[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 554 Introduced in Senate (IS)]







110th CONGRESS
  1st Session
                                 S. 554

     To reduce the Federal budget deficit, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           February 12, 2007

  Mr. Dorgan introduced the following bill; which was read twice and 
                  referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


 
     To reduce the Federal budget deficit, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

Sec. 1. Short title; table of contents.
                TITLE I--REDUCTIONS IN FEDERAL SPENDING

                    Subtitle A--Specific Reductions

Sec. 101. Prohibition on television broadcasting to Cuba.
Sec. 102. Termination of United States Court of Federal Claims.
Sec. 103. Reduction of administrative expenses of agencies.
Sec. 104. Elimination of Medicare Advantage regional plan stabilization 
                            (slush) fund.
               Subtitle B--Reform of Federal Contracting

                 Part I--Elimination of Fraud and Abuse

Sec. 111. Prohibition of war profiteering and fraud.
Sec. 112. Suspension and debarment of unethical contractors.
Sec. 113. Disclosure of audit reports.
                 subpart a--competition in contracting
Sec. 114. Prohibition on award of monopoly contracts.
Sec. 115. Competisubpart b--contract personnel matters
Sec. 116. Contractor conflicts of interest.
Sec. 117. Elimination of revolving door between Federal personnel and 
                            contractors.
                   Part III--Other Personnel Matters

Sec. 118. Minimum requirements for political appointees holding public 
                            contracting and safety positions.
Sec. 119. Protection of certain disclosures of information by Federal 
                            employees.
             Subtitle C--Importation of Prescription Drugs

Sec. 121. Short title.
Sec. 122. Findings.
Sec. 123. Repeal of certain section regarding importation of 
                            prescription drugs.
Sec. 124. Importation of prescription drugs; waiver of certain import 
                            restrictions.
Sec. 125. Disposition of certain drugs denied admission into United 
                            States.
Sec. 126. Wholesale distribution of drugs; statements regarding prior 
                            sale, purchase, or trade.
Sec. 127. Internet sales of prescription drugs.
Sec. 128. Prohibiting payments to unregistered foreign pharmacies.
Sec. 129. Importation exemption under Controlled Substances Import and 
                            Export Act.
Sec. 130. Severability.
        Subtitle D--Royalties Under Offshore Oil and Gas Leases

Sec. 141. Price thresholds for royalty suspension provisions.
Sec. 142. Clarification of authority to impose price thresholds for 
                            certain lease sales.
Sec. 143. Eligibility for new leases and the transfer of leases; 
                            conservation of resources fees.
                     TITLE II--REVENUE ENHANCEMENTS

Sec. 200. Amendment of 1986 Code.
  Subtitle A--Rescission of Various Tax Cuts for Millionaire Taxpayers

Sec. 201. Repeal of top income tax rate reduction for taxpayers with 
                            $1,000,000 or more of taxable income.
Sec. 202. Elimination of the scheduled phaseout of the limitations on 
                            personal exemptions and itemized deductions 
                            for taxpayers earning in excess of 
                            $1,000,000.
Sec. 203. Modification of tax rates on capital gains and dividends for 
                            taxpayers with $1,000,000 or more of 
                            taxable income.
Subtitle B--Provisions to Discourage Offshore Shelters and Expatriation

Sec. 211. Taxation of income of controlled foreign corporations 
                            attributable to imported property.
Sec. 212. Tax treatment of controlled foreign corporations established 
                            in tax havens.
Sec. 213. Revision of tax rules on expatriation of individuals.
Sec. 214. Modification of effective date of leasing provisions of the 
                            American Jobs Creation Act of 2004.
Sec. 215. Application of rules treating inverted corporations as 
                            domestic corporations to certain 
                            transactions occurring after March 20, 
                            2002.
                Subtitle C--Economic Substance Doctrine

Sec. 221. Clarification of economic substance doctrine.
Sec. 222. Penalty for understatements attributable to transactions 
                            lacking economic substance, etc.
Sec. 223. Denial of deduction for interest on underpayments 
                            attributable to noneconomic substance 
                            transactions.
                    Subtitle D--Penalties and Fines

Sec. 231. Denial of deduction for certain fines, penalties, and other 
                            amounts.
Sec. 232. Denial of deduction for punitive damages.
                       Subtitle E--Duty Surcharge

Sec. 241. Temporary emergency duty surcharge.
                      Subtitle F--Other Provisions

Sec. 251. Offshore oil and gas leasing in 181 Area of Gulf of Mexico.
Sec. 252. Transfer of surplus funds of Federal Reserve Banks to 
                            Treasury.
Sec. 253. Permanent extension of FCC authority to auction licenses to 
                            use radio spectrum.
Sec. 254. Travel between the United States and Cuba.

                TITLE I--REDUCTIONS IN FEDERAL SPENDING

                    Subtitle A--Specific Reductions

SEC. 101. PROHIBITION ON TELEVISION BROADCASTING TO CUBA.

    (a) Repeal of the Television Broadcasting to Cuba Act.--
            (1) In general.--The Television Broadcasting to Cuba Act 
        (22 U.S.C. 1465aa et seq.) is repealed.
            (2) Conforming amendment.--Section 107 of the Cuban Liberty 
        and Democratic Solidarity (LIBERTAD) Act of 1996 (22 U.S.C. 
        6037) is amended to read as follows:

``SEC. 107. TERMINATION OF RADIO BROADCASTING AUTHORITY.

    ``Upon transmittal of a determination under section 203(c)(3), the 
Radio Broadcasting to Cuba Act (22 U.S.C. 1465 et seq.) is repealed.''.
    (b) Prohibition on Funding of Television Broadcasting to Cuba.--
Notwithstanding any other provision of law, no funds may appropriated 
or otherwise made available to carry out any program of the United 
States Government to provide television broadcasting to Cuba.

SEC. 102. TERMINATION OF UNITED STATES COURT OF FEDERAL CLAIMS.

    (a) Filing of Claims.--Notwithstanding any other provision of law, 
no claim may be filed in the United States Court of Federal Claims on 
or after the date of enactment of this Act.
    (b) Pending Claims.--Not later than 60 days after the date of 
enactment of this Act, the Chief Justice of the United States shall 
promulgate regulations to carry out an orderly transfer of all claims 
pending before the United States Court of Federal Claims to appropriate 
courts of the United States. Such transfers shall be completed during 
the 1-year period beginning on the date of enactment of this Act. 
Regulations under this subsection may provide for some claims to 
proceed in the United States Court of Federal Claims during that 1-year 
period. A congressional reference case for which a report is not 
transmitted to the appropriate House of Congress before the end of that 
1-year period shall not be transferred and shall terminate.
    (c) Termination.--Notwithstanding any other provision of law, the 
United States Court of Federal Claims is terminated effective on and 
after the date occurring 1 year after the date of enactment of this 
Act.

SEC. 103. REDUCTION OF ADMINISTRATIVE EXPENSES OF AGENCIES.

    (a) Requirement To Reduce Expenses.--An agency (as defined under 
section 101 of title 31, United States Code) shall not make, or 
obligate to make, expenditures for administrative expenses--
            (1) in the case of each of the fiscal years 2008 through 
        2012, in an aggregate amount greater than 95 percent of the 
        amount of such expenses for the preceding fiscal year 
        (determined after application of this section); and
            (2) in the case of fiscal year 2013 and each fiscal year 
        thereafter, in an aggregate amount greater than the aggregate 
        amount of such expenses for fiscal year 2012 (determined after 
        application of this section).
    (b) Exception for Program Expenses.--Nothing in this section shall 
be treated as requiring any reduction in program expenses.
    (c) Identification of Affected Expenses.--The Director of the 
Office of Management and Budget shall, not later than September 1, 
2007, establish guidelines for the determination of what expenses 
constitute administrative expenses or program expenses for purposes of 
this section. The guidelines shall identify specific expenses, and 
classes of expenses, that are to be treated as administrative expenses 
or program expenses.

SEC. 104. ELIMINATION OF MEDICARE ADVANTAGE REGIONAL PLAN STABILIZATION 
              (SLUSH) FUND.

    (a) Elimination.--
            (1) In general.--Subsection (e) of section 1858 of the 
        Social Security Act (42 U.S.C. 1395w-27a) is repealed.
            (2) Conforming amendment.--Section 1858(f)(1) of the Social 
        Security Act (42 U.S.C. 1395w-27a(f)(1)) is amended by striking 
        ``subject to subsection (e),''.
    (b) Effective Date.--The amendments made by this section shall take 
effect on the date of enactment of this Act.

               Subtitle B--Reform of Federal Contracting

                 PART I--ELIMINATION OF FRAUD AND ABUSE

SEC. 111. PROHIBITION OF WAR PROFITEERING AND FRAUD.

    (a) Prohibition.--
            (1) In general.--Chapter 47 of title 18, United States 
        Code, is amended by adding at the end the following:
``Sec. 1039. War profiteering and fraud
    ``(a) Prohibition.--
            ``(1) In general.--Whoever, in any matter involving a 
        contract or the provision of goods or services, directly or 
        indirectly, in connection with a war or military action 
        knowingly and willfully--
                    ``(A) executes or attempts to execute a scheme or 
                artifice to defraud the United States or the entity 
                having jurisdiction over the area in which such 
                activities occur;
                    ``(B) falsifies, conceals, or covers up by any 
                trick, scheme, or device a material fact;
                    ``(C) makes any materially false, fictitious, or 
                fraudulent statements or representations, or makes or 
                uses any materially false writing or document knowing 
                the same to contain any materially false, fictitious, 
                or fraudulent statement or entry; or
                    ``(D) materially overvalues any good or service 
                with the specific intent to excessively profit from the 
                war or military action;
        shall be fined under paragraph (2), imprisoned not more than 20 
        years, or both.
            ``(2) Fine.--A person convicted of an offense under 
        paragraph (1) may be fined the greater of--
                    ``(A) $1,000,000; or
                    ``(B) if such person derives profits or other 
                proceeds from the offense, not more than twice the 
                gross profits or other proceeds.
    ``(b) Extraterritorial Jurisdiction.--There is extraterritorial 
Federal jurisdiction over an offense under this section.
    ``(c) Venue.--A prosecution for an offense under this section may 
be brought--
            ``(1) as authorized by chapter 211 of this title;
            ``(2) in any district where any act in furtherance of the 
        offense took place; or
            ``(3) in any district where any party to the contract or 
        provider of goods or services is located.''.
            (2) Clerical amendment.--The table of sections for chapter 
        47 of title 18, United States Code, is amended by adding at the 
        end the following:

``1039. War profiteering and fraud.''.
    (b) Civil Forfeiture.--Section 981(a)(1)(C) of title 18, United 
States Code, is amended by inserting ``1039,'' after ``1032,''.
    (c) Criminal Forfeiture.--Section 982(a)(2)(B) of title 18, United 
States Code, is amended by striking ``or 1030'' and inserting ``1030, 
or 1039''.
    (d) Treatment Under Money Laundering Offense.--Section 
1956(c)(7)(D) of title 18, United States Code, is amended by inserting 
the following: ``, section 1039 (relating to war profiteering and 
fraud)'' after ``liquidating agent of financial institution),''.

SEC. 112. SUSPENSION AND DEBARMENT OF UNETHICAL CONTRACTORS.

    (a) In General.--Not later than 90 days after the date of enactment 
of this Act, the Federal Acquisition Regulation issued pursuant to 
section 25 of the Office of Federal Procurement Policy Act (41 U.S.C. 
421) shall be revised to provide that no prospective contractor shall 
be considered to have a satisfactory record of integrity and business 
ethics if it--
            (1) has exhibited a pattern of overcharging the Government 
        under Federal contracts; or
            (2) has exhibited a pattern of failing to comply with the 
        law, including tax, labor and employment, environmental, 
        antitrust, and consumer protection laws.
    (b) Effective Date.--The revised regulation required by this 
section shall apply with respect to all contracts for which 
solicitations are issued after the date that is 90 days after the date 
of the enactment of this Act.

SEC. 113. DISCLOSURE OF AUDIT REPORTS.

    (a) Disclosure of Information to Congress.--
            (1) In general.--The head of each executive agency shall 
        maintain a list of audit reports issued by the agency during 
        the current and previous calendar years that--
                    (A) describe significant contractor costs that have 
                been identified as unjustified, unsupported, 
                questioned, or unreasonable under any contract, task or 
                delivery order, or subcontract; or
                    (B) identify significant or substantial 
                deficiencies in any business system of any contractor 
                under any contract, task or delivery order, or 
                subcontract.
            (2) Submission of individual audits.--The head of each 
        executive agency shall provide, within 14 days of a request in 
        writing by the chairman or ranking member of a committee of 
        jurisdiction, a full and unredacted copy of--
                    (A) the current version of the list maintained 
                pursuant to paragraph (1); or
                    (B) any audit or other report identified on such 
                list.
    (b) Publication of Information on Federal Contractor Penalties and 
Violations.--
            (1) In general.--Not later than 180 days after the date of 
        the enactment of this Act, the Federal Procurement Data System 
        shall be modified to include--
                    (A) information on instances in which any major 
                contractor has been fined, paid penalties or 
                restitution, settled, plead guilty to, or had judgments 
                entered against it in connection with allegations of 
                improper conduct; and
                    (B) information on all sole source contract awards 
                in excess of $2,000,000 entered into by an executive 
                agency.
            (2) Publicly available website.--The information required 
        by paragraph (1) shall be made available through the publicly 
        available website of the Federal Procurement Data System.

                       PART II--CONTRACT MATTERS

                 Subpart A--Competition in Contracting

SEC. 114. PROHIBITION ON AWARD OF MONOPOLY CONTRACTS.

    (a) Civilian Agency Contracts.--Section 303H(d) of the Federal 
Property and Administrative Services Act of 1949 (41 U.S.C. 253h(d)) is 
amended by adding at the end the following new paragraph:
    ``(4)(A) No task or delivery order contract in an amount estimated 
to exceed $100,000,000 (including all options) may be awarded to a 
single contractor unless the head of the agency determines in writing 
that--
            ``(i) because of the size, scope, or method of performance 
        of the requirement, it would not be practical to award multiple 
        task or delivery order contracts;
            ``(ii) the task orders expected under the contract are so 
        integrally related that only a single contractor can reasonably 
        perform the work; or
            ``(iii) for any other reason, it is necessary in the public 
        interest to award the contract to a single contractor.
    ``(B) The head of the agency shall notify Congress within 30 days 
of any determination under subparagraph (A)(iii).''.
    (b) Defense Contracts.--Section 2304a(d) of title 10, United States 
Code, is amended by adding at the end the following new paragraph:
    ``(4)(A) No task or delivery order contract in an amount estimated 
to exceed $100,000,000 (including all options) may be awarded to a 
single contractor unless the head of the agency determines in writing 
that--
            ``(i) because of the size, scope, or method of performance 
        of the requirement, it would not be practical to award multiple 
        task or delivery order contracts;
            ``(ii) the task orders expected under the contract are so 
        integrally related that only a single contractor can reasonably 
        perform the work; or
            ``(iii) for any other reason, it is necessary in the public 
        interest to award the contract to a single contractor.
    ``(B) The head of the agency shall notify Congress within 30 days 
of any determination under subparagraph (A)(iii).''.

SEC. 115. COMPETITION IN MULTIPLE AWARD CONTRACTS.

    (a) Regulations Required.--Not later than 180 days after the date 
of the enactment of this section, the Federal Acquisition Regulation 
shall be revised to require competition in the purchase of goods and 
services by each executive agency pursuant to multiple award contracts.
    (b) Content of Regulations.--(1) The regulations required by 
subsection (a) shall provide, at a minimum, that each individual 
purchase of goods or services in excess of $1,000,000 that is made 
under a multiple award contract shall be made on a competitive basis 
unless a contracting officer of the executive agency--
            (A) waives the requirement on the basis of a determination 
        that--
                    (i) one of the circumstances described in 
                paragraphs (1) through (4) of section 303J(b) of the 
                Federal Property and Administrative Services Act of 
                1949 (41 U.S.C. 253j(b)) applies to such individual 
                purchase; or
                    (ii) a statute expressly authorizes or requires 
                that the purchase be made from a specified source; and
            (B) justifies the determination in writing.
    (2) For purposes of this subsection, an individual purchase of 
goods or services is made on a competitive basis only if it is made 
pursuant to procedures that--
            (A) require fair notice of the intent to make that purchase 
        (including a description of the work to be performed and the 
        basis on which the selection will be made) to be provided to 
        all contractors offering such goods or services under the 
        multiple award contract; and
            (B) afford all contractors responding to the notice a fair 
        opportunity to make an offer and have that offer fairly 
        considered by the official making the purchase.
    (3) Notwithstanding paragraph (2), notice may be provided to fewer 
than all contractors offering such goods or services under a multiple 
award contract described in subsection (c)(2)(A) if notice is provided 
to as many contractors as practicable.
    (4) A purchase may not be made pursuant to a notice that is 
provided to fewer than all contractors under paragraph (3) unless--
            (A) offers were received from at least three qualified 
        contractors; or
            (B) a contracting officer of the executive agency 
        determines in writing that no additional qualified contractors 
        were able to be identified despite reasonable efforts to do so.
    (c) Definitions.--In this section:
            (1) The term ``individual purchase'' means a task order, 
        delivery order, or other purchase.
            (2) The term ``multiple award contract'' means--
                    (A) a contract that is entered into by the 
                Administrator of General Services under the multiple 
                award schedule program referred to in section 309(b)(3) 
                of the Federal Property and Administrative Services Act 
                of 1949 (41 U.S.C. 259(b)(3));
                    (B) a multiple award task order contract that is 
                entered into under the authority of sections 2304a 
                through 2304d of title 10, United States Code, or 
                sections 303H through 303K of the Federal Property and 
                Administrative Services Act of 1949 (41 U.S.C. 253h 
                through 253k); and
                    (C) any other indefinite delivery, indefinite 
                quantity contract that is entered into by the head of 
                an executive agency with two or more sources pursuant 
                to the same solicitation.
    (d) Applicability.--The revisions to the Federal Acquisition 
Regulation pursuant to subsection (a) shall take effect not later than 
180 days after the date of the enactment of this Act, and shall apply 
to all individual purchases of goods or services that are made under 
multiple award contracts on or after the effective date, without regard 
to whether the multiple award contracts were entered into before, on, 
or after such effective date.
    (e) Conforming Amendments to Defense Contract Provision.--Section 
803 of the National Defense Authorization Act for Fiscal Year 2002 
(Public Law 107-107; 10 U.S.C. 2304 note) is amended as follows:
            (1) Goods covered.--(A) The section heading is amended by 
        inserting ``goods or'' before ``services''.
            (B) Subsection (a) is amended by inserting ``goods and'' 
        before ``services''.
            (C) The following provisions are amended by inserting 
        ``goods or'' before ``services'' each place it appears:
                    (i) Paragraphs (1), (2), and (3) of subsection (b).
                    (ii) Subsection (d).
            (D) Such section is amended by adding at the end the 
        following new subsection:
    ``(e) Applicability to Goods.--The Secretary shall revise the 
regulations promulgated pursuant to subsection (a) to cover purchases 
of goods by the Department of Defense pursuant to multiple award 
contracts. The revised regulations shall take effect in final form not 
later than 180 days after the date of the enactment of this subsection 
and shall apply to all individual purchases of goods that are made 
under multiple award contracts on or after the effective date, without 
regard to whether the multiple award contracts were entered into 
before, on, or after such effective date.''.
    (f) Protest Rights for Certain Awards.--
            (1) Civilian agency contracts.--Section 303J(d) of the 
        Federal Property and Administrative Services Act (41 U.S.C. 
        253j(d)) is amended by inserting ``with a value of less than 
        $500,000'' after ``task or delivery order''.
            (2) Defense contracts.--Section 2304c(d) of title 10, 
        United States Code, is amended by inserting ``with a value of 
        less than $500,000'' after ``task or delivery order''.

                 Subpart B--Contract Personnel Matters

SEC. 116. CONTRACTOR CONFLICTS OF INTEREST.

    (a) Prohibition on Contracts Relating to Inherently Governmental 
Functions.--The head of an agency may not enter into a contract for the 
performance of any inherently governmental function.
    (b) Prohibition on Contracts for Contract Oversight.--
            (1) Prohibition.--The head of an agency may not enter into 
        a contract for the performance of acquisition functions closely 
        associated with inherently governmental functions with any 
        entity unless the head of the agency determines in writing 
        that--
                    (A) neither that entity nor any related entity will 
                be responsible for performing any of the work under a 
                contract which the entity will help plan, evaluate, 
                select a source, manage or oversee; and
                    (B) the agency has taken appropriate steps to 
                prevent or mitigate any organizational conflict of 
                interest that may arise because the entity--
                            (i) has a separate ongoing business 
                        relationship, such as a joint venture or 
                        contract, with any of the contractors to be 
                        overseen;
                            (ii) would be placed in a position to 
                        affect the value or performance of work it or 
                        any related entity is doing under any other 
                        Government contract;
                            (iii) has a reverse role with the 
                        contractor to be overseen under one or more 
                        separate Government contracts; or
                            (iv) has some other relationship with the 
                        contractor to be overseen that could reasonably 
                        appear to bias the contractor's judgment.
            (2) Related entity defined.--In this subsection, the term 
        ``related entity'', with respect to a contractor, means any 
        subsidiary, parent, affiliate, joint venture, or other entity 
        related to the contractor.
    (c) Definitions.--In this section:
            (1) The term ``inherently governmental functions'' has the 
        meaning given to such term in part 7.5 of the Federal 
        Acquisition Regulation.
            (2) The term ``functions closely associated with 
        governmental functions'' means the functions described in 
        section 7.503(d) of the Federal Acquisition Regulation.
            (3) The term ``organizational conflict of interest'' has 
        the meaning given such term in part 9.5 of the Federal 
        Acquisition Regulation.
    (d) Effective Date and Applicability.--This section shall take 
effect on the date of the enactment of this Act and shall apply to--
            (1) contracts entered into on or after such date;
            (2) any task or delivery order issued on or after such date 
        under a contract entered into before, on, or after such date; 
        and
            (3) any decision on or after such date to exercise an 
        option or otherwise extend a contract for the performance of a 
        function relating to contract oversight regardless of whether 
        such contract was entered into before, on, or after such date.

SEC. 117. ELIMINATION OF REVOLVING DOOR BETWEEN FEDERAL PERSONNEL AND 
              CONTRACTORS.

    (a) Elimination of Loopholes Allowing Former Federal Officials To 
Accept Compensation From Contractors or Related Entities.--
            (1) In general.--Paragraph (1) of subsection (d) of section 
        27 of the Office of Federal Procurement Policy Act (41 U.S.C. 
        423) is amended--
                    (A) by striking ``or consultant'' and inserting 
                ``consultant, lawyer, or lobbyist'';
                    (B) by striking ``one year'' and inserting ``two 
                years''; and
                    (C) in subparagraph (C), by striking ``personally 
                made for the Federal agency--'' and inserting 
                ``participated personally and substantially in--''.
            (2) Definition.--Paragraph (2) of such subsection is 
        amended to read as follows:
    ``(2) For purposes of paragraph (1), the term `contractor' includes 
any division, affiliate, subsidiary, parent, joint venture, or other 
related entity of a contractor.''.
    (b) Prohibition on Award of Government Contracts to Former 
Employers.--Such section is further amended by adding at the end the 
following new subsection:
    ``(i) Prohibition on Involvement by Certain Former Contractor 
Employees in Procurements.--A former employee of a contractor who 
becomes an employee of the Federal Government shall not be personally 
and substantially involved with any Federal agency procurement 
involving the employee's former employer, including any division, 
affiliate, subsidiary, parent, joint venture, or other related entity 
of the former employer, for a period of two years beginning on the date 
on which the employee leaves the employment of the contractor unless 
the designated agency ethics officer for the agency determines in 
writing that the government's interest in the former employee's 
participation in a particular procurement outweighs any appearance of 
impropriety.''.
    (c) Requirement for Federal Procurement Officers To Disclose Job 
Offers Made to Relatives.--Subsection (c)(1) of such section is amended 
by inserting after ``that official'' the following: ``, or for a 
relative of that official (as defined in section 3110 of title 5, 
United States Code),''.
    (d) Additional Criminal Penalties.--Paragraph (1) of subsection (e) 
of such section is amended to read as follows:
            ``(1) Criminal penalties.--Whoever engages in conduct 
        constituting a violation of--
                    ``(A) subsection (a) or (b) for the purpose of 
                either--
                            ``(i) exchanging the information covered by 
                        such subsection for anything of value, or
                            ``(ii) obtaining or giving anyone a 
                        competitive advantage in the award of a Federal 
                        agency procurement contract; or
                    ``(B) subsection (c) or (d);
        shall be imprisoned for not more than 5 years, fined as 
        provided under title 18, Untied States Code, or both.''.
    (e) Regulations.--Such section is further amended by adding at the 
end the following new subsection:
    ``(j) Regulations.--The Director of the Office of Government 
Ethics, in consultation with the Administrator, shall--
            ``(1) promulgate regulations to carry out and ensure the 
        enforcement of this section; and
            ``(2) monitor and investigate individual and agency 
        compliance with this section.''.

                   PART III--OTHER PERSONNEL MATTERS

SEC. 118. MINIMUM REQUIREMENTS FOR POLITICAL APPOINTEES HOLDING PUBLIC 
              CONTRACTING AND SAFETY POSITIONS.

    (a) In General.--A position specified in subsection (b) may not be 
held by any political appointee who does not meet the requirements of 
subsection (c).
    (b) Specified Positions.--A position specified in this subsection 
is any position as follows:
            (1) A public contracting position.
            (2) A public safety position.
    (c) Minimum Requirements.--An individual shall not, with respect to 
any position, be considered to meet the requirements of this subsection 
unless such individual--
            (1) has academic, management, and leadership credentials in 
        one or more areas relevant to such position;
            (2) has a superior record of achievement in one or more 
        areas relevant to such position;
            (3) has training and expertise in one or more areas 
        relevant to such position; and
            (4) has not, within the 2-year period ending on the date of 
        such individual's nomination for or appointment to such 
        position, been a lobbyist for any entity or other client that 
        is subject to the authority of the agency within which, if 
        appointed, such individual would serve.
    (d) Political Appointee.--For purposes of this section, the term 
``political appointee'' means any individual who--
            (1) is employed in a position listed in sections 5312 
        through 5316 of title 5, United States Code (relating to the 
        Executive Schedule);
            (2) is a limited term appointee, limited emergency 
        appointee, or noncareer appointee in the Senior Executive 
        Service; or
            (3) is employed in the executive branch of the Government 
        in a position which has been excepted from the competitive 
        service by reason of its policy-determining, policy-making, or 
        policy-advocating character.
    (e) Public Contracting Position.--For purposes of this section, the 
term ``public contracting position'' means the following:
            (1) The Administrator for Federal Procurement Policy.
            (2) The Administrator of the General Services 
        Administration.
            (3) The Chief Acquisition Officer of any executive agency, 
        as appointed or designated pursuant to section 16 of the Office 
        of Federal Procurement Policy Act (41 U.S.C. 414).
            (4) The Under Secretary of Defense for Acquisition, 
        Technology, and Logistics.
            (5) Any position (not otherwise identified under any of the 
        preceding provisions of this subsection) a primary function of 
        which involves government procurement and procurement policy, 
        as identified by the head of each employing agency in 
        consultation with the Office of Personnel Management.
    (f) Public Safety Position.--For purposes of this section, the term 
``public safety position'' means the following:
            (1) The Under Secretary for Emergency Preparedness and 
        Response, Department of Homeland Security.
            (2) The Director of the Federal Emergency Management 
        Agency, Department of Homeland Security.
            (3) Each regional director of the Federal Emergency 
        Management Agency, Department of Homeland Security.
            (4) The Recovery Division Director of the Federal Emergency 
        Management Agency, Department of Homeland Security.
            (5) The Assistant Secretary for Immigration and Customs 
        Enforcement, Department of Homeland Security.
            (6) The Assistant Secretary for Public Health Emergency 
        Preparedness, Department of Health and Human Services.
            (7) The Assistant Administrator for Solid Waste and 
        Emergency Response, Environmental Protection Agency.
            (8) Any position (not otherwise identified under any of the 
        preceding provisions of this subsection) a primary function of 
        which involves responding to a direct threat to life or 
        property or a hazard to health, as identified by the head of 
        each employing agency in consultation with the Office of 
        Personnel Management.
    (g) Publication of Positions.--Beginning not later than 30 days 
after the date of the enactment of this Act, the head of each agency 
shall maintain on such agency's public website a current list of all 
public contracting positions and public safety positions within such 
agency.
    (h) Coordination With Other Requirements.--The requirements set 
forth in subsection (c) shall be in addition to, and not in lieu of, 
any requirements that might otherwise apply with respect to any 
particular position.
    (i) Definitions.--In this section:
            (1) The term ``agency'' means an Executive agency (as 
        defined by section 105 of title 5, United States Code).
            (2) The terms ``limited term appointee'', ``limited 
        emergency appointee'', and ``noncareer appointee'' have the 
        meanings given such terms in section 3132 of title 5, United 
        States Code.
            (3) The term ``Senior Executive Service'' has the meaning 
        given such term by section 2101a of title 5, United States 
        Code.
            (4) The term ``competitive service'' has the meaning given 
        such term by section 2102 of title 5, United States Code.
            (5) The terms ``lobbyist'' and ``client'' have the 
        respective meanings given them by section 3 of the Lobbying 
        Disclosure Act of 1995 (2 U.S.C. 1602).
    (j) Conforming Amendment.--Section 16(a) of the Office of Federal 
Procurement Policy Act (41 U.S.C. 414(a)) is amended by striking ``non-
career employee as''.

SEC. 119. PROTECTION OF CERTAIN DISCLOSURES OF INFORMATION BY FEDERAL 
              EMPLOYEES.

