In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.

Ex Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Federal Courts of Appeals 
Modernization Act''.

SEC. 2. ESTABLISHMENT.

    There is established a Commission on Structural Alternatives for 
the Federal Courts of Appeals (in this Act referred to as the 
``Commission'').

SEC. 3. MEMBERSHIP.

    (a) Composition.--The Commission shall be composed of 5 members who 
shall be appointed by the Chief Justice of the United States.
    (b) Appointment.--The members of the Commission shall be appointed 
not later than 30 days after the date of enactment of this Act.
    (c) Vacancy.--Any vacancy in the Commission shall be filled in the 
same manner as the original appointment.
    (d) Chair.--The Commission shall elect a chair and vice chair from 
among its members.
    (e) Quorum.--Three members of the Commission shall constitute a 
quorum.

SEC. 4. DUTIES.

    The Commission shall--
            (1) study the present division of the United States courts 
        of appeals, with particular references to the United States 
        Court of Appeals for the Ninth Circuit; and
            (2) submit to the President and Congress a report on the 
        recommendations of the Commission with respect to changes in 
        circuit boundaries or structure as may be appropriate for the 
        expeditious and effective disposition of the caseload of the 
        United States courts of appeals, consistent with fundamental 
        concepts of fairness and due process.

SEC. 5. COMMISSION PERSONNEL MATTERS.

    (a) Compensation of Members.--Each member of the Commission who is 
not an officer or employee of the Federal Government shall be 
compensated at a rate equal to $300 for each day (including travel 
time) during which such member is engaged in the performance of the 
duties of the Commission. All members of the Commission who are 
officers or employees of the United States shall serve without 
compensation in addition to that received for their services as 
officers or employees of the United States.
    (b) Travel Expenses.--Each member of the Commission shall be 
allowed travel expenses, including per diem in lieu of subsistence, at 
rates not greater than those described in section 456 of title 28, 
United States Code.

SEC. 6. STAFF.

    (a) Executive Director.--The Commission may appoint an executive 
director who shall be compensated at a rate not greater than the daily 
equivalent of the annual rate of basic pay prescribed for a position at 
GS-15 of the General Schedule for each day (including travel time) 
during which the executive director is engaged in the performance of 
the duties of the Commission.
    (b) Staff.--The Executive Director, with the approval of the 
Commission, may appoint and fix the compensation of such additional 
personnel as the Executive Director determines necessary, without 
regard to the provisions of title 5, United States Code, governing 
appointments in the competitive service, and without regard to the 
provisions of chapter 51 and subchapter III of chapter 53 of such title 
relating to classification and General Schedule pay rates, except that 
a rate of pay fixed under this subsection may not exceed the annual 
maximum rate of basic pay for a position above GS-15 of the General 
Schedule under section 5108 of title 5, United States Code.
    (c) Experts and Consultants.--The Executive Director may procure by 
contract the temporary or intermittent services of experts or 
consultants in accordance with section 3109 of title 5, United States 
Code, at rates for individuals that are not greater than the daily 
equivalent of the annual rate of basic pay for a comparable position 
paid under the General Schedule.
    (d) Services.--The Administrative Office of the United States 
Courts shall provide administrative services, including financial and 
budgeting services, to the Commission on a reimbursable basis. The 
Federal Judicial Center shall provide necessary research services to 
the Commission on a reimbursable basis.

SEC. 7. INFORMATION.

    The Commission is authorized to request from any department, 
agency, or independent instrumentality of the United States any 
information and assistance the Commission determines necessary to carry 
out its functions under this Act. Each such department, agency, and 
independent instrumentality is authorized to provide such information 
and assistance to the extent permitted by law when requested by the 
Chair of the Commission.

SEC. 8. STUDY AND REPORT.

    (a) Study.--Not later than the 10-month period beginning on the 
date on which a quorum of the Commission is present, the Commission 
shall conclude a study on the issues described in section 4(1).
    (b) Report.--Not later than 60 days after the date on which the 
period described in subsection (a) expires, the Commission shall submit 
to the President and Congress the report described in section 4(1).

