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withdrawn,object_id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-2013-D-1143-0099,FDA,FDA-2013-D-1143,"Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile
Virus From Living Donors of Human Cells, Tissues, and Cellular and
Tissue-Based Products; Guidance for Industry; Correction",Notice,Correction,2016-09-29T04:00:00Z,2016,9,2016-09-29T04:00:00Z,,2016-09-29T15:15:04Z,2016-23514,0,0,090000648227f819
FDA-2013-D-1143-0097,FDA,FDA-2013-D-1143,"Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile
Virus From Living Donors of Human Cells, Tissues, and Cellular and
Tissue-Based Products; Guidance for Industry; Availability",Notice,Notice of Availability,2016-09-13T04:00:00Z,2016,9,2016-09-13T04:00:00Z,2016-12-13T04:59:59Z,2016-09-13T14:43:16Z,2016-21969,0,0,0900006482202771
FDA-2013-D-1143-0098,FDA,FDA-2013-D-1143,"Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry",Other,Guidance,2016-09-08T04:00:00Z,2016,9,2016-09-08T04:00:00Z,,2024-11-07T23:49:39Z,,1,0,09000064821e37f2
FDA-2013-D-1143-0094,FDA,FDA-2013-D-1143,Reference 6 Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus April 2008,Supporting & Related Material,Reference (internal unless indicated),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T20:38:59Z,,0,0,0900006481da8779
FDA-2013-D-1143-0065,FDA,FDA-2013-D-1143,Reference 16 Epidemic West Nile Encephalitis New York 1999 Results of a Household-based Seroepidemiological Survey,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T18:36:14Z,,0,0,0900006481da87fe
FDA-2013-D-1143-0067,FDA,FDA-2013-D-1143,Reference 18 Manifestations of West Nile Virus Neuroinvasive Diesease,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T18:50:18Z,,0,0,0900006481da8800
FDA-2013-D-1143-0070,FDA,FDA-2013-D-1143,"Reference 21 West Nile Virus and Other Arboviral Diseases - United States, 2010",Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T19:07:45Z,,0,0,0900006481da8803
FDA-2013-D-1143-0068,FDA,FDA-2013-D-1143,"Reference 19  West Nile Virus Screening of Blood Donations and Transfusion-Associated Transmission - United States, 2003",Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T18:55:57Z,,0,0,0900006481da8801
FDA-2013-D-1143-0071,FDA,FDA-2013-D-1143,"Reference 22 Invasive Staphylococcus aureus Infections Associated with Pain Injections and Reuse of Single-Dose Vials - Arizona and Delaware, 2012",Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T19:12:07Z,,0,0,0900006481da8804
FDA-2013-D-1143-0075,FDA,FDA-2013-D-1143,"Reference 26 Risk Factors for West Nile Virus Neuroinvasive Disease, California, 2005",Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T19:26:56Z,,0,0,0900006481da8a4a
FDA-2013-D-1143-0052,FDA,FDA-2013-D-1143,Reference 2 Food and Drug Administration Workshop on Development of Donor Screening Assays for West Nile Virus,Supporting & Related Material,Reference (internal unless indicated),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T17:49:15Z,,0,0,0900006481da8775
FDA-2013-D-1143-0073,FDA,FDA-2013-D-1143,"Reference 24 West Nile Virus and Other Arboviral Diseases - United States, 2013",Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T19:19:11Z,,0,0,0900006481da8806
FDA-2013-D-1143-0078,FDA,FDA-2013-D-1143,"Reference 29 Estimated Risk of West Nile Virus Transmission Through Blood Transfusion During an Epidemic in Queens, New York City",Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T19:39:09Z,,0,0,0900006481da8a4e
FDA-2013-D-1143-0082,FDA,FDA-2013-D-1143,"Reference 33 Transfusion-Associated Transmission of West Nile Virus, United States 2003 through 2005",Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T19:48:29Z,,0,0,0900006481da8a52
FDA-2013-D-1143-0092,FDA,FDA-2013-D-1143,Reference 43 West Nile encephalitis in 2 Hematopoietic Stem Cell Transplant Recipients: Case Series and Literature Review,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T20:11:55Z,,0,0,0900006481da8aea
FDA-2013-D-1143-0090,FDA,FDA-2013-D-1143,Reference 41 West Nile Virus Transmission Through Organ Transplantation in North Eastern Italy A Case Report and Implications for Pre-Procurement Screening,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T20:07:07Z,,0,0,0900006481da8885