    (a) Clarification of Disclosures Covered.--Section 2302(b)(8) of 
title 5, United States Code, is amended--
            (1) in subparagraph (A)--
                    (A) by striking ``which the employee or applicant 
                reasonably believes evidences'' and inserting ``, 
                without restriction to time, place, form, motive, 
                context, or prior disclosure made to any person by an 
                employee or applicant, including a disclosure made in 
                the ordinary course of an employee's duties, that the 
                employee or applicant reasonably believes is evidence 
                of''; and
                    (B) in clause (i), by striking ``a violation'' and 
                inserting ``any violation'';
            (2) in subparagraph (B)--
                    (A) by striking ``which the employee or applicant 
                reasonably believes evidences'' and inserting ``, 
                without restriction to time, place, form, motive, 
                context, or prior disclosure made to any person by an 
                employee or applicant, including a disclosure made in 
                the ordinary course of an employee's duties, of 
                information that the employee or applicant reasonably 
                believes is evidence of''; and
                    (B) in clause (i), by striking ``a violation'' and 
                inserting ``any violation (other than a violation of 
                this section)''; and
            (3) by adding at the end the following:
                    ``(C) any disclosure that--
                            ``(i) is made by an employee or applicant 
                        of information required by law or Executive 
                        order to be kept secret in the interest of 
                        national defense or the conduct of foreign 
                        affairs that the employee or applicant 
                        reasonably believes is direct and specific 
                        evidence of--
                                    ``(I) any violation of any law, 
                                rule, or regulation;
                                    ``(II) gross mismanagement, a gross 
                                waste of funds, an abuse of authority, 
                                or a substantial and specific danger to 
                                public health or safety; or
                                    ``(III) a false statement to 
                                Congress on an issue of material fact; 
                                and
                            ``(ii) is made to--
                                    ``(I) a member of a committee of 
                                Congress;
                                    ``(II) any other Member of 
                                Congress; or
                                    ``(III) an employee of Congress who 
                                has the appropriate security clearance 
                                and is authorized to receive 
                                information of the type disclosed.''.
    (b) Covered Disclosures.--Section 2302(a)(2) of title 5, United 
States Code, is amended--
            (1) in subparagraph (B)(ii), by striking ``and'' at the 
        end;
            (2) in subparagraph (C)(iii), by striking the period at the 
        end and inserting ``; and''; and
            (3) by adding at the end the following:
            ``(D) `disclosure' means a formal or informal communication 
        or transmission, but does not include a communication 
        concerning policy decisions that lawfully exercise 
        discretionary authority unless the employee providing the 
        disclosure reasonably believes that the disclosure evidences--
                    ``(i) any violation of any law, rule, or 
                regulation; or
                    ``(ii) gross mismanagement, a gross waste of funds, 
                an abuse of authority, or a substantial and specific 
                danger to public health or safety.''.
    (c) Rebuttable Presumption.--Section 2302(b) of title 5, United 
States Code, is amended by amending the matter following paragraph (12) 
to read as follows:
``This subsection shall not be construed to authorize the withholding 
of information from Congress or the taking of any personnel action 
against an employee who discloses information to Congress. For purposes 
of paragraph (8), any presumption relating to the performance of a duty 
by an employee who has authority to take, direct others to take, 
recommend, or approve any personnel action may be rebutted by 
substantial evidence. For purposes of paragraph (8), a determination as 
to whether an employee or applicant reasonably believes that they have 
disclosed information that evidences any violation of law, rule, 
regulation, gross mismanagement, a gross waste of funds, an abuse of 
authority, or a substantial and specific danger to public health or 
safety shall be made by determining whether a disinterested observer 
with knowledge of the essential facts known to and readily 
ascertainable by the employee would reasonably conclude that the 
actions of the Government evidence such violations, mismanagement, 
waste, abuse, or danger.''.
    (d) Nondisclosure Policies, Forms, and Agreements; Security 
Clearances; and Retaliatory Investigations.--
            (1) Personnel action.--Section 2302(a)(2)(A) of title 5, 
        United States Code, is amended--
                    (A) in clause (x), by striking ``and'' after the 
                semicolon; and
                    (B) by redesignating clause (xi) as clause (xiv) 
                and inserting after clause (x) the following:
                            ``(xi) the implementation or enforcement of 
                        any nondisclosure policy, form, or agreement;
                            ``(xii) a suspension, revocation, or other 
                        determination relating to a security clearance 
                        or any other access determination by a covered 
                        agency;
                            ``(xiii) an investigation, other than any 
                        ministerial or nondiscretionary fact finding 
                        activities necessary for the agency to perform 
                        its mission, of an employee or applicant for 
                        employment because of any activity protected 
                        under this section; and''.
            (2) Prohibited personnel practice.--Section 2302(b) of 
        title 5, United States Code, is amended--
                    (A) in paragraph (11), by striking ``or'' at the 
                end;
                    (B) in paragraph (12), by striking the period and 
                inserting a semicolon; and
                    (C) by inserting after paragraph (12) the 
                following:
            ``(13) implement or enforce any nondisclosure policy, form, 
        or agreement, if such policy, form, or agreement does not 
        contain the following statement: `These provisions are 
        consistent with and do not supersede, conflict with, or 
        otherwise alter the employee obligations, rights, or 
        liabilities created by Executive Order No. 12958; section 7211 
        (governing disclosures to Congress); section 1034 of title 10 
        (governing disclosure to Congress by members of the military); 
        section 2302(b)(8) (governing disclosures of illegality, waste, 
        fraud, abuse, or public health or safety threats); the 
        Intelligence Identities Protection Act of 1982 (50 U.S.C. 421 
        et seq.) (governing disclosures that could expose confidential 
        Government agents); and the statutes which protect against 
        disclosures that could compromise national security, including 
        sections 641, 793, 794, 798, and 952 of title 18 and section 
        4(b) of the Subversive Activities Control Act of 1950 (50 
        U.S.C. 783(b)). The definitions, requirements, obligations, 
        rights, sanctions, and liabilities created by such Executive 
        order and such statutory provisions are incorporated into this 
        agreement and are controlling'; or
            ``(14) conduct, or cause to be conducted, an investigation, 
        other than any ministerial or nondiscretionary fact finding 
        activities necessary for the agency to perform its mission, of 
        an employee or applicant for employment because of any activity 
        protected under this section.''.
            (3) Board and court review of actions relating to security 
        clearances.--
                    (A) In general.--Chapter 77 of title 5, United 
                States Code, is amended by inserting after section 7702 
                the following:
``Sec. 7702a. Actions relating to security clearances
    ``(a) In any appeal relating to the suspension, revocation, or 
other determination relating to a security clearance or access 
determination, the Merit Systems Protection Board or any reviewing 
court--
            ``(1) shall determine whether paragraph (8) or (9) of 
        section 2302(b) was violated;
            ``(2) may not order the President or the designee of the 
        President to restore a security clearance or otherwise reverse 
        a determination of clearance status or reverse an access 
        determination; and
            ``(3) subject to paragraph (2), may issue declaratory 
        relief and any other appropriate relief.
    ``(b)(1) If, in any final judgment, the Board or court declares 
that any suspension, revocation, or other determination with regards to 
a security clearance or access determination was made in violation of 
paragraph (8) or (9) of section 2302(b), the affected agency shall 
conduct a review of that suspension, revocation, access determination, 
or other determination, giving great weight to the Board or court 
judgment.
    ``(2) Not later than 30 days after any Board or court judgment 
declaring that a security clearance suspension, revocation, access 
determination, or other determination was made in violation of 
paragraph (8) or (9) of section 2302(b), the affected agency shall 
issue an unclassified report to the congressional committees of 
jurisdiction (with a classified annex if necessary), detailing the 
circumstances of the agency's security clearance suspension, 
revocation, other determination, or access determination. A report 
under this paragraph shall include any proposed agency action with 
regards to the security clearance or access determination.
    ``(c) An allegation that a security clearance or access 
determination was revoked or suspended in retaliation for a protected 
disclosure shall receive expedited review by the Office of Special 
Counsel, the Merit Systems Protection Board, and any reviewing court.
    ``(d) For purposes of this section, corrective action may not be 
ordered if the agency demonstrates by a preponderance of the evidence 
that it would have taken the same personnel action in the absence of 
such disclosure.''.
                    (B) Technical and conforming amendment.--The table 
                of sections for chapter 77 of title 5, United States 
                Code, is amended by inserting after the item relating 
                to section 7702 the following:

``7702a. Actions relating to security clearances.''.
    (e) Exclusion of Agencies by the President.--Section 2302(a)(2)(C) 
of title 5, United States Code, is amended by striking clause (ii) and 
inserting the following:
                    ``(ii)(I) the Federal Bureau of Investigation, the 
                Office of the Director of National Intelligence, the 
                Central Intelligence Agency, the Defense Intelligence 
                Agency, the National Geospatial-Intelligence Agency, 
                and the National Security Agency; and
                    ``(II) as determined by the President, any 
                executive agency or unit thereof the principal function 
                of which is the conduct of foreign intelligence or 
                counterintelligence activities, if the determination 
                (as that determination relates to a personnel action) 
                is made before that personnel action; or''.
    (f) Attorney Fees.--Section 1204(m)(1) of title 5, United States 
Code, is amended by striking ``agency involved'' and inserting ``agency 
where the prevailing party is employed or has applied for employment''.
    (g) Disciplinary Action.--Section 1215(a)(3) of title 5, United 
States Code, is amended to read as follows:
            ``(3)(A) A final order of the Board may impose--
                    ``(i) disciplinary action consisting of removal, 
                reduction in grade, debarment from Federal employment 
                for a period not to exceed 5 years, suspension, or 
                reprimand;
                    ``(ii) an assessment of a civil penalty not to 
                exceed $1,000; or
                    ``(iii) any combination of disciplinary actions 
                described under clause (i) and an assessment described 
                under clause (ii).
            ``(B) In any case in which the Board finds that an employee 
        has committed a prohibited personnel practice under paragraph 
        (8) or (9) of section 2302(b), the Board shall impose 
        disciplinary action if the Board finds that the activity 
        protected under paragraph (8) or (9) of section 2302(b) was a 
        significant motivating factor, even if other factors also 
        motivated the decision, for the employee's decision to take, 
        fail to take, or threaten to take or fail to take a personnel 
        action, unless that employee demonstrates, by preponderance of 
        evidence, that the employee would have taken, failed to take, 
        or threatened to take or fail to take the same personnel 
        action, in the absence of such protected activity.''.
    (h) Special Counsel Amicus Curiae Appearance.--Section 1212 of 
title 5, United States Code, is amended by adding at the end the 
following:
    ``(h)(1) The Special Counsel is authorized to appear as amicus 
curiae in any action brought in a court of the United States related to 
any civil action brought in connection with section 2302(b) (8) or (9), 
or subchapter III of chapter 73, or as otherwise authorized by law. In 
any such action, the Special Counsel is authorized to present the views 
of the Special Counsel with respect to compliance with section 2302(b) 
(8) or (9) or subchapter III of chapter 77 and the impact court 
decisions would have on the enforcement of such provisions of law.
    ``(2) A court of the United States shall grant the application of 
the Special Counsel to appear in any such action for the purposes 
described in subsection (a).''.
    (i) Judicial Review.--
            (1) In general.--Section 7703(b)(1) of title 5, United 
        States Code, is amended to read as follows:
    ``(b)(1)(A) Except as provided in subparagraph (B) and paragraph 
(2), a petition to review a final order or final decision of the Board 
shall be filed in the United States Court of Appeals for the Federal 
Circuit. Notwithstanding any other provision of law, any petition for 
review must be filed within 60 days after the date the petitioner 
received notice of the final order or decision of the Board.
    ``(B) During the 5-year period beginning on the effective date of 
this subsection, a petition to review a final order or final decision 
of the Board in a case alleging a violation of paragraph (8) or (9) of 
section 2302(b) shall be filed in the United States Court of Appeals 
for the Federal Circuit or any court of appeals of competent 
jurisdiction as provided under subsection (b)(2).''.
            (2) Review obtained by office of personnel management.--
        Section 7703(d) of title 5, United States Code, is amended to 
        read as follows:
    ``(d)(1) Except as provided under paragraph (2), this paragraph 
shall apply to any review obtained by the Director of the Office of 
Personnel Management. The Director of the Office of Personnel 
Management may obtain review of any final order or decision of the 
Board by filing, within 60 days after the date the Director received 
notice of the final order or decision of the Board, a petition for 
judicial review in the United States Court of Appeals for the Federal 
Circuit if the Director determines, in his discretion, that the Board 
erred in interpreting a civil service law, rule, or regulation 
affecting personnel management and that the Board's decision will have 
a substantial impact on a civil service law, rule, regulation, or 
policy directive. If the Director did not intervene in a matter before 
the Board, the Director may not petition for review of a Board decision 
under this section unless the Director first petitions the Board for a 
reconsideration of its decision, and such petition is denied. In 
addition to the named respondent, the Board and all other parties to 
the proceedings before the Board shall have the right to appear in the 
proceeding before the Court of Appeals. The granting of the petition 
for judicial review shall be at the discretion of the Court of Appeals.
    ``(2) During the 5-year period beginning on the effective date of 
this subsection, this paragraph shall apply to any review relating to 
paragraph (8) or (9) of section 2302(b) obtained by the Director of the 
Office of Personnel Management. The Director of the Office of Personnel 
Management may obtain review of any final order or decision of the 
Board by filing, within 60 days after the date the Director received 
notice of the final order or decision of the Board, a petition for 
judicial review in the United States Court of Appeals for the Federal 
Circuit or any court of appeals of competent jurisdiction as provided 
under subsection (b)(2) if the Director determines, in his discretion, 
that the Board erred in interpreting paragraph (8) or (9) of section 
2302(b). If the Director did not intervene in a matter before the 
Board, the Director may not petition for review of a Board decision 
under this section unless the Director first petitions the Board for a 
reconsideration of its decision, and such petition is denied. In 
addition to the named respondent, the Board and all other parties to 
the proceedings before the Board shall have the right to appear in the 
proceeding before the court of appeals. The granting of the petition 
for judicial review shall be at the discretion of the Court of 
Appeals.''.
    (j) Nondisclosure Policies, Forms, and Agreements.--
            (1) In general.--
                    (A) Requirement.--Each agreement in Standard Forms 
                312 and 4414 of the Government and any other 
                nondisclosure policy, form, or agreement of the 
                Government shall contain the following statement: 
                ``These restrictions are consistent with and do not 
                supersede, conflict with, or otherwise alter the 
                employee obligations, rights, or liabilities created by 
                Executive Order No. 12958; section 7211 of title 5, 
                United States Code (governing disclosures to Congress); 
                section 1034 of title 10, United States Code (governing 
                disclosure to Congress by members of the military); 
                section 2302(b)(8) of title 5, United States Code 
                (governing disclosures of illegality, waste, fraud, 
                abuse or public health or safety threats); the 
                Intelligence Identities Protection Act of 1982 (50 
                U.S.C. 421 et seq.) (governing disclosures that could 
                expose confidential Government agents); and the 
                statutes which protect against disclosure that may 
                compromise the national security, including sections 
                641, 793, 794, 798, and 952 of title 18, United States 
                Code, and section 4(b) of the Subversive Activities Act 
                of 1950 (50 U.S.C. 783(b)). The definitions, 
                requirements, obligations, rights, sanctions, and 
                liabilities created by such Executive order and such 
                statutory provisions are incorporated into this 
                agreement and are controlling.''.
                    (B) Enforceability.--Any nondisclosure policy, 
                form, or agreement described under subparagraph (A) 
                that does not contain the statement required under 
                subparagraph (A) may not be implemented or enforced to 
                the extent such policy, form, or agreement is 
                inconsistent with that statement.
            (2) Persons other than government employees.--
        Notwithstanding paragraph (1), a nondisclosure policy, form, or 
        agreement that is to be executed by a person connected with the 
        conduct of an intelligence or intelligence-related activity, 
        other than an employee or officer of the United States 
        Government, may contain provisions appropriate to the 
        particular activity for which such document is to be used. Such 
        form or agreement shall, at a minimum, require that the person 
        will not disclose any classified information received in the 
        course of such activity unless specifically authorized to do so 
        by the United States Government. Such nondisclosure forms shall 
        also make it clear that such forms do not bar disclosures to 
        Congress or to an authorized official of an executive agency or 
        the Department of Justice that are essential to reporting a 
        substantial violation of law.
    (k) Clarification of Whistleblower Rights for Critical 
Infrastructure Information.--Section 214(c) of the Homeland Security 
Act of 2002 (6 U.S.C. 133(c)) is amended by adding at the end the 
following: ``For purposes of this section a permissible use of 
independently obtained information includes the disclosure of such 
information under section 2302(b)(8) of title 5, United States Code.''.
    (l) Advising Employees of Rights.--Section 2302(c) of title 5, 
United States Code, is amended by inserting ``, including how to make a 
lawful disclosure of information that is specifically required by law 
or Executive order to be kept secret in the interest of national 
defense or the conduct of foreign affairs to the Special Counsel, the 
Inspector General of an agency, Congress, or other agency employee 
designated to receive such disclosures'' after ``chapter 12 of this 
title''.
    (m) Scope of Due Process.--
            (1) Special counsel.--Section 1214(b)(4)(B)(ii) of title 5, 
        United States Code, is amended by inserting ``, after a finding 
        that a protected disclosure was a contributing factor,'' after 
        ``ordered if''.
            (2) Individual action.--Section 1221(e)(2) of title 5, 
        United States Code, is amended by inserting ``, after a finding 
        that a protected disclosure was a contributing factor,'' after 
        ``ordered if''.

             Subtitle C--Importation of Prescription Drugs

SEC. 121. SHORT TITLE.

    This subtitle may be cited as the ``Pharmaceutical Market Access 
and Drug Safety Act of 2007''.

SEC. 122. FINDINGS.

    Congress finds that--
            (1) Americans unjustly pay up to 5 times more to fill their 
        prescriptions than consumers in other countries;
            (2) the United States is the largest market for 
        pharmaceuticals in the world, yet American consumers pay the 
        highest prices for brand pharmaceuticals in the world;
            (3) a prescription drug is neither safe nor effective to an 
        individual who cannot afford it;
            (4) allowing and structuring the importation of 
        prescription drugs to ensure access to safe and affordable 
        drugs approved by the Food and Drug Administration will provide 
        a level of safety to American consumers that they do not 
        currently enjoy;
            (5) American spend more than $200,000,000,000 on 
        prescription drugs every year;
            (6) the Congressional Budget Office has found that the cost 
        of prescription drugs are between 35 to 55 percent less in 
        other highly-developed countries than in the United States; and
            (7) promoting competitive market pricing would both 
        contribute to health care savings and allow greater access to 
        therapy, improving health and saving lives.

SEC. 123. REPEAL OF CERTAIN SECTION REGARDING IMPORTATION OF 
              PRESCRIPTION DRUGS.

    Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381 et seq.) is amended by striking section 804.

SEC. 124. IMPORTATION OF PRESCRIPTION DRUGS; WAIVER OF CERTAIN IMPORT 
              RESTRICTIONS.

    (a) In General.--Chapter VIII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381 et seq.), as amended by section 123, is 
further amended by inserting after section 803 the following:

``SEC. 804. COMMERCIAL AND PERSONAL IMPORTATION OF PRESCRIPTION DRUGS.

