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withdrawn,object_id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-2006-N-0040-0103,FDA,FDA-2006-N-0040,Request for Extension of Comment Period from AABB,Other,Request for Extension,2016-02-18T05:00:00Z,2016,2,2016-02-18T05:00:00Z,,2016-02-18T17:48:43Z,,0,0,0900006480442297
FDA-2006-N-0040-0105,FDA,FDA-2006-N-0040,Request for Extension of Comment Period from America's Blood Centers,Other,Request for Extension,2016-02-18T05:00:00Z,2016,2,2016-02-18T05:00:00Z,,2016-02-18T17:55:35Z,,0,0,090000648044229d
FDA-2006-N-0040-0107,FDA,FDA-2006-N-0040,Request for Extension of Comment Period from Puget Sound Blood Center,Other,Request for Extension,2016-02-18T05:00:00Z,2016,2,2016-02-18T05:00:00Z,,2016-02-18T18:01:19Z,,0,0,090000648044229f
FDA-2006-N-0040-0106,FDA,FDA-2006-N-0040,Request for Extension of Comment Period from Plasma Protein Therapeutics Association (PPTA),Other,Request for Extension,2016-02-18T05:00:00Z,2016,2,2016-02-18T05:00:00Z,,2016-02-18T17:58:51Z,,0,0,090000648044229e
FDA-2006-N-0040-0104,FDA,FDA-2006-N-0040,Request for Extension of Comment Period from American Red Cross,Other,Request for Extension,2016-02-18T05:00:00Z,2016,2,2016-02-18T05:00:00Z,,2016-02-18T17:52:02Z,,0,0,090000648044229a
FDA-2006-N-0040-0009,FDA,FDA-2006-N-0040,"Requirements for Blood and Blood Components Intended for Transfusion
or for Further Manufacturing Use",Rule,Final Rule,2015-05-22T04:00:00Z,2015,5,2015-05-22T04:00:00Z,,2024-11-07T23:21:58Z,2015-12228,1,0,0900006481af12e2
FDA-2006-N-0040-0073,FDA,FDA-2006-N-0040,Reference 63 Donor Deferral Due to Red Blood Cell Loss During Collection by Automated Plasmapheresis re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:24:31Z,,0,0,0900006481aef991
FDA-2006-N-0040-0101,FDA,FDA-2006-N-0040,"Reference 77-14 Relationship between Bacterial Load, Species Virulence, and Transfusion Reaction with Transfusion re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use",Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:33:00Z,,0,0,0900006481aef9ad
FDA-2006-N-0040-0054,FDA,FDA-2006-N-0040,Reference 44 BPAC June 2010 re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:22:02Z,,0,0,0900006481aef772
FDA-2006-N-0040-0090,FDA,FDA-2006-N-0040,Reference 77-3 AABB Bulletin 08-03 – West Nile Virus – Revised Recommendations for Triggering Individual Donation Nucleic Acid Testing  re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:31:29Z,,0,0,0900006481aef9a2
FDA-2006-N-0040-0010,FDA,FDA-2006-N-0040,Reference List re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T18:53:43Z,,0,0,0900006481aef5f7
FDA-2006-N-0040-0016,FDA,FDA-2006-N-0040,Reference 6 Implementation of Acceptable Full-Length Donor History Questionnaire re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:09:02Z,,0,0,0900006481aef5fd
FDA-2006-N-0040-0028,FDA,FDA-2006-N-0040,Reference 18 How Do I Investigate Septic Transfusion Reactions and Blood Donors with Culture-Positive Platelet Donations re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:18:12Z,,0,0,0900006481aef758
FDA-2006-N-0040-0055,FDA,FDA-2006-N-0040,Reference 45 ACBSA Meeting Minutes December 2008 re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:22:12Z,,0,0,0900006481aef773
FDA-2006-N-0040-0015,FDA,FDA-2006-N-0040,Reference 5 Transfusion-transmitted Emerging Infectious Diseases  30 years of Challenges and Progress re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:08:42Z,,0,0,0900006481aef5fc
FDA-2006-N-0040-0069,FDA,FDA-2006-N-0040,Reference 59 Evaluating the Role of Blood Collection Centers in Public Health  A Status Report re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:24:01Z,,0,0,0900006481aef98d
