{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where docket_id = \"FDA-1996-N-0006\" sorted by posted_date descending", "rows": [["FDA-1996-N-0006-0193", "FDA", "FDA-1996-N-0006", "Meeting Request from Environmental Working Group", "Other", "Letter(s)", "2020-01-15T05:00:00Z", 2020, 1, "2020-01-15T05:00:00Z", null, "2020-01-15T21:48:05Z", null, 0, 0, "09000064842ac71f"], ["FDA-1996-N-0006-0191", "FDA", "FDA-1996-N-0006", "PASS Coalition and FDA Meeting Minutes_November 1 2016", "Other", "Minutes", "2020-01-15T05:00:00Z", 2020, 1, "2020-01-15T05:00:00Z", null, "2020-01-15T21:33:01Z", null, 0, 0, "09000064842ac515"], ["FDA-1996-N-0006-0194", "FDA", "FDA-1996-N-0006", "Meeting Minutes for Meeting between EWG and FDA", "Other", "Letter(s)", "2020-01-15T05:00:00Z", 2020, 1, "2020-01-15T05:00:00Z", null, "2020-01-15T21:49:43Z", null, 0, 0, "09000064842ac721"], ["FDA-1996-N-0006-0192", "FDA", "FDA-1996-N-0006", "Letter from FDA CDER for Announcement of Meeting with PASS Coalition_", "Other", "Letter(s)", "2020-01-15T05:00:00Z", 2020, 1, "2020-01-15T05:00:00Z", null, "2020-01-15T21:35:50Z", null, 0, 0, "09000064842ac517"], ["FDA-1996-N-0006-0190", "FDA", "FDA-1996-N-0006", "Letter from FDA CDER for Announcement of Meeting with PASS Coalition", "Other", "Letter(s)", "2016-10-21T04:00:00Z", 2016, 10, "2016-10-21T04:00:00Z", null, "2016-10-21T14:20:00Z", null, 0, 0, "0900006482330e55"], ["FDA-1996-N-0006-0189", "FDA", "FDA-1996-N-0006", "Letter from FDA CDER for Announcement of Meeting", "Other", "Letter(s)", "2016-10-07T04:00:00Z", 2016, 10, "2016-10-07T04:00:00Z", null, "2016-10-07T12:01:15Z", null, 0, 0, "09000064822a11d4"], ["FDA-1996-N-0006-0188", "FDA", "FDA-1996-N-0006", "Background Material Specific Questions for FDA from Holland&Knight", "Supporting & Related Material", "Background Material", "2016-09-15T04:00:00Z", 2016, 9, null, null, "2016-09-15T19:29:20Z", null, 0, 0, "090000648221463d"], ["FDA-1996-N-0006-0187", "FDA", "FDA-1996-N-0006", "Request for Meeting from PASS Coalition (Holland & Knight)", "Other", "Request", "2016-09-08T04:00:00Z", 2016, 9, "2016-09-08T04:00:00Z", null, "2016-09-08T18:14:49Z", null, 0, 0, "09000064821e3bb9"], ["FDA-1996-N-0006-0183", "FDA", "FDA-1996-N-0006", "Letter from Environmental Working Group to FDA DDM, FDA CDER", "Other", "Letter(s)", "2016-08-29T04:00:00Z", 2016, 8, "2016-08-29T04:00:00Z", null, "2016-08-29T15:56:47Z", null, 0, 0, "09000064821a94be"], ["FDA-1996-N-0006-0185", "FDA", "FDA-1996-N-0006", "Attachment 2 EWG's 2016 Sunscreen Guide (2016), http://www.ewg.org/sunscreen re: Letter from Environmental Working Group to FDA DDM, FDA CDER", "Supporting & Related Material", "Background Material", "2016-08-29T04:00:00Z", 2016, 8, null, null, "2016-08-29T16:01:59Z", null, 0, 0, "09000064821a962a"], ["FDA-1996-N-0006-0186", "FDA", "FDA-1996-N-0006", "Attachment 3 EWG analysis of labeled SPF and in vitro measured SPF from Nash 2009 Market Survey Data re: Letter from Environmental Working Group to FDA DDM, FDA CDER", "Supporting & Related Material", "Background Material", "2016-08-29T04:00:00Z", 2016, 8, null, null, "2016-08-29T16:05:02Z", null, 0, 0, "09000064821a962b"], ["FDA-1996-N-0006-0184", "FDA", "FDA-1996-N-0006", "Attachment 1 Letter from Ken Cook, et al., EWG to Robert M. 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2015, 7, null, null, "2015-07-07T20:27:49Z", null, 0, 0, "09000064804f9940"], ["FDA-1996-N-0006-0172", "FDA", "FDA-1996-N-0006", "Reference 11 CP1, 94P-0215 re Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug", "Supporting & Related Material", "Background Material", "2015-07-07T04:00:00Z", 2015, 7, null, null, "2015-07-07T20:27:49Z", null, 0, 0, "09000064804f993e"], ["FDA-1996-N-0006-0171", "FDA", "FDA-1996-N-0006", "Reference 12 CP2, 94P-0215 re Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug", "Supporting & Related Material", "Background Material", "2015-07-07T04:00:00Z", 2015, 7, null, null, "2015-07-07T20:27:49Z", null, 0, 0, "09000064804f993d"], ["FDA-1996-N-0006-0182", "FDA", "FDA-1996-N-0006", "OMB Revisions of the final Rule re Additional Criteria and Procedures for Classifying OTC Drugs as Generally Recognized as Safe and Effective and not Misbranded", "Supporting & Related Material", "Reference (internal unless indicated)", "2015-07-07T04:00:00Z", 2015, 7, null, null, "2015-07-07T20:27:50Z", null, 0, 0, "09000064804f9979"], ["FDA-1996-N-0006-0164", "FDA", "FDA-1996-N-0006", "Reference 2 Let95, 78N-0038 re Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System", "Supporting & Related Material", "Background Material", "2015-07-07T04:00:00Z", 2015, 7, null, null, "2015-07-07T20:27:48Z", null, 0, 0, "09000064804f9936"], ["FDA-1996-N-0006-0181", "FDA", "FDA-1996-N-0006", "Attachment 1 Letter of Authorization re Comment from Merck KGaA", "Supporting & Related Material", "Background Material", "2015-07-07T04:00:00Z", 2015, 7, null, null, "2015-07-07T20:27:50Z", null, 0, 