home / openregs

documents

Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

27 rows where docket_id = "FDA-2004-N-0511" sorted by posted_date descending

✎ View and edit SQL

This data as json, CSV (advanced)

Suggested facets: subtype, posted_date, posted_month, withdrawn, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

posted_year 4

  • 2016 16
  • 2008 7
  • 2009 3
  • 2005 1

document_type 3

  • Supporting & Related Material 25
  • Proposed Rule 1
  • Rule 1

agency_id 1

  • 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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

Advanced export

JSON shape: default, array, newline-delimited, object

CSV options:

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);
Powered by Datasette · Queries took 34.896ms · Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API