[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 865 Introduced in House (IH)]







108th CONGRESS
  1st Session
                                H. R. 865

  To protect the health and safety of individuals receiving smallpox 
vaccinations and to provide compensation and assured access to care for 
      individuals injured by the vaccine, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 13, 2003

Mr. Waxman (for himself, Mr. Brown of Ohio, Mrs. Capps, and Mr. Markey) 
 introduced the following bill; which was referred to the Committee on 
Energy and Commerce, and in addition to the Committee on Education and 
   the Workforce, for a period to be subsequently determined by the 
  Speaker, in each case for consideration of such provisions as fall 
           within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
  To protect the health and safety of individuals receiving smallpox 
vaccinations and to provide compensation and assured access to care for 
      individuals injured by the vaccine, 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 Vaccine Compensation and 
Safety Act of 2003''.

SEC. 2. SMALLPOX VACCINATIONS.

    The Public Health Service Act (42 U.S.C. 201 et seq.) is amended by 
adding at the end the following:

              ``TITLE XXIX--ADDITIONAL VACCINE PROVISIONS

``SEC. 2901. COVERED COUNTERMEASURE.

    ``For purposes of this title, the terms ``covered countermeasure'' 
and ``covered countermeasure against smallpox'' have the meanings given 
to those terms in section 224(p)(7)(A).

``SEC. 2902. GRANTS TO ASSIST STATE AND LOCAL GOVERNMENTS IN MEETING 
              THE COSTS OF SMALLPOX INOCULATION PROGRAMS.

