[House Report 109-686]
[From the U.S. Government Publishing Office]
109th Congress Report
HOUSE OF REPRESENTATIVES
2d Session 109-686
======================================================================
BIODEFENSE AND PANDEMIC VACCINE AND DRUG DEVELOPMENT ACT OF 2006
_______
September 26, 2006.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mr. Barton of Texas, from the Committee on Energy and Commerce,
submitted the following
R E P O R T
[To accompany H.R. 5533]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (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, having
considered the same, report favorably thereon with an amendment
and recommend that the bill as amended do pass.
CONTENTS
Page
Amendment........................................................ 2
Purpose and Summary.............................................. 8
Background and Need for Legislation.............................. 8
Hearings......................................................... 9
Committee Consideration.......................................... 9
Committee Votes.................................................. 9
Committee Oversight Findings..................................... 9
Statement of General Performance Goals and Objectives............ 9
New Budget Authority, Entitlement Authority, and Tax Expenditures 9
Earmark.......................................................... 10
Committee Cost Estimate.......................................... 10
Congressional Budget Office Estimate............................. 10
Federal Mandates Statement....................................... 12
Advisory Committee Statement..................................... 12
Constitutional Authority Statement............................... 12
Applicability to Legislative Branch.............................. 12
Section-by-Section Analysis of the Legislation................... 13
Changes in Existing Law Made by the Bill, as Reported............ 14
Amendment
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
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. 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) 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.--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 6 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
may 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, relevant 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 and are consistent with National security.
``(F) Establishment of advanced 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 the emergency health
security needs of children 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.
``(c) 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.
``(d) Authorization of Appropriations.--For the purpose of carrying
out advanced research and development under this section, there are
authorized to be appropriated $160,000,000 for each of the fiscal years
2007 and 2008. Such authorizations are in addition to other
authorizations of appropriations that are available for such purpose.
Amounts appropriated under the preceding sentence are available until
expended.
``(e) Definitions.--For purposes of this section:
``(1) BARDA.--The term `BARDA' means the Biomedical Advanced
Research and Development Authority.
``(2) 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.
``(3) Qualified countermeasure.--The term `qualified
countermeasure' has the meaning given such term in section
319F-1.
``(4) Qualified pandemic or epidemic product.--The term
`qualified pandemic or epidemic product' has the meaning given
the term in section 319F-3.
``(5) 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.
``(6) Research tool.--The term `research tool' means a
device, technology, biological material, 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.
``(7) 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.
``(8) 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.
``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 to biodefense or public health security 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) 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.
``(c) Authorization of Appropriations.--There are authorized to be
appropriated $1,000,000 to carry out this section for each of the
fiscal years 2007 and 2008.''.
SEC. 4. CLARIFICATION OF COUNTERMEASURES COVERED BY PROJECT BIOSHIELD.
(a) Qualified Countermeasures.--Section 319F-1(a)(2) of the Public
Health Service Act (42 U.S.C. 247d-6a(a)(2)) is amended--
(1) by amending subparagraph (A) to read as follows:
``(A) diagnose, mitigate, prevent, or treat harm from
any biological agent (including organisms that cause an
infectious disease) or toxin, or from any chemical,
radiological, or nuclear agent, that may cause a public
health emergency affecting national security; or'';
(2) in subparagraph (B), by striking ``treat, identify, or
prevent harm'' and inserting ``diagnose, mitigate, prevent, or
treat harm''; and
(3) by adding after and below subparagraph (B) the following:
``If through publication in the Federal Register the Secretary
makes a determination that there is credible evidence that a
biological agent has the potential to cause an epidemic or
pandemic that may constitute a public health emergency, a
countermeasure to such agent shall, without further
administrative action, be considered a qualified countermeasure
within the meaning of this paragraph.''.
(b) Security Countermeasures.--Section 319F-2(c)(1)(B)(i)(I) of the
Public Health Service Act (42 U.S.C. 247d-6b(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 or from
any 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.
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 advance 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.--The
Secretary may 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: ``In the case of such agreements by the
Secretary, the Secretary may allow other executive
agencies to order qualified and security
countermeasures under procurement contracts or other
agreements established by the Secretary, and 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.''
Purpose and Summary
The purpose of H.R. 5533, the Biodefense and Pandemic
Vaccine and Drug Development Act of 2006, is to prepare and
strengthen the biodefenses of the United States against
deliberate, accidental, and natural outbreaks of illness, and
for other purposes.
