Biodefense and Pandemic Vaccine and Drug Development Act of 2005 - (Sec. 3) Amends the Public Health Service Act to establish the Biomedical Advanced Research and Development Agency (BARDA) within the Department of Health and Human Services (HHS) to coordinate and oversee activities that support and accelerate advanced research and development of qualified countermeasures to exposure to hazardous agents or infectious diseases or qualified pandemic or epidemic products.
Requires the Secretary of HHS, acting through the Director of BARDA, to: (1) increase appropriate communication between the federal government and relevant industries, academia, and other persons; (2) 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; (3) direct the countermeasure and advanced research and development of HHS; (4) award contracts, grants, cooperative agreements, and enter into other transactions to support the cost of such research and development and to ensure accelerated development of countermeasures and products; (5) establish an office within BARDA to facilitate regular and ongoing communication between BARDA and the Food and Drug Administration (FDA) regarding the status of BARDA advanced research and development activities; and (6) coordinate with the FDA to facilitate regulatory review and approval of promising classes of countermeasures or products through the development of research tools.
Allows the Secretary, acting through the Director, to award contracts, grants, cooperative agreements or enter into other transactions to promote innovation in technologies supporting the advanced research and development and production of qualified or security countermeasures or qualified pandemic or epidemic products.
Allows the Director to 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.
Allows the Secretary, acting through the Director, to: (1) support advanced research and development and innovation of potential countermeasures or products by highly qualified persons outside the United States; and (2) establish one or more federally funded research and development centers or university affiliated research centers.
Allows the Director to: (1) 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; and (2) establish working groups to identify innovative technologies that have the potential to be developed as countermeasures or products and to advise the Director on functions.
Requires the Director to establish and convene a Vulnerable Populations Working Group composed of experts on pediatric populations, pregnant women, and other vulnerable populations to advise the Director regarding countermeasures effects on such populations.
Establishes the National Biodefense Advisory Board to 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 agents.
Establishes the Biodefense Medical Countermeasure Development Fund to be administered by the Director.
(Sec. 4) Revises the definition of qualified countermeasure to include "research tool" which means the full range of tools and systems that assist in the discovery, development, or manufacture of drugs, biological products, or devices.
(Sec. 5) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to extend the period of market exclusivity for designated countermeasure products from seven years to ten years.
(Sec. 6) Prohibits any cause of action for liability for damages related to a security countermeasure or a qualified pandemic and epidemic product unless the Secretary, acting through an administrative law judge, finds by clear and convincing evidence that a violation of the FFDCA occurred and that such violation was a result of willful misconduct.
Authorizes the Secretary to issue a declaration 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.
(Sec. 7) Requires the Secretary, if the Secretary issues a proclamation stating that there is a critical public health need for a covered individual to received a covered countermeasure, to establish a process to provide compensation to individuals involved in an emergency response plan who are injured as a result of a countermeasure.
(Sec. 8) Authorizes the Secretary to: (1) award rebates for the expansion of surge capacity for manufacturing vaccines, qualified countermeasures, or qualified pandemic or epidemic products and for research; and (2) 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 such a vaccine, countermeasure, or product.
(Sec. 9) Requires the Secretary to establish within FDA a team of experts on manufacturing and regulatory activities to provide technical assistance to the manufacturers of qualified countermeasures, security countermeasures, or vaccines if the Secretary determines that a shortage or potential shortage may occur.
(Sec. 10) Requires the Secretary, acting through the Director of the National Institutes of Health (NIH), to award grants to study the physiological responses of certain animal species and juvenile models to chemical, biological, radiological, or nuclear agents or toxins or potential pandemic infectious disease and to develop and validate such animal models.
(Sec. 11) Requires the Secretary to establish the Animal Model/Research Tool Scientific Advisory Committee to provide advice, information, and recommendations on: (1) accepted animal models for diseases and conditions associated with any biological, chemical, radiological, or nuclear agent or toxin or potential pandemic infectious disease; and (2) strategies to accelerate animal model and research tool development and validation.
(Sec. 12) Amends the Clayton Act to allow the Secretary or Director of BARDA to conduct meetings and consultations with parties involved in the development of security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products for the purpose of the development, manufacture, distribution, purchase, sale, or storage of countermeasures or products consistent with this Act. Requires such meetings or consultations to be conducted in such manner as to ensure that national security, confidential, and proprietary information is not disclosed outside the meeting or consultation. Prohibits the Secretary or Director from requiring the disclosure of confidential commercial or proprietary information. Exempts such meetings and consultations from antitrust laws. Requires the Secretary or Director to file a written agreement regarding covered activities. Requires the Attorney General to determine whether such an agreement would likely 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. Requires the Attorney General to grant an exemption if: (1) the agreement involved is necessary to ensure the availability of countermeasures or products; (2) the exemption from the antitrust laws would promote the public interest; and (3) there is no substantial competitive impact to areas not directly related to the purposes of the agreement.
