Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``IRA Preservation Act of 2017''.

SEC. 2. EDUCATION AND OUTREACH.

    (a) Information Made Available.--The Secretary shall make available
to the public the following information:
            (1) An overview of the laws and regulations related to
        individual retirement arrangements, including--
                    (A) limits on contributions;
                    (B) limits on deductions for contributions;
                    (C) rollovers;
                    (D) minimum required distributions;
                    (E) non-exempt prohibited transactions; and
                    (F) tax consequences for early distributions.
            (2) Examples of common errors by taxpayers with respect to
        the laws and regulations described in paragraph (1) and
        instructions on how to avoid such errors.
    (b) Targeted Advance Notices.--Based on the information on common
errors identified under subsection (a)(2), the Secretary shall identify
critical failure points and cause notices to be issued to individual
taxpayers in advance of their reaching such critical failure points,
with advice on how to avoid such failures.
    (c) Soft Notice Program.--
            (1) In general.--The Secretary shall, at such time as the
        Secretary considers appropriate, cause a notice under this
        subsection to be issued to a taxpayer if the Secretary detects
        a material inconsistency between or among any tax returns or
        reports filed under the Internal Revenue Code of 1986,
        including an individual tax return and a third-party
        information return, that could represent tax liability incurred
        by the taxpayer because of--
                    (A) an excess contribution to an individual
                retirement arrangement as described in section 4973 of
                the Internal Revenue Code of 1986;
                    (B) an excess accumulation in an individual
                retirement arrangement as described in section 4974 of
                such Code; or
                    (C) any other error associated with an individual
                retirement arrangement that the Secretary has the
                capability to detect automatically because of
                inconsistencies in returns filed or reports made under
                such Code.
            (2) Exceptions.--The Secretary is not required to issue a
        notice under paragraph (1) with respect to an individual
        retirement arrangement in any case in which the Secretary--
                    (A) intends to initiate an audit of the individual
                retirement arrangement;
                    (B) has reason to believe there is no outstanding
                tax liability attributable to an excess contribution,
                excess accumulation, or other error described in
                subparagraph (A), (B), or (C) of paragraph (1); or
                    (C) has other good cause consistent with the
                purposes of this Act.
            (3) Content.--A notice issued under paragraph (1) to a
        taxpayer with respect to an individual retirement arrangement
        shall include--
                    (A) an explanation of taxes that could be owed, as
                of the date of the notice, because of an excess
                contribution, excess accumulation, or other error
                described in subparagraph (A), (B), or (C) of paragraph
                (1), including, if applicable, an explanation of the
                reduced rates of tax available under section 4973(i) or
                4974(e), as the case may be, of the Internal Revenue
                Code of 1986 for voluntary correction of an excess
                contribution or excess accumulation described in
                subparagraph (A) or (B) of paragraph (1) if voluntary
                correction is made within the correction window
                applicable under section 4973(i) or 4974(e), as the
                case may be, of such Code;
                    (B) a statement that any failure to remit any taxes
                owed may result in an audit;
                    (C) in the case of an excess contribution or excess
                accumulation described in subparagraph (A) or (B) of
                paragraph (1), an explanation of taxes that could be
                owed because of such excess contribution or excess
                accumulation, if voluntary correction is not made
                within the correction window applicable under section
                4973(i) or 4974(e), as the case may be, of the Internal
                Revenue Code of 1986; and
                    (D) a copy of the applicable form to be used by the
                taxpayer to remit taxes owed with respect to the
                individual retirement arrangement because of the
                potential excess contribution, excess accumulation, or
                other error described in the notice.
            (4) Coordination with self-correction procedures.--A notice
        issued under this paragraph may not be considered as initiating
        an audit or otherwise demanding payment for purposes of section
        4973(i) or 4974(e) of the Internal Revenue Code of 1986.

SEC. 3. REDUCTION OF EXCISE TAXES FOR VOLUNTARY CORRECTION OF COMMON
              IRA ERRORS.

    (a) Reduction in Excise Tax on Excess Contributions.--Section 4973
of the Internal Revenue Code of 1986 is amended by adding at the end
the following new subsection:
    ``(i) Reduction of Tax in Certain Cases.--
            ``(1) Reduction.--In the case of a taxpayer who--
                    ``(A) corrects, during the correction window, an
                excess contribution that was made to an individual
                retirement arrangement and that resulted in imposition
                of a tax under paragraph (1) or (3) of subsection (a),
                and
                    ``(B) submits a return, during the correction
                window, reflecting such tax (as modified by this
                subsection),
        the first and second sentences of subsection (a) shall be
        applied by substituting `3 percent' for `6 percent' each place
        it appears.
            ``(2) Correction window defined.--For purposes of this
        subsection, the term `correction window' means the period
        beginning on the date on which the tax under subsection (a) is
        imposed with respect to an excess contribution, and ending on
        the earlier of--
                    ``(A) the date on which the Secretary initiates an
                audit, or otherwise demands payment, with respect to
                the excess contribution, or
                    ``(B) the last day of the second tax year that
                begins after the end of the tax year in which the tax
                under subsection (a) is imposed.''.
    (b) Reduction in Excise Tax on Failures To Take Required Minimum
Distributions.--
            (1) In general.--Section 4974 of the Internal Revenue Code
        of 1986 is amended by adding at the end the following new
        subsection:
    ``(e) Reduction of Tax in Certain Cases.--
            ``(1) Reduction.--In the case of a taxpayer who--
                    ``(A) corrects, during the correction window, a
                shortfall of distributions from an individual
                retirement arrangement that resulted in imposition of a
                tax under subsection (a), and
                    ``(B) submits a return, during the correction
                window, reflecting such tax (as modified by this
                subsection),
        the first sentence of subsection (a) shall be applied by
        substituting `5 percent' for `50 percent'.
            ``(2) Correction window defined.--For purposes of this
        subsection, the term `correction window' means the period of
        time beginning on the date on which the tax under subsection
        (a) is imposed with respect to a shortfall of distributions
        from an individual retirement arrangement, and ending on the
        earlier of--
                    ``(A) the date on which the Secretary initiates an
                audit, or otherwise demands payment, with respect to
                the shortfall of distributions, or
                    ``(B) the last day of the second tax year that
                begins after the end of the tax year in which the tax
                under subsection (a) is imposed.''.
            (2) Coordination with waiver provisions.--
                    (A) In general.--Subsection (d) of section 4974 of
                the Internal Revenue Code of 1986 is amended--
                            (i) by redesignating paragraphs (1) and (2)
                        as subparagraphs (A) and (B), respectively;
                            (ii) by striking ``If the taxpayer'' and
                        inserting:
            ``(1) Waiver.--Subject to paragraph (2), if the taxpayer'';
        and
                            (iii) by adding at the end the following:
            ``(2) Exception.--The Secretary may not waive the tax
        imposed by subsection (a) with respect to an individual
        retirement arrangement.''.
                    (B) Authority to compromise.--The amendments made
                by subparagraph (A) shall not limit the authority of
                the Secretary of the Treasury under section 7121 or any
                other provision of the Internal Revenue Code of 1986 to
                compromise the amount of any tax due under section 4974
                of such Code, except that, in determining the amount of
                any such compromise, the Secretary may take into
                account the availability, under section 4974(e) of such
                Code, of voluntary correction during the correction
                window (as defined in section 4974(e)(2) of such Code).

SEC. 4. HARMONIZATION OF TREATMENT OF IRAS WITH EMPLOYER PLANS.

    (a) Elimination of Additional Tax on Certain Distributions.--
Subparagraph (A) of section 72(t)(2) of the Internal Revenue Code of
1986 is amended--
            (1) by striking ``or'' at the end of clause (vii);
            (2) by striking the period at the end of clause (viii) and
        inserting ``, or''; and
            (3) by adding at the end the following new clause:
                            ``(ix) attributable to withdrawal of
                        interest or other income earned on excess
                        contributions to an individual retirement
                        arrangement.''.
    (b) Repeal of Tax Disqualification Penalty.--
            (1) In general.--Paragraph (2) of subsection (e) of section
        408 of the Internal Revenue Code of 1986 is repealed.
            (2) Conforming amendments.--
                    (A) Section 408(e)(1) of such Code is amended by
                striking ``(2) or''.
                    (B) Sections 220(e)(2), 223(e)(2), and 530(e) of
                such Code are amended by striking ``paragraphs (2) and
                (4) of section 408(e)'' each place it appears and
                inserting ``paragraph (4) of section 408(e)''.
                    (C) Section 4975(c)(3) of such Code is amended by
                striking ``the account ceases to be an individual
                retirement account by reason of the application of
                section 408(e)(2)(A) or if''.
    (c) Statute of Limitations.--Subsection (l) of section 6501 of the
Internal Revenue Code of 1986 is amended--
            (1) in paragraph (1), by inserting ``(other than for
        individual retirement arrangements)'' after ``section 4975'';
        and
            (2) by adding at the end the following new paragraph:
            ``(4) Individual retirement arrangements.--For purposes of
        any tax imposed by section 4973, 4974, or 4975 in connection
        with an individual retirement arrangement, the return referred
        to in this section shall be the income tax return filed by the
        person on whom the tax under such section is imposed for the
        year in which the act (or failure to act) giving rise to such
        liability for such tax occurred. In the case of a person who is
        not required to file an income tax return for the year in which
        the act (or failure to act) giving rise to such liability for
        such tax occurred--
                    ``(A) the return referred to in this section shall
                be the income tax return that such person would have
                been required to file but for the fact that such person
                was not required to file such return, and
                    ``(B) the 3-year period referred to in subsection
                (a) with respect to the return shall be deemed to begin
                on the date by which the return would have been
                required to be filed (excluding any extension
                thereof).''.

