[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3697 Introduced in House (IH)]







110th CONGRESS
  1st Session
                                H. R. 3697

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 27, 2007

 Mr. Matheson (for himself, Mr. Ferguson, Mr. Waxman, and Ms. Baldwin) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
    To amend the Public Health Service Act 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 of antimicrobials has also correlated with an 
        increased rate in the development 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 antimicrobials are used, whether appropriately 
        or inappropriately, the more this contributes to the 
        development of antimicrobial resistance.
            (3) Scientific evidence suggests that the source of 
        antibiotic resistance in humans is not just limited to use of 
        antibiotics in humans, but may in fact also be passed to humans 
        from food-producing animals which are exposed to antibiotics.
            (4) Today, antimicrobial resistance poses a serious patient 
        safety and public health threat throughout the United States.
            (5) Tuberculosis is emerging as a virulent and growing 
        threat to public health in the United States and throughout the 
        world. Multidrug resistant tuberculosis (MDR-TB) was first 
        documented in the early 1990s, and by 2004 there were 
        approximately 424,000 new cases. Extensively drug resistant 
        tuberculosis (XDR-TB) emerged in 2005 and has been called 
        ``virtually untreatable'' by the World Health Organization 
        because this strain is resistant to nearly every approved 
        tuberculosis drug.
            (6) Nearly 70 percent of all hospital-acquired bacterial 
        infections in the United States are resistant to at least one 
        drug, and in some cases the situation is much worse. According 
        to the Centers for Disease Control and Prevention, almost half 
        of the identified methicillin-resistant Staphylococcus aureus 
        (MRSA) strains in hospitals are resistant to all but a few 
        antibiotics.
            (7) Each year, nearly 2,000,000 people contract bacterial 
        infections in hospitals, and approximately 90,000 of these 
        people die from these infections -- 7 times more than a decade 
        earlier.
            (8) The costs of antibiotic-resistant bacterial diseases 
        are hard to quantify, but a 1995 report by the Office of 
        Technology Assessment of Congress, which looked at 6 different 
        antibiotic-resistant strains of bacteria, calculated that the 
        minimum nationwide hospital costs of just these strains of 
        bacteria accounted for $1,300,000,000 annually (1992 dollars).
            (9) A 1989-published study has estimated that the total 
        societal cost of all antibiotic-resistant bacteria was up to 
        $30,000,000,000 annually.
            (10) The cost to society of antimicrobial-resistant 
        infections will only rise as antimicrobial resistance continues 
        to spread.
            (11) The Federal interagency Task Force on Antimicrobial 
        Resistance was established in 1999, but the authorization of 
        appropriations for the Task Force expired in 2006 and should be 
        reauthorized to enable the continuation of the important 
        coordinated Federal interagency effort to combat the adverse 
        impacts of antimicrobial resistance on human health.
            (12) The Congress should strengthen the Task Force and give 
        it the tools necessary to carry out the Public Health Action 
        Plan to Combat Antimicrobial Resistance.