FDA-2006-N-0040-0052,FDA,FDA-2006-N-0040,Reference 42 Faint and Prefaint Reactions in Whole-Blood Donors  An Analysis of Predonation Measurements and Their Predictive Value re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:21:40Z,,0,0,0900006481aef770
FDA-2006-N-0040-0087,FDA,FDA-2006-N-0040,Reference 77 Regulatory Impact Analysis re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:26:38Z,,0,0,0900006481aef99f
FDA-2006-N-0040-0019,FDA,FDA-2006-N-0040,Reference 9 Transmission of HIV Possibly Associated with Exposure of Mucous Membrane to Contaminated Blood re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:10:04Z,,0,0,0900006481aef74f
FDA-2006-N-0040-0049,FDA,FDA-2006-N-0040,Reference 39 Recommendations for Assesment of Donor Suitability and Blood and Blood Product Safety in Cases of Possible Exposure to Anthrax re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:21:19Z,,0,0,0900006481aef76d
FDA-2006-N-0040-0053,FDA,FDA-2006-N-0040,Reference 43 BPAC Sept 10 2008 Agenda re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:21:53Z,,0,0,0900006481aef771
FDA-2006-N-0040-0012,FDA,FDA-2006-N-0040,"Reference 2 United States House of Representatives, Committee on Government Reform and Oversight, Subcommittee on Human Resources and Intergovernmental Relations re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use",Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T18:55:23Z,,0,0,0900006481aef5f9
FDA-2006-N-0040-0014,FDA,FDA-2006-N-0040,Reference 4 Emerging Infectious Disease Agents and Their Potential Threat to Transfusion Safety re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T18:55:43Z,,0,0,0900006481aef5fb
FDA-2006-N-0040-0036,FDA,FDA-2006-N-0040,Reference 26 BPAC Sept 2000 re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:19:13Z,,0,0,0900006481aef760
FDA-2006-N-0040-0059,FDA,FDA-2006-N-0040,Reference 49 The difference between fingerstick and venous hemoglobin re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:22:40Z,,0,0,0900006481aef778
FDA-2006-N-0040-0081,FDA,FDA-2006-N-0040,Reference 71 Study of Iron Stores in Regular Plateletphereis Donors re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:25:49Z,,0,0,0900006481aef999
FDA-2006-N-0040-0092,FDA,FDA-2006-N-0040,Reference 77-5 Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:31:43Z,,0,0,0900006481aef9a4
FDA-2006-N-0040-0038,FDA,FDA-2006-N-0040,Reference  28 Guidance for Industry Donor Screening re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:19:28Z,,0,0,0900006481aef762
FDA-2006-N-0040-0050,FDA,FDA-2006-N-0040,"Reference 40 The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use",Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:21:27Z,,0,0,0900006481aef76e
FDA-2006-N-0040-0060,FDA,FDA-2006-N-0040,Reference 50 Iron Deficiency in Blood Donors the REDS II Donor Iron Status Evaluation (RISE II) Study re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:22:47Z,,0,0,0900006481aef77a
FDA-2006-N-0040-0080,FDA,FDA-2006-N-0040,Reference 70  Impairment of short term memory loss Associated with Low Iron Stores in a Volunteer Multidose Plateletpheresis Donor re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:25:25Z,,0,0,0900006481aef998
FDA-2006-N-0040-0043,FDA,FDA-2006-N-0040,Reference 33 Community Blood Donors’ Knowledge of Anemia and Design of a Literacy-Appropriate Educational Intervention re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:20:27Z,,0,0,0900006481aef767
FDA-2006-N-0040-0063,FDA,FDA-2006-N-0040,Reference 53 Recommendations for collecting Red Blood re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:23:09Z,,0,0,0900006481aef77d
FDA-2006-N-0040-0076,FDA,FDA-2006-N-0040,Reference 66 Plasma proteins and lymphocyte phenoyptes in long term plasma donors re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:24:53Z,,0,0,0900006481aef994
