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; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Geospatial 
Preparedness Act''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings and purposes.
Sec. 3. Definitions.
Sec. 4. Homeland security and national geospatial preparedness.
Sec. 5. Security policy and guidelines for geospatial data.
Sec. 6. Office of Geospatial Management and Geospatial Information 
                            Officer.
Sec. 7. Authorization of appropriations.

SEC. 2. FINDINGS AND PURPOSES.

    (a) Findings.--The Congress finds the following:
            (1) Geospatial technologies and geospatial data can provide 
        all levels of government and the private sector with proven 
        capabilities to carry out detection, planning, preparedness, 
        mitigation, response, and recovery activities for homeland 
        security purposes that save lives and protect property.
            (2) The completion and maintenance of the National Spatial 
        Data Infrastructure with integrated applications and systems 
        will provide the level of geospatial preparedness required to 
        protect critical infrastructure, strategic assets, the economic 
        base, and persons.
            (3) Geospatial technology and information have proven to be 
        essential to enabling more informed decisionmaking, greater 
        efficiency, increased accountability, and better management in 
        all levels of government and the private sector.
            (4) Building spatial data once and then sharing it many 
        times between all levels of government and the private sector 
        increases the ability of information technology applications 
        and systems to provide better services to the public in a cost-
        effective manner.
            (5) The use of international, national, and industry 
        consensus standards to develop and deploy interoperable 
        geospatial data and geospatial technologies assists the 
        commercial geospatial industry to provide products that make it 
        easier, faster, and less expensive for all levels of government 
        and the private sector to share, integrate, and use geospatial 
        data for decisionmaking.
            (6) Establishing a new Federal Government program to 
        provide financial incentives to State, regional, local, and 
        tribal governments will greatly accelerate adoption of 
        international, national, and industry consensus standards.
            (7) Geospatial technologies and geospatial data can be 
        essential tools for virtually all functions of government and 
        business.
            (8) Geospatial preparedness in the United States is not 
        adequate due to a variety of factors including inadequate 
        geospatial data compatibility, insufficient geospatial data 
        sharing, technology interoperability barriers, institutional 
        and organizational resistance to new ways of doing business, 
        lack of financial incentives to improved use of geospatial 
        technologies, and inefficient geospatial data collection and 
        sharing.
            (9) Interoperable geospatial technology and geospatial data 
        capabilities are emerging and incentives are needed for full 
        adoption and for collaborative use to meet community and 
        national needs.
            (10) Geospatial technologies and geospatial data are 
        maintained by all levels of government and the private sector. 
        A comprehensive nationwide program is necessary to build and 
        maintain a standards-based geospatial spatial data 
        infrastructure and geographic information systems required to 
        respond to increasing demands.
            (11) State, regional, local, and tribal governments, the 
        private sector, and other non-government organizations are 
        investing in geospatial technologies and geospatial data. 
        Incentives are necessary to leverage these investments for more 
        effective use to meet community and national needs.
            (12) Establishing the Office of Geospatial Management, 
        administered by a Geospatial Information Officer, within the 
        Department of Homeland Security will ensure the most effective 
        and efficient management of programs and activities involving 
        geospatial technologies and geospatial data.

SEC. 3. DEFINITIONS.

