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

Q: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Intelligence Authorization Act for 
Fiscal Year 2015''.

                    TITLE I--INTELLIGENCE ACTIVITIES

SEC. 101. AUTHORIZATION OF APPROPRIATIONS.

    Funds are hereby authorized to be appropriated for fiscal year 2015 
for the conduct of the intelligence and intelligence-related activities 
of the following elements of the United States Government:
            (1) The Office of the Director of National Intelligence.
            (2) The Central Intelligence Agency.
            (3) The Department of Defense.
            (4) The Defense Intelligence Agency.
            (5) The National Security Agency.
            (6) The Department of the Army, the Department of the Navy, 
        and the Department of the Air Force.
            (7) The Coast Guard.
            (8) The Department of State.
            (9) The Department of the Treasury.
            (10) The Department of Energy.
            (11) The Department of Justice.
            (12) The Federal Bureau of Investigation.
            (13) The Drug Enforcement Administration.
            (14) The National Reconnaissance Office.
            (15) The National Geospatial-Intelligence Agency.
            (16) The Department of Homeland Security.

SEC. 102. CLASSIFIED SCHEDULE OF AUTHORIZATIONS.

    (a) Specifications of Amounts and Personnel Levels.--The amounts 
authorized to be appropriated under section 101 and, subject to section 
103, the authorized personnel ceilings as of September 30, 2015, for 
the conduct of the intelligence activities of the elements listed in 
paragraphs (1) through (16) of section 101, are those specified in the 
classified Schedule of Authorizations prepared to accompany the bill 
H.R. __ of the One Hundred Thirteenth Congress.
    (b) Availability of Classified Schedule of Authorizations.--
            (1) Availability.--The classified Schedule of 
        Authorizations referred to in subsection (a) shall be made 
        available to the Committee on Appropriations of the Senate, the 
        Committee on Appropriations of the House of Representatives, 
        and to the President.
            (2) Distribution by the president.--Subject to paragraph 
        (3), the President shall provide for suitable distribution of 
        the classified Schedule of Authorizations, or of appropriate 
        portions of the Schedule, within the executive branch.
            (3) Limits on disclosure.--The President shall not publicly 
        disclose the classified Schedule of Authorizations or any 
        portion of such Schedule except--
                    (A) as provided in section 601(a) of the 
                Implementing Recommendations of the 9/11 Commission Act 
                of 2007 (50 U.S.C. 3306(a));
                    (B) to the extent necessary to implement the 
                budget; or
                    (C) as otherwise required by law.

SEC. 103. PERSONNEL CEILING ADJUSTMENTS.

    (a) Authority for Increases.--With the approval of the Director of 
the Office of Management and Budget, the Director of National 
Intelligence may authorize employment of civilian personnel in excess 
of the number of positions authorized for fiscal year 2015 by the 
classified Schedule of Authorizations referred to in section 102(a) if 
the Director of National Intelligence determines that such action is 
necessary to the performance of important intelligence functions, 
except that the number of personnel employed in excess of the number 
authorized under such section may not, for any element of the 
intelligence community, exceed 3 percent of the number of civilian 
personnel authorized under such Schedule for such element.
    (b) Treatment of Certain Personnel.--The Director of National 
Intelligence shall establish guidelines that govern, for each element 
of the intelligence community, the treatment under the personnel levels 
authorized under section 102(a), including any exemption from such 
personnel levels, of employment or assignment in--
            (1) a student program, trainee program, or similar program;
            (2) a reserve corps or as a reemployed annuitant; or
            (3) details, joint duty, or long-term, full-time training.
    (c) Notice to Congressional Intelligence Committees.--The Director 
of National Intelligence shall notify the congressional intelligence 
committees in writing at least 15 days prior to each exercise of an 
authority described in subsection (a).

SEC. 104. INTELLIGENCE COMMUNITY MANAGEMENT ACCOUNT.

    (a) Authorization of Appropriations.--There is authorized to be 
appropriated for the Intelligence Community Management Account of the 
Director of National Intelligence for fiscal year 2015 the sum of 
$__________. Within such amount, funds identified in the classified 
Schedule of Authorizations referred to in section 102(a) for advanced 
research and development shall remain available until September 30, 
2016.
    (b) Authorized Personnel Levels.--The elements within the 
Intelligence Community Management Account of the Director of National 
Intelligence are authorized __ positions as of September 30, 2015. 
Personnel serving in such elements may be permanent employees of the 
Office of the Director of National Intelligence or personnel detailed 
from other elements of the United States Government.
    (c) Classified Authorizations.--
            (1) Authorization of appropriations.--In addition to 
        amounts authorized to be appropriated for the Intelligence 
        Community Management Account by subsection (a), there are 
        authorized to be appropriated for the Community Management 
        Account for fiscal year 2015 such additional amounts as are 
        specified in the classified Schedule of Authorizations referred 
        to in section 102(a). Such additional amounts for advanced 
        research and development shall remain available until September 
        30, 2016.
            (2) Authorization of personnel.--In addition to the 
        personnel authorized by subsection (b) for elements of the 
        Intelligence Community Management Account as of September 30, 
        2015, there are authorized such additional personnel for the 
        Community Management Account as of that date as are specified 
        in the classified Schedule of Authorizations referred to in 
        section 102(a).

