[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 1873 Reported in Senate (RS)]
Calendar No. 257
109th CONGRESS
1st Session
S. 1873
To prepare and strengthen the biodefenses of the United States against
deliberate, accidental, and natural outbreaks of illness, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
October 17, 2005
Mr. Burr (for himself, Mr. Enzi, Mr. Gregg, Mr. Frist, Mr. Alexander,
and Mrs. Dole) introduced the following bill; which was read
twice and referred to the Committee on Health, Education,
Labor, and PensionsYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYY
October 24, 2005
Reported by Mr. Enzi, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
To prepare and strengthen the biodefenses of the United States against
deliberate, accidental, and natural outbreaks of illness, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Biodefense and Pandemic
Vaccine and Drug Development Act of 2005''.</DELETED>
<DELETED>SEC. 2. TABLE OF CONTENTS.</DELETED>
<DELETED> The table of contents of this Act is as follows:</DELETED>
<DELETED>Sec. 1. Short title.
<DELETED>Sec. 2. Table of contents.
<DELETED>Sec. 3. Biomedical Advanced Research and Development Agency.
<DELETED>Sec. 4. Clarification of countermeasures covered by Project
BioShield.
<DELETED>Sec. 5. Orphan drug market exclusivity for countermeasure
products.
<DELETED>Sec. 6. Liability protections for pandemics, epidemics, and
countermeasures.
<DELETED>Sec. 7. Compensation.
<DELETED>Sec. 8. Rebates and grants for research development, and
manufacturing of vaccines, qualified
countermeasures and pandemic or epidemic
products.
<DELETED>Sec. 9. Technical assistance.
<DELETED>Sec. 10. Animal models for certain diseases.
<DELETED>Sec. 11. Animal Model/Research Tool Scientific Advisory
Committee.
<DELETED>Sec. 12. Collaboration and coordination.
<DELETED>Sec. 13. Procurement.
<DELETED>Sec. 14. National Pathology Center.
<DELETED>SEC. 3. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT
AGENCY.</DELETED>
<DELETED> Title III of the Public Health Service Act (42 U.S.C. 241
et seq.) is amended by inserting after section 319K the
following:</DELETED>
<DELETED>``SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT
AGENCY.</DELETED>
<DELETED> ``(a) Definitions.--In this section:</DELETED>
<DELETED> ``(1) BARDA.--The term `BARDA' means the
Biomedical Advanced Research and Development Agency.</DELETED>
<DELETED> ``(2) Fund.--The term `Fund' means the Biodefense
Medical Countermeasure Development Fund established under
subsection (d).</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(4) Qualified countermeasure.--The term
`qualified countermeasure' has the meaning given such term in
section 319F-1.</DELETED>
<DELETED> ``(5) Qualified countermeasure and qualified
pandemic or epidemic product advanced research and
development.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(7) Security countermeasure.--The term `security
countermeasure' has the meaning given such term in section
319F-2.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(b) Biomedical Advanced Research and Development
Agency.--</DELETED>
<DELETED> ``(1) Establishment.--There is established within
the Department of Health and Human Services, the Biomedical
Advanced Research and Development Agency.</DELETED>
<DELETED> ``(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 as
`countermeasure or product') advanced research and development
by--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(B) supporting countermeasure and
product advanced research and development;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(D) supporting innovation to reduce the
time and cost of countermeasure and product advanced
research and development.</DELETED>
<DELETED> ``(3) Director.--The BARDA shall be headed by a
Director (referred to in this section as the `Director') who
shall--</DELETED>
<DELETED> ``(A) be appointed by the President, with
the advice and consent of the Senate;</DELETED>
<DELETED> ``(B) report to the Secretary;
and</DELETED>
<DELETED> ``(C) serve as the principal advisor to
the Secretary on countermeasure and product advanced
research and development.</DELETED>
<DELETED> ``(4) Duties of Director.--</DELETED>
<DELETED> ``(A) Collaboration.--To carry out the
purpose described in paragraph (2)(A), the Secretary,
acting through the Director, shall--</DELETED>
<DELETED> ``(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--
</DELETED>
<DELETED> ``(I) facilitate regular,
ongoing communication regarding the
processes established under
subparagraph (C)(ii) and new
countermeasures or products of
interest;</DELETED>
<DELETED> ``(II) solicit research
and associated data on potential
countermeasures and products and
related technologies; and</DELETED>
<DELETED> ``(III) provide technical
assistance with respect to such
processes and the Food and Drug