    In this Act:
            (1) Geographic information systems software and hardware.--
        The term ``geographic information systems software and 
        hardware'' means computer software and hardware required to 
        identify, depict, visualize, analyze, maintain, or otherwise 
        utilize geospatial data.
            (2) Geospatial applications.--The term ``geospatial 
        applications'' means computer software and systems that extend 
        the capabilities of geographic information systems software and 
        hardware to identify, depict, visualize, analyze, maintain, or 
        otherwise utilize geospatial data.
            (3) Geospatial data.--The term ``geospatial data'' means 
        information that identifies, depicts, or describes the 
        geographic locations, boundaries, or characteristics of 
        inhabitants and natural or constructed features on the Earth, 
        including such information derived from, among other sources, 
        socio-demographic analysis, economic analysis, land information 
        records and land use information processing, statistical 
        analysis, survey and observational methodologies, environmental 
        analysis, critical infrastructure protection, satellites, 
        remote sensing, airborne imagery collection, mapping, 
        engineering, construction, global positioning systems, and 
        surveying technologies and activities.
            (4) Geospatial preparedness.--The term ``geospatial 
        preparedness'' means the level of overall capability and 
        capacity necessary to enable all levels of government and the 
        private sector to utilize geospatial data, geographic 
        information systems software and hardware, and geospatial 
        applications to perform essential emergency management 
        functions, including detection, planning, mitigation, response, 
        and recovery, in order to minimize loss of life and property 
        from weapons of mass destruction, terrorist threats, major man-
        made accidents, and natural disasters.
            (5) National spatial data infrastructure.--The term 
        ``National Spatial Data Infrastructure'' means the combination 
        of the geographic information systems software and hardware, 
        geospatial applications, geospatial data, standards, policies, 
        programs, and human resources necessary to acquire, process, 
        analyze, store, maintain, distribute, and otherwise utilize 
        geospatial data as a strategic asset for the Nation.
            (6) Office of geospatial management.--The term ``Office of 
        Geospatial Management'' means the administrative organization 
        responsible for designing, managing, coordinating, and 
        implementing comprehensive geospatial initiatives.
            (7) Standards.--The term ``standards'' means documented 
        international, national, or industry consensus agreements 
        containing technical specifications or other precise criteria 
        to be used consistently as rules, guidelines, or definitions to 
        ensure that materials, products, processes, or services are 
        proper for their purposes.

SEC. 4. HOMELAND SECURITY AND NATIONAL GEOSPATIAL PREPAREDNESS.

    The Secretary shall direct the Chief Information Officer to work, 
consistent with Office of Management and Budget Circular A-16, 
Executive Order 12906, and section 216 of the Electronic Government 
Act, with the Department of the Interior, the Department of Justice, 
the Federal Geographic Data Committee, the National Imagery and Mapping 
Agency, other appropriate Federal agencies, and members of the Steering 
Committee and Coordination Group of the Federal Geographic Data 
Committee, to use and enhance the National Spatial Data Infrastructure 
for homeland security purposes, by--
            (1) developing a comprehensive national enterprise 
        strategy, incorporating industry and government standards, for 
        the coordinated acquisition, building, storage, maintenance, 
        and use of Federal Government, non-Federal Government, and 
        private sector geospatial data with, when feasible and 
        appropriate, integrated and interoperable commercially-provided 
        geographic information systems software and hardware, 
        geospatial applications, geospatial data, and services in order 
        to achieve an adequate level of national geospatial 
        preparedness;
            (2) providing grants, technical assistance, and cooperative 
        agreements to State, regional, local, and tribal government as 
        well as non-profit organizations in order to increase 
        geospatial preparedness by actions such as analyzing 
        requirements, performing strategic planning, sharing geospatial 
        data, developing agreements for sharing geospatial data, 
        integrating geospatial data, developing standards, integrating 
        systems, and acquiring, when feasible and appropriate, 
        interoperable commercially-provided geographic information 
        systems software and hardware, geospatial applications, 
        geospatial data, and Global Positioning System equipment and 
        procuring services in order to achieve an adequate level of 
        national geospatial preparedness;
            (3) coordinating with, and assisting, the Federal 
        Geographic Data Committee, the Office of Management and Budget, 
        and the commercial geospatial industry to establish national 
        standards for the development, acquisition, storage, 
        maintenance, distribution, utilization, and application of 
        geospatial data;
            (4) coordinating with, and assisting, the commercial 
        geospatial industry to establish national standards for the 
        development, distribution, and utilization of geographic 
        information systems software and hardware and geospatial 
        applications; and
            (5) utilizing, when feasible and appropriate, commercially-
        provided interoperable geographic information systems software 
        and hardware, geospatial applications, geospatial data, and 
        services to carry out the responsibilities, activities, and 
        programs authorized by this section.

