Strategies to Address Antimicrobial Resistance Act - Amends the Public Health Service Act to reauthorize through FY2018 and revise a program to combat antimicrobial resistance.
Requires the Secretary of Health and Human Services (HHS) to direct the Assistant Secretary of Health to establish the Antimicrobial Resistance Office. Requires the Secretary to establish the Public Health Antimicrobial Advisory Board to advise the Director of the Office (Director).
Requires the Director to update the Public Health Action Plan to Combat Antimicrobial Resistance within one year. Requires the Antimicrobial Resistance Task Force to review, discuss, and further develop the Action Plan.
Authorizes the Food and Drug Administration (FDA) to consult with the Director of the Antimicrobial Resistance Office concerning the pending application of any new human or animal antimicrobial drugs.
Requires the Public Health Antimicrobial Advisory Board to make recommendations to the Secretary and the Antimicrobial Resistance Office regarding issues such as research priorities and implementation of the Action Plan.
Requires the Secretary, acting through the Director of the National Institutes of Health (NIH), to develop an antimicrobial resistance strategic research plan.
Gives the Director of the Antimicrobial Resistance Office direct authority over specified antimicrobial resistance activities of the Secretary.
Revises demonstration programs to require the Secretary to award grants to promote the uptake and measurement of antimicrobial stewardship programs in health care facilities. Defines "antimicrobial stewardship" to mean coordinated interventions designed to improve and measure the appropriate use of antimicrobial agents.
Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to: (1) pilot and test health care quality measures to help providers, facilities, and health systems measure and benchmark appropriate antimicrobial use; (2) develop methods to help providers, facilities, and health systems measure and improve antimicrobial use; (3) establish at least 10 Antimicrobial Resistance Surveillance and Laboratory Network sites; (4) work with state health departments to support regional prevention collaboratives designed to interrupt and prevent the transmission of significant antibiotic resistant pathogens being transmitted across health care settings in a geographic region.
Requires the Secretary, acting through the Director of the National Institute of Allergy and Infectious Diseases, to establish a Clinical Trials Network on Antibacterial Resistance and a Leadership Group for the Network.
Requires the Director of the CDC to: (1) work with various entities to obtain reliable and comparable human antimicrobial drug consumption data by state or metropolitan area, (2) intensify and expand efforts to collect antimicrobial resistance data, (3) report on key trends and major issues related to antimicrobial resistance and use in the United States.
Requires the National Coordinator for Health Information Technology to work with the Director of the CDC to determine how best antimicrobial use, susceptibility, and resistance data can be incorporated into meaningful use reports.
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2285 Introduced in House (IH)]
113th CONGRESS
1st Session
H. R. 2285
To amend the Public Health Service Act to enhance efforts to address
antimicrobial resistance, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 6, 2013
Mr. Matheson 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''.
SEC. 2. FINDINGS.
The Congress finds as follows:
(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 antimicrobial drugs have
correlated with increased rates of antimicrobial resistance.
(2) Through mutation as well as other mechanisms, bacteria
and other infectious disease-causing organisms--viruses, fungi,
and parasites--develop resistance to antimicrobial drugs over
time. The more antimicrobial drugs are used, whether
appropriately or inappropriately, the more this contributes to
the development of antimicrobial resistance.
(3) Scientific evidence suggests that the development of
antimicrobial resistance in humans is not due only to use of
antimicrobial drugs in humans, but also may be caused by the
use of antimicrobial drugs in food-producing animals.
(4) A study estimates that in 2005 more than 94,000
invasive methicillin-resistant Staphylococcus aureus (MRSA)
bacterial infections occurred in the United States and more
than 18,500 of these infections resulted in death--7 times more
than a decade earlier.
