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

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38 rows where docket_id = "FDA-2003-N-0196" and posted_year = 2015 sorted by posted_date descending

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  • 2015 · 38 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2003-N-0196-0100 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Letter from BASF SE (Morgan, Lewis & Bockius LLP) Other Letter(s) 2015-10-15T04:00:00Z 2015 10 2015-10-15T04:00:00Z   2015-10-15T14:36:02Z   0 0 0900006481ccc9d3
FDA-2003-N-0196-0101 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 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   2015-10-15T14:36:07Z   0 0 0900006481ccc9d4
FDA-2003-N-0196-0094 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 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   2015-06-15T17:12:42Z   0 0 0900006481b37d71
FDA-2003-N-0196-0093 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Letter from L'Oreal USA Products, Inc. re March 18, 2015 Meeting with FDA CDER Other Letter(s) 2015-03-09T04:00:00Z 2015 3 2015-03-09T04:00:00Z   2015-06-15T16:42:52Z   0 0 0900006481a317b6
FDA-2003-N-0196-0092 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 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   2015-03-09T13:52:37Z   0 0 0900006481a33ef8
FDA-2003-N-0196-0091 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Letter from FDA/CDER to L'Oreal USA Products Inc. Granting Meeting Request regarding Drometrizole Trisiloxane Other Letter(s) 2015-03-05T05:00:00Z 2015 3 2015-03-05T05:00:00Z   2015-03-09T13:47:26Z   0 0 0900006481a2e7f6
FDA-2003-N-0196-0088 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 28 - International Conference on Harmonization (ICH) Guidance for Industry - S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals SIC(R2) (Revision 1), September 2008 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:19:59Z   0 0 0900006481a1138e
FDA-2003-N-0196-0070 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 10 - Mueller et al, Activation of Estrogen Receptor Alpha and ERbeta by 4-Methylbenzylidene-Camphor in Human and Rat Cells: Comparison With Phyto- and Xenoestrogens re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:17:51Z   0 0 0900006481a11344
FDA-2003-N-0196-0069 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 9 - Ma et al, UV Filters With Antagonistic Action at Androgen Receptors in the MDA-kb2 Cell Transcriptional-Activation Assay re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:17:46Z   0 0 0900006481a11338
FDA-2003-N-0196-0065 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 5 - Janjua et al, Sunscreens in Human Plasma and Urine After Repeated Whole-Body Topical Application re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:17:20Z   0 0 0900006481a1132f
FDA-2003-N-0196-0066 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 6 - Scientific Committee on Consumer Products (SCCP)/1184/08-SCCNFP Opinion on 4-Methylbenzylidene Camphor (4-MBC) Colipa n° S60 Adopted During the 16th Plenary Meeting of June 24, 2008 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:17:26Z   0 0 0900006481a11331
FDA-2003-N-0196-0079 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 19 - Faas et al, Female Sexual Behavior, Estrous Cycle and Gene Expression in Sexually Dimorphic Brain Regions After Pre- and Postnatal Exposure to Endocrine Active UV Filters re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:18:59Z   0 0 0900006481a11366
FDA-2003-N-0196-0081 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 21 - Maerkel et al, Sexually Dimorphic Gene Regulation in Brain as a Target for Endocrine Disrupters: Developmental Exposure of Rats to 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:19:13Z   0 0 0900006481a11376
FDA-2003-N-0196-0084 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 24 - Schlumpf et al, Estrogenic Activity and Estrogen Receptor Beta Binding of the UV Filter 3-Benzylidene Camphor. Comparison With 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:19:34Z   0 0 0900006481a1137c
FDA-2003-N-0196-0067 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 7- Jimenez-Diaz et al, Simultaneous Determination of the UV-Filters Benzyl Salicylate, Phenyl Salicylate, Octyl Salicylate, Homosalate, 3-(4-Methylbenzylidene) Camphor and 3-Benzylidene Camphor in Human Placental Tissue by LC-MS/MS. Assessment of Their In Vitro Endocrine Activity re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:17:33Z   0 0 0900006481a11333
FDA-2003-N-0196-0068 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 8 - Gomez et al, Estrogenic Activity of Cosmetic Components in Reporter Cell Lines: Parabens, UV Screens and Musks re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:17:39Z   0 0 0900006481a11336
FDA-2003-N-0196-0063 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 3 - Janjua, et al Systemic Absorption of the Sunscreens Benzophenone-3, Octyl-Methoxycinnamate, and 3-(4-Methyl-Benzylidene) Camphor After Whole Body Topical Application and Reproductive Hormone Levels in Humans re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:17:06Z   0 0 0900006481a1104a
FDA-2003-N-0196-0075 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 15 - Soeborg et al, Risk Assessment of Topically Applied Products re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:18:29Z   0 0 0900006481a1135e
FDA-2003-N-0196-0077 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 17 - Durrer et al, Estrogen Sensitivity of Target Genes and Expression of Nuclear Receptor Co-Regulators in Rat Prostate After Pre- and Postnatal Exposure to the Ultraviolet Filter 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:18:45Z   0 0 0900006481a11362
