Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act

Document ID: FDA-2012-N-1037-0013
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Drugs, Health, Health Care, Immunization, Prescription Drugs, Public Health
Federal Register Number: 2013-13865
CFR Citation: 21 CFR Part 317
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Details Information

Document Subtype: Notice of Proposed Rulemaking (NPRM)
Received Date: June 12 2013, at 12:00 AM Eastern Daylight Time
Start-End Page: 35155 - 35173
Page Count: 19
Comment Start Date: June 12 2013, at 12:00 AM Eastern Standard Time
Comment Due Date: August 12 2013, at 11:59 PM Eastern Standard Time

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List of References 1 through 157

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Refeence 148 Increase in Pneumococcus Macrolide Resistance United States

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Reference 1 Hospital and Societal Costs of Antimicrobial Resistant Infections in a Chicago Teaching Hospital: Implications for Antibiotic Stewardship

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Reference 10 Clinical Outcomes of Health Care Associated Infections and Antimicrobial Resistance in Patients Admitted to European Intensive Care Units: A Cohort Study

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Reference 100 Mechanisms of Antibiotic Resistance in Staphylococcus aureus

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Reference 101 Staphylococcus aureus Resistant to Vancomycin United States 2002

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Reference 102 Clinical Practice Guideline by the Infectious Disease Society of America for the Treatment of Methicillin Resistant Staphylococcus Aureus Infections in Adults and Children

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Reference 103 Resistance of Group B Streptococcus to Selected Antibiotics Including Erythromycin and Clindamycin

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Reference 104 Group B Strep GBS Fast Facts

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Reference 105 Group B Strep Infection in Newborns

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Reference 106 Group B Strep Infection in Adults

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Reference 107 Antibiotic Resistance Patterns in Invasive Group B Streptococcal Isolates

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Reference 108 Mutation in the Group B Streptococcal pbp2x Gene Conferring Decreased Susceptibility to Beta Lactam Antibiotics

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Reference 109 Resistance to Beta Lactam Antibiotics

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Reference 11 Aspergillus Infection in Lung Transplant Patients Incidence and Prognosis

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Reference 110 Genetic Heterogeniety in pbp Genes Among Clinically Isolated Group B Streptococci With Reduced Penicillin Susceptibility

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Reference 111 In Vitro Resistance to Macrolides and Clindamycin by Group B Streptococcus Isolated From Pregnant and Nonpregnant Women

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Reference 112 Infectious Diseases Related to Travel Pneumococcal Disease Streptococcus pneumoniae

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Reference 113 Streptococcus pneumoniae: Does Antimicrobial Resistance Matter

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Reference 114 Updated Recommendations for Prevention of Invasive Pneumococcal Disease Among Adults Using the 23 Valent Pneumococcal Polysaccharide Vaccine PPSV23

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Reference 115 Disease Listing Streptococcus pneumoniae Disease

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Reference 116 Drug Resistant Streptococcus pneumoniae Rational Antibiotic Choices

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Reference 117 Changing Trends in Antimicrobial Resistance and Serotypes of Streptococcus pneumoniae Isolates in Asian Countries an Asian Network for Surveillance of Resistant Pathogens ANSORP Study

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Reference 118 Antimicrobial Resistance Surveillance in Europe 2009

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Reference 119 The Streptococcus pyogenes Proteome Maps Virulence Factors and Vaccine Candidates

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Reference 12 Emergence of Azole Resistance in Aspergillus fumigatus and Spread of a Single Resistance Mechanism

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Reference 120 Diagnosis and Management of Adults With Pharyngitis A Cost Effectiveness Analysis

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Reference 121 Group A Streptococcal Pharyngitis and Immune Mediated Complications From Diagnosis to Management

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Reference 122 ABCs Report Group A Streptococcus 2011

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Reference 123 Why Have Group A Streptococci Remained Susceptible to Penicillin Report on a Symposium

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Reference 124 Group A Streptococcus and its Antibiotic Resistance

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Reference 125 Cholera Epidemiology and Risk Factors

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Reference 126 Cholera in the United States 1995 2000: Trends at the End of the Twentieth Century

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Reference 127 Drug Resistance Mechanisms in Vibrio cholerae O1 Outbreak Strain Haiti 2010

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Reference 128 Third Generation Cephalosporin Resistant Vibrio cholerae India

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Reference 129 Toxigenic Vibrio cholerae Serogroup O141 Associated Cholera Like Diarrhea and Bloodstream Infection in the United States

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Reference 13 Azole Antifungal Resistance Today Focus on Aspergillus

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Reference 130 The Current ICE Age Biology and Evolution of SXT Related Integrating Conjugative Elements

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Reference 131 Cholera Treatment