(5) The 2009 Influenza A: H1N1 virus outbreak, and the
yearly seasonal influenza outbreaks, exacerbate concerns about
antiviral resistance given that so few antivirals are available
to treat influenza as well as secondary bacterial infections
due to MRSA, antibiotic-resistant Streptococcus pneumonia, and
other bacteria that cause respiratory diseases. Given that,
during the 1918 influenza pandemic, many thousands of deaths
were caused by complications due to secondary bacterial
infections and not by the influenza virus itself.
(6) Each year, nearly 2,000,000 people contract bacterial
infections in hospitals and approximately 90,000 of these
people die from these infections. Many of these infections are
resistant to one or more commonly used antibiotics.
(7) A 2012 study conducted at Columbia University
(``Clinical Infectious Disease'', September 2012) found that
each antibiotic-resistant infection cost, on average, over
$15,000 more to treat than susceptible infections.
(8) The costs of antimicrobial-resistant infections in
terms of lives lost and the economy will only rise as
antimicrobial resistance continues to spread.
SEC. 3. ANTIMICROBIAL RESISTANCE TASK FORCE.
Section 319E of the Public Health Service Act (42 U.S.C. 247d-5) is
amended--
(1) in subsection (a)--
(A) in the subsection heading, by striking ``Task
Force'' and inserting the following: ``Antimicrobial
Resistance Office, Task Force, and Advisory Board'';
(B) in paragraph (1)--
(i) by striking ``as of the date of the
enactment of this section'' and inserting ``as
of September 30, 2006''; and
(ii) by adding at the end the following:
``The Secretary shall, not later than 1 year
after the date of enactment of the Strategies
to Address Antimicrobial Resistance Act, direct
the Assistant Secretary of Health to establish
an Antimicrobial Resistance Office and appoint
a director to that Office. The Secretary shall,
not later than 1 year after the date of
enactment of such Act, establish the Public
Health Antimicrobial Advisory Board as an
advisory board to the Director of the
Antimicrobial Resistance Office. The Director
of the Antimicrobial Resistance Office shall
serve as the Director of the Antimicrobial
Resistance Task Force. To avoid duplication and
ensure that Federal resources are used
efficiently and effectively, the Director shall
work in conjunction with the Federal agencies
represented on the Task Force to coordinate all
antimicrobial resistance activities undertaken
and supported by the Federal Government,
including the activities and budgetary
allocations of the Office, Task Force, and
Public Health Antimicrobial Advisory Board.'';
(C) by amending paragraph (2) to read as follows:
``(2) Members.--
``(A) Members of the antimicrobial resistance task
force.--The task force described in paragraph (1) shall
be composed of representatives of such Federal agencies
as the Secretary determines necessary, including
representation of the following:
``(i) The Antimicrobial Resistance Office.
``(ii) The Assistant Secretary for
Preparedness and Response.
``(iii) The Biomedical Advanced Research
and Development Authority.
``(iv) The Centers for Disease Control and
Prevention.
``(v) The Food and Drug Administration.
``(vi) The National Institutes of Health.
``(vii) The Agency for Healthcare Research
and Quality.
``(viii) The Centers for Medicare &
Medicaid Services.
``(ix) The Health Resources and Services
Administration.
``(x) The Department of Agriculture.
``(xi) The Department of Education.
``(xii) The Department of Defense.
``(xiii) The Department of Veterans
Affairs.
``(xiv) The Environmental Protection
Agency.
``(xv) The Department of Homeland Security.
``(xvi) The United States Agency for
International Development.
``(B) Members of the public health antimicrobial
advisory board.--
``(i) In general.--The Public Health
Antimicrobial Advisory Board shall be composed
of 19 voting members, appointed by the
Secretary. Such members shall include experts
from the medical professions (including
hospital and community-based physicians),
pharmacy, public health, veterinary, research,
and international health communities, as well
as one representative from a public interest
group.
``(ii) Terms.--Each member appointed under
clause (i) shall be appointed for a term of 3
years, except that of the 19 members first
appointed--
``(I) 6 shall be appointed for a
term of 12 months; and
``(II) 6 shall be appointed for a
term of 2 years.
