[Congressional Record Volume 150, Number 71 (Wednesday, May 19, 2004)]
[Senate]
[Pages S5744-S5767]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PROJECT BIOSHIELD ACT OF 2003
The PRESIDING OFFICER. Under the previous order, the Senate will
proceed to the consideration of S. 15, which the clerk will report.
The legislative clerk read as follows:
A bill (S. 15) to amend the Public Health Service Act to
provide for the payment of compensation for certain
individuals with injuries resulting from the administration
of smallpox countermeasures, to provide protections and
countermeasures against chemical, radiological, or nuclear
agents that may be used in a terrorist attack against the
United States, and to improve immunization rates by
increasing the distribution of vaccines and improving and
clarifying the vaccine injury compensation program.
Thereupon, the Senate proceeded to consider the bill, which had been
reported from the Committee on Health, Education, Labor, and Pensions,
with an amendment to strike all after the enacting clause and insert in
lieu thereof the following:
[Strike the part shown in black brackets and insert the part shown in
italic.]
S. 15
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
[SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
[(a) Short Title.--This Act may be cited as the
``Biodefense Improvement and Treatment for America Act''.
[(b) Table of Contents.--The table of contents of this Act
is as follows:
[Sec. 1. Short title; table of contents.
[TITLE I--PROTECTION FOR SMALLPOX EMERGENCY PERSONNEL
[Sec. 101. Short title.
[Sec. 102. Amendment to the Public Health Service Act.
[TITLE II--PROJECT BIOSHIELD
[Sec. 201. Short title.
[Sec. 202. Biomedical countermeasure research and development
authorities.
[Sec. 203. Biomedical countermeasures procurement.
[Sec. 204. Authorization for medical products for use in emergencies.
[Sec. 205. Developing new countermeasures and protecting existing
countermeasures against bioterrorism.
[TITLE III--IMPROVED VACCINE AFFORDABILITY AND AVAILABILITY
[Sec. 301. Short title.
[Subtitle A--State Vaccine Grants
[Sec. 311. Availability of influenza vaccine.
[Sec. 312. Program for increasing immunization rates for adults and
adolescents; collection of additional immunization data.
[Sec. 313. Immunization awareness.
[Sec. 314. Supply of vaccines.
[Sec. 315. Communication.
[Sec. 316. Fast track.
[Sec. 317. Study.
[Subtitle B--Vaccine Injury Compensation Program
[Sec. 321. Administrative revision of vaccine injury table.
[Sec. 322. Equitable relief.
[Sec. 323. Derivative petitions for compensation.
[Sec. 324. Jurisdiction to dismiss actions improperly brought.
[Sec. 325. Clarification of when injury is caused by factor unrelated
to administration of vaccine.
[[Page S5745]]
[Sec. 326. Increase in award in the case of a vaccine-related death and
for pain and suffering.
[Sec. 327. Basis for calculating projected lost earnings.
[Sec. 328. Allowing compensation for family counseling expenses and
expenses of establishing and maintaining guardianship.
[Sec. 329. Allowing payment of interim costs.
[Sec. 330. Procedure for paying attorneys' fees.
[Sec. 331. Extension of statute of limitations.
[Sec. 332. Advisory Commission on Childhood Vaccines.
[Sec. 333. Clarification of standards of responsibility.
[Sec. 334. Clarification of definition of manufacturer.
[Sec. 335. Clarification of definition of vaccine-related injury or
death.
[Sec. 336. Clarification of definition of vaccine and definition of
physical injury.
[Sec. 337. Amendments to Vaccine Injury Compensation Trust Fund.
[Sec. 338. Ongoing review of childhood vaccine data.
[Sec. 339. Pending actions.
[Sec. 340. Report.
[TITLE I--PROTECTION FOR SMALLPOX EMERGENCY PERSONNEL
[SEC. 101. SHORT TITLE.
[This title may be cited as the ``Smallpox Emergency
Personnel Protection Act of 2003''.
[SEC. 102. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.
[Part A of title II of the Public Health Service Act (42
U.S.C. 202 et seq.) is amended by inserting after section 224
the following:
[``SEC. 224A. PROTECTION FOR SMALLPOX EMERGENCY PERSONNEL.
[``(a) Definitions.--In this section:
[``(1) Covered countermeasure.--The term `covered
countermeasure' means a covered countermeasure as specified
in article III of the Declaration.
[``(2) Covered individual.--The term `covered individual'
means an individual--
[``(A) who is--
[``(i) a health care worker, a law enforcement officer, a
firefighter, a security-related worker, an emergency medical
worker, or a public safety worker who is identified in a
State, local, or Department of Health and Human Services plan
that is approved by the Secretary; or
[``(ii) an individual with respect to whom the Secretary
determines and declares that it is advisable to administer
the vaccine (not including any individual to whom the
Secretary determines only that such vaccine should be made
available); and
[``(B) to whom a vaccine is administered during the period
in which the Declaration is effective (including the portion
of such period before the date of enactment of this section)
and ending on the later of--
[``(i) the expiration of the 120-day period that begins on
the effective date of the initial interim final regulations
to implement this section;
[``(ii) the expiration of the 120-day period that begins on
the date on which an individual becomes an individual within
a category specified in subparagraph (A); or
[``(iii) the date on which the Secretary publicly announces
that an active case of smallpox has been identified either
within or outside the United States.
[``(3) Covered injury.--The term `covered injury'
includes--
[``(A) an injury, disability, illness, condition, or death
determined, pursuant to the procedures established under
subsection (b), to have been sustained as the direct result
of administration to an individual of a covered
countermeasure during the effective period of the Declaration
(other than a minor injury such as minor scarring or minor
local reaction); and
[``(B) an injury, disability, illness, condition, or death
determined, pursuant to the procedures established under
subsection (b), to have been sustained as the direct result
of accidental vaccinia inoculation through contact with an
individual who is (or who was accidentally inoculated by) an
individual in a category specified in Article IV of the
Declaration to whom vaccinia vaccine has been administered
during the effective period of the Declaration.
[``(4) Declaration.--The term `Declaration' means the
Declaration Regarding Administration of Smallpox
Countermeasures issued by the Secretary of Health and Human
Services on January 24, 2003, and published in the Federal
Register on January 28, 2003, including any subsequent
amendment.
[``(5) Eligible individual.--The term `eligible individual'
means an individual who is (as determined in accordance with
section 3)--
[``(A) a covered individual who sustains a covered injury
as the direct result of administration of a covered
countermeasure; or
[``(B) any individual who contracts vaccinia during the
effective period of the Declaration or within 30 days after
the end of such period--
[``(i) to whom vaccinia vaccine was not administered;
[``(ii) who has resided with, or has been in close contact
with, a covered individual; and
[``(iii) who sustains a covered injury as the direct result
of contracting vaccinia.
[``(6) Secretary.--Except as provided otherwise, the term
`Secretary' means the Secretary of Health and Human Services.
[``(b) Determination of Eligibility.--
[``(1) In general.--The Secretary, in consultation with the
Attorney General and the Secretary of Labor, shall establish
administrative procedures for determining, as applicable with
respect to an individual--
[``(A) whether the individual is an eligible individual;
[``(B) whether the individual has sustained a covered
injury or injuries for which medical benefits and employment
income-loss compensation may be available under subsections
(d) and (e), and the amount of such benefits or compensation;
and
[``(C) whether the covered injury or injuries of the
individual constitute a compensable disability, or caused the
individual's death, for purposes of benefits under subsection
(f).
[``(2) Covered individuals.--The Secretary may accept a
certification, by a Federal, State, or local government
entity or private health care entity participating in the
administration of covered countermeasures under the
Declaration, that an individual is an individual in a
category specified in article IV of the Declaration to whom
such a countermeasure has been administered by the applicable
deadline specified in subsection (a)(2)(B), as establishing
that the individual is a covered individual.
[``(3) Determination of causation.--
[``(A) Injuries specified in injury table.--In any case
where an injury or other adverse effect specified in the
injury table established under subsection (c) as a known
effect of a covered countermeasure manifests in an individual
within the time period specified in such table, such injury
or other effect shall be rebuttably presumed to have resulted
from administration of such covered countermeasure.
[``(B) Other determinations.--In making determinations
other than those described in subparagraph (A) as to the
causation or severity of an injury, the Secretary shall take
into consideration all relevant medical and scientific
evidence presented for consideration, and may obtain and
consider the views of qualified medical experts.
[``(4) Deadline for filing claim.--The Secretary shall not
consider any claim for a benefit under this subsection with
respect to an individual that is filed later than 1 year
after--
[``(A) the date a covered countermeasure was administered
to the individual; or
[``(B) in the case of a claim based on contact vaccination
(as described in subsection (a)(5)(B)), the date of the first
symptom or manifestation of onset of an adverse effect of
such vaccination.
[``(5) Review of determination.--
[``(A) Secretary's review authority.--The Secretary may
review a determination under this subsection at any time on
the Secretary's own motion or on application, and may affirm,
vacate, or modify such determination.
[``(B) Secretary's action not judicially reviewable.--The
determinations of the Secretary under this subsection shall
not be subject to review by another official of the United
States or by a court by mandamus or otherwise.
[``(c) Countermeasure Injury Table.--
[``(1) Smallpox countermeasure injury table.--The Secretary
shall establish by interim final regulation a table
identifying--
[``(A) adverse effects (including injuries, disabilities,
illnesses, conditions, and deaths) that shall be presumed to
result from the administration of (or exposure to) a covered
countermeasure; and
[``(B) the time periods in which the first symptom, or
manifestation of onset of each such adverse effect, must
manifest in order for such presumption to apply.
[``(2) Amendments.--The Secretary may amend by regulation
the table established under paragraph (1). Such amendments
shall apply retroactively to claims filed or pending at the
time of the promulgation of final amending regulations and to
claims filed after such promulgation.
[``(d) Medical Benefits.--
[``(1) In general.--Subject to paragraph (2), an eligible
individual shall be entitled to payment by the Secretary for
medical items and services as reasonable and necessary to
treat a covered injury. The Secretary may consider the
provisions of chapter 81 of title 5, United States Code, (and
the implementing regulations with respect to such chapter) in
determining the amount of such payment and the circumstances
under which such payments are reasonable and necessary.
[``(2) Limitations.--
[``(A) Benefits secondary to other coverage.--The
obligation of the Secretary to pay for any services or
benefits under paragraph (1) shall be secondary to the
obligation of the United States or any third party (including
any State or local governmental entity, private insurance
carrier, or employer) under any other provision of law or
contractual agreement, to pay for or provide such services or
benefits.
[``(B) No benefits for medicare-eligible individual.--No
benefits shall be available to an individual under this
subsection with respect to any period in which the individual
is eligible for benefits under title XVIII of the Social
Security section (42 U.S.C. 1395 et seq.).
[``(e) Compensation for Lost Employment Income.--
[``(1) In general.--Subject to paragraphs (2) and (3), an
eligible individual shall be entitled to payment of
compensation by the
[[Page S5746]]
Secretary for loss of employment income incurred as a result
of a covered injury, at the rate specified in paragraph (2).
[``(2) Amount of compensation.--
[``(A) In general.--Compensation under this subsection
shall be at the rate of 66\2/3\ percent of monthly pay. The
Secretary may consider the provisions of sections 8114 and
8115 of title 5, United States Code (and any implementing
regulations) in determining the amount of such payment and
the circumstances under which such payments are reasonable
and necessary.
[``(B) Treatment of self-employment income.--For purposes
of this subsection--
[``(i) the term `employment income' includes income from
self-employment; and
[``(ii) for purposes of computation of pay and
determination of wage-earning capacity under subparagraph
(A), self-employment income shall be treated as wages.
[``(3) Limitations.--
[``(A) Benefits secondary to other coverage.--The
obligation of the Secretary to pay compensation under
paragraph (1) shall be secondary to the obligation of the
United States or any third party (including any State or
local governmental entity, private insurance carrier, or
employer), under any other law or contractual agreement, to
pay compensation for loss of employment income.
[``(B) No benefits for death or permanent and total
disability.--No payment shall be made under this subsection
in compensation for loss of employment income due to the
death or permanent and total disability of an eligible
individual.
[``(C) Limit on total benefits.--Total benefits paid to an
individual under this subsection shall not exceed $50,000.
[``(D) Waiting period.--An eligible individual is not
entitled to compensation under this subsection for the first
5 work days of disability.
[``(f) Payment for Death and Permanent, Total Disability.--
[``(1) Benefit for permanent and total disability.--Subject
to the succeeding provisions of this subsection, an eligible
individual who is determined, in accordance with the
procedures established under subsection (b), to have a
covered injury or injuries meeting the definition of
disability in section 216(i) of the Social Security Act (42
U.S.C. 416(i)) shall be entitled to have payment made by the
Secretary of an amount determined under paragraph (3), in the
same manner as disability benefits are paid pursuant to the
Public Safety Officers' Benefits Program under subpart 1 of
part L of title I of the Omnibus Crime Control and Safe
Streets Act of 1968 (42 U.S.C. 3796 et seq.) with respect to
an eligible public safety officer.
[``(2) Death benefit.--Subject to the succeeding provisions
of this subsection, in the case of an eligible individual
whose death is determined, in accordance with the procedures
established under subsection (b), to have directly resulted
from a covered injury or injuries a death benefit in the
amount determined under paragraph (3) shall be payable by the
Secretary to the survivor or survivors in the same manner as
death benefits are paid pursuant to the Public Safety
Officers' Benefits Program under subpart 1 of part L of title
I of the Omnibus Crime Control and Safe Streets Act of 1968
(42 U.S.C. 3796 et seq.) with respect to an eligible deceased
public safety officer.
[``(3) Benefit amount.--The amount of the disability or
death benefit under paragraph (1) or (2) in a fiscal year
shall, subject to paragraph (5)(B), equal the amount of the
comparable benefit calculated under the Public Safety
Officers' Benefits Program under subpart 1 of part L of title
I of the Omnibus Crime Control and Safe Streets Act of 1968
(42 U.S.C. 3796 et seq.) in such fiscal year, without regard
to any reduction attributable to a limitation on
appropriations.
[``(4) Benefit in addition to medical benefits.--A benefit
under this subsection shall be in addition to any amounts to
which an eligible individual may be entitled as medical
benefits under subsection (d).
[``(5) Limitations.--
[``(A) Disability benefits.--No benefit is payable under
paragraph (1) with respect to the disability of an eligible
individual if--
[``(i) a disability benefit is paid or payable with respect
to such individual under Public Safety Officers' Benefits
Program under subpart 1 of part L of title I of the Omnibus
Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et
seq.); or
[``(ii) a death benefit is paid or payable with respect to
such individual under paragraph (2) or the Public Safety
Officers' Benefits Program under subpart 1 of part L of title
I of the Omnibus Crime Control and Safe Streets Act of 1968
(42 U.S.C. 3796 et seq.).
[``(B) Death benefits.--No benefit is payable under
paragraph (2) with respect to the death of an eligible
individual if--
[``(i) a disability benefit is paid with respect to such
individual under paragraph (1) or the Public Safety Officers'
Benefits Program under subpart 1 of part L of title I of the
Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C.
3796 et seq.); or
[``(ii) a death benefit is paid or payable with respect to
such individual under the Public Safety Officers' Benefits
Program under subpart 1 of part L of title I of the Omnibus
Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et
seq.).
[``(g) Administration.--
[``(1) Administration by agreement with other agency or
agencies.--The Secretary may administer any or all of the
provisions of this section through Memorandum of Agreement
with the Attorney General or the Secretary of Labor.
[``(2) Regulations.--The head of the agency administering
this section or any provisions thereof (including any agency
head administering such section or provisions through a
Memorandum of Agreement under paragraph (1)) may promulgate
such implementing regulations as may be determined necessary
and appropriate. Initial implementing regulations may be
interim final regulations.
[``(h) Authorization of Appropriations.--There are
authorized to be appropriated such sums as may be necessary
for fiscal year 2003 and each succeeding fiscal year to carry
out this section, to remain available until expended,
including administrative costs and costs of provision and
payment of benefits.
[``(i) Relationship to Other Laws.--
[``(1) No preemption of individual rights.--Except as
otherwise provided in this section, nothing in this section
shall be construed to override or limit any rights an
individual may have to seek compensation, benefits, or
redress under any other provision of Federal or State law.
[``(2) Relationship to the federal tort claims act.--
[``(A) Exhaustion requirement.--An individual may not seek
any remedy that may be available under section 224(p)
(providing a cause of action under the Federal Tort Claims
Act for injuries resulting from administration of smallpox
countermeasures under such section 224(p)) unless such
individual has first filed a claim for payment or
compensation under this section and has received a final
determination with respect to such claim.
[``(B) Offset of compensation against federal tort claims
act recovery.--The value of any compensation or benefits paid
to an individual, or the survivor or survivors of such an
individual, or the estate of the individual pursuant to a
claim under this section shall be offset against any amount
to which such individual or the individual's survivor,
survivors, or estate are entitled under section 224(p).
[``(3) Preemption of state laws providing exclusive remedy
for work-related injuries.--No provision of a State workers'
compensation law or other State law shall be construed to bar
claims or benefits under this section, to the extent that it
purports to make such State law the exclusive remedy for a
work-related injury or otherwise to make benefits under this
section unavailable to an otherwise eligible individual.''.
[TITLE II--PROJECT BIOSHIELD
[SEC. 201. SHORT TITLE.
[This title may be cited as the ``Project BioShield Act of
2003''.
[SEC. 202. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT
AUTHORITIES.
[Part B of title IV of the Public Health Service Act (42
U.S.C. 284 et seq.) is amended by adding at the end the
following:
[``SEC. 409I. BIOMEDICAL COUNTERMEASURE RESEARCH AND
DEVELOPMENT.
[``(a) In General.--
[``(1) Authority.--In carrying out research
responsibilities under this Act, the Secretary may conduct
and support research and development with respect to
biomedical countermeasures.
[``(2) Implementation.--
[``(A) In general.--Except as provided in subparagraph (C),
authorities assigned by this section to the Secretary shall
be carried out through the Director of NIH and the Director
of the National Institute of Allergy and Infectious Diseases.
[``(B) Lead institute.--The National Institute of Allergy
and Infectious Diseases shall be the lead institute for
biomedical countermeasure research and development under this
section.
[``(C) Chemical, radiological, and nuclear agents.--To the
extent that an authority described in subparagraph (A) is
exercised with respect to a chemical, radiological, or
nuclear agent, the Secretary may authorize the Director of
NIH to carry out the authority through any national research
institute.
[``(3) Interagency cooperation.--
[``(A) In general.--In carrying out activities under this
section, the Secretary is authorized, subject to subparagraph
(B), to enter into interagency agreements and other
collaborative undertakings with other agencies of the Federal
Government and to use other agencies of the Department of
Health and Human Services.
[``(B) Limitation.--An agreement or undertaking under this
paragraph may not authorize another agency to exercise the
authorities provided to the Secretary by this section.
[``(b) Expedited Procurement Authority.--
[``(1) Increased simplified acquisition threshold for
biomedical countermeasure procurements.--
[``(A) In general.--For any procurement by the Secretary,
of property or services for use (as determined by the
Secretary) in performing, administering, or supporting
biomedical countermeasure research or development, the amount
specified in section 4(11) of the Office of Federal
Procurement Policy Act (41 U.S.C. 403(11)), as applicable
pursuant to section 302A(a) of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C. 252a(a)),
shall be deemed to be $25,000,000 in the administration, with
respect to such procurement, of--
[[Page S5747]]
[``(i) section 303(g)(1)(A) of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C. 253(g)(1)(A))
and its implementing regulations; and
[``(ii) section 302A(b) of such Act (41 U.S.C. 252a(b)) and
its implementing regulations.
[``(B) Internal controls to be instituted.--The Secretary
shall institute appropriate internal controls for
procurements made under this paragraph, including
requirements with respect to documenting the justification
for use of the authority provided in this paragraph.
[``(2) Use of noncompetitive procedures.--In addition to
any other authority to use procedures other than competitive
procedures for procurements, the Secretary may use such other
noncompetitive procedures when--
[``(A) the procurement is as described by paragraph (1)(A);
and
[``(B) the property or services needed by the Secretary are
available from only one responsible source or only from a
limited number of responsible sources, and no other type of
property or services will meet the needs of the Secretary.
[``(3) Increased micropurchase threshold.--
[``(A) In general.--For a procurement described by
paragraph (1)(A), the amount specified in subsections (c),
(d), and (f) of section 32 of the Office of Federal
Procurement Policy Act (41 U.S.C. 428) shall be deemed to be
$15,000 in the administration of that section with respect to
such procurement.
[``(B) Internal controls to be instituted.--The Secretary
shall institute appropriate internal controls for
procurements that are made under this paragraph and that are
greater than $2,500.
[``(C) Exception to preference for purchase card
mechanism.--No provision of law establishing a preference for
using a Federal Government purchase card method for purchases
shall apply to procurements made under this paragraph and
that are greater than $2,500.
[``(c) Authority To Expedite Peer Review.--The Secretary
may, as the Secretary determines necessary to respond to
pressing research and development needs under this section,
employ such expedited peer review procedures (including
consultation with appropriate scientific experts) as the
Secretary, in consultation with the Director of NIH,
determines to be appropriate to obtain an assessment of
scientific and technical merit and likely contribution to
the field of biomedical countermeasure research, in place
of the peer review and advisory council review procedures
that would otherwise be required under sections 301(a)(3),
405(b)(1)(B), 405(b)(2), 406(a)(3)(A), 492, and 494, as
applicable to a grant, contract, or cooperative
agreement--
[``(1) that is for performing, administering, or supporting
biomedical countermeasure research and development; and
[``(2) the amount of which is not greater than $1,500,000.
[``(d) Facilities Authority.--
[``(1) Agency facilities.--In addition to any similar
authority provided under any other provision of law, in
carrying out this section, the Secretary may--
[``(A) acquire, lease, construct, improve, renovate,
remodel, repair, operate, and maintain laboratories, other
research facilities and equipment, and other real or personal
property as the Secretary determines necessary for the
purpose of performing, administering, and supporting
biomedical countermeasure research and development; and
[``(B) acquire, without regard to section 8141 of title 40,
United States Code, by lease or otherwise, through the
Administrator of General Services, buildings or parts of
buildings in the District of Columbia.
[``(2) Facilities of grantee or cooperative agreement
partner.--
[``(A) In general.--The Secretary may exercise the
authorities described in section 481A with respect to
biocontainment laboratories and other related or ancillary
specialized research facilities as the Secretary determines
necessary for the purpose of performing, administering, and
supporting biomedical countermeasure research and
development.
[``(B) Availability of facility to secretary.--A grant or
cooperative agreement under subparagraph (A) may provide that
the facility that is the object of such grant or cooperative
agreement shall be available as needed to the Secretary to
respond to public health emergencies affecting national
security.
