Calendar No. 655
109th CONGRESS
2d Session
S. 3982
To amend the Public Health Service Act to provide assured compensation
for first responders injured by experimental vaccines and drugs.
IN THE SENATE OF THE UNITED STATES
September 28, 2006
Mr. KENNEDY introduced the following bill; which was read the first time
September 30 (legislative day, September 29), 2006
Read the second time and placed on the calendar
A BILL
To amend the Public Health Service Act to provide assured compensation
for first responders injured by experimental vaccines and drugs.
Be it enacted by the Senate and House of Representatives of the United
States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the `Assured Compensation for First Responders
Act'.
SEC. 2. ASSURED COMPENSATION FOR FIRST RESPONDERS INJURED BY EXPERIMENTAL
VACCINES AND DRUGS.
(a) Repeal- The Public Readiness and Emergency Preparedness Act (division
C of the Department of Defense, Emergency Supplemental Appropriations to
Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act, 2006
(Public Law 109-148)) is repealed.
(b) National Biodefense Injury Compensation Program-
(1) ESTABLISHMENT- Section 224 of the Public Health Service Act (42 U.S.C.
233) is amended by adding at the end the following:
`(q) Biodefense Injury Compensation Program-
`(1) ESTABLISHMENT- There is established the Biodefense Injury Compensation
Program (referred to in this subsection as the `Compensation Program')
under which compensation may be paid for death or any injury, illness,
disability, or condition that is likely (based on best available evidence)
to have been caused by the administration of a covered countermeasure
to an individual pursuant to a declaration under subsection (p)(2).
`(2) ADMINISTRATION AND INTERPRETATION- The statutory provisions governing
the Compensation Program shall be administered and interpreted in consideration
of the program goals described in paragraph (4)(B)(iii).
`(3) PROCEDURES AND STANDARDS- The Secretary shall by regulation establish
procedures and standards applicable to the Compensation Program that follow
the procedures and standards applicable under the National Vaccine Injury
Compensation Program established under section 2110, except that the regulations
promulgated under this paragraph shall permit a person claiming injury
or death related to the administration of any covered countermeasure to
file either--
`(A) a civil action for relief under subsection (p); or
`(B) a petition for compensation under this subsection.
`(A) INCLUSION- For purposes of receiving compensation under the Compensation
Program with respect to a countermeasure that is the subject of a declaration
under subsection (p)(2), the Vaccine Injury Table under section 2114
shall be deemed to include death and the injuries, disabilities, illnesses,
and conditions specified by the Secretary under subparagraph (B)(ii).
`(B) INJURIES, DISABILITIES, ILLNESSES, AND CONDITIONS-
`(i) INSTITUTE OF MEDICINE- Not later than 30 days after making a
declaration described in subsection (p)(2), the Secretary shall enter
into a contract with the Institute of Medicine, under which the Institute
shall, within 180 days of the date on which the contract is entered
into, and periodically thereafter as new information, including information
derived from the monitoring of those who were administered the countermeasure,
becomes available, provide its expert recommendations on the injuries,
disabilities, illnesses, and conditions whose occurrence in one or
more individuals are likely (based on best available evidence) to
have been caused by the administration of a countermeasure that is
the subject of the declaration.
`(ii) SPECIFICATION BY SECRETARY- Not later than 30 days after the
receipt of the expert recommendations described in clause (i), the
Secretary shall, based on such recommendations, specify those injuries,
disabilities, illnesses, and conditions deemed to be included in the
Vaccine Injury Table under section 2114 for the purposes described
in subparagraph (A).
`(iii) PROGRAM GOALS- The Institute of Medicine, under the contract
under clause (i), shall make such recommendations, the Secretary shall
specify, under clause (ii), such injuries, disabilities, illnesses,
and conditions, and claims under the Compensation Program under this
subsection shall be processed and decided taking into account the
following goals of such program:
`(I) To encourage persons to develop, manufacture, and distribute
countermeasures, and to administer covered countermeasures to individuals,
by limiting such persons' liability for damages related to death
and such injuries, disabilities, illnesses, and conditions.
`(II) To encourage individuals to consent to the administration
of a covered countermeasure by providing adequate and just compensation
for damages related to death and such injuries, disabilities, illnesses,
or conditions.
`(III) To provide individuals seeking compensation for damages related
to the administration of a countermeasure with a non-adversarial
administrative process for obtaining adequate and just compensation.
`(iv) USE OF BEST AVAILABLE EVIDENCE- The Institute of Medicine, under
the contract under clause (i), shall make such recommendations, the
Secretary shall specify, under clause (ii), such injuries, disabilities,
illnesses, and conditions, and claims under the Compensation Program
under this subsection shall be processed and decided using the best
available evidence, including information from adverse event reporting
or other monitoring of those individuals who were administered the
countermeasure, whether evidence from clinical trials or other scientific
studies in humans is available.
`(v) APPLICATION OF SECTION 2115- With respect to section 2115(a)(2)
as applied for purposes of this subsection, an award for the estate
of the deceased shall be--
`(I) if the deceased was under the age of 18, an amount equal to
the amount that may be paid to a survivor or survivors as death
benefits 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.); or
`(II) if the deceased was 18 years of age or older, the greater
of--
`(aa) the amount described in subclause (I); or
`(bb) the projected loss of employment income, except that the
amount under this item may not exceed an amount equal to 400 percent of
the amount that applies under item (aa).
`(vi) APPLICATION OF SECTION 2116- Section 2116(b) shall apply to
injuries, disabilities, illnesses, and conditions initially specified
or revised by the Secretary under clause (ii), except that the exceptions
contained in paragraphs (1) and (2) of such section shall not apply.
`(C) RULE OF CONSTRUCTION- Section 13632 (a)(3) of Public Law 103-66
(107 Stat. 646) (making revisions by Secretary to the Vaccine Injury
Table effective on the effective date of a corresponding tax) shall
not be construed to apply to any revision to the Vaccine Injury Table
made under regulations under this paragraph.
`(5) APPLICATION- The Compensation Program applies to any death or injury,
illness, disability, or condition that is likely (based on best available
evidence) to have been caused by the administration of a covered countermeasure
to an individual pursuant to a declaration under subsection (p)(2).
`(A) HIRING- In accordance with section 2112, the judges of the United
States Claims Court shall appoint a sufficient number of special masters
to address claims for compensation under this subsection.
`(B) BUDGET AUTHORITY- There are appropriated to carry out this subsection
such sums as may be necessary for fiscal year 2006 and each fiscal year
thereafter. This subparagraph constitutes budget authority in advance
of appropriations and represents the obligation of the Federal Government.
`(7) COVERED COUNTERMEASURE- For purposes of this subsection, the term
`covered countermeasure' has the meaning given to such term in subsection
(p)(7)(A).
`(8) FUNDING- Compensation made under the Compensation Program shall be
made from the same source of funds as payments made under subsection (p).'.
(2) EFFECTIVE DATE- This subsection shall take effect as of November 25,
2002 (the date of enactment of the Homeland Security Act of 2002 (Public
Law 107-296; 116 Stat. 2135)).
Calendar No. 655
109th CONGRESS
2d Session
S. 3982
A BILL
To amend the Public Health Service Act to provide assured compensation
for first responders injured by experimental vaccines and drugs.
September 30 (legislative day, September 29), 2006
Read the second time and placed on the calendar
END