Background and Need for Legislation
Project BioShield was signed into law on July 21, 2004, to
encourage the development of countermeasures to address
chemical, biological, radiological, and nuclear threats. The
legislation provided procedures for bioterrorism-related
procurement, hiring, and awarding of research grants, in an
effort to make it easier for the Federal government to quickly
commit substantial funds to countermeasure projects. Congress
has identified a number of improvements to fully realize
Project BioShield's potential and to provide further incentives
toward such development. H.R. 5533 provides a single point of
authority within the Department of Health and Human Services
for the advanced research and development of medical
countermeasures to make important procurement decisions. The
legislation provides needed authorization to fund advanced
research and development activities that were not covered by
Project Bioshield. Additionally, the legislation will provide
for further purchasing and contractual flexibility.
Hearings
On Thursday, April 6, 2006, the Subcommittee on Health held
a hearing entitled ``Project Bioshield Reauthorization
Issues.'' The Subcommittee received testimony from: The
Honorable Alex M. Azar, Deputy Secretary, U.S. Department of
Health and Human Services; Mr. Jean D. Reed, Special Assistant,
Chemical and Biological Defense and Chemical Demilitarization
Programs, Office of the Assistant to the Secretary of Defense
for Nuclear and Chemical and Biological Defense, U.S.
Department of Defense; Dr. Tara O'Toole, CEO and Director,
Center for Biosecurity, University of Pittsburgh Medical
Center; Mr. Peter F. Young, President and CEO, AlphaVax, Inc,
on behalf of the Biotechnology Industry Organization; Mr. Bruce
Cohen, President and CEO, Cellerant Therapeutics, Inc.; Dr.
David P. Wright, President and CEO, PharmAthene, on behalf of
the Alliance for Biosecurity; and Dr. Martin Blaser, President,
Infectious Diseases Society of America.
Committee Consideration
On Wednesday, September 20, 2006, the Committee on Energy
and Commerce met in open markup session and ordered H.R. 5533
favorably reported to the House, amended, by a voice vote, a
quorum being present.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
There were no record votes taken in connection with ordering
H.R. 5533 reported. A motion by Mr. Barton to order H.R. 5533
reported to the House, amended, was agreed to by a voice vote.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee held an oversight
hearing and made findings that are reflected in this report.
Statement of General Performance Goals and Objectives
The goal of H.R. 5533 is to prepare and strengthen the
biodefenses of the United States against deliberate,
accidental, and natural outbreaks of illness.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
5533, Biodefense and Pandemic Vaccine and Drug Development Act
of 2006, would result in no new or increased budget authority,
entitlement authority, or tax expenditures or revenues.
Earmark
In compliance with H. Res. 1000 as passed the House of
Representatives on September 14, 2006, the Committee finds that
H.R. 5533, Biodefense and Pandemic Vaccine and Drug Development
Act of 2006, contains no earmarks.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
September 26, 2006.
Hon. Joe Barton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 5533, the
Biodefense and Pandemic Vaccine and Drug Development Act of
2006.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contacts are Jeanne De
Sa and Sam Papenfuss.
Sincerely,
Donald B. Marron,
Acting Director.
Enclosure.
H.R. 5533--Biodefense and Pandemic Vaccine and Drug Development Act of
2006
Summary: H.R. 5533 would create an office at the Department
of Health and Human Services (HHS) called the Biomedical
Advanced Research and Development Authority (BARDA). BARDA
would oversee advanced research and development of products to
defend against bioterrorism and pandemic influenza. The bill
also would establish the National Biodefense Science Board, an
advisory group that would provide scientific guidance to HHS on
issues involving chemical, biological, radiological, and
nuclear agents. Additionally, the bill would require HHS to
establish a team of experts at the Food and Drug Administration
(FDA) to provide technical assistance to drug manufacturers
when shortages of certain vaccines and drugs occur. H.R. 5533
also would clarify that Project BioShield, a program that
provides incentives to companies to manufacture vaccines and
drugs, covers certain products--so-called qualified and
security countermeasures--that address public health threats
caused by acts of terrorism.
