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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

19 rows where agency_id = "FDA" and docket_id = "FDA-2005-D-0445" sorted by posted_date descending

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posted_year 4

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  • FDA · 19 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2005-D-0445-0012 FDA Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, re FDA-2012-N-0115 FDA-2005-D-0445 References 3 re Draft Guidance for Industry and Food and Drug Administration Staff on Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle; Availability Supporting & Related Material Background Material 2015-01-20T05:00:00Z 2015 1     2015-01-20T23:51:26Z   0 0 09000064804505e1
FDA-2005-D-0445-0015 FDA Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, re FDA-2012-N-0115 FDA-2005-D-0445 Reference 6 re Draft Guidance for Industry and Food and Drug Administration Staff on Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle Availability FDA-2005-D-0445-0001 Supporting & Related Material Background Material 2015-01-20T05:00:00Z 2015 1     2015-01-20T23:52:37Z   0 0 09000064804505e5
FDA-2005-D-0445-0018 FDA Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, re FDA-2012-N-0115 FDA-2005-D-0445 Reference 2 re Guidance for Industry and Food and Drug Administration Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle; Availability, FDA-2005-D-0445-0007 Supporting & Related Material Reference (internal unless indicated) 2015-01-20T05:00:00Z 2015 1     2015-01-21T00:11:51Z   0 0 09000064804505f4
FDA-2005-D-0445-0011 FDA Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, re FDA-2012-N-0115 FDA-2005-D-0445 Reference 2 re Draft Guidance for Industry and Food and Drug Administration Staff on Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle; Availability, FDA-2005-D-0445-0001 Supporting & Related Material Background Material 2015-01-20T05:00:00Z 2015 1     2015-01-20T23:51:09Z   0 0 09000064804505e0
FDA-2005-D-0445-0014 FDA Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, re FDA-2012-N-0115 FDA-2005-D-0445 Reference 5 re Draft Guidance for Industry and Food and Drug Administration Staff on Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle Availability FDA-2005-D-0445-0001 Supporting & Related Material Background Material 2015-01-20T05:00:00Z 2015 1     2015-01-20T23:52:28Z   0 0 09000064804505e3
FDA-2005-D-0445-0019 FDA Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, re FDA-2012-N-0115 FDA-2005-D-0445 Reference 3 re Guidance for Industry and Food and Drug Administration Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle; Availability, FDA-2005-D-0445-0007 Supporting & Related Material Reference (internal unless indicated) 2015-01-20T05:00:00Z 2015 1     2015-01-21T00:11:58Z   0 0 09000064804505f3
FDA-2005-D-0445-0013 FDA Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, re FDA-2012-N-0115 FDA-2005-D-0445 Reference 4 re Draft Guidance for Industry and Food and Drug Administration Staff on Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle Availability FDA-2005-D-0445-0001 Supporting & Related Material Background Material 2015-01-20T05:00:00Z 2015 1     2015-01-20T23:52:23Z   0 0 09000064804505e2
FDA-2005-D-0445-0017 FDA Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, re FDA-2012-N-0115 FDA-2005-D-0445 Reference 1 re Guidance for Industry and Food and Drug Administration Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle; Availability, FDA-2005-D-0455-0007 Supporting & Related Material Reference (internal unless indicated) 2015-01-20T05:00:00Z 2015 1     2015-01-21T00:11:40Z   0 0 09000064804505f5
FDA-2005-D-0445-0009 FDA Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, re FDA-2012-N-0115 FDA-2005-D-0445 Reference List re Draft Guidance for Industry and Food and Drug Administration Staff on Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle; Availability, FDA-2005-D-0445-0001 Supporting & Related Material Background Material 2015-01-20T05:00:00Z 2015 1     2015-01-20T23:50:21Z   0 0 09000064804505e9
FDA-2005-D-0445-0010 FDA Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, re FDA-2012-N-0115 FDA-2005-D-0445 Reference 1 re Draft Guidance for Industry and Food and Drug Administration Staff on Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle; Availability, FDA-2005-D-0445-0001 Supporting & Related Material Background Material 2015-01-20T05:00:00Z 2015 1     2015-01-20T23:50:55Z   0 0 09000064804505df
FDA-2005-D-0445-0016 FDA Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, re FDA-2012-N-0115 FDA-2005-D-0445 Reference List re Guidance for Industry and Food and Drug Administration Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, FDA-2005-D-0445-0007 Supporting & Related Material Reference (internal unless indicated) 2015-01-20T05:00:00Z 2015 1     2015-01-21T00:11:32Z   0 0 09000064804505f6
FDA-2005-D-0445-0007 FDA Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, re FDA-2012-N-0115 FDA-2005-D-0445 Guidance for Industry and Food and Drug Administration Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle; Availability Notice Notice of Availability 2007-11-30T05:00:00Z 2007 11 2007-11-30T05:00:00Z   2015-01-20T23:53:18Z   0 0 09000064804505f1
FDA-2005-D-0445-0008 FDA Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, re FDA-2012-N-0115 FDA-2005-D-0445 Guidance for Industry and Food and Drug Administration Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle; Final Guidance Document Other Guidance 2007-11-30T05:00:00Z 2007 11     2015-01-21T00:13:53Z   0 0 09000064804505f2
FDA-2005-D-0445-0006 FDA Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, re FDA-2012-N-0115 FDA-2005-D-0445 Agency Information Collection Activities ; Announcement of Office of Management and Budget Approval; Guidance for Industry and Food and Drug Administration Staff on Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle Notice Notice of Approval 2007-01-22T05:00:00Z 2007 1 2007-01-19T05:00:00Z   2015-01-20T23:28:44Z   0 0 09000064804505f0
FDA-2005-D-0445-0004 FDA Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, re FDA-2012-N-0115 FDA-2005-D-0445 Supporting Statement for Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle Supporting & Related Material SS-Supporting Statement 2007-01-22T05:00:00Z 2007 1     2015-01-21T00:18:50Z   0 0 09000064804505ee
FDA-2005-D-0445-0005 FDA Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, re FDA-2012-N-0115 FDA-2005-D-0445 Supporting Statement for Draft Guidance for Industry and Food and Drug Administration Staff Class II Special Controls Guidance Document Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle re FDA 2005 D 0445 0006 Supporting & Related Material SS-Supporting Statement 2007-01-22T05:00:00Z 2007 1     2015-01-21T00:18:24Z   0 0 09000064804505ef
FDA-2005-D-0445-0003 FDA Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, re FDA-2012-N-0115 FDA-2005-D-0445 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Food and Drug Administration Staff on Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle Notice 60 Day Proposed Information Collection 2006-06-13T04:00:00Z 2006 6     2015-01-20T23:26:19Z   0 0 09000064804505ed
FDA-2005-D-0445-0002 FDA Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, re FDA-2012-N-0115 FDA-2005-D-0445 Draft Guidance for Industry and Food and Drug Administration Staff on Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle; Guidance Document Other Guidance 2005-03-14T05:00:00Z 2005 3     2015-01-21T00:07:47Z   0 0 09000064804505dd
FDA-2005-D-0445-0001 FDA Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, re FDA-2012-N-0115 FDA-2005-D-0445 Draft Guidance for Industry and Food and Drug Administration Staff on Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle; Availability Notice Notice of Availability 2005-03-14T05:00:00Z 2005 3 2005-03-09T05:00:00Z 2005-06-09T03:59:59Z 2015-01-21T03:02:50Z   0 0 09000064804505dc

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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);