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100 rows where docket_id = "FDA-2012-N-1037" and posted_year = 2014 sorted by posted_date descending

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document_type 2

  • Supporting & Related Material 99
  • Rule 1

posted_year 1

  • 2014 · 100 ✖

agency_id 1

  • FDA 100
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2012-N-1037-0107 FDA None FDA-2012-N-1037 Reference 76 - Meyer, J. M., N. P. Silliman, W. Wang, et al.. “Risk Factors for Helicobacter pylori Resistance in the United States - Establishing a List of Qualifying Pathogens Under the Food and Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T22:47:39Z   0 0 090000648172c518
FDA-2012-N-1037-0124 FDA None FDA-2012-N-1037 Reference 93 - Ribes, J. A., C. L. Vanover-Sams, and D. J. Baker, “Zygomycetes in Human Disease,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-09T01:15:57Z   0 0 090000648172c529
FDA-2012-N-1037-0084 FDA None FDA-2012-N-1037 Reference 53 - Chayakulkeeree, M., J. R. Perfect, “Cryptococcosis,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:02:49Z   0 0 090000648172c501
FDA-2012-N-1037-0101 FDA None FDA-2012-N-1037 Reference 70 - Rosenberg, J. J., “Helicobacter pylori,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:41:30Z   0 0 090000648172c512
FDA-2012-N-1037-0103 FDA None FDA-2012-N-1037 Reference 72 - De Francesco, V., A. Zullo, C. Hassan, et al., “Mechanisms of Helicobacter pylori Antibiotic Resistance: An Updated Appraisal,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T22:46:56Z   0 0 090000648172c514
FDA-2012-N-1037-0125 FDA None FDA-2012-N-1037 Reference 94 - Rees, J. R., R. W. Pinner, R. A. Hajjeh, et al., “The Epidemiologic Features of Invasive Mycotic Infection in the San Francisco Bay Area 1992-1993: Results of a Population-Based Laboratory Active Surveillance,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-09T01:48:45Z   0 0 090000648172c52a
FDA-2012-N-1037-0085 FDA None FDA-2012-N-1037 Reference 54 - Centers for Disease Control and Prevention, “C. neoformans cryptococcosis: Cryptococcosis Statistics” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:03:01Z   0 0 090000648172c502
FDA-2012-N-1037-0091 FDA None FDA-2012-N-1037 Reference 60 - Harris, J. R., S. R. Lockhart, E. Debess, et al., “Cryptococcus gattii in the United States: Clinical Aspects of Infection With an Emerging Pathogen,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:13:08Z   0 0 090000648172c508
FDA-2012-N-1037-0104 FDA None FDA-2012-N-1037 Reference 73 - De Francesco, V., F. Giorgio, C. Hassan, et al., “Worldwide H. pylori Antibiotic Resistance: A Systematic Review,” Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T22:47:12Z   0 0 090000648172c515
FDA-2012-N-1037-0117 FDA None FDA-2012-N-1037 Reference 86 - Mayers, D., Antimicrobial Drug Resistance: Clinical and Epidemiological Aspects - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-09T01:11:46Z   0 0 090000648172c522
FDA-2012-N-1037-0118 FDA None FDA-2012-N-1037 Reference 87 - Cortez, K., E. Roilides, F. Quiroz-Telles, et al., Infections Caused By Scedosporium spp - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-09T01:12:07Z   0 0 090000648172c523
FDA-2012-N-1037-0078 FDA None FDA-2012-N-1037 Reference 47 - CDC Features, “Valley Fever: Awareness is Key” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:01:32Z   0 0 090000648172c0fb
FDA-2012-N-1037-0075 FDA None FDA-2012-N-1037 Reference 44 - Centers for Disease Control and Prevention, “Increase in Reported Coccidioidomycosis--United States, 1998-2011,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T20:23:21Z   0 0 090000648172c0f8
FDA-2012-N-1037-0089 FDA None FDA-2012-N-1037 Reference 58 - Upton, A., J.A. Fraser, S.E. Kidd, et. al., “First Contemporary Case of Human Infection with Cryptococcus Gattii in Puget Sound: Evidence for Spread of the Vancouver Island Outbreak,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:12:39Z   0 0 090000648172c506
