{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" and docket_id = \"FDA-2003-N-0196\" sorted by posted_date descending", "rows": [["FDA-2003-N-0196-0100", "FDA", "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", null, "2015-10-15T14:36:02Z", null, 0, 0, "0900006481ccc9d3"], ["FDA-2003-N-0196-0101", "FDA", "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", null, "2015-10-15T14:36:07Z", null, 0, 0, "0900006481ccc9d4"], ["FDA-2003-N-0196-0094", "FDA", "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", null, "2015-06-15T17:12:42Z", null, 0, 0, "0900006481b37d71"], ["FDA-2003-N-0196-0093", "FDA", "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", null, "2015-06-15T16:42:52Z", null, 0, 0, "0900006481a317b6"], ["FDA-2003-N-0196-0092", "FDA", "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", null, "2015-03-09T13:52:37Z", null, 0, 0, "0900006481a33ef8"], ["FDA-2003-N-0196-0091", "FDA", "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", null, "2015-03-09T13:47:26Z", null, 0, 0, "0900006481a2e7f6"], ["FDA-2003-N-0196-0088", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:19:59Z", null, 0, 0, "0900006481a1138e"], ["FDA-2003-N-0196-0070", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:17:51Z", null, 0, 0, "0900006481a11344"], ["FDA-2003-N-0196-0069", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:17:46Z", null, 0, 0, "0900006481a11338"], ["FDA-2003-N-0196-0065", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:17:20Z", null, 0, 0, "0900006481a1132f"], ["FDA-2003-N-0196-0066", "FDA", "FDA-2003-N-0196", "Reference 6 - Scientific Committee on Consumer Products (SCCP)/1184/08-SCCNFP Opinion on 4-Methylbenzylidene Camphor (4-MBC) Colipa n\u00b0 S60 Adopted During the 16th Plenary Meeting of June 24, 2008 re Over-the-Counter Sunscreen Drug Products\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:17:26Z", null, 0, 0, "0900006481a11331"], ["FDA-2003-N-0196-0079", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:18:59Z", null, 0, 0, "0900006481a11366"], ["FDA-2003-N-0196-0081", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:19:13Z", null, 0, 0, "0900006481a11376"], ["FDA-2003-N-0196-0084", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:19:34Z", null, 0, 0, "0900006481a1137c"], ["FDA-2003-N-0196-0067", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:17:33Z", null, 0, 0, "0900006481a11333"], ["FDA-2003-N-0196-0068", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:17:39Z", null, 0, 0, "0900006481a11336"], ["FDA-2003-N-0196-0063", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:17:06Z", null, 0, 0, "0900006481a1104a"], ["FDA-2003-N-0196-0075", "FDA", "FDA-2003-N-0196", "Reference 15 - Soeborg et al, Risk Assessment of Topically Applied Products re Over-the-Counter Sunscreen Drug Products\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:18:29Z", null, 0, 0, "0900006481a1135e"], ["FDA-2003-N-0196-0077", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:18:45Z", null, 0, 0, "0900006481a11362"], ["FDA-2003-N-0196-0078", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:18:50Z", null, 0, 0, "0900006481a11364"], ["FDA-2003-N-0196-0082", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:19:19Z", null, 0, 0, "0900006481a11378"], ["FDA-2003-N-0196-0060", "FDA", "FDA-2003-N-0196", "Over-the-Counter Sunscreen Drug Products\u2014Regulatory Status of\nEnzacamene", "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", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:18:38Z", null, 0, 0, "0900006481a11360"], ["FDA-2003-N-0196-0080", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:19:07Z", null, 0, 0, "0900006481a11374"], ["FDA-2003-N-0196-0085", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:19:40Z", null, 0, 0, "0900006481a11388"], ["FDA-2003-N-0196-0087", "FDA", "FDA-2003-N-0196", "Reference 27 - Guidance for Industry, S1B Testing for Carcinogenicity of Pharmaceuticals, July 1997 re Over-the-Counter Sunscreen Drug Products\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:19:53Z", null, 0, 0, "0900006481a1138c"], ["FDA-2003-N-0196-0090", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:20:11Z", null, 0, 0, "0900006481a1139f"], ["FDA-2003-N-0196-0061", "FDA", "FDA-2003-N-0196", "Reference 1 - FDA, Guidance for industry, Photosafety Testing, May 2003 re Over-the-Counter Sunscreen Drug Products\u2014Regulatory Status of\nEnzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:16:50Z", null, 0, 