Presidential DocumentExecutive Order 136762014-22805
Combating Antibiotic-Resistant Bacteria
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Published
September 23, 2014
Signed
September 18, 2014
Issuing agencies
Executive Office of the President
Full Text
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<title>Federal Register, Volume 79 Issue 184 (Tuesday, September 23, 2014)</title>
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[Federal Register Volume 79, Number 184 (Tuesday, September 23, 2014)]
[Presidential Documents]
[Pages 56931-56935]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2014-22805]
Presidential Documents
Federal Register / Vol. 184, No. 79 / Tuesday, September 23, 2014 /
Presidential Documents
[[Page 56931]]
Executive Order 13676 of September 18, 2014
Combating Antibiotic-Resistant Bacteria
By the authority vested in me as President by the
Constitution and the laws of the United States of
America, I hereby order as follows:
Section 1. Policy. The discovery of antibiotics in the
early 20th century fundamentally transformed human and
veterinary medicine. Antibiotics save millions of lives
each year in the United States and around the world.
The rise of antibiotic-resistant bacteria, however,
represents a serious threat to public health and the
economy. The Centers for Disease Control and Prevention
(CDC) in the Department of Health and Human Services
(HHS) estimates that annually at least two million
illnesses and 23,000 deaths are caused by antibiotic-
resistant bacteria in the United States alone.
Detecting, preventing, and controlling antibiotic
resistance requires a strategic, coordinated, and
sustained effort. It also depends on the engagement of
governments, academia, industry, healthcare providers,
the general public, and the agricultural community, as
well as international partners. Success in this effort
will require significant efforts to: minimize the
emergence of antibiotic-resistant bacteria; preserve
the efficacy of new and existing antibacterial drugs;
advance research to develop improved methods for
combating antibiotic resistance and conducting
antibiotic stewardship; strengthen surveillance efforts
in public health and agriculture; develop and promote
the use of new, rapid diagnostic technologies;
accelerate scientific research and facilitate the
development of new antibacterial drugs, vaccines,
diagnostics, and other novel therapeutics; maximize the
dissemination of the most up-to-date information on the
appropriate and proper use of antibiotics to the
general public and healthcare providers; work with the
pharmaceutical industry to include information on the
proper use of over-the-counter and prescription
antibiotic medications for humans and animals; and
improve international collaboration and capabilities
for prevention, surveillance, stewardship, basic
research, and drug and diagnostics development.
The Federal Government will work domestically and
internationally to detect, prevent, and control illness
and death related to antibiotic-resistant infections by
implementing measures that reduce the emergence and
spread of antibiotic-resistant bacteria and help ensure
the continued availability of effective therapeutics
for the treatment of bacterial infections.
Sec. 2. Oversight and Coordination. Combating
antibiotic-resistant bacteria is a national security
priority. The National Security Council staff, in
collaboration with the Office of Science and Technology
Policy, the Domestic Policy Council, and the Office of
Management and Budget, shall coordinate the development
and implementation of Federal Government policies to
combat antibiotic-resistant bacteria, including the
activities, reports, and recommendations of the Task
Force for Combating Antibiotic-Resistant Bacteria
established in section 3 of this order.
Sec. 3. Task Force for Combating Antibiotic-Resistant
Bacteria. There is hereby established the Task Force
for Combating Antibiotic-Resistant Bacteria (Task
Force), to be co-chaired by the Secretaries of Defense,
Agriculture, and HHS.
(a) Membership. In addition to the Co-Chairs, the
Task Force shall consist of representatives from:
(i) the Department of State;
[[Page 56932]]
(ii) the Department of Justice;
(iii) the Department of Veterans Affairs;
(iv) the Department of Homeland Security;
(v) the Environmental Protection Agency;
(vi) the United States Agency for International Development;
(vii) the Office of Management and Budget;
(viii) the Domestic Policy Council;
(ix) the National Security Council staff;
(x) the Office of Science and Technology Policy;
(xi) the National Science Foundation; and
(xii) such executive departments, agencies, or offices as the Co-Chairs may
designate.
Each executive department, agency, or office
represented on the Task Force (Task Force agency) shall
designate an employee of the Federal Government to
perform the functions of the Task Force. In performing
its functions, the Task Force may make use of existing
interagency task forces on antibiotic resistance.
(b) Mission. The Task Force shall identify actions
that will provide for the facilitation and monitoring
of implementation of this order and the National
Strategy for Combating Antibiotic-Resistant Bacteria
(Strategy).
(c) Functions.
(i) By February 15, 2015, the Task Force shall submit a 5-year National
Action Plan (Action Plan) to the President that outlines specific actions
to be taken to implement the Strategy. The Action Plan shall include goals,
milestones, and metrics for measuring progress, as well as associated
timelines for implementation. The Action Plan shall address recommendations
made by the President's Council of Advisors on Science and Technology
regarding combating antibiotic resistance.
