Congressional Record: April 6, 2006 (Senate)
Page S3213-S3249
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS
By Mr. BURR (for himself, Mr. Frist, Mr. Enzi, Mr. Gregg, Mr.
Alexander, and Mrs. Dole):
S. 2564. A bill to prepare and strengthen the biodefenses of the
United States against deliberate, accidental, and natural outbreaks of
illness, and for other purposes; to the Committee on Health, Education,
Labor, and Pensions.
Mr. BURR. Mr. President, I ask unanimous consent that the text of the
bill be printed in the Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 2564
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 2006''.
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 Authority;
National Biodefense Science Board.
Sec. 4. Clarification of countermeasures covered by Project BioShield.
Sec. 5. Orphan drug market exclusivity for countermeasure products.
Sec. 6. Technical assistance.
Sec. 7. Collaboration and coordination.
Sec. 8. Procurement.
Sec. 9. Rule of construction.
SEC. 3. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT
AUTHORITY; NATIONAL BIODEFENSE SCIENCE BOARD.
(a) In General.--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
AUTHORITY.
``(a) Definitions.--In this section:
``(1) BARDA.--The term `BARDA' means the Biomedical
Advanced Research and Development Authority.
``(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, such as the Secretary of Defense
may enter into 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 pandemic or epidemic product.--The term
`qualified pandemic or epidemic product' has the meaning
given the term in section 319F-3.
``(6) Advanced research and development.--
``(A) In general.--The term `advanced research and
development' means, with respect to a product that is or may
become a qualified countermeasure or a qualified pandemic or
epidemic product, activities that predominantly--
``(i) are conducted after basic research and preclinical
development of the product; and
``(ii) are related to manufacturing the product on a
commercial scale and in a form that satisfies the regulatory
requirements under the Federal Food, Drug, and Cosmetic Act
or under section 351 of this Act.
``(B) Activities included.--The term under subparagraph (A)
includes--
``(i) testing of the product to determine whether the
product may be approved, cleared, or licensed under the
Federal Food, Drug, and Cosmetic Act or under section 351 of
this Act for a use that is or may be the basis for such
product becoming a qualified countermeasure or qualified
pandemic or epidemic product, or to help obtain such
approval, clearance, or license;
``(ii) design and development of tests or models, including
animal models, for such testing;
``(iii) activities to facilitate manufacture of the product
on a commercial scale with consistently high quality, as well
as to improve and make available new technologies to increase
manufacturing surge capacity;
``(iv) activities to improve the shelf-life of the product
or technologies for administering the product; and
``(v) such other activities as are part of the advanced
stages of testing, refinement, improvement, or preparation of
the product for such use and as are specified by the
Secretary.
``(7) Security countermeasure.--The term `security
countermeasure' has the meaning given such term in section
319F-2.
[[Page S3223]]
``(8) Research tool.--The term `research tool' means a
device, technology, biological material (including a cell
line or an antibody), reagent, animal model, computer system,
computer software, or analytical technique that is developed
to assist in the discovery, development, or manufacture of
qualified countermeasures or qualified pandemic or epidemic
products.
``(9) Program manager.--The term `program manager' means an
individual appointed to carry out functions under this
section and authorized to provide project oversight and
management of strategic initiatives.
``(10) Person.--The term `person' includes an individual,
partnership, corporation, association, entity, or public or
private corporation, and a Federal, State, or local
government agency or department.
``(b) Strategic Plan for Countermeasure Research,
Development, and Procurement.--
``(1) In general.--Not later than 6 months after the date
of enactment of the Biodefense and Pandemic Vaccine and Drug
Development Act of 2006, the Secretary shall develop and make
public a strategic plan to integrate biodefense and emerging
infectious disease requirements with the advanced research
and development, strategic initiatives for innovation, and
the procurement of qualified countermeasures and qualified
pandemic or epidemic products.