0, "0900006481a11046"], ["FDA-2003-N-0196-0086", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:19:46Z", null, 0, 0, "0900006481a1138a"], ["FDA-2003-N-0196-0073", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:18:17Z", null, 0, 0, "0900006481a1134a"], ["FDA-2003-N-0196-0064", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:17:12Z", null, 0, 0, "0900006481a1104c"], ["FDA-2003-N-0196-0071", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:17:58Z", null, 0, 0, "0900006481a11346"], ["FDA-2003-N-0196-0083", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:19:27Z", null, 0, 0, "0900006481a1137a"], ["FDA-2003-N-0196-0089", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:20:05Z", null, 0, 0, "0900006481a11390"], ["FDA-2003-N-0196-0074", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:18:23Z", null, 0, 0, "0900006481a1134c"], ["FDA-2003-N-0196-0062", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:17:00Z", null, 0, 0, "0900006481a11048"], ["FDA-2003-N-0196-0072", "FDA", "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\u2014Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-02-25T18:18:05Z", null, 0, 0, "0900006481a11348"], ["FDA-2003-N-0196-0057", "FDA", "FDA-2003-N-0196", "Sunscreen Feedback Letters; Notice of Availability Under the Sunscreen\nInnovation 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"], ["FDA-2003-N-0196-0055", "FDA", "FDA-2003-N-0196", "Initial Determination and Feedback Letter from FDA/CDER to L'Oreal USA Products, Inc re Time and Extent Application (TEA) Drometrizole Trisiloxane for use in Over-the-Counter (OTC) Sunscreens", "Other", "Letter(s)", "2014-08-29T04:00:00Z", 2014, 8, "2014-08-29T04:00:00Z", null, "2014-08-29T21:20:12Z", null, 0, 0, "09000064818511a4"], ["FDA-2003-N-0196-0054", "FDA", "FDA-2003-N-0196", "Letter from FDA/CDER to BASF AG (Morgan, Lewis & Bockius LLP)", "Other", "Letter(s)", "2014-06-23T04:00:00Z", 2014, 6, "2014-06-23T04:00:00Z", null, "2014-06-23T18:14:09Z", null, 0, 0, "090000648175c494"], ["FDA-2003-N-0196-0053", "FDA", "FDA-2003-N-0196", "Supplement from BASF AG (Morgan Lewis & Bockius, LLP)", "Other", "Supplement (SUP)", "2014-06-11T04:00:00Z", 2014, 6, "2014-06-11T04:00:00Z", null, "2014-06-11T15:51:37Z", null, 0, 0, "090000648048b765"], ["FDA-2003-N-0196-0051", "FDA", "FDA-2003-N-0196", "Data and Information from BASF AG (Morgan Lewis & Bockius, LLP)", "Other", "Submission of Information", "2014-06-11T04:00:00Z", 2014, 6, "2014-06-11T04:00:00Z", null, "2014-06-11T15:48:23Z", null, 0, 0, "090000648173afac"], ["FDA-2003-N-0196-0052", "FDA", "FDA-2003-N-0196", "Supplement from BASF AG (Morgan Lewis & Bockius, LLP)", "Other", "Supplement (SUP)", "2014-06-11T04:00:00Z", 2014, 6, "2014-06-11T04:00:00Z", null, "2014-06-11T15:49:59Z", null, 0, 0, "090000648048b660"], ["FDA-2003-N-0196-0048", "FDA", "FDA-2003-N-0196", "Letter from Symrise North America Cosmetic Division", "Other", "Letter(s)", "2014-06-09T04:00:00Z", 2014, 6, "2014-06-09T04:00:00Z", null, "2014-06-09T21:19:55Z", null, 0, 0, "090000648048b606"], ["FDA-2003-N-0196-0047", "FDA", "FDA-2003-N-0196", "Letter from Buchanan Ingersoll to the Division of Over-The-Counter Drug Products, July 25, 2003", "Other", "Letter(s)", "2014-06-09T04:00:00Z", 2014, 6, "2014-06-09T04:00:00Z", null, "2014-06-09T21:12:37Z", null, 0, 0, "090000648048b600"], ["FDA-2003-N-0196-0049", "FDA", "FDA-2003-N-0196", "Letter from FDA/CDER to BASF AG (Morgan, Lewis & Bockius LLP)", "Other", "Letter(s)", "2014-06-09T04:00:00Z", 2014, 6, "2014-06-09T04:00:00Z", null, "2014-06-09T21:29:26Z", null, 0, 0, "090000648048b61b"], ["FDA-2003-N-0196-0050", "FDA", "FDA-2003-N-0196", "Supplement from BASF AG (Morgan Lewis & Bockius, LLP)", "Other", "Supplement (SUP)", "2014-06-09T04:00:00Z", 2014, 6, "2014-06-09T04:00:00Z", null, "2014-06-09T22:01:14Z", null, 0, 0, "090000648048b622"], ["FDA-2003-N-0196-0039", "FDA", "FDA-2003-N-0196", "Volume 8 Test Substance G 4375 Content in Rat Plasma re Data and Information from L'Oreal, USA Products, Inc.", "Supporting & Related Material", "Data", "2014-05-19T04:00:00Z", 2014, 5, null, null, "2014-05-19T22:36:48Z", null, 0, 0, "090000648170431f"], ["FDA-2003-N-0196-0044", "FDA", "FDA-2003-N-0196", "Volume 12 Report re Data and Information from L'Oreal, USA Products, Inc.", "Supporting & Related Material", "Data", "2014-05-19T04:00:00Z", 2014, 5, null, null, "2014-05-19T22:52:30Z", null, 0, 0, "090000648170445e"], ["FDA-2003-N-0196-0040", "FDA", 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