[``(C) Twenty year use requirement.--A grant or cooperative
agreement under this paragraph shall include an agreement by
the grantee or cooperative agreement partner that, for not
less than 20 years after the completion of the acquisition,
construction, or other work described in subparagraph (A),
the facility will be used for the purposes of the research
and development for which it is to be acquired, constructed,
or otherwise improved.
[``(D) Amount of grant; cost-sharing; payments.--The
provisions of section 481A(e) shall apply to a grant or
cooperative agreement under this paragraph, except that--
[``(i) authorities exercised under that section by the
Director of the National Center for Research Resources shall,
for purposes of this paragraph, be exercised by the
Secretary; and
[``(ii) for purposes of this paragraph, each of the
percentages in subparagraphs (A) and (B) of section
481A(e)(1) shall be deemed to be 75 percent.
[``(E) Recapture of payments.--If, not later than 20 years
after the completion of construction for which a grant or
cooperative agreement has been awarded under this paragraph,
the facility shall cease to be used for the research and
development purposes for which it was constructed (unless the
Secretary determines, in accordance with regulations, that
there is good cause for releasing the applicant or other
owner from obligation to do so), the United States shall be
entitled to recover from the applicant or other owner of the
facility the amount bearing the same ratio to the current
value (as determined by an agreement between the parties or
by action brought in the United States District Court for the
district in which such facility is situated) of the facility
as the amount of the Federal participation bore to the cost
of the construction, acquisition, or other improvement of
such facility.
[``(e) Authority for Personal Services Contracts.--
[``(1) In general.--For the purpose of performing,
administering, and supporting biomedical countermeasure
research and development, the Secretary may, as the Secretary
determines necessary to respond to pressing research and
development needs under this section, obtain by contract (in
accordance with section 3109 of title 5, United States Code,
but without regard to the limitations in such section on the
period of service and on pay) the personal services of
experts or consultants who have scientific or other
professional qualifications.
[``(2) Federal tort claims act coverage.--
[``(A) In general.--A person carrying out a contract under
paragraph (1), and an officer, employee, or governing board
member of such person, shall be deemed to be an employee of
the Department of Health and Human Services for purposes of
claims under sections 1346(b) and 2672 of title 28, United
States Code, for money damages for personal injury, including
death, resulting from performance of functions under such
contract.
[``(B) Exclusivity of remedy.--The remedy provided by
subparagraph (A) shall be exclusive of any other civil action
or proceeding by reason of the same subject matter against
the person, officer, employee, or governing board member.
[``(3) Internal controls to be instituted.--
[``(A) In general.--The Secretary shall institute
appropriate internal controls for contracts under this
subsection, including procedures for the Secretary to make a
determination of whether a person, or an officer, employee,
or governing board member of a person, is deemed to be an
employee of the Department of Health and Human Services
pursuant to paragraph (2).
[``(B) Determination of employee status to be final.--A
determination by the Secretary under subparagraph (A) that a
person, or an officer, employee, or governing board member of
a person, is or is not deemed to be an employee of the
Department of Health and Human Services shall be final and
binding on the Secretary and the Attorney General and other
parties to any civil action or proceeding.
[``(4) Number of personal services contracts limited.--The
number of experts and consultants whose personal services are
obtained under paragraph (1) shall not exceed 30 at any time.
[``(f) Streamlined Personnel Authority.--
[``(1) In general.--In addition to any other personnel
authorities, the Secretary may, as the Secretary determines
necessary to respond to pressing research and development
needs under this section, without regard to such provisions
of title 5, United States Code, governing appointments in the
competitive service, and 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,
appoint professional and technical employees, not to exceed
30 such employees at any time, to positions in the National
Institutes of Health to perform, administer, or support
biomedical countermeasure research and development in
carrying out this section.
[``(2) Internal controls to be instituted.--The Secretary
shall institute appropriate internal controls for
appointments under this subsection.
[``(g) Definition.--As used in this section, the term
`biomedical 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 is used--
[``(1) to treat, identify, or prevent harm from any
biological, chemical, radiological, or nuclear agent that may
cause a public health emergency affecting national security;
or
[``(2) to treat, identify, or prevent 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 paragraph (1).
[``(h) Actions Committed to Agency Discretion.--Actions by
the Secretary under the authority of this section are
committed to agency discretion.''.
[[Page S5748]]
[SEC. 203. BIOMEDICAL COUNTERMEASURES PROCUREMENT.
[Section 121 of the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (42 U.S.C. 300hh-12) is
amended--
[(1) by redesignating subsections (c) through (e) as
subsections (d) through (f), respectively; and
[(2) by inserting after subsection (b) the following:
[``(c) Biomedical Countermeasures Procurement.--
[``(1) Determination of material threats.--
[``(A) Risk of use.--The Secretary, in consultation with
the heads of other agencies as appropriate, shall on an
ongoing basis--
[``(i) assess current and emerging threats of use of
chemical, biological, radiological, and nuclear agents; and
[``(ii) determine which of such agents present a material
risk of use against the United States population.
[``(B) Public health impact.--The Secretary of Health and
Human Services, in consultation with the Secretary, shall on
an ongoing basis--
[``(i) assess the potential public health consequences of
use against the United States population of agents identified
under subparagraph (A)(ii); and
[``(ii) determine, on the basis of such assessment, the
agents for which countermeasures are necessary to protect the
public health.
[``(2) Assessment of availability and appropriateness of
countermeasures.--The Secretary of Health and Human Services,
in consultation with the Secretary, shall assess on an
ongoing basis the availability and appropriateness of
specific countermeasures to address specific threats
identified under paragraph (1).
[``(3) Secretary's determination of countermeasures
appropriate for procurement under this subsection.--
[``(A) In general.--The Secretary of Health and Human
Services, in accordance with this paragraph, shall identify
specific countermeasures to threats identified under
paragraph (1) that such Secretary determines, in consultation
with the Secretary of Homeland Security, to be appropriate
for procurement with appropriations under this subsection for
inclusion in the stockpile under subsection (a).
[``(B) Requirements.--In order for the Secretary of Health
and Human Services to make the determination under
subparagraph (A) with respect to a countermeasure, the
following requirements must be met:
[``(i) Determination of qualified countermeasure.--Such
Secretary must determine that the product is a qualified
countermeasure (as defined in paragraph (7)).
[``(ii) Determination of quantities needed and feasibility
of production and distribution.--Such Secretary must
determine--
[``(I) the quantities of the product that will be needed to
meet the needs of the stockpile; and
[``(II) that production and delivery within 5 years of
sufficient quantities of the product, as so determined, is
reasonably expected to be feasible.
[``(iii) Determination of no significant commercial
market.--Such Secretary shall--
[``(I) determine that, at the time of the initial
determination under this paragraph, there is not a
significant commercial market for the product other than as a
homeland security threat countermeasure; and
[``(II) annually redetermine and report to the President,
while a determination under subparagraph (A) remains in
effect with respect to the product, whether a significant
commercial market exists for the product other than as a
homeland security threat countermeasure.
[``(4) Recommendation for president's approval.--
[``(A) Recommendation for procurement.--In the case of a
countermeasure that the Secretary and the Secretary of Health
and Human Services have determined is appropriate for
procurement under this subsection for inclusion in the
stockpile, in accordance with the preceding provisions of
this subsection, the Secretary and the Secretary of Health
and Human Services shall jointly submit to the President, in
coordination with the Director of the Office of Management
and Budget, a recommendation for procurement under this
subsection.
[``(B) Presidential approval.--A countermeasure may be
procured under this subsection only if the President has
approved a recommendation under subparagraph (A) with respect
to such countermeasure.
[``(C) Notice to congress.--The Secretary shall notify
Congress of each decision of the President to approve a
recommendation under subparagraph (A).
[``(5) Procurement.--The Secretary of Health and Human
Services and the Secretary shall be responsible for the
following, for purposes of procurement of qualified
countermeasures for the stockpile under subsection (a), as
approved by the President under paragraph (4):
[``(A) Interagency agreements.--
[``(i) For procurement.--The Secretary shall enter into an
agreement with the Secretary of Health and Human Services for
the procurement of the countermeasure in accordance with the
provisions of this paragraph. Amounts appropriated under
paragraph (8) shall be available for the Secretary of Health
and Human Service's costs of such procurement, other than as
provided in clause (ii).
[``(ii) For administrative costs.--The agreement entered
into between the Secretary and the Secretary of Health and
Human Services for managing the stockpile under subsection
(a) shall provide for reimbursement of the Secretary of
Health and Human Service's administrative costs relating to
procurements under this subsection from appropriations to
carry out such subsection (a).
[``(B) Procurement.--
[``(i) In general.--The Secretary of Health and Human
Services shall be responsible for--
[``(I) arranging for procurement of the countermeasure,
including negotiating terms (including quantity, production
schedule, and price) of, and entering into, contracts and
cooperative agreements, and for carrying out such other
activities as may reasonably be required, in accordance with
the provisions of this subparagraph; and
[``(II) promulgating regulations to implement clauses (v),
(vi), and (vii), and any other provisions of this subsection.
[``(ii) Contract terms.--A contract for procurements under
this subsection shall (or, as otherwise specified in this
clause, may) include the following terms:
[``(I) Payment conditioned on substantial delivery.--The
contract shall provide that no payment may be made until
delivery has been made of a substantial portion (as
determined by the Secretary of Health and Human Services) of
the total number of units contracted for.
[``(II) Discounted payment for unlicensed product.--The
contract may provide for a discounted price per unit of a
product that is not licensed or approved as described in
paragraph (7)(A) at the time of delivery, and may provide for
payment of an additional amount per unit if the product
becomes so licensed or approved before the expiration date
of the contract (including an additional amount per unit
of product delivered before the effective date of such
licensing or approval).
[``(III) Storage by vendor.--The contract may provide that
the vendor will provide storage for stocks of a product
delivered to the ownership of the Government under the
contract, for such period and under such terms and conditions
as the Secretary of Health and Human Services may specify,
and in such case amounts appropriated under paragraph (8)
shall be available for costs of shipping, handling, storage,
and related costs for such product.
[``(IV) Contract duration.--The contract shall be for a
period not to exceed 5 years, renewable for additional
periods none of which shall exceed 5 years.
[``(V) Termination for nondelivery.--In addition to any
other rights of the Secretary of Health and Human Services to
terminate the contract, the contract may provide that such
Secretary may terminate the contract for failure to deliver a
reasonable number (as determined by such Secretary) of units
of the product by 3 years after the date the contract is
entered into, and may further provide that in such case the
vendor shall not be entitled to any payment under the
contract.
[``(iii) Availability of simplified acquisition
procedures.--The amount of any procurement under this
subsection shall be deemed to be below the threshold amount
specified in section 4(11) of the Office of Federal
Procurement Policy Act (41 U.S.C. 403(11)), for purposes of
application to such procurement, pursuant to section 302A(a)
of the Federal Property and Administrative Services Act of
1949 (41 U.S.C. 252a(a)), of--
[``(I) section 303(g)(1)(A) of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C. 253(g)(1)(A))
and its implementing regulations; and
[``(II) section 302A(b) of such Act (41 U.S.C. 252a(b)) and
its implementing regulations.
[``(iv) Use of noncompetitive procedures.--In addition to
any other authority to use procedures other than competitive
procedures, the Secretary of Health and Human Services may
use such other procedures for a procurement under this
subsection if the product is available from only one
responsible source or only from a limited number of
responsible sources, and no other type of product will
satisfy such Secretary's needs.
[``(v) Premium provision in multiple award contracts.--
[``(I) In general.--If, under this subsection, the
Secretary of Health and Human Services enters into contracts
with more than one person to procure a countermeasure, such
Secretary may, notwithstanding any other provision of law,
include in each of such contracts a provision that--
[``(aa) identifies an increment of the total quantity of
countermeasure required, whether by percentage or by numbers
of units; and
[``(bb) promises to pay one or more specified premiums
based on the priority of such persons' production and
delivery of the increment identified under item (aa), in
accordance with the terms and conditions of the contract.
[``(II) Determination of government's requirement not
reviewable.--If the Secretary of Health and Human Services
includes in each of a set of contracts a provision as
described in clause (I), such Secretary's determination of
the total quantity of countermeasure required, and any
amendment of such determination, is committed to agency
discretion.
[``(vi) Extension of closing date for receipt of proposals
not reviewable.--A decision by the Secretary of Health and
Human
[[Page S5749]]
Services to extend the closing date for receipt of proposals
for a procurement under this subsection is committed to
agency discretion.
[``(vii) Limiting competition to sources responding to
request for information.--In conducting a procurement under
this subsection, the Secretary of Health and Human Services
may exclude a source that has not responded to a request for
information under section 303A(a)(1)(B) of the Federal
Property and Administrative Services Act of 1949 (41 U.S.C.
253a(a)(1)(B)) if such request has given notice that such
Secretary may so exclude such a source.
[``(6) Interagency cooperation.--
[``(A) In general.--In carrying out activities under this
section, the Secretary and the Secretary of Health and Human
Services are authorized, subject to subparagraph (B), to
enter into interagency agreements and other collaborative
undertakings with other agencies of the United States
Government.
[``(B) Limitation.--An agreement or undertaking under this
paragraph shall not authorize another agency to exercise the
authorities provided by this section to the Secretary or to
the Secretary of Health and Human Services.
[``(7) Definitions.--In this subsection:
[``(A) Qualified countermeasure.--The term `qualified
countermeasure' means a biomedical countermeasure--
[``(i) that is approved under section 505(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355) or licensed
under section 351 of the Public Health Service Act (42 U.S.C.
262) for use as such a countermeasure to a chemical,
biological, radiological, or nuclear agent identified as a
material threat under paragraph (1); or
[``(ii) for which the Secretary of Health and Human
Services determines that sufficient and satisfactory clinical
experience or research data (including data, if available,
from preclinical and clinical trials) support a reasonable
conclusion that the product will qualify for approval or
licensing as such a countermeasure within 5 years after the
date of a determination under paragraph (3).
[``(B) Biomedical countermeasure.--The term `biomedical
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))) or biological product (as that term is
defined by section 351(i) of the Public Health Service Act
(42 U.S.C. 262(i))) that is used--
[``(i) to treat, identify, or prevent harm from any
biological, chemical, radiological, or nuclear agent that may
cause a public health emergency affecting national security;
or
[``(ii) to treat, identify, or prevent harm from a
condition that may result in adverse health consequences or
death and may be caused by administering a drug or biological
product that is used as described in clause (i).
[``(8) Appropriations.--
[``(A) In general.-- There are appropriated, out of any
moneys in the Treasury not otherwise appropriated, for fiscal
year 2003 and for each fiscal year thereafter, such sums as
may be necessary for the costs incurred by the Secretary in
the procurement of countermeasures under this subsection as
approved by the President under paragraph (4) (other than
costs specified in subparagraph (B)).
[``(B) Restrictions.--Amounts appropriated under this
paragraph shall not be available to pay--
[``(i) costs for the purchase of vaccines under procurement
contracts entered into before January 1, 2003;
[``(ii) costs under new contracts, or costs of new
obligations under contracts previously entered into, for
procurement of a countermeasure after the date of a
determination under paragraph (3)(B)(iii) that there is a
significant commercial market for the countermeasure other
than as a homeland security threat countermeasure; or
[``(iii) administrative costs.''.
[SEC. 204. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN
EMERGENCIES.
[(a) In General.--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. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN
EMERGENCIES.
[``(a) In General.--Notwithstanding sections 505 and 515 of
this Act and section 351 of the Public Health Service Act,
and subject to the provisions of this section, the Secretary
may authorize the introduction into interstate commerce,
during the effective period of a declaration under subsection
(b), of a drug or device intended solely for use in an actual
or potential emergency.
[``(b) Declaration of Emergency.--
[``(1) In general.--The Secretary may declare an emergency
justifying the authorization of a drug or device under this
subsection on the basis of a determination--
[``(A) by the Secretary of Homeland Security, that there is
a national emergency (or a significant potential of a
national emergency) involving a heightened risk of attack
with a specified biological, chemical, radiological, or
nuclear agent or agents;
[``(B) by the Secretary of Defense, that there is a
military emergency (or a significant potential of a military
emergency) involving a heightened risk to United States
military forces of attack with a biological, chemical,
radiological, or nuclear agent or agents; or
[``(C) by the Secretary of a public health emergency under
section 319 of the Public Health Service Act, involving a
specified disease or condition or a specified biological,
chemical, radiological, or nuclear agent or agents.
[``(2) Termination of declaration.--
[``(A) In general.--A declaration under this subsection
shall terminate upon the earlier of--
[``(i) a determination by the Secretary, in consultation as
appropriate with the Secretary of Homeland Security or the
Secretary of Defense, that the circumstances described in
paragraph (1) have ceased to exist; or
[``(ii) the expiration of the 1-year period beginning on
the date on which the declaration is made.
[``(B) Renewal.--Notwithstanding subparagraph (A), the
Secretary may renew a declaration under this subsection, and
this paragraph shall apply to any such renewal.
[``(3) Publication.--The Secretary shall promptly publish
in the Federal Register each declaration, determination, and
renewal under this subsection.
[``(c) Criteria for Issuance of Authorization.--The
Secretary may issue an authorization under this section with
respect to a product if the Secretary concludes--
[``(1) that an agent specified in a declaration under
subsection (b) can cause a serious or life-threatening
disease or condition;
[``(2) that, based on the totality of scientific evidence
available to the Secretary, including data from adequate and
well-controlled clinical trials, if available, it is
reasonable to believe that--
[``(A) the product may be effective in detecting,
diagnosing, treating, or preventing--
[``(i) such disease or condition; or
[``(ii) a serious or life-threatening disease or condition
caused by a product authorized under this section or approved
under this Act or the Public Health Service Act, for
detecting, diagnosing, treating, or preventing such a disease
or condition caused by such an agent; and
[``(B) the known and potential benefits of the product,
when used to detect, diagnose, prevent, or treat such disease
or condition, outweigh the known and potential risks of the
product;
[``(3) that there is no adequate, approved, and available
alternative to the product for detecting, diagnosing,
preventing, or treating such disease or condition; and
[``(4) that such other criteria as the Secretary may by
regulation prescribe are satisfied.
[``(d) Scope of Authorization.--An authorization of a
product under this section shall state--
[``(1) each disease or condition that the product may be
used to detect, diagnose, prevent, or treat within the scope
of the authorization; and
[``(2) the Secretary's conclusions, under subsection (c),
concerning the safety and potential effectiveness of the
product in detecting, diagnosing, preventing, or treating
such diseases or conditions, including an assessment of the
available scientific evidence.
[``(e) Conditions of Authorization.--
[``(1) In general.--The Secretary is authorized, by order
or regulation, to impose such conditions on an authorization
under this section as the Secretary determines are necessary
or appropriate to protect the public health, including the
following:
[``(A) The Secretary shall impose requirements (including
requirements concerning product labeling and the provision of
information) designed to ensure that, to the maximum extent
feasible given the circumstances of the emergency, health
care professionals administering the product are informed--
[``(i) that the Secretary has authorized the product solely
for emergency use;
[``(ii) of the significant known and potential benefits and
risks of use of the product, and of the extent to which such
benefits and risks are unknown; and
[``(iii) of the alternatives to the product that are
available, and of their benefits and risks.
[``(B) The Secretary shall impose requirements (including
requirements concerning product labeling and the provision of
information) designed to ensure that, to the maximum extent
feasible given the circumstances of the emergency,
individuals to whom the product is administered are
informed--
[``(i) that the Secretary has authorized the product solely
for emergency use;
[``(ii) of the significant known and potential benefits and
risks of use of the product, and of the extent to which such
benefits and risks are unknown; and
[``(iii) of any option to accept or refuse administration
of the product, and of the alternatives to the product that
are available and of their benefits and risks.
[``(C) The Secretary may impose limitations on which
entities may distribute the product (including limitation to
distribution by government entities), and on how distribution
is to be performed.
[``(D) The Secretary may impose limitations on who may
administer the product, and on the categories of individuals
to whom, and the circumstances under which, the product may
be administered.
[``(E) The Secretary may condition the authorization on the
performance of studies, clinical trials, or other research
needed to support marketing approval of the product.
[[Page S5750]]
[``(F) The Secretary may impose requirements concerning
recordkeeping and reporting, including records access by the
Secretary and publication of data.
[``(G) The Secretary may impose (or waive) requirements,
with respect to the product, of current good manufacturing
practice otherwise applicable to the manufacture, processing,
packing, or holding of products subject to regulation under
this Act.
[``(H) The Secretary may impose requirements for the
monitoring and reporting of adverse events associated with
use of the product.
[``(2) Waiver.--The Secretary may waive any condition
imposed under this subsection.
[``(f) Duration of Authorization.--
[``(1) In general.--Except as provided in paragraph (2), an
authorization under this section shall be effective until the
earlier of the termination of the declaration under
subsection (b) or a revocation under subsection (g).
[``(2) Continued use after end of effective period.--An
authorization shall continue to be effective for continued
use with respect to patients to whom it was administered
during the period described by paragraph (1), to the extent
found necessary by such patients' attending physicians.
[``(g) Revocation of Authorization.--
[``(1) Review.--The Secretary shall periodically review the
circumstances and the appropriateness of an authorization
under this section.
[``(2) Revocation.--The Secretary may revoke an
authorization under this section if, in the Secretary's
unreviewable discretion--
[``(A) the conditions for such an authorization are no
longer met; or
[``(B) other circumstances make such revocation
appropriate.
[``(h) Publication.--The Secretary shall promptly publish
in the Federal Register a notice of each authorization, and
each termination or revocation of an authorization, under
this section.
[``(i) Recordkeeping.--
[``(1) In general.--The Secretary may by order or
regulation require persons, including a person who holds an
authorization under this section, or who manufactures,
distributes, prescribes, or administers a product that is the
subject of such an authorization, to establish and maintain--
[``(A) data that is obtained from such activity and that
pertains to the effectiveness or safety of such product;
[``(B) such records as are necessary to determine, or
facilitate a determination, whether there may be any
violation of this section or of a regulation promulgated
under this section; and
[``(C) such additional records as the Secretary may
determine necessary.
[``(2) Access to records by secretary.--
[``(A) Safety and effectiveness information.--The Secretary
may by order or regulation require a person who holds an
authorization under this section, or who manufactures,
distributes, prescribes, or administers a product that is the
subject of such an authorization to provide to the Secretary
all data that is obtained from such activity and that
pertains to the safety or effectiveness of such product.
[``(B) Other information.--Every person required under this
section to establish or maintain records, and every person in
charge or custody of such records, shall, upon request by the
Secretary, permit the Secretary at all reasonable times to
have access to, to copy, and to verify such records.
[``(j) Civil Monetary Penalties.--
[``(1) In general.--A person who violates a requirement of
this section or of a regulation or order promulgated pursuant
to this section shall be subject to a civil money penalty of
not more than $100,000 in the case of an individual, and not
more than $250,000 in the case of any other person, for each
violation, not to exceed $1,000,000 for all such violations
adjudicated in a single proceeding.