SEC. 5. INDIVIDUAL RETIREMENT ARRANGEMENT DEFINED.

    (a) In General.--For purposes of this Act, the term ``individual
retirement arrangement'' means an individual retirement account, an
individual retirement annuity, and a Roth IRA described in sections
408(a), 408(b), and 408A, respectively, of the Internal Revenue Code of
1986.
    (b) Internal Revenue Code.--Section 408 of the Internal Revenue
Code of 1986 is amended--
            (1) by redesignating subsection (r) as subsection (s); and
            (2) by inserting after subsection (q) the following new
        subsection:
    ``(r) Individual Retirement Arrangement Defined.--For purposes of
this section and sections 72(t), 4973, 4974, and 6501(l), the term
`individual retirement arrangement' means an individual retirement
account described in section 408(a), an individual retirement annuity
described in section 408(b), and a Roth IRA described in section
408A.''.

SEC. 6. EFFECTIVE DATE.

    (a) In General.--Subject to subsections (b) and (c), this Act and
the amendments made by this Act shall take effect on the date of the
enactment of this Act.
    (b) Transition Provisions.--
            (1) Requests for waivers.--
                    (A) In general.--Notwithstanding the amendments to
                section 4974(d) of the Internal Revenue Code of 1986
                made by section 3(b)(2) of this Act, a taxpayer may, at
                any time before or during the transition period, file a
                written request for a waiver under section 4974(d) of
                such Code, as in effect on the day before the date of
                the enactment of this Act. The Secretary of the
                Treasury shall consider any such request as if the
                amendments made by section 3(b)(2) had not been made.
                    (B) Transition period defined.--For purposes of
                this paragraph, the term ``transition period'' means
                the period beginning on the date of the enactment of
                this Act and ending on the date that is 1 year after
                such date of enactment.
            (2) Applicability to certain prior acts.--
                    (A) In general.--Except as provided in paragraph
                (1), the amendments made by this Act shall apply to any
                determination of or affecting liability for taxes,
                interest, or penalties that is made on or after the
                date of the enactment of this Act, even if the conduct
                upon which the determination is based occurred before
                such date of enactment.
                    (B) Calculation of correction window in certain
                cases.--In the case of an error that would have been
                eligible for correction under section 4973(i) or
                4974(e) of the Internal Revenue Code of 1986 if tax had
                not been imposed under 4973(a) or 4974(a), as the case
                may be, of such Code before the date of the enactment
                of this Act, the correction window referred to in
                sections 4973(i) and 4974(e) of such Code shall be the
                period beginning on the date on which such tax was
                imposed and ending on the earlier of--
                            (i) the date on which the Secretary of the
                        Treasury initiates an audit or otherwise
                        demands payment with respect to the conduct
                        described in section 4973(a) or 4974(a), as the
                        case may be, of such Code; or
                            (ii) the last day of the second tax year
                        that begins after the tax year in which the
                        date of the enactment of this Act occurs.
    (c) Implementation.--Section 2 shall be implemented as soon as
reasonably practicable after the enactment of this Act but in no case
later than the date that is 1 year after the date of the enactment of
this Act.

Output: IRA Preservation Act of 2017  This bill modifies the requirements for Individual Retirement Arrangements (IRAs) to: (1) require the Department of the Treasury to provide taxpayers with certain educational materials and notifications, and (2) modify various penalties.  Treasury must provide the public with: (1) an overview of the laws and regulations related to IRAs, and (2) examples of common errors with respect to the laws and regulations and instructions on how to avoid the errors.  Treasury must also provide individual taxpayers with specified notices that identify critical failure points, inconsistencies, or errors and include advice on avoiding failures or errors.  The bill amends the Internal Revenue Code to:   reduce penalties for taxpayers who voluntarily correct certain IRA errors, including excess contributions and failures to take required minimum distributions;   eliminate the 10% additional tax on early distributions that are attributable to withdrawal of interest or other income earned on excess contributions to an IRA;   repeal the tax disqualification penalty (loss of tax-exempt status) for accounts where employees engage in certain prohibited transactions; and   revise the statute of limitations for collecting certain taxes in connection with an IRA.


Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Max Cleland Congressional Gold Medal
Act of 2016''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Joseph Maxwell ``Max'' Cleland has demonstrated the
        highest degree of professionalism and has served as an
        inspiration to friends, family, veterans, and many others while
        dedicating his life to the public service of the United States.
            (2) Max Cleland began his career in public service when he
        joined the Reserve Officers' Training Corps as a young college
        student, went on active duty in the United States Army (in this
        section referred to as the ``Army'') in 1965 as a Second
        Lieutenant, and volunteered for service in Vietnam, rising to
        the rank of Captain.
            (3) The Army recognized Max Cleland with a Silver Star for
        his gallantry in action during the Battle of Khe Sanh in April
        of 1968. According to the letter of commendation from the Army,
        ``The President of the United States of America, authorized by
        Act of Congress, July 8, 1918 (amended by Act of July 25,
        1963), takes pleasure in presenting the Silver Star to Captain
        (Signal Corps) Joseph Maxwell Cleland, United States Army, for
        gallantry in action while engaged in military operations
        involving conflict with an armed hostile force in the Republic
        of Vietnam.''.
            (4) Max Cleland, a Battalion Signal Officer dispatched to
        set up a radio relay antenna, was severely wounded on the
        battlefield and, as a result, lost both of his legs and his
        right arm. Cleland would endure 18 months of extremely
        difficult rehabilitation and recovery at Walter Reed Army
        Medical Center and hospitals of the Department of Veterans
        Affairs (in this section referred to as ``VA hospitals'') in
        Washington, DC. In 1969, Cleland testified before the Committee
        on Veterans' Affairs of the Senate on the hardships faced by
        veterans returning home from war.
            (5) Upon returning to Georgia, Max Cleland was determined
        to continue his public service and, in 1970, at the age of 28,
        was elected as the youngest Georgia State senator and helped
        pass legislation to make public facilities accessible for
        veterans, older people, and individuals with disabilities.
            (6) Max Cleland later came to Washington, DC and joined the
        Senate Committee on Veterans' Affairs as a professional staff
        member, investigating VA hospitals across the country and the
        treatment of servicemembers returning from Vietnam.
            (7) In 1977, President Jimmy Carter named Max Cleland, then
        just 34 years old, the youngest ever individual and first
        Vietnam veteran to serve as Administrator of the Veterans
        Administration. As Administrator, Cleland helped create the
        ``Vet Center'' counseling program, which later expanded to 300
        facilities nationwide helping veterans and their families
        receive psychological care for post-traumatic stress disorders
        and other problems associated with warfare.
            (8) Following his term as Administrator of the Veterans
        Administration, Max Cleland returned to elective office in 1982
        when he was elected as Secretary of State of the State of
        Georgia. As Secretary of State, Cleland implemented the
        National Voter Registration Act of 1993 (52 U.S.C. 20501 et
        seq.) in Georgia and added almost 1,000,000 new voters to the
        rolls.
            (9) Max Cleland was elected to the United States Senate in
        1996 and would go on to chair the Subcommittee on Personnel of
        the Committee on Armed Services of the Senate. In the Senate,
        Cleland was known for his work in expanding benefits for
        servicemembers and in improving veterans' health care,
        education, and the environment.
            (10) After his service in the Senate, Max Cleland continued
        his distinguished career in public service by becoming a
        commissioner on the National Commission on Terrorist Attacks
        Upon the United States (commonly referred to as the ``9/11
        Commission'') and later as a member of the Board of Directors
        of the Export-Import Bank of the United States.
            (11) In 2009, President Barack Obama named Max Cleland
        Secretary of the American Battle Monuments Commission. As
        Secretary of the Commission, Cleland is charged with
        commemorating both the permanent cemeteries of the United
        States located in foreign countries and the military memorials,
        monuments, and markers demonstrating where members of the
        United States Armed Forces have served overseas since World War
        I.
            (12) In 2010, President Obama again called on Max Cleland
        to serve his country and Cleland again accepted. This time,
        Cleland agreed to serve as co-chair, and eventually the
        inaugural chair, of the Advisory Committee on Arlington
        National Cemetery, which was established to help fix the
        problems facing the final resting place for many of the heroes
        of the United States. After his tenure as chair, Cleland was
        awarded the Decoration for Distinguished Civilian Service of
        the Army, the highest honorary award that the Secretary of the
        Army can confer on a civilian.
            (13) After overcoming some of the most difficult challenges
        imaginable, Max Cleland has spent almost five decades of his
        life in service to the United States and the country is forever
        indebted to his service.

