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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

16 rows where docket_id = "FDA-2004-N-0511" and posted_year = 2016 sorted by posted_date descending

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  • 2016 · 16 ✖

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  • Supporting & Related Material 16

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  • FDA 16
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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

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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);
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