    ``(a) In General.--
            ``(1) Grants.--For the purposes described in paragraph (2), 
        the Secretary shall make an allotment each fiscal year for each 
        State in an amount determined in accordance with subsection 
        (e). The Secretary shall make a grant to the State of the 
        allotment made for the State for the fiscal year if the State 
        submits to the Secretary an application at such time, in such 
        manner, and containing such information as the Secretary may 
        require.
            ``(2) Purposes.--A funding agreement for a grant under this 
        section is that the State involved will expend the grant only 
        for the following purposes:
                    ``(A) Providing for the administration of covered 
                countermeasures against smallpox.
                    ``(B) Monitoring the health of individuals 
                receiving covered countermeasures against smallpox or 
                individuals in close contact with individuals receiving 
                such countermeasures.
                    ``(C) Providing for the conduct of epidemiological 
                studies related to the administration of covered 
                countermeasures against smallpox.
    ``(b) Supplement Not Supplant.--A funding agreement for a grant 
under this section is that the State involved will use the grant to 
supplement and not supplant funds received from other sources for the 
purposes described in subsection (a).
    ``(c) Local Involvement.--A funding agreement for a grant under 
this section is that the State involved will ensure that a suitable 
portion of the amount received under the grant is expended at the local 
level.
    ``(d) Requirements.--
            ``(1) In general.--A funding agreement for a grant under 
        this section is that the State involved will comply with the 
        requirements of this subsection.
            ``(2) Education program.--
                    ``(A) Establishment.--Each State that receives a 
                grant under this section shall establish an education 
                program to provide to each individual to whom a covered 
                countermeasure against smallpox is proposed to be 
                administered an explanation of--
                            ``(i) the screening and medical 
                        surveillance and evaluation programs available 
                        under paragraphs (3) and (4);
                            ``(ii) the risks and benefits from 
                        administration of such countermeasure for such 
                        individuals and those individuals with whom 
                        they have close contact;
                            ``(iii) the availability of the 
                        compensation program under section 224(q);
                            ``(iv) the eligibility of the individual to 
                        receive health care as described in this Act;
                            ``(v) the right of the individual to refuse 
                        the administration of any covered 
                        countermeasure against smallpox;
                            ``(vi) the right of an individual who 
                        exercises the option described in clause (v) to 
                        be protected from disciplinary action under 
                        section 2903; and
                            ``(vii) the general functions and duties 
                        that such individual may be expected to carry 
                        out if there is a smallpox outbreak.
                    ``(B) Explanations.--Explanations provided under 
                subparagraph (A)--
                            ``(i) shall be made available in a form 
                        that is easily read and understood;
                            ``(ii) shall be provided, as appropriate, 
                        in languages other than English;
                            ``(iii) shall be made available to those 
                        individuals who reside with individuals to whom 
                        such covered countermeasure is proposed to be 
                        administered and, as appropriate, to patients 
                        treated by individuals who have received a 
                        covered countermeasure; and
                            ``(iv) shall be made available without 
                        charge or loss of wages or benefits to an 
                        individual to whom a covered countermeasure 
                        against smallpox is proposed to be administered 
                        and to the individuals described in clause 
                        (iii).
            ``(3) Screening program.--
                    ``(A) In general.--Each State that receives a grant 
                under this section shall, for each individual to whom a 
                covered countermeasure against smallpox is proposed to 
                be administered--
                            ``(i) provide without charge counseling 
                        services that describe conditions which may 
                        exacerbate the risks of receiving such 
                        countermeasure; and
                            ``(ii) offer on a voluntary basis, 
                        screening and testing that can identify health 
                        conditions that can reasonably be expected to 
                        significantly increase risks to the health of 
                        such individual, including screening and 
                        testing for human immunodeficiency virus, 