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Reference 132 Antimicrobial Resistant Pathogens Associated With Healthcare Associated Infections Summary of Data Reported to the National Healthcare Safety Network at the Centers for Disease Control and Prevention 2009 2010

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Reference 133 Pan Resistant Acinetobacter Infection in Neonates in Karachi Pakistan

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Reference 134 National Antimicrobial Resistance Monitoring System Enteric Bacteria: 2010 Human Isolates Final Report

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Reference 135 The Roles of Clostridium difficile and Norovirus Among Gastroenteritis Associated Deaths in the United States 1999 2007

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Reference 136 Making Health Care Safer: Stop Infections from Lethal CRE Germs Now

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Reference 137 Mycobacterium General Characteristics Laboratory Detection and Staining Procedures

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Reference 138 Rifampin Resistant Meningococcal Disease

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Reference 139 Epidemiology of Invasive Meningococcal Disease With Decreased Susceptibility to Penicillin in Ontario Canada 2000 to 2006

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Reference 14 An outbreak of Burkholderia cepacia Bacteremia in Hospitalized Hematology Patients Selectively Affecting Those With Acute Myeloid Leukemia

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Reference 140 Antibiotic Treatment Recommendations for the Use of Antibiotics for the Treatment of Cholera

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Reference 141 Laboratory Based Surveillance of Neisseria meningitides Isolates From Disease Cases in Latin America and Caribbean Countries SIREVA II 2006 2010

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Reference 142 Fluoroquinolone Resistance in Neisseria meningitidis in Spain

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Reference 143 Emergence of Neisseria meningitidis With Decreased Susceptibility to Ciprofloxacin in Argentina

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Reference 144 Mutator Clones of Neisseria meningitidis in Epidemic Serogroup A Disease

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Reference 145 Hospitalizations and Deaths Caused by Methicillin-Resistant Staphylococcus aureus United States 1999 2005

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Reference 146 ABCs Report Methicillin Resistant Staphylococcus aureus 2010

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Reference 147 Emergence of a Multiresistant Serotype 19A Pneumococcal Strain Not Included in the 7 Valent Conjugate Vaccine as an Otopathogen in Children

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Reference 149 Clinical Data in Children With Meningococcal Meningitis in a Spanish Hospital

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Reference 15 Clinical Characteristics and Outcomes of Patients With Burkholderia cepacia Bacteremia in an Intensive Care Unit

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Reference 150 Burkholderia cenocepacia and Burkholderia multivorans Influence on Survival in Cystic Fibrosis

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Reference 151 Overview of Nosocomial Infections Caused by Gram Negative Bacilli

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Reference 152 Multiple Mechanisms of Antimicrobial Resistance in Pseudomonas aeruginosa Our Worst Nightmare

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Reference 153 CDC Grand Rounds The Growing Threat of Multidrug Resistant Gonorrhea

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Reference 154 Antimicrobial Resistance Trends of Shigella Serotypes in New York City 2006 2009

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Reference 155 Antimicrobial Resistance in Nontyphoidal Salmonella

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Reference 156 The Relation Between Farm Specific Factors and Prevalence of Clostridium difficile in Slaughter Pigs

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Reference 157 Clinical Practice Guideline for the Diagnosis and Management of Group A Streptococcal Pharyngitis: 2012 Update by the Infectious Diseases Society of America

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Reference 16 An Episodic Outbreak of Genetically Related Burkholderia cepacia Among Non-Cystic Fibrosis Patients at a University Hospital

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Reference 17 Predictors of Mortality in Adults With Cystic Fibrosis

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Reference 18 Cystic Fibrosis Pulmonary Guidelines: Chronic Medications for Maintenance of Lung Health

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Reference 19 Antibiotic Resistance in Burkholderia cepacia at Two Regional Centres in Northern Ireland: Is There a Need for Synergy Testing

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Reference 2 The Global Impact of Drug Resistance

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Reference 20 Cystic Fibrosis Foundation Achieving the Mission

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Reference 21 Campylobacter General Information

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Reference 22 Antibiotic Resistance in Campylobacter Emergence Transmission and Persistence

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Reference 23 Antimicrobial Resistance Virulence and Genotypic Profile Comparison of Campylobacter jejuni and Campylobacter coli Isolated from Humans and Retail Meats

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Reference 24 Trends in Antibiotic Sensitivity Pattern and Molecular Detection of tet O Mediated Tetracycline Resistance in Campylobacter jejuni Isolates From Human and Poultry Sources

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Reference 25 Treatment of Invasive Candidiasis in Neutropenic Patients Systematic Review of Randomized Controlled Treatment Trials

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Reference 26 Invasive Candidiasis Statistics