SEC. 5. SECURITY POLICY AND GUIDELINES FOR GEOSPATIAL DATA.

    The Chief Information Officer of the Department of Homeland 
Security shall establish, within 180 days after the date of the 
enactment of this Act and consistent with overall homeland security 
goals of the Department of Homeland Security, security policy and 
guidelines for the acquisition, processing, and dissemination of 
geospatial data depicting critical infrastructure and strategic assets 
located in the United States.

SEC. 6. OFFICE OF GEOSPATIAL MANAGEMENT AND GEOSPATIAL INFORMATION 
              OFFICER.

    (a) In General.--The Secretary of Homeland Security shall establish 
the Office of Geospatial Management within the Office of the Chief 
Information Officer. The Office of Geospatial Management shall be 
administered by the Geospatial Information Officer under the direction 
of the Chief Information Officer.
    (b) Geospatial Information Officer.--The Geospatial Information 
Officer--
            (1) shall be appointed by the Secretary from among 
        individuals who are skilled in geographic information 
        technology and systems management; and
            (2) shall be responsible for--
                    (A) designing, managing, coordinating, and 
                implementing comprehensive geospatial initiatives; and
                    (B) working with the Chief Information Officer to 
                carry out section 4 and section 5.

SEC. 7. AUTHORIZATION OF APPROPRIATIONS.

    For the purpose of carrying out this Act, there are authorized to 
be appropriated such sums as may be necessary for each of the fiscal 
years 2004 through 2008. Such authorization is in addition to other 
authorizations of appropriations that are available for such purpose.

A: Geospatial Preparedness Act - Requires the Secretary of Homeland Security to direct the Chief Information Officer (CIO) of the Department of Homeland Security to work with the Departments of the Interior and Justice, the National Imagery and Mapping Agency, other appropriate Federal agencies, and members of the Federal Geographic Data Committee to use and enhance the National Spatial Data Infrastructure for homeland security purposes.

Directs the CIO to establish security and policy guidelines for the acquisition, processing, and dissemination of geospatial data depicting critical infrastructure and strategic assets in the United States.

Requires the: (1) Secretary to establish the Office of Geospatial Management within the Office of the CIO; and (2) Geospatial Manager to work with the CIO to design, manage, coordinate, and implement comprehensive geospatial initiatives.
****
Q: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Independent Contractor Tax 
Simplification Act of 1995''.

SEC. 2. FINDINGS.

    The Congress finds that:
            (1) Simplifying the tax rules with respect to independent 
        contractors was the top vote-getter at the 1995 White House 
        Conference on Small Business. Conference delegates recommended 
        that Congress ``should recognize the legitimacy of an 
        independent contractor''. The Conference found that the current 
        common law is ``too subjective'' and called upon the Congress 
        to establish ``realistic and consistent guidelines''.
            (2) It is in the best interests of taxpayers and the 
        Federal Government to have fair and objective rules for 
        determining who is an employee and who is an independent 
        contractor.

SEC. 3. STANDARDS FOR DETERMINING WHETHER INDIVIDUALS ARE NOT 
              EMPLOYEES.

    (a) In General.--Chapter 25 of the Internal Revenue Code of 1986 
(general provisions relating to employment taxes) is amended by adding 
after section 3510 the following new section:

``SEC. 3511. STANDARDS FOR DETERMINING WHETHER INDIVIDUALS ARE NOT 
              EMPLOYEES.