Sets forth reporting requirements.
(Sec. 13) Allows partial payment on a procurement contract for a security countermeasure for significant milestones or a payment to increase manufacturing capacity. Allows procurement contracts to provide: (1) for advance payments for milestones; (2) that the vendor is the sole and exclusive supplier of the product to the government for a specified period on the condition that the vendor is able to satisfy the government's needs; (3) that the vendor establish domestic manufacturing capacity of the product to ensure that additional production is available as necessary; (4) dosing and administration requirements for countermeasures; and (5) the amount of funding that will be dedicated by the Secretary for countermeasure research and development; and (6) specifications the countermeasure must meet to qualify for procurement under a contract.
(Sec. 14) Establishes the National Pathology Center 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 for civil and military health professionals. Establishes a Board of Regents. Transfers the functions of the Armed Forces Institute of Pathology, with exceptions, to the Center.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 1873 Introduced in Senate (IS)]
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, and Mr.
Alexander) introduced the following bill; which was read twice
and referred to the Committee on Health, Education, Labor, and
PensionsYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYY
_______________________________________________________________________
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,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Biodefense and Pandemic Vaccine and
Drug Development Act of 2005''.
SEC. 2. TABLE OF CONTENTS.
The table of contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Biomedical Advanced Research and Development Agency.
Sec. 4. Clarification of countermeasures covered by Project BioShield.
Sec. 5. Orphan drug market exclusivity for countermeasure products.
Sec. 6. Liability protections for pandemics, epidemics, and
countermeasures.
Sec. 7. Compensation.
Sec. 8. Rebates and grants for research development, and manufacturing
of vaccines, qualified countermeasures and
pandemic or epidemic products.
Sec. 9. Technical assistance.
Sec. 10. Animal models for certain diseases.
Sec. 11. Animal Model/Research Tool Scientific Advisory Committee.
Sec. 12. Collaboration and coordination.
Sec. 13. Procurement.
Sec. 14. National Pathology Center.
SEC. 3. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AGENCY.
Title III of the Public Health Service Act (42 U.S.C. 241 et seq.)
is amended by inserting after section 319K the following:
``SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AGENCY.
``(a) Definitions.--In this section:
``(1) BARDA.--The term `BARDA' means the Biomedical
Advanced Research and Development Agency.
``(2) Fund.--The term `Fund' means the Biodefense Medical
Countermeasure Development Fund established under subsection
(d).
``(3) Other transactions.--The term `other transactions'
means transactions, other than procurement contracts, grants,
and cooperative agreements, including transactions for
prototypes, as provided to the Secretary of Defense under
section 2371 of title 10, United States Code.
``(4) Qualified countermeasure.--The term `qualified
countermeasure' has the meaning given such term in section
319F-1.
``(5) Qualified countermeasure and qualified pandemic or
epidemic product advanced research and development.--
``(A) In general.--The term `qualified
countermeasure and qualified pandemic or epidemic
product advanced research and development' means any
applied research, testing, or evaluation (including
those conducted on humans or animals), related to the
safety or effectiveness, that is required for approval,
clearance, or licensing by the Secretary under this Act
or the Federal Food, Drug, and Cosmetic Act, of such
countermeasure or pandemic or epidemic product to
diagnose, mitigate, prevent, or treat harm from a
deliberate, accidental, or natural exposure to a
chemical, biological, radiological, or nuclear agent,
particularly such exposure resulting from an act of
terrorism or potential pandemic infectious disease.
``(B) Inclusion.--The term under subparagraph (A)
includes any investigation to improve the
manufacturing, formulation, finish, fill, delivery, or
shelf-life of such qualified countermeasures or
qualified pandemic or epidemic products.
``(6) Qualified pandemic or epidemic product.--The term
`qualified pandemic or epidemic product' has the meaning given
the term in section 319F-3(c)(5).
``(7) Security countermeasure.--The term `security
countermeasure' has the meaning given such term in section
319F-2.
``(8) Person.--The term `person' includes an individual,
partnership, corporation, association, entity, or public or
private corporation, including a Federal, State, or local
agency or department.
``(b) Biomedical Advanced Research and Development Agency.--
``(1) Establishment.--There is established within the
Department of Health and Human Services, the Biomedical
Advanced Research and Development Agency.
