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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)

6 rows where docket_id = "FDA-2026-P-12080" sorted by posted_date descending

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document_type 2

  • Supporting & Related Material 4
  • Other 2

posted_year 1

  • 2026 6

agency_id 1

  • FDA 6
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2026-P-12080-0003 FDA Requests that the FDA declare that the drug product Metformin HCL Oral Solution, 1,000 mg/15 mL, is suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-12080 Attachment 1 Supporting & Related Material Background Material 2026-10-13T04:00:00Z 2026 10     2026-10-13T16:27:06Z   0 0 09000064b96484f5
FDA-2026-P-12080-0005 FDA Requests that the FDA declare that the drug product Metformin HCL Oral Solution, 1,000 mg/15 mL, is suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-12080 Attachment 3 Supporting & Related Material Background Material 2026-10-13T04:00:00Z 2026 10     2026-10-13T16:27:12Z   0 0 09000064b96484f7
FDA-2026-P-12080-0001 FDA Requests that the FDA declare that the drug product Metformin HCL Oral Solution, 1,000 mg/15 mL, is suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-12080 Suitability Petition from Hyman, Phelps & McNamara, P.C. Other Petition(s) 2026-10-13T04:00:00Z 2026 10 2026-10-13T04:00:00Z   2026-10-13T16:26:56Z   1 0 09000064b964de38
FDA-2026-P-12080-0006 FDA Requests that the FDA declare that the drug product Metformin HCL Oral Solution, 1,000 mg/15 mL, is suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-12080 Attachment 4 Supporting & Related Material Background Material 2026-10-13T04:00:00Z 2026 10     2026-10-13T16:27:15Z   0 0 09000064b96484f8
FDA-2026-P-12080-0004 FDA Requests that the FDA declare that the drug product Metformin HCL Oral Solution, 1,000 mg/15 mL, is suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-12080 Attachment 2 Supporting & Related Material Background Material 2026-10-13T04:00:00Z 2026 10     2026-10-13T16:27:09Z   0 0 09000064b96484f6
FDA-2026-P-12080-0002 FDA Requests that the FDA declare that the drug product Metformin HCL Oral Solution, 1,000 mg/15 mL, is suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-12080 Acknowledgement Letter from FDA DMB to Hyman, Phelps & McNamara, P.C. Other Acknowledgement Letter/Receipt 2026-10-13T04:00:00Z 2026 10 2026-10-13T04:00:00Z   2026-10-13T16:27:01Z   0 0 09000064b964de3a

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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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