    ``(a) Importation of Prescription Drugs.--
            ``(1) In general.--In the case of qualifying drugs imported 
        or offered for import into the United States from registered 
        exporters or by registered importers--
                    ``(A) the limitation on importation that is 
                established in section 801(d)(1) is waived; and
                    ``(B) the standards referred to in section 801(a) 
                regarding admission of the drugs are subject to 
                subsection (g) of this section (including with respect 
                to qualifying drugs to which section 801(d)(1) does not 
                apply).
            ``(2) Importers.--A qualifying drug may not be imported 
        under paragraph (1) unless--
                    ``(A) the drug is imported by a pharmacy, group of 
                pharmacies, or a wholesaler that is a registered 
                importer; or
                    ``(B) the drug is imported by an individual for 
                personal use or for the use of a family member of the 
                individual (not for resale) from a registered exporter.
            ``(3) Rule of construction.--This section shall apply only 
        with respect to a drug that is imported or offered for import 
        into the United States--
                    ``(A) by a registered importer; or
                    ``(B) from a registered exporter to an individual.
            ``(4) Definitions.--
                    ``(A) Registered exporter; registered importer.--
                For purposes of this section:
                            ``(i) The term `registered exporter' means 
                        an exporter for which a registration under 
                        subsection (b) has been approved and is in 
                        effect.
                            ``(ii) The term `registered importer' means 
                        a pharmacy, group of pharmacies, or a 
                        wholesaler for which a registration under 
                        subsection (b) has been approved and is in 
                        effect.
                            ``(iii) The term `registration condition' 
                        means a condition that must exist for a 
                        registration under subsection (b) to be 
                        approved.
                    ``(B) Qualifying drug.--For purposes of this 
                section, the term `qualifying drug' means a drug for 
                which there is a corresponding U.S. label drug.
                    ``(C) U.S. label drug.--For purposes of this 
                section, the term `U.S. label drug' means a 
                prescription drug that--
                            ``(i) with respect to a qualifying drug, 
                        has the same active ingredient or ingredients, 
                        route of administration, dosage form, and 
                        strength as the qualifying drug;
                            ``(ii) with respect to the qualifying drug, 
                        is manufactured by or for the person that 
                        manufactures the qualifying drug;
                            ``(iii) is approved under section 505(c); 
                        and
                            ``(iv) is not--
                                    ``(I) a controlled substance, as 
                                defined in section 102 of the 
                                Controlled Substances Act (21 U.S.C. 
                                802);
                                    ``(II) a biological product, as 
                                defined in section 351 of the Public 
                                Health Service Act (42 U.S.C. 262), 
                                including--
                                            ``(aa) a therapeutic DNA 
                                        plasmid product;
                                            ``(bb) a therapeutic 
                                        synthetic peptide product;
                                            ``(cc) a monoclonal 
                                        antibody product for in vivo 
                                        use; and
                                            ``(dd) a therapeutic 
                                        recombinant DNA-derived 
                                        product;
                                    ``(III) an infused drug, including 
                                a peritoneal dialysis solution;
                                    ``(IV) an injected drug;
                                    ``(V) a drug that is inhaled during 
                                surgery;
                                    ``(VI) a drug that is the listed 
                                drug referred to in 2 or more 
                                abbreviated new drug applications under 
                                which the drug is commercially 
                                marketed; or
                                    ``(VII) a sterile opthlamic drug 
                                intended for topical use on or in the 
                                eye.
                    ``(D) Other definitions.--For purposes of this 
                section:
                            ``(i)(I) The term `exporter' means a person 
                        that is in the business of exporting a drug to 
                        individuals in the United States from Canada or 
                        from a permitted country designated by the 
                        Secretary under subclause (II), or that, 
                        pursuant to submitting a registration under 
                        subsection (b), seeks to be in such business.
                            ``(II) The Secretary shall designate a 
                        permitted country under subparagraph (E) (other 
                        than Canada) as a country from which an 
                        exporter may export a drug to individuals in 
                        the United States if the Secretary determines 
                        that--
                                    ``(aa) the country has statutory or 
                                regulatory standards that are 
                                equivalent to the standards in the 
                                United States and Canada with respect 
                                to--
                                            ``(AA) the training of 
                                        pharmacists;
                                            ``(BB) the practice of 
                                        pharmacy; and
                                            ``(CC) the protection of 
                                        the privacy of personal medical 
                                        information; and
                                    ``(bb) the importation of drugs to 
                                individuals in the United States from 
                                the country will not adversely affect 
                                public health.
                            ``(ii) The term `importer' means a 
                        pharmacy, a group of pharmacies, or a 
                        wholesaler that is in the business of importing 
                        a drug into the United States or that, pursuant 
                        to submitting a registration under subsection 
                        (b), seeks to be in such business.
                            ``(iii) The term `pharmacist' means a 
                        person licensed by a State to practice 
                        pharmacy, including the dispensing and selling 
                        of prescription drugs.
                            ``(iv) The term `pharmacy' means a person 
                        that--
                                    ``(I) is licensed by a State to 
                                engage in the business of selling 
                                prescription drugs at retail; and
                                    ``(II) employs 1 or more 
                                pharmacists.
                            ``(v) The term `prescription drug' means a 
                        drug that is described in section 503(b)(1).
                            ``(vi) The term `wholesaler'--
                                    ``(I) means a person licensed as a 
                                wholesaler or distributor of 
                                prescription drugs in the United States 
                                under section 503(e)(2)(A); and
                                    ``(II) does not include a person 
                                authorized to import drugs under 
                                section 801(d)(1).
                    ``(E) Permitted country.--The term `permitted 
                country' means--
                            ``(i) Australia;
                            ``(ii) Canada;
                            ``(iii) a member country of the European 
                        Union, but does not include a member country 
                        with respect to which--
                                    ``(I) the country's Annex to the 
                                Treaty of Accession to the European 
                                Union 2003 includes a transitional 
                                measure for the regulation of human 
                                pharmaceutical products that has not 
                                expired; or
                                    ``(II) the Secretary determines 
                                that the requirements described in 
                                subclauses (I) and (II) of clause (vii) 
                                will not be met by the date on which 
                                such transitional measure for the 
                                regulation of human pharmaceutical 
                                products expires;
                            ``(iv) Japan;
                            ``(v) New Zealand;
                            ``(vi) Switzerland; and
                            ``(vii) a country in which the Secretary 
                        determines the following requirements are met:
                                    ``(I) The country has statutory or 
                                regulatory requirements--
                                            ``(aa) that require the 
                                        review of drugs for safety and 
                                        effectiveness by an entity of 
                                        the government of the country;
                                            ``(bb) that authorize the 
                                        approval of only those drugs 
                                        that have been determined to be 
                                        safe and effective by experts 
                                        employed by or acting on behalf 
                                        of such entity and qualified by 
                                        scientific training and 
                                        experience to evaluate the 
                                        safety and effectiveness of 
                                        drugs on the basis of adequate 
                                        and well-controlled 
                                        investigations, including 
                                        clinical investigations, 
                                        conducted by experts qualified 
                                        by scientific training and 
                                        experience to evaluate the 
                                        safety and effectiveness of 
                                        drugs;
                                            ``(cc) that require the 
                                        methods used in, and the 
                                        facilities and controls used 
                                        for the manufacture, 
                                        processing, and packing of 
                                        drugs in the country to be 
                                        adequate to preserve their 
                                        identity, quality, purity, and 
                                        strength;
                                            ``(dd) for the reporting of 
                                        adverse reactions to drugs and 
                                        procedures to withdraw approval 
                                        and remove drugs found not to 
                                        be safe or effective; and
                                            ``(ee) that require the 
                                        labeling and promotion of drugs 
                                        to be in accordance with the 
                                        approval of the drug.
                                    ``(II) The valid marketing 
                                authorization system in the country is 
                                equivalent to the systems in the 
                                countries described in clauses (i) 
                                through (vi).
                                    ``(III) The importation of drugs to 
                                the United States from the country will 
                                not adversely affect public health.
    ``(b) Registration of Importers and Exporters.--
            ``(1) Registration of importers and exporters.--A 
        registration condition is that the importer or exporter 
        involved (referred to in this subsection as a `registrant') 
        submits to the Secretary a registration containing the 
        following:
                    ``(A)(i) In the case of an exporter, the name of 
                the exporter and an identification of all places of 
                business of the exporter that relate to qualifying 
                drugs, including each warehouse or other facility owned 
                or controlled by, or operated for, the exporter.
                    ``(ii) In the case of an importer, the name of the 
                importer and an identification of the places of 
                business of the importer at which the importer 
                initially receives a qualifying drug after importation 
                (which shall not exceed 3 places of business except by 
                permission of the Secretary).
                    ``(B) Such information as the Secretary determines 
                to be necessary to demonstrate that the registrant is 
                in compliance with registration conditions under--
                            ``(i) in the case of an importer, 
                        subsections (c), (d), (e), (g), and (j) 
                        (relating to the sources of imported qualifying 
                        drugs; the inspection of facilities of the 
                        importer; the payment of fees; compliance with 
                        the standards referred to in section 801(a); 
                        and maintenance of records and samples); or
                            ``(ii) in the case of an exporter, 
                        subsections (c), (d), (f), (g), (h), (i), and 
                        (j) (relating to the sources of exported 
                        qualifying drugs; the inspection of facilities 
                        of the exporter and the marking of compliant 
                        shipments; the payment of fees; and compliance 
                        with the standards referred to in section 
                        801(a); being licensed as a pharmacist; 
                        conditions for individual importation; and 
                        maintenance of records and samples).
                    ``(C) An agreement by the registrant that the 
                registrant will not under subsection (a) import or 
                export any drug that is not a qualifying drug.
                    ``(D) An agreement by the registrant to--
                            ``(i) notify the Secretary of a recall or 
                        withdrawal of a qualifying drug distributed in 
                        a permitted country that the registrant has 
                        exported or imported, or intends to export or 
                        import, to the United States under subsection 
                        (a);
                            ``(ii) provide for the return to the 
                        registrant of such drug; and
                            ``(iii) cease, or not begin, the 
                        exportation or importation of such drug unless 
                        the Secretary has notified the registrant that 
                        exportation or importation of such drug may 
                        proceed.
                    ``(E) An agreement by the registrant to ensure and 
                monitor compliance with each registration condition, to 
                promptly correct any noncompliance with such a 
                condition, and to promptly report to the Secretary any 
                such noncompliance.
                    ``(F) A plan describing the manner in which the 
                registrant will comply with the agreement under 
                subparagraph (E).
                    ``(G) An agreement by the registrant to enforce a 
                contract under subsection (c)(3)(B) against a party in 
                the chain of custody of a qualifying drug with respect 
                to the authority of the Secretary under clauses (ii) 
                and (iii) of that subsection.
                    ``(H) An agreement by the registrant to notify the 
                Secretary not more than 30 days before the registrant 
                intends to make the change, of--
                            ``(i) any change that the registrant 
                        intends to make regarding information provided 
                        under subparagraph (A) or (B); and
                            ``(ii) any change that the registrant 
                        intends to make in the compliance plan under 
                        subparagraph (F).
                    ``(I) In the case of an exporter--
                            ``(i) An agreement by the exporter that a 
                        qualifying drug will not under subsection (a) 
                        be exported to any individual not authorized 
                        pursuant to subsection (a)(2)(B) to be an 
                        importer of such drug.
                            ``(ii) An agreement to post a bond, payable 
                        to the Treasury of the United States that is 
                        equal in value to the lesser of--
                                    ``(I) the value of drugs exported 
                                by the exporter to the United States in 
                                a typical 4-week period over the course 
                                of a year under this section; or
                                    ``(II) $1,000,000;
                            ``(iii) An agreement by the exporter to 
                        comply with applicable provisions of Canadian 
                        law, or the law of the permitted country 
                        designated under subsection (a)(4)(D)(i)(II) in 
                        which the exporter is located, that protect the 
                        privacy of personal information with respect to 
                        each individual importing a prescription drug 
                        from the exporter under subsection (a)(2)(B).
                            ``(iv) An agreement by the exporter to 
                        report to the Secretary--
                                    ``(I) not later than August 1 of 
                                each fiscal year, the total price and 
                                the total volume of drugs exported to 
                                the United States by the exporter 
                                during the 6-month period from January 
                                1 through June 30 of that year; and
                                    ``(II) not later than January 1 of 
                                each fiscal year, the total price and 
                                the total volume of drugs exported to 
                                the United States by the exporter 
                                during the previous fiscal year.
                    ``(J) In the case of an importer, an agreement by 
                the importer to report to the Secretary--
                            ``(i) not later than August 1 of each 
                        fiscal year, the total price and the total 
                        volume of drugs imported to the United States 
                        by the importer during the 6-month period from 
                        January 1 through June 30 of that fiscal year; 
                        and
                            ``(ii) not later than January 1 of each 
                        fiscal year, the total price and the total 
                        volume of drugs imported to the United States 
                        by the importer during the previous fiscal 
                        year.
                    ``(K) Such other provisions as the Secretary may 
                require by regulation to protect the public health 
                while permitting--
                            ``(i) the importation by pharmacies, groups 
                        of pharmacies, and wholesalers as registered 
                        importers of qualifying drugs under subsection 
                        (a); and
                            ``(ii) importation by individuals of 
                        qualifying drugs under subsection (a).
            ``(2) Approval or disapproval of registration.--
                    ``(A) In general.--Not later than 90 days after the 
                date on which a registrant submits to the Secretary a 
                registration under paragraph (1), the Secretary shall 
                notify the registrant whether the registration is 
                approved or is disapproved. The Secretary shall 
                disapprove a registration if there is reason to believe 
                that the registrant is not in compliance with one or 
                more registration conditions, and shall notify the 
                registrant of such reason. In the case of a disapproved 
                registration, the Secretary shall subsequently notify 
                the registrant that the registration is approved if the 
                Secretary determines that the registrant is in 
                compliance with such conditions.
                    ``(B) Changes in registration information.--Not 
                later than 30 days after receiving a notice under 
                paragraph (1)(H) from a registrant, the Secretary shall 
                determine whether the change involved affects the 
                approval of the registration of the registrant under 
                paragraph (1), and shall inform the registrant of the 
                determination.
            ``(3) Publication of contact information for registered 
        exporters.--Through the Internet website of the Food and Drug 
        Administration and a toll-free telephone number, the Secretary 
        shall make readily available to the public a list of registered 
        exporters, including contact information for the exporters. 
        Promptly after the approval of a registration submitted under 
        paragraph (1), the Secretary shall update the Internet website 
        and the information provided through the toll-free telephone 
        number accordingly.
            ``(4) Suspension and termination.--
                    ``(A) Suspension.--With respect to the 
                effectiveness of a registration submitted under 
                paragraph (1):
                            ``(i) Subject to clause (ii), the Secretary 
                        may suspend the registration if the Secretary 
                        determines, after notice and opportunity for a 
                        hearing, that the registrant has failed to 
                        maintain substantial compliance with a 
                        registration condition.
                            ``(ii) If the Secretary determines that, 
                        under color of the registration, the exporter 
                        has exported a drug or the importer has 
                        imported a drug that is not a qualifying drug, 
                        or a drug that does not comply with subsection 
                        (g)(2)(A) or (g)(4), or has exported a 
                        qualifying drug to an individual in violation 
                        of subsection (i)(2)(F), the Secretary shall 
                        immediately suspend the registration. A 
                        suspension under the preceding sentence is not 
                        subject to the provision by the Secretary of 
                        prior notice, and the Secretary shall provide 
                        to the registrant an opportunity for a hearing 
                        not later than 10 days after the date on which 
                        the registration is suspended.
                            ``(iii) The Secretary may reinstate the 
                        registration, whether suspended under clause 
                        (i) or (ii), if the Secretary determines that 
                        the registrant has demonstrated that further 
                        violations of registration conditions will not 
                        occur.
                    ``(B) Termination.--The Secretary, after notice and 
                opportunity for a hearing, may terminate the 
                registration under paragraph (1) of a registrant if the 
                Secretary determines that the registrant has engaged in 
                a pattern or practice of violating 1 or more 
                registration conditions, or if on 1 or more occasions 
                the Secretary has under subparagraph (A)(ii) suspended 
                the registration of the registrant. The Secretary may 
                make the termination permanent, or for a fixed period 
                of not less than 1 year. During the period in which the 
                registration is terminated, any registration submitted 
                under paragraph (1) by the registrant, or a person that 
                is a partner in the export or import enterprise, or a 
                principal officer in such enterprise, and any 
                registration prepared with the assistance of the 
                registrant or such a person, has no legal effect under 
                this section.
            ``(5) Default of bond.--A bond required to be posted by an 
        exporter under paragraph (1)(I)(ii) shall be defaulted and paid 
        to the Treasury of the United States if, after opportunity for 
        an informal hearing, the Secretary determines that the exporter 
        has--
                    ``(A) exported a drug to the United States that is 
                not a qualifying drug or that is not in compliance with 
                subsection (g)(2)(A), (g)(4), or (i); or
                    ``(B) failed to permit the Secretary to conduct an 
                inspection described under subsection (d).
    ``(c) Sources of Qualifying Drugs.--A registration condition is 
that the exporter or importer involved agrees that a qualifying drug 
will under subsection (a) be exported or imported into the United 
States only if there is compliance with the following:
            ``(1) The drug was manufactured in an establishment--
                    ``(A) required to register under subsection (h) or 
                (i) of section 510; and
                    ``(B)(i) inspected by the Secretary; or
                    ``(ii) for which the Secretary has elected to rely 
                on a satisfactory report of a good manufacturing 
                practice inspection of the establishment from a 
                permitted country whose regulatory system the Secretary 
                recognizes as equivalent under a mutual recognition 
                agreement, as provided for under section 510(i)(3), 
                section 803, or part 26 of title 21, Code of Federal 
                Regulations (or any corresponding successor rule or 
                regulation).
            ``(2) The establishment is located in any country, and the 
        establishment manufactured the drug for distribution in the 
        United States or for distribution in 1 or more of the permitted 
        countries (without regard to whether in addition the drug is 
        manufactured for distribution in a foreign country that is not 
        a permitted country).
            ``(3) The exporter or importer obtained the drug--
                    ``(A) directly from the establishment; or
                    ``(B) directly from an entity that, by contract 
                with the exporter or importer--
                            ``(i) provides to the exporter or importer 
                        a statement (in such form and containing such 
                        information as the Secretary may require) that, 
                        for the chain of custody from the 
                        establishment, identifies each prior sale, 
                        purchase, or trade of the drug (including the 
                        date of the transaction and the names and 
                        addresses of all parties to the transaction);
                            ``(ii) agrees to permit the Secretary to 
                        inspect such statements and related records to 
                        determine their accuracy;
                            ``(iii) agrees, with respect to the 
                        qualifying drugs involved, to permit the 
                        Secretary to inspect warehouses and other 
                        facilities, including records, of the entity 
                        for purposes of determining whether the 
                        facilities are in compliance with any standards 
                        under this Act that are applicable to 
                        facilities of that type in the United States; 
                        and
                            ``(iv) has ensured, through such 
                        contractual relationships as may be necessary, 
                        that the Secretary has the same authority 
                        regarding other parties in the chain of custody 
                        from the establishment that the Secretary has 
                        under clauses (ii) and (iii) regarding such 
                        entity.
            ``(4)(A) The foreign country from which the importer will 
        import the drug is a permitted country; or
            ``(B) The foreign country from which the exporter will 
        export the drug is the permitted country in which the exporter 
        is located.
            ``(5) During any period in which the drug was not in the 
        control of the manufacturer of the drug, the drug did not enter 
        any country that is not a permitted country.
            ``(6) The exporter or importer retains a sample of each lot 
        of the drug for testing by the Secretary.
    ``(d) Inspection of Facilities; Marking of Shipments.--
            ``(1) Inspection of facilities.--A registration condition 
        is that, for the purpose of assisting the Secretary in 
        determining whether the exporter involved is in compliance with 
        all other registration conditions--
                    ``(A) the exporter agrees to permit the Secretary--
                            ``(i) to conduct onsite inspections, 
                        including monitoring on a day-to-day basis, of 
                        places of business of the exporter that relate 
                        to qualifying drugs, including each warehouse 
                        or other facility owned or controlled by, or 
                        operated for, the exporter;
                            ``(ii) to have access, including on a day-
                        to-day basis, to--
                                    ``(I) records of the exporter that 
                                relate to the export of such drugs, 
                                including financial records; and
                                    ``(II) samples of such drugs;
                            ``(iii) to carry out the duties described 
                        in paragraph (3); and
                            ``(iv) to carry out any other functions 
                        determined by the Secretary to be necessary 
                        regarding the compliance of the exporter; and
                    ``(B) the Secretary has assigned 1 or more 
                employees of the Secretary to carry out the functions 
                described in this subsection for the Secretary 
                randomly, but not less than 12 times annually, on the 
                premises of places of businesses referred to in 
                subparagraph (A)(i), and such an assignment remains in 
                effect on a continuous basis.
            ``(2) Marking of compliant shipments.--A registration 
        condition is that the exporter involved agrees to affix to each 
        shipping container of qualifying drugs exported under 
        subsection (a) such markings as the Secretary determines to be 
        necessary to identify the shipment as being in compliance with 
        all registration conditions. Markings under the preceding 
        sentence shall--
                    ``(A) be designed to prevent affixation of the 
                markings to any shipping container that is not 
                authorized to bear the markings; and
                    ``(B) include anticounterfeiting or track-and-trace 
                technologies, taking into account the economic and 
                technical feasibility of those technologies.
            ``(3) Certain duties relating to exporters.--Duties of the 
        Secretary with respect to an exporter include the following:
                    ``(A) Inspecting, randomly, but not less than 12 
                times annually, the places of business of the exporter 
                at which qualifying drugs are stored and from which 
                qualifying drugs are shipped.
                    ``(B) During the inspections under subparagraph 
                (A), verifying the chain of custody of a statistically 
                significant sample of qualifying drugs from the 
                establishment in which the drug was manufactured to the 
                exporter, which shall be accomplished or supplemented 
                by the use of anticounterfeiting or track-and-trace 
                technologies, taking into account the economic and 
                technical feasibility of those technologies, except 
                that a drug that lacks such technologies from the point 
                of manufacture shall not for that reason be excluded 
                from importation by an exporter.
                    ``(C) Randomly reviewing records of exports to 
                individuals for the purpose of determining whether the 
                drugs are being imported by the individuals in 
                accordance with the conditions under subsection (i). 
                Such reviews shall be conducted in a manner that will 
                result in a statistically significant determination of 
                compliance with all such conditions.
                    ``(D) Monitoring the affixing of markings under 
                paragraph (2).
                    ``(E) Inspecting as the Secretary determines is 
                necessary the warehouses and other facilities, 
                including records, of other parties in the chain of 
                custody of qualifying drugs.
                    ``(F) Determining whether the exporter is in 
                compliance with all other registration conditions.
            ``(4) Prior notice of shipments.--A registration condition 
        is that, not less than 8 hours and not more than 5 days in 
        advance of the time of the importation of a shipment of 
        qualifying drugs, the importer involved agrees to submit to the 
        Secretary a notice with respect to the shipment of drugs to be 
        imported or offered for import into the United States under 
        subsection (a). A notice under the preceding sentence shall 
        include--
                    ``(A) the name and complete contact information of 
                the person submitting the notice;
                    ``(B) the name and complete contact information of 
                the importer involved;
                    ``(C) the identity of the drug, including the 
                established name of the drug, the quantity of the drug, 
                and the lot number assigned by the manufacturer;
                    ``(D) the identity of the manufacturer of the drug, 
                including the identity of the establishment at which 
                the drug was manufactured;
                    ``(E) the country from which the drug is shipped;
                    ``(F) the name and complete contact information for 
                the shipper of the drug;
                    ``(G) anticipated arrival information, including 
                the port of arrival and crossing location within that 
                port, and the date and time;
                    ``(H) a summary of the chain of custody of the drug 
                from the establishment in which the drug was 
                manufactured to the importer;
                    ``(I) a declaration as to whether the Secretary has 
                ordered that importation of the drug from the permitted 
                country cease under subsection (g)(2)(C) or (D); and
                    ``(J) such other information as the Secretary may 
                require by regulation.
            ``(5) Marking of compliant shipments.--A registration 
        condition is that the importer involved agrees, before 
        wholesale distribution (as defined in section 503(e)) of a 
        qualifying drug that has been imported under subsection (a), to 
        affix to each container of such drug such markings or other 
        technology as the Secretary determines necessary to identify 
        the shipment as being in compliance with all registration 
        conditions, except that the markings or other technology shall 
        not be required on a drug that bears comparable, compatible 
        markings or technology from the manufacturer of the drug. 
        Markings or other technology under the preceding sentence 
        shall--
                    ``(A) be designed to prevent affixation of the 
                markings or other technology to any container that is 
                not authorized to bear the markings; and
                    ``(B) shall include anticounterfeiting or track-
                and-trace technologies, taking into account the 
                economic and technical feasibility of such 
                technologies.
            ``(6) Certain duties relating to importers.--Duties of the 
        Secretary with respect to an importer include the following:
                    ``(A) Inspecting, randomly, but not less than 12 
                times annually, the places of business of the importer 
                at which a qualifying drug is initially received after 
                importation.
                    ``(B) During the inspections under subparagraph 
                (A), verifying the chain of custody of a statistically 
                significant sample of qualifying drugs from the 
                establishment in which the drug was manufactured to the 
                importer, which shall be accomplished or supplemented 
                by the use of anticounterfeiting or track-and-trace 
                technologies, taking into account the economic and 
                technical feasibility of those technologies, except 
                that a drug that lacks such technologies from the point 
                of manufacture shall not for that reason be excluded 
                from importation by an importer.
                    ``(C) Reviewing notices under paragraph (4).
                    ``(D) Inspecting as the Secretary determines is 
                necessary the warehouses and other facilities, 
                including records of other parties in the chain of 
                custody of qualifying drugs.
                    ``(E) Determining whether the importer is in 
                compliance with all other registration conditions.
    ``(e) Importer Fees.--
            ``(1) Registration fee.--A registration condition is that 
        the importer involved pays to the Secretary a fee of $10,000 
        due on the date on which the importer first submits the 
        registration to the Secretary under subsection (b).
            ``(2) Inspection fee.--A registration condition is that the 
        importer involved pays a fee to the Secretary in accordance 
        with this subsection. Such fee shall be paid not later than 
        October 1 and April 1 of each fiscal year in the amount 
        provided for under paragraph (3).
            ``(3) Amount of inspection fee.--
                    ``(A) Aggregate total of fees.--Not later than 30 
                days before the start of each fiscal year, the 
                Secretary, in consultation with the Secretary of 
                Homeland Security and the Secretary of the Treasury, 
                shall establish an aggregate total of fees to be 
                collected under paragraph (2) for importers for that 
                fiscal year that is sufficient, and not more than 
                necessary, to pay the costs for that fiscal year of 
                administering this section with respect to registered 
                importers, including the costs associated with--
                            ``(i) inspecting the facilities of 
                        registered importers, and of other entities in 
                        the chain of custody of a qualifying drug as 
                        necessary, under subsection (d)(6);
                            ``(ii) developing, implementing, and 
                        operating under such subsection an electronic 
                        system for submission and review of the notices 
                        required under subsection (d)(4) with respect 
                        to shipments of qualifying drugs under 
                        subsection (a) to assess compliance with all 
                        registration conditions when such shipments are 
                        offered for import into the United States; and
                            ``(iii) inspecting such shipments as 
                        necessary, when offered for import into the 
                        United States to determine if such a shipment 
                        should be refused admission under subsection 
                        (g)(5).
                    ``(B) Limitation.--Subject to subparagraph (C), the 
                aggregate total of fees collected under paragraph (2) 
                for a fiscal year shall not exceed 2.5 percent of the 
                total price of qualifying drugs imported during that 
                fiscal year into the United States by registered 
                importers under subsection (a).
                    ``(C) Total price of drugs.--
                            ``(i) Estimate.--For the purposes of 
                        complying with the limitation described in 
                        subparagraph (B) when establishing under 
                        subparagraph (A) the aggregate total of fees to 
                        be collected under paragraph (2) for a fiscal 
                        year, the Secretary shall estimate the total 
                        price of qualifying drugs imported into the 
                        United States by registered importers during 
                        that fiscal year by adding the total price of 
                        qualifying drugs imported by each registered 
                        importer during the 6-month period from January 
                        1 through June 30 of the previous fiscal year, 
                        as reported to the Secretary by each registered 
                        importer under subsection (b)(1)(J).
                            ``(ii) Calculation.--Not later than March 1 
                        of the fiscal year that follows the fiscal year 
                        for which the estimate under clause (i) is 
                        made, the Secretary shall calculate the total 
                        price of qualifying drugs imported into the 
                        United States by registered importers during 
                        that fiscal year by adding the total price of 
                        qualifying drugs imported by each registered 
                        importer during that fiscal year, as reported 
                        to the Secretary by each registered importer 
                        under subsection (b)(1)(J).
                            ``(iii) Adjustment.--If the total price of 
                        qualifying drugs imported into the United 
                        States by registered importers during a fiscal 
                        year as calculated under clause (ii) is less 
                        than the aggregate total of fees collected 
                        under paragraph (2) for that fiscal year, the 
                        Secretary shall provide for a pro-rata 
                        reduction in the fee due from each registered 
                        importer on April 1 of the subsequent fiscal 
                        year so that the limitation described in 
                        subparagraph (B) is observed.
                    ``(D) Individual importer fee.--Subject to the 
                limitation described in subparagraph (B), the fee under 
                paragraph (2) to be paid on October 1 and April 1 by an 
                importer shall be an amount that is proportional to a 
                reasonable estimate by the Secretary of the semiannual 
                share of the importer of the volume of qualifying drugs 
                imported by importers under subsection (a).
            ``(4) Use of fees.--
                    ``(A) In general.--Subject to appropriations Acts, 
                fees collected by the Secretary under paragraphs (1) 
                and (2) shall be credited to the appropriation account 
                for salaries and expenses of the Food and Drug 
                Administration until expended (without fiscal year 
                limitation), and the Secretary may, in consultation 
                with the Secretary of Homeland Security and the 
                Secretary of the Treasury, transfer some proportion of 
                such fees to the appropriation account for salaries and 
                expenses of the Bureau of Customs and Border Protection 
                until expended (without fiscal year limitation).
                    ``(B) Sole purpose.--Fees collected by the 
                Secretary under paragraphs (1) and (2) are only 
                available to the Secretary and, if transferred, to the 
                Secretary of Homeland Security, and are for the sole 
                purpose of paying the costs referred to in paragraph 
                (3)(A).
            ``(5) Collection of fees.--In any case where the Secretary 
        does not receive payment of a fee assessed under paragraph (1) 
        or (2) within 30 days after it is due, such fee shall be 
        treated as a claim of the United States Government subject to 
        subchapter II of chapter 37 of title 31, United States Code.
    ``(f) Exporter Fees.--
            ``(1) Registration fee.--A registration condition is that 
        the exporter involved pays to the Secretary a fee of $10,000 
        due on the date on which the exporter first submits that 
        registration to the Secretary under subsection (b).
            ``(2) Inspection fee.--A registration condition is that the 
        exporter involved pays a fee to the Secretary in accordance 
        with this subsection. Such fee shall be paid not later than 
        October 1 and April 1 of each fiscal year in the amount 
        provided for under paragraph (3).
            ``(3) Amount of inspection fee.--
                    ``(A) Aggregate total of fees.--Not later than 30 
                days before the start of each fiscal year, the 
                Secretary, in consultation with the Secretary of 
                Homeland Security and the Secretary of the Treasury, 
                shall establish an aggregate total of fees to be 
                collected under paragraph (2) for exporters for that 
                fiscal year that is sufficient, and not more than 
                necessary, to pay the costs for that fiscal year of 
                administering this section with respect to registered 
                exporters, including the costs associated with--
                            ``(i) inspecting the facilities of 
                        registered exporters, and of other entities in 
                        the chain of custody of a qualifying drug as 
                        necessary, under subsection (d)(3);
                            ``(ii) developing, implementing, and 
                        operating under such subsection a system to 
                        screen marks on shipments of qualifying drugs 
                        under subsection (a) that indicate compliance 
                        with all registration conditions, when such 
                        shipments are offered for import into the 
                        United States; and
                            ``(iii) screening such markings, and 
                        inspecting such shipments as necessary, when 
                        offered for import into the United States to 
                        determine if such a shipment should be refused 
                        admission under subsection (g)(5).
                    ``(B) Limitation.--Subject to subparagraph (C), the 
                aggregate total of fees collected under paragraph (2) 
                for a fiscal year shall not exceed 2.5 percent of the 
                total price of qualifying drugs imported during that 
                fiscal year into the United States by registered 
                exporters under subsection (a).
                    ``(C) Total price of drugs.--
                            ``(i) Estimate.--For the purposes of 
                        complying with the limitation described in 
                        subparagraph (B) when establishing under 
                        subparagraph (A) the aggregate total of fees to 
                        be collected under paragraph (2) for a fiscal 
                        year, the Secretary shall estimate the total 
                        price of qualifying drugs imported into the 
                        United States by registered exporters during 
                        that fiscal year by adding the total price of 
                        qualifying drugs exported by each registered 
                        exporter during the 6-month period from January 
                        1 through June 30 of the previous fiscal year, 
                        as reported to the Secretary by each registered 
                        exporter under subsection (b)(1)(I)(iv).
                            ``(ii) Calculation.--Not later than March 1 
                        of the fiscal year that follows the fiscal year 
                        for which the estimate under clause (i) is 
                        made, the Secretary shall calculate the total 
                        price of qualifying drugs imported into the 
                        United States by registered exporters during 
                        that fiscal year by adding the total price of 
                        qualifying drugs exported by each registered 
                        exporter during that fiscal year, as reported 
                        to the Secretary by each registered exporter 
                        under subsection (b)(1)(I)(iv).
                            ``(iii) Adjustment.--If the total price of 
                        qualifying drugs imported into the United 
                        States by registered exporters during a fiscal 
                        year as calculated under clause (ii) is less 
                        than the aggregate total of fees collected 
                        under paragraph (2) for that fiscal year, the 
                        Secretary shall provide for a pro-rata 
                        reduction in the fee due from each registered 
                        exporter on April 1 of the subsequent fiscal 
                        year so that the limitation described in 
                        subparagraph (B) is observed.
                    ``(D) Individual exporter fee.--Subject to the 
                limitation described in subparagraph (B), the fee under 
                paragraph (2) to be paid on October 1 and April 1 by an 
                exporter shall be an amount that is proportional to a 
                reasonable estimate by the Secretary of the semiannual 
                share of the exporter of the volume of qualifying drugs 
                exported by exporters under subsection (a).
            ``(4) Use of fees.--
                    ``(A) In general.--Subject to appropriations Acts, 
                fees collected by the Secretary under paragraphs (1) 
                and (2) shall be credited to the appropriation account 
                for salaries and expenses of the Food and Drug 
                Administration until expended (without fiscal year 
                limitation), and the Secretary may, in consultation 
                with the Secretary of Homeland Security and the 
                Secretary of the Treasury, transfer some proportion of 
                such fees to the appropriation account for salaries and 
                expenses of the Bureau of Customs and Border Protection 
                until expended (without fiscal year limitation).
                    ``(B) Sole purpose.--Fees collected by the 
                Secretary under paragraphs (1) and (2) are only 
                available to the Secretary and, if transferred, to the 
                Secretary of Homeland Security, and are for the sole 
                purpose of paying the costs referred to in paragraph 
                (3)(A).
            ``(5) Collection of fees.--In any case where the Secretary 
        does not receive payment of a fee assessed under paragraph (1) 
        or (2) within 30 days after it is due, such fee shall be 
        treated as a claim of the United States Government subject to 
        subchapter II of chapter 37 of title 31, United States Code.
    ``(g) Compliance With Section 801(a).--
            ``(1) In general.--A registration condition is that each 
        qualifying drug exported under subsection (a) by the registered 
        exporter involved or imported under subsection (a) by the 
        registered importer involved is in compliance with the 
        standards referred to in section 801(a) regarding admission of 
        the drug into the United States, subject to paragraphs (2), 
        (3), and (4).
            ``(2) Section 505; approval status.--
                    ``(A) In general.--A qualifying drug that is 
                imported or offered for import under subsection (a) 
                shall comply with the conditions established in the 
                approved application under section 505(b) for the U.S. 
                label drug as described under this subsection.
                    ``(B) Notice by manufacturer; general provisions.--
                            ``(i) In general.--The person that 
                        manufactures a qualifying drug that is, or will 
                        be, introduced for commercial distribution in a 
                        permitted country shall in accordance with this 
                        paragraph submit to the Secretary a notice 
                        that--
                                    ``(I) includes each difference in 
                                the qualifying drug from a condition 
                                established in the approved application 
                                for the U.S. label drug beyond--
                                            ``(aa) the variations 
                                        provided for in the 
                                        application; and
                                            ``(bb) any difference in 
                                        labeling (except ingredient 
                                        labeling); or
                                    ``(II) states that there is no 
                                difference in the qualifying drug from 
                                a condition established in the approved 
                                application for the U.S. label drug 
                                beyond--
                                            ``(aa) the variations 
                                        provided for in the 
                                        application; and
                                            ``(bb) any difference in 
                                        labeling (except ingredient 
                                        labeling).
                            ``(ii) Information in notice.--A notice 
                        under clause (i)(I) shall include the 
                        information that the Secretary may require 
                        under section 506A, any additional information 
                        the Secretary may require (which may include 
                        data on bioequivalence if such data are not 
                        required under section 506A), and, with respect 
                        to the permitted country that approved the 
                        qualifying drug for commercial distribution, or 
                        with respect to which such approval is sought, 
                        include the following:
                                    ``(I) The date on which the 
                                qualifying drug with such difference 
                                was, or will be, introduced for 
                                commercial distribution in the 
                                permitted country.
                                    ``(II) Information demonstrating 
                                that the person submitting the notice 
                                has also notified the government of the 
                                permitted country in writing that the 
                                person is submitting to the Secretary a 
                                notice under clause (i)(I), which 
                                notice describes the difference in the 
                                qualifying drug from a condition 
                                established in the approved application 
                                for the U.S. label drug.
                                    ``(III) The information that the 
                                person submitted or will submit to the 
                                government of the permitted country for 
                                purposes of obtaining approval for 
                                commercial distribution of the drug in 
                                the country which, if in a language 
                                other than English, shall be 
                                accompanied by an English translation 
                                verified to be complete and accurate, 
                                with the name, address, and a brief 
                                statement of the qualifications of the 
                                person that made the translation.
                            ``(iii) Certifications.--The chief 
                        executive officer and the chief medical officer 
                        of the manufacturer involved shall each certify 
                        in the notice under clause (i) that--
                                    ``(I) the information provided in 
                                the notice is complete and true; and
                                    ``(II) a copy of the notice has 
                                been provided to the Federal Trade 
                                Commission and to the State attorneys 
                                general.
                            ``(iv) Fee.--If a notice submitted under 
                        clause (i) includes a difference that would, 
                        under section 506A, require the submission of a 
                        supplemental application if made as a change to 
                        the U.S. label drug, the person that submits 
                        the notice shall pay to the Secretary a fee in 
                        the same amount as would apply if the person 
                        were paying a fee pursuant to section 
                        736(a)(1)(A)(ii). Subject to appropriations 
                        Acts, fees collected by the Secretary under the 
                        preceding sentence are available only to the 
                        Secretary and are for the sole purpose of 
                        paying the costs of reviewing notices submitted 
                        under clause (i).
                            ``(v) Timing of submission of notices.--
                                    ``(I) Prior approval notices.--A 
                                notice under clause (i) to which 
                                subparagraph (C) applies shall be 
                                submitted to the Secretary not later 
                                than 120 days before the qualifying 
                                drug with the difference is introduced 
                                for commercial distribution in a 
                                permitted country, unless the country 
                                requires that distribution of the 
                                qualifying drug with the difference 
                                begin less than 120 days after the 
                                country requires the difference.
                                    ``(II) Other approval notices.--A 
                                notice under clause (i) to which 
                                subparagraph (D) applies shall be 
                                submitted to the Secretary not later 
                                than the day on which the qualifying 
                                drug with the difference is introduced 
                                for commercial distribution in a 
                                permitted country.
                                    ``(III) Other notices.--A notice 
                                under clause (i) to which subparagraph 
                                (E) applies shall be submitted to the 
                                Secretary on the date that the 
                                qualifying drug is first introduced for 
                                commercial distribution in a permitted 
                                country and annually thereafter.
                            ``(vi) Review by secretary.--
                                    ``(I) In general.--In this 
                                paragraph, the difference in a 
                                qualifying drug that is submitted in a 
                                notice under clause (i) from the U.S. 
                                label drug shall be treated by the 
                                Secretary as if it were a manufacturing 
                                change to the U.S. label drug under 
                                section 506A.
                                    ``(II) Standard of review.--Except 
                                as provided in subclause (III), the 
                                Secretary shall review and approve or 
                                disapprove the difference in a notice 
                                submitted under clause (i), if required 
                                under section 506A, using the safe and 
                                effective standard for approving or 
                                disapproving a manufacturing change 
                                under section 506A.
                                    ``(III) Bioequivalence.--If the 
                                Secretary would approve the difference 
                                in a notice submitted under clause (i) 
                                using the safe and effective standard 
                                under section 506A and if the Secretary 
                                determines that the qualifying drug is 
                                not bioequivalent to the U.S. label 
                                drug, the Secretary shall--
                                            ``(aa) include in the 
                                        labeling provided under 
                                        paragraph (3) a prominent 
                                        advisory that the qualifying 
                                        drug is safe and effective but 
                                        is not bioequivalent to the 
                                        U.S. label drug if the 
                                        Secretary determines that such 
                                        an advisory is necessary for 
                                        health care practitioners and 
                                        patients to use the qualifying 
                                        drug safely and effectively; or
                                            ``(bb) decline to approve 
                                        the difference if the Secretary 
                                        determines that the 
                                        availability of both the 
                                        qualifying drug and the U.S. 
                                        label drug would pose a threat 
                                        to the public health.
                                    ``(IV) Review by the secretary.--
                                The Secretary shall review and approve 
                                or disapprove the difference in a 
                                notice submitted under clause (i), if 
                                required under section 506A, not later 
                                than 120 days after the date on which 
                                the notice is submitted.
                                    ``(V) Establishment inspection.--If 
                                review of such difference would require 
                                an inspection of the establishment in 
                                which the qualifying drug is 
                                manufactured--
                                            ``(aa) such inspection by 
                                        the Secretary shall be 
                                        authorized; and
                                            ``(bb) the Secretary may 
                                        rely on a satisfactory report 
                                        of a good manufacturing 
                                        practice inspection of the 
                                        establishment from a permitted 
                                        country whose regulatory system 
                                        the Secretary recognizes as 
                                        equivalent under a mutual 
                                        recognition agreement, as 
                                        provided under section 
                                        510(i)(3), section 803, or part 
                                        26 of title 21, Code of Federal 
                                        Regulations (or any 
                                        corresponding successor rule or 
                                        regulation).
                            ``(vii) Publication of information on 
                        notices.--
                                    ``(I) In general.--Through the 
                                Internet website of the Food and Drug 
                                Administration and a toll-free 
                                telephone number, the Secretary shall 
                                readily make available to the public a 
                                list of notices submitted under clause 
                                (i).
                                    ``(II) Contents.--The list under 
                                subclause (I) shall include the date on 
                                which a notice is submitted and 
                                whether--
                                            ``(aa) a notice is under 
                                        review;
                                            ``(bb) the Secretary has 
                                        ordered that importation of the 
                                        qualifying drug from a 
                                        permitted country cease; or
                                            ``(cc) the importation of 
                                        the drug is permitted under 
                                        subsection (a).
                                    ``(III) Update.--The Secretary 
                                shall promptly update the Internet 
                                website with any changes to the list.
                    ``(C) Notice; drug difference requiring prior 
                approval.--In the case of a notice under subparagraph 
                (B)(i) that includes a difference that would, under 
                section 506A(c) or (d)(3)(B)(i), require the approval 
                of a supplemental application before the difference 
                could be made to the U.S. label drug the following 
                shall occur:
                            ``(i) Promptly after the notice is 
                        submitted, the Secretary shall notify 
                        registered exporters, registered importers, the 
                        Federal Trade Commission, and the State 
                        attorneys general that the notice has been 
                        submitted with respect to the qualifying drug 
                        involved.
                            ``(ii) If the Secretary has not made a 
                        determination whether such a supplemental 
                        application regarding the U.S. label drug would 
                        be approved or disapproved by the date on which 
                        the qualifying drug involved is to be 
                        introduced for commercial distribution in a 
                        permitted country, the Secretary shall--
                                    ``(I) order that the importation of 
                                the qualifying drug involved from the 
                                permitted country not begin until the 
                                Secretary completes review of the 
                                notice; and
                                    ``(II) promptly notify registered 
                                exporters, registered importers, the 
                                Federal Trade Commission, and the State 
                                attorneys general of the order.
                            ``(iii) If the Secretary determines that 
                        such a supplemental application regarding the 
                        U.S. label drug would not be approved, the 
                        Secretary shall--
                                    ``(I) order that the importation of 
                                the qualifying drug involved from the 
                                permitted country cease, or provide 
                                that an order under clause (ii), if 
                                any, remains in effect;
                                    ``(II) notify the permitted country 
                                that approved the qualifying drug for 
                                commercial distribution of the 
                                determination; and
                                    ``(III) promptly notify registered 
                                exporters, registered importers, the 
                                Federal Trade Commission, and the State 
                                attorneys general of the determination.
                            ``(iv) If the Secretary determines that 
                        such a supplemental application regarding the 
                        U.S. label drug would be approved, the 
                        Secretary shall--
                                    ``(I) vacate the order under clause 
                                (ii), if any;
                                    ``(II) consider the difference to 
                                be a variation provided for in the 
                                approved application for the U.S. label 