FDA-2012-N-1037-0093 FDA None FDA-2012-N-1037 Reference 62 - Pfaller, M. A., D. J. Diekema, D. L. Gibbs, et al., “Results from the ARTEMIS DISK Global Antifungal Surveillance Study, 1997 to 2007 - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:13:40Z   0 0 090000648172c50a
FDA-2012-N-1037-0113 FDA None FDA-2012-N-1037 Reference 82 - Murdock, D. A., “Gram-Positive Anaerobic Cocci,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T22:59:46Z   0 0 090000648172c51e
FDA-2012-N-1037-0121 FDA None FDA-2012-N-1037 Reference 90 - Song, M. J., J. H. Lee, and N. Y. Lee, “Fatal Scedosporium prolificans Infection in a Paediatric Patient with Acute Lymphoblastic Leukaemia,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-09T01:13:58Z   0 0 090000648172c526
FDA-2012-N-1037-0129 FDA None FDA-2012-N-1037 Reference 98 - Centers for Disease Control and Prevention, “C. gattii Cryptococcosis Statistics” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-09T01:49:52Z   0 0 090000648172c52e
FDA-2012-N-1037-0122 FDA None FDA-2012-N-1037 Reference 91 - Munoz, P., M. Marin, P. Tornero, et al., “Successful Outcome of Scedosporium apiospermum Disseminated Infection Treated with Voriconazole in a Patient Receiving Corticosteroid Therapy,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-09T01:14:15Z   0 0 090000648172c527
FDA-2012-N-1037-0127 FDA None FDA-2012-N-1037 Reference 96 - Neofytos, D., D. Horn, E. Anaissie, et al., “Epidemiology and Outcome of Invasive Fungal Infection in Adult Hematopoietic Stem Cell Transplant Recipients: - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-09T01:49:31Z   0 0 090000648172c52c
FDA-2012-N-1037-0070 FDA None FDA-2012-N-1037 Reference 39 - Leal, J., D. B. Gregson, T. Ross, et al., “Epidemiology of Clostridium Species Bacteremia in Calgary, Canada, 2000-2006,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T20:22:28Z   0 0 090000648172c0f3
FDA-2012-N-1037-0094 FDA None FDA-2012-N-1037 Reference 63 - Gast, C. E, L. R. Basso Jr., I. Bruzual, et al., “Azole Resistance in Cryptococcus gattii from the Pacific Northwest: Investigation of the Role of ERG11,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:13:51Z   0 0 090000648172c50b
FDA-2012-N-1037-0095 FDA None FDA-2012-N-1037 Reference 64 - Nir-Paz, R., J. Strahilevitz, M. Shapiro, et al., “Clinical and Epidemiological Aspects of Infection Caused By Fusarium Species: a Collaborative Study From Israel,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:14:05Z   0 0 090000648172c50c
FDA-2012-N-1037-0099 FDA None FDA-2012-N-1037 Reference 68 - Centers for Disease Control and Prevention, “Helicobacter pylori: Fact Sheet for Health Care Professionals,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:26:21Z   0 0 090000648172c510
FDA-2012-N-1037-0100 FDA None FDA-2012-N-1037 Reference 69 - Seck, A., C. Burucoa, D. Dia, et al., “Primary Antibiotic Resistance and Associated Mechanisms in Helicobacter pylori Isolates from Senegalese Patients,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:31:04Z   0 0 090000648172c511
FDA-2012-N-1037-0109 FDA None FDA-2012-N-1037 Reference 78 - Costello, A., G. Herbert, L. Fabunmi, et al. “Virulence of an Emerging Respiratory Pathogen, Genus Pandoraea, in vivo and its Interactions with Lung Epithelial Cells,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T22:51:59Z   0 0 090000648172c51a
FDA-2012-N-1037-0126 FDA None FDA-2012-N-1037 Reference 95 - Marr, K. A., R. A. Carter, F. Crippa, et al., “Epidemiology and Outcome of Mold Infections in Hematopoietic Stem Cell Transplant Recipients,” Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-09T01:49:15Z   0 0 090000648172c52b
FDA-2012-N-1037-0128 FDA None FDA-2012-N-1037 Reference 97 - Bayram, Y., H. Korkoca, C. Aypak, et al., “Antimicrobial Susceptibilities of Brucella Isolates from Various Clinical Specimens,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-09T01:51:04Z   0 0 090000648172c52d
