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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

18 rows where docket_id = "FDA-2000-N-0108" and posted_year = 2003 sorted by posted_date descending

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Suggested facets: title, subtype, posted_date, posted_month, comment_start_date, comment_end_date, withdrawn, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

document_type 2

  • Supporting & Related Material 14
  • Proposed Rule 4

posted_year 1

  • 2003 · 18 ✖

agency_id 1

  • FDA 18
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2000-N-0108-0008 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Tab B - "OMB Review March 14, 2003, Executive Order 12866, Changes in the Regulatory Action Made by OIRA" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 79-174) Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2010-02-26T21:17:41Z   0 0 09000064804c2946
FDA-2000-N-0108-0012 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Tab A - "OMB Review March 14, 2003, Executive Order 12866, Substantive Changes Between the Draft Submitted to OIRA and Action Subsequently Announced" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 200-307) Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2010-02-26T21:34:12Z   0 0 09000064804c2951
FDA-2000-N-0108-0018 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Tab A - "OMB Review March 14, 2003, Executive Order 12866, Substantive Changes Between the Draft Submitted to OIRA and Action Subsequently Announced" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 308-406) Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2010-02-26T21:36:23Z   0 0 09000064804c2967
FDA-2000-N-0108-0013 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Tab B - "OMB Review March 14, 2003, Executive Order 12866, Changes in the Regulatory Action Made by OIRA" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 377-464) Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2010-02-26T21:27:30Z   0 0 09000064804c2954
FDA-2000-N-0108-0017 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Tab B - "OMB Review March 14, 2003, Executive Order 12866, Changes in the Regulatory Action Made by OIRA" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 278-376) Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2010-02-26T21:21:09Z   0 0 09000064804c2964
FDA-2000-N-0108-0015 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Tab B - "OMB Review March 14, 2003, Executive Order 12866, Changes in the Regulatory Action Made by OIRA" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 1-78) Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2010-02-26T21:11:52Z   0 0 09000064804c295e
FDA-2000-N-0108-0011 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Tab A - "OMB Review March 14, 2003, Executive Order 12866, Substantive Changes Between the Draft Submitted to OIRA and Action Subsequently Announced" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 100-199) Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2010-02-26T21:32:47Z   0 0 09000064804c294e
FDA-2000-N-0108-0009 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Reference Regulations Policy Management Staff to the Docket, OMB Review March 14, 2003, Executive Order 12866" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2016-02-24T16:51:58Z   0 0 09000064804c294a
FDA-2000-N-0108-0016 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Tab B - "OMB Review March 14, 2003, Executive Order 12866, Changes in the Regulatory Action Made by OIRA" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 175-277) Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2010-02-26T21:19:39Z   0 0 09000064804c2961
FDA-2000-N-0108-0014 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Tab A - "OMB Review March 14, 2003, Executive Order 12866, Substantive Changes Between the Draft Submitted to OIRA and Action Subsequently Announced" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 407-464) Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2010-02-26T21:35:14Z   0 0 09000064804c2957
FDA-2000-N-0108-0010 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Tab A - "OMB Review March 14, 2003, Executive Order 12866, Substantive Changes Between the Draft Submitted to OIRA and Action Subsequently Announced" - (Safety Reporting Requirements for Human Drug and Biological Products), re FDA-2000-N-0108-0006 - Reference (Pages 1-99) Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-03T05:00:00Z 2003 11     2010-02-26T21:16:06Z   0 0 09000064804c294b
FDA-2000-N-0108-0007 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Safety Reporting Requirements for Human Drug and Biological Products; Extension of Comment Period Proposed Rule NEC-Notice of Extension 2003-07-01T04:00:00Z 2003 7 2003-06-17T04:00:00Z 2003-10-15T03:59:59Z 2016-12-21T02:02:24Z   0 0 09000064804c2749
FDA-2000-N-0108-0001 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Notice of Proposed Rulemaking re Safety Reporting Requirements for Human Drug and Biological Products See FDA-2000-N-0108-0006 Proposed Rule Notice of Proposed Rulemaking (NPRM) 2003-03-18T05:00:00Z 2003 3 2003-03-18T05:00:00Z 2003-07-15T03:59:59Z 2016-12-24T19:42:06Z   0 0 09000064804c265e
FDA-2000-N-0108-0006 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 Notice of Proposed Rulemaking re Safety Reporting Requirements for Human Drug and Biological Products Proposed Rule Notice of Proposed Rulemaking (NPRM) 2003-03-18T05:00:00Z 2003 3 2003-03-18T05:00:00Z 2003-07-15T03:59:59Z 2016-02-24T19:29:20Z   0 0 09000064804c2702
FDA-2000-N-0108-0004 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 See FDA-2000-N-0108-0006 Supporting & Related Material   2003-03-18T00:00:00Z 2003 3     2016-03-02T20:20:20Z   0 1 09000064804c26fd
FDA-2000-N-0108-0002 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 See FDA-2000-N-0108-0006 Supporting & Related Material   2003-03-18T00:00:00Z 2003 3     2016-02-24T19:16:56Z   0 1 09000064804c26f7
FDA-2000-N-0108-0003 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 See FDA-2000-N-0108-0006 Proposed Rule   2003-03-18T00:00:00Z 2003 3     2016-03-02T20:23:54Z   0 1 09000064804c26fb
FDA-2000-N-0108-0005 FDA Safety Reporting Requirements Human Drug/Biological Products - CLOSED FDA-2000-N-0108 See FDA-2000-N-0108-0006 Supporting & Related Material   2003-03-18T00:00:00Z 2003 3     2016-03-02T19:41:42Z   0 1 09000064804c2700

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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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