    ``(a) General Rule.--For purposes of this subtitle, and 
notwithstanding any provision of this subtitle to the contrary, if the 
requirements of subsections (b), (c), and (d) are met with respect to 
any service performed by any individual, then with respect to such 
service--
            ``(1) the service provider shall not be treated as an 
        employee,
            ``(2) the service recipient shall not be treated as an 
        employer, and
            ``(3) the payor shall not be treated as an employer.
    ``(b) Service Provider Requirements With Regard to Service 
Recipient.--For the purposes of subsection (a), the requirements of 
this subsection are met if the service provider, in connection with 
performing the service--
            ``(1) has a significant investment in assets and/or 
        training,
            ``(2) incurs significant unreimbursed expenses,
            ``(3) agrees to perform the service for a particular amount 
        of time or to complete a specific result and is liable for 
        damages for early termination without cause,
            ``(4) is paid primarily on a commissioned basis, or
            ``(5) purchases products for resale.
    ``(c) Additional Service Provider Requirements With Regard to 
Others.--For the purposes of subsection (a), the requirements of this 
subsection are met if--
            ``(1) the service provider--
                    ``(A) has a principal place of business,
                    ``(B) does not primarily provide the service in the 
                service recipient's place of business, or
                    ``(C) pays a fair market rent for use of the 
                service recipient's place of business; or
            ``(2) the service provider--
                    ``(A) is not required to perform service 
                exclusively for the service recipient, and
                    ``(B) in the year involved, or in the preceding or 
                subsequent year--
                            ``(i) has performed a significant amount of 
                        service for other persons,
                            ``(ii) has offered to perform service for 
                        other persons through--
                                    ``(I) advertising,
                                    ``(II) individual written or oral 
                                solicitations,
                                    ``(III) listing with registries, 
                                agencies, brokers, and other persons in 
                                the business of providing referrals to 
                                other service recipients, or
                                    ``(IV) other similar activities, or
                            ``(iii) provides service under a business 
                        name which is registered with (or for which a 
                        license has been obtained from) a State, a 
                        political subdivision of a State, or any agency 
                        or instrumentality of 1 or more States or 
                        political subdivisions.
    ``(d) Written Document Requirements.--For purposes of subsection 
(a), the requirements of this subsection are met if the services 
performed by the individual are performed pursuant to a written 
contract between such individual and the person for whom the services 
are performed, or the payor, and such contract provides that the 
individual will not be treated as an employee with respect to such 
services for purposes of this subtitle.
    ``(e) Special Rules.--For purposes of this section--
            ``(1) If for any taxable year any service recipient or 
        payor fails to meet the applicable reporting requirements of 
        sections 6041(a), 6041A(a), or 6051 with respect to a service 
        provider, then, unless such failure is due to reasonable cause 
        and not willful neglect, this section shall not apply in 
        determining whether such service provider shall not be treated 
        as an employee of such service recipient or payor for such 
        year.
            ``(2) If the service provider is performing services 
        through an entity owned in whole or in part by such service 
        provider, then the references to `service provider' in 
        subsections (b) through (d) may include such entity, provided 
        that the written contract referred to in paragraph (1) of 
        subsection (d) may be with either the service provider or such 
        entity and need not be with both.
    ``(f) Definitions.--For the purposes of this section--
            ``(1) Service provider.--The term `service provider' means 
        any individual who performs service for another person.
            ``(2) Service recipient.--Except as provided in paragraph 
        (5), the term `service recipient' means the person for whom the 
        service provider performs such service.
            ``(3) Payor.--Except as provided in paragraph (5), the term 
        `payor' means the person who pays the service provider for the 
        performance of such service in the event that the service 
        recipients do not pay the service provider.
            ``(4) In connection with performing the service.--The term 
        `in connection with performing the service' means in connection 
        or related to--
                    ``(A) the actual service performed by the service 
                provider for the service recipients or for other 
                persons for whom the service provider has performed 
                similar service, or
                    ``(B) the operation of the service provider's trade 
                or business.
            ``(5) Exceptions.--The terms `service recipient' and 
        `payor' do not include any entity which is owned in whole or in 
        part by the service provider.''
    (b) Clerical Amendment.--The table of sections for chapter 25 of 
such Code is amended by adding at the end the following new item:

                              ``Sec. 3511. Standards for determining 
                                        whether individuals are not 
                                        employees.''
    (c) Effective Date.--The amendments made by this Act shall apply to 
services performed after December 31, 1995.

