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

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

17 rows where docket_id = "FDA-2005-N-0453" and posted_year = 2014 sorted by posted_date descending

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Suggested facets: subtype, posted_date, posted_month, comment_start_date, withdrawn, posted_date (date), comment_start_date (date), last_modified (date)

document_type 2

  • Supporting & Related Material 13
  • Other 4

posted_year 1

  • 2014 · 17 ✖

agency_id 1

  • FDA 17
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0453-0035 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

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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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