FDA-2012-N-1037-0092 FDA None FDA-2012-N-1037 Reference 61- Perfect, J. R., W. E. Dismukes, F. Dromer, et al., “Clinical Practice Guidelines for the Management of Cryptococcal Disease: 2010 Update by the Infectious Diseases Society of America,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:13:30Z   0 0 090000648172c509
FDA-2012-N-1037-0096 FDA None FDA-2012-N-1037 Reference 65 - Al-Abdely, H. M., “Management of Rare Fungal Infections,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:14:17Z   0 0 090000648172c50d
FDA-2012-N-1037-0110 FDA None FDA-2012-N-1037 Reference 79 - Schneider, I. and A. Bauernfeind, “Intrinsic Carbapenem-Hydrolysing Oxacillinases of Pandoraea species-- A Tool for Species Identification?,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T22:52:51Z   0 0 090000648172c51b
FDA-2012-N-1037-0111 FDA None FDA-2012-N-1037 Reference 80 - LiPuma, J., “The Changing Microbial Epidemiology in Cystic Fibrosis,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T22:53:19Z   0 0 090000648172c51c
FDA-2012-N-1037-0116 FDA None FDA-2012-N-1037 Reference 85 - Brazier, J. S., V. Hall, T. E. Morris, et al., “Antibiotic Susceptibilities of Gram-Positive Anaerobic Cocci: Results of a Sentinel Study in England and Wales,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-09T01:11:32Z   0 0 090000648172c521
FDA-2012-N-1037-0123 FDA None FDA-2012-N-1037 Reference 92 - Rogers, T. R., “Treatment of Zygomycosis: Current and New Options,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-09T01:14:59Z   0 0 090000648172c528
FDA-2012-N-1037-0073 FDA None FDA-2012-N-1037 Reference 42 - Soge, O. O., L. D. Tivoli, J. S. Meschke, et al., “A Conjugative Macrolide Resistance Gene, mef(A), in Environmental Clostridium perfringens Carrying Multiple Macrolide and/or Tetracycline Resistance Genes,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T20:22:59Z   0 0 090000648172c0f6
FDA-2012-N-1037-0071 FDA None FDA-2012-N-1037 Reference 40 - Tansuphasiri, U., W. Matra, and L. Sangsuk, “Antimicrobial Resistance among Clostridium perfringens Isolated from Various Sources in Thailand,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T20:22:37Z   0 0 090000648172c0f4
FDA-2012-N-1037-0072 FDA None FDA-2012-N-1037 Reference 41- Bannam, T. L., W. L. Teng, D. Bulach, et al., “Functional Identification of Conjugation and Replication Regions of the Tetracycline Resistance Plasmid pCW3 from Clostridium perfringens,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T20:22:46Z   0 0 090000648172c0f5
FDA-2012-N-1037-0076 FDA None FDA-2012-N-1037 Reference 45 - Galgiani, J. N., N. M. Ampel, J. E. Blair, et al., “Coccidioidomycosis,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T20:23:35Z   0 0 090000648172c0f9
FDA-2012-N-1037-0069 FDA None FDA-2012-N-1037 Reference 38 - Lee, Y., Y. Park., M. S. Kim, et al., “Antimicrobial Susceptibility Patterns for Recent Clinical Isolates of Anaerobic Bacteria in South Korea,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T20:22:01Z   0 0 090000648172c0f2
FDA-2012-N-1037-0105 FDA None FDA-2012-N-1037 Reference 74 - Megraud, F., S. Coenen, A. Versporten, et al., “Helicobacter pylori Resistance to Antibiotics in Europe and its Relationship to Antibiotic Consumption,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T22:47:21Z   0 0 090000648172c516
FDA-2012-N-1037-0119 FDA None FDA-2012-N-1037 Reference 88- Cremer, G. and P. Boirin, “Scedosporium Species: The Rising Importance of Newly Emerging Fungal Pathogens,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-09T01:12:33Z   0 0 090000648172c524
FDA-2012-N-1037-0120 FDA None FDA-2012-N-1037 Reference 89 - Cooley, L., D. Spelman, K. Thursky, et al., “Infection with Scedosporium apiospermum and S. prolificans, Australia,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-09T01:13:27Z   0 0 090000648172c525
