16:19:48Z   0 0 090000648190293f
FDA-2005-N-0453-0024 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 4 of 12 re Supplement from Ciba Specialty Chemicals Corporation Supporting & Related Material Background Material 2014-11-10T05:00:00Z 2014 11     2014-11-10T16:22:05Z   0 0 09000064819029bb
FDA-2005-N-0453-0027 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 7 of 12 re Supplement from Ciba Specialty Chemicals Corporation Supporting & Related Material Background Material 2014-11-10T05:00:00Z 2014 11     2014-11-10T16:27:57Z   0 0 0900006481902a10
FDA-2005-N-0453-0033 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Bemotrizinol Dermal Carcinogenicity Summary re Supplement from Ciba Specialty Chemicals Supporting & Related Material Background Material 2014-11-10T05:00:00Z 2014 11     2014-11-10T16:34:50Z   0 0 0900006481902a2b
FDA-2005-N-0453-0026 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 6 of 12 re Supplement from Ciba Specialty Chemicals Corporation Supporting & Related Material Background Material 2014-11-10T05:00:00Z 2014 11     2014-11-10T16:27:16Z   0 0 09000064819029e2
FDA-2005-N-0453-0030 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 10 of 12 re Supplement from Ciba Specialty Chemicals Corporation Supporting & Related Material Background Material 2014-11-10T05:00:00Z 2014 11     2014-11-10T16:29:54Z   0 0 0900006481902a25
FDA-2005-N-0453-0023 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 3 of 12 re Supplement from Ciba Specialty Chemicals Corporation Supporting & Related Material Background Material 2014-11-10T05:00:00Z 2014 11     2014-11-10T16:21:25Z   0 0 09000064819029b9
FDA-2005-N-0453-0032 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 12 of 12 re Supplement from Ciba Specialty Chemicals Corporation Supporting & Related Material Background Material 2014-11-10T05:00:00Z 2014 11     2014-11-10T16:31:54Z   0 0 0900006481902a29
FDA-2005-N-0453-0029 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 9 of 12 re Supplement from Ciba Specialty Chemicals Corporation Supporting & Related Material Background Material 2014-11-10T05:00:00Z 2014 11     2014-11-10T16:29:14Z   0 0 0900006481902a17
FDA-2005-N-0453-0020 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Initial Determination and Feedback Letter from FDA/CDER to Ciba Specialty Chemicals Corporation (Ciba) (Morgan, Lewis & Bockius LLP) re Time and Extent Application (TEA) Bisoctrizole for use in Over-the-Counter (OTC) Sunscreens Other Letter(s) 2014-09-03T04:00:00Z 2014 9 2014-09-03T04:00:00Z   2014-09-03T21:02:03Z   0 0 090000648185a6e7
FDA-2005-N-0453-0019 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Ciba Specialty Chemicals Corporation Correspondence with FDA Center for Drug Evaluation & Research - Electronic Letter re FDA-2005-N-0453-0002 and FDA-2005-N-0453-0003 Other Electronic Letter 2014-09-03T04:00:00Z 2014 9 2014-09-03T04:00:00Z   2014-09-03T20:44:01Z   0 0 09000064812be491
FDA-2005-N-0453-0017 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Electronic Correspondence From Ciba to FDA re Confidential Information in Bisoctrizole and Bemotrizinol TEAs FDA-2005-N-0453-0001- Background Supporting & Related Material Background Material 2013-05-07T04:00:00Z 2013 5     2013-05-07T21:36:09Z   0 0 09000064804507d4
FDA-2005-N-0453-0018 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Electronic Correspondence From Ciba to FDA re Confidential Information in Bisoctrizole and Bemotrizinol TEAs FDA-2005-N-0453-0001 - Background Supporting & Related Material Background Material 2013-05-07T04:00:00Z 2013 5     2013-05-07T21:36:43Z   0 0 09000064804507d9
FDA-2005-N-0453-0016 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Skin Cancer Foundation to the Food and Drug Administration - Letter Other Letter(s) 2008-08-19T04:00:00Z 2008 8 2008-08-19T04:00:00Z   2019-07-05T19:37:20Z   0 0 090000648063d6c7