``(iii) Chair.--The Secretary shall appoint
a Chair of the Public Health Antimicrobial
Advisory Board from among its members to lead
and supervise the activities of the Advisory
Board.
``(iv) Disclosure of financial interests.--
Prior to a meeting of the Public Health
Antimicrobial Advisory Board, each member of
the Advisory Board shall disclose to the
Secretary any potential, relevant financial
interests as defined under section 208(a) of
title 18, United States Code.'';
(D) in paragraph (3)(B), by striking ``in
consultation with the task force described in paragraph
(1) and'' and inserting ``acting through the Director
of the Antimicrobial Resistance Office and the Director
of the Centers for Disease Control and Prevention, and
in consultation with''; and
(E) by amending paragraph (4) to read as follows:
``(4) Meetings and duties.--
``(A) Antimicrobial resistance office duties.--The
Director of the Antimicrobial Resistance Office,
working in conjunction with the Federal agencies that
are represented on the task force described in
paragraph (1), shall issue an update to the Public
Health Action Plan to Combat Antimicrobial Resistance
within 1 year of the establishment of the Office and
annually thereafter. The updates shall include enhanced
plans for addressing antimicrobial resistance in the
United States and internationally. The Director of the
Office shall post on a website these updates as well as
summaries of all non-proprietary data the Task Force
makes available. The Director of the Antimicrobial
Resistance Office shall work in conjunction with the
Federal agencies that are represented on the task force
described in paragraph (1), and in consultation with
the Public Health Antimicrobial Advisory Board, to--
``(i) establish benchmarks for achieving
the goals set forth in the action plan;
``(ii) assess the ongoing, observed
patterns of emergence of antimicrobial
resistance, and their impact on clinical
outcomes in terms of how patients feel,
function, or survive;
``(iii) assess how antimicrobial products
are being used in humans, animals, plants, and
the environment and the risks and benefits of
those uses in furthering the development of
resistance and the implications thereof for
patient safety and public health;
``(iv) establish a priority list of human
infectious diseases with the greatest need for
development of new point-of-care and other
diagnostics, antimicrobial drugs, and vaccines,
and in particular serious and life-threatening
resistant infections, for which there are few
or no diagnostic, treatment, or prevention
options;
``(v) recommend basic, clinical,
epidemiological, prevention, and translational
research where additional federally supported
studies may be beneficial;
``(vi) recommend how to support
antimicrobial development through Food and Drug
Administration activities, including through
the agency's Critical Path Initiative and the
Reagan-Udall Foundation;
``(vii) recommend how best to strengthen
and link antimicrobial resistance-related
surveillance and prevention and control
activities; and
``(viii) collaborate with the Assistant
Secretary for Preparedness and Response to
ensure that strategies to address
antimicrobial-resistance are coordinated with
initiatives aimed at pandemic influenza, severe
acute respiratory syndrome, and bioterrorism.
``(B) Antimicrobial resistance task force meetings
and duties.--
``(i) Meetings.--The Antimicrobial
Resistance Task Force shall convene
periodically as the Director of the
Antimicrobial Resistance Task Force determines
to be appropriate, but not fewer than twice a
year, to consider issues relating to
antimicrobial resistance.
