H. R. 1770

One Hundred Eighth Congress

of the

United States of America

AT THE FIRST SESSION

Begun and held at the City of Washington on Tuesday,

the seventh day of January, two thousand and three

An Act

To provide benefits and other compensation for certain individuals with injuries

resulting from administration of smallpox countermeasures, and for other purposes.

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 ‘‘Smallpox Emergency Personnel

Protection Act of 2003’’.

SEC. 2. SMALLPOX EMERGENCY PERSONNEL PROTECTION.

Title II of the Public Health Service Act (42 U.S.C. 202 et

seq.) is amended by adding at the end the following part:

‘‘PART C—SMALLPOX EMERGENCY PERSONNEL PROTECTION

‘‘SEC. 261. GENERAL PROVISIONS.

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

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

countermeasure’ means a covered countermeasure as specified

in a Declaration made pursuant to section 224(p).

‘‘(2) COVERED INDIVIDUAL.—The term ‘covered individual’

means an individual—

‘‘(A) who is a health care worker, law enforcement

officer, firefighter, security personnel, emergency medical

personnel, other public safety personnel, or support personnel for such occupational specialities;

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

in a State, local, or Department of Health and Human

Services smallpox emergency response plan (as defined in

paragraph (7)) approved by the Secretary;

‘‘(C) who has volunteered and been selected to be a

member of a smallpox emergency response plan described

in subparagraph (B) prior to the time at which the Secretary publicly announces that an active case of smallpox

has been identified either within or outside of the United

States; and

‘‘(D) to whom a smallpox vaccine is administered pursuant to such approved plan during the effective period of

the Declaration (including the portion of such period before

the enactment of this part).

‘‘(3) COVERED INJURY.—The term ‘covered injury’ means

an injury, disability, illness, condition, or death (other than

a minor injury such as minor scarring or minor local reaction)
H. R. 1770—2

determined, pursuant to the procedures established under section 262, to have been sustained by an individual as the direct

result of—

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

countermeasure during the effective period of the Declaration; or

‘‘(B) accidental vaccinia inoculation of the individual

in circumstances in which—

‘‘(i) the vaccinia is contracted during the effective

period of the Declaration or within 30 days after the

end of such period;

‘‘(ii) smallpox vaccine has not been administered

to the individual; and

‘‘(iii) the individual has been in contact with an

individual who is (or who was accidentally inoculated

by) a covered individual.

‘‘(4) DECLARATION.—The term ‘Declaration’ means the Declaration Regarding Administration of Smallpox Countermeasures issued by the Secretary on January 24, 2003, and

published in the Federal Register on January 28, 2003.

‘‘(5) EFFECTIVE PERIOD OF THE DECLARATION.—The term

‘effective period of the Declaration’ means the effective period

specified in the Declaration, unless extended by the Secretary.

‘‘(6) ELIGIBLE INDIVIDUAL.—The term ‘eligible individual’

means an individual who is (as determined in accordance with

section 262)—

‘‘(A) a covered individual who sustains a covered injury

in the manner described in paragraph (3)(A); or

‘‘(B) an individual who sustains a covered injury in

the manner described in paragraph (3)(B).

‘‘(7) SMALLPOX EMERGENCY RESPONSE PLAN.—The term

‘smallpox emergency response plan’ or ‘plan’ means a response

plan detailing actions to be taken in preparation for a possible

smallpox-related emergency during the period prior to the

identification of an active case of smallpox either within or

outside the United States.

‘‘(b) VOLUNTARY PROGRAM.—The Secretary shall ensure that

a State, local, or Department of Health and Human Services plan

to vaccinate individuals that is approved by the Secretary establishes procedures to ensure, consistent with the Declaration and

any applicable guidelines of the Centers for Disease Control and

Prevention, that—

‘‘(1) potential participants are educated with respect to

contraindications, the voluntary nature of the program, and

the availability of potential benefits and compensation under

this part;

‘‘(2) there is voluntary screening provided to potential

participants that can identify health conditions relevant to

contraindications; and

‘‘(3) there is appropriate post-inoculation medical surveillance that includes an evaluation of adverse health effects

that may reasonably appear to be due to such vaccine and

prompt referral of, or the provision of appropriate information

to, any individual requiring health care as a result of such

adverse health event.
H. R. 1770—3

‘‘SEC. 262. DETERMINATION OF ELIGIBILITY AND BENEFITS.

