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withdrawn,object_id FDA-2000-D-0187-0052,FDA,FDA-2000-D-0187,Reference 5 - Malaria _ CDC Yellow Book 2024,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:55:21Z,,0,0,09000064868c15dc FDA-2000-D-0187-0057,FDA,FDA-2000-D-0187,Reference 10 - Mungai M,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:56:15Z,,0,0,09000064868c15e1 FDA-2000-D-0187-0053,FDA,FDA-2000-D-0187,Reference 6 - Local Transmission of I Plasmodium vivax I Malaria --- Palm Beach County Florida 2003,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:55:34Z,,0,0,09000064868c15dd FDA-2000-D-0187-0065,FDA,FDA-2000-D-0187,Reference 18 - Khan J,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:57:36Z,,0,0,09000064868c15f5 FDA-2000-D-0187-0072,FDA,FDA-2000-D-0187,Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria; Draft Guidance for Industry,Other,Guidance,2025-01-16T05:00:00Z,2025,1,2025-01-16T05:00:00Z,2025-03-18T03:59:59Z,2025-03-22T01:00:44Z,,1,0,09000064868c694a FDA-2000-D-0187-0050,FDA,FDA-2000-D-0187,Reference 3 - Doolan D,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:55:01Z,,0,0,09000064868c156b FDA-2000-D-0187-0062,FDA,FDA-2000-D-0187,Reference 15 - Stubbs L,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:57:09Z,,0,0,09000064868c15f2 FDA-2000-D-0187-0064,FDA,FDA-2000-D-0187,Reference 17 - Dike A,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:57:27Z,,0,0,09000064868c15f4 FDA-2000-D-0187-0056,FDA,FDA-2000-D-0187,Reference 9 - Muneer A,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:56:04Z,,0,0,09000064868c15e0 FDA-2000-D-0187-0049,FDA,FDA-2000-D-0187,Reference 2 - World Malaria Report 2022,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:54:49Z,,0,0,09000064868c156a FDA-2000-D-0187-0070,FDA,FDA-2000-D-0187,Reference 23 Malaria Surveillance United States 2016 MMWR,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:58:21Z,,0,0,09000064868c161c FDA-2000-D-0187-0051,FDA,FDA-2000-D-0187,Reference 4 - Mace K,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:55:11Z,,0,0,09000064868c15db FDA-2000-D-0187-0059,FDA,FDA-2000-D-0187,Reference 12 - Uneke C,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:56:37Z,,0,0,09000064868c15e3 FDA-2000-D-0187-0063,FDA,FDA-2000-D-0187,Reference 16 - Neiderhauer C,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:57:18Z,,0,0,09000064868c15f3 FDA-2000-D-0187-0061,FDA,FDA-2000-D-0187,Reference 14 - Anand A,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:56:57Z,,0,0,09000064868c15f1 FDA-2000-D-0187-0054,FDA,FDA-2000-D-0187,Reference 7 - Blackburn D,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:55:44Z,,0,0,09000064868c15de FDA-2000-D-0187-0066,FDA,FDA-2000-D-0187,Reference 19 - Israelyan N,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:57:46Z,,0,0,09000064868c15f6 FDA-2000-D-0187-0048,FDA,FDA-2000-D-0187,Reference 1 -Guidance for Industry. Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:54:30Z,,0,0,09000064868c1569 FDA-2000-D-0187-0055,FDA,FDA-2000-D-0187,Reference 8 - Duwell M,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:55:54Z,,0,0,09000064868c15df FDA-2000-D-0187-0071,FDA,FDA-2000-D-0187,Reference-24 Malaria Surveillance United States 2017 MMWR,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:58:29Z,,0,0,09000064868c161d FDA-2000-D-0187-0069,FDA,FDA-2000-D-0187,Reference 22-MalariaRBDMAnalysis_FINAL_2024-05-28,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:58:13Z,,0,0,09000064868c15f9 FDA-2000-D-0187-0060,FDA,FDA-2000-D-0187,Reference 13 - Katz L,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:56:49Z,,0,0,09000064868c15e4 FDA-2000-D-0187-0068,FDA,FDA-2000-D-0187,Reference 21- Blood Products Advisory Committee May 9..,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:58:04Z,,0,0,09000064868c15f8 FDA-2000-D-0187-0067,FDA,FDA-2000-D-0187,Reference 20 - cobas Malaria _ FDA,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:57:55Z,,0,0,09000064868c15f7 FDA-2000-D-0187-0047,FDA,FDA-2000-D-0187,References,Supporting & Related Material,Background Material,2025-01-16T05:00:00Z,2025,1,,,2025-01-16T16:54:14Z,,0,0,09000064868c1568 FDA-2000-D-0187-0046,FDA,FDA-2000-D-0187,Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2025-01-16T05:00:00Z,2025,1,2025-01-16T05:00:00Z,,2025-01-24T18:59:15Z,2025-01028,0,0,09000064868c6752 FDA-2000-D-0187-0058,FDA,FDA-2000-D-0187,Malaria Guidance 2024-434,Supporting & Related Material,,2025-01-16T00:00:00Z,2025,1,,,2025-01-16T17:11:32Z,,0,1,09000064868c15e2 FDA-2000-D-0187-0044,FDA,FDA-2000-D-0187,"Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry; Availability",Notice,Notice of Availability,2022-12-08T05:00:00Z,2022,12,2022-12-08T05:00:00Z,,2022-12-08T15:46:19Z,2022-26711,0,0,0900006485524919 FDA-2000-D-0187-0045,FDA,FDA-2000-D-0187,Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry - Final Guidance,Other,Guidance,2022-12-08T05:00:00Z,2022,12,2022-12-08T05:00:00Z,,2024-11-07T00:45:38Z,,1,0,090000648552199f FDA-2000-D-0187-0031,FDA,FDA-2000-D-0187,Ref 4 Mace KE et al - MMWR 2017 Re: Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria,Supporting & Related Material,Background Material,2020-06-17T04:00:00Z,2020,6,,,2020-06-17T15:02:06Z,,0,0,09000064846f6952 FDA-2000-D-0187-0030,FDA,FDA-2000-D-0187,Ref 3 - OBrien SF - Transfusion medicine reviews 2015 Re: Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria,Supporting & Related Material,Background Material,2020-06-17T04:00:00Z,2020,6,,,2020-06-17T15:01:54Z,,0,0,09000064846f6951 FDA-2000-D-0187-0043,FDA,FDA-2000-D-0187,"Ref 15 FDA BPAC Transcripts 111609 Re: Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria",Supporting & Related Material,Background Material,2020-06-17T04:00:00Z,2020,6,,,2020-06-17T15:05:11Z,,0,0,09000064846f69b0 FDA-2000-D-0187-0026,FDA,FDA-2000-D-0187,Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria,Other,Guidance,2020-06-17T04:00:00Z,2020,6,2020-06-17T04:00:00Z,,2022-12-08T15:47:25Z,,0,0,09000064846f6586 FDA-2000-D-0187-0027,FDA,FDA-2000-D-0187,Reference List Re: Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria,Supporting & Related Material,Background Material,2020-06-17T04:00:00Z,2020,6,,,2020-06-17T15:00:39Z,,0,0,09000064846f658e FDA-2000-D-0187-0039,FDA,FDA-2000-D-0187,"Ref 11 Doolan D L et al Acquired immunity to malaria Re: Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria",Supporting & Related Material,Background Material,2020-06-17T04:00:00Z,2020,6,,,2020-06-17T15:04:15Z,,0,0,09000064846f69ac FDA-2000-D-0187-0033,FDA,FDA-2000-D-0187,Ref 5 - Mace KE et al - MMWR 2018Re: Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria,Supporting & Related Material,Background Material,2020-06-17T04:00:00Z,2020,6,,,2020-06-17T15:02:37Z,,0,0,09000064846f697e FDA-2000-D-0187-0036,FDA,FDA-2000-D-0187,Ref 8 - Reesink et al - Transfusion 2010 Re: Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria,Supporting & Related Material,Background Material,2020-06-17T04:00:00Z,2020,6,,,2020-06-17T15:03:23Z,,0,0,09000064846f6981 FDA-2000-D-0187-0041,FDA,FDA-2000-D-0187,Ref 13 FDA Workshop Testing for malarial infections in blood donors July 12 2006 FDA Blood Products Advisory Committee Testing for malarial infections in blood donors July 13 2006,Supporting & Related Material,Background Material,2020-06-17T04:00:00Z,2020,6,,,2020-06-17T15:04:50Z,,0,0,09000064846f69ae FDA-2000-D-0187-0029,FDA,FDA-2000-D-0187,Ref 2 - Mungai M et al - NEJM 2001 Re: Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria,Supporting & Related Material,Background Material,2020-06-17T04:00:00Z,2020,6,,,2020-06-17T15:01:44Z,,0,0,09000064846f6950 FDA-2000-D-0187-0035,FDA,FDA-2000-D-0187,Ref 7 Spencer B et al Risk for malaria in United States donors deferred for travel to malaria endemic areas Re: Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria,Supporting & Related Material,Background Material,2020-06-17T04:00:00Z,2020,6,,,2020-06-17T15:03:14Z,,0,0,09000064846f6980 FDA-2000-D-0187-0032,FDA,FDA-2000-D-0187,Ref 5 - Mace KE et al - MMWR 2018 Re: Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria,Supporting & Related Material,Background Material,2020-06-17T04:00:00Z,2020,6,,,2020-06-17T15:02:16Z,,0,0,09000064846f6953 FDA-2000-D-0187-0034,FDA,FDA-2000-D-0187,Ref 6 - Mace KE et al - MMWR 2019 Re: Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria,Supporting & Related Material,Background Material,2020-06-17T04:00:00Z,2020,6,,,2020-06-17T15:03:00Z,,0,0,09000064846f697f FDA-2000-D-0187-0037,FDA,FDA-2000-D-0187,Ref 9 - Spenser B et al - Transfusion Re: Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria,Supporting & Related Material,Background Material,2020-06-17T04:00:00Z,2020,6,,,2020-06-17T15:03:35Z,,0,0,09000064846f6982 FDA-2000-D-0187-0042,FDA,FDA-2000-D-0187,"Ref 14 FDA Blood Products Advisory Committee - Sept 2008 Re: Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria",Supporting & Related Material,Background Material,2020-06-17T04:00:00Z,2020,6,,,2020-06-17T15:05:00Z,,0,0,09000064846f69af FDA-2000-D-0187-0038,FDA,FDA-2000-D-0187,"Ref 10 Liljander A et al Influences of intermittent preventive treatment and persistent multiclonal Plasmodium falciparum in-1 Re: Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria",Supporting & Related Material,Background Material,2020-06-17T04:00:00Z,2020,6,,,2020-06-17T15:03:48Z,,0,0,09000064846f6983 FDA-2000-D-0187-0028,FDA,FDA-2000-D-0187,Ref 1 - Katz LM & Spenser BR - AABB Press 2019 Re: Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria,Supporting & Related Material,Background Material,2020-06-17T04:00:00Z,2020,6,,,2020-06-17T15:00:59Z,,0,0,09000064846f694f FDA-2000-D-0187-0025,FDA,FDA-2000-D-0187,"Revised Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry; Availability",Notice,Notice of Availability,2020-06-17T04:00:00Z,2020,6,2020-06-17T04:00:00Z,,2020-06-17T13:13:25Z,2020-13066,0,0,09000064846f5e19 FDA-2000-D-0187-0040,FDA,FDA-2000-D-0187,"Ref 12 - Nguyen ML et al - Transfusion 2013 Re: Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria",Supporting & Related Material,Background Material,2020-06-17T04:00:00Z,2020,6,,,2020-06-17T15:04:26Z,,0,0,09000064846f69ad FDA-2000-D-0187-0024,FDA,FDA-2000-D-0187,Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria Guidance for Industry,Other,Guidance,2020-04-03T04:00:00Z,2020,4,2020-04-03T04:00:00Z,,2024-11-06T23:34:52Z,,1,0,0900006484485685 FDA-2000-D-0187-0021,FDA,FDA-2000-D-0187,"Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria; Availability",Notice,Notice of Availability,2013-08-19T04:00:00Z,2013,8,2013-08-19T04:00:00Z,,2013-08-19T14:42:09Z,2013-19962,0,0,09000064813b8a55 FDA-2000-D-0187-0022,FDA,FDA-2000-D-0187,"Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria: Guidance for Industry",Other,Guidance,2013-08-01T04:00:00Z,2013,8,2013-08-01T04:00:00Z,,2022-12-08T15:47:42Z,,0,0,09000064813b9117 FDA-2000-D-0187-0003,FDA,FDA-2000-D-0187,"Draft Guidance for Industry Recommedations for Donor Questioning, Deferral, Reentry, and Product Management to Reduce Risk of Transfusion-Transmitted Malaria",Other,Guidance,2012-07-06T04:00:00Z,2012,7,2012-07-06T04:00:00Z,2012-09-05T03:59:59Z,2024-11-07T22:45:32Z,,1,0,090000648107d6f4 FDA-2000-D-0187-0002,FDA,FDA-2000-D-0187,"Draft Guidance for Industry:Recommedations for Donor Questioning, Deferral, Reentry, and Product Management to Reduce Risk of Transfusion-Transmitted Malaria; Availability",Notice,Notice of Data Availability,2012-07-06T04:00:00Z,2012,7,2012-07-06T04:00:00Z,2012-09-05T03:59:59Z,2012-09-07T02:01:07Z,2012-16528,0,0,090000648107d34d FDA-2000-D-0187-0001,FDA,FDA-2000-D-0187,FDA,Notice,NAD-Notice of Availability of Data,2000-06-14T04:00:00Z,2000,6,2000-06-14T04:00:00Z,2000-09-07T03:59:59Z,2008-04-25T01:14:48Z,,0,0,09000064804d2c71