II 114th CONGRESS 2d Session S. 3176 IN THE SENATE OF THE UNITED STATES July 13, 2016 Mr. Brown introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Public Health Service Act to enhance efforts to address antibiotic resistance, and for other purposes.

1. Short title This Act may be cited as the Strategies to Address Antibiotic Resistance Act or the STAAR Act . 2. Findings Congress makes the following findings: (1) The advent of the antibiotic era has saved millions of lives and allowed for incredible medical progress; however, the increased use and overuse of antibiotic drugs have correlated with increased rates of antibiotic resistance. (2) Through mutation as well as other mechanisms, bacteria develop resistance to antibiotic drugs over time. Overuse and other inappropriate use of antibiotics lessen their effectiveness and contribute to the development of antibiotic resistance. (3) Scientific evidence suggests that the development of antibiotic resistance in human pathogens is due not only to use of antibiotic drugs in humans, but also may be caused by the use of antibiotics in food-producing animals. (4) Each year, nearly 2,000,000 people become infected with bacteria that are resistant to antibiotics and at least 23,000 people die as a result of such infections. Many more die from other conditions that were complicated by an antibiotic-resistant infection. (5) According to a 2013 report from the Centers for Disease Control and Prevention, carbapenem-resistant Enterobacteriaceae (CRE) bacteria are on the rise among patients in medical facilities. CRE bacteria have become resistant to all or nearly all the antibiotics currently available. Invasive infections, such as a bloodstream infection, with CRE bacteria are associated with mortality rates exceeding 40 percent. (6) A 2012 study conducted at Columbia University ( Clinical Infectious Disease , September 2012) found that each antibiotic-resistant infection costs, on average, over $15,000 more to treat than antibiotic-susceptible infections. (7) The costs of antibiotic-resistant infections in terms of lives lost and the economy will only rise as antibiotic resistance continues to spread. (8) Antibiotic resistance is one of the greatest threats to human health worldwide, calling for increased prevention, antibiotic stewardship, surveillance, and research and development for new antibiotics and rapid diagnostics. (9) The President’s National Action Plan for Combating Antibiotic-Resistant Bacteria, issued in March 2015 (referred to in this section as the Action Plan ), which was developed in response to Executive Order 13676, dated September 18, 2014 (79 Fed. Reg. 56931; relating to combating antibiotic-resistant bacteria), outlines specific steps to address antibiotic resistance. (10) The Action Plan includes the domestic and international efforts of the United States to prevent, detect, 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 infections. (11) Misuse and overuse of antibiotics has contributed to antibiotic resistance. A recent study on antibiotic prescribing practices found that 1 in 3 antibiotic prescriptions were determined unnecessary or inappropriate. 3. Task force for combating antibiotic-resistant bacteria; advisory council on combating antibiotic-resistant bacteria (a) Task force Section 319E of the Public Health Service Act ( 42 U.S.C. 247d–5 ) is amended— (1) in subsection (a)— (A) in paragraph (1), by striking The Secretary shall establish and inserting In accordance with the objectives of Executive Order 13676, dated September 18, 2014 (79 Fed. Reg. 56931; relating to combating antibiotic-resistant bacteria), the Secretary shall establish ; (B) by amending paragraph (2) to read as follows: (2) Members of the antimicrobial resistance task force The task force described in paragraph (1) shall be co-chaired by the Secretaries of Health and Human Services, Agriculture, and Defense, and shall be composed of representatives of relevant Federal agencies and such executive departments, agencies, or offices as the co-chairs may designate. ; (C) by amending paragraph (4) to read as follows: (4) Meetings At least twice a year, the task force described in paragraph (1) shall have a public meeting to assess progress and obstacles to implementing the President’s National Action Plan for Combating Antibiotic-Resistant Bacteria, issued in March 2015 (referred to in this section as the Action Plan ). Among other issues, the task force may discuss and review, based on need or concern— (A) Federal activities to slow the emergence of resistant bacteria and prevention of the spread of resistant infections, including promotion of the optimal use of vaccines to prevent infections, and implementation of health care policies and antibiotic stewardship programs that improve patient outcomes; (B) Federal activities to strengthen national One-Health surveillance efforts as described in the Action Plan to combat resistance, including enhancement and integration of data from surveillance systems that monitor human pathogens, including the National Healthcare Safety Network, the Emerging Infections Program, and the National Antimicrobial Resistance Monitoring System, with data from surveillance systems that monitor animal pathogens, including the National Animal Health Monitoring System, the National Animal Health Laboratory Network, and the Veterinary Laboratory Investigation and Response Network; (C) Federal efforts to advance the development and use of rapid and innovative diagnostic tests for identification and characterization of resistant bacteria; (D) Federal efforts to accelerate basic and applied research and development for new antibiotics, other therapeutics, and vaccines; and (E) improvements in international collaboration and capacities for antibiotic-resistance prevention, surveillance, control, and antibiotic research and development. ; and (D) by adding at the end the following: (5) Availability of information The task