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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-2009-D-0008" sorted by posted_date descending

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

posted_year 10

  • 2011 3
  • 2017 3
  • 2019 3
  • 2009 2
  • 2018 2
  • 2010 1
  • 2013 1
  • 2014 1
  • 2025 1
  • 2026 1

document_type 2

  • Notice 11
  • Other 7

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2009-D-0008-0039 FDA None FDA-2009-D-0008 Response Letter Other Letter(s) 2026-01-23T05:00:00Z 2026 1 2026-01-23T05:00:00Z   2026-01-23T19:56:34Z   0 0 09000064b9179963
FDA-2009-D-0008-0038 FDA None FDA-2009-D-0008 Petition for Stay of Action from C. Humphrey & Associates, P.A. Other Petition(s) 2025-03-17T04:00:00Z 2025 3 2025-06-05T04:00:00Z   2025-06-05T21:37:05Z   0 0 09000064b8ddd062
FDA-2009-D-0008-0035 FDA None FDA-2009-D-0008 Citizen Petitions and Petitions for Stay of Action Subject to the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability Notice Notice of Availability 2019-09-19T04:00:00Z 2019 9 2019-09-19T04:00:00Z   2025-03-20T17:18:30Z 2019-20312 0 0 0900006483f9b3a1
FDA-2009-D-0008-0036 FDA None FDA-2009-D-0008 Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry Other Guidance 2019-09-18T04:00:00Z 2019 9 2019-09-18T04:00:00Z   2025-11-14T23:58:27Z   1 0 0900006483fcdaae
FDA-2009-D-0008-0037 FDA None FDA-2009-D-0008 Evaluation of Internal Standard Responses During Chromatographic Bioanalysis Questions and Answers Other Guidance 2019-09-04T04:00:00Z 2019 9 2025-03-20T04:00:00Z   2025-03-20T17:25:25Z   1 0 090000648464ea51
FDA-2009-D-0008-0021 FDA None FDA-2009-D-0008 Draft Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act Other Guidance 2018-10-03T04:00:00Z 2018 10 2018-10-03T04:00:00Z 2018-12-04T04:59:59Z 2019-09-26T17:37:30Z   0 0 09000064837909cd
FDA-2009-D-0008-0020 FDA None FDA-2009-D-0008 Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability Notice Notice of Availability 2018-10-03T04:00:00Z 2018 10 2018-10-03T04:00:00Z 2018-12-04T04:59:59Z 2025-06-05T21:34:13Z 2018-21532 0 0 0900006483790116
FDA-2009-D-0008-0019 FDA None FDA-2009-D-0008 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2017-08-23T04:00:00Z 2017 8 2017-08-23T04:00:00Z   2017-08-23T14:35:48Z 2017-17871 0 0 0900006482aa02d5
FDA-2009-D-0008-0016 FDA None FDA-2009-D-0008 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act Notice 30 Day Proposed Information Collection 2017-04-25T04:00:00Z 2017 4 2017-04-25T04:00:00Z 2017-05-26T03:59:59Z 2017-05-26T01:01:53Z 2017-08307 0 0 0900006482573477
FDA-2009-D-0008-0015 FDA None FDA-2009-D-0008 Agency Information Collection Activities; Proposed Collection; Comment Request; Citizen Petitions and Petitions for Stay of Action Subject Section 505(q) of the Federal Food, Drug, and Cosmetic Act Notice 60 Day Proposed Information Collection 2017-01-10T05:00:00Z 2017 1 2017-01-10T05:00:00Z 2017-03-14T03:59:59Z 2017-01-10T15:07:08Z 2017-00193 0 0 0900006482456bec
FDA-2009-D-0008-0014 FDA None FDA-2009-D-0008 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to the Federal Food, Drug, and Cosmetic Act Notice General Notice 2014-03-11T04:00:00Z 2014 3 2014-03-11T04:00:00Z 2014-04-11T03:59:59Z 2014-03-11T13:36:48Z 2014-05190 0 0 090000648165e20b
FDA-2009-D-0008-0013 FDA None FDA-2009-D-0008 Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act Notice General Notice 2013-10-01T04:00:00Z 2013 10 2013-10-01T04:00:00Z 2013-12-03T04:59:59Z 2014-01-14T16:27:06Z 2013-23886 0 0 09000064814422b6
FDA-2009-D-0008-0012 FDA None FDA-2009-D-0008 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals: Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act Notice NAL-Notice of Approval 2011-06-10T04:00:00Z 2011 6 2011-06-10T04:00:00Z   2011-06-10T13:48:35Z 2011-14411 0 0 0900006480e44627
FDA-2009-D-0008-0011 FDA None FDA-2009-D-0008 Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry Other GDL-Guidance (Supporting and Related Materials) 2011-06-08T04:00:00Z 2011 6 2011-06-08T04:00:00Z   2019-09-26T17:39:25Z   0 0 0900006480e3e6cf
FDA-2009-D-0008-0010 FDA None FDA-2009-D-0008 Guidance for Industry; Availability: Citizen Petitions and Petitions for Stay of Action Notice NAD-Notice of Availability of Data 2011-06-08T04:00:00Z 2011 6 2011-06-08T04:00:00Z   2011-06-08T14:12:00Z 2011-14058 0 0 0900006480e4008d
FDA-2009-D-0008-0009 FDA None FDA-2009-D-0008 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of Federal Food, Drug, and Cosmetic Act Notice N-Notice 2010-12-15T05:00:00Z 2010 12     2010-12-15T22:16:59Z 2010-31380 0 0 0900006480bb70ec
FDA-2009-D-0008-0002 FDA None FDA-2009-D-0008 Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Cood, Drug , and Cosmetic Act - Draft Guidance Other GDL-Guidance (Supporting and Related Materials) 2009-01-21T05:00:00Z 2009 1 2009-01-21T05:00:00Z   2019-09-26T17:38:35Z   0 0 09000064808296b7
FDA-2009-D-0008-0001 FDA None FDA-2009-D-0008 Draft Guidance for Industry: Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act; Availability Notice NAD-Notice of Availability of Data 2009-01-21T05:00:00Z 2009 1 2009-01-21T05:00:00Z 2009-03-24T03:59:59Z 2009-03-20T20:21:21Z E9-00937 0 0 09000064808293db

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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);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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