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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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26 rows where docket_id = "FDA-2016-D-4308" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2016-D-4308-0032 FDA None FDA-2016-D-4308 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2019-02-11T05:00:00Z 2019 2 2019-02-11T05:00:00Z   2019-02-11T12:59:41Z 2019-01812 0 0 0900006483a5e832
FDA-2016-D-4308-0026 FDA None FDA-2016-D-4308 04 Reference 3 Compliance Program Guidance Manual Chapter 42 Blood and Blood Components Inspection of Licensed and Unlicensed Blood Banks Brokers Reference Laboratories and Contractors Supporting & Related Material Background Material 2018-12-21T05:00:00Z 2018 12     2018-12-21T14:36:48Z   0 0 09000064839beb23
FDA-2016-D-4308-0023 FDA None FDA-2016-D-4308 01 RBC Antigen_Reference List Supporting & Related Material Background Material 2018-12-21T05:00:00Z 2018 12     2018-12-21T14:34:03Z   0 0 09000064839beb20
FDA-2016-D-4308-0022 FDA None FDA-2016-D-4308 Labeling of Red Blood Cell Units with Historical Antigen Typing Results; Guidance for Industry Other Guidance 2018-12-21T05:00:00Z 2018 12 2018-12-21T05:00:00Z   2024-11-12T22:52:35Z   1 0 09000064839beb1e
FDA-2016-D-4308-0021 FDA None FDA-2016-D-4308 Labeling of Red Blood Cell Units With Historical Antigen Typing Results; Guidance for Industry; Availability Notice Notice of Availability 2018-12-21T05:00:00Z 2018 12 2018-12-21T05:00:00Z   2018-12-21T14:24:57Z 2018-27654 0 0 09000064839be0a5
FDA-2016-D-4308-0028 FDA None FDA-2016-D-4308 06 Reference 5 AABB Standards for Blood Banks and Transfusion Services 30th edition Supporting & Related Material Background Material 2018-12-21T05:00:00Z 2018 12     2018-12-21T14:38:11Z   0 0 09000064839beb25
FDA-2016-D-4308-0029 FDA None FDA-2016-D-4308 07 Reference 6 FDA Guidance for Industry Computer Crossmatch Computerized Analysis of the Compatibility between the Donors Cell Type and the Recipients Serum or Plasma Type April 2011 Supporting & Related Material Background Material 2018-12-21T05:00:00Z 2018 12     2018-12-21T14:39:29Z   0 0 09000064839be828
FDA-2016-D-4308-0027 FDA None FDA-2016-D-4308 05 Reference 4 Blood Product Advisory Committee Meeting Transcripts_ Dec 4 2012 Supporting & Related Material Background Material 2018-12-21T05:00:00Z 2018 12     2018-12-21T14:37:26Z   0 0 09000064839beb24
FDA-2016-D-4308-0031 FDA None FDA-2016-D-4308 09 Reference 8 FDA Guidance for Industry Availability of FDAs e_Submitter Program for Regulatory Submissions from Licensed Blood Establishments August 2011 Supporting & Related Material Background Material 2018-12-21T05:00:00Z 2018 12     2018-12-21T14:40:39Z   0 0 09000064839be82a
FDA-2016-D-4308-0025 FDA None FDA-2016-D-4308 03 Reference 2 Poole J Daniels G Blood group antibodies and their significance in transfusion medicine Transfus Med Rev 2007 21_58_71 Supporting & Related Material Background Material 2018-12-21T05:00:00Z 2018 12     2018-12-21T14:36:02Z   0 0 09000064839beb22
FDA-2016-D-4308-0024 FDA None FDA-2016-D-4308 02 Reference 1 Daniels G Reid ME Blood groups the past 50 years Transfusion 2010 Feb 50_2_281_9 Supporting & Related Material Background Material 2018-12-21T05:00:00Z 2018 12     2018-12-21T14:35:17Z   0 0 09000064839beb21
FDA-2016-D-4308-0030 FDA None FDA-2016-D-4308 08 Reference 7 FDA Guidance for Industry Submission of CMC and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture Supporting & Related Material Background Material 2018-12-21T05:00:00Z 2018 12     2018-12-21T14:40:04Z   0 0 09000064839be829
FDA-2016-D-4308-0020 FDA None FDA-2016-D-4308 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry: Labeling of Red Blood Cell Units With Historical Antigen Typing Results Notice 30 Day Proposed Information Collection 2018-10-22T04:00:00Z 2018 10 2018-10-22T04:00:00Z 2018-11-22T04:59:59Z 2018-10-22T18:26:51Z 2018-22959 0 0 0900006483837d3f
FDA-2016-D-4308-0008 FDA None FDA-2016-D-4308 Reference 5 Blood Product Advisory ommittee Meeting Transcripts_ Dec 4 2012 re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry Supporting & Related Material Background Material 2017-01-03T05:00:00Z 2017 1     2017-01-03T15:13:53Z   0 0 0900006482446f1b
