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Q: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Oceans Act of 1998''.

SEC. 2. DEFINITIONS.

    As used in this Act:
            (1) Commission.--The term ``Commission'' means the 
        Commission on Ocean Policy established under section 4.
            (2) Coastal state.--The term ``coastal State'' means a 
        State in, or bordering on, the Atlantic, Pacific, or Arctic 
        Ocean, the Gulf of Mexico, Long Island Sound, or one or more of 
        the Great Lakes.
            (3) Marine environment.--The term ``marine environment'' 
        includes--
                    (A) the oceans, including coastal and offshore 
                waters and nearshore saltwater estuaries;
                    (B) the continental shelf; and
                    (C) the Great Lakes.
            (4) Ocean and coastal activities.--The term ``ocean and 
        coastal activities'' includes activities consisting of, 
        affecting, or otherwise related to oceanography, fisheries, or 
        the management or use of any ocean and coastal resource. The 
        term does not include military operations and training.
            (5) Ocean and coastal resource.--The term ``ocean and 
        coastal resource'' means any living or nonliving natural, 
        historic, or cultural resource or mineral found in the marine 
        environment.
            (6) State.--The term ``State'' means any State of the 
        United States, the District of Columbia, the Commonwealth of 
        Puerto Rico, the Virgin Islands, Guam, American Samoa, the 
        Commonwealth of the Northern Mariana Islands, and any other 
        territory or possession of the United States.

SEC. 3. EXECUTIVE RESPONSIBILITIES.

    (a) National Ocean and Coastal Policy.--The Congress and the 
President, after receiving and considering the report of the Commission 
under section 4, shall develop and propose a coordinated, 
comprehensive, and long-range national policy for the responsible use 
and stewardship of ocean and coastal resources for the benefit of the 
United States, including a plan to meet the resource monitoring and 
assessment facilities and equipment requirements of Federal ocean and 
coastal programs.
    (b) Biennial Report.--Beginning in January 1999, the President 
shall transmit to the Congress biennially a report that shall include a 
detailed listing of all existing Federal programs relating to ocean and 
coastal activities, including a description of each program, the 
current funding for the program, and a projection of the funding level 
for the program for each of the following 5 fiscal years.
    (c) Budget Coordination.--Each agency or department involved in 
ocean and coastal activities shall include with its annual request for 
appropriations a report that identifies significant elements of the 
proposed agency or department budget relating to ocean and coastal 
activities.
    (d) Cooperation and Consultation.--In carrying out responsibilities 
under this Act, the President--
            (1) may use such staff, interagency, and advisory 
        arrangements as the President finds necessary and appropriate; 
        and
            (2) shall consult with State and local governments and non-
        Federal organizations and individuals involved in ocean and 
        coastal activities.

SEC. 4. COMMISSION ON OCEAN POLICY.

