[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 3176 Introduced in Senate (IS)]

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114th CONGRESS
  2d Session
                                S. 3176

 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 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.

    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) 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.

SEC. 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:

``SEC. 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.''.

SEC. 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:

``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 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.''.

SEC. 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.

SEC. 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.

SEC. 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.

SEC. 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.

SEC. 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.''.

SEC. 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).
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