SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Clean Energy Technology
Manufacturing and Export Assistance Act of 2011''.

SEC. 2. CLEAN ENERGY TECHNOLOGY MANUFACTURING AND EXPORT ASSISTANCE
              PROGRAM.

    (a) Definitions.--In this section:
            (1) Clean energy technology.--The term ``clean energy
        technology'' means a technology related to the production, use,
        transmission, storage, control, or conservation of energy that
        is designed to--
                    (A) reduce the need for additional energy
                supplies--
                            (i) by using existing energy supplies with
                        greater efficiency; or
                            (ii) by transmitting, distributing, or
                        transporting energy with greater effectiveness
                        through the infrastructure of the United
                        States;
                    (B) diversify the sources of the energy supply of
                the United States to strengthen energy security and to
                increase supplies of energy with a favorable balance of
                environmental effects if the entire technology system
                is considered; or
                    (C) contribute to a stabilization of atmospheric
                greenhouse gas concentrations through reduction,
                avoidance, or long-term sequestration of energy-related
                emissions.
            (2) Small- and medium-sized businesses.--The term ``small-
        and medium-sized businesses'' means businesses with not more
        than 500 employees.
            (3) Under secretary.--The term ``Under Secretary'' means
        the Under Secretary for International Trade of the Department
        of Commerce.
    (b) Establishment.--The Secretary of Commerce shall establish a
Clean Energy Technology Manufacturing and Export Assistance Program, to
be carried out by the Under Secretary, for the purposes of--
            (1) promoting policies to reduce production costs and
        encourage innovation, investment, and productivity among
        businesses in the United States that produce or export clean
        energy technologies or related services;
            (2) implementing a national strategy with respect to the
        exportation of clean energy technologies and related services
        from the United States; and
            (3) ensuring that businesses in the United States that
        produce or export clean energy technologies or related
        services, including suppliers of parts for the production of
        clean energy technologies and engineering and design firms,
        have the information and assistance necessary--
                    (A) to be competitive; and
                    (B) to create and maintain clean energy technology
                jobs in the United States.
    (c) Assistance.--
            (1) In general.--The Under Secretary shall, consistent with
        the National Export Initiative (established by Executive Order
        13534 (75 Fed. Reg. 12433)), provide information and other
        assistance under the program established under subsection (b)
        to businesses in the United States, particularly small- and
        medium-sized businesses, to promote the production and
        exportation of clean energy technologies and related services.
            (2) Types of assistance.--The assistance provided under
        paragraph (1) shall include--
                    (A) analyzing and making recommendations with
                respect to policies to reduce production costs and
                encourage innovation, investment, and productivity
                among businesses in the United States that produce or
                export clean energy technologies or related services;
                    (B) providing information to businesses in the
                United States with respect to--
                            (i) the process of exporting clean energy
                        technologies and related services to foreign
                        countries;
                            (ii) opportunities for the exportation of
                        such technologies and services to foreign
                        countries;
                            (iii) tailoring their products and
                        activities to the needs of specific markets in
                        foreign countries; and
                            (iv) conducting business in foreign
                        countries, including with respect to the
                        financing, marketing, and assembly of exported
                        products and other logistics with respect to
                        those products; and
                    (C) assisting businesses in the United States in
                expressing their views and providing input with respect
                to any policy developments relating to the production
                or exportation of clean energy technologies or related
                services.
    (d) Reports to Congress.--
            (1) Report on implementation of program.--Not later than
        180 days after the date of the enactment of this Act, the Under
        Secretary shall submit to Congress a report describing how the
        program established under subsection (b) will be used to--
                    (A) encourage the production and exportation of
                clean energy technologies and related services in the
                United States;
                    (B) encourage the creation and maintenance of clean
                energy technology jobs in the United States; and
                    (C) benefit small- and medium-sized businesses in
                the United States.
            (2) Report on effectiveness of program.--Not later than
        January 1, 2015, the Under Secretary shall submit to Congress a
        report on the program established under subsection (b) that
        includes--
                    (A) an assessment of the extent to which the
                program has been successful--
                            (i) in analyzing and making recommendations
                        with respect to policies to reduce production
                        costs and encourage innovation, investment, and
                        productivity among businesses in the United
                        States that produce or export clean energy
                        technologies or related services;
                            (ii) in increasing the competitiveness of
                        businesses in the United States that export
                        clean energy technologies or related services
                        to foreign countries;
                            (iii) in assisting businesses in the United
                        States, particularly small- and medium-sized
                        businesses, in exporting clean energy
                        technologies and related services;
                            (iv) in creating and maintaining clean
                        energy technology jobs in the United States;
                        and
                            (v) in assisting businesses in the United
                        States in expressing their views and providing
                        input with respect to any policy developments
                        relating to the production or exportation of
                        clean energy technologies or related services;
                    (B) detailed information with respect to the
                nature, location, and duration of any jobs created or
                maintained as a result of the program established under
                subsection (b) and a description of the methodology
                used by the Under Secretary to compile that
                information; and
                    (C) any recommendations with respect to continuing
                or improving the program.

Summary: Clean Energy Technology Manufacturing and Export Assistance Act of 2011 - Requires the Secretary of Commerce to establish a Clean Energy Technology Manufacturing and Export Assistance Program, to be carried out by the Under Secretary for International Trade, to: (1) promote policies to reduce production costs and encourage innovation, investment, and productivity among businesses in the United States that produce or export clean energy technologies or related services. (2) implement a national strategy with respect to the exportation of such technologies and related services. And (3) ensure that such businesses, including suppliers of parts for the production of such technologies and engineering and design firms, have the information and assistance necessary to be competitive and to create and maintain clean energy technology jobs. Defines clean energy technology to means a technology related to the production, use, transmission, storage, control, or conservation of energy that is designed to: (1) reduce the need for additional energy supplies by using existing energy supplies with greater efficiency or by transmitting, distributing, or transporting energy with greater effectiveness. (2) diversify the sources of the energy supply of the United States to strengthen energy security and to increase supplies of energy with a favorable balance of environmental effects if the entire technology system is considered. Or (3) contribute to a stabilization of atmospheric greenhouse gas concentrations through reduction, avoidance, or long-term sequestration of energy-related emissions. Requires the Under Secretary, consistent with the National Export Initiative, to provide information and other assistance under the Program to businesses, particularly businesses with no more than 500 employees, to promote the production and exportation of such technologies and related services.

A bill to require the Secretary of Commerce to establish a Clean Energy Technology Manufacturing and Export Assistance Program, and for other purposes.


