Combating Antibiotic-Resistant Bacteria, 56931-56935 [2014-22805]

Agencies

• Executive Office of the President

[Federal Register Volume 79, Number 184 (Tuesday, September 23, 2014)]
[Presidential Documents]
[Pages 56931-56935]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[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;

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(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

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                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

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                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

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                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.
                
                
                    (Presidential Sig.)

                THE WHITE HOUSE,

                    September 18, 2014.

[FR Doc. 2014-22805
Filed 9-22-14; 11:15 am]
Billing code 3295-F4