FDA-2006-N-0040-0085,FDA,FDA-2006-N-0040,Reference 75 Safety Reporting Requirements for Human Drug and Biological Products Proposed Rule re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:26:24Z,,0,0,0900006481aef99d
FDA-2006-N-0040-0058,FDA,FDA-2006-N-0040,Reference 48 Examination of Blood Cells Willliams Hematology re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:22:33Z,,0,0,0900006481aef777
FDA-2006-N-0040-0021,FDA,FDA-2006-N-0040,Reference 11 Revised Preventive Measures to Reduce Risk of Tranmsission of CJD and vCJD re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:10:50Z,,0,0,0900006481aef751
FDA-2006-N-0040-0027,FDA,FDA-2006-N-0040,Reference 17 Further Guidance on Methods to Detect Bacterial Contamination of Platelet Components re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:18:06Z,,0,0,0900006481aef757
FDA-2006-N-0040-0065,FDA,FDA-2006-N-0040,Reference 55 Use of Blood Therapeutically Drawn From Hemochromatosis Patients re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:23:28Z,,0,0,0900006481aef77f
FDA-2006-N-0040-0022,FDA,FDA-2006-N-0040,Reference 12 Screening of Single-Donor Apheresis Platelets for Bacterial Contamination  the PASSPORT Study Results re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:11:12Z,,0,0,0900006481aef752
FDA-2006-N-0040-0061,FDA,FDA-2006-N-0040,Reference 51 Vital Signs Anthropometric Data and Pain Introduction re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:22:54Z,,0,0,0900006481aef77b
FDA-2006-N-0040-0098,FDA,FDA-2006-N-0040,"Reference 77-11 Regulatory Impact Analysis Prevalence, incidence, and residual risk of human immunodeficiency virus and hepatitis C virus infections re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use",Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:32:34Z,,0,0,0900006481aef9aa
FDA-2006-N-0040-0032,FDA,FDA-2006-N-0040,"Reference 22 A Computerized National Blood Donor Deferral Register,” The Journal of the American Medical Association re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use",Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:18:42Z,,0,0,0900006481aef75c
FDA-2006-N-0040-0024,FDA,FDA-2006-N-0040,"Reference 14 Relationship Between Bacterial Load, Species Virulence, and Transfusion Reaction with Transfusion of Bacterially Contaminated Platelets,” Clinical Infectious Disease re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use",Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:17:45Z,,0,0,0900006481aef754
FDA-2006-N-0040-0057,FDA,FDA-2006-N-0040,Reference 47 Effect of Reversible Androgen Deprivation on Hemoglobin and Serum Immunoreactive Erythropoietin in Men re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:22:25Z,,0,0,0900006481aef775
FDA-2006-N-0040-0031,FDA,FDA-2006-N-0040,Reference 21 An Evaluation of the Need for Shared Blood Donor Deferral Registries re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:18:35Z,,0,0,0900006481aef75b
FDA-2006-N-0040-0035,FDA,FDA-2006-N-0040,Reference 25 April 2009 BPAC Transcripts UCM155628 pdf re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:19:06Z,,0,0,0900006481aef75f
FDA-2006-N-0040-0084,FDA,FDA-2006-N-0040,Reference 74 QSEAL Plasma Protein Therapeutics Association (PPTA) re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:26:17Z,,0,0,0900006481aef99c
FDA-2006-N-0040-0088,FDA,FDA-2006-N-0040,Reference 77-1 Occupational Employment Statistics re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:26:45Z,,0,0,0900006481aef9a0
FDA-2006-N-0040-0072,FDA,FDA-2006-N-0040,Reference 62 Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:24:23Z,,0,0,0900006481aef990
FDA-2006-N-0040-0062,FDA,FDA-2006-N-0040,Reference 52 BPAC April 2011 re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:23:02Z,,0,0,0900006481aef77c
