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

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.
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.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Weather Modification Research and 
Technology Transfer Authorization Act of 2005''.

SEC. 2. PURPOSE.

    It is the purpose of this Act to develop and implement a 
comprehensive and coordinated national weather modification policy and 
a national cooperative Federal and State program of weather 
modification research and development.

SEC. 3. DEFINITIONS.

    In this Act:
            (1) Board.--The term ``Board'' means the Weather 
        Modification Advisory and Research Board.
            (2) Executive director.--The term ``Executive Director'' 
        means the Executive Director of the Weather Modification 
        Advisory and Research Board.
            (3) Research and development.--The term ``research and 
        development'' means theoretical analysis, exploration, 
        experimentation, and the extension of investigative findings 
        and theories of scientific or technical nature into practical 
        application for experimental and demonstration purposes, 
        including the experimental production and testing of models, 
        devices, equipment, materials, and processes.
            (4) Weather modification.--The term ``weather 
        modification'' means changing or controlling, or attempting to 
        change or control, by artificial methods the natural 
        development of atmospheric cloud forms or precipitation forms 
        which occur in the troposphere.

SEC. 4. WEATHER MODIFICATION ADVISORY AND RESEARCH BOARD ESTABLISHED.

    (a) In General.--There is established in the Department of Commerce 
the Weather Modification Advisory and Research Board.
    (b) Membership.--
            (1) In general.--The Board shall consist of 11 members 
        appointed by the Secretary of Commerce, of whom--
                    (A) at least 1 shall be a representative of the 
                American Meteorological Society;
                    (B) at least 1 shall be a representative of the 
                American Society of Civil Engineers;
                    (C) at least 1 shall be a representative of the 
                National Academy of Sciences;
                    (D) at least 1 shall be a representative of the 
                National Center for Atmospheric Research of the 
                National Science Foundation;
                    (E) at least 2 shall be representatives of the 
                National Oceanic and Atmospheric Administration of the 
                Department of Commerce;
                    (F) at least 1 shall be a representative of 
                institutions of higher education or research 
                institutes; and
                    (G) at least 1 shall be a representative of a State 
                that is currently supporting operational weather 
                modification projects.
            (2) Tenure.--A member of the Board serves at the pleasure 
        of the Secretary of Commerce.
            (3) Vacancies.--Any vacancy on the Board shall be filled in 
        the same manner as the original appointment.
    (b) Advisory Committees.--The Board may establish advisory 
committees to advise the Board and to make recommendations to the Board 
concerning legislation, policies, administration, research, and other 
matters.
    (c) Initial Meeting.--Not later than 30 days after the date on 
which all members of the Board have been appointed, the Board shall 
hold its first meeting.
    (d) Meetings.--The Board shall meet at the call of the Chair.
    (e) Quorum.--A majority of the members of the Board shall 
constitute a quorum, but a lesser number of members may hold hearings.
    (f) Chair and Vice Chair.--The Board shall select a Chair and Vice 
Chair from among its members.

SEC. 5. DUTIES OF THE BOARD.

    (a) Promotion of Research and Development.--In order to assist in 
expanding the theoretical and practical knowledge of weather 
modification, the Board shall promote and fund research and 
development, studies, and investigations with respect to--
            (1) improved forecast and decisionmaking technologies for 
        weather modification operations, including tailored computer 
        workstations and software and new observation systems with 
        remote sensors; and
            (2) assessments and evaluations of the efficacy of weather 
        modification, both purposeful (including cloud-seeding 
        operations) and inadvertent (including downwind effects and 
        anthropogenic effects).
    (b) Financial Assistance.--Unless the use of the money is 
restricted or subject to any limitations provided by law, the Board 
shall use amounts in the Weather Modification Research and Development 
Fund--
            (1) to pay its expenses in the administration of this Act; 
        and
            (2) to provide for research and development with respect to 
        weather modifications by grants to, or contracts or cooperative 
        arrangements with, public or private agencies.
    (c) Report.--The Board shall submit to the Secretary of Commerce 
biennially a report on its findings and research results.

SEC. 6. POWERS OF THE BOARD.

    (a) Studies, Investigations, and Hearings.--The Board may make any 
studies or investigations, obtain any information, and hold any 
hearings necessary or proper to administer or enforce this Act or any 
rules or orders issued under this Act.
    (b) Personnel.--The Board may employ, as provided for in 
appropriations Acts, an Executive Director and other support staff 
necessary to perform duties and functions under this Act.
    (c) Cooperation With Other Agencies.--The Board may cooperate with 
public or private agencies to promote the purposes of this Act.
    (d) Cooperative Agreements.--The Board may enter into cooperative 
agreements with the head of any department or agency of the United 
States, an appropriate official of any State or political subdivision 
of a State, or an appropriate official of any private or public agency 
or organization for conducting weather modification activities or 
cloud-seeding operations.
    (e) Conduct and Contracts for Research and Development.--The 
Executive Director, with the approval of the Board, may conduct and may 
contract for research and development activities relating to the 
purpose described in section 2.

