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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

9 rows where docket_id = "FDA-1996-N-0274" sorted by posted_date descending

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

document_type 5

  • Supporting & Related Material 4
  • Other 2
  • Notice 1
  • Proposed Rule 1
  • Rule 1

posted_year 2

  • 2017 7
  • 2016 2

agency_id 1

  • FDA 9
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1996-N-0274-0016 FDA Sterility Requirements for Inhalation Solution Products- CLOSED FDA-1996-N-0274 Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation Rule Final Rule 2017-01-13T05:00:00Z 2017 1 2017-01-13T05:00:00Z 2002-05-28T03:59:59Z 2017-04-12T16:39:39Z 2000-13210 0 0 090000648050450d
FDA-1996-N-0274-0017 FDA Sterility Requirements for Inhalation Solution Products- CLOSED FDA-1996-N-0274 Reference 1: Eastern Research Group: "Cost Impact on the Pharmaceutical Industry of Final Sterility Requirements for Inhalation Solution Products" Final Report July 23, 1998 Supporting & Related Material Background Material 2017-01-13T05:00:00Z 2017 1     2017-01-13T15:39:25Z   0 0 090000648050450c
FDA-1996-N-0274-0019 FDA Sterility Requirements for Inhalation Solution Products- CLOSED FDA-1996-N-0274 Letter from FDA CDER to Pascal Company, Inc Other Letter(s) 2017-01-13T05:00:00Z 2017 1 2017-01-13T05:00:00Z   2017-01-13T15:47:21Z   0 0 0900006480504510
FDA-1996-N-0274-0021 FDA Sterility Requirements for Inhalation Solution Products- CLOSED FDA-1996-N-0274 Tab A - Draft Regulatory Action as submitted to OMB OIRA for review re: Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation; Final Rule Supporting & Related Material Background Material 2017-01-13T05:00:00Z 2017 1     2017-01-13T16:18:42Z   0 0 0900006480504516
FDA-1996-N-0274-0018 FDA Sterility Requirements for Inhalation Solution Products- CLOSED FDA-1996-N-0274 Letter from Pascal Company, Inc to FDA CDER Other Letter(s) 2017-01-13T05:00:00Z 2017 1 2017-01-13T05:00:00Z   2017-01-13T15:43:54Z   0 0 090000648050450f
FDA-1996-N-0274-0022 FDA Sterility Requirements for Inhalation Solution Products- CLOSED FDA-1996-N-0274 Tab B - Substantive Changes between Draft submitted to OIRA for Review and Action Subsequently Announced re: Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation; Final Rule Supporting & Related Material Background Material 2017-01-13T05:00:00Z 2017 1     2017-01-13T16:22:27Z   0 0 0900006480504512
FDA-1996-N-0274-0020 FDA Sterility Requirements for Inhalation Solution Products- CLOSED FDA-1996-N-0274 OMB Review Notice to Dockets re: Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation; Final Rule Supporting & Related Material Background Material 2017-01-13T05:00:00Z 2017 1     2017-01-13T16:15:14Z   0 0 0900006480504515
FDA-1996-N-0274-0012 FDA Sterility Requirements for Inhalation Solution Products- CLOSED FDA-1996-N-0274 Agency Information Collection Activities; Announcement of OMB Approval (Sterility Requirements for Inhalation Solution Products) Notice Notice of Approval 2016-10-06T04:00:00Z 2016 10 1997-12-30T05:00:00Z 2000-12-01T04:59:59Z 2017-04-12T16:37:47Z   0 0 0900006480504504
FDA-1996-N-0274-0001 FDA Sterility Requirements for Inhalation Solution Products- CLOSED FDA-1996-N-0274 Sterility Requirements for Inhalation Solution Products Proposed Rule Notice of Proposed Rulemaking (NPRM) 2016-09-21T04:00:00Z 2016 9 1997-09-23T04:00:00Z 1997-12-23T04:59:59Z 2017-04-12T16:36:07Z 1997–25130 0 0 09000064805044ca

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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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