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withdrawn,object_id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-2015-D-1211-0368,FDA,FDA-2015-D-1211,Reference 7 Van de perre p re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:33Z,,0,0,09000064859fc420
FDA-2015-D-1211-0397,FDA,FDA-2015-D-1211,Reference 36_FAIR_Conclusions from the For the Assessment of Individualized Risk (FAIR) group re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:55Z,,0,0,09000064859fd93c
FDA-2015-D-1211-0402,FDA,FDA-2015-D-1211,Reference 41_Blood safety implications of donors using HIV preexposure prophylaxis re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:59Z,,0,0,09000064859fd941
FDA-2015-D-1211-0394,FDA,FDA-2015-D-1211,Reference 33- O Brien - Donor screening question alternatives to men who have sex with men time deferral  Potential (1) re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:52Z,,0,0,09000064859fd865
FDA-2015-D-1211-0403,FDA,FDA-2015-D-1211,Reference 42_AABB_Updated Recommendations on Donor Deferral for Use of Antiretroviral Medications for HIV Prevention and Treatment re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:08:00Z,,0,0,09000064859fd942
FDA-2015-D-1211-0362,FDA,FDA-2015-D-1211,Reference 1 REV. Epstein_et_al-2013-Transfusion re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:29Z,,0,0,09000064859fbfcf
FDA-2015-D-1211-0370,FDA,FDA-2015-D-1211,Reference 9 HIV and the blood supply re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:35Z,,0,0,09000064859fc422
FDA-2015-D-1211-0390,FDA,FDA-2015-D-1211,Reference 29 REV. Custer - Transfusion-transmissible infection re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:50Z,,0,0,09000064859fd861
FDA-2015-D-1211-0360,FDA,FDA-2015-D-1211,Recommendations for Evaluating Donor Eligibility Using Individual Risk- Based Questions To Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry; Availability,Notice,Notice of Availability,2023-05-12T04:00:00Z,2023,5,2023-05-12T04:00:00Z,,2023-05-12T12:59:32Z,2023-10252,0,0,09000064859fa444
FDA-2015-D-1211-0387,FDA,FDA-2015-D-1211,Reference 26 Offergeld2014 re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:48Z,,0,0,09000064859fd85e
FDA-2015-D-1211-0363,FDA,FDA-2015-D-1211,Reference 2 Stramer_et_al-2013-Transfusion re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:30Z,,0,0,09000064859fbfd0
FDA-2015-D-1211-0371,FDA,FDA-2015-D-1211,Reference 10 Current Trends Prevention of Acquired Immune Deficiency Syndrome (AIDS)_ Report of Inter-Agency Recommendations re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:35Z,,0,0,09000064859fc423
FDA-2015-D-1211-0374,FDA,FDA-2015-D-1211,Reference 13 Donor-Testing-and-Risk-2012 re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:38Z,,0,0,09000064859fd845
FDA-2015-D-1211-0386,FDA,FDA-2015-D-1211,Reference 25 REV. Custer - Blood DROPS re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:47Z,,0,0,09000064859fd85b
FDA-2015-D-1211-0399,FDA,FDA-2015-D-1211,Reference 38_NHS Blood and Transplant_Our Improved Donations Safety Check re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:56Z,,0,0,09000064859fd93e
FDA-2015-D-1211-0405,FDA,FDA-2015-D-1211,Reference 44_New Ref 44_HIV incidence in US first-time blood donors during 12-month and 3-month MSM deferral policy periods re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:08:01Z,,0,0,09000064859fd944
FDA-2015-D-1211-0385,FDA,FDA-2015-D-1211,Reference 24 REV. Custer2014 re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:46Z,,0,0,09000064859fd85a
FDA-2015-D-1211-0395,FDA,FDA-2015-D-1211,Reference 34 Goldman.MSM Policy changes in Canada.Transfusion.2022 re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:53Z,,0,0,09000064859fd866
FDA-2015-D-1211-0400,FDA,FDA-2015-D-1211,Reference 39_FDA_Important Information for Potential Donors of Blood and Blood Products re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:56Z,,0,0,09000064859fd93f
