[Congressional Record Volume 151, Number 131 (Monday, October 17, 2005)]
[Senate]
[Pages S11423-S11439]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS
By Mrs. FEINSTEIN:
S. 1870. a bill to clarify the authorities for the use of certain
National Park Services properties within Golden Gate National
Recreation Area and San Francisco Maritime National Historical Park,
and for other purposes; to the Committee on Energy and Natural
Resources.
Mrs. FEINSTEIN. Mr. President, I rise today to introduce a bill which
will clarify certain National Park Service authorities for the Golden
Gate
[[Page S11424]]
National Recreation Area and San Francisco Maritime National Historic
Park.
I also want to thank Congresswoman Pelosi for introducing a similar
bill in the house. As a San Francisco native and a former mayor, I know
these parks are extremely popular tourist sites and I believe this bill
will allow the National Park Service to restore and renovate these
parks in order to maintain their status as top tourist destinations.
The Golden Gate National Recreation Area is one of the largest urban
national parks in the world--home to such renowned sites as the
Presidio of San Francisco and Alcatraz Island. Additionally, the San
Francisco Maritime National Historic Park, located at the west end of
San Francisco's Fisherman's Wharf, includes a fleet of landmark vessels
and a maritime museum.
Presently, the revenue collected by these parks must be spent in the
same fiscal year in which it is collected. Otherwise, any revenue that
is not spent is deposited in the National Treasury. This current policy
makes it difficult for these two parks to pursue long term, major
restoration projects. This bill makes the necessary changes to allow
these parks to undertake needed substantive restoration as opposed to
smaller, less significant projects allowed under the current revenue
system.
The bill also calls for a modest boundary adjustment between the two
adjacent parks in order to be consistent with the current
administration of San Francisco's Municipal Pier.
I am introducing this bill with the hope that it will allow these two
parks to retain the revenue necessary for maintenance in order to
continue to attract visitors from around the world to these historic
sites of California.
I ask unanimous consent that the text of the bill be printed in the
Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 1870
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. GOLDEN GATE NATIONAL RECREATION AREA.
Section 4(f) of Public Law 92-589 (16 U.S.C. 460bb-3) is
amended by striking ``Haslett Warehouse, Cliff House
Properties and Louis' Restaurant,'' and all that follows and
inserting ``Cliff House Properties and Louis' Restaurant, the
Secretary may enter into a contract for the management
(including rental or lease) of the aforementioned properties
with such terms and conditions as will protect the
Government's interest. Any proceeds from the use of such
properties shall be available until expended, without further
appropriation, for the administration, maintenance, repair
and related expenses of the properties and for major
renovation and park rehabilitation of those buildings
included in the Fort Mason Foundation Agreement''.
SEC. 2. SAN FRANCISCO MARITIME NATIONAL HISTORICAL PARK.
Section 3 of Public Law 100-348 (16 U.S.C. 410nn-1) is
amended--
(1) by amending the text of subsection (c) to read as
follows: ``Notwithstanding any other provision of law, in the
administration of any real or personal property (including
vessels and heavy marine equipment such as floating drydocks)
that is administered as part of the park, the Secretary may
enter into a contract for the management (including rental or
lease) of such property with such terms and conditions as
will protect the Government's interest. Any proceeds from the
use of such property shall be available until expended,
without further appropriation, for the administration,
maintenance, repair, and related expenses of the property.'';
and
(2) in the second sentence of subsection (d) by striking
``shall be credited'' and all that follows and by inserting
``shall be available until expended, without further
appropriation, for use at the park for purposes of facility
maintenance and repair, interpretation, signage, habitat or
facility enhancement, resource preservation, annual
operations (including fee collection), and law
enforcement.''.
SEC. 3. CONFORMING AMENDMENTS.
(a) Section 2(b) of Public Law 100-348 (16 U.S.C. 410nn) is
amended--
(1) by striking ``numbered 641/80,053 and dated April 7,
1987'' and inserting ``numbered 350/80,012 and dated June
2004''; and
(2) by striking the third and fourth sentences and
inserting the following: ``The Secretary of the Interior''
(hereinafter in this Act referred to as the ``Secretary'')
may make minor revisions to the boundary of the park in
accordance with section 7(c) of the Land and Water
Conservation Act of 1965 (16 U.S.C. 460l-9(c)).
(b) Section 4(e) of Public Law 92-589 (16 U.S.C. 460bb-3)
is amended by striking ``and for admission to the sailing
vessel Balclutha and other historic vessels of the National
Maritime Museum''.
______
By Mr. BURR (for himself, Mr. Enzi, Mr. Gregg, Mr. Frist, and Mr.
Alexander):
S. 1873. A bill to prepare and strengthen the biodefenses of the
United States against deliberate, accidental, and natural outbreaks of
illness, and for other purposes; to the Committee on Health, Education,
Labor, and Pensions.
Mr. BURR. Mr. President, I ask unanimous consent that the text of the
bill be printed in the Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 1873
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Biodefense and Pandemic
Vaccine and Drug Development Act of 2005''.
SEC. 2. TABLE OF CONTENTS.
The table of contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Biomedical Advanced Research and Development Agency.
Sec. 4. Clarification of countermeasures covered by Project BioShield.
Sec. 5. Orphan drug market exclusivity for countermeasure products.
Sec. 6. Liability protections for pandemics, epidemics, and
countermeasures.
Sec. 7. Compensation.
Sec. 8. Rebates and grants for research development, and manufacturing
of vaccines, qualified countermeasures and pandemic or
epidemic products.
Sec. 9. Technical assistance.
Sec. 10. Animal models for certain diseases.
Sec. 11. Animal Model/Research Tool Scientific Advisory Committee.
Sec. 12. Collaboration and coordination.
Sec. 13. Procurement.
Sec. 14. National Pathology Center.
SEC. 3. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AGENCY.
Title III of the Public Health Service Act (42 U.S.C. 241
et seq.) is amended by inserting after section 319K the
following:
``SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT
AGENCY.
``(a) Definitions.--In this section:
``(1) BARDA.--The term `BARDA' means the Biomedical
Advanced Research and Development Agency.
``(2) Fund.--The term `Fund' means the Biodefense Medical
Countermeasure Development Fund established under subsection
(d).
``(3) Other transactions.--The term `other transactions'
means transactions, other than procurement contracts, grants,
and cooperative agreements, including transactions for
prototypes, as provided to the Secretary of Defense under
section 2371 of title 10, United States Code.
``(4) Qualified countermeasure.--The term `qualified
countermeasure' has the meaning given such term in section
319F-1.
``(5) Qualified countermeasure and qualified pandemic or
epidemic product advanced research and development.--
``(A) In general.--The term `qualified countermeasure and
qualified pandemic or epidemic product advanced research and
development' means any applied research, testing, or
evaluation (including those conducted on humans or animals),
related to the safety or effectiveness, that is required for
approval, clearance, or licensing by the Secretary under this
Act or the Federal Food, Drug, and Cosmetic Act, of such
countermeasure or pandemic or epidemic product to diagnose,
mitigate, prevent, or treat harm from a deliberate,
accidental, or natural exposure to a chemical, biological,
radiological, or nuclear agent, particularly such exposure
resulting from an act of terrorism or potential pandemic
infectious disease.
``(B) Inclusion.--The term under subparagraph (A) includes
any investigation to improve the manufacturing, formulation,
finish, fill, delivery, or shelf-life of such qualified
countermeasures or qualified pandemic or epidemic products.
``(6) Qualified pandemic or epidemic product.--The term
`qualified pandemic or epidemic product' has the meaning
given the term in section 319F-3(c)(5).
``(7) Security countermeasure.--The term `security
countermeasure' has the meaning given such term in section
319F-2.
``(8) Person.--The term `person' includes an individual,
partnership, corporation, association, entity, or public or
private corporation, including a Federal, State, or local
agency or department.
``(b) Biomedical Advanced Research and Development
Agency.--
``(1) Establishment.--There is established within the
Department of Health and Human Services, the Biomedical
Advanced Research and Development Agency.
``(2) Purpose.--It shall be the purpose of the BARDA to
coordinate and oversee activities that support and accelerate
qualified countermeasure or qualified pandemic or epidemic
product (referred to in this section
[[Page S11425]]
as `countermeasure or product') advanced research and
development by--
``(A) directing and coordinating collaboration among the
Department of Health and Human Services, other Federal
agencies, relevant industries, academia, and other persons,
with respect to such advanced research and development;
``(B) supporting countermeasure and product advanced
research and development;
``(C) recommending approaches to modernize and streamline
the countermeasure or product development process and reduce
regulatory burdens with respect to procurement of security
countermeasures and qualified pandemic or epidemic products;
and
``(D) supporting innovation to reduce the time and cost of
countermeasure and product advanced research and development.
``(3) Director.--The BARDA shall be headed by a Director
(referred to in this section as the `Director') who shall--
``(A) be appointed by the President, with the advice and
consent of the Senate;
``(B) report to the Secretary; and
``(C) serve as the principal advisor to the Secretary on
countermeasure and product advanced research and development.
``(4) Duties of Director.--
``(A) Collaboration.--To carry out the purpose described in
paragraph (2)(A), the Secretary, acting through the Director,
shall--
``(i) increase appropriate communication between the
Federal Government and relevant industries, academia, and
other interested persons with respect to countermeasure and
product advanced research and development by establishing
transparent, expeditious, and direct processes to--
``(I) facilitate regular, ongoing communication regarding
the processes established under subparagraph (C)(ii) and new
countermeasures or products of interest;
``(II) solicit research and associated data on potential
countermeasures and products and related technologies; and
``(III) provide technical assistance with respect to such
processes and the Food and Drug Administration approval
process;
``(ii) at least annually--
``(I) convene meetings with representatives from relevant
industries, academia, other Federal agencies, international
agencies, and other interested persons; and
``(II) sponsor relevant biodefense countermeasure
technology demonstrations;
``(iii) carry out the activities described in subsection
(g) of section 2 of the Clayton Act; and
``(iv) encourage and coordinate countermeasure or product
advanced research and development, including by convening
working groups as identified in paragraph (5).
``(B) Support advanced research and development.--To carry
out the purpose described in paragraph (2)(B), the Secretary,
acting through the Director, shall--
``(i) conduct continuous searches and support calls for
potential countermeasures or products for drugs, biological
products, devices, or research tools to diagnose, mitigate,
prevent, or treat harm from existing, emerging, or possible
chemical, biological, radiological, and nuclear agents or
potential pandemic infectious diseases that threaten public
health and national security, as identified by the Assistant
Secretary for Public Health Emergency Preparedness;
``(ii) direct the countermeasure and product advanced
research and development activities of the Department of
Health and Human Services, in consultation with the Assistant
Secretary for Public Health Emergency Preparedness, the
Director of the National Institutes of Health, the Director
of the Centers for the Disease Control and Prevention, and
the Commissioner of Food and Drugs; and
``(iii) award contracts, grants, cooperative agreements,
and enter into other transactions, to include use of
simplified acquisition authorities provided under sections
319F-1 and 319F-2(c)(7)(C)(iii), to public and private
persons, including for-profit and nonprofit persons,
federally funded research and development centers, and
universities, to--
``(I) support the cost of countermeasure and product
advanced research and development; and
``(II) ensure accelerated development of countermeasures
and products.
``(C) Streamline processes.--To carry out the purpose
described in paragraph (2)(C), the Secretary, acting through
the Director, shall--
``(i) receive from the Assistant Secretary for Public
Health Emergency Preparedness, requirements for national
civilian biodefense needs, particularly countermeasures or
products and other technologies, to diagnose, mitigate,
prevent, or treat harm from existing, emerging, or potential
chemical, biological, radiological, or nuclear agents or
potential pandemic infectious diseases;
``(ii) establish transparent, expeditious, and direct
processes for selecting promising countermeasures and
products, supporting them through advanced research and
development and recommending them for procurement;
``(iii) establish an office within the BARDA, in
consultation with the Commissioner of Food and Drugs, to--
``(I) facilitate regular and ongoing communication between
the BARDA and the Food and Drug Administration regarding the
status of BARDA advanced research and development activities;
``(II) ensure that such activities are coordinated with the
approval requirements of the Food and Drug Administration,
with the goal of expediting the development and approval of
countermeasures and products; and
``(III) connect interested persons with additional
technical assistance made available under section 565 of the
Federal Food, Drug, and Cosmetic Act;
``(iv) coordinate with the Food and Drug Administration to
facilitate regulatory review and approval of promising
classes of countermeasures or products through the
development of research tools; and
``(v) recommend to the Secretary, through the Assistant
Secretary for Public Health Emergency Preparedness,
procurement of the most promising eligible security
countermeasures or qualified pandemic or epidemic products
identified in clause (i).
``(D) Supporting Innovation.--To carry out the purpose
described in paragraph (2)(D), the Secretary, acting through
the Director, shall award contracts, grants, cooperative
agreements, or enter into other transactions, to include use
of simplified acquisition authorities provided under sections
319F-1 and 319F-2(c)(7)(C)(iii), to the entities described in
subparagraph (B)(iii), to promote innovation in technologies
supporting the advanced research and development and
production of qualified or security countermeasures or
qualified pandemic or epidemic products, such as research
tools, manufacturing, countermeasure administration, storage,
and bioinformatics and other devices.
``(E) Other duties.--
``(i) In general.--The Director may--
``(I) prepare and submit to the President and Congress, an
annual budget estimate for qualified countermeasure and
pandemic or epidemic product advanced research and
development and other BARDA activities, after opportunity for
comment by the Secretary; and
``(II) receive from the President and the Office of
Management and Budget directly all funds appropriated by
Congress for obligation and expenditure by the BARDA.
``(ii) Secretary duties.--The Secretary, acting through the
Director, may--
``(I) enter into such contracts, leases, cooperative
agreements, or other transactions, as may be necessary to
carry out the functions of BARDA, without regard to section
3648 and 3709 of the Revised Statutes of the United States
(31 U.S.C. 3324(a) and (b), (41 U.S.C. 5), with any public
agency, any firm, association, corporation, or educational
institution, or any other person;
``(II) support advanced research and development and
innovation of potential countermeasures or products by highly
qualified foreign nationals outside the United States that
may inure to the benefit of the American people and
collaborative research involving American and foreign
participants;
``(III) administer grants using milestone-based awards and
payments; and
``(IV) establish 1 or more federally funded research and
development centers or university affiliated research centers
in accordance with section 253(c)(3) of title 41, United
States Code.
``(5) Vulnerable populations.--In carrying out the
activities under this section, the Director, in consultation
with the Vulnerable Populations Working Group, may give
priority to supporting and facilitating advanced research and
development of countermeasures or products, and formulations
of countermeasures or products, that are likely to be safe
and effective for pediatric populations, pregnant women, and
other vulnerable populations.
``(6) Working groups.--
``(A) Identification of technologies.--
``(i) In general.--The Director may establish and convene,
or enter into a contract with a public or private research
institution to convene, one or more working groups that
consists of experts on countermeasure technology to identify
innovative technologies that have the potential to be
developed as countermeasures or products.
``(ii) Meetings.--A working group established under clause
(i) shall participate in regular meetings with sponsors of
countermeasures, products, or related technologies to--
``(I) review the scientific evidence or concept of such
countermeasures, products, or related technologies;
``(II) provide guidance on research protocols or studies;
and
``(III) provide guidance on the regulatory approval process
for countermeasures, products, and related technologies.