FDA-2005-N-0453-0004 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Time and Extent Application (TEA) Review for Bemotrizinol [FDA-2005-N-0453-0001] - Background Supporting & Related Material Background Material 2008-06-13T04:00:00Z 2008 6     2013-05-02T17:00:12Z   0 0 09000064804507cf
FDA-2005-N-0453-0005 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Time and Extent Application (TEA) Review for Bisoctrizole [FDA-2005-N-0453-0001] - Background Supporting & Related Material Background Material 2008-06-13T04:00:00Z 2008 6     2013-05-02T17:03:52Z   0 0 09000064804507d0
FDA-2005-N-0453-0010 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 FDA Center for Drug Evaluation and Reseach (OTC) to Ciba Specialty Chemical Corporation Letter dated 10/31/2005 [FDA-2005-N-0453-0001] - Background Supporting & Related Material BKG-Background Material 2008-06-13T04:00:00Z 2008 6     2013-05-02T17:12:19Z   0 0 09000064804507d8
FDA-2005-N-0453-0003 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Ciba Specialty Chemicals Corporation - [Bemotrizinol] - Supplement Other Supplement (SUP) 2008-06-13T04:00:00Z 2008 6 2008-06-13T04:00:00Z   2013-05-07T21:31:57Z   0 0 09000064804507e3
FDA-2005-N-0453-0013 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Time and Extend Application Bemotrizinol [Product Labeling] [FDA-2005-N-0453-0001] - Background Supporting & Related Material Background Material 2008-06-13T04:00:00Z 2008 6     2013-05-02T17:31:03Z   0 0 09000064804507dc
FDA-2005-N-0453-0012 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Time and Extend Application Bemotrizinol - [Appendices] [FDA-2005-N-0453-0001] - Background Supporting & Related Material Background Material 2008-06-13T04:00:00Z 2008 6     2013-05-02T17:29:25Z   0 0 09000064804507db
FDA-2005-N-0453-0009 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Time and Extend Application Bisoctrizole [Product Labeling] [FDA-2005-N-0453-0001] - Background Supporting & Related Material Background Material 2008-06-13T04:00:00Z 2008 6     2013-05-02T17:10:59Z   0 0 09000064804507d7
FDA-2005-N-0453-0011 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Time and Extend Application Bemotrizinol - [Prepared to support the Inclusion of Bemotrizinol into FDA’s Monograph for Sunscreen Drug Products] [FDA-2005-N-0453-0001] - Background Supporting & Related Material Background Material 2008-06-13T04:00:00Z 2008 6     2013-05-02T17:15:05Z   0 0 09000064804507da
FDA-2005-N-0453-0007 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Time and Extend Application Bisoctrizole - [Prepared to support the Inclusion of Bisoctrizole into FDA’s Monograph for Sunscreen Drug Products] [FDA-2005-N-0453-0001] - Background Supporting & Related Material Background Material 2008-06-13T04:00:00Z 2008 6     2013-05-02T17:06:46Z   0 0 09000064804507d5
FDA-2005-N-0453-0008 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Time and Extend Application Bisoctrizole - [Appendices] [FDA-2005-N-0453-0001] - Background Supporting & Related Material Background Material 2008-06-13T04:00:00Z 2008 6     2013-05-02T17:09:09Z   0 0 09000064804507d6
FDA-2005-N-0453-0002 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Ciba Specialty Chemicals Corporation re Bisoctrizole - Supplement Other Supplement (SUP) 2008-06-13T04:00:00Z 2008 6 2008-06-13T04:00:00Z   2013-05-07T21:31:02Z   0 0 09000064804507e2
FDA-2005-N-0453-0006 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 FDA Center for Drug Evaluation and Reseach (OTC) to Ciba Specialty Chemical Corporation Letter dated 10/31/2005 [FDA-2005-N-0453-0001] - Background Supporting & Related Material Background Material 2008-06-13T04:00:00Z 2008 6     2013-05-02T17:03:01Z   0 0 09000064804507d3
FDA-2005-N-0453-0001 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2005-N-0453 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients Notice NRD-Notice of Requesting Data, Info, & Views 2005-12-02T05:00:00Z 2005 12 2005-12-05T05:00:00Z 2006-03-07T04:59:59Z 2009-12-30T19:54:55Z   0 0 09000064804507c9

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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