Biodefense and Pandemic Vaccine and Drug Development Act of 2006 - Amends the Public Health Service Act to establish the Biomedical Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services (HHS). Requires the Secretary of Health and Human Services to coordinate and oversee the acceleration of countermeasure and product advanced research and development.
Requires the Secretary to: (1) facilitate and increase expeditious and direct communication with respect to such research and development; (2) conduct ongoing searches for, and support calls for, potential qualified countermeasures and qualified pandemic or epidemic products; (3) direct and coordinate such research and development activities of HHS; (4) establish strategic initiatives to accelerate such research and development and innovation in priority unmet need areas; and (5) connect interested persons with authorized offices or employees to advise such persons regarding relevant regulatory requirements related to qualified countermeasures or qualified pandemic or epidemic products. Allows the Secretary to award contracts, grants, and cooperative agreements or enter into other transactions to promote: (1) innovation in technologies that may assist such research and development; (2) research on and development of research tools and other devices and technologies; and (3) research to promote strategic initiatives, such as rapid diagnostics, broad spectrum antimicrobials, and vaccine manufacturing technologies.
Authorizes the Secretary to enter into other transactions for countermeasure and product advanced research and development. Gives the Secretary expedited procurement authorities, the authority to expedite peer review, and the authority for personal services contracts. Authorizes the Secretary to require that, as a condition of being awarded a contract, grant, cooperative agreement, or other transaction, a person make available to the Secretary relevant data related to or resulting from such research and development. Exempts the Secretary's authority to enter into contracts from advertising and advance payment requirements.
Allows the Secretary to: (1) use milestone-based awards and payments; (2) make awards to and enter into transactions with highly qualified foreign national persons outside the United States under certain circumstances; (3) establish one or more federally-funded research and development centers or university-affiliated research centers; (4) 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 the emergency health security needs of children and other vulnerable populations; (5) appoint highly qualified individuals to scientific or professional positions in BARDA without regard to federal provisions governing appointments in the competitive service; (6) appoint special consultants; and (7) accept voluntary and uncompensated services.
Requires the Secretary to withhold from disclosure under the Freedom of Information Act 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 reveals vulnerabilities of existing medical or public health defenses against biological, chemical, nuclear, or radiological threats.
Authorizes appropriations for FY2007-FY2008.
Requires the Secretary to establish the National Biodefense Science Board to provide expert advice and guidance to the Secretary on scientific, technical, and other matters of special interest to HHS regarding current and future chemical, biological, nuclear, and radiological agents.
(Sec. 4) Includes within the definitions of "qualified countermeasure" and "security countermeasure" an agent to diagnose, mitigate, prevent, or treat harm from organisms that cause an infectious disease. Deems as a qualified countermeasure without further administrative action any countermeasure for a biological agent if the Secretary determines that there is credible evidence that such agent has the potential to cause an epidemic or pandemic that may constitute a public health emergency.
(Sec. 5) Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary to establish within the Food and Drug Administration (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, 6) 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 if 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; (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.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5533 Introduced in House (IH)]
109th CONGRESS
2d Session
H. R. 5533
To prepare and strengthen the biodefenses of the United States against
deliberate, accidental, and natural outbreaks of illness, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 6, 2006
Mr. Rogers of Michigan (for himself, Ms. Eshoo, Mr. Hoekstra, and Mr.
McHugh) introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
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 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. Technical assistance.
Sec. 6. Procurement.
Sec. 7. Rule of construction.
SEC. 3. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY;
NATIONAL BIODEFENSE SCIENCE BOARD.
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) 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.
``(8) 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.
``(9) 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, make
public, and present to the appropriate Congressional committees
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. The Secretary shall periodically review
and, as appropriate, revise the plan.
``(2) Content.--The strategic plan under paragraph (1)
shall--
``(A) guide 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) guide 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');
``(C) guide procurement of such qualified
countermeasures and qualified pandemic or epidemic
products by such Department;
``(D) include immediate, short-term, and long-term
goals;
``(E) include immediate, short-term, and long-term
procurement priorities; and
``(F) identify processes used to designate a range
of funds available for various types of countermeasure
procurements.
``(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)), provided
that such centers are consistent and complementary with
the duties described in paragraph (4), and are
consistent and complementary with, and deemed necessary
after considering the availability of, existing
federally-supported basic research programs.
``(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, 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 in addition to such amounts
as are otherwise available for this purpose.
``(2) Funding.--To carry out the purposes of this section,
there are authorized to be appropriated to the Fund--
``(A) $1,070,000,000 for fiscal years 2006 through
2008, the amounts to remain available until expended;
and
``(B) such sums as may be necessary for subsequent
fiscal years, the amounts to 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.''.
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
``(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)(i)(I) is
amended by striking ``to treat'' the first place such term appears and
all that follows through ``from a condition'' and inserting the
following: ``to diagnose, mitigate, prevent, or treat harm from any
biological agent (including organisms that cause an infectious disease)
or toxin, chemical, radiological, or nuclear agent identified as a
material threat under paragraph (2)(A)(ii), or to diagnose, mitigate,
prevent, or treat harm from a condition''.
SEC. 5. 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. 6. PROCUREMENT.
(a) Security Countermeasures.--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) Procurement of multiple
products and technologies.--
Notwithstanding any other provision of
law or regulation, the Secretary shall,
where possible, enter into multiple
transactions for the procurement of
multiple technologies and products from
multiple manufacturers of security
countermeasures in order to mitigate
against the risks associated with
dependence on a single supplier or
technology.
``(VIII) 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)).
``(IX) 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.
``(X) Additional 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.''.
(b) Qualified Countermeasures.--Section 319F-1(b) of the Public
Health Service Act (42 U.S.C. 247d-6a(b)) is amended by adding at the
end the following:
``(5) Procurement of multiple products and technologies.--
Notwithstanding any other provision of law or regulation, the
Secretary shall, where possible, enter into multiple
transactions for the procurement of multiple technologies and
products from multiple manufacturers of qualified
countermeasures in order to mitigate against the risks
associated with dependence on a single supplier or
technology.''.
SEC. 7. 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.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Committee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended) by Voice Vote.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 109-686.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 109-686.
Placed on the Union Calendar, Calendar No. 416.
Mr. Deal (GA) moved to suspend the rules and pass the bill, as amended.
Considered under suspension of the rules. (consideration: CR H7445-7450)
DEBATE - The House proceeded with forty mintues of debate on H.R. 5533.
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Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H7445-7447)
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H7445-7447)
Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.