FDA-2015-D-1211-0404,FDA,FDA-2015-D-1211,Reference 43 New Reference 43_HIV antiretroviral therapy and prevention use in US blood re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:08:00Z,,0,0,09000064859fd943
FDA-2015-D-1211-0379,FDA,FDA-2015-D-1211,Reference 18_FDA Blood Products Advisory Committee Meeting_September 14-15 2000 re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:41Z,,0,0,09000064859fd84a
FDA-2015-D-1211-0384,FDA,FDA-2015-D-1211,Reference 23 REV. ACBTSA re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:46Z,,0,0,09000064859fd859
FDA-2015-D-1211-0392,FDA,FDA-2015-D-1211,Refernce 31_HIV Risk Behavior Profiles Among Men Who Have Sex with Men Interested in Donating Blood_ADVANCE Study re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:51Z,,0,0,09000064859fd863
FDA-2015-D-1211-0401,FDA,FDA-2015-D-1211,Reference 40_Initiation of anti-retroviral therapy during acute HIV-1 infection leads to a high rate of nonreactive HIV serology re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:57Z,,0,0,09000064859fd940
FDA-2015-D-1211-0367,FDA,FDA-2015-D-1211,Reference 6 Pubhealthrep00106-0104 re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:33Z,,0,0,09000064859fbfd4
FDA-2015-D-1211-0372,FDA,FDA-2015-D-1211,Reference 11 Transfusion-associated_infections re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:36Z,,0,0,09000064859fd727
FDA-2015-D-1211-0380,FDA,FDA-2015-D-1211,Reference 19 FDA Workshop on Behavior-Based Donor Deferral in the NAT Era 2006 re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:42Z,,0,0,09000064859fd84b
FDA-2015-D-1211-0383,FDA,FDA-2015-D-1211,Reference 22_FDA workshop on Quarantine Release Errors in Blood Establishments_September 2011 re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:45Z,,0,0,09000064859fd858
FDA-2015-D-1211-0393,FDA,FDA-2015-D-1211,Reference 32_Caffrey_Removing MSM.Canada.CliniqueTransfusion.2022 re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:52Z,,0,0,09000064859fd864
FDA-2015-D-1211-0376,FDA,FDA-2015-D-1211,Reference 15 MMWR_Revised Public Health Service Definition of Persons Who Should Refrain from Donating Blood and Plasma -- United States re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:39Z,,0,0,09000064859fd847
FDA-2015-D-1211-0389,FDA,FDA-2015-D-1211,Reference 28 Lucky2014 re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:49Z,,0,0,09000064859fd860
FDA-2015-D-1211-0398,FDA,FDA-2015-D-1211,Reference 37_Patel et al_Estimating per-act HIV transmission risk re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:55Z,,0,0,09000064859fd93d
FDA-2015-D-1211-0406,FDA,FDA-2015-D-1211,Reference 45_New Ref 45_Modeling the Effect of an Individual-Risk Based Deferral Policy re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:08:02Z,,0,0,09000064859fd945
FDA-2015-D-1211-0364,FDA,FDA-2015-D-1211,Reference 3 Dubin_et_al-2013-Transfusion re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:31Z,,0,0,09000064859fbfd1
FDA-2015-D-1211-0365,FDA,FDA-2015-D-1211,Reference 4 Epidemiologic Notes and Reports Pneumocystis carinii Pneumonia among Persons with Hemophilia A re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:31Z,,0,0,09000064859fbfd2
FDA-2015-D-1211-0366,FDA,FDA-2015-D-1211,Reference 5 Epidemiologic Notes and Reports Possible Transfusion-Associated Acquired Immune Deficiency Syndrome (AIDS) -- California re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:32Z,,0,0,09000064859fbfd3
FDA-2015-D-1211-0375,FDA,FDA-2015-D-1211,Reference 14 Klamroth2014 re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:38Z,,0,0,09000064859fd846
FDA-2015-D-1211-0373,FDA,FDA-2015-D-1211,Reference 12 Ward et al_JAMA_256_3_028 re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:37Z,,0,0,09000064859fd844
FDA-2015-D-1211-0361,FDA,FDA-2015-D-1211,Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Other,Guidance,2023-05-12T04:00:00Z,2023,5,2023-05-12T04:00:00Z,,2024-11-11T21:24:16Z,,1,0,09000064859fa827