FDA-2003-N-0196-0078 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 18 - Durrer et al, Estrogen Target Gene Regulation and Coactivator Expression in Rat Uterus After Developmental Exposure to the Ultraviolet Filter 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:18:50Z   0 0 0900006481a11364
FDA-2003-N-0196-0082 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 22 - Maerkel et al, Sex- and Region-Specific Alterations of Progesterone Receptor mRNA Levels and Estrogen Sensitivity in Rat Brain Following Developmental Exposure to the Estrogenic UV Filter 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:19:19Z   0 0 0900006481a11378
FDA-2003-N-0196-0060 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Proposed Rule Notice of Proposed Rulemaking (NPRM) 2015-02-25T05:00:00Z 2015 2 2015-02-25T05:00:00Z 2015-04-14T03:59:59Z 2015-03-23T02:01:20Z 2015-03884 0 0 0900006481a16b76
FDA-2003-N-0196-0076 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 16 -Tinwell et al, Confirmation of Uterotrophic Activity of 3-(4-Methylbenzylidine) Camphor in the Immature Rat re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:18:38Z   0 0 0900006481a11360
FDA-2003-N-0196-0080 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 20 - Hofkamp et al, Region-Specific Growth Effects in the Developing Rat Prostate Following Fetal Exposure to Estrogenic Ultraviolet Filters re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:19:07Z   0 0 0900006481a11374
FDA-2003-N-0196-0085 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 25 - Schlumpf et al, Endocrine Activity and Developmental Toxicity of Cosmetic UV Filters-An Update re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:19:40Z   0 0 0900006481a11388
FDA-2003-N-0196-0087 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 27 - Guidance for Industry, S1B Testing for Carcinogenicity of Pharmaceuticals, July 1997 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:19:53Z   0 0 0900006481a1138c
FDA-2003-N-0196-0090 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 30 - International Conference on Harmonization (ICH) Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies S3A, March 1995 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:20:11Z   0 0 0900006481a1139f
FDA-2003-N-0196-0061 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 1 - FDA, Guidance for industry, Photosafety Testing, May 2003 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:16:50Z   0 0 0900006481a11046
FDA-2003-N-0196-0086 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 26 - International Conference on Harmonization (ICH), Guidance for Industry, The Need for Long Term Rodent Carcinogenicity Studies of Pharmaceuticals S1A, March 1996 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:19:46Z   0 0 0900006481a1138a
FDA-2003-N-0196-0073 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 13 - Schreurs et al, Estrogenic Activity of UV Filters Determined by an In Vitro Reporter Gene Assay and an In Vivo Transgenic Zebrafish Assay re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:18:17Z   0 0 0900006481a1134a
FDA-2003-N-0196-0064 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 4 - Schauer, et al, Kinetics of 3-(methylbenzlidene) Camphor in Rats and Humans After Dermal Application re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:17:12Z   0 0 0900006481a1104c
FDA-2003-N-0196-0071 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 11 - Schlumpf et al, Estrogenic Activity and Estrogen Receptor Beta Binding of the UV Filter 3-Benzylidene Camphor. Comparison With 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:17:58Z   0 0 0900006481a11346
FDA-2003-N-0196-0083 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 23 - Schlumpf et al, In Vitro and In Vivo Estrogenicity of UV Screens re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:19:27Z   0 0 0900006481a1137a
FDA-2003-N-0196-0089 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 29 - International Conference on Harmonization (ICH) Harmonized Tripartite Guideline for Industry, Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(R2), 2005 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:20:05Z   0 0 0900006481a11390
FDA-2003-N-0196-0074 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 14 - Seidlova Wuttke et al, Comparison of Effects of Estradiol With Those of Octylmethoxycinnamate and 4-Methylbenzylidene Camphor on Fat Tissue, Lipids and Pituitary Hormones re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:18:23Z   0 0 0900006481a1134c
FDA-2003-N-0196-0062 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 2 - FDA, Guidance for Industry, Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application, February 1987 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:17:00Z   0 0 0900006481a11048
FDA-2003-N-0196-0072 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Reference 12 - Schmutzler et al, Endocrine Disruptors and the Thyroid Gland-A Combined In Vitro and In Vivo Analysis of Potential New Biomarkers re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T18:18:05Z   0 0 0900006481a11348
FDA-2003-N-0196-0057 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 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 2015-02-24T03:14:01Z 2015-00002 0 0 09000064819a971f

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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);