``(2) Purpose.--It shall be the purpose of the BARDA to
coordinate and oversee activities that support and accelerate
qualified countermeasure or qualified pandemic or epidemic
product (referred to in this section as `countermeasure or
product') advanced research and development by--
``(A) directing and coordinating collaboration
among the Department of Health and Human Services,
other Federal agencies, relevant industries, academia,
and other persons, with respect to such advanced
research and development;
``(B) supporting countermeasure and product
advanced research and development;
``(C) recommending approaches to modernize and
streamline the countermeasure or product development
process and reduce regulatory burdens with respect to
procurement of security countermeasures and qualified
pandemic or epidemic products; and
``(D) supporting innovation to reduce the time and
cost of countermeasure and product advanced research
and development.
``(3) Director.--The BARDA shall be headed by a Director
(referred to in this section as the `Director') who shall--
``(A) be appointed by the President, with the
advice and consent of the Senate;
``(B) report to the Secretary; and
``(C) serve as the principal advisor to the
Secretary on countermeasure and product advanced
research and development.
``(4) Duties of Director.--
``(A) Collaboration.--To carry out the purpose
described in paragraph (2)(A), the Secretary, acting
through the Director, shall--
``(i) increase appropriate communication
between the Federal Government and relevant
industries, academia, and other interested
persons with respect to countermeasure and
product advanced research and development by
establishing transparent, expeditious, and
direct processes to--
``(I) facilitate regular, ongoing
communication regarding the processes
established under subparagraph (C)(ii)
and new countermeasures or products of
interest;
``(II) solicit research and
associated data on potential
countermeasures and products and
related technologies; and
``(III) provide technical
assistance with respect to such
processes and the Food and Drug
Administration approval process;
``(ii) at least annually--
``(I) convene meetings with
representatives from relevant
industries, academia, other Federal
agencies, international agencies, and
other interested persons; and
``(II) sponsor relevant biodefense
countermeasure technology
demonstrations;
``(iii) carry out the activities described
in subsection (g) of section 2 of the Clayton
Act; and
``(iv) encourage and coordinate
countermeasure or product advanced research and
development, including by convening working
groups as identified in paragraph (5).
``(B) Support advanced research and development.--
To carry out the purpose described in paragraph (2)(B),
the Secretary, acting through the Director, shall--
``(i) conduct continuous searches and
support calls for potential countermeasures or
products for drugs, biological products,
devices, or research tools to diagnose,
mitigate, prevent, or treat harm from existing,
emerging, or possible chemical, biological,
radiological, and nuclear agents or potential
pandemic infectious diseases that threaten
public health and national security, as
identified by the Assistant Secretary for
Public Health Emergency Preparedness;
``(ii) direct the countermeasure and
product advanced research and development
activities of the Department of Health and
Human Services, in consultation with the
Assistant Secretary for Public Health Emergency
Preparedness, the Director of the National
Institutes of Health, the Director of the
Centers for the Disease Control and Prevention,
and the Commissioner of Food and Drugs; and
``(iii) award contracts, grants,
cooperative agreements, and enter into other
transactions, to include use of simplified
acquisition authorities provided under sections
319F-1 and 319F-2(c)(7)(C)(iii), to public and
private persons, including for-profit and
nonprofit persons, federally funded research
and development centers, and universities, to--
``(I) support the cost of
countermeasure and product advanced
research and development; and
``(II) ensure accelerated
development of countermeasures and
products.
``(C) Streamline processes.--To carry out the
purpose described in paragraph (2)(C), the Secretary,
acting through the Director, shall--
``(i) receive from the Assistant Secretary
for Public Health Emergency Preparedness,
requirements for national civilian biodefense
needs, particularly countermeasures or products
and other technologies, to diagnose, mitigate,
prevent, or treat harm from existing, emerging,
or potential chemical, biological,
radiological, or nuclear agents or potential
pandemic infectious diseases;
``(ii) establish transparent, expeditious,
and direct processes for selecting promising
countermeasures and products, supporting them
through advanced research and development and
recommending them for procurement;
``(iii) establish an office within the
BARDA, in consultation with the Commissioner of
Food and Drugs, to--
``(I) facilitate regular and
ongoing communication between the BARDA
and the Food and Drug Administration
regarding the status of BARDA advanced
research and development activities;
``(II) ensure that such activities
are coordinated with the approval
requirements of the Food and Drug
Administration, with the goal of
expediting the development and approval
of countermeasures and products; and
``(III) connect interested persons
with additional technical assistance
made available under section 565 of the
Federal Food, Drug, and Cosmetic Act;
``(iv) coordinate with the Food and Drug
Administration to facilitate regulatory review
and approval of promising classes of
countermeasures or products through the
development of research tools; and
``(v) recommend to the Secretary, through
the Assistant Secretary for Public Health
Emergency Preparedness, procurement of the most
promising eligible security countermeasures or
qualified pandemic or epidemic products
identified in clause (i).