FDA-2012-N-1037-0088 FDA None FDA-2012-N-1037 Reference 57 - Iqbal, N., E. E. DeBess, R. Wohrle, et al., “Correlation of Genotype and In Vitro Susceptibilities of Cryptococcus gattii Strains from the Pacific Northwest of the United States,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:12:26Z   0 0 090000648172c505
FDA-2012-N-1037-0108 FDA None FDA-2012-N-1037 Reference 77 - Megraud, F., “The Challenge of Helicobacter pylori Resistance to Antibiotics: The Comeback of Bismuth-Based Quadruple Therapy,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T22:48:14Z   0 0 090000648172c519
FDA-2012-N-1037-0112 FDA None FDA-2012-N-1037 Reference 81 - Jørgensen, I. M., H. K. Johansen, B. Frederiksen, et al., “Epidemic Spread of Pandoreaea apista, a New Pathogen Causing Severe Lung Disease in Cystic Fibrosis Patients,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T22:57:09Z   0 0 090000648172c51d
FDA-2012-N-1037-0115 FDA None FDA-2012-N-1037 Reference 84 - Koeth, L. M., C. E. Good, P. C. Appelbaum, et al., Surveillance of Susceptibility Patterns - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-09T01:11:10Z   0 0 090000648172c520
FDA-2012-N-1037-0074 FDA None FDA-2012-N-1037 Reference 43 -Centers for Disease Control and Prevention, “Definition of Coccidioidomycosis (Valley Fever),” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T20:23:11Z   0 0 090000648172c0f7
FDA-2012-N-1037-0077 FDA None FDA-2012-N-1037 Reference 46 - Centers for Disease Control and Prevention, “Summary of Notifiable Diseases--United States, 2009,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:01:01Z   0 0 090000648172c0fa
FDA-2012-N-1037-0079 FDA None FDA-2012-N-1037 Reference 48 - Iowa State University, The Center for Food Security & Public Health, “Coccidioidomycosis,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:01:43Z   0 0 090000648172c0fc
FDA-2012-N-1037-0081 FDA None FDA-2012-N-1037 Reference 50 - Huang, J. Y, B. Bristow, S. Shafir, and F.Sorvillo. Coccidioidomycosis- Associated Deaths - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:02:03Z   0 0 090000648172c0fe
FDA-2012-N-1037-0082 FDA None FDA-2012-N-1037 Reference 51 - Kriesel, J. D., D. A. Sutton, S. Schulman, et al., “Persistent Pulmonary Infection with an Azole-Resistant Coccidioides Species,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:02:15Z   0 0 090000648172c0ff
FDA-2012-N-1037-0083 FDA None FDA-2012-N-1037 Reference 52 - Mathisen, G., A. Shelub, J. Truong, and C. Wigen, “Coccidioidal Meningitis: Clinical Presentation and Management in the Fluconazole Era,” -Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:02:40Z   0 0 090000648172c500
FDA-2012-N-1037-0087 FDA None FDA-2012-N-1037 Reference 56 - Pfaller, M.A. and D. J. Diekema, “Epidemiology of Invasive Mycoses in North America,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:12:12Z   0 0 090000648172c504
FDA-2012-N-1037-0097 FDA None FDA-2012-N-1037 Reference 66 - Cave, D. R., “How is Helicobacter pylori Transmitted?,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:19:14Z   0 0 090000648172c50e
FDA-2012-N-1037-0098 FDA None FDA-2012-N-1037 Reference 67 - Duck, W. M., J. Sobel, J. M. Prucker, et al., “Antimicrobial Resistance Incidence and Risk Factors Among Helicobacter pylori-Infected Persons, United States,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:23:36Z   0 0 090000648172c50f
FDA-2012-N-1037-0102 FDA None FDA-2012-N-1037 Reference 71 - Everhart, J. E., D. Kruszon-Moran, G. I. Perez-Perez, et al., “Seroprevalence and Ethnic Difference in Helicobacter pylori Infection Among Adults in the United States,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:45:27Z   0 0 090000648172c513
FDA-2012-N-1037-0114 FDA None FDA-2012-N-1037 Reference 83 - Ryan, K. J. and C. G. Ray, Sherris Medical Microbiology: An Introduction to Infectious Disease, McGraw-Hill, New York, 4th Ed., 2004. - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T23:04:06Z   0 0 090000648172c51f
