108TH CONGRESS

1ST SESSION H. R. 1770

AN ACT

To provide benefits and other compensation for certain individuals with injuries resulting from administration of

smallpox countermeasures, and for other purposes.

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

2 This Act may be cited as the ‘‘Smallpox Emergency

3 Personnel Protection Act of 2003’’.

4 SEC. 2. SMALLPOX EMERGENCY PERSONNEL PROTECTION.

5 Title II of the Public Health Service Act (42 U.S.C.

6 202 et seq.) is amended by adding at the end the following

7 part:

8 ‘‘PART C—SMALLPOX EMERGENCY PERSONNEL

9 PROTECTION

10 ‘‘SEC. 261. GENERAL PROVISIONS.

11 ‘‘(a) DEFINITIONS.—For purposes of this part:

12 ‘‘(1) COVERED COUNTERMEASURE.—The term

13 ‘covered countermeasure’ means a covered counter14 measure as specified in a Declaration made pursu15 ant to section 224(p).

16 ‘‘(2) COVERED INDIVIDUAL.—The term ‘cov17 ered individual’ means an individual—

18 ‘‘(A) who is a health care worker, law en19 forcement officer, firefighter, security per20 sonnel, emergency medical personnel, other

21 public safety personnel, or support personnel

22 for such occupational specialities;

23 ‘‘(B) who is or will be functioning in a role

24 identified in a State, local, or Department of

25 Health and Human Services smallpox emer-
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1 gency response plan (as defined in paragraph

2 (7)) approved by the Secretary;

3 ‘‘(C) who has volunteered and been se4 lected to be a member of a smallpox emergency

5 response plan described in subparagraph (B)

6 prior to the time at which the Secretary pub7 licly announces that an active case of smallpox

8 has been identified either within or outside of

9 the United States; and

10 ‘‘(D) to whom a smallpox vaccine is admin11 istered pursuant to such approved plan during

12 the effective period of the Declaration (includ13 ing the portion of such period before the enact14 ment of this part).

15 ‘‘(3) COVERED INJURY.—The term ‘covered in16 jury’ means an injury, disability, illness, condition,

17 or death (other than a minor injury such as minor

18 scarring or minor local reaction) determined, pursu19 ant to the procedures established under section 262,

20 to have been sustained by an individual as the direct

21 result of—

22 ‘‘(A) administration to the individual of a

23 covered countermeasure during the effective pe24 riod of the Declaration; or
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1 ‘‘(B) accidental vaccinia inoculation of the

2 individual in circumstances in which—

3 ‘‘(i) the vaccinia is contracted during

4 the effective period of the Declaration or

5 within 30 days after the end of such pe6 riod;

7 ‘‘(ii) smallpox vaccine has not been

8 administered to the individual; and

9 ‘‘(iii) the individual has been in con10 tact with an individual who is (or who was

11 accidentally inoculated by) a covered indi12 vidual.

13 ‘‘(4) DECLARATION.—The term ‘Declaration’

14 means the Declaration Regarding Administration of

15 Smallpox Countermeasures issued by the Secretary

16 on January 24, 2003, and published in the Federal

17 Register on January 28, 2003.

18 ‘‘(5) EFFECTIVE PERIOD OF THE DECLARA19 TION.—The term ‘effective period of the Declara20 tion’ means the effective period specified in the Dec21 laration, unless extended by the Secretary.

22 ‘‘(6) ELIGIBLE INDIVIDUAL.—The term ‘eligible

23 individual’ means an individual who is (as deter24 mined in accordance with section 262)—
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1 ‘‘(A) a covered individual who sustains a

2 covered injury in the manner described in para3 graph (3)(A); or

4 ‘‘(B) an individual who sustains a covered

5 injury in the manner described in paragraph

6 (3)(B).

7 ‘‘(7) SMALLPOX EMERGENCY RESPONSE

8 PLAN.—The term ‘smallpox emergency response

9 plan’ or ‘plan’ means a response plan detailing ac10 tions to be taken in preparation for a possible small11 pox-related emergency during the period prior to the

12 identification of an active case of smallpox either

13 within or outside the United States.