SECTION 1. SHORT TITLE.
    This Act may be cited as the ``Secure and Responsible Drug Disposal
Act of 2010''.
SEC. 2. FINDINGS.
    Congress finds the following:
        (1) The nonmedical use of prescription drugs is a growing
    problem in the United States, particularly among teenagers.
        (2) According to the Department of Justice's 2009 National
    Prescription Drug Threat Assessment--
            (A) the number of deaths and treatment admissions for
        controlled prescription drugs (CPDs) has increased
        significantly in recent years;
            (B) unintentional overdose deaths involving prescription
        opioids, for example, increased 114 percent from 2001 to 2005,
        and the number of treatment admissions for prescription opioids
        increased 74 percent from 2002 to 2006; and
            (C) violent crime and property crime associated with abuse
        and diversion of CPDs has increased in all regions of the
        United States over the past 5 years.
        (3) According to the Office of National Drug Control Policy's
    2008 Report ``Prescription for Danger'', prescription drug abuse is
    especially on the rise for teens--
            (A) one-third of all new abusers of prescription drugs in
        2006 were 12- to 17-year-olds;
            (B) teens abuse prescription drugs more than any illicit
        drug except marijuana--more than cocaine, heroin, and
        methamphetamine combined; and
            (C) responsible adults are in a unique position to reduce
        teen access to prescription drugs because the drugs often are
        found in the home.
        (4)(A) Many State and local law enforcement agencies have
    established drug disposal programs (often called ``take-back''
    programs) to facilitate the collection and destruction of unused,
    unwanted, or expired medications. These programs help get outdated
    or unused medications off household shelves and out of the reach of
    children and teenagers.
        (B) However, take-back programs often cannot dispose of the
    most dangerous pharmaceutical drugs--controlled substance
    medications--because Federal law does not permit take-back programs
    to accept controlled substances unless they get specific permission
    from the Drug Enforcement Administration and arrange for full-time
    law enforcement officers to receive the controlled substances
    directly from the member of the public who seeks to dispose of
    them.
        (C) Individuals seeking to reduce the amount of unwanted
    controlled substances in their household consequently have few
    disposal options beyond discarding or flushing the substances,
    which may not be appropriate means of disposing of the substances.
    Drug take-back programs are also a convenient and effective means
    for individuals in various communities to reduce the introduction
    of some potentially harmful substances into the environment,
    particularly into water.
        (D) Long-term care facilities face a distinct set of obstacles
    to the safe disposal of controlled substances due to the increased
    volume of controlled substances they handle.
        (5) This Act gives the Attorney General authority to promulgate
    new regulations, within the framework of the Controlled Substances
    Act, that will allow patients to deliver unused pharmaceutical
    controlled substances to appropriate entities for disposal in a
    safe and effective manner consistent with effective controls
    against diversion.
        (6) The goal of this Act is to encourage the Attorney General
    to set controlled substance diversion prevention parameters that
    will allow public and private entities to develop a variety of
    methods of collection and disposal of controlled substances,
    including some pharmaceuticals, in a secure, convenient, and
    responsible manner. This will also serve to reduce instances of
    diversion and introduction of some potentially harmful substances
    into the environment.
SEC. 3. DELIVERY OF CONTROLLED SUBSTANCES BY ULTIMATE USERS FOR
DISPOSAL.
    (a) Regulatory Authority.--Section 302 of the Controlled Substances
Act (21 U.S.C. 822) is amended by adding at the end the following:
    ``(g)(1) An ultimate user who has lawfully obtained a controlled
substance in accordance with this title may, without being registered,
deliver the controlled substance to another person for the purpose of
disposal of the controlled substance if--
        ``(A) the person receiving the controlled substance is
    authorized under this title to engage in such activity; and
        ``(B) the disposal takes place in accordance with regulations
    issued by the Attorney General to prevent diversion of controlled
    substances.
    ``(2) In developing regulations under this subsection, the Attorney
General shall take into consideration the public health and safety, as
well as the ease and cost of program implementation and participation
by various communities. Such regulations may not require any entity to
establish or operate a delivery or disposal program.
    ``(3) The Attorney General may, by regulation, authorize long-term
care facilities, as defined by the Attorney General by regulation, to
dispose of controlled substances on behalf of ultimate users who
reside, or have resided, at such long-term care facilities in a manner
that the Attorney General determines will provide effective controls
against diversion and be consistent with the public health and safety.
    ``(4) If a person dies while lawfully in possession of a controlled
substance for personal use, any person lawfully entitled to dispose of
the decedent's property may deliver the controlled substance to another
person for the purpose of disposal under the same conditions as
provided in paragraph (1) for an ultimate user.''.
    (b) Conforming Amendment.--Section 308(b) of the Controlled
Substances Act (21 U.S.C. 828(b)) is amended--
        (1) by striking the period at the end of paragraph (2) and
    inserting ``; or''; and
        (2) by adding at the end the following:
        ``(3) the delivery of such a substance for the purpose of
    disposal by an ultimate user, long-term care facility, or other
    person acting in accordance with section 302(g).''.
SEC. 4. DIRECTIVE TO THE UNITED STATES SENTENCING COMMISSION.
    Pursuant to its authority under section 994 of title 28, United
States Code, the United States Sentencing Commission shall review and,
if appropriate, amend the Federal sentencing guidelines and policy
statements to ensure that the guidelines and policy statements provide
an appropriate penalty increase of up to 2 offense levels above the
sentence otherwise applicable in Part D of the Guidelines Manual if a
person is convicted of a drug offense resulting from the authorization
of that person to receive scheduled substances from an ultimate user or
long-term care facility as set forth in the amendments made by section
3.

                               Speaker of the House of Representatives.

                            Vice President of the United States and
                                               President of the Senate.

Summary: Secure and Responsible Drug Disposal Act of 2010 - Amends the Controlled Substances Act to allow an ultimate user of a controlled substance who has lawfully obtained such substance to deliver that substance to another person, without being registered, for disposal if: (1) the person receiving the controlled substance is authorized to engage in such activity. And (2) the disposal takes place in accordance with regulations issued by the Attorney General to prevent diversion of controlled substances. Requires the Attorney General, in developing regulations under this Act, to consider the public health and safety, as well as the ease and cost of program implementation and participation by various communities. Permits the Attorney General to authorize long-term care facilities to dispose of controlled substances on behalf of ultimate users who reside, or have resided, at such facilities in a manner that will provide effective controls against diversion and that is consistent with public health and safety. Directs the United States Sentencing Commission to review and, if appropriate, amend its guidelines and policy statements to ensure an appropriate penalty increase for persons convicted of a drug offense involving receipt of a controlled substance for disposal.

A bill to amend the Controlled Substances Act to provide for take-back disposal of controlled substances in certain instances, and for other purposes.


SECTION 1. RURAL COMMUNITY SERVICE.

    Title XI of the of the Higher Education Act of 1965 (20 U.S.C. 1136
et seq.) is amended by adding at the end the following new part:

                   ``PART C--RURAL COMMUNITY SERVICE

``SEC. 1171. FINDINGS; PURPOSE.

    ``(a) Findings.--The Congress finds that--
            ``(1) the Nation's rural centers are facing increasingly
        pressing problems and needs in the areas of economic
        development, community infrastructure and service, social
        policy, public health, housing, crime, education, environmental
        concerns, planning and work force preparation;
            ``(2) there are, in the Nation's rural institutions, people
        with underutilized skills, knowledge, and experience who are
        capable of providing a vast range of services towards the
        amelioration of the problems described in paragraph (1);
            ``(3) the skills, knowledge, and experience in these rural
        institutions, if applied in a systematic and sustained manner,
        can make a significant contribution to the solution of such
        problems; and
            ``(4) the application of such skills, knowledge, and
        experience is hindered by the limited funds available to
        redirect attention to solutions to such rural problems.
    ``(b) Purpose.--It is the purpose of this part to provide
incentives to rural academic institutions to enable such institutions
to work with private and civic organizations to devise and implement
solutions to pressing and severe problems in their communities.

``SEC. 1172. PROGRAM.

    ``The Secretary is authorized to carry out a program of providing
assistance to eligible institutions to enable such institutions to
carry out the authorized activities described in section 1174 in
accordance with the provisions of this part.

``SEC. 1173. APPLICATIONS FOR RURAL COMMUNITY SERVICE GRANTS.

    ``(a) Application.--
            ``(1) In general.--Each eligible institution desiring a
        grant under this part shall submit to the Secretary an
        application at such time, in such form, and containing or
        accompanied by such information and assurances, as the
        Secretary may require by regulation.
            ``(2) Contents.--Each application submitted pursuant to
        paragraph (1) shall--
                    ``(A) describe the activities and services for
                which assistance is sought; and
                    ``(B) contain assurances that the eligible
                institution will enter into a consortium to carry out
                the provisions of this part that includes, in addition
                to the eligible institution, one or more of the
                following entities:
                            ``(i) A community college.
                            ``(ii) A rural local educational agency.
                            ``(iii) A local government.
                            ``(iv) A business or other employer.
                            ``(v) A nonprofit institution.
            ``(3) Waiver.--The Secretary may waive the consortium
        requirements described in paragraph (2) for any applicant who
        can demonstrate to the satisfaction of the Secretary that the
        applicant has devised an integrated and coordinated plan which
        meets the purpose of this part.
    ``(b) Priority in Selection of Applications.--The Secretary shall
give priority to applications that propose to conduct joint projects
supported by other local, State, and Federal programs.
    ``(c) Selection Procedures.--The Secretary, by regulation, shall
develop a formal procedure for the submission of applications under
this part and shall publish in the Federal Register an announcement of
that procedure and the availability of funds under this part.

``SEC. 1174. AUTHORIZED ACTIVITIES.