FDA-2006-N-0040-0067,FDA,FDA-2006-N-0040,Reference 57 Blood from Patients with Hereditary Hemochromatosisa Wasted Resource re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:23:44Z,,0,0,0900006481aef98b
FDA-2006-N-0040-0078,FDA,FDA-2006-N-0040,Reference 68 A Frequent Plateletpheresis Does Not Clinically Significantly Decrease Platelet Counts in Donors re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:25:09Z,,0,0,0900006481aef996
FDA-2006-N-0040-0082,FDA,FDA-2006-N-0040,Reference 72 Influence of multicomonent aheresis on donors re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:25:55Z,,0,0,0900006481aef99a
FDA-2006-N-0040-0071,FDA,FDA-2006-N-0040,Reference 61 Multiple Myeloma re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:24:16Z,,0,0,0900006481aef98f
FDA-2006-N-0040-0039,FDA,FDA-2006-N-0040,Reference  29 Guidance for Industry Requalification Method re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:19:36Z,,0,0,0900006481aef763
FDA-2006-N-0040-0100,FDA,FDA-2006-N-0040,Reference 77-13 Public Conference  Secondary Bacterial Screening of Platelet Components re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:32:49Z,,0,0,0900006481aef9ac
FDA-2006-N-0040-0042,FDA,FDA-2006-N-0040,Reference 32 Donor fatigue. The Red Cross Has Banned Chronic Fatigue Syndrome Sufferers from Giving Blood. But Does a Virus Really Cause the Disease re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:20:02Z,,0,0,0900006481aef766
FDA-2006-N-0040-0070,FDA,FDA-2006-N-0040,Reference 60 Specific Proteins Henry's Clinical Diagnosis re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:24:09Z,,0,0,0900006481aef98e
FDA-2006-N-0040-0030,FDA,FDA-2006-N-0040,"Reference 20 Public Conference July 17 2002 – Secondary Bacterial Screening of Platelet Components, 7_ re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use",Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:18:27Z,,0,0,0900006481aef75a
FDA-2006-N-0040-0040,FDA,FDA-2006-N-0040,Reference 30 Recommendations to Decrease the Risk of Transmitting Acquired Immune Deficiency Syndrome (AIDS) from Blood Donors re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:19:47Z,,0,0,0900006481aef764
FDA-2006-N-0040-0075,FDA,FDA-2006-N-0040,Reference 65 Specific Protein Content of Pools of Plasma for Fractionation from Different Sources  Impact of Frequency of Donations re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:24:46Z,,0,0,0900006481aef993
FDA-2006-N-0040-0099,FDA,FDA-2006-N-0040,"Reference 77-12 U.S. Centers for Disease Control and Prevention, Hepatitis C Fact Sheet re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use",Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:32:41Z,,0,0,0900006481aef9ab
FDA-2006-N-0040-0025,FDA,FDA-2006-N-0040,Reference 15 Fatalities Reported to FDA Following Blood Collection and Transfusion Annual Summary for Fiscal Year 2012 re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:17:51Z,,0,0,0900006481aef755
FDA-2006-N-0040-0074,FDA,FDA-2006-N-0040,Reference 64 Collection of Platelets by Automated Methods re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:24:39Z,,0,0,0900006481aef992
FDA-2006-N-0040-0086,FDA,FDA-2006-N-0040,Reference 76 Exceptions and Alternative Procedures Approved Under 21 CFR 640 re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:26:31Z,,0,0,0900006481aef99e
FDA-2006-N-0040-0066,FDA,FDA-2006-N-0040,Reference 56 Blood Safety Summary April 1999 re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:23:37Z,,0,0,0900006481aef780
FDA-2006-N-0040-0089,FDA,FDA-2006-N-0040,Reference 77-2 AABB Bulletin 06-08 Information Concerning Implementation of a Licensed Test for Antibodies to Trypanosoma cruzi re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:26:51Z,,0,0,0900006481aef9a1