14 ‘‘(b) VOLUNTARY PROGRAM.—The Secretary shall

15 ensure that a State, local, or Department of Health and

16 Human Services plan to vaccinate individuals that is ap17 proved by the Secretary establishes procedures to ensure,

18 consistent with the Declaration and any applicable guide19 lines of the Centers for Disease Control and Prevention,

20 that—

21 ‘‘(1) potential participants are educated with

22 respect to contraindications, the voluntary nature of

23 the program, and the availability of potential bene24 fits and compensation under this part;
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1 ‘‘(2) there is voluntary screening provided to

2 potential participants that can identify health condi3 tions relevant to contraindications; and

4 ‘‘(3) there is appropriate post-inoculation med5 ical surveillance that includes an evaluation of ad6 verse health effects that may reasonably appear to

7 be due to such vaccine and prompt referral of, or the

8 provision of appropriate information to, any indi9 vidual requiring health care as a result of such ad10 verse health event.

11 ‘‘SEC. 262. DETERMINATION OF ELIGIBILITY AND BENE12 FITS.

13 ‘‘(a) IN GENERAL.—The Secretary shall establish

14 procedures for determining, as applicable with respect to

15 an individual—

16 ‘‘(1) whether the individual is an eligible indi17 vidual;

18 ‘‘(2) whether an eligible individual has sus19 tained a covered injury or injuries for which medical

20 benefits or compensation may be available under sec21 tions 264 and 265, and the amount of such benefits

22 or compensation; and

23 ‘‘(3) whether the covered injury or injuries of

24 an eligible individual caused the individual’s death

25 for purposes of benefits under section 266.
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1 ‘‘(b) COVERED INDIVIDUALS.—The Secretary may

2 accept a certification, by a Federal, State, or local govern3 ment entity or private health care entity participating in

4 the administration of covered countermeasures under the

5 Declaration, that an individual is a covered individual.

6 ‘‘(c) CRITERIA FOR REIMBURSEMENT.—

7 ‘‘(1) INJURIES SPECIFIED IN INJURY TABLE.—

8 In any case where an injury or other adverse effect

9 specified in the injury table established under section

10 263 as a known effect of a vaccine manifests in an

11 individual within the time period specified in such

12 table, such injury or other effect shall be presumed

13 to have resulted from administration of such vaccine.

14 ‘‘(2) OTHER DETERMINATIONS.—In making de15 terminations other than those described in para16 graph (1) as to the causation or severity of an in17 jury, the Secretary shall employ a preponderance of

18 the evidence standard and take into consideration all

19 relevant medical and scientific evidence presented for

20 consideration, and may obtain and consider the

21 views of qualified medical experts.

22 ‘‘(d) DEADLINE FOR FILING REQUEST.—The Sec23 retary shall not consider any request for a benefit under

24 this part with respect to an individual, unless—
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1 ‘‘(1) in the case of a request based on the ad2 ministration of the vaccine to the individual, the in3 dividual files with the Secretary an initial request

4 for benefits or compensation under this part not

5 later than one year after the date of administration

6 of the vaccine; or

7 ‘‘(2) in the case of a request based on acci8 dental vaccinia inoculation, the individual files with

9 the Secretary an initial request for benefits or com10 pensation under this part not later than two years

11 after the date of the first symptom or manifestation

12 of onset of the adverse effect.

13 ‘‘(e) STRUCTURED SETTLEMENTS AT SECRETARY’S

14 OPTION.—In any case in which there is a reasonable likeli15 hood that compensation or payment under section 264,

16 265, or 266(b) will be required for a period in excess of

17 one year from the date an individual is determined eligible

18 for such compensation or payment, the Secretary shall

19 have the discretion to make a lump-sum payment, pur20 chase an annuity or medical insurance policy, or execute

21 an appropriate structured settlement agreement, provided

22 that such payment, annuity, policy, or agreement is actu23 arially determined to have a value equal to the present

24 value of the projected total amount of benefits or com-
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1 pensation that the individual is eligible to receive under

2 such section or sections.

