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27 rows where agency_id = "FDA" and docket_id = "FDA-2004-N-0511" sorted by posted_date descending
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- FDA · 27 ✖
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 | Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 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 |
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CREATE TABLE documents (
id TEXT PRIMARY KEY,
agency_id TEXT,
docket_id TEXT REFERENCES dockets(id),
title TEXT,
document_type TEXT,
subtype TEXT,
posted_date TEXT,
posted_year INTEGER,
posted_month INTEGER,
comment_start_date TEXT,
comment_end_date TEXT,
last_modified TEXT,
fr_doc_num TEXT,
open_for_comment INTEGER,
withdrawn INTEGER,
object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);