FDA-2015-D-1211-0369,FDA,FDA-2015-D-1211,Reference 8 FDA Memorandum Recommendations to decrease the Risk of Tramitting AIDS fro Blood donors re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:34Z,,0,0,09000064859fc421
FDA-2015-D-1211-0377,FDA,FDA-2015-D-1211,Reference 16_FDA Blood Products Advisory Committee Meeting_December 11 1997 re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:40Z,,0,0,09000064859fd848
FDA-2015-D-1211-0396,FDA,FDA-2015-D-1211,Reference 35_Advisory Committee on the Safety of Blood Tissues and Organs (SaBTO)_Donor Selection Criteria Report re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:54Z,,0,0,09000064859fd867
FDA-2015-D-1211-0378,FDA,FDA-2015-D-1211,Reference 17_FDA Workshop on Donor Suitability 1998 re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:40Z,,0,0,09000064859fd849
FDA-2015-D-1211-0382,FDA,FDA-2015-D-1211,Reference 21 Quarantine-release-errors-white-paper re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:44Z,,0,0,09000064859fd84d
FDA-2015-D-1211-0391,FDA,FDA-2015-D-1211,Reference 30_ADVANCE Study re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:50Z,,0,0,09000064859fd862
FDA-2015-D-1211-0381,FDA,FDA-2015-D-1211,Reference 20 HHS Advisory Committee for blood safety and availability mtg 2010 re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:43Z,,0,0,09000064859fd84c
FDA-2015-D-1211-0388,FDA,FDA-2015-D-1211,Reference 27 Seed2010 re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Supporting & Related Material,Background Material,2023-05-12T04:00:00Z,2023,5,,,2023-05-12T20:07:48Z,,0,0,09000064859fd85f
FDA-2015-D-1211-0274,FDA,FDA-2015-D-1211,Guidance Documents Related to Coronavirus Disease 2019 (COVID–19),Notice,General Notice,2023-03-13T04:00:00Z,2023,3,2023-03-13T04:00:00Z,,2023-03-13T14:09:01Z,2023-05094,0,0,090000648579b2d7
FDA-2015-D-1211-0151,FDA,FDA-2015-D-1211,Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions To Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2023-01-30T05:00:00Z,2023,1,2023-01-30T05:00:00Z,,2023-02-28T14:29:29Z,2023-01796,0,0,0900006485618fef
FDA-2015-D-1211-0155,FDA,FDA-2015-D-1211,Reference 17_FDA Workshop on Donor Suitability 1998,Supporting & Related Material,Background Material,2023-01-30T05:00:00Z,2023,1,,,2023-01-30T14:18:43Z,,0,0,0900006485618a78
FDA-2015-D-1211-0156,FDA,FDA-2015-D-1211,Reference 18_FDA Blood Products Advisory Committee Meeting_September 14-15 2000,Supporting & Related Material,Background Material,2023-01-30T05:00:00Z,2023,1,,,2023-01-30T14:19:40Z,,0,0,0900006485618a79
FDA-2015-D-1211-0157,FDA,FDA-2015-D-1211,Reference 19 FDA Workshop on Behavior-Based Donor Deferral in the NAT Era 2006,Supporting & Related Material,Background Material,2023-01-30T05:00:00Z,2023,1,,,2023-01-30T14:20:46Z,,0,0,0900006485618a6b
FDA-2015-D-1211-0158,FDA,FDA-2015-D-1211,Reference 22_FDA workshop on Quarantine Release Errors in Blood Establishments_September 2011,Supporting & Related Material,Background Material,2023-01-30T05:00:00Z,2023,1,,,2023-01-30T14:21:52Z,,0,0,0900006485618a6c
FDA-2015-D-1211-0152,FDA,FDA-2015-D-1211,Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions To Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry; Availability,Other,Guidance,2023-01-30T05:00:00Z,2023,1,2023-01-30T05:00:00Z,2023-04-01T03:59:59Z,2025-02-05T02:00:53Z,,1,0,0900006485618a68
FDA-2015-D-1211-0159,FDA,FDA-2015-D-1211,New Reference 30_ADVANCE Study,Supporting & Related Material,Background Material,2023-01-30T05:00:00Z,2023,1,,,2023-01-30T14:22:43Z,,0,0,0900006485618a6d
FDA-2015-D-1211-0160,FDA,FDA-2015-D-1211,New Ref 32- O Brien - Donor screening question alternatives to men who have sex with men time deferral  Potential (1),Supporting & Related Material,Background Material,2023-01-30T05:00:00Z,2023,1,,,2023-01-30T14:24:06Z,,0,0,0900006485618a6e