3 ‘‘(f) REVIEW OF DETERMINATION.—

4 ‘‘(1) SECRETARY’S REVIEW AUTHORITY.—The

5 Secretary may review a determination under this

6 section at any time on the Secretary’s own motion

7 or on application, and may affirm, vacate, or modify

8 such determination in any manner the Secretary

9 deems appropriate. The Secretary shall develop a

10 process by which an individual may file a request for

11 reconsideration of any determination made by the

12 Secretary under this section.

13 ‘‘(2) JUDICIAL AND ADMINISTRATIVE RE14 VIEW.—No court of the United States, or of any

15 State, District, territory or possession thereof, shall

16 have subject matter jurisdiction to review, whether

17 by mandamus or otherwise, any action by the Sec18 retary under this section. No officer or employee of

19 the United States shall review any action by the Sec20 retary under this section (unless the President spe21 cifically directs otherwise).

22 ‘‘SEC. 263. SMALLPOX VACCINE INJURY TABLE.

23 ‘‘(a) SMALLPOX VACCINE INJURY TABLE.—

24 ‘‘(1) ESTABLISHMENT REQUIRED.—The Sec25 retary shall establish by interim final regulation a
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1 table identifying adverse effects (including injuries,

2 disabilities, illnesses, conditions, and deaths) that

3 shall be presumed to result from the administration

4 of (or exposure to) a smallpox vaccine, and the time

5 period in which the first symptom or manifestation

6 of onset of each such adverse effect must manifest

7 in order for such presumption to apply.

8 ‘‘(2) AMENDMENTS.—The Secretary may by

9 regulation amend the table established under para10 graph (1). An amendment to the table takes effect

11 on the date of the promulgation of the final rule

12 that makes the amendment, and applies to all re13 quests for benefits or compensation under this part

14 that are filed on or after such date or are pending

15 as of such date. In addition, the amendment applies

16 retroactively to an individual who was not with re17 spect to the injury involved an eligible individual

18 under the table as in effect before the amendment

19 but who with respect to such injury is an eligible in20 dividual under the table as amended. With respect to

21 a request for benefits or compensation under this

22 part by an individual who becomes an eligible indi23 vidual as described in the preceding sentence, the

24 Secretary may not provide such benefits or com25 pensation unless the request (or amendment to a re-
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1 quest, as applicable) is filed before the expiration of

2 one year after the effective date of the amendment

3 to the table in the case of an individual to whom the

4 vaccine was administered and before the expiration

5 of two years after such effective date in the case of

6 a request based on accidental vaccinia inoculation.

7 ‘‘SEC. 264. MEDICAL BENEFITS.

8 ‘‘(a) IN GENERAL.—Subject to the succeeding provi9 sions of this section, the Secretary shall make payment

10 or reimbursement for medical items and services as rea11 sonable and necessary to treat a covered injury of an eligi12 ble individual, including the services, appliances, and sup13 plies prescribed or recommended by a qualified physician,

14 which the Secretary considers likely to cure, give relief,

15 reduce the degree or the period of disability, or aid in less16 ening the amount of monthly compensation.

17 ‘‘(b) BENEFITS SECONDARY TO OTHER COV18 ERAGE.—Payment or reimbursement for services or bene19 fits under subsection (a) shall be secondary to any obliga20 tion of the United States or any third party (including

21 any State or local governmental entity, private insurance

22 carrier, or employer) under any other provision of law or

23 contractual agreement, to pay for or provide such services

24 or benefits.
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1 ‘‘SEC. 265. COMPENSATION FOR LOST EMPLOYMENT IN2 COME.

3 ‘‘(a) IN GENERAL.—Subject to the succeeding provi4 sions of this section, the Secretary shall provide compensa5 tion to an eligible individual for loss of employment income

6 (based on such income at the time of injury) incurred as

7 a result of a covered injury, at the rate specified in sub8 section (b).

9 ‘‘(b) AMOUNT OF COMPENSATION.—

10 ‘‘(1) IN GENERAL.—Compensation under sub11 section (a) shall be at the rate of 66 2/3 percent of

12 the relevant pay period (weekly, monthly, or other13 wise), except as provided in paragraph (2).

14 ‘‘(2) AUGMENTED COMPENSATION FOR DE15 PENDENTS.—If an eligible individual has one or

16 more dependents, the basic compensation for loss of

17 employment income as described in paragraph (1)

18 shall be augmented at the rate of 8 1/3 percent.