Administration approval
process;</DELETED>
<DELETED> ``(ii) at least annually--
</DELETED>
<DELETED> ``(I) convene meetings
with representatives from relevant
industries, academia, other Federal
agencies, international agencies, and
other interested persons; and</DELETED>
<DELETED> ``(II) sponsor relevant
biodefense countermeasure technology
demonstrations;</DELETED>
<DELETED> ``(iii) carry out the activities
described in subsection (g) of section 2 of the
Clayton Act; and</DELETED>
<DELETED> ``(iv) encourage and coordinate
countermeasure or product advanced research and
development, including by convening working
groups as identified in paragraph
(5).</DELETED>
<DELETED> ``(B) Support advanced research and
development.--To carry out the purpose described in
paragraph (2)(B), the Secretary, acting through the
Director, shall--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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--
</DELETED>
<DELETED> ``(I) support the cost of
countermeasure and product advanced
research and development; and</DELETED>
<DELETED> ``(II) ensure accelerated
development of countermeasures and
products.</DELETED>
<DELETED> ``(C) Streamline processes.--To carry out
the purpose described in paragraph (2)(C), the
Secretary, acting through the Director, shall--
</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(iii) establish an office within
the BARDA, in consultation with the
Commissioner of Food and Drugs, to--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(III) connect interested
persons with additional technical
assistance made available under section
565 of the Federal Food, Drug, and
Cosmetic Act;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(E) Other duties.--</DELETED>
<DELETED> ``(i) In general.--The Director
may--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(ii) Secretary duties.--The
Secretary, acting through the Director, may--
</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(III) administer grants
using milestone-based awards and
payments; and</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(6) Working groups.--</DELETED>
<DELETED> ``(A) Identification of technologies.--
</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(ii) Meetings.--A working group
established under clause (i) shall participate
in regular meetings with sponsors of
countermeasures, products, or related
technologies to--</DELETED>
<DELETED> ``(I) review the
scientific evidence or concept of such
countermeasures, products, or related
technologies;</DELETED>
<DELETED> ``(II) provide guidance on
research protocols or studies;
and</DELETED>
<DELETED> ``(III) provide guidance
on the regulatory approval process for
countermeasures, products, and related
technologies.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(B) Public working group.--The Director
may establish and convene one or more working groups
composed of private citizens and officials of Federal,
State, and local governments to advise such Director
with respect to the functions of the BARDA and the
Director.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(i) supporting and facilitating
advanced research and development of
countermeasures, and formulations of
countermeasures, that are safe and effective
for such populations; and</DELETED>
<DELETED> ``(ii) other activities of the
BARDA that effect such populations.</DELETED>
<DELETED> ``(7) Personnel Authorities.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(B) Special consultants.--The Director
may accept special consultants as personnel for the
BARDA under section 207(f).</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(D) Other services.--The Director may
accept voluntary and uncompensated services.</DELETED>
<DELETED> ``(c) National Biodefense Advisory Board.--</DELETED>
<DELETED> ``(1) In general.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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:</DELETED>
<DELETED> ``(i) Ex officio.--The following
members shall serve on the Board ex
officio:</DELETED>
<DELETED> ``(I) The Assistant to the
President for Homeland Security and
Counterterrorism.</DELETED>
<DELETED> ``(II) The Director of the
Office of Science and Technology
Policy.</DELETED>
<DELETED> ``(III) The Assistant
Secretary for Public Health Emergency
Preparedness.</DELETED>
<DELETED> ``(IV) The Director of the
National Institutes of
Health.</DELETED>
<DELETED> ``(V) The Director of the
Centers for Disease Control and
Prevention.</DELETED>
<DELETED> ``(VI) The Commissioner of
Food and Drugs.</DELETED>
<DELETED> ``(VII) The Director of
BARDA.</DELETED>
<DELETED> ``(VIII) The Assistant
Secretary of Defense for Health
Affairs.</DELETED>
<DELETED> ``(IX) The Assistant
Secretary of Homeland Security for
Science and Technology.</DELETED>
<DELETED> ``(X) The Secretary of
Agriculture (or a designee).</DELETED>