                                drug;
                                    ``(III) permit importation of the 
                                qualifying drug under subsection (a); 
                                and
                                    ``(IV) promptly notify registered 
                                exporters, registered importers, the 
                                Federal Trade Commission, and the State 
                                attorneys general of the determination.
                    ``(D) Notice; drug difference not requiring prior 
                approval.--In the case of a notice under subparagraph 
                (B)(i) that includes a difference that would, under 
                section 506A(d)(3)(B)(ii), not require the approval of 
                a supplemental application before the difference could 
                be made to the U.S. label drug the following shall 
                occur:
                            ``(i) During the period in which the notice 
                        is being reviewed by the Secretary, the 
                        authority under this subsection to import the 
                        qualifying drug involved continues in effect.
                            ``(ii) If the Secretary determines that 
                        such a supplemental application regarding the 
                        U.S. label drug would not be approved, the 
                        Secretary shall--
                                    ``(I) order that the importation of 
                                the qualifying drug involved from the 
                                permitted country cease;
                                    ``(II) notify the permitted country 
                                that approved the qualifying drug for 
                                commercial distribution of the 
                                determination; and
                                    ``(III) promptly notify registered 
                                exporters, registered importers, the 
                                Federal Trade Commission, and the State 
                                attorneys general of the determination.
                            ``(iii) If the Secretary determines that 
                        such a supplemental application regarding the 
                        U.S. label drug would be approved, the 
                        difference shall be considered to be a 
                        variation provided for in the approved 
                        application for the U.S. label drug.
                    ``(E) Notice; drug difference not requiring 
                approval; no difference.--In the case of a notice under 
                subparagraph (B)(i) that includes a difference for 
                which, under section 506A(d)(1)(A), a supplemental 
                application would not be required for the difference to 
                be made to the U.S. label drug, or that states that 
                there is no difference, the Secretary--
                            ``(i) shall consider such difference to be 
                        a variation provided for in the approved 
                        application for the U.S. label drug;
                            ``(ii) may not order that the importation 
                        of the qualifying drug involved cease; and
                            ``(iii) shall promptly notify registered 
                        exporters and registered importers.
                    ``(F) Differences in active ingredient, route of 
                administration, dosage form, or strength.--
                            ``(i) In general.--A person who 
                        manufactures a drug approved under section 
                        505(b) shall submit an application under 
                        section 505(b) for approval of another drug 
                        that is manufactured for distribution in a 
                        permitted country by or for the person that 
                        manufactures the drug approved under section 
                        505(b) if--
                                    ``(I) there is no qualifying drug 
                                in commercial distribution in permitted 
                                countries whose combined population 
                                represents at least 50 percent of the 
                                total population of all permitted 
                                countries with the same active 
                                ingredient or ingredients, route of 
                                administration, dosage form, and 
                                strength as the drug approved under 
                                section 505(b); and
                                    ``(II) each active ingredient of 
                                the other drug is related to an active 
                                ingredient of the drug approved under 
                                section 505(b), as defined in clause 
                                (v).
                            ``(ii) Application under section 505(b).--
                        The application under section 505(b) required 
                        under clause (i) shall--
                                    ``(I) request approval of the other 
                                drug for the indication or indications 
                                for which the drug approved under 
                                section 505(b) is labeled;
                                    ``(II) include the information that 
                                the person submitted to the government 
                                of the permitted country for purposes 
                                of obtaining approval for commercial 
                                distribution of the other drug in that 
                                country, which if in a language other 
                                than English, shall be accompanied by 
                                an English translation verified to be 
                                complete and accurate, with the name, 
                                address, and a brief statement of the 
                                qualifications of the person that made 
                                the translation;
                                    ``(III) include a right of 
                                reference to the application for the 
                                drug approved under section 505(b); and
                                    ``(IV) include such additional 
                                information as the Secretary may 
                                require.
                            ``(iii) Timing of submission of 
                        application.--An application under section 
                        505(b) required under clause (i) shall be 
                        submitted to the Secretary not later than the 
                        day on which the information referred to in 
                        clause (ii)(II) is submitted to the government 
                        of the permitted country.
                            ``(iv) Notice of decision on application.--
                        The Secretary shall promptly notify registered 
                        exporters, registered importers, the Federal 
                        Trade Commission, and the State attorneys 
                        general of a determination to approve or to 
                        disapprove an application under section 505(b) 
                        required under clause (i).
                            ``(v) Related active ingredients.--For 
                        purposes of clause (i)(II), 2 active 
                        ingredients are related if they are--
                                    ``(I) the same; or
                                    ``(II) different salts, esters, or 
                                complexes of the same moiety.
            ``(3) Section 502; labeling.--
                    ``(A) Importation by registered importer.--
                            ``(i) In general.--In the case of a 
                        qualifying drug that is imported or offered for 
                        import by a registered importer, such drug 
                        shall be considered to be in compliance with 
                        section 502 and the labeling requirements under 
                        the approved application for the U.S. label 
                        drug if the qualifying drug bears--
                                    ``(I) a copy of the labeling 
                                approved for the U.S. label drug under 
                                section 505, without regard to whether 
                                the copy bears any trademark involved;
                                    ``(II) the name of the manufacturer 
                                and location of the manufacturer;
                                    ``(III) the lot number assigned by 
                                the manufacturer;
                                    ``(IV) the name, location, and 
                                registration number of the importer; 
                                and
                                    ``(V) the National Drug Code number 
                                assigned to the qualifying drug by the 
                                Secretary.
                            ``(ii) Request for copy of the labeling.--
                        The Secretary shall provide such copy to the 
                        registered importer involved, upon request of 
                        the importer.
                            ``(iii) Requested labeling.--The labeling 
                        provided by the Secretary under clause (ii) 
                        shall--
                                    ``(I) include the established name, 
                                as defined in section 502(e)(3), for 
                                each active ingredient in the 
                                qualifying drug;
                                    ``(II) not include the proprietary 
                                name of the U.S. label drug or any 
                                active ingredient thereof;
                                    ``(III) if required under paragraph 
                                (2)(B)(vi)(III), a prominent advisory 
                                that the qualifying drug is safe and 
                                effective but not bioequivalent to the 
                                U.S. label drug; and
                                    ``(IV) if the inactive ingredients 
                                of the qualifying drug are different 
                                from the inactive ingredients for the 
                                U.S. label drug, include--
                                            ``(aa) a prominent notice 
                                        that the ingredients of the 
                                        qualifying drug differ from the 
                                        ingredients of the U.S. label 
                                        drug and that the qualifying 
                                        drug must be dispensed with an 
                                        advisory to people with 
                                        allergies about this difference 
                                        and a list of ingredients; and
                                            ``(bb) a list of the 
                                        ingredients of the qualifying 
                                        drug as would be required under 
                                        section 502(e).
                    ``(B) Importation by individual.--
                            ``(i) In general.--In the case of a 
                        qualifying drug that is imported or offered for 
                        import by a registered exporter to an 
                        individual, such drug shall be considered to be 
                        in compliance with section 502 and the labeling 
                        requirements under the approved application for 
                        the U.S. label drug if the packaging and 
                        labeling of the qualifying drug complies with 
                        all applicable regulations promulgated under 
                        sections 3 and 4 of the Poison Prevention 
                        Packaging Act of 1970 (15 U.S.C. 1471 et seq.) 
                        and the labeling of the qualifying drug 
                        includes--
                                    ``(I) directions for use by the 
                                consumer;
                                    ``(II) the lot number assigned by 
                                the manufacturer;
                                    ``(III) the name and registration 
                                number of the exporter;
                                    ``(IV) if required under paragraph 
                                (2)(B)(vi)(III), a prominent advisory 
                                that the drug is safe and effective but 
                                not bioequivalent to the U.S. label 
                                drug;
                                    ``(V) if the inactive ingredients 
                                of the drug are different from the 
                                inactive ingredients for the U.S. label 
                                drug--
                                            ``(aa) a prominent advisory 
                                        that persons with an allergy 
                                        should check the ingredient 
                                        list of the drug because the 
                                        ingredients of the drug differ 
                                        from the ingredients of the 
                                        U.S. label drug; and
                                            ``(bb) a list of the 
                                        ingredients of the drug as 
                                        would be required under section 
                                        502(e); and
                                    ``(VI) a copy of any special 
                                labeling that would be required by the 
                                Secretary had the U.S. label drug been 
                                dispensed by a pharmacist in the United 
                                States, without regard to whether the 
                                special labeling bears any trademark 
                                involved.
                            ``(ii) Packaging.--A qualifying drug 
                        offered for import to an individual by an 
                        exporter under this section that is packaged in 
                        a unit-of-use container (as those items are 
                        defined in the United States Pharmacopeia and 
                        National Formulary) shall not be repackaged, 
                        provided that--
                                    ``(I) the packaging complies with 
                                all applicable regulations under 
                                sections 3 and 4 of the Poison 
                                Prevention Packaging Act of 1970 (15 
                                U.S.C. 1471 et seq.); or
                                    ``(II) the consumer consents to 
                                waive the requirements of such Act, 
                                after being informed that the packaging 
                                does not comply with such Act and that 
                                the exporter will provide the drug in 
                                packaging that is compliant at no 
                                additional cost.
                            ``(iii) Request for copy of special 
                        labeling and ingredient list.--The Secretary 
                        shall provide to the registered exporter 
                        involved a copy of the special labeling, the 
                        advisory, and the ingredient list described 
                        under clause (i), upon request of the exporter.
                            ``(iv) Requested labeling and ingredient 
                        list.--The labeling and ingredient list 
                        provided by the Secretary under clause (iii) 
                        shall--
                                    ``(I) include the established name, 
                                as defined in section 502(e)(3), for 
                                each active ingredient in the drug; and
                                    ``(II) not include the proprietary 
                                name of the U.S. label drug or any 
                                active ingredient thereof.
            ``(4) Section 501; adulteration.--A qualifying drug that is 
        imported or offered for import under subsection (a) shall be 
        considered to be in compliance with section 501 if the drug is 
        in compliance with subsection (c).
            ``(5) Standards for refusing admission.--A drug exported 
        under subsection (a) from a registered exporter or imported by 
        a registered importer may be refused admission into the United 
        States if 1 or more of the following applies:
                    ``(A) The drug is not a qualifying drug.
                    ``(B) A notice for the drug required under 
                paragraph (2)(B) has not been submitted to the 
                Secretary.
                    ``(C) The Secretary has ordered that importation of 
                the drug from the permitted country cease under 
                paragraph (2) (C) or (D).
                    ``(D) The drug does not comply with paragraph (3) 
                or (4).
                    ``(E) The shipping container appears damaged in a 
                way that may affect the strength, quality, or purity of 
                the drug.
                    ``(F) The Secretary becomes aware that--
                            ``(i) the drug may be counterfeit;
                            ``(ii) the drug may have been prepared, 
                        packed, or held under insanitary conditions; or
                            ``(iii) the methods used in, or the 
                        facilities or controls used for, the 
                        manufacturing, processing, packing, or holding 
                        of the drug do not conform to good 
                        manufacturing practice.
                    ``(G) The Secretary has obtained an injunction 
                under section 302 that prohibits the distribution of 
                the drug in interstate commerce.
                    ``(H) The Secretary has under section 505(e) 
                withdrawn approval of the drug.
                    ``(I) The manufacturer of the drug has instituted a 
                recall of the drug.
                    ``(J) If the drug is imported or offered for import 
                by a registered importer without submission of a notice 
                in accordance with subsection (d)(4).
                    ``(K) If the drug is imported or offered for import 
                from a registered exporter to an individual and 1 or 
                more of the following applies:
                            ``(i) The shipping container for such drug 
                        does not bear the markings required under 
                        subsection (d)(2).
                            ``(ii) The markings on the shipping 
                        container appear to be counterfeit.
                            ``(iii) The shipping container or markings 
                        appear to have been tampered with.
    ``(h) Exporter Licensure in Permitted Country.--A registration 
condition is that the exporter involved agrees that a qualifying drug 
will be exported to an individual only if the Secretary has verified 
that--
            ``(1) the exporter is authorized under the law of the 
        permitted country in which the exporter is located to dispense 
        prescription drugs; and
            ``(2) the exporter employs persons that are licensed under 
        the law of the permitted country in which the exporter is 
        located to dispense prescription drugs in sufficient number to 
        dispense safely the drugs exported by the exporter to 
        individuals, and the exporter assigns to those persons 
        responsibility for dispensing such drugs to individuals.
    ``(i) Individuals; Conditions for Importation.--
            ``(1) In general.--For purposes of subsection (a)(2)(B), 
        the importation of a qualifying drug by an individual is in 
        accordance with this subsection if the following conditions are 
        met:
                    ``(A) The drug is accompanied by a copy of a 
                prescription for the drug, which prescription--
                            ``(i) is valid under applicable Federal and 
                        State laws; and
                            ``(ii) was issued by a practitioner who, 
                        under the law of a State of which the 
                        individual is a resident, or in which the 
                        individual receives care from the practitioner 
                        who issues the prescription, is authorized to 
                        administer prescription drugs.
                    ``(B) The drug is accompanied by a copy of the 
                documentation that was required under the law or 
                regulations of the permitted country in which the 
                exporter is located, as a condition of dispensing the 
                drug to the individual.
                    ``(C) The copies referred to in subparagraphs 
                (A)(i) and (B) are marked in a manner sufficient--
                            ``(i) to indicate that the prescription, 
                        and the equivalent document in the permitted 
                        country in which the exporter is located, have 
                        been filled; and
                            ``(ii) to prevent a duplicative filling by 
                        another pharmacist.
                    ``(D) The individual has provided to the registered 
                exporter a complete list of all drugs used by the 
                individual for review by the individuals who dispense 
                the drug.
                    ``(E) The quantity of the drug does not exceed a 
                90-day supply.
                    ``(F) The drug is not an ineligible subpart H drug. 
                For purposes of this section, a prescription drug is an 
                `ineligible subpart H drug' if the drug was approved by 
                the Secretary under subpart H of part 314 of title 21, 
                Code of Federal Regulations (relating to accelerated 
                approval), with restrictions under section 520 of such 
                part to assure safe use, and the Secretary has 
                published in the Federal Register a notice that the 
                Secretary has determined that good cause exists to 
                prohibit the drug from being imported pursuant to this 
                subsection.
            ``(2) Notice regarding drug refused admission.--If a 
        registered exporter ships a drug to an individual pursuant to 
        subsection (a)(2)(B) and the drug is refused admission to the 
        United States, a written notice shall be sent to the individual 
        and to the exporter that informs the individual and the 
        exporter of such refusal and the reason for the refusal.
    ``(j) Maintenance of Records and Samples.--
            ``(1) In general.--A registration condition is that the 
        importer or exporter involved shall--
                    ``(A) maintain records required under this section 
                for not less than 2 years; and
                    ``(B) maintain samples of each lot of a qualifying 
                drug required under this section for not more than 2 
                years.
            ``(2) Place of record maintenance.--The records described 
        under paragraph (1) shall be maintained--
                    ``(A) in the case of an importer, at the place of 
                business of the importer at which the importer 
                initially receives the qualifying drug after 
                importation; or
                    ``(B) in the case of an exporter, at the facility 
                from which the exporter ships the qualifying drug to 
                the United States.
    ``(k) Drug Recalls.--
            ``(1) Manufacturers.--A person that manufactures a 
        qualifying drug imported from a permitted country under this 
        section shall promptly inform the Secretary--
                    ``(A) if the drug is recalled or withdrawn from the 
                market in a permitted country;
                    ``(B) how the drug may be identified, including lot 
                number; and
                    ``(C) the reason for the recall or withdrawal.
            ``(2) Secretary.--With respect to each permitted country, 
        the Secretary shall--
                    ``(A) enter into an agreement with the government 
                of the country to receive information about recalls and 
                withdrawals of qualifying drugs in the country; or
                    ``(B) monitor recalls and withdrawals of qualifying 
                drugs in the country using any information that is 
                available to the public in any media.
            ``(3) Notice.--The Secretary may notify, as appropriate, 
        registered exporters, registered importers, wholesalers, 
        pharmacies, or the public of a recall or withdrawal of a 
        qualifying drug in a permitted country.
    ``(l) Drug Labeling and Packaging.--
            ``(1) In general.--When a qualifying drug that is imported 
        into the United States by an importer under subsection (a) is 
        dispensed by a pharmacist to an individual, the pharmacist 
        shall provide that the packaging and labeling of the drug 
        complies with all applicable regulations promulgated under 
        sections 3 and 4 of the Poison Prevention Packaging Act of 1970 
        (15 U.S.C. 1471 et seq.) and shall include with any other 
        labeling provided to the individual the following:
                    ``(A) The lot number assigned by the manufacturer.
                    ``(B) The name and registration number of the 
                importer.
                    ``(C) If required under paragraph (2)(B)(vi)(III) 
                of subsection (g), a prominent advisory that the drug 
                is safe and effective but not bioequivalent to the U.S. 
                label drug.
                    ``(D) If the inactive ingredients of the drug are 
                different from the inactive ingredients for the U.S. 
                label drug--
                            ``(i) a prominent advisory that persons 
                        with allergies should check the ingredient list 
                        of the drug because the ingredients of the drug 
                        differ from the ingredients of the U.S. label 
                        drug; and
                            ``(ii) a list of the ingredients of the 
                        drug as would be required under section 502(e).
            ``(2) Packaging.--A qualifying drug that is packaged in a 
        unit-of-use container (as those terms are defined in the United 
        States Pharmacopeia and National Formulary) shall not be 
        repackaged, provided that--
                    ``(A) the packaging complies with all applicable 
                regulations under sections 3 and 4 of the Poison 
                Prevention Packaging Act of 1970 (15 U.S.C. 1471 et 
                seq.); or
                    ``(B) the consumer consents to waive the 
                requirements of such Act, after being informed that the 
                packaging does not comply with such Act and that the 
                pharmacist will provide the drug in packaging that is 
                compliant at no additional cost.
    ``(m) Charitable Contributions.--Notwithstanding any other 
provision of this section, this section does not authorize the 
importation into the United States of a qualifying drug donated or 
otherwise supplied for free or at nominal cost by the manufacturer of 
the drug to a charitable or humanitarian organization, including the 
United Nations and affiliates, or to a government of a foreign country.
    ``(n) Unfair and Discriminatory Acts and Practices.--
            ``(1) In general.--It is unlawful for a manufacturer, 
        directly or indirectly (including by being a party to a 
        licensing agreement or other agreement), to--
                    ``(A) discriminate by charging a higher price for a 
                prescription drug sold to a registered exporter or 
                other person in a permitted country that exports a 
                qualifying drug to the United States under this section 
                than the price that is charged, inclusive of rebates or 
                other incentives to the permitted country or other 
                person, to another person that is in the same country 
                and that does not export a qualifying drug into the 
                United States under this section;
                    ``(B) discriminate by charging a higher price for a 
                prescription drug sold to a registered importer or 
                other person that distributes, sells, or uses a 
                qualifying drug imported into the United States under 
                this section than the price that is charged to another 
                person in the United States that does not import a 
                qualifying drug under this section, or that does not 
                distribute, sell, or use such a drug;
                    ``(C) discriminate by denying, restricting, or 
                delaying supplies of a prescription drug to a 
                registered exporter or other person in a permitted 
                country that exports a qualifying drug to the United 
                States under this section or to a registered importer 
                or other person that distributes, sells, or uses a 
                qualifying drug imported into the United States under 
                this section;
                    ``(D) discriminate by publicly, privately, or 
                otherwise refusing to do business with a registered 
                exporter or other person in a permitted country that 
                exports a qualifying drug to the United States under 
                this section or with a registered importer or other 
                person that distributes, sells, or uses a qualifying 
                drug imported into the United States under this 
                section;
                    ``(E) knowingly fail to submit a notice under 
                subsection (g)(2)(B)(i), knowingly fail to submit such 
                a notice on or before the date specified in subsection 
                (g)(2)(B)(v) or as otherwise required under subsection 
                (e) (3), (4), and (5) of section 4 of the 
                Pharmaceutical Market Access and Drug Safety Act of 
                2007, knowingly submit such a notice that makes a 
                materially false, fictitious, or fraudulent statement, 
                or knowingly fail to provide promptly any information 
                requested by the Secretary to review such a notice;
                    ``(F) knowingly fail to submit an application 
                required under subsection (g)(2)(F), knowingly fail to 
                submit such an application on or before the date 
                specified in subsection (g)(2)(F)(ii), knowingly submit 
                such an application that makes a materially false, 
                fictitious, or fraudulent statement, or knowingly fail 
                to provide promptly any information requested by the 
                Secretary to review such an application;
                    ``(G) cause there to be a difference (including a 
                difference in active ingredient, route of 
                administration, dosage form, strength, formulation, 
                manufacturing establishment, manufacturing process, or 
                person that manufactures the drug) between a 
                prescription drug for distribution in the United States 
                and the drug for distribution in a permitted country;
                    ``(H) refuse to allow an inspection authorized 
                under this section of an establishment that 
                manufactures a qualifying drug that is, or will be, 
                introduced for commercial distribution in a permitted 
                country;
                    ``(I) fail to conform to the methods used in, or 
                the facilities used for, the manufacturing, processing, 
                packing, or holding of a qualifying drug that is, or 
                will be, introduced for commercial distribution in a 
                permitted country to good manufacturing practice under 
                this Act;
                    ``(J) become a party to a licensing agreement or 
                other agreement related to a qualifying drug that fails 
                to provide for compliance with all requirements of this 
                section with respect to such drug;
                    ``(K) enter into a contract that restricts, 
                prohibits, or delays the importation of a qualifying 
                drug under this section;
                    ``(L) engage in any other action to restrict, 
                prohibit, or delay the importation of a qualifying drug 
                under this section; or
                    ``(M) engage in any other action that the Federal 
                Trade Commission determines to discriminate against a 
                person that engages or attempts to engage in the 
                importation of a qualifying drug under this section.
            ``(2) Referral of potential violations.--The Secretary 
        shall promptly refer to the Federal Trade Commission each 
        potential violation of subparagraph (E), (F), (G), (H), or (I) 
        of paragraph (1) that becomes known to the Secretary.
            ``(3) Affirmative defense.--
                    ``(A) Discrimination.--It shall be an affirmative 
                defense to a charge that a manufacturer has 
                discriminated under subparagraph (A), (B), (C), (D), or 
                (M) of paragraph (1) that the higher price charged for 
                a prescription drug sold to a person, the denial, 
                restriction, or delay of supplies of a prescription 
                drug to a person, the refusal to do business with a 
                person, or other discriminatory activity against a 
                person, is not based, in whole or in part, on--
                            ``(i) the person exporting or importing a 
                        qualifying drug into the United States under 
                        this section; or
                            ``(ii) the person distributing, selling, or 
                        using a qualifying drug imported into the 
                        United States under this section.
                    ``(B) Drug differences.--It shall be an affirmative 
                defense to a charge that a manufacturer has caused 
                there to be a difference described in subparagraph (G) 
                of paragraph (1) that--
                            ``(i) the difference was required by the 
                        country in which the drug is distributed;
                            ``(ii) the Secretary has determined that 
                        the difference was necessary to improve the 
                        safety or effectiveness of the drug;
                            ``(iii) the person manufacturing the drug 
                        for distribution in the United States has given 
                        notice to the Secretary under subsection 
                        (g)(2)(B)(i) that the drug for distribution in 
                        the United States is not different from a drug 
                        for distribution in permitted countries whose 
                        combined population represents at least 50 
                        percent of the total population of all 
                        permitted countries; or
                            ``(iv) the difference was not caused, in 
                        whole or in part, for the purpose of 
                        restricting importation of the drug into the 
                        United States under this section.
            ``(4) Effect of subsection.--
                    ``(A) Sales in other countries.--This subsection 
                applies only to the sale or distribution of a 
                prescription drug in a country if the manufacturer of 
                the drug chooses to sell or distribute the drug in the 
                country. Nothing in this subsection shall be construed 
                to compel the manufacturer of a drug to distribute or 
                sell the drug in a country.
                    ``(B) Discounts to insurers, health plans, pharmacy 
                benefit managers, and covered entities.--Nothing in 
                this subsection shall be construed to--
                            ``(i) prevent or restrict a manufacturer of 
                        a prescription drug from providing discounts to 
                        an insurer, health plan, pharmacy benefit 
                        manager in the United States, or covered entity 
                        in the drug discount program under section 340B 
                        of the Public Health Service Act (42 U.S.C. 
                        256b) in return for inclusion of the drug on a 
                        formulary;
                            ``(ii) require that such discounts be made 
                        available to other purchasers of the 
                        prescription drug; or
                            ``(iii) prevent or restrict any other 
                        measures taken by an insurer, health plan, or 
                        pharmacy benefit manager to encourage 
                        consumption of such prescription drug.
                    ``(C) Charitable contributions.--Nothing in this 
                subsection shall be construed to--
                            ``(i) prevent a manufacturer from donating 
                        a prescription drug, or supplying a 
                        prescription drug at nominal cost, to a 
                        charitable or humanitarian organization, 
                        including the United Nations and affiliates, or 
                        to a government of a foreign country; or
                            ``(ii) apply to such donations or supplying 
                        of a prescription drug.
            ``(5) Enforcement.--
                    ``(A) Unfair or deceptive act or practice.--A 
                violation of this subsection shall be treated as a 
                violation of a rule defining an unfair or deceptive act 
                or practice prescribed under section 18(a)(1)(B) of the 
                Federal Trade Commission Act (15 U.S.C. 57a(a)(1)(B)).
                    ``(B) Actions by the commission.--The Federal Trade 
                Commission--
                            ``(i) shall enforce this subsection in the 
                        same manner, by the same means, and with the 
                        same jurisdiction, powers, and duties as though 
                        all applicable terms and provisions of the 
                        Federal Trade Commission Act (15 U.S.C. 41 et 
                        seq.) were incorporated into and made a part of 
                        this section; and
                            ``(ii) may seek monetary relief threefold 
                        the damages sustained, in addition to any other 
                        remedy available to the Federal Trade 
                        Commission under the Federal Trade Commission 
                        Act (15 U.S.C. 41 et seq.).
            ``(6) Actions by states.--
                    ``(A) In general.--
                            ``(i) Civil actions.--In any case in which 
                        the attorney general of a State has reason to 
                        believe that an interest of the residents of 
                        that State have been adversely affected by any 
                        manufacturer that violates paragraph (1), the 
                        attorney general of a State may bring a civil 
                        action on behalf of the residents of the State, 
                        and persons doing business in the State, in a 
                        district court of the United States of 
                        appropriate jurisdiction to--
                                    ``(I) enjoin that practice;
                                    ``(II) enforce compliance with this 
                                subsection;
                                    ``(III) obtain damages, 
                                restitution, or other compensation on 
                                behalf of residents of the State and 
                                persons doing business in the State, 
                                including threefold the damages; or
                                    ``(IV) obtain such other relief as 
                                the court may consider to be 
                                appropriate.
                            ``(ii) Notice.--
                                    ``(I) In general.--Before filing an 
                                action under clause (i), the attorney 
                                general of the State involved shall 
                                provide to the Federal Trade 
                                Commission--
                                            ``(aa) written notice of 
                                        that action; and
                                            ``(bb) a copy of the 
                                        complaint for that action.
                                    ``(II) Exemption.--Subclause (I) 
                                shall not apply with respect to the 
                                filing of an action by an attorney 
                                general of a State under this 
                                paragraph, if the attorney general 
                                determines that it is not feasible to 
                                provide the notice described in that 
                                subclause before filing of the action. 
                                In such case, the attorney general of a 
                                State shall provide notice and a copy 
                                of the complaint to the Federal Trade 
                                Commission at the same time as the 
                                attorney general files the action.
                    ``(B) Intervention.--
                            ``(i) In general.--On receiving notice 
                        under subparagraph (A)(ii), the Federal Trade 
                        Commission shall have the right to intervene in 
                        the action that is the subject of the notice.
                            ``(ii) Effect of intervention.--If the 
                        Federal Trade Commission intervenes in an 
                        action under subparagraph (A), it shall have 
                        the right--
                                    ``(I) to be heard with respect to 
                                any matter that arises in that action; 
                                and
                                    ``(II) to file a petition for 
                                appeal.
                    ``(C) Construction.--For purposes of bringing any 
                civil action under subparagraph (A), nothing in this 
                subsection shall be construed to prevent an attorney 
                general of a State from exercising the powers conferred 
                on the attorney general by the laws of that State to--
                            ``(i) conduct investigations;
                            ``(ii) administer oaths or affirmations; or
                            ``(iii) compel the attendance of witnesses 
                        or the production of documentary and other 
                        evidence.
                    ``(D) Actions by the commission.--In any case in 
                which an action is instituted by or on behalf of the 
                Federal Trade Commission for a violation of paragraph 
                (1), a State may not, during the pendency of that 
                action, institute an action under subparagraph (A) for 
                the same violation against any defendant named in the 
                complaint in that action.
                    ``(E) Venue.--Any action brought under subparagraph 
                (A) may be brought in the district court of the United 
                States that meets applicable requirements relating to 
                venue under section 1391 of title 28, United States 
                Code.
                    ``(F) Service of process.--In an action brought 
                under subparagraph (A), process may be served in any 
                district in which the defendant--
                            ``(i) is an inhabitant; or
                            ``(ii) may be found.
                    ``(G) Measurement of damages.--In any action under 
                this paragraph to enforce a cause of action under this 
                subsection in which there has been a determination that 
                a defendant has violated a provision of this 
                subsection, damages may be proved and assessed in the 
                aggregate by statistical or sampling methods, by the 
                computation of illegal overcharges or by such other 
                reasonable system of estimating aggregate damages as 
                the court in its discretion may permit without the 
                necessity of separately proving the individual claim 
                of, or amount of damage to, persons on whose behalf the 
                suit was brought.
                    ``(H) Exclusion on duplicative relief.--The 
                district court shall exclude from the amount of 
                monetary relief awarded in an action under this 
                paragraph brought by the attorney general of a State 
                any amount of monetary relief which duplicates amounts 
                which have been awarded for the same injury.
            ``(7) Effect on antitrust laws.--Nothing in this subsection 
        shall be construed to modify, impair, or supersede the 
        operation of the antitrust laws. For the purpose of this 
        subsection, the term `antitrust laws' has the meaning given it 
        in the first section of the Clayton Act, except that it 
        includes section 5 of the Federal Trade Commission Act to the 
        extent that such section 5 applies to unfair methods of 
        competition.
            ``(8) Manufacturer.--In this subsection, the term 
        `manufacturer' means any entity, including any affiliate or 
        licensee of that entity, that is engaged in--
                    ``(A) the production, preparation, propagation, 
                compounding, conversion, or processing of a 
                prescription drug, either directly or indirectly by 
                extraction from substances of natural origin, or 
                independently by means of chemical synthesis, or by a 
                combination of extraction and chemical synthesis; or
                    ``(B) the packaging, repackaging, labeling, 
                relabeling, or distribution of a prescription drug.''.
    (b) Prohibited Acts.--The Federal Food, Drug, and Cosmetic Act is 
amended--
            (1) in section 301 (21 U.S.C. 331), by striking paragraph 
        (aa) and inserting the following:
    ``(aa)(1) The sale or trade by a pharmacist, or by a business 
organization of which the pharmacist is a part, of a qualifying drug 
that under section 804(a)(2)(A) was imported by the pharmacist, other 
than--
            ``(A) a sale at retail made pursuant to dispensing the drug 
        to a customer of the pharmacist or organization; or
            ``(B) a sale or trade of the drug to a pharmacy or a 
        wholesaler registered to import drugs under section 804.
    ``(2) The sale or trade by an individual of a qualifying drug that 
under section 804(a)(2)(B) was imported by the individual.
    ``(3) The making of a materially false, fictitious, or fraudulent 
statement or representation, or a material omission, in a notice under 
clause (i) of section 804(g)(2)(B) or in an application required under 
section 804(g)(2)(F), or the failure to submit such a notice or 
application.
    ``(4) The importation of a drug in violation of a registration 
condition or other requirement under section 804, the falsification of 
any record required to be maintained, or provided to the Secretary, 
under such section, or the violation of any registration condition or 
other requirement under such section.''; and
            (2) in section 303(a) (21 U.S.C. 333(a)), by striking 
        paragraph (6) and inserting the following:
    ``(6) Notwithstanding subsection (a), any person that knowingly 
violates section 301(i) (2) or (3) or section 301(aa)(4) shall be 
imprisoned not more than 10 years, or fined in accordance with title 
18, United States Code, or both.''.
    (c) Amendment of Certain Provisions.--
            (1) In general.--Section 801 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 381) is amended by striking subsection 
        (g) and inserting the following:
    ``(g) With respect to a prescription drug that is imported or 
offered for import into the United States by an individual who is not 
in the business of such importation, that is not shipped by a 
registered exporter under section 804, and that is refused admission 
under subsection (a), the Secretary shall notify the individual that--
            ``(1) the drug has been refused admission because the drug 
        was not a lawful import under section 804;
            ``(2) the drug is not otherwise subject to a waiver of the 
        requirements of subsection (a);
            ``(3) the individual may under section 804 lawfully import 
        certain prescription drugs from exporters registered with the 
        Secretary under section 804; and
            ``(4) the individual can find information about such 
        importation, including a list of registered exporters, on the 
        Internet website of the Food and Drug Administration or through 
        a toll-free telephone number required under section 804.''.
            (2) Establishment registration.--Section 510(i) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(i)) is 
        amended in paragraph (1) by inserting after ``import into the 
        United States'' the following: ``, including a drug that is, or 
        may be, imported or offered for import into the United States 
        under section 804,''.
            (3) Effective date.--The amendments made by this subsection 
        shall take effect on the date that is 90 days after the date of 
        enactment of this Act.
    (d) Exhaustion.--
            (1) In general.--Section 271 of title 35, United States 
        Code, is amended--
                    (A) by redesignating subsections (h) and (i) as (i) 
                and (j), respectively; and
                    (B) by inserting after subsection (g) the 
                following:
    ``(h) It shall not be an act of infringement to use, offer to sell, 
or sell within the United States or to import into the United States 
any patented invention under section 804 of the Federal Food, Drug, and 
Cosmetic Act that was first sold abroad by or under authority of the 
owner or licensee of such patent.''.
            (2) Rule of construction.--Nothing in the amendment made by 
        paragraph (1) shall be construed to affect the ability of a 
        patent owner or licensee to enforce their patent, subject to 
        such amendment.
    (e) Effect of Section 804.--
            (1) In general.--Section 804 of the Federal Food, Drug, and 
        Cosmetic Act, as added by subsection (a), shall permit the 
        importation of qualifying drugs (as defined in such section 
        804) into the United States without regard to the status of the 
        issuance of implementing regulations--
                    (A) from exporters registered under such section 
                804 on the date that is 90 days after the date of 
                enactment of this Act; and
                    (B) from permitted countries, as defined in such 
                section 804, by importers registered under such section 
                804 on the date that is 1 year after the date of 
                enactment of this Act.
            (2) Review of registration by certain exporters.--
                    (A) Review priority.--In the review of 
                registrations submitted under subsection (b) of such 
                section 804, registrations submitted by entities in 
                Canada that are significant exporters of prescription 
                drugs to individuals in the United States as of the 
                date of enactment of this Act will have priority during 
                the 90 day period that begins on such date of 
                enactment.
                    (B) Period for review.--During such 90-day period, 
                the reference in subsection (b)(2)(A) of such section 
                804 to 90 days (relating to approval or disapproval of 
                registrations) is, as applied to such entities, deemed 
                to be 30 days.
                    (C) Limitation.--That an exporter in Canada 
                exports, or has exported, prescription drugs to 
                individuals in the United States on or before the date 
                that is 90 days after the date of enactment of this Act 
                shall not serve as a basis, in whole or in part, for 
                disapproving a registration under such section 804 from 
                the exporter.
                    (D) First year limit on number of exporters.--
                During the 1-year period beginning on the date of 
                enactment of this Act, the Secretary of Health and 
                Human Services (referred to in this section as the 
                ``Secretary'') may limit the number of registered 
                exporters under such section 804 to not less than 50, 
                so long as the Secretary gives priority to those 
                exporters with demonstrated ability to process a high 
                volume of shipments of drugs to individuals in the 
                United States.
                    (E) Second year limit on number of exporters.--
                During the 1-year period beginning on the date that is 
                1 year after the date of enactment of this Act, the 
                Secretary may limit the number of registered exporters 
                under such section 804 to not less than 100, so long as 
                the Secretary gives priority to those exporters with 
                demonstrated ability to process a high volume of 
                shipments of drugs to individuals in the United States.
                    (F) Further limit on number of exporters.--During 
                any 1-year period beginning on a date that is 2 or more 
                years after the date of enactment of this Act, the 
                Secretary may limit the number of registered exporters 
                under such section 804 to not less than 25 more than 
                the number of such exporters during the previous 1-year 
                period, so long as the Secretary gives priority to 
                those exporters with demonstrated ability to process a 
                high volume of shipments of drugs to individuals in the 
                United States.
            (3) Limits on number of importers.--
                    (A) First year limit on number of importers.--
                During the 1-year period beginning on the date that is 
                1 year after the date of enactment of this Act, the 
                Secretary may limit the number of registered importers 
                under such section 804 to not less than 100 (of which 
                at least a significant number shall be groups of 
                pharmacies, to the extent feasible given the 
                applications submitted by such groups), so long as the 
                Secretary gives priority to those importers with 
                demonstrated ability to process a high volume of 
                shipments of drugs imported into the United States.
                    (B) Second year limit on number of importers.--
                During the 1-year period beginning on the date that is 
                2 years after the date of enactment of this Act, the 
                Secretary may limit the number of registered importers 
                under such section 804 to not less than 200 (of which 
                at least a significant number shall be groups of 
                pharmacies, to the extent feasible given the 
                applications submitted by such groups), so long as the 
                Secretary gives priority to those importers with 
                demonstrated ability to process a high volume of 
                shipments of drugs into the United States.
                    (C) Further limit on number of importers.--During 
                any 1-year period beginning on a date that is 3 or more 
                years after the date of enactment of this Act, the 
                Secretary may limit the number of registered importers 
                under such section 804 to not less than 50 more (of 
                which at least a significant number shall be groups of 
                pharmacies, to the extent feasible given the 
                applications submitted by such groups) than the number 
                of such importers during the previous 1-year period, so 
                long as the Secretary gives priority to those importers 
                with demonstrated ability to process a high volume of 
                shipments of drugs to the United States.
            (4) Notices for drugs for import from canada.--The notice 
        with respect to a qualifying drug introduced for commercial 
        distribution in Canada as of the date of enactment of this Act 
        that is required under subsection (g)(2)(B)(i) of such section 
        804 shall be submitted to the Secretary not later than 30 days 
        after the date of enactment of this Act if--
                    (A) the U.S. label drug (as defined in such section 
                804) for the qualifying drug is 1 of the 100 
                prescription drugs with the highest dollar volume of 
                sales in the United States based on the 12 calendar 
                month period most recently completed before the date of 
                enactment of this Act; or
                    (B) the notice is a notice under subsection 
                (g)(2)(B)(i)(II) of such section 804.
            (5) Notice for drugs for import from other countries.--The 
        notice with respect to a qualifying drug introduced for 
        commercial distribution in a permitted country other than 
        Canada as of the date of enactment of this Act that is required 
        under subsection (g)(2)(B)(i) of such section 804 shall be 
        submitted to the Secretary not later than 180 days after the 
        date of enactment of this Act if--
                    (A) the U.S. label drug for the qualifying drug is 
                1 of the 100 prescription drugs with the highest dollar 
                volume of sales in the United States based on the 12 
                calendar month period that is first completed on the 
                date that is 120 days after the date of enactment of 
                this Act; or
                    (B) the notice is a notice under subsection 
                (g)(2)(B)(i)(II) of such section 804.
            (6) Notice for other drugs for import.--
                    (A) Guidance on submission dates.--The Secretary 
                shall by guidance establish a series of submission 
                dates for the notices under subsection (g)(2)(B)(i) of 
                such section 804 with respect to qualifying drugs 
                introduced for commercial distribution as of the date 
                of enactment of this Act and that are not required to 
                be submitted under paragraph (4) or (5).
                    (B) Consistent and efficient use of resources.--The 
                Secretary shall establish the dates described under 
                subparagraph (A) so that such notices described under 
                subparagraph (A) are submitted and reviewed at a rate 
                that allows consistent and efficient use of the 
                resources and staff available to the Secretary for such 
                reviews. The Secretary may condition the requirement to 
                submit such a notice, and the review of such a notice, 
                on the submission by a registered exporter or a 
                registered importer to the Secretary of a notice that 
                such exporter or importer intends to import such 
                qualifying drug to the United States under such section 
                804.
                    (C) Priority for drugs with higher sales.--The 
                Secretary shall establish the dates described under 
                subparagraph (A) so that the Secretary reviews the 
                notices described under such subparagraph with respect 
                to qualifying drugs with higher dollar volume of sales 
                in the United States before the notices with respect to 
                drugs with lower sales in the United States.
            (7) Notices for drugs approved after effective date.--The 
        notice required under subsection (g)(2)(B)(i) of such section 
        804 for a qualifying drug first introduced for commercial 
        distribution in a permitted country (as defined in such section 
        804) after the date of enactment of this Act shall be submitted 
        to and reviewed by the Secretary as provided under subsection 
        (g)(2)(B) of such section 804, without regard to paragraph (4), 
        (5), or (6).
            (8) Report.--Beginning with the first full fiscal year 
        after the date of enactment of this Act, not later than 90 days 
        after the end of each fiscal year during which the Secretary 
        reviews a notice referred to in paragraph (4), (5), or (6), the 
        Secretary shall submit a report to Congress concerning the 
        progress of the Food and Drug Administration in reviewing the 
        notices referred to in paragraphs (4), (5), and (6).
            (9) User fees.--
                    (A) Exporters.--When establishing an aggregate 
                total of fees to be collected from exporters under 
                subsection (f)(2) of such section 804, the Secretary 
                shall, under subsection (f)(3)(C)(i) of such section 
                804, estimate the total price of drugs imported under 
                subsection (a) of such section 804 into the United 
                States by registered exporters during the first fiscal 
                year in which this Act takes effect to be an amount 
                equal to the amount which bears the same ratio to 
                $1,000,000,000 as the number of days in such fiscal 
                year during which this Act is effective bears to 365.
                    (B) Importers.--When establishing an aggregate 
                total of fees to be collected from importers under 
                subsection (e)(2) of such section 804, the Secretary 
                shall, under subsection (e)(3)(C)(i) of such section 
                804, estimate the total price of drugs imported under 
                subsection (a) of such section 804 into the United 
                States by registered importers during--
                            (i) the first fiscal year in which this Act 
                        takes effect to be an amount equal to the 
                        amount which bears the same ratio to 
                        $1,000,000,000 as the number of days in such 
                        fiscal year during which this Act is effective 
                        bears to 365; and
                            (ii) the second fiscal year in which this 
                        Act is in effect to be $3,000,000,000.
                    (C) Second year adjustment.--
                            (i) Reports.--Not later than February 20 of 
                        the second fiscal year in which this Act is in 
                        effect, registered importers shall report to 
                        the Secretary the total price and the total 
                        volume of drugs imported to the United States 
                        by the importer during the 4-month period from 
                        October 1 through January 31 of such fiscal 
                        year.
                            (ii) Reestimate.--Notwithstanding 
                        subsection (e)(3)(C)(ii) of such section 804 or 
                        subparagraph (B), the Secretary shall 
                        reestimate the total price of qualifying drugs 
                        imported under subsection (a) of such section 
                        804 into the United States by registered 
                        importers during the second fiscal year in 
                        which this Act is in effect. Such reestimate 
                        shall be equal to--
                                    (I) the total price of qualifying 
                                drugs imported by each importer as 
                                reported under clause (i); multiplied 
                                by
                                    (II) 3.
                            (iii) Adjustment.--The Secretary shall 
                        adjust the fee due on April 1 of the second 
                        fiscal year in which this Act is in effect, 
                        from each importer so that the aggregate total 
                        of fees collected under subsection (e)(2) for 
                        such fiscal year does not exceed the total 
                        price of qualifying drugs imported under 
                        subsection (a) of such section 804 into the 
                        United States by registered importers during 
                        such fiscal year as reestimated under clause 
                        (ii).
                    (D) Failure to pay fees.--Notwithstanding any other 
                provision of this section, the Secretary may prohibit a 
                registered importer or exporter that is required to pay 
                user fees under subsection (e) or (f) of such section 
                804 and that fails to pay such fees within 30 days 
                after the date on which it is due, from importing or 
                offering for importation a qualifying drug under such 
                section 804 until such fee is paid.
                    (E) Annual report.--
                            (i) Food and drug administration.--Not 
                        later than 180 days after the end of each 
                        fiscal year during which fees are collected 
                        under subsection (e), (f), or (g)(2)(B)(iv) of 
                        such section 804, the Secretary shall prepare 
                        and submit to the House of Representatives and 
                        the Senate a report on the implementation of 
                        the authority for such fees during such fiscal 
                        year and the use, by the Food and Drug 
                        Administration, of the fees collected for the 
                        fiscal year for which the report is made and 
                        credited to the Food and Drug Administration.
                            (ii) Customs and border control.--Not later 
                        than 180 days after the end of each fiscal year 
                        during which fees are collected under 
                        subsection (e) or (f) of such section 804, the 
                        Secretary of Homeland Security, in consultation 
                        with the Secretary of the Treasury, shall 
                        prepare and submit to the House of 
                        Representatives and the Senate a report on the 
                        use, by the Bureau of Customs and Border 
                        Protection, of the fees, if any, transferred by 
                        the Secretary to the Bureau of Customs and 
                        Border Protection for the fiscal year for which 
                        the report is made.
            (10) Special rule regarding importation by individuals.--
                    (A) In general.--Notwithstanding any provision of 
                this Act (or an amendment made by this Act), the 
                Secretary shall expedite the designation of any 
                additional countries from which an individual may 
                import a qualifying drug into the United States under 
                such section 804 if any action implemented by the 
                Government of Canada has the effect of limiting or 
                prohibiting the importation of qualifying drugs into 
                the United States from Canada.
                    (B) Timing and criteria.--The Secretary shall 
                designate such additional countries under subparagraph 
                (A)--
                            (i) not later than 6 months after the date 
                        of the action by the Government of Canada 
                        described under such subparagraph; and
                            (ii) using the criteria described under 
                        subsection (a)(4)(D)(i)(II) of such section 
                        804.
    (f) Implementation of Section 804.--
            (1) Interim rule.--The Secretary may promulgate an interim 
        rule for implementing section 804 of the Federal Food, Drug, 
        and Cosmetic Act, as added by subsection (a) of this section.
            (2) No notice of proposed rulemaking.--The interim rule 
        described under paragraph (1) may be developed and promulgated 
        by the Secretary without providing general notice of proposed 
        rulemaking.
            (3) Final rule.--Not later than 1 year after the date on 
        which the Secretary promulgates an interim rule under paragraph 
        (1), the Secretary shall, in accordance with procedures under 
        section 553 of title 5, United States Code, promulgate a final 
        rule for implementing such section 804, which may incorporate 
        by reference provisions of the interim rule provided for under 
        paragraph (1), to the extent that such provisions are not 
        modified.
    (g) Consumer Education.--The Secretary shall carry out activities 
that educate consumers--
            (1) with regard to the availability of qualifying drugs for 
        import for personal use from an exporter registered with and 
        approved by the Food and Drug Administration under section 804 
        of the Federal Food, Drug, and Cosmetic Act, as added by this 
        section, including information on how to verify whether an 
        exporter is registered and approved by use of the Internet 
        website of the Food and Drug Administration and the toll-free 
        telephone number required by this Act;
            (2) that drugs that consumers attempt to import from an 
        exporter that is not registered with and approved by the Food 
        and Drug Administration can be seized by the United States 
        Customs Service and destroyed, and that such drugs may be 
        counterfeit, unapproved, unsafe, or ineffective;
            (3) with regard to the suspension and termination of any 
        registration of a registered importer or exporter under such 
        section 804; and
            (4) with regard to the availability at domestic retail 
        pharmacies of qualifying drugs imported under such section 804 
        by domestic wholesalers and pharmacies registered with and 
        approved by the Food and Drug Administration.
    (h) Effect on Administration Practices.--Notwithstanding any 
provision of this Act (and the amendments made by this Act), the 
practices and policies of the Food and Drug Administration and Bureau 
of Customs and Border Protection, in effect on January 1, 2004, with 
respect to the importation of prescription drugs into the United States 
by an individual, on the person of such individual, for personal use, 
shall remain in effect.
    (i) Report to Congress.--The Federal Trade Commission shall, on an 
annual basis, submit to Congress a report that describes any action 
taken during the period for which the report is being prepared to 
enforce the provisions of section 804(n) of the Federal Food, Drug, and 
Cosmetic Act (as added by this Act), including any pending 
investigations or civil actions under such section.