    (a) Establishment.--
            (1) In general.--There is hereby established the Commission 
        on Ocean Policy.
            (2) Membership.--(A) The Commission shall be composed of 16 
        members appointed by the President from among individuals who 
        are knowledgeable in ocean and coastal activities, including 
        individuals representing State and local governments, ocean-
        related industries, academic and technical institutions, and 
        public interest organizations involved with scientific, 
        regulatory, economic, and environmental ocean and coastal 
        activities. The membership of the Commission shall be balanced 
        geographically to the extent consistent with maintaining the 
        highest level of expertise on the Commission.
            (B) Of the members of the Commission appointed under this 
        paragraph--
                    (i) 4 shall be appointed from a list of 8 
                individuals who shall be recommended by the majority 
                leader of the Senate in consultation with the Chairman 
                of the Senate Committee on Commerce, Science, and 
                Transportation;
                    (ii) 4 shall be appointed from a list of 8 
                individuals who shall be recommended by the Speaker of 
                the House of Representatives in consultation with the 
                Chairmen of the Committee on Resources, Transportation 
                and Infrastructure, and Science;
                    (iii) 2 shall be appointed from a list of 4 
                individuals who shall be recommended by the minority 
                leader of the Senate in consultation with the ranking 
                member of the Senate Committee on Commerce, Science, 
                and Transportation; and
                    (iv) 2 shall be appointed from a list of 4 
                individuals who shall be recommended by the by the 
                minority leader of the House of Representatives in 
                consultation with the ranking members of the Committees 
                on Resources, Transportation and Infrastructure, and 
                Science.
            (C) The members of the Commission shall be appointed for 
        the life of the Commission by not later than 90 days after the 
        date of the enactment of this Act.
            (3) First meeting.--The Commission shall hold its first 
        meeting within 30 days after it is established.
            (4) Chairman.--The Commission shall elect one of its 
        members as Chair.
    (b) Report.--
            (1) In general.--The Commission shall submit to the 
        Congress and the President, by not later than 18 months after 
        the date of the establishment of the Commission, a final report 
        of its findings and recommendations regarding United States 
        ocean policy.
            (2) Public and state review.--Before submitting the final 
        report to the Congress, the Commission shall--
                    (A) publish in the Federal Register a notice that 
                the draft report is available for public review; and
                    (B) provide a copy of the draft report to the 
                Governor of each coastal State, the Committees on 
                Resources, Transportation and Infrastructure, and 
                Science of the House of Representatives, and the 
                Committee on Commerce, Science, and Transportation of 
                the Senate.
            (3) Final report contents, generally.--Subject to paragraph 
        (4), the final report of the Commission shall include 
        recommendations for the responsible use and stewardship of 
        ocean and coastal resources, including the following:
                    (A) Recommendations for any modifications to United 
                States laws and regulations, and the administrative 
                structure of the Executive agencies, that are necessary 
                to improve the understanding, management, and 
                conservation and use of, and access to, ocean and 
                coastal resources.
                    (B) An assessment of the condition and adequacy of 
                existing and planned facilities associated with ocean 
                and coastal activities, including human resources, 
                vessels, computers, satellites, and other appropriate 
                platforms and technologies, and recommendations for 
                investments and improvements in those facilities.
                    (C) A review of existing and planned ocean and 
                coastal activities of Federal entities, and 
                recommendations for changes in such activities 
                necessary to reduce duplication of Federal efforts.
                    (D) A review of the cumulative effect of Federal 
                laws and regulations on United States ocean policy, an 
                examination of those laws and regulations for 
                inconsistencies and contradictions that might adversely 
                affect the conduct of ocean and coastal activities, and 
                recommendations for resolving any such inconsistencies. 
                In particular, this portion of the report shall include 
                an examination of the relationship between the 
                fisheries development and fisheries conservation 
                responsibilities of the National Marine Fisheries 
                Service.
                    (E) A review of the known and anticipated supply of 
                and demand for ocean and coastal resources of the 
                United States.
                    (F) A review of the relationship between Federal, 
                State, and local governments and the private sector in 
                planning and carrying out ocean and coastal activities, 
                and recommendations for enhancing the role of State and 
                local governments.
                    (G) A review of opportunities for the development 
                of or investment in new products, technologies, or 
                markets related to ocean and coastal activities.
                    (H) A review of previous and ongoing State efforts 
                and Federal efforts to enhance the effectiveness and 
                integration of ocean activities, including those 
                occurring offshore and in nearshore saltwater 
                estuaries.
            (4) State comments.--The Commission shall include in the 
        final report comments received from the Governor of any coastal 
        State regarding recommendations in the draft report that apply 
        to areas within the boundaries of that coastal State.
            (5) Consideration of factors.--In making its assessments 
        and reviews and developing its recommendations, the Commission 
        shall give full and balanced consideration to environmental, 
        technical, economic, and other relevant factors, with an equal 
        opportunity for all parties to present a fair and reasonable 
        case for unbiased consideration by the Commission. All 
        recommendations should consider effects on private property. To 
        the greatest extent possible, no recommendations shall have a 