[``(2) Assessment of civil penalties.--Paragraphs (3), (4),
and (5) of section 303(g) shall apply to a civil penalty
under this subsection, and references in such paragraphs to
`paragraph (1) or (2)' shall, for purposes of this
subsection, be deemed to refer to paragraph (1) of this
subsection.
[``(k) Actions Committed to Agency Discretion.--Actions
under the authority of this section by the Secretary, by the
Secretary of Defense, or by the Secretary of Homeland
Security are committed to agency discretion.
[``(l) Regulations.--The Secretary may promulgate
regulations to implement this section.
[``(m) Construction.--Nothing in this section shall be
construed to impair or otherwise affect--
[``(1) the authority of the President as Commander in Chief
of the Armed Forces of the United States under article II,
section 2 of the United States Constitution; or
[``(2) the authority of the Secretary of Defense with
respect to the Department of Defense, including the armed
forces, under other provisions of Federal law.
[``(n) Application to Members of Armed Forces.--
[``(1) Waiver of requirement relating to option to
refuse.--In the case of the administration of a
countermeasure to members of the armed forces, a requirement,
under subsection (e)(2)(C), designed to ensure that
individuals are informed of an option to accept or refuse
administration of a product, may be waived by the President
if the President determines, in writing, that complying with
such requirement is not feasible, is contrary to the best
interests of the members affected, or is not in the interests
of national security.
[``(2) Effect on statute pertaining to investigational new
drugs.--In the case of an authorization based on a
determination by the Secretary of Defense under subsection
(b)(1)(B), section 1107 of title 10, United States Code,
shall not apply to use of a product that is the subject of
such authorization, within the scope of such authorization
and while such authorization is effective.
[``(o) Relation to Other Provisions.--If a product is the
subject of an authorization under this section, the use of
such product within the scope of the authorization--
[``(1) shall not be subject to any requirements pursuant to
section 505(i) or 520(g); and
[``(2) shall not be subject to any requirements otherwise
applicable to clinical investigations pursuant to other
provisions of this Act.''.
[(b) Prohibited Acts.--Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331) is amended--
[(1) in subsection (e)--
[(A) by striking ``504, 703'' and inserting ``504, 564,
703''; and
[(B) by striking ``or 519'' and inserting ``519, or 564'';
and
[(2) by adding at the end the following:
[``(hh)(1) Promotion or use of a product that is the
subject of an authorization under section 564 other than as
stated in the authorization, or other than during the period
described by section 564(g), unless such promotion or use is
permitted under another provision of this Act.
[``(2) Failure to comply with an information requirement
under section 564(e)(1).''.
[SEC. 205. DEVELOPING NEW COUNTERMEASURES AND PROTECTING
EXISTING COUNTERMEASURES AGAINST BIOTERRORISM.
[Section 319F of the Public Health Service Act (42 U.S.C.
247d-6) is amended by adding at the end the following:
[``(k) Limited Antitrust Exemption.--
[``(1) Countermeasures development meetings.--
[``(A) Countermeasures development meetings and
consultations.--The Secretary may conduct meetings and
consultations with parties involved in the development of
countermeasures for the purpose of the development,
manufacture, distribution, or sale of priority
countermeasures consistent with the purposes of this title.
The Secretary shall give notice of such meetings and
consultations to the Attorney General and the Chairperson of
the Federal Trade Commission (referred to in this subsection
as the `Chairperson').
[``(B) Meeting and consultation conditions.--A meeting or
consultation conducted under subparagraph (A) shall--
[``(i) be chaired or, in the case of a consultation,
facilitated by the Secretary or the designee of the
Secretary;
[``(ii) be open to parties involved in the development,
manufacture, distribution, purchase, or sale of priority
countermeasures, as determined by the Secretary;
[``(iii) be open to the Attorney General and the
Chairperson;
[``(iv) be limited to discussions involving the
development, manufacture, distribution, or sale of priority
countermeasures, consistent with the purposes of this title;
and
[``(v) be conducted in such manner as to ensure that
national security, confidential, and proprietary information
is not disclosed outside the meeting or consultation.
[``(C) Minutes.--The Secretary shall maintain minutes of
meetings and consultations under this subsection, which shall
not be disclosed under section 552 of title 5, United States
Code.
[``(D) Exemption.--The antitrust laws shall not apply to
meetings and consultations under this paragraph, except that
any agreement that results from a meeting or consultation and
that has been denied an exemption pursuant to this subsection
shall be subject to the antitrust laws.
[``(2) Written agreements or conduct.--The Secretary or any
party to an agreement or other conduct regarding covered
activities entered into or undertaken pursuant to meetings or
consultations conducted under paragraph (1), and that is
consistent with this paragraph, shall file such written
agreement or a description of the conduct involved with the
Attorney General and the Chairperson for a determination of
whether such agreement or conduct should be exempt from the
antitrust laws. In addition to the proposed agreement or
description of conduct itself, any such filing shall
include--
[``(A) an explanation of the intended purpose of the
agreement or conduct;
[``(B) a specific statement of the substance of the
agreement or conduct;
[``(C) a description of the methods that will be utilized
to achieve the objectives of the agreement or conduct;
[``(D) an explanation of the necessity of a cooperative
effort among the particular participating parties to achieve
the objectives of the agreement or conduct; and
[``(E) any other relevant information reasonably requested
by the Attorney General, in consultation with the Chairperson
and the Secretary.
[``(3) Determination.--The Attorney General, in
consultation with the Chairperson,
[[Page S5751]]
shall determine whether an agreement or description of
conduct submitted under paragraph (2) should be exempt from
the antitrust laws.
[``(4) Limited antitrust exemption.--
[``(A) In general.--The Attorney General, in consultation
with the Chairperson, may, within 30 days of the receipt of a
notification pursuant to paragraph (2), revoke in whole or in
part, the scope of any exemption granted by the Attorney
General under a determination under paragraph (3).
[``(B) Extension.--The Attorney General may extend the 35-
day period referred to in subparagraph (A) for an additional
period of not to exceed 20 days. Such additional period may
be further extended only by the United States district court,
upon an application by the Attorney General after notice to
the Secretary and the parties involved.
[``(C) Application of laws.--
[``(i) In general.--The antitrust laws shall not apply to
an agreement or conduct (described in a description of
conduct) that is submitted for review pursuant to paragraph
(2) until such time as the Attorney General determines,
pursuant to subparagraph (D), that such agreement or
conduct should not, in whole or in part, be exempt from
the antitrust laws.
[``(ii) Limited liability.--No party to an agreement or
conduct referred to in clause (i) shall be liable under the
antitrust laws for any actions reasonably necessary to carry
out the agreement or for conduct taken after the agreement or
description has been submitted pursuant to paragraph (2) and
prior to any revocation of the exemption by the Attorney
General pursuant to subparagraph (D).
[``(D) Determination.--In making a determination under this
subparagraph, the Attorney General, in consultation with the
Chairperson and the Secretary shall consider--
[``(i) whether the agreement or conduct involved would
facilitate the availability of priority countermeasures;
[``(ii) whether the exemption from the antitrust laws would
promote the public interest;
[``(iii) the competitive impact to areas not directly
related to the purposes of the agreement or conduct; and
[``(iv) any other factors determined relevant by the
Attorney General and the Chairperson.
[``(5) Limitation on and renewal of exemptions.--An
exemption provided under paragraphs (3) or (4) shall be
limited to covered activities, and shall expire on the date
that is 3 years after the date on which the exemption becomes
effective (and at 3 year intervals thereafter, if renewed)
unless the Attorney General in consultation with the
Chairperson determines that the exemption should be renewed
(with modifications, as appropriate) considering the factors
described in paragraph (4).
[``(6) Limitation on parties.--Any exemption from the
antitrust laws provided under this subsection shall not apply
to the use of any information acquired in conducting exempted
activities for any purposes other than those expressly
specified in the antitrust exemption provided for by this
subsection.
[``(7) Guidelines.--The Attorney General and the
Chairperson may develop and issue guidelines to implement
this subsection.
[``(8) Report.--Not later than 1 year after the date of
enactment of this subsection, and annually thereafter, the
Attorney General and the Chairperson shall report to the
Committee on Health, Education, Labor, and Pensions and the
Committee on the Judiciary of the Senate and the Committee on
Energy and Commerce and the Committee on the Judiciary of the
House of Representatives on the use and continuing need for
the exemption from the antitrust laws provided by this
subsection.
[``(9) Sunset.--The authority of any party to apply for or
to obtain a limited antitrust exemption under this subsection
shall expire at the end of the 6-year period that begins on
the date of enactment of this subsection.
[``(l) Definitions.--In this section:
[``(1) Antitrust laws.--The term `antitrust laws'--
[``(A) has the meaning given such term in subsection (a) of
the first section of the Clayton Act (15 U.S.C. 12(a)),
except that such term includes the Act of June 19, 1936 (15
U.S.C. 13 et seq.) commonly known as the Robinson-Patman
Act), and section 5 of the Federal Trade Commission Act (15
U.S.C. 45) to the extent such section 5 applies to unfair
methods of competition; and
[``(B) includes any State law similar to the laws referred
to in subparagraph (A).
[``(2) Covered activities.--
[``(A) In general.--Except as provided in subparagraph (B),
the term `covered activities' means any group of activities
or conduct, including attempting to make, making, or
performing a contract or agreement or engaging in other
conduct, for the purpose of--
[``(i) theoretical analysis, experimentation, or the
systematic study of phenomena or observable facts related to
the development of priority countermeasures;
[``(ii) the development or testing of basic engineering
techniques related to the development of priority
countermeasures;
[``(iii) the extension of investigative findings or theory
of a scientific or technical nature into practical
application for experimental and demonstration purposes,
including the experimental production and testing of models,
prototypes, equipment, materials, and processes related to
the development of priority countermeasures;
[``(iv) the production, distribution, or marketing of a
product, process, or service related to the development of
priority countermeasures;
[``(v) the testing in connection with the production of a
product, process, or service related to the development of
priority countermeasures;
[``(vi) the collection, exchange, and analysis of research
or production information related to the development of
priority countermeasures; or
[``(vii) any combination of the purposes described in
clauses (i) through (vi);
and such term may include the establishment and operation of
facilities for the conduct of covered activities described in
clauses (i) through (vi), the conduct of such covered
activities on a protracted and proprietary basis, and the
processing of applications for patents and the granting of
licenses for the results of such covered activities.
[``(B) Exception.--The term `covered activities' shall not
include the following activities involving 2 or more persons:
[``(i) Exchanging information among competitors relating to
costs, sales, profitability, prices, marketing, or
distribution of any product, process, or service if such
information is not reasonably necessary to carry out the
purposes of covered activities.
[``(ii) Entering into any agreement or engaging in any
other conduct--
[``(I) to restrict or require the sale, licensing, or
sharing of inventions, developments, products, processes, or
services not developed through, produced by, or distributed
or sold through such covered activities; or
[``(II) to restrict or require participation by any person
who is a party to such covered activities in other research
and development activities, that is not reasonably necessary
to prevent the misappropriation of proprietary information
contributed by any person who is a party to such covered
activities or of the results of such covered activities.
[``(iii) Entering into any agreement or engaging in any
other conduct allocating a market with a competitor that is
not expressly exempted from the antitrust laws by a
determination under subsection (k)(4).
[``(iv) Exchanging information among competitors relating
to production (other than production by such covered
activities) of a product, process, or service if such
information is not reasonably necessary to carry out the
purpose of such covered activities.
[``(v) Except as otherwise provided in this subsection or
subsection (k), entering into any agreement or engaging in
any other conduct to restrict or require participation by any
person who is a party to such activities, in any unilateral
or joint activity that is not reasonably necessary to carry
out the purpose of such covered activities.
[``(3) Development.--The term `development' includes the
identification of suitable compounds or biological materials,
the conduct of preclinical and clinical studies, the
preparation of an application for marketing approval, and any
other actions related to preparation of a countermeasure.
[``(4) Person.--The term `person' has the meaning given
such term in subsection (a) of the first section of the
Clayton Act (15 U.S.C. 12(a)).
[``(5) Priority countermeasure.--The term `priority
countermeasure' means a countermeasure, including a drug,
medical device, biological product, or diagnostic test to
treat, identify, or prevent infection by a biological agent
or toxin on the list developed under section 351A(a)(1) and
prioritized under subsection (a)(1).''.
[TITLE III--IMPROVED VACCINE AFFORDABILITY AND AVAILABILITY
[SEC. 301. SHORT TITLE.
[This title may be cited as the ``Improved Vaccine
Affordability and Availability Act''.
[Subtitle A--State Vaccine Grants
[SEC. 311. AVAILABILITY OF INFLUENZA VACCINE.
[Section 317(j) of the Public Health Service Act (42 U.S.C.
247b(j)) is amended by adding at the end the following:
[``(3)(A) For the purpose of carrying out activities
relating to influenza vaccine under the immunization program
under this subsection, there are authorized to be
appropriated such sums as may be necessary for each of fiscal
years 2003 and 2004. Such authorization shall be in addition
to amounts available under paragraphs (1) and (2) for such
purpose.
[``(B) The authorization of appropriations established in
subparagraph (A) shall not be effective for a fiscal year
unless the total amount appropriated under paragraphs (1) and
(2) for the fiscal year is not less than such total for
fiscal year 2000.
[``(C) The purposes for which amounts appropriated under
subparagraph (A) are available to the Secretary include
providing for improved State and local infrastructure for
influenza immunizations under this subsection in accordance
with the following:
[``(i) Increasing influenza immunization rates in
populations considered by the Secretary to be at high risk
for influenza-related complications and in their contacts.
[``(ii) Recommending that health care providers actively
target influenza vaccine that is available in September,
October, and November to individuals who are at increased
risk for influenza-related complications and to their
contacts.
[``(iii) Providing for the continued availability of
influenza immunizations through
[[Page S5752]]
December of such year, and for additional periods to the
extent that influenza vaccine remains available.
[``(iv) Encouraging States, as appropriate, to develop
contingency plans (including plans for public and
professional educational activities) for maximizing influenza
immunizations for high-risk populations in the event of a
delay or shortage of influenza vaccine.
[``(D) The Secretary shall submit to the Committee on
Energy and Commerce of the House of Representatives, and the
Committee on Health, Education, Labor, and Pensions of the
Senate, periodic reports describing the activities of the
Secretary under this subsection regarding influenza vaccine.
The first such report shall be submitted not later than June
6, 2003, the second report shall be submitted not later than
June 6, 2004, and subsequent reports shall be submitted
biennially thereafter.''.
[SEC. 312. PROGRAM FOR INCREASING IMMUNIZATION RATES FOR
ADULTS AND ADOLESCENTS; COLLECTION OF
ADDITIONAL IMMUNIZATION DATA.
[(a) Activities of Centers for Disease Control and
Prevention.--Section 317(j) of the Public Health Service Act
(42 U.S.C. 247b(j)), as amended by section 311, is further
amended by adding at the end the following:
[``(4)(A) For the purpose of carrying out activities to
increase immunization rates for adults and adolescents
through the immunization program under this subsection, and
for the purpose of carrying out subsection (k)(2), there are
authorized to be appropriated $50,000,000 for fiscal year
2003, and such sums as may be necessary for each of the
fiscal years 2004 through 2006. Such authorization is in
addition to amounts available under paragraphs (1), (2), and
(3) for such purposes.
[``(B) In expending amounts appropriated under subparagraph
(A), the Secretary shall give priority to adults and
adolescents who are medically underserved and are at risk for
vaccine-preventable diseases, including as appropriate
populations identified through projects under subsection
(k)(2)(E).
[``(C) The purposes for which amounts appropriated under
subparagraph (A) are available include (with respect to
immunizations for adults and adolescents) the payment of the
costs of storing vaccines, outreach activities to inform
individuals of the availability of the immunizations, and
other program expenses necessary for the establishment or
operation of immunization programs carried out or supported
by States or other public entities pursuant to this
subsection.
[``(5) The Secretary shall annually submit to Congress a
report that--
[``(A) evaluates the extent to which the immunization
system in the United States has been effective in providing
for adequate immunization rates for adults and adolescents,
taking into account the applicable year 2010 health
objectives established by the Secretary regarding the health
status of the people of the United States; and
[``(B) describes any issues identified by the Secretary
that may affect such rates.
[``(6) In carrying out this subsection and paragraphs (1)
and (2) of subsection (k), the Secretary shall consider
recommendations regarding immunizations that are made in
reports issued by the Institute of Medicine of the National
Academy of Sciences.''.
[(b) Research, Demonstrations, and Education.--Section
317(k) of the Public Health Service Act (42 U.S.C. 247b(k))
is amended--
[(1) by redesignating paragraphs (2) through (4) as
paragraphs (3) through (5), respectively;
[(2) by inserting after paragraph (1) the following:
[``(2)(A) The Secretary, directly and through grants under
paragraph (1), shall provide for a program of research,
demonstration projects, and education in accordance with the
following:
[``(i) The Secretary shall coordinate with public and
private entities (including nonprofit private entities), and
develop and disseminate guidelines, toward the goal of
ensuring that immunizations are routinely offered to adults
and adolescents by public and private health care providers.
[``(ii) The Secretary shall cooperate with public and
private entities to obtain information for the annual
evaluations required in subsection (j)(5)(A).
[``(iii) The Secretary shall (relative to fiscal year 2003)
increase the extent to which the Secretary collects data on
the incidence, prevalence, and circumstances of diseases and
adverse events that are experienced by adults and adolescents
and may be associated with immunizations, including
collecting data in cooperation with commercial laboratories.
[``(iv) The Secretary shall ensure that the entities with
which the Secretary cooperates for purposes of subparagraphs
(A) through (C) include managed care organizations,
community-based organizations that provide health services,
and other health care providers.
[``(v) The Secretary shall provide for projects to identify
racial and ethnic minority groups and other health disparity
populations for which immunization rates for adults and
adolescents are below such rates for the general population,
and to determine the factors underlying such disparities.
[``(B) Authorization of appropriations.--There are
authorized to be appropriated to carry out this subsection,
such sums as may be necessary for each of fiscal years 2003
through 2007.''.
[SEC. 313. IMMUNIZATION AWARENESS.
[(a) Development of Information Concerning Meningitis.--
[(1) In general.--The Secretary of Health and Human
Services (in this title referred to as the ``Secretary''), in
consultation with the Director of the Centers for Disease
Control and Prevention, shall develop and make available to
entities described in paragraph (2) information concerning
bacterial meningitis and the availability and effectiveness
of vaccinations for populations targeted by the Advisory
Committee on Immunization Practices (an advisory committee
established by the Secretary, acting through the Director of
the Centers for Disease Control and Prevention).
[(2) Entities.--An entity is described in this paragraph if
the entity--
[(A) is--
[(i) a college or university; or
[(ii) any other facility with a setting similar to a
dormitory that houses age-appropriate populations for whom
the Advisory Committee on Immunization Practices recommends
such a vaccination; and
[(B) is determined appropriate by the Secretary.
[(b) Development of Information Concerning Hepatitis.--
[(1) In general.--The Secretary, in consultation with the
Director of the Centers for Disease Control and Prevention,
shall develop and make available to entities described in
paragraph (2) information concerning hepatitis A and B and
the availability and effectiveness of vaccinations with
respect to such diseases.
[(2) Entities.--An entity is described in this paragraph if
the entity--
[(A) is--
[(i) a health care clinic that serves individuals diagnosed
as being infected with HIV or as having other sexually
transmitted diseases;
[(ii) an organization or business that counsels individuals
about international travel or who arranges for such travel;
[(iii) a police, fire, or emergency medical services
organization that responds to natural or man-made disasters
or emergencies;
[(iv) a prison or other detention facility;
[(v) a college or university; or
[(vi) a public health authority or children's health
service provider in areas of intermediate or high endemicity
for hepatitis A as defined by the Centers for Disease Control
and Prevention; and
[(B) is determined appropriate by the Secretary.
[SEC. 314. SUPPLY OF VACCINES.
[(a) In General.--The Secretary of Health and Human
Services, acting through the Director of the Centers for
Disease Control and Prevention, shall prioritize, acquire,
and maintain a supply of such prioritized vaccines sufficient
to provide vaccinations throughout a 6-month period.
[(b) Proceeds.--Any proceeds received by the Secretary of
Health and Human Services from the sale of vaccines contained
in the supply described in subsection (a), shall be available
to the Secretary for the purpose of purchasing additional
vaccines for the supply. Such proceeds shall remain available
until expended.
[(c) Authorization of Appropriations.--There are authorized
to be appropriated for the purpose of carrying out subsection
(a) such sums as may be necessary for each of fiscal years
2003 through 2008.
[SEC. 315. COMMUNICATION.
[The Commissioner of Food and Drugs shall ensure that
vaccine manufacturers receive all forms of compliance
guidelines for vaccines and that such guidelines are kept up
to date.
[SEC. 316. FAST TRACK.
[The Commissioner of Food and Drugs shall issue regulations
to revise the policies of the Food and Drug Administration
regarding fast-tracking and priority review approval of
vaccine products currently under development, to allow for
the use of new forms of existing vaccines in cases where a
determination is made that applying such approvals is in the
public health interest to address the unmet need of
strengthening the overall vaccine supply.
[SEC. 317. STUDY.
[(a) In General.--The Secretary shall contract with the
Institute of Medicine of the National Academy of Sciences or
another independent and competent authority, to conduct a
study of the statutes, regulations, guidelines, and
compliance, inspection, and enforcement practices and
policies of the Department of Health and Human Services and
of the Food and Drug Administration that are applicable to
vaccines intended for human use that are in periodic short
supply in the United States.
[(b) Requirements.--The study under subsection (a) shall
include a review of the regulatory requirements, guidelines,
practices, and policies--
[(1) for the development and licensing of vaccines and the
licensing of vaccine manufacturing facilities;
[(2) for inspections and other activities for maintaining
compliance and enforcement of the requirements applicable to
such vaccines and facilities; and
[(3) that may have contributed to temporary or long-term
shortages of vaccines.
[(c) Report.--Not later than 6 months after the date of
enactment of this Act, the Secretary shall submit to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House
of Representatives a report that contains--
[[Page S5753]]
[(1) the results of the study under subsection (a); and
[(2) recommendations for modifications to the regulatory
requirements, guidelines, practices, and policies described
in subsection (b).
[Subtitle B--Vaccine Injury Compensation Program
[SEC. 321. ADMINISTRATIVE REVISION OF VACCINE INJURY TABLE.
[Section 2114 of the Public Health Service Act (42 U.S.C.
300aa-14) is amended--
[(1) by striking subsection (c)(1) and inserting the
following:
[``(1) The Secretary may promulgate regulations to modify
in accordance with paragraph (3) the Vaccine Injury Table. In
promulgating such regulations, the Secretary shall provide
for notice and for at least 60 days of public comment.''; and
[(2) in subsection (d), by striking ``90 days'' and
inserting ``60 days''.
[SEC. 322. EQUITABLE RELIEF.