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

for determining, as applicable with respect to an individual—

‘‘(1) whether the individual is an eligible individual;

‘‘(2) whether an eligible individual has sustained a covered

injury or injuries for which medical benefits or compensation

may be available under sections 264 and 265, and the amount

of such benefits or compensation; and

‘‘(3) whether the covered injury or injuries of an eligible

individual caused the individual’s death for purposes of benefits

under section 266.

‘‘(b) COVERED INDIVIDUALS.—The Secretary may accept a certification, by a Federal, State, or local government entity or private

health care entity participating in the administration of covered

countermeasures under the Declaration, that an individual is a

covered individual.

‘‘(c) CRITERIA FOR REIMBURSEMENT.—

‘‘(1) INJURIES SPECIFIED IN INJURY TABLE.—In any case

where an injury or other adverse effect specified in the injury

table established under section 263 as a known effect of a

vaccine manifests in an individual within the time period specified in such table, such injury or other effect shall be presumed

to have resulted from administration of such vaccine.

‘‘(2) OTHER DETERMINATIONS.—In making determinations

other than those described in paragraph (1) as to the causation

or severity of an injury, the Secretary shall employ a preponderance of the evidence standard and take into consideration all

relevant medical and scientific evidence presented for consideration, and may obtain and consider the views of qualified

medical experts.

‘‘(d) DEADLINE FOR FILING REQUEST.—The Secretary shall not

consider any request for a benefit under this part with respect

to an individual, unless—

‘‘(1) in the case of a request based on the administration

of the vaccine to the individual, the individual files with the

Secretary an initial request for benefits or compensation under

this part not later than one year after the date of administration

of the vaccine; or

‘‘(2) in the case of a request based on accidental vaccinia

inoculation, the individual files with the Secretary an initial

request for benefits or compensation under this part not later

than two years after the date of the first symptom or manifestation of onset of the adverse effect.

‘‘(e) STRUCTURED SETTLEMENTS AT SECRETARY’S OPTION.—In

any case in which there is a reasonable likelihood that compensation

or payment under section 264, 265, or 266(b) will be required

for a period in excess of one year from the date an individual

is determined eligible for such compensation or payment, the Secretary shall have the discretion to make a lump-sum payment,

purchase an annuity or medical insurance policy, or execute an

appropriate structured settlement agreement, provided that such

payment, annuity, policy, or agreement is actuarially determined

to have a value equal to the present value of the projected total

amount of benefits or compensation that the individual is eligible

to receive under such section or sections.

‘‘(f) REVIEW OF DETERMINATION.—
H. R. 1770—4

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

review a determination under this section at any time on the

Secretary’s own motion or on application, and may affirm,

vacate, or modify such determination in any manner the Secretary deems appropriate. The Secretary shall develop a process

by which an individual may file a request for reconsideration

of any determination made by the Secretary under this section.

‘‘(2) JUDICIAL AND ADMINISTRATIVE REVIEW.—No court of

the United States, or of any State, District, territory or possession thereof, shall have subject matter jurisdiction to review,

whether by mandamus or otherwise, any action by the Secretary under this section. No officer or employee of the United

States shall review any action by the Secretary under this

section (unless the President specifically directs otherwise).

‘‘SEC. 263. SMALLPOX VACCINE INJURY TABLE.

‘‘(a) SMALLPOX VACCINE INJURY TABLE.— ‘‘(1) ESTABLISHMENT REQUIRED.—The Secretary shall establish by interim final regulation a table identifying adverse

effects (including injuries, disabilities, illnesses, conditions, and

deaths) that shall be presumed to result from the administration of (or exposure to) a smallpox vaccine, and the time period

in which the first symptom or manifestation of onset of each

such adverse effect must manifest in order for such presumption

to apply.

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

amend the table established under paragraph (1). An amendment to the table takes effect on the date of the promulgation

of the final rule that makes the amendment, and applies to

all requests for benefits or compensation under this part that

are filed on or after such date or are pending as of such

date. In addition, the amendment applies retroactively to an

individual who was not with respect to the injury involved

an eligible individual under the table as in effect before the

amendment but who with respect to such injury is an eligible

individual under the table as amended. With respect to a

request for benefits or compensation under this part by an

individual who becomes an eligible individual as described in

the preceding sentence, the Secretary may not provide such

benefits or compensation unless the request (or amendment

to a request, as applicable) is filed before the expiration of

one year after the effective date of the amendment to the

table in the case of an individual to whom the vaccine was

administered and before the expiration of two years after such

effective date in the case of a request based on accidental

vaccinia inoculation.