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: ``Office of 
                Antimicrobial Resistance, Task Force, and Advisory 
                Board'';
                    (B) in paragraph (1)--
                            (i) by striking ``as of the date of the 
                        enactment of this section'' and inserting 
                        ``September 30, 2006''; and
                            (ii) by adding at the end the following: 
                        ``The Secretary shall, not later than the end 
                        of the calendar year 2008, establish an Office 
                        of Antimicrobial Resistance in the Office of 
                        the Assistant Secretary for Health and appoint 
                        a director to that Office. The Secretary shall, 
                        not later than the end of the calendar year 
                        2008, establish the Public Health Antimicrobial 
                        Advisory Board as a permanent advisory board to 
                        the Director of the Office of Antimicrobial 
                        Resistance. The Director of the Office of 
                        Antimicrobial Resistance shall serve as the 
                        Director of the task force and supervise the 
                        activities and budgetary allocations of the 
                        Office, task force, and 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 the following members:
                            ``(i) The Director of the Office of 
                        Antimicrobial Resistance.
                            ``(ii) Representatives of such Federal 
                        agencies as the Secretary determines necessary, 
                        including at a minimum representatives of the 
                        following:
                                    ``(I) The Centers for Disease 
                                Control and Prevention.
                                    ``(II) The Food and Drug 
                                Administration.
                                    ``(III) The National Institutes of 
                                Health.
                                    ``(IV) The Agency for Healthcare 
                                Research and Quality.
                                    ``(V) The Centers for Medicare & 
                                Medicaid Services.
                                    ``(VI) The Health Resources and 
                                Services Administration.
                                    ``(VII) The Department of 
                                Agriculture.
                                    ``(VIII) The Department of Defense.
                                    ``(IX) The Department of Veterans 
                                Affairs.
                                    ``(X) The Environmental Protection 
                                Agency.
                    ``(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 
                        representatives of the infectious diseases, 
                        medical (including hospital and community-based 
                        physicians), public health, veterinary, 
                        research, and international health communities.
                            ``(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 1 year; 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 to lead and supervise the 
                        activities of the advisory board.'';
                    (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 Office of Antimicrobial Resistance 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) Office of antimicrobial resistance duties.--
                The Director of the Office of Antimicrobial Resistance, 
                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 
                biennial updates thereafter. The updates shall include 
                enhanced plans for addressing resistance in the United 
                States and internationally. The Director of the Office 
                shall establish and maintain a website for posting 
                these updates as well as summaries of all non-
                proprietary data made available to the task force. The 
                Director of the Office of Antimicrobial Resistance 
                shall, as appropriate--
                            ``(i) establish milestones 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 antimicrobials 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 the Food and 
                        Drug Administration's Critical Path Initiative; 
                        and
                            ``(vii) recommend how best to strengthen 
                        and link antimicrobial resistance-related 
                        surveillance and prevention and control 
                        activities.
                    ``(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 less than twice a 
                        year, to consider issues relating to 
                        antimicrobial resistance.
                            ``(ii) Public health action plan.--At least 
                        twice a year, the task force 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 on emerging 
                                antimicrobial resistance related to 
                                clinical outcomes in terms of how 
                                patients function, feel, or survive as 
                                well as data related to how 
                                antimicrobials may have been used 
                                inappropriately, obtained by government 
                                agencies including the Centers for 
                                Disease Control and Prevention, the 
                                Food and Drug Administration, the 
                                Department of Defense, the Department 
                                of Veterans Affairs, the Centers for 
                                Medicare & Medicaid Services, and as 
                                possible from private sources;
                                    ``(III) surveillance data and 
                                prevention and control activities 
                                regarding emerging antimicrobial 
                                resistance from reliable sources, 
                                including such data obtained by 
                                government agencies such as 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 possible from 
                                private sources and international 
                                bodies;
                                    ``(IV) data on the amount of 
                                antimicrobials used in humans, animals, 
                                and plants from reliable sources, 
                                including such data obtained by 
                                government agencies such as 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, and the Department of 
                                Agriculture, and as possible 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 the National Institutes 
                                of Health, the Centers for Disease 
                                Control and Prevention, the Department 
                                of Veterans Affairs, the Department of 
                                Defense, the Environmental Protection 
                                Agency, and the Department of 
                                Agriculture, 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 
                                antimicrobials; and
                                    ``(IX) other data and issues the 
                                task force identifies as relevant to 
                                the issue of antimicrobial resistance.
                            ``(iii) Pending applications.--The task 
                        force shall meet as necessary to provide input 
                        to the Secretary relevant to the pending 
                        application of any antimicrobial drug 
                        application submitted to the Secretary under 
                        the Federal Food, Drug, and Cosmetic Act or the 
                        Public Health Service Act, including to provide 
                        the Secretary with recommendations regarding--
                                    ``(I) the potential impact of the 
                                approval of the drug on antimicrobial 
