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withdrawn,object_id FDA-2015-D-1211-0098,FDA,FDA-2015-D-1211,"Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and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Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T18:45:47Z,,0,0,0900006481ae6b04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Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T19:53:20Z,,0,0,0900006481ae6c63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Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry",Supporting & Related Material,Background Material,2015-05-18T04:00:00Z,2015,5,,,2015-05-18T19:53:48Z,,0,0,0900006481ae6c67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 FDA-2015-D-1211-0021,FDA,FDA-2015-D-1211,"Ref. 18 FDA Workshop on Donor Suitability, 1998 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,,,2015-05-18T18:45:05Z,,0,0,0900006481ae6a9d FDA-2015-D-1211-0024,FDA,FDA-2015-D-1211,"Ref. 21 HHS Advisory Committee for blood safety and availability mtg, 2010 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,,,2015-05-18T18:45:25Z,,0,0,0900006481ae6aa0 FDA-2015-D-1211-0039,FDA,FDA-2015-D-1211,"Ref. 36 Seed CR, Kiely P, Law M, Keller AJ, No evidence of a significantly increased risk of transfusion-transmitted human immunodeficiency virus infection in Australia subsequent to implementing a 12-month deferral for men who have had 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,,,2015-05-18T19:53:41Z,,0,0,0900006481ae6c66 FDA-2015-D-1211-0016,FDA,FDA-2015-D-1211,"Ref. 13 Centers for Disease Control and Prevention, Update: Revised Public Health Service Definition of Persons Who Should Refrain from Donating Blood and Plasma – United States 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,,,2015-05-18T16:17:38Z,,0,0,0900006481ae631e FDA-2015-D-1211-0032,FDA,FDA-2015-D-1211,"Ref. 29 AABB on Quarantine Release Errors, White Paper 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,,,2015-05-18T18:46:10Z,,0,0,0900006481ae6b08 FDA-2015-D-1211-0013,FDA,FDA-2015-D-1211,"Ref. 10 Leveton LB, Sox Jr HC, Stoto MA, eds, HIV and the blood supply: an analysis of crisis decisionmaking, Institute of Medicine, National Academy Press, Washington DC 1995 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,,,2015-05-18T16:17:17Z,,0,0,0900006481ae631b FDA-2015-D-1211-0018,FDA,FDA-2015-D-1211,"Ref. 15 Zou S, Stramer SL, Dodd RY, Donor testing and risk: current prevalence, incidence, and residual risk of transfusion-transmissible agents in US allogeneic donations 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,,,2015-05-18T16:17:50Z,,0,0,0900006481ae6320 FDA-2015-D-1211-0004,FDA,FDA-2015-D-1211,Reference. 1 FDA Memorandum to all Registered Blood Establishments 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,,,2015-05-18T16:16:07Z,,0,0,0900006481ae668a FDA-2015-D-1211-0005,FDA,FDA-2015-D-1211,"Ref. 2 Epstein JS, Jaffe HW, Alter HJ, Klein HG, Blood system changes since recognition of transfusion-associated AIDS 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,,,2015-05-18T16:16:15Z,,0,0,0900006481ae668b FDA-2015-D-1211-0007,FDA,FDA-2015-D-1211,"Ref. 4 Dubin C, Francis D, Closing the circle: a thirty-year retrospective on the AIDS/blood epidemic 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,,,2015-05-18T16:16:28Z,,0,0,0900006481ae668e FDA-2015-D-1211-0008,FDA,FDA-2015-D-1211,"Ref. 5 Centers for Disease Control and Prevention, Epidemiologic Notes and Reports Pneumocystis carinii Pneumonia among Persons with Hemophilia A 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,,,2015-05-18T16:16:36Z,,0,0,0900006481ae668f FDA-2015-D-1211-0001,FDA,FDA-2015-D-1211,Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2015-05-15T04:00:00Z,2015,5,2015-05-15T04:00:00Z,2015-07-15T03:59:59Z,2023-04-27T01:00:42Z,2015-11690,0,0,0900006481ae2a95 FDA-2015-D-1211-0002,FDA,FDA-2015-D-1211,Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry,Other,Guidance,2015-05-15T04:00:00Z,2015,5,2015-05-15T04:00:00Z,,2023-02-28T14:36:50Z,,0,0,0900006481ae3a52