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withdrawn,object_id FDA-2012-N-1037-0107,FDA,FDA-2012-N-1037,"Reference 76 - Meyer, J. M., N. P. Silliman, W. Wang, et al..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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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