    ``Grant funds made available under this part shall be used to
support planning, applied research, training, resource exchanges or
technology transfers, the delivery of services, or other activities the
purpose of which is to design and implement programs to assist rural
communities to meet and address their pressing and severe problems,
such as any of the following:
            ``(1) Work force preparation.
            ``(2) Rural poverty and the alleviation of such poverty.
            ``(3) Health care, including health care delivery and
        access as well as health education, prevention and wellness.
            ``(4) Underperforming school systems and students.
            ``(5) Problems faced by the elderly and individuals with
        disabilities in rural settings.
            ``(6) Problems faced by families and children.
            ``(7) Campus and community crime prevention, including
        enhanced security and safety awareness measures as well as
        coordinated programs addressing the root causes of crime.
            ``(8) Rural housing.
            ``(9) Rural infrastructure.
            ``(10) Economic development.
            ``(11) Rural farming and environmental concerns.
            ``(12) Other problem areas which participants in the
        consortium described in section 1173(a)(2)(B) concur are of
        high priority in rural areas.
            ``(13)(A) Problems faced by individuals with disabilities
        and economically disadvantaged individuals regarding
        accessibility to institutions of higher education and other
        public and private community facilities.
            ``(B) Amelioration of existing attitudinal barriers that
        prevent full inclusion of individuals with disabilities in
        their community.

``SEC. 1175. PEER REVIEW.

    ``The Secretary shall designate a peer review panel to review
applications submitted under this part and make recommendations for
funding to the Secretary. In selecting the peer review panel, the
Secretary may consult with other appropriate Cabinet-level Federal
officials and with non-Federal organizations, to ensure that the panel
will be geographically balanced and be composed of representatives from
public and private institutions of higher education, labor, business,
and State and local government, who have expertise in rural community
service or in education.

``SEC. 1176. DISBURSEMENT OF FUNDS.

    ``(a) Multiyear Availability.--Subject to the availability of
appropriations, grants under this part may be made on a multiyear
basis, except that no institution, individually or as a participant in
a consortium, may receive a grant for more than 5 years.
    ``(b) Equitable Geographic Distribution.--The Secretary shall award
grants under this part in a manner that achieves equitable geographic
distribution of such grants.
    ``(c) Matching Requirement.--An applicant under this part and the
local governments associated with its application shall contribute to
the conduct of the program supported by the grant an amount from non-
Federal funds equal to at least one-fourth of the amount grant, which
contribution may be in cash or in kind, fairly evaluated.

``SEC. 1177. DESIGNATION OF RURAL GRANT INSTITUTIONS.

    ``The Secretary shall publish a list of eligible institutions under
this part and shall designate such institutions of higher education as
`Rural Grant Institutions'. The Secretary shall establish a national
network of Rural Grant Institutions so that the results of individual
projects achieved in 1 rural area can be generalized, disseminated,
replicated and applied throughout the Nation.

``SEC. 1178. DEFINITIONS.

    ``As used in this part:
            ``(1) Rural area.--The term `rural area' means any area
        that is--
                    ``(A) outside an urbanized area, as such term is
                defined by the Bureau of the Census; and
                    ``(B) outside any place that--
                            ``(i) is incorporated or Bureau of the
                        Census designated; and
                            ``(ii) has a population of 75,000 or more.
            ``(2) Eligible institution.--The term `eligible
        institution' means an institution of higher education, or a
        consortium of such institutions any one of which meets all the
        requirements of this paragraph, which--
                    ``(A) is located in a rural area;
                    ``(B) draws a substantial portion of its
                undergraduate students from the rural area in which
                such institution is located, or from contiguous areas;
                    ``(C) carries out programs to make postsecondary
                educational opportunities more accessible to residents
                of such rural areas, or contiguous areas;
                    ``(D) has the present capacity to provide resources
                responsive to the needs and priorities of such rural
                areas and contiguous areas;
                    ``(E) offers a range of professional, technical, or
                graduate programs sufficient to sustain the capacity of
                such institution to provide such resources; and
                    ``(F) has demonstrated and sustained a sense of
                responsibility to such rural area and contiguous areas
                and the people of such areas.

``SEC. 1179. AUTHORIZATION OF APPROPRIATIONS; FUNDING RULE.

    ``(a) In General.--There are authorized to be appropriated such
sums as may be necessary in each fiscal year to carry out the
provisions of this part.
    ``(b) Funding Rule.--If in any fiscal year the amount appropriated
pursuant to the authority of subsection (a) is less than 50 percent of
the funds appropriated to carry out part A in such year, then the
Secretary shall make available in such year from funds appropriated to
carry out part A an amount equal to the difference between 50 percent
of the funds appropriated to carry out part A and the amount
appropriated pursuant to the authority of subsection (a).''.

Summary: Amends the Higher Education Act of 1965 to establish a rural community service program. Authorizes appropriations.

A bill to establish a rural community service program, and for other purposes.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Beginning Farmers and Ranchers Tax
Incentive Act of 2003''.

SEC. 2. EXCLUSION OF GAIN FROM SALE OF CERTAIN FARMLAND.

    (a) In General.--Part III of subchapter B of chapter 1 of the
Internal Revenue Code of 1986 (relating to items specifically excluded
from gross income) is amended by adding after section 121 the following
new section:

``SEC. 121A. EXCLUSION OF GAIN FROM SALE OF QUALIFIED FARM PROPERTY.

    ``(a) Exclusion.--In the case of a natural person, gross income
shall not include--
            ``(1) 100 percent of the gain from the sale or exchange of
        qualified farm property to a first-time farmer (as defined in
        section 147(c)(2)(C) (determined without regard to clause
        (i)(II) thereof)) who certifies that the use of such property
        shall be as a farm for farming purposes for not less than 10
        years after such sale or exchange,
            ``(2) 50 percent of the gain from the sale or exchange of
        qualified farm property to any other person who certifies that
        the use of such property shall be as a farm for farming
        purposes for not less than 10 years after such sale or
        exchange, and
            ``(3) 25 percent of the gain from the sale or exchange of
        qualified farm property to any other person for any other use.
    ``(b) Limitation on Amount of Exclusion.--
            ``(1) In general.--The amount of gain excluded from gross
        income under subsection (a) with respect to any taxable year
        shall not exceed $500,000 ($250,000 in the case of a married
        individual filing a separate return), reduced by the aggregate
        amount of gain excluded under subsection (a) for all preceding
        taxable years.
            ``(2) Special rule for joint returns.--The amount of the
        exclusion under subsection (a) on a joint return for any
        taxable year shall be allocated equally between the spouses for
        purposes of applying the limitation under paragraph (1) for any
        succeeding taxable year.
    ``(c) Qualified Farm Property.--
            ``(1) Qualified farm property.--For purposes of this
        section, the term `qualified farm property' means real property
        located in the United States if, during periods aggregating 3
        years or more of the 5-year period ending on the date of the
        sale or exchange of such real property--
                    ``(A) such real property was used as a farm for
                farming purposes by the taxpayer or a member of the
                family of the taxpayer, and
                    ``(B) there was material participation by the
                taxpayer (or such a member) in the operation of the
                farm.
            ``(2) Definitions.--For purposes of this subsection, the
        terms `member of the family', `farm', and `farming purposes'
        have the respective meanings given such terms by paragraphs
        (2), (4), and (5) of section 2032A(e).
            ``(3) Special rules.--For purposes of this section, rules
        similar to the rules of paragraphs (4) and (5) of section
        2032A(b) and paragraphs (3) and (6) of section 2032A(e) shall
        apply.
    ``(d) Other Rules.--For purposes of this section, rules similar to
the rules of subsection (e) and subsection (f) of section 121 shall
apply.
    ``(e) Treatment of Disposition or Change in Use of Property.--
            ``(1) In general.--If, as of the close of any taxable year,
        there is a recapture event with respect to any qualified farm
        property transferred to the taxpayer in a sale or exchange
        described in paragraph (1) or (2) of subsection (a), then the
        tax of the taxpayer under this chapter for such taxable year
        shall be increased by an amount equal to the product of--
                    ``(A) the applicable recapture percentage, and
                    ``(B) 10 percent of the taxpayer's adjusted basis
                in the property on the date such property was
                transferred to the taxpayer.
            ``(2) Applicable recapture percentage.--
                    ``(A) In general.--For purposes of this subsection,
                the applicable recapture percentage shall be determined
                from the following table:

``If the recapture event occurs in: The applicable recapture percentage
                                            is:
                Years 1 through 5....................          100
                Year 6...............................           80
                Year 7...............................           60
                Year 8...............................           40
                Year 9...............................           20
                Years 10 and thereafter..............            0.
                    ``(B) Years.--For purposes of subparagraph (A),
                year 1 shall begin on the date of the sale or exchange
                described in paragraph (1) or (2) of subsection (a).
            ``(3) Recapture event defined.--For purposes of this
        subsection, the term `recapture event' means--
                    ``(A) Cessation of operation.--The cessation of the
                operation of any property the sale or exchange of which
                to the taxpayer is described in paragraph (1) or (2) of
                subsection (a) as a farm for farming purposes.
                    ``(B) Change in ownership.--
                            ``(i) In general.--Except as provided in
                        clause (ii), the disposition of a taxpayer's
                        interest in any property the sale or exchange
                        of which to the taxpayer is described in
                        paragraph (1) or (2) of subsection (a).
                            ``(ii) Agreement to assume recapture
                        liability.--Clause (i) shall not apply if the
                        person acquiring such interest in the property
                        agrees in writing to assume the recapture
                        liability of the person disposing of such
                        interest in effect immediately before such
                        disposition. In the event of such an
                        assumption, the person acquiring the interest
                        in the property shall be treated as the
                        taxpayer for purposes of assessing any
                        recapture liability (computed as if there had
                        been no change in ownership).
            ``(4) Special rules.--
                    ``(A) No credits against tax.--Any increase in tax
                under this subsection shall not be treated as a tax
                imposed by this chapter for purposes of determining the
                amount of any credit under subpart A, B, or D of this
                part.
                    ``(B) No recapture by reason of hardship.--The
                increase in tax under this subsection shall not apply
                to any disposition of property or cessation of the
                operation of any property as a farm for farming
                purposes by reason of any hardship as determined by the
                Secretary.''.
    (b) Conforming Amendment.--The table of sections for part III of
subchapter B of chapter 1 of the Internal Revenue Code of 1986 is
amended by adding after the item relating to section 121 the following
new item:

``Sec. 121A. Exclusion of gain from sale of qualified farm property.''.
    (c) Effective Date.--The amendment made by this section shall apply
to any sale or exchange on or after the date of the enactment of this
Act, in taxable years ending after such date.

Summary: Beginning Farmers and Ranchers Tax Incentive Act of 2003 - Amends the Internal Revenue Code to exclude from gross income: (1) 100 percent of the gain from the sale or exchange of qualified farm property to a first-time farmer who certifies that the use of such property shall be as a farm for farming purposes for not less than 10 years after such sale or exchange. (2) 50 percent of the gain from the sale or exchange of qualified farm property to any other person who certifies that the use of such property shall be as a farm for farming purposes for not less than 10 years after such sale or exchange. And (3) 25 percent of the gain from the sale or exchange of qualified farm property to any other person for any other use. Limits the amount of any of the above exclusions with respect to any taxable year to $500,000 on a joint return.

A bill to amend the Internal Revenue Code of 1986 to provide an exclusion for gain from the sale of farmland to encourage the continued use of the property for farming, and for other purposes.


.--For purposes of section
822(a)(2), the term `joint resolution' means only a joint resolution of
the two Houses of Congress---
            ``(1) the matter after the resolving clause of which is as
        follows: `That the Congress hereby concurs in the determination
        and report of the President relating to compliance by North
        Korea with certain international obligations transmitted
        pursuant to section 822(a)(1) of the North Korea Threat
        Reduction Act of 1999.';
            ``(2) which does not have a preamble; and
            ``(3) the title of which is as follows: `Joint Resolution
        relating to compliance by North Korea with certain
        international obligations pursuant to the North Korea Threat
        Reduction Act of 1999.'.
    ``(b) Congressional Review Procedures.--
            ``(1) Rulemaking.--The provisions of this section are
        enacted by the Congress--
                    ``(A) as an exercise of the rulemaking power of the
                House of Representatives and the Senate, respectively,
                and, as such, shall be considered as part of the rules
                of either House and shall supersede other rules only to
                the extent they are inconsistent therewith; and
                    ``(B) with full recognition of the constitutional
                right of either House to change the rules so far as
                they relate to the procedures of that House at any
                time, in the same manner, and to the same extent as in
                the case of any other rule of that House.
            ``(2) Introduction and referral.--
                    ``(A) Introduction.--A joint resolution described
                in subsection (a)--
                            ``(i) shall be introduced in the House of
                        Representatives by the majority leader or
                        minority leader or by a Member of the House of
                        Representatives designated by the majority
                        leader or minority leader; and
                            ``(ii) shall be introduced in the Senate by
                        the majority leader or minority leader or a
                        Member of the Senate designated by the majority
                        leader or minority leader.
                    ``(B) Referral.--The joint resolution shall be
                referred to the Committee on International Relations of
                the House of Representatives and the Committee on
                Foreign Relations of the Senate.
            ``(3) Discharge of committees.--If a committee to which a
        joint resolution described in subsection (a) is referred has
        not reported such joint resolution by the end of 30 days
        beginning on the date of its introduction, such committee shall
        be discharged from further consideration of such joint
        resolution, and such joint resolution shall be placed on the
        appropriate calendar of the House involved.
            ``(4) Floor consideration in the house of
        representatives.--
                    ``(A) In general.--On or after the third calendar
                day (excluding Saturdays, Sundays, or legal holidays,
                except when the House of Representatives is in session
                on such a day) after the date on which the committee to
                which a joint resolution described in subsection (a) is
                referred has reported, or has been discharged from
                further consideration of, such a joint resolution, it
                shall be in order for any Member of the House to move
                to proceed to the consideration of the joint
                resolution. A Member of the House may make the motion
                only on the day after the calendar day on which the
                Member announces to the House the Member's intention to
                do so. Such motion is privileged and is not debatable.
                The motion is not subject to amendment or to a motion
                to postpone. A motion to reconsider the vote by which
                the motion is agreed to shall not be in order. If a
                motion to proceed to the consideration of the joint
                resolution is agreed to, the House shall immediately
                proceed to consideration of the joint resolution which
                shall remain the unfinished business until disposed of.
                    ``(B) Debate.--Debate on a joint resolution
                described in subsection (a), and on all debatable
                motions and appeals in connection therewith, shall be
                limited to not more than two hours, which shall be
                divided equally between those favoring and those
                opposing the joint resolution. An amendment to the
                joint resolution is not in order. A motion further to
                limit debate is in order and is not debatable. A motion
                to table, a motion to postpone, or a motion to recommit
                the joint resolution is not in order. A motion to
                reconsider the vote by which the joint resolution is
                agreed to or disagreed to is not in order.
                    ``(C) Appeals.--Appeals from the decisions of the
                Chair to the procedure relating to a joint resolution
                described in subsection (a) shall be decided without
                debate.
            ``(5) Floor consideration in the senate.--Any joint
        resolution described in subsection (a) shall be considered in
        the Senate in accordance with the provisions of section
        601(b)(4) of the International Security Assistance and Arms
        Export Control Act of 1976.
            ``(6) Consideration by the other house.--If, before the
        passage by one House of a joint resolution of that House
        described in subsection (a), that House receives from the other
        House a joint resolution described in subsection (a), then the
        following procedures shall apply:
                    ``(A) The joint resolution of the other House shall
                not be referred to a committee and may not be
                considered in the House receiving it except in the case
                of final passage as provided in subparagraph (B)(ii).
                    ``(B) With respect to a joint resolution described
                in subsection (a) of the House receiving the joint
                resolution--
                            ``(i) the procedure in that House shall be
                        the same as if no joint resolution had been
                        received from the other House; but
                            ``(ii) the vote on final passage shall be
                        on the joint resolution of the other House.
                    ``(C) Upon disposition of the joint resolution
                received from the other House, it shall no longer be in
                order to consider the joint resolution that originated
                in the receiving House.
            ``(7) Computation of days.--In the computation of the
        period of 30 days referred to in paragraph (3), there shall be
        excluded the days on which either House of Congress is not in
        session because of an adjournment of more than 3 days to a day
        certain or because of an adjournment of the Congress sine
        die.''.

SEC. 3. EXPANSION OF RESTRICTIONS ON NUCLEAR COOPERATION WITH NORTH
              KOREA.

    Section 822(a) of the North Korea Threat Reduction Act of 1999 is
amended by striking ``such agreement,'' both places it appears and
inserting in both places ``such agreement (or that are controlled under
the Export Trigger List of the Nuclear Suppliers Group),''.