[Section 2111(a)(2)(A) of the Public Health Service Act (42
U.S.C. 300aa-11(a)(2)(A)) is amended by striking ``No
person'' and all that follows through ``and--'' and inserting
the following: ``No person may bring or maintain a civil
action against a vaccine administrator or manufacturer in a
Federal or State court for damages arising from, or equitable
relief relating to, a vaccine-related injury or death
associated with the administration of a vaccine after October
1, 1988 and no such court may award damages or equitable
relief for any such vaccine-related injury or death, unless
the person proves past or present physical injury and a
timely petition has been filed in accordance with section
2116 for compensation under the Program for such injury or
death and--''.
[SEC. 323. DERIVATIVE PETITIONS FOR COMPENSATION.
[(a) Limitations on Derivative Petitions.--Section
2111(a)(2) of the Public Health Service Act (42 U.S.C. 300aa-
11(a)(2)) is amended--
[(1) in subparagraph (B), by inserting ``or (B)'' after
``subparagraph (A)'';
[(2) by redesignating subparagraph (B) as subparagraph (C);
and
[(3) by inserting after subparagraph (A) the following:
[``(B)(i) No parent or other third party may bring or
maintain a civil action against a vaccine administrator or
manufacturer in a Federal or State court for damages or
equitable relief relating to a vaccine-related injury or
death, including without limitation damages for loss of
consortium, society, companionship, or services, loss of
earnings, medical or other expenses, and emotional distress,
and no court may award damages or equitable relief in such an
action, unless--
[``(I) the person who sustained the underlying vaccine-
related injury or death upon which such parent's or other
third party's claim is premised has timely filed a petition
for compensation in accordance with section 2111;
[``(II) such parent or other third party is the legal
representative or spouse of the person who sustained the
underlying vaccine-related injury or death, and such legal
representative or spouse has filed a timely derivative
petition, in accordance with section 2116; and
[``(III)(aa) the United States Court of Federal Claims has
issued judgment under section 2112 on the derivative
petition, and such legal representative or spouse elects
under section 2121(a) to file a civil action; or
[``(bb) such legal representative or spouse elects to
withdraw such derivative petition under section 2121(b) or
such petition is considered withdrawn under such section.
[``(ii) Any civil action brought in accordance with this
subparagraph shall be subject to the standards and procedures
set forth in sections 2122 and 2123, regardless of whether
the action arises directly from a vaccine-related injury or
death associated with the administration of a vaccine. In a
case in which the person who sustained the underlying
vaccine-related injury or death upon which such legal
representative's or spouse's civil action is premised elects
under section 2121(a) to receive the compensation awarded,
such legal representative or spouse may not bring a civil
action for damages or equitable relief, and no court may
award damages or equitable relief, for any injury or loss of
the type set forth in section 2115(a) or that might in any
way overlap with or otherwise duplicate compensation of the
type available under section 2115(a).''.
[(b) Eligible Persons.--Section 2111(a)(9) of the Public
Health Service Act (42 U.S.C. 300aa-11(a)(9)) is amended by
striking the period and inserting ``and to a parent or other
third party to the extent such parent or other third party
seeks damages or equitable relief relating to a vaccine-
related injury or death sustained by a person who is
qualified to file a petition for compensation under the
Program.''.
[(c) Petitioners.--Section 2111(b) of the Public Health
Service Act (42 U.S.C. 300aa-11(b)) is amended--
[(1) in paragraph (1)--
[(A) in subparagraph (A), by striking ``(B)'' and inserting
``(C)'';
[(B) by redesignating subparagraph (B) as subparagraph (C);
and
[(C) by inserting after subparagraph (A) the following:
[``(B) Except as provided in subparagraph (C), any legal
representative or spouse of a person--
[``(i) who has sustained a vaccine-related injury or death;
and
[``(ii) who has filed a petition for compensation under the
Program (or whose legal representative has filed such a
petition as authorized in subparagraph (A));
may, if such legal representative or spouse meets the
requirements of subsection (d), file a derivative petition
under this section.''; and
[(2) in paragraph (2)--
[(A) by inserting ``by or on behalf of the person who
sustained the vaccine-related injury or death'' after
``filed''; and
[(B) by adding at the end the following: ``A legal
representative or spouse may file only 1 derivative petition
with respect to each underlying petition.''.
[(d) Derivative Petition Contents.--Section 2111 of the
Public Health Service Act (42 U.S.C. 300aa-11) is amended--
[(1) by redesignating subsections (d) and (e) as
subsections (e) and (f), respectively; and
[(2) by inserting after subsection (c) the following:
[``(d) Derivative Petitions.--
[``(1) If the legal representative or spouse of the person
who sustained the vaccine-related injury or death seeks
compensation under the Program, such legal representative or
spouse shall file a timely derivative petition for
compensation under the Program in accordance with this
section.
[``(2) Such a derivative petition shall contain--
[``(A) except for records that are unavailable as described
in subsection (c)(3), an affidavit, and supporting
documentation, demonstrating that--
[``(i) the child or spouse of such person has, in
accordance with section 2111, timely filed a petition for
compensation for the underlying vaccine-related injury or
death upon which such legal representative's or spouse's
derivative petition is premised;
[``(ii) the derivative petition was timely filed;
[``(iii) such legal representative or spouse suffered a
loss compensable under section 2115(b) as a result of the
vaccine-related injury or death sustained by such person; and
[``(iv) such legal representative or spouse has not
previously collected an award or settlement of a civil action
for damages for such loss; and
[``(B) records establishing such legal representative's or
spouse's relationship to the person who sustained the
vaccine-related injury or death.''.
[(e) Determination of Eligibility for Compensation.--
Section 2113(a)(1) of the Public Health Service Act (42
U.S.C. 300aa-13(a)(1)) is amended--
[(1) in subparagraph (A), by striking ``and'' and inserting
``or, as applicable, section 2111(d),'';
[(2) in subparagraph (B), by striking the period and
inserting ``, and''; and
[(3) by inserting before the flush matter at the end, the
following:
[``(C) in the case of a derivative petition, that the
person who sustained the underlying vaccine-related injury or
death upon which the derivative petition is premised has
timely filed a petition for compensation in accordance with
section 2111 and that, with respect to such underlying
petition, the special master or court has made the findings
specified in subparagraphs (A) and (B) of this paragraph.''.
[(f) Compensation.--Section 2115 of the Public Health
Service Act (42 U.S.C. 300aa-15) is amended--
[(1) by redesignating subsections (b) through (j) as
subsections (c) through (k), respectively;
[(2) by inserting after subsection (a) the following:
[``(b) Derivative Petitions.--
[``(1) In general.--Compensation awarded under the Program
to a legal representative or spouse who files a derivative
petition under section 2111 for a loss sustained as a result
of a vaccine-related injury or death sustained by such
petitioner's child or spouse shall only include compensation
for any loss of consortium, society, companionship, or
services, in an amount not to exceed the lesser of $250,000
or the total amount of compensation awarded to the person who
sustained the underlying vaccine-related injury or death.
[``(2) Multiple individuals.--Where more than 1 person
files a derivative petition under section 2111 for losses
sustained as a result of the same underlying vaccine-related
injury or death, the aggregate compensation to such persons
shall not exceed the lesser of $250,000, or the total amount
of compensation awarded to the person who sustained the
underlying vaccine-related injury or death. The special
master or court shall apportion compensation among the
derivative petitioners in proportion to their respective
losses.'';
[(3) in subsection (e)(2), as so redesignated by paragraph
(1)--
[(A) by striking ``(2) and (3)'' and inserting ``(2), (3),
(4), (5), and (6)''; and
[(B) by inserting ``and subsection (b),'' after ``(a),'';
[(4) in subsection (g), as so redesignated by paragraph
(1), in paragraph (4)(B), by striking ``subsection (j)'' and
inserting ``subsection (k)'';
[(5) in subsection (j), as so redesignated by paragraph
(1)--
[(A) in paragraph (1), by striking ``subsection (j)'' and
inserting ``subsection (k)''; and
[(B) in paragraph (2), by inserting ``, or to a legal
representative or spouse of a person
[[Page S5754]]
who sustained a vaccine-related injury or death,'' after
``death''; and
[(6) in subsection (k), as so redesignated by paragraph
(1), by striking ``subsection (f)(4)(B)'' and inserting
``subsection (g)(4)(B)''.
[SEC. 324. JURISDICTION TO DISMISS ACTIONS IMPROPERLY
BROUGHT.
[Section 2111(a)(3) of the Public Health Service Act (42
U.S.C. 300aa-11(a)(3)) is amended by adding at the end the
following: ``If any civil action which is barred under
subparagraph (A) or (B) of paragraph (2) is filed or
maintained in a State court, or any vaccine administrator or
manufacturer is made a party to any civil action brought in
State court (other than a civil action which may be brought
under paragraph (2)) for damages or equitable relief for a
vaccine-related injury or death associated with the
administration of a vaccine after October 1, 1988, the civil
action may be removed at any time before final judgment by
the defendant or defendants to the United States Court of
Federal Claims. Once removed, the United States Court of
Federal Claims shall have jurisdiction solely for the purpose
of adjudicating whether the civil action should be dismissed
pursuant to this section. If the United States Court of
Federal Claims determines that the civil action should not be
dismissed, the court shall remand the action to the State
Court. The notice required by section 1446 of title 28,
United States Code, shall be filed with the United States
Court of Federal Claims, and that court shall, except as
otherwise provided in this section, proceed in accordance
with sections 1446 through 1451 of title 28, United States
Code.''.
[SEC. 325. CLARIFICATION OF WHEN INJURY IS CAUSED BY FACTOR
UNRELATED TO ADMINISTRATION OF VACCINE.
[Section 2113(a)(2)(B) of the Public Health Service Act (42
U.S.C. 300aa-13(a)(2)(B)) is amended--
[(1) by inserting ``structural lesions, genetic
disorders,'' after ``and related anoxia),'';
[(2) by inserting ``(without regard to whether the cause of
the infection, toxin, trauma, structural lesion, genetic
disorder, or metabolic disturbance is known)'' after
``metabolic disturbances''; and
[(3) by striking ``but'' and inserting ``and''.
[SEC. 326. INCREASE IN AWARD IN THE CASE OF A VACCINE-RELATED
DEATH AND FOR PAIN AND SUFFERING.
[(a) In General.--Section 2115(a) of the Public Health
Service Act (42 U.S.C. 300aa-15(a)) is amended--
[(1) in paragraph (2), by striking ``$250,000'' and
inserting ``$350,000''; and
[(2) in paragraph (4), by striking ``$250,000'' and
inserting ``$350,000''.
[(b) Death Awards.--Section 2115(a)(2) of the Public Health
Service Act (42 U.S.C. 300aa-15(a)(2)) is amended by
inserting ``(if the deceased incurred unreimbursable expenses
due to the vaccine-related injury prior to death in excess of
$50,000, the award shall also include reimbursement for those
unreimbursable expenses that exceed $50,000)'' before the
period.
[SEC. 327. BASIS FOR CALCULATING PROJECTED LOST EARNINGS.
[Section 2115(a)(3)(B) of the Public Health Service Act (42
U.S.C. 300aa-15(a)(3)(B)) is amended by striking ``loss of
earnings'' and all that follows and inserting the following:
``loss of earnings determined on the basis of the annual
estimate of the average (mean) gross weekly earnings of wage
and salary workers age 18 and over (excluding the
incorporated self-employed) in the private non-farm sector
(which includes all industries other than agricultural
production crops and livestock), as calculated annually by
the Bureau of Labor Statistics from the quarter sample data
of the Current Population Survey, or as calculated by such
similar method as the Secretary may prescribe by regulation,
less appropriate taxes and the average cost of a health
insurance policy, as determined by the Secretary.''.
[SEC. 328. ALLOWING COMPENSATION FOR FAMILY COUNSELING
EXPENSES AND EXPENSES OF ESTABLISHING AND
MAINTAINING GUARDIANSHIP.
[(a) Family Counseling Expenses in Post-1988 Cases.--
Section 2115(a) of the Public Health Service Act (42 U.S.C.
300aa-15(a)) is amended by adding at the end the following:
[``(5) Actual unreimbursable expenses that have been or
will be incurred for family counseling as is determined to be
reasonably necessary and that result from the vaccine-related
injury from which the petitioner seeks compensation.''.
[(b) Expenses of Establishing and Maintaining Guardianships
in Post-1988 Cases.--Section 2115(a) of the Public Health
Service Act (42 U.S.C. 300aa-15(a)), as amended by subsection
(a), is further amended by adding at the end the following:
[``(6) Actual unreimbursable expenses that have been, or
will be reasonably incurred to establish and maintain a
guardianship or conservatorship for an individual who has
suffered a vaccine-related injury, including attorney fees
and other costs incurred in a proceeding to establish and
maintain such guardianship or conservatorship.''.
[(c) Conforming Amendment for Cases From 1988 and
Earlier.--Section 2115 of the Public Health Service Act (42
U.S.C. 300aa-15) is amended in subsection (c), as so
redesignated by section 323(f)--
[(1) in paragraph (2), by striking ``and'' at the end;
[(2) in paragraph (3), by striking ``(e)'' and inserting
``(f)'';
[(3) by redesignating paragraph (3) as paragraph (5); and
[(4) by inserting after paragraph (2), the following:
[``(3) family counseling expenses (as provided for in
paragraph (5) of subsection (a));
[``(4) expenses of establishing and maintaining
guardianships (as provided for in paragraph (6) of subsection
(a)); and''.
[SEC. 329. ALLOWING PAYMENT OF INTERIM COSTS.
[Section 2115 of the Public Health Service Act (42 U.S.C.
300aa-15) is amended in subsection (f), as so redesignated by
section 323(f), by adding at the end the following:
[``(4) A special master or court may make an interim award
of costs subject to final adjustment if--
[``(A) the case involves a vaccine administered on or after
October 1, 1988;
[``(B) the special master or court has determined that the
petitioner is entitled to compensation under the Program;
[``(C) the award is limited to other costs (within the
meaning of paragraph (1)(B)) incurred in the proceeding;
[``(D) not more than 1 prior award has been made with
respect to such petition; and
[``(E) the petitioner provides documentation verifying the
expenditure of the amount for which compensation is
sought.''.
[SEC. 330. PROCEDURE FOR PAYING ATTORNEYS' FEES.
[Section 2115 of the Public Health Service Act (42 U.S.C.
300aa-15), is amended in subsection (f), as so redesignated
by section 323(f) and amended by section 329, by adding at
the end the following:
[``(5) When a special master or court awards attorney fees
or costs under paragraph (1) or (4), it may order that such
fees or costs be payable solely to the petitioner's attorney
if--
[``(A) the petitioner expressly consents; or
[``(B) the special master or court determines, after
affording to the Secretary and to all interested persons the
opportunity to submit relevant information, that--
[``(i) the petitioner cannot be located or refuses to
respond to a request by the special master or court for
information, and there is no practical alternative means to
ensure that the attorney will be reimbursed for such fees or
costs expeditiously; or
[``(ii) there are otherwise exceptional circumstances and
good cause for paying such fees or costs solely to the
petitioner's attorney.''.
[SEC. 331. EXTENSION OF STATUTE OF LIMITATIONS.
[(a) General Rule.--Section 2116(a) of the Public Health
Service Act (42 U.S.C. 300aa-16(a)) is amended--
[(1) in paragraph (2), by striking ``36 months'' and
inserting ``6 years''; and
[(2) in paragraph (3), by striking ``48 months'' and
inserting ``6 years''.
[(b) Claims Based on Revisions to Table.--Section 2116 of
the Public Health Service Act (42 U.S.C. 300aa-16) is amended
by striking subsection (b) and inserting the following:
[``(b) Effect of Revised Table.--If at any time the Vaccine
Injury Table is revised and the effect of such revision is to
make an individual eligible for compensation under the
program, where, before such revision, such individual was not
eligible for compensation under the program, or to
significantly increase the likelihood that an individual will
be able to obtain compensation under the program, such person
may, and shall before filing a civil action for equitable
relief or monetary damages, notwithstanding section
2111(b)(2), file a petition for such compensation if--
[``(1) the vaccine-related death or injury with respect to
which the petition is filed occurred not more than 10 years
before the effective date of the revision of the table; and
[``(2) either--
[``(A) the petition satisfies the conditions described in
subsection (a); or
[``(B) the date of the occurrence of the first symptom or
manifestation of onset of the injury occurred more than 4
years before the petition is filed, and the petition is filed
not more than 2 years after the effective date of the
revision of the table.''.
[(c) Derivative Petitions.--Section 2116 of the Public
Health Service Act (42 U.S.C. 300aa-16) is amended by adding
at the end the following:
[``(d) Derivative Petitions.--No derivative petition may be
filed for compensation under the Program later than the
earlier of--
[``(1) the last day on which the petition for compensation
for the underlying claim of the person who sustained the
vaccine-related injury or death upon which the derivative
petition is premised may be timely filed; or
[``(2) 60 days after the date on which the special master
has issued a decision pursuant to section 2112(d)(3) on the
underlying claim of the person who sustained the vaccine-
related injury or death upon which the derivative petition is
premised.''.
[(d) Timely Resolutions of Claims.--
[(1) Special master decision.--Section 2112(d)(3)(A) of the
Public Health Service Act (42 U.S.C. 300aa-12(d)(3)(A)) is
amended by adding at the end the following: ``For purposes of
this subparagraph, the petition shall be deemed to be filed
on the date on which the special master issues a certificate
of completeness, indicating that all petition contents and
supporting documents required under section 2111(c) and, when
applicable, section 2111(d) and the Vaccine Rules of the
United States Court of Federal Claims, such as an affidavit
and supporting documentation, have been served on the
Secretary and
[[Page S5755]]
filed with the clerk of the United States Court of Federal
Claims.''.
[(2) Derivative petitions.--Section 2112(d)(3)(C) of the
Public Health Service Act (42 U.S.C. 300aa-12(d)(3)(C)) is
amended by adding at the end the following: ``With respect to
any derivative petition filed under section 2111, the period
of time during which the petition for compensation for the
underlying vaccine-related injury or death upon which such
derivative petition is premised is pending shall be treated
as a suspension for purposes of this subparagraph.''.
[(3) Court of federal claims decision.--Section 2121(b) of
the Public Health Service Act (42 U.S.C. 300aa-21(b)) is
amended by adding at the end the following: ``For purposes of
this subsection, the petition shall be deemed to be filed on
the date on which the special master issues a certificate of
completeness, indicating that all petition contents and
supporting documents required under section 2111(c) and, when
applicable, section 2111(d) and the Vaccine Rules of the
United States Court of Federal Claims, such as an affidavit
and supporting documentation, have been served on the
Secretary and filed with the clerk of the United States Court
of Federal Claims.''.
[SEC. 332. ADVISORY COMMISSION ON CHILDHOOD VACCINES.
[(a) Selection of Persons Injured by Vaccines as Public
Members.--Section 2119(a)(1)(B) of the Public Health Service
Act (42 U.S.C. 300aa-19(a)(1)(B)) is amended by striking ``of
whom'' and all that follows and inserting the following: ``of
whom 1 shall be the legal representative of a child who has
suffered a vaccine-related injury or death, and at least 1
other shall be either the legal representative of a child who
has suffered a vaccine-related injury or death or an
individual who has personally suffered a vaccine-related
injury.''.
[(b) Mandatory Meeting Schedule Eliminated.--Section
2119(c) of the Public Health Service Act (42 U.S.C. 300aa-
19(c)) is amended by striking ``not less often than four
times per year and''.
[SEC. 333. CLARIFICATION OF STANDARDS OF RESPONSIBILITY.
[(a) General Rule.--Section 2122(a) of the Public Health
Service Act (42 U.S.C. 300aa-22(a)) is amended by striking
``and (e) State law shall apply to a civil action brought for
damages'' and inserting ``(d), and (f) State law shall apply
to a civil action brought for damages or equitable relief'';
and
[(b) Unavoidable Adverse Side Effects.--Section 2122(b)(1)
of the Public Health Service Act (42 U.S.C. 300aa-22(b)(1))
is amended by inserting ``or equitable relief'' after ``for
damages''.
[(c) Direct Warnings.--Section 2122(c) of the Public Health
Service Act (42 U.S.C. 300aa-22(c)) is amended by inserting
``or equitable relief'' after ``for damages''.
[(d) Construction.--Section 2122(d) of the Public Health
Service Act (42 U.S.C. 300aa-22(d)) is amended--
[(1) by inserting ``or equitable relief'' after ``for
damages''; and
[(2) by inserting ``or relief'' after ``which damages''.
[(e) Past or Present Physical Injury.--Section 2122 of the
Public Health Service Act (42 U.S.C. 300aa-22) is amended--
[(1) by redesignating subsections (d) and (e) as
subsections (e) and (f), respectively; and
[(2) by inserting after subsection (c) the following:
[``(d) Past or Present Physical Injury.--No vaccine
manufacturer or vaccine administrator shall be liable in a
civil action brought after October 1, 1988, for equitable or
monetary relief absent proof of past or present physical
injury from the administration of a vaccine, nor shall any
vaccine manufacturer or vaccine administrator be liable in
any such civil action for claims of medical monitoring, or
increased risk of harm.''.
[SEC. 334. CLARIFICATION OF DEFINITION OF MANUFACTURER.
[Section 2133(3) of the Public Health Service Act (42
U.S.C. 300aa-33(3)) is amended--
[(1) in the first sentence, by striking ``under its label
any vaccine set forth in the Vaccine Injury Table'' and
inserting ``any vaccine set forth in the Vaccine Injury
table, including any component or ingredient of any such
vaccine''; and
[(2) in the second sentence, by inserting ``including any
component or ingredient of any such vaccine'' before the
period.
[SEC. 335. CLARIFICATION OF DEFINITION OF VACCINE-RELATED
INJURY OR DEATH.
[Section 2133(5) of the Public Health Service Act (42
U.S.C. 300aa-33(5)) is amended by adding at the end the
following: ``For purposes of the preceding sentence, an
adulterant or contaminant shall not include any component or
ingredient listed in a vaccine's product license application
or product label.''.
[SEC. 336. CLARIFICATION OF DEFINITION OF VACCINE AND
DEFINITION OF PHYSICAL INJURY.
[Section 2133 of the Public Health Service Act (42 U.S.C.
300aa-33) is amended by adding at the end the following:
[``(7) The term `vaccine' means any preparation or
suspension, including a preparation or suspension containing
an attenuated or inactive microorganism or subunit thereof or
toxin, developed or administered to produce or enhance the
body's immune response to a disease or diseases and includes
all components and ingredients listed in the vaccine's
product license application and product label.
[``(8) The term `physical injury' means a manifest physical
illness, condition, or death, including a neurological
disease or disorder.''.
[SEC. 337. AMENDMENTS TO VACCINE INJURY COMPENSATION TRUST
FUND.
[(a) Expansion of Compensated Loss.--Section 9510(c)(1)(A)
of the Internal Revenue Code of 1986 is amended by inserting
``, or related loss,'' after ``death''.