‘‘SEC. 264. MEDICAL BENEFITS.

‘‘(a) IN GENERAL.—Subject to the succeeding provisions of this

section, the Secretary shall make payment or reimbursement for

medical items and services as reasonable and necessary to treat

a covered injury of an eligible individual, including the services,

appliances, and supplies prescribed or recommended by a qualified

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

reduce the degree or the period of disability, or aid in lessening

the amount of monthly compensation.

‘‘(b) BENEFITS SECONDARY TO OTHER COVERAGE.—Payment or

reimbursement for services or benefits under subsection (a) shall
H. R. 1770—5

be secondary to any obligation of the United States or any third

party (including any State or local governmental entity, private

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

or contractual agreement, to pay for or provide such services or

benefits.

‘‘SEC. 265. COMPENSATION FOR LOST EMPLOYMENT INCOME.

‘‘(a) IN GENERAL.—Subject to the succeeding provisions of this

section, the Secretary shall provide compensation to an eligible

individual for loss of employment income (based on such income

at the time of injury) incurred as a result of a covered injury,

at the rate specified in subsection (b).

‘‘(b) AMOUNT OF COMPENSATION.—

‘‘(1) IN GENERAL.—Compensation under subsection (a) shall

be at the rate of 662⁄3 percent of the relevant pay period

(weekly, monthly, or otherwise), except as provided in paragraph (2).

‘‘(2) AUGMENTED COMPENSATION FOR DEPENDENTS.—If an

eligible individual has one or more dependents, the basic compensation for loss of employment income as described in paragraph (1) shall be augmented at the rate of 81⁄3 percent.

‘‘(3) CONSIDERATION OF OTHER PROGRAMS.—

‘‘(A) IN GENERAL.—The Secretary may consider the

provisions of sections 8114, 8115, and 8146a of title 5,

United States Code, and any implementing regulations,

in determining the amount of payment under subsection

(a) and the circumstances under which such payments are

reasonable and necessary.

‘‘(B) MINORS.—With respect to an eligible individual

who is a minor, the Secretary may consider the provisions

of section 8113 of title 5, United States Code, and any

implementing regulations, in determining the amount of

payment under subsection (a) and the circumstances under

which such payments are reasonable and necessary.

‘‘(4) TREATMENT OF SELF-EMPLOYMENT INCOME.—For purposes of this section, the term ‘employment income’ includes

income from self-employment.

‘‘(c) LIMITATIONS.—

‘‘(1) BENEFITS SECONDARY TO OTHER COVERAGE.—

‘‘(A) IN GENERAL.—Any compensation under subsection

(a) shall be secondary to the obligation of the United States

or any third party (including any State or local governmental entity, private insurance carrier, or employer),

under any other law or contractual agreement, to pay compensation for loss of employment income or to provide

disability or retirement benefits.

‘‘(B) RELATION TO OTHER OBLIGATIONS.—Compensation

under subsection (a) shall not be made to an eligible individual to the extent that the total of amounts paid to

the individual under such subsection and under the other

obligations referred to in subparagraph (A) is an amount

that exceeds the rate specified in subsection (b)(1). If under

any such other obligation a lump-sum payment is made,

such payment shall, for purposes of this paragraph, be

deemed to be received over multiple years rather than
H. R. 1770—6

received in a single year. The Secretary may, in the discretion of the Secretary, determine how to apportion such

payment over multiple years.

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

be made under subsection (a) in compensation for loss of

employment income subsequent to the receipt, by the survivor

or survivors of an eligible individual, of benefits under section

266 for death.

‘‘(3) LIMIT ON TOTAL BENEFITS.— ‘‘(A) IN GENERAL.—Except as provided in subparagraph

(B)—

‘‘(i) total compensation paid to an individual under

subsection (a) shall not exceed $50,000 for any year;

and

‘‘(ii) the lifetime total of such compensation for

the individual may not exceed an amount equal to

the amount authorized to be paid under section 266.

‘‘(B) PERMANENT AND TOTAL DISABILITY.—The limitation under subparagraph (A)(ii) does not apply in the case

of an eligible individual who is determined to have a covered injury or injuries meeting the definition of disability

in section 216(i) of the Social Security Act (42 U.S.C. 416(i)).

‘‘(4) WAITING PERIOD.—

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

(B), an eligible individual shall not be provided compensation under this section for the first 5 work days of loss

of employment income.

‘‘(B) EXCEPTION.—Subparagraph (A) does not apply if

the period of loss of employment income of an eligible

individual is 10 or more work days.

