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[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2469 Introduced in Senate (IS)]

<DOC>

115th CONGRESS
  2d Session
                                S. 2469

 To amend the Public Health Service Act to enhance efforts to address 
             antibiotic resistance, and for other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           February 28, 2018

   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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Strategies to Address Antibiotic 
Resistance Act'' or the ``STAAR Act''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) Antibiotic resistance is one of the greatest threats to 
        human health worldwide, necessitating increased prevention 
        efforts, antimicrobial stewardship programs and surveillance 
        programs, and research and development of new antibiotics and 
        rapid diagnostics.
            (2) Since the discovery of antibiotic drugs, these powerful 
        drugs have saved millions of lives and allowed for incredible 
        medical progress. However, antibiotic resistance is accelerated 
        by over- and inappropriate use of antibiotic drugs by which 
        bacteria, through mutation and other mechanisms, can develop 
        resistance to antibiotic drugs.
            (3) Antibiotic-resistant infections significantly 
        complicate a wide variety of complex medical services, 
        including chemotherapy to treat cancer, solid organ and bone 
        marrow transplants, joint replacements and other surgeries, and 
        care of preterm infants and other immunocompromised 
        individuals.
            (4) According to the Centers for Disease Control and 
        Prevention, each year in the United States at least 2,000,000 
        people become infected with bacteria that are resistant to 
        antibiotics and at least 23,000 people die as a result of 
        antibiotic-resistant infections. Many more people die from 
        other conditions that were complicated by an antibiotic-
        resistant infection.
            (5) According to a 2015 report from the New England Journal 
        of Medicine, Clostridium difficile infects approximately 
        500,000 patients in the United States each year, resulting in 
        almost 30,000 deaths and an estimated $4,800,000,000 in excess 
        health care costs each year. Clostridium difficile infections 
        are most common as a result of over-prescribing antibiotics, 
        and antibiotic-resistant strains of Clostridium difficile are 
        on the rise.
            (6) The Centers for Disease Control and Prevention estimate 
        that the annual impact of antibiotic-resistant infections on 
        the United States economy is more than $20,000,000,000 in 
        excess direct health care costs. Additional costs to the United 
        States economy for lost productivity from antibiotic-resistant 
        infections may be as great as $35,000,000,000 per year.
            (7) Data from the Centers for Disease Control and 
        Prevention indicate that at least 30 percent of antibiotic 
        drugs used in hospitals are unnecessary or prescribed 
        incorrectly. Similarly, the Centers for Disease Control and 
        Prevention estimate that approximately 30 percent of antibiotic 
        drugs prescribed in outpatient clinics are unnecessary and that 
        approximately 40 percent of orders for antibiotic drugs in 
        nursing homes lacked important prescribing information. Thus, 
        improvements in prescribing antibiotic drugs are necessary 
        across health care settings.
            (8) The National Action Plan for Combating Antibiotic-
        Resistant Bacteria, published in March 2015, in response to 
        Executive Order 13676 of September 18, 2014 (79 Fed. Reg. 
        56931; relating to combating antibiotic-resistant bacteria), 
        outlines the domestic and international efforts to be conducted 
        by the United States to prevent, detect, and control illness 
        and death related to infections caused by antibiotic-resistant 
        bacteria.

SEC. 3. COMBATING ANTIMICROBIAL RESISTANCE.