                                resistance and any potential benefits 
                                of the approval as measured by 
                                substantial evidence from adequate and 
                                well-controlled trials; and
                                    ``(II) suggestions for 
                                antimicrobial management strategies 
                                that could increase appropriate use and 
                                mitigate unnecessary increases in 
                                antimicrobial resistance predicted to 
                                result from approval of the drug 
                                application.
                    ``(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, 
                        but not less than 2 times each year.
                            ``(ii) Recommendations.--The Public Health 
                        Antimicrobial Advisory Board shall make 
                        recommendations to the Secretary, and the 
                        Office of Antimicrobial Resistance, 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) the establishment of uniform 
                                mechanisms and data sets for the 
                                reporting of resistance data;
                                    ``(V) the adequacy of existing 
                                surveillance systems to collect 
                                antimicrobial resistance and other 
                                infectious disease data, how best to 
                                improve the collection, reporting, and 
                                analysis of such data to help direct 
                                prevention, control, and research 
                                initiatives;
                                    ``(VI) 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 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 Office of 
                Antimicrobial Resistance shall ensure that all 
                information made available to the public on the website 
                described in subparagraph (A) shall be made public only 
                to the extent not inconsistent with national security 
                concerns and respectful of confidential business 
                information.'';
            (2) by amending subsection (b) to read as follows:
    ``(b) Antimicrobial Resistance Research and Product Development.--
The Secretary, acting through the Director of the Office of 
Antimicrobial Resistance, 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, shall develop 
an antimicrobial resistance strategic research plan that strengthens 
existing epidemiological, interventional, clinical, translational, and 
basic research efforts and funds directly or through the awards of 
grants or cooperative agreements to public or private entities the 
conduct of research, investigations, experiments, demonstrations, and 
studies that advance 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 antibiotic pressure for 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 
        antimicrobials;
            ``(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, the diagnosis, the 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 diseases 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 advisory board), in collaboration with the 
        Department of Defense and the Joint Genome Institute of the 
        Department of Energy.
To the extent practical, such research shall be conducted in 
conjunction with the Antimicrobial Resistance Clinical Research and 
Public Health Network.'';
            (3) in subsection (c)--
                    (A) by inserting ``acting through the Director of 
                the Office of Antimicrobial Resistance'' after ``The 
                Secretary,''; and
                    (B) by striking ``members of the task force 
                described in subsection (a) of this section,'';
            (4) in subsection (d)(1), by inserting ``, through the 
        Office of Antimicrobial Resistance,'' after ``The Secretary'';
            (5) in subsection (e)--
                    (A) in paragraph (1), by inserting ``, acting 
                through the Director of the Office of Antimicrobial 
                Resistance,'' after ``The Secretary''; and
                    (B) in paragraph (3), by inserting ``, acting 
                through the Office of Antimicrobial Resistance,'' after 
                ``The Secretary''; and
            (6) by amending subsection (g) to read as follows:
    ``(g) Authorization of Appropriations.--
            ``(1) Authorization.--There are authorized to be 
        appropriated to carry out this section $45,000,000 for fiscal 
        year 2008, $65,000,000 for fiscal year 2009, $120,000,000 for 
        fiscal year 2010, and such sums as may be necessary for each 
        subsequent fiscal year.
            ``(2) Allocation.--Of the amount appropriated to carry out 
        this section for a fiscal year, not less than $15,000,000 shall 
        be made available for activities of the Centers for Disease 
        Control and Prevention under subsections (a)(3)(B) and (c), of 
        which at least $5,000,000 shall be made available for the 
        Centers for Disease Control and Prevention educational programs 
        dedicated to the reduction of inappropriate antimicrobial use.
            ``(3) Ratable reduction.--If amounts appropriated under 
        paragraph (1) for any fiscal year are less than the amounts 
        required to comply with paragraph (2), the Secretary shall 
        ratably reduce the amounts to be made available under paragraph 
        (2) accordingly.''.
    (b) Ensure Access to Antimicrobial Data and Research.--The heads of 
government departments and agencies, including the Secretary of Health 
and Human Services, the Under Secretary for Health of the Department of 
Veterans Affairs, the Secretary of Defense, the Secretary of 
Agriculture, the Administrator of the Environmental Protection Agency, 
the Administrator of the Centers for Medicare & Medicaid Services, the 
Director of the Centers for Disease Control and Prevention, the 
Director of the National Institutes of Health, and the Commissioner of 
Food and Drugs, shall work with the Director of the Office of 
Antimicrobial Resistance and the Antimicrobial Resistance Task Force to 
identify relevant data and formats, and mechanisms for communicating 
these data to the Office of Antimicrobial Resistance, the Antimicrobial 
Resistance Task Force, and the Public Health Antimicrobial Advisory 
Board, including relevant data obtained by the agencies through 
contracts with other organizations, including--
            (1) use and clinical outcomes data on patients receiving 
        antimicrobial agents for the treatment, prevention, or 
        diagnosis of infection or infectious diseases;
            (2) surveillance data regarding emerging antimicrobial 
        resistance;
            (3) susceptibility data related to antimicrobial drug use;
            (4) data related to the amount of antimicrobials 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 prescribing practices.
In a manner not inconsistent with national security, summaries of such 
data (excluding any proprietary data) shall be made available to the 
public 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)).
    (c) Consultation Before Drug Approval.--At least 90 days prior to 
granting approval to any antimicrobial drug application under the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the 
Public Health Service Act (42 U.S.C. 201 et seq.), the Secretary of 
Health and Human Services shall consult with the Antimicrobial 
Resistance Task Force regarding antimicrobial resistance issues 
associated with the drug for which the application was submitted, 
including the potential emergence of antimicrobial resistance.
    (d) Relevant Portions of Pending Applications.--The Secretary of 
Health and Human Services shall make relevant portions of pending 
antimicrobial drug applications submitted under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service 
Act (42 U.S.C. 201 et seq.) available to the Antimicrobial Resistance 
Task Force for the purposes of this Act and the amendments made by this 
Act.
    (e) Improper Disclosure of Proprietary Data.--The Secretary of 
Health and Human Services shall take appropriate steps to prevent the 
improper disclosure of proprietary data by the Antimicrobial Resistance 
Task Force, the Public Health Antimicrobial Advisory Board, or any of 
their members.