<DELETED> ``(ii) Appointed members.--The
following individuals, as appointed by the
Secretary:</DELETED>
<DELETED> ``(I) Four representatives
of the pharmaceutical and biotechnology
industries.</DELETED>
<DELETED> ``(II) Four
representatives of academia.</DELETED>
<DELETED> ``(III) Five other members
as determined appropriate by the
Secretary.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(2) Duties.--The Board shall--</DELETED>
<DELETED> ``(A) advise the Secretary on major
biodefense initiatives and review ongoing and proposed
biodefense programs, which may include potential
activities of the BARDA; and</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(4) Vacancies.--Any vacancy in the Board shall
not affect its powers, but shall be filled in the same manner
as the original appointment.</DELETED>
<DELETED> ``(5) Chairperson.--The Secretary shall appoint a
chairperson from among the members of the Board.</DELETED>
<DELETED> ``(6) Powers.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(7) Personnel.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(d) Fund.--</DELETED>
<DELETED> ``(1) Establishment.--There is established the
Biodefense Medical Countermeasure Development Fund, which shall
be administered by the Director of the BARDA.</DELETED>
<DELETED> ``(2) Funds.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(f) Inapplicability of Certain Acts.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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).''.</DELETED>
<DELETED>SEC. 4. CLARIFICATION OF COUNTERMEASURES COVERED BY PROJECT
BIOSHIELD.</DELETED>
<DELETED> (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:</DELETED>
<DELETED> ``(2) Definitions.--In this section:</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(iii) in the case of a research
tool, enable the rapid and effective
identification, assessment, or development of a
drug, biological product, or device to
diagnose, mitigate, prevent, or treat harm, as
described in clause (i) or (ii).</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (b) Security Countermeasure.--Section 319F-2(c)(1)(B) is
amended by--</DELETED>
<DELETED> (A) striking ``treat, identify, or
prevent'' each place it appears and inserting
``diagnose, mitigate, prevent, or treat'';
and</DELETED>
<DELETED> (B) inserting ``agent (including organisms
that cause an infectious disease) or toxin'' after
``any biological''.</DELETED>
<DELETED> (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:</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED>SEC. 5. ORPHAN DRUG MARKET EXCLUSIVITY FOR COUNTERMEASURE
PRODUCTS.</DELETED>
<DELETED> (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:</DELETED>
<DELETED>``SEC. 505C. ORPHAN DRUG MARKET EXCLUSIVITY FOR COUNTERMEASURE
PRODUCTS.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED>SEC. 6. LIABILITY PROTECTIONS FOR PANDEMICS, EPIDEMICS, AND
COUNTERMEASURES.</DELETED>
<DELETED> 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:</DELETED>
<DELETED>``SEC. 319F-3. LIABILITY PROTECTIONS FOR PANDEMIC AND EPIDEMIC
PRODUCTS AND SECURITY COUNTERMEASURES.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(b) Litigation Management.--</DELETED>
<DELETED> ``(1) Limitation on cause of action.--</DELETED>
<DELETED> ``(A) In general.--</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(B) Rule.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(C) Potential liability upon
determination.--</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(D) Determination by secretary.--
</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(II) in violating such
Act, such manufacturer, distributor,
administrator, or health care provider
acted with willful
misconduct.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(I) caused the product
to present a significant or
unreasonable risk to human health;
and</DELETED>
<DELETED> ``(II) proximately caused
the injury alleged by the
party.</DELETED>
<DELETED> ``(iii) 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.</DELETED>
<DELETED> ``(iv) 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).</DELETED>
<DELETED> ``(v) 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 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.</DELETED>
<DELETED> ``(vi) 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.</DELETED>
<DELETED> ``(vii) 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.</DELETED>
<DELETED> ``(viii) 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--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(2) Declaration by secretary.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(D) Publication.--The Secretary shall
promptly publish each such declaration and amendment in
the Federal Register.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(d) Definitions.--In this section:</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(3) Loss.--The term `loss' means death, physical