                        eczema or other significant chronic skin 
                        irritation, pregnancy, and such other 
                        conditions as determined appropriate by the 
                        Secretary.
                    ``(B) Results.--The results or other information 
                (including information concerning an individual's 
                refusal to be screened or tested) generated or obtained 
                from the screening and testing described in 
                subparagraph (A)--
                            ``(i) shall be deemed protected health 
                        information under the meaning of the term in 
                        the regulations promulgated pursuant to the 
                        authority of section 264(c) of the Health 
                        Insurance Portability and Accountability Act of 
                        1996;
                            ``(ii) shall not be made available to an 
                        employer; and
                            ``(iii) shall be provided without charge to 
                        the individual receiving such screening and 
                        testing.
            ``(4) Medical surveillance and evaluation program.--If the 
        Secretary declares vaccinia vaccine or any other measure to be 
        a covered countermeasure under section 224(p), each State that 
        receives a grant under this section shall ensure that an 
        ongoing active medical surveillance and evaluation program is 
        provided to all individuals to whom such countermeasure is 
        administered and to the close contacts of such individuals. 
        Such program shall--
                    ``(A) be provided from the date that vaccinia 
                vaccine or another covered countermeasure is 
                administered to a date that is not less than 60 days 
                from the date of administration;
                    ``(B) include evaluation of any adverse health 
                effect that may reasonably appear to be due to vaccinia 
                vaccine or another covered countermeasure and shall 
provide prompt medical treatment or referral of any individual 
requiring health care as a result of such adverse health effect; and
                    ``(C) be provided without charge to any individual 
                to whom vaccinia vaccine or another covered 
                countermeasure is administered and to the close 
                contacts of such individuals.
            ``(5) Needles.--If the Secretary declares vaccinia vaccine 
        to be a covered countermeasure under section 224(p), each State 
        that receives a grant under this section shall ensure that for 
        any administration of such vaccine, the individual 
        administering such vaccine shall use a sheathed bifurcated 
        needle--
                    ``(A) to the extent that such needle is approved 
                under the Federal Food, Drug, and Cosmetic Act; and
                    ``(B) to the extent that such sheathed bifurcated 
                needle is available in such State.
    ``(e) Funding.--
            ``(1) Authorization of appropriations.--For carrying out 
        this section, there are authorized to be appropriated 
        $850,000,000 for fiscal year 2003 and such sums as may be 
        necessary for each subsequent fiscal year.
            ``(2) Allocation.--From the amounts appropriated and 
        available for allotment under this subsection for any fiscal 
        year, the Secretary shall allot to each State that submits an 
        application in accordance with subsection (a)(1) an amount that 
        is the greater of--
                    ``(A) the base amount as determined under paragraph 
                (3); or
                    ``(B) the minimum amount as determined under 
                paragraph (4).
            ``(3) Base amount.--For each State receiving an award under 
        this section, the Secretary shall determine the base amount, 
        which shall be equal to the product of--
                    ``(A) the amount appropriated under this subsection 
                for the fiscal year, less an amount equal to the sum of 
                all minimum amounts determined for the States under 
                paragraph (4); and
                    ``(B) the percentage constituted by the ratio of an 
                amount equal to the population of the State over an 
                amount equal to the total population of the States (as 
                indicated by the most recent data collected by the 
                Bureau of the Census).
            ``(4) Minimum amount.--For each State receiving an award 
        under this subsection, the minimum amount is--
                    ``(A) in the case of each of the several States, 
                the District of Columbia, and the Commonwealth of 
                Puerto Rico, an amount equal to the lesser of--
                            ``(i) $5,000,000; or
                            ``(ii) if the amount appropriated under 
                        this subsection is less than $667,000,000, an 
                        amount equal to 0.75 percent of the amount 
                        appropriated under this subsection; or
                    ``(B) in the case of each of American Samoa, Guam, 
                the Commonwealth of the Northern Mariana Islands, and 
                the United States Virgin Islands, an amount determined 
                by the Secretary to be appropriate, except that such 
                amount may not exceed the amount determined under 
                subparagraph (A).

