II 

109TH CONGRESS 

2D SESSION S. 2291 

To provide for the establishment of a biodefense injury compensation program 

and to provide indemnification for producers of countermeasures. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 15, 2006 

Mr. KENNEDY (for himself, Mr. DODD, Mr. HARKIN, and Mr. BINGAMAN) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To provide for the establishment of a biodefense injury compensation program and to provide indemnification for 

producers of countermeasures. 

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 ‘‘Responsible Public 

5 Readiness and Emergency Preparedness Act’’. 

6 SEC. 2. REPEAL. 

7 The Public Readiness and Emergency Preparedness 

8 Act (division C of the Department of Defense, Emergency 

9 Supplemental Appropriations to Address Hurricanes in 
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1 the Gulf of Mexico, and Pandemic Influenza Act, 2006 

2 (Public Law 109–148)) is repealed. 

3 SEC. 3. NATIONAL BIODEFENSE INJURY COMPENSATION 

4 PROGRAM. 

5 (a) ESTABLISHMENT.—Section 224 of the Public 

6 Health Service Act (42 U.S.C. 233) is amended by adding 

7 at the end the following: 

8 ‘‘(q) BIODEFENSE INJURY COMPENSATION PRO9 GRAM.— 

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

11 the Biodefense Injury Compensation Program (re12 ferred to in this subsection as the ‘Compensation 

13 Program’) under which compensation may be paid 

14 for death or any injury, illness, disability, or condi15 tion that is likely (based on best available evidence) 

16 to have been caused by the administration of a cov17 ered countermeasure to an individual pursuant to a 

18 declaration under subsection (p)(2). 

19 ‘‘(2) ADMINISTRATION AND INTERPRETA20 TION.—The statutory provisions governing the Com21 pensation Program shall be administered and inter22 preted in consideration of the program goals de23 scribed in paragraph (4)(B)(iii). 

24 ‘‘(3) PROCEDURES AND STANDARDS.—The Sec25 retary shall by regulation establish procedures and 
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1 standards applicable to the Compensation Program 

2 that follow the procedures and standards applicable 

3 under the National Vaccine Injury Compensation 

4 Program established under section 2110, except that 

5 the regulations promulgated under this paragraph 

6 shall permit a person claiming injury or death re7 lated to the administration of any covered counter8 measure to file either— 

9 ‘‘(A) a civil action for relief under sub10 section (p); or 

11 ‘‘(B) a petition for compensation under 

12 this subsection. 

13 ‘‘(4) INJURY TABLE.— 

14 ‘‘(A) INCLUSION.—For purposes of receiv15 ing compensation under the Compensation Pro16 gram with respect to a countermeasure that is 

17 the subject of a declaration under subsection 

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

19 2114 shall be deemed to include death and the 

20 injuries, disabilities, illnesses, and conditions 

21 specified by the Secretary under subparagraph 

22 (B)(ii). 

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

24 AND CONDITIONS.— 
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1 ‘‘(i) INSTITUTE OF MEDICINE.—Not 

2 later than 30 days after making a declara3 tion described in subsection (p)(2), the 

4 Secretary shall enter into a contract with 

5 the Institute of Medicine, under which the 

6 Institute shall, within 180 days of the date 

7 on which the contract is entered into, and 

8 periodically thereafter as new information, 

9 including information derived from the 

10 monitoring of those who were administered 

11 the countermeasure, becomes available, 

12 provide its expert recommendations on the 

13 injuries, disabilities, illnesses, and condi14 tions whose occurrence in one or more in15 dividuals are likely (based on best available 

16 evidence) to have been caused by the ad17 ministration of a countermeasure that is 

18 the subject of the declaration. 

19 ‘‘(ii) SPECIFICATION BY SEC20 RETARY.—Not later than 30 days after the 

21 receipt of the expert recommendations de22 scribed in clause (i), the Secretary shall, 

23 based on such recommendations, specify 

24 those injuries, disabilities, illnesses, and 

25 conditions deemed to be included in the 
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1 Vaccine Injury Table under section 2114 

2 for the purposes described in subparagraph 

3 (A). 

