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withdrawn,object_id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-2005-D-0140-0012,FDA,FDA-2005-D-0140,"Reference 1 FDA Memorandum to All Registered Blood Establishments: “Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV-1) Transmission by Blood and Blood Products,”",Supporting & Related Material,Background Material,2017-12-28T05:00:00Z,2017,12,,,2017-12-28T20:40:42Z,,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,,,2017-12-28T20:40:28Z,,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,,2024-11-07T01:15:24Z,,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,,,2017-12-28T20:40:23Z,,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,,,2017-12-28T20:39:54Z,,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,,,2017-12-28T20:40:50Z,,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,,,2017-12-28T20:39:59Z,,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,,,2017-12-28T20:40:08Z,,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 (“Lookback”); Final Rule.",Supporting & Related Material,Background Material,2017-12-28T05:00:00Z,2017,12,,,2017-12-28T20:40:03Z,,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,,,2017-12-28T20:40:13Z,,0,0,0900006482d7ee4e
FDA-2005-D-0140-0014,FDA,FDA-2005-D-0140,"Reference 3 FDA Memorandum to All Registered Blood Establishments: “Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV),” August 5, 1993.",Supporting & Related Material,Background Material,2017-12-28T05:00:00Z,2017,12,,,2017-12-28T20:40:33Z,,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,,,2017-12-28T20:40:18Z,,0,0,0900006482d7ee44
FDA-2005-D-0140-0013,FDA,FDA-2005-D-0140,"Reference 2 FDA Memorandum to All Registered Blood and Plasma Establishments: “Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen,”",Supporting & Related Material,Background Material,2017-12-28T05:00:00Z,2017,12,,,2017-12-28T20:40:38Z,,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,,,2017-12-28T20:39:49Z,,0,0,0900006482d7ee53