The bill would authorize the appropriation of $160 million
for each of fiscal years 2007 and 2008 for activities related
to the operation of BARDA. The bill also would authorize the
appropriation of $1 million for each of fiscal years 2007 and
2008 for the National Biodefense Science Board. CBO estimates
that $1 million a year would be necessary for FDA to implement
activities outlined in the bill. Assuming appropriation of the
authorized and necessary amounts, CBO estimates that
implementing H.R. 5533 would cost $33 million in 2007 and $319
million over the 2007-2011 period. Enacting the bill would not
affect direct spending or receipts.
H.R 5533 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA)
and would impose no costs on state, local, or tribal
governments.
Estimated cost to the Federal Government: The estimated
budgetary impact of H.R. 5533 is shown in the following table.
The costs of this legislation fall within budget function 550
(health).
------------------------------------------------------------------------
By fiscal year, in millions of
dollars--
---------------------------------------
2007 2008 2009 2010 2011
------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
BARDA:
Authorization Level......... 160 160 0 0 0
Estimated Outlays........... 31 148 101 24 8
National Biodefense Science
Board:
Authorization Level......... 1 1 0 0 0
Estimated Outlays........... 1 1 0 0 0
FDA:
Estimated Authorization 1 1 1 1 1
Level......................
Estimated Outlays........... 1 1 1 1 1
Total Changes:
Estimated 162 162 1 1 1
Authorization Level
Estimated Outlays... 33 150 102 25 9
------------------------------------------------------------------------
Basis of estimate: For this estimate, CBO assumes that H.R.
5533 will be enacted before the end of calendar year 2006, and
that the authorized and necessary amounts will be provided each
year.
Biomedical Advanced Research and Development Authority (BARDA)
H.R. 5533 would establish BARDA as a new agency within HHS.
BARDA would provide incentives and guidance for research and
development of products to counter bioterrorism and pandemic
influenza. The bill would authorize the appropriation of $160
million for each of fiscal years 2007 and 2008 for activities
to be performed by this new agency. Those activities would
include facilitating collaboration among government, private
industry, and academia; encouraging advanced research and
development of those products; and promoting scientific
innovation to reduce the time and cost of development.
Specifically, BARDA would direct and coordinate research and
development activities for countermeasures to bioterrorism and
pandemic influenza at HHS. The agency also would offer grants,
awards, and prizes to industry to provide incentives to develop
certain countermeasures deemed priorities.
For this estimate, CBO assumes that spending by BARDA would
follow historical spending patterns for similar research and
development activities in health care and defense programs.
Assuming appropriation of the authorized amounts, CBO estimates
that BARDA spending would total $31 million in 2007 and $312
million over the 2007-2011 period.
National Biodefense Science Board
The bill would authorize the appropriation of $1 million
for each of fiscal years 2007 and 2008 to establish the
National Biodefense Science Board, an advisory group that would
provide scientific and technical guidance to HHS on current and
future chemical, biological, radiological, and nuclear agents.
Assuming appropriation of the authorized amounts, CBO estimates
that provision would cost $2 million over the 2007-2008 period.
Food and Drug Administration (FDA)
H.R. 5533 would require the FDA to provide technical
assistance to drug manufacturers in cases where there are
shortages of certain vaccines and drugs that the Secretary
deems priorities for addressing a public health threat. Based
on similar technical-advisory activities conducted by HHS, CBO
estimates that the program would require funding of about $1
million a year. CBO estimates that this provision of the bill
would cost $1 million in 2007 and $5 million over the 2007-2011
period, assuming appropriation of the necessary amounts.
Intergovernmental and private-sector impact: H.R. 5533
contains no intergovernmental or private-sector mandates as
defined in UMRA and would impose no costs on state, local, or
tribal governments.
Estimate prepared by: Federal Costs: Jeanne De Sa and Sam
Papenfuss. Impact on State, Local, and Tribal Governments: Leo
Lex. Impact on the Private Sector: Paige Shevlin.
Estimate approved by: Peter H. Fontaine, Deputy Assistant
Director for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
Constitutional authority for this legislation is provided in
Article I, section 8, clause 3, which grants Congress the power
to regulate commerce with foreign nations, among the several
States, and with the Indian tribes.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 establishes the short title as the Biodefense and
Pandemic Vaccine and Drug Development Act of 2006.
Section 2. Table of contents
Section 2 sets out the table of contents for the Act.
Section 3. Biomedical Advanced Research and Development Authority;
National Biodefense Science Board
Section 3 amends Title III of the Public Health Service Act
by adding a new Section 319L and new Section 319M.