``(2) Content.--The strategic plan under paragraph (1)
shall guide--
``(A) research and development, conducted or supported by
the Department of Health and Human Services, of qualified
countermeasures and qualified pandemic or epidemic products
against possible biological, chemical, radiological, and
nuclear agents and to emerging infectious diseases;
``(B) innovation in technologies that may assist advanced
research and development of qualified countermeasures and
qualified pandemic or epidemic products (such research and
development referred to in this section as `countermeasure
and product advanced research and development'); and
``(C) procurement of such qualified countermeasures and
qualified pandemic or epidemic products by such Department.
``(c) Biomedical Advanced Research and Development
Authority.--
``(1) Establishment.--There is established within the
Department of Health and Human Services the Biomedical
Advanced Research and Development Authority.
``(2) In general.--Based upon the strategic plan described
in subsection (b), the Secretary shall coordinate and oversee
the acceleration of countermeasure and product advanced
research and development by--
``(A) facilitating collaboration among the Department of
Health and Human Services, other Federal agencies, relevant
industries, academia, and other persons, with respect to such
advanced research and development;
``(B) promoting countermeasure and product advanced
research and development;
``(C) facilitating contacts between interested persons and
the offices or employees authorized by the Secretary to
advise such persons regarding requirements under the Federal
Food, Drug, and Cosmetic Act and under section 351 of this
Act; and
``(D) promoting 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 be
appointed by the Secretary and to whom the Secretary shall
delegate such functions and authorities as necessary to
implement this section.
``(4) Duties.--
``(A) Collaboration.--To carry out the purpose described in
paragraph (2)(A), the Secretary shall--
``(i) facilitate and increase the expeditious and direct
communication between the Department of Health and Human
Services and relevant persons with respect to countermeasure
and product advanced research and development, including by--
``(I) facilitating such communication regarding the
processes for procuring such advanced research and
development with respect to qualified countermeasures and
qualified pandemic or epidemic products of interest; and
``(II) soliciting information about and data from research
on potential qualified countermeasures and qualified pandemic
or epidemic products and related technologies;
``(ii) at least annually--
``(I) convene meetings with representatives from relevant
industries, academia, other Federal agencies, international
agencies as appropriate, and other interested persons;
``(II) sponsor opportunities to demonstrate the operation
and effectiveness of relevant biodefense countermeasure
technologies; and
``(III) convene such working groups on countermeasure and
product advanced research and development as the Secretary
may determine are necessary to carry out this section; and
``(iii) carry out the activities described in section 7 of
the Biodefense and Pandemic Vaccine and Drug Development Act
of 2006.
``(B) Support advanced research and development.--To carry
out the purpose described in paragraph (2)(B), the Secretary
shall--
``(i) conduct ongoing searches for, and support calls for,
potential qualified countermeasures and qualified pandemic or
epidemic products;
``(ii) direct and coordinate the countermeasure and product
advanced research and development activities of the
Department of Health and Human Services;
``(iii) establish strategic initiatives to accelerate
countermeasure and product advanced research and development
and innovation in such areas as the Secretary may identify as
priority unmet need areas; and
``(iv) award contracts, grants, cooperative agreements, and
enter into other transactions, for countermeasure and product
advanced research and development.
``(C) Facilitating advice.--To carry out the purpose
described in paragraph (2)(C) the Secretary shall--
``(i) connect interested persons with the offices or
employees authorized by the Secretary to advise such persons
regarding the regulatory requirements under the Federal Food,
Drug, and Cosmetic Act and under section 351 of this Act
related to the approval, clearance, or licensure of qualified
countermeasures or qualified pandemic or epidemic products;
and
``(ii) ensure that, with respect to persons performing
countermeasure and product advanced research and development
funded under this section, such offices or employees provide
such advice in a manner that is ongoing and that is otherwise
designated to facilitate expeditious development of qualified
countermeasures and qualified pandemic or epidemic products
that may achieve such approval, clearance, or licensure.