FDA-2015-D-1211-0154,FDA,FDA-2015-D-1211,Reference 16_FDA Blood Products Advisory Committee Meeting_December 11 1997,Supporting & Related Material,Background Material,2023-01-30T05:00:00Z,2023,1,,,2023-01-30T14:17:37Z,,0,0,0900006485618a77
FDA-2015-D-1211-0153,FDA,FDA-2015-D-1211,New Ref 15 MMWR_Revised Public Health Service Definition of Persons Who Should Refrain from Donating Blood and Plasma -- United States,Supporting & Related Material,Background Material,2023-01-30T05:00:00Z,2023,1,,,2023-01-30T14:17:49Z,,0,0,0900006485618a6a
FDA-2015-D-1211-0161,FDA,FDA-2015-D-1211,New Ref 37_NHS Blood and Transplant_Our Improved Donations Safety Check,Supporting & Related Material,Background Material,2023-01-30T05:00:00Z,2023,1,,,2023-01-30T14:24:58Z,,0,0,0900006485618a7c
FDA-2015-D-1211-0147,FDA,FDA-2015-D-1211,Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance Level 2 Update Final AUGUST 2020,Other,Guidance,2020-08-31T04:00:00Z,2020,8,2020-08-31T04:00:00Z,,2024-11-12T23:24:17Z,,1,0,0900006484828fc5
FDA-2015-D-1211-0136,FDA,FDA-2015-D-1211,Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products,Other,Guidance,2020-06-17T04:00:00Z,2020,6,2020-06-17T04:00:00Z,,2023-02-28T14:36:33Z,,0,0,09000064846f63b7
FDA-2015-D-1211-0135,FDA,FDA-2015-D-1211,"Revised Recommendations for Reducing the Risk of Human
Immunodeficiency Virus Transmission by Blood and Blood Products;
Guidance for Industry; Availability",Notice,Notice of Data Availability,2020-06-17T04:00:00Z,2020,6,2020-06-17T04:00:00Z,,2023-02-28T14:29:54Z,2020-13051,0,0,09000064846f5d6b
FDA-2015-D-1211-0111,FDA,FDA-2015-D-1211,Ref 37 - Custer - Transfusion-transmissible infection,Supporting & Related Material,Background Material,2020-04-03T04:00:00Z,2020,4,,,2020-04-03T14:28:54Z,,0,0,0900006484485938
FDA-2015-D-1211-0109,FDA,FDA-2015-D-1211,Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Other,Guidance,2020-04-03T04:00:00Z,2020,4,2020-04-03T04:00:00Z,,2023-02-28T14:41:01Z,,0,0,0900006484485934
FDA-2015-D-1211-0110,FDA,FDA-2015-D-1211,Reference 26 - Custer - Blood DROPS,Supporting & Related Material,Background Material,2020-04-03T04:00:00Z,2020,4,,,2020-04-03T14:28:04Z,,0,0,0900006484485937
FDA-2015-D-1211-0107,FDA,FDA-2015-D-1211,"Attachment 1 Article from CDC ""HIV Among Transgender People"" re: Comment from Rhode Island Blood Center",Supporting & Related Material,Background Material,2016-08-29T04:00:00Z,2016,8,,,2016-08-29T14:29:31Z,,0,0,09000064821a8e09
FDA-2015-D-1211-0098,FDA,FDA-2015-D-1211,"Revised Recommendations for Reducing the Risk of Human  Immunodeficiency Virus Transmission by Blood and Blood Products;
Guidance for Industry; Availability,",Notice,Notice of Availability,2015-12-23T05:00:00Z,2015,12,2015-12-23T05:00:00Z,,2023-02-28T14:29:06Z,2015-32250,0,0,0900006481dca583
FDA-2015-D-1211-0099,FDA,FDA-2015-D-1211,Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry,Other,Guidance,2015-12-23T05:00:00Z,2015,12,2015-12-23T05:00:00Z,,2023-02-28T14:36:21Z,,0,0,0900006481dcd33a
FDA-2015-D-1211-0028,FDA,FDA-2015-D-1211,"Ref. 25 Soriano V, Vispo E, Labarga P, Medrano J, Barreiro P, Viral hepatitis and HIV co-infection re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T18:45:47Z,,0,0,0900006481ae6b04
FDA-2015-D-1211-0036,FDA,FDA-2015-D-1211,"Ref. 33 Custer B, Sheon N, Siedle-Khan B, Pollack L, Spencer B, Bialkowski W, D’Andrea P, Sullivan M, Glynn S, Williams A, NHLBI Recipient Epidemiology and Donor Evaluation-III (REDS-III), Noncompliance with the men who have sex with me re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T19:53:20Z,,0,0,0900006481ae6c63
FDA-2015-D-1211-0040,FDA,FDA-2015-D-1211,"Ref. 37 Lucky TTA, Seed CR, Waller D, Lee JF, McDonald A, Wand H, Wroth S, Shuttleworth G, Keller AJ, Pink J, Wilson DP, Understanding noncompliance with selective donor deferral criteria for high-risk behaviors in Australian blood donors re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T19:53:48Z,,0,0,0900006481ae6c67
