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withdrawn,object_id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-2009-D-0137-0045,FDA,FDA-2009-D-0137,Use of Serological Tests to Reduce the Risk of Transmission of  Trypanosoma cruzi Infection in Blood and Blood Components; Guidance for Industry; Availability,Notice,Notice of Availability,2017-12-06T05:00:00Z,2017,12,2017-12-06T05:00:00Z,,2017-12-06T15:20:12Z,2017-26226,0,0,0900006482ce90a2
FDA-2009-D-0137-0046,FDA,FDA-2009-D-0137,Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components Guidance for Industry,Other,Guidance,2017-12-06T05:00:00Z,2017,12,2017-12-06T05:00:00Z,,2024-11-07T01:13:38Z,,1,0,0900006482ce9dc0
FDA-2009-D-0137-0028,FDA,FDA-2009-D-0137,"Amendment to Guidance for Industry: Use of Serological Tests To Reduce
the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion; Draft Guidance for Industry; Availability",Notice,Notice of Availability,2016-11-10T05:00:00Z,2016,11,2016-11-10T05:00:00Z,2017-02-09T04:59:59Z,2017-02-07T02:02:05Z,2016-27107,0,0,0900006482387508
FDA-2009-D-0137-0036,FDA,FDA-2009-D-0137,"Reference 7 Donors deferred for self-reported Chagas disease history:
does it reduce risk?",Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:31:11Z,,0,0,09000064823877ec
FDA-2009-D-0137-0031,FDA,FDA-2009-D-0137,"Reference 2-Autochthonous Transmission of Trypanosoma cruzi, Louisiana",Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:30:56Z,,0,0,0900006482387a72
FDA-2009-D-0137-0038,FDA,FDA-2009-D-0137,Reference 9 Trypanosoma cruzi (E. coli Recombinant) Antigen ABBOTT PRISM Chagas Package Insert (2010),Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:31:17Z,,0,0,09000064823877ee
FDA-2009-D-0137-0029,FDA,FDA-2009-D-0137,Amendment to “Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion”,Other,Guidance,2016-11-10T05:00:00Z,2016,11,2016-11-10T05:00:00Z,2017-02-09T04:59:59Z,2024-11-12T06:15:55Z,,1,0,0900006482387a6f
FDA-2009-D-0137-0039,FDA,FDA-2009-D-0137,Reference 10  FDA Blood Products Advisory Committee T. cruzi Incidence Study in Blood Donors and its Implications for One-time Testing of Blood Donors August 2 2011,Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:31:20Z,,0,0,09000064823877ef
FDA-2009-D-0137-0042,FDA,FDA-2009-D-0137,Reference 13 Trypanosoma cruzi (E coli) Recombinant Antigen ABBOTT ESA Chagas Package Insert 2011,Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:31:29Z,,0,0,09000064823877f2
FDA-2009-D-0137-0035,FDA,FDA-2009-D-0137,Reference 6-Epidemiology of American Trypanosomiasis (Chagas Disease),Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:31:08Z,,0,0,09000064823877eb
FDA-2009-D-0137-0037,FDA,FDA-2009-D-0137,Reference 8 Trypanosoma cruzi (T cruzi) Whole Cell Lysate Antigen ORTHO T cruzi ELISA Test System Package Insert 2009,Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:31:15Z,,0,0,09000064823877ed
FDA-2009-D-0137-0032,FDA,FDA-2009-D-0137,Reference 3-Case Report: Evidence of Autochthonous Chagas Disease in Southeastern Texas,Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:30:58Z,,0,0,0900006482387a73
FDA-2009-D-0137-0033,FDA,FDA-2009-D-0137,Reference 4-An Estimate of the Burden of Chagas Disease in the United States,Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:31:02Z,,0,0,0900006482387a74
FDA-2009-D-0137-0034,FDA,FDA-2009-D-0137,"Reference 5-Trypanosoma cruzi infection in North America and Spain:
evidence in support of transfusion transmission",Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:31:05Z,,0,0,09000064823877ea
FDA-2009-D-0137-0040,FDA,FDA-2009-D-0137,Reference 11 FDA Blood Products Advisory Committee Reentry of blood donors deferred on the basis of screening test results for antibodies to T. cruzi July 31 2014,Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:31:23Z,,0,0,09000064823877f0
FDA-2009-D-0137-0030,FDA,FDA-2009-D-0137,AMENDMENT TO “GUIDANCE FOR INDUSTRY: USE OF SEROLOGICAL TESTS TO REDUCE THE RISK OF TRANSMISSION OF TRYPANOSOMA CRUZI INFECTION IN WHOLE BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION” DRAFT GUIDANCE FOR INDUSTRY,Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:30:52Z,,0,0,0900006482387a71