``SEC. 2903. PROTECTION FROM DISCIPLINARY ACTION.

    ``(a) Finding.--The Congress finds that unlawful employment 
practices described in subsection (b) are detrimental to the general 
public health and an interference with the interstate control of 
infectious disease.
    ``(b) In General.--It shall be an unlawful employment practice for 
an employer--
            ``(1) to fail or refuse to hire or to discharge any 
        individual, or otherwise to discriminate against any individual 
        with respect to the compensation, terms, conditions, or 
        privileges of employment of the individual, because of a 
        refusal or inability to receive the administration of a covered 
        countermeasure against smallpox or because of an adverse 
        reaction or reactions to such countermeasure; or
            ``(2) subject to subsection (c), to limit, segregate, or 
        classify the employees of the employer in any way that would 
        deprive or tend to deprive any individual of employment 
        opportunities or otherwise adversely affect the status of the 
        individual as an employee, because of a refusal or inability to 
        receive a covered countermeasure against smallpox or because of 
        an adverse reaction or reactions to such countermeasure.
    ``(c) Exception.--
            ``(1) In general.--This section does not prohibit an 
        employer from limiting, segregating, or classifying for a 
        period of 30 days or less an employee to whom a covered 
        countermeasure against smallpox has been administered for the 
        purpose of protecting the close contacts (including patients) 
        of such employee.
            ``(2) Regular wages and benefits required.--Nothing in 
        paragraph (1) shall be construed to permit an employer to 
        reduce the wages or benefits of an employee because a covered 
        countermeasure against smallpox has been administered to such 
        employee.
    ``(d) Definitions of Employee and Employer.--The terms `employee' 
and `employer' have the meanings given such terms in section 701 of the 
Civil Rights Act of 1964 (42 U.S.C. 2000e), except that the terms 
`employee' and `employer' shall also include the meanings given such 
terms in section 717 of the Civil Rights Act of 1964 (42 U.S.C. 2000e-
16).
    ``(e) Filing Complaints and Procedures.--
            ``(1) Complaint.--
                    ``(A) In general.--Not later than 180 days after an 
                alleged violation of subsection (b) has occurred, the 
                employee alleging such violation or another individual 
                at the employee's request, may file a complaint with 
                the Secretary.
                    ``(B) Notice.--Not later than 15 days after receipt 
                of a complaint described in subparagraph (A), the 
                Secretary shall notify the employer alleged in the 
                complaint to have committed a violation of subsection 
                (b) of the filing of such complaint.
            ``(2) Findings and preliminary order.--
                    ``(A) In general.--Not later than 60 days after 
                receiving a complaint described in paragraph (1), the 
                Secretary shall--
                            ``(i) conduct an investigation of the 
                        matters alleged in the complaint;
                            ``(ii) determine whether it is reasonable 
                        to believe that the complaint has merit; and
                            ``(iii) notify the complainant and the 
                        employer alleged to have committed the 
                        violation of subsection (b) of the 
                        determination.
                    ``(B) Reasonable belief that a violation has 
                occurred.--If the Secretary determines pursuant to 
                subparagraph (A) that it is reasonable to believe that 
                a violation of subsection (b) has occurred, the 
                Secretary shall include with the notice under such 
                subparagraph findings and a preliminary order for the 
                relief provided under paragraph (3).
                    ``(C) Objections.--
                            ``(i) In general.--Not later than 30 days 
                        after receipt of the notice under subparagraph 
                        (A), the complainant and the employer alleged 
                        to have committed the violation of subsection 
                        (b) may file objections to the findings or the 
                        preliminary order and request a hearing on the 
                        record.
                            ``(ii) Reinstatement.--The filing of 
                        objections under clause (i) does not stay a 
                        reinstatement ordered in the preliminary order.
                            ``(iii) Failure to object.--If a hearing is 
                        not requested pursuant to the requirements of 
                        clause (i), the preliminary order is final and 
                        not subject to judicial review.
                    ``(D) Hearings and final order.--
                            ``(i) Hearings.--A hearing under this 
                        subsection shall be conducted expeditiously.
                            ``(ii) Final order.--Not later that 120 
                        days after the end of a hearing under this 
                        subsection, the Secretary shall issue a final 
                        order.
                            ``(iii) Settlement.--At any time prior to 
                        the issuance of a final order, any further 
                        action under this subsection may be ended by a 
                        settlement agreement made by the complainant 
                        and the employer alleged to have committed the 
                        violation of subsection (b), and approved by 
                        the Secretary.
            ``(3) Relief.--
                    ``(A) In general.--If the Secretary determines on 
                the basis of a complaint, that an employer violated 
                subsection (b) of this section, the Secretary shall 
                order such employer to provide relief including--
                            ``(i) taking affirmative action to abate 
                        the violation;
                            ``(ii) reinstating the complainant to the 
                        former position with the same pay and terms and 
                        privileges of employment; and
                            ``(iii) paying compensatory damages, 
                        including back pay.
                    ``(B) Costs incurred in bringing a complaint.--If 
                the Secretary issues an order under subparagraph (A), 
                and the complainant so requests, the Secretary may 
                order that the employer who violated subsection (b) pay 
                the costs (including attorney's fees) reasonably 
                incurred by the complainant in bringing the complaint, 
                as determined by the Secretary.
    ``(f) Judicial Review and Venue.--
            ``(1) In general.--Not later than 60 days after an order 
        has been issued under subsection (e), a party adversely 
        affected by such order may file a petition for review in the 
        United States circuit court for the circuit in which the 
        violation occurred or in which the party resided on the date of 
        the violation.
            ``(2) Review.--A review conducted pursuant to this 
        subsection shall be heard and decided expeditiously.
            ``(3) Review in other proceedings.--An order of the 
        Secretary subject to review under this subsection is not 
        subject to judicial review in a criminal or other civil 
        proceeding.
    ``(g) Civil Actions To Enforce.--If an employer fails to comply 
with an order issued under subsection (e), the Secretary shall bring a 
civil action to enforce such order in the United States district court 
for the district in which the violation occurred.

``SEC. 2904. MEDICAL LEAVE FOR CERTAIN VACCINE RECIPIENTS.

    ``(a) In General.--In accordance with regulations promulgated by 
the Secretary, an employee (as defined in section 3 of the Fair Labor 
Standards Act of 1938) shall be entitled to a total of not more than 4 
workdays of paid leave because of a health condition that makes the 
employee unable to perform the functions of the position of such 
employee that arose as a result of the employee having received or come 
into close contact with an individual who received a covered 
countermeasure against smallpox.
    ``(b) Application of Certain Provisions.--Leave shall be provided 
under subsection (a) in accordance with the provisions of the Family 
and Medical Leave Act of 1993 except that--
            ``(1) such leave shall be provided for a condition 
        described in subsection (a) regardless of whether such 
        condition requires inpatient care or continuing treatment;
            ``(2) such leave shall be fully paid; and
            ``(3) this section shall apply to all employers regardless 
        of size.
    ``(c) Reimbursement From the Program.--
            ``(1) Non-federal employees.--Any employer, other than a 
        Federal agency, that provides paid leave to an employee for the 
        reasons described in subsection (a) may seek reimbursement for 
        such leave from the compensation program under section 224(q).
            ``(2) Federal employees.--A Federal agency that provides 
        leave under this section shall treat such leave as paid 
        administrative leave.