A: Independent Contractor Tax Simplification Act of 1995 - Amends the Internal Revenue Code to provide that, for purposes of determining the employment status of individuals as employees, a service provider shall not be treated as an employee, a service recipient shall not be treated as an employer, and a payor shall not be treated as an employer if:  (1) a service provider has a significant investment in assets and training, incurs significant unreimbursed expenses, agrees to perform the service for a specified amount of time or to complete a specific result and is responsible for damages for early termination without cause, receives payment primarily on a commission basis, or has purchased resale products; (2) the service provider has a principal place of business, does not primarily provide service in the service recipient's place of business, or pays a fair market rent for use of the recipient's place of business or does not have to perform service only for the service recipient and, in the current year or in the proceeding or subsequent years, has performed or has offered to perform a significant amount of service for other persons; and (3) the services by an individual are performed according to a written contract between the service recipient or payor which provides that the individual will not be treated as an employee.
****
Q: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Increasing Competition in 
Pharmaceuticals Act''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) As part of the Food and Drug Administration's mission 
        to protect the public health, the Food and Drug Administration 
        approves generic drugs that help establish competitive markets 
        for treatments that improve the lives of millions of patients 
        in the United States.
            (2) Rising health care costs, including prescription drug 
        costs, continue to be a major concern for patients in the 
        United States.
            (3) Eighty-eight percent of prescription drugs dispensed in 
        the United States, or nearly 9 out of every 10 prescriptions 
        dispensed, are generic drugs.
            (4) Studies suggest that generic drugs account for only 28 
        percent of total prescription drug spending and were 
        responsible for $1,680,000,000,000 in estimated savings over 
        the period of 2005 to 2014.
            (5) Increasing generic competition can be an effective way 
        to help keep prescription drug costs low for patients, the 
        health care system, and Federal and State government.
            (6) Despite enactment of the Generic Drug User Fee 
        Amendments of 2012 (21 U.S.C. 379j-41 et seq.), which was 
        established to provide the Food and Drug Administration with 
        industry funding to ensure a more consistent timeline for 
        generic drug approvals, a significant backlog of abbreviated 
        new drug applications for generic drugs remains.
            (7) The sudden, aggressive price hikes for a variety of 
        recently acquired off-patent drugs that have been used widely 
        for decades, for which there is no generic drug competitor, 
        also affects access to affordable prescriptions for patients 
        and the overall cost of health care in the United States.
            (8) Improving the review of abbreviated new drug 
        applications and the approval of generic drugs would help to 
        improve competition and lower prices for patients.
            (9) Establishing a clear timeframe for the Food and Drug 
        Administration to expedite the review of certain applications 
        for generic drugs would also help keep drug prices down and 
        improve timely access for patients.

          TITLE I--REMOVING REGULATORY BARRIERS TO COMPETITION

SEC. 101. IMPROVING GENERIC ACCESS.

    Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)) is amended by adding at the end the following:
    ``(11)(A) The Secretary shall prioritize the review, and act not 
later than 150 calendar days after the date of the submission of an 
application, on an application that has been submitted for review under 
this subsection, or on a supplement to such an application, that is for 
a drug that--
            ``(i) has been introduced into interstate commerce by not 
        more than one manufacturer or sponsor, as applicable, in the 
        last 3 months and with respect to which tentative approval 
        under paragraph (5) has been granted for not more than 2 
        applications; or
            ``(ii) has been included on the list under section 506E.
    ``(B) The fees pursuant to section 744B(a)(3) shall be waived with 
respect to an application described in subparagraph (A), unless such 
application contains a certification under paragraph (2)(A)(vii)(IV).
    ``(C) The Secretary may expedite an inspection or reinspection 
under section 704 of an establishment that proposes to manufacture a 
drug described in subparagraph (A).''.