‘‘(5) TERMINATION OF BENEFITS.—No payment shall be made

under subsection (a) in compensation for loss of employment

income once the eligible individual involves reaches the age

of 65.

‘‘(d) BENEFIT IN ADDITION TO MEDICAL BENEFITS.—A benefit

under subsection (a) shall be in addition to any amounts received

by an eligible individual under section 264.

‘‘SEC. 266. PAYMENT FOR DEATH.

‘‘(a) DEATH BENEFIT.—

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

of an eligible individual whose death is determined to have

resulted from a covered injury or injuries, a death benefit

in the amount determined under paragraph (2) to the survivor

or survivors in the same manner as death benefits are paid

pursuant to 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.) with

respect to an eligible deceased (except that in the case of

an eligible individual who is a minor with no living parent,

the legal guardian shall be considered the survivor in the

place of the parent).

‘‘(2) BENEFIT AMOUNT.—

‘‘(A) IN GENERAL.—The amount of the death benefit

under paragraph (1) in a fiscal year shall equal the amount

of the comparable benefit calculated under the Public

Safety Officers’ Benefits Program under subpart 1 of part
H. R. 1770—7

L of title I of the Omnibus Crime Control and Safe Streets

Act of 1968 (42 U.S.C. 3796 et seq.) in such fiscal year,

without regard to any reduction attributable to a limitation

on appropriations, but subject to subparagraph (B).

‘‘(B) REDUCTION FOR PAYMENTS FOR LOST EMPLOYMENT

INCOME.—The amount of the benefit as determined under

subparagraph (A) shall be reduced by the total amount

of any benefits paid under section 265 with respect to

lost employment income.

‘‘(3) LIMITATIONS.—

‘‘(A) IN GENERAL.—No benefit is payable under paragraph (1) with respect to the death of an eligible individual

if—

‘‘(i) a disability benefit is paid with respect to

such individual 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) a death benefit is paid or payable with respect

to such individual 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.).

‘‘(B) EXCEPTION IN THE CASE OF A LIMITATION ON APPROPRIATIONS FOR DISABILITY BENEFITS UNDER PSOB.—In the

event that disability benefits available to an eligible individual 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.) are reduced because of a limitation on appropriations,

and such reduction would affect the amount that would

be payable under subparagraph (A) without regard to this

subparagraph, benefits shall be available under paragraph

(1) to the extent necessary to ensure that the survivor

or survivors of such individual receives a total amount

equal to the amount described in paragraph (2).

‘‘(b) ELECTION IN CASE OF DEPENDENTS.—

‘‘(1) IN GENERAL.—In the case of an eligible individual

whose death is determined to have resulted from a covered

injury or injuries, if the individual had one or more dependents

under the age of 18, the legal guardian of the dependents

may, in lieu of the death benefit under subsection (a), elect

to receive on behalf of the aggregate of such dependents payments in accordance with this subsection. An election under

the preceding sentence is effective in lieu of a request under

subsection (a) by an individual who is not the legal guardian

of such dependents.

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

(1) with respect to an eligible individual described in such

paragraph shall be made as if such individual were an eligible

individual to whom compensation would be paid under subsection (a) of section 265, with the rate augmented in accordance with subsection (b)(2) of such section and with such individual considered to be an eligible individual described in subsection (c)(3)(B) of such section.

‘‘(3) LIMITATIONS.—
H. R. 1770—8

‘‘(A) AGE OF DEPENDENTS.—No payments may be made

under paragraph (1) once the youngest of the dependents

involved reaches the age of 18.

‘‘(B) BENEFITS SECONDARY TO OTHER COVERAGE.—

‘‘(i) IN GENERAL.—Any payment under paragraph

(1) shall be secondary to the obligation of the United

States or any third party (including any State or local

governmental entity, private insurance carrier, or

employer), under any other law or contractual agreement, to pay compensation for loss of employment

income or to provide disability benefits, retirement

benefits, life insurance benefits on behalf of dependents

under the age of 18, or death benefits.

‘‘(ii) RELATION TO OTHER OBLIGATIONS.—Payments

under paragraph (1) shall not be made to with respect

to an eligible individual to the extent that the total

of amounts paid with respect to the individual under

such paragraph and under the other obligations

referred to in clause (i) is an amount that exceeds

the rate of payment that applies under paragraph (2).