``(ii) Public health action plan.--At least
twice a year, the task force described in
paragraph (1) shall have a meeting to review,
discuss, and further develop the Public Health
Action Plan to Combat Antimicrobial Resistance
first issued by the interagency task force on
antimicrobial resistance in 2001. Among other
issues, the task force may discuss and review,
based on current need or concern--
``(I) antimicrobial clinical
susceptibility concentrations proposed,
established, or updated by the Food and
Drug Administration;
``(II) data obtained by government
agencies and, as possible, by private
sources on emerging antimicrobial
resistance related to clinical outcomes
as well as data related to how
antimicrobial drugs may have been used
inappropriately;
``(III) surveillance data and
prevention and control activities
regarding emerging antimicrobial
resistance from reliable sources
including the Centers for Disease
Control and Prevention, the Food and
Drug Administration, the Department of
Defense, the Department of Veterans
Affairs, the Department of Agriculture,
the Environmental Protection Agency,
and as feasible from private sources
and international bodies;
``(IV) data on the amount of
antimicrobial products used in humans,
animals, plants, and the environment
from reliable sources, including data
from the Centers for Disease Control
and Prevention, the Food and Drug
Administration, the Environmental
Protection Agency, the Department of
Veterans Affairs, the Centers for
Medicare & Medicaid Services, the
Department of Homeland Security, and
the Department of Agriculture, and as
feasible from private sources and
international bodies;
``(V) the impact of antimicrobial
resistance on human health resulting
from the approval of antimicrobial
drugs for use in humans, animals, or
plants (including consideration of and
recommendations on potential management
plans to limit and reduce the negative
impacts of such resistance on human
health and consideration of the
benefits to animal health and food
safety);
``(VI) reports of federally
supported antimicrobial resistance
research and antimicrobial drug,
related diagnostics, and vaccine
development for antimicrobial resistant
infections (such as methicillin-
resistant Staphylococcus aureus (MRSA))
and other research activities
(including clinical, epidemiological,
prevention, and translational research)
obtained from Federal agencies, as well
as reports of research sponsored by
other countries, industry, and non-
governmental organizations;
``(VII) reports on efforts by the
Food and Drug Administration to develop
policies and guidance which encourage
antimicrobial drug, related
diagnostics, and vaccine development
and appropriate use while maintaining
high standards for safety and
effectiveness;
``(VIII) quality measures, which
may include health plan employer data
and information set (HEDIS) measures,
pertaining to appropriate use of
antimicrobial drugs; and
``(IX) other data and issues the
task force described in paragraph (1)
identifies as relevant to the issue of
antimicrobial resistance.
``(iii) Pending applications.--The Food and
Drug Administration may consult with the
Director of the Antimicrobial Resistance Office
concerning the pending application of any
antimicrobial drug application submitted to the
Secretary under section 505 or 512 of the
Federal Food, Drug, and Cosmetic Act or the
Public Health Service Act.
``(C) Public health antimicrobial advisory board
meetings and duties.--
``(i) Meetings.--The Public Health
Antimicrobial Advisory Board shall meet as the
Chair of the Public Health Antimicrobial
Advisory Board determines to be appropriate,
preferably in conjunction with meetings of the
Antimicrobial Resistance Task Force, but not
fewer than 2 times each year.
``(ii) Recommendations.--The Public Health
Antimicrobial Advisory Board shall make
recommendations to the Secretary, and the
Antimicrobial Resistance Office, regarding--
``(I) ways to encourage the
availability of an adequate supply of
safe and effective antimicrobial
products, related diagnostics, and
vaccines;
``(II) research priorities and
other measures (such as antimicrobial
drug resistance management plans) to
enhance the safety and efficacy of
antimicrobial products;
``(III) how best to implement and
update the goals of the Public Health
Action Plan to Combat Antimicrobial
Resistance;
``(IV) incentives necessary to
establish uniform mechanisms (which
could include electronic surveillance
systems) and data sets for State and
local reporting of resistance;
``(V) the adequacy of existing
United States antimicrobial resistance
and use surveillance;
``(VI) the development of a
national plan for the collection and
analysis of isolates of resistant
pathogens, including establishing
priorities as to which isolates should
be collected; and
``(VII) areas for government,
nongovernment, and international
cooperation to strengthen
implementation of the Public Health
Action Plan to Combat Antimicrobial
Resistance.
