[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 2236 Introduced in Senate (IS)]

113th CONGRESS
  2d Session
                                S. 2236

 To amend the Public Health Service Act to enhance efforts to address 
           antimicrobial resistance, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 10, 2014

   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 
           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 costs, 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 accelerate 
        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 and Prevention, 
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 2015 through 
2021 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 for 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 2015 through 2019'' 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>