``SEC. 2905. RESPONSIBILITIES OF THE SECRETARY.

    ``(a) Supplies of Vaccinia Immune Globulin.--If the Secretary 
declares vaccinia vaccine to be a covered countermeasure under section 
224(p), the Secretary shall ensure that adequate supplies of vaccinia 
immune globulin are made available to any individual to whom vaccinia 
vaccine is administered during the period of such declaration.
    ``(b) Uniform System of Reporting.--
            ``(1) In general.--The Secretary shall establish a uniform 
        system for reporting adverse responses to any covered 
        countermeasure against smallpox to the Secretary.
            ``(2) Report to congress.--Not later than 1 year after the 
        date of enactment of this Act and every year in which covered 
        countermeasures against smallpox are administered, the 
        Secretary shall submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives, a report that 
        describes for the preceding year--
                    ``(A) the number of individuals to whom a covered 
                countermeasure against smallpox was administered; and
                    ``(B) the number and kind of adverse reactions 
                caused by the administration of a covered 
                countermeasure against smallpox.

``SEC. 2906. PROVISION OF NEEDLES.

    ``The Director of the Centers for Disease Control and Prevention 
shall provide needles to States that receive a grant under section 2902 
for the purpose of administering vaccinia vaccine in accordance with 
section 2902(d)(5).''.

SEC. 3. HEALTH CARE FOR HEALTH CARE WORKERS AND FIRST RESPONDERS 
              SUFFERING ADVERSE REACTIONS OR COMPLICATIONS FROM 
              SMALLPOX VACCINE; CONTINUED INSURANCE COVERAGE.

    (a) Payments for Provision of Medical Assistance.--Title XXIX of 
the Public Health Service Act (as added by section 2) is amended by 
adding at the end the following:

``SEC. 2907. HEALTH CARE FOR INDIVIDUALS SUFFERING ADVERSE REACTIONS OR 
              COMPLICATIONS FROM SMALLPOX VACCINE.

