[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3291 Introduced in Senate (IS)]
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117th CONGRESS
1st Session
S. 3291
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
December 1, 2021
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 2022 through
2028.''; 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 2022 through 2028.
``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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