SEC. 125. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION INTO UNITED 
              STATES.

    (a) In General.--Chapter VIII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381 et seq.), as amended by section 124, is 
further amended by adding at the end the following section:

``SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION.

    ``(a) In General.--The Secretary of Homeland Security shall deliver 
to the Secretary a shipment of drugs that is imported or offered for 
import into the United States if--
            ``(1) the shipment has a declared value of less than 
        $10,000; and
            ``(2)(A) the shipping container for such drugs does not 
        bear the markings required under section 804(d)(2); or
            ``(B) the Secretary has requested delivery of such shipment 
        of drugs.
    ``(b) No Bond or Export.--Section 801(b) does not authorize the 
delivery to the owner or consignee of drugs delivered to the Secretary 
under subsection (a) pursuant to the execution of a bond, and such 
drugs may not be exported.
    ``(c) Destruction of Violative Shipment.--The Secretary shall 
destroy a shipment of drugs delivered by the Secretary of Homeland 
Security to the Secretary under subsection (a) if--
            ``(1) in the case of drugs that are imported or offered for 
        import from a registered exporter under section 804, the drugs 
        are in violation of any standard described in section 
        804(g)(5); or
            ``(2) in the case of drugs that are not imported or offered 
        for import from a registered exporter under section 804, the 
        drugs are in violation of a standard referred to in section 
        801(a) or 801(d)(1).
    ``(d) Certain Procedures.--
            ``(1) In general.--The delivery and destruction of drugs 
        under this section may be carried out without notice to the 
        importer, owner, or consignee of the drugs except as required 
        by section 801(g) or section 804(i)(2). The issuance of 
        receipts for the drugs, and recordkeeping activities regarding 
        the drugs, may be carried out on a summary basis.
            ``(2) Objective of procedures.--Procedures promulgated 
        under paragraph (1) shall be designed toward the objective of 
        ensuring that, with respect to efficiently utilizing Federal 
        resources available for carrying out this section, a 
        substantial majority of shipments of drugs subject to described 
        in subsection (c) are identified and destroyed.
    ``(e) Evidence Exception.--Drugs may not be destroyed under 
subsection (c) to the extent that the Attorney General of the United 
States determines that the drugs should be preserved as evidence or 
potential evidence with respect to an offense against the United 
States.
    ``(f) Rule of Construction.--This section may not be construed as 
having any legal effect on applicable law with respect to a shipment of 
drugs that is imported or offered for import into the United States and 
has a declared value equal to or greater than $10,000.''.
    (b) Procedures.--Procedures for carrying out section 805 of the 
Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall 
be established not later than 90 days after the date of the enactment 
of this Act.
    (c) Effective Date.--The amendments made by this section shall take 
effect on the date that is 90 days after the date of enactment of this 
Act.

SEC. 126. WHOLESALE DISTRIBUTION OF DRUGS; STATEMENTS REGARDING PRIOR 
              SALE, PURCHASE, OR TRADE.

    (a) Striking of Exemptions; Applicability to Registered 
Exporters.--Section 503(e) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 353(e)) is amended--
            (1) in paragraph (1)--
                    (A) by striking ``and who is not the manufacturer 
                or an authorized distributor of record of such drug'';
                    (B) by striking ``to an authorized distributor of 
                record or''; and
                    (C) by striking subparagraph (B) and inserting the 
                following:
    ``(B) The fact that a drug subject to subsection (b) is exported 
from the United States does not with respect to such drug exempt any 
person that is engaged in the business of the wholesale distribution of 
the drug from providing the statement described in subparagraph (A) to 
the person that receives the drug pursuant to the export of the drug.
    ``(C)(i) The Secretary shall by regulation establish requirements 
that supersede subparagraph (A) (referred to in this subparagraph as 
`alternative requirements') to identify the chain of custody of a drug 
subject to subsection (b) from the manufacturer of the drug throughout 
the wholesale distribution of the drug to a pharmacist who intends to 
sell the drug at retail if the Secretary determines that the 
alternative requirements, which may include standardized anti-
counterfeiting or track-and-trace technologies, will identify such 
chain of custody or the identity of the discrete package of the drug 
from which the drug is dispensed with equal or greater certainty to the 
requirements of subparagraph (A), and that the alternative requirements 
are economically and technically feasible.
    ``(ii) When the Secretary promulgates a final rule to establish 
such alternative requirements, the final rule in addition shall, with 
respect to the registration condition established in clause (i) of 
section 804(c)(3)(B), establish a condition equivalent to the 
alternative requirements, and such equivalent condition may be met in 
lieu of the registration condition established in such clause (i).'';
            (2) in paragraph (2)(A), by adding at the end the 
        following: ``The preceding sentence may not be construed as 
        having any applicability with respect to a registered exporter 
        under section 804.''; and
            (3) in paragraph (3), by striking ``and subsection (d)--'' 
        in the matter preceding subparagraph (A) and all that follows 
        through ``the term `wholesale distribution' means'' in 
        subparagraph (B) and inserting the following: ``and subsection 
        (d), the term `wholesale distribution' means''.
    (b) Conforming Amendment.--Section 503(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 353(d)) is amended by adding at the 
end the following:
    ``(4) Each manufacturer of a drug subject to subsection (b) shall 
maintain at its corporate offices a current list of the authorized 
distributors of record of such drug.
    ``(5) For purposes of this subsection, the term `authorized 
distributors of record' means those distributors with whom a 
manufacturer has established an ongoing relationship to distribute such 
manufacturer's products.''.
    (c) Effective Date.--
            (1) In general.--The amendments made by paragraphs (1) and 
        (3) of subsection (a) and by subsection (b) shall take effect 
        on January 1, 2010.
            (2) Drugs imported by registered importers under section 
        804.--Notwithstanding paragraph (1), the amendments made by 
        paragraphs (1) and (3) of subsection (a) and by subsection (b) 
        shall take effect on the date that is 90 days after the date of 
        enactment of this Act with respect to qualifying drugs imported 
        under section 804 of the Federal Food, Drug, and Cosmetic Act, 
        as added by section 4.
            (3) Effect with respect to registered exporters.--The 
        amendment made by subsection (a)(2) shall take effect on the 
        date that is 90 days after the date of enactment of this Act.
            (4) Alternative requirements.--The Secretary shall issue 
        regulations to establish the alternative requirements, referred 
        to in the amendment made by subsection (a)(1), that take effect 
        not later than January 1, 2010.
            (5) Intermediate requirements.--The Secretary shall by 
        regulation require the use of standardized anti-counterfeiting 
        or track-and-trace technologies on prescription drugs at the 
        case and pallet level effective not later than 1 year after the 
        date of enactment of this Act.
            (6) Additional requirements.--
                    (A) In general.--Notwithstanding any other 
                provision of this section, the Secretary shall, not 
                later than 18 months after the date of enactment of 
                this Act, require that the packaging of any 
                prescription drug incorporates--
                            (i) a standardized numerical identifier 
                        unique to each package of such drug, applied at 
                        the point of manufacturing and repackaging (in 
                        which case the numerical identifier shall be 
                        linked to the numerical identifier applied at 
                        the point of manufacturing); and
                            (ii)(I) overt optically variable 
                        counterfeit-resistant technologies that--
                                    (aa) are visible to the naked eye, 
                                providing for visual identification of 
                                product authenticity without the need 
                                for readers, microscopes, lighting 
                                devices, or scanners;
                                    (bb) are similar to that used by 
                                the Bureau of Engraving and Printing to 
                                secure United States currency;
                                    (cc) are manufactured and 
                                distributed in a highly secure, tightly 
                                controlled environment; and
                                    (dd) incorporate additional layers 
                                of nonvisible convert security features 
                                up to and including forensic 
                                capability, as described in 
                                subparagraph (B); or
                            (II) technologies that have a function of 
                        security comparable to that described in 
                        subclause (I), as determined by the Secretary.
                    (B) Standards for packaging.--For the purpose of 
                making it more difficult to counterfeit the packaging 
                of drugs subject to this paragraph, the manufacturers 
                of such drugs shall incorporate the technologies 
                described in subparagraph (A) into at least 1 
                additional element of the physical packaging of the 
                drugs, including blister packs, shrink wrap, package 
                labels, package seals, bottles, and boxes.

SEC. 127. INTERNET SALES OF PRESCRIPTION DRUGS.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 503A 
the following:

``SEC. 503B. INTERNET SALES OF PRESCRIPTION DRUGS.