SEC. 3. CONGRESSIONAL GOLD MEDAL.

    (a) Presentation Authorized.--The Speaker of the House of
Representatives and the President pro tempore of the Senate shall make
appropriate arrangements for the presentation, on behalf of Congress,
of a gold medal of appropriate design to Joseph Maxwell ``Max''
Cleland.
    (b) Design and Striking.--For the purposes of the presentation
described in subsection (a), the Secretary of the Treasury (in this Act
referred to as the ``Secretary'') shall strike the gold medal with
suitable emblems, devices, and inscriptions, to be determined by the
Secretary.
    (c) Duplicate Medals.--
            (1) In general.--Under such regulations as the Secretary
        may prescribe, the Secretary may strike and sell duplicates in
        bronze of the gold medal struck under this Act at a price
        sufficient to cover the costs of the medals, including labor,
        materials, dies, use of machinery, and overhead expenses.
            (2) Sale of duplicate medals.--The amounts received from
        the sale of duplicate medals under paragraph (1) shall be
        deposited in the United States Mint Public Enterprise Fund.

SEC. 4. STATUS OF MEDALS.

    (a) National Medals.--Medals struck under this Act are national
medals for purposes of chapter 51 of title 31, United States Code.
    (b) Numismatic Items.--For purposes of section 5134 of title 31,
United States Code, all medals struck under this Act shall be
considered to be numismatic items.

Output: Max Cleland Congressional Gold Medal Act of 2016 This bill directs the Speaker of the House of Representatives and the President pro tempore of the Senate to arrange for the presentation of a Congressional Gold Medal to Joseph Maxwell "Max" Cleland.


Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pharmacotherapy Development Act of
1996''.

   TITLE I--DEVELOPMENT OF DRUGS FOR THE TREATMENT OF ADDICTIONS TO
                             ILLEGAL DRUGS

SEC. 101. RECOMMENDATION FOR INVESTIGATION OF DRUGS.

    Section 525(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360aa(a)) is amended--
            (1) by striking ``States'' each place it appears and
        inserting ``States, or for treatment of an addiction to illegal
        drugs''; and
            (2) by striking ``such disease or condition'' each place it
        appears and inserting ``such disease, condition, or treatment
        of such addiction''.

SEC. 102. DESIGNATION OF DRUGS.

    Section 526(a) of the Federal, Food, Drug, and Cosmetic Act (21
U.S.C. 360bb(a)) is amended--
            (1) in paragraph (1)--
                    (A) by inserting before the period in the first
                sentence the following: ``or for treatment of an
                addiction to illegal drugs'';
                    (B) in the third sentence, by striking ``rare
                disease or condition'' and inserting ``rare disease or
                condition, or for treatment of an addiction to illegal
                drugs,''; and
                    (C) by striking ``such disease or condition'' each
                place it appears and inserting ``such disease,
                condition, or treatment of such addiction''; and
            (2) in paragraph (2)--
                    (A) by striking ``(2) For'' and inserting ``(2)(A)
                For'';
                    (B) by striking ``(A) affects'' and inserting ``(i)
                affects'';
                    (C) by striking ``(B) affects'' and inserting
                ``(ii) affects''; and
                    (D) by adding at the end thereof the following new
                subparagraphs:
    ``(B) The term `treatment of an addiction to illegal drugs' means
any pharmacological agent or medication that--
            ``(i) reduces the craving for an illegal drug for an
        individual who--
                    ``(I) habitually uses the illegal drug in a manner
                that endangers the public health, safety, or welfare;
                or
                    ``(II) is so addicted to the use of the illegal
                drug that the individual is not able to control the
                addiction through the exercise of self-control;
            ``(ii) blocks the behavioral and physiological effects of
        an illegal drug for an individual described in clause (i);
            ``(iii) safely serves as a replacement therapy for the
        treatment of drug abuse for an individual described in clause
        (i);
            ``(iv) moderates or eliminates the process of withdrawal
        for an individual described in clause (i);
            ``(v) blocks or reverses the toxic effect of an illegal
        drug on an individual described in clause (i); or
            ``(vi) prevents, where possible, the initiation of drug
        abuse in individuals at high risk.
    ``(C) The term `illegal drug' means a controlled substance
identified under schedules I, II, III, IV, and V in section 202(c) of
the Controlled Substance Act (21 U.S.C. 812(c)).''.

SEC. 103. PROTECTION FOR DRUGS.

    Section 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360cc) is amended--
            (1) by striking ``rare disease or condition'' each place it
        appears and inserting ``rare disease or condition or for
        treatment of an addiction to illegal drugs'';
            (2) by striking ``such disease or condition'' each place it
        appears and inserting ``such disease, condition, or treatment
        of the addiction''; and
            (3) in subsection (b)(1), by striking ``the disease or
        condition'' and inserting ``the disease, condition, or
        addiction''.

SEC. 104. OPEN PROTOCOLS FOR INVESTIGATIONS OF DRUGS.

    Section 528 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360dd) is amended--
            (1) by striking ``rare disease or condition'' and inserting
        ``rare disease or condition or for treatment of an addiction to
        illegal drugs''; and
            (2) by striking ``the disease or condition'' each place it
        appears and inserting ``the disease, condition, or addiction''.

 TITLE II--DEVELOPMENT, MANUFACTURE, AND PROCUREMENT OF DRUGS FOR THE
               ADDICTION OF COCAINE AND HEROIN ADDICTIONS

SEC. 201. DEVELOPMENT, MANUFACTURE, AND PROCUREMENT OF DRUGS FOR THE
              TREATMENT OF ADDICTIONS TO ILLEGAL DRUGS.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351 et seq.) is amended by adding at the end thereof the following new
subchapter:

        ``Subchapter D--Drugs for Cocaine and Heroin Addictions

``SEC. 551. CRITERIA FOR AN ACCEPTABLE DRUG TREATMENT FOR COCAINE AND
              HEROIN ADDICTIONS.

    ``(a) In General.--Subject to the provisions of subsections (b) and
(c), the Secretary shall, through the Institute of Medicine of the
National Academy of Sciences, establish criteria for an acceptable drug
for the treatment of an addiction to cocaine and for an acceptable drug
for the treatment of an addiction to heroin. The criteria shall be used
by the Secretary in making a contract, or entering to a licensing
agreement, under section 552.
    ``(b) Requirements.--The criteria established under subsection (a)
for a drug shall include requirements--
            ``(1) that the application to use the drug for the
        treatment of addiction to cocaine or heroin was filed and
        approved by the Secretary under this Act after the date of
        enactment of this section;
            ``(2) that a performance-based test on the drug--
                    ``(A) has been conducted through the use of a
                randomly selected test group that received the drug as
                a treatment and a randomly selected control group that
                received a placebo; and
                    ``(B) has compared the long-term differences in the
                addiction levels of control group participants and test
                group participants;
            ``(3) that the performance-based test conducted under
        paragraph (2) demonstrates that the drug is effective through
        evidence that--
                    ``(A) a significant number of the participants in
                the test who have an addiction to cocaine or heroin are
                willing to take the drug for the addiction;
                    ``(B) a significant number of the participants in
                the test who have an addiction to cocaine or heroin and
                who were provided the drug for the addiction during the
                test are willing to continue taking the drug as long as
                necessary for the treatment of the addiction; and
                    ``(C) a significant number of the participants in
                the test who were provided the drug for the period of
                time required for the treatment of the addiction
                refrained from the use of cocaine or heroin for a
                period of 3 years after the date of the initial
                administration of the drug on the participants; and
            ``(4) that the drug shall have a reasonable cost of
        production.
    ``(c) Review and Publication of Criteria.--The criteria established
under subsection (a) shall, prior to the publication and application of
such criteria, be submitted for review to the Committee on the
Judiciary and the Committee on Economic and Educational Opportunities
of the House of Representatives, and the Committee on the Judiciary and
the Committee on Labor and Human Resources of the Senate. Not later
than 90 days after notifying each of the committees, the Secretary
shall publish the criteria in the Federal Register.

``SEC. 552. PURCHASE OF PATENT RIGHTS FOR DRUG DEVELOPMENT.