        negative impact on local economies that are dependent on ocean 
        and coastal resources. Any data used by the Commission in 
        making its recommendations for regulations shall be peer 
        reviewed.
            (6) Limitation on recommendations.--The Commission shall 
        not make any specific recommendations with respect to lands and 
        waters within the boundary of any State located north of 51 
        degrees North latitude, or with respect to lands and waters 
        within the State of Idaho.
    (c) Duties of the Chair.--In carrying out the provisions of this 
section, the Chair of the Commission shall be responsible for--
            (1) the assignment of duties and responsibilities among 
        staff personnel and their continuing supervision; and
            (2) the use and expenditures of funds available to the 
        Commission.
    (d) Compensation.--Members of the Commission shall, subject to the 
availability of appropriations, when engaged in the actual performance 
of duties of the Commission, receive reimbursement of travel expenses, 
including per diem in lieu of subsistence as authorized for persons 
employed intermittently in the Government service under section 3109 of 
title 5, United States Code.
    (e) Staff.--
            (1) Executive director.--The Chair of the Commission may, 
        with the consent of the Commission and without regard to the 
        civil service laws and regulations, appoint and terminate an 
        executive director who is knowledgeable in administrative 
        management and ocean and coastal policy and such other 
        additional personnel as may be necessary to enable the 
        Commission to perform its duties.
            (2) Compensation.--The executive director shall, subject to 
        the availability of appropriations, be compensated at a rate 
        not to exceed the rate payable for Level V of the Executive 
        Schedule under section 5316 of title 5, United States Code. The 
        Chairman may fix the compensation of other personnel without 
        regard to the provisions of chapter 51 and subchapter III of 
        chapter 53 of title 5, United States Code, relating to 
        classification of positions and General Schedule pay rates, 
        except that the rate of pay for such personnel may not exceed 
        the rate payable for GS-15, step 7, of the General Schedule 
        under section 5332 of such title.
            (3) Detailees.--Upon a request of the Chair of the 
        Commission made after consulting with the head of any Federal 
        agencies responsible for managing ocean and coastal resources, 
        the head of any such Federal agency may detail appropriate 
        personnel of the agency to the Commission to assist the 
        Commission in carrying out its functions under this Act. 
        Federal Government employees detailed to the Commission shall 
        serve without reimbursement from the Commission, and shall 
        retain the rights, status, and privileges of his or her regular 
        employment without interruption.
            (4) Experts and consultants.--To the extent that funds are 
        available, and subject to such rules as may be prescribed by 
        the Commission, the executive director of the Commission may 
        procure the temporary and intermittent services of experts and 
        consultants in accordance with section 3109 of title 5, United 
        States Code, but at rates not to exceed the daily rate payable 
        for GS-15, step 7, of the General Schedule under section 5332 
        of title 5, United States Code.
    (f) Administration.--
            (1) Meetings.--All meetings of the Commission shall be open 
        to the public, except that a meeting or any portion of it may 
        be closed to the public if it concerns matters or information 
        described in section 552b(c) of title 5, United States Code. 
        Interested persons shall be permitted to appear at open 
        meetings and present written statements or oral statements at 
        the discretion of the Commission on the subject matter of the 
        meeting. The Commission may administer oaths or affirmations to 
        any person appearing before it.
            (2) Notice of meetings.--All open meetings of the 
        Commission shall be preceded by timely public notice, including 
        notice in the Federal Register, of the time, place, and subject 
        of the meeting.
            (3) Minutes and other records.--(A) Minutes of each meeting 
        shall be kept and shall contain a record of the people present, 
        a description of the discussion that occurred, and copies of 
        all statements filed. Subject to restrictions set forth in 
        section 552 of title 5, United States Code, the minutes and 
        records of all meetings and other documents that were made 
        available to or prepared for the Commission shall be available 
        for public inspection and copying at a single location in the 
        offices of the Commission.
            (B) The Commission shall have at least one meeting in each 
        of the following 6 geographic regions of the United States:
                    (i) The Northeast.
                    (ii) The Southeast.
                    (iii) The Southwest.
                    (iv) The Northwest.
                    (v) The Great Lakes States.
                    (vi) The Gulf of Mexico States.
    (g) Cooperation With Other Federal Entities.--
            (1) Other federal agencies and departments.--The Commission 
        may secure directly from any Federal agency or department any 
        information it considers necessary to carry out its functions 
        under this Act. Each such agency or department may cooperate 
        with the Commission and, to the extent permitted by law, 
        furnish such information to the Commission, upon the request of 
        the Chair of the Commission.
            (2) Mails.--The Commission may use the United States mails 
        in the same manner and under the same conditions as departments 
        and agencies of the United States.
            (3) Acquisitions.--The Commission may enter into contracts 
        with Federal and State agencies, private firms, institutions, 
        and individuals to assist the Commission in carrying out its 
        duties. The Commission may purchase and contract without regard 
        to section 18 of the Office of Federal Procurement Policy Act 
        (41 U.S.C. 416) and section 8 of the Small Business Act (15 
        U.S.C. 637), pertaining to competition and publication 
        requirements, and may arrange for printing without regard to 
        the provisions of title 44, United States Code. The contracting 
        authority of the Commission under this Act is effective only to 
        the extent that appropriations are available for contracting 
        purposes.
    (h) Termination.--The Commission shall cease to exist 30 days after 
the date on which it submits its final report.
    (i) Authorization of Appropriations.--There are authorized to be 
appropriated to support the activities of the Commission $2,000,000 for 
fiscal year 1999 and $1,000,000 for fiscal year 2000. Any sums 
appropriated may remain available without fiscal year limitation until 
the Commission ceases to exist.