    ``(a) Requirements Regarding Information on Internet Site.--
            ``(1) In general.--A person may not dispense a prescription 
        drug pursuant to a sale of the drug by such person if--
                    ``(A) the purchaser of the drug submitted the 
                purchase order for the drug, or conducted any other 
                part of the sales transaction for the drug, through an 
                Internet site;
                    ``(B) the person dispenses the drug to the 
                purchaser by mailing or shipping the drug to the 
                purchaser; and
                    ``(C) such site, or any other Internet site used by 
                such person for purposes of sales of a prescription 
                drug, fails to meet each of the requirements specified 
                in paragraph (2), other than a site or pages on a site 
                that--
                            ``(i) are not intended to be accessed by 
                        purchasers or prospective purchasers; or
                            ``(ii) provide an Internet information 
                        location tool within the meaning of section 
                        231(e)(5) of the Communications Act of 1934 (47 
                        U.S.C. 231(e)(5)).
            ``(2) Requirements.--With respect to an Internet site, the 
        requirements referred to in subparagraph (C) of paragraph (1) 
        for a person to whom such paragraph applies are as follows:
                    ``(A) Each page of the site shall include either 
                the following information or a link to a page that 
                provides the following information:
                            ``(i) The name of such person.
                            ``(ii) Each State in which the person is 
                        authorized by law to dispense prescription 
                        drugs.
                            ``(iii) The address and telephone number of 
                        each place of business of the person with 
                        respect to sales of prescription drugs through 
                        the Internet, other than a place of business 
                        that does not mail or ship prescription drugs 
                        to purchasers.
                            ``(iv) The name of each individual who 
                        serves as a pharmacist for prescription drugs 
                        that are mailed or shipped pursuant to the 
                        site, and each State in which the individual is 
                        authorized by law to dispense prescription 
                        drugs.
                            ``(v) If the person provides for medical 
                        consultations through the site for purposes of 
                        providing prescriptions, the name of each 
                        individual who provides such consultations; 
                        each State in which the individual is licensed 
                        or otherwise authorized by law to provide such 
                        consultations or practice medicine; and the 
                        type or types of health professions for which 
                        the individual holds such licenses or other 
                        authorizations.
                    ``(B) A link to which paragraph (1) applies shall 
                be displayed in a clear and prominent place and manner, 
                and shall include in the caption for the link the words 
                `licensing and contact information'.
    ``(b) Internet Sales Without Appropriate Medical Relationships.--
            ``(1) In general.--Except as provided in paragraph (2), a 
        person may not dispense a prescription drug, or sell such a 
        drug, if--
                    ``(A) for purposes of such dispensing or sale, the 
                purchaser communicated with the person through the 
                Internet;
                    ``(B) the patient for whom the drug was dispensed 
                or purchased did not, when such communications began, 
                have a prescription for the drug that is valid in the 
                United States;
                    ``(C) pursuant to such communications, the person 
                provided for the involvement of a practitioner, or an 
                individual represented by the person as a practitioner, 
                and the practitioner or such individual issued a 
                prescription for the drug that was purchased;
                    ``(D) the person knew, or had reason to know, that 
                the practitioner or the individual referred to in 
                subparagraph (C) did not, when issuing the 
                prescription, have a qualifying medical relationship 
                with the patient; and
                    ``(E) the person received payment for the 
                dispensing or sale of the drug.
        For purposes of subparagraph (E), payment is received if money 
        or other valuable consideration is received.
            ``(2) Exceptions.--Paragraph (1) does not apply to--
                    ``(A) the dispensing or selling of a prescription 
                drug pursuant to telemedicine practices sponsored by--
                            ``(i) a hospital that has in effect a 
                        provider agreement under title XVIII of the 
                        Social Security Act (relating to the Medicare 
                        program); or
                            ``(ii) a group practice that has not fewer 
                        than 100 physicians who have in effect provider 
                        agreements under such title; or
                    ``(B) the dispensing or selling of a prescription 
                drug pursuant to practices that promote the public 
                health, as determined by the Secretary by regulation.
            ``(3) Qualifying medical relationship.--
                    ``(A) In general.--With respect to issuing a 
                prescription for a drug for a patient, a practitioner 
                has a qualifying medical relationship with the patient 
                for purposes of this section if--
                            ``(i) at least one in-person medical 
                        evaluation of the patient has been conducted by 
                        the practitioner; or
                            ``(ii) the practitioner conducts a medical 
                        evaluation of the patient as a covering 
                        practitioner.
                    ``(B) In-person medical evaluation.--A medical 
                evaluation by a practitioner is an in-person medical 
                evaluation for purposes of this section if the 
                practitioner is in the physical presence of the patient 
                as part of conducting the evaluation, without regard to 
                whether portions of the evaluation are conducted by 
                other health professionals.
                    ``(C) Covering practitioner.--With respect to a 
                patient, a practitioner is a covering practitioner for 
                purposes of this section if the practitioner conducts a 
                medical evaluation of the patient at the request of a 
                practitioner who has conducted at least one in-person 
                medical evaluation of the patient and is temporarily 
                unavailable to conduct the evaluation of the patient. A 
                practitioner is a covering practitioner without regard 
                to whether the practitioner has conducted any in-person 
                medical evaluation of the patient involved.
            ``(4) Rules of construction.--
                    ``(A) Individuals represented as practitioners.--A 
                person who is not a practitioner (as defined in 
                subsection (e)(1)) lacks legal capacity under this 
                section to have a qualifying medical relationship with 
                any patient.
                    ``(B) Standard practice of pharmacy.--Paragraph (1) 
                may not be construed as prohibiting any conduct that is 
                a standard practice in the practice of pharmacy.
                    ``(C) Applicability of requirements.--Paragraph (3) 
                may not be construed as having any applicability beyond 
                this section, and does not affect any State law, or 
                interpretation of State law, concerning the practice of 
                medicine.
    ``(c) Actions by States.--
            ``(1) In general.--Whenever an attorney general of any 
        State has reason to believe that the interests of the residents 
        of that State have been or are being threatened or adversely 
        affected because any person has engaged or is engaging in a 
        pattern or practice that violates section 301(l), the State may 
        bring a civil action on behalf of its residents in an 
        appropriate district court of the United States to enjoin such 
        practice, to enforce compliance with such section (including a 
        nationwide injunction), to obtain damages, restitution, or 
        other compensation on behalf of residents of such State, to 
        obtain reasonable attorneys fees and costs if the State 
        prevails in the civil action, or to obtain such further and 
        other relief as the court may deem appropriate.
            ``(2) Notice.--The State shall serve prior written notice 
        of any civil action under paragraph (1) or (5)(B) upon the 
        Secretary and provide the Secretary with a copy of its 
        complaint, except that if it is not feasible for the State to 
        provide such prior notice, the State shall serve such notice 
        immediately upon instituting such action. Upon receiving a 
        notice respecting a civil action, the Secretary shall have the 
        right--
                    ``(A) to intervene in such action;
                    ``(B) upon so intervening, to be heard on all 
                matters arising therein; and
                    ``(C) to file petitions for appeal.
            ``(3) Construction.--For purposes of bringing any civil 
        action under paragraph (1), nothing in this chapter shall 
        prevent an attorney general of a State from exercising the 
        powers conferred on the attorney general by the laws of such 
        State to conduct investigations or to administer oaths or 
        affirmations or to compel the attendance of witnesses or the 
        production of documentary and other evidence.
            ``(4) Venue; service of process.--Any civil action brought 
        under paragraph (1) in a district court of the United States 
        may be brought in the district in which the defendant is found, 
        is an inhabitant, or transacts business or wherever venue is 
        proper under section 1391 of title 28, United States Code. 
        Process in such an action may be served in any district in 
        which the defendant is an inhabitant or in which the defendant 
        may be found.
            ``(5) Actions by other state officials.--
                    ``(A) Nothing contained in this section shall 
                prohibit an authorized State official from proceeding 
                in State court on the basis of an alleged violation of 
                any civil or criminal statute of such State.
                    ``(B) In addition to actions brought by an attorney 
                general of a State under paragraph (1), such an action 
                may be brought by officers of such State who are 
                authorized by the State to bring actions in such State 
                on behalf of its residents.
    ``(d) Effect of Section.--This section shall not apply to a person 
that is a registered exporter under section 804.
    ``(e) General Definitions.--For purposes of this section:
            ``(1) The term `practitioner' means a practitioner referred 
        to in section 503(b)(1) with respect to issuing a written or 
        oral prescription.
            ``(2) The term `prescription drug' means a drug that is 
        described in section 503(b)(1).
            ``(3) The term `qualifying medical relationship', with 
        respect to a practitioner and a patient, has the meaning 
        indicated for such term in subsection (b).
    ``(f) Internet-Related Definitions.--
            ``(1) In general.--For purposes of this section:
                    ``(A) The term `Internet' means collectively the 
                myriad of computer and telecommunications facilities, 
                including equipment and operating software, which 
                comprise the interconnected world-wide network of 
                networks that employ the transmission control protocol/
                internet protocol, or any predecessor or successor 
                protocols to such protocol, to communicate information 
                of all kinds by wire or radio.
                    ``(B) The term `link', with respect to the 
                Internet, means one or more letters, words, numbers, 
                symbols, or graphic items that appear on a page of an 
                Internet site for the purpose of serving, when 
                activated, as a method for executing an electronic 
                command--
                            ``(i) to move from viewing one portion of a 
                        page on such site to another portion of the 
                        page;
                            ``(ii) to move from viewing one page on 
                        such site to another page on such site; or
                            ``(iii) to move from viewing a page on one 
                        Internet site to a page on another Internet 
                        site.
                    ``(C) The term `page', with respect to the 
                Internet, means a document or other file accessed at an 
                Internet site.
                    ``(D)(i) The terms `site' and `address', with 
                respect to the Internet, mean a specific location on 
                the Internet that is determined by Internet Protocol 
                numbers. Such term includes the domain name, if any.
                    ``(ii) The term `domain name' means a method of 
                representing an Internet address without direct 
                reference to the Internet Protocol numbers for the 
                address, including methods that use designations such 
                as `.com', `.edu', `.gov', `.net', or `.org'.
                    ``(iii) The term `Internet Protocol numbers' 
                includes any successor protocol for determining a 
                specific location on the Internet.
            ``(2) Authority of secretary.--The Secretary may by 
        regulation modify any definition under paragraph (1) to take 
        into account changes in technology.
    ``(g) Interactive Computer Service; Advertising.--No provider of an 
interactive computer service, as defined in section 230(f)(2) of the 
Communications Act of 1934 (47 U.S.C. 230(f)(2)), or of advertising 
services shall be liable under this section for dispensing or selling 
prescription drugs in violation of this section on account of another 
person's selling or dispensing such drugs, provided that the provider 
of the interactive computer service or of advertising services does not 
own or exercise corporate control over such person.''.
    (b) Inclusion as Prohibited Act.--Section 301 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 331) is amended by inserting after 
paragraph (k) the following:
    ``(l) The dispensing or selling of a prescription drug in violation 
of section 503B.''.
    (c) Internet Sales of Prescription Drugs; Consideration by 
Secretary of Practices and Procedures for Certification of Legitimate 
Businesses.--In carrying out section 503B of the Federal Food, Drug, 
and Cosmetic Act (as added by subsection (a) of this section), the 
Secretary of Health and Human Services shall take into consideration 
the practices and procedures of public or private entities that certify 
that businesses selling prescription drugs through Internet sites are 
legitimate businesses, including practices and procedures regarding 
disclosure formats and verification programs.
    (d) Reports Regarding Internet-Related Violations of Federal and 
State Laws on Dispensing of Drugs.--
            (1) In general.--The Secretary of Health and Human Services 
        (referred to in this subsection as the ``Secretary'') shall, 
        pursuant to the submission of an application meeting the 
        criteria of the Secretary, make an award of a grant or contract 
        to the National Clearinghouse on Internet Prescribing (operated 
        by the Federation of State Medical Boards) for the purpose of--
                    (A) identifying Internet sites that appear to be in 
                violation of Federal or State laws concerning the 
                dispensing of drugs;
                    (B) reporting such sites to State medical licensing 
                boards and State pharmacy licensing boards, and to the 
                Attorney General and the Secretary, for further 
                investigation; and
                    (C) submitting, for each fiscal year for which the 
                award under this subsection is made, a report to the 
                Secretary describing investigations undertaken with 
                respect to violations described in subparagraph (A).
            (2) Authorization of appropriations.--For the purpose of 
        carrying out paragraph (1), there is authorized to be 
        appropriated $100,000 for each of the first 3 fiscal years in 
        which this section is in effect.
    (e) Effective Date.--The amendments made by subsections (a) and (b) 
take effect 90 days after the date of enactment of this Act, without 
regard to whether a final rule to implement such amendments has been 
promulgated by the Secretary of Health and Human Services under section 
701(a) of the Federal Food, Drug, and Cosmetic Act. The preceding 
sentence may not be construed as affecting the authority of such 
Secretary to promulgate such a final rule.

SEC. 128. PROHIBITING PAYMENTS TO UNREGISTERED FOREIGN PHARMACIES.

    (a) In General.--Section 303 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the 
following:
    ``(g) Restricted Transactions.--
            ``(1) In general.--The introduction of restricted 
        transactions into a payment system or the completion of 
        restricted transactions using a payment system is prohibited.
            ``(2) Payment system.--
                    ``(A) In general.--The term `payment system' means 
                a system used by a person described in subparagraph (B) 
                to effect a credit transaction, electronic fund 
                transfer, or money transmitting service that may be 
                used in connection with, or to facilitate, a restricted 
                transaction, and includes--
                            ``(i) a credit card system;
                            ``(ii) an international, national, 
                        regional, or local network used to effect a 
                        credit transaction, an electronic fund 
                        transfer, or a money transmitting service; and
                            ``(iii) any other system that is centrally 
                        managed and is primarily engaged in the 
                        transmission and settlement of credit 
                        transactions, electronic fund transfers, or 
                        money transmitting services.
                    ``(B) Persons described.--A person referred to in 
                subparagraph (A) is--
                            ``(i) a creditor;
                            ``(ii) a credit card issuer;
                            ``(iii) a financial institution;
                            ``(iv) an operator of a terminal at which 
                        an electronic fund transfer may be initiated;
                            ``(v) a money transmitting business; or
                            ``(vi) a participant in an international, 
                        national, regional, or local network used to 
                        effect a credit transaction, electronic fund 
                        transfer, or money transmitting service.
            ``(3) Restricted transaction.--The term `restricted 
        transaction' means a transaction or transmittal, on behalf of 
        an individual who places an unlawful drug importation request 
        to any person engaged in the operation of an unregistered 
        foreign pharmacy, of--
                    ``(A) credit, or the proceeds of credit, extended 
                to or on behalf of the individual for the purpose of 
                the unlawful drug importation request (including credit 
                extended through the use of a credit card);
                    ``(B) an electronic fund transfer or funds 
                transmitted by or through a money transmitting 
                business, or the proceeds of an electronic fund 
                transfer or money transmitting service, from or on 
                behalf of the individual for the purpose of the 
                unlawful drug importation request;
                    ``(C) a check, draft, or similar instrument which 
                is drawn by or on behalf of the individual for the 
                purpose of the unlawful drug importation request and is 
                drawn on or payable at or through any financial 
                institution; or
                    ``(D) the proceeds of any other form of financial 
                transaction (identified by the Board by regulation) 
                that involves a financial institution as a payor or 
                financial intermediary on behalf of or for the benefit 
                of the individual for the purpose of the unlawful drug 
                importation request.
            ``(4) Unlawful drug importation request.--The term 
        `unlawful drug importation request' means the request, or 
        transmittal of a request, made to an unregistered foreign 
        pharmacy for a prescription drug by mail (including a private 
        carrier), facsimile, phone, or electronic mail, or by a means 
        that involves the use, in whole or in part, of the Internet.
            ``(5) Unregistered foreign pharmacy.--The term 
        `unregistered foreign pharmacy' means a person in a country 
        other than the United States that is not a registered exporter 
        under section 804.
            ``(6) Other definitions.--
                    ``(A) Credit; creditor; credit card.--The terms 
                `credit', `creditor', and `credit card' have the 
                meanings given the terms in section 103 of the Truth in 
                Lending Act (15 U.S.C. 1602).
                    ``(B) Access device; electronic fund transfer.--The 
                terms `access device' and `electronic fund transfer'--
                            ``(i) have the meaning given the term in 
                        section 903 of the Electronic Fund Transfer Act 
                        (15 U.S.C. 1693a); and
                            ``(ii) the term `electronic fund transfer' 
                        also includes any fund transfer covered under 
                        Article 4A of the Uniform Commercial Code, as 
                        in effect in any State.
                    ``(C) Financial institution.--The term `financial 
                institution'--
                            ``(i) has the meaning given the term in 
                        section 903 of the Electronic Transfer Fund Act 
                        (15 U.S.C. 1693a); and
                            ``(ii) includes a financial institution (as 
                        defined in section 509 of the Gramm-Leach-
                        Bliley Act (15 U.S.C. 6809)).
                    ``(D) Money transmitting business; money 
                transmitting service.--The terms `money transmitting 
                business' and `money transmitting service' have the 
                meaning given the terms in section 5330(d) of title 31, 
                United States Code.
                    ``(E) Board.--The term `Board' means the Board of 
                Governors of the Federal Reserve System.
            ``(7) Policies and procedures required to prevent 
        restricted transactions.--
                    ``(A) Regulations.--The Board shall promulgate 
                regulations requiring--
                            ``(i) an operator of a credit card system;
                            ``(ii) an operator of an international, 
                        national, regional, or local network used to 
                        effect a credit transaction, an electronic fund 
                        transfer, or a money transmitting service;
                            ``(iii) an operator of any other payment 
                        system that is centrally managed and is 
                        primarily engaged in the transmission and 
                        settlement of credit transactions, electronic 
                        transfers or money transmitting services where 
                        at least one party to the transaction or 
                        transfer is an individual; and
                            ``(iv) any other person described in 
                        paragraph (2)(B) and specified by the Board in 
                        such regulations,
                to establish policies and procedures that are 
                reasonably designed to prevent the introduction of a 
                restricted transaction into a payment system or the 
                completion of a restricted transaction using a payment 
                system
                    ``(B) Requirements for policies and procedures.--In 
                promulgating regulations under subparagraph (A), the 
                Board shall--
                            ``(i) identify types of policies and 
                        procedures, including nonexclusive examples, 
                        that shall be considered to be reasonably 
                        designed to prevent the introduction of 
                        restricted transactions into a payment system 
                        or the completion of restricted transactions 
                        using a payment system; and
                            ``(ii) to the extent practicable, permit 
                        any payment system, or person described in 
                        paragraph (2)(B), as applicable, to choose 
                        among alternative means of preventing the 
                        introduction or completion of restricted 
                        transactions.
                    ``(C) No liability for blocking or refusing to 
                honor restricted transaction.--
                            ``(i) In general.--A payment system, or a 
                        person described in paragraph (2)(B) that is 
                        subject to a regulation issued under this 
                        subsection, and any participant in such payment 
                        system that prevents or otherwise refuses to 
                        honor transactions in an effort to implement 
                        the policies and procedures required under this 
                        subsection or to otherwise comply with this 
                        subsection shall not be liable to any party for 
                        such action.
                            ``(ii) Compliance.--A person described in 
                        paragraph (2)(B) meets the requirements of this 
                        subsection if the person relies on and complies 
                        with the policies and procedures of a payment 
                        system of which the person is a member or in 
                        which the person is a participant, and such 
                        policies and procedures of the payment system 
                        comply with the requirements of the regulations 
                        promulgated under subparagraph (A).
                    ``(D) Enforcement.--
                            ``(i) In general.--This section shall be 
                        enforced by the Federal functional regulators 
                        and the Federal Trade Commission under 
                        applicable law in the manner provided in 
                        section 505(a) of the Gramm-Leach-Bliley Act 
                        (15 U.S.C. 6805(a)).
                            ``(ii) Factors to be considered.--In 
                        considering any enforcement action under this 
                        subsection against a payment system or person 
                        described in paragraph (2)(B), the Federal 
                        functional regulators and the Federal Trade 
                        Commission shall consider the following 
                        factors:
                                    ``(I) The extent to which the 
                                payment system or person knowingly 
                                permits restricted transactions.
                                    ``(II) The history of the payment 
                                system or person in connection with 
                                permitting restricted transactions.
                                    ``(III) The extent to which the 
                                payment system or person has 
                                established and is maintaining policies 
                                and procedures in compliance with 
                                regulations prescribed under this 
                                subsection.
            ``(8) Transactions permitted.--A payment system, or a 
        person described in paragraph (2)(B) that is subject to a 
        regulation issued under this subsection, is authorized to 
        engage in transactions with foreign pharmacies in connection 
        with investigating violations or potential violations of any 
        rule or requirement adopted by the payment system or person in 
        connection with complying with paragraph (7). A payment system, 
        or such a person, and its agents and employees shall not be 
        found to be in violation of, or liable under, any Federal, 
        State or other law by virtue of engaging in any such 
        transaction.
            ``(9) Relation to state laws.--No requirement, prohibition, 
        or liability may be imposed on a payment system, or a person 
        described in paragraph (2)(B) that is subject to a regulation 
        issued under this subsection, under the laws of any state with 
        respect to any payment transaction by an individual because the 
        payment transaction involves a payment to a foreign pharmacy.
            ``(10) Timing of requirements.--A payment system, or a 
        person described in paragraph (2)(B) that is subject to a 
        regulation issued under this subsection, must adopt policies 
        and procedures reasonably designed to comply with any 
        regulations required under paragraph (7) within 60 days after 
        such regulations are issued in final form.''.
    (b) Effective Date.--The amendment made by this section shall take 
effect on the day that is 90 days after the date of enactment of this 
Act.
    (c) Implementation.--The Board of Governors of the Federal Reserve 
System shall promulgate regulations as required by subsection (g)(7) of 
section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
333), as added by subsection (a), not later than 90 days after the date 
of enactment of this Act.

SEC. 129. IMPORTATION EXEMPTION UNDER CONTROLLED SUBSTANCES IMPORT AND 
              EXPORT ACT.

    Section 1006(a)(2) of the Controlled Substances Import and Export 
Act (21 U.S.C. 956(a)(2)) is amended by striking ``not import the 
controlled substance into the United States in an amount that exceeds 
50 dosage units of the controlled substance.'' and inserting ``import 
into the United States not more than 10 dosage units combined of all 
such controlled substances.''.

SEC. 130. SEVERABILITY.

    If any provision of this subtitle, an amendment by this subtitle, 
or the application of such provision or amendment to any person or 
circumstance is held to be unconstitutional, the remainder of this 
subtitle, the amendments made by this subtitle, and the application of 
the provisions of such to any person or circumstance shall not affected 
thereby.

        Subtitle D--Royalties Under Offshore Oil and Gas Leases

SEC. 141. PRICE THRESHOLDS FOR ROYALTY SUSPENSION PROVISIONS.

    (a) In General.--The Secretary of the Interior (referred to in this 
subtitle as the ``Secretary'') shall agree to a request by any lessee 
to amend any lease issued for any Central and Western Gulf of Mexico 
tract during the period of January 1, 1998, through December 31, 1999, 
to incorporate price thresholds applicable to royalty suspension 
provisions, that are equal to or less than the price thresholds 
described in clauses (v) through (vii) of section 8(a)(3)(C) of the 
Outer Continental Shelf Lands Act (43 U.S.C. 1337(a)(3)(C)).
    (b) Effective Date.--
            (1) In general.--Any lease amended under subsection (a) 
        shall impose the new or revised price thresholds effective 
        beginning October 1, 2006.
            (2) Existing provisions.--Existing lease provisions in a 
        lease amended under subsection (a) shall apply through 
        September 30, 2006.

SEC. 142. CLARIFICATION OF AUTHORITY TO IMPOSE PRICE THRESHOLDS FOR 
              CERTAIN LEASE SALES.

    Congress reaffirms the authority of the Secretary under section 
8(a)(1)(H) of the Outer Continental Shelf Lands Act (43 U.S.C. 
1337(a)(1)(H)) to vary, based on the price of production from a lease, 
the suspension of royalties under any lease subject to section 304 of 
the Outer Continental Shelf Deep Water Royalty Relief Act (43 U.S.C. 
1337; Public Law 104-58).

SEC. 143. ELIGIBILITY FOR NEW LEASES AND THE TRANSFER OF LEASES; 
              CONSERVATION OF RESOURCES FEES.

    (a) Definitions.--In this section--
            (1) Covered lease.--The term ``covered lease'' means a 
        lease for oil or gas production in the Gulf of Mexico that is--
                    (A) in existence on the date of enactment of this 
                Act;
                    (B) issued by the Department of the Interior under 
                section 304 of the Outer Continental Shelf Deep Water 
                Royalty Relief Act (43 U.S.C. 1337 note; Public Law 
                104-58); and
                    (C) not subject to limitations on royalty relief 
                based on market price that are equal to or less than 
                the price thresholds described in clauses (v) through 
                (vii) of section 8(a)(3)(C) of the Outer Continental 
                Shelf Lands Act (43 U.S.C. 1337(a)(3)(C)).
            (2) Lessee.--The term ``lessee'' includes any person or 
        other entity that controls, is controlled by, or is in or under 
        common control with, a lessee.
    (b) Issuance of New Leases.--
            (1) In general.--The Secretary shall not issue any new 
        lease that authorizes the production of oil or natural gas in 
        the Gulf of Mexico under the Outer Continental Shelf Lands Act 
        (43 U.S.C. 1331 et seq.) to a person described in paragraph (2) 
        unless--
                    (A) the person has renegotiated each covered lease 
                with respect to which the person is a lessee, to modify 
                the payment responsibilities of the person to include 
                price thresholds that are equal to or less than the 
                price thresholds described in clauses (v) through (vii) 
                of section 8(a)(3)(C) of the Outer Continental Shelf 
                Lands Act (43 U.S.C. 1337(a)(3)(C)); or
                    (B) the person has--
                            (i) paid all fees established by the 
                        Secretary under subsection (c) that are due 
                        with respect to each covered lease for which 
                        the person is a lessee; or
                            (ii) entered into an agreement with the 
                        Secretary under which the person is obligated 
                        to pay the fees.
            (2) Persons described.--A person referred to in paragraph 
        (1) is--
                    (A) a lessee that--
                            (i) holds a covered lease on the date on 
                        which the Secretary considers the issuance of 
                        the new lease; or
                            (ii) was issued a covered lease before the 
                        date of enactment of this Act, but transferred 
                        the covered lease to another person or entity 
                        (including a subsidiary or affiliate of the 
                        lessee) after the date of enactment of this 
                        Act; or
                    (B) any other person or entity who has any direct 
                or indirect interest in, or who derives any benefit 
                from, a covered lease.
            (3) Multiple lessees.--
                    (A) In general.--For purposes of paragraph (1), if 
                there are multiple lessees that own a share of a 
                covered lease, the Secretary may implement separate 
                agreements with any lessee with a share of the covered 
                lease that modifies the payment responsibilities with 
                respect to the share of the lessee to include price 
                thresholds that are equal to or less than the price 
                thresholds described in clauses (v) through (vii) of 
                section 8(a)(3)(C) of the Outer Continental Shelf Lands 
                Act (43 U.S.C. 1337(a)(3)(C)).
                    (B) Treatment of share as covered lease.--Beginning 
                on the effective date of an agreement under 
                subparagraph (A), any share subject to the agreement 
                shall not constitute a covered lease with respect to 
                any lessees that entered into the agreement.
    (c) Conservation of Resources Fees.--
            (1) In general.--Not later than 60 days after the date of 
        enactment of this Act, the Secretary shall establish, by 
        regulation, a conservation of resources fee for producing 
        Federal oil and gas leases in the Gulf of Mexico.
            (2) Producing lease fee terms.--The fee under paragraph 
        (1)--
                    (A) subject to subparagraph (C), shall apply to 
                covered leases that are producing leases;
                    (B) shall be set at $9 per barrel for oil and $1.25 
                per million Btu for gas, respectively, in 2005 dollars; 
                and
                    (C) shall apply only to production of oil or gas 
                occurring--
                            (i) in any calendar year in which the 
                        arithmetic average of the daily closing prices 
                        for light sweet crude oil on the New York 
                        Mercantile Exchange (NYMEX) exceeds $34.73 per 
                        barrel for oil and $4.34 per million Btu for 
                        gas in 2005 dollars; and
                            (ii) on or after October 1, 2006.
            (3) Treatment of receipts.--Amounts received by the United 
        States as fees under this subsection shall be treated as 
        offsetting receipts.
    (d) Transfers.--A lessee or any other person who has any direct or 
indirect interest in, or who derives a benefit from, a lease shall not 
be eligible to obtain by sale or other transfer (including through a 
swap, spinoff, servicing, or other agreement) any covered lease, the 
economic benefit of any covered lease, or any other lease for the 
production of oil or natural gas in the Gulf of Mexico under the Outer 
Continental Shelf Lands Act (43 U.S.C. 1331 et seq.), unless--
            (1) the lessee or other person has--
                    (A) renegotiated all covered leases of the lessee 
                or other person; and
                    (B) entered into an agreement with the Secretary to 
                modify the terms of all covered leases of the lessee or 
                other person to include limitations on royalty relief 
                based on market prices that are equal to or less than 
                the price thresholds described in clauses (v) through 
                (vii) of section 8(a)(3)(C) of the Outer Continental 
                Shelf Lands Act (43 U.S.C. 1337(a)(3)(C)); or
            (2) the lessee or other person has--
                    (A) paid all fees established by the Secretary 
                under subsection (c) that are due with respect to each 
                covered lease for which the person is a lessee; or
                    (B) entered into an agreement with the Secretary 
                under which the person is obligated to pay the fees.

                     TITLE II--REVENUE ENHANCEMENTS

SEC. 200. AMENDMENT OF 1986 CODE.

    Except as otherwise expressly provided, whenever in this title an 
amendment or repeal is expressed in terms of an amendment to, or repeal 
of, a section or other provision, the reference shall be considered to 
be made to a section or other provision of the Internal Revenue Code of 
1986.

  Subtitle A--Rescission of Various Tax Cuts for Millionaire Taxpayers

SEC. 201. REPEAL OF TOP INCOME TAX RATE REDUCTION FOR TAXPAYERS WITH 
              $1,000,000 OR MORE OF TAXABLE INCOME.

    (a) In General.--Section 1(i) (relating to rate reductions) is 
amended by redesignating paragraph (3) as paragraph (4) and by 
inserting after paragraph (2) the following new paragraph:
            ``(3) Exception for taxpayers with taxable income of 
        $1,000,000, or more.--Notwithstanding paragraph (2), in the 
        case of taxable years beginning in a calender year after 2007, 
        the last item in the fourth column of the table under paragraph 
        (2) shall be applied by substituting `39.6%' for `35.0%' with 
        respect to taxable income in excess of $1,000,000 ($500,000 in 
        the case of taxpayers to whom subsection (d) applies).''.
    (b) Effective Date.--The amendment made by this section shall apply 
to taxable years beginning after December 31, 2007.
    (c) Application of Egtrra Sunset.--The amendment made by this 
section shall be subject to title IX of the Economic Growth and Tax 
Relief Reconciliation Act of 2001 to the same extent and in the same 
manner as the provision of such Act to which such amendment relates.

SEC. 202. ELIMINATION OF THE SCHEDULED PHASEOUT OF THE LIMITATIONS ON 
              PERSONAL EXEMPTIONS AND ITEMIZED DEDUCTIONS FOR TAXPAYERS 
              EARNING IN EXCESS OF $1,000,000.

    (a) Personal Exemptions.--Section 151(d)(3)(E) is amended by adding 
at the end the following new clause:
                            ``(iii) Exception.--This subparagraph shall 
                        not apply with respect to any taxpayer whose 
                        adjusted gross income for the taxable year 
                        exceeds $1,000,000 ($500,000 in the case of a 
                        married individual filing a separate 
                        return).''.
    (b) Itemized Deductions.--Section 68(f) amended by adding at the 
end the following new paragraph:
            ``(3) Exception.--This subsection shall not apply with 
        respect to any taxpayer whose adjusted gross income for the 
        taxable year exceeds $1,000,000 ($500,000 in the case of a 
        married individual filing a separate return).''.
    (c) Effective Date.--The amendments made by this section shall 
apply to taxable years beginning after December 31, 2007.
    (d) Application of EGTRRA Sunset.--The amendments made by this 
section shall be subject to title IX of the Economic Growth and Tax 
Relief Reconciliation Act of 2001 to the same extent and in the same 
manner as the provision of such Act to which such amendment relates.

SEC. 203. MODIFICATION OF TAX RATES ON CAPITAL GAINS AND DIVIDENDS FOR 
              TAXPAYERS WITH $1,000,000 OR MORE OF TAXABLE INCOME.

    (a) In General.--Section 1(h) is amended by adding at the end the 
following new paragraph:
            ``(12) Modified rates for individuals with $1,000,000 or 
        more of taxable income.--If a taxpayer has taxable income of 
        $1,000,000 ($500,000 in the case of taxpayers to whom 
        subsection (d) applies) or more for any taxable year--
                    ``(A) paragraph (11) (relating to dividends taxed 
                as capital gain) shall not apply to any qualified 
                dividend income of the taxpayer for the taxable year, 
                and
                    ``(B) paragraph (1)(C) shall be applied by 
                substituting `20 percent' for `15 percent' with respect 
                to the adjusted net capital gain of the taxpayer for 
                the taxable year, determined by only taking into 
                account gain or loss properly allocable to the portion 
                of the taxable year after December 31, 2007.''
    (b) Application to Minimum Tax.--Section 55(b)(3) is amended by 
adding at the end the following new sentence: ``In the case of a 
taxpayer with alternative minimum taxable income of $1,000,000 
($500,000 in the case of taxpayers to whom section 1(d) applies) or 
more for any taxable year, the rules of section 1(h)(12) shall apply 
for purposes of this paragraph.''
    (c) Effective Dates.--
            (1) Capital gains.--Section 1(h)(12)(B) of the Internal 
        Revenue Code of 1986 (as added by paragraph (1)) shall apply to 
        taxable years beginning after December 31, 2007.
            (2) Dividend rates.--Section 1(h)(12)(A) of such Code (as 
        added by paragraph (1)) shall apply to dividends received after 
        December 31, 2007.
    (d) Application of Jgtrra Sunset.--The amendments made by this 
section shall be subject to section 303 of the Jobs and Growth Tax 
Relief Reconciliation Act of 2003 to the same extent and in the same 
manner as the provision of such Act to which such amendment relates.

Subtitle B--Provisions to Discourage Offshore Shelters and Expatriation

SEC. 211. TAXATION OF INCOME OF CONTROLLED FOREIGN CORPORATIONS 
              ATTRIBUTABLE TO IMPORTED PROPERTY.