SEC. 9. TERMINATION.

    The Commission shall terminate 90 days after the Commission submits 
the report described in section 8(b).

SEC. 10. AUTHORIZATION OF APPROPRIATIONS.

    There are authorized to be appropriated such sums as are necessary 
not to exceed $1,000,000 to carry out this Act, to remain available 
until expended.

Ex Output:
Federal Courts of Appeals Modernization Act This bill establishes a Commission on Structural Alternatives for the Federal Courts of Appeals to: (1) study the present division of the U.S. courts of appeals, with particular references to the U.S. Court of Appeals for the Ninth Circuit; and (2) submit to the President and Congress recommendations for changes in circuit boundaries or structure for the expeditious and effective disposition of the caseload of such courts. The commission shall be composed of five members appointed by the Chief Justice of the United States.


Ex Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Helping Effective Antibiotics Last 
Act of 2015'' or the ``HEAL Act''.

SEC. 2. APPROVAL OF CERTAIN DRUGS FOR USE IN A WELL-DEFINED POPULATION 
              OF PATIENTS.

    (a) Approval of Certain Antibacterial.--Section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at 
the end the following:
    ``(x) Approval of Certain Antibacterial Drugs for Use in a Well-
Defined Population of Patients.--
            ``(1) Unmet medical need defined.--In this subsection, the 
        term `unmet medical need' means that the antibacterial drug 
        involved--
                    ``(A) has improved efficacy, as demonstrated in 
                adequate, well-controlled studies in humans, for 
                specific diseases or conditions, where current 
                therapies have been shown to be less effective;
                    ``(B) has clinically meaningful decreased harms, 
                demonstrated in adequate, well-controlled studies in 
                humans, for diseases or conditions, where current 
                therapies have unacceptable adverse effects; or
                    ``(C) has improved convenience, as demonstrated in 
                adequate, well-controlled studies in humans, where 
                improved convenience results in improved effectiveness 
                or decreased harms.
            ``(2) Approval.--Upon receipt of an application under 
        subsection (b) for an antibacterial drug that is intended to 
        treat a serious or life-threatening disease or condition, 
        irrespective of whether the drug is intended to address an 
        unmet medical need, the Secretary--
                    ``(A) may approve the drug under subsection (c) 
                only for treating a well-defined population of 
                patients, and based upon the results of clinical trials 
                inclusive of human subjects representative of such 
                well-defined population;
                    ``(B) in determining whether to grant such 
                approval, shall rely on superior outcomes over 
                available therapies based on direct measures of patient 
                benefits, as demonstrated in adequate, well-controlled 
                studies in the well-defined patient population, such 
                as--
                            ``(i) decreased mortality;
                            ``(ii) irreversible morbidity; or
                            ``(iii) validated surrogate endpoints that 
                        reflect mortality or irreversible morbidity; 
                        and
                    ``(C) shall require the labeling of drugs approved 
                pursuant to this subsection to prominently include in 
                the prescribing information required by section 201.57 
                of title 21, Code of Federal Regulations (or any 
                successor regulation)--
                            ``(i) the population of patients with 
                        respect to which the added benefit over 
                        available therapies is expected as studied in 
                        adequate, well-controlled studies that form the 
                        basis for approval; and
                            ``(ii) the method for identifying members 
                        of that population.
            ``(3) Risk evaluation and mitigation strategy.--The 
        Secretary--
                    ``(A) shall require a risk evaluation and 
                mitigation strategy (REMS) under section 505-1 for each 
                drug approved under this subsection; and
                    ``(B) may include in any such strategy additional 
                elements to assure the safe use of the drug under 
                subsections (e) and (f) of section 505-1.
            ``(4) Rule of construction.--Nothing in this subsection 
        shall be construed to alter the standards of evidence under 
        subsection (c) or (d) (including the substantial evidence 
        standard in subsection (d)). Subsections (c) and (d) and such 
        standards of evidence apply to the review and approval of drugs 
        under this subsection, including whether a drug is safe and 
        effective. Nothing in this subsection shall be construed to 
        limit the authority of the Secretary to approve products 
        pursuant to this Act and the Public Health Service Act as 
        authorized prior to the date of enactment of this subsection.
            ``(5) Effective immediately.--The Secretary shall have the 
        authorities vested in the Secretary by this subsection 
        beginning on the date of enactment of this subsection, 
        irrespective of when and whether the Secretary promulgates 
        final regulations to carry out this subsection.''.
    (b) Licensure of Certain Biological Products.--Section 351(j) of 
the Public Health Service Act (42 U.S.C. 262(j)) is amended--
            (1) by striking ``(j)'' and inserting ``(j)(1)'';
            (2) by inserting ``505(x),'' after ``505(p),''; and
            (3) by adding at the end the following:
    ``(2) In applying section 505(x) of the Federal Food, Drug, and 
Cosmetic Act to the licensure of biological products under this 
section--
            ``(A) references to an antibacterial drug with added 
        benefits over available therapies for a well-defined population 
        that is intended to treat a serious or life-threatening disease 
        or condition shall be construed to refer to biological products 
        with added benefits over available therapies for a well-defined 
        population intended to treat a bacterial infection associated 
        with a serious or life-threatening disease; and
            ``(B) references to an application submitted under section 
        505(b) of such Act and to approval of a drug under section 
        505(c) of such Act shall be construed to refer to an 
        application submitted under subsection (a) of this section and 
        to licensure of a biological product under such subsection (a), 
        respectively.''.
    (c) Monitoring.--Title III of the Public Health Service Act is 
amended by inserting after section 317T (42 U.S.C. 247b-22) the 
following:

``SEC. 317U. MONITORING OF ANTIBACTERIAL DRUG USE, PATIENT OUTCOMES, 
              AND RESISTANCE.

    ``(a) Monitoring.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, shall use the National 
Healthcare Safety Network or another appropriate monitoring system to 
monitor--
            ``(1) changes in patient outcomes such as mortality and 
        irreversible morbidity causally related to antibacterial 
        resistance; and
            ``(2) changes in bacterial resistance to drugs in relation 
        to patient outcomes.
    ``(b) Public Availability of Data.--The Secretary, acting through 
the Director of the Centers for Disease Control and Prevention, shall 
make the data derived from monitoring under this section publicly 
available for the purposes of--
            ``(1) improving the monitoring of important trends in 
        patient outcomes in relation to antibacterial resistance; and
            ``(2) ensuring appropriate stewardship of antibacterial 
        drugs, including those receiving approval or licensure for a 
        well-defined population pursuant to section 505(x) of the 
        Federal Food, Drug, and Cosmetic Act.''.

SEC. 3. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR MICROBIAL 
              ORGANISMS.

    (a) In General.--Section 511 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360a) is amended to read as follows:

``SEC. 511. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR MICROBIAL 
              ORGANISMS.

    ``(a) In General.--The Secretary shall--
            ``(1) identify upon approval or licensing of antibacterial 
        drugs (including biological products intended to treat a 
        bacterial infection and other types of antimicrobial drugs, as 
        deemed appropriate by the Secretary), including qualified 
        infectious disease products, susceptibility test interpretive 
        criteria for such drugs based upon patient outcomes of 
        mortality and morbidity from adequate and well-controlled 
        studies and such other confirmatory evidence as the Secretary 
        deems necessary; and
            ``(2) update, consistent with subsection (b), such criteria 
        as needed based upon scientific evidence of changes in patient 
        outcomes.
    ``(b) Responding to Changes in Patient Outcomes To Evaluate 
Susceptibility Test Interpretive Criteria.--
            ``(1) In general.--As needed based on evidence related to 
        changes in patient outcomes, the Secretary shall--
                    ``(A) evaluate any new scientific studies on 
                changes in patient outcomes in relation to 
                susceptibility test interpretive criteria; and
                    ``(B) publish on the public Website of the Food and 
                Drug Administration a notice--
                            ``(i) presenting suggested new or updated 
                        interpretive criteria; and
                            ``(ii) if needed, hold a public advisory 
                        committee to discuss scientific evidence 
                        related to changes in interpretative criteria.
            ``(2) Annual compilation of notices.--Each year, the 
        Secretary shall compile the notices published under paragraph 
        (1)(B) noting any changes from prior notices and publish such 
        compilation in the Federal Register.
    ``(c) Definition.--In this section, the term `susceptibility test 
interpretive criteria' means one or more specific values which 
characterize patient outcomes in relation to the degree to which 