FDA-2012-N-1037-0086 FDA None FDA-2012-N-1037 Reference 55 - Pyrgos, V., A. E. Seitz, C. A. Steiner, et al., “Epidemiology of Cryptococcal Meningitis in the US: 1997-2009,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:12:02Z   0 0 090000648172c503
FDA-2012-N-1037-0090 FDA None FDA-2012-N-1037 Reference 59 - Duggan, J. and H. M. Walls, "Ocular Complications of Cryptococcal Meningitis in Patients with HIV," - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:12:54Z   0 0 090000648172c507
FDA-2012-N-1037-0106 FDA None FDA-2012-N-1037 Reference 75 - Gao, W., H. Cheng, F. Hu, et al., “The Evolution of Helicobacter pylori Antibiotics Resistance Over 10 years in Beijing, China,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T22:47:30Z   0 0 090000648172c517
FDA-2012-N-1037-0080 FDA None FDA-2012-N-1037 Reference 49 - Tsang, C. A., S. M. Anderson, S. B. Imholte, et al., “Enhanced Surveillance of Coccidioidomycosis, Arizona, USA, 2007-2008.” Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-08T04:00:00Z 2014 6     2014-06-08T21:01:51Z   0 0 090000648172c0fd
FDA-2012-N-1037-0068 FDA None FDA-2012-N-1037 Reference 37 - Wybo, I., et al., “Third Belgian Multicentre Survey of Antibiotic Susceptibility of Anaerobic Bacteria,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-06T04:00:00Z 2014 6     2014-06-06T19:08:06Z   0 0 090000648172c0f1
FDA-2012-N-1037-0067 FDA None FDA-2012-N-1037 Reference 36 - Hall, A. J., A. T. Curns, L. C. McDonald, et al., “The Roles of Clostridium difficile and Norovirus Among Gastroenteritis-Associated Deaths in the United States, 1999-2007,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-06T04:00:00Z 2014 6     2014-06-06T18:58:06Z   0 0 090000648172c0f0
FDA-2012-N-1037-0033 FDA None FDA-2012-N-1037 Reference 2 - Howard, D. H., R. D. Scott II, R. Packard, et al., “The Global Impact of Drug Resistance” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T02:47:52Z   0 0 090000648172c028
FDA-2012-N-1037-0036 FDA None FDA-2012-N-1037 Reference 5 - Wong, M. R., V. Reddy, H. Hanson, et al., “Antimicrobial Resistance Trends of Shigella Serotypes in New York City, 2006-2009 - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:00:33Z   0 0 090000648172c02b
FDA-2012-N-1037-0039 FDA None FDA-2012-N-1037 Reference 8 - Shah, H. N., I. Olsen, K. Bernard, et al., “Approaches to the Study of the Systematics of Anaerobic, Gram-negative, Non-sporeforming Rods: Current Status and Perspectives,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:01:23Z   0 0 090000648172c02e
FDA-2012-N-1037-0040 FDA None FDA-2012-N-1037 Reference 9 - Feingold, S. M., Microbiology. 4th Ed. Galveston: University of Texas Medical Branch at Galveston, 1996, Ch. 20 - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:01:58Z   0 0 090000648172c0d5
FDA-2012-N-1037-0051 FDA None FDA-2012-N-1037 Reference 20 - Centers for Disease Control and Prevention, “Bioterrorism Agents/Diseases” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:05:10Z   0 0 090000648172c0e0
FDA-2012-N-1037-0055 FDA None FDA-2012-N-1037 Reference 24 - Tanyele, E., A. Y. Coban, S. T. Koruk, et al., “Actual Antibiotic Resistance Pattern of Brucella melitensis in Central Anatolia: An Update From and Endemic Region,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:06:23Z   0 0 090000648172c0e4
FDA-2012-N-1037-0062 FDA None FDA-2012-N-1037 Reference 31- Roach, R. L. and D. G. Sienko, “Clostridium perfringens Outbreak Associated with Minestrone Soup,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:08:34Z   0 0 090000648172c0eb
FDA-2012-N-1037-0056 FDA None FDA-2012-N-1037 Reference 25 - Parlak, M., H. Güdücüoğlu, Y. Bayram, et al., “Identification and Determination of Antibiotic Susceptibilities of Brucella Strains Isolated from Patients in Van, Turkey by Conventional and Molecular Methods - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:06:37Z   0 0 090000648172c0e5