19 ‘‘(3) CONSIDERATION OF OTHER PROGRAMS.—

20 ‘‘(A) IN GENERAL.—The Secretary may

21 consider the provisions of sections 8114, 8115,

22 and 8146a of title 5, United States Code, and

23 any implementing regulations, in determining

24 the amount of payment under subsection (a)

25 and the circumstances under which such pay26 ments are reasonable and necessary.
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1 ‘‘(B) MINORS.—With respect to an eligible

2 individual who is a minor, the Secretary may

3 consider the provisions of section 8113 of title

4 5, United States Code, and any implementing

5 regulations, in determining the amount of pay6 ment under subsection (a) and the cir7 cumstances under which such payments are

8 reasonable and necessary.

9 ‘‘(4) TREATMENT OF SELF-EMPLOYMENT IN10 COME.—For purposes of this section, the term ‘em11 ployment income’ includes income from self-employ12 ment.

13 ‘‘(c) LIMITATIONS.—

14 ‘‘(1) BENEFITS SECONDARY TO OTHER COV15 ERAGE.—

16 ‘‘(A) IN GENERAL.—Any compensation

17 under subsection (a) shall be secondary to the

18 obligation of the United States or any third

19 party (including any State or local govern20 mental entity, private insurance carrier, or em21 ployer), under any other law or contractual

22 agreement, to pay compensation for loss of em23 ployment income or to provide disability or re24 tirement benefits.
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1 ‘‘(B) RELATION TO OTHER OBLIGA2 TIONS.—Compensation under subsection (a)

3 shall not be made to an eligible individual to

4 the extent that the total of amounts paid to the

5 individual under such subsection and under the

6 other obligations referred to in subparagraph

7 (A) is an amount that exceeds the rate specified

8 in subsection (b)(1). If under any such other

9 obligation a lump-sum payment is made, such

10 payment shall, for purposes of this paragraph,

11 be deemed to be received over multiple years

12 rather than received in a single year. The Sec13 retary may, in the discretion of the Secretary,

14 determine how to apportion such payment over

15 multiple years.

16 ‘‘(2) NO BENEFITS IN CASE OF DEATH.—No

17 payment shall be made under subsection (a) in com18 pensation for loss of employment income subsequent

19 to the receipt, by the survivor or survivors of an eli20 gible individual, of benefits under section 266 for

21 death.

22 ‘‘(3) LIMIT ON TOTAL BENEFITS.—

23 ‘‘(A) IN GENERAL.—Except as provided in

24 subparagraph (B)—
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1 ‘‘(i) total compensation paid to an in2 dividual under subsection (a) shall not ex3 ceed $50,000 for any year; and

4 ‘‘(ii) the lifetime total of such com5 pensation for the individual may not ex6 ceed an amount equal to the amount au7 thorized to be paid under section 266.

8 ‘‘(B) PERMANENT AND TOTAL DIS9 ABILITY.—The limitation under subparagraph

10 (A)(ii) does not apply in the case of an eligible

11 individual who is determined to have a covered

12 injury or injuries meeting the definition of dis13 ability in section 216(i) of the Social Security

14 Act (42 U.S.C. 416(i)).

15 ‘‘(4) WAITING PERIOD.—

16 ‘‘(A) IN GENERAL.—Except as provided in

17 subparagraph (B), an eligible individual shall

18 not be provided compensation under this section

19 for the first 5 work days of loss of employment

20 income.

21 ‘‘(B) EXCEPTION.—Subparagraph (A)

22 does not apply if the period of loss of employ23 ment income of an eligible individual is 10 or

24 more work days.
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1 ‘‘(5) TERMINATION OF BENEFITS.—No pay2 ment shall be made under subsection (a) in com3 pensation for loss of employment income once the el4 igible individual involves reaches the age of 65.

5 ‘‘(d) BENEFIT IN ADDITION TO MEDICAL BENE6 FITS.—A benefit under subsection (a) shall be in addition

7 to any amounts received by an eligible individual under

8 section 264.

9 ‘‘SEC. 266. PAYMENT FOR DEATH.