``(D) Availability of information.--The
Antimicrobial Resistance Office shall ensure that all
information shall be made available to the public on
the website described in subparagraph (A) consistent
with section 9 of the Strategies to Address
Antimicrobial Resistance Act.'';
(2) by amending subsection (b) to read as follows:
``(b) Antimicrobial Resistance Strategic Research Plan.--The
Secretary, acting through the Director of the National Institutes of
Health, working in consultation with the Director of the Centers for
Disease Control and Prevention, the Assistant Secretary for
Preparedness and Response, the Director of the Biomedical Advanced
Research and Development Authority, the Director of the Antimicrobial
Resistance Office, the Public Health Antimicrobial Advisory Board, and
other non-government experts, including representatives from
professional societies and the pharmaceutical, vaccine, and medical
device industries, and other Federal agencies shall develop a blue-
ribbon antimicrobial resistance strategic research plan that
strengthens existing epidemiological, interventional, clinical,
behavioral, translational, and basic research efforts to advance the
understanding of--
``(1) the development, implementation, and efficacy of
interventions to prevent and control the emergence and
transmission of antimicrobial resistance;
``(2) how best to optimize antimicrobial effectiveness
while limiting the emergence of resistance, including
addressing issues related to duration of therapy, effectiveness
of therapy in self-resolving diseases, and determining
populations most likely to benefit from antimicrobial drugs;
``(3) the extent to which specific uses of antimicrobial
products in humans, animals, plants, and other uses accelerates
development and transmission of antimicrobial resistance;
``(4) the natural histories of infectious diseases
(including defining the disease, diagnosis, severity, and the
time course of illness);
``(5) the development of new therapeutics, including
antimicrobial drugs, biologics, and devices against resistant
pathogens, and in particular diseases for which few or no
therapeutics are in development;
``(6) the development and testing of medical diagnostics to
identify patients with infectious disease and identify the
exact cause of infectious diseases syndromes, particularly with
respect to the detection of pathogens resistant to
antimicrobial drugs;
``(7) the epidemiology, pathogenesis, mechanisms, and
genetics of antimicrobial resistance; and
``(8) the sequencing of the genomes, or other DNA analysis,
or other comparative analysis of priority pathogens (as
determined by the Public Health Antimicrobial Advisory Board),
in collaboration with the Department of Defense and the Joint
Genome Institute of the Department of Energy.'';
(3) in subsection (c)--
(A) by inserting ``acting through the Director of
the Antimicrobial Resistance Office,'' after ``The
Secretary,''; and
(B) by striking ``members of the task force
described in subsection (a),'';
(4) in subsection (d)(1), by inserting ``, through the
Antimicrobial Resistance Office,'' after ``The Secretary'';
(5) in subsection (e)--
(A) by amending the subsection heading to read as
follows: ``Improving Uptake and Measurement of
Antimicrobial Stewardship'';
(B) in paragraph (1)--
(i) by inserting ``, acting through the
Director of the Antimicrobial Resistance
Office,'' after ``The Secretary''; and
(ii) by striking ``judicious use of
antimicrobial drugs or control the spread of
antimicrobial-resistant pathogens'' and
inserting ``the uptake and measurement of
antimicrobial stewardship programs in the
Nation's health care facilities'';
(C) in paragraph (2), by striking ``laboratory'';
(D) in paragraph (3), by inserting ``, acting
through the Antimicrobial Resistance Office,'' after
``The Secretary''; and
(E) by adding at the end the following new
paragraphs:
``(4) Definition of antimicrobial stewardship.--For
purposes of this subsection and Act, `antimicrobial
stewardship' means coordinated interventions designed to
improve and measure the appropriate use of antimicrobial
agents, including promoting the use of antimicrobials only when
clinically indicated, and, when antimicrobials are indicated,
promoting the selection of the optimal antimicrobial drug
regimen including dosing, duration of therapy, and route of
administration.