SEC. 7. COOPERATION WITH THE WEATHER MODIFICATION OPERATIONS AND 
              RESEARCH BOARD.

    The heads of the departments and agencies of the United States and 
the heads of any other public or private agencies and institutions that 
receive research funds from the United States shall, to the extent 
possible, give full support and cooperation to the Board and to 
initiate independent research and development programs that address 
weather modifications.

SEC. 8. FUNDING.

    (a) In General.--There is established within the Treasury of the 
United States the Weather Modification Research and Development Fund, 
which shall consist of amounts appropriated pursuant to subsection (b) 
or received by the Board under subsection (c).
    (b) Authorization of Appropriations.--There are authorized to be 
appropriated to the Board for the purposes of carrying out this Act 
$10,000,000 for each of fiscal years 2006 through 2015. Any sums 
appropriated under this subsection shall remain available, without 
fiscal year limitation, until expended.
    (c) Gifts.--The Board may accept, use, and dispose of gifts or 
donations of services or property.
Weather Modification Research and Technology Transfer Authorization Act of 2005 - Establishes in the Department of Commerce the Weather Modification Advisory and Research Board to promote and fund research and development (R&D), studies, and investigations with respect to: (1) improved forecast and decisionmaking technologies for weather modification operations, including tailored computer workstations and software and new observation systems with remote sensors; and (2) assessments and evaluations of the efficacy of weather modification, both purposeful (including cloud-seeding operations) and inadvertent (including downwind effects and anthropogenic effects).

Establishes within the U.S. Treasury the Weather Modification Research and Development Fund. Directs the Board, unless the use of the money is restricted or subject to any limitations provided by law, to use amounts in the Fund to: (1) pay its expenses in the administration of this Act; and (2) provide for R&D with respect to weather modifications by grants to, or contracts or cooperative arrangements with, public or private agencies.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Centennial Historic District 
Authorization Act of 2008''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) The Centennial Historic District in the Commonwealth of 
        Pennsylvania was the site of an international exhibition to 
        celebrate the Centennial of the United States in 1876.
            (2) On March 3, 1871, an Act of Congress created the United 
        States Centennial Commission and provided that an Exhibition of 
        American and foreign arts, products, and manufactures be held 
        in Philadelphia in 1876.
            (3) Held only 11 years after the end of the Civil War, the 
        Centennial Exhibition was a both a national celebration of 
        unity and a recognition by the world community that the United 
        States was emerging as the leading nation in the world.
            (4) The Centennial Exhibition displayed 60,000 exhibits 
        from more than 28 countries around the world in 240 buildings 
        and hosted nearly 10 million visitors, estimated to be nearly 
        25 percent of the population of the United States at the time. 
        It was the first World's Fair to be held in the United States.
            (5) The Exhibition became the center of cultural, 
        technological, economic and geopolitical development in the 
        United States by demonstrating groundbreaking innovations, 
        including root beer, the telephone, kindergarten, the 
        typewriter, the phonograph, and the monorail.
            (6) More than 100 American companies who participated in 
        the Centennial Exhibition are still in business today, 
        including Bausch and Lomb, John Deere, Campbell's, Heinz, and 
        Wyeth.
            (7) The Centennial Historic District is located in 
        Fairmount Park, which is listed on the National Register of 
        Historic Places.
            (8) Memorial Hall, a centerpiece of the Centennial 
        celebration, is a National Historic Landmark and is being 
        renovated to join other cultural institutions as an anchor for 
        the Centennial Historic District.
            (9) The Centennial Historic District will commemorate the 
        historic significance of the Centennial celebration in our 
        Nation's history.

SEC. 3. DEFINITIONS.

    In this Act:
            (1) Historic district.--The term ``historic district'' 
        means the Centennial Historic District established by section 
        4.
            (2) Management plan.--The term ``management plan'' means 
        the management plan described in section 5(b).
            (3) Secretary.--The term ``Secretary'' means--
                    (A) the Secretary of the Interior; or
                    (B) the head of any Federal agency to which funds 
                are appropriated to carry out this Act.

SEC. 4. CENTENNIAL HISTORIC DISTRICT.