force, to the extent permitted by law, shall— (A) provide the Advisory Council described in section 319E–1 with such information as may be required for carrying out the functions of such Advisory Council, including information on progress in advancing the Action Plan, meeting minutes, and other key information of the task force; and (B) ensure that all information described in subparagraph (A) is made available on the websites of the Department of Health and Human Services, the Department of Agriculture, and the Department of Defense. ; and (2) by adding at the end the following: (h) Annual progress report to Congress on implementation of national action plan for combating antibiotic-Resistant bacteria Not later than 1 year after the date of the enactment of the Strategies to Address Antibiotic Resistance Act , and annually thereafter, the Secretary, in cooperation with the Secretary of Agriculture, the Secretary of Defense, and the task force described in subsection (a) shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and make available on the websites of the Department of Health and Human Services, the Department of Agriculture, and the Department of Defense, a report on the progress made in implementing the goals of the Action Plan. . (b) Advisory council Part B of title III of the Public Health Service Act ( 42 U.S.C. 243 et seq. ) is amended by inserting after section 319E the following: 319E–1. Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (a) In general The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria established through Executive Order 13676, dated September 18, 2014 (79 Fed. Reg. 56931; relating to combating antibiotic-resistant bacteria) (referred to in this section as the Advisory Council ), shall provide advice, information, and recommendations to the Secretary regarding programs and policies intended to support and evaluate the implementation of such Executive Order 13676, including the National Strategy for Combating Antibiotic-Resistant Bacteria and the President’s National Action Plan for Combating Antibiotic-Resistant Bacteria, issued in March 2015. (b) Meetings and duties (1) Meetings The Advisory Council shall meet as the Chair determines to be appropriate but not less than twice per year, and, to the extent practicable, in conjunction with meetings of the task force described in section 319E. (2) Recommendations The Advisory Council shall make recommendations to the Secretary, in consultation with the Secretary of Agriculture and the Secretary of Defense, regarding programs and policies intended to— (A) preserve the effectiveness of antibiotics by optimizing their use; (B) advance research to develop improved methods for combating antibiotic resistance and conducting antibiotic stewardship; (C) strengthen surveillance of antibiotic-resistant bacterial infections; (D) prevent the transmission of antibiotic-resistant bacterial infections; (E) advance the development of rapid point-of-care and agricultural diagnostics; (F) further research on new treatments for bacterial infections; (G) develop alternatives to antibiotics for agricultural purposes; (H) 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 providers; and (I) improve international coordination of efforts to combat antibiotic resistance. . 4. Surveillance and reporting of antibiotic use and resistance Part B of title III of the Public Health Service Act ( 42 U.S.C. 243 et seq. ), as amended by section 3(b), is further amended by inserting after section 319E–1 the following: 319E–2. Surveillance and reporting of antibiotic use and resistance (a) In general The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall use the National Healthcare Safety Network and other appropriate surveillance systems to assess— (1) appropriate conditions, outcomes, and measures causally related to antibacterial resistance, including types of infections, the causes for infections, and whether infections are acquired in a community or hospital setting, increased lengths of hospital stay, increased costs, and rates of mortality; and (2) changes in bacterial resistance to drugs in relation to patient outcomes, including changes in percent resistance, prevalence of antibiotic-resistant infections, and other such changes. (b) Antibiotic use data The Director of the Centers for Disease Control and Prevention shall work with Federal agencies (including the Department of Veterans Affairs and the Department of Defense), private vendors, health care organizations, pharmacy benefit managers, and other entities as appropriate to obtain reliable and comparable human antibiotic drug consumption data (including, as available and appropriate, volume antibiotic distribution data and antibiotic use, including prescription data) by State or metropolitan areas. (c) 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 care, including, as appropriate, acute care hospitals, dialysis facilities, nursing homes, and ambulatory surgical centers. 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 use. (d) Public availability of data The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, for the purposes of improving the monitoring of important trends in patient outcomes in relation to antibacterial resistance— (1) make the data derived from surveillance under this section publicly available on a regular basis that is not less than annually; and (2) examine opportunities to make such data available in near real time. . 