II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Assured Compensation 

5 for First Responders Act’’. 


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1 SEC. 2. ASSURED COMPENSATION FOR FIRST RESPONDERS 

2 INJURED BY EXPERIMENTAL VACCINES AND 

3 DRUGS. 

4 (a) REPEAL.—The Public Readiness and Emergency 

5 Preparedness Act (division C of the Department of De6 fense, Emergency Supplemental Appropriations to Ad7 dress Hurricanes in the Gulf of Mexico, and Pandemic In8 fluenza Act, 2006 (Public Law 109–148)) is repealed. 

9 (b) NATIONAL BIODEFENSE INJURY COMPENSATION

10 PROGRAM.— 

11 (1) ESTABLISHMENT.—Section 224 of the Pub12 lic Health Service Act (42 U.S.C. 233) is amended 

13 by adding at the end the following: 

14 ‘‘(q) BIODEFENSE INJURY COMPENSATION PRO15 GRAM.— 

16 ‘‘(1) ESTABLISHMENT.—There is established 

17 the Biodefense Injury Compensation Program (re18 ferred to in this subsection as the ‘Compensation 

19 Program’) under which compensation may be paid 

20 for death or any injury, illness, disability, or condi21 tion that is likely (based on best available evidence) 

22 to have been caused by the administration of a cov23 ered countermeasure to an individual pursuant to a 

24 declaration under subsection (p)(2). 

25 ‘‘(2) ADMINISTRATION AND INTERPRETA26 TION.—The statutory provisions governing the ComVerDate Aug 31 2005 03:46 Oct 01, 2006 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3982.PCS S3982

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1 pensation Program shall be administered and inter2 preted in consideration of the program goals de3 scribed in paragraph (4)(B)(iii). 

4 ‘‘(3) PROCEDURES AND STANDARDS.—The Sec5 retary shall by regulation establish procedures and 

6 standards applicable to the Compensation Program 

7 that follow the procedures and standards applicable 

8 under the National Vaccine Injury Compensation 

9 Program established under section 2110, except that 

10 the regulations promulgated under this paragraph 

11 shall permit a person claiming injury or death re12 lated to the administration of any covered counter13 measure to file either— 

14 ‘‘(A) a civil action for relief under sub15 section (p); or 

16 ‘‘(B) a petition for compensation under 

17 this subsection. 

18 ‘‘(4) INJURY TABLE.— 

19 ‘‘(A) INCLUSION.—For purposes of receiv20 ing compensation under the Compensation Pro21 gram with respect to a countermeasure that is 

22 the subject of a declaration under subsection 

23 (p)(2), the Vaccine Injury Table under section 

24 2114 shall be deemed to include death and the 

25 injuries, disabilities, illnesses, and conditions 


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1 specified by the Secretary under subparagraph 

2 (B)(ii). 

3 ‘‘(B) INJURIES, DISABILITIES, ILLNESSES, 

4 AND CONDITIONS.— 

5 ‘‘(i) INSTITUTE OF MEDICINE.—Not 

6 later than 30 days after making a declara7 tion described in subsection (p)(2), the 

8 Secretary shall enter into a contract with 

9 the Institute of Medicine, under which the 

10 Institute shall, within 180 days of the date 

11 on which the contract is entered into, and 

12 periodically thereafter as new information, 

13 including information derived from the 

14 monitoring of those who were administered 

15 the countermeasure, becomes available, 

16 provide its expert recommendations on the 

17 injuries, disabilities, illnesses, and condi18 tions whose occurrence in one or more in19 dividuals are likely (based on best available 

20 evidence) to have been caused by the ad21 ministration of a countermeasure that is 

22 the subject of the declaration. 

23 ‘‘(ii) SPECIFICATION BY SEC24 RETARY.—Not later than 30 days after the 

25 receipt of the expert recommendations deVerDate Aug 31 2005 03:46 Oct 01, 2006 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3982.PCS S3982

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1 scribed in clause (i), the Secretary shall, 

2 based on such recommendations, specify 

3 those injuries, disabilities, illnesses, and 

4 conditions deemed to be included in the 

5 Vaccine Injury Table under section 2114 

6 for the purposes described in subparagraph 

7 (A). 

8 ‘‘(iii) PROGRAM GOALS.—The Insti9 tute of Medicine, under the contract under 

10 clause (i), shall make such recommenda11 tions, the Secretary shall specify, under 

12 clause (ii), such injuries, disabilities, ill13 nesses, and conditions, and claims under 

14 the Compensation Program under this sub15 section shall be processed and decided tak16 ing into account the following goals of such 

17 program: 

18 ‘‘(I) To encourage persons to de19 velop, manufacture, and distribute 

20 countermeasures, and to administer 

21 covered countermeasures to individ22 uals, by limiting such persons’ liability 

23 for damages related to death and such 

24 injuries, disabilities, illnesses, and 

25 conditions. 