injury, or loss of or damage to property, including business
interruption loss.</DELETED>
<DELETED> ``(4) Manufacturer.--The term `manufacturer'
includes--</DELETED>
<DELETED> ``(A) a contractor or subcontractor of a
manufacturer;</DELETED>
<DELETED> ``(B) a supplier of any product or
service, research tool, or component to the
manufacturer; and</DELETED>
<DELETED> ``(C) any or all of the parents,
subsidiaries, affiliates, successors, and assigns of a
manufacturer.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(A) is approved or cleared under chapter
V of the Federal Food, Drug, and Cosmetic Act or
licensed under section 351 of this Act;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(8) Security countermeasure.--The term `security
countermeasure' has the meaning given such term in section
319F-2(c)(1)(B).''.</DELETED>
<DELETED>SEC. 7. COMPENSATION.</DELETED>
<DELETED> Title II of the Public Health Service Act (42 U.S.C. 202
et seq.) is amended by adding at the end the following:</DELETED>
<DELETED>``PART D--OTHER COMPENSATION PROGRAMS</DELETED>
<DELETED>``SEC. 271. COVERED COUNTERMEASURES PROGRAM.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(b) Definition.--For purposes of this section:</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(2) Covered individual.--The term `covered
individual' means an individual--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(C) who has volunteered and been
selected to be a member of an emergency response plan;
and</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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).''.</DELETED>
<DELETED>SEC. 8. REBATES AND GRANTS FOR RESEARCH DEVELOPMENT, AND
MANUFACTURING OF VACCINES, QUALIFIED COUNTERMEASURES AND
PANDEMIC OR EPIDEMIC PRODUCTS.</DELETED>
<DELETED> (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)--</DELETED>
<DELETED> (1) a rebate pursuant to subsection (b);
or</DELETED>
<DELETED> (2) a grant pursuant to section 319M of the Public
Health Service Act (as added by subsection (c)).</DELETED>
<DELETED> (b) Surge Capacity and Research Rebates.--</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (2) Vaccines, countermeasures or products
manufacturing facilities investment rebate.--</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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--</DELETED>
<DELETED> (i)(I) the original use of which
commences with the person applying for the
rebate; or</DELETED>
<DELETED> (II) which is acquired through
purchase (as defined by section 179(d)(2) of
the Internal Revenue Code of 1986);</DELETED>
<DELETED> (ii) which is depreciable under
section 167 of the Internal Revenue Code of
1986;</DELETED>
<DELETED> (iii) which is physically located
in a State;</DELETED>
<DELETED> (iv) which is used for the
manufacture, distribution, or research and
development of vaccines, countermeasures, or
products; and</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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--</DELETED>
<DELETED> (i) a detailed description and
intended use of the facilities that is the
basis of application;</DELETED>
<DELETED> (ii) a detailed description of the
vaccine, countermeasure, or product being
produced or that may be produced at the
facility;</DELETED>
<DELETED> (iii) a detailed accounting of
qualified manufacturing facilities investment
of the person;</DELETED>
<DELETED> (iv) a certification as to the
compliance of the person with clauses (i)
through (iv) of subparagraph (C); and</DELETED>
<DELETED> (v) copies of tax returns for the
taxable year involved.</DELETED>
<DELETED> (F) Effective date.--This paragraph shall
apply to property placed in service after December 31,
2005.</DELETED>
<DELETED> (G) Termination.--This paragraph shall not
apply to any property placed in service after December
31, 2010.</DELETED>
<DELETED> (3) Medical research related to developing
vaccines, countermeasures or qualified pandemic or epidemic
products rebate.--</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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--</DELETED>
<DELETED> (i) a detailed description of the
vaccine, countermeasure, or product being
researched or developed;</DELETED>
<DELETED> (ii) a detailed description of the
research that is the subject of the
rebate;</DELETED>
<DELETED> (iii) a detailed accounting of the
qualified research expenses involved;</DELETED>
<DELETED> (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</DELETED>
<DELETED> (v) copies of tax returns for the
taxable year involved.</DELETED>
<DELETED> (F) Effective date.--This paragraph shall
apply to expenses for taxable years beginning after
December 31, 2005.</DELETED>
<DELETED> (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).</DELETED>