``Section 319L. Biomedical Advanced Research and
Development Authority.''
New Section 319L in Title III of the Public Health Service
Act would set out a Biomedical Advanced Research and
Development Authority. Many of the functions and duties set out
in this section currently exist at the Department under prior
authorizations and decisions of the Secretary. This provision
reorganizes and expands upon these existing authorities and
duties. Among other items, new section 319L will establish a
single point of authority in the Federal government for
civilian medical countermeasure advanced research and
development, direct and coordinate advanced research and
development of promising new medical countermeasures; and spur
innovation to accelerate countermeasure development. The
exception builds on the efforts authorized under the Project
Bioshield Act of 2003. The additional authorities will address
the development area beyond research and before manufacturing.
The activities intended for inclusion under the definition
of ``advanced research and development'' include the broad
array of activities that are predominantly conducted after
basic research and are conducted to enable the efficient
development, testing, manufacture, storage, or use of a product
that is or may become a qualified countermeasure or a qualified
pandemic or epidemic product. These include the duties of BARDA
described in new Section 319L(a)(2)(B) and (a)(4)(D).
New Section 319L would also exempt the Secretary from
requirements under the Freedom of Information Act in order to
withhold from forced disclosure of specific technical data or
scientific information that would reveal vulnerabilities of
existing medical or public health defenses against biological,
chemical, nuclear, or radiological threats.
New Section 319L also provides for authorizations of $160
million for FY 2007 and $160 million FY 2008 for advanced
research and development activities.
``Section 319M. National Biodefense Science Board and
Working Groups.''
New section 319M provides for the Public Health Service Act
which establishes a National Biodefense Science Board.
Section 4. Clarification of countermeasures covered by Project
BioShield
Section 4 clarifies the definition of qualified
countermeasures under Project BioShield to include organisms
that might cause infectious disease that may cause a public
health emergency affecting national security.
Section 5. Technical assistance
Section 5 amends subchapter E of chapter V of the Federal
Food, Drug, and Cosmetic Act by adding a new Section 565.
``Section 565. Technical Assistance.''
New Section 565 provides for the Secretary, in consultation
with the Commissioner of Food and Drugs, to establish a team to
work with manufacturers to identify and resolve problems to
alleviate or avert significant shortage of a vaccine or
countermeasure.
Section 6. Procurement
Section 6 provides authority to allow the Secretary, under
certain circumstances, to enter into an exclusive sales
contract with a particular manufacturer for a particular
product, but also allows for procurement of technologies and
products from multiple manufacturers. The section provides
authority to allow contracts to support the cost of
establishing domestic manufacturing capacity; and to include
additional advance payments for meeting specified milestones.
The section further allows other executive agencies to order
countermeasures through the Department of Health and Human
Services.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, existing law in which no change is
proposed is shown in roman):
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
Part B--Federal-State Cooperation
* * * * * * *
SEC. 319F-1. AUTHORITY FOR USE OF CERTAIN PROCEDURES REGARDING
QUALIFIED COUNTERMEASURE RESEARCH AND DEVELOPMENT
ACTIVITIES.
(a) In General.--
(1) * * *
* * * * * * *
(2) Qualified countermeasure.--For purposes of this
section, 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--
[(A) treat, identify, or prevent harm from
any biological, chemical, radiological, or
nuclear agent that may cause a public health
emergency affecting national security; or]
(A) diagnose, mitigate, prevent, or treat
harm from any biological agent (including
organisms that cause an infectious disease) or
toxin, or from any chemical, radiological, or
nuclear agent, that may cause a public health
emergency affecting national security; or
(B) [treat, identify, or prevent harm]
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
subparagraph (A).
If through publication in the Federal Register the
Secretary makes a determination that there is credible
evidence that a biological agent has the potential to
cause an epidemic or pandemic that may constitute a
public health emergency, a countermeasure to such agent
shall, without further administrative action, be
considered a qualified countermeasure within the
meaning of this paragraph.
* * * * * * *
SEC. 319F-2. STRATEGIC NATIONAL STOCKPILE AND SECURITY COUNTERMEASURE
PROCUREMENTS.