``(D) Supporting innovation.--To carry out the purpose
described in paragraph (2)(D), the Secretary may award
contracts, grants, and cooperative agreements, or enter into
other transactions, such as prize payments, to promote--
``(i) innovation in technologies that may assist
countermeasure and product advanced research and development;
``(ii) research on and development of research tools and
other devices and technologies; and
``(iii) research to promote strategic initiatives, such as
rapid diagnostics, broad spectrum antimicrobials, and vaccine
manufacturing technologies.
``(5) Transaction authorities.--
``(A) Other transactions.--In carrying out the functions
under subparagraph (B) or (D) of paragraph (4), the Secretary
shall have authority to enter into other transactions for
countermeasure and product advanced research and development.
``(B) Expedited authorities.--
``(i) In general.--In awarding contracts, grants, and
cooperative agreements, and in entering into other
transactions under subparagraph (B) or (D) of paragraph (4),
the Secretary shall have the expedited procurement
authorities, the authority to expedite peer review, and the
authority for personal services contracts, supplied by
subsections (b), (c), and (d) of section 319F-1.
``(ii) Application of provisions.--Provisions in such
section 319F-1 that apply to such authorities and that
require institution of internal controls, limit review,
provide for Federal Tort Claims Act coverage of personal
services contractors, and commit decisions to the discretion
of the Secretary shall apply to the authorities as exercised
pursuant to this paragraph.
``(iii) Authority to limit competition.--For purposes of
applying section 319F-1(b)(1)(D) to this paragraph, the
phrase `BioShield Program under the Project BioShield Act of
2004' shall be deemed to mean the countermeasure and product
advanced research and development program under this section.
``(iv) Availability of data.--The Secretary shall require
that, as a condition of being awarded a contract, grant,
cooperative agreement, or other transaction under
subparagraph (B) or (D) of paragraph (4), a person make
available to the Secretary on an ongoing basis, and submit
upon request to the Secretary, all data related to or
resulting from countermeasure and product advanced research
and development carried out pursuant to this section.
``(C) Advance payments; advertising.--The authority of the
Secretary to enter into contracts under this section shall
not be limited by section 3324(a) of title 31, United States
Code, or by section 3709 of the Revised Statutes of the
United States (41 U.S.C. 5).
``(D) Milestone-based payments allowed.--In awarding
contracts, grants, and cooperative agreements, and in
entering into other transactions, under this section, the
Secretary may use milestone-based awards and payments.
``(E) Foreign nationals eligible.--The Secretary may under
this section award contracts, grants, and cooperative
agreements to, and may enter into other transactions with,
highly qualified foreign national persons outside the United
States, alone or in collaboration with American participants,
when such transactions may inure to the benefit of the
American people.
``(F) Establishment of research centers.--The Secretary may
establish one or more federally-funded research and
development centers, or university-affiliated research
centers in accordance with section 303(c)(3) of the Federal
Property and Administrative Services Act of 1949 (41 U.S.C.
253(c)(3)).
``(6) Vulnerable populations.--In carrying out the
functions under this section, the Secretary may give priority
to the advanced research and development of qualified
countermeasures and qualified pandemic or epidemic products
that are likely to be safe and effective with respect to
children,
[[Page S3224]]
pregnant women, and other vulnerable populations.
``(7) Personnel authorities.--
``(A) Specially qualified scientific and professional
personnel.--In addition to any other personnel authorities,
the Secretary may--
``(i) without regard to those provisions of title 5, United
States Code, governing appointments in the competitive
service, appoint highly qualified individuals to scientific
or professional positions in BARDA, such as program managers,
to carry out this section; and
``(ii) compensate them in the same manner in which
individuals appointed under section 9903 of such title are
compensated, without regard to the provisions of chapter 51
and subchapter III of chapter 53 of such title relating to
classification and General Schedule pay rates.
``(B) Special consultants.--In carrying out this section,
the Secretary may--
``(i) appoint special consultants pursuant to section
207(f); and
``(ii) accept voluntary and uncompensated services.