<DELETED> (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:</DELETED>
<DELETED>``SEC. 319M. GRANTS TO EXPAND AND IMPROVE RESEARCH AND
DEVELOPMENT AND MANUFACTURING OF VACCINES, QUALIFIED
COUNTERMEASURES OR QUALIFIED PANDEMIC OR EPIDEMIC
PRODUCTS.</DELETED>
<DELETED> ``(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)).</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(1) a detailed description of the planned
expansion;</DELETED>
<DELETED> ``(2) a detailed description of the equipment,
facility, or property involved;</DELETED>
<DELETED> ``(3) a certification that such facility or
property is physically located in a State;</DELETED>
<DELETED> ``(4) a detailed description of the vaccine,
qualified countermeasure or qualified pandemic or epidemic
product involved;</DELETED>
<DELETED> ``(5) a detailed description of the research and
development, manufacturer, or distribution involved;</DELETED>
<DELETED> ``(6) a description of how such equipment,
facility, or property is to be used;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(8) a certification that the equipment,
facility, or property involved complies with all applicable
Federal, State, and local laws.</DELETED>
<DELETED> ``(c) Recapture.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(d) Authorization of Appropriations.--There is
authorized to be appropriated such sums as may be necessary to carry
out this section.''.</DELETED>
<DELETED>SEC. 9. TECHNICAL ASSISTANCE.</DELETED>
<DELETED> 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:</DELETED>
<DELETED>``SEC. 565. TECHNICAL ASSISTANCE.</DELETED>
<DELETED> ``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.''.</DELETED>
<DELETED>SEC. 10. ANIMAL MODELS FOR CERTAIN DISEASES.</DELETED>
<DELETED> 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:</DELETED>
<DELETED>``SEC. 409J. ANIMAL MODELS FOR CERTAIN DISEASES.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(b) Eligibility.--To be eligible to receive a grant
under this section, an entity shall--</DELETED>
<DELETED> ``(1) provide assurances to the Secretary that the
entity--</DELETED>
<DELETED> ``(A) has access to an appropriate
biosafety laboratory or facility, as determined by the
Secretary; and</DELETED>
<DELETED> ``(B) will follow good laboratory
practices;</DELETED>
<DELETED> ``(2) submit to the Secretary an application at
such time, in such manner, and containing such information as
the Secretary may require, including--</DELETED>
<DELETED> ``(A) a detailed description of the animal
model involved;</DELETED>
<DELETED> ``(B) a detailed description of the
chemical, biological, radiological, nuclear, or other
infectious agents involved;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(D) a detailed description of validation
methods; and</DELETED>
<DELETED> ``(E) an assurance that the entity will
follow good laboratory practices; and</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(c) Authorization of Appropriations.--There are
authorized to be appropriated such sums as may be necessary to carry
out this section.''.</DELETED>
<DELETED>SEC. 11. ANIMAL MODEL/RESEARCH TOOL SCIENTIFIC ADVISORY
COMMITTEE.</DELETED>
<DELETED> 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:</DELETED>
<DELETED>``SEC. 566. ANIMAL MODEL/RESEARCH TOOL SCIENTIFIC ADVISORY
COMMITTEE.</DELETED>
<DELETED> ``(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').</DELETED>
<DELETED> ``(b) Membership.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(3) Chairperson.--The Secretary shall designate
1 of the members of the Advisory Committee to serve as the
chairperson.</DELETED>
<DELETED> ``(c) Duties.--The Advisory Committee shall provide
advice, information, and recommendations to the Secretary on--
</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(2) strategies to accelerate animal model and
research tool development and validation; and</DELETED>
<DELETED> ``(3) scientific issues raised in applications as
requested by the Secretary.</DELETED>
<DELETED> ``(d) Priorities.--Priorities for animal models and
research tools shall be established by the Secretary.</DELETED>
<DELETED> ``(e) Compensation; Support; FACA.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(2) Administrative support.--The Secretary shall
furnish the Advisory Committee clerical and other
assistance.</DELETED>
<DELETED> ``(3) Nonapplication of faca.--Section 14 of the
Federal Advisory Committee Act (5 U.S.C. App.) shall not apply
to the Advisory Committee.</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED>SEC. 12. COLLABORATION AND COORDINATION.</DELETED>
<DELETED> Section 2 of the Clayton Act (15 U.S.C. 13) is amended by
adding at the end the following:</DELETED>
<DELETED> ``(g) Limited Antitrust Exemption.--</DELETED>
<DELETED> ``(1) Security countermeasures, qualified
countermeasures and qualified pandemic or epidemic product