            Passed the House of Representatives September 15, 1998.

            Attest:

                                                                 Clerk.

A: Oceans Act of 1998 - Requires that the Congress and the President, after considering the Commission report under this Act, develop a coordinated, comprehensive, and long-range national policy for the use and stewardship of ocean and coastal resources for the benefit of the United States, including a plan to meet the resource monitoring and assessment facilities and equipment requirements of Federal ocean and coastal programs.  Mandates a biennial report by the President to the Congress listing all existing Federal programs relating to ocean and coastal activities.  Requires each agency or department involved in ocean and coastal activities to include with its annual appropriations request a report identifying elements of its budget relating to ocean and coastal activities. 
Establishes the Commission on Ocean Policy and requires it to report to the Congress and the President regarding U.S. ocean policy. Requires opening the draft report for public comment before submitting the final report.  Prohibits Commission recommendations regarding lands and waters within:  (1) the boundary of any State north of 51 degrees North latitude; or (2) the State of Idaho.  Terminates the Commission after submission of its final report.  Authorizes appropriations.
****
Q: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Preservation of Antibiotics for 
Medical Treatment Act of 2011''.

SEC. 2. FINDINGS.

    The Congress finds the following:
            (1) In January 2001, a Federal interagency task force--
                    (A) released an action plan to address the 
                continuing decline in effectiveness of antibiotics 
                against common bacterial infections, referred to as 
                antibiotic resistance;
                    (B) determined that antibiotic resistance is a 
                growing menace to all people and poses a serious threat 
                to public health; and
                    (C) cautioned that if current trends continue, 
                treatments for common infections will become 
                increasingly limited and expensive, and, in some cases, 
                nonexistent.
            (2) Antibiotic resistance, resulting in a reduced number of 
        effective antibiotics, may significantly impair the ability of 
        the United States to respond to terrorist attacks involving 
        bacterial infections or a large influx of hospitalized 
        patients.
            (3)(A) Any overuse or misuse of antibiotics contributes to 
        the spread of antibiotic resistance, whether in human medicine 
        or in agriculture.
            (B) Recognizing the public health threat caused by 
        antibiotic resistance, Congress took several steps to curb 
        antibiotic overuse in human medicine through amendments to the 
        Public Health Service Act (42 U.S.C. 201 et seq.) made by 
        section 102 of the Public Health Threats and Emergencies Act 
        (Public Law 106-505, title I; 114 Stat. 2315), but has not yet 
        addressed antibiotic overuse in agriculture.
            (4) In a March 2003 report, the National Academy of 
        Sciences stated that--
                    (A) a decrease in antimicrobial use in human 
                medicine alone will have little effect on the current 
                situation; and
                    (B) substantial efforts must be made to decrease 
                inappropriate overuse in animals and agriculture.
            (5) In 2010, the FDA determined that--
                    (A) 13.1 million kilograms of antibacterial drugs 
                were sold for use on food animals in the United States 
                in 2009;
                    (B) 3.3 million kilograms of antibacterial drugs 
                were used for human health in 2009; and
                    (C) therefore, 80 percent of antibacterial drugs 
                disseminated in the United States in 2009 were sold for 
                use on food animals, rather than being used for human 
                health.
            (6)(A) Large-scale, voluntary surveys by the Department of 
        Agriculture's Animal and Plant Health Inspection Service in 
        1999, 2001, and 2006 revealed that--
                    (i) 84 percent of grower-finisher swine farms, 83 
                percent of cattle feedlots, and 84 percent of sheep 
                farms administer antimicrobials in the feed or water 
                for health or growth promotion reasons; and
                    (ii) many of the antimicrobials identified are 
                identical or closely related to drugs used in human 
                medicine, including tetracyclines, macrolides, 
                Bacitracin, penicillins, and sulfonamides; and
            (B) these drugs are used in people to treat serious 
        diseases such as pneumonia, scarlet fever, rheumatic fever, 
        venereal disease, skin infections, and even pandemics like 
        malaria and plague, as well as bioterrorism agents like 
        smallpox and anthrax.
            (7) Many scientific studies confirm that the nontherapeutic 
        use of antibiotics in agricultural animals contributes to the 
        development of antibiotic-resistant bacterial infections in 
        people.
            (8) The periodical entitled ``Clinical Infectious 
        Diseases'' published a report in June 2002, that--
                    (A) was based on a 2-year review by experts in 
                human and veterinary medicine, public health, 
                microbiology, biostatistics, and risk analysis, of more 
                than 500 scientific studies on the human health impacts 
                of antimicrobial use in agriculture; and
                    (B) recommended that antimicrobial agents should no 
                longer be used in agriculture in the absence of 
                disease, but should be limited to therapy for diseased 
                individual animals and prophylaxis when disease is 
                documented in a herd or flock.
            (9) The United States Geological Survey reported in March 
        2002 that--
                    (A) antibiotics were present in 48 percent of the 
                streams tested nationwide; and
                    (B) almost half of the tested streams were 
                downstream from agricultural operations.
            (10) An April 1999 study by the General Accounting Office 
        concluded that resistant strains of 3 microorganisms that cause 
        food-borne illness or disease in humans (Salmonella, 
        Campylobacter, and E. coli) are linked to the use of 
        antibiotics in animals.
            (11) Epidemiological research has shown that resistant 
        Salmonella and Campylobacter infections are associated with 
        increased numbers of ill patients and bloodstream infections, 
        and increased death.
            (12) In 2010, the peer-reviewed journal Molecular Cell 
        published a study demonstrating that low-dosage use of 
        antibiotics causes a dramatic increase in genetic mutation, 
        raising new concerns about the agricultural practice of using 
        low-dosage antibiotics in order to stimulate growth promotion 
        and routinely prevent disease in unhealthy conditions.
            (13)(A) In January 2003, Consumer Reports published test 
        results on poultry products bought in grocery stores nationwide 
        showing disturbingly high levels of Campylobacter and 
        Salmonella bacteria that were resistant to the antibiotics used 
        to treat food-borne illnesses.
            (B) The Food and Drug Administration's National 
        Antimicrobial Resistance Monitoring System routinely finds that 
        retail meat products are contaminated with bacteria (including 
        the foodborne pathogens Campylobacter and Salmonella) that are 
        resistant to antibiotics important in human medicine.
            (C) In December 2007, the USDA issued a fact sheet on the 
        recently recognized link between antimicrobial drug use in 
        animals and Methicillin Resistant Staphylococcus Aureas (MRSA) 
        infections in humans.
            (14) In October 2001, the New England Journal of Medicine 
        published an editorial urging a ban on nontherapeutic use of 
        medically important antibiotics in animals.
            (15)(A) In 1998, the National Academy of Sciences noted 
        that antibiotic-resistant bacteria generate a minimum of 
        $4,000,000,000 to $5,000,000,000 in costs to United States 
        society and individuals yearly.
            (B) In 2009, Cook County Hospital and the Alliance for 
        Prudent Use of Antibiotics estimated that the total health care 
        cost of antibiotic resistant infections in the United States 
        was between $16,600,000,000 and $26,000,000,000 annually.
            (16) The American Medical Association, the American Public 
        Health Association, the National Association of County and City 
        Health Officials, and the National Campaign for Sustainable 
        Agriculture are among the more than 300 organizations 
        representing health, consumer, agricultural, environmental, 
        humane, and other interests that have supported enactment of 
        legislation to phase out nontherapeutic use in farm animals of 
        medically important antibiotics.
            (17) In 2010, the Danish Veterinary and Food Administration 
        testified that the Danish ban of the non-therapeutic use of 
        antibiotics in food animal production resulted in a marked 
        reduction in antimicrobial resistance in multiple bacterial 
        species, including Campylobacter and Enterococci.
            (18) In 2009, the Congressional Research Service concluded 
        that restrictions overseas on the use of antimicrobial drugs in 
        the production of livestock could impact U.S. export markets 
        for livestock and poultry.
            (19) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        301 et seq.)--
                    (A) requires that all drugs be shown to be safe 
                before the drugs are approved; and
                    (B) places the burden on manufacturers to account 
                for health consequences and prove safety.
            (20)(A) The Food and Drug Administration recently modified 
        the drug approval process for antibiotics to recognize the 
        development of resistant bacteria as an important aspect of 
        safety, but most antibiotics currently used in animal 
        production systems for nontherapeutic purposes were approved 
        before the Food and Drug Administration began considering 
        resistance during the drug-approval process.
            (B) The Food and Drug Administration has not established a 
        schedule for reviewing those existing approvals.
            (21) Certain non-routine uses of antibiotics in animal 
        agriculture are legitimate to prevent animal disease.
            (22) An April 2004 study by the General Accounting Office--
                    (A) concluded that Federal agencies do not collect 
                the critical data on antibiotic use in animals that 
                they need to support research on human health risks; 
                and
                    (B) recommends that the Department of Agriculture 
                and the Department of Health and Human Services develop 
                and implement a plan to collect data on antibiotic use 
                in animals.