    (a) General Rule.--Subsection (a) of section 954 (defining foreign 
base company income) is amended by striking ``and'' at the end of 
paragraph (4), by striking the period at the end of paragraph (5) and 
inserting ``, and'', and by adding at the end the following new 
paragraph:
            ``(6) imported property income for the taxable year 
        (determined under subsection (j) and reduced as provided in 
        subsection (b)(5)).''.
    (b) Definition of Imported Property Income.--Section 954 is amended 
by adding at the end the following new subsection:
    ``(j) Imported Property Income.--
            ``(1) In general.--For purposes of subsection (a)(6), the 
        term `imported property income' means income (whether in the 
        form of profits, commissions, fees, or otherwise) derived in 
        connection with--
                    ``(A) manufacturing, producing, growing, or 
                extracting imported property;
                    ``(B) the sale, exchange, or other disposition of 
                imported property; or
                    ``(C) the lease, rental, or licensing of imported 
                property.
        Such term shall not include any foreign oil and gas extraction 
        income (within the meaning of section 907(c)) or any foreign 
        oil related income (within the meaning of section 907(c)).
            ``(2) Imported property.--For purposes of this subsection--
                    ``(A) In general.--Except as otherwise provided in 
                this paragraph, the term `imported property' means 
                property which is imported into the United States by 
                the controlled foreign corporation or a related person.
                    ``(B) Imported property includes certain property 
                imported by unrelated persons.--The term `imported 
                property' includes any property imported into the 
                United States by an unrelated person if, when such 
                property was sold to the unrelated person by the 
                controlled foreign corporation (or a related person), 
                it was reasonable to expect that--
                            ``(i) such property would be imported into 
                        the United States; or
                            ``(ii) such property would be used as a 
                        component in other property which would be 
                        imported into the United States.
                    ``(C) Exception for property subsequently 
                exported.--The term `imported property' does not 
                include any property which is imported into the United 
                States and which--
                            ``(i) before substantial use in the United 
                        States, is sold, leased, or rented by the 
                        controlled foreign corporation or a related 
                        person for direct use, consumption, or 
                        disposition outside the United States; or
                            ``(ii) is used by the controlled foreign 
                        corporation or a related person as a component 
                        in other property which is so sold, leased, or 
                        rented.
                    ``(D) Exception for certain agricultural 
                commodities.--The term `imported property' does not 
                include any agricultural commodity which is not grown 
                in the United States in commercially marketable 
                quantities.
            ``(3) Definitions and special rules.--
                    ``(A) Import.--For purposes of this subsection, the 
                term `import' means entering, or withdrawal from 
                warehouse, for consumption or use. Such term includes 
                any grant of the right to use intangible property (as 
                defined in section 936(h)(3)(B)) in the United States.
                    ``(B) United states.--For purposes of this 
                subsection, the term `United States' includes the 
                Commonwealth of Puerto Rico, the Virgin Islands of the 
                United States, Guam, American Samoa, and the 
                Commonwealth of the Northern Mariana Islands.
                    ``(C) Unrelated person.--For purposes of this 
                subsection, the term `unrelated person' means any 
                person who is not a related person with respect to the 
                controlled foreign corporation.
                    ``(D) Coordination with foreign base company sales 
                income.--For purposes of this section, the term 
                `foreign base company sales income' shall not include 
                any imported property income.''.
    (c) Separate Application of Limitations on Foreign Tax Credit for 
Imported Property Income.--
            (1) In general.--Paragraph (1) of section 904(d) (relating 
        to separate application of section with respect to certain 
        categories of income) is amended by striking ``and'' at the end 
        of subparagraph (A), by redesignating subparagraph (B) as 
        subparagraph (C), and by inserting after subparagraph (A) the 
        following new subparagraph:
                    ``(B) imported property income, and''.
            (2) Imported property income defined.--Paragraph (2) of 
        section 904(d) is amended by redesignating subparagraphs (I) 
        and (J) as subparagraphs (J) and (K), respectively, and by 
        inserting after subparagraph (H) the following new 
        subparagraph:
                    ``(I) Imported property income.--The term `imported 
                property income' means any income received or accrued 
                by any person which is of a kind which would be 
                imported property income (as defined in section 
                954(j)).''.
            (3) Conforming amendment.--Clause (ii) of section 
        904(d)(2)(A) is amended by inserting ``or imported property 
        income'' after ``passive category income''.
    (d) Technical Amendments.--
            (1) Clause (iii) of section 952(c)(1)(B) (relating to 
        certain prior year deficits may be taken into account) is 
        amended--
                    (A) by redesignating subclauses (II), (III), (IV), 
                and (V) as subclauses (III), (IV), (V), and (VI), and
                    (B) by inserting after subclause (I) the following 
                new subclause:
                                    ``(II) imported property income,''.
            (2) Paragraph (5) of section 954(b) (relating to deductions 
        to be taken into account) is amended by striking ``and the 
        foreign base company oil related income'' and inserting ``the 
        foreign base company oil related income, and the imported 
        property income''.
    (e) Effective Date.--The amendments made by this section shall 
apply to taxable years of foreign corporations beginning after the date 
of the enactment of this Act, and to taxable years of United States 
shareholders within which or with which such taxable years of such 
foreign corporations end.

SEC. 212. TAX TREATMENT OF CONTROLLED FOREIGN CORPORATIONS ESTABLISHED 
              IN TAX HAVENS.

    (a) In General.--Subchapter C of chapter 80 (relating to provisions 
affecting more than one subtitle) is amended by adding at the end the 
following new section:

``SEC. 7875. CONTROLLED FOREIGN CORPORATIONS IN TAX HAVENS TREATED AS 
              DOMESTIC CORPORATIONS.

    ``(a) General Rule.--If a controlled foreign corporation is a tax-
haven CFC, then, notwithstanding section 7701(a)(4), such corporation 
shall be treated for purposes of this title as a domestic corporation.
    ``(b) Tax-Haven CFC.--For purposes of this section--
            ``(1) In general.--The term `tax-haven CFC' means, with 
        respect to any taxable year, a foreign corporation which--
                    ``(A) was created or organized under the laws of a 
                tax-haven country, and
                    ``(B) is a controlled foreign corporation 
                (determined without regard to this section) for an 
                uninterrupted period of 30 days or more during the 
                taxable year.
            ``(2) Exception.--The term `tax-haven CFC' does not include 
        a foreign corporation for any taxable year if substantially all 
        of its income for the taxable year is derived from the active 
        conduct of trades or businesses within the country under the 
        laws of which the corporation was created or organized.
    ``(c) Tax-Haven Country.--For purposes of this section--
            ``(1) In general.--The term `tax-haven country' means any 
        of the following:


``Andorra                                  Guernsey                                  Panama
Anguilla                                   Isle of Man                               Samoa
Antigua and Barbuda                        Jersey                                    San Marino
Aruba                                      Liberia                                   Federation of
Commonwealth of the                        Principality of                             Saint
   Bahamas                                   Liechtenstein                             Christopher
Bahrain                                    Republic of the                             and Nevis
Barbados                                     Maldives                                Saint Lucia
Belize                                     Malta                                     Saint Vincent
Bermuda                                    Republic of the                             and the
British Virgin Islands                       Marshall Islands                          Grenadines
Cayman Islands                             Mauritius                                 Republic of the
Cook Islands                               Principality of Monaco                      Seychelles
Cyprus                                     Montserrat                                Tonga
Commonwealth of the                        Republic of Nauru                         Turks and Caicos
   Dominica                                Netherlands                               Republic of
Gibraltar                                    Antilles                                  Vanuatu
Grenada                                    Niue

            ``(2) Secretarial authority.--The Secretary may remove or 
        add a foreign jurisdiction from the list of tax-haven countries 
        under paragraph (1) if the Secretary determines such removal or 
        addition is consistent with the purposes of this section.''.
    (b) Conforming Amendment.--The table of sections for subchapter C 
of chapter 80 is amended by adding at the end the following new item:

``Sec. 7875. Controlled foreign corporations in tax havens treated as 
                            domestic corporations.''.
    (c) Effective Date.--The amendments made by this section shall 
apply to taxable years beginning after December 31, 2008.

SEC. 213. REVISION OF TAX RULES ON EXPATRIATION OF INDIVIDUALS.

    (a) In General.--Subpart A of part II of subchapter N of chapter 1 
is amended by inserting after section 877 the following new section:

``SEC. 877A. TAX RESPONSIBILITIES OF EXPATRIATION.

    ``(a) General Rules.--For purposes of this subtitle--
            ``(1) Mark to market.--Except as provided in subsections 
        (d) and (f), all property of a covered expatriate to whom this 
        section applies shall be treated as sold on the day before the 
        expatriation date for its fair market value.
            ``(2) Recognition of gain or loss.--In the case of any sale 
        under paragraph (1)--
                    ``(A) notwithstanding any other provision of this 
                title, any gain arising from such sale shall be taken 
                into account for the taxable year of the sale, and
                    ``(B) any loss arising from such sale shall be 
                taken into account for the taxable year of the sale to 
                the extent otherwise provided by this title, except 
                that section 1091 shall not apply to any such loss.
        Proper adjustment shall be made in the amount of any gain or 
        loss subsequently realized for gain or loss taken into account 
        under the preceding sentence.
            ``(3) Exclusion for certain gain.--
                    ``(A) In general.--The amount which, but for this 
                paragraph, would be includible in the gross income of 
                any individual by reason of this section shall be 
                reduced (but not below zero) by $600,000. For purposes 
                of this paragraph, allocable expatriation gain taken 
                into account under subsection (f)(2) shall be treated 
                in the same manner as an amount required to be 
                includible in gross income.
                    ``(B) Cost-of-living adjustment.--
                            ``(i) In general.--In the case of an 
                        expatriation date occurring in any calendar 
                        year after 2008, the $600,000 amount under 
                        subparagraph (A) shall be increased by an 
                        amount equal to--
                                    ``(I) such dollar amount, 
                                multiplied by
                                    ``(II) the cost-of-living 
                                adjustment determined under section 
                                1(f)(3) for such calendar year, 
                                determined by substituting `calendar 
                                year 2007' for `calendar year 1992' in 
                                subparagraph (B) thereof.
                            ``(ii) Rounding rules.--If any amount after 
                        adjustment under clause (i) is not a multiple 
                        of $1,000, such amount shall be rounded to the 
                        next lower multiple of $1,000.
            ``(4) Election to continue to be taxed as united states 
        citizen.--
                    ``(A) In general.--If a covered expatriate elects 
                the application of this paragraph--
                            ``(i) this section (other than this 
                        paragraph and subsection (i)) shall not apply 
                        to the expatriate, but
                            ``(ii) in the case of property to which 
                        this section would apply but for such election, 
                        the expatriate shall be subject to tax under 
                        this title in the same manner as if the 
                        individual were a United States citizen.
                    ``(B) Requirements.--Subparagraph (A) shall not 
                apply to an individual unless the individual--
                            ``(i) provides security for payment of tax 
                        in such form and manner, and in such amount, as 
                        the Secretary may require,
                            ``(ii) consents to the waiver of any right 
                        of the individual under any treaty of the 
                        United States which would preclude assessment 
                        or collection of any tax which may be imposed 
                        by reason of this paragraph, and
                            ``(iii) complies with such other 
                        requirements as the Secretary may prescribe.
                    ``(C) Election.--An election under subparagraph (A) 
                shall apply to all property to which this section would 
                apply but for the election and, once made, shall be 
                irrevocable. Such election shall also apply to property 
                the basis of which is determined in whole or in part by 
                reference to the property with respect to which the 
                election was made.
    ``(b) Election to Defer Tax.--
            ``(1) In general.--If the taxpayer elects the application 
        of this subsection with respect to any property treated as sold 
        by reason of subsection (a), the payment of the additional tax 
        attributable to such property shall be postponed until the due 
        date of the return for the taxable year in which such property 
        is disposed of (or, in the case of property disposed of in a 
        transaction in which gain is not recognized in whole or in 
        part, until such other date as the Secretary may prescribe).
            ``(2) Determination of tax with respect to property.--For 
        purposes of paragraph (1), the additional tax attributable to 
        any property is an amount which bears the same ratio to the 
        additional tax imposed by this chapter for the taxable year 
        solely by reason of subsection (a) as the gain taken into 
        account under subsection (a) with respect to such property 
        bears to the total gain taken into account under subsection (a) 
        with respect to all property to which subsection (a) applies.
            ``(3) Termination of postponement.--No tax may be postponed 
        under this subsection later than the due date for the return of 
        tax imposed by this chapter for the taxable year which includes 
        the date of death of the expatriate (or, if earlier, the time 
        that the security provided with respect to the property fails 
        to meet the requirements of paragraph (4), unless the taxpayer 
        corrects such failure within the time specified by the 
        Secretary).
            ``(4) Security.--
                    ``(A) In general.--No election may be made under 
                paragraph (1) with respect to any property unless 
                adequate security is provided to the Secretary with 
                respect to such property.
                    ``(B) Adequate security.--For purposes of 
                subparagraph (A), security with respect to any property 
                shall be treated as adequate security if--
                            ``(i) it is a bond in an amount equal to 
                        the deferred tax amount under paragraph (2) for 
                        the property, or
                            ``(ii) the taxpayer otherwise establishes 
                        to the satisfaction of the Secretary that the 
                        security is adequate.
            ``(5) Waiver of certain rights.--No election may be made 
        under paragraph (1) unless the taxpayer consents to the waiver 
        of any right under any treaty of the United States which would 
        preclude assessment or collection of any tax imposed by reason 
        of this section.
            ``(6) Elections.--An election under paragraph (1) shall 
        only apply to property described in the election and, once 
        made, is irrevocable. An election may be made under paragraph 
        (1) with respect to an interest in a trust with respect to 
        which gain is required to be recognized under subsection 
        (f)(1).
            ``(7) Interest.--For purposes of section 6601--
                    ``(A) the last date for the payment of tax shall be 
                determined without regard to the election under this 
                subsection, and
                    ``(B) section 6621(a)(2) shall be applied by 
                substituting `5 percentage points' for `3 percentage 
                points' in subparagraph (B) thereof.
    ``(c) Covered Expatriate.--For purposes of this section--
            ``(1) In general.--Except as provided in paragraph (2), the 
        term `covered expatriate' means an expatriate.
            ``(2) Exceptions.--An individual shall not be treated as a 
        covered expatriate if--
                    ``(A) the individual--
                            ``(i) became at birth a citizen of the 
                        United States and a citizen of another country 
                        and, as of the expatriation date, continues to 
                        be a citizen of, and is taxed as a resident of, 
                        such other country, and
                            ``(ii) has not been a resident of the 
                        United States (as defined in section 
                        7701(b)(1)(A)(ii)) during the 5 taxable years 
                        ending with the taxable year during which the 
                        expatriation date occurs, or
                    ``(B)(i) the individual's relinquishment of United 
                States citizenship occurs before such individual 
                attains age 18\1/2\, and
                    ``(ii) the individual has been a resident of the 
                United States (as so defined) for not more than 5 
                taxable years before the date of relinquishment.
    ``(d) Exempt Property; Special Rules for Pension Plans.--
            ``(1) Exempt property.--This section shall not apply to the 
        following:
                    ``(A) United states real property interests.--Any 
                United States real property interest (as defined in 
                section 897(c)(1)), other than stock of a United States 
                real property holding corporation which does not, on 
                the day before the expatriation date, meet the 
                requirements of section 897(c)(2).
                    ``(B) Specified property.--Any property or interest 
                in property not described in subparagraph (A) which the 
                Secretary specifies in regulations.
            ``(2) Special rules for certain retirement plans.--
                    ``(A) In general.--If a covered expatriate holds on 
                the day before the expatriation date any interest in a 
                retirement plan to which this paragraph applies--
                            ``(i) such interest shall not be treated as 
                        sold for purposes of subsection (a)(1), but
                            ``(ii) an amount equal to the present value 
                        of the expatriate's nonforfeitable accrued 
                        benefit shall be treated as having been 
                        received by such individual on such date as a 
                        distribution under the plan.
                    ``(B) Treatment of subsequent distributions.--In 
                the case of any distribution on or after the 
                expatriation date to or on behalf of the covered 
                expatriate from a plan from which the expatriate was 
                treated as receiving a distribution under subparagraph 
                (A), the amount otherwise includible in gross income by 
                reason of the subsequent distribution shall be reduced 
                by the excess of the amount includible in gross income 
                under subparagraph (A) over any portion of such amount 
                to which this subparagraph previously applied.
                    ``(C) Treatment of subsequent distributions by 
                plan.--For purposes of this title, a retirement plan to 
                which this paragraph applies, and any person acting on 
                the plan's behalf, shall treat any subsequent 
                distribution described in subparagraph (B) in the same 
                manner as such distribution would be treated without 
                regard to this paragraph.
                    ``(D) Applicable plans.--This paragraph shall apply 
                to--
                            ``(i) any qualified retirement plan (as 
                        defined in section 4974(c)),
                            ``(ii) an eligible deferred compensation 
                        plan (as defined in section 457(b)) of an 
                        eligible employer described in section 
                        457(e)(1)(A), and
                            ``(iii) to the extent provided in 
                        regulations, any foreign pension plan or 
                        similar retirement arrangements or programs.
    ``(e) Definitions.--For purposes of this section--
            ``(1) Expatriate.--The term `expatriate' means--
                    ``(A) any United States citizen who relinquishes 
                citizenship, and
                    ``(B) any long-term resident of the United States 
                who--
                            ``(i) ceases to be a lawful permanent 
                        resident of the United States (within the 
                        meaning of section 7701(b)(6)), or
                            ``(ii) commences to be treated as a 
                        resident of a foreign country under the 
                        provisions of a tax treaty between the United 
                        States and the foreign country and who does not 
                        waive the benefits of such treaty applicable to 
                        residents of the foreign country.
            ``(2) Expatriation date.--The term `expatriation date' 
        means--
                    ``(A) the date an individual relinquishes United 
                States citizenship, or
                    ``(B) in the case of a long-term resident of the 
                United States, the date of the event described in 
                clause (i) or (ii) of paragraph (1)(B).
            ``(3) Relinquishment of citizenship.--A citizen shall be 
        treated as relinquishing United States citizenship on the 
        earliest of--
                    ``(A) the date the individual renounces such 
                individual's United States nationality before a 
                diplomatic or consular officer of the United States 
                pursuant to paragraph (5) of section 349(a) of the 
                Immigration and Nationality Act (8 U.S.C. 1481(a)(5)),
                    ``(B) the date the individual furnishes to the 
                United States Department of State a signed statement of 
                voluntary relinquishment of United States nationality 
                confirming the performance of an act of expatriation 
                specified in paragraph (1), (2), (3), or (4) of section 
                349(a) of the Immigration and Nationality Act (8 U.S.C. 
                1481(a)(1)-(4)),
                    ``(C) the date the United States Department of 
                State issues to the individual a certificate of loss of 
                nationality, or
                    ``(D) the date a court of the United States cancels 
                a naturalized citizen's certificate of naturalization.
        Subparagraph (A) or (B) shall not apply to any individual 
        unless the renunciation or voluntary relinquishment is 
        subsequently approved by the issuance to the individual of a 
        certificate of loss of nationality by the United States 
        Department of State.
            ``(4) Long-term resident.--The term `long-term resident' 
        has the meaning given to such term by section 877(e)(2).
    ``(f) Special Rules Applicable to Beneficiaries' Interests in 
Trust.--
            ``(1) In general.--Except as provided in paragraph (2), if 
        an individual is determined under paragraph (3) to hold an 
        interest in a trust on the day before the expatriation date--
                    ``(A) the individual shall not be treated as having 
                sold such interest,
                    ``(B) such interest shall be treated as a separate 
                share in the trust, and
                    ``(C)(i) such separate share shall be treated as a 
                separate trust consisting of the assets allocable to 
                such share,
                    ``(ii) the separate trust shall be treated as 
                having sold its assets on the day before the 
                expatriation date for their fair market value and as 
                having distributed all of its assets to the individual 
                as of such time, and
                    ``(iii) the individual shall be treated as having 
                recontributed the assets to the separate trust.
        Subsection (a)(2) shall apply to any income, gain, or loss of 
        the individual arising from a distribution described in 
        subparagraph (C)(ii). In determining the amount of such 
        distribution, proper adjustments shall be made for liabilities 
        of the trust allocable to an individual's share in the trust.
            ``(2) Special rules for interests in qualified trusts.--
                    ``(A) In general.--If the trust interest described 
                in paragraph (1) is an interest in a qualified trust--
                            ``(i) paragraph (1) and subsection (a) 
                        shall not apply, and
                            ``(ii) in addition to any other tax imposed 
                        by this title, there is hereby imposed on each 
                        distribution with respect to such interest a 
                        tax in the amount determined under subparagraph 
                        (B).
                    ``(B) Amount of tax.--The amount of tax under 
                subparagraph (A)(ii) shall be equal to the lesser of--
                            ``(i) the highest rate of tax imposed by 
                        section 1(e) for the taxable year which 
                        includes the day before the expatriation date, 
                        multiplied by the amount of the distribution, 
                        or
                            ``(ii) the balance in the deferred tax 
                        account immediately before the distribution 
                        determined without regard to any increases 
                        under subparagraph (C)(ii) after the 30th day 
                        preceding the distribution.
                    ``(C) Deferred tax account.--For purposes of 
                subparagraph (B)(ii)--
                            ``(i) Opening balance.--The opening balance 
                        in a deferred tax account with respect to any 
                        trust interest is an amount equal to the tax 
                        which would have been imposed on the allocable 
                        expatriation gain with respect to the trust 
                        interest if such gain had been included in 
                        gross income under subsection (a).
                            ``(ii) Increase for interest.--The balance 
                        in the deferred tax account shall be increased 
                        by the amount of interest determined (on the 
                        balance in the account at the time the interest 
                        accrues), for periods after the 90th day after 
                        the expatriation date, by using the rates and 
                        method applicable under section 6621 for 
                        underpayments of tax for such periods, except 
                        that section 6621(a)(2) shall be applied by 
                        substituting `5 percentage points' for `3 
                        percentage points' in subparagraph (B) thereof.
                            ``(iii) Decrease for taxes previously 
                        paid.--The balance in the tax deferred account 
                        shall be reduced--
                                    ``(I) by the amount of taxes 
                                imposed by subparagraph (A) on any 
                                distribution to the person holding the 
                                trust interest, and
                                    ``(II) in the case of a person 
                                holding a nonvested interest, to the 
                                extent provided in regulations, by the 
                                amount of taxes imposed by subparagraph 
                                (A) on distributions from the trust 
                                with respect to nonvested interests not 
                                held by such person.
                    ``(D) Allocable expatriation gain.--For purposes of 
                this paragraph, the allocable expatriation gain with 
                respect to any beneficiary's interest in a trust is the 
                amount of gain which would be allocable to such 
                beneficiary's vested and nonvested interests in the 
                trust if the beneficiary held directly all assets 
                allocable to such interests.
                    ``(E) Tax deducted and withheld.--
                            ``(i) In general.--The tax imposed by 
                        subparagraph (A)(ii) shall be deducted and 
                        withheld by the trustees from the distribution 
                        to which it relates.
                            ``(ii) Exception where failure to waive 
                        treaty rights.--If an amount may not be 
                        deducted and withheld under clause (i) by 
                        reason of the distributee failing to waive any 
                        treaty right with respect to such 
                        distribution--
                                    ``(I) the tax imposed by 
                                subparagraph (A)(ii) shall be imposed 
                                on the trust and each trustee shall be 
                                personally liable for the amount of 
                                such tax, and
                                    ``(II) any other beneficiary of the 
                                trust shall be entitled to recover from 
                                the distributee the amount of such tax 
                                imposed on the other beneficiary.
                    ``(F) Disposition.--If a trust ceases to be a 
                qualified trust at any time, a covered expatriate 
                disposes of an interest in a qualified trust, or a 
                covered expatriate holding an interest in a qualified 
                trust dies, then, in lieu of the tax imposed by 
                subparagraph (A)(ii), there is hereby imposed a tax 
                equal to the lesser of--
                            ``(i) the tax determined under paragraph 
                        (1) as if the day before the expatriation date 
                        were the date of such cessation, disposition, 
                        or death, whichever is applicable, or
                            ``(ii) the balance in the tax deferred 
                        account immediately before such date.
                Such tax shall be imposed on the trust and each trustee 
                shall be personally liable for the amount of such tax 
                and any other beneficiary of the trust shall be 
                entitled to recover from the covered expatriate or the 
                estate the amount of such tax imposed on the other 
                beneficiary.
                    ``(G) Definitions and special rules.--For purposes 
                of this paragraph--
                            ``(i) Qualified trust.--The term `qualified 
                        trust' means a trust which is described in 
                        section 7701(a)(30)(E).
                            ``(ii) Vested interest.--The term `vested 
                        interest' means any interest which, as of the 
                        day before the expatriation date, is vested in 
                        the beneficiary.
                            ``(iii) Nonvested interest.--The term 
                        `nonvested interest' means, with respect to any 
                        beneficiary, any interest in a trust which is 
                        not a vested interest. Such interest shall be 
                        determined by assuming the maximum exercise of 
                        discretion in favor of the beneficiary and the 
                        occurrence of all contingencies in favor of the 
                        beneficiary.
                            ``(iv) Adjustments.--The Secretary may 
                        provide for such adjustments to the bases of 
                        assets in a trust or a deferred tax account, 
                        and the timing of such adjustments, in order to 
                        ensure that gain is taxed only once.
                            ``(v) Coordination with retirement plan 
                        rules.--This subsection shall not apply to an 
                        interest in a trust which is part of a 
                        retirement plan to which subsection (d)(2) 
                        applies.
            ``(3) Determination of beneficiaries' interest in trust.--
                    ``(A) Determinations under paragraph (1).--For 
                purposes of paragraph (1), a beneficiary's interest in 
                a trust shall be based upon all relevant facts and 
                circumstances, including the terms of the trust 
                instrument and any letter of wishes or similar 
                document, historical patterns of trust distributions, 
                and the existence of and functions performed by a trust 
                protector or any similar adviser.
                    ``(B) Other determinations.--For purposes of this 
                section--
                            ``(i) Constructive ownership.--If a 
                        beneficiary of a trust is a corporation, 
                        partnership, trust, or estate, the 
                        shareholders, partners, or beneficiaries shall 
                        be deemed to be the trust beneficiaries for 
                        purposes of this section.
                            ``(ii) Taxpayer return position.--A 
                        taxpayer shall clearly indicate on its income 
                        tax return--
                                    ``(I) the methodology used to 
                                determine that taxpayer's trust 
                                interest under this section, and
                                    ``(II) if the taxpayer knows (or 
                                has reason to know) that any other 
                                beneficiary of such trust is using a 
                                different methodology to determine such 
                                beneficiary's trust interest under this 
                                section.
    ``(g) Termination of Deferrals, etc.--In the case of any covered 
expatriate, notwithstanding any other provision of this title--
            ``(1) any period during which recognition of income or gain 
        is deferred shall terminate on the day before the expatriation 
        date, and
            ``(2) any extension of time for payment of tax shall cease 
        to apply on the day before the expatriation date and the unpaid 
        portion of such tax shall be due and payable at the time and in 
        the manner prescribed by the Secretary.
    ``(h) Imposition of Tentative Tax.--
            ``(1) In general.--If an individual is required to include 
        any amount in gross income under subsection (a) for any taxable 
        year, there is hereby imposed, immediately before the 
        expatriation date, a tax in an amount equal to the amount of 
        tax which would be imposed if the taxable year were a short 
        taxable year ending on the expatriation date.
            ``(2) Due date.--The due date for any tax imposed by 
        paragraph (1) shall be the 90th day after the expatriation 
        date.
            ``(3) Treatment of tax.--Any tax paid under paragraph (1) 
        shall be treated as a payment of the tax imposed by this 
        chapter for the taxable year to which subsection (a) applies.
            ``(4) Deferral of tax.--The provisions of subsection (b) 
        shall apply to the tax imposed by this subsection to the extent 
        attributable to gain includible in gross income by reason of 
        this section.
    ``(i) Special Liens for Deferred Tax Amounts.--
            ``(1) Imposition of lien.--
                    ``(A) In general.--If a covered expatriate makes an 
                election under subsection (a)(4) or (b) which results 
                in the deferral of any tax imposed by reason of 
                subsection (a), the deferred amount (including any 
                interest, additional amount, addition to tax, 
                assessable penalty, and costs attributable to the 
                deferred amount) shall be a lien in favor of the United 
                States on all property of the expatriate located in the 
                United States (without regard to whether this section 
                applies to the property).
                    ``(B) Deferred amount.--For purposes of this 
                subsection, the deferred amount is the amount of the 
                increase in the covered expatriate's income tax which, 
                but for the election under subsection (a)(4) or (b), 
                would have occurred by reason of this section for the 
                taxable year including the expatriation date.
            ``(2) Period of lien.--The lien imposed by this subsection 
        shall arise on the expatriation date and continue until--
                    ``(A) the liability for tax by reason of this 
                section is satisfied or has become unenforceable by 
                reason of lapse of time, or
                    ``(B) it is established to the satisfaction of the 
                Secretary that no further tax liability may arise by 
                reason of this section.
            ``(3) Certain rules apply.--The rules set forth in 
        paragraphs (1), (3), and (4) of section 6324A(d) shall apply 
        with respect to the lien imposed by this subsection as if it 
        were a lien imposed by section 6324A.
    ``(j) Regulations.--The Secretary shall prescribe such regulations 
as may be necessary or appropriate to carry out the purposes of this 
section.''.
    (b) Inclusion in Income of Gifts and Bequests Received by United 
States Citizens and Residents From Expatriates.--Section 102 (relating 
to gifts, etc. not included in gross income) is amended by adding at 
the end the following new subsection:
    ``(d) Gifts and Inheritances From Covered Expatriates.--
            ``(1) In general.--Subsection (a) shall not exclude from 
        gross income the value of any property acquired by gift, 
        bequest, devise, or inheritance from a covered expatriate after 
        the expatriation date. For purposes of this subsection, any 
        term used in this subsection which is also used in section 877A 
        shall have the same meaning as when used in section 877A.
            ``(2) Exceptions for transfers otherwise subject to estate 
        or gift tax.--Paragraph (1) shall not apply to any property if 
        either--
                    ``(A) the gift, bequest, devise, or inheritance 
                is--
                            ``(i) shown on a timely filed return of tax 
                        imposed by chapter 12 as a taxable gift by the 
                        covered expatriate, or
                            ``(ii) included in the gross estate of the 
                        covered expatriate for purposes of chapter 11 
                        and shown on a timely filed return of tax 
                        imposed by chapter 11 of the estate of the 
                        covered expatriate, or
                    ``(B) no such return was timely filed but no such 
                return would have been required to be filed even if the 
                covered expatriate were a citizen or long-term resident 
                of the United States.''.
    (c) Definition of Termination of United States Citizenship.--
Section 7701(a) is amended by adding at the end the following new 
paragraph:
            ``(49) Termination of united states citizenship.--
                    ``(A) In general.--An individual shall not cease to 
                be treated as a United States citizen before the date 
                on which the individual's citizenship is treated as 
                relinquished under section 877A(e)(3).
                    ``(B) Dual citizens.--Under regulations prescribed 
                by the Secretary, subparagraph (A) shall not apply to 
                an individual who became at birth a citizen of the 
                United States and a citizen of another country.''.
    (d) Ineligibility for Visa or Admission to United States.--
            (1) In general.--Section 212(a)(10)(E) of the Immigration 
        and Nationality Act (8 U.S.C. 1182(a)(10)(E)) is amended to 
        read as follows:
                    ``(E) Former citizens not in compliance with 
                expatriation revenue provisions.--Any alien who is a 
                former citizen of the United States who relinquishes 
                United States citizenship (within the meaning of 
                section 877A(e)(3) of the Internal Revenue Code of 
                1986) and who is not in compliance with section 877A of 
                such Code (relating to expatriation) is 
                inadmissible.''.
            (2) Availability of information.--
                    (A) In general.--Section 6103(l) (relating to 
                disclosure of returns and return information for 
                purposes other than tax administration) is amended by 
                adding at the end the following new paragraph:
            ``(21) Disclosure to deny visa or admission to certain 
        expatriates.--Upon written request of the Attorney General or 
        the Attorney General's delegate, the Secretary shall disclose 
        whether an individual is in compliance with section 877A (and 
        if not in compliance, any items of noncompliance) to officers 
        and employees of the Federal agency responsible for 
        administering section 212(a)(10)(E) of the Immigration and 
        Nationality Act solely for the purpose of, and to the extent 
        necessary in, administering such section 212(a)(10)(E).''.
                    (B) Safeguards.--Section 6103(p)(4) (relating to 
                safeguards) is amended by striking ``or (20)'' each 
                place it appears and inserting ``(20), or (21)''.
            (3) Effective dates.--The amendments made by this 
        subsection shall apply to individuals who relinquish United 
        States citizenship on or after the date of the enactment of 
        this Act.
    (e) Conforming Amendments.--
            (1) Section 877 is amended by adding at the end the 
        following new subsection:
    ``(h) Application.--This section shall not apply to an expatriate 
(as defined in section 877A(e)) whose expatriation date (as so defined) 
occurs on or after the date of the enactment of this subsection.''.
            (2) Section 2107 is amended by adding at the end the 
        following new subsection:
    ``(f) Application.--This section shall not apply to any expatriate 
subject to section 877A.''.
            (3) Section 2501(a)(3) is amended by adding at the end the 
        following new subparagraph:
                    ``(C) Application.--This paragraph shall not apply 
                to any expatriate subject to section 877A.''.
            (4) Section 6039G(a) is amended by inserting ``or 877A'' 
        after ``section 877(b)''.
            (5) The second sentence of section 6039G(d) is amended by 
        inserting ``or who relinquishes United States citizenship 
        (within the meaning of section 877A(e)(3))'' after ``section 
        877(a))''.
    (f) Clerical Amendment.--The table of sections for subpart A of 
part II of subchapter N of chapter 1 is amended by inserting after the 
item relating to section 877 the following new item:

``Sec. 877A. Tax responsibilities of expatriation.''.
    (g) Effective Date.--
            (1) In general.--Except as provided in this subsection, the 
        amendments made by this section shall apply to expatriates 
        (within the meaning of section 877A(e) of the Internal Revenue 
        Code of 1986, as added by this section) whose expatriation date 
        (as so defined) occurs on or after the date of the enactment of 
        this Act.
            (2) Gifts and bequests.--Section 102(d) of the Internal 
        Revenue Code of 1986 (as added by subsection (b)) shall apply 
        to gifts and bequests received on or after the date of the 
        enactment of this Act, from an individual or the estate of an 
        individual whose expatriation date (as so defined) occurs after 
        such date.
            (3) Due date for tentative tax.--The due date under section 
        877A(h)(2) of the Internal Revenue Code of 1986, as added by 
        this section, shall in no event occur before the 90th day after 
        the date of the enactment of this Act.