(a) * * *
* * * * * * *
(c) Additional Authority Regarding Procurement of Certain
[Biomedical] Countermeasures; Availability of Special Reserve
Fund.--
(1) In general.--
(A) * * *
(B) Security countermeasure.--For purposes of
this subsection, the term ``security
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--
(i)(I) the Secretary determines to be
a priority (consistent with sections
302(2) and 304(a) of the Homeland
Security Act of 2002) [to treat,
identify, or prevent harm from any
biological, chemical, radiological, or
nuclear agent identified as a material
threat under paragraph (2)(A)(ii), or
to treat, identify, or prevent harm
from a condition] to diagnose,
mitigate, prevent, or treat harm from
any biological agent (including
organisms that cause an infectious
disease) or toxin or from any 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 that may result in adverse
health consequences or death and may be
caused by administering a drug,
biological product, or device against
such an agent;
* * * * * * *
(5) Secretary's determination of countermeasures
appropriate for funding from special reserve fund.--
(A) * * *
(B) Requirements.--In making a determination
under subparagraph (A) with respect to a
security countermeasure, the Secretary shall
determine and consider the following:
(i) The quantities of the product
that will be needed [to meet the needs
of the stockpile] to meet the stockpile
needs.
* * * * * * *
(7) Procurement.--
(A) * * *
(B) [Interagency agreement; costs.--
(i) Interagency agreement.--The
Homeland Security Secretary]
Interagency agreement; cost.--The
Homeland Security Secretary shall enter
into an agreement with the Secretary
for procurement of a security
countermeasure in accordance with the
provisions of this paragraph. The
special reserve fund under paragraph
(10) shall be available for payments
made by the Secretary to a vendor for
such procurement.
[(ii) Other costs.--The actual costs
to the Secretary under this section,
other than the costs described in
clause (i), shall be paid from the
appropriation provided for under
subsection (f)(1).]
(C) Procurement.--
(i) * * *
(ii) Contract terms.--A contract for
procurements under this subsection
shall (or, as specified below, may)
include the following terms:
[(I) Payment conditioned on
delivery.--The contract shall
provide that no payment may be
made until delivery has been
made 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 is
necessary to ensure success of
a project, the Secretary may
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.
Nothing in this subclause may
be construed as affecting
rights of vendors under
provisions of law or regulation
(including the Federal
Acquisition Regulation)
relating to termination of
contracts for the convenience
of the Government.]
(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 advance 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.
* * * * * * *
(VII) Procurement of multiple
products and technologies.--The
Secretary may 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.
* * * * * * *
(8) Interagency cooperation.--
(A) In general.--In carrying out activities
under this section, the Homeland Security
Secretary and the Secretary are authorized,
subject to subparagraph (B), to enter into
interagency agreements and other collaborative
undertakings with other agencies of the United
States Government. In the case of such
agreements by the Secretary, the Secretary may
allow other executive agencies to order
qualified and security countermeasures under
procurement contracts or other agreements
established by the Secretary, and 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. 319L. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.
(a) 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.--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 6 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 may 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, relevant 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 and are consistent with
National security.
(F) Establishment of advanced 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 the emergency health security
needs of children 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.
(c) 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.
(d) Authorization of Appropriations.--For the purpose of
carrying out advanced research and development under this
section, there are authorized to be appropriated $160,000,000
for each of the fiscal years 2007 and 2008. Such authorizations
are in addition to other authorizations of appropriations that
are available for such purpose. Amounts appropriated under the
preceding sentence are available until expended.
(e) Definitions.--For purposes of this section:
(1) BARDA.--The term ``BARDA'' means the Biomedical
Advanced Research and Development Authority.
(2) 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.
(3) Qualified countermeasure.--The term ``qualified
countermeasure'' has the meaning given such term in
section 319F-1.
(4) Qualified pandemic or epidemic product.--The term
``qualified pandemic or epidemic product'' has the
meaning given the term in section 319F-3.
(5) 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.
(6) Research tool.--The term ``research tool'' means
a device, technology, biological material, 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.
(7) 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.
(8) 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.
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 to
biodefense or public health security 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) 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.
(c) Authorization of Appropriations.--There are authorized to
be appropriated $1,000,000 to carry out this section for each
of the fiscal years 2007 and 2008.
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FEDERAL FOOD, DRUG, AND COSMETIC ACT
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CHAPTER V--DRUGS AND DEVICES
* * * * * * *
Subchapter E--General Provisions Relating to Drugs and Devices
* * * * * * *
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.
* * * * * * *