``(iii) Recommendations.--Not later than 30 days after each
meeting with a sponsor of a countermeasure, product, or
related technology, the working group shall make
recommendations to the Director concerning such
countermeasure, product, or related technology.
``(iv) Confidentiality.--Any commercial confidential or
proprietary information that is disclosed to the working
group in a meeting under this section shall remain
confidential and shall not be disclosed other than to the
Secretary or the Director, or their designees.
``(v) Construction.--Nothing in this subparagraph shall be
construed to prohibit a sponsor from meeting with the
Director to discuss potential countermeasures, products, or
related technologies.
``(B) Public working group.--The Director may establish and
convene one or more working groups composed of private
citizens
[[Page S11426]]
and officials of Federal, State, and local governments to
advise such Director with respect to the functions of the
BARDA and the Director.
``(C) Vulnerable populations working group.--The Director
shall establish and convene a Vulnerable Populations Working
Group composed of experts on pediatric populations, pregnant
women, and other vulnerable populations to advise such
Director with respect to--
``(i) supporting and facilitating advanced research and
development of countermeasures, and formulations of
countermeasures, that are safe and effective for such
populations; and
``(ii) other activities of the BARDA that effect such
populations.
``(7) Personnel Authorities.--
``(A) Specially qualified scientific and professional
personnel.--In hiring personnel for the BARDA, the Director
shall have the hiring and management authorities described in
section 1101 of the Strom Thurmond National Defense
Authorization Act for Fiscal Year 1999 (5 U.S.C. 3104 note;
Public Law 105-261). With respect to the personnel of the
BARDA, the term of appointments for employees referred to
under subsection (c)(1) of that section may not exceed 5
years before the granting of any extension under subsection
(c)(2) of that section.
``(B) Special consultants.--The Director may accept special
consultants as personnel for the BARDA under section 207(f).
``(C) Intergovernmental personnel act.--The Director may
accept as personnel for the BARDA, employees under subchapter
VI of chapter 33 of subpart B of part III of title 5, United
States Code.
``(D) Other services.--The Director may accept voluntary
and uncompensated services.
``(c) National Biodefense Advisory Board.--
``(1) In general.--
``(A) Purpose.--The National Biodefense Advisory Board
shall provide expert advice and guidance to the Secretary on
the threats, challenges, and opportunities presented by
advances in biological and life sciences and the threat from
natural infectious diseases and chemical, biological,
radiological, and nuclear threats.
``(B) Membership.--There is established the National
Biodefense Advisory Board (hereinafter in this section
referred to as the `Board') to be composed of 23 members who
represent the Nation's preeminent scientific, public health,
and medical experts on the subject of biological, chemical,
nuclear, and radiological threats, whether naturally
occurring, accidental, or deliberate, as follows:
``(i) Ex officio.--The following members shall serve on the
Board ex officio:
``(I) The Assistant to the President for Homeland Security
and Counterterrorism.
``(II) The Director of the Office of Science and Technology
Policy.
``(III) The Assistant Secretary for Public Health Emergency
Preparedness.
``(IV) The Director of the National Institutes of Health.
``(V) The Director of the Centers for Disease Control and
Prevention.
``(VI) The Commissioner of Food and Drugs.
``(VII) The Director of BARDA.
``(VIII) The Assistant Secretary of Defense for Health
Affairs.
``(IX) The Assistant Secretary of Homeland Security for
Science and Technology.
``(X) The Secretary of Agriculture (or a designee).
``(ii) Appointed members.--The following individuals, as
appointed by the Secretary:
``(I) Four representatives of the pharmaceutical and
biotechnology industries.
``(II) Four representatives of academia.
``(III) Five other members as determined appropriate by the
Secretary.
``(C) Term of appointment.--A member of the Board described
in subparagraph (B)(ii) shall serve for a term of 3 years,
except that the Secretary may adjust the terms of the initial
Board appointees in order to provide for a staggered term of
appointment for all members.
``(D) Consecutive appointments; maximum terms.--A member
may be appointed to serve not more than 3 terms on the Board
and may serve not more than 2 consecutive terms.
``(2) Duties.--The Board shall--
``(A) advise the Secretary on major biodefense initiatives
and review ongoing and proposed biodefense programs, which
may include potential activities of the BARDA; and
``(B) in consultation with the Director of BARDA, and in
coordination with the Director of National Institute of
Allergy and Infectious Diseases, provide to the Secretary,
recommendations and findings for an expanded, intensified,
and coordinated biodefense research program encompassing the
programs of the BARDA and other Federal agencies and related
programs of the other research institutes.
``(3) Meetings.--The Board shall meet at the call of the
Secretary, but in no case less than twice annually to provide
to the Secretary updated assessments, findings, and
recommendations of the current trends, challenges, and
opportunities posed in biotechnology and genetic engineering.
``(4) Vacancies.--Any vacancy in the Board shall not affect
its powers, but shall be filled in the same manner as the
original appointment.
``(5) Chairperson.--The Secretary shall appoint a
chairperson from among the members of the Board.
``(6) Powers.--
``(A) Hearings.--The Board may hold such hearings, sit and
act at such times and places, take such testimony, and
receive such evidence as the Board considers advisable to
carry out this subsection.
``(B) Postal services.--The Board may use the United States
mails in the same manner and under the same conditions as
other departments and agencies of the Federal Government.
``(7) Personnel.--
``(A) Officers of the federal government.--A member of the
Board that is an employee of the Federal Government may not
receive additional pay, allowances, or benefits by reason of
the member's service on the Board.
``(B) Other members.--A member of the Board that is not an
employee of the Federal Government shall be compensated at a
rate equivalent to the daily equivalent of the annual rate of
basic pay prescribed for level IV of the Executive Schedule
under section 5315 of title 5, United States Code, for each
day (including travel time) during which the member is
engaged in the actual performance of duties as a member of
the Board.
``(C) Travel expenses.--Each member of the Board shall
receive travel expenses, including per diem in lieu of
subsistence, in accordance with applicable provisions under
subchapter I of chapter 57 of title 5, United States Code.
``(D) Detail of government employees.--Any Federal
Government employee may be detailed to the Board without
reimbursement, and such detail shall be without interruption
or loss of civil service status or privilege.
``(d) Fund.--
``(1) Establishment.--There is established the Biodefense
Medical Countermeasure Development Fund, which shall be
administered by the Director of the BARDA.
``(2) Funds.--
``(A) First fiscal year.--Of the amounts appropriated to
carry out the Project BioShield Act of 2004 (Public Law 108-
276) and not obligated, $1,000,000,000 shall be available to
the Fund to carry out this section for fiscal year 2006. Such
amounts shall remain available until expended.
``(B) Subsequent fiscal years.--There are authorized to be
appropriated such sums as may be necessary to carry out this
section for fiscal year 2007 and each subsequent fiscal year.
Such sums shall remain available until expended.
``(e) Effect of Section.--Nothing in this section shall be
construed to limit any authority of the Department of Health
and Human Services, including those authorities provided
under the Project BioShield Act of 2004 (Public Law 108-276).
``(f) Inapplicability of Certain Acts.--
``(1) FACA.--The Federal Advisory Committee Act (5 U.S.C.
App.) shall not apply to the duties, activities, working
groups, and advisory boards of the BARDA.
``(2) FOIA.--Information that relates to the activities,
working groups, and advisory boards of the BARDA shall not be
subject to disclosure under section 552 of title 5, United
States Code, unless the Secretary or Director determines that
such disclosure would pose no threat to national security.
Such a determination shall not be subject to judicial review.
``(3) Certain cost principles and cost accounting
standards.--Notwithstanding any other provision of law, the
cost principles set forth under part 31 of title 48, Code of
Federal Regulations, the cost accounting standards set forth
under chapter 99 of title 48, Code of Federal Regulations,
and the requirement for the submission of certified cost and
pricing information under section 304A of the Federal
Property and Administrative Services Act of 1949 (41 U.S.C.
254b), shall not apply to any contract, grant, cooperative
agreement, or other transaction entered into under the
Project BioShield Act of 2004 (Public Law 108-276).''.
SEC. 4. CLARIFICATION OF COUNTERMEASURES COVERED BY PROJECT
BIOSHIELD.
(a) Qualified countermeasure.--Section 319F-1(a) of the
Public Health Service Act (42 U.S.C. 247d-6a(a)) is amended
by striking paragraph (2) and inserting the following:
``(2) Definitions.--In this section:
``(A) Qualified countermeasure.--The term `qualified
countermeasure' means a drug (as that term is defined by
section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(g)(1))), biological product (as that term is
defined by section 351(i) of this Act (42 U.S.C. 262(i))),
device (as that term is defined by section 201(h) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))), or
research tool (as that term is defined in section 201(rr) of
the Federal Food, Drug, and Cosmetic Act) that the Secretary
determines to be a priority (consistent with sections 302(2)
and 304(a) of the Homeland Security Act of 2002) to--
``(i) diagnose, mitigate, prevent, or treat harm from any
biological agent (including organisms that cause an
infectious disease) or toxins, chemical, radiological, or
nuclear agent that may cause a public health emergency
affecting national security;
``(ii) diagnose, mitigate, prevent, or treat harm from a
condition that may result in adverse health consequences or
death and may be caused by administering a drug, biological
product, or device that is used as described in this
subparagraph; or
``(iii) in the case of a research tool, enable the rapid
and effective identification, assessment, or development of a
drug, biological
[[Page S11427]]
product, or device to diagnose, mitigate, prevent, or treat
harm, as described in clause (i) or (ii).
``(B) Infectious disease.--The term `infectious disease'
means a disease potentially caused by a pathogenic organism
(including a bacteria, virus, fungus, or parasite) that is
acquired by a person and that reproduces in that person.''.
(b) Security countermeasure.--Section 319F-2(c)(1)(B) is
amended by--
(A) striking ``treat, identify, or prevent'' each place it
appears and inserting ``diagnose, mitigate, prevent, or
treat''; and
(B) inserting ``agent (including organisms that cause an
infectious disease) or toxin'' after ``any biological''.
(c) Research tool.--Section 201 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321) is amended by adding at the
end the following:
``(rr) Research tool.--The term `research tool' includes
the full range of tools and systems that assist in the
discovery, development, or manufacture of drugs, biological
products (as defined in section 351 of the Public Health
Service Act), or devices.''.
SEC. 5. ORPHAN DRUG MARKET EXCLUSIVITY FOR COUNTERMEASURE
PRODUCTS.
(a) Market Exclusivity.--Subchapter A of chapter V of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.)
is amended by inserting after section 505B the following:
``SEC. 505C. ORPHAN DRUG MARKET EXCLUSIVITY FOR
COUNTERMEASURE PRODUCTS.
``(a) In General.--With respect to countermeasure products
(as such term is defined in this section), if a
countermeasure product is designated under section 526 for a
rare disease or condition, the period referred to in section
527(a) shall be 10 years instead of 7 years.
``(b) Definition.--For the purpose of this section, the
term `countermeasure' means a drug or biological product (as
such term is defined by section 351(i) of the Public Health
Service Act) that the Secretary determines to be a priority
(consistent with sections 302(2) and 304(a) of the Homeland
Security Act of 2002) to diagnose, mitigate, prevent, or
treat harm from any biological, chemical, radiological, or
nuclear agent (including organisms that cause an infectious
disease) or toxin identified as a material threat under
subsection (c)(2)(A)(ii) of section 319F-2 of the Public
Health Service Act.''.
(b) Orphan Drugs.--For purposes of section 526 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) a
biological, chemical, radiological, or nuclear agent
(including organisms that cause an infectious disease) or
toxin identified as a material threat under subsection
(c)(2)(A)(ii) of section 319F-2 of the Public Health Service
Act shall be considered to be a ``rare disease or condition''
within the meaning of such term in such section 526. The
Secretary may designate antibiotics and anti-infective
products that treat infectious diseases as designated drugs
or biological products under such section 526.
(c) Effect of Section.--This section, and the amendments
made by this section, shall apply to new drug applications
and biological product licenses approved under the Federal
Food, Drug, and Cosmetic Act or the Public Health Service Act
after the date of enactment of this Act.
SEC. 6. LIABILITY PROTECTIONS FOR PANDEMICS, EPIDEMICS, AND
COUNTERMEASURES.
Part B of title III of the Public Health Service Act is
amended by inserting after section 319F-2 (42 U.S.C. 247d-6b)
the following:
``SEC. 319F-3. LIABILITY PROTECTIONS FOR PANDEMIC AND
EPIDEMIC PRODUCTS AND SECURITY COUNTERMEASURES.
``(a) Authority.--As provided in subsection (b), and
subject to subsection (b)(1)(C), a manufacturer, distibutor,
or administrator of a security countermeasure, or a qualified
pandemic and epidemic product, described in subsection
(b)(1)(A) or a health care provider shall be immune from suit
or liability caused by or arising out of the design,
development, clinical testing and investigation, manufacture,
labeling, distribution, sale, purchase, donation, dispensing,
prescribing, administration, or use of a security
countermeasure, or a qualified pandemic and epidemic product,
described in subsection (b)(1)(A).
``(b) Litigation Management.--
``(1) Limitation on cause of action.--
``(A) In general.--
``(i) In general.--No cause of action shall exist against a
person described in subsection (a) for claims for loss of
property, personal injury, or death arising out of,
reasonably relating to, or resulting from the design,
development, clinical testing and investigation, manufacture,
labeling, distribution, sale, purchase, donation, dispensing,
prescribing, administration, or use of a security
countermeasure or qualified pandemic or epidemic product
distributed, sold, purchased, donated, dispensed, prescribed,
administered, or used in anticipation of and preparation for,
in defense against, or in response to, or recovery from an
actual or potential public health emergency that is a
designated security countermeasure or a qualified pandemic or
epidemic product by the Secretary in a declaration described
in paragraph (2).
``(ii) Rule of construction.--For purposes of this section,
the phrase `arising out of, reasonably relating to, or
resulting from' shall not be construed to apply to loss of
property, personal injury, or death that has no alleged or
potential causal relationship with the design, development,
clinical testing and investigation, manufacture, labeling,
distribution, sale, purchase, donation, dispensing,
prescribing, administration, or use of a product described in
clause (i).
``(B) Rule.--
``(i) Subsequent injury.--The protections set forth in
subsection (a) and subparagraph (A) shall apply to all claims
identified in subparagraph (A) that involve products
distributed, sold, purchased, donated, dispensed, prescribed,
administered, or used during the effective period set forth
in the designation provided for in paragraph (2), regardless
of the date of alleged injury.
``(ii) Private donation or sale.--The protections set forth
in subsection (a) and subparagraph (A) shall apply to all
claims identified in subparagraph (A) that involve security
countermeasures or qualified pandemic or epidemic products
distributed, sold, purchased, donated, dispensed, prescribed,
administered, or used during the effective period set forth
in the designation provided for in paragraph (2) by a
manufacturer through the commercial market, provided that the
security countermeasures or the qualified pandemic or
epidemic product are the security countermeasure or qualified
pandemic or epidemic product described in a declaration
described in paragraph (2) and the Secretary does not
specifically prohibit such private donation or sale in such
declaration.