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Reference 27 Risk Factors for Fluconazole Resistant Candidiasis in Human Immunodeficiency Virus Infected Patients

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Reference 28 Epidemiology of Candidaemia and Antifungal Susceptibility Patterns in an Italian Tertiary Care Hospital

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Reference 29 Organ Procurement and Transplantation Network and Scientific Registry of Transplant Recipients: 2010 Data Report

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Reference 3 Costs of Healthcare and Community Associated Infections With Antimicrobial Resistant Versus Antimicrobial Susceptible Organisms

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Reference 30 Fungal Infections in Solid Organ Transplantation

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Reference 31 Evolution of Anti-Fungal Drug Resistance Mechanisms and Pathogen Fitness

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Reference 32 The Epidemiology of Hematogenous Candidiasis Caused by Different Candida Species

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Reference 33 Increase in Candida krusei Infection Among Patients With Bone Marrow Transplantation and Neutropenia Treated Prophylactically With Fluconazole

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Reference 34 ESCMID Guideline for the Diagnosis and Management of Candida Diseases 2012 Adults With Haematological Malignancies and After Haematopoietic Stem Cell Transplantation HCT

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Reference 35 Frequently Asked Questions About Clostridium difficile for Healthcare Providers

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Reference 36 Clostridium difficile Excerpt Guideline for Environmental Infection Control in Health Care Facilities 2003

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Reference 37 Making Healthcare Safer Stopping C difficile Infections

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Reference 38 Clinical Practice Guidelines for Clostridium difficile Infection in Adults 2010 Update by the Society for Healthcare Epidemiology of America SHEA and the Infectious Diseases Society of America IDSA

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Reference 39 Emergence and Global Spread of Epidemic Healthcare-Associated Clostridium difficile

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Reference 4 Principles and Practice of Infectious Diseases. 7th Ed Staphylococcus aureus including Staphylococcal Shock p. 2543 3253

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Reference 40 Carbapenem Resistant Enterobacteriaceae a Review of Treatment and Outcomes

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Reference 41 Preventing Lethal Hospital Outbreaks of Antibiotic Resistant Bacteria

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Reference 42 Foodborne Illness Acquired in the United States Major Pathogens

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Reference 43 Inpatient Care for Septicemia or Sepsis A Challenge for Patients and Hospitals

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Reference 44 Growing Antimicrobial Resistance of Shigella Isolates

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Reference 45 Outbreak of Infections Caused by Shigella sonnei with Reduced Susceptibility to Azithromycin in the United States

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Reference 46 Prevalence and Mechanisms of Cephalosporin Resistance in Enterobacteriaceae in London and South East England

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Reference 47 A Multinational Survey of Risk Factors for Infection with Extended Spectrum beta Lactamase Producing Enterobacteriaceae in Nonhospitalized Patients

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Reference 48 Carbapenem Resistant Enterobacteriaceae

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Reference 49 Klebsiella pneumoniae in Healthcare Settings

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Reference 5 Bad Bugs No Drugs No ESKAPE An Update from the Infectious Diseases Society of America

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Reference 50 Carbapenem Resistant Enterobacteriaceae Containing New Delhi Metallo Beta Lactamase in Two Patients Rhode Island March 2012

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Reference 51 First NDM Positive Salmonella sp Strain Identified in the United States

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Reference 52 Presence of Integron Associated Resistance in the Community Is Widespread and Contributes to Multidrug Resistance in the Hospital

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Reference 53 Carbapenem-Resistant Enterobacteriaceae--A Potential Threat

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Reference 54 Global Spread of Carbapenemase Producing Enterobacteriaceae

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Reference 55 Outcomes of Carbapenem--Resistant Klebsiella pneumoniae Infection and the Impact of Antimicrobial and Adjunctive Therapies

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Reference 56 Toxicity of Polymyxins A Systematic Review of the Evidence From Old and Recent Studies

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Reference 57 Vancomycin-Resistant Enterococci Mechanisms and Clinical Observations

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Reference 58 Major Trends in the Microbial Etiology of Nosocomial Infection

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Reference 59 Nosocomial Spread of Linezolid-Resistant, Vancomycin Resistant Enterococcus faecium

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Reference 6 Federal Funding for the Study of Antimicrobial Resistance in Nosocomial Pathogens No ESKAPE

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Reference 60 Clinical Prevalence Antimicrobial Susceptibility and Geographic Resistant Patterns of Enterococci Results From the SENTRY Antimicrobial Surveillance Program 1997 1999

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Reference 61 Outcomes Associated With Vancomycin Resistant Enterococci: A Meta Analysis

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Reference 62 Comparison of Mortality Associated With Vancomycin Resistant and Vancomycin Susceptible Enterococcal Bloodstream Infections A MetaAnalysis