``(D) Supporting Innovation.--To carry out the
purpose described in paragraph (2)(D), the Secretary,
acting through the Director, shall award contracts,
grants, cooperative agreements, or enter into other
transactions, to include use of simplified acquisition
authorities provided under sections 319F-1 and 319F-
2(c)(7)(C)(iii), to the entities described in
subparagraph (B)(iii), to promote innovation in
technologies supporting the advanced research and
development and production of qualified or security
countermeasures or qualified pandemic or epidemic
products, such as research tools, manufacturing,
countermeasure administration, storage, and
bioinformatics and other devices.
``(E) Other duties.--
``(i) In general.--The Director may--
``(I) prepare and submit to the
President and Congress, an annual
budget estimate for qualified
countermeasure and pandemic or epidemic
product advanced research and
development and other BARDA activities,
after opportunity for comment by the
Secretary; and
``(II) receive from the President
and the Office of Management and Budget
directly all funds appropriated by
Congress for obligation and expenditure
by the BARDA.
``(ii) Secretary duties.--The Secretary,
acting through the Director, may--
``(I) enter into such contracts,
leases, cooperative agreements, or
other transactions, as may be necessary
to carry out the functions of BARDA,
without regard to section 3648 and 3709
of the Revised Statutes of the United
States (31 U.S.C. 3324(a) and (b)), (41
U.S.C. 5), with any public agency, any
firm, association, corporation, or
educational institution, or any other
person;
``(II) support advanced research
and development and innovation of
potential countermeasures or products
by highly qualified foreign nationals
outside the United States that may
inure to the benefit of the American
people and collaborative research
involving American and foreign
participants;
``(III) administer grants using
milestone-based awards and payments;
and
``(IV) establish 1 or more
federally funded research and
development centers or university
affiliated research centers in
accordance with section 253(c)(3) of
title 41, United States Code.
``(5) Vulnerable populations.--In carrying out the
activities under this section, the Director, in consultation
with the Vulnerable Populations Working Group, may give
priority to supporting and facilitating advanced research and
development of countermeasures or products, and formulations of
countermeasures or products, that are likely to be safe and
effective for pediatric populations, pregnant women, and other
vulnerable populations.
``(6) Working groups.--
``(A) Identification of technologies.--
``(i) In general.--The Director may
establish and convene, or enter into a contract
with a public or private research institution
to convene, one or more working groups that
consists of experts on countermeasure
technology to identify innovative technologies
that have the potential to be developed as
countermeasures or products.
``(ii) Meetings.--A working group
established under clause (i) shall participate
in regular meetings with sponsors of
countermeasures, products, or related
technologies to--
``(I) review the scientific
evidence or concept of such
countermeasures, products, or related
technologies;
``(II) provide guidance on research
protocols or studies; and
``(III) provide guidance on the
regulatory approval process for
countermeasures, products, and related
technologies.
``(iii) Recommendations.--Not later than 30
days after each meeting with a sponsor of a
countermeasure, product, or related technology,
the working group shall make recommendations to
the Director concerning such countermeasure,
product, or related technology.
``(iv) Confidentiality.--Any commercial
confidential or proprietary information that is
disclosed to the working group in a meeting
under this section shall remain confidential
and shall not be disclosed other than to the
Secretary or the Director, or their designees.
``(v) Construction.--Nothing in this
subparagraph shall be construed to prohibit a
sponsor from meeting with the Director to
discuss potential countermeasures, products, or
related technologies.
``(B) Public working group.--The Director may
establish and convene one or more working groups
composed of private citizens and officials of Federal,
State, and local governments to advise such Director
with respect to the functions of the BARDA and the
Director.
``(C) Vulnerable populations working group.--The
Director shall establish and convene a Vulnerable
Populations Working Group composed of experts on
pediatric populations, pregnant women, and other
vulnerable populations to advise such Director with
respect to--
``(i) supporting and facilitating advanced
research and development of countermeasures,
and formulations of countermeasures, that are
safe and effective for such populations; and
``(ii) other activities of the BARDA that
effect such populations.