``(C) Potential liability upon determination.--
``(i) In general.--A manufacturer, distributor,
administrator, or health care provider shall not be immune
under subsection (a) or exempted from a cause of action under
subparagraph (A) if the Secretary makes a determination as
provided for in subparagraph (D).
``(ii) Investigation by secretary.--A party seeking a
determination under subparagraph (D) may petition the
Secretary to investigate allegations against a manufacturer,
distributor, administrator, or health care provider arising
out of, relating to, or resulting from the design,
development, clinical testing and investigation, manufacture,
labeling, distribution, sale, purchase, donation, dispensing,
prescribing, administration, or use of products as provided
for in subparagraph (A)(i). The decision to undertake such
investigation shall be within the Secretary's discretion and
shall not be subject to judicial review.
``(iii) Rule of construction.--Nothing in this section
shall be construed to abrogate or limit the application of
subtitle II of chapter 5 and chapter 7 of title 5, United
States Code (commonly known as the Administrative Procedure
Act).
``(D) Determination by secretary.--
``(i) In general.--In making a determination under this
subparagraph, the Secretary, acting through an administrative
law judge, must find clear and convincing evidence that--
``(I) the manufacturer, distributor, administrator, or
health care provider violated a provision of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or this
Act; and
``(II) in violating such Act, such manufacturer,
distributor, administrator, or health care provider acted
with willful misconduct.
``(ii) Effect of determination.--If the Secretary finds
such clear and convincing evidence under clause (i), the
Secretary shall examine whether such willful misconduct to
violate an Act under such clause--
``(I) caused the product to present a significant or
unreasonable risk to human health; and
``(II) proximately caused the injury alleged by the party.
``(ii) Notice and hearing.--Prior to the Secretary's making
a determination under clause (i), the manufacturer,
distributor, administrator, or health care provider shall
have notice and a right to a formal hearing in accordance
with section 556 of title 5, United States Code.
``(iii) Effect of determination.--Subject to subsection
(c), the sole exception to the immunity from suit and
liability of manufacturers, distributors, administrators, or
healthcare providers set forth in subsection (a) and
subparagraph (A) shall be for actions against a manufacturer,
distributor, administrator, or healthcare provider as
provided in subparagraph (A).
``(iv) Judicial review.--At any time prior to the 90th day
following a determination by the Secretary under clause (i),
any manufacturer, distributor, administrator, or health care
provider named in such determination may file a petition with
the United States Court District Court for the District of
Columbia, for a judicial review of such determination. A copy
of the petition shall be forthwith transmitted by the clerk
of the court to the Secretary or other officer designated by
the Secretary for that purpose. The Secretary thereupon shall
file in the court the record of the findings on which the
Secretary based his or her determination. The filing of a
petition under this clause shall automatically stay the
Secretary's determination for the duration of the judicial
proceeding. The sole parties to the judicial proceeding shall
be the Secretary and the petitioner. Intervention by third
parties in the judicial proceeding shall not be permitted. No
subpoenas shall be issued nor shall other compulsory process
apply. The court's review of a determination by the Secretary
under this clause shall conform to the procedures for
judicial review of administrative
[[Page S11428]]
orders set forth in paragraphs (2) through (6) of section
701(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
371(f)) to the extent consistent with this section.
``(v) Tolling of statute of limitations.--The computation
of the statute of limitations for any action against a
manufacturer, distributor, administrator, or health care
provider described under this subparagraph shall not include
any time occurring before the determination by the Secretary
under this subparagraph.
``(vi) Regulatory authority.--The Secretary, in
consultation with the Attorney General, shall promulgate
regulations defining what actions by a manufacturer,
distributor, administrator, or healthcare provider of a
security countermeasure or a qualified pandemic and epidemic
product shall be deemed to constitute `willful misconduct'
for purposes of clause (i). In promulgating such regulations,
the Secretary shall consider the nature of the actual or
potential public health emergency, the timing and extent of
any vaccination or countermeasure program, and any other
circumstances they deem significant, so that any civil
actions permitted under this subsection will not adversely
affect the public health. The Secretary may specify the
period of time for which such regulations apply.
``(vii) Evidence required.--The Secretary, in consultation
with the Attorney General, shall promulgate regulations that
require, in order to be a party under this section, that an
individual present evidence that reasonably demonstrates
that--
``(I) such individual has suffered a loss as a direct
result of the design, development, clinical testing and
investigation, manufacture, labeling, distribution, sale,
purchase, donation, dispensing, prescribing, or
administration of a security countermeasure or qualified
epidemic or pandemic product; and
``(II) the loss as described in subclause (I) was a direct
result of the willful misconduct of the manufacturer,
distributor, administrator, or health care provider in
violating the Federal Food, Drug, and Cosmetic Act or this
Act.
``(E) Scope.--Subparagraph (C) shall apply regardless of
whether the suit or liability described in subsection (a) or
the claim described in subparagraph (A) arises from the
design, development, clinical testing and investigation,
manufacture, labeling, distribution, sale, purchase,
donation, dispensing, prescribing, administration, or use by
the Federal Government or by any person.
``(2) Declaration by secretary.--
``(A) In general.--The Secretary may issue a declaration,
pursuant to this paragraph, that an actual or potential
public health emergency makes advisable the distribution,
administration, or use of a security countermeasure or
qualified pandemic or epidemic product.
``(B) Security countermeasure or qualified pandemic or
epidemic product.--The Secretary shall specify in such
declaration the security countermeasures or qualified
pandemic or epidemic products to be sold by, purchased from,
or donated by a manufacturer or drawn from the Strategic
National Stockpile.
``(C) Effective period.--The Secretary shall specify in
such declaration the beginning and the ending dates of the
effective period of the declaration, which shall be not
longer than 6 months. The Secretary may subsequently amend
such declaration to shorten or extend such effective period,
provided that the new ending data is after the date on which
the declaration is amended.
``(D) Publication.--The Secretary shall promptly publish
each such declaration and amendment in the Federal Register.
``(c) Actions by the United States.--Nothing in this
section shall be construed to abrogate or limit any right,
remedy, or authority that the United States or any agency
thereof may possess under any other provision of law.
``(d) Definitions.--In this section:
``(1) Administrator.--The term `administrator' means a
person employed by the State or local government, or their
designee, who supervised or administered a program with
respect to the administration, dispensing, distribution, or
provision of a security countermeasure or a qualified
pandemic or epidemic product, including a person who has
established requirements, provided policy guidance, supplied
technical or scientific advice or assistance.
``(2) Health care provider.--The term `health care
provider' means a person, including a volunteer, who
distributes, prescribes, administers, dispenses, provides a
facility to administer, or supervises or oversees the
administration of a security countermeasure or a qualified
pandemic or epidemic product, including persons who
distribute, prescribe, administer, dispense, or provide a
facility to administer in accordance with a designation under
subsection (b)(2).
``(3) Loss.--The term `loss' means death, physical injury,
or loss of or damage to property, including business
interruption loss.
``(4) Manufacturer.--The term `manufacturer' includes--
``(A) a contractor or subcontractor of a manufacturer;
``(B) a supplier of any product or service, research tool,
or component to the manufacturer; and
``(C) any or all of the parents, subsidiaries, affiliates,
successors, and assigns of a manufacturer.
``(5) Qualified pandemic or epidemic product.--The term
`qualified pandemic or epidemic product' means a drug (as
such term is defined in section 201(g)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))),
biological product (as such term is defined by section 351(i)
of this Act) or device (as such term is defined by section
201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C.
321(h))) designed, developed, modified, or procured to
diagnose, mitigate, prevent, treat, or cure a pandemic or
epidemic or limit the harm such pandemic or epidemic might
otherwise cause or a serious or life-threatening disease or
condition caused by such a product, that--
``(A) is approved or cleared under chapter V of the Federal
Food, Drug, and Cosmetic Act or licensed under section 351 of
this Act;
``(B) is a product for which the Secretary determines that
sufficient and satisfactory clinical experience or research
data (including data, if available, from pre-clinical and
clinical trials) support a reasonable conclusion that the
product will qualify for approval or licensing within 8 years
after the date the Secretary makes a declaration under
paragraph (2); or
``(C) is authorized for emergency use section 564 of the
Federal Food, Drug, and Cosmetic Act, except that subsection
(b) of such section shall not apply.
``(6) Party.-- The term `party' means an individual who can
reasonably demonstrate to the Secretary that such individual
has suffered a loss (as defined in paragraph (3)) as a direct
result of the willful misconduct of a manufacturer,
distributor, administrator, or health care provider.
``(7) Person.--The term `person' includes an individual,
partnership, corporation, association, entity, or public or
private corporation, including a Federal, State, or local
agency or department.
``(8) Security countermeasure.--The term `security
countermeasure' has the meaning given such term in section
319F-2(c)(1)(B).''.
SEC. 7. COMPENSATION.
Title II of the Public Health Service Act (42 U.S.C. 202 et
seq.) is amended by adding at the end the following:
``PART D--OTHER COMPENSATION PROGRAMS
``SEC. 271. COVERED COUNTERMEASURES PROGRAM.
``(a) In General.--If the Secretary issues a Proclamation
stating that there is a critical public health need for a
covered individual to receive a covered countermeasure during
the effective period of the Proclamation, the Secretary shall
establish a process to provide compensation to such covered
individuals for a covered injury, consistent with the
Smallpox Emergency Personnel Protection program under part C.
``(b) Definition.--For purposes of this section:
``(1) Covered countermeasure.--The term `covered
countermeasure' means a qualified pandemic or epidemic (as
defined in section 319F-3(c)(5)) or a security countermeasure
(as defined in section 319F-2(c)(1)(B)) specified in the
Proclamation.
``(2) Covered individual.--The term `covered individual'
means an individual--
``(A) who is a health care worker, law enforcement officer,
firefighter, security personnel, emergency medical personnel,
other public health or safety personnel, or support personnel
for such occupational specialties;
``(B) who is or will be functioning in a role identified in
a State, local, or Department of Health and Human Services
emergency response plan approved by the Secretary;
``(C) who has volunteered and been selected to be a member
of an emergency response plan; and
``(D) to whom a covered countermeasure is administered
pursuant to such approved plan during the effective period of
the Proclamation and prior to the time at which the Secretary
declares a public health emergency pursuant to section 319
related to a covered countermeasure specified in the
Proclamation.
``(3) Covered injury.--The term `covered injury' means an
injury, disability, illness, condition, or death (other than
a minor injury such as minor scarring or minor local
reaction) determined by the Secretary to have been sustained
by a covered individual as the direct result of
administration to the individual of a covered countermeasure.
``(4) Effective period of the proclamation.--The term
`effective period of the Proclamation' means the effective
period specified in the Proclamation, unless extended by the
Secretary.
``(5) Emergency response plan.--The term `emergency
response plan' or `plan' means a response plan detailing
actions to be taken in preparation for a pandemic, epidemic,
or biological, chemical, nuclear agent or toxin that
presents, or may present, a public health emergency.
``(6) Proclamation.--The term `Proclamation' means a
Proclamation regarding the critical public health need for
the administration of a covered countermeasure issued by the
Secretary and published in the Federal Register. Such
Proclamation shall specify the specific covered
countermeasure recommended for administration.
``(c) Rule of Construction.--Nothing in this section shall
be construed to require the creation of a compensation
program if the covered injuries are only minor injuries
consistent with section (b)(3).''.
[[Page S11429]]
SEC. 8. REBATES AND GRANTS FOR RESEARCH DEVELOPMENT, AND
MANUFACTURING OF VACCINES, QUALIFIED
COUNTERMEASURES AND PANDEMIC OR EPIDEMIC
PRODUCTS.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') may award
to a person with respect to an investment described in this
section (or an amendment made by this section)--
(1) a rebate pursuant to subsection (b); or
(2) a grant pursuant to section 319M of the Public Health
Service Act (as added by subsection (c)).
(b) Surge Capacity and Research Rebates.--
(1) In general.--The Secretary may award rebates out of any
money in the Treasury not otherwise appropriated to persons
for the expansion of surge capacity for manufacturing
vaccines, qualified countermeasures (as defined in 319F-1 of
the Public Health Service Act, as amended by this Act) or
qualified pandemic or epidemic products (as defined in 319F-
3(c)(5) of such Act, as added by this Act) (referred to in
this section as ``vaccines, countermeasures or products'')
and for vaccines, countermeasures, or products research.
(2) Vaccines, countermeasures or products manufacturing
facilities investment rebate.--
(A) In general.--For purposes of this section, vaccines,
countermeasures or products manufacturing facilities
investment rebate for any taxable year for a person (as
defined with respect to such person for purposes of the
Internal Revenue Code of 1986) shall be an amount equal to 20
percent of the qualified investment for such taxable year.
(B) Vaccines, countermeasures or products manufacturing
facilities investment.--For purposes of subparagraph (A), the
qualified investment for any taxable year for a person is the
basis of each vaccines, countermeasures or products
manufacturing facilities property placed in service by the
person during the taxable year involved.
(C) Vaccines, countermeasures and products manufacturing
facilities property.--For purposes of this subsection, the
term ``vaccines, countermeasures and products manufacturing
facilities property'' means real and tangible personal
property--
(i)(I) the original use of which commences with the person
applying for the rebate; or
(II) which is acquired through purchase (as defined by
section 179(d)(2) of the Internal Revenue Code of 1986);
(ii) which is depreciable under section 167 of the Internal
Revenue Code of 1986;
(iii) which is physically located in a State;
(iv) which is used for the manufacture, distribution, or
research and development of vaccines, countermeasures, or
products; and
(v) which is in compliance with applicable good
manufacturing practice and with any other applicable
requirements which are promulgated by the Secretary, the
Occupational Safety and Health Administration, or the
Environmental Protection Agency, and which are applicable to
such property.
(D) Denial of double benefit for manufacturing facilities
expenses.--If any portion of the vaccines, countermeasures,
and products manufacturing facilities property investment
expenses is otherwise allowable as a deduction for the
taxable year involved, the Secretary shall only provide a
rebate under this section for the portion of such expenses
not covered by the rebate determined by such deduction.
(E) Eligibility.--To be eligible to receive a rebate under
this subsection, a manufacturer shall submit to the Secretary
an application at such time, in such manner, and containing
such information as the Secretary may require, including--
(i) a detailed description and intended use of the
facilities that is the basis of application;
(ii) a detailed description of the vaccine, countermeasure,
or product being produced or that may be produced at the
facility;
(iii) a detailed accounting of qualified manufacturing
facilities investment of the person;
(iv) a certification as to the compliance of the person
with clauses (i) through (iv) of subparagraph (C); and
(v) copies of tax returns for the taxable year involved.
(F) Effective date.--This paragraph shall apply to property
placed in service after December 31, 2005.
(G) Termination.--This paragraph shall not apply to any
property placed in service after December 31, 2010.
(3) Medical research related to developing vaccines,
countermeasures or qualified pandemic or epidemic products
rebate.--
(A) In general.--For purposes of this subsection, the
research rebate determined under this section for the taxable
year involved (as determined as provided for in paragraph
(2)(A)) is an amount equal to 35 percent of the vaccines,
qualified countermeasures, or qualified pandemic or epidemic
products (referred to in this section as ``vaccine,
countermeasure, or product'') research expenses for the
taxable year.