    ``(a) Application.--
            ``(1) In general.--The patent owner of a drug to treat an
        addiction to cocaine or heroin, may submit an application to
        the Secretary--
                    ``(A) to enter into a contract with the Secretary
                to sell to the Secretary the patent rights of the owner
                relating to the drug; or
                    ``(B) in the case in which the drug is approved by
                the Secretary for more than 1 indication, to enter into
                an exclusive licensing agreement with the Secretary for
                the manufacture and distribution of the drug to treat
                an addiction to cocaine or heroin.
            ``(2) Requirements.--An application described in paragraph
        (1) shall be submitted at such time and in such manner, and
        accompanied by such information, as the Secretary may require.
    ``(b) Contract and Licensing Agreement.--
            ``(1) Requirements.--The Secretary shall enter into a
        contract or a licensing agreement with a patent owner who has
        submitted an application in accordance with (a) if the drug
        covered under the contract or licensing agreement meets the
        criteria established by the Secretary under section 551(a).
            ``(2) Special rule.--The Secretary shall enter into--
                    ``(A) not more than 1 contract or exclusive
                licensing agreement relating to a drug for the
                treatment of an addiction to cocaine; and
                    ``(B) not more than 1 contract or licensing
                agreement relating to a drug for the treatment of an
                addiction to heroin.
        A contract or licensing agreement described in subparagraph (A)
        or (B) shall cover not more than 1 drug.
            ``(3) Purchase amount.--Subject to appropriations--
                    ``(A) the amount to be paid to a patent owner who
                has entered into a contract or licensing agreement
                under this subsection relating to a drug to treat an
                addiction to cocaine shall be $100,000,000; and
                    ``(B) the amount to be paid to a patent owner who
                has entered into a contract or licensing agreement
                under this subsection relating to a drug to treat an
                addiction to heroin shall be $50,000,000.
    ``(c) Transfer of Rights Under Contracts and Licensing Agreement.--
            ``(1) Contracts.--A contract under subsection (b)(1) to
        purchase the patent rights relating to a drug to treat cocaine
        or heroin addiction shall transfer to the Secretary--
                    ``(A) the exclusive right to make, use, or sell the
                patented drug within the United States for the term of
                the patent;
                    ``(B) any foreign patent rights held by the patent
                owner;
                    ``(C) any patent rights relating to the process of
                manufacturing the drug; and
                    ``(D) any trade secret or confidential business
                information relating to the development of the drug,
                process for manufacturing the drug, and therapeutic
                effects of the drug.
            ``(2) Licensing agreements.--A licensing agreement under
        subsection (b)(1) to purchase an exclusive license relating to
        manufacture and distribution of a drug to treat an addiction to
        cocaine or heroin shall transfer to the Secretary--
                    ``(A) the exclusive right to make, use, or sell the
                patented drug for the purpose of treating an addiction
                to cocaine or heroin within the United States for the
                term of the patent;
                    ``(B) the right to use any patented processes
                relating to manufacturing the drug; and
                    ``(C) any trade secret or confidential business
                information relating to the development of the drug,
                process for manufacturing the drug, and therapeutic
                effects of the drug relating to use of the drug to
                treat an addiction to cocaine or heroin.

``SEC. 553. PLAN FOR MANUFACTURE AND DEVELOPMENT.

    ``(a) In General.--Not later than 90 days after the date on which
the Secretary purchases the patent rights of a patent owner, or enters
into a licensing agreement with a patent owner, relating to a drug
under section 551, the Secretary shall develop a plan for the
manufacture and distribution of the drug.
    ``(b) Plan Requirements.--The plan shall set forth--
            ``(1) procedures for the Secretary to enter into licensing
        agreements with private entities for the manufacture and the
        distribution of the drug;
            ``(2) procedures for making the drug available to nonprofit
        entities and private entities to use in the treatment of a
        cocaine or heroin addiction;
            ``(3) a system to establish the sale price for the drug;
        and
            ``(4) policies and procedures with respect to the use of
        Federal funds by State and local governments or nonprofit
        entities to purchase the drug from the Secretary.
    ``(c) Applicability of Procurement and Licensing Laws.--The
procurement and licensing laws of the United States shall be applicable
to procurements and licenses covered under the plan described in
subsection (a).
    ``(d) Review of Plan.--
            ``(1) In general.--Upon completion of the plan under
        subsection (a), the Secretary shall notify the Committee on the
        Judiciary and the Committee on Economic and Educational
        Opportunities of the House of Representatives, and the
        Committee on the Judiciary and the Committee on Labor and Human
        Resources of the Senate, of the development of the plan and
        publish the plan in the Federal Register. The Secretary shall
        provide an opportunity for public comment on the plan for a
        period of not more than 30 days after the date of the
        publication of the plan in the Federal Register.
            ``(2) Final plan.--Not later than 60 days after the date of
        the expiration of the comment period described in paragraph
        (1), the Secretary shall publish in the Federal Register a
        final plan. The implementation of the plan shall begin on the
        date of the final publication of the plan.
    ``(e) Construction.--The development, publication, or
implementation of the plan, or any other agency action with respect to
the plan, shall not be considered agency action subject to judicial
review.
    ``(f) Regulations.--The Secretary may promulgate regulations to
carry out this section.

``SEC. 554. AUTHORIZATION OF APPROPRIATIONS.

    ``There are authorized to be appropriated to carry out this
subchapter, such sums as may be necessary in each of the fiscal years
1997 through 1999.''.

Output:
TABLE OF CONTENTS:
     Title I:  Development of Drugs for the Treatment of
          Addictions to Illegal Drugs
     Title II:  Development, Manufacture, and Procurement of Drugs
          for the Addiction (sic) of Cocaine and Heroin Addictions
Pharmacotherapy Development Act of 1996 -
Title I:  Development of Drugs for the Treatment of Addictions to Illegal Drugs
 - Amends the Federal Food, Drug, and Cosmetic Act to add references to drugs for the treatment of addiction to illegal drugs to provisions relating to drugs for rare diseases or conditions, allowing exclusive approval, certification, or licensure, subject to exception.  Requires that the sponsor of such a treatment drug be encouraged to design open protocols.
Title II:  Development, Manufacture, and Procurement of Drugs for the Addiction (sic) of Cocaine and Heroin Addictions
 - Requires that the Institute of Medicine of the National Academy of Sciences establish criteria for an acceptable drug for the treatment of addiction to cocaine and an acceptable drug for the treatment of addiction to heroin.
Allows the patent owner of a drug to treat cocaine or heroin addiction to apply to the Secretary of Health and Human Services to sell the patent rights to, or make an exclusive licensing agreement with, the Secretary.  Sets the purchase amount at $100 million for the cocaine treatment drug and $50 million for the heroin treatment drug.  Directs the Secretary, after the sale or licensing, to develop a manufacturing and distribution plan.
Authorizes appropriations.


Input:
SECTION 1. RELIQUIDATION OF CERTAIN ENTRIES OF SELF-TAPPING SCREWS.

    (a) In General.--Notwithstanding section 514 of the Tariff Act of
1930 (19 U.S.C. 1514) or any other provision of law, upon proper
request filed with the United States Customs Service within 180 days
after the date of the enactment of this Act, the Customs Service--
            (1) shall reliquidate each entry described in subsection
        (c) containing any merchandise which, at the time of original
        liquidation, had been classified under subheading 7318.12 of
        the Harmonized Tariff Schedule of the United States (relating
        to wood screws); and
            (2) shall reliquidate such merchandise under subheading
        7318.14 of the Harmonized Tariff Schedule of the United States
        (relating to self-tapping screws), depending upon their
        diameter, at the rate of duty then applicable for such
        merchandise.
    (b) Payment of Amounts Owed.--Any amounts owed by the United States
pursuant to the reliquidation of an entry under subsection (a) shall be
paid within 180 days after the date on which the request is made.
    (c) Affected Entries.--The entries referred to in subsection (a),
filed at the port of Philadelphia, are as follows:

------------------------------------------------------------------------
       Entry No.              Date of entry          Liquidation Date
------------------------------------------------------------------------
     Av1-0893629-3               08-11-93                01-14-94
     Av1-0893735-8               09-09-93                01-14-94
     Av1-0893766-3               09-20-93                01-14-94
     Av1-0893809-1               10-13-93                01-14-94
     Av1-0893810-9               10-11-93                01-14-94
     Av1-0893811-7               10-06-93                01-14-94
     Av1-0893846-3               10-19-93                03-18-94
     Av1-0893872-9               10-25-93                01-14-94
     Av1-0893873-7               10-25-93                01-14-94
     Av1-0893904-0               11-02-93                03-18-94
     Av1-0893913-1               11-08-93                01-14-94
     Av1-0893936-2               11-15-93                01-14-94
     Av1-0893949-5               11-18-93                01-14-94
     Av1-0893963-6               11-22-93                01-14-94
     Av1-0893981-8               11-30-93                03-18-94
     Av1-0894012-1               12-06-93                03-18-94
     Av1-0894013-9               12-06-93                03-18-94
     Av1-0894057-6               12-20-93                03-18-94
     Av1-0894058-4               12-20-93                03-18-94
     Av1-0894095-6               12-29-93                04-01-94
     Av1-0894100-4               01-05-94                04-01-94
     Av1-0894108-7               01-04-94                04-22-94
     Av1-0894159-0               01-31-94                05-20-94
     Av1-0894222-6               02-14-94                04-08-94
     Av1-0894245-7               02-19-94                04-08-94
     Av1-0894274-7               02-25-94                04-08-94
     Av1-0894298-6               03-07-94                04-22-94
     Av1-0894299-4               03-08-94                04-22-94
     Av1-0894335-6               03-14-94                05-06-94
     Av1-0894348-9               03-17-94                05-06-94
     Av1-0894355-4               03-30-94                05-06-94
     Av1-0894382-8               03-24-94                06-17-94
     Av1-0894420-6               04-06-94                06-17-94
     Av1-0894429-7               04-11-94                06-24-94
     Av1-0894356-2               04-04-94                08-12-94
     Av1-0894516-1               05-23-94                07-29-94
     Av1-0894517-9               05-23-94                07-29-94
     Av1-0894531-0               06-01-94                07-29-94
     Av1-0894570-8               05-27-94                09-30-94
     Av1-0894580-7               05-31-94                07-29-94
     Av1-0894606-0               06-07-94                07-29-94
     Av1-0894607-8               06-15-94                07-29-94
     Av1-0894608-6               06-06-94                07-29-94
     Av1-0894661-5               06-21-94                08-19-94
     Av1-0894682-1               06-24-94                08-12-94
     Av1-0894685-4               07-05-94                08-12-94
     Av1-0894697-9               07-06-94                08-12-94
     Av1-0894698-7               07-12-94                08-12-94
     Av1-0894820-7               07-27-94                09-16-94
     Av1-0894910-6               08-18-94                09-30-94
------------------------------------------------------------------------

