,,ii #aadth ,,congress #b;d ,session ,s4 #cagf ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #ac1 #bjaf,mr4 ,brown introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,public ,health ,service ,act to enhance efforts to address antibiotic resistance1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,strategies to ,address ,antibiotic ,resistance ,act or the ,,staar ,act4 #b4 ,findings ,congress makes the following findings3 7#a7 ,the advent of the antibiotic era has saved millions of lives and allowed for incredible medical progress2 however1 the increased use and overuse of antibiotic drugs have correlated with increased rates of antibiotic resistance4 7#b7 ,through mutation as well as other mechanisms1 bacteria develop resistance to antibiotic drugs over time4 ,overuse and other inappropriate use of antibiotics lessen their effectiveness and contribute to the development of antibiotic resistance4 7#c7 ,scientific evidence suggests that the development of antibiotic resistance in human pathogens is due not only to use of antibiotic drugs in humans1 but also may be caused by the use of antibiotics in food-producing animals4 7#d7 ,each year1 nearly #b1jjj1jjj people become infected with bacteria that are resistant to antibiotics and at least #bc1jjj people die as a result of such infections4 ,many more die from other conditions that were complicated by an antibiotic-resistant infection4 7#e7 ,according to a #bjac report from the ,centers for ,disease ,control and ,prevention1 carbapenem-resistant ,enterobacteriaceae 7,,cre7 bacteria are on the rise among patients in medical facilities4 ,,cre bacteria have become resistant to all or nearly all the antibiotics currently available4 ,invasive infections1 such as a bloodstream infection1 with ,,cre bacteria are associated with mortality rates exceeding #dj percent4 7#f7 ,a #bjab study conducted at ,columbia ,university 7,clinical ,infectious ,disease1 ,september #bjab7 found that each antibiotic-resistant infection costs1 on average1 over #ae1jjj more to treat than antibiotic-susceptible infections4 7#g7 ,the costs of antibiotic-resistant infections in terms of lives lost and the economy will only rise as antibiotic resistance continues to spread4 7#h7 ,antibiotic resistance is one of the greatest threats to human health worldwide1 calling for increased prevention1 antibiotic stewardship1 surveillance1 and research and development for new antibiotics and rapid diagnostics4 7#i7 ,the ,president's ,national ,action ,plan for ,combating ,antibiotic-,resistant ,bacteria1 issued in ,march #bjae 7referred to in this section as the ,action ,plan71 which was developed in response to ,executive ,order #acfgf1 dated ,september #ah1 #bjad 7#gi ,fed4 ,reg4 #efica2 relating to combating antibiotic-resistant bacteria71 outlines specific steps to address antibiotic resistance4 7#aj7 ,the ,action ,plan includes the domestic and international efforts of the ,united ,states to prevent1 detect1 and control illness and death related to infections caused by antibiotic-resistant bacteria by implementing measures to mitigate the emergence and spread of antibiotic resistance and ensuring the continued availability of therapeutics for the treatment of bacterial infections4 7#aa7 ,misuse and overuse of antibiotics has contributed to antibiotic resistance4 ,a recent study on antibiotic prescribing practices found that #a in #c antibiotic prescriptions were determined unnecessary or inappropriate4 #c4 ,task force for combating antibiotic-resistant bacteria2 advisory council on combating antibiotic-resistant bacteria 7a7 ,task force ,section #cai;,e of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#e7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#a71 by striking ,the ,secretary shall establish and inserting ,in accordance with the objectives of ,executive ,order #acfgf1 dated ,september #ah1 #bjad 7#gi ,fed4 ,reg4 #efica2 relating to combating antibiotic-resistant bacteria71 the ,secretary shall establish2 7,b7 by amending paragraph 7#b7 to read as follows3 7#b7 ,members of the antimicrobial resistance task force ,the task force described in paragraph 7#a7 shall be co-chaired by the ,secretaries of ,health and ,human ,services1 ,agriculture1 and ,defense1 and shall be composed of representatives of relevant ,federal agencies and such executive departments1 agencies1 or offices as the co-chairs may designate4 2 7,c7 by amending paragraph 7#d7 to read as follows3 7#d7 ,meetings ,at least twice a year1 the task force described in paragraph 7#a7 shall have a public meeting to assess progress and obstacles to implementing the ,president's ,national ,action ,plan for ,combating ,antibiotic-,resistant ,bacteria1 issued in ,march #bjae 7referred to in this section as the ,action ,plan74 ,among other issues1 the task force may discuss and review1 based on need or concern-- 7,a7 ,federal activities to slow the emergence of resistant bacteria and prevention of the spread of resistant infections1 including promotion of the optimal