    ``(a) Payment.--
            ``(1) In general.--The Secretary shall pay to each State 
        with an agreement described in subsection (b) an amount equal 
        to the costs incurred by that State to provide medical 
        assistance described in subsection (b)(1), subject to paragraph 
        (2).
            ``(2) Limitation on payment.--The Secretary shall not make 
        any payment under paragraph (1) for costs for medical 
        assistance insofar as such costs may reasonably be reimbursed 
        from a third party under the terms of the agreement described 
        in subsection (b)(2). Any payment under this section to a State 
        with respect to medical assistance shall be conditioned on 
        reimbursement to the Secretary when notice or other information 
        is received that payment for such medical assistance has been 
        or could be made by a third party under subsection (b)(2).
    ``(b) Agreement.--An agreement described in this subsection is an 
agreement between a State and the Secretary in which the State--
            ``(1) agrees to provide such medical assistance as may be 
        medically necessary to--
                    ``(A) any health care worker or first responder 
                who--
                            ``(i) has suffered any adverse reaction or 
                        complication as a result of a covered 
                        countermeasure against smallpox or exposure to 
                        vaccinia virus or any other substance 
                        administered for the prevention or treatment of 
                        smallpox; and
                            ``(ii) has not received compensation under 
                        the National Smallpox Vaccine Injury 
                        Compensation Program established under section 
                        224; and
                    ``(B) any individual who--
                            ``(i) has suffered any adverse reaction or 
                        complication as a result of contact with 
                        another person who received a covered 
                        countermeasure; and
                            ``(ii) has not received compensation under 
                        the National Smallpox Vaccine Injury 
                        Compensation Program established under section 
                        224; and
            ``(2) agrees to take all reasonable measures to obtain 
        reimbursement for the costs of providing such assistance from 
        any third party (including health insurers and group health 
        plans (as defined in section 2791)) with responsibility for 
        such costs.
    ``(c) State Entitlement.--This section constitutes budget authority 
in advance of appropriations Acts and represents the obligation of the 
Federal Government to provide for the payment to States of amounts 
provided under this section.
    ``(d) Rule of Construction.--
            ``(1) Insurance coverage.--Nothing in this section shall be 
        construed to invalidate or otherwise abridge any provision of 
        law or any contractual obligation that otherwise obligates a 
        health insurance issuer to provide reimbursement or otherwise 
        defray the cost to an individual of health care needed to treat 
        the health consequences of the administration of or exposure to 
        a covered countermeasure against smallpox or exposure to 
        vaccinia virus.
            ``(2) Health care facilities.--Nothing in this section 
        shall be construed to invalidate or otherwise abridge any 
        provision of law or any contractual obligation that otherwise 
        obligates a health care facility to provide health care or 
        other health services to an individual that are needed to treat 
        the health consequences of the administration of a covered 
        countermeasure against smallpox or exposure to vaccinia virus.
            ``(3) Employers.--Nothing in this section shall be 
        construed to invalidate or otherwise abridge any provision of 
        law or any contractual obligation that otherwise obligates an 
        employer to provide leave, wages, vacation time, or any other 
        benefit to an individual.
            ``(4) State or local governments.--Nothing in this section 
        shall be construed to invalidate or otherwise abridge any 
        provision of law or any contractual obligation that otherwise 
        obligates a State or local government to provide health care, 
        workers' compensation, or any other benefit to an individual.
    ``(e) Authorizing Utilization of Medicaid in Providing Medical 
Assistance.--Nothing in this section shall be construed to prevent a 
State from utilizing its medicaid program under title XIX of the Social 
Security Act in order to provide medical assistance under this section. 
The Secretary shall waive such provisions of such Act as are necessary 
to permit a State to so utilize such program under this subsection.''.
    (b) Continued Coverage of Benefits for Smallpox Vaccine Side 
Effects.--
            (1) State maintained plans.--Section 2907 of the Public 
        Health Service Act (as added by subsection (a)) is amended by 
        adding at the end the following:
    ``(f) Continued Coverage of Benefits for Smallpox Vaccine Side 
Effects.--
            ``(1) In general.--In accordance with regulations which the 
        Secretary shall prescribe, each group health plan that is 
        maintained by any State that receives funds under this Act, by 
        any political subdivision of such State, or by any agency or 
        instrumentality of such State or political subdivision, shall 
        provide coverage of benefits for side effects resulting from 
        covered countermeasures against smallpox at the level of such 
        coverage it provided as of September 10, 2001.
            ``(2) Enforcement.--For purposes of section 2207, the 
        requirement of paragraph (1) is deemed a requirement of title 
        XXII.''.
            (2) Private plans.--
                    (A) Amendment to tax code.--
                            (i) In general.--Paragraph (1) of section 
                        4980B(f) of the Internal Revenue Code of 1986 
                        is amended by inserting before the period at 
                        the end the following: ``, and (C) only if the 
                        coverage of the side effects from covered 
                        countermeasures against smallpox (as such term 
                        is defined in section 224(p) of the Public 
                        Health Service Act) is not less than the level 
                        of coverage provided by the plan as of 
                        September 10, 2001''.
                            (ii) Conforming amendments.--Section 
                        4980B(f)(1) of such Code is amended--
                                    (I) by inserting ``(A)'' before 
                                ``only if'' the first place it appears, 
                                and
                                    (II) by striking ``and only if'' 
                                and inserting ``, (B) only if''.
                            (iii) Effective date.--The amendments made 
                        by this section shall apply to covered 
                        countermeasures against smallpox taken after 
                        the date of the enactment of this Act.
                    (B) Amendment to ERISA.--Section 609 of the 
                Employee Retirement Income Security Act of 1974 (29 
                U.S.C. 1169) is amended--
                            (i) by redesignating subsection (e) as 
                        subsection (f); and
                            (ii) by inserting after subsection (d) the 
                        following:
    ``(e) Continued Coverage of Benefits for Smallpox Vaccine Side 
Effects.--A group health plan shall provide coverage of the side 
effects from covered countermeasures against smallpox (as such term is 
defined in section 224(p) of the Public Health Service Act) at the 
level of coverage provided by the plan as of September 10, 2001.''.