development meetings.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(B) Meeting and consultation
conditions.--A meeting or consultation conducted under
subparagraph (A) shall--</DELETED>
<DELETED> ``(i) be chaired or, in the case
of a consultation, facilitated by the Secretary
or Director;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(iii) be open to the Attorney
General, the Secretary of Homeland Security,
and the Chairperson;</DELETED>
<DELETED> ``(iv) be limited to discussions
involving the development, manufacture,
distribution, or sale of countermeasures or
products, consistent with the purposes of this
title; and</DELETED>
<DELETED> ``(v) be conducted in such manner
as to ensure that national security,
confidential, and proprietary information is
not disclosed outside the meeting or
consultation.</DELETED>
<DELETED> ``(C) Limitation.--The Secretary or
Director may not require the disclosure of confidential
commercial or proprietary information.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(E) Exemption.--</DELETED>
<DELETED> ``(i) In general.--The antitrust
laws shall not apply to meetings and
consultations under this paragraph.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(A) an explanation of the intended
purpose of the agreement;</DELETED>
<DELETED> ``(B) a specific statement of the
substance of the agreement;</DELETED>
<DELETED> ``(C) a description of the methods that
will be utilized to achieve the objectives of the
agreement;</DELETED>
<DELETED> ``(D) an explanation of the necessity of a
cooperative effort among the particular participating
parties to achieve the objectives of the agreement;
and</DELETED>
<DELETED> ``(E) any other relevant information
determined necessary by the Secretary or Director in
consultation with the Attorney General and the
Chairperson.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(A) be in compliance with the antitrust
laws, and so inform the Secretary or Director and the
participating parties; or</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(4) Action on request for exemption.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(C) Determination.--In granting an
exemption under this paragraph, the Attorney General,
in consultation with the Chairperson and the Secretary
or Director--</DELETED>
<DELETED> ``(i) shall find--</DELETED>
<DELETED> ``(I) that the agreement
involved is necessary to ensure the
availability of countermeasures or
products;</DELETED>
<DELETED> ``(II) that the exemption
from the antitrust laws would promote
the public interest; and</DELETED>
<DELETED> ``(III) that there is no
substantial competitive impact to areas
not directly related to the purposes of
the agreement; and</DELETED>
<DELETED> ``(ii) may consider any other
factors determined relevant by the Attorney
General and the Chairperson.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(7) Guidelines.--The Attorney General and the
Chairperson may develop and issue guidelines to implement this
subsection.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(i) Definitions.--In this section:</DELETED>
<DELETED> ``(1) Antitrust laws.--The term `antitrust laws'--
</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(B) includes any State law similar to
the laws referred to in subparagraph (A).</DELETED>
<DELETED> ``(2) Covered activities.--</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(i) theoretical analysis,
experimentation, or the systematic study of
phenomena or observable facts necessary to the
development of countermeasures or
products;</DELETED>
<DELETED> ``(ii) the development or testing
of basic engineering techniques necessary to
the development of countermeasures or
products;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(iv) the production,
distribution, or marketing of a product,
process, or service that is a countermeasures
or products;</DELETED>
<DELETED> ``(v) the testing in connection
with the production of a product, process, or
services necessary to the development of
countermeasures or products;</DELETED>
<DELETED> ``(vi) the collection, exchange,
and analysis of research or production
information necessary to the development of
countermeasures or products; or</DELETED>
<DELETED> ``(vii) any combination of the
purposes described in clauses (i) through
(vi);</DELETED>
<DELETED>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.</DELETED>
<DELETED> ``(B) Exception.--The term `covered
activities' shall not include the following activities
involving 2 or more persons:</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(ii) Entering into any agreement
or engaging in any other conduct--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(3) 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.''.</DELETED>
<DELETED>SEC. 13. PROCUREMENT.</DELETED>
<DELETED> Section 319F-2 of the Public Health Service Act (42 U.S.C.