FDA-2009-D-0137-0041,FDA,FDA-2009-D-0137,Reference 12 FDA Blood Products Advisory Committee Potential Testing Strategies for T. cruzi Infection in Blood Donors April 1 2009,Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:31:26Z,,0,0,09000064823877f1
FDA-2009-D-0137-0027,FDA,FDA-2009-D-0137,Guidance for Industry Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion,Other,Guidance,2010-12-06T05:00:00Z,2010,12,2010-12-06T05:00:00Z,,2024-11-07T22:30:35Z,,1,0,0900006480bafc56
FDA-2009-D-0137-0025,FDA,FDA-2009-D-0137,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry; Use of Serological Tests to Reduce Risk of Transmission of Trypanosoma cruzi Infection, etc.",Notice,30 Day Proposed Information Collection,2010-12-06T05:00:00Z,2010,12,2010-12-06T05:00:00Z,2011-01-06T04:59:59Z,2016-10-28T18:34:06Z,2010-30404,0,0,0900006480bafe83
FDA-2009-D-0137-0026,FDA,FDA-2009-D-0137,"Guidance for Industry: Use of Serological Tests to Reduce Riskof Transmission of Trypanosoma cruzi Infection, etc.",Notice,Notice of Availability,2010-12-06T05:00:00Z,2010,12,2010-12-06T05:00:00Z,,2016-10-28T18:39:30Z,2010-30405,0,0,0900006480baff0b
FDA-2009-D-0137-0011,FDA,FDA-2009-D-0137,"Tab 27 - PubMed Results - ""Chagas Disease & The U. S. Blood Supply""  - Reference [re FDA-2009-D-0137-0002]",Supporting & Related Material,REF-Reference (internal unless indicated),2009-04-10T04:00:00Z,2009,4,,,2009-04-10T16:00:00Z,,0,0,090000648092ff9e
FDA-2009-D-0137-0009,FDA,FDA-2009-D-0137,"Reference 26 - ""Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments, October 2006"" - [re FDA-2009-D-0137-0002]",Supporting & Related Material,REF-Reference (internal unless indicated),2009-03-30T04:00:00Z,2009,3,,,2011-06-29T19:45:14Z,,0,0,090000648092ff42
FDA-2009-D-0137-0010,FDA,FDA-2009-D-0137,"Reference 29 - ""FDA Blood Products Advisory Committee Meeting, September 12, 2002"" - [re FDA-2009-D-0137-0002]",Supporting & Related Material,REF-Reference (internal unless indicated),2009-03-30T04:00:00Z,2009,3,,,2011-06-29T19:49:33Z,,0,0,090000648092ffba
FDA-2009-D-0137-0006,FDA,FDA-2009-D-0137,"Reference 15 -  CDC/MMWR , ""Chagas Disease After Organ Transplantation - Los Angeles, California, 2006"" - [re FDA-2009-D-0137-0002]",Supporting & Related Material,REF-Reference (internal unless indicated),2009-03-30T04:00:00Z,2009,3,,,2011-06-29T19:37:58Z,,0,0,090000648092fd18
FDA-2009-D-0137-0005,FDA,FDA-2009-D-0137,"Reference 14 - CDC/MMWR , ""Chagas Disease After Organ Transplantation - United States, 2001"" - [re FDA-2009-D-0137-0002]",Supporting & Related Material,REF-Reference (internal unless indicated),2009-03-30T04:00:00Z,2009,3,,,2011-06-29T19:35:35Z,,0,0,090000648092fd07
FDA-2009-D-0137-0007,FDA,FDA-2009-D-0137,"Reference 24 - CDC/MMWR, ""Blood Donor Screening for Chagas Disease - United States, 2006-2007"" - [re FDA-2009-D-0137-0002]",Supporting & Related Material,REF-Reference (internal unless indicated),2009-03-30T04:00:00Z,2009,3,,,2011-06-29T19:39:42Z,,0,0,090000648092ff2c
FDA-2009-D-0137-0008,FDA,FDA-2009-D-0137,"Reference 25 - ""FDA Blood Products Advisory Committee, 89th Meeting, April 27, 2007 (Concept Paper)"" - [re FDA-2009-D-0137-0002]",Supporting & Related Material,REF-Reference (internal unless indicated),2009-03-30T04:00:00Z,2009,3,,,2011-06-29T19:43:30Z,,0,0,090000648092ff3a
FDA-2009-D-0137-0004,FDA,FDA-2009-D-0137,"Reference 1 - ""Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), August 2007"" - [re FDA-2009-D-0137-0002]",Supporting & Related Material,REF-Reference (internal unless indicated),2009-03-29T04:00:00Z,2009,3,,,2011-06-29T19:14:36Z,,0,0,090000648092fa11
FDA-2009-D-0137-0002,FDA,FDA-2009-D-0137,"Guidance for Industry - Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Guidance",Other,Guidance,2009-03-26T04:00:00Z,2009,3,2009-03-26T04:00:00Z,,2011-06-29T17:49:54Z,,0,0,0900006480930814
FDA-2009-D-0137-0003,FDA,FDA-2009-D-0137,Table of Contents - References [re FDA-2009-D-0137-0002],Supporting & Related Material,REF-Reference (internal unless indicated),2009-03-26T04:00:00Z,2009,3,,,2011-06-29T19:10:28Z,,0,0,0900006480931787
FDA-2009-D-0137-0001,FDA,FDA-2009-D-0137,"Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products",Notice,NAD-Notice of Availability of Data,2009-03-26T04:00:00Z,2009,3,2009-03-26T04:00:00Z,2009-06-25T03:59:59Z,2011-06-29T17:38:37Z,E9-06684,0,0,0900006480930640