FDA-2013-D-1143-0053,FDA,FDA-2013-D-1143,Reference 3 Transmission of West Nile Virus through Blood Transfusion in the United States in 2002,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T17:51:56Z,,0,0,0900006481da8776
FDA-2013-D-1143-0058,FDA,FDA-2013-D-1143,Reference 10 The Outbreak of West Nile Virus Infection in the New York City Area in 1999,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T18:11:16Z,,0,0,0900006481da87d5
FDA-2013-D-1143-0076,FDA,FDA-2013-D-1143,Reference 27 Centers for Disease Control and Prevention website for Surveillance Resources,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T19:32:00Z,,0,0,0900006481da8a4c
FDA-2013-D-1143-0081,FDA,FDA-2013-D-1143,"Reference 32 Acute Flaccid Paralysis Syndrome Associated with West Nile Virus Infection — Mississippi and Louisiana, July–August 2002",Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T19:45:51Z,,0,0,0900006481da8a51
FDA-2013-D-1143-0093,FDA,FDA-2013-D-1143,Reference 44 West Nile virus infection transmitted by granulocyte transfusion,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T20:14:18Z,,0,0,0900006481da8aeb
FDA-2013-D-1143-0062,FDA,FDA-2013-D-1143,List of References,Supporting & Related Material,List,2015-12-15T05:00:00Z,2015,12,,,2015-12-15T18:27:31Z,,0,0,0900006481da8773
FDA-2013-D-1143-0056,FDA,FDA-2013-D-1143,Reference 7 Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion,Supporting & Related Material,Reference (internal unless indicated),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T17:59:45Z,,0,0,0900006481da877b
FDA-2013-D-1143-0060,FDA,FDA-2013-D-1143,Reference 12 An Update on the Potential of North American Mosquitoes Diptera: Culicidae to Transmit West Nile Virus,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T18:15:43Z,,0,0,0900006481da87d9
FDA-2013-D-1143-0069,FDA,FDA-2013-D-1143,"Reference 20 Surveillance for Human West Nile Virus Disease - United States, 1999-2008",Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T19:05:52Z,,0,0,0900006481da8802
FDA-2013-D-1143-0089,FDA,FDA-2013-D-1143,Reference 40 Absence of Neuroinvasive Disease in a Liver Transplant Recipient Who Acquired West Nile Virus (WNV) Infection from the Organ Donor and Who Received WNV Antibodies Prophylactically,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T20:04:28Z,,0,0,0900006481da8884
FDA-2013-D-1143-0051,FDA,FDA-2013-D-1143,"Reference 1 Food and Drug Administration, Guidance for Industry  Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products",Supporting & Related Material,Reference (internal unless indicated),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T17:47:11Z,,0,0,0900006481da8774
FDA-2013-D-1143-0064,FDA,FDA-2013-D-1143,Reference 15 Epidemiology and Transmission Dynamics of West Nile Virus Disease,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T18:32:45Z,,0,0,0900006481da87dc
FDA-2013-D-1143-0085,FDA,FDA-2013-D-1143,Reference 36 West Nile Transmission Via Organ Transplantation and Blood Transfusion-Louisiana 2008,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T19:55:07Z,,0,0,0900006481da8880
FDA-2013-D-1143-0086,FDA,FDA-2013-D-1143,Reference 37 Organ Procurement Transplantation Network Guidance for Identifying Risk Factors for West Nile Virus during Evaluation of Potential Living Donors,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T19:58:45Z,,0,0,0900006481da8881
FDA-2013-D-1143-0057,FDA,FDA-2013-D-1143,Reference 8 West Nile Virus Workshop: Scientific Considerations for Tissue Donors,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T18:08:18Z,,0,0,0900006481da87d3
FDA-2013-D-1143-0059,FDA,FDA-2013-D-1143,Reference 11 West Nile Fever,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T18:13:26Z,,0,0,0900006481da87d6
FDA-2013-D-1143-0088,FDA,FDA-2013-D-1143,"Reference 39 West Nile Virus Infections in Organ Transplant Recipients-New York and Pennsylvania, August - September 2005",Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T20:02:09Z,,0,0,0900006481da8883
FDA-2013-D-1143-0049,FDA,FDA-2013-D-1143,"Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile
Virus From Living Donors of Human Cells, Tissues, and Cellular and
Tissue-Based Products; Draft Guidance for Industry; Availability",Notice,Notice of Availability,2015-12-15T05:00:00Z,2015,12,2015-12-15T05:00:00Z,2016-03-15T03:59:59Z,2016-08-31T16:43:07Z,2015-31405,0,0,0900006481da74bd
