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[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2400 Introduced in House (IH)]

111th CONGRESS
  1st Session
                                H. R. 2400

 To amend the Public Health Service Act to enhance efforts to address 
                       antimicrobial resistance.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                              May 13, 2009

 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.

    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) The recent 2009 Influenza A: H1N1 virus (also known as 
        ``Swine Flu Virus'') outbreak clearly illustrates why 
        infectious diseases experts are concerned about drug 
        resistance; although the H1N1 virus currently appears to be 
        treatable by two classes of available antiviral drugs, it is 
        resistant to other classes, and should the virus mutate and 
        become resistant to all classes, which is possible, we would be 
        left extremely vulnerable.
            (4) 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.
            (5) A study estimates that in 2005 more than 94,000 
        invasive methicillin-resistant Staphylococcus aureus (MRSA) 
        infections occurred in the United States and more than 18,500 
        of these infections resulted in death--7 times more than a 
        decade earlier.
            (6) The recent 2009 Influenza A: H1N1 virus outbreak 
        exacerbates concerns about MRSA 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.
            (7) Each year, nearly 2,000,000 people contract bacterial 
        infections in hospitals and approximately 90,000 of these 
        people die from these infections.
            (8) The current annual costs of antimicrobial-resistant 
        bacterial diseases are hard to quantify, but a 1995 report by 
        the Office of Technology Assessment, an agency of Congress, 
        which looked at 6 different antimicrobial-resistant strains of 
        bacteria, calculated that the minimum nationwide hospital costs 
        of just these strains of bacteria accounted for $1,300,000,000 
        annually in 1992 dollars ($1,870,000,000 in 2006 dollars).
            (9) A 1998 Institute of Medicine report estimated the 
        societal cost of resistance as between $4,000,000,000 to 
        $5,000,000,000; many experts argue the cost in 2009 may be 
        close to 10 times greater.
            (10) The costs of antimicrobial-resistant infections in 
        terms of lives lost and economically will only rise as 
        antimicrobial resistance continues to spread.

SEC. 3. ANTIMICROBIAL RESISTANCE TASK FORCE.

    (a) In General.--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, 
                        establish an Antimicrobial Resistance Office in 
                        the Office of the Secretary 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 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 of 
                        Preparedness and Response.
                            ``(iii) The Centers for Disease Control and 
                        Prevention.
                            ``(iv) The Food and Drug Administration.
                            ``(v) The National Institutes of Health.
                            ``(vi) The Agency for Healthcare Research 
                        and Quality.
                            ``(vii) The Centers for Medicare & Medicaid 
                        Services.
                            ``(viii) The Health Resources and Services 
                        Administration.
                            ``(ix) The Department of Agriculture.
                            ``(x) The Department of Education.
                            ``(xi) The Department of Defense.
                            ``(xii) The Department of Veterans Affairs.
                            ``(xiii) The Environmental Protection 
                        Agency.
                            ``(xiv) The Department of Homeland 
                        Security.
                            ``(xv) 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 resistance 
                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 18 months of the establishment of the 
                Office and biennial updates 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, and plants, 
                        and the impact of such use 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 
                        bacterial diseases, for which there are few or 
                        no diagnostic or treatment 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;
                            ``(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, 
                        including the 2009 Influenza A: H1N1 virus and 
                        H1N1 Avian Influenza virus, severe acute 
                        respiratory syndrome, bioterrorism, and other 
                        emerging health threats.
                    ``(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 
                        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 
                                in terms of how patients function, 
                                feel, or survive 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, and plants 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 or animals 
                                (including consideration of and 
                                recommendations on potential management 
                                plans to limit and reduce the negative 
                                impacts of such resistance on human 
                                health);
                                    ``(VI) reports of federally 
                                supported antimicrobial resistance 
                                research and antimicrobial drug 
                                development 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 guidances which encourage 
                                antimicrobial drug development and 
                                appropriate use while maintaining high 
                                standards for safety and effectiveness;
                                    ``(VIII) 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;
                                    ``(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 and data 
                                sets for State and local reporting of 
                                resistance data;
                                    ``(V) the adequacy of existing 
                                surveillance systems to collect 
                                antimicrobial resistance data and how 
                                best to improve the collection, 
                                reporting, and analysis of such data;
                                    ``(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;
                                    ``(VII) the implementation and 
                                evaluation of interventions to promote 
                                appropriate antimicrobial drug use in 
                                both inpatient and outpatient settings; 
                                and
                                    ``(VIII) 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 8 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 Antimicrobial Resistance 
Office, the Director of the Centers for Disease Control and Prevention, 
and the Director of the National Institutes of Health, and in 
consultation with other Federal agencies and the Public Health 
Antimicrobial Advisory Board, shall develop an 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 the use 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''; and
            (5) in subsection (e)--
                    (A) in paragraph (1), by inserting ``, acting 
                through the Director of the Antimicrobial Resistance 
                Office,'' after ``The Secretary'';
                    (B) in paragraph (3), by inserting ``, acting 
                through the Antimicrobial Resistance Office,'' after 
                ``The Secretary''; and
                    (C) by adding at the end the following:
            ``(4) 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 to assess the scope of the antimicrobial resistance 
        problem and the level of appropriate and inappropriate use of 
        antimicrobial drugs especially related to self-resolving 
        infections, including the validation of models that may lead to 
        the development of quality measures for health care providers 
        prescribing antimicrobial drugs.''.
    (b) Ensure Access to Antimicrobial Data and Research.--The Director 
of the Antimicrobial Resistance Office shall work with the 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 8 of this 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;
            (3) susceptibility data related to antimicrobial drug use;
            (4) data related to the amount of antimicrobial products 
        used in humans, animals, and plants;
            (5) data from federally funded research intended to support 
        antimicrobial drug 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. COLLECTION OF ANTIMICROBIAL DRUG DATA.