    (a) Establishment.--There is established the Centennial Historic 
District in the city of Philadelphia, Pennsylvania.
    (b) Boundaries.--The boundaries of the historic district shall be 
as depicted on the map titled ``Fairmount Park's Proposed Centennial 
Authorization Boundary'', numbered A, and dated December 2007. The map 
shall be on file and available for public inspection in the appropriate 
offices of the National Park Service.

SEC. 5. ADMINISTRATION OF CENTENNIAL HISTORIC DISTRICT.

    (a) In General.--The Secretary may make grants to, and enter into 
cooperative agreements with, any State or local government agencies, 
any nonprofit entities designated by the Secretary to operate the 
historic district, or any leaseholders for--
            (1) the preparation of the management plan; and
            (2) the implementation of projects approved by the 
        Secretary under the management plan.
    (b) Management Plan.--
            (1) In general.--The Secretary shall prepare a plan for the 
        development of historic, architectural, natural, cultural, 
        recreational, and interpretive resources within the historic 
        district.
            (2) Requirements.--The management plan shall include--
                    (A) an evaluation of--
                            (i) the condition of historic and 
                        architectural resources in the historic 
                        district; and
                            (ii) the environmental conditions in the 
                        historic district; and
                    (B) recommendations for--
                            (i) rehabilitating, reconstructing, and 
                        adaptively reusing the historic and 
                        architectural resources evaluated under 
                        subparagraph (A)(i);
                            (ii) preserving viewsheds, focal points, 
                        and streetscapes in the historic district;
                            (iii) establishing gateways to the historic 
                        district;
                            (iv) establishing and maintaining parks and 
                        public spaces in the historic district;
                            (v) developing public parking areas in the 
                        historic district;
                            (vi) improving pedestrian and vehicular 
                        circulation in the historic district; and
                            (vii) improving security in the historic 
                        district.
            (3) Restoration, maintenance, and interpretation.--
                    (A) Cooperative agreements.--For projects 
                recommended in the management plan, the Secretary may 
                enter into cooperative agreements with the city of 
                Philadelphia, agents of the city, and designated 
                partners to--
                            (i) provide technical assistance with 
                        respect to the preservation and interpretation 
                        of properties within the historic district; and
                            (ii) mark, improve, restore, and provide 
                        interpretation of properties within the 
                        historic district.
                    (B) Contents.--A cooperative agreement under 
                subparagraph (A) shall ensure that--
                            (i) the Secretary has a right of access at 
                        reasonable times to public portions of the 
                        historic district for interpretive and other 
                        purposes; and
                            (ii) no change or alteration shall be made 
                        in the property except with the agreement of 
                        the property owner, the Secretary, and any 
                        Federal agency that may have regulatory 
                        jurisdiction over the property.
    (c) Capital Projects.--
            (1) In general.--The Secretary shall, to the extent funds 
        are available, make grants for capital improvements in the 
        historic district.
            (2) Application.--To be eligible for a grant under this 
        subsection, an entity shall submit to the Secretary an 
        application that includes information concerning how the 
        proposed capital project will improve the historic district.
            (3) Considerations.--In making grants under this 
        subsection, the Secretary shall--
                    (A) consider the cost and benefit of the proposed 
                capital project; and
                    (B) give priority to proposed capital projects--
                            (i) providing gateways to, and signage for, 
                        the historic district;
                            (ii) improving historical monuments in the 
                        historic district;
                            (iii) maintaining public parks and spaces 
                        in the historic district;
                            (iv) establishing a trail in the historic 
                        district;
                            (v) maintaining and improving the lake in 
                        the historic district;
                            (vi) improving the streetscape, including 
                        lighting, of the Girard Gateway;
                            (vii) improving pedestrian and vehicular 
                        traffic circulation and parking at the western 
                        end of the Centennial Exhibition grounds; or
                            (viii) restoring Memorial Hall.
            (4) Matching funds.--To be eligible for a grant under this 
        subsection, the recipient shall provide matching, non-Federal 
        funds in an amount equal to not less than 20 percent of the 
        total amount of the grant.

SEC. 6. AUTHORIZATION OF APPROPRIATIONS.

    There is authorized to be appropriated to carry out this Act 
$45,000,000 for fiscal years 2009 through 2013. Of the amount 
appropriated pursuant to this section, the Secretary shall obligate not 
more than 12 percent for planning and technical assistance.

Centennial District Authorization Act of 2008 - Establishes in the City of Philadelphia, Pennsylvania, the Centennial Historic District (District).

Authorizes the Secretary of the Interior to make grants to, or enter into cooperative agreements with, state or local government agencies, nonprofit entities, and any leaseholders to administer the District. Directs the Secretary to: (1) prepare a plan for the development of historic, architectural, natural, cultural, recreational, and interpretive resources within the District; and (2) make grants for capital improvement projects in the District.