SEC. 3. PURPOSE.

    The purpose of this Act is to preserve the effectiveness of 
medically important antibiotics used in the treatment of human and 
animal diseases by reviewing the safety of certain antibiotics for 
nontherapeutic purposes in food-producing animals.

SEC. 4. PROOF OF SAFETY OF CRITICAL ANTIMICROBIAL ANIMAL DRUGS.

    (a) Definitions.--Section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the 
following:
    ``(ss) Critical Antimicrobial Animal Drug.--The term `critical 
antimicrobial animal drug' means a drug that--
            ``(1) is intended for use in food-producing animals; and
            ``(2) is composed wholly or partly of--
                    ``(A) any kind of penicillin, tetracycline, 
                macrolide, lincosamide, streptogramin, aminoglycoside, 
                or sulfonamide; or
                    ``(B) any other drug or derivative of a drug that 
                is used in humans or intended for use in humans to 
                treat or prevent disease or infection caused by 
                microorganisms.
    ``(tt) Nontherapeutic Use.--The term `nontherapeutic use', with 
respect to a critical antimicrobial animal drug, means any use of the 
drug as a feed or water additive for an animal in the absence of any 
clinical sign of disease in the animal for growth promotion, feed 
efficiency, weight gain, routine disease prevention, or other routine 
purpose.''.
    (b) Applications Pending or Submitted After Enactment.--Section 
512(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360b(d)(1)) is amended--
            (1) in the first sentence--
                    (A) in subparagraph (H), by striking ``or'' at the 
                end;
                    (B) in subparagraph (I), by inserting ``or'' at the 
                end; and
                    (C) by inserting after subparagraph (I) the 
                following:
                    ``(J) with respect to a critical antimicrobial 
                animal drug or a drug of the same chemical class as a 
                critical antimicrobial animal drug, the applicant has 
                failed to demonstrate that there is a reasonable 
                certainty of no harm to human health due to the 
                development of antimicrobial resistance that is 
                attributable, in whole or in part, to the 
                nontherapeutic use of the drug; or''; and
            (2) in the second sentence, by striking ``(A) through (I)'' 
        and inserting ``(A) through (J)''.
    (c) Phased Elimination of Nontherapeutic Use in Animals of Critical 
Antimicrobial Animal Drugs Important for Human Health.--Section 512 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b) is amended by 
adding at the end the following:
    ``(q) Phased Elimination of Nontherapeutic Use in Animals of 
Critical Antimicrobial Animal Drugs Important for Human Health.--
            ``(1) Applicability.--This subsection applies to the 
        nontherapeutic use in a food-producing animal of a drug--
                    ``(A)(i) that is a critical antimicrobial animal 
                drug; or
                    ``(ii) that is of the same chemical class as a 
                critical antimicrobial animal drug; and
                    ``(B)(i) for which there is in effect an approval 
                of an application or an exemption under subsection (b), 
                (i), or (j) of section 505; or
                    ``(ii) that is otherwise marketed for use.
            ``(2) Withdrawal.--The Secretary shall withdraw the 
        approval of a nontherapeutic use in food-producing animals 
        described in paragraph (1) on the date that is 2 years after 
        the date of enactment of this subsection unless--
                    ``(A) before the date that is 2 years after the 
                date of the enactment of this subsection, the Secretary 
                makes a final written determination that the holder of 
                the approved application has demonstrated that there is 
                a reasonable certainty of no harm to human health due 
                to the development of antimicrobial resistance that is 
                attributable in whole or in part to the nontherapeutic 
                use of the drug; or
                    ``(B) before the date specified in subparagraph 
                (A), the Secretary makes a final written determination 
                under this subsection, with respect to a risk analysis 
                of the drug conducted by the Secretary and other 
                relevant information, that there is a reasonable 
                certainty of no harm to human health due to the 
                development of antimicrobial resistance that is 
                attributable in whole or in part to the nontherapeutic 
                use of the drug.
            ``(3) Exemptions.--Except as provided in paragraph (5), if 
        the Secretary grants an exemption under section 505(i) for a 
        drug that is a critical antimicrobial animal drug, the 
        Secretary shall rescind each approval of a nontherapeutic use 
        in a food-producing animal of the critical antimicrobial animal 
        drug, or of a drug in the same chemical class as the critical 
        antimicrobial animal drug, as of the date that is 2 years after 
        the date on which the Secretary grants the exemption.
            ``(4) Approvals.--Except as provided in paragraph (5), if 
        an application for a drug that is a critical antimicrobial 
        animal drug is submitted to the Secretary under section 505(b), 
        the Secretary shall rescind each approval of a nontherapeutic 
        use in a food-producing animal of the critical antimicrobial 
        animal drug, or of a drug in the same chemical class as the 
        critical antimicrobial animal drug, as of the date that is 2 
        years after the date on which the application is submitted to 
        the Secretary.
            ``(5) Exception.--Paragraph (3) or (4), as the case may be, 
        shall not apply if--
                    ``(A) before the date on which approval would be 
                rescinded under that paragraph, the Secretary makes a 
                final written determination that the holder of the 
                application for the approved nontherapeutic use has 
                demonstrated that there is a reasonable certainty of no 
                harm to human health due to the development of 
                antimicrobial resistance that is attributable in whole 
                or in part to the nontherapeutic use in the food-
                producing animal of the critical antimicrobial animal 
                drug; or
                    ``(B) before the date specified in subparagraph 
                (A), the Secretary makes a final written determination 
                under this subsection, with respect to a risk analysis 
                of the critical antimicrobial animal drug conducted by 
                the Secretary and any other relevant information, that 
                there is a reasonable certainty of no harm to human 
                health due to the development of antimicrobial 
                resistance that is attributable in whole or in part to 
                the nontherapeutic use of the drug.''.