    (a) Submission of Human and Animal Drug Distribution Data.--Chapter 
V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) 
is amended by inserting after section 512 the following:

``SEC. 512A. SUBMISSION OF HUMAN AND ANIMAL DRUG DISTRIBUTION DATA.

    ``(a) In General.--Notwithstanding any other provision of law, the 
Secretary shall require that each sponsor of a human antimicrobial drug 
product which is approved under section 505 (including section 505(j)) 
and sold or distributed in the United States, submit antimicrobial drug 
sales and distribution data. Such data shall be--
            ``(1) submitted not later than 60 days after the beginning 
        of the subsequent calendar year;
            ``(2) reported on the calendar year and segregated by 
        month;
            ``(3) in such format, and utilize any such unit of measure, 
        as the Secretary by regulation deems necessary and appropriate 
        to ensure the reported data is comparable and reliable; and
            ``(4) made available to the Antimicrobial Resistance Office 
        and the Antimicrobial Resistance Task Force.
    ``(b) Confidentiality.--To protect proprietary commercial 
information, officials who serve in the Antimicrobial Resistance Office 
and on the Antimicrobial Resistance Task Force shall sign a 
confidentiality agreement prior to reviewing any such data to which 
access is granted under subsection (a)(4).''.
    (b) Submission of Animal Sales and Distribution Data.--Section 
512(l)(3) (21 U.S.C. 360b(l)(3)) is amended--
            (1) in subparagraph (C)--
                    (A) in clause (ii), by deleting ``and'' at the end;
                    (B) in clause (iii), by striking the period at the 
                end and inserting ``; and''; and
                    (C) by adding at the end the following:
                            ``(iv) contain any such additional 
                        information, be in such format, and utilize any 
                        such unit of measure as the Secretary by 
                        regulation deems necessary and appropriate to 
                        ensure the reported data is comparable and 
                        reliable.''; and
            (2) in subparagraph (D), by striking ``may'' and inserting 
        ``shall''.
    (c) Data From Additional Sources.--
            (1) In general.--The Secretary, acting through the Director 
        of the Antimicrobial Resistance Office, shall explore 
        opportunities to secure from private vendors and health care 
        organizations reliable and comparable animal and human 
        antimicrobial drug consumption data (volume antimicrobial 
        distribution data and antimicrobial use, including prescription 
        data) by State or metropolitan area, as necessary, to 
        supplement the antimicrobial drug consumption data to be 
        collected under this section for the purpose of demonstrating 
        how the consumption of antimicrobial drugs for human and animal 
        uses may affect the development of resistance over time and 
        within geographic locations and to institute preventive 
        interventions.
            (2) Negotiations.--The Director of the Antimicrobial 
        Resistance Office may enter into negotiations with private 
        vendors and health care organizations to determine acceptable 
        scope and parameters for summaries of antimicrobial drug 
        consumption data that is collected under this section publicly 
        available for research purposes.
            (3) Other means to secure data.--If the Director of the 
        Antimicrobial Resistance Office is not able to secure 
        sufficient supplemental antimicrobial drug consumption data for 
        human and animal uses through private vendors and health care 
        organizations as provided for in this section, the Secretary 
        shall consider other means to secure such consumption data, 
        including through the conduct of surveys about how 
        antimicrobial drugs are used in various settings.
    (d) Collection of Antimicrobial Prescription Data.--
            (1) Clinical outcomes data.--The Director of the 
        Antimicrobial Resistance Office, the Under Secretary for Health 
        of the Department of Veterans Affairs, and the Administrator of 
        the Centers for Medicare & Medicaid Services shall work 
        together to collect and analyze relevant drug utilization data 
        and clinical outcomes data, as determined relevant by the 
        Director of the Antimicrobial Resistance Office, on patients 
        who receive services funded by such agencies and who are 
        receiving prescription antimicrobial agents for the treatment 
        or prevention of infection or infectious diseases.
            (2) Organization.--Any data collected under paragraph (1) 
        shall be organized by--
                    (A) indication (including results of diagnostic 
                studies when available);
                    (B) dosage;
                    (C) route of administration;
                    (D) duration;
                    (E) age of the patient; and
                    (F) geographic region.
            (3) Interventions and analysis.--The Under Secretary for 
        Health of the Department of Veterans Affairs, the Administrator 
        of the Centers for Medicare & Medicaid Services, and the 
        Director of the Antimicrobial Resistance Office shall work 
        together to identify and report upon interventions that prevent 
        and control the development of antimicrobial resistance and to 
        include within such reports, where appropriate, an analysis of 
        the following--
                    (A) intra- and extra-label antimicrobial use;
                    (B) where challenges to appropriate use remain;
                    (C) trends and variations in antimicrobial 
                resistance rates; and
                    (D) the relationship between drug use and 
                resistance.
    (e) Public Availability of Data.--The Director of the Antimicrobial 
Resistance Office shall make summaries of the data received under this 
section publicly available and ensure that such summaries are updated 
and published, in a manner consistent with section 8, at least once 
annually on the website described in section 319E(a)(4)(A) of the 
Public Health Service Act (42 U.S.C. 247d-5(a)(4)(A)) in order to 
support epidemiologic and microbiologic research.

