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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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52 rows where docket_id = "FDA-2013-D-1143" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;