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withdrawn,object_id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-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,,,2016-03-04T15:51:55Z,,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,,,2016-03-04T15:14:22Z,,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,,,2016-03-04T15:22:07Z,,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,,,2016-03-04T19:07:58Z,,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,,,2016-03-01T17:39:54Z,,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,,,2016-03-01T16:54:28Z,,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,,,2016-03-01T17:00:59Z,,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,,,2016-03-01T17:36:29Z,,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,,,2016-03-01T15:23:52Z,,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,,,2016-03-01T16:33:50Z,,0,0,0900006481e950b2
FDA-2004-N-0511-0019,FDA,FDA-2004-N-0511,"Attachment 2 Cates, W. The NIH Condom Report: The Glass is 90% Full re: Comment from Family Health International",Supporting & Related Material,Background Material,2016-03-01T05:00:00Z,2016,3,,,2016-03-01T15:03:52Z,,0,0,0900006481e94b97
FDA-2004-N-0511-0033,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 Medical Institute for Sexual Health,Supporting & Related Material,Background Material,2016-03-01T05:00:00Z,2016,3,,,2016-03-01T17:32:33Z,,0,0,0900006480477c33
FDA-2004-N-0511-0022,FDA,FDA-2004-N-0511,"Attachment 1 Copy of Federal Register 70FR218 Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicrdal Lubricant re: Comment from J. Thomas Fitch, M.D., P.A.",Supporting & Related Material,Background Material,2016-03-01T05:00:00Z,2016,3,,,2016-03-01T15:19:19Z,,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. Thomas Fitch, M.D., P.A.",Supporting & Related Material,Background Material,2016-03-01T05:00:00Z,2016,3,,,2016-03-01T16:57:30Z,,0,0,0900006481e95de3
FDA-2004-N-0511-0020,FDA,FDA-2004-N-0511,"Attachment 3 Steiner, Cates, and Warner The Real Problem with Male Condome is Nonuse re: Comment from Family Health Internationa",Supporting & Related Material,Background Material,2016-03-01T05:00:00Z,2016,3,,,2016-03-01T15:04:58Z,,0,0,0900006481e94b98
FDA-2004-N-0511-0032,FDA,FDA-2004-N-0511,Attachment 1 Recommended Changes to Proposed Rule Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant re: Comment from Medical Institute for Sexual Health,Supporting & Related Material,Background Material,2016-03-01T05:00:00Z,2016,3,,,2016-03-01T17:32:44Z,,0,0,0900006480477c34
FDA-2004-N-0511-0013,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; Final Rule,Supporting & Related Material,Background Material,2009-06-21T04:00:00Z,2009,6,,,2016-03-04T19:13:18Z,,0,0,09000064809d21a0
FDA-2004-N-0511-0012,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; Final Rule,Supporting & Related Material,Background Material,2009-06-21T04:00:00Z,2009,6,,,2016-03-04T19:10:44Z,,0,0,09000064809d1c3c
FDA-2004-N-0511-0014,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; Final Rule",Supporting & Related Material,Background Material,2009-06-21T04:00:00Z,2009,6,,,2016-03-04T19:16:03Z,,0,0,09000064809d2751
FDA-2004-N-0511-0010,FDA,FDA-2004-N-0511,"Reference 1 - CDC and Prevention ""Table 41.  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,,,2016-03-04T17:45:56Z,,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,,,2016-03-04T17:43:54Z,,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,,,2016-03-04T17:44:33Z,,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,,,2016-03-04T17:43:23Z,,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,,,2016-03-04T17:45:26Z,,0,0,0900006480477be2
FDA-2004-N-0511-0011,FDA,FDA-2004-N-0511,"Reference 1 - Centers for Disease Control and Prevention ""Table 41. 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]",Supporting & Related Material,,2008-11-12T00:00:00Z,2008,11,,,2016-03-04T15:45:49Z,,0,1,090000648079cd25
FDA-2004-N-0511-0005,FDA,FDA-2004-N-0511,Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex,Rule,Final Rule,2008-11-10T05:00:00Z,2008,11,2008-11-10T05:00:00Z,,2016-03-04T16:13:54Z,E8-26825,0,0,09000064807a13e7
FDA-2004-N-0511-0001,FDA,FDA-2004-N-0511,Obstetrical and Gynecological Devices; for Condom and Condom with Spermicidal Lubricant,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2005-11-14T05:00:00Z,2005,11,2005-11-14T05:00:00Z,2006-02-14T04:59:59Z,2016-02-29T21:00:43Z,,0,0,0900006480477bc1