``(d) Fund.--
``(1) Establishment.--There is established the Biodefense
Medical Countermeasure Development Fund, which shall be
available to carry out this section.
``(2) Funds.--
``(A) First fiscal year.--
``(i) Authorization and appropriation.--There are
authorized to be appropriated and there are appropriated to
the Fund $340,000,000 to carry out this section for fiscal
year 2007. Such funds shall remain available until expended.
``(ii) Authorization of appropriations.--There are
authorized to be appropriated, in addition to the amounts
appropriated under clause (i), $160,000,000 to carry out this
section for fiscal year 2007. Such funds shall remain
available until expended.
``(B) Subsequent fiscal years.--
``(i) In general.--There are authorized to be appropriated
to carry out this section--
``(I) $500,000,000 for fiscal year 2008; and
``(II) such sums as may be necessary for fiscal years 2009
through 2012.
``(ii) Availability of funds.--Such sums authorized under
clause (i) shall remain available until expended.
``(e) Inapplicability of Certain Provisions.--
``(1) Disclosure.--
``(A) In general.--The Secretary shall withhold from
disclosure under section 552 of title 5, United States Code,
specific technical data or scientific information that is
created or obtained during the countermeasure and product
advanced research and development funded by the Secretary
that reveal vulnerabilities of existing medical or public
health defenses against biological, chemical, nuclear, or
radiological threats. Such information shall be deemed to be
information described in section 552(b)(3) of title 5, United
States Code.
``(B) Oversight.--Information subject to nondisclosure
under subparagraph (A) shall be reviewed by the Secretary
every 5 years to determine the relevance or necessity of
continued nondisclosure.
``(2) Federal advisory committee act.--Section 14 of the
Federal Advisory Committee Act (5 U.S.C. App.) shall not
apply to a working group of BARDA or to the National
Biodefense Science Board under section 319M.
``SEC. 319M. NATIONAL BIODEFENSE SCIENCE BOARD AND WORKING
GROUPS.
``(a) In General.--
``(1) Establishment and function.--The Secretary shall
establish the National Biodefense Science Board (referred to
in this section as the `Board') to provide expert advice and
guidance to the Secretary on scientific, technical and other
matters of special interest to the Department of Health and
Human Services regarding current and future chemical,
biological, nuclear, and radiological agents, whether
naturally occurring, accidental, or deliberate.
``(2) Membership.--The membership of the Board shall be
comprised of individuals who represent the Nation's
preeminent scientific, public health, and medical experts, as
follows--
``(A) such Federal officials as the Secretary may determine
are necessary to support the functions of the Board;
``(B) four individuals representing the pharmaceutical,
biotechnology, and device industries;
``(C) four individuals representing academia; and
``(D) five other members as determined appropriate by the
Secretary.
``(3) Term of appointment.--A member of the Board described
in subparagraph (B), (C), or (D) of paragraph (2) 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.
``(4) 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.
``(5) Duties.--The Board shall--
``(A) advise the Secretary on current and future trends,
challenges, and opportunities presented by advances in
biological and life sciences, biotechnology, and genetic
engineering with respect to threats posed by naturally
occurring infectious diseases and chemical, biological,
radiological, and nuclear agents;
``(B) at the request of the Secretary, review and consider
any information and findings received from the working groups
established under subsection (b); and
``(C) at the request of the Secretary, provide
recommendations and findings for expanded, intensified, and
coordinated biodefense research and development activities.
``(6) Meetings.--
``(A) Initial meeting.--Not later than one year after the
date of enactment of the Biodefense and Pandemic Vaccine and
Drug Development Act of 2006, the Secretary shall hold the
first meeting of the Board.
``(B) Subsequent meetings.--The Board shall meet at the
call of the Secretary, but in no case less than twice
annually.
``(7) Vacancies.--Any vacancy in the Board shall not affect
its powers, but shall be filled in the same manner as the
original appointment.
``(8) Chairperson.--The Secretary shall appoint a
chairperson from among the members of the Board.
``(9) 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.