SEC. 5. COMMITTEE HEARINGS ON IMPLEMENTATION.

    (a) In General.--The Committee on Energy and Commerce of the House 
of Representatives and the Committee on Energy of the Senate shall each 
hold a hearing on the implementation by the Commissioner of Food and 
Drugs of section 512(q) of the Federal Food, Drug, and Cosmetic Act, as 
added by section 4 of this Act.
    (b) Exercise of Rulemaking Authority.--Subsection (a) is enacted--
            (1) as an exercise of the rulemaking power of the House of 
        Representatives and Senate, and, as such, they shall be 
        considered as part of the rules of the House or Senate (as the 
        case may be), and such rules shall supersede any other rule of 
        the House or Senate only to the extent that rule is 
        inconsistent therewith; and
            (2) with full recognition of the constitutional right of 
        either House to change such rules (so far as relating to the 
        procedure in such House) at any time, in the same manner, and 
        to the same extent as in the case of any other rule of the 
        House or Senate.

A: Preservation of Antibiotics for Medical Treatment Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to deny an application for a new animal drug that is a critical antimicrobial animal drug unless the applicant demonstrates that there is a reasonably certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Defines "critical antimicrobial animal drug" as a drug intended for use in food-producing animals that contains specified antibiotics or other drugs used in humans to treat or prevent disease or infection caused by microorganisms.

Requires the Secretary to withdraw approval of a nontherapeutic use of such drugs in food-producing animals two years after the date of enactment of this Act unless certain safety requirements are met. Directs specified congressional committees to hold hearings on the implementation of such a withdrawal of approval.
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Q: SECTION 1 SHORT TITLE.

    This Act may be cited as the ``Justin Bailey Veterans Substance Use 
Disorders Prevention and Treatment Act of 2008''.

SEC. 2. EXPANSION OF VETERANS SUBSTANCE USE DISORDER PROGRAMS.

    Subsection (d) of section 1720A of title 38, United States Code, is 
amended by adding at the end the following new paragraph:
    ``(3)(A) Each plan under paragraph (1) shall ensure that the 
medical center provides ready access to a full continuum of care for 
substance use disorders for veterans in need of such care.
    ``(B) In this paragraph, the term `full continuum of care' includes 
all of the following care, treatment, and services:
            ``(i) Screening for substance use disorder in all settings, 
        including primary care settings.
            ``(ii) Detoxification and stabilization services.
            ``(iii) Intensive outpatient care services.
            ``(iv) Relapse prevention services.
            ``(v) Outpatient counseling services.
            ``(vi) Residential substance use disorder treatment.
            ``(vii) Pharmacological treatment to reduce cravings, and 
        opioid substitution therapy referred to in paragraph (2).
            ``(viii) Coordination with groups providing peer to peer 
        counseling.
            ``(ix) Short-term, early interventions for substance use 
        disorders, such as motivational counseling, that are readily 
        available and provided in a manner to overcome stigma 
        associated with the provision of such interventions and related 
        care.
            ``(x) Marital and family counseling.
    ``(C) The Secretary shall provide for outreach to veterans who 
served in Operation Enduring Freedom or Operation Iraqi Freedom to 
increase awareness of the availability of care, treatment, and services 
from the Department for substance use disorders.''.