(B) Vaccines, countermeasures, or products research
expenses.--Except as otherwise provided in this paragraph,
the term ``vaccines, countermeasures, or products research
expenses'' means the amounts which are paid or incurred by
the researcher or manufacturer during the taxable year with
respect to any research and development of vaccines,
countermeasures, or products. Qualified research and
development expenses include expenses related to
reformulating existing vaccines, countermeasures, or
products.
(C) Determining research expenses.--Any vaccines,
countermeasures, or products research expenses for any
taxable year which are qualified research expenses (within
the meaning of this subsection) shall be taken into account
in determining base period research expenses for purposes of
applying this paragraph to subsequent taxable years.
(D) Denial of double benefit for vaccines, countermeasures,
or products research expenses.--If any portion of the
vaccines, countermeasures, or products research expenses is
otherwise allowable as a deduction for the taxable year
involved, the Secretary shall only provide a rebate under
this section for the portion of such expenses not covered by
any rebate determined by such deduction.
(E) Eligibility.--To be eligible to receive a rebate under
this paragraph, a manufacturer or researcher shall submit to
the Secretary an application at such time, in such manner,
and containing such information as the Secretary may require,
including--
(i) a detailed description of the vaccine, countermeasure,
or product being researched or developed;
(ii) a detailed description of the research that is the
subject of the rebate;
(iii) a detailed accounting of the qualified research
expenses involved;
(iv) an assurance that the researcher or manufacturer is
following good laboratory practice, as required by the
Secretary pursuant to the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.) and the Public Health Service Act
(42 U.S.C. 201 et seq.); and
(v) copies of tax returns for the taxable year involved.
(F) Effective date.--This paragraph shall apply to expenses
for taxable years beginning after December 31, 2005.
(4) Exclusion for amounts funded by grants, etc.--The terms
``vaccines, countermeasures, or products manufacturing
investment'' and ``qualified research expenses'' shall not
include any amount to the extent such amount is funded by any
grant, contract, or otherwise funded by another person (or
any governmental entity).
(c) Grants to Expand and Improve Research and Development
and Manufacturing of Vaccines, Countermeasures or Products.--
Part B of title III of the Public Health Service Act is
amended by inserting after section 319L, as added by this
Act, the following:
``SEC. 319M. GRANTS TO EXPAND AND IMPROVE RESEARCH AND
DEVELOPMENT AND MANUFACTURING OF VACCINES,
QUALIFIED COUNTERMEASURES OR QUALIFIED PANDEMIC
OR EPIDEMIC PRODUCTS.
``(a) In General.--The Secretary may award grants to a
manufacturer to purchase or improve real property and
tangible personal property used in the research and
development, manufacture, or distribution of a vaccine,
qualified countermeasure (as defined in section 319F-1) or
qualified pandemic or epidemic product (as defined in section
319F-3(c)(5)).
``(b) Eligibility.--To be eligible to receive a grant under
subsection (a), a manufacturer shall submit to the Secretary
an application at such time, in such manner, and containing
such information as the Secretary may require, including--
``(1) a detailed description of the planned expansion;
``(2) a detailed description of the equipment, facility, or
property involved;
``(3) a certification that such facility or property is
physically located in a State;
``(4) a detailed description of the vaccine, qualified
countermeasure or qualified pandemic or epidemic product
involved;
``(5) a detailed description of the research and
development, manufacturer, or distribution involved;
``(6) a description of how such equipment, facility, or
property is to be used;
``(7) a description of whether such equipment, facility, or
property can be used for the research and development,
manufacture, or distribution of a drug, biological product,
device or other countermeasure not described in paragraph
(4); and
``(8) a certification that the equipment, facility, or
property involved complies with all applicable Federal,
State, and local laws.
``(c) Recapture.--
``(1) In general.--If, at any time prior to the expiration
of the 20-year period beginning on the date on which a grant
is awarded under this section, the facility or property
involved ceases to be used for the purpose for which the
grant was awarded, the United States shall be entitled to
recover from the manufacturer an amount bearing the same
ratio to the value of the facility or property at such time
as the amount of the grant bore to the total cost of the
purchase or improvement involved. The value of the facility
or property at such time may be determined by agreement of
the manufacturer and the Secretary, or by order of the United
States District Court for the district in which such facility
or property is situated.
``(2) Limitation.--The Secretary may not recapture the
facility or property under this subsection if the Secretary
determines, in accordance with regulations promulgated by the
Secretary, that there is good cause for the failure of proper
use.
``(d) Authorization of Appropriations.--There is authorized
to be appropriated such
[[Page S11430]]
sums as may be necessary to carry out this section.''.
SEC. 9. TECHNICAL ASSISTANCE.
Subchapter E of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding
at the end the following:
``SEC. 565. TECHNICAL ASSISTANCE.
``The Secretary, in consultation with the Commissioner of
Food and Drugs, shall establish within the Food and Drug
Administration a team of experts on manufacturing and
regulatory activities (including compliance with current Good
Manufacturing Practices) to provide both off-site and on-site
technical assistance to the manufacturers of qualified
countermeasures (as defined in section 319F-1 of the Public
Health Service Act), security countermeasures (as defined in
section 319F-2 of such Act), or vaccines, at the request of
such a manufacturer and at the discretion of the Secretary,
if the Secretary determines that a shortage or potential
shortage may occur in the United States in the supply of such
vaccines or products and that the provision of such
assistance would be beneficial in helping alleviate or avert
such shortage.''.
SEC. 10. ANIMAL MODELS FOR CERTAIN DISEASES.
Part B of title IV of the Public Health Service Act (42
U.S.C. 284 et seq.) is amended by adding at the end the
following:
``SEC. 409J. ANIMAL MODELS FOR CERTAIN DISEASES.
``(a) In General.--The Secretary, acting through the
Director of NIH, in coordination with the Director of the
Biomedical Advanced Research and Development Agency, the
Director of the Centers for Disease Control and Prevention,
and the Commissioner of Food and Drugs, shall establish and
award grants under this section to eligible entities,
including other Federal agencies, to study the physiological
responses of certain animal species and, where appropriate,
juvenile models, to chemical, biological, radiological, or
nuclear agents or toxins or potential pandemic infectious
disease, and to develop and validate such animal models.
``(b) Eligibility.--To be eligible to receive a grant under
this section, an entity shall--
``(1) provide assurances to the Secretary that the entity--
``(A) has access to an appropriate biosafety laboratory or
facility, as determined by the Secretary; and
``(B) will follow good laboratory practices;
``(2) submit to the Secretary an application at such time,
in such manner, and containing such information as the
Secretary may require, including--
``(A) a detailed description of the animal model involved;
``(B) a detailed description of the chemical, biological,
radiological, nuclear, or other infectious agents involved;
``(C) a detailed description of how the animal model will
be used for the development of a drug, biological product, or
device for use as a countermeasure;
``(D) a detailed description of validation methods; and
``(E) an assurance that the entity will follow good
laboratory practices; and
``(3) agree to submit the results of the research funded
under the grant to the Director of the Biomedical Advanced
Research and Development Agency and the Director of NIH.
``(c) Authorization of Appropriations.--There are
authorized to be appropriated such sums as may be necessary
to carry out this section.''.
SEC. 11. ANIMAL MODEL/RESEARCH TOOL SCIENTIFIC ADVISORY
COMMITTEE.
Subchapter E of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb et seq.), as amended by this
Act, is amended by adding at the end the following:
``SEC. 566. ANIMAL MODEL/RESEARCH TOOL SCIENTIFIC ADVISORY
COMMITTEE.
``(a) Establishment.--Not later than 6 months after the
date of enactment of this section, the Secretary shall
establish an 11-member advisory committee to be known as the
`Animal Model/Research Tool Scientific Advisory Committee'
(referred to in this section as the `Advisory Committee').
``(b) Membership.--
``(1) In general.--The Secretary shall appoint as members
of the Advisory Committee individuals who are technically
qualified by training and experience, including in medicine,
veterinarian medicine, biology, technology involving the
manufacture, evaluation, or use of research tools, who are of
appropriately diversified professional backgrounds to
evaluate the priority animal models and research tools.
``(2) Ex officio members.--The Secretary may appoint
Federal officials, including at least 1 representative of the
Biomedical Advanced Research and Development Agency, to serve
as ex officio members of the Advisory Committee.
``(3) Chairperson.--The Secretary shall designate 1 of the
members of the Advisory Committee to serve as the
chairperson.
``(c) Duties.--The Advisory Committee shall provide advice,
information, and recommendations to the Secretary on--
``(1) accepted animal models for diseases and conditions
associated with any biological (including organisms that
cause infectious diseases), chemical, radiological, or
nuclear agent or toxin or potential pandemic infectious
disease;
``(2) strategies to accelerate animal model and research
tool development and validation; and
``(3) scientific issues raised in applications as requested
by the Secretary.
``(d) Priorities.--Priorities for animal models and
research tools shall be established by the Secretary.
``(e) Compensation; Support; FACA.--
``(1) Compensation and travel.--Members of the Advisory
Committee who are not officers or employees of the United
States, while attending conferences or meetings of the
committee or otherwise engaged in its business, shall be
entitled to receive compensation at rates to be fixed by the
Secretary, which may not exceed daily equivalent of the rate
in effect for level 4 of the Senior Executive Schedule under
section 5382 of title 5, United States Code, for each day
(including travel time) they are so engaged, and while so
serving away from their homes or regular places of business
each member may be allowed travel expenses, including per
diem in lieu of subsistence, as authorized by section 5703 of
title 5, United States Code, for persons in the Federal
Government service employed intermittently.
``(2) Administrative support.--The Secretary shall furnish
the Advisory Committee clerical and other assistance.
``(3) Nonapplication of faca.--Section 14 of the Federal
Advisory Committee Act (5 U.S.C. App.) shall not apply to the
Advisory Committee.
``(f) Proceedings.--The Advisory Committee shall make and
maintain a transcript of any proceeding of the Committee. The
Committee shall delete from any transcript made under this
subsection information, which is exempt from disclosure under
section 552(b) of title 5, United States Code.''.
SEC. 12. COLLABORATION AND COORDINATION.
Section 2 of the Clayton Act (15 U.S.C. 13) is amended by
adding at the end the following:
``(g) Limited Antitrust Exemption.--
``(1) Security countermeasures, qualified countermeasures
and qualified pandemic or epidemic product development
meetings.--
``(A) Countermeasures and products development meetings and
consultations.--The Secretary of Health and Human Services
(referred to in this subsection as the `Secretary') or the
Director of the Biomedical Advanced Research and Development
Agency (referred to in this subsection as the `Director'), in
coordination with the Attorney General and the Secretary of
Homeland Security, may conduct meetings and consultations
with parties involved in the development of security
countermeasures (as defined in section 319F-2 of the Public
Health Service Act) qualified countermeasures (as defined in
section 319F-1 of the Public Health Service Act) or qualified
pandemic or epidemic products (as defined in section 319F-
3(c)(5) of the Public Health Service Act) (referred to in
this section as ``countermeasures or products'') for the
purpose of the development, manufacture, distribution,
purchase, sale, or storage of countermeasures or products
consistent with the purposes of this title. The Secretary or
Director may convene such meeting or consultation at the
request of any person, the Secretary of Homeland Security,
the Attorney General, the Chairperson of the Federal Trade
Commission, an industry representative or member, or upon
initiation by such Secretary. The Secretary or Director shall
give notice of such meetings and consultations to the
Chairperson of the Federal Trade Commission (referred to in
this subsection as the `Chairperson') and the Attorney
General.
``(B) Meeting and consultation conditions.--A meeting or
consultation conducted under subparagraph (A) shall--
``(i) be chaired or, in the case of a consultation,
facilitated by the Secretary or Director;
``(ii) be open to parties involved in the development,
manufacture, distribution, purchase, or sale of
countermeasures or products, as determined by the Secretary
or Director;
``(iii) be open to the Attorney General, the Secretary of
Homeland Security, and the Chairperson;
``(iv) be limited to discussions involving the development,
manufacture, distribution, or sale of countermeasures or
products, consistent with the purposes of this title; and
``(v) be conducted in such manner as to ensure that
national security, confidential, and proprietary information
is not disclosed outside the meeting or consultation.
``(C) Limitation.--The Secretary or Director may not
require the disclosure of confidential commercial or
proprietary information.
``(D) Minutes.--The Secretary or Director shall maintain
minutes of meetings and consultations under this subsection,
which shall not be disclosed under section 552 of title 5,
United States Code, unless such Secretary or Director, in
consultation with the Attorney General, determines that
disclosure would pose no threat to national security. Such
determination shall not be subject to judicial review.
``(E) Exemption.--
``(i) In general.--The antitrust laws shall not apply to
meetings and consultations under this paragraph.
``(ii) Limitation.--Clause (i) shall not apply to any
agreement or conduct that results from a meeting or
consultation and that does not receive an exemption pursuant
to this subsection.
[[Page S11431]]
``(2) Written agreements.--The Secretary or the Director
shall file a written agreement regarding covered activities,
made pursuant to meetings or consultations conducted under
paragraph (1) and that is consistent with this paragraph,
with the Attorney General and the Chairperson for a
determination of the compliance of such agreement with
antitrust laws. In addition to the proposed agreement itself,
any such filing shall include--
``(A) an explanation of the intended purpose of the
agreement;
``(B) a specific statement of the substance of the
agreement;
``(C) a description of the methods that will be utilized to
achieve the objectives of the agreement;
``(D) an explanation of the necessity of a cooperative
effort among the particular participating parties to achieve
the objectives of the agreement; and
``(E) any other relevant information determined necessary
by the Secretary or Director in consultation with the
Attorney General and the Chairperson.
``(3) Determination.--The Attorney General, in consultation
with the Chairperson, shall determine whether an agreement
regarding covered activities referred to in paragraph (2)
would likely--
``(A) be in compliance with the antitrust laws, and so
inform the Secretary or Director and the participating
parties; or
``(B) violate the antitrust laws, in which case, the filing
shall be deemed to be a request for an exemption from the
antitrust laws, limited to the performance of the agreement
consistent with the purposes of this title.
``(4) Action on request for exemption.--
``(A) In general.--The Attorney General, in consultation
with the Chairperson, shall grant, deny, grant in part and
deny in part, or propose modifications to a request for
exemption from the antitrust laws under paragraph (3) within
15 business days of the receipt of such request.
``(B) Extension.--The Attorney General may extend the 15-
day period referred to in subparagraph (A) for an additional
period of not to exceed 10 days. Such additional period may
be further extended only by the United States district court,
upon an application by the Attorney General after notice to
the Secretary or Director and the parties involved.
``(C) Determination.--In granting an exemption under this
paragraph, the Attorney General, in consultation with the
Chairperson and the Secretary or Director--
``(i) shall find--
``(I) that the agreement involved is necessary to ensure
the availability of countermeasures or products;
``(II) that the exemption from the antitrust laws would
promote the public interest; and
``(III) that there is no substantial competitive impact to
areas not directly related to the purposes of the agreement;
and
``(ii) may consider any other factors determined relevant
by the Attorney General and the Chairperson.
``(5) Limitation on and renewal of exemptions.--An
exemption granted under paragraph (4) shall be limited to
covered activities, and shall be renewed (with modifications,
as appropriate) on the date that is 3 years after the date on
which the exemption becomes effective (and at 3-year
intervals thereafter, if renewed) unless the Attorney General
in consultation with the Chairperson determines that the
exemption should not be renewed (with modifications, as
appropriate) considering the factors described in paragraph
(4).