[(b) Increase in Limit on Administrative Expenses.--
Subparagraph (B) of section 9510(c)(1) of the Internal
Revenue Code of 1986 is amended--
[(1) by striking ``(but not in excess of the base amount of
$9,500,000 for any fiscal year)''; and
[(2) by striking the period and inserting ``, provided that
such administrative costs shall not exceed the greater of--
[``(i) the base amount of $9,500,000 for any fiscal year,
[``(ii) 125 percent of the base amount for any fiscal year
in which the total number of claims pending under such
subtitle exceeds 150 percent of the average number of claims
pending in the preceding 5 years,
[``(iii) 175 percent of the base amount for any fiscal year
in which the total number of claims pending under such
subtitle exceeds 200 percent of the average number of claims
pending in the preceding 5 years,
[``(iv) 225 percent of the base amount for any fiscal year
in which the total number of claims pending under such
subtitle exceeds 250 percent of the average number of claims
pending in the preceding 5 years, or
[``(v) 275 percent of the base amount for any fiscal year
in which the total number of claims pending under such
subtitle exceeds 300 percent of the average number of claims
pending in the preceding 5 years.''.
[(c) Conforming Amendment.--Section 9510(c)(1)(A) of the
Internal Revenue Code of 1986 is amended by striking
``October 18, 2000'' and inserting ``the date of enactment of
the Improved Vaccine Affordability and Availability Act''.
[SEC. 338. ONGOING REVIEW OF CHILDHOOD VACCINE DATA.
[Part C of title XXI of the Public Health Service Act (42
U.S.C. 300a-25 et seq.) is amended by adding at the end the
following:
[``SEC. 2129A. ONGOING REVIEW OF CHILDHOOD VACCINE DATA.
[``(a) In General.--Not later than 6 months after the date
of enactment of this section, the Secretary shall enter into
a contract with the Institute of Medicine of the National
Academy of Science under which the Institute shall conduct an
ongoing, comprehensive review of new scientific data on
childhood vaccines (according to priorities agreed upon from
time to time by the Secretary and the Institute of Medicine).
[``(b) Reports.--Not later than 3 years after the date on
which the contract is entered into under subsection (a), the
Institute of Medicine shall submit to the Secretary a report
on the findings of the studies conducted under such contract,
including findings as to any adverse events associated with
childhood vaccines, including conclusions concerning
causation of adverse events by such vaccines, and other
appropriate recommendations, based on such findings and
conclusions.
[``(c) Failure to Enter Into Contract.--If the Secretary
and the Institute of Medicine are unable to enter into the
contract described in subsection (a), the Secretary shall
enter into a contract with another qualified nongovernmental
scientific organization for the purposes described in
subsections (a) and (b).
[``(d) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated such sums as
may be necessary for each of fiscal years 2003, 2004, 2005
and 2006.''.
[SEC. 339. PENDING ACTIONS.
[The amendments made by this title shall apply to all
actions or proceedings pending on or after the date of
enactment of this Act, unless a court of competent
jurisdiction has entered judgment (regardless of whether the
time for appeal has expired) in such action or proceeding
disposing of the entire action or proceeding.
[SEC. 340. REPORT.
[Not later than 1 year after the date of enactment of this
Act, and annually thereafter, the Advisory Commission on
Childhood Vaccines shall report to the Secretary regarding
the status of the Vaccine Injury Compensation Trust Fund, and
shall make recommendations to the Secretary regarding the
allocation of funds from the Vaccine Injury Compensation
Trust Fund.]
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Project BioShield Act of
2003''.
SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT
AUTHORITIES.
(a) In General.--Part B of title IV of the Public Health
Service Act (42 U.S.C. 284 et seq.) is amended by adding at
the end the following:
``SEC. 409J. BIOMEDICAL COUNTERMEASURE RESEARCH AND
DEVELOPMENT.
``(a) In General.--
``(1) Authority.--In carrying out research responsibilities
under this Act, the Secretary may conduct and support
research and development with respect to biomedical
countermeasures.
``(2) Implementation.--
``(A) In general.--Except as provided in subparagraph (C),
authorities assigned by this section to the Secretary shall
be carried out through the Director of NIH.
[[Page S5756]]
``(B) Lead institute.--The National Institute of Allergy
and Infectious Diseases shall be the lead institute for
performing, administering, or supporting biomedical
countermeasure research and development. The Director of NIH
may delegate to the Director of the Institute authorities as
are necessary to carry out this function.
``(C) Chemical, radiological, and nuclear agents.--To the
extent that an authority described in subparagraph (A) is
exercised with respect to a chemical, radiological, or
nuclear agent, the Secretary may authorize the Director of
NIH to carry out the authority through any national research
institute.
``(D) Availability of facilities to the secretary.--In any
grant or cooperative agreement entered into under the
authority provided in this section with respect to a
biocontainment laboratory or other related or ancillary
specialized research facility that the Secretary determines
necessary for the purpose of preforming, administering, and
supporting biomedical countermeasures research and
development, the Secretary may provide that the facility that
is the object of such grant or cooperative agreement shall be
available as needed to the Secretary to respond to public
health emergencies affecting national security.
``(3) Interagency cooperation.--
``(A) In general.--In carrying out activities under this
section, the Secretary is authorized, subject to subparagraph
(B), to enter into interagency agreements and other
collaborative undertakings with other agencies of the Federal
Government and to use other agencies of the Department of
Health and Human Services.
``(B) Limitation.--An agreement or undertaking under this
paragraph may not authorize another agency to exercise the
authorities provided to the Secretary by this section.
``(b) Expedited Procurement Authority.--
``(1) Increased simplified acquisition threshold for
biomedical countermeasure procurements.--
``(A) In general.--For any procurement by the Secretary, of
property or services for use (as determined by the Secretary)
in performing, administering, or supporting biomedical
countermeasure research or development, the amount specified
in section 4(11) of the Office of Federal Procurement Policy
Act (41 U.S.C. 403(11)), as applicable pursuant to section
302A(a) of the Federal Property and Administrative Services
Act of 1949 (41 U.S.C. 252a(a)), shall be deemed to be
$25,000,000 in the administration, with respect to such
procurement, of--
``(i) section 303(g)(1)(A) of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C. 253(g)(1)(A))
and its implementing regulations; and
``(ii) section 302A(b) of such Act (41 U.S.C. 252a(b)) and
its implementing regulations.
``(B) Internal controls to be instituted.--The Secretary
shall institute appropriate internal controls for
procurements made under this paragraph, including
requirements with respect to documenting the justification
for use of the authority provided in this paragraph.
``(2) Use of noncompetitive procedures.--In addition to any
other authority to use procedures other than competitive
procedures for procurements, the Secretary may use such other
noncompetitive procedures when--
``(A) the procurement is as described by paragraph (1)(A);
and
``(B) the property or services needed by the Secretary are
available from only one responsible source or only from a
limited number of responsible sources, and no other type of
property or services will meet the needs of the Secretary.
``(3) Increased micropurchase threshold.--
``(A) In general.--For a procurement described by paragraph
(1)(A), the amount specified in subsections (c), (d), and (f)
of section 32 of the Office of Federal Procurement Policy Act
(41 U.S.C. 428) shall be deemed to be $15,000 in the
administration of that section with respect to such
procurement.
``(B) Internal controls to be instituted.--The Secretary
shall institute appropriate internal controls for
procurements that are made under this paragraph and that are
greater than $2,500.
``(C) Exception to preference for purchase card
mechanism.--No provision of law establishing a preference for
using a Federal Government purchase card method for purchases
shall apply to procurements made under this paragraph and
that are greater than $2,500.
``(c) Authority To Expedite Peer Review.--The Secretary
may, as the Secretary determines necessary to respond to
pressing research and development needs under this section,
employ such expedited peer review procedures (including
consultation with appropriate scientific experts) as the
Secretary, in consultation with the Director of NIH,
determines to be appropriate to obtain an assessment of
scientific and technical merit and likely contribution to the
field of biomedical countermeasure research, in place of the
peer review and advisory council review procedures that would
otherwise be required under sections 301(a)(3), 405(b)(1)(B),
405(b)(2), 406(a)(3)(A), 492, and 494, as applicable to a
grant, contract, or cooperative agreement--
``(1) that is for performing, administering, or supporting
biomedical countermeasure research and development; and
``(2) the amount of which is not greater than $1,500,000.
``(d) Agency Facilities.--In addition to any similar
authority provided under any other provision of law, in
carrying out this section, the Secretary may--
``(1) acquire, lease, construct, improve, renovate,
remodel, repair, operate, and maintain laboratories, other
research facilities and equipment, and other real or personal
property as the Secretary determines necessary for the
purpose of performing, administering, and supporting
biomedical countermeasure research and development; and
``(2) acquire, without regard to section 8141 of title 40,
United States Code, by lease or otherwise, through the
Administrator of General Services, buildings or parts of
buildings in the District of Columbia.
``(e) Authority for Personal Services Contracts.--
``(1) In general.--For the purpose of performing,
administering, and supporting biomedical countermeasure
research and development, the Secretary may, as the Secretary
determines necessary to respond to pressing research and
development needs under this section, obtain by contract (in
accordance with section 3109 of title 5, United States Code,
but without regard to the limitations in such section on the
period of service and on pay) the personal services of
experts or consultants who have scientific or other
professional qualifications.
``(2) Federal tort claims act coverage.--
``(A) In general.--A person carrying out a contract under
paragraph (1), and an officer, employee, or governing board
member of such person, shall be deemed to be an employee of
the Department of Health and Human Services for purposes of
claims under sections 1346(b) and 2672 of title 28, United
States Code, for money damages for personal injury, including
death, resulting from performance of functions under such
contract.
``(B) Exclusivity of remedy.--The remedy provided by
subparagraph (A) shall be exclusive of any other civil action
or proceeding by reason of the same subject matter against
the person, officer, employee, or governing board member for
any act or omission within the scope of the Federal Tort
Claims Act.
``(C) Recourse in case of gross misconduct or contract
violation.--
``(i) In general.--Should payment be made by the United
States to any claimant bringing a claim under this paragraph,
either by way of administrative determination, settlement, or
court judgment, the United States shall have, notwithstanding
any provision of State law, the right to recover for that
portion of the damages so awarded or paid, as well as
interest and any costs of litigation, resulting from the
failure of any person, officer, employee, or governing board
member to carry out any obligation or responsibility assumed
by such person, officer, employee, or governing board member
under a contract with the United States or from any grossly
negligent, reckless, or illegal conduct or willful misconduct
on the part of such person, officer, employee, or governing
board member.
``(ii) Venue.--The United States may maintain an action
under this subparagraph against such person, officer,
employee, or governing board member in the district court of
the United States in which such person, officer, employee, or
governing board member resides or has its principal place of
business.
``(3) Internal controls to be instituted.--
``(A) In general.--The Secretary shall institute
appropriate internal controls for contracts under this
subsection, including procedures for the Secretary to make a
determination of whether a person, or an officer, employee,
or governing board member of a person, is deemed to be an
employee of the Department of Health and Human Services
pursuant to paragraph (2).
``(B) Determination of employee status to be final.--A
determination by the Secretary under subparagraph (A) that a
person, or an officer, employee, or governing board member of
a person, is or is not deemed to be an employee of the
Department of Health and Human Services shall be final and
binding on the Secretary and the Attorney General and other
parties to any civil action or proceeding.
``(4) Number of personal services contracts limited.--The
number of experts and consultants whose personal services are
obtained under paragraph (1) shall not exceed 30 at any time.
``(f) Streamlined Personnel Authority.--
``(1) In general.--In addition to any other personnel
authorities, the Secretary may, as the Secretary determines
necessary to respond to pressing research and development
needs under this section, without regard to such provisions
of title 5, United States Code, governing appointments in the
competitive service, and 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,
appoint professional and technical employees, not to exceed
30 such employees at any time, to positions in the National
Institutes of Health to perform, administer, or support
biomedical countermeasure research and development in
carrying out this section.
``(2) Internal controls to be instituted.--The Secretary
shall institute appropriate internal controls for
appointments under this subsection.
``(g) Definition.--As used in this section, the term
`biomedical 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 is used--
``(1) to treat, identify, or prevent harm from any
biological, chemical, radiological, or nuclear agent that may
cause a public health emergency affecting national security;
or
``(2) to treat, identify, or prevent 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 paragraph (1).
``(h) Actions Committed to Agency Discretion.--Actions by
the Secretary under the authority of this section are
committed to agency discretion.''.
(b) Technical Amendment.--Section 481A of the Public Health
Service Act (42 U.S.C. 287a-2) is amended--
[[Page S5757]]
(1) in subsection (a)(1), by inserting ``or the Director of
the National Institute of Allergy and Infectious Diseases''
after ``Director of the Center'';
(2) in subsection (c)--
(A) in paragraph (1), by inserting ``or the Director of the
National Institute of Allergy and Infectious Diseases'' after
``Director of the Center''; and
(B) in paragraph (2), in the matter preceding subparagraph
(A), by striking ``subsection (i)'' and inserting
``subsection (i)(1)'';
(3) in subsection (d), by inserting ``or the Director of
the National Institute of Allergy and Infectious Diseases''
after ``Director of the Center'';
(4) in subsection (e)--
(A) in paragraph (1)--
(i) in the matter preceding subparagraph (A), by inserting
``or the Director of the National Institute of Allergy and
Infectious Diseases'' after ``Director of the Center'';
(ii) in subparagraph (A), by inserting ``(or, in the case
of the Institute, 75 percent)'' after ``50 percent''; and
(iii) in subparagraph (B), by inserting ``(or, in the case
of the Institute, 75 percent)'' after ``40 percent'';
(B) in paragraph (2), by inserting ``or the Director of the
National Institute of Allergy and Infectious Diseases'' after
``Director of the Center''; and
(C) in paragraph (4), by inserting ``of the Center or the
Director of the National Institute of Allergy and Infectious
Diseases'' after ``Director''; and
(5) in subsection (f)--
(A) in paragraph (1), by inserting ``in the case of an
award by the Director of the Center,'' before ``the
applicant''; and
(B) in paragraph (2), by inserting ``of the Center or the
Director of the National Institute of Allergy and Infectious
Diseases'' after ``Director''.
SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT.
Part B of title III of the Public Health Service Act (42
U.S.C. 243 et seq.) is amended by inserting after section
319A, the following:
``SEC. 319A-1. BIOMEDICAL COUNTERMEASURES PROCUREMENT.
``(a) Determination of Material Threats.--
``(1) Risk of use.--The Secretary of Homeland Security, in
consultation with the heads of other agencies as appropriate,
shall on an ongoing basis--
``(A) assess current and emerging threats of use of
chemical, biological, radiological, and nuclear agents; and
``(B) determine which of such agents present a material
risk of use against the United States population.
``(2) Public health impact.--The Secretary, in consultation
with the Secretary of Homeland Security, shall on an ongoing
basis--
``(A) assess the potential public health consequences of
use against the United States population of agents identified
under paragraph (1)(B); and
``(B) determine, on the basis of such assessment, the
agents for which countermeasures are necessary to protect the
public health.
``(b) Assessment of Availability and Appropriateness of
Countermeasures.--The Secretary, in consultation with the
Secretary of Homeland Security, shall assess on an ongoing
basis the availability and appropriateness of specific
countermeasures to address specific threats identified under
subsection (a).
``(c) Call for Necessary Countermeasures; Commitment for
Recommendation for Procurement.--
``(1) Proposal to the president.--Based on a determination
of necessary countermeasures under subsection (a), and the
assessment of availability and appropriateness of
countermeasures under subsection (b), the Secretary of
Homeland Security and the Secretary may jointly submit to the
President a proposal to--
``(A) call for a necessary countermeasure that is not
available; and
``(B) commit to make a recommendation for procurement under
subsection (e) of the first such specific countermeasure that
meets the conditions for procurement under subsection (d).
``(2) Countermeasure specifications.--The Secretary of
Homeland Security and the Secretary shall, to the extent
practicable, include in the recommendation under paragraph
(1)--
``(A) estimated quantity of purchase (in the form of number
of doses or number of effective courses of treatments
regardless of dosage form);
``(B) necessary measures of minimum safety and
effectiveness;
``(C) estimated price for each dose or effective course of
treatment regardless of dosage form; and
``(D) other information that may be necessary to encourage
and facilitate research, development, and manufacture of the
countermeasure or to provide specifications for the
countermeasure.
``(3) Presidential approval.--If the President has approved
a request under paragraph (1), the Secretary of Homeland
Security and the Secretary shall make known to persons who
may respond to a call for the countermeasure--
``(A) the call for the countermeasure;
``(B) specifications for the countermeasure under paragraph
(2); and
``(C) a commitment for a recommendation for procurement
under subsection (e) of the first such specific
countermeasure that meets the conditions for procurement
under subsection (d) and the specifications under paragraph
(2).
``(4) Subsequent specific countermeasures.--Procurement
under subsection (f) of the first such specific
countermeasure, or any other such countermeasure, that meets
the conditions for procurement under subsection (d) and the
specifications under paragraph (2) shall not preclude the
additional procurement under subsection (f) of a subsequent
such countermeasure that meets the conditions of procurement
under subsection (d) if such a countermeasure provides
improved safety or effectiveness or for other reasons
enhances preparedness to respond to threats of use of a
biological, chemical, radiological, or nuclear agent.
``(d) Secretary's Determination of Countermeasures
Appropriate for Procurement under this Section.--
``(1) In general.--The Secretary, in accordance with this
section, shall identify specific countermeasures to threats
identified under subsection (a) that the Secretary
determines, in consultation with the Secretary of Homeland
Security, to be appropriate for procurement with
appropriations under this subsection for inclusion in the
stockpile under section 121(a) of the Public Health and
Bioterrorism Preparedness and Response Act of 2002 (42 U.S.C.
300hh-12(a)).
``(2) Requirements.--In order for the Secretary to make the
determination under paragraph (1) with respect to a
countermeasure, the following requirements must be met:
``(A) Determination of qualified countermeasure.--The
Secretary must determine that the product is a qualified
countermeasure (as defined in subsection (h)).
``(B) Determination of quantities needed and feasibility of
production and distribution.--The Secretary must determine--
``(i) the quantities of the product that will be needed to
meet the needs of the stockpile; and
``(ii) that production and delivery within 5 years of
sufficient quantities of the product, as so determined, is
reasonably expected to be feasible.
``(C) Determination of no significant commercial market.--
The Secretary shall--
``(i) determine that, at the time of the initial
determination under this subsection, there is not a
significant commercial market for the product other than as a
biomedical countermeasure; and
``(ii) annually redetermine and report to the President,
while a determination under paragraph (1) remains in effect
with respect to the product, whether a significant commercial
market exists for the product other than as a biomedical
countermeasure.
``(e) Recommendation for President's Approval.--
``(1) Recommendation for procurement.--In the case of a
countermeasure that the Secretary of Homeland Security and
the Secretary have determined is appropriate for procurement
under this section for inclusion in the stockpile, in
accordance with the preceding provisions of this section, the
Secretary of Homeland Security and the Secretary shall
jointly submit to the President, in coordination with the
Director of the Office of Management and Budget, a
recommendation for procurement under this section.
``(2) Presidential approval.--A countermeasure may be
procured under this section only if the President has
approved a recommendation under paragraph (1) with respect to
such countermeasure.
``(3) Notice to congress.--The Secretary of Homeland
Security shall notify Congress of each decision of the
President to approve a recommendation under paragraph (1).
``(f) Procurement.--The Secretary and the Secretary of
Homeland Security shall be responsible for the following, for
purposes of procurement of qualified countermeasures for the
stockpile under section 121(a) of the Public Health and
Bioterrorism Preparedness and Response Act of 2002 (42 U.S.C.
300hh-12(a)), as approved by the President under subsection
(e):
``(1) In general.--The Secretary shall be responsible for--
``(A) arranging for procurement of the countermeasure,
including negotiating terms (including quantity, production
schedule, and price) of, and entering into, contracts and
cooperative agreements, and for carrying out such other
activities as may reasonably be required, in accordance with
the provisions of this paragraph; and
``(B) promulgating regulations to implement subparagraphs
(E), (F), and (G), and any other provisions of this section.
``(2) Contract terms.--A contract for procurement under
this section shall (or, as otherwise specified in this
paragraph, may) include the following terms:
``(A) Payment conditioned on substantial delivery.--The
contract shall provide that no payment may be made until
delivery has been made of a substantial portion (as
determined by the Secretary) of the total number of units
contracted for.
``(B) Discounted payment for unlicensed product.--The
contract may provide for a discounted price per unit of a
product that is not licensed or approved as described in
subsection (h)(1) at the time of delivery, and may provide
for payment of an additional amount per unit if the product
becomes so licensed or approved before the expiration date of
the contract (including an additional amount per unit of
product delivered before the effective date of such licensing
or approval).
``(C) Storage by vendor.--The contract may provide that the
vendor will provide storage for stocks of a product delivered
to the ownership of the Government under the contract, for
such period and under such terms and conditions as the
Secretary may specify, and in such case amounts appropriated
under subsection (i) shall be available for costs of
shipping, handling, storage, and related costs for such
product.
``(D) Contract duration.--The contract shall be for a
period not to exceed 5 years, renewable for additional
periods none of which shall exceed 5 years.
``(E) Termination for nondelivery.--In addition to any
other rights of the Secretary to terminate the contract, the
contract may provide
[[Page S5758]]
that such Secretary may terminate the contract for failure to
deliver a reasonable number (as determined by the Secretary)
of units of the product by 3 years after the date the
contract is entered into, and may further provide that in
such case the vendor shall not be entitled to any payment
under the contract.
``(F) Product approval.--The contract shall provide that
the vendor seek approval, clearance, or licensing of the
product from the Secretary for a timetable for the
development of data and other information to support such
approval, clearance, or licensing, and that the Secretary may
waive part of all of this contract term on request of the
vendor or on the initiative of the Secretary.
``(3) Availability of simplified acquisition procedures.--
The amount of any procurement under this section shall be
deemed to be below the threshold amount specified in section
4(11) of the Office of Federal Procurement Policy Act (41
U.S.C. 403(11)), for purposes of application to such
procurement, pursuant to section 302A(a) of the Federal
Property and Administrative Services Act of 1949 (41 U.S.C.
252a(a)), of--
``(A) section 303(g)(1)(A) of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C. 253(g)(1)(A))
and its implementing regulations; and
``(B) section 302A(b) of such Act (41 U.S.C. 252a(b)) and
its implementing regulations.
``(4) Use of noncompetitive procedures.--In addition to any
other authority to use procedures other than competitive
procedures, the Secretary may use such other procedures for a
procurement under this section if the product is available
from only one responsible source or only from a limited
number of responsible sources, and no other type of product
will satisfy such Secretary's needs.
``(5) Premium provision in multiple award contracts.--
``(A) In general.--If, under this section, the Secretary
enters into contracts with more than one person to procure a
countermeasure, such Secretary may, notwithstanding any other
provision of law, include in each of such contracts a
provision that--
``(i) identifies an increment of the total quantity of
countermeasure required, whether by percentage or by numbers
of units; and
``(ii) promises to pay one or more specified premiums based
on the priority of such persons' production and delivery of
the increment identified under clause (i), in accordance with
the terms and conditions of the contract.