``(5) Preference in making awards.--In making awards under
paragraph (1), the Secretary shall give preference to eligible
entities that will use grant funds to establish demonstration
projects that lead to the development of quality measures for
health care providers prescribing antimicrobial drugs.'';
(6) by redesignating subsections (f) and (g) as subsections
(i) and (j), respectively; and
(7) by inserting after subsection (e) the following new
subsections:
``(f) Appropriate Antimicrobial Use.--The Secretary, acting through
the Director of the Centers for Disease Control and Prevention, shall
take such additional actions as follows:
``(1) To pilot and test health care quality measures to
help providers, facilities, and health systems measure and
benchmark appropriate antimicrobial use. As appropriate, the
Director shall work with standard setting organizations (such
as the National Quality Forum, the Joint Commission, and the
National Committee for Quality Assurance) to determine if any
such measure is suitable for national quality reporting
efforts.
``(2) To develop methods to help providers, facilities, and
health systems measure and improve appropriate antimicrobial
use, including methods and tools to assess the change in
antimicrobial use, the impact on antibiotic resistance and
adverse effects (such as Clostridium difficile infections), and
the economic impact and cost savings of antimicrobial
stewardship programs.
``(g) Collection of Human Antimicrobial Consumption and Resistance
Trend Data.--
``(1) Antimicrobial use data.--The Director of the Centers
for Disease Control and Prevention shall work with private
vendors, health care organizations, pharmacy benefit managers,
and other entities to obtain reliable and comparable human
antimicrobial drug consumption data (including volume
antimicrobial distribution data and antimicrobial use,
including prescription data) by State or metropolitan area.
``(2) Antimicrobial resistance trend data.--The Director of
the Centers for Disease Control and Prevention shall intensify
and expand their efforts to collect antimicrobial resistance
data including through the establishment of an Antimicrobial
Resistance Surveillance and Laboratory Network, established in
section 4 of the Strategies to Address Antimicrobial Resistance
Act, and development of a fully automated antimicrobial
resistance and use module within the National Healthcare Safety
Network. The Director shall seek to collect data from
electronic medication administration reports (eMAR) and
laboratory systems to produce regular reports on antimicrobial
resistance patterns and antimicrobial use.
``(3) Meaningful use reporting.--The Office of the National
Coordinator for Health Information Technology shall work with
the Director of the Centers for Disease Control and Prevention
to determine how best antimicrobial use, susceptibility, and
resistance data can be incorporated into meaningful use
reporting.
``(4) Report.--Not later than 2 years after the date of the
enactment of the Strategies to Address Antimicrobial Resistance
Act, and every two years thereafter, the Director of the
Centers for Disease Control and Prevention shall submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor
and Pensions of the Senate and make available on the agency's
website a report summarizing key trends and major issues
related to antimicrobial resistance and use in the United
States. Each such report shall include the most relevant and
up-to-date data available from the infectious diseases and
surveillance programs of the Centers for Disease Control and
Prevention. Each such report shall--
``(A) outline major issues and threats in
antimicrobial resistance facing the United States;
``(B) provide data on the incidence, prevalence,
morbidity, mortality, and general societal burden,
including economic, of antimicrobial resistant
pathogens;
``(C) provide updates on resistance patterns and
antimicrobials use data and potential impacts on human
health and patient safety;
``(D) articulate activities of the Centers for
Disease Control and Prevention targeted toward
measuring and preventing the spread of drug resistant
pathogens;
``(E) describe any international developments that
may impact antimicrobial resistance in the United
States; and
``(F) identify the major gaps that the Nation faces
in the areas of antimicrobial resistance surveillance,
prevention, use, and antimicrobial stewardship.