``(6) Limitation on parties.--The use of any information
acquired under an exempted agreement by the parties to such
an agreement for any purposes other than those specified in
the antitrust exemption granted by the Attorney General shall
be subject to the antitrust laws and any other applicable
laws.
``(7) Guidelines.--The Attorney General and the Chairperson
may develop and issue guidelines to implement this
subsection.
``(8) Report.--Not later than 1 year after the date of
enactment of the Biodefense and Pandemic Vaccine and Drug
Development Act of 2005, and annually thereafter, the
Attorney General and the Chairperson shall report to Congress
on the use and continuing need for the exemption from the
antitrust laws provided by this subsection.
``(9) Status of memorandums.--Minutes maintained by the
Secretary or Director pursuant to paragraph (1)(D) shall not
be disclosed under section 552 of title 5, United States
Code, if the exemption is not renewed under paragraph (5), or
if meetings are no longer conducted, unless the Secretary or
Director, in consultation with the Attorney General,
determines that the disclosure would pose no threat to
national security. Such determination shall not be subject to
judicial review.
``(h) Sunset.--The authority of the Attorney General to
grant or renew a limited antitrust exemption under this
section shall expire at the end of the 6-year period that
begins on the date of enactment of the Biodefense and
Pandemic Vaccine and Drug Development Act of 2005.
``(i) Definitions.--In this section:
``(1) Antitrust laws.--The term `antitrust laws'--
``(A) has the meaning given such term in subsection (a) of
the first section of this Act, except that such term includes
the Act of June 19, 1936 (15 U.S.C. 13 et seq.) (commonly
known as the Robinson-Patman Act), and section 5 of the
Federal Trade Commission Act (15 U.S.C. 45) to the extent
such section 5 applies to unfair methods of competition; and
``(B) includes any State law similar to the laws referred
to in subparagraph (A).
``(2) Covered activities.--
``(A) In general.--Except as provided in subparagraph (B),
the term `covered activities' means any group of activities
or conduct, including attempting to make, making, or
performing a contract or agreement or engaging in other
conduct, for the purpose of--
``(i) theoretical analysis, experimentation, or the
systematic study of phenomena or observable facts necessary
to the development of countermeasures or products;
``(ii) the development or testing of basic engineering
techniques necessary to the development of countermeasures or
products;
``(iii) the extension of investigative findings or theory
of a scientific or technical nature into practical
application for experimental and demonstration purposes,
including the experimental production and testing of models,
prototypes, equipment, materials, and processes necessary to
the development of countermeasures or products;
``(iv) the production, distribution, or marketing of a
product, process, or service that is a countermeasures or
products;
``(v) the testing in connection with the production of a
product, process, or services necessary to the development of
countermeasures or products;
``(vi) the collection, exchange, and analysis of research
or production information necessary to the development of
countermeasures or products; or
``(vii) any combination of the purposes described in
clauses (i) through (vi);
and such term may include the establishment and operation of
facilities for the conduct of covered activities described in
clauses (i) through (vi), the conduct of such covered
activities on a protracted and proprietary basis, and the
processing of applications for patents and the granting of
licenses for the results of such covered activities.
``(B) Exception.--The term `covered activities' shall not
include the following activities involving 2 or more persons:
``(i) Exchanging information among competitors relating to
costs, profitability, marketing, or distribution of any
product, process, or service if such information is not
reasonably necessary to carry out the purposes of covered
activities.
``(ii) Entering into any agreement or engaging in any other
conduct--
``(I) to restrict or require the sale, licensing, or
sharing of inventions, developments, products, processes, or
services not developed through, produced by, or distributed
or sold through such covered activities; or
``(II) to restrict or require participation by any person
who is a party to such covered activities in other research
and development activities, that is not reasonably necessary
to prevent the misappropriation of proprietary information
contributed by any person who is a party to such covered
activities or of the results of such covered activities.
``(iii) Entering into any agreement or engaging in any
other conduct allocating a market with a competitor that is
not expressly exempted from the antitrust laws by a
determination under subsection (g)(4).
``(iv) Exchanging information among competitors relating to
production (other than production by such covered activities)
of a product, process, or service if such information is not
reasonably necessary to carry out the purpose of such covered
activities.
``(v) Entering into any agreement or engaging in any other
conduct restricting, requiring, or otherwise involving the
production of a product, process, or service that is not so
expressly exempted from the antitrust laws by a determination
under subsection (g)(4).
``(vi) Except as otherwise provided in this subsection,
entering into any agreement or engaging in any other conduct
to restrict or require participation by any person who is a
party to such activities, in any unilateral or joint activity
that is not reasonably necessary to carry out the purpose of
such covered activities.
``(vii) Entering into any agreement or engaging in any
other conduct restricting or setting the price at which a
product is offered for sale, whether by bid or otherwise.
``(4) Development.--The term `development' includes the
identification of suitable compounds or biological materials,
the conduct of preclinical and clinical studies, the
preparation of an application for marketing approval, and any
other actions related to preparation of a countermeasure or
product.''.
SEC. 13. PROCUREMENT.
Section 319F-2 of the Public Health Service Act (42 U.S.C.
247d-6b) is amended--
(1) in the section heading, by inserting ``AND SECURITY
COUNTERMEASURE PROCUREMENTS'' before the period; and
(2) in subsection (c)--
(A) in the subsection heading, by striking ``Biomedical'';
(B) in paragraph (5)(B)(i), by striking ``to meet the needs
of the stockpile'' and inserting ``to meet the stockpile
needs'';
(C) in paragraph (7)(C)(ii)--
(i) by amending clause (I) to read as follows:
``(I) Payment conditioned on delivery.--The contract shall
provide that no payment may be made until delivery of a
portion, acceptable to the Secretary, of the total number of
units contracted for, except that, notwithstanding any other
provision of law, the
[[Page S11432]]
contract may provide that, if the Secretary determines (as
the Secretary's discretion) that an advance payment, partial
payment for significant milestones, or payment to increase
manufacturing capacity is necessary to ensure success of a
project, the Secretary shall pay an amount, not to exceed 10
percent of the contract amount, in advance of delivery. The
contract shall provide that such advance payment is required
to be repaid if there is a failure to perform by the vendor
under the contract. The contract may also provide for up to 3
additional advance payments of 5 percent each for meeting the
milestones specified in such contract. Provided that the
specified milestones are reached, these advanced payments of
5 percent shall not be required to be repaid. Nothing in this
subclause shall be construed as affecting the rights of
vendors under provisions of law or regulation (including the
Federal Acquisition Regulation) relating to the termination
of contracts for the convenience of the Government.''; and
(ii) by adding at the end the following:
``(VII) Sales exclusivity.--The contract may provide that
the vendor is the sole and exclusive supplier of the product
to the Federal Government for a specified period of time, not
to exceed 15 years, on the condition that the vendor is able
to satisfy the needs of the Government. During the agreed
period of sales exclusivity, the vendor shall not assign its
rights of sales exclusivity to another entity or entities
without approval by the Secretary.
``(VIII) Surge capacity.--The contract may provide that the
vendor establish domestic manufacturing capacity of the
product to ensure that additional production of the product
is available in the event that the Secretary determines that
there is a need to quickly purchase additional quantities of
the product. Such contract may provide a fee to the vendor
for establishing and maintaining such capacity in excess of
the initial requirement for the purchase of the product.
Additionally, the cost of maintaining the domestic
manufacturing capacity shall be an allowable and allocable
direct cost of the contract.
``(IX) Contract terms.--The Secretary, in any contract for
procurement under this section, may specify--
``(aa) the dosing and administration requirements for
countermeasures to be developed and procured;
``(bb) the amount of funding that will be dedicated by the
Secretary for research and development of the countermeasure;
and
``(cc) the specifications the countermeasure must meet to
qualify for procurement under a contract under this
section.''; and
(D) in paragraph (8)(A), by adding at the end the
following: ``Such agreements may allow other executive
agencies to order qualified and security countermeasures
under procurement contracts or other agreements established
by the Secretary. Such ordering process (including transfers
of appropriated funds between an agency and the Department of
Health and Human Services as reimbursements for such orders
for countermeasures) may be conducted under the authority of
section 1535 of title 31, United States Code, except that all
such orders shall be processed under the terms established
under the Biodefense and Pandemic Vaccine and Drug
Development Act of 2005 and the Project BioShield Act of
2004, for the procurement of countermeasures under section
319F-1 or 319F-2.''
SEC. 14. NATIONAL PATHOLOGY CENTER.
(a) In General.--Title IV of the Public Health Service Act
(42 U.S.C. 281 et seq.) is amended--
(1) in section 401(b)(2), by adding at the end the
following:
``(H) The National Pathology Center.''; and
(2) by adding at the end of part E (42 U.S.C. 287 et seq.)
the following:
``Subpart 7--National Pathology Center
``SEC. 485A. ESTABLISHMENT OF NATIONAL PATHOLOGY CENTER.
``In order to provide pathology consultation for civilian
and military health professionals (including Department of
Veterans Affairs health professionals) there is established
the National Pathology Center (in this subpart referred to as
the `Center'). The Center shall be headed by a director, who
shall be appointed by the Secretary. The Director of the
Center shall report directly to the Director of NIH.
``SEC. 485B. PURPOSES AND FUNCTIONS OF THE CENTER.
``(a) Purposes of the Center.--The general purposes of the
Center are to--
``(1) conduct and support research, education, training,
and other programs with respect to the science and clinical
practice of pathology;
``(2) maintain and improve a pathology tissue repository;
and
``(3) provide pathology consultation services.
``(b) Activities of the Director.--In order to carry out
the purposes of the Center described in subsection (a), the
Director of the Center--
``(1) shall--
``(A) maintain and improve a comprehensive repository of
pathological specimens;
``(B) provide consultations on request regarding clinical
cases;
``(C) conduct educational programs and publish educational
materials on the science and clinical practice of pathology;
``(D) maintain and improve registries on such clinical
conditions as the Director of the Center determines
appropriate; and
``(E) conduct and support research on pathology; and
``(2) may--
``(A) collect reasonable and appropriate fees for the
activities described in paragraph (1)(B); and
``(B) conduct such other activities as the Director of the
Center determines appropriate to carry out the purposes
described in subsection (a).
``(c) Authority for Expert Opinions.--The Director of the
Center may enter into memoranda of understanding with
officials at the Department of Veterans Affairs and the
Department of Defense to provide expert second opinion
pathology consultations and pathology education or training
if the Secretary of either such Department determines that
such provision would be in the best interest of either of
their respective departments.
``SEC. 485C. BOARD OF REGENTS.
``(a) Membership.--
``(1) In general.--There is established a Board of Regents
of the Center (in this subpart referred to as the `Board')
consisting of--
``(A) the Surgeons General of--
``(i) the Public Health Service;
``(ii) the Army;
``(iii) the Navy; and
``(iv) the Air Force;
``(B) the Chief Medical Director of the Department of
Medicine and Surgery of the Department of Veterans Affairs;
``(C) the Deputy Director of the National Library of
Medicine;
``(D) the Assistant Secretary of Health of the Department
of Defense;
``(E) the Dean of the Uniformed Services University of the
Health Sciences; and
``(F) 11 members to be appointed by the Secretary from
among leaders in pathology research, education and clinical
practice.
``(2) Ex officio members.--The members of the Board
described in subparagraphs (A) through (E) of paragraph (1)
shall serve as ex officio members of the Board.
``(3) Chairperson.--The members of the Board appointed
under paragraph (1)(F) shall annually elect one of such
members to serve as the Chairperson of the Board until the
next election.
``(b) Duties of the Board.--It shall be the duty of the
Board to advise, consult with, and make recommendations to
the Director of NIH on important matters of policy in regard
to the Center, including such matters as the scope, content
and organization of the research, education and consultative
services provided by the Center. The Board shall make
recommendations to the Director of NIH regarding the rules
under which specimens from the tissue repository will be used
and under which it's publications, facilities and services
will be made available to various kinds of users.
``(c) Terms of Office.--Each appointed member of the Board
shall hold office for a term of 4 years, except that any
member appointed to fill a vacancy occurring prior to the
expiration of the term for which the predecessor of such
member was appointed shall be appointed for the remainder of
such term. None of the appointed members shall be eligible
for reappointment within 1 year after the end of the
preceding term of such member.
``(d) Compensation.--Appointed members of the Board who are
not otherwise in the employ of the United States, while
attending conferences of the Board or otherwise serving at
the request of the Secretary in connection with the
administration of the Board, shall be entitled to receive
compensation, per diem in lieu of subsistence, and travel
expenses in the same manner and under the same conditions as
that prescribed under section 208(c).
``SEC. 485D. GIFTS TO THE CENTER.
``Section 231 shall be applicable to the acceptance and
administration of gifts made for the benefit of the Center or
for carrying out any of its functions.
``SEC. 485E. CENTER FACILITIES.
``There are authorized to be appropriated amounts
sufficient for the erection and equipment of suitable and
adequate buildings and facilities for use of the Center. The
Administrator of General Services may acquire, by purchase,
condemnation, donation, or otherwise, a suitable site or
sites, selected by the Secretary in accordance with the
direction of the Board, for such buildings and facilities and
to erect thereon, furnish, and equip such buildings and
facilities. The amounts authorized to be appropriated by this
section include the cost of preparation of drawings and
specifications, supervision of construction, and other
administrative expenses incident to the work. The
Administrator of General Services shall prepare the plans and
specifications, make all necessary contracts, and supervise
construction.''.
(b) Report.--Not later than 12 months after the date of
enactment of this Act, the Secretary of Health and Human
Services shall submit a report to the appropriate committees
of Congress that contains--
(1) a review of all functions and duties of the National
Pathology Center under subpart 7 of part E of title IV of the
Public Health Service Act,as established by subsection (a);
(2) areas where such functions and duties overlap with the
functions and duties of the National Institutes of Health;
and
(3) recommendations concerning necessary modifications to
the National Pathology Center.
(c) Transfer of the Armed Forces Institute of Pathology.--
[[Page S11433]]
(1) In general.--
(A) In general.--Except as provided in subparagraph (B),
there are transferred to the National Pathology Center
established under subpart 7 of part E of title IV of the
Public Health Service Act all functions, duties, personnel,
assets, liabilities, contracts, property, records, and
unexpended balances of appropriations of the Armed Forces
Institute of Pathology. The preceding sentence shall not
affect any proceedings, pending applications, suits, or other
actions pending on the date of enactment of this Act.
(B) Exceptions.--The following components of the Armed
Forces Institute of Pathology shall not be transferred from
the Department of Defense pursuant to subparagraph (A):
(i) The Armed Forces Medical Examiner.
(ii) The Department of Defense DNA registry.
(iii) Accident Investigation Program.
(iv) The histopathology training program.
(v) The patient safety center.
(vi) Department of Legal Medicine.
(vii) Center for Clinical Laboratory Medicine.
(viii) Drug Testing and Quality Assurance Program.
(ix) Subject to the discretion of the Secretary of Defense,
medical research programs on the following:
(I) Body armor.
(II) Environmental sarcoidosis.
(III) Depleted uranium.
(IV) Military working dogs.
(V) Such other areas of research related to pathology as
the Secretary of Defense shall choose to conduct.