FDA-2015-D-1211-0043,FDA,FDA-2015-D-1211,"Ref. 40 Weller S, Davis-Beaty K, Condom effectiveness in reducing heterosexual HIV transmission re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T19:54:05Z,,0,0,0900006481ae6c6a
FDA-2015-D-1211-0033,FDA,FDA-2015-D-1211,"Ref. 30 FDA workshop on Quarantine Release Errors in Blood Establishments, September 2011 re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T19:53:01Z,,0,0,0900006481ae6d98
FDA-2015-D-1211-0034,FDA,FDA-2015-D-1211,"Ref. 31 HHS Advisory Committee on Blood and Tissue Safety and Availability, Results from the Uniform Donor History Questionnaire, December 2013 re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T19:53:09Z,,0,0,0900006481ae6d99
FDA-2015-D-1211-0019,FDA,FDA-2015-D-1211,"Ref. 16 Klamroth R, Gröner A, Simon TL, Pathogen inactivation and removal methods for plasma-derived clotting factor concentrates re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T16:17:56Z,,0,0,0900006481ae6322
FDA-2015-D-1211-0006,FDA,FDA-2015-D-1211,"Ref. 3 Stramer SL, Dodd RY, Transfusion-transmitted emerging infectious disease: 30 years of challenges and progress re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T16:16:22Z,,0,0,0900006481ae668d
FDA-2015-D-1211-0009,FDA,FDA-2015-D-1211,"Ref. 6 Centers for Disease Control and Prevention, Epidemiologic Notes and Reports Possible Transfusion-Associated Acquired Immune Deficiency Syndrome re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T16:16:51Z,,0,0,0900006481ae6317
FDA-2015-D-1211-0041,FDA,FDA-2015-D-1211,"Ref. 38 Mark KP, Janssen E, Milhausen RR, Infidelity in heterosexual couples: demographic, interpersonal, and personality-related predictors of extradyadic sex, Arch Sex Behav 2011 re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T19:53:53Z,,0,0,0900006481ae6c68
FDA-2015-D-1211-0027,FDA,FDA-2015-D-1211,"Ref. 24 United Kingdom Scientific, SaBTO Advisory Committee on the Safety of Blood, Tissues and Organs, Donor Selection Criteria Review, April 2011 re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T18:45:41Z,,0,0,0900006481ae6aa3
FDA-2015-D-1211-0029,FDA,FDA-2015-D-1211,"Ref. 26 Purcell DW, Johnson CH, Lansky A, Prejean J, Stein R, Denning P, Gaul Z, Weinstock H, Su J, Crepaz N, Estimating the population size of men who have sex with men in the United States to obtain HIV and syphilis rates re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T18:45:52Z,,0,0,0900006481ae6b05
FDA-2015-D-1211-0038,FDA,FDA-2015-D-1211,"Ref. 35 Offergeld R, et al, Sexual risk behavior and donor deferral in Europe, Vox Sanguinis 2014 re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T19:53:34Z,,0,0,0900006481ae6c65
FDA-2015-D-1211-0044,FDA,FDA-2015-D-1211,"Ref. 41 Smith DK, Herbst JH, Zhang X, Rose CE, Condom effectiveness for HIV prevention by consistency of use among men who have sex with men in the united states, J Acquir Immune Defic Syndr 2015 re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T19:54:10Z,,0,0,0900006481ae6c6b
FDA-2015-D-1211-0022,FDA,FDA-2015-D-1211,"Ref. 19 FDA Blood Products Advisory Committee Meeting, September 14, 2000 re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T18:45:12Z,,0,0,0900006481ae6a9e
FDA-2015-D-1211-0026,FDA,FDA-2015-D-1211,"Ref. 23 Kucirka LM1, Sarathy H, Govindan P, Wolf JH, Ellison TA, Hart LJ, Montgomery RA, Ros RL, Segev DL, Risk of window period HIV infection in high infectious risk donors re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T18:45:36Z,,0,0,0900006481ae6aa2
FDA-2015-D-1211-0011,FDA,FDA-2015-D-1211,"Ref. 8 Van de Perre P, Clumeck N, Carael M, Nzabihimana E, Robert-Guroff M, De Mol P, Freyens P, Butzler JP, Gallo RC, Kanyamupira JB, Female prostitutes: a risk group for infection with human T-cell lymphotropic virus type III re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T16:17:05Z,,0,0,0900006481ae6319