``(B) Determination of government's requirement not
reviewable.--If the Secretary includes in each of a set of
contracts a provision as described in subparagraph (A), such
Secretary's determination of the total quantity of
countermeasure required, and any amendment of such
determination, is committed to agency discretion.
``(6) Extension of closing date for receipt of proposals
not reviewable.--A decision by the Secretary to extend the
closing date for receipt of proposals for a procurement under
this subsection is committed to agency discretion.
``(7) Limiting competition to sources responding to request
for information.--In conducting a procurement under this
section, the Secretary may exclude a source that has not
responded to a request for information under section
303A(a)(1)(B) of the Federal Property and Administrative
Services Act of 1949 (41 U.S.C. 253a(a)(1)(B)) if such
request has given notice that such Secretary may so exclude
such a source.
``(g) Interagency Cooperation.--
``(1) In general.--In carrying out activities under this
section, the Secretary of Homeland Security and the Secretary
are authorized, subject to paragraph (2), to enter into
interagency agreements and other collaborative undertakings
with other agencies of the United States Government.
``(2) Limitation.--An agreement or undertaking under this
subsection shall not authorize another agency to exercise the
authorities provided by this section to the Secretary of
Homeland Security or to the Secretary.
``(h) Definitions.--In this section:
``(1) Qualified countermeasure.--The term `qualified
countermeasure' means a biomedical countermeasure--
``(A) that is approved under section 505(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355) or licensed
under section 351 of this Act (42 U.S.C. 262) or that is
approved under section 515 or cleared under section 510(k) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e and
360) for use as such a countermeasure to a chemical,
biological, radiological, or nuclear agent identified as a
material threat under subsection (a); or
``(B) for which the Secretary determines that sufficient
and satisfactory clinical experience or research data
(including data, if available, from preclinical and clinical
trials) support a reasonable conclusion that the product will
qualify for approval or licensing as such a countermeasure
within 5 years after the date of a determination under
subsection (d).
``(2) Biomedical countermeasure.--The term `biomedical
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))), device (as that term is defined by
section 201(h) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(h))), or biological product (as that term is
defined by section 351(i) of this Act (42 U.S.C. 262(i)))
that is used--
``(A) to treat, identify, or prevent harm from any
biological, chemical, radiological, or nuclear agent that may
cause a public health emergency affecting national security;
or
``(B) to treat, identify, or prevent harm from a condition
that may result in adverse health consequences or death and
may be caused by administering a drug or biological product
that is used as described in subparagraph (A).
``(i) Appropriations.--
``(1) In general.-- There are appropriated, out of any
moneys in the Treasury not otherwise appropriated, for fiscal
year 2003 and for each fiscal year thereafter, such sums as
may be necessary for the costs incurred by the Secretary in
the procurement of countermeasures under this subsection as
approved by the President under subsection (e) (other than
costs specified in paragraph (2)).
``(2) Restrictions.--Amounts appropriated under this
subsection shall not be available to pay--
``(A) costs for the purchase of vaccines under procurement
contracts entered into before January 1, 2003;
``(B) costs under new contracts, or costs of new
obligations under contracts previously entered into, for
procurement of a countermeasure after the date of a
determination under subsection (d)(2)(C) that there is a
significant commercial market for the countermeasure other
than as a biomedical countermeasure; or
``(C) administrative costs.''.
SEC. 4. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN
EMERGENCIES.
(a) In General.--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. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN
EMERGENCIES.
``(a) In General.--Notwithstanding sections 505, 510(k),
and 515 of this Act and section 351 of the Public Health
Service Act, and subject to the provisions of this section,
the Secretary may authorize the introduction into interstate
commerce, during the effective period of a declaration under
subsection (b), of a drug, biological product, or device
intended solely for use in an actual or potential emergency.
``(b) Declaration of Emergency.--
``(1) In general.--The Secretary may declare an emergency
justifying the authorization of a drug, biological product,
or device under this subsection on the basis of a
determination--
``(A) by the Secretary of Homeland Security, that there is
a domestic emergency (or a significant potential of a
domestic emergency) involving a heightened risk of attack
with a specified biological, chemical, radiological, or
nuclear agent;
``(B) by the Secretary of Defense, that there is a military
emergency (or a significant potential of a military
emergency) involving a heightened risk to United States
military forces of attack with a biological, chemical,
radiological, or nuclear agent; or
``(C) by the Secretary of a public health emergency under
section 319 of the Public Health Service Act, affecting
national security and involving a specified biological,
chemical, radiological, or nuclear agent or a specified
disease or condition that may be attributable to such agent.
``(2) Termination of declaration.--
``(A) In general.--A declaration under this subsection
shall terminate upon the earlier of--
``(i) a determination by the Secretary, in consultation as
appropriate with the Secretary of Homeland Security or the
Secretary of Defense, that the circumstances described in
paragraph (1) have ceased to exist; or
``(ii) the expiration of the 1-year period beginning on the
date on which the declaration is made.
``(B) Renewal.--Notwithstanding subparagraph (A), the
Secretary may renew a declaration under this subsection, and
this paragraph shall apply to any such renewal.
``(3) Notification.--The Secretary shall promptly publish
in the Federal Register, and shall notify the appropriate
committees of Congress concerning, each declaration,
determination, and renewal under this subsection.
``(c) Criteria for Issuance of Authorization.--The
Secretary may issue an authorization under this section with
respect to a product if the Secretary concludes--
``(1) that an agent specified in a declaration under
subsection (b) can cause a serious or life-threatening
disease or condition;
``(2) that, based on the totality of scientific evidence
available to the Secretary, including data from adequate and
well-controlled clinical trials, if available, it is
reasonable to believe that--
``(A) the product may be effective in detecting,
diagnosing, treating, or preventing--
``(i) such disease or condition; or
``(ii) a serious or life-threatening disease or condition
caused by a product authorized under this section or approved
under this Act or the Public Health Service Act, for
detecting, diagnosing, treating, or preventing such a disease
or condition caused by such an agent; and
``(B) the known and potential benefits of the product, when
used to detect, diagnose, prevent, or treat such disease or
condition, outweigh the known and potential risks of the
product;
``(3) that there is no adequate, approved, and available
alternative to the product for detecting, diagnosing,
preventing, or treating such disease or condition; and
``(4) that such other criteria as the Secretary may by
regulation prescribe are satisfied.
``(d) Scope of Authorization.--An authorization of a
product under this section shall state--
``(1) each disease or condition and the intended use of the
product within the scope of the authorization; and
``(2) the Secretary's conclusions, under subsection (c),
concerning the safety and potential effectiveness of the
product in detecting, diagnosing, preventing, or treating
such diseases or conditions, including an assessment of the
available scientific evidence.
``(e) Conditions of Authorization.--The Secretary is
authorized to impose such conditions on an authorization
under this section as the Secretary determines are necessary
or appropriate to protect the public health, including the
following:
[[Page S5759]]
``(1) The Secretary shall impose requirements (including
requirements concerning product labeling and the provision of
information) designed to ensure that, to the maximum extent
feasible given the circumstances of the emergency, health
care professionals administering the product are informed--
``(A) that the Secretary has authorized the product solely
for emergency use;
``(B) of the significant known and potential benefits and
risks of use of the product, and of the extent to which such
benefits and risks are unknown; and
``(C) of the alternatives to the product that are
available, and of their benefits and risks.
``(2) The Secretary shall impose requirements (including
requirements concerning product labeling and the provision of
information) designed to ensure that, to the maximum extent
feasible given the circumstances of the emergency,
individuals to whom the product is administered are
informed--
``(A) that the Secretary has authorized the product solely
for emergency use;
``(B) of the significant known and potential benefits and
risks of use of the product, and of the extent to which such
benefits and risks are unknown; and
``(C) of any option to accept or refuse administration of
the product, and of the alternatives to the product that are
available and of their benefits and risks.
``(3) The Secretary may impose limitations on which
entities may distribute the product (including limitation to
distribution by government entities), and on how distribution
is to be performed.
``(4) The Secretary may impose limitations on who may
administer the product, and on the categories of individuals
to whom, and the circumstances under which, the product may
be administered.
``(5) The Secretary may condition the authorization on the
performance of studies, clinical trials, or other research
needed to support marketing approval of the product.
``(6) The Secretary shall impose, to the extent feasible
and appropriate given the circumstances of the emergency,
requirements concerning recordkeeping and reporting,
including records access by the Secretary and publication of
data.
``(7) The Secretary may waive, to the extent appropriate
given the circumstances of the emergency, requirements, with
respect to the product, of current good manufacturing
practice otherwise applicable to the manufacture, processing,
packing, or holding of products subject to regulation under
this Act.
``(8) The Secretary shall, to the extent feasible and
appropriate given the circumstances of the emergency, impose
requirements for the monitoring and reporting of adverse
events associated with use of the product.
``(f) Duration of Authorization.--
``(1) In general.--Except as provided in paragraph (2), an
authorization under this section shall be effective until the
earlier of the termination of the declaration under
subsection (b) or a revocation under subsection (g).
``(2) Continued use after end of effective period.--An
authorization shall continue to be effective for continued
use with respect to patients to whom it was administered
during the period described by paragraph (1), to the extent
found necessary by such patients' attending physicians.
``(g) Revocation of Authorization.--
``(1) Review.--The Secretary shall periodically review the
circumstances and the appropriateness of an authorization
under this section.
``(2) Revocation.--The Secretary may revoke an
authorization under this section if, in the Secretary's
unreviewable discretion--
``(A) the conditions for such an authorization are no
longer met; or
``(B) other circumstances make such revocation appropriate.
``(h) Publication.--The Secretary shall promptly publish in
the Federal Register, and provide to the appropriate
committees of Congress, a notice of each authorization, and
each termination or revocation of an authorization, under
this section.
``(i) Recordkeeping.--
``(1) In general.--The Secretary may require persons,
including a person who holds an authorization under this
section, or who manufactures, distributes, prescribes, or
administers a product that is the subject of such an
authorization, to establish and maintain--
``(A) data that is obtained from such activity and that
pertains to the effectiveness or safety of such product;
``(B) such records as are necessary to determine, or
facilitate a determination, whether there may be any
violation of this section or of a regulation promulgated
under this section; and
``(C) such additional records as the Secretary may
determine necessary.
``(2) Access to records by secretary.--
``(A) Safety and effectiveness information.--The Secretary
may require a person who holds an authorization under this
section, or who manufactures, distributes, prescribes, or
administers a product that is the subject of such an
authorization to provide to the Secretary all data that is
obtained from such activity and that pertains to the safety
or effectiveness of such product.
``(B) Other information.--Every person required under this
section to establish or maintain records, and every person in
charge or custody of such records, shall, upon request by the
Secretary, permit the Secretary at all reasonable times to
have access to, to copy, and to verify such records.
``(j) Civil Monetary Penalties.--
``(1) In general.--A person who violates a requirement of
this section or of a regulation or order promulgated pursuant
to this section shall be subject to a civil money penalty of
not more than $100,000 in the case of an individual, and not
more than $250,000 in the case of any other person, for each
violation, not to exceed $1,000,000 for all such violations
adjudicated in a single proceeding.
``(2) Assessment of civil penalties.--Paragraphs (3), (4),
and (5) of section 303(g) shall apply to a civil penalty
under this subsection, and references in such paragraphs to
`paragraph (1) or (2)' shall, for purposes of this
subsection, be deemed to refer to paragraph (1) of this
subsection.
``(k) Actions Committed to Agency Discretion.--Actions
under the authority of this section by the Secretary, by the
Secretary of Defense, or by the Secretary of Homeland
Security are committed to agency discretion.
``(l) Regulations.--The Secretary may promulgate
regulations to implement this section.
``(m) Construction.--Nothing in this section shall be
construed to impair or otherwise affect--
``(1) the authority of the President as Commander in Chief
of the Armed Forces of the United States under article II,
section 2 of the United States Constitution; or
``(2) the authority of the Secretary of Defense with
respect to the Department of Defense, including the armed
forces, under other provisions of Federal law.
``(n) Application to Members of Armed Forces.--
``(1) Waiver of requirement relating to option to refuse.--
In the case of the administration of a countermeasure to
members of the armed forces, a requirement, under subsection
(e)(2), designed to ensure that individuals are informed of
an option to accept or refuse administration of a product,
may be waived by the President if the President determines,
in writing, that complying with such requirement is not
feasible, is contrary to the best interests of the members
affected, or is not in the interests of national security.
``(2) Effect on statute pertaining to investigational new
drugs.--In the case of an authorization based on a
determination by the Secretary of Defense under subsection
(b)(1)(B), section 1107 of title 10, United States Code,
shall not apply to use of a product that is the subject of
such authorization, within the scope of such authorization
and while such authorization is effective.
``(o) Relation to Other Provisions.--If a product is the
subject of an authorization under this section, the use of
such product within the scope of the authorization--
``(1) shall not be subject to any requirements pursuant to
section 505(i) or 520(g); and
``(2) shall not be subject to any requirements otherwise
applicable to clinical investigations pursuant to other
provisions of this Act.''.
(b) Prohibited Acts.--Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331) is amended--
(1) in subsection (e)--
(A) by striking ``504, 703'' and inserting ``504, 564,
703''; and
(B) by striking ``or 519'' and inserting ``519, or 564'';
and
(2) by adding at the end the following:
``(hh)(1) Promotion or use of a product that is the subject
of an authorization under section 564 other than as stated in
the authorization, or other than during the period described
by section 564(g), unless such promotion or use is permitted
under another provision of this Act.
``(2) Failure to comply with an information requirement
under section 564(e).''.
SEC. 5. AMENDMENTS TO PROVISIONS OF THE HOMELAND SECURITY
ACT.
(a) Declaration Recommending Making Countermeasure
Available to Individuals.--Section 224(p)(2)(A)(i) of the
Public Health Service Act (42 U.S.C. 233(p)(2)(A)(i)) is
amended--
(1) by striking ``advisable the administration'' and
inserting the following: ``advisable--
``(I) the administration'';
(2) by striking the period and inserting ``; or''; and
(3) by adding at the end the following:
``(II) making a covered countermeasure available to a
category or categories of individuals who may wish to receive
it.''.
(b) Amendment to Accidental Vaccinia Inoculation
Provision.--Section 224(p)(2)(C)(ii)(II) of the Public Health
Service Act (42 U.S.C. 233(p)(2)(C)(ii)(II)) is amended by
striking ``resides or has resided with'' and inserting ``has
resided with, or has had close contact with,''.
(c) Deeming Acts and Omissions to be Within Scope of
Employment.--Section 224(p)(2) of the Public Health Service
Act (42 U.S.C. 233(p)(2)) is amended by adding at the end the
following:
``(D) Acts and omissions deemed to be within scope of
employment.--
``(i) In general.--In the case of a claim arising out of
alleged transmission of vaccinia from an individual described
in clause (ii), acts or omissions by such individual shall be
deemed to have been taken within the scope of such
individual's office or employment for purposes of--
``(I) subsection (a); and
``(II) section 1346(b) and chapter 171 of title 28, United
States Code.
``(ii) Individuals to whom deeming applies.--An individual
is described by this clause if--
``(I) vaccinia vaccine was administered to such individual
as provided by paragraph (2)(B); and
``(II) such individual was within a category of individuals
covered by a declaration under paragraph (2)(A)(i)(I).''.
(d) Requirement to Cooperate with United States.--Section
224(p)(5) of the Public Health Service Act (42 U.S.C.
233(p)(5)) is amended in paragraph heading by striking
``Defendant'' and inserting ``Covered person''.
(e) Amendment to Definition of Covered Countermeasure.--
Subclause (II) of section
[[Page S5760]]
224(p)(7)(A)(i) of the Public Health Service Act (42 U.S.C.
233(p)(7)(A)(i)(II)) is amended to read as follows:
``(II) used to control or treat the adverse effects of
vaccinia inoculation or of administration of another covered
countermeasure; and''.
(f) Amendment to Definition of Covered Person.--Section
224(p)(7)(B) of the Public Health Service Act (42 U.S.C.
233(p)(7)(B)) is amended--
(1) in the matter preceding clause (i), by striking
``includes any person'' and inserting ``means a person'';
(2) in clause (ii)--
(A) by striking ``auspices such'' and inserting the
following: ``auspices--
``(I) such''; and
(B) by adding at the end the following:
``(II) a determination was made as to whether, or under
what circumstances, an individual should receive a covered
countermeasure;
``(III) the immediate site of administration of a covered
countermeasure was monitored, managed, or cared for; or
``(IV) an evaluation was made of whether the administration
of a covered countermeasure was effective;'';
(3) in clause (iii) by striking ``or'';
(4) by striking clause (iv) and inserting the following:
``(iv) a State, a political subdivision of a State, or an
agency or official of a State or of such a political
subdivision, if such State, subdivision, agency, or official
has established requirements, provided policy guidance, or
supplied technical or scientific advice or assistance with
respect to administration of such countermeasures;
``(v) in the case of a claim arising out of alleged
transmission of vaccinia from an individual--
``(I) the individual who allegedly transmitted the
vaccinia, if vaccinia vaccine was administered to such
individual as provided by paragraph (2)(B) and such
individual was within a category of individuals covered by a
declaration under paragraph (2)(A)(i)(I); or
``(II) an entity that employs an individual described by
clause (I) or where such individual has privileges to provide
health care;
``(vi) an official, agent, or employee of a person
described in clause (i), (ii), (iii), or (iv);
``(vii) a contractor of, or a volunteer working for, a
person described in clause (i), (ii), or (iv), if the
contractor or volunteer performs a function for which a
person described in clause (i), (ii), or (iv) is a covered
person; or
``(viii) an individual who has privileges to provide health
care under the auspices of an entity described in clause (ii)
or (v)(II).''.
(g) Amendment to Definition of Qualified Person.--Section
224(p)(7)(C) of the Public Health Service Act (42 U.S.C.
233(p)(7)(C)) is amended--
(1) by striking ``who is authorized to'' and inserting the
following: ``who--
``(i) is authorized to'';
(2) by striking the period and inserting ``; or''; and
(3) by adding at the end the following:
``(ii) is otherwise authorized by the Secretary to
administer such countermeasure.''.
(h) Definition of ``Arising Out of Administration of a
Covered Countermeasure''.--Section 224(p)(7) of the Public
Health Service Act (42 U.S.C. 233(p)(7)) is amended by adding
at the end the following:
``(D) Arising out of administration of a covered
countermeasure.--
``(i) In general.--The term `arising out of administration
of a covered countermeasure', when used with respect to a
claim or liability, includes, except as provided in clause
(ii), a claim or liability arising out of--
``(I) determining whether, or under what conditions, an
individual should receive a covered countermeasure;
``(II) obtaining informed consent of an individual to the
administration of a covered countermeasure;
``(III) monitoring, management, or care of an immediate
site of administration of a covered countermeasure, or
evaluation of whether the administration of the
countermeasure has been effective; or
``(IV) transmission of vaccinia virus by an individual to
whom vaccinia vaccine was administered as provided by
paragraph (2)(B).
``(ii) Exception.--Such term shall not include a claim or
liability arising out of care for or treatment of
complications arising out of the administration of the
countermeasure.''.
(i) Technical Correction.--Section 224(p)(2)(A)(ii) of the
Public Health Service Act (42 U.S.C. 233(p)(2)(A)(ii)) is
amended by striking ``paragraph (8)(A)'' and inserting
``paragraph (7)(A)''.
(j) Effective Date.--This amendments made by this section
shall take effect as if enacted on November 25, 2002.
SEC. 6. GAO REPORT.
Not later than 4 years after the date of enactment of this
Act, the Comptroller General of the United States shall
submit to the appropriate committees of Congress a report
that--
(1) describes the activities conducted under the
authorities provided for in section 409J(b)(1) of the Public
Health Service Act (as added by section 2) and section 319A-
1(f)(3) and (4) of such Act (as added by section 3);
(2) identifies any procurements that would have been
prohibited except for the authorities provided in the
sections described in paragraph (1); and
(3) assesses the adequacy of the internal controls
established by the Secretary of Health and Human Services
regarding procurements made under the authorities provided
for in the sections described in paragraph (1).
The PRESIDING OFFICER. Under the previous order, there will now be 2
hours of debate equally divided on the measure.
The majority leader.
Mr. FRIST. Mr. President, agents of bioterror are potentially the
most powerful and devastating weapons of mass destruction that are
known to man. Bioterror agents are more powerful than traditional
weapons of mass destruction, are more powerful than chemical weapons,
are more powerful than nuclear weapons.
When I say that, people oftentimes say: How can you say that? And it
really comes down to one simple concern: that many of the bioterror
agents are and can be infectious. They are agents of virus, of
bacteria, of another living organism that cannot be seen, that cannot
be touched, that cannot be smelled or heard. Yet they are deadly. They
know no borders. There are no geographic borders. They attack
indiscriminately, and they can travel through a school, they can travel
through a community, they can travel through a State, they can travel
through a country, and they can travel, indeed, through a continent.
They are powerful, powerful agents.
The United States is less than adequately prepared today in terms of
defense against these agents of bioterror. Over the next 2 hours, we
will be talking about a bill--and ultimately will pass a bill--that is
long overdue, legislation that bolsters, that strengthens our Nation's
defenses against threats from bioterrorism.
I applaud the leadership of Senator Judd Gregg, the distinguished
chairman of the Health, Education, Labor, and Pensions Committee. He
has done a tremendous service to this Nation by bringing this
legislation through his committee and to the floor of the Senate today
for passage.
We absolutely must--we absolutely must--strengthen our defenses
against the threats of biological weapons which I just referred to. But
also covered in this bill are other weapons of mass destruction,
including nuclear, including chemical, and including radiological
weapons.
I also commend the distinguished Senator from Massachusetts, Mr.
Kennedy, for his efforts to achieve a bipartisan consensus on the
bioshield legislation we are now considering on the Senate floor.
This legislation has been a priority for President Bush. I
congratulate him. He first outlined his bold initiative in his State of
the Union Address in January 2003. Since then, we have worked closely
with the administration and with our colleagues here in Congress to
pass this critical legislation.
What the legislation allows us to do is be proactive in developing a
broad range of countermeasures to combat biological, chemical,
radiological, and nuclear threats.
It was just several months ago in my own office that there was a
bioterror attack and ricin was sent. It is a deadly agent. It is an
interesting agent to think about because it is deadly. It is ricin. It
was here in our Nation's capital city, in an adjacent building. There
is no antidote. We do not have a medicine that can counteract the
effects of ricin today.
It is now 3, almost 4 years ago that anthrax hit this same capital.
It was deadly. With ricin, thank goodness, nobody was hurt and injured.
With the anthrax, 3 years ago, the reality was being demonstrated that
bioterror is here, it is on our own soil. It hit this Nation. It hit
this Capitol. It hit the entire east coast. Indeed, it was deadly, that
little anthrax bacteria that you cannot see.