10 ‘‘(a) DEATH BENEFIT.—

11 ‘‘(1) IN GENERAL.—The Secretary shall pay, in

12 the case of an eligible individual whose death is de13 termined to have resulted from a covered injury or

14 injuries, a death benefit in the amount determined

15 under paragraph (2) to the survivor or survivors in

16 the same manner as death benefits are paid pursu17 ant to the Public Safety Officers’ Benefits Program

18 under subpart 1 of part L of title I of the Omnibus

19 Crime Control and Safe Streets Act of 1968 (42

20 U.S.C. 3796 et seq.) with respect to an eligible de21 ceased (except that in the case of an eligible indi22 vidual who is a minor with no living parent, the legal

23 guardian shall be considered the survivor in the

24 place of the parent).

25 ‘‘(2) BENEFIT AMOUNT.—
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1 ‘‘(A) IN GENERAL.—The amount of the

2 death benefit under paragraph (1) in a fiscal

3 year shall equal the amount of the comparable

4 benefit calculated under the Public Safety Offi5 cers’ Benefits Program under subpart 1 of part

6 L of title I of the Omnibus Crime Control and

7 Safe Streets Act of 1968 (42 U.S.C. 3796 et

8 seq.) in such fiscal year, without regard to any

9 reduction attributable to a limitation on appro10 priations, but subject to subparagraph (B).

11 ‘‘(B) REDUCTION FOR PAYMENTS FOR

12 LOST EMPLOYMENT INCOME.—The amount of

13 the benefit as determined under subparagraph

14 (A) shall be reduced by the total amount of any

15 benefits paid under section 265 with respect to

16 lost employment income.

17 ‘‘(3) LIMITATIONS.—

18 ‘‘(A) IN GENERAL.—No benefit is payable

19 under paragraph (1) with respect to the death

20 of an eligible individual if—

21 ‘‘(i) a disability benefit is paid with

22 respect to such individual under the Public

23 Safety Officers’ Benefits Program under

24 subpart 1 of part L of title I of the Omni-
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1 bus Crime Control and Safe Streets Act of

2 1968 (42 U.S.C. 3796 et seq.); or

3 ‘‘(ii) a death benefit is paid or payable

4 with respect to such individual under the

5 Public Safety Officers’ Benefits Program

6 under subpart 1 of part L of title I of the

7 Omnibus Crime Control and Safe Streets

8 Act of 1968 (42 U.S.C. 3796 et seq.).

9 ‘‘(B) EXCEPTION IN THE CASE OF A LIMI10 TATION ON APPROPRIATIONS FOR DISABILITY

11 BENEFITS UNDER PSOB.—In the event that dis12 ability benefits available to an eligible individual

13 under the Public Safety Officers’ Benefits Pro14 gram under subpart 1 of part L of title I of the

15 Omnibus Crime Control and Safe Streets Act of

16 1968 (42 U.S.C. 3796 et seq.) are reduced be17 cause of a limitation on appropriations, and

18 such reduction would affect the amount that

19 would be payable under subparagraph (A) with20 out regard to this subparagraph, benefits shall

21 be available under paragraph (1) to the extent

22 necessary to ensure that the survivor or sur23 vivors of such individual receives a total amount

24 equal to the amount described in paragraph (2).

25 ‘‘(b) ELECTION IN CASE OF DEPENDENTS.—
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1 ‘‘(1) IN GENERAL.—In the case of an eligible

2 individual whose death is determined to have re3 sulted from a covered injury or injuries, if the indi4 vidual had one or more dependents under the age of

5 18, the legal guardian of the dependents may, in lieu

6 of the death benefit under subsection (a), elect to re7 ceive on behalf of the aggregate of such dependents

8 payments in accordance with this subsection. An

9 election under the preceding sentence is effective in

10 lieu of a request under subsection (a) by an indi11 vidual who is not the legal guardian of such depend12 ents.

13 ‘‘(2) AMOUNT OF PAYMENTS.—Payments under

14 paragraph (1) with respect to an eligible individual

15 described in such paragraph shall be made as if such

16 individual were an eligible individual to whom com17 pensation would be paid under subsection (a) of sec18 tion 265, with the rate augmented in accordance

19 with subsection (b)(2) of such section and with such

20 individual considered to be an eligible individual de21 scribed in subsection (c)(3)(B) of such section.