(2) References.--Any reference in any Federal law,
Executive order, rule, regulation, or delegation of
authority, or any document of or relating to the Armed Forces
Institute of Pathology shall be deemed to be a reference to
the National Pathology Center established under subpart 7 of
part E of title IV of the Public Health Service Act.
______
By Mrs. FEINSTEIN:
S. 1874. A bill to amend title 28, United States Code, to clarify
jurisdiction of Federal Courts over a tort action brought by an alien,
and for other purposes; to the Committee on the Judiciary.
Mrs. FEINSTEIN. Mr. President, I am pleased to introduce legislation
that clarifies the meaning and scope of the Alien Tort Statute.
This 200-year-old law has spawned dozens of legal cases involving
U.S. multinational companies, human rights groups, foreign plaintiffs,
the State Department, and millions of dollars in litigation costs.
Numerous companies in California are in the midst of these lawsuits as
defendants and it is my view that legislation can help refine and
improve the law.
Judges have grappled in interpreting and applying the statute for
years now without a consensus view emerging. I think it would be fair
to say that confusion reigns supreme when it comes to alien tort suits.
Given this opaque legal picture, last summer the Supreme Court ruled
on a case, Sosa v. Alvarez Machain, in an attempt to reconcile
conflicting decisions from judges across the country.
The Court's June 2004 ruling was notable, for embracing certain
principles that will help guide the Judiciary branch on alien tort
claim issues but for leaving many questions unanswered as well.
It held that a substantive, legal basis exists for foreigners to sue
U.S. individuals and corporations over alleged human rights violations
occurring in overseas locations. The Court essentially affirmed that a
limited, implicit sanction for courts exists to decide certain alien
tort claims.
At the same time, the opinion provided a wide berth for what the
claims might actually be. The Court hedged on key issues, without
clearly demarcating what suits ought to go forward under the statute
and which ones should be summarily dismissed.
In particular the ruling did not address: which international law
claims by foreigners should be heard in a U.S. district court, and the
standard of liability for U.S. companies facing these human rights
charges.
To clarify these areas, the Justices wrote that they would welcome
``any congressional guidance'' on the breadth of the statute. During
oral arguments a number of the Justices appeared to concur that a
legislative approach would make sense. One Justice even commented that
``I just wonder if it isn't wise to . . . let Congress have a look at
this thing.''
Those views were echoed by a Washington Post editorial that followed
soon after. The paper stated that the alien tort law has ``formed the
basis for litigation against U.S. companies involved with nefarious
regimes abroad. And while horrid conduct by an American company ought
to be, where proven, grounds for action in American courts, the
parameters of such litigation are surely a legislative question, not
one for the freewheeling discretion of judges. . . . But the court left
open the possibility that at least some of these suits can proceed in
the absence of further congressional action.''
The Court's perspective, along with the Post commentary, indicates,
at least to me, a sense of caution about imposing by judicial fiat
action that is better left to consideration and refinement by the
Congress.
The Court's hesitation to legislate from the bench shifts the
responsibility to this body, I believe, to pass legislation that
settles on a reasonable legal means that plaintiffs and defendants
alike can rely on to litigate their differences.
I believe the measure we are introducing today accomplishes this
basic and important goal.
Right now, courts are essentially adrift in terms of being able to
pinpoint the underlying meaning, scope and intent of this 200-year-old
statute. In its entirety, it reads: ``The district courts shall have
original jurisdiction of any civil action by an alien for a tort only,
committed in violation of the law of nations or a treaty of the United
States.''
The economy of words makes the law abstruse and subject to varying
interpretation. And complex, lengthy and unnecessary litigation has
burdened the courts as a result.
This new bill will establish a fair, legal basis for filing suit
under the Alien Tort Statute (ATS). And it will have the added benefit
of explicating the law's dual jurisdictional and substantive nature.
The measure: specifies a legal standard convicting defendants of
wrongdoing if they directly participate with specific intent to commit
the alleged tort; codifies international claims under the Alien Tort
law to include genocide, torture, slavery and slave trade,
extrajudicial killing, and piracy; expands on existing statutory law,
the Torture Victim Protection Act; states that Federal courts shall not
proceed with tort claims when the President adequately certifies that
such exercise of jurisdiction will have a negative impact on the
foreign policy interests of the U.S.; maintains that every effort
should be made to try these cases in the country of origin before
granting jurisdiction in U.S. courts; invokes a 10-year statute of
limitations on ATS charges filed against U.S. multinational companies;
and disallows contingency fee arrangements for legal representatives of
plaintiffs or defendants.
The Supreme Court's delineation that the Alien Tort law is
jurisdictional in one sense, but recognizes a restricted category of
substantive claims encompassed by the law of nations, leaves many
unresolved questions.
The historical origins of the ATS, passed by the First Congress as
part of the Judiciary Act of 1789, suggest that certain offenses
relevant to that period in American history--piracy, infringing the
rights of ambassadors, and prevention of safe travel abroad--were meant
to be prosecutable. But Justice Souter's Alvarez-Machain opinion notes
that a slim legislative history of the statute makes it difficult to
surmise the law's true intent.
At the same time, Justice Souter opined: ``Still, the history does
tend to support two propositions. First, there is every reason to
suppose that the First Congress did not pass the ATS as a
jurisdictional convenience to be placed on the shelf for use by a
future Congress or state legislature that might, some day, authorize
the creation of causes of action or itself decide to make some element
of the law of nations actionable for the benefit of foreigners. The
anxieties of the preconstitutional period cannot be ignored easily
enough to think that the statute was not meant to have a practical
effect. . . . The second inference to be drawn from the history is that
Congress intended the ATS to furnish jurisdiction for a relatively
modest set of actions alleging violations of the law of nations.''
The opinion ranges further, that, such a ``modest set of actions''
indeed applies to current times, not merely offenses grounded in law
two hundred
[[Page S11434]]
years ago. The critical portion reads: ``Accordingly, we think courts
should require any claim based on the present-day law of nations to
rest on a norm of international character accepted by the civilized
world and defined with specificity comparable to the features of the
18th century paradigms we have recognized.''
I am uncomfortable with such a nebulous, open-ended legal approach
permitting courts to entertain suits based on a ``norm of international
character'' and ``specificity'' consistent with crimes of early
American history. Adjudicating cases based on these broad historical
and legal precepts is admirable. In practical terms it remains very
difficult.
The Congress ought to weigh in and play a constructive role. Without
legislation, judges will continue to reach markedly different
conclusions under the law, based on arbitrary interpretations of case-
specific facts and other considerations.
Let's take the legal mystery out of the statute and what qualifies as
an alien tort and replace it with something that is concrete and
appropriate for the times.
At the heart of this legislation is codifying a class of violations
of international law that will discourage defendant companies from
consorting with human rights violators in any respect. They will be
held liable if they do so by a specific standard that judges whether
they intentionally and directly caused certain violations of human
rights.
A plaintiff victim will be able to vindicate their rights by filing
an express statutory cause of action based on a half dozen egregious
wrongs. Regardless of the foreign policy and trade implications,
defendant U.S. companies will be held fully accountable under the bill
for bad corporate behavior in their overseas business operations.
That is as it should be. Certain alien torts in violation of the law
of nations ought to be cognizable and this legislation ensures that
result. Moreover, the fact that specific crimes are made actionable and
enforceable will aid human rights organizations in their fight to
strengthen the deterrent effect of the law for potential violators.
Regarding the defendant perspective, in one friend of the court brief
submitted in the Alvarez Machain case, the argument was made that ``. .
. companies face enormous uncertainty regarding the scope of potential
claims under the statute. . . . Because ATS cases are based upon an
implied cause of action without any clear standards of liability, there
may be little companies can do to protect themselves against potential
claims, short of simply ceasing to do business in the many nations
whose human rights practices come up short against evolving Western
ideals.''
The business community ought to embrace this legislation precisely
because it wipes away this uncertainty. The best way to encourage U.S.
multinationals to invest abroad is: 1. by specifying a universe of the
most egregious human rights violations that they may be held liable for
and 2. offering a clear, understandable legal standard that judges
their actions accordingly. This legislative measure tackles both issues
head on.
There are estimates that dozens of existing alien tort suits claim
damages--collectively--in excess of $200 billion dollars. That's an
extraordinary sum that rightly concerns the U.S. business community,
particularly given numerous inconsistent federal courts verdicts handed
down in the past two decades.
This legislation deters private plaintiffs from filing sweeping and
specious claims simply because a corporation has a U.S. legal nexus and
deep pockets. Yet, it expands the basis for foreign plaintiffs pursuing
certain international law causes of action in federal court by
codifying their rights in a judicious way.
While some in the U.S. business community would prefer that the Alien
Tort statute be deleted from the U.S. Code altogether, I would
respectfully disagree. A fair compromise that balances the interests of
U.S. companies and human rights organizations is what this legislation
seeks to accomplish.
The Congress has waded into this debate before, passing the Torture
Victim Protection Act in 1991, and this new legislation contains many
similar elements: a statute of limitations, a statutory exhaustion
provision, and specifying torture and extrajudicial killing as within
the adjudicatory discretion of a district court.
There is precedent, then, for the Legislative branch acting to
provide civil redress for victims of torture. Asserting
extraterritorial jurisdiction under the ATS, for torture and other jus
cogen violations, has a firm footing in American jurisprudence.
The legislative history of the TVPA is important because it spells
out the constitutional grounds justifying that statutory law and this
new legislation as well.
The Senate Judiciary Committee report on the TVPA states as follows:
``Under article III of the Constitution, the Federal judiciary has the
power to adjudicate cases `arising under' the `law of the United
States.' The Supreme Court has held that the law of the United States
includes international law. . . . Congress's ability to enact this
legislation also derives from article I, section 8 of the Constitution
which authorizes Congress `to define and punish . . . Offenses against
the Law of Nations.' ''
Existing case law confirms the point that Congress has given the
federal courts the power to interpret and apply international human
rights law. The notable Paquete Habana decision states, in part, that
``international law is part of our law, and must be ascertained and
administered by the courts of justice of appropriate jurisdiction, as
often as questions of right depending upon it are duly presented for
their determination. . . Congress, however, has not only expressed no
disagreement with our view of the proper exercise of the judicial
power, but has responded to its most notable instance by enacting
legislation [the Torture Victim Protection Act] supplementing the
judicial determination in some detail.''
The view expressed in the Alvarez Machain case last year was much the
same, that no development in the last two centuries has ``categorically
precluded federal courts from recognizing a claim under the law of
nations as an element of common law.''
Different precedent, Tel Oren v. Libyan Arab Republic, also posits
that civil liability should ensue from certain violations of
international law, suggesting that the ``limits of section 1350's [the
ATS] reach'' be defined by ``a handful of heinous actions--each of
which violates definable, universal and obligatory norms.''
This legislation fills that legal vessel with the most egregious
crimes: genocide, torture, slavery and slave trading, extrajudicial
killing, and piracy. These jus cogen offenses are singled out through
1. stare decisis, 2. the Restatement (Third) of Foreign Relations Law,
3. academic writings, 4. official annual human rights assessments from
the State Department and 5. among the writings and publications of many
human rights and international law advocacy groups.
Congress is in the best position to make the determination of what
falls within the ambit of the statute, not judges across America who
lack expertise, time, and resources to assess what constitutes
definable, specific, universal, and obligatory norms of international
law. The bill, I would submit, represents a good faith effort in
permitting these tortious acts, all firmly established and well defined
in international law norms, to be prosecuted in U.S. district courts.
I was interested to read the views last year of the head of the
National Foreign Trade Council, William Reinsch, that ``these cases are
going to end up in the Supreme Court . . . and the Court will over time
end up defining what in its judgment constitutes the law of nations and
what does not. But that seems to us a fairly circuitous way of doing
things.'' I would concur, particularly since the Supreme Court's
decision last year in the Alvarez Machain case did not clear up the
inherent vagaries in the law.
A significant provision in this legislation creates a standard of
liability that requires plaintiffs to show that a defendant directly
participated with specific intent in carrying out the alleged tort. In
my view, we need to deter legal fishing expeditions, whereby plaintiffs
come to the bar with flinty facts backing weak charges.
[[Page S11435]]
Their real intent, it seems, is to rely on an extensive legal discovery
process to uncover matters that embarrass companies and delay their
business plans.
In the groundbreaking 1980 Filartiga v. Pena-Irala case, for example,
the threshold requirement laid out was that the offense needed to be
``clear and unambiguous'' to be viable under the statute. Succeeding
cases have affirmed a standard essentially requiring proof of a
defendant aiding and abetting the worst human rights violations. This
bill replaces the current aiding and liability standard for good
reason: these foreign-based claims demand a particularity of facts that
is both strong and specific.
I would submit that the existing ambiguous grant of jurisdiction
needs more refinement to provide judges legal bright lines for deciding
these cases. My bill offers precise, and fair, treatment for which
cases get standing in a U.S. court.
A common theme in dozens of cases alien tort cases is whether the
facts and law combine to present a nonjusticiable political question.
Each cause of action is obviously different, and whether the matter
ought to be under the province of a different branch of government
requires careful analysis.
I would certainly agree that certain prudential doctrines, act of
state, political question, foreign sovereign immunity, forum non
conveniens, and considerations of comity among nations, at times can be
appropriately invoked to limit jurisdiction.
Part of that consideration can usefully come from statements of
interest and certifications submitted by the Executive branch; for that
reason, the legislation I'm offering preserves a suitable role for the
Executive branch to weigh in. If a judge determines that a
certification offered by the State Department adequately justifies that
harm will come to U.S. foreign policy interests if an alien tort suit
proceeds, then dismissal is warranted.
In regards to restricting the statute of limitations to ten years,
equitable tolling considerations should be explicitly considered in
interpreting provisions in the legislation. There are numerous factors
that give rise to equitable tolling and long-established judge-made
doctrine in this area is not inconsistent with the goals of my bill.
Complementary legislation which I raised earlier, the Torture Victim
Protection Act, upholds the principle of equitable tolling. The
Judiciary Committee report on that measure notes some common examples:
``The statute of limitation should be tolled during the time the
defendant was absent from the United States or from any jurisdiction in
which the same or a similar action arising from the same facts may be
maintained by the plaintiff, provided that the remedy in that
jurisdiction is adequate and available. Excluded also from calculation
of the statute of limitations would be the period when a defendant has
immunity from suit. The statute of limitations should also be tolled
for the period of time in which the plaintiff is imprisoned or
otherwise incapacitated.''
I would submit that all of these listed circumstances, and others,
are sufficient to suspend the running of the time under my legislation.
Let me conclude by referring back to one of the Supreme Court's
foundational points in the Alvarez-Machain case that ``despite
considerable scholarly attention, it is fair to say that a consensus
understanding of what Congress intended has proven elusive.''
The 33 words contained in the law remain a ``legal Lohengrin'' since
``no one seems to know whence it came'' added a judge hearing a
different case some years ago. As a result, costly, complex litigation
proceeds forward across the country.
Courts deserve guidance from Congress about how to treat and
interpret the statute, particularly in light of the growing importance
of international trade and commerce. In a major address Supreme Court
Justice O'Connor recently observed that ``international law has emerged
in ways that affect all courts, both here and abroad. The reason is
globalization. Its importance should not be underestimated. Thirty
percent or more of our gross domestic product is internationally
derived.'' Yet these particular suits, brought by foreigners for
massive monetary damages, threaten the international economic
activities that are important to sustaining the American economy.