SEC. 214. MODIFICATION OF EFFECTIVE DATE OF LEASING PROVISIONS OF THE 
              AMERICAN JOBS CREATION ACT OF 2004.

    (a) Leases to Foreign Entities.--Section 849(b) of the American 
Jobs Creation Act of 2004 is amended by adding at the end the following 
new paragraph:
            ``(5) Leases to foreign entities.--In the case of tax-
        exempt use property leased to a tax-exempt entity which is a 
        foreign person or entity, the amendments made by this part 
        shall apply to taxable years beginning after December 31, 2006, 
        with respect to leases entered into on or before March 12, 
        2004.''.
    (b) Effective Date.--The amendment made by this section shall take 
effect as if included in the enactment of the American Jobs Creation 
Act of 2004.

SEC. 215. APPLICATION OF RULES TREATING INVERTED CORPORATIONS AS 
              DOMESTIC CORPORATIONS TO CERTAIN TRANSACTIONS OCCURRING 
              AFTER MARCH 20, 2002.

    (a) In General.--Section 7874(b) (relating to inverted corporations 
treated as domestic corporations) is amended to read as follows:
    ``(b) Inverted Corporations Treated as Domestic Corporations.--
            ``(1) In general.--Notwithstanding section 7701(a)(4), a 
        foreign corporation shall be treated for purposes of this title 
        as a domestic corporation if such corporation would be a 
        surrogate foreign corporation if subsection (a)(2) were applied 
        by substituting `80 percent' for `60 percent'.
            ``(2) Special rule for certain transactions occurring after 
        march 20, 2002.--
                    ``(A) In general.--If--
                            ``(i) paragraph (1) does not apply to a 
                        foreign corporation, but
                            ``(ii) paragraph (1) would apply to such 
                        corporation if, in addition to the substitution 
                        under paragraph (1), subsection (a)(2) were 
                        applied by substituting `March 20, 2002' for 
                        `March 4, 2003' each place it appears,
                then paragraph (1) shall apply to such corporation but 
                only with respect to taxable years of such corporation 
                beginning after December 31, 2006.
                    ``(B) Special rules.--Subject to such rules as the 
                Secretary may prescribe, in the case of a corporation 
                to which paragraph (1) applies by reason of this 
                paragraph--
                            ``(i) the corporation shall be treated, as 
                        of the close of its last taxable year beginning 
                        before January 1, 2007, as having transferred 
                        all of its assets, liabilities, and earnings 
                        and profits to a domestic corporation in a 
                        transaction with respect to which no tax is 
                        imposed under this title,
                            ``(ii) the bases of the assets transferred 
                        in the transaction to the domestic corporation 
                        shall be the same as the bases of the assets in 
                        the hands of the foreign corporation, subject 
                        to any adjustments under this title for built-
                        in losses,
                            ``(iii) the basis of the stock of any 
                        shareholder in the domestic corporation shall 
                        be the same as the basis of the stock of the 
                        shareholder in the foreign corporation for 
                        which it is treated as exchanged, and
                            ``(iv) the transfer of any earnings and 
                        profits by reason of clause (i) shall be 
                        disregarded in determining any deemed dividend 
                        or foreign tax creditable to the domestic 
                        corporation with respect to such transfer.
                    ``(C) Regulations.--The Secretary may prescribe 
                such regulations as may be necessary or appropriate to 
                carry out this paragraph, including regulations to 
                prevent the avoidance of the purposes of this 
                paragraph.''.
    (b) Effective Date.--The amendment made by this section shall apply 
to taxable years beginning after December 31, 2006.

                Subtitle C--Economic Substance Doctrine

SEC. 221. CLARIFICATION OF ECONOMIC SUBSTANCE DOCTRINE.

    (a) In General.--Section 7701 is amended by redesignating 
subsection (o) as subsection (p) and by inserting after subsection (n) 
the following new subsection:
    ``(o) Clarification of Economic Substance Doctrine; etc.--
            ``(1) General rules.--
                    ``(A) In general.--In any case in which a court 
                determines that the economic substance doctrine is 
                relevant for purposes of this title to a transaction 
                (or series of transactions), such transaction (or 
                series of transactions) shall have economic substance 
                only if the requirements of this paragraph are met.
                    ``(B) Definition of economic substance.--For 
                purposes of subparagraph (A)--
                            ``(i) In general.--A transaction has 
                        economic substance only if--
                                    ``(I) the transaction changes in a 
                                meaningful way (apart from Federal tax 
                                effects) the taxpayer's economic 
                                position, and
                                    ``(II) the taxpayer has a 
                                substantial nontax purpose for entering 
                                into such transaction and the 
                                transaction is a reasonable means of 
                                accomplishing such purpose.
                        In applying subclause (II), a purpose of 
                        achieving a financial accounting benefit shall 
                        not be taken into account in determining 
                        whether a transaction has a substantial nontax 
                        purpose if the origin of such financial 
                        accounting benefit is a reduction of income 
                        tax.
                            ``(ii) Special rule where taxpayer relies 
                        on profit potential.--A transaction shall not 
                        be treated as having economic substance by 
                        reason of having a potential for profit 
                        unless--
                                    ``(I) the present value of the 
                                reasonably expected pre-tax profit from 
                                the transaction is substantial in 
                                relation to the present value of the 
                                expected net tax benefits that would be 
                                allowed if the transaction were 
                                respected, and
                                    ``(II) the reasonably expected pre-
                                tax profit from the transaction exceeds 
                                a risk-free rate of return.
                    ``(C) Treatment of fees and foreign taxes.--Fees 
                and other transaction expenses and foreign taxes shall 
                be taken into account as expenses in determining pre-
                tax profit under subparagraph (B)(ii).
            ``(2) Special rules for transactions with tax-indifferent 
        parties.--
                    ``(A) Special rules for financing transactions.--
                The form of a transaction which is in substance the 
                borrowing of money or the acquisition of financial 
                capital directly or indirectly from a tax-indifferent 
                party shall not be respected if the present value of 
                the deductions to be claimed with respect to the 
                transaction is substantially in excess of the present 
                value of the anticipated economic returns of the person 
                lending the money or providing the financial capital. A 
                public offering shall be treated as a borrowing, or an 
                acquisition of financial capital, from a tax-
                indifferent party if it is reasonably expected that at 
                least 50 percent of the offering will be placed with 
                tax-indifferent parties.
                    ``(B) Artificial income shifting and basis 
                adjustments.--The form of a transaction with a tax-
                indifferent party shall not be respected if--
                            ``(i) it results in an allocation of income 
                        or gain to the tax-indifferent party in excess 
                        of such party's economic income or gain, or
                            ``(ii) it results in a basis adjustment or 
                        shifting of basis on account of overstating the 
                        income or gain of the tax-indifferent party.
            ``(3) Definitions and special rules.--For purposes of this 
        subsection--
                    ``(A) Economic substance doctrine.--The term 
                `economic substance doctrine' means the common law 
                doctrine under which tax benefits under subtitle A with 
                respect to a transaction are not allowable if the 
                transaction does not have economic substance or lacks a 
                business purpose.
                    ``(B) Tax-indifferent party.--The term `tax-
                indifferent party' means any person or entity not 
                subject to tax imposed by subtitle A. A person shall be 
                treated as a tax-indifferent party with respect to a 
                transaction if the items taken into account with 
                respect to the transaction have no substantial impact 
                on such person's liability under subtitle A.
                    ``(C) Exception for personal transactions of 
                individuals.--In the case of an individual, this 
                subsection shall apply only to transactions entered 
                into in connection with a trade or business or an 
                activity engaged in for the production of income.
                    ``(D) Treatment of lessors.--In applying paragraph 
                (1)(B)(ii) to the lessor of tangible property subject 
                to a lease--
                            ``(i) the expected net tax benefits with 
                        respect to the leased property shall not 
                        include the benefits of--
                                    ``(I) depreciation,
                                    ``(II) any tax credit, or
                                    ``(III) any other deduction as 
                                provided in guidance by the Secretary, 
                                and
                            ``(ii) subclause (II) of paragraph 
                        (1)(B)(ii) shall be disregarded in determining 
                        whether any of such benefits are allowable.
            ``(4) Other common law doctrines not affected.--Except as 
        specifically provided in this subsection, the provisions of 
        this subsection shall not be construed as altering or 
        supplanting any other rule of law, and the requirements of this 
        subsection shall be construed as being in addition to any such 
        other rule of law.
            ``(5) Regulations.--The Secretary shall prescribe such 
        regulations as may be necessary or appropriate to carry out the 
        purposes of this subsection. Such regulations may include 
        exemptions from the application of this subsection.''.
    (b) Effective Date.--The amendments made by this section shall 
apply to transactions entered into after the date of the enactment of 
this Act.

SEC. 222. PENALTY FOR UNDERSTATEMENTS ATTRIBUTABLE TO TRANSACTIONS 
              LACKING ECONOMIC SUBSTANCE, ETC.

    (a) In General.--Subchapter A of chapter 68 is amended by inserting 
after section 6662A the following new section:

``SEC. 6662B. PENALTY FOR UNDERSTATEMENTS ATTRIBUTABLE TO TRANSACTIONS 
              LACKING ECONOMIC SUBSTANCE, ETC.

    ``(a) Imposition of Penalty.--If a taxpayer has an noneconomic 
substance transaction understatement for any taxable year, there shall 
be added to the tax an amount equal to 40 percent of the amount of such 
understatement.
    ``(b) Reduction of Penalty for Disclosed Transactions.--Subsection 
(a) shall be applied by substituting `20 percent' for `40 percent' with 
respect to the portion of any noneconomic substance transaction 
understatement with respect to which the relevant facts affecting the 
tax treatment of the item are adequately disclosed in the return or a 
statement attached to the return.
    ``(c) Noneconomic Substance Transaction Understatement.--For 
purposes of this section--
            ``(1) In general.--The term `noneconomic substance 
        transaction understatement' means any amount which would be an 
        understatement under section 6662A(b)(1) if section 6662A were 
        applied by taking into account items attributable to 
        noneconomic substance transactions rather than items to which 
        section 6662A would apply without regard to this paragraph.
            ``(2) Noneconomic substance transaction.--The term 
        `noneconomic substance transaction' means any transaction if--
                    ``(A) there is a lack of economic substance (within 
                the meaning of section 7701(o)(1)) for the transaction 
                giving rise to the claimed benefit or the transaction 
                was not respected under section 7701(o)(2), or
                    ``(B) the transaction fails to meet the 
                requirements of any similar rule of law.
    ``(d) Rules Applicable to Compromise of Penalty.--
            ``(1) In general.--If the 1st letter of proposed deficiency 
        which allows the taxpayer an opportunity for administrative 
        review in the Internal Revenue Service Office of Appeals has 
        been sent with respect to a penalty to which this section 
        applies, only the Commissioner of Internal Revenue may 
        compromise all or any portion of such penalty.
            ``(2) Applicable rules.--The rules of paragraphs (2) and 
        (3) of section 6707A(d) shall apply for purposes of paragraph 
        (1).
    ``(e) Coordination With Other Penalties.--Except as otherwise 
provided in this part, the penalty imposed by this section shall be in 
addition to any other penalty imposed by this title.
    ``(f) Cross References.--

            ``(1) For coordination of penalty with 
            understatements under section 6662 and other 
            special rules, see section 6662A(e).
            ``(2) For reporting of penalty imposed under 
            this section to the Securities and Exchange 
            Commission, see section 6707A(e).''.
    (b) Coordination With Other Understatements and Penalties.--
            (1) The second sentence of section 6662(d)(2)(A) is amended 
        by inserting ``and without regard to items with respect to 
        which a penalty is imposed by section 6662B'' before the period 
        at the end.
            (2) Subsection (e) of section 6662A is amended--
                    (A) in paragraph (1), by inserting ``and 
                noneconomic substance transaction understatements'' 
                after ``reportable transaction understatements'' both 
                places it appears,
                    (B) in paragraph (2)(A), by inserting ``and a 
                noneconomic substance transaction understatement'' 
                after ``reportable transaction understatement'',
                    (C) in paragraph (2)(B), by inserting ``6662B or'' 
                before ``6663'',
                    (D) in paragraph (2)(C)(i), by inserting ``or 
                section 6662B'' before the period at the end,
                    (E) in paragraph (2)(C)(ii), by inserting ``and 
                section 6662B'' after ``This section'',
                    (F) in paragraph (3), by inserting ``or noneconomic 
                substance transaction understatement'' after 
                ``reportable transaction understatement'', and
                    (G) by adding at the end the following new 
                paragraph:
            ``(4) Noneconomic substance transaction understatement.--
        For purposes of this subsection, the term `noneconomic 
        substance transaction understatement' has the meaning given 
        such term by section 6662B(c).''.
            (3) Subsection (e) of section 6707A is amended--
                    (A) by striking ``or'' at the end of subparagraph 
                (B), and
                    (B) by striking subparagraph (C) and inserting the 
                following new subparagraphs:
                    ``(C) is required to pay a penalty under section 
                6662B with respect to any noneconomic substance 
                transaction, or
                    ``(D) is required to pay a penalty under section 
                6662(h) with respect to any transaction and would (but 
                for section 6662A(e)(2)(C)) have been subject to 
                penalty under section 6662A at a rate prescribed under 
                section 6662A(c) or under section 6662B,''.
    (c) Clerical Amendment.--The table of sections for part II of 
subchapter A of chapter 68 is amended by inserting after the item 
relating to section 6662A the following new item:

``Sec. 6662B. Penalty for understatements attributable to transactions 
                            lacking economic substance, etc.''.
    (d) Effective Date.--The amendments made by this section shall 
apply to transactions entered into after the date of the enactment of 
this Act.

SEC. 223. DENIAL OF DEDUCTION FOR INTEREST ON UNDERPAYMENTS 
              ATTRIBUTABLE TO NONECONOMIC SUBSTANCE TRANSACTIONS.

    (a) In General.--Section 163(m) (relating to interest on unpaid 
taxes attributable to nondisclosed reportable transactions) is 
amended--
            (1) by striking ``attributable'' and all that follows and 
        inserting the following: ``attributable to--
            ``(1) the portion of any reportable transaction 
        understatement (as defined in section 6662A(b)) with respect to 
        which the requirement of section 6664(d)(2)(A) is not met, or
            ``(2) any noneconomic substance transaction understatement 
        (as defined in section 6662B(c)).'', and
            (2) by inserting ``And Noneconomic Substance Transactions'' 
        in the heading thereof after ``Transactions''.
    (b) Effective Date.--The amendments made by this section shall 
apply to transactions after the date of the enactment of this Act in 
taxable years ending after such date.

                    Subtitle D--Penalties and Fines

SEC. 231. DENIAL OF DEDUCTION FOR CERTAIN FINES, PENALTIES, AND OTHER 
              AMOUNTS.

    (a) In General.--Subsection (f) of section 162 (relating to trade 
or business expenses) is amended to read as follows:
    ``(f) Fines, Penalties, and Other Amounts.--
            ``(1) In general.--Except as provided in paragraph (2), no 
        deduction otherwise allowable shall be allowed under this 
        chapter for any amount paid or incurred (whether by suit, 
        agreement, or otherwise) to, or at the direction of, a 
        government or entity described in paragraph (4) in relation to 
        the violation of any law or the investigation or inquiry by 
        such government or entity into the potential violation of any 
        law.
            ``(2) Exception for amounts constituting restitution or 
        paid to come into compliance with law.--Paragraph (1) shall not 
        apply to any amount which--
                    ``(A) the taxpayer establishes--
                            ``(i) constitutes restitution (including 
                        remediation of property) for damage or harm 
                        caused by or which may be caused by the 
                        violation of any law or the potential violation 
                        of any law, or
                            ``(ii) is paid to come into compliance with 
                        any law which was violated or involved in the 
                        investigation or inquiry, and
                    ``(B) is identified as restitution or as an amount 
                paid to come into compliance with the law, as the case 
                may be, in the court order or settlement agreement.
        Identification pursuant to subparagraph (B) alone shall not 
        satisfy the requirement under subparagraph (A). This paragraph 
        shall not apply to any amount paid or incurred as reimbursement 
        to the government or entity for the costs of any investigation 
        or litigation.
            ``(3) Exception for amounts paid or incurred as the result 
        of certain court orders.--Paragraph (1) shall not apply to any 
        amount paid or incurred by order of a court in a suit in which 
        no government or entity described in paragraph (4) is a party.
            ``(4) Certain nongovernmental regulatory entities.--An 
        entity is described in this paragraph if it is--
                    ``(A) a nongovernmental entity which exercises 
                self-regulatory powers (including imposing sanctions) 
                in connection with a qualified board or exchange (as 
                defined in section 1256(g)(7)), or
                    ``(B) to the extent provided in regulations, a 
                nongovernmental entity which exercises self-regulatory 
                powers (including imposing sanctions) as part of 
                performing an essential governmental function.
            ``(5) Exception for taxes due.--Paragraph (1) shall not 
        apply to any amount paid or incurred as taxes due.''.
    (b) Reporting of Deductible Amounts.--
            (1) In general.--Subpart B of part III of subchapter A of 
        chapter 61, as amended by this Act, is amended by adding at the 
        end the following new section:

``SEC. 6050V. INFORMATION WITH RESPECT TO CERTAIN FINES, PENALTIES, AND 
              OTHER AMOUNTS.

    ``(a) Requirement of Reporting.--
            ``(1) In general.--The appropriate official of any 
        government or entity which is described in section 162(f)(4) 
        which is involved in a suit or agreement described in paragraph 
        (2) shall make a return in such form as determined by the 
        Secretary setting forth--
                    ``(A) the amount required to be paid as a result of 
                the suit or agreement to which paragraph (1) of section 
                162(f) applies,
                    ``(B) any amount required to be paid as a result of 
                the suit or agreement which constitutes restitution or 
                remediation of property, and
                    ``(C) any amount required to be paid as a result of 
                the suit or agreement for the purpose of coming into 
                compliance with any law which was violated or involved 
                in the investigation or inquiry.
            ``(2) Suit or agreement described.--
                    ``(A) In general.--A suit or agreement is described 
                in this paragraph if--
                            ``(i) it is--
                                    ``(I) a suit with respect to a 
                                violation of any law over which the 
                                government or entity has authority and 
                                with respect to which there has been a 
                                court order, or
                                    ``(II) an agreement which is 
                                entered into with respect to a 
                                violation of any law over which the 
                                government or entity has authority, or 
                                with respect to an investigation or 
                                inquiry by the government or entity 
                                into the potential violation of any law 
                                over which such government or entity 
                                has authority, and
                            ``(ii) the aggregate amount involved in all 
                        court orders and agreements with respect to the 
                        violation, investigation, or inquiry is $600 or 
                        more.
                    ``(B) Adjustment of reporting threshold.--The 
                Secretary may adjust the $600 amount in subparagraph 
                (A)(ii) as necessary in order to ensure the efficient 
                administration of the internal revenue laws.
            ``(3) Time of filing.--The return required under this 
        subsection shall be filed not later than--
                    ``(A) 30 days after the date on which a court order 
                is issued with respect to the suit or the date the 
                agreement is entered into, as the case may be, or
                    ``(B) the date specified Secretary.
    ``(b) Statements to Be Furnished to Individuals Involved in the 
Settlement.--Every person required to make a return under subsection 
(a) shall furnish to each person who is a party to the suit or 
agreement a written statement showing--
            ``(1) the name of the government or entity, and
            ``(2) the information supplied to the Secretary under 
        subsection (a)(1).
The written statement required under the preceding sentence shall be 
furnished to the person at the same time the government or entity 
provides the Secretary with the information required under subsection 
(a).
    ``(c) Appropriate Official Defined.--For purposes of this section, 
the term `appropriate official' means the officer or employee having 
control of the suit, investigation, or inquiry or the person 
appropriately designated for purposes of this section.''.
            (2) Conforming amendment.--The table of sections for 
        subpart B of part III of subchapter A of chapter 61, as amended 
        by this Act, is amended by adding at the end the following new 
        item:

``Sec. 6050V. Information with respect to certain fines, penalties, and 
                            other amounts.''.
    (c) Effective Date.--The amendments made by this section shall 
apply to amounts paid or incurred on or after the date of the enactment 
of this Act, except that such amendments shall not apply to amounts 
paid or incurred under any binding order or agreement entered into 
before such date. Such exception shall not apply to an order or 
agreement requiring court approval unless the approval was obtained 
before such date.

SEC. 232. DENIAL OF DEDUCTION FOR PUNITIVE DAMAGES.

    (a) Disallowance of Deduction.--
            (1) In general.--Section 162(g) (relating to treble damage 
        payments under the antitrust laws) is amended--
                    (A) by redesignating paragraphs (1) and (2) as 
                subparagraphs (A) and (B), respectively,
                    (B) by striking ``If'' and inserting:
            ``(1) Treble damages.--If'', and
                    (C) by adding at the end the following new 
                paragraph:
            ``(2) Punitive damages.--No deduction shall be allowed 
        under this chapter for any amount paid or incurred for punitive 
        damages in connection with any judgment in, or settlement of, 
        any action. This paragraph shall not apply to punitive damages 
        described in section 104(c).''.
            (2) Conforming amendment.--The heading for section 162(g) 
        is amended by inserting ``Or Punitive Damages'' after ``Laws''.
    (b) Inclusion in Income of Punitive Damages Paid by Insurer or 
Otherwise.--
            (1) In general.--Part II of subchapter B of chapter 1 
        (relating to items specifically included in gross income) is 
        amended by adding at the end the following new section:

``SEC. 91. PUNITIVE DAMAGES COMPENSATED BY INSURANCE OR OTHERWISE.

    ``Gross income shall include any amount paid to or on behalf of a 
taxpayer as insurance or otherwise by reason of the taxpayer's 
liability (or agreement) to pay punitive damages.''.
            (2) Reporting requirements.--Section 6041 (relating to 
        information at source) is amended by adding at the end the 
        following new subsection:
    ``(f) Section to Apply to Punitive Damages Compensation.--This 
section shall apply to payments by a person to or on behalf of another 
person as insurance or otherwise by reason of the other person's 
liability (or agreement) to pay punitive damages.''.
            (3) Conforming amendment.--The table of sections for part 
        II of subchapter B of chapter 1 is amended by adding at the end 
        the following new item:

``Sec. 91. Punitive damages compensated by insurance or otherwise.''.
    (c) Effective Date.--The amendments made by this section shall 
apply to damages paid or incurred on or after the date of the enactment 
of this Act.

                       Subtitle E--Duty Surcharge

SEC. 241. TEMPORARY EMERGENCY DUTY SURCHARGE.

    (a) In General.--Notwithstanding any other provision of law, in 
addition to any other duty, there is hereby imposed a duty on the entry 
of any good during the 2-year period beginning on the day that is 15 
days after the date of the enactment of this Act.
    (b) Rate of Duty.--The rate of duty imposed by subsection (a) is 2 
percent ad valorem.
    (c) Entry.--For purposes of this section, the term ``entry'' means 
entry, or withdrawal from warehouse, for consumption in the customs 
territory of the United States.

                      Subtitle F--Other Provisions

SEC. 251. OFFSHORE OIL AND GAS LEASING IN 181 AREA OF GULF OF MEXICO.

    (a) Definitions.--In this section:
            (1) 181 area.--The term ``181 Area'' means the area 
        identified in map 15, page 58, of the Proposed Final Outer 
        Continental Shelf Oil and Gas Leasing Program for 1997-2002 of 
        the Minerals Management Service.
            (2) Secretary.--The term ``Secretary'' means the Secretary 
        of the Interior, acting through the Minerals Management 
        Service.
    (b) Lease Sale.--Except as otherwise provided in this section, the 
Secretary shall offer the 181 Area for oil and gas leasing pursuant to 
the Outer Continental Shelf Lands Act (43 U.S.C. 1331 et seq.) as soon 
as practicable, but not later than 1 year, after the date of enactment 
of this Act.
    (c) Leasing Program.--The 181 Area shall be offered for lease under 
this section notwithstanding the omission of the 181 Area from any 
outer Continental Shelf leasing program under section 18 of the Outer 
Continental Shelf Lands Act (43 U.S.C. 1344).

SEC. 252. TRANSFER OF SURPLUS FUNDS OF FEDERAL RESERVE BANKS TO 
              TREASURY.

    Section 7 of the Federal Reserve Act (12 U.S.C. 789 et seq.) is 
amended by adding at the end the following:
    ``(d) Additional Transfers for Fiscal Year 2008.--
            ``(1) In general.--The Federal reserve banks shall transfer 
        from the surplus funds of such banks to the Board for transfer 
        to the Secretary of the Treasury for deposit in the General 
        Fund of the Treasury, a total amount of $13,000,000,000 for 
        fiscal year 2008.
            ``(2) Allocation by fed.--Of the total amount required to 
        be paid by the Federal reserve banks under paragraph (1) for 
        fiscal year 2008, the Board shall determine the amount that 
        each such bank shall pay in such fiscal year.
            ``(3) Replenishment of surplus fund prohibited.--No Federal 
        reserve bank may replenish the surplus fund of such bank by the 
        amount of any transfer by such bank under paragraph (1) during 
        fiscal year 2008.''.

SEC. 253. PERMANENT EXTENSION OF FCC AUTHORITY TO AUCTION LICENSES TO 
              USE RADIO SPECTRUM.

    Section 309(j)(11) of the Communications Act of 1934 (47 U.S.C. 
309(j)(11)) is repealed.

SEC. 254. TRAVEL BETWEEN THE UNITED STATES AND CUBA.

    (a) Short Title.--This section may be cited as the ``Freedom to 
Travel to Cuba Act of 2007''.
    (b) Travel to Cuba.--
            (1) Freedom of travel for united states citizens and legal 
        residents.--Notwithstanding any other provision of law, subject 
        to subsection (c), the President shall not regulate or 
        prohibit, directly or indirectly, travel to or from Cuba by a 
        United States citizen or legal resident, or any of the 
        transactions incident to such travel that are set forth in 
        paragraph (2).
            (2) Transactions incident to travel.--The transactions 
        referred to in paragraph (1) are--
                    (A) any transactions ordinarily incident to travel 
                to or from Cuba, including the importation into Cuba or 
                the United States of accompanied baggage for personal 
                use only;
                    (B) any transactions ordinarily incident to travel 
                to or from Cuba, or maintenance within Cuba, including 
                the payment of living expenses and the acquisition of 
                goods or services for personal use;
                    (C) any transactions ordinarily incident to the 
                arrangement, promotion, or facilitation of travel to, 
                from, or within Cuba;
                    (D) any transactions incident to nonscheduled air, 
                sea, or land voyages, except that this paragraph does 
                not authorize the carriage of articles into Cuba or the 
                United States other than accompanied baggage; and
                    (E) normal banking transactions incident to the 
                activities described in the preceding provisions of 
                this subsection, including the issuance, clearing, 
                processing, or payment of checks, drafts, traveler's 
                checks, credit or debit card instruments, or similar 
                instruments.
    (c) Exceptions.--
            (1) Special circumstances.--The restrictions on authority 
        contained in subsection (b) do not apply in a case in which the 
        United States is at war with Cuba, armed hostilities between 
        the two countries are in progress, or there is imminent danger 
        to the public health or the physical safety of United States 
        citizens or legal residents traveling to or from Cuba.
            (2) Importation of goods for personal consumption.--
        Subsection (b) does not authorize the importation into the 
        United States of any goods for personal consumption acquired in 
        Cuba.
    (d) Applicability.--This section applies to actions taken by the 
President before the date of the enactment of this Act that are in 
effect on such date of enactment, and to actions taken on or after such 
date.
    (e) Inapplicability of Other Provisions.--This section applies 
notwithstanding section 102(h) of the Cuban Liberty and Democratic 
Solidarity (LIBERTAD) Act of 1996 (22 U.S.C. 6032(h)) and section 
910(b) of the Trade Sanctions Reform and Export Enhancement Act of 2000 
(22 U.S.C. 7209(b)).
                                 <all>