Output: Provides, upon request, for the reliquidation of certain entries of self-tapping screws.


Input:
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Generic
Pharmaceutical Access and Choice for Consumers Act of 2001''.
    (b) Table of Contents.--The table of contents of this Act is as
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings and purposes.
              TITLE I--REQUIRING THE USE OF GENERIC DRUGS

Sec. 101. Requiring the use of generic drugs under the Public Health
                            Service Act.
Sec. 102. Application to Federal employees health benefits program.
Sec. 103. Application to medicare program.
Sec. 104. Application to medicaid program.
Sec. 105. Application to Indian Health Service.
Sec. 106. Application to veterans programs.
Sec. 107. Application to recipients of uniformed services health care.
Sec. 108. Application to Federal prisoners.
    TITLE II--THERAPEUTIC EQUIVALENCE REQUIREMENTS FOR GENERIC DRUGS

Sec. 201. Therapeutic equivalence of generic drugs.
         TITLE III--GENERIC PHARMACEUTICALS AND MEDICARE REFORM

Sec. 301. Sense of the Senate on requiring the use of generic
                            pharmaceuticals under the medicare program.

SEC. 2. FINDINGS AND PURPOSES.

    (a) Findings.--Congress makes the following findings:
            (1) Generic pharmaceuticals are approved by the Food and
        Drug Administration on the basis of scientific testing and
        other information establishing that such pharmaceuticals are
        therapeutically equivalent to brand-name pharmaceuticals,
        ensuring consumers a safe, efficacious, and cost-effective
        alternative to brand-name innovator pharmaceuticals.
            (2) The pharmaceutical market has become increasingly
        competitive during the last decade because of the increasing
        availability and accessibility of generic pharmaceuticals.
            (3) The Congressional Budget Office estimates that--
                    (A) the substitution of generic pharmaceuticals for
                brand-name pharmaceuticals will save purchasers of
                pharmaceuticals between $8,000,000,000 and
                $10,000,000,000 each year; and
                    (B) quality generic pharmaceuticals cost between 25
                percent and 60 percent less than brand-name
                pharmaceuticals, resulting in an estimated average
                savings of $15 to $30 on each prescription filled.
            (4) Independent studies have estimated that generics
        provide an average savings of $45.50 for each prescription drug
        sold.
            (5) Generic pharmaceuticals are widely accepted by both
        consumers and the medical profession, as the market share held
        by generic pharmaceuticals compared to brand-name
        pharmaceuticals has more than doubled during the last decade,
        from approximately 19 percent to 43 percent, according to the
        Congressional Budget Office.
            (6) Generic pharmaceuticals can save consumers an
        additional $1,320,000,000 each year for each 1 percent increase
        in the use of such pharmaceuticals.
            (7) Generic pharmaceutical use can help both consumers and
        the Government reduce the cost of prescription drugs.
    (b) Purposes.--The purposes of this Act are--
            (1) to reduce the cost of prescription drugs to the United
        States Government and to beneficiaries under Federal health
        care programs while maintaining the quality of health care by
        requiring the use of generic drugs rather than nongeneric
        drugs, unless no therapeutically equivalent generic drug has
        been approved under the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.) or the nongeneric drug is specifically--
                    (A) ordered by the prescribing provider; or
                    (B) requested by the individual for whom the drug
                is prescribed; and
            (2) to increase the utilization of generic pharmaceuticals
        by requiring the Food and Drug Administration, where
        appropriate, to determine that a generic pharmaceutical is the
        therapeutic equivalent of its brand-name counterpart, and by
        affording national uniformity to that determination.

              TITLE I--REQUIRING THE USE OF GENERIC DRUGS

SEC. 101. REQUIRING THE USE OF GENERIC DRUGS UNDER THE PUBLIC HEALTH
              SERVICE ACT.

    (a) In General.--Part B of title II of the Public Health Service
Act (42 U.S.C. 238 et seq.) is amended by adding at the end the
following new section:

``SEC. 247. USE OF GENERIC DRUGS REQUIRED.

    ``(a) Requirement.--Each grant or contract entered into under this
Act that involves the provision of health care items or services to
individuals shall include provisions to ensure that any prescription
drug provided for under such grant or contract is filled by providing
the generic form of the drug involved, unless no generic form of the
drug has been approved under the Federal Food, Drug, and Cosmetic Act
or the nongeneric form of the drug is specifically--
            ``(1) ordered by the prescribing provider; or
            ``(2) requested by the individual for whom the drug is
        prescribed.
    ``(b) Definitions.--In this section:
            ``(1) Generic form of the drug.--The term `generic form of
        the drug' means a drug that is the subject of an application
        approved under subsection (b)(2) or (j) of section 505 of the
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), for which
        the Secretary has made a determination that the drug is the
        therapeutic equivalent of a listed drug under section 505(o) of
        that Act (21 U.S.C. 355(o)).
            ``(2) Nongeneric form of the drug.--The term `nongeneric
        form of the drug' means a drug that is the subject of an
        application approved under--
                    ``(A) section 505(b)(1) of the Federal Food, Drug,
                and Cosmetic Act (21 U.S.C. 355(b)(1)); or
                    ``(B) section 505(b)(2) of such Act and that has
                been determined to be not therapeutically equivalent to
                any listed drug.
            ``(3) Prescription drug.--The term `prescription drug'
        means a drug that is subject to the provisions of section
        503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
        353(b)).''.
    (b) Effective Date.--The amendment made by this section shall apply
with respect to any drug furnished on or after the date of enactment of
this Act.

SEC. 102. APPLICATION TO FEDERAL EMPLOYEES HEALTH BENEFITS PROGRAM.

    (a) In General.--Section 8902 of title 5, United States Code, is
amended by adding at the end the following new subsection:
    ``(p) If a contract under this chapter provides for the provision
of, the payment for, or the reimbursement of the cost of any
prescription drug (as defined in paragraph (3) of section 247(b) of the
Public Health Service Act), the carrier shall provide, pay, or
reimburse the cost of the generic form of the drug (as defined in
paragraph (1) of such section), except that this subsection shall not
apply if the nongeneric form of the drug (as defined in paragraph (2)
of such section) is specifically--
            ``(1) ordered by the prescribing provider; or
            ``(2) requested by the individual for whom the drug is
        prescribed.''.
    (b) Effective Date.--The amendment made by this section shall apply
to any prescription drug furnished during contract years beginning on
or after January 1, 2002.

SEC. 103. APPLICATION TO MEDICARE PROGRAM.

    (a) In General.--Section 1861(t) of the Social Security Act (42
U.S.C. 1395x(t)) is amended by adding at the end the following new
paragraph:
    ``(3) For purposes of paragraph (1), the term `drugs' means the
generic form of the drug (as defined in section 247(b)(1) of the Public
Health Service Act), unless no generic form of the drug has been
approved under the Federal Food, Drug, and Cosmetic Act or the
nongeneric form of such drug (as defined in section 247(b)(2) of such
Act) is specifically--
            ``(A) ordered by the health care provider; or
            ``(B) requested by the individual to whom the drug is
        provided.''.
    (b) Effective Date.--
            (1) In general.--Except as provided in paragraph (2), the
        amendment made by this section shall apply with respect to any
        prescription drug furnished on or after the date of enactment
        of this Act.
            (2) Medicare+choice plans.--In the case of a
        Medicare+Choice plan offered by a Medicare+Choice organization
        under part C of title XVIII of the Social Security Act (42
        U.S.C. 1395w-21 et seq.), the amendment made by this section
        shall apply to any prescription drug furnished during contract
        years beginning on or after January 1, 2002.