SEC. 4. PROHIBITION ON ASSUMPTION BY UNITED STATES GOVERNMENT OF
              LIABILITY FOR NUCLEAR ACCIDENTS IN NORTH KOREA.

    The North Korea Threat Reduction Act of 1999 is amended--
            (1) by redesignating section 824 (as redesignated by
        section 2(b)(1)) as section 825; and
            (2) by inserting after section 823 (as added by section
        2(b)(2)) the following new section:

``SEC. 824. PROHIBITION ON ASSUMPTION BY UNITED STATES GOVERNMENT OF
              LIABILITY FOR NUCLEAR ACCIDENTS IN NORTH KOREA.

    ``(a) Prohibition.--In supporting the provision of nuclear reactors
to North Korea pursuant to the Agreed Framework, neither the President
nor any department, agency, or instrumentality of the United States
Government may enter into any international agreement, contract, or
other arrangement, the purpose or effect of which is to impose
liability on the United States Government, or otherwise require
financial indemnity by the United States Government, for nuclear
accidents that may occur at nuclear reactors provided to North Korea
pursuant to the Agreed Framework.
    ``(b) Construction.-- Except as provided in subsection (c), the
prohibition of subsection (a) shall apply notwithstanding any other
provision of law.
    ``(c) Exception.--Subsection (a) shall not apply to any treaty
subject to approval by the Senate pursuant to article II, section 2,
clause 2 of the Constitution of the United States.''.

Summary: Prohibits any such agreement, export license, or transfer of any such items unless Congress approves the President's report by enactment of a joint resolution. Subjects to the same prohibition and approval requirements any export license for, or transfer or retransfer to North Korea of, any nuclear material, facilities, goods, services, or technology controlled under the Export Trigger List of the Nuclear Suppliers Group. Declares that in supporting the provision of nuclear reactors to North Korea pursuant to the Agreed Framework, neither the President nor any US agency may enter into any international agreement, contract, or other arrangement to impose liability on the US Government for nuclear accidents that may occur at nuclear reactors provided to North Korea.

Accountability to Congress for Nuclear Transfers to North Korea Act of 2000


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Empowerment of Iraqi Women Act of
2006''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) The Saddam Hussein regime committed human rights
        atrocities against the citizens of Iraq.
            (2) In the past, women in Iraq played important roles in
        public and private industries, including the government.
            (3) Iraqi women currently are serving in the National
        Assembly, government ministries, and local governments.
            (4) The reconstruction of Iraq and the writing of the
        permanent Iraqi Constitution provide a unique opportunity to
        continue this success and to affirm women's human rights under
        law.
            (5) For women to fully participate in Iraqi society, they
        must have the guaranteed right to vote, the guaranteed right to
        run for office, guaranteed equality of opportunity, guaranteed
        equality in family law, guaranteed equal access to the civil
        courts, protection from gender-motivated violence, and
        guaranteed access to health care, education, and employment.
            (6) The United States, through its involvement in Iraq,
        must be actively working toward guaranteeing the full inclusion
        and participation of Iraqi women in the political and economic
        life of their country, and must continue to do so throughout
        the reconstruction process.
            (7) The United States must be actively working to ensure
        that the lives of Iraqi women are made better, not worse,
        because of United States intervention.

SEC. 3. ESTABLISHMENT OF IRAQI WOMEN'S FUND.

    (a) Establishment.--The Administrator of the United States Agency
for International Development shall establish a fund for the purpose of
assisting women and girls in Iraq in the areas of political, legal, and
human rights, health care, education, training, security, and shelter.
    (b) Activities Supported.--The fund established under subsection
(a) shall support the following activities:
            (1) Direct financial and programmatic assistance to the
        Iraq Ministry of Women's Affairs (hereafter in this section
        referred to as the ``Ministry'') to promote the strengthening
        of the Ministry as the Government of Iraq continues its
        transition to a long-term government structure. The Ministry
        may use such assistance to support activities such as the
        following:
                    (A) Multiyear women-centered economic development
                programs, including programs to assist widows, female
                heads of household, women in rural areas, and disabled
                women.
                    (B) Collaboration with the Iraq Ministry of Health
                to construct health infrastructure and delivery of
                high-quality comprehensive health care programs,
                including primary, maternal, child, reproductive, and
                mental health care.
                    (C) Programs to prevent trafficking in persons,
                assist victims, and apprehend and prosecute traffickers
                in persons.
                    (D) Programs to prevent gender-motivated violence
                targeted at women, including domestic violence.
            (2) Collaboration with the Iraq Ministry of Education to
        construct women's educational facilities in Iraq and promote
        the education of Iraqi girls beyond primary school.
    (c) Report.--Not later than 60 days after the date of the enactment
of this Act, and annually thereafter, the Administrator of the United
States Agency for International Development shall prepare and submit to
Congress a report that contains documentation of activities of the
United States Agency for International Development, the Iraq Ministry
of Women's Affairs, the Iraq Ministry of Health, and the Iraq Ministry
of Education to implement the requirements of this section.
    (d) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $22,500,000 for each of the
fiscal years 2007, 2008, and 2009 and such sums as are necessary for
each subsequent fiscal year.

SEC. 4. ASSISTANCE TO IRAQ.

    Notwithstanding any other provision of law, not less than 15
percent of the aggregate amount of economic and humanitarian assistance
authorized to be made available to Iraq for each of the fiscal years
2007, 2008, and 2009 shall be made available for assistance directly to
Iraqi-led local nongovernmental organizations, including not less than
5 percent of that 15 percent for Iraqi women-led organizations, with
demonstrated experience in delivering services to Iraqi women and
children to support their programmatic activities and organizational
development. In recognition of the appreciating capacity of Iraqi-led
local nongovernmental organizations, including Iraqi women-led
organizations, an appropriate percentage of the aggregate amount of
economic and humanitarian assistance authorized to be made available to
Iraq for fiscal year 2010 and each subsequent fiscal year shall be made
available for assistance directly to Iraqi-led local nongovernmental
organizations, including Iraqi women-led organizations.

SEC. 5. REQUIREMENTS RELATING TO UNITED STATES ACTIVITIES IN IRAQ.

    (a) In General.--Activities described in subsections (b) through
(d) that are carried out by the United States in Iraq shall comply with
the applicable requirements contained in such subsections.
    (b) Governance of Iraq.--With respect to the governance of Iraq,
the applicable requirements are the following:
            (1) Include the perspectives and advice of Iraqi women's
        organizations, networks, and leaders in United States
        policymaking related to the governance of Iraq.
            (2) Promote the achievement of 25 percent of the seats in
        the National Assembly to be held by Iraqi women to ensure that
        women's full range of human rights are included and upheld in
        any constitution or legal structures of Iraq.
            (3) Encourage the appointment of women to high level
        positions within Iraqi Ministries.
    (c) Post-Conflict Reconstruction and Development.--With respect to
activities relating to post-conflict stability in Iraq, the applicable
requirements are the following:
            (1) Encourage United States organizations that receive
        funds authorized by this Act to partner with or create Iraqi-
        led counterpart organizations and provide these organizations
        with significant financial resources, technical assistance, and
        capacity building.
            (2) Increase women's access to or ownership of productive
        assets such as land, water, agricultural inputs, credit, and
        property.
            (3) Provide long-term financial assistance for primary,
        secondary, higher, nontraditional, and vocational education for
        Iraqi girls, women, boys, and men.
            (4) Integrate education and training programs for former
        combatants with economic development programs to encourage
        their reintegration into society and to promote post-conflict
        stability.
    (d) Iraqi Military and Police.--With respect to training for
military and police forces in Iraq, the applicable requirements are the
following:
            (1) Include training on the protection, rights, and the
        particular needs of women and emphasize that violations of
        women's rights are intolerable and should be prosecuted.
            (2) Encourage such trainers who will carry out the
        activities in paragraph (1) to consult with women's
        organizations in Iraq to ensure that training content and
        materials are adequate, appropriate, and comprehensive.

SEC. 6. REPORTING REQUIREMENTS.

    Not later than 60 days after the date of the enactment of this Act,
and annually thereafter, the President shall prepare and transmit to
Congress a report that contains documentation of activities of the
United States to guarantee the rights of Iraqi women, including
progress in implementing the requirements of section 5 and on the
status of women's rights in Iraq. All data in the report shall be
disaggregated by gender.

