{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" and docket_id = \"FDA-2005-D-0140\" sorted by posted_date descending", "rows": [["FDA-2005-D-0140-0012", "FDA", "FDA-2005-D-0140", "Reference 1 FDA Memorandum to All Registered Blood Establishments: \u201cRevised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV-1) Transmission by Blood and Blood Products,\u201d", "Supporting & Related Material", "Background Material", "2017-12-28T05:00:00Z", 2017, 12, null, null, "2017-12-28T20:40:42Z", null, 0, 0, "0900006482d7ee3f"], ["FDA-2005-D-0140-0015", "FDA", "FDA-2005-D-0140", "Reference 4 Busch MP. Closing the windows on viral transmission by blood transfusion. In Stramer SL ed. Blood Safety in the New Millenium. Bethesda, MD: American Association of Blood Banks, 2001: Chapter 2, p.36.", "Supporting & Related Material", "Background Material", "2017-12-28T05:00:00Z", 2017, 12, null, null, "2017-12-28T20:40:28Z", null, 0, 0, "0900006482d7ee42"], ["FDA-2005-D-0140-0010", "FDA", "FDA-2005-D-0140", "Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry:  Guidance for Industry", "Other", "Guidance", "2017-12-28T05:00:00Z", 2017, 12, "2017-12-28T05:00:00Z", null, "2024-11-07T01:15:24Z", null, 1, 0, "0900006482d7ee3c"], ["FDA-2005-D-0140-0016", "FDA", "FDA-2005-D-0140", "Reference 5 Glynn SA, Kleinman SH, Wright DJ, Busch MP. International application of the incidence rate/window period model. Transfusion 42:966-972 (2002).", "Supporting & Related Material", "Background Material", "2017-12-28T05:00:00Z", 2017, 12, null, null, "2017-12-28T20:40:23Z", null, 0, 0, "0900006482d7ee43"], ["FDA-2005-D-0140-0022", "FDA", "FDA-2005-D-0140", "Reference 11 Alter HJ. To C or not to C: These are the questions. Blood 85:1681-1695 (1995).", "Supporting & Related Material", "Background Material", "2017-12-28T05:00:00Z", 2017, 12, null, null, "2017-12-28T20:39:54Z", null, 0, 0, "0900006482d7ee52"], ["FDA-2005-D-0140-0011", "FDA", "FDA-2005-D-0140", "001 - List of References - Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry Guidance for Industry", "Supporting & Related Material", "Background Material", "2017-12-28T05:00:00Z", 2017, 12, null, null, "2017-12-28T20:40:50Z", null, 0, 0, "0900006482d7ee3e"], ["FDA-2005-D-0140-0021", "FDA", "FDA-2005-D-0140", "Reference 10 Blood Products Advisory Committee, 69th Meeting, June 14, 2001", "Supporting & Related Material", "Background Material", "2017-12-28T05:00:00Z", 2017, 12, null, null, "2017-12-28T20:39:59Z", null, 0, 0, "0900006482d7ee51"], ["FDA-2005-D-0140-0019", "FDA", "FDA-2005-D-0140", "Reference 8 Federal Register, December 14, 1999 (64 FR 71147), Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2, December 1999.", "Supporting & Related Material", "Background Material", "2017-12-28T05:00:00Z", 2017, 12, null, null, "2017-12-28T20:40:08Z", null, 0, 0, "0900006482d7ee4f"], ["FDA-2005-D-0140-0020", "FDA", "FDA-2005-D-0140", "Reference 9 Federal Register, August 24, 2007 (72 FR 48765), Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatitis C Virus Infection (\u201cLookback\u201d); Final Rule.", "Supporting & Related Material", "Background Material", "2017-12-28T05:00:00Z", 2017, 12, null, null, "2017-12-28T20:40:03Z", null, 0, 0, "0900006482d7ee50"], ["FDA-2005-D-0140-0018", "FDA", "FDA-2005-D-0140", "Reference 7 Fiebig EW, Wright DJ, Rawal BD, et. al. Dynamics of HIV-1 viremia and antibody seroconversion in plasma donors: Implications for diagnosis and staging of primary HIV-1 infection. AIDS 17:1871-1879 (2003).", "Supporting & Related Material", "Background Material", "2017-12-28T05:00:00Z", 2017, 12, null, null, "2017-12-28T20:40:13Z", null, 0, 0, "0900006482d7ee4e"], ["FDA-2005-D-0140-0014", "FDA", "FDA-2005-D-0140", "Reference 3 FDA Memorandum to All Registered Blood Establishments: \u201cRevised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV),\u201d August 5, 1993.", "Supporting & Related Material", "Background Material", "2017-12-28T05:00:00Z", 2017, 12, null, null, "2017-12-28T20:40:33Z", null, 0, 0, "0900006482d7ee41"], ["FDA-2005-D-0140-0017", "FDA", "FDA-2005-D-0140", "Reference 6 (final) - Zou S, Dorsey KA, Notari EP, Foster GA, et al. Prevalence, incidence and residual risk of human immunodeficiency virus and hepatitis C virus infections among United States blood donors since the introduction of nucleic acid testing.", "Supporting & Related Material", "Background Material", "2017-12-28T05:00:00Z", 2017, 12, null, null, "2017-12-28T20:40:18Z", null, 0, 0, "0900006482d7ee44"], ["FDA-2005-D-0140-0013", "FDA", "FDA-2005-D-0140", "Reference 2 FDA Memorandum to All Registered Blood and Plasma Establishments: \u201cRecommendations for Donor Screening with a Licensed Test for HIV-1 Antigen,\u201d", "Supporting & Related Material", "Background Material", "2017-12-28T05:00:00Z", 2017, 12, null, null, "2017-12-28T20:40:38Z", null, 0, 0, "0900006482d7ee40"], ["FDA-2005-D-0140-0023", "FDA", "FDA-2005-D-0140", "Reference 12 Centers for Disease Control, Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. MMWR 47; (RR-19) (1998).", "Supporting & Related Material", "Background Material", "2017-12-28T05:00:00Z", 2017, 12, null, null, "2017-12-28T20:39:49Z", null, 0, 0, "0900006482d7ee53"], ["FDA-2005-D-0140-0007", "FDA", "FDA-2005-D-0140", "Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV), etc.", "Notice", "NAD-Notice of Availability of Data", "2010-04-30T04:00:00Z", 2010, 4, "2010-04-30T04:00:00Z", null, "2024-11-07T22:14:16Z", "2010-10048", 1, 0, "0900006480ae4312"], ["FDA-2005-D-0140-0009", "FDA", "FDA-2005-D-0140", "Reference 9 - Federal Register, August 24, 2007 (72 FR 48765), Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfussion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatitis C Virus Infection (\"Lookback\"); Final Rule", "Supporting & Related Material", "BKG-Background Material", "2010-04-30T04:00:00Z", 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