``(10) Personnel.--
``(A) Employees 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 may be compensated at a
rate not to exceed the daily equivalent of the annual rate of
basic pay prescribed for level IV of the Executive Schedule
under section 5315 of title 5, United States Code, for each
day (including travel time) during which the member is
engaged in the actual performance of duties as a member of
the Board.
``(C) Travel expenses.--Each member of the Board shall
receive travel expenses, including per diem in lieu of
subsistence, in accordance with applicable provisions under
subchapter I of chapter 57 of title 5, United States Code.
``(D) Detail of government employees.--Any Federal
Government employee may be detailed to the Board with the
approval for the contributing agency without reimbursement,
and such detail shall be without interruption or loss of
civil service status or privilege.
``(b) Other Working Groups.--The Secretary may establish a
working group of experts, or may use an existing working
group or advisory committee, to--
``(1) identify innovative research with the potential to be
developed as a qualified countermeasure or a qualified
pandemic or epidemic product;
``(2) identify accepted animal models for particular
diseases and conditions associated with any biological,
chemical, radiological, or nuclear agent, any toxin, or any
potential pandemic infectious disease, and identify
strategies to accelerate animal model and research tool
development and validation; and
``(3) obtain advice regarding supporting and facilitating
advanced research and development related to qualified
countermeasures and qualified pandemic or epidemic products
that are likely to be safe and effective with respect to
children, pregnant women, and other vulnerable populations,
and other issues regarding activities under this section that
affect such populations.
``(c) Definitions.--Any term that is defined in section
319L and that is used in this section shall have the same
meaning in this section as such term is given in section
319L.
``(d) Authorization of Appropriations.--There are
authorized to be appropriated $1,000,000 to carry out this
section for fiscal year 2007 and each fiscal year
thereafter.''.
(b) Offset of Funding.--The amount appropriated under the
subheading ``Biodefense Countermeasures'' under the heading
``Emergency Preparedness and Response'' in title III of the
Department of Homeland Security Appropriations Act, 2004
(Public Law 108-90) shall be decreased by $340,000,000.
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))), or
device (as that term is defined by section 201(h) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))),
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 toxin, chemical, radiological, or
nuclear agent that may cause a public health emergency
affecting national security; or
[[Page S3225]]
``(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.
``(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 striking ``treat, identify, or prevent'' each
place it appears and inserting ``diagnose, mitigate, prevent,
or treat''.
(c) Limitation on Use of Funds.--Section 510(a) of the
Homeland Security Act of 2002 (6 U.S.C. 320(a)) is amended by
adding at the end the following: ``None of the funds made
available under this subsection shall be used to procure
countermeasures to diagnose, mitigate, prevent, or treat harm
resulting from any naturally occurring infectious disease.''.
SEC. 5. ORPHAN DRUG MARKET EXCLUSIVITY FOR COUNTERMEASURE
PRODUCTS.
(a) In General.--Section 527 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360cc) is amended by adding at the
end the following:
``(c) Market Exclusivities for Countermeasures,
Antibiotics, and Antiinfectives.--
``(1) In general.--Except as provided in paragraph (2),
with respect to a drug that is designated under section 526
for a rare disease or condition, the period referred to in
this section is deemed to be 10 years in lieu of 7 years if--
``(A) such rare disease or condition is directly caused by
a--
``(i)(I) biological agent (including an organism that
causes infectious disease);
``(II) toxin; or
``(III) chemical, radiological, or nuclear agent; and
``(ii) such biological agent (including an organism that
causes an infectious disease), toxin, or chemical,
radiological or nuclear agent, is identified as a material
threat under subsection (c)(2)(A)(ii) of section 319F-2 of
the Public Health Service Act;
``(B) such drug is determined by the Secretary to be a
security countermeasure under subsection (c)(1)(B) of such
section 319F-2 with respect to such agent or toxin;
``(C) no active ingredient (including a salt or ester of
the active ingredient) of the drug has been approved under an
application under section 505(b) prior to the submission of
the request for designation of the new drug under section
526; and
``(D) notice respecting the designation of a drug under
section 526 has been made available to the public.