Summary: Empowerment of Iraqi Women Act of 2006 - Directs the United States Agency for International Development (USAID) establish a fund to assist women and girls in Iraq in the areas of political, legal, and human rights, health care, education, training, security, and shelter. Directs that the fund: (1) provide direct financial and programmatic assistance to the Iraq Ministry of Women's Affairs to strengthen the Ministry as the government of Iraq transitions to a long-term government structure. And (2) collaborate with the Iraq Ministry of Education to construct women's educational facilities and promote the education of Iraqi girls beyond primary school. Obligates specified economic and humanitarian assistance to Iraq for assistance directly to Iraqi-led local nongovernmental organizations, including Iraqi women-led organizations, with demonstrated experience in delivering services to Iraqi women and children.

To authorize assistance for women and girls in Iraq, and for other purposes.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Treat and Reduce Obesity Act of
2017''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) According to the Centers for Disease Control, about 34
        percent of adults aged 65 and over were obese in the period of
        2009 through 2012, representing almost 15 million people.
            (2) Obesity increases the risk for chronic diseases and
        conditions, including high blood pressure, heart disease,
        certain cancers, arthritis, mental illness, lipid disorders,
        sleep apnea, and type 2 diabetes.
            (3) More than half of Medicare beneficiaries are treated
        for 5 or more chronic conditions per year. The rate of obesity
        among Medicare patients doubled from 1987 to 2002, and Medicare
        spending on obese individuals during that time more than
        doubled.
            (4) Men and women with obesity at age 65 have decreased
        life expectancy of 1.6 years for men and 1.4 years for women.
            (5) The direct and indirect cost of obesity is more than
        $450 billion annually.
            (6) On average, a Medicare beneficiary with obesity costs
        $1,964 more than a normal-weight beneficiary.
            (7) The prevalence of obesity among older individuals in
        the United States is growing at a linear rate and, if nothing
        changes, nearly half of the elderly population of the United
        States will have obesity in 2030 according to a Congressional
        Research Report on obesity.

SEC. 3. AUTHORITY TO EXPAND HEALTH CARE PROVIDERS QUALIFIED TO FURNISH
              INTENSIVE BEHAVIORAL THERAPY.

    Section 1861(ddd) of the Social Security Act (42 U.S.C. 1395x(ddd))
is amended by adding at the end the following new paragraph:
            ``(4)(A) Subject to subparagraph (B), the Secretary may, in
        addition to qualified primary care physicians and other primary
        care practitioners, cover intensive behavioral therapy for
        obesity furnished by any of the following:
                    ``(i) A physician (as defined in subsection (r)(1))
                who is not a qualified primary care physician.
                    ``(ii) Any other appropriate health care provider
                (including a physician assistant, nurse practitioner,
                or clinical nurse specialist (as those terms are
                defined in subsection (aa)(5)), a clinical
                psychologist, a registered dietitian or nutrition
                professional (as defined in subsection (vv))).
                    ``(iii) An evidence-based, community-based
                lifestyle counseling program approved by the Secretary.
            ``(B) In the case of intensive behavioral therapy for
        obesity furnished by a provider described in clause (ii) or
        (iii) of subparagraph (A), the Secretary may only cover such
        therapy if such therapy is furnished--
                    ``(i) upon referral from, and in coordination with,
                a physician or primary care practitioner operating in a
                primary care setting or any other setting specified by
                the Secretary; and
                    ``(ii) in an office setting, a hospital out-patient
                department, a community-based site that complies with
                the Federal regulations concerning the privacy of
                individually identifiable health information
                promulgated under section 264(c) of the Health
                Insurance Portability and Accountability Act of 1996,
                or another setting specified by the Secretary.
            ``(C) In order to ensure a collaborative effort, the
        coordination described in subparagraph (B)(i) shall include the
        health care provider or lifestyle counseling program
        communicating to the referring physician or primary care
        practitioner any recommendations or treatment plans made
        regarding the therapy.''.

SEC. 4. MEDICARE PART D COVERAGE OF OBESITY MEDICATION.

    (a) In General.--Section 1860D-2(e)(2)(A) of the Social Security
Act (42 U.S.C. 1395w-102(e)(2)(A)) is amended, in the first sentence--
            (1) by striking ``and other than'' and inserting ``other
        than''; and
            (2) by inserting after ``benzodiazepines),'' the following:
        ``and other than subparagraph (A) of such section if the drug
        is used for the treatment of obesity (as defined in section
        1861(yy)(2)(C)) or for weight loss management for an individual
        who is overweight (as defined in section 1861(yy)(2)(F)(i)) and
        has one or more related comorbidities,''.
    (b) Effective Date.--The amendments made by subsection (a) shall
apply to plan years beginning on or after the date that is 2 years
after the date of the enactment of this Act.

SEC. 5. REPORT TO CONGRESS.

    Not later than the date that is 1 year after the date of the
enactment of this Act, and every 2 years thereafter, the Secretary of
Health and Human Services shall submit a report to Congress describing
the steps the Secretary has taken to implement the provisions of, and
amendments made by, this Act. Such report shall also include
recommendations for better coordination and leveraging of programs
within the Department of Health and Human Services and other Federal
agencies that relate in any way to supporting appropriate research and
clinical care (such as any interactions between physicians and other
health care providers and their patients) to treat, reduce, and prevent
obesity in the adult population.

Summary: Treat and Reduce Obesity Act of 2017 This bill allows coverage, under Medicare, of intensive behavioral therapy for obesity furnished by providers other than primary care physicians and practitioners. Additionally, it allows coverage under Medicare's prescription drug benefit of drugs used for the treatment of obesity or for weight loss management for individuals who are overweight.

Treat and Reduce Obesity Act of 2017


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Improving Medical Device Innovation
Act''.

SEC. 2. RECOGNITION OF STANDARDS.

    (a) In General.--Section 514(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360d(c)) is amended--
            (1) in paragraph (1), by inserting after subparagraph (B)
        the following new subparagraphs:
                    ``(C)(i) Any person may submit a request for
                recognition under subparagraph (A) of all or part of an
                appropriate standard established by a nationally or
                internationally recognized standard organization.
                    ``(ii) Not later than 60 calendar days after the
                Secretary receives such a request, the Secretary
                shall--
                            ``(I) make a determination to recognize
                        all, part, or none of the standard that is the
                        subject of the request; and
                            ``(II) issue to the person who submitted
                        such request a response in writing that states
                        the Secretary's rationale for that
                        determination, including the scientific,
                        technical, regulatory, or other basis for such
                        determination.
                    ``(iii) The Secretary shall take such actions as
                may be necessary to implement all or part of a standard
                recognized under subclause (I) of clause (ii), in
                accordance with subparagraph (A).
                    ``(D) The Secretary shall make publicly available,
                in such manner as the Secretary determines appropriate,
                the rationale for recognition of all, part, or none of
                a standard, including the scientific, technical,
                regulatory, or other basis for the decision regarding
                such recognition.''; and
            (2) by adding at the end the following:
            ``(4) Training on use of standards.--The Secretary shall
        provide to all employees of the Food and Drug Administration
        who review premarket submissions for devices periodic training
        on the concept and use of recognized standards for purposes of
        meeting a premarket submission requirement or other applicable
        requirement under this Act, including standards relevant to an
        employee's area of device review.''.
    (b) Guidance.--The Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall review and update, if
necessary, previously published guidance and standard operating
procedures identifying the principles for recognizing standards, and
for withdrawing the recognition of standards, under section 514(c) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)), taking
into account the experience with and reliance on a standard by foreign
regulatory authorities and the device industry, and whether recognition
of a standard will promote harmonization among regulatory authorities
in the regulation of devices.

SEC. 3. CERTAIN CLASS I AND CLASS II DEVICES.