4 ‘‘(iii) PROGRAM GOALS.—The Insti5 tute of Medicine, under the contract under 

6 clause (i), shall make such recommenda7 tions, the Secretary shall specify, under 

8 clause (ii), such injuries, disabilities, ill9 nesses, and conditions, and claims under 

10 the Compensation Program under this sub11 section shall be processed and decided tak12 ing into account the following goals of such 

13 program: 

14 ‘‘(I) To encourage persons to de15 velop, manufacture, and distribute 

16 countermeasures, and to administer 

17 covered countermeasures to individ18 uals, by limiting such persons’ liability 

19 for damages related to death and such 

20 injuries, disabilities, illnesses, and 

21 conditions. 

22 ‘‘(II) To encourage individuals to 

23 consent to the administration of a 

24 covered countermeasure by providing 

25 adequate and just compensation for 
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1 damages related to death and such in2 juries, disabilities, illnesses, or condi3 tions. 

4 ‘‘(III) To provide individuals 

5 seeking compensation for damages re6 lated to the administration of a coun7 termeasure with a non-adversarial ad8 ministrative process for obtaining ade9 quate and just compensation. 

10 ‘‘(iv) USE OF BEST AVAILABLE EVI11 DENCE.—The Institute of Medicine, under 

12 the contract under clause (i), shall make 

13 such recommendations, the Secretary shall 

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

15 disabilities, illnesses, and conditions, and 

16 claims under the Compensation Program 

17 under this subsection shall be processed 

18 and decided using the best available evi19 dence, including information from adverse 

20 event reporting or other monitoring of 

21 those individuals who were administered 

22 the countermeasure, whether evidence from 

23 clinical trials or other scientific studies in 

24 humans is available. 
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1 ‘‘(v) APPLICATION OF SECTION

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

3 as applied for purposes of this subsection, 

4 an award for the estate of the deceased 

5 shall be— 

6 ‘‘(I) if the deceased was under 

7 the age of 18, an amount equal to the 

8 amount that may be paid to a sur9 vivor or survivors as death benefits 

10 under the Public Safety Officers’ Ben11 efits Program under subpart 1 of part 

12 L of title I of the Omnibus Crime 

13 Control and Safe Streets Act of 1968 

14 (42 U.S.C. 3796 et seq.); or 

15 ‘‘(II) if the deceased was 18 

16 years of age or older, the greater of— 

17 ‘‘(aa) the amount described 

18 in subclause (I); or 

19 ‘‘(bb) the projected loss of 

20 employment income, except that 

21 the amount under this item may 

22 not exceed an amount equal to 

23 400 percent of the amount that 

24 applies under item (aa). 
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1 ‘‘(vi) APPLICATION OF SECTION

2 2116.—Section 2116(b) shall apply to in3 juries, disabilities, illnesses, and conditions 

4 initially specified or revised by the Sec5 retary under clause (ii), except that the ex6 ceptions contained in paragraphs (1) and 

7 (2) of such section shall not apply. 

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

9 13632 (a)(3) of Public Law 103–66 (107 Stat. 

10 646) (making revisions by Secretary to the Vac11 cine Injury Table effective on the effective date 

12 of a corresponding tax) shall not be construed 

13 to apply to any revision to the Vaccine Injury 

14 Table made under regulations under this para15 graph. 

16 ‘‘(5) APPLICATION.—The Compensation Pro17 gram applies to any death or injury, illness, dis18 ability, or condition that is likely (based on best 

19 available evidence) to have been caused by the ad20 ministration of a covered countermeasure to an indi21 vidual pursuant to a declaration under subsection 

22 (p)(2). 

23 ‘‘(6) SPECIAL MASTERS.— 

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

25 2112, the judges of the United States Claims 
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1 Court shall appoint a sufficient number of spe2 cial masters to address claims for compensation 

3 under this subsection. 

4 ‘‘(B) BUDGET AUTHORITY.—There are ap5 propriated to carry out this subsection such 

6 sums as may be necessary for fiscal year 2006 

7 and each fiscal year thereafter. This subpara8 graph constitutes budget authority in advance 

9 of appropriations and represents the obligation 

10 of the Federal Government. 

11 ‘‘(7) COVERED COUNTERMEASURE.—For pur12 poses of this subsection, the term ‘covered counter13 measure’ has the meaning given to such term in sub14 section (p)(7)(A). 

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

16 Compensation Program shall be made from the same 

17 source of funds as payments made under subsection 

18 (p).’’. 