SEC. 4. NATIONAL SMALLPOX VACCINE INJURY COMPENSATION PROGRAM.

    (a) Establishment.--Section 224 of the Public Health Service Act 
(42 U.S.C. 233), as amended by section 304(c) of Public Law 107-296 
(116 Stat. 2135), is amended by adding at the end the following:
    ``(q) National Smallpox Vaccine Injury Compensation Program.--
            ``(1) Establishment.--The Secretary shall establish the 
        National Smallpox Vaccine Injury Compensation Program (referred 
        to in this subsection as the `Smallpox Program') under which 
        compensation may be paid for injury or death related to the 
        administration of any covered countermeasure against smallpox.
            ``(2) Procedures and standards.--The Secretary shall by 
        regulation establish procedures and standards applicable to the 
        Smallpox Program that follow the procedures and standards 
        applicable under the National Vaccine Injury Compensation 
        Program established under section 2110, except for the 
        following:
                    ``(A) A person may not file a civil action under 
                subsection (p) unless the person has first filed a 
                petition for compensation under the Smallpox Program 
                under section 2111.
                    ``(B) After filing a petition under section 2111, a 
                person may elect to instead bring a civil action under 
                subsection (p) if the person would be authorized under 
                clause (i) or (ii) of section 2111(a)(2)(A) and under 
                section 2121 to elect to bring a civil action.
                    ``(C) Notwithstanding section 2111(c)(1)(A), a 
                person who did not receive a covered countermeasure 
                against smallpox or any other substance administered 
                for the prevention or treatment of smallpox (including 
                vaccinia virus) may receive compensation under the 
                Smallpox Program if the person was injured as a result 
                of contact with another person who received such a 
                countermeasure or substance.
                    ``(D) Section 2111(c)(1)(D) (requiring petitioner 
                to demonstrate death, residual effects for more than 6 
                months, or inpatient hospitalization and surgical 
                intervention) shall not apply.
                    ``(E) Notwithstanding section 2115(a)(2), in the 
                event of a death related to the administration of 
                vaccinia virus or other substance or medication 
                administered for the purpose of preventing or treating 
                smallpox (including any covered countermeasure against 
                smallpox), compensation under the Smallpox Program 
                shall include an award for the estate of the deceased 
                of $850,000, in addition to any other compensation to 
                which the petitioner is entitled under this section.
            ``(3) Vaccine injury table.--
                    ``(A) Inclusion.--For purposes of receiving 
                compensation under the Smallpox Program, the Vaccine 
                Injury Table under section 2114 is deemed to include 
                the following table of injuries, disabilities, 
                illnesses, conditions, and deaths resulting from the 
                administration of the smallpox vaccine, and the time 
                period in which the first symptom or manifestation of 
                onset or of significant aggravation of such injuries, 
                disabilities, illnesses, conditions, and deaths is to 
                occur after administration of vaccinia virus or other 
                substance or medication administered for the purpose of 
                preventing or treating smallpox (including a covered 
                countermeasure against smallpox):


                    ``Adverse event:           Time period for first
                                                symptom or manifestation
                                                of onset or of
                                                significant aggravation
                                                after administration of
                                                vaccinia virus or other
                                                substance or medication
                                                administered for the
                                                purpose of preventing or
                                                treating smallpox
                                                (including a covered
                                                countermeasure against
                                                smallpox):
                    A. Anaphylaxis or              0-4 hours
                     anaphylactic shock......
                    B. Eczema vaccinatum           any
                     (including in a contact
                     case)...................
                    C. Accidental inoculation      any
                     (including in a contact
                     case)...................
                    D. Progressive vaccinia..      any
                    E. Encephalopathy (or          0-21 days
                     encephalitis)...........
                    F. Stevens-Johnson             3-21 days
                     syndrome................
                    G. Generalized vaccinia..      0-60 days
                    H. Any acute complication      Not applicable
                     or sequela (including
                     death) of an illness,
                     disability, injury, or
                     condition referred to
                     above which illness,
                     disability, injury, or
                     condition arose within
                     the time period
                     prescribed..............
 