The suits should be able to go forward, but judges need better legal
tools to make heads or tails of the cases that come before them hence
the motivation for introducing the Alien Tort Statute Reform Act.
With full understanding of the Supreme Court's admonition to act with
judicial caution in framing the alien tort statute, I believe it is
time for Congress to bring clarity to the law and this proposed
legislation does so.
I look forward to working with colleagues on the Judiciary Committee,
through the hearing process and other means, to give this matter
serious consideration by the Legislative branch.
I ask unanimous consent that the text of the legislation be printed
in the Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 1874
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Alien Tort Statute Reform
Act''.
SEC. 2. SUITS BY ALIENS.
Section 1350 of title 28, United States Code, is amended to
read as follows:
``Sec. 1350. Alien's action for tort
``(a) Jurisdiction of District Courts.--The district courts
shall have original and exclusive jurisdiction of any civil
action brought by an alien asserting a claim of torture,
extrajudicial killing, genocide, piracy, slavery, or slave
trading if a defendant is a direct participant acting with
specific intent to commit the alleged tort. The district
courts shall not have jurisdiction over such civil suits
brought by an alien if a foreign state is responsible for
committing the tort in question within its sovereign
territory.
``(b) Definitions.--For the purposes of this section:
``(1) Defendant.--The term `defendant' means any person
subject to the jurisdiction of the district courts of the
United States, including--
``(A) a United States citizen;
``(B) a natural person who is a permanent resident of the
United States;
``(C) a natural person who resides in the United States; or
``(D) a partnership, corporation, or other legal entity
organized under the laws of the United States or of a foreign
state.
``(2) Foreign state.--The term `foreign state' has the
meaning given that term in section 1603 of title 28, United
States Code.
``(3) Extrajudicial killing.--The term `extrajudicial
killing'--
``(A) means a deliberated killing, which--
``(i) notwithstanding the jurisdictional limitations
referred to in subsection (a), is carried out by an
individual under actual or apparent authority, or color of
law, of any foreign state;
``(ii) is directed against another individual in the
offender's custody or physical control; and
``(iii) is not authorized by a previous judgment pronounced
by a regularly constituted court affording all the judicial
guarantees which are recognized as indispensable by civilized
peoples; and
``(B) does not include any such killing that, under
international law, is lawfully carried out under the
authority of a foreign state.
``(4) Genocide.--The term `genocide' means, whether in time
of peace or in time of war, an act carried out, or an attempt
to carry out an act, with the specific intent to destroy, in
whole or in substantial part, a national, ethnic, racial, or
religious group as such, which--
``(A) kills members of that group;
``(B) causes serious bodily injury to members of that
group;
``(C) causes the permanent impairment of the mental
faculties of members of the group through drugs, torture, or
similar techniques;
``(D) subjects the group to conditions of life that are
intended to cause the physical destruction of the group in
whole or in part;
``(E) imposes measures intended to prevent births within
the group; or
``(F) transfers by force children of the group to another
group.
``(5) Piracy.--The term `piracy' means--
``(A) any illegal acts of violence or detention, or any act
of depredation, committed for private ends by the crew or the
passengers of a private ship or a private aircraft, and
directed--
``(i) on the high seas, against another ship or aircraft,
or against persons or property on board such ship or
aircraft; or
``(ii) against a ship, aircraft, persons, or property in a
place outside the jurisdiction of any country;
``(B) any act of voluntary participation in the operations
of a ship or of an aircraft with knowledge of facts making it
a pirate ship or aircraft; or
``(C) any act of inciting or of intentionally facilitating
an act described in subparagraph (A) or (B).
[[Page S11436]]
``(6) Slave trading.--The term `slave trading' includes--
``(A) all acts involved in the capture, acquisition, or
disposal of a person with intent to reduce such person to
slavery;
``(B) all acts involved in the acquisition of a slave with
a view to selling or exchanging such slave;
``(C) all acts of disposal by sale or exchange of a slave
acquired with a view to being sold or exchanged; and
``(D) in general, every act of trade or transport of
slaves.
``(7) Slavery.--The term `slavery' means the status or
condition of a person over whom any or all of the powers
attaching to the right of ownership are exercised.
``(8) Torture.--
``(A) In general.--Notwithstanding the jurisdictional
limitations referred to in subsection (a), the term `torture'
means any act, carried out by an individual under actual or
apparent authority, or color of law, of any foreign state,
directed against another individual in the offender's custody
or physical control, by which severe pain or suffering (other
than pain or suffering arising only from or inherent in, or
incidental to, lawful sanctions), whether physical or mental,
is intentionally inflicted on that individual for such
purposes as obtaining from that individual or a third person
information or a confession, punishing that individual for an
act that individual or a third person has committed or is
suspected of having committed, intimidating or coercing that
individual or a third person, or for any reason based on
discrimination of any kind.
``(B) Mental pain or suffering.--In subparagraph (A),
mental pain or suffering refers to prolonged mental harm
caused by or resulting from--
``(i) the intentional infliction or threatened infliction
of severe physical pain or suffering;
``(ii) the administration or application, or threatened
administration or application, of mind altering substances,
or other procedures calculated to disrupt profoundly the
senses or the personality;
``(iii) the threat of imminent death; or
``(iv) the threat that another individual will imminently
be subjected to death, severe physical pain or suffering, or
the administration or application of mind altering substances
or other procedures calculated to disrupt profoundly the
senses or personality.
``(c) Liability for Damages.--Any defendant who is a direct
participant acting with specific intent to commit a tort
referred to in subsection (a) against an alien shall be
liable for damages to that alien or to any person who may be
a claimant in an action for the wrongful death of that alien.
``(d) Exhaustion of Remedies.--A district court shall
abstain from the exercise of jurisdiction over a civil action
described in subsection (a) if the claimant has not exhausted
adequate and available remedies in the place in which the
injury occurred. Adequate and available remedies include
those available through local courts, claims tribunals, and
similar legal processes.
``(e) Foreign Policy Interests of the United States.--No
court in the United States shall proceed in considering the
merits of a claim under subsection (a) if the President, or a
designee of the President, adequately certifies to the court
in writing that such exercise of jurisdiction will have a
negative impact on the foreign policy interests of the United
States.
``(f) Procedural Requirements.--
``(1) Specificity.--In any action brought under this
section, the complaint shall state with particularity
specific facts that--
``(A) describe each tort alleged to have been committed and
demonstrate the reason or reasons why the tort action may be
brought under this section, provided that if an allegation is
made on information and belief, the complaint shall state
with particularity all facts on which that belief is formed;
and
``(B) demonstrate that the defendant had the specific
intent to commit the tort alleged to have been committed.
``(2) Motion to dismiss.--In any action brought under this
section, the court shall, on the motion of any defendant,
dismiss the complaint if the requirements of subparagraphs
(A) and (B) of paragraph (1) are not met.
``(3) Stay of discovery.--In any action brought under this
section, all discovery related to the merits of the claim and
other proceedings shall be stayed during the pendency of any
motion to dismiss, unless the court finds upon the motion of
any party that particularized discovery is necessary to
preserve evidence or to prevent undue prejudice to that
party.
``(4) Plaintiff identity.--
``(A) Requirement.--Subject to subparagraph (B), in any
action brought under this section, the first and last names
of all plaintiffs shall be disclosed in the complaint filed
with the court.
``(B) Exception.--A court may permit an anonymous filing of
a complaint if a plaintiff's life or safety would be
endangered by publicly disclosing the plaintiff's identity.
``(g) Fees.--Contingency fee arrangements are prohibited in
any action brought under the jurisdiction provided in this
section.
``(h) Statute of Limitations.--No action shall be
maintained under this section unless it is commenced not
later than 10 years from the date the injury occurred.
``(i) Application of Other Laws.--Nothing in this section
may be construed to waive or modify the application of any
provision of the Class Action Fairness Act of 2005 (Public
Law 109-2; 119 Stat. 4) and any amendment made by that Act,
or of title 28, United States Code, to any class action law
suit brought under this section.''.
______
By Mr. BINGAMAN:
S. 1875. A bill to provide financial aid to local law enforcement
officials along the Nation's borders, and for other purposes; to the
Committee on the Judiciary.
Mr. BINGAMAN. Mr. President, I rise today to introduce the Border Law
Enforcement Relief Act of 2005. This bill will provide local law
enforcement in border communities with much needed assistance in
combating border-related criminal activity. For far too long, law
enforcement agencies operating along the border have had to incur
significant costs due to the inability of the Federal Government to
secure our Nation's borders. It is time that the Federal Government
recognizes that border communities should not have to bear this burden
alone.
The bill I am introducing today is aimed at enhancing security in the
border region by giving law enforcement agencies the manpower and
resources they need to combat border-related crimes. Specifically, the
bill would establish a competitive grant program within the Department
of Homeland Security to help local law enforcement situated along the
border cover some of the costs they incur as a result of dealing with
illegal immigration, drug trafficking, stolen vehicles, and other
border-related crimes, and authorizes $30 million a year to carry out
the program. Funds allocated under the grant program could be used to
hire additional personnel, obtain necessary equipment, upgrade law
enforcement technology, and cover overtime and transportations costs.
Law enforcement agencies serving communities within 100 miles of the
U.S. border with Mexico or Canada, as well as any other agencies
located outside of this geographical limit located in an area which has
been designated by the Secretary of Homeland Security as a ``High
Impact Area,'' would be eligible to apply for the grants. Priority in
awarding grants would go to law enforcement agencies serving
communities with populations under 50,000. Two-thirds of the funds
would be set aside for the six states with the highest alien
apprehension rates and one-third for areas designated as ``High Impact
Areas.''
It is the responsibility of the Federal Government to adequately
secure the Nation's borders and prevent the flow of undocumented
persons and illegal drugs into the country. Despite the fact that the
Border Patrol apprehends over 1 million people each year trying to
illegally enter the United States, the number of illegal aliens in the
United States continues to rise as thousands of individuals enter the
country through our porous borders. The border region is also a major
corridor for the shipment of drugs--according to the El Paso
Intelligence Center, 65 percent of the narcotics that are sold in the
United States enter the country through the Southwest border.
By virtue of their proximity to an international border, many of
adverse consequences of the failure of the Federal Government to
adequately secure the border fall on the border communities. In
traveling around the New Mexico-Mexico border region, I have heard
repeatedly how drug trafficking, kidnappings, human smuggling, and the
destruction of private property, such as the tearing down ranchers'
cattle fences, are impacting our communities.
The United States shares 5,525 miles of border with Canada and 1,989
miles with Mexico. Many of the local law enforcement agencies located
along the border are small, rural departments charged with patrolling
large areas of land with few officers and very limited resources.
Counties along the Southwest border are some of the poorest in the
country and are not in the position to cover the additional costs
associated with illegal immigration, drug trafficking, and other
border-related crimes.
According to a 2001 study by the United States-Mexico Border Counties
Coalition, local law enforcement and criminal justice costs associated
with illegal immigration exceed $89 million every year. The States of
Arizona and New Mexico have declared states of emergency in order to
provide local
[[Page S11437]]
law enforcement with immediate assistance in addressing criminal
activity along the border. It is time that the Federal Government step
up and share some of this burden.
We are making some headway in terms of increasing the number of
Border Patrol agents along the border. Despite the fact that the
administration only requested funding to hire an additional 210 Border
Patrol agents in its 2006 Budget Request, Congress has appropriated
enough funding to hire and train an additional 1,500 agents. We are
making some progress, and I am pleased that additional agents have been
sent to New Mexico, but we must face the reality that much more needs
to be done and we are a long way off from securing our borders and
preventing the illegal flow of drugs and undocumented person into this
country. I believe that this is an area that Congress can, and should,
be doing more.
We need more Border Patrol agents, better technology, and a
comprehensive strategy to meet our security needs. We also need to
reform our broken immigration system so we are able to more effectively
target those who pose a threat to our country. However, we must also
remember the role local law enforcement play in responding to criminal
activity that occurs in the border region. Increasing funding for local
law enforcement will help border communities alleviate some of these
problems and enhance security in the border region.
Federal assistance is desperately needed to help border law
enforcement agencies address the unique challenges that arise from
being situated along an international border and the lack of overall
border security. I urge my colleagues to lend their support to this
important bill and give law enforcement the resources they need to meet
these challenges.
______
By Mr. AKAKA:
S. 1878. A bill to prohibit predatory payday loans, and for other
purposes; to the Committee on Banking, Housing, and Urban Affairs.
______
By Mr. AKAKA:
S. 1879. A bill to amend title 11, United States Code, to limit
claims in bankruptcy by certain unsecured creditors; to the Committee
on the Judiciary.
Bankruptcy Reform Implementation
Mr. AKAKA. Mr. President, I opposed the bankruptcy reform bill
because it was an outdated bill that failed to include adequate
consumer protections. We saw a record number of consumer bankruptcy
filing prior to the October 17 implementation deadline for the harsh
new bankruptcy. Not enough was included in the legislation to protect
consumers from predatory lenders or to make credit counseling a viable
alternative to bankruptcy or to better inform over extended consumers
about the true costs of their debts. I was disappointed that the Senate
failed to effectively address these issues in a meaningful way, and
instead, passed an outdated bill that forces working families into more
costly and difficult bankruptcy proceedings. I am committed to making
improvements in this flawed law.
Today, I am introducing two bills that address flaws in the
bankruptcy reform law. The first bill is the Predatory Payday Loan
Prohibition Act. This bill would prevent federally-insured financial
institutions from originating predatory payday loans. Payday loans are
small cash loans repaid by borrowers' postdated checks or borrowers'
authorizations to make electronic debits against existing financial
accounts. Payday loan amounts are usually in the range of $100 to $500
with full payment due in 2 weeks. Finance charges on payday loans are
typically in the range of $15 to $30 per $100 borrowed, which
translates into triple digit interest rates in the range of 390 percent
to 780 percent when expressed as an annual percentage rate. Loan
flipping, which is a common practice, is the renewing of loans at
maturity by paying additional fees without any principal reduction.
Loan flipping often leads to instances where the fees paid for a payday
loan well exceed the principal borrowed. This situation often creates a
cycle of debt that is hard to break.
Industry analysts conservatively estimate that more than 15,000
payday advance locations across America extend about $25 billion in
short-term credit to millions of households experiencing cash-flow
shortfalls. Too many of its customers are low-income, working families.
More and more customers are the financially stretched middle class,
including people who have maxed out their credit cards, people perhaps
who have lost a job, or people with no savings to fall back on during a
situation that causes a cash-flow shortfall, such as a medical
emergency.
Payday lending is also rampant in the military. One in five
servicemembers have used payday lenders in the last year, according to
the report, ``Payday Lenders Target the Military,'' by the Center for
Responsible Lending. Payday lenders exploit people in financial need
and profit enormously from these loans. We must act to protect
vulnerable consumers from these predatory lenders.
In addition, I previously introduced S. 1347, the Low-Cost
Alternatives to Payday Loans Act. This bill would authorize award
demonstration project grants for eligible entities to provide consumers
with low-cost, small loan alternatives to more costly and predatory
payday loans. Loan alternatives that meet the needs of consumers and
are at a fair price must be developed.