SEC. 3. REQUIREMENT FOR ALLOCATION OF DEPARTMENT RESOURCES TO ENSURE 
              AVAILABILITY FOR ALL VETERANS REQUIRING TREATMENT FOR 
              SUBSTANCE USE DISORDERS.

    (a) Equitable Allocation of Funding; Annual Report.--Section 1720A 
of title 38, United States Code, as amended by section 2, is further 
amended by adding at the end the following new subsection:
    ``(e)(1) The Secretary shall ensure that amounts made available for 
care, treatment, and services provided under this section are allocated 
in such a manner that a full continuum of care (as defined in 
subsection (d)(3)(B)) is available to veterans seeking such care, 
treatment, or services, without regard to the location of the residence 
of any such veterans.
    ``(2)(A) In addition to the report required under section 
1703(c)(1) of this title (relating to furnishing of contract care and 
services under this section), the Secretary shall include in the budget 
documents which the Secretary submits to Congress for any fiscal year a 
detailed report on the care, treatment, and services furnished by the 
Department under this section during the most recently completed fiscal 
year.
    ``(B) Each report under subparagraph (A) shall include data on the 
following for each medical facility of the Department:
            ``(i) The number of veterans who have been provided care, 
        treatment, or services under this section at the facility for 
        each 1,000 veterans who have received hospital care (if 
        applicable) or medical services at the facility.
            ``(ii) The number of veterans for whom substance use 
        disorder screening was carried out under subsection 
        (d)(3)(B)(i) at the facility.
            ``(iii) The number of veterans for whom a substance use 
        disorder was identified after a screening was carried out under 
        subsection (d)(3)(B)(i) at the facility.
            ``(iv) The number of veterans who were referred by the 
        facility for care, treatment, or services for substance use 
        disorders under this section.
            ``(v) The number of veterans who received care, treatment 
        or services at the facility for substance use disorders under 
        this section.
            ``(vi) Availability of the full continuum of care (as 
        defined in subsection (d)(3)(B)) at the facility.
    ``(C) Each report prepared under subparagraph (A) shall be reviewed 
by the Committee on Care of Severely Chronically Mentally Ill Veterans 
authorized by section 7321 of this title. The Committee shall provide 
an independent assessment of the care, treatment, and services 
furnished directly by the Department under this section to veterans. 
Such assessment shall include a detailed analysis of the availability, 
the barriers to access (if any), and the quality of such care, 
treatment, and services.''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
apply to fiscal years beginning on or after October 1, 2009.

SEC. 4. PILOT PROGRAM FOR INTERNET-BASED SUBSTANCE USE DISORDER 
              TREATMENT FOR VETERANS OF OPERATION IRAQI FREEDOM AND 
              OPERATION ENDURING FREEDOM.

    (a) Findings.--Congress makes the following findings:
            (1) Stigma associated with seeking treatment for mental 
        health disorders has been demonstrated to prevent some veterans 
        from seeking such treatment at a medical facility operated by 
        the Department of Defense or the Department of Veterans 
        Affairs.
            (2) There is a significant incidence among veterans of 
        post-deployment mental health problems, especially among 
        members of a reserve component who return as veterans to 
        civilian life.
            (3) Computer-based self-guided training has been 
        demonstrated to be an effective strategy for supplementing the 
        care of psychological conditions.
            (4) Younger veterans, especially those who served in 
        Operation Enduring Freedom or Operation Iraqi Freedom, are 
        comfortable with and proficient at computer-based technology.
            (5) Veterans living in rural areas find access to treatment 
        for substance use disorder limited.
            (6) Self-assessment and treatment options for substance use 
        disorders through an Internet website may reduce stigma and 
        provides additional access for individuals seeking care and 
        treatment for such disorders.
    (b) In General.--Not later than October 1, 2009, the Secretary of 
Veterans Affairs shall initiate a pilot program to test the feasibility 
and advisability of providing veterans who seek treatment for substance 
use disorders access to a computer-based self-assessment, education, 
and specified treatment program through a secure Internet website 
operated by the Secretary. Participation in the pilot program is 
available on a voluntary basis for those veterans who have served in 
Operation Enduring Freedom or Operation Iraqi Freedom.
    (c) Elements of Pilot Program.--
            (1) In general.--In designing and carrying out the pilot 
        program under this section, the Secretary of Veterans Affairs 
        shall ensure that--
                    (A) access to the Internet website and the programs 
                available on the website by a veteran (or family 
                member) does not involuntarily generate an identifiable 
                medical record of that access by that veteran in any 
                medical database maintained by the Department;
                    (B) the Internet website is accessible from remote 
                locations, especially rural areas; and
                    (C) the Internet website includes a self-assessment 
                tool for substance use disorders, self-guided treatment 
                and educational materials for such disorders, and 
                appropriate information and materials for family 
                members of veterans.
            (2) Consideration of similar projects.--In designing the 
        pilot program under this section, the Secretary of Veterans 
        Affairs shall consider similar pilot projects of the Department 
        of Defense for the early diagnosis and treatment of post-
        traumatic stress disorder and other mental health conditions 
        established under section 741 of the John Warner National 
        Defense Authorization Act of Fiscal Year 2007 (Public Law 109-
        364; 120 Stat. 2304).
            (3) Location of pilot program.--The Secretary shall carry 
        out the pilot program through those medical centers of the 
        Department of Veterans Affairs that have established Centers 
        for Excellence for Substance Abuse Treatment and Education or 
        that have established a Substance Abuse Program Evaluation and 
        Research Center.
            (4) Contract authority.--The Secretary of Veterans Affairs 
        may enter into contracts with qualified entities or 
        organizations to carry out the pilot program required under 
        this section.
    (d) Duration of Pilot Program.--The pilot program required by 
subsection (a) shall be carried out during the two-year period 
beginning on the date of the commencement of the pilot program.
    (e) Authorization of Appropriations.--There are authorized to be 
appropriated to the Secretary of Veterans Affairs $1,500,000 for each 
of fiscal years 2010 and 2011 to carry out the pilot program under this 
section.
    (f) Report.--Not later than six months after the completion of the 
pilot program, the Secretary shall submit to Congress a report on the 
pilot program, and shall include in that report an assessment of the 
feasibility and advisability of the pilot program, of any cost savings 
or other benefits associated with the pilot program, and 
recommendations for the continuation or expansion of the pilot program.