If under any such other obligation a lump-sum payment is made, such payment shall, for purposes of

this subparagraph, be deemed to be received over multiple years rather than received in a single year. The

Secretary may, in the discretion of the Secretary, determine how to apportion such payment over multiple

years.

‘‘(c) BENEFIT IN ADDITION TO MEDICAL BENEFITS.—A benefit

under subsection (a) or (b) shall be in addition to any amounts

received by an eligible individual under section 264.

‘‘SEC. 267. ADMINISTRATION.

‘‘(a) ADMINISTRATION BY AGREEMENT WITH OTHER AGENCY OR

AGENCIES.—The Secretary may administer any or all of the provisions of this part through Memorandum of Agreement with the

head of any appropriate Federal agency.

‘‘(b) REGULATIONS.—The head of the agency administering this

part or provisions thereof (including any agency head administering

such Act or provisions through a Memorandum of Agreement under

subsection (a)) may promulgate such implementing regulations as

may be found necessary and appropriate. Initial implementing regulations may be interim final regulations.

‘‘SEC. 268. AUTHORIZATION OF APPROPRIATIONS.

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

to be appropriated such sums as may be necessary for each of

the fiscal years 2003 through 2007, to remain available until

expended, including administrative costs and costs of provision and

payment of benefits. The Secretary’s payment of any benefit under

section 264, 265, or 266 shall be subject to the availability of

appropriations under this section.

‘‘SEC. 269. RELATIONSHIP TO OTHER LAWS.

‘‘Except as explicitly provided herein, nothing in this part shall

be construed to override or limit any rights an individual may

have to seek compensation, benefits, or redress under any other

provision of Federal or State law.’’.
H. R. 1770—9

SEC. 3. AMENDMENTS TO PROVISION REGARDING TORT LIABILITY

FOR ADMINISTRATION OF SMALLPOX COUNTERMEASURES.

(a) AMENDMENT TO ACCIDENTAL VACCINIA INOCULATION PROVI- SION.—Section 224(p)(2)(C)(ii)(II) of such Act (42 U.S.C.

233(p)(2)(C)(ii)(II)) is amended by striking ‘‘resides or has resided

with’’ and inserting ‘‘has resided with, or has had contact with,’’.

(b) DEEMING ACTS AND OMISSIONS TO BE WITHIN SCOPE OF

EMPLOYMENT.—Section 224(p)(2) of such Act (42 U.S.C. 233(p)(2))

is amended by adding at the end the following new subparagraph:

‘‘(D) ACTS AND OMISSIONS DEEMED TO BE WITHIN SCOPE

OF EMPLOYMENT.— ‘‘(i) IN GENERAL.—In the case of a claim arising

out of alleged transmission of vaccinia from an individual described in clause (ii), acts or omissions by

such individual shall be deemed to have been taken

within the scope of such individual’s office or employment for purposes of—

‘‘(I) subsection (a); and

‘‘(II) section 1346(b) and chapter 171 of title

28, United States Code.

‘‘(ii) INDIVIDUALS TO WHOM DEEMING APPLIES.—An

individual is described by this clause if—

‘‘(I) vaccinia vaccine was administered to such

individual as provided by subparagraph (B); and

‘‘(II) such individual was within a category

of individuals covered by a declaration under

subparagraph (A)(i).’’.

(c) EXHAUSTION; EXCLUSIVITY; OFFSET.—Section 224(p)(3) of

such Act (42 U.S.C. 233(p)(3)) is amended to read as follows:

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

‘‘(A) EXHAUSTION.— ‘‘(i) IN GENERAL.—A person may not bring a claim

under this subsection unless such person has

exhausted such remedies as are available under part

C of this title, except that if the Secretary fails to

make a final determination on a request for benefits

or compensation filed in accordance with the requirements of such part within 240 days after such request

was filed, the individual may seek any remedy that

may be available under this section.

‘‘(ii) TOLLING OF STATUTE OF LIMITATIONS.—The

time limit for filing a claim under this subsection,

or for filing an action based on such claim, shall be

tolled during the pendency of a request for benefits

or compensation under part C of this title.

‘‘(iii) CONSTRUCTION.—This subsection shall not be

construed as superseding or otherwise affecting the

application of a requirement, under chapter 171 of

title 28, United States Code, to exhaust administrative

remedies.

‘‘(B) EXCLUSIVITY.—The remedy provided by subsection

(a) shall be exclusive of any other civil action or proceeding

for any claim or suit this subsection encompasses, except

for a proceeding under part C of this title.