``(h) Ensure Access to Antimicrobial Resistance Data and
Research.--The Director of the Antimicrobial Resistance Office shall
work with the Federal agencies represented on the Antimicrobial
Resistance Task Force to identify relevant data and formats, and
mechanisms for communicating such data to the Antimicrobial Resistance
Office and Antimicrobial Resistance Task Force and, in a manner
consistent with section 9 of the Strategies to Address Antimicrobial
Resistance Act, with the Public Health Antimicrobial Advisory Board and
the public, including relevant data obtained by the agencies through
contracts with other organizations, including--
``(1) use and clinical outcomes data on patients receiving
antimicrobial drugs for the treatment, prevention, or diagnosis
of infection or infectious diseases;
``(2) surveillance data regarding emerging antimicrobial
drug resistance and existing resistance patterns;
``(3) susceptibility data related to antimicrobial drug
use;
``(4) data related to the amount of antimicrobial products
used in humans, animals, plants, and the environment;
``(5) data from federally funded research intended to
support antimicrobial drug, vaccine, and related diagnostics
development;
``(6) data demonstrating the impact of research,
surveillance, and prevention and control initiatives in
understanding and controlling antimicrobial resistance; and
``(7) data regarding implementation and evaluation of
interventions to improve antimicrobial drug prescribing
practices.''.
SEC. 4. ANTIMICROBIAL RESISTANCE SURVEILLANCE AND LABORATORY NETWORK.
(a) In General.--The Secretary of Health and Human Services, acting
through the Director of the Centers for Disease Control, shall
establish at least 10 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) study the epidemiology of infections from such
pathogens;
(6) evaluate commonly used antimicrobial susceptibility
testing methods to improve the accuracy of resistance testing
and reporting; and
(7) as necessary, develop novel diagnostic tests capable of
detecting new or emerging resistance in pathogens.
(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. 5. 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 establish
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) advance clinical trial efforts to develop antimicrobial
therapies, vaccines and diagnostics, and evaluate and optimize
their usage;
(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 effect on
development of resistance.
(b) Leadership Group for a Clinical Research Network on
Antibacterial Resistance.--The Secretary, acting through the Director
of the National Institute of Allergy and Infectious Diseases, shall
establish a Leadership Group for the Clinical Research Network on
Antibacterial Resistance described in subsection (a) to develop and
implement a comprehensive clinical research agenda to address
antibacterial resistance that takes into consideration the
recommendations contained in the Strategic Research Plan on
Antimicrobial Resistance developed in accordance with section 319E of
the Public Health Service Act. The Leadership Group shall provide
support for the following components--
(1) scientific leadership and operations;
(2) network laboratories; and
(3) statistical and data management.
(c) Appropriations.--There are authorized to be appropriated from
the existing budget of the National Institute of Allergy and Infectious
Diseases, $100,000,000 annually for each of fiscal years 2014 through
2020 to carry out this section.
SEC. 6. REGIONAL PREVENTION COLLABORATIVES.
The Secretary, acting through the Director of the Centers for
Disease Control and Prevention, shall work with State health
departments to support regional prevention collaboratives designed to
interrupt and prevent the transmission of significant antibiotic
resistant pathogens being transmitted across health care settings in a
geographic region. Such regional prevention collaboratives shall work
to--
(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 such pathogens; and
(3) evaluate the impact of such measures on hospital
readmissions, transitions of care, rates of health care
associated infections, or any other relevant measures that
characterize the health or economic impact of the
collaboratives.
SEC. 7. PREVENTION EPICENTERS.
To provide the regional prevention collaboratives established under
section 6 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 of Disease
Control and Prevention. The Centers for Disease Control and Prevention
and the epicenters participating in such program shall work with the
regional prevention collaboratives to--
(1) evaluate new and existing interventions to prevent or
limit the emergence of antimicrobial resistance throughout the
geographic region of the collaboratives;
(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.
SEC. 8. CONTINUATION OF CURRENT PROGRAMS.
Subsection (j) of section 319E of the Public Health Service Act (42
U.S.C. 247d-5), as redesignated by section 3(6), is amended by
inserting ``and for each of the fiscal years 2014 through 2018'' after
``2006''.
SEC. 9. PROTECTION OF CONFIDENTIAL AND NATIONAL SECURITY INFORMATION.
Except as otherwise required by law, this Act (and the amendments
made by this Act) shall not permit public disclosure of trade secrets,
confidential commercial information, or material inconsistent with
national security that is obtained by any person under this Act (or
amendments made by this Act).
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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