22 ‘‘(3) LIMITATIONS.—

23 ‘‘(A) AGE OF DEPENDENTS.—No pay24 ments may be made under paragraph (1) once
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1 the youngest of the dependents involved reaches

2 the age of 18.

3 ‘‘(B) BENEFITS SECONDARY TO OTHER

4 COVERAGE.—

5 ‘‘(i) IN GENERAL.—Any payment

6 under paragraph (1) shall be secondary to

7 the obligation of the United States or any

8 third party (including any State or local

9 governmental entity, private insurance car10 rier, or employer), under any other law or

11 contractual agreement, to pay compensa12 tion for loss of employment income or to

13 provide disability benefits, retirement bene14 fits, life insurance benefits on behalf of de15 pendents under the age of 18, or death

16 benefits.

17 ‘‘(ii) RELATION TO OTHER OBLIGA18 TIONS.—Payments under paragraph (1)

19 shall not be made to with respect to an eli20 gible individual to the extent that the total

21 of amounts paid with respect to the indi22 vidual under such paragraph and under

23 the other obligations referred to in clause

24 (i) is an amount that exceeds the rate of

25 payment that applies under paragraph (2).
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1 If under any such other obligation a lump2 sum payment is made, such payment shall,

3 for purposes of this subparagraph, be

4 deemed to be received over multiple years

5 rather than received in a single year. The

6 Secretary may, in the discretion of the Sec7 retary, determine how to apportion such

8 payment over multiple years.

9 ‘‘(c) BENEFIT IN ADDITION TO MEDICAL BENE10 FITS.—A benefit under subsection (a) or (b) shall be in

11 addition to any amounts received by an eligible individual

12 under section 264.

13 ‘‘SEC. 267. ADMINISTRATION.

14 ‘‘(a) ADMINISTRATION BY AGREEMENT WITH OTHER

15 AGENCY OR AGENCIES.—The Secretary may administer

16 any or all of the provisions of this part through Memo17 randum of Agreement with the head of any appropriate

18 Federal agency.

19 ‘‘(b) REGULATIONS.—The head of the agency admin20 istering this part or provisions thereof (including any

21 agency head administering such Act or provisions through

22 a Memorandum of Agreement under subsection (a)) may

23 promulgate such implementing regulations as may be

24 found necessary and appropriate. Initial implementing

25 regulations may be interim final regulations.
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1 ‘‘SEC. 268. AUTHORIZATION OF APPROPRIATIONS.

2 ‘‘For the purpose of carrying out this part, there are

3 authorized to be appropriated such sums as may be nec4 essary for each of the fiscal years 2003 through 2007, to

5 remain available until expended, including administrative

6 costs and costs of provision and payment of benefits. The

7 Secretary’s payment of any benefit under section 264,

8 265, or 266 shall be subject to the availability of appro9 priations under this section.

10 ‘‘SEC. 269. RELATIONSHIP TO OTHER LAWS.

11 ‘‘Except as explicitly provided herein, nothing in this

12 part shall be construed to override or limit any rights an

13 individual may have to seek compensation, benefits, or re14 dress under any other provision of Federal or State law.’’.

15 SEC. 3. AMENDMENTS TO PROVISION REGARDING TORT LI16 ABILITY FOR ADMINISTRATION OF SMALL17 POX COUNTERMEASURES.

18 (a) AMENDMENT TO ACCIDENTAL VACCINIA INOCU19 LATION PROVISION.—Section 224(p)(2)(C)(ii)(II) of such

20 Act (42 U.S.C. 233(p)(2)(C)(ii)(II)) is amended by strik21 ing ‘‘resides or has resided with’’ and inserting ‘‘has re22 sided with, or has had contact with,’’.

