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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

comment_end_date
A FULL UTC INSTANT, not a calendar date, despite the column name: '2026-08-29T03:59:59Z' is 11:59:59 PM EASTERN on 2026-08-28. Federal comment periods close at 11:59:59 PM Eastern, so the UTC calendar date is ONE DAY LATER than the official deadline on every end-of-day close — 444,689 of the 444,690 populated rows (measured 2026-09-06). Convert to America/New_York before presenting a deadline, and compare with julianday(comment_end_date) > julianday('now'): a plain > datetime('now') is a TEXT comparison between two different formats and keeps already-closed dockets matching for up to ~20 hours. The sibling column on open_comments.documents WAS corrected to an Eastern calendar date (queue #498); this one is unchanged and still an instant — the two databases do not agree on grain. (queue #644)
comment_start_date
A FULL UTC INSTANT, not a calendar date, despite the column name — same grain as comment_end_date on this table. Convert to America/New_York before presenting it. (queue #644)

7 rows where docket_id = "FDA-2022-E-2011" sorted by posted_date descending

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posted_year 4

  • 2022 3
  • 2023 2
  • 2024 1
  • 2025 1

document_type 2

  • Other 6
  • Notice 1

agency_id 1

  • FDA 7
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2022-E-2011-0007 FDA Patent Extension Application for LYBALVI® (olanzapine and samidorphan), Patent No. 9,126,977 FDA-2022-E-2011 Letter to U.S. Patent and Trademark Office Other Letter(s) 2025-01-27T05:00:00Z 2025 1 2025-01-27T05:00:00Z   2025-01-27T16:59:11Z   0 0 090000648690058b
FDA-2022-E-2011-0006 FDA Patent Extension Application for LYBALVI® (olanzapine and samidorphan), Patent No. 9,126,977 FDA-2022-E-2011 Letter from U.S. Patent and Trademark Office to FDA CDER Other Letter(s) 2024-02-27T05:00:00Z 2024 2 2024-02-27T05:00:00Z   2024-02-27T15:45:08Z   0 0 09000064863e558d
FDA-2022-E-2011-0005 FDA Patent Extension Application for LYBALVI® (olanzapine and samidorphan), Patent No. 9,126,977 FDA-2022-E-2011 Letter to U. S. Patent and Trademark Office from FDA CDER Other Letter(s) 2023-12-29T05:00:00Z 2023 12 2023-12-29T05:00:00Z   2023-12-29T14:12:16Z   0 0 0900006486365699
FDA-2022-E-2011-0004 FDA Patent Extension Application for LYBALVI® (olanzapine and samidorphan), Patent No. 9,126,977 FDA-2022-E-2011 Determination of Regulatory Review Period for Purposes of Patent Extension; LYBALV Notice Determinations 2023-12-21T05:00:00Z 2023 12 2023-12-21T05:00:00Z 2024-02-21T04:59:59Z 2023-12-21T15:32:46Z 2023-28094 0 0 090000648634e3d5
FDA-2022-E-2011-0003 FDA Patent Extension Application for LYBALVI® (olanzapine and samidorphan), Patent No. 9,126,977 FDA-2022-E-2011 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2022-09-28T04:00:00Z 2022 9 2022-09-28T04:00:00Z   2022-09-28T20:28:55Z   0 0 090000648537ac33
FDA-2022-E-2011-0001 FDA Patent Extension Application for LYBALVI® (olanzapine and samidorphan), Patent No. 9,126,977 FDA-2022-E-2011 Letter from U S Patent and Trademark Office Other Letter(s) 2022-08-25T04:00:00Z 2022 8 2022-08-25T04:00:00Z   2022-08-25T13:53:24Z   0 0 09000064852734ff
FDA-2022-E-2011-0002 FDA Patent Extension Application for LYBALVI® (olanzapine and samidorphan), Patent No. 9,126,977 FDA-2022-E-2011 Patent Term Extension Application for LYBALVI® Patent No 9,126,977 Other Application 2022-08-25T04:00:00Z 2022 8 2022-08-25T04:00:00Z   2022-08-25T13:54:53Z   0 0 0900006485273901

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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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