``(7) Personnel Authorities.--
``(A) Specially qualified scientific and
professional personnel.--In hiring personnel for the
BARDA, the Director shall have the hiring and
management authorities described in section 1101 of the
Strom Thurmond National Defense Authorization Act for
Fiscal Year 1999 (5 U.S.C. 3104 note; Public Law 105-
261). With respect to the personnel of the BARDA, the
term of appointments for employees referred to under
subsection (c)(1) of that section may not exceed 5
years before the granting of any extension under
subsection (c)(2) of that section.
``(B) Special consultants.--The Director may accept
special consultants as personnel for the BARDA under
section 207(f).
``(C) Intergovernmental personnel act.--The
Director may accept as personnel for the BARDA,
employees under subchapter VI of chapter 33 of subpart
B of part III of title 5, United States Code.
``(D) Other services.--The Director may accept
voluntary and uncompensated services.
``(c) National Biodefense Advisory Board.--
``(1) In general.--
``(A) Purpose.--The National Biodefense Advisory
Board shall provide expert advice and guidance to the
Secretary on the threats, challenges, and opportunities
presented by advances in biological and life sciences
and the threat from natural infectious diseases and
chemical, biological, radiological, and nuclear
threats.
``(B) Membership.--There is established the
National Biodefense Advisory Board (hereinafter in this
section referred to as the `Board') to be composed of
23 members who represent the Nation's preeminent
scientific, public health, and medical experts on the
subject of biological, chemical, nuclear, and
radiological threats, whether naturally occurring,
accidental, or deliberate, as follows:
``(i) Ex officio.--The following members
shall serve on the Board ex officio:
``(I) The Assistant to the
President for Homeland Security and
Counterterrorism.
``(II) The Director of the Office
of Science and Technology Policy.
``(III) The Assistant Secretary for
Public Health Emergency Preparedness.
``(IV) The Director of the National
Institutes of Health.
``(V) The Director of the Centers
for Disease Control and Prevention.
``(VI) The Commissioner of Food and
Drugs.
``(VII) The Director of BARDA.
``(VIII) The Assistant Secretary of
Defense for Health Affairs.
``(IX) The Assistant Secretary of
Homeland Security for Science and
Technology.
``(X) The Secretary of Agriculture
(or a designee).
``(ii) Appointed members.--The following
individuals, as appointed by the Secretary:
``(I) Four representatives of the
pharmaceutical and biotechnology
industries.
``(II) Four representatives of
academia.
``(III) Five other members as
determined appropriate by the
Secretary.
``(C) Term of appointment.--A member of the Board
described in subparagraph (B)(ii) shall serve for a
term of 3 years, except that the Secretary may adjust
the terms of the initial Board appointees in order to
provide for a staggered term of appointment for all
members.
``(D) Consecutive appointments; maximum terms.--A
member may be appointed to serve not more than 3 terms
on the Board and may serve not more than 2 consecutive
terms.
``(2) Duties.--The Board shall--
``(A) advise the Secretary on major biodefense
initiatives and review ongoing and proposed biodefense
programs, which may include potential activities of the
BARDA; and
``(B) in consultation with the Director of BARDA,
and in coordination with the Director of National
Institute of Allergy and Infectious Diseases, provide
to the Secretary, recommendations and findings for an
expanded, intensified, and coordinated biodefense
research program encompassing the programs of the BARDA
and other Federal agencies and related programs of the
other research institutes.
``(3) Meetings.--The Board shall meet at the call of the
Secretary, but in no case less than twice annually to provide
to the Secretary updated assessments, findings, and
recommendations of the current trends, challenges, and
opportunities posed in biotechnology and genetic engineering.
``(4) Vacancies.--Any vacancy in the Board shall not affect
its powers, but shall be filled in the same manner as the
original appointment.
``(5) Chairperson.--The Secretary shall appoint a
chairperson from among the members of the Board.
``(6) Powers.--
``(A) Hearings.--The Board may hold such hearings,
sit and act at such times and places, take such
testimony, and receive such evidence as the Board
considers advisable to carry out this subsection.
``(B) Postal services.--The Board may use the
United States mails in the same manner and under the
same conditions as other departments and agencies of
the Federal Government.
``(7) Personnel.--
``(A) Officers of the federal government.--A member
of the Board that is an employee of the Federal
Government may not receive additional pay, allowances,
or benefits by reason of the member's service on the
Board.
``(B) Other members.--A member of the Board that is
not an employee of the Federal Government shall be
compensated at a rate equivalent to the daily
equivalent of the annual rate of basic pay prescribed
for level IV of the Executive Schedule under section
5315 of title 5, United States Code, for each day
(including travel time) during which the member is
engaged in the actual performance of duties as a member
of the Board.