SEC. 104. APPLICATION TO MEDICAID PROGRAM.

    (a) In General.--Section 1902(a) of the Social Security Act (42
U.S.C. 1396a(a)) is amended--
            (1) in paragraph (64), by striking ``and'' at the end;
            (2) in paragraph (65), by striking the period at the end
        and inserting ``; and''; and
            (3) by adding the following new paragraph:
            ``(66) provide that the State shall, in conjunction with
        the program established under section 1927(g), provide for the
        use of a generic form of a drug (as defined in paragraph (1) of
        section 247(b) of the Public Health Service Act), unless no
        generic form of the drug has been approved under the Federal
        Food, Drug, and Cosmetic Act or the nongeneric form of the drug
        (as defined in paragraph (2) of such section) is specifically--
                    ``(A) ordered by the provider; or
                    ``(B) requested by the individual to whom the drug
                is provided.''.
    (b) Effective Date.--The amendment made by this section shall apply
with respect to any prescription drug furnished under State plans that
are approved or renewed on or after the date of enactment of this Act.

SEC. 105. APPLICATION TO INDIAN HEALTH SERVICE.

    (a) In General.--Title II of the Indian Health Care Improvement Act
(25 U.S.C. 1621 et seq.) is amended by adding at the end the following
new section:

``SEC. 225. USE OF GENERIC DRUGS REQUIRED.

    ``In providing health care items or services under this Act, the
Indian Health Service shall ensure that any prescription drug (as
defined in paragraph (3) of section 247(b) of the Public Health Service
Act) that is provided under this Act is the generic form of the drug
(as defined in paragraph (1) of such section) involved, unless no
generic form of the drug has been approved under the Federal Food,
Drug, and Cosmetic Act or the nongeneric form of the drug (as defined
in paragraph (2) of such section) is specifically--
            ``(1) ordered by the prescribing provider; or
            ``(2) requested by the individual for whom the drug is
        prescribed.''.
    (b) Effective Date.--The amendment made by this section shall apply
with respect to any prescription drug furnished on or after the date of
enactment of this Act.

SEC. 106. APPLICATION TO VETERANS PROGRAMS.

    (a) Use of Generic Drugs Required.--Subchapter III of chapter 17 of
title 38, United States Code, is amended by inserting after section
1722A the following new section:
``Sec. 1722B. Use of generic drugs required
    ``When furnishing a prescription drug (as defined in paragraph (3)
of section 247(b) of the Public Health Service Act) under this chapter,
the Secretary shall furnish a generic form of the drug (as defined in
paragraph (1) of such section), unless no generic form of the drug has
been approved under the Federal Food, Drug, and Cosmetic Act or the
nongeneric form of the drug (as defined in paragraph (2) of such
section) is specifically--
            ``(1) ordered by the prescribing provider; or
            ``(2) requested by the individual for whom the drug is
        prescribed.''.
    (b) Clerical Amendment.--The table of sections at the beginning of
chapter 17 of such title is amended by inserting after the item
relating to section 1722A the following new item:

``1722B. Use of generic drugs required.''.
    (c) Effective Date.--The amendments made by this section shall
apply with respect to any prescription drug furnished on or after the
date of enactment of this Act.

SEC. 107. APPLICATION TO RECIPIENTS OF UNIFORMED SERVICES HEALTH CARE.

    (a) Use of Generic Drugs Required.--Chapter 55 of title 10, United
States Code, as amended by section 751(b) of the Floyd D. Spence
National Defense Authorization Act for Fiscal Year 2001 (as enacted
into law by Public Law 106-398), is amended by adding at the end the
following new section:
``Sec. 1111. Use of generic drugs required
    ``The Secretary of Defense shall ensure that each health care
provider who furnishes a prescription drug (as defined in paragraph (3)
of section 247(b) of the Public Health Service Act) furnishes the
generic form of the drug (as defined in paragraph (1) of such section),
unless no generic form of the drug has been approved under the Federal
Food, Drug, and Cosmetic Act or the nongeneric form of the drug (as
defined in paragraph (2) of such section) is specifically--
            ``(1) ordered by the prescribing provider; or
            ``(2) requested by the individual for whom the drug is
        prescribed.''.
    (b) Clerical Amendment.--The table of sections at the beginning of
such chapter is amended by inserting after the item relating to section
1109 the following new item:

``1111. Use of generic drugs required.''.
    (c) Effective Date.--The amendments made by this section shall
apply with respect to any drug furnished on or after the date of
enactment of this Act.

SEC. 108. APPLICATION TO FEDERAL PRISONERS.

    (a) In General.--Section 4006(b) of title 18, United States Code,
is amended by adding at the end the following new paragraph:
            ``(3) Use of generic drugs required.--The Attorney General
        shall ensure that each health care provider who furnishes a
        prescription drug (as defined in paragraph (3) of section
        247(b) of the Public Health Service Act) to a prisoner charged
        with or convicted of an offense against the United States
        furnishes the generic form of the drug (as defined in paragraph
        (1) of such section), unless no generic form of the drug has
        been approved under the Federal Food, Drug, and Cosmetic Act or
        the nongeneric form of the drug (as defined in paragraph (2) of
        such section) is specifically--
                    ``(A) ordered by the prescribing provider; or
                    ``(B) requested by the prisoner for whom the drug
                is prescribed.''.
    (b) Effective Date.--The amendment made by this section shall apply
with respect to any prescription drug furnished on or after the date of
enactment of this Act.

    TITLE II--THERAPEUTIC EQUIVALENCE REQUIREMENTS FOR GENERIC DRUGS

SEC. 201. THERAPEUTIC EQUIVALENCE OF GENERIC DRUGS.

    (a) In General.--Section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) is amended--
            (1) by adding at the end the following new subsection:
    ``(o)(1) For each application filed under subsection (b)(2) or
subsection (j), the Secretary shall determine whether the drug for
which the application is filed is the therapeutic equivalent of the
drug for which the investigations have been made under subsection
(b)(1)(A) (in this subsection referred to as the `reference drug') or
the listed drug referred to in subsection (j)(2)(A)(i). For
applications approved after the date of enactment of this subsection,
the Secretary's determination shall be made before the approval of the
application. For such applications approved before such date, the most
recent determination made by the Secretary shall be confirmed.
    ``(2) For purposes of paragraph (1), a drug is the therapeutic
equivalent of a reference drug or a listed drug if--
            ``(A) each active ingredient of the drug and either the
        reference drug or the listed drug is the same;
            ``(B) the drug and either the reference drug or the listed
        drug--
                    ``(i) are of the same dosage form;
                    ``(ii) have the same route of administration;
                    ``(iii) are identical in strength or concentration;
                and
                    ``(iv) are expected to have the same clinical
                effect and safety profile when administered to patients
                under conditions specified in the labeling; and
            ``(C) the drug does not present a known bioequivalence
        problem, or if the drug presents such a problem, the drug is
        shown to meet an appropriate bioequivalence standard.
    ``(3) With respect to a drug for which a therapeutic equivalence
determination has been made or confirmed under this subsection, no
State or political subdivision of a State may establish or continue in
effect with respect to therapeutic equivalence of the drug to either a
reference drug or a listed drug, any requirement which is different
from, or in addition to, or is otherwise not identical with, the
Secretary's determination or confirmation under this subsection.''; and
            (2) in subsection (j)(7)(A), by adding at the end the
        following:
            ``(iv) The Secretary shall include in each revision of the
        list under clause (ii) on or after the date of enactment of
        this clause the official and proprietary name of each reference
        drug or listed drug that is therapeutically equivalent to a
        drug approved under subsection (b)(2) or under this subsection
        during the preceding 30-day period, as determined under
        subsection (o).''.
    (b) Effective Date.--The amendments made by this section shall take
effect on the date of enactment of this Act.

         TITLE III--GENERIC PHARMACEUTICALS AND MEDICARE REFORM

SEC. 301. SENSE OF THE SENATE ON REQUIRING THE USE OF GENERIC
              PHARMACEUTICALS UNDER THE MEDICARE PROGRAM.

    It is the sense of the Senate that legislative language requiring
the safe and cost-effective use of generic pharmaceuticals should be
considered in conjunction with any legislation that adds a
comprehensive prescription drug benefit to the medicare program under
title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.).

Output: Generic Pharmaceutical Access and Choice for Consumers Act of 2001 -Amends the Public Health Service Act to require each grant or contract entered into under the Act that involves the provision of health care items or services to individuals to include provisions to ensure that any prescriptions provided for under such grant or contract are filled by providing the generic form of the drug involved, unless there is no approved generic form of the drug, or the nongeneric form of the drug is either specifically ordered by the prescribing provider or requested by the individual for whom the drug is prescribed.Makes similar changes under the Federal Employee Health Benefits program, Medicare program, Medicaid program, and programs affecting Indians, veterans, the uniformed services, and prisoners.Amends the Federal Food, Drug, and Cosmetic Act to require that for each drug application filed there shall be a determination as to whether there is a therapeutic equivalent for such drug.


Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Foreign Investment National Security
Review Act of 2006''.

SEC. 2. INVESTIGATION OF CERTAIN TRANSACTIONS FOR NATIONAL SECURITY
              IMPLICATIONS.

    (a) In General.--Section 721 of the Defense Production Act of 1950
(50 U.S.C. App. 2170) is amended to read as follows:

``SEC. 721. INVESTIGATION OF CERTAIN TRANSACTIONS FOR NATIONAL SECURITY
              IMPLICATIONS.

    ``(a) Investigations.--
            ``(1) In general.--Upon receiving written notification, as
        prescribed by regulations under this section, of any merger,
        acquisition, or takeover proposed or pending on or after the
        date of the enactment of this section by or with any foreign
        person which could result in foreign control of any person
        engaged in interstate commerce in the United States, the
        President, acting through the President's designee and the
        Committee on Foreign Investment in the United States shall
        conduct an investigation to determine the effects, if any, of
        the proposed or pending merger, acquisition, or takeover on the
        national security of the United States.
            ``(2) Timing.--Any investigation required under paragraph
        (1) shall be completed before the end of the 75-day period
        beginning on the date of the receipt by the President or the
        President's designee of written notification of the proposed or
        pending merger, acquisition, or takeover.
    ``(b) Confidentiality of Information.--
            ``(1) In general.--Any information or documentary material
        filed with the President or the President's designee pursuant
        to this section shall be exempt from disclosure under section
        552 of title 5, United States Code, and no such information or
        documentary material may be made public, except as may be
        relevant to any administrative or judicial action or
        proceeding.
            ``(2) Availability to the congress.--No provision of
        paragraph (1) shall be construed as preventing the disclosure
        of any information or documentary material to either House of
        Congress or to any duly authorized committee or subcommittee of
        the Congress.
    ``(c) Committee on Foreign Investment in the United States.--
            ``(1) Establishment.--The Committee on Foreign Investment
        in the United States established pursuant to Executive Order
        No. 11858 (hereafter in this section referred to as the
        `Committee') shall be a multi-agency committee to carry out
        this section and such other assignments as the President may
        designate.
            ``(2) Membership.--The Committee shall be comprised of the
        following members:
                    ``(A) The Secretary of the Treasury.
                    ``(B) The Secretary of State.
                    ``(C) The Secretary of Defense.
                    ``(D) The Secretary of Homeland Security.
                    ``(E) The Attorney General.
                    ``(F) The Secretary of Commerce.
                    ``(G) The Director of the Office of Management and
                Budget.
                    ``(H) The United States Trade Representative.
                    ``(I) The Chairman of the Council of Economic
                Advisors.
                    ``(J) The Director of the Office of Science and
                Technology Policy.
            ``(3) Chairperson.--The Secretary of the Treasury shall be
        the Chairperson of the Committee.
            ``(4) Other members.--The Chairperson of the Committee
        shall involve the heads of such other Federal agencies, the
        Assistant to the President for National Security Affairs, and
        the Assistant to the President for Domestic Policy in any
        investigation under subsection (a) as the Chairperson
        determines to be appropriate on the basis of the facts and
        circumstances of the transaction under investigation.
            ``(5) Role of the director of national intelligence.--The
        Director of National Intelligence shall provide appropriate
        intelligence analysis and intelligence briefings to the
        Committee.
    ``(d) Action by the President.--
            ``(1) In general.--No proposed or pending acquisition,
        merger, or takeover, of a person engaged in interstate commerce
        in the United States by or with foreign persons may occur
        unless the President, on the basis of an investigation and
        report by the Committee, finds that such acquisition, merger or
        takeover, will not threaten to impair the national security of
        the United States, as defined by regulations prescribed
        pursuant to this section, and approves the transaction.
            ``(2) Enforcement.--The President shall direct the Attorney
        General to seek appropriate relief, including divestment
        relief, in the district courts of the United States in order to
        implement and enforce--
                    ``(A) any finding, action, or determination under
                this section of disapproval of an acquisition, merger,
                or takeover; or
                    ``(B) any conditions imposed on any approval of any
                acquisition, merger, or takeover.
            ``(3) Finality of determinations.--All actions and
        determinations under this section shall be final and not
        subject to judicial review.
    ``(e) Findings by the President.--
            ``(1) In general.--A finding under this section of
        impairment or threatened impairment to national security shall
        be based on credible evidence that leads the President to
        believe that--
                    ``(A) the foreign interest exercising control might
                take action that threatens to impair the national
                security; and
                    ``(B) other provisions of law do not provide
                adequate and appropriate authority for the President to
                protect the national security.
            ``(2) Factors to be considered.--Any investigation under
        this section shall take into account the following factors:
                    ``(A) Domestic production needed for projected
                national defense requirements.
                    ``(B) The capability and capacity of domestic
                industries to meet national defense requirements,
                including the availability of human resources,
                products, technology, materials, and other supplies and
                services.
                    ``(C) The control of domestic industries and
                commercial activity by foreign citizens as it affect
                the capability and capacity of the United States to
                meet the requirements of national security.
                    ``(D) The potential effects of the proposed or
                pending transaction on sales of military goods,
                equipment, or technology to any country--
                            ``(i) identified by the Secretary of
                        State--
                                    ``(I) under section 6(j) of the
                                Export Administration Act of 1979, as a
                                country that supports terrorism;
                                    ``(II) under section 6(l) of the
                                Export Administration Act of 1979, as a
                                country of concern regarding missile
                                proliferation; or
                                    ``(III) under section 6(m) of the
                                Export Administration Act of 1979, as a
                                country of concern regarding the
                                proliferation of chemical and
                                biological weapons; or
                            ``(ii) listed under section 309(c) of the
                        Nuclear Non-Proliferation Act of 1978 on the
                        `Nuclear Non-Proliferation-Special Country
                        List' (15 C.F.R. Part 778, Supplement No. 4) or
                        any successor list.
                    ``(E) The potential effects on the proposed or
                pending transaction on United States international
                technological leadership in areas affecting United
                States national security.
    ``(f) Report to the Congress.--Upon making any determination to
approve or disapprove any merger, acquisition, or takeover by or with
any foreign person which could result in foreign control of any person
engaged in interstate commerce in the United States, the President
shall immediately transmit to the Secretary of the Senate and the Clerk
of the House of Representatives a written report of the President's
determination under this section to approve or disapprove such merger,
acquisition, or takeover, including a detailed explanation of the
finding made and factors considered.
    ``(g) Congressional Action.--
            ``(1) In general.--If the determination of the President
        contained in the report transmitted to the Congress under
        subsection (f) is that the President will approve any merger,
        acquisition, or takeover under subsection (d) and not later
        than 30 days after the date on which Congress receives the
        report, a joint resolution described in paragraph (2) is
        enacted into law, then the President shall take such action
        under subsection (d) as is necessary to prohibit the merger,
        acquisition, or takeover, including, if such acquisition has
        been completed, directing the Attorney General to seek
        divestment or other appropriate relief in the district courts
        of the United States.
            ``(2) Joint resolution described.--For purposes of
        paragraph (1), the term `joint resolution' means a joint
        resolution of the Congress, the sole matter after the resolving
        clause of which is as follows: `That the Congress disapproves
        the determination of approval of the President contained in the
        report submitted to Congress pursuant to section 721(f) of the
        Defense Production Act of 1950 on _____.', with the blank space
        being filled with the appropriate date.
            ``(3) Computation of review period.--In computing the 30-
        day period referred to in paragraph (1), there shall be
        excluded any day described in section 154(b) of the Trade Act
        of 1974.
    ``(h) Regulations.--The President shall direct the issuance of
regulations to carry out this section. Such regulations shall, to the
extent possible, minimize paperwork burdens and shall to the extent
possible coordinate reporting requirements under this section with
reporting requirements under any other provision of Federal law.
    ``(i) Effect on Other Law.--No provision of this section shall be
construed as altering or affecting any existing authority, power,
process, regulation, investigation, enforcement measure, or review
provided by any other provision of law.
    ``(j) Technology Risk Assessments.--In any case in which an
assessment of the risk of diversion of defense critical technology is
performed by the Committee or any other designee of the President, a
copy of such assessment shall be provided to any other designee of the
President responsible for reviewing or investigating a merger,
acquisition, or takeover under this section.
    ``(k) Biennial Report on Critical Technologies.--
            ``(1) In general.--In order to assist the Congress in its
        oversight responsibilities with respect to this section, the
        President and such agencies as the President shall designate
        shall complete and furnish to the Congress, not later than May
        1, 2007, and upon the expiration of every 2 years thereafter, a
        report, both in classified and unclassified form, which--
                    ``(A) evaluates whether there is credible evidence
                of a coordinated strategy by 1 or more countries or
                companies to acquire United States companies involved
                in research, development, or production of critical
                technologies for which the United States is a leading
                producer; and
                    ``(B) evaluates whether there are industrial
                espionage activities directed or directly assisted by
                foreign governments against private United States
                companies aimed at obtaining commercial secrets related
                to critical technology.
            ``(2) Definition.--For the purposes of this subsection, the
        term `critical technologies' means technologies identified
        under title VI of the National Science and Technology Policy,
        Organization, and Priorities Act of 1976 or other critical
        technology, critical components, or critical technology items
        essential to national defense or security identified pursuant
        to this section.
    ``(l) Biennial Report on Critical Infrastructure.--In order to
assist the Congress in its oversight responsibilities, the President
and such agencies as the President shall designate shall complete and
furnish to the Congress, not later than 90 days after the date of
enactment of this subsection and upon the expiration of every 2 years
thereafter, a report, both in classified and unclassified form, which--
            ``(1) lists all critical infrastructure, as defined under
        subtitle B of title II of Public Law 107-296, that is owned,
        controlled or dominated by an alien, a foreign corporation, or
        a foreign government;
            ``(2) evaluates whether there is credible evidence of a
        coordinated strategy by 1 or more countries or companies to
        acquire United States critical infrastructure; and
            ``(3) evaluates whether there are industrial espionage
        activities directed or directly assisted by foreign governments
        against private United States companies controlling critical
        infrastructure.''.
    (b) Effective Date.--The amendments made by subsection (a) shall
apply to the review and investigation of any acquisition, merger, or
takeover which is or becomes subject to section 721 of the Defense
Production Act of 1950 (50 U.S.C. App. 2170) (as in effect immediately
before the date of the enactment of this Act or on or after such date)
that has not become final before the date of the enactment of this Act.