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Reference 63 Increase in Clostridium difficile Related Mortality Rates United States 1999 2004

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Reference 64 Global Tuberculosis Report 2012

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Reference 65 Fact Sheet Multi Drug Resistant Tuberculosis MDR TB

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Reference 66 Plan to Combat Extensively Drug Resistant Tuberculosis Recommendations of the Federal Tuberculosis Task Force

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Reference 67 Fact Sheet Trends in Tuberculosis 2011

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Reference 68 Mechanisms of Drug Resistance in Mycobacterium Tuberculosis

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Reference 69 Overview of Anti-Tuberculosis (TB) Drugs and Their Resistance Mechanisms

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Reference 7 Multidrug Resistant Acinetobacter Infection Mortality Rate and Length of Hospitalization

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Reference 70 Fact Sheet Extensively Drug Resistant Tuberculosis XDR TB

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Reference 71 Outbreak of Multidrug Resistant Tuberculosis at a Hospital New York City 1991

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Reference 72 Extensively Drug Resistant Tuberculosis in the United States 1993 2007

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Reference 73 2011 Sexually Transmitted Diseases Surveillance Gonorrhea

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Reference 74 Sexually Transmitted Diseases Treatment Guidelines 2010 Gonococcal Infections

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Reference 75 Sexually Transmitted Infections Among US Women and Men Prevalence and Incidence Estimates 2008

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Reference 76 Antimicrobial Resistance in Neisseria gonorrhoeae in the United States 1988 1994 The Emergence of Decreased Susceptibility to the Fluoroquinolones

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Reference 77 Update to CDC's Sexually Transmitted Diseases Treatment Guidelines, 2010: Oral Cephalosporins No Longer a Recommended Treatment for Gonococcal Infections

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Reference 78 The Emerging Threat of Untreatable Gonococcal Infection

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Reference 79 Meningococcal Disease

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Reference 8 The Emergence and Implications of Metallo-Beta Lactamases in Gram Negative Bacteria

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Reference 80 Meningococcal Meningitis

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Reference 81 Active Bacterial Core Surveillance ABCs Report Neisseria meningitidis 2010

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Reference 82 Manual for the Surveillance of Vaccine Preventable Diseases

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Reference 83 Antimicrobial Drug Resistance Clinical and Epidemiological Aspects Vol 2

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Reference 84 Emergence of Ciprofloxacin Resistant Neisseria meningitidis in North America

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Reference 85 Antibiotic Resistance in Neisseria meningitidis

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Reference 86 Antimicrobial Susceptibility Testing, Drug Resistance Mechanisms, and Therapy of Infections With Nontuberculous Mycobacteria

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Reference 87 An Official ATS IDSA Statement Diagnosis Treatment and Prevention of Nontuberculous Mycobacterial Diseases

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Reference 88 Nontuberculous Mycobacteria Associated Lung Disease in Hospitalized Persons United States 1998 2005

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Reference 89 Prevalence of Nontuberculous Mycobacterial Lung Disease in US Medicare Beneficiaries

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Reference 9 Mechanisms of Multidrug Resistance in Acinetobacter Species and Pseudomonas aeruginosa

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Reference 90 Isolation Prevalence of Pulmonary Non Tuberculous Mycobacteria in Ontario 1997 2003

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Reference 91 Resistance Mechanisms and Drug Susceptibility Testing of Nontuberculous Mycobacteria

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Reference 92 Nontuberculous Mycobacterial Disease

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Reference 93 Cefepime-Resistant Pseudomonas aeruginosa

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Reference 94 The Epidemiological Profile of Infections With Multidrug Resistant Pseudomonas aeruginosa and Acinetobacter Species

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Reference 95 Bacteraemia Due to Pseudomonas putida and Other Pseudomonas Non aeruginosa in Children

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Reference 96 Vancomycin-Intermediate Resistant Staphylococcus VISA VRSA in Healthcare Settings

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Reference 97 Predictors of Clinical Virulence in Community Onset Methicillin Resistant Staphylococcus aureus Infections The Importance of USA300 and Pneumonia

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Reference 98 Emergence of Community Acquired Methicillin Resistant Staphylococcus aureus USA 300 Clone as the Predominant Cause of Skin and Soft Tissue Infections

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Reference 99 Invasive Methicillin Resistant Staphylococcus aureus Infections in the United States

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Comments

   
Total: 2
Jason P. Folster - Comment
Posted: 07/01/2013     ID: FDA-2012-N-1037-0015

Aug 12,2013 11:59 PM ET
Marla Kathleen Cheezem, RN - Comment
Posted: 06/24/2013     ID: FDA-2012-N-1037-0014

Aug 12,2013 11:59 PM ET

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