``(C) Travel expenses.--Each member of the Board
shall receive travel expenses, including per diem in
lieu of subsistence, in accordance with applicable
provisions under subchapter I of chapter 57 of title 5,
United States Code.
``(D) Detail of government employees.--Any Federal
Government employee may be detailed to the Board
without reimbursement, and such detail shall be without
interruption or loss of civil service status or
privilege.
``(d) Fund.--
``(1) Establishment.--There is established the Biodefense
Medical Countermeasure Development Fund, which shall be
administered by the Director of the BARDA.
``(2) Funds.--
``(A) First fiscal year.--Of the amounts
appropriated to carry out the Project BioShield Act of
2004 (Public Law 108-276) and not obligated,
$1,000,000,000 shall be available to the Fund to carry
out this section for fiscal year 2006. Such amounts
shall remain available until expended.
``(B) Subsequent fiscal years.--There are
authorized to be appropriated such sums as may be
necessary to carry out this section for fiscal year
2007 and each subsequent fiscal year. Such sums shall
remain available until expended.
``(e) Effect of Section.--Nothing in this section shall be
construed to limit any authority of the Department of Health and Human
Services, including those authorities provided under the Project
BioShield Act of 2004 (Public Law 108-276).
``(f) Inapplicability of Certain Acts.--
``(1) FACA.--The Federal Advisory Committee Act (5 U.S.C.
App.) shall not apply to the duties, activities, working
groups, and advisory boards of the BARDA.
``(2) FOIA.--Information that relates to the activities,
working groups, and advisory boards of the BARDA shall not be
subject to disclosure under section 552 of title 5, United
States Code, unless the Secretary or Director determines that
such disclosure would pose no threat to national security. Such
a determination shall not be subject to judicial review.
``(3) Certain cost principles and cost accounting
standards.--Notwithstanding any other provision of law, the
cost principles set forth under part 31 of title 48, Code of
Federal Regulations, the cost accounting standards set forth
under chapter 99 of title 48, Code of Federal Regulations, and
the requirement for the submission of certified cost and
pricing information under section 304A of the Federal Property
and Administrative Services Act of 1949 (41 U.S.C. 254b), shall
not apply to any contract, grant, cooperative agreement, or
other transaction entered into under the Project BioShield Act
of 2004 (Public Law 108-276).''.
SEC. 4. CLARIFICATION OF COUNTERMEASURES COVERED BY PROJECT BIOSHIELD.
(a) Qualified Countermeasure.--Section 319F-1(a) of the Public
Health Service Act (42 U.S.C. 247d-6a(a)) is amended by striking
paragraph (2) and inserting the following:
``(2) Definitions.--In this section:
``(A) Qualified countermeasure.--The term
`qualified countermeasure' means a drug (as that term
is defined by section 201(g)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))),
biological product (as that term is defined by section
351(i) of this Act (42 U.S.C. 262(i))), device (as that
term is defined by section 201(h) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321(h))), or research
tool (as that term is defined in section 201(rr) of the
Federal Food, Drug, and Cosmetic Act) that the
Secretary determines to be a priority (consistent with
sections 302(2) and 304(a) of the Homeland Security Act
of 2002) to--
``(i) diagnose, mitigate, prevent, or treat
harm from any biological agent (including
organisms that cause an infectious disease) or
toxins, chemical, radiological, or nuclear
agent that may cause a public health emergency
affecting national security;
``(ii) diagnose, mitigate, prevent, or
treat harm from a condition that may result in
adverse health consequences or death and may be
caused by administering a drug, biological
product, or device that is used as described in
this subparagraph; or
``(iii) in the case of a research tool,
enable the rapid and effective identification,
assessment, or development of a drug,
biological 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.
``(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.
``(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).
``(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.
``(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.
``(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.
``(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--
``(I) such individual has suffered
a loss as a direct result of the
design, development, clinical testing
and investigation, manufacture,
labeling, distribution, sale, purchase,
donation, dispensing, prescribing, or
administration of a security
countermeasure or qualified epidemic or
pandemic product; and
``(II) the loss as described in
subclause (I) was a direct result of
the willful misconduct of the
manufacturer, distributor,
administrator, or health care provider
in violating the Federal Food, Drug,
and Cosmetic Act or this Act.