use of vaccines to prevent infections1 and implementation of health care policies and antibiotic stewardship programs that improve patient outcomes2 7,b7 ,federal activities to strengthen national ,one-,health surveillance efforts as described in the ,action ,plan to combat resistance1 including enhancement and integration of data from surveillance systems that monitor human pathogens1 including the ,national ,healthcare ,safety ,network1 the ,emerging ,infections ,program1 and the ,national ,antimicrobial ,resistance ,monitoring ,system1 with data from surveillance systems that monitor animal pathogens1 including the ,national ,animal ,health ,monitoring ,system1 the ,national ,animal ,health ,laboratory ,network1 and the ,veterinary ,laboratory ,investigation and ,response ,network2 7,c7 ,federal efforts to advance the development and use of rapid and innovative diagnostic tests for identification and characterization of resistant bacteria2 7,d7 ,federal efforts to accelerate basic and applied research and development for new antibiotics1 other therapeutics1 and vaccines2 and 7,e7 improvements in international collaboration and capacities for antibiotic-resistance prevention1 surveillance1 control1 and antibiotic research and development4 2 and 7,d7 by adding at the end the following3 7#e7 ,availability of information ,the task force1 to the extent permitted by law1 shall-- 7,a7 provide the ,advisory ,council described in section #cai;,e-#a with such information as may be required for carrying out the functions of such ,advisory ,council1 including information on progress in advancing the ,action ,plan1 meeting minutes1 and other key information of the task force2 and 7,b7 ensure that all information described in subparagraph 7,a7 is made available on the websites of the ,department of ,health and ,human ,services1 the ,department of ,agriculture1 and the ,department of ,defense4 2 and 7#b7 by adding at the end the following3 7h7 ,annual progress report to ,congress on implementation of national action plan for combating antibiotic-,resistant bacteria ,not later than #a year after the date of the enactment of the ,strategies to ,address ,antibiotic ,resistance ,act1 and annually thereafter1 the ,secretary1 in cooperation with the ,secretary of ,agriculture1 the ,secretary of ,defense1 and the task force described in subsection 7a7 shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 and make available on the websites of the ,department of ,health and ,human ,services1 the ,department of ,agriculture1 and the ,department of ,defense1 a report on the progress made in implementing the goals of the ,action ,plan4 4 7b7 ,advisory council ,part ,b of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdc et seq47 is amended by inserting after section #cai;,e the following3 #cai;,e-#a4 ,presidential ,advisory ,council on ,combating ,antibiotic-,resistant ,bacteria 7a7 ,in general ,the ,presidential ,advisory ,council on ,combating ,antibiotic-,resistant ,bacteria established through ,executive ,order #acfgf1 dated ,september #ah1 #bjad 7#gi ,fed4 ,reg4 #efica2 relating to combating antibiotic-resistant bacteria7 7referred to in this section as the ,advisory ,council71 shall provide advice1 information1 and recommendations to the ,secretary regarding programs and policies intended to support and evaluate the implementation of such ,executive ,order #acfgf1 including the ,national ,strategy for ,combating ,antibiotic-,resistant ,bacteria and the ,president's ,national ,action ,plan for ,combating ,antibiotic-,resistant ,bacteria1 issued in ,march #bjae4 7b7 ,meetings and duties 7#a7 ,meetings ,the ,advisory ,council shall meet as the ,chair determines to be appropriate but not less than twice per year1 and1 to the extent practicable1 in conjunction with meetings of the task force described in section #cai;,e4 7#b7 ,recommendations ,the ,advisory ,council shall make recommendations to the ,secretary1 in consultation with the ,secretary of ,agriculture and the ,secretary of ,defense1 regarding programs and policies intended to-- 7,a7 preserve the effectiveness of antibiotics by optimizing their use2 7,b7 advance research to develop improved methods for combating antibiotic resistance and conducting antibiotic stewardship2 7,c7 strengthen surveillance of antibiotic-resistant bacterial infections2 7,d7 prevent the transmission of antibiotic-resistant bacterial infections2 7,e7 advance the development of rapid point-of-care and agricultural diagnostics2 7,f7 further research on new treatments for bacterial infections2 7,g7 develop alternatives to antibiotics for agricultural purposes2 7,h7 maximize the dissemination of up-to-date information on the appropriate and proper use of antibiotics to the general public and human and animal health care providers2 and 7,i7 improve international coordination of efforts to combat antibiotic resistance4 4 #d4 ,surveillance and reporting of antibiotic use and resistance ,part ,b of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdc et seq471 as amended by section #c7;b71 is further amended by inserting after section #cai;,e-#a the following3 #cai;,e-#b4 ,surveillance and reporting of antibiotic use and resistance 7a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall use the ,national ,healthcare ,safety ,network and other appropriate surveillance systems to assess-- 7#a7 appropriate conditions1 outcomes1 and measures causally related to antibacterial resistance1 including types of infections1 the causes for infections1 and whether infections are acquired in a community or hospital setting1 increased lengths of hospital stay1 increased costs1 and rates of mortality2 and 7#b7 changes in bacterial resistance to drugs in relation to patient outcomes1 including changes in percent resistance1 prevalence of antibiotic-resistant infections1 and other such changes4 7b7 ,antibiotic use data ,the ,director of the ,centers for ,disease ,control and ,prevention shall work with ,federal agencies 7including the ,department of ,veterans ,affairs and the ,department of ,defense71 private vendors1 health care organizations1 pharmacy benefit managers1 and other entities as appropriate to obtain reliable and comparable human antibiotic drug consumption data 7including1 as available and appropriate1 volume antibiotic distribution data and antibiotic use1 including prescription data7 by ,state or metropolitan areas4 7c7 ,antibiotic resistance trend data ,the ,director of the ,centers for ,disease ,control and ,prevention shall intensify and expand efforts to collect antibiotic resistance data and encourage adoption of the antibiotic resistance and use module within the ,national ,healthcare ,safety ,network among all health care facilities across the continuum of care1 including1 as appropriate1 acute care hospitals1 dialysis facilities1 nursing homes1 and ambulatory surgical centers4 ,the ,director shall seek to collect data from electronic medication administration reports and laboratory systems to produce regular reports on antibiotic resistance patterns and antibiotic use4 7d7 ,public availability of data ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall1 for the purposes of improving the monitoring of important trends in patient outcomes in relation to antibacterial resistance-- 7#a7 make the data derived from surveillance under this section publicly available on a regular basis that is not less than annually2 and 7#b7 examine opportunities to make such data available in near real time4 4 #e4 ,detect network of antibiotic resistance regional laboratories 7a7 ,in general ,the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall establish not less than #g ,antibiotic ,resistance ,surveillance and ,laboratory ,network sites1 building upon the intramural and extramural programs and laboratories of the ,centers for ,disease ,control and ,prevention1 to intensify1 strengthen1 and expand the national capacity to-- 7#a7 monitor the emergence and changes in the patterns of antibiotic-resistant bacteria2 7#b7 describe1 confirm1 and1 as necessary1 facilitate a response to1 local or regional outbreaks of resistant bacteria2 7#c7 assess and describe antibiotic resistance patterns to inform public health and improve prevention practices2 7#d7 obtain isolates of pathogens1 and in particular1 bacteria that show new or atypical patterns of resistance adversely affecting public health2 7#e7 assist in studying the epidemiology of infections from such pathogens2 7#f7 evaluate commonly used antibiotic susceptibility testing methods to improve the accuracy of resistance testing and reporting2 7#g7 as necessary1 develop or evaluate novel diagnostic tests capable of detecting new or emerging resistance in bacteria2 7#h7 link data generated by regional laboratory networks under existing public health surveillance networks and relevant government agencies2 and 7#i7 provide laboratory assistance and reference testing of antibiotic-resistant bacteria to enhance infection control and facilitate outbreak detection and response in health care and community settings4 7b7 ,geographic distribution ,the sites established under subsection 7a7 shall be geographically distributed across the ,united ,states4 7c7 ,nonduplication of current national capacity ,the sites established under subsection 7a7 may be based in academic centers1 health departments1 and existing surveillance and laboratory sites4 #f4 ,clinical trials network on antibacterial resistance 7a7 ,in ,general ,the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,national ,institute of ,allergy and ,infectious ,diseases1 shall maintain a ,clinical ,trials ,network on ,antibacterial ,resistance to enhance1 strengthen1 and expand research on clinical science1 antibacterial and diagnostic development1 and optimal usage strategies1 and shall1 at a minimum-- 7#a7 facilitate research to better understand resistance mechanisms and how to prevent1 control1 and treat resistant organisms2 7#b7 link data generated by regional laboratory networks under existing public