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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

12 rows where docket_id = "FDA-2016-D-4308" and posted_year = 2018 sorted by posted_date descending

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posted_year 1

  • 2018 · 12 ✖

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-4308-0026 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

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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;