19 (b) EFFECTIVE DATE.—This section shall take effect 

20 as of November 25, 2002 (the date of enactment of the 

21 Homeland Security Act of 2002 (Public Law 107–296; 

22 116 Stat. 2135)). 
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1 SEC. 4. INDEMNIFICATION FOR MANUFACTURERS AND 

2 HEALTH CARE PROFESSIONALS WHO ADMIN3 ISTER MEDICAL PRODUCTS NEEDED FOR 

4 BIODEFENSE. 

5 Section 224(p) of the Public Health Service Act (42 

6 U.S.C. 233(p)) is amended— 

7 (1) in the subsection heading by striking 

8 ‘‘SMALLPOX’’; 

9 (2) in paragraph (1), by striking ‘‘against 

10 smallpox’’; 

11 (3) in paragraph (2)— 

12 (A) in the paragraph heading, by striking 

13 ‘‘AGAINST SMALLPOX’’; and 

14 (B) in subparagraph (B), by striking 

15 clause (ii); 

16 (4) by striking paragraph (3) and inserting the 

17 following: 

18 ‘‘(3) EXCLUSIVITY; OFFSET.— 

19 ‘‘(A) EXCLUSIVITY.—With respect to an 

20 individual to which this subsection applies, such 

21 individual may bring a claim for relief under— 

22 ‘‘(i) this subsection; 

23 ‘‘(ii) subsection (q); or 

24 ‘‘(iii) part C. 

25 ‘‘(B) ELECTION OF ALTERNATIVES.—An 

26 individual may only pursue one remedy under 
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1 subparagraph (A) at any one time based on the 

2 same incident or series of incidents. An indi3 vidual who elects to pursue the remedy under 

4 subsection (q) or part C may decline any com5 pensation awarded with respect to such remedy 

6 and subsequently pursue the remedy provided 

7 for under this subsection. An individual who 

8 elects to pursue the remedy provided for under 

9 this subsection may not subsequently pursue 

10 the remedy provided for under subsection (q) or 

11 part C. 

12 ‘‘(C) STATUTE OF LIMITATIONS.—For pur13 poses of determining how much time has lapsed 

14 when applying statute of limitations require15 ments relating to remedies under subparagraph 

16 (A), any limitation of time for commencing an 

17 action, or filing an application, petition, or 

18 claim for such remedies, shall be deemed to 

19 have been suspended for the periods during 

20 which an individual pursues a remedy under 

21 such subparagraph. 

22 ‘‘(D) OFFSET.—The value of all compensa23 tion and benefits provided under subsection (q) 

24 or part C of this title for an incident or series 

25 of incidents shall be offset against the amount 
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1 of an award, compromise, or settlement of 

2 money damages in a claim or suit under this 

3 subsection based on the same incident or series 

4 of incidents.’’; 

5 (5) in paragraph (6)— 

6 (A) in subparagraph (A), by inserting ‘‘or 

7 under subsection (q) or part C’’ after ‘‘under 

8 this subsection’’; and 

9 (B) by redesignating subparagraph (B) as 

10 subparagraph (C); 

11 (C) by inserting after subparagraph (A), 

12 the following: 

13 ‘‘(B) GROSSLY NEGLIGENT, RECKLESS, OR

14 ILLEGAL CONDUCT AND WILLFUL MIS15 CONDUCT.—For purposes of subparagraph (A), 

16 grossly negligent, reckless, or illegal conduct or 

17 willful misconduct shall include the administra18 tion by a qualified person of a covered counter19 measure to an individual who was not within a 

20 category of individuals covered by a declaration 

21 under subsection (p)(2) with respect to such 

22 countermeasure where the qualified person fails 

23 to have had reasonable grounds to believe such 

24 individual was within such a category.’’; and 

25 (D) by adding at the end the following: 
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1 ‘‘(D) LIABILITY OF THE UNITED

2 STATES.—The United States shall be liable 

3 under this subsection with respect to a claim 

4 arising out of the manufacture, distribution, or 

5 administration of a covered countermeasure re6 gardless of whether— 

7 ‘‘(i) the cause of action seeking com8 pensation is alleged as negligence, strict li9 ability, breach of warranty, failure to warn, 

10 or other action; or 

11 ‘‘(ii) the covered countermeasure is 

12 designated as a qualified anti-terrorism 

13 technology under the SAFETY Act (6 

14 U.S.C. 441 et seq.).’’ 

15 ‘‘(E) GOVERNING LAW.—Notwithstanding 

16 the provisions of section 1346(b)(1) and chap17 ter 171 of title 28, United States Code, as they 

18 relate to governing law, the liability of the 

19 United States as provided in this subsection 

20 shall be in accordance with the law of the place 

21 of injury. 