FDA-2012-N-1037-0043 FDA None FDA-2012-N-1037 Reference 12 - Goldstein, E. J. C., D. M. Citron, S. A. Vaidya, et al., “In Vitro Activity of 11 Antibiotics Against 74 Anaerobes Isolated from Pediatric Intra-abdominal Infections,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:02:39Z   0 0 090000648172c0d8
FDA-2012-N-1037-0057 FDA None FDA-2012-N-1037 Reference 26 - Maves, R. C., R. Castillo, A. Guillen, et al., “Antimicrobial Susceptibility of Brucella melitensis Isolates in Peru,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:06:55Z   0 0 090000648172c0e6
FDA-2012-N-1037-0064 FDA None FDA-2012-N-1037 Reference 33 - Stevens, D. L., M. J. Aldape, and A. E. Bryant, “Life-threatening Clostridial Infections,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:09:01Z   0 0 090000648172c0ed
FDA-2012-N-1037-0052 FDA None FDA-2012-N-1037 Reference 21 - Pappas, G., N. Akritidis, M. Bosilkovski, et al., “Brucellosis,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:05:25Z   0 0 090000648172c0e1
FDA-2012-N-1037-0048 FDA None FDA-2012-N-1037 Reference 17 - Summary of Notifiable Diseases--United States, 2006 - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:04:07Z   0 0 090000648172c0dd
FDA-2012-N-1037-0042 FDA None FDA-2012-N-1037 Reference 11 - Lassmann, B., D. R. Gustafson, C. M. Wood, and J. E. Rosenblatt, “Reemergence of Anaerobic Bacteremia,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:02:26Z   0 0 090000648172c0d7
FDA-2012-N-1037-0058 FDA None FDA-2012-N-1037 Reference 27 - Centers for Disease Control and Prevention, “Healthcare-associated Infections: Clostridium sordellii” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:07:13Z   0 0 090000648172c0e7
FDA-2012-N-1037-0047 FDA None FDA-2012-N-1037 Reference 16 - Liu, C. Y., Y. T. Huang, C. H. Liao, et al., “Increasing Trends in Antimicrobial Resistance among Clinically Important Anaerobes and Bacteroides fragilis Isolates Causing Nosocomial Infections: Emerging Resistance to Carbapenems,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:03:54Z   0 0 090000648172c0dc
FDA-2012-N-1037-0046 FDA None FDA-2012-N-1037 Reference 15 - Teng, L. J., P. R. Hsueh, J. C. Tsai, et al., “High Incidence of Cefoxitin and Clindamycin Resistance among Anaerobes in Taiwan,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:03:37Z   0 0 090000648172c0db
FDA-2012-N-1037-0032 FDA None FDA-2012-N-1037 Reference 1- Roberts, R. R., B. Hota, I. Ahmad, et al., “Hospital and Societal Costs of Antimicrobial-Resistant Infections in a Chicago Teaching Hospital: Implications for Antibiotic Stewardship,” Clinical Infectious Diseases, 2009;49:1175-1184 - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T02:47:06Z   0 0 090000648172c027
FDA-2012-N-1037-0038 FDA None FDA-2012-N-1037 Reference 7 - Mandell, G. L., J. E. Bennett, R. Dolin, et al., Mandell, Douglas, and Bennett’s Principles and Practice of Infectious Diseases. 7th Ed. Philadelphia: Churchill Livingstone Elsevier, 2010 - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:01:02Z   0 0 090000648172c02d
FDA-2012-N-1037-0053 FDA None FDA-2012-N-1037 Reference 22 - Abdel-Maksoud, M., B. House, M. Wasfy, et al., “In Vitro Antibiotic Susceptibility Testing of Brucella Isolates from Egypt between 1999 and 2007 and Evidence of Probable Rifampin Resistance,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:05:38Z   0 0 090000648172c0e2
FDA-2012-N-1037-0044 FDA None FDA-2012-N-1037 Reference 13 - Jamal W., M. Shahin, and V. O. Rotimi, “Surveillance and Trends of Antimicrobial Resistance Among Clinical Isolates of Anaerobes in Kuwait Hospitals from 2002 to 2007,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:02:54Z   0 0 090000648172c0d9
FDA-2012-N-1037-0050 FDA None FDA-2012-N-1037 Reference 19 - Centers for Disease Control and Prevention, “Notifiable Diseases and Mortality Tables,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:04:55Z   0 0 090000648172c0df
FDA-2012-N-1037-0060 FDA None FDA-2012-N-1037 Reference 29 -Centers for Disease Control and Prevention, “Food Safety: Clostridium perfringens” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:07:54Z   0 0 090000648172c0e9
