[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 3982 Placed on Calendar Senate (PCS)]







                                                       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Pandemic Influenza Act, 2006 (Public Law 109-148)) is repealed.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.
            ``(4) Injury table.--
                    ``(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).
            ``(6) Special masters.--
                    ``(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