FDA-2016-D-4308-0011 FDA None FDA-2016-D-4308 09 Reference 8 FDA Guidance for Industry Computer Crossmatch Computerized Analysis of the Compatibility between the Donors Cell Type and the Recipients Serum or Plasma Type April 2011 re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry Supporting & Related Material Background Material 2017-01-03T05:00:00Z 2017 1     2017-01-03T15:14:06Z   0 0 0900006482446f1e
FDA-2016-D-4308-0004 FDA None FDA-2016-D-4308 Reference 1 Daniels G Reid ME Blood groups the past 50 years Transfusion 2010 Feb 50_2_281_9 re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry Supporting & Related Material Background Material 2017-01-03T05:00:00Z 2017 1     2017-01-03T15:13:38Z   0 0 0900006482446e45
FDA-2016-D-4308-0012 FDA None FDA-2016-D-4308 10 Reference 9 FDA Guidance for Industry For the Submission of Chemistry Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry Supporting & Related Material Background Material 2017-01-03T05:00:00Z 2017 1     2017-01-03T15:14:09Z   0 0 0900006482446f1f
FDA-2016-D-4308-0005 FDA None FDA-2016-D-4308 Reference 2 Poole J Daniels G Blood group antibodies and their significance in transfusion medicine Transfus Med Rev 2007 21_58_71 re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry Supporting & Related Material Background Material 2017-01-03T05:00:00Z 2017 1     2017-01-03T15:13:41Z   0 0 0900006482446f18
FDA-2016-D-4308-0001 FDA None FDA-2016-D-4308 Labeling of Red Blood Cell Units With Historical Antigen Typing Results; Draft Guidance for Industry; Availability Notice Notice of Availability 2017-01-03T05:00:00Z 2017 1 2017-01-03T05:00:00Z   2017-01-03T14:44:35Z 2016-31771 0 0 0900006482445ef6
FDA-2016-D-4308-0003 FDA None FDA-2016-D-4308 RBC Antigen Reference List re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry Supporting & Related Material Background Material 2017-01-03T05:00:00Z 2017 1     2017-01-03T15:13:34Z   0 0 0900006482446e44
FDA-2016-D-4308-0006 FDA None FDA-2016-D-4308 Reference 3 Compliance Program Guidance Manual Chapter 42 Blood and Blood Components Inspection of Licensed and Unlicensed Blood Banks Brokers Reference Laboratories and Contractors 7342_001 dated Jun 1 16 re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry Supporting & Related Material Background Material 2017-01-03T05:00:00Z 2017 1     2017-01-03T15:13:44Z   0 0 0900006482446f19
FDA-2016-D-4308-0010 FDA None FDA-2016-D-4308 Reference 7 FDA Guidance for Industry Biological Product Deviation Reporting for Blood and Plasma Establishments October 2006 re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry Supporting & Related Material Background Material 2017-01-03T05:00:00Z 2017 1     2017-01-03T15:14:03Z   0 0 0900006482446f1d
FDA-2016-D-4308-0009 FDA None FDA-2016-D-4308 Reference 6 AABB Standards for Blood Banks and Transfusion Services 30th edition re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry Supporting & Related Material Background Material 2017-01-03T05:00:00Z 2017 1     2017-01-03T15:13:59Z   0 0 0900006482446f1c
FDA-2016-D-4308-0002 FDA None FDA-2016-D-4308 Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry Other Guidance 2017-01-03T05:00:00Z 2017 1 2017-01-03T05:00:00Z 2017-04-04T03:59:59Z 2024-11-07T23:52:00Z   1 0 0900006482446e42
FDA-2016-D-4308-0007 FDA None FDA-2016-D-4308 Reference 4 AABB_FDA Liaison Meeting April 12 2012 re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry Supporting & Related Material Background Material 2017-01-03T05:00:00Z 2017 1     2017-01-03T15:13:50Z   0 0 0900006482446f1a
FDA-2016-D-4308-0013 FDA None FDA-2016-D-4308 Reference 10 FDA Guidance for Industry Availability of FDAs e_Submitter Program for Regulatory Submissions from Licensed Blood Establishments August 2011 re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry Supporting & Related Material Background Material 2017-01-03T05:00:00Z 2017 1     2017-01-03T15:14:12Z   0 0 0900006482446f20

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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;