SEC. 102. REPORTING ON PENDING GENERIC DRUG APPLICATIONS.

    Not later than 90 calendar days after the date of enactment of this 
Act, and every 90 calendar days thereafter until October 1, 2022, the 
Secretary of Health and Human Services shall submit to the Committee on 
Health, Education, Labor, and Pensions of the Senate, the Special 
Committee on Aging of the Senate, and the Committee on Energy and 
Commerce of the House of Representatives a report that provides--
            (1) the number of applications that were filed under 
        section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(j)) prior to October 1, 2015, that are pending at 
        the time the report is submitted;
            (2) the average and median total time such applications 
        have been pending;
            (3) the number of such applications that contain 
        certifications under section 505(j)(2)(A)(vii)(IV) of such Act; 
        and
            (4) the number of such applications that are subject to 
        priority review.

                  TITLE II--INCENTIVIZING COMPETITION

SEC. 201. GENERIC PRIORITY REVIEW VOUCHER.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 506G the following:

``SEC. 506H. GENERIC PRIORITY REVIEW VOUCHER.

    ``(a) Definitions.--In this section:
            ``(1) The term `priority review' with respect to an 
        application under section 505(j) means review and action by the 
        Secretary on such application by the Secretary not later than 
        150 calendar days after such application has been submitted for 
        review.
            ``(2) The term `priority review voucher' means a voucher 
        for priority review for an application under section 505(j). 
        Such voucher shall be awarded upon the approval of the 
        application described in 505(j)(11)(A), unless such application 
        contains a certification under subclauses (III) and (IV) of 
        section 505(j)(2)(A)(vii).
    ``(b) Generic Priority Review Vouchers, in General.--The Secretary 
shall award a priority review voucher to the sponsor of an application 
described in 505(j)(11)(A) upon approval by the Secretary of such 
application.
    ``(c) Transferability.--
            ``(1) In general.--The recipient of a priority review 
        voucher under subsection (a) may transfer (including by sale) 
        the entitlement to such voucher. There is no limit on the 
        number of times a priority review voucher may be transferred 
        before such voucher is used.
            ``(2) Notification to the secretary.--Each person to whom a 
        voucher is transferred shall notify the Secretary of such 
        change in ownership of such voucher not later than 30 calendar 
        days after such transfer.
    ``(d) Notification.--The sponsor shall notify the Secretary not 
later than 30 calendar days prior to the submission of a human drug 
application that is intended to be the subject of a priority review 
voucher, except in the case of such an application that was pending as 
of October 1, 2015, in which case the sponsor of such pending 
application shall notify the Secretary not later than 30 days after the 
date on which such voucher is awarded.
    ``(e) Fees.--The sponsor of an application that is the subject of a 
priority review voucher shall be subject to the fees required under 
section 744A.
    ``(f) Clarification.--Nothing in this section affects any period of 
exclusivity under this Act or the protection of any patent.
    ``(g) Revocation.--The Secretary may revoke any priority review 
voucher awarded under subsection (b) if the drug for which such voucher 
was awarded is not marketed in the United States within the 365-day 
period beginning on the date of the approval of such drug.
    ``(h) Sunset.--The authority of the Secretary to carry out the 
generic priority review voucher program under this section shall 
terminate on October 1, 2022.''.

SEC. 202. TROPICAL DISEASE PRODUCT APPLICATION.

    Section 524(a)(4)(A) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360n(a)(4)(A)) is amended--
            (1) in clause (i), by striking ``and'';
            (2) in clause (ii), by adding ``and'' after the semicolon; 
        and
            (3) by adding at the end the following:
                            ``(iii) that contains reports of new 
                        clinical investigations (other than 
                        bioavailability studies) essential to the 
                        approval of the application and conducted or 
                        sponsored by the applicant;''.

                        TITLE III--STUDY ON REMS

SEC. 301. STUDY ON REMS.