FDA-2006-N-0040-0045,FDA,FDA-2006-N-0040,Reference  35 Guidance for Industry Assessing Donor Suitability West Nile June 2005 re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:20:50Z,,0,0,0900006481aef769
FDA-2006-N-0040-0026,FDA,FDA-2006-N-0040,Reference 16 Commission on Laboratory Accreditation Laboratory Accreditation Program re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:18:00Z,,0,0,0900006481aef756
FDA-2006-N-0040-0083,FDA,FDA-2006-N-0040,Reference 73 Blood Plasma Safety-Plasma Product Risks Are Low if Good Manufacturing Practices are Followed re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:26:02Z,,0,0,0900006481aef99b
FDA-2006-N-0040-0091,FDA,FDA-2006-N-0040,Reference 77-4 Use of Serological Testss to Reduce the Risk of Transmission of Trypanosoma cruzi re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:31:36Z,,0,0,0900006481aef9a3
FDA-2006-N-0040-0011,FDA,FDA-2006-N-0040,"Reference 1 Department of Health and Human Services, Blood Action Plan, FDACBER, July 1997 re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use",Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T18:55:08Z,,0,0,0900006481aef5f8
FDA-2006-N-0040-0013,FDA,FDA-2006-N-0040,"Reference 3 U. S. General Accounting Office, “Blood Supply FDA Oversight and Remaining Issues of Safety re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use",Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T18:55:33Z,,0,0,0900006481aef5fa
FDA-2006-N-0040-0029,FDA,FDA-2006-N-0040,Reference  19 Gold JS Bayor S Salem RR Association of Streptococcus re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:18:19Z,,0,0,0900006481aef759
FDA-2006-N-0040-0020,FDA,FDA-2006-N-0040,"Reference 10 Memorandum Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products (April 23, 1992) re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use",Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:10:30Z,,0,0,0900006481aef750
FDA-2006-N-0040-0023,FDA,FDA-2006-N-0040,Reference 13 ph and Glucose Testing of Single Donor Apheresis Platelets Should be Discontinued In Favor of a More Sensitive Detection Method re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:17:29Z,,0,0,0900006481aef753
FDA-2006-N-0040-0068,FDA,FDA-2006-N-0040,Reference 58 Evaluating the role of blood collection in public health re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:23:52Z,,0,0,0900006481aef98c
FDA-2006-N-0040-0056,FDA,FDA-2006-N-0040,Reference 46 Public Workshops Hemoglobin Standards and Maintaining Adequate Iron Stores in Blood Donors re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:22:19Z,,0,0,0900006481aef774
FDA-2006-N-0040-0095,FDA,FDA-2006-N-0040,Reference 77-8 AABB Bulletin 10-05 Suggested Options For Transfusion Services re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:32:09Z,,0,0,0900006481aef9a7
FDA-2006-N-0040-0097,FDA,FDA-2006-N-0040,"Reference 77-10 U.S. Centers for Disease Control and Prevention, Hepatitis B Fact Sheet re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use",Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:32:26Z,,0,0,0900006481aef9a9
FDA-2006-N-0040-0018,FDA,FDA-2006-N-0040,Reference 8 Impementation of an Acceptable Abbreviated Donor Hisotry Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:09:44Z,,0,0,0900006481aef74e
FDA-2006-N-0040-0034,FDA,FDA-2006-N-0040,Reference  24 Guidance For Industry Use of Serological Tests to Reduce the Risk of Transmission of T  Cruzi re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:18:59Z,,0,0,0900006481aef75e
FDA-2006-N-0040-0046,FDA,FDA-2006-N-0040,Reference  36 Guidance for Industry Revised Recommendations for the Asssessment of Donor Suitability SARS re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:20:58Z,,0,0,0900006481aef76a