bacteria or other microbes are more resistant to treatment as measured 
by patient outcomes.''.
    (b) Conforming Amendment.--Section 1111 of the Food and Drug 
Administration Amendments Act of 2007 (42 U.S.C. 247d-5a; relating to 
identification of clinically susceptible concentrations of 
antimicrobials) is repealed.
    (c) Report to Congress.--Not later than one year after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
submit to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report on the progress made in implementing 
section 511 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360a), as amended by this section.

SEC. 4. REQUIRING DEMONSTRATION OF SUPERIOR OUTCOMES FOR QUALIFIED 
              INFECTIOUS DISEASE PRODUCTS TO RECEIVE AN EXTENDED 
              EXCLUSIVITY PERIOD.

    Section 505E(g) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355f(g)) is amended by striking ``means an antibacterial or 
antifungal drug for human use intended to treat'' and inserting ``means 
an antibacterial or antifungal drug for human use that is demonstrated 
to produce superior outcomes over available therapies, based on direct 
measures of patient benefits in clinical trials, and that is intended 
to treat''.

SEC. 5. GUIDANCE ON TARGET PRODUCT PROFILES.

    Not later than 18 months after the date of enactment of this Act, 
the Commissioner of Food and Drugs, in consultation with the 
Administrator of the Centers for Medicare & Medicaid Services, the 
Director of the Indian Health Service, the Secretary of Defense, and 
the Secretary of Veterans Affairs, shall issue guidance on the 
development of target product profiles for novel antibacterial drugs 
focused on public health priorities.

Ex Output:
Helping Effective Antibiotics Last Act of 2015 or the HEAL Act This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to approve an antibacterial drug or biological product that is intended to treat a serious or life-threatening condition only for treating a well-defined population of patients. To be approved, the antibacterial product must produce superior outcomes over available therapies in the well-defined patient population. A product approved by this pathway must include in its prescribing information the population of patients expected to benefit from using the product and the method for identifying members of that population. The FDA must require each product to have a risk evaluation and mitigation strategy. The Centers for Disease Control and Prevention must monitor changes to bacterial drug resistance and changes to patient outcomes caused by bacterial drug resistance. Upon approval of antibacterial products, the FDA must identify susceptibility test interpretive criteria (the drug concentrations where a type of bacteria is categorized as susceptible, intermediate, or resistant) and update the criteria as needed based upon evidence of changes in patient outcomes.  To be eligible for an exclusivity period extension, a qualified infectious disease product must be demonstrated to produce superior outcomes over available therapies. The FDA must issue guidance on the development of target product profiles for antibacterial drugs.


Ex Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Affordability Is Access Act''.

SEC. 2. PURPOSE.

    The purpose of this Act is to ensure timely access to affordable 
birth control by requiring coverage without cost-sharing for oral birth 
control for routine, daily use that is approved by, or otherwise 
legally marketed under regulation by, the Food and Drug Administration 
for use by women without a prescription.

SEC. 3. FINDINGS.