``(E) Scope.--Subparagraph (C) shall apply
regardless of whether the suit or liability described
in subsection (a) or the claim described in
subparagraph (A) arises from the design, development,
clinical testing and investigation, manufacture,
labeling, distribution, sale, purchase, donation,
dispensing, prescribing, administration, or use by the
Federal Government or by any person.
``(2) Declaration by secretary.--
``(A) In general.--The Secretary may issue a
declaration, pursuant to this paragraph, that an actual
or potential public health emergency makes advisable
the distribution, administration, or use of a security
countermeasure or qualified pandemic or epidemic
product.
``(B) Security countermeasure or qualified pandemic
or epidemic product.--The Secretary shall specify in
such declaration the security countermeasures or
qualified pandemic or epidemic products to be sold by,
purchased from, or donated by a manufacturer or drawn
from the Strategic National Stockpile.
``(C) Effective period.--The Secretary shall
specify in such declaration the beginning and the
ending dates of the effective period of the
declaration, which shall be not longer than 6 months.
The Secretary may subsequently amend such declaration
to shorten or extend such effective period, provided
that the new ending data is after the date on which the
declaration is amended.
``(D) Publication.--The Secretary shall promptly
publish each such declaration and amendment in the
Federal Register.
``(c) Actions by the United States.--Nothing in this section shall
be construed to abrogate or limit any right, remedy, or authority that
the United States or any agency thereof may possess under any other
provision of law.
``(d) Definitions.--In this section:
``(1) Administrator.--The term `administrator' means a
person employed by the State or local government, or their
designee, who supervised or administered a program with respect
to the administration, dispensing, distribution, or provision
of a security countermeasure or a qualified pandemic or
epidemic product, including a person who has established
requirements, provided policy guidance, supplied technical or
scientific advice or assistance.
``(2) Health care provider.--The term `health care
provider' means a person, including a volunteer, who
distributes, prescribes, administers, dispenses, provides a
facility to administer, or supervises or oversees the
administration of a security countermeasure or a qualified
pandemic or epidemic product, including persons who distribute,
prescribe, administer, dispense, or provide a facility to
administer in accordance with a designation under subsection
(b)(2).
``(3) Loss.--The term `loss' means death, physical injury,
or loss of or damage to property, including business
interruption loss.
``(4) Manufacturer.--The term `manufacturer' includes--
``(A) a contractor or subcontractor of a
manufacturer;
``(B) a supplier of any product or service,
research tool, or component to the manufacturer; and
``(C) any or all of the parents, subsidiaries,
affiliates, successors, and assigns of a manufacturer.
``(5) Qualified pandemic or epidemic product.--The term
`qualified pandemic or epidemic product' means a drug (as such
term is defined in section 201(g)(1) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as
such term is defined by section 351(i) of this Act) or device
(as such term is defined by section 201(h) of the Federal Food,
Drug and Cosmetic Act (21 U.S.C. 321(h))) designed, developed,
modified, or procured to diagnose, mitigate, prevent, treat, or
cure a pandemic or epidemic or limit the harm such pandemic or
epidemic might otherwise cause or a serious or life-threatening
disease or condition caused by such a product, that--
``(A) is approved or cleared under chapter V of the
Federal Food, Drug, and Cosmetic Act or licensed under
section 351 of this Act;
``(B) is a product for which the Secretary
determines that sufficient and satisfactory clinical
experience or research data (including data, if
available, from pre-clinical and clinical trials)
support a reasonable conclusion that the product will
qualify for approval or licensing within 8 years after
the date the Secretary makes a declaration under
paragraph (2); or
``(C) is authorized for emergency use section 564
of the Federal Food, Drug, and Cosmetic Act, except
that subsection (b) of such section shall not apply.
``(6) Party.-- The term `party' means an individual who can
reasonably demonstrate to the Secretary that such individual
has suffered a loss (as defined in paragraph (3)) as a direct
result of the willful misconduct of a manufacturer,
distributor, administrator, or health care provider.
``(7) Person.--The term `person' includes an individual,
partnership, corporation, association, entity, or public or
private corporation, including a Federal, State, or local
agency or department.
``(8) Security countermeasure.--The term `security
countermeasure' has the meaning given such term in section
319F-2(c)(1)(B).''.
SEC. 7. COMPENSATION.
Title II of the Public Health Service Act (42 U.S.C. 202 et seq.)
is amended by adding at the end the following:
``PART D--OTHER COMPENSATION PROGRAMS
``SEC. 271. COVERED COUNTERMEASURES PROGRAM.