    Section 319E of the Public Health Service Act (42 U.S.C. 247d-5) is 
amended--
            (1) in subsection (a)--
                    (A) in paragraph (1), in the first sentence, by 
                striking ``and coordinate Federal programs relating to 
                antimicrobial resistance'' and inserting ``relating to 
                antimicrobial resistance, coordinate Federal programs 
                relating to antimicrobial resistance, and implement the 
                objectives of the National Action Plan for Combating 
                Antibiotic-Resistant Bacteria, published in March 2015 
                in response to Executive Order 13676 of September 18, 
                2014 (79 Fed. Reg. 56931; relating to combating 
                antibiotic-resistant bacteria) (referred to in this 
                section as the `Action Plan')'';
                    (B) by amending paragraph (2) to read as follows:
            ``(2) Members of task force.--The task force described in 
        paragraph (1) shall be co-chaired by the Secretary of Health 
        and Human Services, the Secretary of Agriculture, and the 
        Secretary of 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 objectives of 
        the Action Plan. The task force may discuss and review based on 
        need or concern the following (among other issues):
                    ``(A) Federal activities to slow the emergence of 
                antimicrobial-resistant bacteria and prevent the spread 
                of resistant infections. Such activities may include 
                optimal use of vaccines and other infection control 
                measures to prevent infections, implementation of 
                health care policies and antimicrobial stewardship 
                programs that improve patient outcomes, regional 
                efforts to control transmission across community and 
                health care settings, and public awareness campaigns.
                    ``(B) Federal activities to strengthen national 
                One-Health surveillance efforts, which are efforts 
                addressing the interactions between human, animal, and 
                environmental health, to combat antibiotic resistance. 
                One-Health surveillance efforts to combat antibiotic 
                resistance may include enhanced data sharing and 
                coordination of surveillance and laboratory systems 
                across human and animal settings, and enhanced 
                monitoring of sales, usage, resistance, and management 
                practices of antibiotic drugs along the food-production 
                chain. Such surveillance and laboratory systems may 
                include the National Healthcare Safety Network, the 
                Emerging Infections Program, the National Antimicrobial 
                Resistance Monitoring System, the National Animal 
                Health Monitoring System, the National Animal Health 
                Laboratory Network, the Veterinary Laboratory 
                Investigation and Response Network, and the Antibiotic 
                Resistance Laboratory Network.
                    ``(C) Federal efforts to advance the development 
                and use of rapid and innovative diagnostic tests for 
                identification and characterization of antibiotic-
                resistant bacteria. Such efforts may include 
                development of new diagnostic tests and expansion of 
                their availability and use to improve treatment, 
                infection control, and outbreak response.
                    ``(D) Federal efforts to accelerate basic and 
                applied research and development for new antibiotic 
                drugs, other therapeutics, prevention efforts, and 
                vaccines. Such efforts may include support for basic 
                and applied research, provision of scientific services 
                and guidance to researchers, and fostering of public-
                private partnerships.
                    ``(E) Federal efforts to improve international 
                collaboration and capacities for antibiotic-resistance 
                prevention, surveillance, and control and antibiotic 
                research and development. Such efforts may include 
                collaborations with foreign ministries of health and 
                agriculture, the World Health Organization, the Food 
                and Agriculture Organization, the World Organization 
                for Animal Health, and other multinational 
                organizations.''; and
                    (D) by adding at the end the following:
            ``(5) Availability of information.--The task force 
        described in paragraph (1), to the extent permitted by law, 
        shall--
                    ``(A) provide the Advisory Council defined in 
                section 319E-1(a) 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.'';
            (2) in subsection (h)--
                    (A) in the heading, by striking ``Information 
                Related to'';
                    (B) by striking ``The Secretary'' and inserting the 
                following:
            ``(1) Dissemination of information.--The Secretary''; and
                    (C) by adding at the end the following:
            ``(2) Encouraging antimicrobial stewardship programs.--The 
        Secretary shall encourage health care facilities to establish 
        antimicrobial stewardship programs that are consistent with 
        documents issued by the Centers for Disease Control and 
        Prevention relating to the core elements of antimicrobial 
        stewardship programs.
            ``(3) Definition of antimicrobial stewardship.--For 
        purposes of this section, the term `antimicrobial stewardship' 
        means coordinated interventions designed to improve and 
        evaluate the appropriate use of antimicrobial agents, including 
        promoting the use of antimicrobial drugs only when clinically 
        indicated, and, when antimicrobial drugs are clinically 
        indicated, promoting the selection of the optimal antimicrobial 
        drug regimen, including through factors such as dosage, 
        duration of therapy, and route of administration.'';
            (3) in subsection (m), 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 fiscal years 2018 through 
        2024.''; and
            (4) by adding at the end the following:
    ``(n) Annual Report on Implementing the Action Plan Objectives.--
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 objectives of the Action Plan.''.

SEC. 4. ADDITIONAL STRATEGIES FOR COMBATING ANTIBIOTIC RESISTANCE.

    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:

``SEC. 319E-1. PRESIDENTIAL ADVISORY COUNCIL ON COMBATING ANTIBIOTIC-
              RESISTANT BACTERIA.

