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

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

36 rows where docket_id = "FDA-2014-D-2175" sorted by posted_date descending

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document_type 3

  • Supporting & Related Material 32
  • Notice 2
  • Other 2

posted_year 2

  • 2015 34
  • 2017 2

agency_id 1

  • FDA 36
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2014-D-2175-0041 FDA None FDA-2014-D-2175 Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus Guidance for Industry Other Guidance 2017-01-10T05:00:00Z 2017 1 2017-01-10T05:00:00Z   2024-11-12T06:17:52Z   1 0 090000648245701d
FDA-2014-D-2175-0040 FDA None FDA-2014-D-2175 Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry; Availability Notice Notice of Availability 2017-01-10T05:00:00Z 2017 1 2017-01-10T05:00:00Z   2017-01-10T14:40:59Z 2017-00200 0 0 0900006482456a50
FDA-2014-D-2175-0022 FDA None FDA-2014-D-2175 Reference -19 Molecular Evidence of Sexual Transmission of Ebola Virus re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:45:46Z   0 0 0900006481d88bb3
FDA-2014-D-2175-0024 FDA None FDA-2014-D-2175 Reference 21 - Risk Factors for Zaire Ebolavirus re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:46:39Z   0 0 0900006481d88c02
FDA-2014-D-2175-0007 FDA None FDA-2014-D-2175 Reference 4 - Horowitz-1992-Solvent detergent-treated plasma: a virus-inactivated substitute for fresh frozen plasma re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:39:29Z   0 0 0900006481d83cbc
FDA-2014-D-2175-0013 FDA None FDA-2014-D-2175 Reference 10 - Ebola Virus Disease in West Africa -The First 9 Months of the Epidemic and Forward Projections re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:41:43Z   0 0 0900006481d8405a
FDA-2014-D-2175-0021 FDA None FDA-2014-D-2175 Reference 18 - CDC-Possible Sexual on of Ebola Virus–Liberia re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:45:23Z   0 0 0900006481d84b63
FDA-2014-D-2175-0008 FDA None FDA-2014-D-2175 Reference 5 - Robustness of Solvent/Detergent Treatment of Plasma Derivatives: A Data collection from Plasma Protein Therapeutics Association member companies re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:39:55Z   0 0 0900006481d83cbd
FDA-2014-D-2175-0020 FDA None FDA-2014-D-2175 Reference -17 Ebola RNA Persistence in Semen of Ebola Virus Disease Survivors Preliminary Report re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:44:52Z   0 0 0900006481d88baf
FDA-2014-D-2175-0023 FDA None FDA-2014-D-2175 Reference - 20 Leroy_Human Asymptomatic Ebola Infection re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:46:13Z   0 0 0900006481d88bfd
FDA-2014-D-2175-0027 FDA None FDA-2014-D-2175 Reference 24 - Correlates of Immunity to Filovirus Infection re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:47:55Z   0 0 0900006481d89163
FDA-2014-D-2175-0026 FDA None FDA-2014-D-2175 Reference 23 - Ebola Virus Can Be Effectively Neutralized by Antibody Produced in Natural Human Infection re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:47:27Z   0 0 0900006481d8915f
FDA-2014-D-2175-0032 FDA None FDA-2014-D-2175 Reference 29 - Ebola haemorrhagic fever in Zaire, 1976 re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:49:54Z   0 0 0900006481d89352
FDA-2014-D-2175-0005 FDA None FDA-2014-D-2175 Reference 2 - Towner-2008-Newly Discovered Ebola virus Associated with Hemorrhagic Fever Outbreak in Uganda re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:38:28Z   0 0 0900006481d83cac
FDA-2014-D-2175-0009 FDA None FDA-2014-D-2175 Reference 6 - Solvent-Detergent Filtered (S/D-F) Fresh Frozen Plasma and Cryoprecipitate Minipools Prepared in a Newly Designed Integral Disposable Processing Bag System re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:40:20Z   0 0 0900006481d8411c
FDA-2014-D-2175-0031 FDA None FDA-2014-D-2175 Reference 28 -Ebola Hemorrhagic Fever: Evaluation of Passive Immunotherapy in Nonhuman Primates re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:49:30Z   0 0 0900006481d898d3
FDA-2014-D-2175-0017 FDA None FDA-2014-D-2175 Reference 14 - Persistence and Genetic Stability of Ebola Virus during the Outbreak in Kikwit, Democratic Republic of the Congo, 1995 re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:43:24Z   0 0 0900006481d84255