23 (b) DEEMING ACTS AND OMISSIONS TO BE WITHIN

24 SCOPE OF EMPLOYMENT.—Section 224(p)(2) of such Act

25 (42 U.S.C. 233(p)(2)) is amended by adding at the end

26 the following new subparagraph:
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1 ‘‘(D) ACTS AND OMISSIONS DEEMED TO BE

2 WITHIN SCOPE OF EMPLOYMENT.—

3 ‘‘(i) IN GENERAL.—In the case of a

4 claim arising out of alleged transmission of

5 vaccinia from an individual described in

6 clause (ii), acts or omissions by such indi7 vidual shall be deemed to have been taken

8 within the scope of such individual’s office

9 or employment for purposes of—

10 ‘‘(I) subsection (a); and

11 ‘‘(II) section 1346(b) and chap12 ter 171 of title 28, United States

13 Code.

14 ‘‘(ii) INDIVIDUALS TO WHOM DEEMING

15 APPLIES.—An individual is described by

16 this clause if—

17 ‘‘(I) vaccinia vaccine was admin18 istered to such individual as provided

19 by subparagraph (B); and

20 ‘‘(II) such individual was within

21 a category of individuals covered by a

22 declaration under subparagraph

23 (A)(i).’’.
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1 (c) EXHAUSTION; EXCLUSIVITY; OFFSET.—Section

2 224(p)(3) of such Act (42 U.S.C. 233(p)(3)) is amended

3 to read as follows:

4 ‘‘(3) EXHAUSTION; EXCLUSIVITY; OFFSET.—

5 ‘‘(A) EXHAUSTION.—

6 ‘‘(i) IN GENERAL.—A person may not

7 bring a claim under this subsection unless

8 such person has exhausted such remedies

9 as are available under part C of this title,

10 except that if the Secretary fails to make

11 a final determination on a request for ben12 efits or compensation filed in accordance

13 with the requirements of such part within

14 240 days after such request was filed, the

15 individual may seek any remedy that may

16 be available under this section.

17 ‘‘(ii) TOLLING OF STATUTE OF LIMI18 TATIONS.—The time limit for filing a claim

19 under this subsection, or for filing an ac20 tion based on such claim, shall be tolled

21 during the pendency of a request for bene22 fits or compensation under part C of this

23 title.

24 ‘‘(iii) CONSTRUCTION.—This sub25 section shall not be construed as super-
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1 seding or otherwise affecting the applica2 tion of a requirement, under chapter 171

3 of title 28, United States Code, to exhaust

4 administrative remedies.

5 ‘‘(B) EXCLUSIVITY.—The remedy provided

6 by subsection (a) shall be exclusive of any other

7 civil action or proceeding for any claim or suit

8 this subsection encompasses, except for a pro9 ceeding under part C of this title.

10 ‘‘(C) OFFSET.—The value of all compensa11 tion and benefits provided under part C of this

12 title for an incident or series of incidents shall

13 be offset against the amount of an award, com14 promise, or settlement of money damages in a

15 claim or suit under this subsection based on the

16 same incident or series of incidents.’’.

17 (d) REQUIREMENT TO COOPERATE WITH UNITED

18 STATES.—Section 224(p)(5) of such Act (42 U.S.C.

19 233(p)(5)) is amended in the caption by striking ‘‘DE20 FENDANT’’ and inserting ‘‘COVERED PERSON’’.

21 (e) AMENDMENT TO DEFINITION OF COVERED

22 COUNTERMEASURE.—Section 224(p)(7)(A)(i)(II) of such

23 Act (42 U.S.C. 233(p)(7)(A)(i)(II)) is amended to read

24 as follows:
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1 ‘‘(II) used to control or treat the

2 adverse effects of vaccinia inoculation

3 or of administration of another cov4 ered countermeasure; and’’.

5 (f) AMENDMENT TO DEFINITION OF COVERED PER6 SON.—Section 224(p)(7)(B) of such Act (42 U.S.C.

7 233(p)(7)(B)) is amended—

8 (1) by striking ‘‘includes any person’’ and in9 serting ‘‘means a person’’;

10 (2) in clause (ii)—

11 (A) by striking ‘‘auspices’’ and inserting

12 ‘‘auspices—’’;

13 (B) by redesignating ‘‘such counter14 measure’’ and all that follows as clause (I) and

15 indenting accordingly; and

16 (C) by adding at the end the following:

17 ‘‘(II) a determination was made

18 as to whether, or under what cir19 cumstances, an individual should re20 ceive a covered countermeasure;

21 ‘‘(III) the immediate site of ad22 ministration on the body of a covered

23 countermeasure was monitored, man24 aged, or cared for; or
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1 ‘‘(IV) an evaluation was made of