This legislation allows us to further our response to such agents,
both here on our soil, which exist and are being used today, as well as
internationally.
It was just 2 days ago that a canister of sarin gas--it shifted just
a little bit, with a mixing of two other chemicals, to become sarin
gas--began to leak through that canister, again reminding us of the
impact that chemical weapons can have today.
So whether it is domestically or internationally, this piece of
legislation will bolster and strengthen our defenses to fight, to use
countermeasures that will prevent, hopefully, the use of and have an
appropriate response to the use of these biological and chemical
weapons.
The bioshield legislation really does do just that. It improves our
ability to investigate, to develop, and to produce these new such
countermeasures. For the first time, we have well defined
[[Page S5761]]
this new paradigm of a public and private partnership working together
to develop these countermeasures in our Nation's interests.
While maintaining high standards of scientific excellence, the bill
streamlines the ability of agencies and entities, such as the National
Institutes of Health, to rapidly advance research into these much
needed countermeasures, countermeasures to the realities of biological
weapons today.
The bill provides the private sector with new incentives to invest in
research and development of biomedical countermeasures that otherwise
simply would not have the business potential. We need to give those
appropriate incentives to the private sector, to use its ingenuity, to
use its innovation, to use its capitalism, to use its knowledge to
respond to the realities, these real threats that are out there today.
The legislation is critical to our efforts to protect our citizens.
There is a whole series of biological threats that are categorized by
categories 1, 2, and 3. For the category 1 list, we have vaccines for
only two, one being anthrax and the other being smallpox. Both of those
vaccines need continued research and refinement in order to minimize
those side effects and to make sure we can improve the ease of delivery
so that in the event we need to respond, we can respond quickly,
efficiently, and safely, whether it be for our soldiers or for citizens
throughout America.
This bill also is a major component of our overall much larger
strategy to improve our overall biodefense.
There are other initiatives such as strengthening our public health
system. Our public health system has been neglected over the last 25 or
30 years. That public health system, that public health infrastructure,
is the frontline in response to these agents.
Another component I hope we will be able to address in the future,
which is important as we develop this broad strategy against
bioterrorism, is this whole element of vaccine liability. Clearly, our
vaccine liability system needs reform.
We have the latest public health challenges, things such as SARS,
sudden acute respiratory syndrome--a year and a half ago that virus
came, and nobody knew what it was, and the terror it created--West Nile
virus, and vancomycin-resistant staphylococcus aureus. All of those
have taught us the danger of sitting back and being too complacent and
not being proactive. In this bill we are being proactive.
I commend especially Chairman Gregg, the President of the United
States for his bold leadership, Senator Kennedy, and all of our
colleagues who have worked to craft this legislation to see that we
respond to a clearly identifiable need. Passage of this legislation,
indeed, is a major step forward in strengthening our national security.
The PRESIDING OFFICER (Ms. Murkowski). The Senator from New
Hampshire.
Mr. GREGG. Madam President, I thank the majority leader for his kind
statements. I certainly want to recognize the fact that without the
majority leader's very strong and thoughtful leadership in this area,
we would not have gotten this far. He is obviously an expert in the
area of health care and especially sensitive to the need to do
something in the area of fighting those agents which might be used
against us as biological agents. His leadership and knowledge have made
a significant difference in our ability to be successful with this
bill. I thank him for that leadership.
I join him in thanking the President. Obviously, this is an
initiative high on the President's agenda and the people at NIH, Dr.
Zerhouni and Dr. Fauci, who understand the threat and understand the
need to address the threat.
We have to put the threat in context, and, regrettably, the context
is serious. Were this 1950, 1960, were this any time prior to the
latter part of last century and the beginning of our century, and we
had terrorists out there who wanted to do us harm, who were as
fanatical as are the people who wish to do us harm, the Islamic
fundamentalist movement, we would fight them and we would be concerned
about them. But our concerns and our ability to handle their threat
would be proportional. We would have been able to manage it at that
time in an effective and rather contained way.
The problem today is that when you have a fanatical group, a group
willing to not only pursue its purposes without limitation and as part
of that to be willing to kill innocent individuals, and when you have a
group such as that that is also able to get or potentially take
possession of weapons of mass destruction, you have created a whole new
issue, a whole new threat, a threat of massive proportions. Because if
individuals are willing to use weapons of mass destruction--biological,
chemical, or nuclear--and they have no compunction about killing
innocents--and in fact the purpose of Islamic fundamentalism is
specifically to kill Western individuals, people who subscribe to the
American philosophy, to our Nation--and their purpose is to undermine
our country, to destroy our culture because they deem Western culture
to be a threat to them, when you have people like that and they have
the ability to possess weapons of mass destruction and the delivery
systems to get those weapons into places where they could do massive
harm, then you have a problem of immense proportion. The Nation must
protect itself from that type of threat. That is what this bioshield
initiative is an attempt to do.
We recognize, as the majority leader stated, that probably the single
most threatening weapon which these individuals can get their hands on
easily and disperse easily--it is not the single most threatening
weapon overall; I suspect a nuclear device, were they able to produce
one, would be more threatening--the type of weaponry which they most
likely can get their hands on which has the potential to do the most
harm to the most innocent individuals is a biological weapon or
potentially a chemical weapon, but more likely a biological weapon.
Because if they were able, for example, as was seen in a small
contained area in the Capitol, to spread anthrax or to spread smallpox
or to spread botulism, Ebola, or any other agents which would be a
disease which would be carried, as the majority leader mentioned,
without sight, without sound, without smell, without noise, across a
large dispersal area, they could literally harm tens of thousands,
potentially even more, Americans.
There is no question but if these fundamentalist terrorists, Islamic
fundamentalists, get their hands on that type of weapon, get their
hands on a biological weapon, come into possession of an anthrax
capability or a smallpox capability, they will use it. There is no
question about that. They will use it in a place where people gather
who are gathering simply to go through their daily lives, whether it is
in a subway system as occurred in Japan, or whether it is in a building
as occurred here in the Capitol, or whether it is in some other area
where people congregate.
So we as a nation--and the President has made this very clear--have a
responsibility to try to defend ourselves from that type of a threat.
It is not an inexpensive responsibility. It is going to cost us a lot
of money. Regrettably, it is a complex responsibility. There is no
magic wand you can wave that will inoculate the American public against
these threats. But we understand there is a procedure to go as far down
the road as we can possibly go to accomplish that sort of an
inoculation or have the capacity to defend our people from that type of
a threat.
One of the great advantages we have in fighting Islamic
fundamentalism is that we are a sophisticated society which has
technical capabilities which we can bring to bear in this war--and it
is a war--and bring it to bear in a manner which allows us to take the
position that gives us self-defense and also the capacity to carry the
battle to them rather than have them carry the battle to us.
This bioshield bill grew out of an initiative that the President
suggested, which was that in the case of a series of agents which are
biologically driven, which we know can do the most harm, the top seven
or eight agents which we know can do the most harm--six or seven
agents--we are going to initiate an effort to try to develop the
science necessary to develop ways to interdict, to stop, to cure, to
make the attacks that use those types of agents less harmful to our
people. But in order to accomplish that, we had to recognize as a
government--and the administration certainly did--that there is no
commercial applicability for this type
[[Page S5762]]
of research. There is no commercial demand for this type of a
commodity.
A vaccine for anthrax is not in great commercial demand. People are
not just going to go out and buy it or take it for the purposes of
going through their daily lives. It is not like some other cure to some
other sickness, and, therefore, we had to set up a structure where we
make it viable for our private sector pharmaceutical industry and
biotechnology industry to invest the extraordinary amount of money it
takes to invest in the production of this type of response capability.
That is essentially what bioshield does. It puts in place a regime
which accomplishes three things.
First, it creates a research and development initiative which is
public and private, using the great strength of NIH, which is refocused
under the leadership of Dr. Zerhouni and Dr. Fauci, which has refocused
a large amount of their energy, time, and expertise on this issue. It
combines that public effort, which is aggressive, with a private
initiative.
In order to get the private initiative going, it sets up a funding
stream which makes it clear to the private sector that should they
pursue development of vaccines or other ways to treat these agents
which we see as the most threatening, whether it be anthrax, plague,
smallpox, viral hemorrhagic fevers such as Ebola, or botulism, when
they set up processes to address those diseases, whether it is a
vaccine or whether it is something else, they will know there are going
to be dollars in the pipeline to support that research and, more
importantly, to purchase their product once they have produced it. And
it will be purchased by the Government, obviously, because there is no
market in the private sector for that.
So along with the research component of having NIH focused on this
and the private sector focused on this, this bill sets up a stockpiling
and procurement procedure to make it clear that, first, once we develop
these types of vaccines, we are going to have enough of them to be able
to deal with a major attack. Second, the producers of these vaccines or
other treatment processes developed--it might be a pharmaceutical--are
going to be able to have adequate return on their investment so they
can pay the cost of producing that and still make a reasonable return.
Third, the bill sets up a process where, should the event occur, should
we be attacked with some sort of an agent that we do not yet have the
actual approved response to--don't have an approved vaccine--and it has
not received all of the FDA clearing that vaccines must go through,
which is a long, complicated process in order to approve a vaccine for
human use, or approve a pharmaceutical, but should there be somewhere
in the pipeline a vaccine which appears to have some success in
remediating damage caused by one of these biological attacks, or a
pharmaceutical which remediates that, and it is in the pipeline, we set
up a procedure that allows, under certain very limited situations where
there is a clear and obvious emergency, the administration to use that
treatment that is in development for human consumption in order to
confront an emergency situation where specifically we have been
attacked.
So that is the basic theme of the way this bill works. It creates the
research component, the stockpiling and purchasing component, and
creates an emergency outlet valve, if you will, for addressing a
situation where we are attacked and we don't have a finalized product
to address it.
As the majority leader mentioned, of the six major areas of threat
that we see in the biological area, today we only have vaccines to
address two of them. One of the vaccine regimes is sort of difficult to
deliver. That, of course, is in the anthrax area. We have, obviously, a
very strong vaccine capability, and we are getting the production of
new vaccines in the area of smallpox. Hopefully, people will get back
to being vaccinated for smallpox because this is a legitimate threat.
But in the area of plague, viral hemorrhagic fever, and botulism, there
are no vaccines yet. That is why it is very important that we focus the
resources, energy, and the genius of the American health community on
making sure that we try to develop these types of responses.
We are, regrettably, living in a world that has people who would do
harm, who would pursue a course of inflicting massive harm for the
purpose of making their political and quasi-religious point. It is an
unfortunate fact. We need look no further than 9/11 to recognize that
the killing of innocent people by the thousands is something that
fundamentalist Islamic people, who ascribe to that belief, who are
terrorists, basically are willing to pursue. We know that, regrettably,
these biologic agents exist. Anthrax can be produced probably fairly
easily if they have a chemistry background. We know it can be delivered
and, regrettably, it was in the Capitol Building.
We know that other types of agents can also be produced. Regrettably,
there may even be a vial of smallpox somewhere out there that could be
used. So it is critical, as the President has so appropriately stated,
that we put into place the process for trying to, in this area, reduce
the threat, and hopefully someday be able to totally mute the threat.
Obviously, if we are capable as a culture of developing a vaccine or
some other treatment that will neutralize the effect of these types of
biological agents, then they will not be used against us because the
harm they would cause would not be worth the risk of developing and
spreading of the agent. So it is definitely in our interest to pursue
this course.
It is regrettable that it has taken us this long to get to this point
from a legislative standpoint. But I congratulate the administration
because they have not waited on us, the Congress. They have gone down
the road as far as they think they can go toward letting contracts and
putting into place the processes necessary to begin the development of
these various vaccines and regimes necessary to address these risks.
They have sort of come to a dead end, where they need this
authorization in order to take the next steps necessary in the process
of developing and expediting the process of getting these cures in
place and the regimes in place.
So this bill remains critical to our efforts in the fight on the war
against terrorism. Therefore, it is good that we have finally been able
to reach a consensus in the Senate, where we will be able to pass this
bill later today. It is my understanding that the House of
Representatives is likely to accept this bill as it passes the Senate.
Hopefully, that will be the case, and we can move it down to the
President, who I know has been waiting anxiously. He has talked to us
many times about the need for this piece of legislation. This will be a
good way, obviously, to complete this week.
Amendment No. 3178
Mr. GREGG. Madam President, I send to the desk a substitute
amendment.
The PRESIDING OFFICER. The clerk will report the amendment.
The legislative clerk read as follows:
The Senator from New Hampshire [Mr. Gregg], for himself and
Mr. Kennedy, proposes an amendment numbered 3178.
Mr. GREGG. Madam President, I ask unanimous consent that further
reading of the amendment be dispensed with.
The PRESIDING OFFICER. Without objection, it is so ordered.
(The amendment is printed in today's Record under ``Text of
Amendments.'')
Mr. GREGG. Madam President, I thank the staff of the HELP Committee,
Vincent Ventimiglia and Sharon Soderstrom, Steve Irizarry, and the
other members of the staff who have done a great job in pulling this
legislation together and following it through the process.
It has been a complicated, tortured, difficult exercise. It would not
have gotten to this point without strong and effective staff work. The
country owes them a debt of gratitude.
In the end, this bill is going to be one of the major components of
our ability to protect ourselves as we move through this world that has
such fundamentally evil individuals in it who might actually use this
type of weapon against us or anyone else.
There will also be some side benefits to this initiative. I honestly
believe as we evolve various vaccines and initiate this research effort
in trying to address issues such as anthrax and botulism and plague, we
will actually have some spinoffs that will be positive in other health
areas, and specifically in ways to deliver these types of vaccines in a
[[Page S5763]]
less intrusive way. For example, anthrax has already gone from a six-
shot series down to a three-shot series. I understand there is
significant progress being made toward having a single vaccination
event, potentially, in the anthrax area. There is great progress being
made that I think may pay dividends to the American people beyond just
the fight on terrorism but in addressing other types of agents which
need and require vaccines or pharmaceuticals.
So this is a bill that not only is going to be a plus from the
standpoint of fighting the war on terrorism but will be a plus from the
standpoint of improving the health care delivery system in the United
States, and specifically giving Americans better and more effective
pharmaceuticals and vaccines.
I reserve the remainder of our time.
Madam President, I ask unanimous consent that at the conclusion or
yielding back of time on S. 15, the bill be temporarily set aside, and
the Senate then vote on passage at 2 p.m. today.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. GREGG. Madam President, I ask that if we proceed to a quorum
call, the time be charged equally to both sides.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. GREGG. I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. BROWNBACK. Madam President, I ask unanimous consent that the
order for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. BROWNBACK. Madam President, I ask unanimous consent to speak on
the side of the proponent, Senator Gregg, for up to 7 minutes.
The PRESIDING OFFICER (Mr. Hagel). Without objection, it is so
ordered.
Mr. BROWNBACK. Mr. President, I am here to address the Bioshield Act
and particularly section 3 of that bill that directs the Secretary of
Homeland Security on an ongoing basis to assess threats of use of
chemical, biological, radiological, and nuclear agents and determine
which threats pose a material risk of use against the U.S. population.
I draw my colleagues' particular attention to what has recently been
reported in the newspaper about one of the most recent uses of sarin
gas that has occurred and its possibility of being used in the United
States.
I commend my colleagues for bringing this bill to the Senate, for a
chance to talk about it. It is a very important issue. I see in this
particular section our need to assess this. The discovery and
confirmation of sarin gas in artillery shells in Iraq highlights
evidence that Saddam Hussein had a weapons of mass destruction program
that was not only fully operational but ready for use against U.S.
troops.
I raise this for two reasons. One, the argument that we have not been
able to find WMD in Iraq is ongoing. I hope we will not dismiss the
lack of any findings in the past and what we are finding now, the
actual use of sarin gas against our troops. That should continue to be
a focus that we hunt for, and we should be vigilant in looking for
weapons of mass destruction, particularly chemicals such as sarin gas.
But more importantly, Iraq had told the U.N. weapons inspection team
they had produced tons of sarin gas and other chemical weapons. We
should be concerned about where those are today and whether some of
them may have found their way into Syria or other countries.
I ask unanimous consent to have printed in the Record a news story
that appeared today from Fox News.
There being no objection, the material was ordered to be printed in
the Record, as follows:
[From Fox News, May 19, 2004]
Tests Confirm Sarin in Iraqi Artillery Shell
(By Liza Porteus)
New York.--Tests on an artillery shell that blew up in Iraq
on Saturday confirm that it did contain an estimated three or
four liters of the deadly nerve agent sarin (search), Defense
Department officials told Fox News Tuesday.
The artillery shell was being used as an improvised
roadside bomb, the U.S. military said Monday. The 155-mm
shell exploded before it could be rendered inoperable, and
two U.S. soldiers were treated for minor exposure to the
nerve agent.
Three liters is about three-quarters of a gallon; four
liters is a little more than a gallon.
``A little drop on your skin will kill you'' in the binary
form, said Ret. Air Force Col. Randall Larsen, founder of
Homeland Security Associates. ``So for those in immediate
proximity, three liters is a lot,'' but he added that from a
military standpoint, a barrage of shells with that much sarin
in them would more likely be used as a weapon than one single
shell.
The soldiers displayed ``classic'' symptoms of sarin
exposure, most notably dilated pupils and nausea, officials
said. The symptoms ran their course fairly quickly, however,
and as of Tuesday the two had returned to duty.
The munition found was a binary chemical shell, meaning it
featured two chambers, each containing separate chemical
compounds. Upon impact with the ground after the shell is
fired, the barrier between the chambers is broken, the
chemicals mix and sarin is created and dispersed.
Intelligence officials stressed that the compounds did not
mix effectively on Saturday. Due to the detonation, burn-off
and resulting spillage, it was not clear exactly how much
harmful material was inside the shell.
A 155-mm shell can hold two to five liters of sarin; three
to four liters is likely the right number, intelligence
officials said.
Another shell filled with mustard gas (search), possibly
also part of an improvised explosive device (IED) was
discovered on May 2, Defense Dept. officials said.
The second shell was found by passing soldiers in a median
on a thoroughfare west of Baghdad. It probably was simply
left there by someone, officials said, and it was unclear
whether it was meant to be used as a bomb.
Testing done by the Iraqi Survey Group (search)--a U.S.-
organized group of weapons inspectors who have been searching
for weapons of mass destruction (search) since the ouster of
Saddam Hussein--concluded that the mustard gas was ``stored
improperly'' and was thus ``ineffective.''
``It's not out of the ordinary or unusual that you would
find something [like these weapons] in a haphazard fashion''
in Iraq, Edward Turzanski, a political and national security
analyst, told Fox News on Tuesday.
But ``you have to be very careful not to be entirely
dismissive of it,'' he added. ``It remains to be seen whether
they have more shells like this.''
Iraq: A ``Bazaar of Weapons''
New weapons caches are being found every day, experts said,
including ``hundreds of thousands'' of rocket-propelled
grenades and portable anti-aircraft weapons.
``Clearly, if we're gonna find one or two of these every so
often--used as an IED or some other way--the threat is not
all that high, but it does confirm suspicion that he [Saddam]
did have this stuff,'' said Ret. U.S. Army Col. Robert
Maginnis.
``It is a bazaar of weapons that are available on every
marketplace throughout that country,'' Maginnis added.
``We're doing everything we can to aggressively disarm these
people, but there were so many things that were stored away
by Saddam Hussein in that country . . . it's a huge job that
we're tackling.''
Some experts were concerned that enemy fighters with access
to potential weapons of mass destruction in a country full of
stockpiles could mean more risk to coalition forces and
Iraqis.
``What we don't know is if there are other shells, which
there certainly could be,'' said Dennis Ross, a former
ambassador and special Middle East coordinator and a Fox News
foreign affairs analyst. ``We also don't know whether or not
these kind of shells could be used as explosives, which could
have a more devastating effect on our troops.''
Other experts said the individual shells themselves don't
pose a threat to the masses.
``I'm not as concerned they're going to use a lot of
chemical munitions,'' Maginnis said. ``They're not gonna use
these as improvised explosive devices because they don't have
a big blast associated with them, but they do combine those
two compounds into the noxious sarin gas. But they can't do
it all that well with a small explosive charge.''
``The reality is, they'd have to have a whole bunch of
these things,'' he added, ``have to find some way of blowing
them with a large charge to even create a cloud.''
That doesn't mean insurgents couldn't find a better way to
make the devices to create a more ``terrorist-type of
attack'' against U.S. forces, Maginnis continued.
The task of military analysts in Baghdad will be determine
how old the sarin shells is. A final determination will have
a significant effect on how weapons researchers and
inspectors proceed.
Some experts suggested that the two shells, which were
unmarked, date back to the first Persian Gulf War. The
mustard gas shell may have been one of 550 projectiles that
Saddam failed to account for in his weapons declaration
shortly before Operation Iraqi Freedom began. Iraq also
failed to account for 450 aerial bombs containing mustard
gas.
It's not clear if enemy fighters simply found an old
stockpile of weapons, or if they even knew what was inside.
Defense Secretary Donald Rumsfeld reacted cautiously to the
news of the discoveries.
[[Page S5764]]
``What we have to then do is to try to track down and
figure out how it might be there, what caused that to be
there in this improvised explosive device, and what might it
mean in terms of the risks to our forces,'' Rumsfeld said
Monday.
Kurds: We Have Evidence of WMD
An Iraqi Kurdish official had no doubt similar substances
will be found as the weapons hunt continues.
``We don't know where they are, but we suspect they are
hidden in many locations in Iraq,'' Howar Ziad, the Kurdish
representatives to the United Nations, told Fox News on
Tuesday. ``It's quite possible that even the neighboring
states who are against the reform of Iraq . . . are helping
the Saddamites in hiding.''
``As we know, the Baathist regime had a track record of
using'' these chemicals against people in Iraq, such as the
Kurds, Ziad continued. ``He's [Saddam] never kept any
commitment he's ever made to the international committee nor
to the people'' to not use such deadly materials.
Saddam's regime used sarin in mass amounts during an air
attack on the Kurdish town of Halabja (search) in 1988,
toward the end of the Iran-Iraq War. More than 5,000 people
are believed to have died in Halabja and surrounding
villages, where more than 65,000 were injured.
Both Iraq and Iran used chemical weapons during the 1980-88
war.
Ziad said the United Nations, the World Health Organization
and others had not ``bothered'' to travel to the Iraqi
Kurdistan to see the firsthand effects sarin and other
chemical weapons had on people and to get proof that Saddam
did in fact possess such weapons.
``We have evidence--we have victims of the use of those
agents, and we're still waiting for WHO and the U.N. to come
investigate,'' Ziad said.
Mr. BROWNBACK. I will read portions of this news story, dated today,
Fox News:
Tests on an artillery shell that blew up in Iraq on
Saturday confirmed that it did contain an estimated three or
four liters of the deadly nerve agent sarin.
This has been confirmed by Defense Department officials. This is
obviously a danger to our troops. It is obviously of great concern to
us if this were to find its way into the United States.