FDA-2015-D-1211-0012,FDA,FDA-2015-D-1211,Ref. 9 FDA Memorandum Recommendations to decrease the Risk of Tramitting AIDS fro Blood donors re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry,Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T16:17:11Z,,0,0,0900006481ae631a
FDA-2015-D-1211-0025,FDA,FDA-2015-D-1211,"Ref. 22 Federal Register Notice, “Request for Information (RFI) on Design of a Pilot Operational Study To Assess Alternative Blood Donor Deferral Criteria for Men Who Have Had Sex With Other Men re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T18:45:30Z,,0,0,0900006481ae6aa1
FDA-2015-D-1211-0030,FDA,FDA-2015-D-1211,"Ref. 27  CDC, HIV Surveillance Report, 2012; vol 24. Published November 2014 re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T18:45:59Z,,0,0,0900006481ae6b06
FDA-2015-D-1211-0010,FDA,FDA-2015-D-1211,"Ref. 7 Ginzburg HM, Intravenous drug users and the acquired immune deficiency syndrome re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T16:16:58Z,,0,0,0900006481ae6318
FDA-2015-D-1211-0003,FDA,FDA-2015-D-1211,REFERENCE LIST re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry,Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T16:16:00Z,,0,0,0900006481ae6688
FDA-2015-D-1211-0035,FDA,FDA-2015-D-1211,"Ref. 32 Custer B, Kessler D, Vahidnia F, Leparc G, Krysztof DE, Shaz B, Kamel H, Glynn S, Dodd RY, Stramer SL; NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II), Risk factors for retrovirus and hepatitis virus  re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T19:53:14Z,,0,0,0900006481ae6d9a
FDA-2015-D-1211-0015,FDA,FDA-2015-D-1211,"Ref. 12 Perkins HA, Busch MP, Transfusion-associated infections: 50 years of relentless challenges and remarkable progress re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T16:17:33Z,,0,0,0900006481ae631d
FDA-2015-D-1211-0031,FDA,FDA-2015-D-1211,"Ref. 28 CDC, Estimated HIV incidence in the United States, 2007–2010. HIV Surveillance Supplemental Report 2012; 17(No. 4). Published December 2012 re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T18:46:05Z,,0,0,0900006481ae6b07
FDA-2015-D-1211-0037,FDA,FDA-2015-D-1211,"Ref. 34 Benjamin RJ, et al, Deferral of males who had sex with other males, Vox Sanguinis 2011 re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T19:53:27Z,,0,0,0900006481ae6c64
FDA-2015-D-1211-0042,FDA,FDA-2015-D-1211,"Ref. 39 Stone E, Heagerty P, Vittinghoff E, Douglas JM Jr, Koblin BA, Mayer KH, Celum CL, Gross M, Woody GE, Marmor M, Seage GR III, Buchbinder SP, Correlates of condom failure in a sexually active cohort of men who have sex with men re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T19:53:59Z,,0,0,0900006481ae6c69
FDA-2015-D-1211-0020,FDA,FDA-2015-D-1211,"Ref. 17 FDA Blood Products Advisory Committee Meeting, December 11-12, 1997 re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T18:45:00Z,,0,0,0900006481ae6a9c
FDA-2015-D-1211-0017,FDA,FDA-2015-D-1211,"Ref. 14 Ward JW, Grindon AJ, Feorino PM, Schable C, Parvin M, Allen JR, Laboratory and epidemiologic evaluation of an enzyme immunoassay for antibodies to HTLV-III re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T16:17:44Z,,0,0,0900006481ae631f
FDA-2015-D-1211-0014,FDA,FDA-2015-D-1211,"Ref. 11 Centers for Disease Control and Prevention, Current Trends Prevention of Acquired Immune Deficiency Syndrome (AIDS): Report of Inter-Agency Recommendations re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T16:17:26Z,,0,0,0900006481ae631c
FDA-2015-D-1211-0023,FDA,FDA-2015-D-1211,"Ref. 20 FDA Workshop on Behavior-Based Donor Deferral in the NAT Era, 2006 re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T18:45:18Z,,0,0,0900006481ae6a9f
FDA-2015-D-1211-0045,FDA,FDA-2015-D-1211,"Ref. 42 FDA Blood Products Advisory Committee Meeting, December 2014 transcript re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T19:54:17Z,,0,0,0900006481ae6c6c