{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" and docket_id = \"FDA-2004-N-0511\" sorted by posted_date descending", "rows": [["FDA-2004-N-0511-0046", "FDA", "FDA-2004-N-0511", "Reference 5 - Johns Hopkins Bloomberg School of Public Health, Information and Knoledge for Optimal Health (INFO) Project, http://www.infoforhealth.org/globalhandbook/book/fph_chapter13/fph_chap13_how_to_use.shtml re: Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant; Proposed Rule", "Supporting & Related Material", "Background Material", "2016-03-04T05:00:00Z", 2016, 3, null, null, "2016-03-04T15:51:55Z", null, 0, 0, "0900006481ea08b8"], ["FDA-2004-N-0511-0044", "FDA", "FDA-2004-N-0511", "Tab A - Draft Regulatory Action as submitted to OMB OIRA for review re: Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant; Proposed Rule", "Supporting & Related Material", "Background Material", "2016-03-04T05:00:00Z", 2016, 3, null, null, "2016-03-04T15:14:22Z", null, 0, 0, "0900006480477c1a"], ["FDA-2004-N-0511-0045", "FDA", "FDA-2004-N-0511", "Tab B - Substantive Changes between Draft Submitted to OIRA for Review and Action Subsequently Announced, including changes in Regulatory Action re: Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant; Proposed Rule", "Supporting & Related Material", "Background Material", "2016-03-04T05:00:00Z", 2016, 3, null, null, "2016-03-04T15:22:07Z", null, 0, 0, "0900006480477c18"], ["FDA-2004-N-0511-0043", "FDA", "FDA-2004-N-0511", "OMB Review Notice to Dockets re: Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant; Proposed Rule", "Supporting & Related Material", "Background Material", "2016-03-04T05:00:00Z", 2016, 3, null, null, "2016-03-04T19:07:58Z", null, 0, 0, "0900006480477c19"], ["FDA-2004-N-0511-0035", "FDA", "FDA-2004-N-0511", "Attachment 4 Nonoxynol-9 & STDs, Including HIV re: Comment from Medical Institute for Sexual Health", "Supporting & Related Material", "Background Material", "2016-03-01T05:00:00Z", 2016, 3, null, null, "2016-03-01T17:39:54Z", null, 0, 0, "0900006481e95bec"], ["FDA-2004-N-0511-0025", "FDA", "FDA-2004-N-0511", "Attachment 4  Condom Effectiveness Fact Sheet by J. Thomas Fitch re: Comment from J. Thomas Fitch, M.D., P.A.", "Supporting & Related Material", "Background Material", "2016-03-01T05:00:00Z", 2016, 3, null, null, "2016-03-01T16:54:28Z", null, 0, 0, "0900006481e95de2"], ["FDA-2004-N-0511-0027", "FDA", "FDA-2004-N-0511", "Attachment 6 Mathematical Model for Effectiveness of Condoms Over Time with Multiple Acts of Sex with an Infected Partner re: Comment from J. Thomas Fitch, M.D., P.A.", "Supporting & Related Material", "Background Material", "2016-03-01T05:00:00Z", 2016, 3, null, null, "2016-03-01T17:00:59Z", null, 0, 0, "0900006481e95de4"], ["FDA-2004-N-0511-0034", "FDA", "FDA-2004-N-0511", "Attachment 3 Condom Label Comprehension Study Protocol MI2005CON-001 re: Comment from Medical Institute for Sexual Health", "Supporting & Related Material", "Background Material", "2016-03-01T05:00:00Z", 2016, 3, null, null, "2016-03-01T17:36:29Z", null, 0, 0, "0900006480477c35"], ["FDA-2004-N-0511-0023", "FDA", "FDA-2004-N-0511", "Attachment 2 Draft Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex re: Comment from J. Thomas Fitch, M.D., P.A.", "Supporting & Related Material", "Background Material", "2016-03-01T05:00:00Z", 2016, 3, null, null, "2016-03-01T15:23:52Z", null, 0, 0, "0900006481e950b1"], ["FDA-2004-N-0511-0024", "FDA", "FDA-2004-N-0511", "Attachment 3 Bibliography re: Comment from J. Thomas Fitch, M.D., P.A.", "Supporting & Related Material", "Background Material", "2016-03-01T05:00:00Z", 2016, 3, null, null, "2016-03-01T16:33:50Z", null, 0, 0, "0900006481e950b2"], ["FDA-2004-N-0511-0019", "FDA", "FDA-2004-N-0511", "Attachment 2 Cates, W. 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Thomas Fitch, M.D., P.A.", "Supporting & Related Material", "Background Material", "2016-03-01T05:00:00Z", 2016, 3, null, null, "2016-03-01T15:19:19Z", null, 0, 0, "0900006481e950b0"], ["FDA-2004-N-0511-0026", "FDA", "FDA-2004-N-0511", "Attachment 5 FDA Condoms and Sexually Transmitted Diseases...especially AIDS re: Comment from J. 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Chancroid--Reported Cases and Rates by State/Area Listed in Alphabetical Order: United States and Outlying Areas, 2002-2006\" [Last accessed 5/15/2008 at http://www.cdc.gov/std/stats/tables/table41.htm] re: Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex", "Supporting & Related Material", "Background Material", "2008-11-12T05:00:00Z", 2008, 11, null, null, "2016-03-04T17:45:56Z", null, 0, 0, "09000064807a1574"], ["FDA-2004-N-0511-0007", "FDA", "FDA-2004-N-0511", "Reference 34 - 11th Report on Carcinongens, National Toxicology Program, January 31, 2005. (Fact Sheet) re: Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex", "Supporting & Related Material", "Background Material", "2008-11-12T05:00:00Z", 2008, 11, null, null, "2016-03-04T17:43:54Z", null, 0, 0, "0900006480477bd8"], ["FDA-2004-N-0511-0008", "FDA", "FDA-2004-N-0511", "Reference 4 - National Institute of Allergy and Infectious Disease, Workshop Summary: Scientific Evidence on Condom Effectiveness for Sexually Transmitted Diseases (STD) Prevention, July 2001. re: Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex", "Supporting & Related Material", "Background Material", "2008-11-12T05:00:00Z", 2008, 11, null, null, "2016-03-04T17:44:33Z", null, 0, 0, "0900006480477bdd"], ["FDA-2004-N-0511-0006", "FDA", "FDA-2004-N-0511", "Reference 22 - Centers for Disease Control and Prevention, Tracking the Hidden Epidemics 2000, Trends in STDs in the United States, Chancroid (http://www.cdc/gov/nchstp/dstd/Stats_Trends/Trends2000.pdf). re: Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex", "Supporting & Related Material", "Background Material", "2008-11-12T05:00:00Z", 2008, 11, null, null, "2016-03-04T17:43:23Z", null, 0, 0, "0900006480477bc6"], ["FDA-2004-N-0511-0009", "FDA", "FDA-2004-N-0511", "Reference 9 - CDC Prevention, Dept of Health and Human Services, Report to Congress: Prevention of Genital Human Papillomavirus Infection, 18, January 2004. re: Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex", "Supporting & Related Material", "Background Material", "2008-11-12T05:00:00Z", 2008, 11, null, null, "2016-03-04T17:45:26Z", null, 0, 0, "0900006480477be2"], ["FDA-2004-N-0511-0011", "FDA", "FDA-2004-N-0511", "Reference 1 - Centers for Disease Control and Prevention \"Table 41. 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