    Congress makes the following findings:
            (1) Access to the full range of health benefits and 
        preventive services, including access to birth control, as 
        guaranteed under Federal law, provides all people of the United 
        States with the opportunity to lead healthier and more 
        productive lives.
            (2) Birth control is a critical health care benefit and 
        service for women. Almost all women use birth control at some 
        point in their lifetimes. The Centers for Disease Control and 
        Prevention declared it one of the Ten Great Public Health 
        Achievements of the 20th Century.
            (3) Birth control prevents and reduces unintended 
        pregnancies and provides many health and socioeconomic benefits 
        for women. Women with access to birth control are more likely 
        to have higher educational and career achievement, and to earn 
        higher wages.
            (4) Affordability and timely access have long been barriers 
        for women being able to use birth control. Many women struggle 
        to obtain the birth control they need because of cost or other 
        access barriers, which has contributed to the high unintended 
        pregnancy rate in the United States. A national survey found 
        that 1 in 3 women have struggled to afford birth control at 
        some point in their lives, and as a result, have used birth 
        control inconsistently. The rate is even higher for young women 
        who are most likely to experience an unintended pregnancy.
            (5) Three separate studies have found that lack of health 
        coverage is significantly associated with reduced use of 
        prescription contraceptive methods, including birth control.
            (6) The Patient Protection and Affordable Care Act (Public 
        Law 111-148) sought to remove barriers to care and improve 
        access by requiring all new health plans to cover recommended 
        preventive services without cost-sharing, which include women's 
        preventive services, including all contraceptive methods, 
        including birth control and sterilization for women approved by 
        the Food and Drug Administration and related education and 
        counseling.
            (7) The Patient Protection and Affordable Care Act women's 
        preventive services benefit has significantly improved women's 
        access to birth control, including oral birth control for 
        routine, daily use. The Department of Health and Human Services 
        has reported that, as of 2014, more than 55,000,000 women are 
        benefitting from coverage without cost-sharing for women's 
        preventive services, including birth control, under the Patient 
        Protection and Affordable Care Act. Women have saved more than 
        $483,000,000 in out-of-pocket costs for birth control with no 
        copayments in 2012 compared to 2013, an average savings of $269 
        per woman.
            (8) The most appropriate method of birth control varies 
        according to each individual woman's needs, medical history, 
        and stage of life. For instance, women may have medical 
        contraindications that limit their ability to use certain birth 
        control methods. It is critical that the full range of birth 
        control methods approved by the Food and Drug Administration 
        are available and covered without cost-sharing in order to 
        ensure that each woman has access to the birth control method 
        that best meets her needs.
            (9) The determination as to whether a drug should be 
        available for use without a prescription is appropriately and 
        solely made by the Food and Drug Administration. To ensure the 
        safety and efficacy of a drug, including a drug available for 
        over-the-counter use, the appropriate scientific and medical 
        personnel at the Food and Drug Administration, often with input 
        from independent advisory panels of experts, review clinical 
        and other data relating to the safety and efficacy of the drug. 
        This scientific and medical review can occur as part of the 
        Food and Drug Administration's over-the-counter drug review for 
        potential inclusion in a monograph as generally recognized as 
        safe and effective, or as part of the review of a new drug 
        application (or an abbreviated new drug application). As part 
        of these regulatory processes, the appropriate scientific and 
        medical personnel review clinical and other data, including 
        data generated in controlled clinical trials. The Food and Drug 
        Administration also reviews consumer studies and monitors post-
        marketing safety data. All of these processes ensure that the 
        appropriate scientific and medical personnel make the 
        determination of safety, quality, and efficacy of drugs 
        marketed to the people of the United States.
            (10) Leading women's health experts, providers, and medical 
        associations, including the American College of Obstetricians 
        and Gynecologists and the American Academy of Family 
        Physicians, support full insurance coverage and increased 
        access to oral birth control over-the-counter. In 2012, the 
        American College of Obstetricians and Gynecologists issued a 
        Committee Opinion recommending approval by the Food and Drug 
        Administration of certain forms of birth control for over-the-
        counter use to increase timely access to birth control. 
        Furthermore, data demonstrates that birth control that is 
        available over-the-counter has public support and would 
        increase birth control usage and continuation. The Committee 
        Opinion followed similar recommendations made by leading 
        reproductive health experts and published in the American 
        Journal of Public Health.
            (11) Research shows that birth control available over-the-
        counter, as an addition to, not a substitute for, the women's 
        preventive health benefit under the Patient Protection and 
        Affordable Care Act, would increase accessibility for oral 
        birth control for routine, daily use.