health surveillance networks and industry2 7#c7 advance clinical trial efforts to develop antibiotics diagnostics1 and evaluate and optimize the usage of such antibiotics2 7#d7 conduct clinical research to develop natural histories of resistant infectious diseases2 7#e7 examine patient outcomes with currently available antibiotic therapy and validate and improve upon biomarkers and other surrogate endpoints2 and 7#f7 study shorter treatment duration and early cessation of antibiotic therapy for treatment efficacy and effect on development of resistance4 7b7 ,antibiotic resistance leadership group ,the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,national ,institute of ,allergy and ,infectious ,diseases1 shall maintain an antibiotic resistance leadership group 7referred to in this section as the leadership group7 to advance the development and implementation of a comprehensive clinical research agenda to address antibacterial resistance that takes into consideration the recommendations contained in the ,president's ,national ,action ,plan for ,combating ,antibiotic-,resistant ,bacteria1 issued in ,march #bjae4 ,the leadership group shall provide support for the following components-- 7#a7 scientific leadership and operations2 7#b7 clinical studies design and implementation2 7#c7 network laboratories2 and 7#d7 statistical and data management4 7c7 ,appropriations ,there are authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years #bjag through #bjbc4 #g4 ,regional prevention collaborative efforts ,the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall work with ,state and local health departments to support the expansion of collaborative efforts by groups of health care facilities that focus on preventing the spread of antibiotic-resistant bacteria that pose a serious threat to public health1 and that are designed to interrupt and prevent the transmission of significant antibiotic-resistant pathogens being transmitted across health care settings in a geographic region4 ,such collaborative efforts shall-- 7#a7 identify significant drug resistant pathogens being transmitted across health care settings locally2 7#b7 implement evidence-based interventions to interrupt and prevent the transmission of infections associated with health care and antibiotic-resistant strains of bacteria1 including evidence-based transmission prevention guidelines1 rigorous hand hygiene protocols1 and infection control and prevention measures2 7#c7 assess compliance and identify barriers to adherence to such measures2 7#d7 evaluate the impact of such measures on hospital readmissions1 in health care facilities across the continuum of care1 rates of health care associated infections1 or any other relevant measures that characterize the health or economic impact of the collaborative efforts2 and 7#e7 provide recommendations for improved outcomes and compliance with such measures4 #h4 ,prevention ,epicenters 7a7 ,in general ,to provide the regional prevention collaborative efforts established under section #g with tools1 strategies1 and evidence-based interventions1 the ,director of the ,centers for ,disease ,control and ,prevention may intensify and expand academic public health partnerships through the work of the ,prevention ,epicenters ,program of the ,centers for ,disease ,control and ,prevention4 ,the ,centers for ,disease ,control and ,prevention and the epicenters participating in such program shall work with entities1 including the regional prevention collaborative efforts1 to-- 7#a7 evaluate new and existing interventions to prevent or limit infection rates in health care facilities across the continuum of care and in community settings2 7#b7 facilitate public health research on the prevention and control of resistant organisms2 and 7#c7 assess the feasibility1 cost effectiveness1 and appropriateness of surveillance and prevention programs in differing health care and institutional settings4 7b7 ,educational materials ,the ,centers for ,disease ,control and ,prevention shall use the research and evidence from the epicenters participating in the ,prevention ,epicenters ,program to create and disseminate educational materials focused on infection prevention and control for use in health care facilities across the continuum of care and in community settings4 #i4 ,continuation of current programs ,subsection 7g7 of section #cai;,e of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#e7 is amended by striking #dj1jjj1jjj and all that follows through the period at the end and inserting such sums as may be necessary for each of the fiscal years #bjag through #bjba44 #aj4 ,protection of confidential and national security information ,except as otherwise required by law1 this ,act 7and the amendments made by this ,act7 shall not be construed to permit an otherwise-prohibited disclosure of trade secrets1 confidential commercial information1 or material inconsistent with national security that is obtained by any person under this ,act 7or any amendment made by this ,act74