Title: STAAR Act
Policy area: Health

Summary:
Strategies To Address Antimicrobial Resistance Act or the STAAR Act This bill expands various initiatives to address antimicrobial resistance.
The bill reestablishes the interagency Antimicrobial Resistance Task Force to coordinate and develop efforts addressing antimicrobial resistance.
The Department of Health and Human Services must encourage health care facilities to implement antimicrobial stewardship programs to evaluate and improve the use of antimicrobial drugs.
The bill also requires the use of the National Healthcare Safety Network and similar surveillance systems to collect and report data about the usage of antimicrobial drugs, changes in resistance to such drugs, and other trends impacting patient outcomes.
Additionally, the bill increases nationwide efforts to monitor, research, and prevent the spread of infection from resistant organisms by

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9094 Introduced in House (IH)]

<DOC>






117th CONGRESS
  2d Session
                                H. R. 9094

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 30, 2022

 Mr. Bera (for himself and Mr. Peters) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Public Health Service Act to enhance efforts to address 
           antimicrobial 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 Antimicrobial 
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 pursue the 
                goals of the National Strategy for Combating 
                Antibiotic-Resistant Bacteria (referred to in this 
                section as the `National Strategy')'';
                    (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 National Strategy. 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 pathogens 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 antimicrobial 
                resistance. One-Health surveillance efforts to combat 
                antimicrobial 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 antimicrobial 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 
                antimicrobial resistance Laboratory Network.
                    ``(C) Federal efforts to advance the development 
                and use of rapid and innovative diagnostic tests for 
                identification and characterization of antimicrobial-
                resistant pathogens. 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 antimicrobial 
                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 antimicrobial-
                resistance prevention, surveillance, and control and 
                antimicrobial 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, the United Nations 
                Environment Programme, 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 National 
                Strategy, 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 2023 through 
        2029.''; and
            (4) by adding at the end the following:
    ``(n) Annual Report on Implementing the National Strategy 
Objectives.--Not later than 1 year after the date of the enactment of 
the Strategies To Address Antimicrobial Resistance Act, and annually 
thereafter, the Secretary, in consultation 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 National Strategy.''.

SEC. 3. ADDITIONAL STRATEGIES FOR COMBATING ANTIMICROBIAL 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 ANTIMICROBIAL USE AND 
              RESISTANCE.

    ``(a) In General.--The Secretary shall use the National Healthcare 
Safety Network and other appropriate surveillance systems to assess--
            ``(1) appropriate conditions, outcomes, and measures 
        causally related to antimicrobial 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 microbial resistance to drugs in relation 
        to patient outcomes, including changes in percent resistance, 
        prevalence of antimicrobial-resistant infections, and other 
        such changes.
    ``(b) Antimicrobial Use Data.--The Secretary 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 antimicrobial drug consumption data (including, as 
available and appropriate, volume antimicrobial distribution data and 
antimicrobial use data, including prescription data) by State or 
metropolitan areas.
    ``(c) Antimicrobial Resistance Trend Data.--The Secretary shall 
intensify and expand efforts to collect antimicrobial resistance data 
and encourage adoption of the antimicrobial 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 shall, for the 
purposes of improving the monitoring of important trends in patient 
outcomes in relation to antimicrobial 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 ANTIMICROBIAL RESISTANCE REGIONAL 
              LABORATORIES.

    ``(a) In General.--The Secretary shall establish not less than 7 
Antimicrobial 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 
        antimicrobial-resistant pathogens;
            ``(2) describe, confirm, and, as necessary, facilitate a 
        response to, local or regional outbreaks of resistant 
        pathogens;
            ``(3) assess and describe antimicrobial resistance patterns 
        to inform public health and improve prevention practices;
            ``(4) obtain isolates of pathogens, and in particular, 
        pathogens 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 antimicrobial 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 
        pathogens;
            ``(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 antimicrobial-resistant pathogens 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 ANTIMICROBIAL RESISTANCE.

    ``(a) In General.--The Secretary shall maintain a Clinical Trials 
Network on Antimicrobial Resistance to enhance, strengthen, and expand 
research on clinical science, antimicrobial and diagnostic development, 
and optimal usage strategies with respect to addressing antimicrobial 
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 
        antimicrobial diagnostics, and evaluate and optimize the usage 
        of such antimicrobial diagnostics;
            ``(3) conduct clinical research to develop natural 
        histories of resistant infectious diseases;
            ``(4) examine patient outcomes with currently available 
        antimicrobial therapy and validate and improve upon biomarkers 
        and other surrogate endpoints; and
            ``(5) study shorter treatment duration and early cessation 
        of antimicrobial 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 2023 through 2029.

``SEC. 319E-4. REGIONAL PREVENTION COLLABORATIVE EFFORTS.

    ``(a) In General.--The Secretary 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 
antimicrobial-resistant pathogens that pose a serious threat to public 
health, and that are designed to interrupt and prevent the transmission 
of significant antimicrobial-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 antimicrobial-resistant strains of 
        pathogens and prevent the infections caused by such pathogens, 
        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 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 shall use the 
evaluations, research, and assessments described in subsection (b), 
along with other scientific evidence, 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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