    ``(a) Definitions.--In this section:
            ``(1) Action plan.--The term `Action Plan' means the Action 
        Plan described in section 319E(a)(1).
            ``(2) Advisory council.--The term `Advisory Council' means 
        the Presidential Advisory Council on Combating Antibiotic-
        Resistant Bacteria established by Executive Order 13676 of 
        September 18, 2014 (79 Fed. Reg. 56931; relating to combating 
        antibiotic-resistant bacteria).
            ``(3) National strategy.--The term `National Strategy' 
        means the National Strategy for Combating Antibiotic-Resistant 
        Bacteria issued by the White House in September 2014, and any 
        subsequent update to such strategy or a successor strategy.
    ``(b) Advisory Council.--The Advisory Council shall provide advice, 
information, and recommendations to the Secretary regarding programs 
and policies intended to support and evaluate the implementation of 
Executive Order 13676 of September 18, 2014 (79 Fed. Reg. 56931; 
relating to combating antibiotic-resistant bacteria), including the 
National Strategy, and the Action Plan.
    ``(c) Meetings and Duties.--
            ``(1) Meetings.--The Advisory Council shall meet as the 
        Chair determines 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 
                antimicrobial stewardship, as defined in section 
                319E(h)(3);
                    ``(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 
                animal health 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.

``SEC. 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 Secretary, acting through the 
Director of the Centers for Disease Control and Prevention, shall work 
with Federal agencies (including the Department of Veterans Affairs, 
the Department of Defense, and the Centers for Medicare & Medicaid 
Services), 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 data, including prescription data) by State or 
metropolitan areas.
    ``(c) Antibiotic Resistance Trend Data.--The Secretary, acting 
through 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 Secretary shall seek to collect such 
data from electronic medication administration reports and laboratory 
systems to produce the reports described in subsection (d).
    ``(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 through reports issued on a regular 
        basis that is not less than annually; and
            ``(2) examine opportunities to make such data available in 
        near real time.

``SEC. 319E-3. DETECTING NETWORK OF ANTIBIOTIC RESISTANCE REGIONAL 
              LABORATORIES.

    ``(a) In General.--The Secretary, 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.

``SEC. 319E-4. CLINICAL TRIALS NETWORK ON ANTIBACTERIAL RESISTANCE.

    ``(a) In General.--The Secretary, 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 
with respect to addressing antibacterial resistance. Such Network 
shall, at a minimum--
            ``(1) facilitate research to better understand resistance 
        mechanisms and how to prevent, control, and treat resistant 
        organisms;
            ``(2) advance clinical trial efforts to develop antibiotics 
        diagnostics, and evaluate and optimize the usage of such 
        antibiotics diagnostics;
            ``(3) conduct clinical research to develop natural 
        histories of resistant infectious diseases;
            ``(4) examine patient outcomes with currently available 
        antibiotic therapy and validate and improve upon biomarkers and 
        other surrogate endpoints; and
            ``(5) study shorter treatment duration and early cessation 
        of antibiotic therapy for treatment efficacy and the effect on 
        development of resistance.
    ``(b) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section such sums as may be necessary 
for each of fiscal years 2018 through 2024.

``SEC. 319E-5. REGIONAL PREVENTION COLLABORATIVE EFFORTS.

    ``(a) In General.--The Secretary, 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 
        the transmission of antibiotic-resistant strains of bacteria 
        and prevent the infections caused by such 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, to the extent 
        possible, 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.
    ``(b) Prevention Epicenters.--
            ``(1) Expansion.--The Secretary, acting through the 
        Director of the Centers for Disease Control and Prevention, may 
        intensify and expand academic public health partnerships 
        through the Prevention Epicenters Program to provide the 
        regional prevention collaboration efforts described in 
        subsection (a) with tools, strategies, and evidence-based 
        interventions.
            ``(2) Evaluations and research.--The Director of the 
        Centers for Disease Control and Prevention and the epicenters 
        participating in the Prevention Epicenters Program shall work 
        with entities, including the entities participating in the 
        regional prevention collaborative efforts, to--
                    ``(A) evaluate new and existing interventions to 
                prevent or limit infection rates in health care 
                facilities across the continuum of care and in 
                community settings;
                    ``(B) facilitate public health research on the 
                prevention and control of resistant organisms; and
                    ``(C) assess the feasibility, cost-effectiveness, 
                and appropriateness of surveillance and prevention 
                programs in differing health care and institutional 
                settings.
    ``(c) Educational Materials.--The Secretary, acting through the 
Director of the Centers for Disease Control and Prevention, shall use 
the evaluations, research, and assessments described in subsection (b) 
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.''.

SEC. 5. PROTECTION OF CONFIDENTIAL AND NATIONAL SECURITY INFORMATION.

    This Act, and the amendments made by this Act, shall not be 
construed to permit the disclosure of any trade secret, confidential 
commercial information, or material inconsistent with national 
security, that is otherwise prohibited by law.
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