FDA-2006-N-0040-0094,FDA,FDA-2006-N-0040,Reference 77-7 The 2011 National Blood Collection and Utilization Survey and Report re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:31:59Z,,0,0,0900006481aef9a6
FDA-2006-N-0040-0051,FDA,FDA-2006-N-0040,"Reference 41 A Case-Controlled Multicenter Study of Vasovagal Reactions in Blood Donors Influence of Sex, Age, Donation Status, Weight, Blood Pressure and Pulse re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use",Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:21:34Z,,0,0,0900006481aef76f
FDA-2006-N-0040-0096,FDA,FDA-2006-N-0040,Reference 77-9 The hazards of blood transfusion in historical perspective re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:32:16Z,,0,0,0900006481aef9a8
FDA-2006-N-0040-0044,FDA,FDA-2006-N-0040,Reference  34 Guidance for Industry Recommendations for Blood Establishments Training of Back Up Personnel re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:20:42Z,,0,0,0900006481aef768
FDA-2006-N-0040-0093,FDA,FDA-2006-N-0040,Reference 77-6 Public Conference July 17 2012 Secondary Bacterial Screening of Platelet Components re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:31:51Z,,0,0,0900006481aef9a5
FDA-2006-N-0040-0037,FDA,FDA-2006-N-0040,Reference 27 Antiphospholipid Syndrome  Laboratory Testing and Diagnostic Strategies re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:19:20Z,,0,0,0900006481aef761
FDA-2006-N-0040-0079,FDA,FDA-2006-N-0040,"Reference 69 Sustained Decreases in Platelet Count Associated with Multiple, Regular Plateletpheresis Donations re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use",Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:25:16Z,,0,0,0900006481aef997
FDA-2006-N-0040-0017,FDA,FDA-2006-N-0040,Reference 7 Impementation of an Acceptable Abbreviated Donor Hisotry Questionnaire and Accompanying Materials for Use in Screening Donors of Source Plasma re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:09:23Z,,0,0,0900006481aef5fe
FDA-2006-N-0040-0041,FDA,FDA-2006-N-0040,Reference 31 Deferral for Risk of Leishmaniasis Exposure re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:19:55Z,,0,0,0900006481aef765
FDA-2006-N-0040-0077,FDA,FDA-2006-N-0040,Reference 67 Revised Recommendations for Testing Whole Blood Blood Components Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:25:01Z,,0,0,0900006481aef995
FDA-2006-N-0040-0047,FDA,FDA-2006-N-0040,Reference  37 Draft Guidance for Industry Precautionary Measures to Reduce   Zoonosis re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:21:05Z,,0,0,0900006481aef76b
FDA-2006-N-0040-0033,FDA,FDA-2006-N-0040,Reference 23 National Donor Deferral Registry (NDDR) re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:18:49Z,,0,0,0900006481aef75d
FDA-2006-N-0040-0048,FDA,FDA-2006-N-0040,Reference  38 Memorandum to Blood Establishments Deferral of BLood and Plasma Donors based on Medications re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:21:13Z,,0,0,0900006481aef76c
FDA-2006-N-0040-0064,FDA,FDA-2006-N-0040,Reference 54 Variances for Blood Collection from Indviduals with Hereditary Hemochromatosis re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,Supporting & Related Material,Background Material,2015-05-22T04:00:00Z,2015,5,,,2015-05-22T19:23:20Z,,0,0,0900006481aef77e
FDA-2006-N-0040-0008,FDA,FDA-2006-N-0040,References for Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; Proposed Rule,Supporting & Related Material,Background Material,2009-02-12T05:00:00Z,2009,2,,,2016-02-24T16:21:51Z,,0,0,090000648084fa35
FDA-2006-N-0040-0007,FDA,FDA-2006-N-0040,Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; Extension of Comment Period,Notice,Extension of Comment Period,2009-02-10T05:00:00Z,2009,2,2008-01-11T05:00:00Z,2008-08-05T03:59:59Z,2016-02-24T16:30:21Z,,0,0,090000648084f715