FDA-2014-D-2175-0006 FDA None FDA-2014-D-2175 Reference 3 Mitchell-1984-Physicochemical Inactivation of Lassa, Ebola, and Marburg Viruses and Effect on Clinical Laboratory Analyses re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:38:57Z   0 0 0900006481d83cbb
FDA-2014-D-2175-0012 FDA None FDA-2014-D-2175 Reference 9 - Incubation Period of Ebola Hemorrhagic Virus Subtype Zaire re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:41:22Z   0 0 0900006481d84124
FDA-2014-D-2175-0028 FDA None FDA-2014-D-2175 Reference 25 -Successful Treatment of Ebola Virus-Infected Cynomolgus Macaques with Monoclonal Antibodies re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:48:19Z   0 0 0900006481d89218
FDA-2014-D-2175-0033 FDA None FDA-2014-D-2175 Reference 30 - A Case of Ebola Virus Infection re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:50:22Z   0 0 0900006481d89356
FDA-2014-D-2175-0004 FDA None FDA-2014-D-2175 Reference 1 - Feldmann-2003-Ebola virus from discovery to vaccine re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:38:07Z   0 0 0900006481d83c18
FDA-2014-D-2175-0034 FDA None FDA-2014-D-2175 Reference 31- Treatment of Ebola Hemorrhagic Fever with Blood Transfusions from Convalescent Patients re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:50:44Z   0 0 0900006481d8937b
FDA-2014-D-2175-0015 FDA None FDA-2014-D-2175 Reference 12 - Persistence of Ebola Virus in Ocular Fluid during Convalescence re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:42:36Z   0 0 0900006481d8424f
FDA-2014-D-2175-0030 FDA None FDA-2014-D-2175 Reference 27 - Postexposure antibody prophylaxis protects nonhuman primates from filovirus disease re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:49:06Z   0 0 0900006481d898cc
FDA-2014-D-2175-0025 FDA None FDA-2014-D-2175 Reference 22 -Efficacy of Immune Plasma in Treatment of Argentine re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:47:02Z   0 0 0900006481d8915d
FDA-2014-D-2175-0029 FDA None FDA-2014-D-2175 Reference 26 - Delayed treatment of Ebola virus infection with plant-derived monoclonal antibodies provides protection in rhesus macaques re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:48:41Z   0 0 0900006481d8921b
FDA-2014-D-2175-0014 FDA None FDA-2014-D-2175 Reference 11 - On The Quarantine Period For Ebola Virus re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:42:16Z   0 0 0900006481d8405e
FDA-2014-D-2175-0016 FDA None FDA-2014-D-2175 Reference 13 - Assessment of the Risk of Ebola Virus Transmission from Bodily Fluids and Fomites re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:43:00Z   0 0 0900006481d84252
FDA-2014-D-2175-0003 FDA None FDA-2014-D-2175 Reference List re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:37:31Z   0 0 0900006481d83c17
FDA-2014-D-2175-0011 FDA None FDA-2014-D-2175 Reference 8 - Inactivation of Viruses in Platelet Concentrates by Photochemical Treatment with Amotosalen and Long-Wavelength Ultraviolet Light re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:41:02Z   0 0 0900006481d84122
FDA-2014-D-2175-0018 FDA None FDA-2014-D-2175 Reference 15 - Clinical, Virologic, and Immunologic Follow-Up of Convalescent Ebola Hemorrhagic Fever Patients and Their Household Contacts, Kikwit, Democratic Republic of the Congo re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:43:49Z   0 0 0900006481d84333
FDA-2014-D-2175-0019 FDA None FDA-2014-D-2175 Reference 16 - Unexpected Ebola Virus in a Tertiary Setting: Clinical and Epidemiologic Aspects re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:44:17Z   0 0 0900006481d844c9
FDA-2014-D-2175-0010 FDA None FDA-2014-D-2175 Reference 7 - Photochemical Treatment of Plasma with Amotosalen and Longwavelength Ultraviolet Light Inactivates Pathogens while Retaining Coagulation Function re Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T14:40:40Z   0 0 0900006481d8411e
FDA-2014-D-2175-0002 FDA None FDA-2014-D-2175 Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry Other Guidance 2015-12-03T05:00:00Z 2015 12 2015-12-03T05:00:00Z   2024-11-11T21:15:27Z   1 0 0900006481d83b25
FDA-2014-D-2175-0001 FDA None FDA-2014-D-2175 Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Notice Notice of Availability 2015-12-03T05:00:00Z 2015 12 2015-12-03T05:00:00Z 2015-03-03T04:59:59Z 2015-12-03T15:01:08Z 2015-30589 0 0 0900006481d82bc1

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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;
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