 TITLE II--CENTRAL INTELLIGENCE AGENCY RETIREMENT AND DISABILITY SYSTEM

SEC. 201. AUTHORIZATION OF APPROPRIATIONS.

    There is authorized to be appropriated for the Central Intelligence 
Agency Retirement and Disability Fund for fiscal year 2015 the sum of 
$__________.

                     TITLE III--GENERAL PROVISIONS

SEC. 301. INCREASE IN EMPLOYEE COMPENSATION AND BENEFITS AUTHORIZED BY 
              LAW.

    Appropriations authorized by this Act for salary, pay, retirement, 
and other benefits for Federal employees may be increased by such 
additional or supplemental amounts as may be necessary for increases in 
such compensation or benefits authorized by law.

SEC. 302. RESTRICTION ON CONDUCT OF INTELLIGENCE ACTIVITIES.

    The authorization of appropriations by this Act shall not be deemed 
to constitute authority for the conduct of any intelligence activity 
which is not otherwise authorized by the Constitution or the laws of 
the United States.

A: Intelligence Authorization Act for Fiscal Year 2015 - Authorizes FY2015 appropriations for the conduct of intelligence and intelligence-related activities of the: (1) Office of the Director of National Intelligence (DNI); (2) Central Intelligence Agency (CIA); (3) Department of Defense (DOD); (4) Defense Intelligence Agency (DIA); (5) National Security Agency (NSA); (6) Departments of the Army, Navy, and Air Force; (7) Coast Guard; (8) Departments of State, the Treasury, Energy (DOE), and Justice (DOJ); (9) Federal Bureau of Investigation (FBI); (10) Drug Enforcement Administration (DEA); (11) National Reconnaissance Office; (12) National Geospatial-Intelligence Agency; and (13) Department of Homeland Security (DHS). Specifies that the amounts authorized and the authorized personnel ceilings as of September 30, 2015, for such activities are those in the classified Schedule of Authorizations, which shall be made available to the congressional appropriations committees and the President. Allows the DNI, with the approval of the Office of Management and Budget (OMB), to authorize employment of civilian personnel in excess of the number authorized for FY2015 when necessary for the performance of important intelligence functions. Requires notification to the intelligence committees on the use of such authority. Requires the DNI to establish guidelines to govern the treatment under such authorized personnel levels of employment or assignment in: (1) a student or trainee program; (2) a reserve corps or as a reemployed annuitant; or (3) details, joint duty, or long term, full-time training. Authorizes appropriations for the Intelligence Community Management Account for FY2015, as well as for personnel positions for elements within such Account. Authorizes appropriations for FY2015 for the Central Intelligence Agency Retirement and Disability Fund. Permits appropriations authorized by this Act for salary, pay, retirement, and other benefits for federal employees to be increased by such additional or supplemental amounts as necessary for increases in such compensation or benefits authorized by law. Prohibits the authorization of appropriations by this Act from being deemed to constitute authority to conduct any intelligence activity not otherwise authorized by the Constitution or laws of the United States.
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Q: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Lewis and Clark Voyage of Scientific 
Discovery Act''.

SEC. 2. LONG-TERM MONITORING PROGRAM.

