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withdrawn,object_id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,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,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
FDA-2016-D-4308-0008,FDA,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,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,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,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,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,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,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,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,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,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,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,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,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