``(a) In General.--If the Secretary issues a Proclamation stating
that there is a critical public health need for a covered individual to
receive a covered countermeasure during the effective period of the
Proclamation, the Secretary shall establish a process to provide
compensation to such covered individuals for a covered injury,
consistent with the Smallpox Emergency Personnel Protection program
under part C.
``(b) Definition.--For purposes of this section:
``(1) Covered countermeasure.--The term `covered
countermeasure' means a qualified pandemic or epidemic (as
defined in section 319F-3(c)(5)) or a security countermeasure
(as defined in section 319F-2(c)(1)(B)) specified in the
Proclamation.
``(2) Covered individual.--The term `covered individual'
means an individual--
``(A) who is a health care worker, law enforcement
officer, firefighter, security personnel, emergency
medical personnel, other public health or safety
personnel, or support personnel for such occupational
specialties;
``(B) who is or will be functioning in a role
identified in a State, local, or Department of Health
and Human Services emergency response plan approved by
the Secretary;
``(C) who has volunteered and been selected to be a
member of an emergency response plan; and
``(D) to whom a covered countermeasure is
administered pursuant to such approved plan during the
effective period of the Proclamation and prior to the
time at which the Secretary declares a public health
emergency pursuant to section 319 related to a covered
countermeasure specified in the Proclamation.
``(3) Covered injury.--The term `covered injury' means an
injury, disability, illness, condition, or death (other than a
minor injury such as minor scarring or minor local reaction)
determined by the Secretary to have been sustained by a covered
individual as the direct result of administration to the
individual of a covered countermeasure.
``(4) Effective period of the proclamation.--The term
`effective period of the Proclamation' means the effective
period specified in the Proclamation, unless extended by the
Secretary.
``(5) Emergency response plan.--The term `emergency
response plan' or `plan' means a response plan detailing
actions to be taken in preparation for a pandemic, epidemic, or
biological, chemical, nuclear agent or toxin that presents, or
may present, a public health emergency.
``(6) Proclamation.--The term `Proclamation' means a
Proclamation regarding the critical public health need for the
administration of a covered countermeasure issued by the
Secretary and published in the Federal Register. Such
Proclamation shall specify the specific covered countermeasure
recommended for administration.
``(c) Rule of Construction.--Nothing in this section shall be
construed to require the creation of a compensation program if the
covered injuries are only minor injuries consistent with section
(b)(3).''.
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 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.
``(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.''.
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 it's publications, facilities and services will be made available
to various kinds of users.
``(c) Terms of Office.--Each appointed member of the Board shall
hold office for a term of 4 years, except that any member appointed to
fill a vacancy occurring prior to the expiration of the term for which
the predecessor of such member was appointed shall be appointed for the
remainder of such term. None of the appointed members shall be eligible
for reappointment within 1 year after the end of the preceding term of
such member.
``(d) Compensation.--Appointed members of the Board who are not
otherwise in the employ of the United States, while attending
conferences of the Board or otherwise serving at the request of the
Secretary in connection with the administration of the Board, shall be
entitled to receive compensation, per diem in lieu of subsistence, and
travel expenses in the same manner and under the same conditions as
that prescribed under section 208(c).
``SEC. 485D. GIFTS TO THE CENTER.
``Section 231 shall be applicable to the acceptance and
administration of gifts made for the benefit of the Center or for
carrying out any of its functions.
``SEC. 485E. CENTER FACILITIES.
``There are authorized to be appropriated amounts sufficient for
the erection and equipment of suitable and adequate buildings and
facilities for use of the Center. The Administrator of General Services
may acquire, by purchase, condemnation, donation, or otherwise, a
suitable site or sites, selected by the Secretary in accordance with
the direction of the Board, for such buildings and facilities and to
erect thereon, furnish, and equip such buildings and facilities. The
amounts authorized to be appropriated by this section include the cost
of preparation of drawings and specifications, supervision of
construction, and other administrative expenses incident to the work.
The Administrator of General Services shall prepare the plans and
specifications, make all necessary contracts, and supervise
construction.''.
(b) Report.--Not later than 12 months after the date of enactment
of this Act, the Secretary of Health and Human Services shall submit a
report to the appropriate committees of Congress that contains--
(1) a review of all functions and duties of the National
Pathology Center under subpart 7 of part E of title IV of the
Public Health Service Act,as established by subsection (a);
(2) areas where such functions and duties overlap with the
functions and duties of the National Institutes of Health; and
(3) recommendations concerning necessary modifications to
the National Pathology Center.
(c) Transfer of the Armed Forces Institute of Pathology.--
(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.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S11424-11433)
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Enzi with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Enzi with an amendment in the nature of a substitute. Without written report.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 257.
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