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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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93 rows where docket_id = "FDA-2006-N-0040" and posted_year = 2015 sorted by posted_date descending

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  • Supporting & Related Material 92
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  • 2015 · 93 ✖

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  • FDA 93
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0040-0009 FDA Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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 Requirements for Human Blood & Blood Components Intended for Transfusion or for Further Manufacturing Use 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

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
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