‘‘(C) OFFSET.—The value of all compensation and benefits provided under part C of this title for an incident
H. R. 1770—10

or series of incidents shall be offset against the amount

of an award, compromise, or settlement of money damages

in a claim or suit under this subsection based on the

same incident or series of incidents.’’.

(d) REQUIREMENT TO COOPERATE WITH UNITED STATES.—Section 224(p)(5) of such Act (42 U.S.C. 233(p)(5)) is amended in

the caption by striking ‘‘DEFENDANT’’ and inserting ‘‘COVERED PERSON’’.

(e) AMENDMENT TO DEFINITION OF COVERED COUNTERMEASURE.—Section 224(p)(7)(A)(i)(II) of such Act (42 U.S.C.

233(p)(7)(A)(i)(II)) is amended to read as follows:

‘‘(II) used to control or treat the adverse effects

of vaccinia inoculation or of administration of

another covered countermeasure; and’’.

(f) AMENDMENT TO DEFINITION OF COVERED PERSON.—Section

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

(1) by striking ‘‘includes any person’’ and inserting ‘‘means

a person’’;

(2) in clause (ii)—

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

’’;

(B) by redesignating ‘‘such countermeasure’’ and all

that follows as clause (I) and indenting accordingly; and

(C) by adding at the end the following:

‘‘(II) a determination was made as to whether,

or under what circumstances, an individual should

receive a covered countermeasure;

‘‘(III) the immediate site of administration on

the body of a covered countermeasure was monitored, managed, or cared for; or

‘‘(IV) an evaluation was made of whether the

administration of a countermeasure was effective;’’;

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

(4) by striking clause (iv) and inserting the following:

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

or an agency or official of a State or of such a political

subdivision, if such State, subdivision, agency, or official has established requirements, provided policy guidance, supplied technical or scientific advice or assistance, or otherwise supervised or administered a program with respect to administration of such countermeasures;

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

transmission of vaccinia from an individual—

‘‘(I) the individual who allegedly transmitted

the vaccinia, if vaccinia vaccine was administered

to such individual as provided by paragraph (2)(B)

and such individual was within a category of

individuals covered by a declaration under paragraph (2)(A)(i); or

‘‘(II) an entity that employs an individual

described by clause (I) or where such individual

has privileges or is otherwise authorized to provide

health care;

‘‘(vi) an official, agent, or employee of a person

described in clause (i), (ii), (iii), or (iv);
H. R. 1770—11

‘‘(vii) a contractor of, or a volunteer working for,

a person described in clause (i), (ii), or (iv), if the

contractor or volunteer performs a function for which

a person described in clause (i), (ii), or (iv) is a covered

person; or

‘‘(viii) an individual who has privileges or is otherwise authorized to provide health care under the auspices of an entity described in clause (ii) or (v)(II).’’.

(g) AMENDMENT TO DEFINITION OF QUALIFIED PERSON.—Section

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

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

as clause (i) and indenting accordingly;

(2) by striking ‘‘individual who’’ and inserting ‘‘individual

who—’’; and

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

‘‘(ii) is otherwise authorized by the Secretary to

administer such countermeasure.’’.

(h) DEFINITION OF ‘‘ARISING OUT OF ADMINISTRATION OF A COVERED COUNTERMEASURE’’.—Section 224(p)(7) of such Act (42 U.S.C.

233(p)(7)) is amended by adding at the end the following new

subparagraph:

‘‘(D) ARISING OUT OF ADMINISTRATION OF A COVERED

COUNTERMEASURE.—The term ‘arising out of administration

of a covered countermeasure’, when used with respect to

a claim or liability, includes a claim or liability arising

out of—

‘‘(i) determining whether, or under what conditions, an individual should receive a covered countermeasure;

‘‘(ii) obtaining informed consent of an individual

to the administration of a covered countermeasure;

‘‘(iii) monitoring, management, or care of an immediate site of administration on the body of a covered

countermeasure, or evaluation of whether the administration of the countermeasure has been effective; or

‘‘(iv) transmission of vaccinia virus by an individual to whom vaccinia vaccine was administered as

provided by paragraph (2)(B).’’.

(i) TECHNICAL CORRECTION.—Section 224(p)(2)(A)(ii) of such Act

(42 U.S.C. 233(p)(2)(A)(ii)) is amended by striking ‘‘paragraph (8)(A)’’

and inserting ‘‘paragraph (7)(A)’’.
H. R. 1770—12

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

November 25, 2002.

Speaker of the House of Representatives.

Vice President of the United States and

President of the Senate.