SEC. 5. ANTIMICROBIAL RESISTANCE SURVEILLANCE AND RESEARCH NETWORK.

    (a) In General.--The Secretary, through the Director of the Centers 
for Disease Control and Prevention and the Director of the National 
Institutes of Health, shall establish at least 10 Antimicrobial 
Resistance Surveillance and Research Network sites to strengthen the 
national capacity to--
            (1) describe and confirm regional outbreaks through 
        surveillance of locally available clinical specimens;
            (2) assess, integrate, and address local and national 
        antimicrobial resistance patterns;
            (3) facilitate research on prevention, control, and 
        treatment of resistant organisms; and
            (4) serve as a clinical trials network for optimizing 
        antimicrobial drug effectiveness.
    (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 sites.
    (d) Responsibilities.--The Network of sites established under 
subsection (a) shall--
            (1) monitor the emergence and changes in the patterns of 
        antimicrobial resistant pathogens in individuals;
            (2) study the molecular epidemiology of such pathogens;
            (3) evaluate the efficacy of new and existing interventions 
        to prevent or limit the emergence of antimicrobial resistance 
        throughout the geographic region of the site;
            (4) provide to the Centers for Disease Control and 
        Prevention isolates of resistant pathogens, and in particular, 
        pathogens that show new or atypical patterns of resistance 
        adversely affecting public health;
            (5) conduct clinical research to develop natural histories 
        of infectious disease and to study duration of antimicrobial 
        use related to resistance development, among other things;
            (6) assess the feasibility, cost-effectiveness, and 
        appropriateness of surveillance and screening programs in 
        differing health care and institutional settings, such as 
        schools; and
            (7) evaluate current treatment protocols and make 
        appropriate recommendations on best practices for treating drug 
        resistant infections.
    (e) Coordination.--The sites established under subsection (a) shall 
share data and cooperate with the Centers for Disease Control and 
Prevention and the National Institutes of Health.
    (f) Data Access.--The Director of the Centers for Disease Control 
and Prevention and the Director of the National Institutes of Health 
shall ensure that summary reports of data obtained by the Antimicrobial 
Resistance Surveillance and Research Network sites are made available 
to the Antimicrobial Resistance Task Force and, in a manner consistent 
with section 8 of this Act, with the Public Health Antimicrobial 
Advisory Board and the public, for review on an ongoing basis .

SEC. 6. SUPPLEMENT NOT SUPPLANT.

    Section 319E(f) of the Public Health Service Act (42 U.S.C. 247d-
5(f)) is amended to read as follows:
    ``(f) Supplement Not Supplant.--Funds appropriated under this 
section shall be used to supplement and not supplant other Federal, 
State, and local public funds provided for activities under this 
section, including funds appropriated for the Centers for Disease 
Control and Prevention and the National Institutes of Health.''.

SEC. 7. AUTHORIZATION OF APPROPRIATIONS.

    Section 319E(g) of the Public Health Service Act (42 U.S.C. 247d-
5(g)) is amended to read as follows:
    ``(g) Authorization of Appropriations.--
            ``(1) Authorization.--There are authorized to be 
        appropriated to carry out this section (other than subsection 
        (b)) $45,000,000 for fiscal year 2010, $65,000,000 for fiscal 
        year 2011, and $120,000,000 for fiscal years 2012 through 2014.
            ``(2) Allocation.--Of the amount appropriated to carry out 
        this section for a fiscal year, not less than one-third of such 
        amount shall be made available for activities of the Centers 
        for Disease Control and Prevention under subsections (a)(3)(B) 
        and (c), of which an appropriate amount shall be allocated to 
        educational programs under subsection (c) dedicated to the 
        reduction of inappropriate antimicrobial use.''.

SEC. 8. 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.
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