Output:
Foreign Investment National Security Review Act of 2006 - Amends the Defense Production Act of 1950 to revise provisions concerning presidential authority to review pending or proposed mergers, acquisitions, or takeovers (transactions) which could result in foreign control of any person engaged in interstate commerce in the United States. Directs the President, after receiving written notification of a transaction, and acting through the Committee on Foreign Investment in the United States (CFIUS), to conduct an investigation to determine the effects, if any, of the transaction on U.S. national security. Requires investigations to be completed within 75 days.

Reestablishes CFIUS as a multi-agency committee (currently, a committee within the Department of the Treasury).

Prohibits a transaction unless the President finds that it will not threaten to impair U.S. national security. Provides for enforcement of presidential findings. Prohibits judicial review of such determinations. Outlines factors to be considered during an investigation, including domestic production and national defense requirements.

Requires the President, after a determination to approve or disapprove a transaction, to immediately notify (by written report) both Houses of Congress. Allows Congress 30 days after notification of an approved transaction to pass a joint resolution disapproving the transaction.

Directs the President and designated agencies to submit biennial reports to Congress on: (1) evidence of coordinated strategies by one or more countries to acquire U.S. companies involved in research, development, or production of critical technologies for which the United States is a leading producer; and (2) U.S. critical infrastructure owned, controlled, or dominated by an alien, foreign corporation, or foreign government.


Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Expanding Seniors Receiving Dialysis
Choice Act of 2016'' or as the ``ESRD Choice Act of 2016''.

SEC. 2. EXPANDING MEDICARE ADVANTAGE COVERAGE FOR INDIVIDUALS WITH END-
              STAGE RENAL DISEASE (ESRD).

    (a) Expanded MA Eligibility.--
            (1) In general.--Section 1851(a)(3) of the Social Security
        Act (42 U.S.C. 1395w-21(a)(3)) is amended--
                    (A) by striking subparagraph (B); and
                    (B) by striking ``eligible individual'' and all
                that follows through ``In this title, subject to
                subparagraph (B),'' and inserting ``eligible
                individual.--In this title,''.
            (2) Conforming amendments.--
                    (A) Section 1852(b)(1) of the Social Security Act
                (42 U.S.C. 1395w-22(b)(1)) is amended--
                            (i) by striking subparagraph (B); and
                            (ii) by striking ``Beneficiaries'' and all
                        that follows through ``A Medicare+Choice
                        organization'' and inserting ``Beneficiaries.--
                        A Medicare Advantage organization''.
                    (B) Section 1859(b)(6) of the Social Security Act
                (42 U.S.C. 1395w-28(b)(6)) is amended by striking ``may
                waive'' and all that follows through ``subparagraph
                and''.
    (b) Excluding Costs for Kidney Acquisitions From MA Benchmark.--
Section 1853 of the Social Security Act (42 U.S.C. 1395w-23) is
amended--
            (1) in subsection (k)--
                    (A) in paragraph (1)--
                            (i) in the matter preceding subparagraph
                        (A), by striking ``paragraphs (2) and (4)'' and
                        inserting ``paragraphs (2), (4), and (5)''; and
                            (ii) in subparagraph (B)(i), by striking
                        ``paragraphs (2) and (4)'' and inserting
                        ``paragraphs (2), (4), and (5)''; and
                    (B) by adding at the end the following new
                paragraph:
            ``(5) Exclusion of costs for kidney acquisitions from
        capitation rates.--After determining the applicable amount for
        an area for a year under paragraph (1) (beginning with 2019),
        the Secretary shall adjust such applicable amount to exclude
        from such applicable amount the Secretary's estimate of the
        standardized costs for payments for organ acquisitions for
        kidney transplants covered under this title (including expenses
        covered under section 1881(d)) in the area for the year.''; and
            (2) in subsection (n)(2)--
                    (A) in subparagraph (A)(i), by inserting ``and, for
                2019 and subsequent years, the exclusion of payments
                for organ acquisitions for kidney transplants from the
                capitation rate as described in subsection (k)(5)''
                before the semicolon at the end;
                    (B) in subparagraph (E), in the matter preceding
                clause (i), by striking ``subparagraph (F)'' and
                inserting ``subparagraphs (F) and (G)''; and
                    (C) by adding at the end the following new
                subparagraph:
                    ``(G) Application of kidney acquisitions
                adjustment.--The base payment amount specified in
                subparagraph (E) for a year (beginning with 2019) shall
                be adjusted in the same manner under paragraph (5) of
                subsection (k) as the applicable amount is adjusted
                under such subsection.''.
    (c) FFS Coverage of Kidney Acquisitions.--
            (1) In general.--Section 1852(a)(1)(B)(i) of the Social
        Security Act (42 U.S.C. 1395w-22(a)(1)(B)(i)) is amended by
        inserting ``or coverage for organ acquisitions for kidney
        transplants, including as covered under section 1881(d)'' after
        ``hospice care''.
            (2) Conforming amendment.--Section 1851(i) of the Social
        Security Act (42 U.S.C. 1395w-21(i)) is amended by adding at
        the end the following new paragraph:
            ``(3) FFS payment for expenses for kidney acquisitions.--
        Paragraphs (1) and (2) do not apply with respect to expenses
        for organ acquisitions for kidney transplants described in
        section 1852(a)(1)(B)(i).''.
    (d) Sense of Congress Regarding Application of Appropriate Medicare
Advantage Risk Adjustment for Payment for Increased ESRD Enrollees.--It
is the sense of Congress that in implementing the policies under this
section, the Centers for Medicare & Medicaid Services should provide,
in an accurate and transparent manner, for risk adjustment to payment
under the Medicare Advantage program to account for the increased
enrollment in Medicare Advantage plans of individuals with end-stage
renal disease.
    (e) Expanded MA Education.--Section 1851(d)(2)(A)(iii) of the
Social Security Act (42 U.S.C. 1395w-21(d)(2)(A)(iii)) is amended by
inserting before the period at the end the following: ``, including any
additional information that individuals determined to have end-stage
renal disease may need to make informed decisions with respect to such
an election''.
    (f) Report.--Not later than April 1, 2022, the Administrator of the
Centers for Medicare & Medicaid Services shall submit to Congress a
report on the impact of the amendments made by this section on spending
under the traditional Medicare fee-for-service program under parts A
and B of title XVIII of the Social Security Act as well as on spending
under parts C and D of such title. The report shall include an
assessment of the risk adjustment payment methodologies under such
parts C and D and their adequacy with respect to individuals with end-
stage renal disease and such recommendations as the Administrator deems
appropriate.
    (g) Effective Date.--The amendments made by this section shall
apply to plans years beginning on or after January 1, 2020.

            Passed the House of Representatives September 21, 2016.

            Attest:

                                                 KAREN L. HAAS,

                                                                 Clerk.

Output: (This measure has not been amended since it was reported to the House on September 19, 2016.  Expanding Seniors Receiving Dialysis Choice Act of 2016 or the ESRD Choice Act of 2016 (Sec. 2) This bill amends title XVIII (Medicare) of the Social Security Act to allow individuals with end-stage renal disease (ESRD) to be eligible for Medicare Advantage (MA). Under current law, only individuals who develop ESRD while already enrolled in an MA plan may be considered eligible. With respect to payment, the bill: (1) shifts responsibility for the cost of kidney acquisitions from MA plans to Medicare's fee-for-service program, and (2) excludes such costs from the calculation of certain benchmarks that form the basis for payment under MA plans.