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