247d-6b) is amended--</DELETED>
<DELETED> (1) in the section heading, by inserting ``and
security countermeasure procurements'' before the period;
and</DELETED>
<DELETED> (2) in subsection (c)--</DELETED>
<DELETED> (A) in the subsection heading, by striking
``Biomedical'';</DELETED>
<DELETED> (B) in paragraph (5)(B)(i), by striking
``to meet the needs of the stockpile'' and inserting
``to meet the stockpile needs'';</DELETED>
<DELETED> (C) in paragraph (7)(C)(ii)--</DELETED>
<DELETED> (i) by amending clause (I) to read
as follows:</DELETED>
<DELETED> ``(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 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</DELETED>
<DELETED> (ii) by adding at the end the
following:</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(IX) Contract Terms.--
The Secretary, in any contract for
procurement under this section, may
specify--</DELETED>
<DELETED> ``(aa) the dosing
and administration requirements
for countermeasures to be
developed and
procured;</DELETED>
<DELETED> ``(bb) the amount
of funding that will be
dedicated by the Secretary for
research and development of the
countermeasure; and</DELETED>
<DELETED> ``(cc) the
specifications the
countermeasure must meet to
qualify for procurement under a
contract under this section.'';
and</DELETED>
<DELETED> (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.''</DELETED>
<DELETED>SEC. 14. NATIONAL PATHOLOGY CENTER.</DELETED>
<DELETED> (a) In General.--Title IV of the Public Health Service Act
(42 U.S.C. 281 et seq.) is amended--</DELETED>
<DELETED> (1) in section 401(b)(2), by adding at the end the
following:</DELETED>
<DELETED> ``(H) The National Pathology Center.'';
and</DELETED>
<DELETED> (2) by adding at the end of part E (42 U.S.C. 287
et seq.) the following:</DELETED>
<DELETED>``Subpart 7--National Pathology Center</DELETED>
<DELETED>``SEC. 485A. ESTABLISHMENT OF NATIONAL PATHOLOGY
CENTER.</DELETED>
<DELETED> ``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.</DELETED>
<DELETED>``SEC. 485B. PURPOSES AND FUNCTIONS OF THE CENTER.</DELETED>
<DELETED> ``(a) Purposes of the Center.--The general purposes of the
Center are to--</DELETED>
<DELETED> ``(1) conduct and support research, education,
training, and other programs with respect to the science and
clinical practice of pathology;</DELETED>
<DELETED> ``(2) maintain and improve a pathology tissue
repository; and</DELETED>
<DELETED> ``(3) provide pathology consultation
services.</DELETED>
<DELETED> ``(b) Activities of the Director.--In order to carry out
the purposes of the Center described in subsection (a), the Director of
the Center--</DELETED>
<DELETED> ``(1) shall--</DELETED>
<DELETED> ``(A) maintain and improve a comprehensive
repository of pathological specimens;</DELETED>
<DELETED> ``(B) provide consultations on request
regarding clinical cases;</DELETED>
<DELETED> ``(C) conduct educational programs and
publish educational materials on the science and
clinical practice of pathology;</DELETED>
<DELETED> ``(D) maintain and improve registries on
such clinical conditions as the Director of the Center
determines appropriate; and</DELETED>
<DELETED> ``(E) conduct and support research on
pathology; and</DELETED>
<DELETED> ``(2) may--</DELETED>
<DELETED> ``(A) collect reasonable and appropriate
fees for the activities described in paragraph (1)(B);
and</DELETED>
<DELETED> ``(B) conduct such other activities as the
Director of the Center determines appropriate to carry
out the purposes described in subsection (a).</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED>``SEC. 485C. BOARD OF REGENTS.</DELETED>
<DELETED> ``(a) Membership.--</DELETED>
<DELETED> ``(1) In general.--There is established a Board of
Regents of the Center (in this subpart referred to as the
`Board') consisting of--</DELETED>
<DELETED> ``(A) the Surgeons General of--</DELETED>
<DELETED> ``(i) the Public Health
Service;</DELETED>
<DELETED> ``(ii) the Army;</DELETED>
<DELETED> ``(iii) the Navy; and</DELETED>
<DELETED> ``(iv) the Air Force;</DELETED>
<DELETED> ``(B) the Chief Medical Director of the
Department of Medicine and Surgery of the Department of
Veterans Affairs;</DELETED>
<DELETED> ``(C) the Deputy Director of the National
Library of Medicine;</DELETED>
<DELETED> ``(D) the Assistant Secretary of Health of
the Department of Defense;</DELETED>
<DELETED> ``(E) the Dean of the Uniformed Services
University of the Health Sciences; and</DELETED>
<DELETED> ``(F) 11 members to be appointed by the
Secretary from among leaders in pathology research,
education and clinical practice.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED>``SEC. 485D. GIFTS TO THE CENTER.</DELETED>
<DELETED> ``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.</DELETED>
<DELETED>``SEC. 485E. CENTER FACILITIES.</DELETED>
<DELETED> ``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.''.</DELETED>
<DELETED> (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--</DELETED>
<DELETED> (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);</DELETED>
<DELETED> (2) areas where such functions and duties overlap
