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withdrawn,object_id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