``(2) Application of provision.--Paragraph (1) shall apply
with respect to an antibiotic drug or antiinfective drug
designated under section 526 only if--
``(A) no active ingredient (including a salt or ester of
the active ingredient) of such drug has been approved as a
feed or water additive for an animal in the absence of any
clinical sign of disease in the animal for growth promotion,
feed efficiency, weight gain, routine disease prevention, or
other routine purpose;
``(B) no active ingredient (including a salt or ester of
the active ingredient) of such drug has been approved for use
in humans under section 505 or approved for human use under
section 507 (as in effect prior to November 21, 1997) prior
to the submission of the request for designation of the new
drug under section 526;
``(C) the Secretary has made a determination that--
``(i) such drug is not a member of a class of antibiotics
that is particularly prone to creating antibiotic resistance;
``(ii) sufficient antibiotics do not already exist in the
same class;
``(iii) such drug represents a significant clinical
improvement over other antibiotic drugs;
``(iv) such drug is for a serious or life-threatening
disease or conditions; and
``(v) such drug is for a countermeasure use; and
``(D) notice respecting the designation of a drug under
section 526 has been made available to the public.
``(3) Rule of construction.--With respect to a drug to
which this subsection applies, and which is also approved for
additional uses to which this subsection does not apply,
nothing in section 505(b)(2) or 505(j) shall prohibit the
Secretary from approving a drug under section 505(b)(2) or
505(j) with different or additional labeling for the drug as
the Secretary deems necessary to ensure that the drug is safe
and effective for the uses to which this subsection does not
apply.
``(4) Study and report.--Not later than January 1, 2011,
the Comptroller General of the United States shall conduct a
study and submit to Congress a report concerning the effect
of and activities under this subsection. Such study and
report shall examine all relevant issues including--
``(A) the effectiveness of this subsection in improving the
availability of novel countermeasures for procurement under
section 319F-2 of the Public Health Service Act;
``(B) the effectiveness of this subsection in improving the
availability of drugs that treat serious or life threatening
diseases or conditions and offer significant clinical
improvements;
``(C) the continued need for additional incentives to
create more antibiotics and antiinfectives;
``(D) the economic impact of the section on taxpayers and
consumers, including--
``(i) the economic value of additional drugs provided for
under this subsection, including the impact of improved
health care and hospitalization times associated with
treatment of nosocomial infections; and
``(ii) the economic cost of any delay in the availability
of lower cost generic drugs on patients, the insured, and
Federal and private health plans;
``(E) the adequacy of limits under subparagraphs (A) and
(B) of paragraph (2) to maximize the useful period during
which antibiotic drugs or antiinfective drugs remain
therapeutically useful treatments; and
``(F) any recommendations for modifications to this
subsection that the Comptroller determines to be appropriate.
``(5) Effective date.--This subsection shall apply only to
products for which an applicant has applied for designation
under section 526 after the date of enactment of the
Biodefense and Pandemic Vaccine and Drug Development Act of
2006.
``(6) Sunset.--This subsection shall not apply with respect
to any designation of a drug under section 526 made by the
Secretary on or after October 1, 2011.''.
SEC. 6. 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 Practice) 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 countermeasures and that the provision of such
assistance would be beneficial in helping alleviate or avert
such shortage.''.
SEC. 7. COLLABORATION AND COORDINATION.
(a) Limited Antitrust Exemption.--
(1) Meetings and consultations to discuss security
countermeasures, qualified countermeasures, or qualified
pandemic or epidemic product development.--
(A) Authority to conduct meetings and consultations.--The
Secretary of Health and Human Services (referred to in this
subsection as the ``Secretary''), in coordination with the
Attorney General and the Secretary of Homeland Security, may
conduct meetings and consultations with persons engaged in
the development of a security countermeasure (as defined in
section 319F-2 of the Public Health Service Act (42 U.S.C.