Today, I am also introducing the Bankruptcy Prevention Credit
Counseling Act. The new bankruptcy reform law does not allow consumers
to declare personal bankruptcy in either chapter 7 or chapter 13,
unless they receive a briefing from an approved nonprofit credit
counseling agency within 6 months of filing. The credit counseling
instructional course requirement is intended to provide financial
education to consumers who declare bankruptcy so they can attempt to
avoid future financial problems.
About one in three consumers in credit counseling enter a debt
management plan. In exchange, creditors may agree to concessions so
that consumers pay off as much of their outstanding debt as possible.
Examples of concessions can include a reduced interest rate on the
amount they owe and the elimination of fees. Unfortunately, most credit
card companies have become increasingly unwilling to significantly
reduce interest rates for consumers in credit counseling.
The Bankruptcy Prevention Credit Counseling Act would prevent
unsecured creditors, primarily credit card issuers, from attempting to
collect accruing interest and additional fees from consumers in
bankruptcy, if the creditor does not have a policy of waiving interest
and fees for debtors who enter a consolidated payment plan at a credit
counseling agency. Since the new bankruptcy law requires that consumers
enter credit counseling before filing for bankruptcy, we must ensure
that consumers are given a fair chance at reducing their debt burden.
I also offered the text of the amendment of my bill, S. 393, the
Credit Card Minimum Payment Warning Act, as an amendment to the
bankruptcy bill. My amendment, intended to provide consumers with
adequate, timely, and meaningful disclosures, was unfortunately
defeated. As the bankruptcy reform law makes it more difficult for
consumers to discharge their debts in bankruptcy, we have a
responsibility to provide meaningful additional information so that
consumers can make better informed debt management decisions. The
bankruptcy reform law includes a requirement that credit card issuers
provide a generic warning about the consequences of only making the
minimum payment. This requirement fails to provide consumers the
detailed information that my amendment would have provided, which means
detailed, personalized information necessary for them to make better
informed choices about their credit card use and repayment. My
amendment would have required companies to inform consumers of how many
years and months it would take to repay their entire balance, and the
total cost in interest and principal, if the consumer makes only the
minimum payment. My legislation would also have required consumers to
be provided with the amount they would need to pay to eliminate their
outstanding balance in 36 months. Finally, my legislation would have
required that creditors establish a toll-free number so that consumers
can access trustworthy credit counselors. In response to criticisms
that my amendment was not feasible, I, along with
[[Page S11438]]
Senator Sarbanes, requested that the Government Accountability Office
study the issue. I am hopeful the report will provide helpful
information as we must continue to improve meaningful and
understandable disclosures that will help Americans better manage their
credit card debts.
I want to take a moment to thank Senator Sarbanes, and his Banking
Committee staff, for working with me on this and many other financial
literacy related issues. In addition, I also want to thank Senator
Leahy and the staff of the Judiciary Committee for all of their efforts
to try and improve the flawed bankruptcy legislation.
I fear that the bankruptcy reform law will significantly harm
families who have suffered financially due to illnesses, the loss of a
job, or the death of a loved one. I remain committed to working with
all of my colleagues to better protect and inform consumers and to hold
the credit card industry accountable for its aggressive marketing of
credit to our debt burdened society.
Mr. AKAKA. Mr. President, I rise to introduce the Predatory Payday
Loan Prohibition Act of 2005. Currently, federal law authorizes insured
depository institutions to export interest rates, as provided under the
laws of the state where the bank or credit union is located, to out-of-
state borrowers. My bill would effectively eliminate the ability of
financial institutions to do this by prohibiting federally-insured
financial institutions from originating predatory payday loans.
What constitutes a payday loan? These are small cash loans repaid by
borrowers' postdated checks or borrowers' authorizations to make
electronic debits against existing financial accounts. Payday loan
amounts are usually in the range of $100 to $500 with payment in full
due in two weeks. Finance charges on payday loans are typically in the
range of $15 to $30 per $100 borrowed, which translates into triple
digit interest rates in the range of 390 percent to 780 percent when
expressed as an annual percentage rate. Loan flipping, which is a
common practice, is the renewing of loans at maturity by paying
additional fees without any principal reduction. Loan flipping often
leads to instances where the fees paid for a payday loan well exceed
the principal borrowed. This situation often creates a cycle of debt
that is hard to break. Today, industry analysts conservatively estimate
that more than 15,000 payday advance locations across America extend
about $25 billion in short-term credit to millions of households
experiencing cash-flow shortfalls.
I am appalled that the payday lending industry is portrayed as a
legitimate business. Too many of its customers are low-income, working
families. More and more customers are the financially stretched middle
class including people who have maxed out their credit cards, people
perhaps who have lost a job, or people with no savings to fall back on
during a situation that causes a cash-flow shortfall, such as a medical
emergency. Payday lending is also rampant in the military. One in five
servicemembers have used payday lenders in the last year, according to
the report, ``Payday Lenders Target the Military,'' by the Center for
Responsible Lending. Payday lenders are concentrated around military
bases, such as the Navy bases in Norfolk, Virginia, the Army's Fort
Lewis in Washington State, and the Marine Corps base at Camp Pendleton
in California. The Department of Defense confirms the Center's report
by listing payday lending as one of the top 10 priority issues facing
military families, according to Dr. David Chu, the Under Secretary of
Defense for Personnel and Readiness. To the predatory lenders, our
military personnel's government paychecks represent a reliable source
of fees. Also, payday lenders can be relatively confident that
borrowers will continue to pay, because military personnel face harsh
consequences, such as court martial or dishonorable discharge, for not
repaying their debts. I am pleased that in my home state a local credit
union, Windward Community Federal Credit Union, Kailua, Hawaii, has
developed an affordable, alternative product to offer the many Marines
who live in its service area. Earlier this year I introduced another
bill to encourage replication of such practices. S. 1347, the Low-Cost
Alternatives to Payday Loans Act, would authorize demonstration project
grants to eligible entities to provide low-cost, small loans to
consumers that would provide alternatives to more costly, predatory
payday loans so that more people could have access to payday loan
alternatives.
Payday loan providers claim that they are offering a simple financial
product that addresses an emergency or temporary credit need that
usually cannot be met by traditional financial institutions. An
analysis of payday lending statistics by the Center for Responsible
Lending indicates that the majority of payday loan borrowers have
multiple loans each year with two thirds having five or more payday
loans annually and half of these borrowers having 12 or more payday
loans annually. Some borrowers seek loans from two or more payday
lenders, multiplying the potential for getting trapped in debt.
Research by the Community Financial Services Association of America,
the payday loan industry's national trade association, found that 40
percent of payday loan customers renew their payday loans a staggering
five times or more.
The payday loan industry exploits people that are in financial need.
Congress has failed to act to prevent the exploitation of working
families that are short on cash due to unexpected medical expenses or
other needs. We must act to protect consumers from these unscrupulous
lenders. I remain committed to restricting all forms of predatory
lending, including payday loans, and I encourage my colleagues to
support this legislation.
Mr. President, I ask unanimous consent that the text of the bill and
a letter of support be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
S. 1878
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Predatory Payday Loan
Prohibition Act of 2005''.
SEC. 2. PROHIBITION ON CREDITORS MAKING PAYDAY LOANS.
The Truth in Lending Act (15 U.S.C. 1601 et seq.) is
amended by inserting after section 109 the following:
``SEC. 110. PROHIBITION ON PAYDAY LOANS.
``(a) In General.--A creditor may not make a payday loan to
any person, if the creditor knows or has reasonable cause to
believe that--
``(1) the personal check or share draft that the creditor
receives from the person in exchange for the loan is drawn on
an insured depository institution or an insured credit union;
or
``(2) the account that will be debited in exchange for the
loan is a transaction account or share draft account at an
insured depository institution or an insured credit union.
``(b) Definitions.--In this section, the following
definitions shall apply:
``(1) Insured institutions.--The terms `insured depository
institution' and `insured credit union' have the meanings
given those terms in section 3 of the Federal Deposit
Insurance Act and section 101 of the Federal Credit Union
Act, respectively.
``(2) Payday loan.--The term `payday loan' means any
transaction in which a short-term cash advance is made to a
consumer in exchange for--
``(A) the personal check or share draft of the consumer, in
the amount of the advance plus a fee, where presentment or
negotiation of such check or share draft is deferred by
agreement of the parties until a designated future date; or
``(B) the authorization of a consumer to debit the
transaction account or share draft account of the consumer,
in the amount of the advance plus a fee, where such account
will be debited on or after a designated future date.''.
SEC. 3. PROHIBITION ON INSURED DEPOSITORY INSTITUTIONS MAKING
PAYDAY LOANS.
Section 18 of the Federal Deposit Insurance Act (12 U.S.C.
1828) is amended by adding at the end the following:
``(x) Prohibition on Certain Unsafe and Unsound Banking
Practices.--
``(1) In general.--An insured depository institution may
not--
``(A) make any payday loan, either directly or indirectly;
or
``(B) make any loan to any other lender for purposes of
financing a payday loan or refinancing or extending any
payday loan.
``(2) Payday loan defined.--For purposes of this
subsection, the term `payday loan' means any transaction in
which a short-term cash advance is made to a consumer in
exchange for--
``(A) the personal check or share draft of the consumer, in
the amount of the advance plus a fee, where presentment or
negotiation of such check or share draft is deferred by
agreement of the parties until a designated future date; or
[[Page S11439]]
``(B) the authorization of the consumer to debit the
transaction account or share draft account of the consumer,
in the amount of the advance plus a fee, where such account
will be debited on or after a designated future date.''.
____
October 6, 2005.
Hon. Daniel K. Akaka,
U.S. Senate,
Washington, DC.
Dear Senator Akaka: Consumer Federation of America,
Community Reinvestment Association of NC, Consumer Action,
Consumers Union, National Community Reinvestment Coalition,
National Consumer Law Center and U.S. PIRG applaud you for
sponsoring legislation to prohibit lending based on checks or
debits drawn on federally insured depository institutions.
You have recognized that it is an unsafe banking practice for
consumers to be enticed by payday lenders to write checks or
authorize debits when there is no money on deposit to cover
these cash advances. We are also pleased that your bill would
prohibit banks from partnering with payday lenders, a tactic
used by storefront lenders to evade state small loan and
usury laws.
The ``Predatory Payday Loan Prohibition Act of 2005''
prohibits the relatively new practice of holding a check as
security for a loan. Using the check as security for the
payment of a payday loan is the key to the coercive
collection tactics used by the lenders. As the lender holds
the check, at the end of the short term loan, the consumer is
generally forced to choose among three untenable options: 1)
allowing the check to be debited from their bank account
where it will deplete money needed for food and other living
necessities, 2) allowing the check to bounce, exposing the
borrower to coercive collection tactics when lenders threaten
civil or criminal liability for unpaid checks, and from the
risk of losing their bank account or checkwriting privileges,
or 3) renewing the loan at the original high cost. Loans
based on personal checks drawn on the borrower's bank account
that will be deposited to repay the loan on the next payday
is the modern version of lending secured by wage assignments,
a credit practice long recognized as inherently unfair which
violates FTC rules.
Your legislation also stops payday lenders from partnering
with federally insured depository institutions to evade state
usury or small loan rate caps. A few federally insured state
chartered banks persist in ``renting'' their charters to
payday lenders, a practice curtailed by most federal bank
regulators, to make loans in states that enforce their usury
or small loan laws.
Although payday lender-bank charter renting has been
curtailed by regulatory action, only legislation will create
a clear prohibition to stop this practice that undermines
state small loan regulation.
Sincerely,
Jean Ann Fox,
Director of Consumer Protection, Consumer Federation of
America.
Peter Skillern,
Executive Director, Community Reinvestment Association of
NC.
Linda Sherry,
Director, National Priorities, Consumer Action.
Susanna Montezemolo,
Policy Analyst, Consumers Union.
Monica Gonzales,
Vice President of Legislation and Regulatory Affairs,
National Community Reinvestment Coalition.
Margot Saunders,
Of Counsel, National Consumer Law Center.
Ed Mierzwinski,
Consumer Program Director, U.S. Public Interest Research
Group (U.S. PIRG).
Mr. AKAKA. Mr. President, I rise to introduce the Bankruptcy
Prevention Credit Counseling Act. The new bankruptcy reform law does
not allow consumers to declare personal bankruptcy in either Chapter 7
or Chapter 13, unless they receive a briefing from an approved
nonprofit credit counseling agency within 6 months of filing. The
credit counseling instructional course requirement is intended to
provide financial education to consumers who declare bankruptcy so they
can attempt to avoid future financial problems.
About one in three consumers in credit counseling enter a debt
management plan. In exchange, creditors may agree to concessions so
that consumers pay off as much of their outstanding debt as possible.
Concessions can include a reduced interest rate on the amount they owe
and the elimination of fees. Unfortunately, most credit card companies
have become increasingly unwilling to significantly reduce interest
rates for consumers in credit counseling. A study by the National
Consumer Law Center and the Consumer Federation of America revealed
that 5 of 13 credit card issuers increased the interest rates they
offered to consumers in credit counseling between 1999 and 2003.
American Express and Wells Fargo completely waive all interest for
consumers in credit counseling. However, the majority of credit card
issuers charge interest rates above 9 percent for account holders that
enter into credit counseling, with several charging more than 15
percent.
My bill would prevent unsecured creditors, primarily credit card
issuers, from attempting to collect accruing interest and additional
fees from consumers in bankruptcy, if the creditor does not have a
policy of waiving interest and fees for debtors who enter a
consolidated payment plan at a credit counseling agency.
Since the new bankruptcy law requires that consumers enter credit
counseling before filing for bankruptcy, we must ensure that credit
counseling is truly effective and a viable alternative to bankruptcy.
Credit card issuers undermine the good intentions of those consumers.
They have sharply curtailed the concessions they offer to consumers in
credit counseling, contributing to increased bankruptcy filings.
According to a survey by VISA USA, 33 percent of consumers who failed
to complete a debt management plan in credit counseling said they would
have stayed on the plan if creditors had lowered interest rates or
waived fees. Credit card companies have an obligation to ensure that
effective alternatives are readily available to the consumers they
aggressively pursue.
We must make sure that credit counseling is an effective tool to help
consumers avoid bankruptcy. In order to do this, credit card issuers
should waive the amount owed in interest and fees for consumers who
enter a consolidated payment plan. Successful completion of a debt
management plan benefits both creditors and consumers. Mr. President,
for many consumers, paying off their debt is not easy. My bill will
help people who are struggling to repay their obligations. I encourage
all of my colleagues to support this legislation to help consumers
enrolled in debt management plans to successfully repay their
creditors, free themselves from debt, and avoid bankruptcy.
I ask unanimous consent that the text of the bill be printed in the
Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 1879
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Bankruptcy Prevention Credit
Counseling Act of 2005''.
SEC. 2. REDUCTION OF UNSECURED CLAIMS.
Section 502(b) of title 11, United States Code, is
amended--
(1) in paragraph (8), by striking ``or'' at the end;
(2) in paragraph (9), by striking the period at the end and
inserting ``; or''; and
(3) by adding at the end the following:
``(10) such consumer debt is an unsecured claim arising
from a debt to a creditor that does not have, as of the date
of the order for relief, a policy of waiving additional
interest for all debtors who participate in a debt management
plan administered by a nonprofit budget and credit counseling
agency described in section 111(a).''.
____________________