FDA-2013-D-1143-0050,FDA,FDA-2013-D-1143,"Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Draft Guidance for Industry",Other,Guidance,2015-12-15T05:00:00Z,2015,12,2015-12-15T05:00:00Z,,2024-11-11T21:14:43Z,,1,0,0900006481da8904
FDA-2013-D-1143-0061,FDA,FDA-2013-D-1143,Reference 13 Indigenous Wild Birds of the Nile Delta as Potential West Nile Virus Circulating Reservoirs,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T18:17:59Z,,0,0,0900006481da87da
FDA-2013-D-1143-0063,FDA,FDA-2013-D-1143,Reference 14 Serologic Evidence for West Nile Virus Infection in BIrds in the New York City Vicinity During an Outbreak in 1999,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T18:30:35Z,,0,0,0900006481da87db
FDA-2013-D-1143-0066,FDA,FDA-2013-D-1143,Reference 17 West Nile Virus Neuroinvasisve Disease,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T18:47:08Z,,0,0,0900006481da87ff
FDA-2013-D-1143-0077,FDA,FDA-2013-D-1143,Reference 28 Centers for Disease Control and Prevention website for West Nile Virus,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T19:33:46Z,,0,0,0900006481da8a4d
FDA-2013-D-1143-0080,FDA,FDA-2013-D-1143,"Reference 31 West Nile Virus Infections Projected From Blood Donor Screening Data, United States, 2003",Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T19:43:16Z,,0,0,0900006481da8a50
FDA-2013-D-1143-0079,FDA,FDA-2013-D-1143,Reference 30 Associations Between West Nile Virus Infection and Symptoms Reported by Blood Donors Identified Through Nucleic Acid Test Screening,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T19:41:19Z,,0,0,0900006481da8a4f
FDA-2013-D-1143-0084,FDA,FDA-2013-D-1143,"Reference 35 West Nile Virus Transmission Through Blood Transfusion - South Dakota, 2006",Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T19:56:09Z,,0,0,0900006481da887f
FDA-2013-D-1143-0055,FDA,FDA-2013-D-1143,Reference 5 Transfusion Transmitted Infections in Solid Organ Transplantation,Supporting & Related Material,Reference (internal unless indicated),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T17:56:11Z,,0,0,0900006481da8778
FDA-2013-D-1143-0095,FDA,FDA-2013-D-1143,Reference 9 Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus October 2013,Supporting & Related Material,Reference (internal unless indicated),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T20:40:09Z,,0,0,0900006481da87d4
FDA-2013-D-1143-0074,FDA,FDA-2013-D-1143,Reference 25 World Health Organization Media Centre West Nile Virus Fact Sheet,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T19:21:09Z,,0,0,0900006481da8807
FDA-2013-D-1143-0087,FDA,FDA-2013-D-1143,Reference 38 Update Investigations of West Nile Virus Infections in Recipients of Organ Transplantation and Blood Transfusion,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T20:00:28Z,,0,0,0900006481da8882
FDA-2013-D-1143-0083,FDA,FDA-2013-D-1143,"Reference 34 Heat Illness and Deaths - New York City, 2000-2011",Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T19:50:15Z,,0,0,0900006481da8a53
FDA-2013-D-1143-0091,FDA,FDA-2013-D-1143,Reference 42 Fatal West Nile Virus Encephalitis in a Renal Transplant Recipient,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T20:09:22Z,,0,0,0900006481da8ae9
FDA-2013-D-1143-0054,FDA,FDA-2013-D-1143,Reference 4 Transmission of West Nile Virus from an Organ Donor to Four Transplant Recipients,Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T17:54:12Z,,0,0,0900006481da8777
FDA-2013-D-1143-0072,FDA,FDA-2013-D-1143,"Reference 23 West Nile Virus and Other Arboviral Diseases  - United States, 2012",Supporting & Related Material,Reference (external attachments),2015-12-15T05:00:00Z,2015,12,,,2015-12-15T19:17:28Z,,0,0,0900006481da8805
FDA-2013-D-1143-0002,FDA,FDA-2013-D-1143,"Draft Guidance for Industry:  Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products",Other,Guidance,2013-10-24T04:00:00Z,2013,10,2013-10-24T04:00:00Z,,2024-11-12T05:20:29Z,,1,0,090000648145d7aa
FDA-2013-D-1143-0001,FDA,FDA-2013-D-1143,"Draft Guidance for Industry:  Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability",Notice,Notice of Availability,2013-10-24T04:00:00Z,2013,10,2013-10-24T04:00:00Z,2014-01-23T04:59:59Z,2014-03-28T01:01:32Z,2013-24940,0,0,090000648145d509