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

5 rows where docket_id = "FDA-2018-N-2727" and posted_year = 2018 sorted by posted_date descending

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

posted_year 1

  • 2018 · 5 ✖

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2018-N-2727-0011 FDA None FDA-2018-N-2727 Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations; Extension of Comment Period Proposed Rule Extension of Comment Period 2018-12-20T05:00:00Z 2018 12 2018-12-20T05:00:00Z 2019-02-14T04:59:59Z 2019-02-15T02:02:47Z 2018-27519 0 0 09000064839b9103
FDA-2018-N-2727-0006 FDA None FDA-2018-N-2727 Request for Extension from Advanced Medical Technology Association (AdvaMed) Other Request for Extension 2018-11-28T05:00:00Z 2018 11 2018-11-28T05:00:00Z   2018-11-28T21:09:16Z   0 0 09000064838e21ce
FDA-2018-N-2727-0001 FDA None FDA-2018-N-2727 Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-11-15T05:00:00Z 2018 11 2018-11-15T05:00:00Z 2019-01-15T04:59:59Z 2019-01-15T02:01:45Z 2018-24822 0 0 09000064838d9668
FDA-2018-N-2727-0002 FDA None FDA-2018-N-2727 Reference - 2 - 2017-9-20 Memo to file.FDA data analysis re: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations Supporting & Related Material Background Material 2018-11-15T05:00:00Z 2018 11     2018-11-15T21:03:12Z   0 0 09000064838db0ae
FDA-2018-N-2727-0003 FDA None FDA-2018-N-2727 Reference 3- 2018-8-20 Memo re: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations Supporting & Related Material Background Material 2018-11-15T05:00:00Z 2018 11     2018-11-15T21:00:17Z   0 0 09000064838db657

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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;