SEC. 4. SENSE OF THE HOUSE OF REPRESENTATIVES.

    It is the sense of the House of Representatives that--
            (1) in order to increase women's access to oral birth 
        control, it must be both easier to obtain and affordable and, 
        to make it either easier to obtain or more affordable, but not 
        both, is to leave unacceptable barriers in place for women;
            (2) it is imperative that the entities that research and 
        develop oral birth control and whose medical and scientific 
        experts have developed clinical and other evidence that oral 
        birth control for routine, daily use is safe and effective for 
        women when sold without a prescription, apply to the Food and 
        Drug Administration for review and approval for sale of such 
        birth control without a prescription;
            (3) upon the receipt of such an application, the Food and 
        Drug Administration should determine whether the oral birth 
        control meets the rigorous safety, efficacy, and quality 
        standards for over-the-counter use under the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), and if the 
        product meets those standards, the Food and Drug Administration 
        should approve the application without delay; and
            (4) if and when the Food and Drug Administration approves 
        an oral birth control that is available over-the-counter, such 
        birth control should be covered by health insurance, without a 
        prescription and without cost-sharing.

SEC. 5. ENSURING COVERAGE OF ORAL BIRTH CONTROL FOR USE WITHOUT A 
              PRESCRIPTION.

    Section 2713(a)(4) of the Public Health Service Act (42 U.S.C. 
300gg-13(a)(4)) is amended by inserting ``(including oral 
contraceptives for routine, daily use approved by the Food and Drug 
Administration for use without a prescription, even if the individual 
does not have a prescription for such contraceptive)'' after 
``additional preventive care''.

SEC. 6. RULES OF CONSTRUCTION.

    (a) Non-Interference With FDA Regulation.--Nothing in this Act (or 
the amendment made by this Act) shall be construed to modify or 
interfere with Food and Drug Administration processes to review or 
approve, or otherwise determine the safety and efficacy of, and make 
available, non-prescription drugs or devices, modify or interfere with 
the scientific and medical considerations of the Food and Drug 
Administration, or alter any other authority of the Food and Drug 
Administration.
    (b) Non-Preemption.--Nothing in this Act (or the amendment made by 
this Act) preempts any provision of Federal or State law to the extent 
that such Federal or State law provides protections for consumers that 
are greater than the protections provided for in this Act.

SEC. 7. DUTIES OF RETAILERS TO ENSURE ACCESS TO ORAL BIRTH CONTROL FOR 
              USE WITHOUT A PRESCRIPTION.

    (a) In General.--Any retailer that stocks oral birth control for 
routine, daily use that is approved by, or otherwise legally marketed 
under regulation by, the Food and Drug Administration for use without a 
prescription may not interfere with an individual's access to or 
purchase of such birth control or access to medically accurate, 
comprehensive information about such birth control.
    (b) Limitation.--Nothing in this section shall prohibit a retailer 
that stocks oral birth control for routine, daily use from refusing to 
provide an individual with such oral birth control that is approved by, 
or otherwise legally marketed under regulation by, the Food and Drug 
Administration if the individual is unable to pay for the birth 
control, directly or through insurance coverage.

Ex Output:

Affordability Is Access Act This bill amends the Public Health Service Act to require health insurance and group health plans to cover, as preventive care for women, over-the-counter oral contraceptives for daily use, regardless of whether an enrollee has a prescription for the contraceptive. (Insurers and plans cannot impose cost sharing for preventive care.)