SEC. 4. COLLECTION OF ANTIMICROBIAL DRUG DATA.

    (a) Collection of Antimicrobial Product Amount Data.--
            (1) Human antimicrobial use reports.--Notwithstanding any 
        other provision of law, starting in 2008 each sponsor of an 
        antimicrobial drug product subject to section 505 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) which is 
        sold or distributed in the United States shall, by March 31 of 
        each calendar year, submit to the Office of Antimicrobial 
        Resistance the amount of the antimicrobial drug product sold or 
        distributed in the United States from January 1 to December 31 
        of the preceding calendar year to support epidemiologic and 
        microbiologic research on the impact of antimicrobial drug use 
        and resistance development. To ensure uniform reporting 
        standards, the Director of the Office of Antimicrobial 
        Resistance shall establish the specific content and format of 
        antimicrobial use data submissions.
            (2) Animal antimicrobial use report.--Notwithstanding any 
        other provision of law, starting in 2008 each sponsor of an 
        antimicrobial drug product subject to section 512 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b) which is 
        sold or distributed in the United States shall, by March 31 of 
        each calendar year, submit to the Office of Antimicrobial 
        Resistance the amount of the antimicrobial drug product sold or 
        distributed in the United States from January 1 to December 31 
        of the preceding calendar year to support epidemiologic and 
        microbiologic research on the impact of antimicrobial drug use 
        in food-producing animals and resistance development. The data 
        shall be reported as follows:
                    (A) By volume separately for use in poultry, 
                cattle, aquaculture, and swine.
                    (B) By total volume sold for use in all food-
                producing animals.
                    (C) Whatever additional standard criteria for 
                reporting the Director of the Office of Antimicrobial 
                Resistance may establish.
            (3) Public availability of summaries.--The Director of the 
        Office of Antimicrobial Resistance shall make summaries of the 
        data received under paragraphs (1) and (2) publicly available 
        and ensure that such summaries are updated and published, in a 
        manner not inconsistent with national security and respectful 
        of confidential business information, 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 on the impact 
        on human health of antimicrobial drug use in humans and food-
        producing animals.
    (b) Collection of Antimicrobial Prescription Data.--
            (1) Clinical outcomes data.--The Under Secretary for Health 
        of the Department of Veterans Affairs and the Administrator of 
        the Centers for Medicare & Medicaid Services shall, as 
        determined to be relevant by the Director of the Office of 
        Antimicrobial Resistance, collect drug utilization data and 
        clinical outcomes data on patients within the Department of 
        Veterans Affairs and the Medicare and Medicaid service systems, 
        respectively, who are receiving prescription antimicrobial 
        agents for the treatment, prevention, or diagnosis of infection 
        or infectious diseases.
            (2) Organization.--The 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; and
                    (F) geographic region.
            (3) Comprehensive annual reports.--The Under Secretary for 
        Health of the Department of Veterans Affairs and the 
        Administrator of the Centers for Medicare & Medicaid Services 
        shall submit comprehensive annual reports on such data, to be 
        developed in coordination with the Director of the Centers for 
        Disease Control and Prevention, to the Director of the Office 
        of Antimicrobial Resistance. Such reports shall identify, where 
        appropriate, interventions to prevent and control the 
        development of antimicrobial resistance and may include an 
        analysis of the following:
                    (A) Intra- and extra-label antimicrobial use.
                    (B) Where challenges to appropriate use remain.
                    (C) Trends and variations in rates of antimicrobial 
                resistance.
                    (D) The relationship between drug use and 
                resistance.
            (4) Data review.--The Under Secretary for Health of the 
        Department of Veterans Affairs and the Administrator of the 
        Centers for Medicare & Medicaid Services shall ensure that all 
        of the data collected under paragraph (1), including all such 
        data obtained through contracts with other organizations, are 
        made accessible to the Office of Antimicrobial Resistance for 
        review on an ongoing basis.
            (5) Public availability of reports.--The Director of the 
        Office of Antimicrobial Resistance shall make the reports 
        received under paragraph (3) publicly available and ensure that 
        it is updated and published, in a manner not inconsistent with 
        national security, 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)).

