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withdrawn,object_id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-1996-N-0006-0176,FDA,FDA-1996-N-0006,"Reference 9 CP1, 81N-0033 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,,,2015-07-07T20:27:50Z,,0,0,09000064804f9942
FDA-1996-N-0006-0177,FDA,FDA-1996-N-0006,Attachment 5 Conference Report re Comment from Merck KGaA,Supporting & Related Material,Background Material,2015-07-07T04:00:00Z,2015,7,,,2015-07-07T20:27:50Z,,0,0,09000064804f9955
FDA-1996-N-0006-0178,FDA,FDA-1996-N-0006,Attachment 4 Review Of Over The Counter Active Ingredients re Comment from Merck KGaA,Supporting & Related Material,Background Material,2015-07-07T04:00:00Z,2015,7,,,2015-07-07T20:27:50Z,,0,0,09000064804f9956
FDA-1996-N-0006-0180,FDA,FDA-1996-N-0006,"Attachment 3 American Academy Of Dermatology, Sun Protection re Comment from Merck KGaA",Supporting & Related Material,Background Material,2015-07-07T04:00:00Z,2015,7,,,2015-07-07T20:27:50Z,,0,0,09000064804f9958
FDA-1996-N-0006-0179,FDA,FDA-1996-N-0006,"Attachment 3 Ostroff, The Bottom Line On ASIA re Comment from Merck KGaA",Supporting & Related Material,Background Material,2015-07-07T04:00:00Z,2015,7,,,2015-07-07T20:27:50Z,,0,0,09000064804f9957
FDA-1996-N-0006-0167,FDA,FDA-1996-N-0006,"Reference 4 CP1, 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,,,2015-07-07T20:27:48Z,,0,0,09000064804f9939
FDA-1996-N-0006-0168,FDA,FDA-1996-N-0006,"Reference 5 CP2, 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,,,2015-07-07T20:27:49Z,,0,0,09000064804f993a
FDA-1996-N-0006-0166,FDA,FDA-1996-N-0006,List of References 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,,,2015-07-07T20:27:48Z,,0,0,09000064804f9938
FDA-1996-N-0006-0170,FDA,FDA-1996-N-0006,"Reference 13 CP1, 95P-0145 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,,,2015-07-07T20:27:49Z,,0,0,09000064804f993c
FDA-1996-N-0006-0175,FDA,FDA-1996-N-0006,"Reference 8 C105, 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,,,2015-07-07T20:27:49Z,,0,0,09000064804f9941
FDA-1996-N-0006-0165,FDA,FDA-1996-N-0006,"Reference 1 PDN2, 77N-0094 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,,,2015-07-07T20:27:48Z,,0,0,09000064804f9937
FDA-1996-N-0006-0163,FDA,FDA-1996-N-0006,Reference 3 Letter from Thomas Scarlett 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,,,2015-07-07T20:27:48Z,,0,0,09000064804f9935
FDA-1996-N-0006-0173,FDA,FDA-1996-N-0006,"Reference 10 CP1, 92P-0309 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,,,2015-07-07T20:27:49Z,,0,0,09000064804f993f
FDA-1996-N-0006-0161,FDA,FDA-1996-N-0006,"Request for Extension from Merck KGaA & U.S. EM Industries, Inc.",Other,Request for Extension,2015-07-07T04:00:00Z,2015,7,2015-07-07T04:00:00Z,,2015-07-07T20:25:46Z,,0,0,09000064804f9965
FDA-1996-N-0006-0174,FDA,FDA-1996-N-0006,"Reference 7 CP4, 78N-0308 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,,,2015-07-07T20:27:49Z,,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,,,2015-07-07T20:27:49Z,,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,,,2015-07-07T20:27:49Z,,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,,,2015-07-07T20:27:50Z,,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,,,2015-07-07T20:27:48Z,,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,,,2015-07-07T20:27:50Z,,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,,,2015-07-07T20:27:49Z,,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,,2015-05-05T20:05:57Z,,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,,,2015-06-22T15:14:46Z,,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,,,2015-06-22T15:26:23Z,,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
Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-06-22T14:09:48Z,,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,,,2015-06-22T15:58:34Z,,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,,,2015-06-22T14:26:52Z,,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,,,2015-06-22T15:16:09Z,,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,,,2015-06-22T15:36:17Z,,0,0,0900006481a1138b
FDA-1996-N-0006-0100,FDA,FDA-1996-N-0006,"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,2015-02-25T17:40:37Z,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,,,2015-06-22T15:38:44Z,,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,,,2015-06-22T14:51:58Z,,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,,,2015-06-22T15:22:10Z,,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,,,2015-06-22T15:51:28Z,,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,,,2015-06-22T14:20:03Z,,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,,,2015-06-22T14:22:03Z,,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,,,2015-06-22T14:41:11Z,,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,,,2015-06-22T14:46:34Z,,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,,,2015-06-22T14:50:16Z,,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,,,2015-06-22T14:59:57Z,,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,,,2015-06-22T15:31:30Z,,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,,,2015-06-22T14:56:40Z,,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,,,2015-06-22T15:21:22Z,,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,,,2015-06-22T15:09:41Z,,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,,,2015-06-22T15:19:32Z,,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,,,2015-06-22T14:30:38Z,,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° 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,,,2015-06-22T14:37:31Z,,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,,,2015-06-22T14:47:50Z,,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,,,2015-06-22T15:27:47Z,,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,,,2015-06-22T14:46:11Z,,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,,,2015-06-22T15:03:10Z,,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,,,2015-06-22T15:10:46Z,,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. 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,,,2015-06-22T14:48:48Z,,0,0,0900006481a11345
FDA-1996-N-0006-0098,FDA,FDA-1996-N-0006,"Summary of Meeting Announcement from FDA CDER re FDA Implementation of the Sunscreen Innovation Act SIA February 4 2015, FDA-1996-N-0006-0097",Supporting & Related Material,Meeting Summary,2015-02-23T05:00:00Z,2015,2,,,2015-05-13T13:55:57Z,,0,0,0900006481a103e1
FDA-1996-N-0006-0099,FDA,FDA-1996-N-0006,"Slide Presentatition from the Sunscreen Innovation Act Stakeholder Meeting re FDA Implementation of the Sunscreen Innovation Act SIA February 4 2015, FDA-1996-N-0006-0097",Supporting & Related Material,Meeting Materials,2015-02-23T05:00:00Z,2015,2,,,2015-02-23T22:19:50Z,,0,0,0900006481a1078d
FDA-1996-N-0006-0097,FDA,FDA-1996-N-0006,"Meeting Announcement from FDA CDER re FDA Implementation of the Sunscreen Innovation Act (SIA), February 4 2015",Other,Memorandum,2015-01-26T05:00:00Z,2015,1,2015-01-26T05:00:00Z,,2015-05-05T20:00:27Z,,0,0,09000064819e06e2