2 whether the administration of a coun3 termeasure was effective;’’;

4 (3) in clause (iii) by striking ‘‘or’’;

5 (4) by striking clause (iv) and inserting the fol6 lowing:

7 ‘‘(iv) a State, a political subdivision of

8 a State, or an agency or official of a State

9 or of such a political subdivision, if such

10 State, subdivision, agency, or official has

11 established requirements, provided policy

12 guidance, supplied technical or scientific

13 advice or assistance, or otherwise super14 vised or administered a program with re15 spect to administration of such counter16 measures;

17 ‘‘(v) in the case of a claim arising out

18 of alleged transmission of vaccinia from an

19 individual—

20 ‘‘(I) the individual who allegedly

21 transmitted the vaccinia, if vaccinia

22 vaccine was administered to such indi23 vidual as provided by paragraph

24 (2)(B) and such individual was within

25 a category of individuals covered by a
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1 declaration under paragraph (2)(A)(i);

2 or

3 ‘‘(II) an entity that employs an

4 individual described by clause (I) or

5 where such individual has privileges or

6 is otherwise authorized to provide

7 health care;

8 ‘‘(vi) an official, agent, or employee of

9 a person described in clause (i), (ii), (iii),

10 or (iv);

11 ‘‘(vii) a contractor of, or a volunteer

12 working for, a person described in clause

13 (i), (ii), or (iv), if the contractor or volun14 teer performs a function for which a per15 son described in clause (i), (ii), or (iv) is

16 a covered person; or

17 ‘‘(viii) an individual who has privileges

18 or is otherwise authorized to provide health

19 care under the auspices of an entity de20 scribed in clause (ii) or (v)(II).’’.

21 (g) AMENDMENT TO DEFINITION OF QUALIFIED

22 PERSON.—Section 224(p)(7)(C) of such Act (42 U.S.C.

23 233(p)(7)(C)) is amended—

24 (1) by designating ‘‘is authorized to’’ and all

25 that follows as clause (i) and indenting accordingly;
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1 (2) by striking ‘‘individual who’’ and inserting

2 ‘‘individual who—’’; and

3 (3) by striking the period and inserting ‘‘; or

4 ‘‘(ii) is otherwise authorized by the

5 Secretary to administer such counter6 measure.’’.

7 (h) DEFINITION OF ‘‘ARISING OUT OF ADMINISTRA8 TION OF A COVERED COUNTERMEASURE’’.—Section

9 224(p)(7) of such Act (42 U.S.C. 233(p)(7)) is amended

10 by adding at the end the following new subparagraph:

11 ‘‘(D) ARISING OUT OF ADMINISTRATION

12 OF A COVERED COUNTERMEASURE.—The term

13 ‘arising out of administration of a covered

14 countermeasure’, when used with respect to a

15 claim or liability, includes a claim or liability

16 arising out of—

17 ‘‘(i) determining whether, or under

18 what conditions, an individual should re19 ceive a covered countermeasure;

20 ‘‘(ii) obtaining informed consent of an

21 individual to the administration of a cov22 ered countermeasure;

23 ‘‘(iii) monitoring, management, or

24 care of an immediate site of administration

25 on the body of a covered countermeasure,
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1 or evaluation of whether the administration

2 of the countermeasure has been effective;

3 or

4 ‘‘(iv) transmission of vaccinia virus by

5 an individual to whom vaccinia vaccine was

6 administered as provided by paragraph

7 (2)(B).’’.

8 (i) TECHNICAL CORRECTION.—Section

9 224(p)(2)(A)(ii) of such Act (42 U.S.C. 233(p)(2)(A)(ii))

10 is amended by striking ‘‘paragraph (8)(A)’’ and inserting

11 ‘‘paragraph (7)(A)’’.

12 (j) EFFECTIVE DATE.—This section shall take effect

13 as of November 25, 2002.

Passed the House of Representatives April 11, 2003.

Attest:

Clerk.
108TH CONGRESS

1ST SESSION H. R. 1770

AN ACT

To provide benefits and other compensation for certain individuals with injuries resulting from administration of smallpox countermeasures, and

for other purposes.