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.
Part II--Contract Matters
SUBPART A--COMPETITION IN CONTRACTING
Sec. 114. Prohibition on award of monopoly contracts.
Sec. 115. Competition in multiple award contracts.
SUBPART 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. 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.
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.
(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.
(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
`(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--
`(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).
(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
`(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).'.
(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-
(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.
(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.
`(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
`(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;
`(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--
`(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;
`(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
`(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.