(ii) Within 180 days of the release of the Action Plan and each year
thereafter, the Task Force shall provide the President with an update on
Federal Government actions to combat antibiotic resistance consistent with
this order, including progress made in implementing the Strategy and Action
Plan, plans for addressing any barriers preventing full implementation of
the Strategy and Action Plan, and recommendations for new or modified
actions. Annual updates shall include specific goals, milestones, and
metrics for all proposed actions and recommendations. The Task Force shall
take Federal Government resources into consideration when developing these
proposed actions and recommendations.
(iii) In performing its functions, the Task Force shall review relevant
statutes, regulations, policies, and programs, and shall consult with
relevant domestic and international organizations and experts, as
necessary.
(iv) The Task Force shall conduct an assessment of progress made towards
achieving the milestones and goals outlined in the Strategy in conjunction
with the Advisory Council established pursuant to section 4 of this order.
Sec. 4. Presidential Advisory Council on Combating
Antibiotic-Resistant Bacteria. (a) The Secretary of HHS
(Secretary), in consultation with the Secretaries of
Defense and Agriculture, shall establish the
Presidential Advisory Council on Combating Antibiotic-
Resistant Bacteria (Advisory Council). The Advisory
Council shall be composed of not more than 30 members
to be appointed or designated by the Secretary.
(b) The Secretary shall designate a chairperson
from among the members of the Advisory Council.
(c) The Advisory Council shall provide advice,
information, and recommendations to the Secretary
regarding programs and policies intended to: preserve
the effectiveness of antibiotics by optimizing their
use; advance
[[Page 56933]]
research to develop improved methods for combating
antibiotic resistance and conducting antibiotic
stewardship; strengthen surveillance of antibiotic-
resistant bacterial infections; prevent the
transmission of antibiotic-resistant bacterial
infections; advance the development of rapid point-of-
care and agricultural diagnostics; further research on
new treatments for bacterial infections; develop
alternatives to antibiotics for agricultural purposes;
maximize the dissemination of up-to-date information on
the appropriate and proper use of antibiotics to the
general public and human and animal healthcare
providers; and improve international coordination of
efforts to combat antibiotic resistance. The Secretary
shall provide the President with all written reports
created by the Advisory Council.
(d) Task Force agencies shall, to the extent
permitted by law, provide the Advisory Council with
such information as it may require for purposes of
carrying out its functions.
(e) To the extent permitted by law, and subject to
the availability of appropriations, HHS shall provide
the Advisory Council with such funds and support as may
be necessary for the performance of its functions.
Sec. 5. Improved Antibiotic Stewardship. (a) By the end
of calendar year 2016, HHS shall review existing
regulations and propose new regulations or other
actions, as appropriate, that require hospitals and
other inpatient healthcare delivery facilities to
implement robust antibiotic stewardship programs that
adhere to best practices, such as those identified by
the CDC. HHS shall also take steps to encourage other
healthcare facilities, such as ambulatory surgery
centers and dialysis facilities, to adopt antibiotic
stewardship programs.
(b) Task Force agencies shall, as appropriate,
define, promulgate, and implement stewardship programs
in other healthcare settings, including office-based
practices, outpatient settings, emergency departments,
and institutional and long-term care facilities such as
nursing homes, pharmacies, and correctional facilities.
(c) By the end of calendar year 2016, the
Department of Defense (DoD) and the Department of
Veterans Affairs (VA) shall review their existing
regulations and, as appropriate, propose new
regulations and other actions that require their
hospitals and long-term care facilities to implement
robust antibiotic stewardship programs that adhere to
best practices, such as those defined by the CDC. DoD
and the VA shall also take steps to encourage their
other healthcare facilities, such as ambulatory surgery
centers and outpatient clinics, to adopt antibiotic
stewardship programs.
(d) Task Force agencies shall, as appropriate,
monitor improvements in antibiotic use through the
National Healthcare Safety Network and other systems.
(e) The Food and Drug Administration (FDA) in HHS,
in coordination with the Department of Agriculture
(USDA), shall continue taking steps to eliminate the
use of medically important classes of antibiotics for
growth promotion purposes in food-producing animals.
(f) USDA, the Environmental Protection Agency
(EPA), and FDA shall strengthen coordination in common
program areas, such as surveillance of antibiotic use
and resistance patterns in food-producing animals,
inter-species disease transmissibility, and research
findings.
(g) DoD, HHS, and the VA shall review existing
regulations and propose new regulations and other
actions, as appropriate, to standardize the collection
and sharing of antibiotic resistance data across all
their healthcare settings.