SEC. 5. REPORT ON RESIDENTIAL MENTAL HEALTH CARE FACILITIES OF THE 
              VETERANS HEALTH ADMINISTRATION.

    (a) Review and Report.--Not later than six months after the date of 
the enactment of this Act, the Secretary of Veterans Affairs, acting 
through the Office of the Medical Inspector of the Department of 
Veterans Affairs, shall--
            (1) conduct a review of all residential mental health care 
        facilities, including domiciliary facilities, of the Veterans 
        Health Administration; and
            (2) submit to the Committee on Veterans' Affairs of the 
        Senate and the Committee on Veterans' Affairs of the House of 
        Representatives a report on the review conducted under 
        paragraph (1).
    (b) Elements of Report.--The report required by subsection (a)(2) 
shall include the following:
            (1) A description of the availability of care in 
        residential mental health care facilities in each Veterans 
        Integrated Service Network (VISN).
            (2) An assessment of the supervision and support provided 
        in the residential mental health care facilities of the 
        Veterans Health Administration.
            (3) The ratio of staff members at each residential mental 
        health care facility to patients at such facility.
            (4) An assessment of the appropriateness of rules and 
        procedures for the prescription and administration of 
        medications to patients in such residential mental health care 
        facilities.
            (5) A description of the protocols at each residential 
        mental health care facility for handling missed appointments.
            (6) Any recommendations the Secretary considers appropriate 
        for improvements to such residential mental health care 
        facilities and the care provided in such facilities.

SEC. 6. TRIBUTE TO JUSTIN BAILEY.

    This Act is enacted in tribute to Justin Bailey, who, after 
returning to the United States from service as a member of the Armed 
Forces in Operation Iraqi Freedom, died in a domiciliary facility of 
the Department of Veterans Affairs while receiving care for post-
traumatic stress disorder and a substance use disorder.

            Passed the House of Representatives May 20, 2008.

            Attest:

                                            LORRAINE C. MILLER,

                                                                 Clerk.

A:
Justin Bailey Veterans Substance Use Disorders Prevention and Treatment Act of 2008 - Requires each substance use disorder treatment plan developed by a Department of Veterans Affairs (VA) medical center to ensure that such center provides ready access to a full continuum of care for substance use disorders for veterans in need of such care. Includes under a full continuum of care: (1) screening for substance use disorder; (2) detoxification and stabilization; (3) intensive outpatient care; (4) relapse prevention; (5) outpatient counseling; (6) residential substance use disorder treatment; (7) pharmacological treatment to reduce cravings and opioid substitution therapy; (8) coordination with groups providing peer-to-peer counseling; (9) short-term, early interventions for substance use disorders; and (10) marital and family counseling. Requires the Secretary of Veterans Affairs to provide outreach to veterans of Operations Enduring Freedom or Iraqi Freedom to increase awareness of the availability of such care.

Requires the Secretary to: (1) ensure that amounts made available to the VA for substance use disorder care, treatment, and services are allocated to ensure a full continuum of such care to veterans regardless of the location of their residence; and (2) include in annual budget reports a report on such care, treatment, and services. Requires: (1) each such report to be reviewed by the Committee on Care of Severely Chronically Mentally Ill Veterans; and (2) the Committee to provide an independent assessment of such care, treatment, and services furnished directly by the VA to veterans.

Directs the Secretary to carry out a two-year pilot program to test the feasibility and advisability of providing veterans who seek treatment for substance use disorders with access to a computer-based self-assessment, education, and specific treatment program through a secure Internet website operated by the Secretary. Authorizes appropriations. Requires a pilot program report from the Secretary to Congress.

Requires the Secretary to: (1) conduct a review of all residential mental health care facilities, including domiciliary facilities, of the Veterans Health Administration; and (2) report review results to the congressional veterans' committees.

States that this Act is in tribute to Justin Bailey, who, after returning to the United States from service in Operation Iraqi Freedom, died in a VA domiciliary facility while receiving care for post-traumatic stress disorder (PTSD) and a substance use disorder.
****