22 ‘‘(F) MILITARY PERSONNEL AND UNITED

23 STATES CITIZENS OVERSEAS.— 

24 ‘‘(i) MILITARY PERSONNEL.—The li25 ability of the United States as provided in 
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1 this subsection shall extend to claims 

2 brought by United States military per3 sonnel. 

4 ‘‘(ii) CLAIMS ARISING IN A FOREIGN

5 COUNTRY.—Notwithstanding the provisions 

6 of section 2680(k) of title 28, United 

7 States Code, the liability of the United 

8 States as provided for in the subsection 

9 shall extend to claims based on injuries 

10 arising in a foreign country where the in11 jured party is a member of the United 

12 States military, is the spouse or child of a 

13 member of the United States military, or is 

14 a United States citizen. 

15 ‘‘(iii) GOVERNING LAW.—With regard 

16 to all claims brought under clause (ii), and 

17 notwithstanding the provisions of section 

18 1346(b)(1) and chapter 171 of title 28, 

19 United States Code, and of subparagraph 

20 (C), as they relate to governing law, the li21 ability of the United States as provided in 

22 this subsection shall be in accordance with 

23 the law of the claimant’s domicile in the 

24 United States or most recent domicile with 

25 the United States.’’; and 
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1 (6) in paragraph (7)— 

2 (A) by striking subparagraph (A) and in3 serting the following: 

4 ‘‘(A) COVERED COUNTERMEASURE.—The 

5 term ‘covered countermeasure’, means— 

6 ‘‘(i) a substance that is— 

7 ‘‘(I)(aa) used to prevent or treat 

8 smallpox (including the vaccinia or 

9 another vaccine); or 

10 ‘‘(bb) vaccinia immune globulin 

11 used to control or treat the adverse 

12 effects of vaccinia inoculation; and 

13 ‘‘(II) specified in a declaration 

14 under paragraph (2); or 

15 ‘‘(ii) a drug (as such term is defined 

16 in section 201(g)(1) of the Federal Food, 

17 Drug, and Cosmetic Act), biological prod18 uct (as such term is defined in section 

19 351(i) of this Act), or device (as such term 

20 is defined in section 201(h) of the Federal 

21 Food, Drug, and Cosmetic Act) that— 

22 ‘‘(I) the Secretary determines to 

23 be a priority (consistent with sections 

24 302(2) and 304(a) of the Homeland 

25 Security Act of 2002) to treat, iden-
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1 tify, or prevent harm from any bio2 logical, chemical, radiological, or nu3 clear agent identified as a material 

4 threat under section 319F– 

5 2(c)(2)(A)(ii), or to treat, identify, or 

6 prevent harm from a condition that 

7 may result in adverse health con8 sequences or death and may be caused 

9 by administering a drug, biological 

10 product, or device against such an 

11 agent; 

12 ‘‘(II) is— 

13 ‘‘(aa) authorized for emer14 gency use under section 564 of 

15 the Federal Food, Drug, and 

16 Cosmetic Act, so long as the 

17 manufacturer of such drug, bio18 logical product, or device has— 

19 ‘‘(AA) made all reason20 able efforts to obtain appli21 cable approval, clearance, or 

22 licensure; and 

23 ‘‘(BB) cooperated fully 

24 with the requirements of the 
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1 Secretary under such section 

2 564; or 

3 ‘‘(bb) approved or licensed 

4 solely pursuant to the regulations 

5 under subpart I of part 314 or 

6 under subpart H of part 601 of 

7 title 21, Code of Federal Regula8 tions (as in effect on the date of 

9 enactment of the National Bio10 defense Act of 2005); and 

11 ‘‘(III) is specified in a declaration 

12 under paragraph (2).’’; and 

13 (B) in subparagraph (B)— 

14 (i) by striking clause (ii), and insert15 ing the following: 

16 ‘‘(ii) a health care entity, a State, or 

17 a political subdivision of a State under 

18 whose auspices such countermeasure was 

19 administered;’’ and 

20 (vi) in clause (viii), by inserting before 

21 the period ‘‘if such individual performs a 

22 function for which a person described in 

23 clause (i), (ii), or (iv) is a covered person’’. 

Æ