    (a) Class I Devices.--Section 510(l) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(l)) is amended--
            (1) by striking ``A report under subsection (k)'' and
        inserting ``(1) A report under subsection (k)''; and
            (2) by adding at the end the following new paragraph:
            ``(2) Not later than 120 calendar days after the date of
        enactment of the Improving Medical Device Innovation Act and at
        least once every 5 years thereafter, as the Secretary
        determines appropriate, the Secretary shall identify, through
        publication in the Federal Register, any type of class I device
        that the Secretary determines no longer requires a report under
        subsection (k) to provide reasonable assurance of safety and
        effectiveness. Upon such publication--
                    ``(A) each type of class I device so identified
                shall be exempt from the requirement for a report under
                subsection (k); and
                    ``(B) the classification regulation applicable to
                each such type of device shall be deemed amended to
                incorporate such exemption.''.
    (b) Class II Devices.--Section 510(m) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360(m)) is amended--
            (1) by striking paragraph (1) and inserting the following
        new paragraph:
            ``(1) The Secretary shall--
                    ``(A) not later than 90 days after the date of
                enactment of the Improving Medical Device Innovation
                Act and at least once every 5 years thereafter, as the
                Secretary determines appropriate--
                            ``(i) publish in the Federal Register a
                        notice that contains a list of each type of
                        class II device that the Secretary determines
                        no longer requires a report under subsection
                        (k) to provide reasonable assurance of safety
                        and effectiveness; and
                            ``(ii) provide for a period of not less
                        than 60 calendar days for public comment
                        beginning on the date of the publication of
                        such notice; and
                    ``(B) not later than 210 calendar days after the
                date of enactment of the Improving Medical Device
                Innovation Act, publish in the Federal Register a list
                representing the Secretary's final determination with
                respect to the devices contained in the list published
                under subparagraph (A).''; and
            (2) in paragraph (2)--
                    (A) by striking ``1 day after the date of
                publication of a list under this subsection,'' and
                inserting ``1 calendar day after the date of
                publication of the final list under paragraph
                (1)(B),''; and
                    (B) by striking ``30-day period'' and inserting
                ``60-calendar-day period''; and
                    (C) by adding at the end the following new
                paragraph:
            ``(3) Upon the publication of the final list under
        paragraph (1)(B)--
                    ``(A) each type of class II device so listed shall
                be exempt from the requirement for a report under
                subsection (k); and
                    ``(B) the classification regulation applicable to
                each such type of device shall be deemed amended to
                incorporate such exemption.''.

SEC. 4. CLASSIFICATION PANELS.

    (a) Classification Panels.--Paragraph (5) of section 513(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended--
            (1) by striking ``(5)'' and inserting ``(5)(A)''; and
            (2) by adding at the end the following:
                    ``(B) When a device is specifically the subject of
                review by a classification panel, the Secretary shall--
                            ``(i) ensure that adequate expertise is
                        represented on the classification panel to
                        assess--
                                    ``(I) the disease or condition
                                which the device is intended to cure,
                                treat, mitigate, prevent, or diagnose;
                                and
                                    ``(II) the technology of the
                                device; and
                            ``(ii) provide an opportunity for the
                        person whose device is specifically the subject
                        of panel review to provide recommendations on
                        the expertise needed among the voting members
                        of the panel.
                    ``(C) For purposes of subparagraph (B)(i), the term
                `adequate expertise' means that the membership of the
                classification panel includes--
                            ``(i) two or more voting members, with a
                        specialty or other expertise clinically
                        relevant to the device under review; and
                            ``(ii) at least one voting member who is
                        knowledgeable about the technology of the
                        device.
                    ``(D) The Secretary shall provide an annual
                opportunity for patients, representatives of patients,
                and sponsors of medical device submissions to provide
                recommendations for individuals with appropriate
                expertise to fill voting member positions on
                classification panels.''.
    (b) Panel Review Process.--Section 513(b)(6) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360c(b)(6)) is amended--
            (1) in subparagraph (A)(iii), by inserting before the
        period at the end ``, including by designating a representative
        who will be provided a time during the panel meeting to address
        the panel individually (or accompanied by experts selected by
        such representative) for the purpose of correcting
        misstatements of fact or providing clarifying information,
        subject to the discretion of the panel chairperson''; and
            (2) by striking subparagraph (B) and inserting the
        following new subparagraph:
                    ``(B)(i) Any meeting of a classification panel with
                respect to the review of a device shall--
                            ``(I) provide adequate time for initial
                        presentations by the person whose device is
                        specifically the subject of such review and by
                        the Secretary; and
                            ``(II) provide adequate time for and
                        encourage free and open participation by all
                        interested persons.
                    ``(ii) Following the initial presentations
                described in clause (i), the panel may--
                            ``(I) pose questions to the designated
                        representative described in subparagraph
                        (A)(iii); and
                            ``(II) consider the responses to such
                        questions in the panel's review of the
                        device.''.

SEC. 5. POSTMARKET PILOT TO IMPROVE MEDICAL DEVICE REPORTING.

    (a) Pilot Projects.--
            (1) In general.--In order to improve the value and
        efficiency of reporting so as to advance the objectives of
        section 519(a) of the Federal Food, Drug, and Cosmetic Act (21
        U.S.C. 360i(a)), within one year of the date of enactment of
        this Act, the Secretary of Health and Human Services shall
        establish one or more pilot projects, in coordination with
        device manufacturers, to explore and evaluate the use of
        alternative methods of compliance with such subsection for
        manufacturers of devices described in section 513(a)(1)(C) of
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
        360c(a)(1)(C)).
            (2) Voluntary participation.--Participation in such pilot
        projects shall be voluntary for device manufacturers. The
        Secretary may establish the conditions for such voluntary
        participation and may establish a process for authorizing
        participation.
            (3) Purposes.--The pilot projects established under
        paragraph (1) shall be designed to--
                    (A) test methods of reporting for one or more
                device types, with priority given to devices for which
                device manufacturers submit a relatively high volume of
                reports under the regulations implementing section
                519(a) of the Federal Food, Drug, and Cosmetic Act (21
                U.S.C. 360i(a));
                    (B) evaluate forms of data monitoring and reporting
                that improve the usability of report data by focusing
                on events and information that are most relevant to
                reasonably assuring the safety and effectiveness of the
                device;
                    (C) identify methods of reporting that will be
                least burdensome for device manufacturers; and
                    (D) evaluate methods that are alternative to, and
                do not duplicate, compliance with requirements of part
                803 of title 21, Code of Federal Regulations (or
                successor regulations).
            (4) Notification to congress.--The Secretary of Health and
        Human Services shall notify the Committee on Health, Education,
        Labor, and Pensions of the Senate and the Committee on Energy
        and Commerce of the House of Representatives not later than 18
        months after the date of enactment of this Act of the number of
        manufacturers that have agreed to participate in a pilot
        project under this subsection with the Secretary of Health and
        Human Services.
            (5) Rule of construction.--Nothing in this subsection shall
        limit the authority of the Secretary of Health and Human
        Services to provide for alternative methods of medical device
        reporting under part 803 of title 21, Code of Federal
        Regulations (or successor regulations), including such methods
        described in this subsection.
            (6) Compliance with requirements for records or reports on
        devices.--
                    (A) In general.--A device manufacturer that
                participates in a pilot project under this subsection
                shall be required to comply with all applicable
                provisions of section 519 of the Federal Food, Drug,
                and Cosmetic Act (21 U.S.C. 360i), and implementing
                regulations, except as described in subparagraph (B).
                    (B) Conditional exemption.--The Secretary may
                determine that, for a specified time period to be
                determined by the Secretary, a manufacturer
                participating in a pilot project under this subsection
                is exempt from certain provisions of section 519(a) of
                the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
                360i(a)), and implementing regulations, if such
                manufacturer complies with the conditions set forth in
                a pilot project under this subsection.
    (b) GAO Review.--
            (1) Review of pilot projects.--The Comptroller General of
        the United States shall conduct a review of the pilot projects
        established under subsection (a), and of the reporting system
        under part 803 of title 21, Code of Federal Regulations (or
        successor regulations).
            (2) Report.--Not later than January 31, 2021, the
        Comptroller General of the United States shall submit to
        Congress a report containing the results of the review
        described in paragraph (1). Such report shall analyze the
        value, efficiency, and effectiveness of reporting methods under
        subsections (a) and (b) of section 519 of Federal Food, Drug,
        and Cosmetic Act (21 U.S.C. 360i) and identify any
        recommendations for statutory amendments that would enhance the
        objectives of section 519(a) of such Act.

