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113 rows where docket_id = "FDA-2015-D-1211" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2015-D-1211-0368 FDA None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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

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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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