Sec. 6. Strengthening National Surveillance Efforts for
Resistant Bacteria. (a) The Task Force shall ensure
that the Action Plan includes procedures for creating
and integrating surveillance systems and laboratory
networks to provide timely, high-quality data across
healthcare and agricultural settings, including
detailed genomic and other information, adequate to
track resistant bacteria across diverse settings. The
network-integrated surveillance
[[Page 56934]]
systems and laboratory networks shall include common
information requirements, repositories for bacteria
isolates and other samples, a curated genomic database,
rules for access to samples and scientific data,
standards for electronic health record-based reporting,
data transparency, budget coordination, and
international coordination.
(b) Task Force agencies shall, as appropriate, link
data from Federal Government sample isolate
repositories for bacteria strains to an integrated
surveillance system, and, where feasible, the
repositories shall enhance their sample collections and
further interoperable data systems with national
surveillance efforts.
(c) USDA, EPA, and FDA shall work together with
stakeholders to monitor and report on changes in
antibiotic use in agriculture and their impact on the
environment.
(d) Task Force agencies shall, as appropriate,
monitor antibiotic resistance in healthcare settings
through the National Healthcare Safety Network and
related systems.
Sec. 7. Preventing and Responding to Infections and
Outbreaks with Antibiotic-Resistant Organisms. (a) Task
Force agencies shall, as appropriate, utilize the
enhanced surveillance activities described in section 6
of this order to prevent antibiotic-resistant
infections by: actively identifying and responding to
antibiotic-resistant outbreaks; preventing outbreaks
and transmission of antibiotic-resistant infections in
healthcare, community, and agricultural settings
through early detection and tracking of resistant
organisms; and identifying and evaluating additional
strategies in the healthcare and community settings for
the effective prevention and control of antibiotic-
resistant infections.
(b) Task Force agencies shall take steps to
implement the measures and achieve the milestones
outlined in the Strategy and Action Plan.
(c) DoD, HHS, and the VA shall review and, as
appropriate, update their hospital and long-term care
infectious disease protocols for identifying,
isolating, and treating antibiotic-resistant bacterial
infection cases.
Sec. 8. Promoting New and Next Generation Antibiotics
and Diagnostics. (a) As part of the Action Plan, the
Task Force shall describe steps that agencies can take
to encourage the development of new and next-generation
antibacterial drugs, diagnostics, vaccines, and novel
therapeutics for both the public and agricultural
sectors, including steps to develop infrastructure for
clinical trials and options for attracting greater
private investment in the development of new
antibiotics and rapid point-of-care diagnostics. Task
Force agency efforts shall focus on addressing areas of
unmet medical need for individuals, including those
antibiotic-resistant bacteria CDC has identified as
public and agricultural health threats.
(b) Together with the countermeasures it develops
for biodefense threats, the Biomedical Advanced
Research Development Authority in HHS shall develop new
and next-generation countermeasures that target
antibiotic-resistant bacteria that present a serious or
urgent threat to public health.
(c) The Public Health Emergency Medical
Countermeasures Enterprise in HHS shall, as
appropriate, coordinate with Task Force agencies'
efforts to promote new and next-generation
countermeasures to target antibiotic-resistant bacteria
that present a serious or urgent threat to public
health.
Sec. 9. International Cooperation. Within 30 days of
the date of this order, the Secretaries of State, USDA,
and HHS shall designate representatives to engage in
international action to combat antibiotic-resistant
bacteria, including the development of the World Health
Organization (WHO) Global Action Plan for Antimicrobial
Resistance with the WHO, Member States, and other
relevant organizations. The Secretaries of State, USDA,
and HHS shall conduct a review of international
collaboration activities and partnerships, and identify
and pursue opportunities for enhanced prevention,
surveillance, research and development, and policy
engagement. All Task Force
[[Page 56935]]
agencies with research and development activities
related to antibiotic resistance shall, as appropriate,
expand existing bilateral and multilateral scientific
cooperation and research pursuant to the Action Plan.
Sec. 10. General Provisions. (a) This order shall be
implemented consistent with applicable law and subject
to the availability of appropriations.
(b) Nothing in this order shall be construed to
impair or otherwise affect:
(i) the authority granted by law to an executive department or agency, or
the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget
relating to budgetary, administrative, or legislative proposals.
(c) This order is not intended to, and does not,
create any right or benefit, substantive or procedural,
enforceable at law or in equity by any party against
the United States, its departments, agencies, or
entities, its officers, employees, or agents, or any
other person.
(d) Insofar as the Federal Advisory Committee Act,
as amended (5 U.S.C. App.) (the ``Act''), may apply to
the Advisory Council, any functions of the President
under the Act, except for that of reporting to the
Congress, shall be performed by the Secretary in
accordance with the guidelines issued by the
Administrator of General Services.
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
(Presidential Sig.)
THE WHITE HOUSE,
September 18, 2014.
[FR Doc. 2014-22805
Filed 9-22-14; 11:15 am]
Billing code 3295-F4
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</html>Indexed from Federal Register on September 23, 2014.
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