with the functions and duties of the National Institutes of
Health; and</DELETED>
<DELETED> (3) recommendations concerning necessary
modifications to the National Pathology Center.</DELETED>
<DELETED> (c) Transfer of the Armed Forces Institute of Pathology.--
</DELETED>
<DELETED> (1) In general.--</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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):</DELETED>
<DELETED> (i) The Armed Forces Medical
Examiner.</DELETED>
<DELETED> (ii) The Department of Defense DNA
registry.</DELETED>
<DELETED> (iii) Accident Investigation
Program.</DELETED>
<DELETED> (iv) The histopathology training
program.</DELETED>
<DELETED> (v) The patient safety
center.</DELETED>
<DELETED> (vi) Department of Legal
Medicine.</DELETED>
<DELETED> (vii) Center for Clinical
Laboratory Medicine.</DELETED>
<DELETED> (viii) Drug Testing and Quality
Assurance Program.</DELETED>
<DELETED> (ix) Subject to the discretion of
the Secretary of Defense, medical research
programs on the following:</DELETED>
<DELETED> (I) Body armor.</DELETED>
<DELETED> (II) Environmental
sarcoidosis.</DELETED>
<DELETED> (III) Depleted
uranium.</DELETED>
<DELETED> (IV) Military working
dogs.</DELETED>
<DELETED> (V) Such other areas of
research related to pathology as the
Secretary of Defense shall choose to
conduct.</DELETED>
<DELETED> (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.</DELETED>
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. 15. Rule of construction.
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
government 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 as `countermeasure or
product') advanced research and development by--
``(A) facilitating 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 (consistent
with sections 302(2) and 304(a) of the Homeland
Security Act of 2002) 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, may award contracts,
grants, cooperative agreements, or enter into other
transactions, such as prize payments, 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 national
persons 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 concluding a 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 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 9903 of
title 5, United States Code (as added by section 1101
of the National Defense Authorization Act for Fiscal
Year 2004 (Public Law 108-136)). 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 Under 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, biotechnology, and
device 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 life sciences 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 with
the approval for the contributing agency 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 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
health care providers set forth in subsection
(a) and subparagraph (A) shall be for actions
against a manufacturer, distributor,
administrator, or health care 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 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 health care 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 in accordance
with 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
government 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 product
(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 or used 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 or use 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, radiological, 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 or use 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).''.
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 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.
``(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 business 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 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 publications, facilities and services of the Center 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 1 year 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.--
(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.
SEC. 15. RULE OF CONSTRUCTION.
Nothing in this Act, or any amendment made by this Act, shall be
construed to affect any law that applies to the National Vaccine Injury
Compensation Program under title XXI of the Public Health Service Act
(42 U.S.C. 300aa-1 et seq.), including such laws regarding--
(1) whether claims may be filed or compensation may be paid
for a vaccine-related injury or death under such Program;
(2) claims pending under such Program; and
(3) any petitions, cases, or other proceedings before the
United States Court of Federal Claims pursuant to such title.
Calendar No. 257
109th CONGRESS
1st Session
S. 1873
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A BILL
To prepare and strengthen the biodefenses of the United States against
deliberate, accidental, and natural outbreaks of illness, and for other
purposes.
_______________________________________________________________________
October 24, 2005
Reported with an amendment