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withdrawn,object_id FDA-2016-D-4308-0026,FDA,FDA-2016-D-4308,04 Reference 3 Compliance Program Guidance Manual Chapter 42 Blood and Blood Components Inspection of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,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,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,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,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,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,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,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,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,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,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,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