5. Detect network of antibiotic resistance regional laboratories (a) In general The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall establish not less than 7 Antibiotic Resistance Surveillance and Laboratory Network sites, building upon the intramural and extramural programs and laboratories of the Centers for Disease Control and Prevention, to intensify, strengthen, and expand the national capacity to— (1) monitor the emergence and changes in the patterns of antibiotic-resistant bacteria; (2) describe, confirm, and, as necessary, facilitate a response to, local or regional outbreaks of resistant bacteria; (3) assess and describe antibiotic resistance patterns to inform public health and improve prevention practices; (4) obtain isolates of pathogens, and in particular, bacteria that show new or atypical patterns of resistance adversely affecting public health; (5) assist in studying the epidemiology of infections from such pathogens; (6) evaluate commonly used antibiotic susceptibility testing methods to improve the accuracy of resistance testing and reporting; (7) as necessary, develop or evaluate novel diagnostic tests capable of detecting new or emerging resistance in bacteria; (8) link data generated by regional laboratory networks under existing public health surveillance networks and relevant government agencies; and (9) 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 settings. (b) Geographic distribution The sites established under subsection (a) shall be geographically distributed across the United States. (c) Nonduplication of current national capacity The sites established under subsection (a) may be based in academic centers, health departments, and existing surveillance and laboratory sites. 6. Clinical trials network on antibacterial resistance (a) In General The Secretary of Health and Human Services, acting through the Director of the National Institute of Allergy and Infectious Diseases, shall maintain a Clinical Trials Network on Antibacterial Resistance to enhance, strengthen, and expand research on clinical science, antibacterial and diagnostic development, and optimal usage strategies, and shall, at a minimum— (1) facilitate research to better understand resistance mechanisms and how to prevent, control, and treat resistant organisms; (2) link data generated by regional laboratory networks under existing public health surveillance networks and industry; (3) advance clinical trial efforts to develop antibiotics diagnostics, and evaluate and optimize the usage of such antibiotics; (4) conduct clinical research to develop natural histories of resistant infectious diseases; (5) examine patient outcomes with currently available antibiotic therapy and validate and improve upon biomarkers and other surrogate end­points; and (6) study shorter treatment duration and early cessation of antibiotic therapy for treatment efficacy and effect on development of resistance. (b) Antibiotic resistance leadership group The Secretary of Health and Human Services, acting through the Director of the National Institute of Allergy and Infectious Diseases, shall maintain an antibiotic resistance leadership group (referred to in this section as the leadership group ) 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 Bacteria, issued in March 2015. The leadership group shall provide support for the following components— (1) scientific leadership and operations; (2) clinical studies design and implementation; (3) network laboratories; and (4) statistical and data management. (c) Appropriations There are authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years 2017 through 2023. 7. Regional prevention collaborative efforts The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, 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 health, and that are designed to interrupt and prevent the transmission of significant antibiotic-resistant pathogens being transmitted across health care settings in a geographic region. Such collaborative efforts shall— (1) identify significant drug resistant pathogens being transmitted across health care settings locally; (2) implement evidence-based interventions to interrupt and prevent the transmission of infections associated with health care and antibiotic-resistant strains of bacteria, including evidence-based transmission prevention guidelines, rigorous hand hygiene protocols, and infection control and prevention measures; (3) assess compliance and identify barriers to adherence to such measures; (4) evaluate the impact of such measures on hospital readmissions, in health care facilities across the continuum of care, rates of health care associated infections, or any other relevant measures that characterize the health or economic impact of the collaborative efforts; and (5) provide recommendations for improved outcomes and compliance with such measures. 8. Prevention Epicenters (a) In general To provide the regional prevention collaborative efforts established under section 7 with tools, strategies, and evidence-based interventions, 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 Prevention. The Centers for Disease Control and Prevention and the epicenters participating in such program shall work with entities, including the regional prevention collaborative efforts, to— (1) evaluate new and existing interventions to prevent or limit infection rates in health care facilities across the continuum of care and in community settings; (2) facilitate public health research on the prevention and control of resistant organisms; and (3) assess the feasibility, cost effectiveness, and appropriateness of surveillance and prevention programs in differing health care and institutional settings. (b) 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 settings. 9. Continuation of current programs Subsection (g) of section 319E of the Public Health Service Act ( 42 U.S.C. 247d–5 ) is amended by striking $40,000,000 and all that follows through the period at the end and inserting such sums as may be necessary for each of the fiscal years 2017 through 2021. . 10. Protection of confidential and national security information Except as otherwise required by law, this Act (and the amendments made by this Act) shall not be construed to permit an otherwise-prohibited disclosure of trade secrets, confidential commercial information, or material inconsistent with national security that is obtained by any person under this Act (or any amendment made by this Act).