0, "09000064804f9959"], ["FDA-1996-N-0006-0169", "FDA", "FDA-1996-N-0006", "Reference 6 CP3, 78N-0038 re Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug", "Supporting & Related Material", "Background Material", "2015-07-07T04:00:00Z", 2015, 7, null, null, "2015-07-07T20:27:49Z", null, 0, 0, "09000064804f993b"], ["FDA-1996-N-0006-0131", "FDA", "FDA-1996-N-0006", "Letter from Personal Care Products Council and Consumer Healthcare Products Association to FDA CDER", "Other", "Letter(s)", "2015-03-20T04:00:00Z", 2015, 3, "2015-03-20T04:00:00Z", null, "2015-05-05T20:05:57Z", null, 0, 0, "0900006481a548dc"], ["FDA-1996-N-0006-0119", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T15:14:46Z", null, 0, 0, "0900006481a11365"], ["FDA-1996-N-0006-0124", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T15:26:23Z", null, 0, 0, "0900006481a1137b"], ["FDA-1996-N-0006-0101", "FDA", "FDA-1996-N-0006", "Reference 1 - FDA, Guidance for industry, Photosafety Testing, May 2003 re Over-the-Counter Sunscreen Drug Products - Regulatory Status of\r\nEnzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-06-22T14:09:48Z", null, 0, 0, "0900006481a11045"], ["FDA-1996-N-0006-0130", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T15:58:34Z", null, 0, 0, "0900006481a1139e"], ["FDA-1996-N-0006-0104", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T14:26:52Z", null, 0, 0, "0900006481a1104b"], ["FDA-1996-N-0006-0120", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T15:16:09Z", null, 0, 0, "0900006481a11373"], ["FDA-1996-N-0006-0127", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T15:36:17Z", null, 0, 0, "0900006481a1138b"], ["FDA-1996-N-0006-0100", "FDA", "FDA-1996-N-0006", "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", "2015-02-25T17:40:37Z", "2015-03884", 0, 0, "0900006481a16b78"], ["FDA-1996-N-0006-0128", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T15:38:44Z", null, 0, 0, "0900006481a1138d"], ["FDA-1996-N-0006-0113", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T14:51:58Z", null, 0, 0, "0900006481a11349"], ["FDA-1996-N-0006-0123", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T15:22:10Z", null, 0, 0, "0900006481a11379"], ["FDA-1996-N-0006-0129", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T15:51:28Z", null, 0, 0, "0900006481a1138f"], ["FDA-1996-N-0006-0102", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T14:20:03Z", null, 0, 0, "0900006481a11047"], ["FDA-1996-N-0006-0103", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T14:22:03Z", null, 0, 0, "0900006481a11049"], ["FDA-1996-N-0006-0107", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T14:41:11Z", null, 0, 0, "0900006481a11332"], ["FDA-1996-N-0006-0109", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T14:46:34Z", null, 0, 0, "0900006481a11337"], ["FDA-1996-N-0006-0112", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T14:50:16Z", null, 0, 0, "0900006481a11347"], ["FDA-1996-N-0006-0115", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T14:59:57Z", null, 0, 0, "0900006481a1135d"], ["FDA-1996-N-0006-0126", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T15:31:30Z", null, 0, 0, "0900006481a11389"], ["FDA-1996-N-0006-0114", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T14:56:40Z", null, 0, 0, "0900006481a1134b"], ["FDA-1996-N-0006-0122", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T15:21:22Z", null, 0, 0, "0900006481a11377"], ["FDA-1996-N-0006-0117", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T15:09:41Z", null, 0, 0, "0900006481a11361"], ["FDA-1996-N-0006-0121", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T15:19:32Z", null, 0, 0, "0900006481a11375"], ["FDA-1996-N-0006-0105", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T14:30:38Z", null, 0, 0, "0900006481a1104d"], ["FDA-1996-N-0006-0106", "FDA", "FDA-1996-N-0006", "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 - Regulatory Status of Enzacamene", "Supporting & Related Material", "Background Material", "2015-02-25T05:00:00Z", 2015, 2, null, null, "2015-06-22T14:37:31Z", null, 0, 0, "0900006481a11330"], ["FDA-1996-N-0006-0110", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T14:47:50Z", null, 0, 0, "0900006481a11343"], ["FDA-1996-N-0006-0125", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T15:27:47Z", null, 0, 0, "0900006481a11387"], ["FDA-1996-N-0006-0108", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T14:46:11Z", null, 0, 0, "0900006481a11335"], ["FDA-1996-N-0006-0116", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T15:03:10Z", null, 0, 0, "0900006481a1135f"], ["FDA-1996-N-0006-0118", "FDA", "FDA-1996-N-0006", "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, null, null, "2015-06-22T15:10:46Z", null, 0, 0, "0900006481a11363"], ["FDA-1996-N-0006-0111", "FDA", "FDA-1996-N-0006", "Reference 11 - Schlumpf et al, Estrogenic Activity and Estrogen Receptor Beta Binding of the UV Filter 3-Benzylidene Camphor. 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