SEC. 5. ANTIMICROBIAL RESISTANCE CLINICAL RESEARCH AND PUBLIC HEALTH 
              NETWORK.

    (a) In General.--The Secretary, through the Directors of the 
Centers for Disease Control and Prevention and the National Institutes 
of Health, shall establish at least 10 Antimicrobial Resistance 
Clinical Research and Public Health Network sites to strengthen the 
national capacity to do the following:
            (1) Describe and confirm regional outbreaks through 
        surveillance of locally available clinical specimens.
            (2) Rapidly assess, integrate, and address local and 
        national antimicrobial resistance patterns.
            (3) Facilitate research concerning prevention, control, and 
        treatment of resistant organisms.
            (4) Serve as a clinical trials network for optimizing 
        antimicrobial effectiveness.
    (b) Geographic Distribution.--The sites established under 
subsection (a) shall be geographically distributed across the United 
States, based in academic centers, health departments, and existing 
surveillance sites.
    (c) Responsibilities.--The persons employed at the sites 
established under subsection (a) shall--
            (1) monitor the emergence and changes in the patterns of 
        antimicrobial resistant pathogens in people;
            (2) study the molecular epidemiology of these 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; and
            (6) conduct basic antimicrobial resistance-related 
        research.
    (d) Coordination.--These sites established under subsection (a) 
shall be authorized to share data and cooperate with the Centers for 
Disease Control and Prevention and the National Institutes of Health.
    (e) Data Access.--The Directors of the Centers for Disease Control 
and Prevention and the National Institutes of Health shall ensure that 
summary reports of data obtained by the Antimicrobial Resistance 
Clinical Research and Public Health Network sites are made accessible 
to the Antimicrobial Task Force for review on an ongoing basis.

SEC. 6. ANTIMICROBIAL RESISTANCE QUALITY MEASURES DEMONSTRATION 
              PROJECTS.

    Under section 319E(e) of the Public Health Service Act (42 U.S.C. 
247d-5(e)), the Secretary of Health and Human Services, acting through 
the Director of the Office of Antimicrobial Resistance, shall award 
competitive grants to eligible entities 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 acute bacterial otitis media and upper 
respiratory infections, and in particular acute exacerbation of chronic 
bronchitis. One goal of the demonstration projects shall be the 
validation of models that may lead to the development of quality 
measures for health care providers prescribing antimicrobials. These 
demonstration programs shall be developed and implemented through the 
direction of the Centers for Disease Control and Prevention educational 
programs dedicated to the reduction of inappropriate antimicrobial use.

SEC. 7. GAO REPORT.

    Not later than January 1, 2012, the Comptroller General of the 
United States shall submit a report to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives that examines 
whether and how this Act has affected the ability to monitor, prevent 
the spread of, and otherwise limit the impact of antimicrobial 
resistance on human health. The report shall include any 
recommendations of the Comptroller General for modifying this Act.
                                 <all>