    (a) In General.--The Comptroller General shall conduct a review of 
the implementation and effectiveness of section 505-1 of the Food, 
Drug, and Cosmetic Act (21 U.S.C. 355-1) (referred to in this section 
as the ``REMS program''), which section--
            (1) authorizes the Secretary of Health and Human Services 
        to require a risk evaluation and mitigation strategy (referred 
        to in this section as ``REMS''); and
            (2) codifies and expands regulations issued by the Food and 
        Drug Administration under which the Food and Drug 
        Administration may impose restrictions on distribution 
        necessary to ensure a drug is safely used.
    (b) Contents of Study.--In conducting the review under subsection 
(a), the Comptroller General shall examine each relevant element 
described in subsection (c) with respect to each of the following 
categories:
            (1) New drug applications under subsection (b) of section 
        505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355(b)).
            (2) Abbreviated new drug applications under subsection (j) 
        of such section.
            (3) Applications for the license of a biological product 
        under section 351 of the Public Health Service Act (42 U.S.C. 
        262).
            (4) Single, shared system REMS, as described in section 
        505-1(i) of the Food, Drug, and Cosmetic Act (21 U.S.C. 355-
        1(i)).
            (5) Controlled substances as defined in section 102 of the 
        Controlled Substances Act (21 U.S.C. 802).
            (6) RISKMAPs or other risk management processes employed by 
        the Food and Drug Administration.
    (c) Elements Under Review.--In conducting the review under 
subsection (a), the Comptroller General shall examine each of the 
following elements with respect to each relevant category described in 
subsection (b).
            (1) For each type of application, and by year, the number 
        of REMS required, submitted, voluntarily submitted, modified, 
        added, approved, or removed, and whether those REMS included 
        elements to assure safe use, such as restricted distribution.
            (2) For each type of application, the number of REMS in 
        effect at the time of the review and the number of years that 
        each such REMS has been in effect at such time.
            (3) If and how the REMS program has improved drug safety, 
        as compared to the time before the REMS program became 
        effective, and how the Food and Drug Administration tracks such 
        improvements.
            (4) The burdens associated with REMS, including burdens on 
        patients, health care providers, generic drug manufacturers, 
        and brand drug manufacturers.
            (5) In the case of a REMS program for a drug containing a 
        controlled substance, the coordination between the Food and 
        Drug Administration and the Drug Enforcement Administration.
            (6) The impact of additional risk mitigation strategies, 
        including non-REMS restricted distribution systems, imposed by 
        companies outside of what is required under the REMS program.
            (7) The standards and policies applied by the Food and Drug 
        Administration to require, modify, add, or remove, a REMS, and 
        how those standards and policies have changed since the REMS 
        program became effective.
    (d) Report.--Not later than May 1, 2018, the Comptroller General 
shall submit a report to the Committee on Health, Education, Labor, and 
Pensions of the Senate, the Special Committee on Aging of the Senate, 
and the Committee on Energy and Commerce of the House of 
Representatives, containing the results of the review described in this 
section.

A:
Increasing Competition in Pharmaceuticals Act This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs: (1) for which there is a shortage, or (2) that have not been recently introduced to the market by more than one manufacturer and for which tentative approval has not been granted to more than two applications. The Food and Drug Administration (FDA) must prioritize the review of such submissions and act on them within 150 days. User fees are waived for such an application unless the drug is under patent. The FDA may expedite the inspection of a facility proposed to manufacture such a drug. The FDA must award a transferrable generic drug priority review voucher to the sponsor of such an application upon approval. A voucher may be used to have the FDA review and take action upon a generic drug application within 150 days of submission. The FDA may revoke a voucher awarded for a drug that is not marketed within one year of approval. This voucher program is terminated at the end of FY2022. The FDA must periodically report on generic drug applications filed before FY2016 that are still pending. For a new drug application to be eligible for a priority review voucher as a tropical disease product application, the application must include new, essential clinical investigations. The Government Accountability Office must study the FDA's program for drug risk evaluation and mitigation strategies.
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