    (a) Establishment.--Not later than 2 years after the date of the 
enactment of this Act, the Secretary of the Interior, in consultation 
with the Director of the United States Geological Survey, shall 
establish a program at the River Studies Center of the Biological 
Resources Division of the United States Geological Survey, located in 
Columbia, Missouri--
            (1) to determine and monitor the biological and chemical 
        characteristics of the Missouri River;
            (2) to determine and monitor the interrelationship of those 
        characteristics with the hydrology and geomorphology of the 
        river; and
            (3) to monitor and assess the biota, including threatened 
        or endangered species, habitats, and water quality of the 
        Missouri River.
    (b) Development.--To develop the program, the Secretary of the 
Interior and the Director of the United States Geological Survey shall 
consult with--
            (1) the Governors of affected States, acting through--
                    (A) the Missouri River Natural Resources Committee; 
                and
                    (B) the Missouri River Basin Association; and
            (2) the Secretary of Agriculture;
            (3) the Secretary of the Army;
            (4) the Western Area Power Administration;
            (5) the Administrator of the Environmental Protection 
        Agency; and
            (6) the Missouri River Basin Tribes.
    (c) Activities.--The program under subsection (b) shall provide 
scientific information to--
            (1) guide operation and management of the Missouri River; 
        and
            (2) measure and model the impact of management alternatives 
        through--
                    (A) monitoring of biota, including threatened or 
                endangered species, habitats, and water quality;
                    (B) focused investigations of cause and effect 
                relationships; and
                    (C) identification and evaluation of methods to 
                conserve fish and wildlife, including threatened and 
                endangered species.
    (d) Baseline.--The program under subsection (b) shall establish a 
baseline of conditions against which future activities can be measured.
    (e) Database.--The Secretary of the Interior shall--
            (1) establish a database on Missouri River biota, including 
        threatened or endangered species, habitats, and water quality; 
        and
            (2) make the database readily available to the public.
    (f) Report.--Not later than 3 years after the date of establishment 
of the program under subsection (b), and not less frequently than every 
3 years thereafter, the Secretary of the Interior, acting through the 
Director of the United States Geological Survey, shall--
            (1) review the program;
            (2) as necessary, establish and revise the objectives of 
        the program; and
            (3) submit to Congress a report on the environmental health 
        of the Missouri River.
    (g) Indian Tribes.--Notwithstanding any other provision of law, the 
Secretary of the Interior shall enter into contracts, pursuant to the 
Indian Self Determination Act (title I of the Indian Self Determination 
and Education Assistance Act; 25 U.S.C. chapter 14, subchapter II, part 
A (25 U.S.C. 450f et. seq.)) with Tribes whose Reservations are located 
along the Missouri River and have an interest in environmental 
restoration. The tasks to be contracted shall implement the goals set 
forth in this section and shall complement the activities undertaken by 
the Secretary of the Interior and the affected State Governments.
    (h) Authorization of Appropriations.--
            (1) In general.--There are authorized to be appropriated to 
        the Secretary of the Interior to carry out this section--
                    (A) $6,500,000 for fiscal year 2002;
                    (B) $8,500,000 for fiscal year 2003; and
                    (C) $15,100,000 for each of fiscal years 2004 
                through 2016.
            (2) Allocation of funds.--Funding of the program shall be 
        implemented in the following manner:
                    (A) Not more than the following percentage of the 
                funds available shall be directed to the River Studies 
                Center of the Biological Resources Division of the 
                United States Geological Survey, located in Columbia, 
                Missouri:
                            (i) 25 percent in fiscal year 2002
                            (ii) 40 perccent in fiscal year 2003
                            (iii) 65 percent in fiscal years after 
                        2003.
                At least 50 percent of such funds shall be directed to 
                the River Studies Center in fiscal years after 2003.
                    (B) The remaining funds shall be made available to 
                State fish and wildlife agencies in the Missouri River 
                basin to conduct monitoring activities designed to 
                enhance and supplement existing scientific knowledge of 
                the Missouri River system.
            (3) Threatened and endangered species.--Of the amounts made 
        available under paragraph (1) for each fiscal year, $1,500,000 
        shall be made available to the Secretary of the Interior and 
        the State agencies with jurisdiction for Missouri River fish 
        and wildlife to monitor and conduct focused investigations of 
        endangered fish, including pallid sturgeon response to main 
        stem reservoir operations.
            (4) State agency funding.--Funds authorized to be 
        appropriated under this section shall be made available as 
        necessary to contract with the State agencies with jurisdiction 
        for Missouri River fish and wildlife to collect field data and 
        support field operations for the monitoring component of the 
        program.
            (5) Funding of focused investigations.--The focused 
        investigations component of the program established under this 
        section shall be funded using a competitive process. Each year, 
        the directors of the State fish and game agencies with 
        jurisdiction for Missouri River fish and wildlife, in 
        consultation with the Secretary of the Interior, and the 
        entities listed under section 2(b)(1), shall prioritize 
        information needs and issue a request for proposals to State, 
        Federal, for-profit, and not-for-profit organizations with 
        Missouri River interest and expertise. The directors and the 
        Secretary shall review and select those proposals to be funded.

A: Lewis and Clark Voyage of Scientific Discovery Act - Directs the Secretary of the Interior to establish a program at the River Studies Center of the Biological Resources Division of the United States Geological Survey in Columbia, Missouri, to determine and monitor the biological and chemical characteristics of the Missouri River, determine and monitor the relationship of those characteristics with the river's hydrology and geomorphology, and monitor and assess the river's biota and water quality. Requires contracts with Indian tribes whose reservations are located along the Missouri River and have an interest in environmental restoration.Requires establishment of a publicly available database.Makes a specified amount of funds provided under this Act available to monitor and conduct focused investigations of endangered fish, including pallid sturgeon.
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Q: 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.

A:
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.
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