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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 2304 Introduced in Senate (IS)]

<DOC>

116th CONGRESS
  1st Session
                                S. 2304

 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

                             July 29, 2019

   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. 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 Presidential Advisory Council on 
                Combating Antibiotic-Resistant Bacteria described in 
                section 505 of the Pandemic and All-Hazards 
                Preparedness and Advancing Innovation Act of 2019 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 2020 through 
        2026.''; 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. 3. 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. 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, ambulatory 
surgical centers, and other ambulatory health care settings in which 
antimicrobial medications are routinely prescribed. 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-2. 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-3. 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 2020 through 2026.

``SEC. 319E-4. 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. 4. 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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