[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 15 Introduced in Senate (IS)]
108th CONGRESS
1st Session
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.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 11, 2003
Mr. Gregg (for himself, Mr. Frist, Mr. Alexander, Mr. Warner, Mr. Enzi,
Mr. Sessions, Mr. Roberts, and Mr. Graham of South Carolina) introduced
the following bill; which was read twice and referred to the Committee
on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
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.
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.
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 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--
``(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.''.
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
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.
``(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, 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 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--
(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 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
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.
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