Summary: Improving Medical Device Innovation Act This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions related to medical device performance standards, reporting requirements, and classification panels. A person may request that the Food and Drug Administration (FDA) recognize a performance standard established by a recognized standards organization as a standard to which a medical device may conform in order to meet an FDA requirement. When a request to recognize a standard is received, the FDA must determine whether to recognize all, part, or none of the standard and publish the rationale for that determination. The FDA must: train employees who review premarket submissions for medical devices on recognized standards, review its published principles for recognizing standards. Identify types of medical devices for which a premarket report is no longer needed to provide reasonable assurance of safety and effectiveness. Ensure that adequate expertise is represented on medical device classification panels. Provide an opportunity for a person whose premarket submission is subject to review by a classification panel to recommend expertise needed on the panel. And provide opportunities for patients, patient representatives, and medical device sponsors to recommend individuals for positions on classification panels. The FDA, in coordination with medical device manufacturers, must establish pilot projects to evaluate alternative methods of compliance with reporting requirements for certain medical devices. The Government Accountability Office must report on these pilot projects.

Improving Medical Device Innovation Act


SECTION 1. REQUIREMENT TO DISCLOSE TO INSURANCE APPLICANTS CERTAIN
              MEDICAL TEST RESULTS.

    (a) In General.--Except as provided in subsections (c) and (d), a
life or disability insurer who requires, as a condition for the sale of
a covered insurance product, that an applicant for the purchase of the
product submit to an examination or test by a physician, health
professional, or medical laboratory--
            (1) shall require the physician, health professional, or
        laboratory to provide the results to the insurer in the form of
        a written report containing the findings of the physician,
        professional, or laboratory, including the results of all
        tests, diagnoses, and conclusions made; and
            (2) shall mail, not later than 30 days after the date on
        which the insurer receives such report, the report to the
        applicant at an address provided for this purpose by the
        applicant.
    (b) Abnormal Finding.--In any case in which a life or disability
insurer mails a report to an applicant under subsection (a) that
contains a finding of abnormality or irregularity with respect to the
health or condition of the applicant, the insurer shall include with
the report a document that--
            (1) highlights the abnormal or irregular finding in
        language that is understandable to a person of average
        intelligence with no medical training; and
            (2) advises the applicant to consult with a suitable health
        professional for further explanation and appropriate follow-up.
    (c) Election To Receive Results through Physician.--An applicant
described in subsection (a) may elect to have the report described in
such subsection, and the document described in subsection (b), mailed
to a physician of the applicant's choice designated by the applicant
for such purpose, in lieu of having the report and document mailed to
the applicant. The election shall be effective in any case where the
applicant, before the date of the examination or test, submits to the
insurer an election form described in subsection (e)(1) that includes--
            (1) a check-off box, marked by hand by the applicant,
        showing the applicant's election to have the report and
        document mailed to such physician;
            (2) the applicant's signature; and
            (3) the date on which the form was completed by the
        applicant.
    (d) Waiver by Applicant.--Subsections (a) and (b) shall not apply
where the applicant, before the date of the examination or test,
declines to receive the results by submitting to the insurer a waiver
form described in subsection (e)(1) that includes--
            (1) a check-off box, marked by hand by the applicant,
        showing the applicant's choice to waive the applicant's right
        to receive any reports under subsection (a);
            (2) the applicant's signature; and
            (3) the date on which the form was completed by the
        applicant.
    (e) Requirements Relating to Forms.--
            (1) Requirement to supply forms.--A life or disability
        insurer described in subsection (a) shall furnish to an
        applicant described in such subsection an election form,
        sufficient for purposes of subsection (c), and a waiver form,
        sufficient for purposes of subsection (d), at the same time the
        insurer furnishes to the applicant the application for sale of
        the covered product. The forms shall be distinct from, and not
        a part of, such application.
            (2) Copy.--A life or disability insurer described in
        subsection (a) shall furnish to an applicant described in such
        subsection a copy of an election form or a waiver form
        submitted to the insurer by the applicant upon the insurer's
        receipt of the form.
            (3) Revocation.--An election under subsection (c), or a
        waiver under subsection (d), may be revoked by the applicant at
        any time, through a written or oral notification to the life or
        disability insurer.

SEC. 2. PROHIBITION ON CERTAIN DISCLOSURES OF EXAMINATION RESULTS.

    A life or disability insurer who requires, as a condition for the
sale of a covered insurance product, that an applicant for the purchase
of the product submit to an examination or test by a physician, health
professional, or medical laboratory may not disclose to any other
person, in any form, the results of such examination or test, except--
            (1) as provided in section 1;
            (2) pursuant to a valid and fully executed written
        authorization for such disclosure--
                    (A) during the period specified by the
                authorization, in the case of an authorization that
                permits the disclosure to be made only during a period
                that is shorter than the 2-year period beginning on the
                date the authorization is executed by the applicant; or
                    (B) during 2-year period beginning on the date the
                authorization is executed by the applicant, in the case
                of any other authorization;
            (3) pursuant to a court order, subpoena, warrant, or search
        warrant, for use by a law enforcement agency in an official law
        enforcement investigation or proceeding inquiring into a
        violation of any civil or criminal law, and where such
        disclosure is expressly required by an applicable law other
        than this Act;
            (4) where the disclosure is made to a public health
        authority and is expressly required by an applicable law other
        than this Act.

SEC. 3. CIVIL ACTION BY AGGRIEVED PERSON.

    (a) In General.--Any person who is aggrieved by a violation of this
Act by a life or disability insurer may commence a civil action against
the insurer in an appropriate State court or district court of the
United States.
    (b) Relief.--
            (1) In general.--In an action under this section, if the
        court finds that the defendant has failed to comply with this
        Act, the aggrieved person may recover--
                    (A) statutory damages in an amount equal to $10,000
                for each such violation;
                    (B) compensatory damages; and
                    (C) punitive damages.
            (2) Attorney's fees.--In an action under this section, the
        court, in its discretion, may allow a prevailing plaintiff,
        other than the United States, a reasonable attorney's fee
        (including expert fee) as part of the costs, and the United
        States shall be liable for costs the same as a private person.

SEC. 4. INAPPLICABILITY OF MCCARRAN-FERGUSON ACT.

    For purposes of section 2(b) of the Act of March 9, 1945 (15 U.S.C.
1012(b); commonly known as the McCarran-Ferguson Act), this Act shall
be considered to specifically relate to the business of insurance.

SEC. 5. REGULATIONS.

    The Secretary of Health and Human Services may issue regulations to
carry out this Act.

SEC. 6. DEFINITIONS.

    As used in this Act:
            (1) Applicant.--The term ``applicant'' means an individual
        whose death or disability will be, or is, the subject of a
        covered insurance product, upon the acceptance by the life or
        disability insurer selling the product of the application for
        the purchase of the product.
            (2) Covered insurance product.--The term ``covered
        insurance product'' means--
                    (A) a life insurance policy or contract, or
                benefits under such a policy or contract; or
                    (B) a disability insurance policy or contract, or
                benefits under such a policy or contract.
            (3) Disclose.--The term ``disclose'', means to release,
        transfer, provide access to, or otherwise divulge the
        information to any person other than an individual who is the
        subject of the information. Such term includes the placement of
        information into a computerized data base, networked computer
        system, or any other electronic or magnetic data system, that
        more than one person may access by any means.
            (4) Life or disability insurer.--The term ``life or
        disability insurer'' means--
                    (A) a person doing business in interstate commerce
                who is licensed or certified by a State to provide a
                covered insurance product; or
                    (B) a person who acts as an agent of a person
                described in subparagraph (A) with respect to the sale
                of a covered insurance product.

SEC. 7. EFFECTIVE DATE.

    This Act shall take effect on July 1, 1998.

Summary: Requires that a life or disability insurer, if the insurer requires an applicant for life or disability insurance to submit to a medical examination or test, ensure disclosure to the applicant of the test results. Prohibits the insurer from disclosing the results to any other person, except under a written authorization made by the applicant, pursuant to certain legal process, or to a public health authority when expressly required by law. Provides for civil actions for violations of this Act by any aggrieved person, allowing recovery of statutory, compensatory, and punitive damages and attorney's fees. Declares that, for provisions of Federal law commonly known as the McCarran-Ferguson Act prohibiting Federal insurance law from preempting State law unless the Federal law specifically relates to the business of insurance, this Act shall be considered to specifically relate to the business of insurance.

To require life and disability insurers to disclose an insurance applicant's medical test results to the applicant, unless the applicant specifically declines to receive the results, and otherwise to restrict the disclosure of such results by such insurers.