[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 2313 Introduced in Senate (IS)]







110th CONGRESS
  1st Session
                                S. 2313

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            November 6, 2007

 Mr. Brown (for himself and Mr. Hatch) 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.

    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 source of 
        antimicrobial resistance in humans is not just limited to use 
        of antimicrobial drugs in humans, but may in fact also be from 
        food-producing animals which are exposed to antimicrobial 
        drugs.
            (4) 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.
            (5) Each year, nearly 2,000,000 people contract bacterial 
        infections in hospitals and approximately 90,000 of these 
        people die from these infections.
            (6) The costs of antimicrobial-resistant bacterial diseases 
        are hard to quantify, but a 1995 report by the Office of 
        Technology Assessment of and 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).
            (7) The cost to society of antimicrobial-resistant 
        infections 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: ``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 1 year 
                        after the date of enactment of the Strategies 
                        to Address Antimicrobial Resistance Act, 
                        establish an Office of Antimicrobial Resistance 
                        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 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 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 representatives of such Federal agencies 
                as the Secretary determines necessary, including 
                representation of the following:
                            ``(i) The Office of Antimicrobial 
                        Resistance.
                            ``(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.
                    ``(B) Members of the public health antimicrobial 
                advisory board.--
                            ``(i) In general.--The Public Health 
                        Antimicrobial Advisory Board shall be composed 
                        of 13 voting members, appointed by the 
                        Secretary. Such members shall include experts 
                        from the medical professions (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 13 members first 
                        appointed--
                                    ``(I) 4 shall be appointed for a 
                                term of 12 months; and
                                    ``(II) 4 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.'';
                    (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 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 Office of 
                Antimicrobial Resistance shall, as appropriate--
                            ``(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 the Food and 
                        Drug Administration'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 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 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) 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;
                                    ``(VI) 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;
                                    ``(VII) health plan employer data 
                                and information set (HEDIS) measures 
                                pertaining to appropriate use of 
                                antimicrobial drugs; and
                                    ``(VIII) other data and issues the 
                                task force identifies as relevant to 
                                the issue of antimicrobial resistance.
                            ``(iii) Pending applications.--The Food and 
                        Drug Administration may consult with the 
                        Director of the Office of Antimicrobial 
                        Resistance 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, 
                        but not fewer 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) incentives necessary to 
                                establish uniform mechanisms and data 
                                sets for State 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 Office of 
                Antimicrobial Resistance shall ensure that all 
                information shall be made available to the public on 
                the website described in subparagraph (A) consistent 
                with section 7 of the Strategies to Address 
                Antimicrobial Resistance Act.'';
            (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, 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 advisory board), in collaboration with the 
        Department of Defense and the Joint Genome Institute of the 
        Department of Energy.''; and
            (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),'';
            (4) in subsection (d)(1), by inserting ``, through the 
        Office of Antimicrobial Resistance,'' after ``The Secretary''; 
        and
            (5) in subsection (e)--
                    (A) in paragraph (1), by inserting ``, acting 
                through the Director of the Office of Antimicrobial 
                Resistance,'' after ``The Secretary'';
                    (B) in paragraph (3), by inserting ``, acting 
                through the Office of Antimicrobial Resistance,'' 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 acute bacterial 
        otitis media and upper respiratory infections, and in 
        particular acute exacerbation of chronic bronchitis, 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 Office of Antimicrobial Resistance 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 Office of Antimicrobial Resistance and the Antimicrobial 
Resistance Task Force, 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 human drug distribution data required to 
be submitted for each calendar year under section 314.81(b)(ii) of 
title 21, Code of Federal Regulations (or any successor regulation) and 
the animal drug distribution data required to be submitted for each 
such calendar year under section 514.80(b)(4)(i) of title 21, Code of 
Federal Regulations (or any successor regulation) be--
            ``(1) submitted not later than 60 days after the beginning 
        of the subsequent calendar year; and
            ``(2) made available to the Office of Antimicrobial 
        Resistance, the Antimicrobial Resistance Task Force, and the 
        Public Health Antimicrobial Advisory Board.
    ``(b) Confidentiality.--The Office of Antimicrobial Resistance, the 
Antimicrobial Resistance Task Force, and the Public Health 
Antimicrobial Advisory Board shall sign a confidentiality agreement to 
protect proprietary information made available under subsection 
(a)(2).''.
    (b) Comparable Data.--
            (1) In general.--The Secretary, acting through the Director 
        of the Office of Antimicrobial Resistance, shall explore 
        opportunities to secure from private vendors 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 Office of 
        Antimicrobial Resistance may enter into negotiations with 
        private vendors to determine acceptable formats for making 
        summaries of antimicrobial drug consumption data that is 
        collected under this section publicly available for research 
        purposes while maintaining the confidentiality of any 
        proprietary commercial data.
            (3) Other means to secure data.--If the Director of the 
        Office of Antimicrobial Resistance is not able to secure 
        sufficient supplemental antimicrobial drug consumption data for 
        human and animal uses through private vendors 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 and make such data available to the public consistent 
        with section 7.
    (c) Collection of Antimicrobial Prescription Data.--
            (1) Clinical outcomes data.--The Director of the Office of 
        Antimicrobial Resistance shall work with the Under Secretary 
        for Health of the Department of Veterans Affairs and the 
        Administrator of the Centers for Medicare & Medicaid Services 
        to collect relevant drug utilization data and clinical outcomes 
        data, as determined relevant by the Director of the Office of 
        Antimicrobial Resistance, on patients who receive services 
        funded by such agencies and who are receiving prescription 
        antimicrobial agents for the treatment, prevention, or 
        diagnosis 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.
    (d) Public Availability of Summaries.--The Director of the Office 
of Antimicrobial Resistance shall make summaries of the data received 
under this section publicly available by antimicrobial drug class and 
ensure that such summaries are updated and published, in a manner 
consistent with section 7, 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. In the case of an antimicrobial drug class 
where only one antimicrobial drug has been approved, such summary data 
shall not be made public.

SEC. 5. ANTIMICROBIAL RESISTANCE CLINICAL RESEARCH AND PUBLIC HEALTH 
              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 Clinical Research and Public Health 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, based in academic centers, health departments, and existing 
surveillance sites.
    (c) Responsibilities.--The 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.
    (d) Coordination.--The sites established under subsection (a) may 
share data and cooperate with the Centers for Disease Control and 
Prevention and the National Institutes of Health.
    (e) 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 Clinical Research and Public Health Network sites are made 
accessible to the Antimicrobial Task Force for review on an ongoing 
basis.

SEC. 6. 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 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 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 at least one-third of such amount shall be 
        made available for the Centers for Disease Control and 
        Prevention educational programs dedicated to the reduction of 
        inappropriate antimicrobial use.''.

SEC. 7. 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.
                                 <all>