I will read from retired United States Army COL Robert Maginnis:
Clearly, if we're gonna find one or two of these every so
often--used as an IED or some other way--the threat is not
all that high, but it does confirm suspicion that he [Saddam]
did have this stuff.
He goes on to say this:
It is a bazaar of weapons that are available on every
market place through that country. We're doing everything we
can to aggressively disarm these people but there are so many
things that were stored away by Saddam Hussein in that
country . . . it's a huge job that we're tackling.
This next quote is from Dennis Ross, the former Ambassador, special
envoy to the Middle East, a well-known figure on Middle East peace
negotiations that took place:
What we don't know is if there are other shells which there
certainly could be.
He goes on to say:
We also don't know whether or not these kinds of shells
could be used as explosives, which could have a more
devastating effect on our troops.
A final quote for the Record from this story:
Saddam's regime used sarin gas in mass amounts during an
air attack on the Kurdish town of Halabja in 1988, toward the
end of the Iran-Iraq War. More than 5,000 people are believed
to have died in Halabja and surrounding villages, with more
than 65,000 injured.
This is deadly stuff. It exists. We are now finding it. We need to be
aware of that as we move forward with this bioshield bill.
Earlier this week the Wall Street Journal reported that U.S.
inspectors found within the last few months ``warehouses full of
commercial and agricultural chemicals'' which, if mixed and packaged
properly, ``could quickly become chemical weapons.'' U.S. forces in
Karbala have uncovered 55-gallon drums loaded with chemicals that were
said to be ``pesticides,'' some of which were stored in what military
sources described as a camouflaged bunker complex. Why would anyone
camouflage insecticide?
According to another article, the alleged agricultural site just
happened to be located alongside a military ammunition dump. Why are we
storing insecticide by a military ammunition dump?
According to the Journal, the Iraq Survey Group, headed by Charles
Duelfer, recently told Congress that some of Saddam's WMD facilities
were newly built and contained stockpiled raw materials that would have
allowed them to ``produce such weapons on a moment's notice.''
If I recall, in early April, Jordanian authorities foiled an al-Qaida
plot to kill 80,000 people in a chemical weapons attack in Amman.
According to one of the conspirators whose confession was broadcast
on Jordanian TV, al-Qaida WMD specialist Abu Musab al-Zarqawi, who was
last seen in that chilling video beheading Nick Berg, trained and
outfitted the WMD attackers in prewar Iraq. Like notorious terrorists
Abu Nidal and Abu Abi Abbas, Zarqawi enjoyed sanctuary in Baghdad,
courtesy of Saddam Hussein. Jordanian coverage of the plot included
footage of 100-gallon jugs containing chemical weapons that had been
intercepted 75 miles from the Syrian border where much of Saddam
Hussein's prewar WMD stockpiles are believed to be hidden.
The Zarqawi revelation comes on the heels of the April 26 explosion
at a suspected chemical weapons factory in Baghdad just as a U.S.
weapons team arrived to inspect its contents. This was disguised as ``a
perfume factory,'' and the facility was boobytrapped to destroy
evidence, investigators believe, of whatever was inside.
We should not be surprised if, within the coming weeks, more sarin-
laden shells are uncovered in Iraq. In the meantime, we should focus on
this and get coverage on what is taking place and what has been found
of this deadly sarin gas.
I note that Secretary Ridge, Homeland Security Department, has been
warning of an increased risk of attack in coming months. In light of
what we found in Iraq, it would not be farfetched to say if al-Qaida
wants to strike on U.S. soil, it would likely be with a chemical or
biological weapon, something other than a conventional explosive.
In a recent interview with the Associated Press, retired LTG Patrick
Hughes said that America has gotten better at predicting and
safeguarding itself against attacks since September 11, but still
Lieutenant General Hughes indicated that significant threats remain,
especially now as high ``background noise'' from terrorists and
heightened sensitivity during the election year has officials on guard
for a possible attack whose nature they cannot quite pin down.
Based on captured material, interviews, and other sources of
information, Lieutenant General Hughes believes that al-Qaida will
likely strike with something other than a conventional explosive
device. He is particularly worried about chemical and biological
attacks, including a dirty bomb, and particularly points to the
possibility of another anthrax biological attack following the one that
wreaked havoc on the postal system, closed a Senate office building for
3 months, and killed five people in 2001.
We first heard about sarin gas in an attack at a Japanese subway
where twelve people died. It is a potent weapon in which a little drop
on your skin will kill you. Sarin gas was confirmed in the 155-mm shell
and contained an estimated 3 or 4 liters. Fortunately, the two soldiers
who may have been exposed are now safe and are returned to duty. They
did show signs of being hit by chemical weapons, but it was a mild case
and they are back on duty. This could have ended in tragedy had our
soldiers not been more vigilant.
I hope we will continue to be focused on finding these weapons of
mass destruction, particularly before they find their way to our shores
so we can make sure our troops are safe and that such weapons do not
find their way here to the United States. I believe my colleagues' bill
will go a long way toward securing that goal. I urge its immediate
passage.
I yield the floor and suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. KENNEDY. Mr. President, I ask unanimous consent that the order
for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. KENNEDY. Mr. President, I strongly support the Project Bioshield
Act. It is an essential part of our Nation's ability to respond
effectively to the threat of terrorist attacks that use biological or
chemical weapons.
[[Page S5765]]
I commend Senators Gregg, Frist, Reed, and other members of our HELP
Committee for their efficient and effective bipartisan work on this
bill, and I thank Senator Levin for his expertise and thoughtful
considerations.
I also commend our colleagues on the Appropriations Committee, and
especially the chairman, Senator Stevens, and the ranking member,
Senator Byrd, for already providing the funding that Project Bioshield
needs to be effective. Their leadership is essential in protecting the
Nation.
We have worked closely, too, with Secretary Tommy Thompson and CMS
Administrator Mark McClellan on this important legislation. They
deserve great credit for their leadership as well.
The Project Bioshield Act is an important addition to the Public
Health Security and Bioterrorism Preparedness and Response Act that we
passed 2 years ago. Since that major legislation was enacted, we have
seen new examples of the vicious impact of terrorism around the world.
The brutal pictures from the appalling bomb attack in Madrid and the
horrifying images of other terror attacks around the world are savage
reminders that we must never let down our guard.
The will to protect the Nation from terrorism is not enough. We must
also provide the resources and the means. Bioshield is a major step
toward giving the Nation's health care professionals the support they
need to respond to attacks of biological, chemical, and nuclear
weapons.
A terrorist armed with a vial of a deadly pathogen could inflict pain
and death on a vast scale. For too many of the weapons we face, our
defenses are inadequate. The Nation needs better vaccines and drugs to
fight ancient enemies such as smallpox or new plagues launched by
genetically modified disease bacteria.
The members of our HELP Committee have worked together to help
America's skilled physicians and scientists develop the vaccines, the
diagnostic tests, and treatments needed to meet these disease
challenges. Clearly, new legislation is needed to improve America's
defensive arsenal against these threats.
The current bill will help guide the talents of America's medical
researchers and biotechnology industry in building the stronger medical
defenses we need to keep families safe from bioterrorism.
I am proud that Boston is, once again, leading the way in developing
pioneering new biodefense countermeasures. We have taken steps to
expedite the discovery of new vaccines and cures needed to protect the
Nation.
This chart is a statement about this overall legislation:
Bioshield will accelerate the development of new vaccines,
treatments and diagnostics to keep America safe from
biological, chemical and radiological weapons.
The fact remains that there is little commercial interest in the
development of countermeasures, because they will only be used in the
event of some kind of assault or attack on the United States.
Nonetheless, we need to develop these vaccines and the various
treatments for treating these kinds of dangers because we may very well
face them. If we are going to be serious about dealing with biodefense
and bioterrorism, this is a very important part of the whole process.
Harvard Medical School has worked with other academic centers to
create a New England Regional Center for Excellence for Biodefense. The
new center will be the incubator for innovative ideas for treatments of
the future. The Boston University Medical Center is building a major
new laboratory to enable these pioneering new treatments be tested in a
safe and secure research facility.
At the new laboratory, researchers from across America will be able
to help turn promising new ideas into treatments to help patients. NIH
has recognized the excellence of the center and the laboratory by
making substantial investments in their development. The Project
Bioshield will help complete this pipeline of discovery by harnessing
the creativity and the skill of the flourishing biotechnology industry.
The legislation will ensure companies know that investing in new
responses for bioterrorist attacks is a risk worth taking. The bill
before the Senate guarantees that any company which develops a
successful new product for these threats will find a willing buyer in
the Federal Government. With that guarantee, companies will make the
investments needed to prepare for any attack. Without that guarantee,
they will not. It is as simple as that.
The act will accomplish several other important goals. It will
streamline and accelerate the research at NIH on bioterrorism and other
weapons of mass destruction. The most effective weapons in the war
against biological and chemical attacks are often the skills of our
health professionals and the ingenuity of our scientists. The new
flexibility for NIH under this legislation will help use these
extraordinary talents in the search for new responses.
The act will also encourage the biotechnology, pharmaceutical, and
medical device industries to use their creativity to develop
countermeasures against the dangerous pathogens and chemical or
radioactive agents. In addition, it authorizes the Food and Drug
Administration to allow the emergency use of unapproved medicines when
needed to deal with such attacks.
The authorization for the emergency use of unapproved products also
includes strong provisions on informed consent for patients and limits
the scope of products that can qualify for emergency authorization. The
FDA must carefully monitor adverse reactions to unapproved products and
must require the recordkeeping and studies necessary to assure the
safest possible use of these products.
The enactment of the Project BioShield Act is a significant
accomplishment, but there is much more work to be done.
This is a brief outline of what this legislation is all about. It
establishes the $5.6 billion fund as a guaranteed market for the new
biodefense products, and it ensures that the Departments of Homeland
Security and HHS set priorities in developing medicines for the threats
that America faces. So you combine intelligence about the nature of the
threat with expertise from HHS to set the priorities in developing
medicines.
It gives NIH, the gold standard in terms of research throughout the
world, much needed flexibility to ensure promising research areas can
advance quickly. Finally, it allows the FDA to authorize the emergency
use of medicines under the tightly controlled conditions outlined in
this legislation.
The most sophisticated disease monitoring system will be of little
use if public health agencies are so starved of funds that they cannot
keep our communities safe.
I want to take a few moments of the Senate's time to look at the
progress for bioterror preparedness.
This is taken from a GAO study from February 10 of this year. It
says:
No State reported meeting what they call the third
benchmark, a plan for the hospitals in the State to respond
to an epidemic involving at least 500 patients.
This is extraordinary. On the one hand, dealing with bioterrorism we
have to be able to detect and contain it, and then we have to be able
to treat people. That is where BioShield can be enormously effective.
But if we are going to be able to contain and treat a bioterror attack,
we must be able to deal with it in our medical centers. What we are
finding out now, as we review our preparedness, is that we are not
making the progress that is absolutely essential to protect
communities.
Report after report shows that we are falling short in preparing our
defenses against the threat of bioterrorism. The GAO conducted a
detailed analysis of the readiness of hospitals for such attacks. How
many communities do you think have plans--just plans to be able to
treat a surge of 500 additional patients in a terrorism emergency?
Would you say 75 percent? 50 percent? Only 25 percent? No, you would be
wrong. The correct answer is none. Zero! Not a single community in the
GAO survey had a plan to treat an additional 500 patients. That is
basic--and none of the communities in the GAO survey could do it. That
is a situation that has to be remedied.
An expert panel assembled by the Trust for America's Health conducted
an analysis of the readiness for bioterrorism of public health agencies
in all 50 States. They examined 10 key indicators of readiness, such as
adequate laboratory capacity to respond to bioterrorism emergencies.
How many
[[Page S5766]]
States do you think were fully prepared? The answer, again, shockingly,
is none.
This chart shows the different grades of States in bioterror
preparedness. The highest we find is 7 out of 10. That would be the
green. That includes California, Florida, Tennessee, and Maryland. But
if you look at most of this chart you will see it is red or pink, which
means they have only 2 or 3 of the 10 required actions necessary to be
successful in dealing with bioterrorism. You need to have laboratories,
hospital capacity and, as mentioned before in Bioshield, the basic
medicines to treat the victims.
The Institute of Medicine in 2003 found that America's health
agencies have ``vulnerable and outdated health information systems and
technologies, an insufficient and inadequately trained public health
workforce, antiquated laboratory capacity, a lack of realtime
surveillance in epidemiological systems, an ineffective and fragmented
communications network, incomplete domestic preparedness and emergency
response capabilities, and communities without access to essential
public health services.''
That is really the challenge. If we talk about homeland security,
this is a key aspect in ensuring homeland security. It is a challenge
we have to address. That puts the Project BioShield Act in an ominous
perspective. It is a large step in the right direction, but without a
commitment to adequately fund our hospitals and our health agencies,
genuine preparedness and effective homeland security will still be far
from what is needed.
I urge my colleagues in approving this important bipartisan
legislation to also do what it takes to see that our hospitals and
health agencies have the resources they need to use the new tools that
BioShield gives them. We don't know how much time we have, but we do
know we have to get the job done and do it as quickly as we can.
Mr. President, I want to take a moment to thank a number of our
colleagues' staffs who have worked tirelessly in this endeavor over the
period of these last 2 years. This has been an enormous effort on the
part of many of them. They have done an extraordinary job working this
through.
The passage of the BioShield legislation owes much to the hard work
and skill of dedicated staff members on both sides of the aisle in the
Senate and the House of Representatives, and in the administration too.
I would like to take a moment to thank the effective and skillful
work of Senator Gregg's staff, particularly Vince Ventimiglia and Steve
Irizarry. Their expertise was helpful in so many ways. I also want to
thank Craig Burton of Senator Frist's staff for his effective work on
the legislation.
Our Republican colleagues on the House Commerce and Homeland Security
committees were ably assisted by Tom DiLenge and Nandan Kenkeremath.
John Ford worked tirelessly on behalf of the many Democratic Members
with an interest in this legislation.
I also commend many senior staff in the Department of Health and
Human Services for their work in seeing this important legislation
enacted. We owe particular thanks to Stewart Simonsen, the Assistant
Secretary for Public Health Preparedness, as well as Raissa Downs, Ken
Bernard and Scott Whitaker from the Office of the Secretary, and Amit
Sachdev of the FDA.
Staff members from many Democratic Senators made numerous helpful
contributions to the success of this legislation. I would like to thank
Peter Levine and Gary Leeling from Senator Levin's staff, as well as
Lisa German from Senator Reed's staff. I would also like to thank my
health staff, particularly David Nexon, David Bowen, David Dorsey and
Paul Kim for their excellent work on this legislation.
I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The legislative clerk proceeded to call the roll.
Mr. GREGG. Mr. President, I ask unanimous consent that the order for
the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. GREGG. Mr. President, I ask that my substitute amendment be
accepted.
The PRESIDING OFFICER. Under the previous order, the amendment is
agreed to.
The amendment (No. 3178) was agreed to.
The PRESIDING OFFICER. Under the previous order, the committee
substitute amendment, as amended, is agreed to.
The committee amendment, in the nature of a substitute, as amended,
was agreed to.
bioshield funding
Mr. GREGG. Mr. President, I appreciate the hard work and cooperation
of many of my colleagues to build a program to protect Americans from
bioterrorism. I am grateful to Senator Cochran for his work last year
to ensure that adequate funds were provided in advance to incentivize
the immediate development of countermeasures. I also commend Senator
Nickles for his efforts to safeguard these funds and ensure that they
remain available solely for the intended purpose of protecting our
citizens from biological attack.
Mr. COCHRAN. I was pleased to work with the administration and my
colleagues on the Appropriations Committee to secure funding for the
program. It is my intention that any unobligated balances of funds
appropriated for project BioShield remain available until expended, as
the law requires, to ensure that the program has adequate resources in
fiscal year 2005 to continue developing necessary countermeasures.
Mr. NICKLES. I appreciate the leadership of my colleague from
Mississippi in this effort, and agree that the funds should remain
dedicated to the rapid development of effective countermeasures against
emerging threats.
Mr. BYRD. Mr. President, I commend Senators Gregg and Kennedy for
their hard work in bringing this important legislation to the floor. I
share in their commitment to protect Americans from bio-terrorism. Last
year, I worked with Senator Cochran, the chairman of the Homeland
Security Subcommittee of the Senate Appropriations Committee, to
develop an extraordinary funding mechanism for the funding of Project
Bioshield. The Congress approved $5.6 billion of advanced
appropriations to create incentives for the development of vaccines,
pharmaceuticals and other countermeasures for responding to a potential
terrorist attack. This funding demonstrated a strong commitment to
implementing this important program.
During debate on the budget resolution, the Senate approved an
amendment offered by Senator Cochran and myself that struck from the
resolution a provision that would have established different rules in
the House and Senate for the treatment of Project Bioshield funding. I
believe such a provision would have created confusion and potentially
undermined future funding for homeland security programs.
Is it the understanding of the Senator from New Hampshire that no
such provision will be included in the final version of this
legislation that will be presented to the President?
Mr. GREGG. I thank the Senator from West Virginia for his cooperation
and appreciate his efforts to help secure funding for this important
program. While I am unable to guarantee an outcome in conference, I
have no intention of including this provision and I will work to ensure
that no such provision will be included in the bill presented to the
President.
Mr. BYRD. Is it also his understanding that no such provision, which
is in neither the House nor Senate-passed budget resolutions, will be
included in a conference report on the budget resolution?
Mr. GREGG. I have discussed this with the chairman of the Budget
Committee and the Senator's understanding is correct that no such
provision will be included.
Mr. BYRD. I thank the chairman for his assurances and cooperation in
this matter and I commend both he and Senator Kennedy for their
cooperation in bringing to the Senate this important legislation.
purchase of vaccines
Mr. LEVIN. Mr. President, I would like to clarify the understanding
of the managers of this bill with regard to the restriction in section
319F-2(c)(9), as amended by the Gregg-Kennedy amendment, on the use of
Bioshield funds from paying the costs for purchase of vaccines under
procurement contracts
[[Page S5767]]
entered into before the date of enactment. Is it the understanding of
the bill's managers that this restriction would not apply to the
purchase of additional doses of vaccines otherwise qualifying as
security countermeasures if they are acquired under either new
contracts or modifications to existing contracts to increase the
numbers of doses to be procured for the Strategic National Stockpile?
Mr. GREGG. I thank the Senator for his question. That is my
understanding.
Mr. KENNEDY. I agree with the Senator from Michigan and the Senator
from New Hampshire that that is my understanding of the provision.
However, it is also my understanding that the primary intent of the
Bioshield program is to accelerate the development of new products
rather than providing an additional funding source to pay for products
developed prior to the enactment of the legislation.
special reserve fund
Mr. KENNEDY. Mr. President, I commend the leadership of our
distinguished chairman in bringing the Bioshield legislation to the
Senate floor. I am optimistic that our colleagues will approve this
urgently needed legislation. I would like to clarify with the chairman
the intent behind one of the key provisions in the legislation.
Would the chairman agree that as we have considered this legislation
during our bipartisan and bicameral negotiations, it has been clear
that the congressional intent is for the Bioshield special reserve fund
to be one option for the Secretary with respect to procuring
countermeasures against chemical, biological, radiological, or nuclear
agents. A second option is ordinary appropriations for the stockpile
outside of the special reserve fund. It is clear though that we expect
that the Secretary will endeavor not to use the Bioshield special
reserve fund as a substitute for the commercial market in procuring
such countermeasures.
Mr. GREGG. I thank my colleague from Massachusetts for his comments.
I agree that his statements reflect the intent of Congress regarding
the use of the Bioshield special reserve fund.
Mr. LEVIN. Mr. President, I come to the floor today to express my
support for the Project Bioshield legislation. This bill will make an
important contribution to our Nation's preparedness by authorizing the
expenditure of $5.6 billion from fiscal year 2004 to fiscal year 2013
for the procurement of biomedical countermeasures for inclusion in a
Strategic National Stockpile. Project Bioshield will bolster the
Nation's ability to provide protections and countermeasures against
biological, chemical, radiological, and nuclear agents that may be used
in a terrorist attack. It includes provisions to facilitate research
and development of biomedical countermeasures by the National
Institutes of Health; to provide for procurement of needed
countermeasures through a special reserve fund and to authorize, under
limited circumstances, the emergency use of medical products that have
not been approved by the Food and Drug Administration.
I am pleased that the final version of the bill requires that any
bioshield contract be awarded pursuant to full and open competition
unless the Secretary determines that the mission of the bioshield
program would be seriously impaired by this requirement. This provision
ensures that the bioshield program, like other Federal programs, will
be subject to governmentwide competition requirements.
I am also pleased that the final version of the bill will not make it
more likely that military personnel will be required to take unapproved
products without their consent. This subject has been addressed in an
appropriate manner in the National Defense Authorization Act for Fiscal
Year 2005, which is being debated on the Senate floor right now.
This legislation will help to better prepare our Nation and bolster
our critical infrastructure to help us deal effectively with terrorist
attacks. The mailing of anthrax and ricin tainted letters to Capitol
Hill and other locations in 2001 and 2004, respectively, have
highlighted our Nation's weaknesses in this area of biodefense. Now
Project Bioshield will help give us the tools we need to develop
appropriate countermeasures and combat bioterrorism more effectively.
The PRESIDING OFFICER. The question is on the engrossment and third
reading of the bill.
The bill was ordered to be engrossed for a third reading and was read
the third time.
Mr. GREGG. Mr. President, I ask for the yeas and nays.
The PRESIDING OFFICER. Is there a sufficient second?
There is a sufficient second.
The bill having been read the third time, the question is, Shall the
bill, as amended, pass?
The clerk will call the roll.
The legislative clerk called the roll.
Mr. REID. I announce that the Senator from Massachusetts (Mr. Kerry)
is necessarily absent.
The PRESIDING OFFICER (Mr. Sununu). Are there any other Senators in
the Chamber desiring to vote?
The result was announced--yeas 99, nays 0, as follows:
[Rollcall Vote No. 99 Leg.]
YEAS--99
Akaka
Alexander
Allard
Allen
Baucus
Bayh
Bennett
Biden
Bingaman
Bond
Boxer
Breaux
Brownback
Bunning
Burns
Byrd
Campbell
Cantwell
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NOT VOTING--1
Kerry
The bill (S. 15), as amended, was passed.
Mr. WARNER. Mr. President, I move to reconsider the vote.
Mr. REID. I move to lay that motion on the table.
The motion to lay on the table was agreed to.
The amendment (No. 3180) was agreed to, as follows:
amendment no. 3180
(Purpose: To amend the title of the bill)
Amend the title so as to read: To amend the Public Health
Service Act to provide protections and countermeasures
against chemical, radiological, or nuclear agents that may be
used in a terrorist attack against the United States by
giving the National Institutes of Health contracting
flexibility, infrastructure improvements, and expediting the
scientific peer review process, and streamlining the Food and
Drug Administration approval process of countermeasures.''.
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