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1 ‘‘(II) To encourage individuals to 

2 consent to the administration of a 

3 covered countermeasure by providing 

4 adequate and just compensation for 

5 damages related to death and such in6 juries, disabilities, illnesses, or condi7 tions. 

8 ‘‘(III) To provide individuals 

9 seeking compensation for damages re10 lated to the administration of a coun11 termeasure with a non-adversarial ad12 ministrative process for obtaining ade13 quate and just compensation. 

14 ‘‘(iv) USE OF BEST AVAILABLE EVI15 DENCE.—The Institute of Medicine, under 

16 the contract under clause (i), shall make 

17 such recommendations, the Secretary shall 

18 specify, under clause (ii), such injuries, 

19 disabilities, illnesses, and conditions, and 

20 claims under the Compensation Program 

21 under this subsection shall be processed 

22 and decided using the best available evi23 dence, including information from adverse 

24 event reporting or other monitoring of 

25 those individuals who were administered 


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1 the countermeasure, whether evidence from 

2 clinical trials or other scientific studies in 

3 humans is available. 

4 ‘‘(v) APPLICATION OF SECTION

5 2115.—With respect to section 2115(a)(2) 

6 as applied for purposes of this subsection, 

7 an award for the estate of the deceased 

8 shall be— 

9 ‘‘(I) if the deceased was under 

10 the age of 18, an amount equal to the 

11 amount that may be paid to a sur12 vivor or survivors as death benefits 

13 under the Public Safety Officers’ Ben14 efits Program under subpart 1 of part 

15 L of title I of the Omnibus Crime 

16 Control and Safe Streets Act of 1968 

17 (42 U.S.C. 3796 et seq.); or 

18 ‘‘(II) if the deceased was 18 

19 years of age or older, the greater of— 

20 ‘‘(aa) the amount described 

21 in subclause (I); or 

22 ‘‘(bb) the projected loss of 

23 employment income, except that 

24 the amount under this item may 

25 not exceed an amount equal to 


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1 400 percent of the amount that 

2 applies under item (aa). 

3 ‘‘(vi) APPLICATION OF SECTION

4 2116.—Section 2116(b) shall apply to in5 juries, disabilities, illnesses, and conditions 

6 initially specified or revised by the Sec7 retary under clause (ii), except that the ex8 ceptions contained in paragraphs (1) and 

9 (2) of such section shall not apply. 

10 ‘‘(C) RULE OF CONSTRUCTION.—Section 

11 13632 (a)(3) of Public Law 103–66 (107 Stat. 

12 646) (making revisions by Secretary to the Vac13 cine Injury Table effective on the effective date 

14 of a corresponding tax) shall not be construed 

15 to apply to any revision to the Vaccine Injury 

16 Table made under regulations under this para17 graph. 

18 ‘‘(5) APPLICATION.—The Compensation Pro19 gram applies to any death or injury, illness, dis20 ability, or condition that is likely (based on best 

21 available evidence) to have been caused by the ad22 ministration of a covered countermeasure to an indi23 vidual pursuant to a declaration under subsection 

24 (p)(2). 

25 ‘‘(6) SPECIAL MASTERS.— 


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1 ‘‘(A) HIRING.—In accordance with section 

2 2112, the judges of the United States Claims 

3 Court shall appoint a sufficient number of spe4 cial masters to address claims for compensation 

5 under this subsection. 

6 ‘‘(B) BUDGET AUTHORITY.—There are ap7 propriated to carry out this subsection such 

8 sums as may be necessary for fiscal year 2006 

9 and each fiscal year thereafter. This subpara10 graph constitutes budget authority in advance 

11 of appropriations and represents the obligation 

12 of the Federal Government. 

13 ‘‘(7) COVERED COUNTERMEASURE.—For pur14 poses of this subsection, the term ‘covered counter15 measure’ has the meaning given to such term in sub16 section (p)(7)(A). 

17 ‘‘(8) FUNDING.—Compensation made under the 

18 Compensation Program shall be made from the same 

19 source of funds as payments made under subsection 

20 (p).’’. 

21 (2) EFFECTIVE DATE.—This subsection shall 

22 take effect as of November 25, 2002 (the date of en23 actment of the Homeland Security Act of 2002 

24 (Public Law 107–296; 116 Stat. 2135)). 


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Calendar No. 655 

109TH CONGRESS 

2D SESSION S. 3982 

A BILL 

To amend the Public Health Service Act to provide 

by experimental vaccines and drugs. assured compensation for first responders injured 

SEPTEMBER 30 (legislative day, SEPTEMBER 29), 2006 

Read the second time and placed on the calendar 


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