247d-6b)) (as amended by this Act), a qualified
countermeasure (as defined in section 319F-1 of the Public
Health Service Act (42 U.S.C. 247d-6a))) (as amended by this
Act), or a qualified pandemic or epidemic product (as defined
in section 319F-3 of the Public Health Service Act (42 U.S.C.
247d-6d)) for the purpose of the development, manufacture,
distribution, purchase, or storage of a countermeasure or
product. The Secretary may convene such meeting or
consultation at the request of the Secretary of Homeland
Security, the Attorney General, the Chairman of the Federal
Trade Commission (referred to in this section as the
``Chairman''), or any interested person, or upon initiation
by the Secretary. The Secretary shall give prior notice of
any such meeting or consultation, and the topics to be
discussed, to the Attorney General, the Chairman, and the
Secretary of Homeland Security.
(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;
(ii) be open to persons involved in the development,
manufacture, distribution, purchase, or storage of a
countermeasure or product, as determined by the Secretary;
(iii) be open to the Attorney General, the Secretary of
Homeland Security, and the Chairman;
(iv) be limited to discussions involving covered
activities; and
(v) be conducted in such manner as to ensure that no
national security, confidential commercial, or proprietary
information is disclosed outside the meeting or consultation.
(C) Limitation.--The Secretary may not require participants
to disclose confidential commercial or proprietary
information.
(D) Transcript.--The Secretary shall maintain a complete
verbatim transcript of each meeting or consultation conducted
under this subsection, which shall not be disclosed under
section 552 of title 5, United States Code, unless such
Secretary, in consultation with the Attorney General and the
Secretary of Homeland Security, determines that disclosure
would pose no threat to national security. The determination
regarding possible threats to national security shall not be
subject to judicial review.
(E) Exemption.--
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(i) In general.--Subject to clause (ii), it shall not be a
violation of the antitrust laws for any person to participate
in a meeting or consultation conducted in accordance with
this paragraph.
(ii) Limitation.--Clause (i) shall not apply to any
agreement or conduct that results from a meeting or
consultation and that is not covered by an exemption granted
under paragraph (4).
(2) Submission of written agreements.--The Secretary shall
submit each written agreement regarding covered activities
that is made pursuant to meetings or consultations conducted
under paragraph (1) to the Attorney General and the Chairman
for consideration. In addition to the proposed agreement
itself, any submission 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 for a cooperative
effort among the particular participating persons to achieve
the objectives of the agreement; and
(E) any other relevant information determined necessary by
the Attorney General, in consultation with the Chairman and
the Secretary.
(3) Exemption for conduct under approved agreement.--It
shall not be a violation of the antitrust laws for a person
to engage in conduct in accordance with a written agreement
to the extent that such agreement has been granted an
exemption under paragraph (4), during the period for which
the exemption is in effect.
(4) Action on written agreements.--
(A) In general.--The Attorney General, in consultation with
the Chairman, shall grant, deny, grant in part and deny in
part, or propose modifications to an exemption request
regarding a written agreement submitted under paragraph (2),
in a written statement to the Secretary, within 15 business
days of the receipt of such request. An exemption granted
under this paragraph shall take effect immediately.
(B) Extension.--The Attorney General may extend the 15-day
period referred to in subparagraph (A) for an additional
period of not to exceed 10 business days.
(C) Determination.--An exemption shall be granted regarding
a written agreement submitted in accordance with paragraph
(2) only to the extent that the Attorney General, in
consultation with the Chairman and the Secretary, finds that
the conduct that will be exempted will not have any
substantial anticompetitive effect that is not reasonably
necessary for ensuring the availability of the countermeasure
or product involved.
(5) Limitation on and renewal of exemptions.--An exemption
granted under paragraph (4) shall be limited to covered
activities, and such exemption shall be renewed (with
modifications, as appropriate, consistent with the finding
described in paragraph (4)(C)), on the date that is 3 years
after the date on which the exemption is granted unless the
Attorney General in consultation with the Chairman determines
that the exemption should not be renewed (with modifications,
as appropriate) considering the factors described in
paragraph (4).