FDA-2012-N-1037-0045 FDA None FDA-2012-N-1037 Reference 14 - Behra-Miellet, J., L. Calveta, F. Mory, et al., “Antibiotic Resistance Among Anaerobic Gram-negative Bacilli: Lessons from a French Multicentric Survey,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:03:19Z   0 0 090000648172c0da
FDA-2012-N-1037-0063 FDA None FDA-2012-N-1037 Reference 32 - Bad Bug Book: Handbook of Foodborne Pathogenic Microorganisms and Natural Toxins - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:08:47Z   0 0 090000648172c0ec
FDA-2012-N-1037-0054 FDA None FDA-2012-N-1037 Reference 23 - Kinsara, A., A. Al-Mowallad, and A. O. Osoba, “Increasing Resistance of Brucellae to Co-Trimoxazole,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:05:55Z   0 0 090000648172c0e3
FDA-2012-N-1037-0031 FDA None FDA-2012-N-1037 List of References - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T02:34:50Z   0 0 090000648172c026
FDA-2012-N-1037-0049 FDA None FDA-2012-N-1037 Reference 18 - Centers for Disease Control and Prevention, “Summary of Notifiable Diseases--United States, 2008,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:04:29Z   0 0 090000648172c0de
FDA-2012-N-1037-0059 FDA None FDA-2012-N-1037 Reference 28 - McGuigan, C. C., G. M. Penrice, L. Gruer, et al., “Lethal Outbreak of Infection with Clostridium novyi Type A and Other Spore-Forming Organisms in Scottish Injecting Drug Users,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:07:32Z   0 0 090000648172c0e8
FDA-2012-N-1037-0061 FDA None FDA-2012-N-1037 Reference 30 - Wahl, E., S. Rømma, and P. E. Granum, “A Clostridium perfringens Outbreak Traced to Temperature-Abused Beef Stew, Norway, 2012,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:08:17Z   0 0 090000648172c0ea
FDA-2012-N-1037-0037 FDA None FDA-2012-N-1037 Reference 6 - Alcaine, S. D., L. D. Warnick, and M. Wiedmann, “Antimicrobial Resistance in Nontyphoidal Salmonella” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:00:47Z   0 0 090000648172c02c
FDA-2012-N-1037-0041 FDA None FDA-2012-N-1037 Reference 10 - Ngo, J. T., M. D. Parkins, D. B. Gregson, et al., “Population-based Assessment of the Incidence, Risk Factors, and Outcomes of Anaerobic Bloodstream Infections,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:02:12Z   0 0 090000648172c0d6
FDA-2012-N-1037-0065 FDA None FDA-2012-N-1037 Reference 34 - Centers for Disease Control and Prevention, “Making Healthcare Safer: Stopping C. difficile Infections,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:09:19Z   0 0 090000648172c0ee
FDA-2012-N-1037-0066 FDA None FDA-2012-N-1037 Reference 35 - Redelings, M. D., F. Sorvino, and L. Mascola, “Increase in Clostridium difficile-Related Mortality Rates, United States, 1999-2004,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T03:09:39Z   0 0 090000648172c0ef
FDA-2012-N-1037-0034 FDA None FDA-2012-N-1037 Reference 3 Niedell, M. J., B. Cohen, Y. Furuya, et al., “Costs of Healthcare- and Community-Associated Infections With Antimicrobial-Resistant Versus Antimicrobial- Susceptible Organisms” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T02:48:50Z   0 0 090000648172c029
FDA-2012-N-1037-0035 FDA None FDA-2012-N-1037 Reference 4 - Sjölund Karlsson, M., A. Bowen, R. Reporter, et al., “Outbreak of Infections Caused by Shigella sonnei with Reduced Susceptibility to Azithromycin in the United States,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-06T02:50:04Z   0 0 090000648172c02a
FDA-2012-N-1037-0030 FDA None FDA-2012-N-1037 Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act Rule Final Rule 2014-06-05T04:00:00Z 2014 6 2014-06-05T04:00:00Z   2014-06-05T14:39:54Z 2014-13023 0 0 090000648172a9f3

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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);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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