(6) Authority to obtain information.--Consideration by the
Attorney General for granting or renewing an exemption
submitted under this section shall be considered an antitrust
investigation for purposes of the Antitrust Civil Process Act
(15 U.S.C. 1311 et seq.).
(7) Limitation on parties.--The use of any information
acquired under an agreement for which an exemption has been
granted under paragraph (4), for any purpose other than
specified in the exemption, shall be subject to the antitrust
laws and any other applicable laws.
(8) Report.--Not later than one year after the date of
enactment of this Act and biannually thereafter, the Attorney
General and the Chairman shall report to Congress on the use
of the exemption from the antitrust laws provided by this
subsection.
(b) Sunset.--The applicability of this section shall expire
at the end of the 6-year period that begins on the date of
enactment of this Act.
(c) 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 the Clayton Act (15 U.S.C. 12(a)),
except that such term includes 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) Countermeasure or product.--The term ``countermeasure
or product'' refers to a security countermeasure, qualified
countermeasure, or qualified pandemic or epidemic product (as
those terms are defined in subsection (a)(1)).
(3) Covered activities.--
(A) In general.--Except as provided in subparagraph (B),
the term ``covered activities'' includes any activity
relating to the development, manufacture, distribution,
purchase, or storage of a countermeasure or product.
(B) Exception.--The term ``covered activities'' shall not
include, with respect to a meeting or consultation conducted
under subsection (a)(1) or an agreement for which an
exemption has been granted under subsection (a)(4), the
following activities involving 2 or more persons:
(i) Exchanging information among competitors relating to
costs, profitability, or distribution of any product,
process, or service if such information is not reasonably
necessary to carry out covered activities--
(I) with respect to a countermeasure or product regarding
which such meeting or consultation is being conducted; or
(II) that are described in the agreement as exempted.
(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
participating in such covered activities, in other research
and development activities, except as reasonably necessary to
prevent the misappropriation of proprietary information
contributed by any person participating in 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 under subsection
(a)(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 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
expressly exempted from the antitrust laws under subsection
(a)(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
participating in such covered activities, in any unilateral
or joint activity that is not reasonably necessary to carry
out such covered activities.
(vii) Entering into any agreement or engaging in any other
conduct restricting or setting the price at which a
countermeasure or product is offered for sale, whether by bid
or otherwise.
SEC. 8. 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)(B)--
(i) by striking the subparagraph heading and all that
follows through ``Homeland Security Secretary'' and inserting
the following: ``Interagency agreement; cost.--The Homeland
Security Secretary''; and
(ii) by striking clause (ii);
(D) 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 (in 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 Secretary shall, to the extent
practicable, make the determination of advance payment at the
same time as the issuance of a solicitation. 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 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 exclusive supplier of the product to the
Federal Government for a specified period of time, not to
exceed the term of the contract, 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. Such a sales
exclusivity provision in such a contract shall constitute a
valid basis for a sole source procurement under section
303(c)(1) of the Federal Property and Administrative Services
Act of 1949 (41 U.S.C. 253(c)(1)).
[[Page S3227]]
``(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 development and acquisition of the
countermeasure; and
``(cc) the specifications the countermeasure must meet to
qualify for procurement under a contract under this
section.''; and
(E) 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 this section for the procurement of countermeasures.''.
SEC. 9. RULE OF CONSTRUCTION.
Nothing in this Act, or any amendment made by this Act,
shall be construed to affect any law that applies to the
National Vaccine Injury Compensation Program under title XXI
of the Public Health Service Act (42 U.S.C. 300aa-1 et seq.),
including such laws regarding--
(1) whether claims may be filed or compensation may be paid
for a vaccine-related injury or death under such Program;
(2) claims pending under such Program; and
(3) any petitions, cases, or other proceedings before the
United States Court of Federal Claims pursuant to such title.
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