                    ``(B) Rule of construction.--Section 13632 (a)(3) 
                of Public Law 103-66 (107 Stat. 646) (making revisions 
                by Secretary to the Vaccine Injury Table effective on 
                the effective date of a corresponding tax) shall not be 
                construed to apply to the revision to the Vaccine 
                Injury Table made by this paragraph.
            ``(4) Prohibition.--The Secretary may not provide any 
        compensation under the Smallpox Program for any minor scarring 
        or minor local reaction.
            ``(5) Application.--The Smallpox Program applies to any 
        injury or death associated with the administration of any 
        covered countermeasure on or after November 25, 2002.
            ``(6) Reimbursement.--Notwithstanding paragraph (4), the 
        Secretary may reimburse under this section an employer who 
        seeks reimbursement pursuant to section 2904.
            ``(7) Special masters.--
                    ``(A) Hiring.--In accordance with section 2112, the 
                judges of the United States Claims Court shall appoint 
                a sufficient number of special masters to address 
                claims for compensation under this subsection.
                    ``(B) Budget authority.--There are appropriated to 
                carry out this paragraph such sums as may be necessary 
                for fiscal year 2003 and each fiscal year thereafter. 
                This subparagraph constitutes budget authority in 
                advance of appropriations and represents the obligation 
                of the Federal Government.
            ``(8) Covered countermeasure.--For purposes of this 
        subsection, the terms `covered countermeasure' and `covered 
        countermeasure against smallpox' have the meanings given to 
        those terms in subsection (p)(7)(A).
            ``(9) Funding.--Compensation made under the Smallpox 
        Program shall be made from the same source of funds as payments 
        made under subsection (p).''.
    (b) Relation to Federal Tort Claims Act.--Paragraph (3) of section 
224(p) of the Public Health Service Act (42 U.S.C. 233(p)) is amended 
to read as follows:
            ``(3) Exhaustion; exclusivity.--
                    ``(A)  National smallpox vaccine injury 
                compensation program.--A person may not bring a claim 
                under this subsection unless the person has first filed 
                a petition for compensation under the program 
                established under subsection (q) and made a proper 
                election under sections 2111(a)(2)(A) and 2121.
                    ``(B) Exclusivity.--Except for filing a petition 
                for compensation under the program established under 
                subsection (q), the remedy provided by subsection (a) 
                shall be exclusive of any other civil action or 
                proceeding for any claim or suit this subsection 
                encompasses, during the effective period of a 
                declaration by the Secretary under paragraph (2)(A).''.
    (c) Persons Susceptible to Vaccine-Related Injury.--Subsection (b) 
of section 2114 of the Public Health Service Act (42 U.S.C. 300aa-14) 
is amended by adding at the end the following:
            ``(5) A petitioner shall be considered to have suffered an 
        injury related to the administration of a covered 
        countermeasure even if the petitioner might not have suffered 
        the injury absent an infection, disease, or other condition 
        that made him or her more susceptible to the injury.''.

SEC. 5. TECHNICAL MODIFICATION.

    (a) Circumstances in Which Presumption in Cases of Accidental 
Vaccinia Inoculation Applies.--Section 224(p)(2)(C)(ii)(II) of the 
Public Health Service Act (42 U.S.C. 233(p)(2)(C)(ii)(II)) is amended 
by striking ``resides or has resided with'' and inserting ``has had 
close contact with''.
    (b) Covered Countermeasure.--Subparagraph (A) of section 224(p)(7) 
of the Public Health Service Act (42 U.S.C. 233(p)(7)(A)) is amended to 
read as follows:
                    ``(A) Covered countermeasure.--The term `covered 
                countermeasure', or `covered countermeasure against 
                smallpox', means a substance specified in a declaration 
                under paragraph (2) that is--
                            ``(i) a substance used to prevent or treat 
                        smallpox (including vaccinia or another 
                        vaccine); or
                            ``(ii) a substance (including vaccinia 
                        immune globulin and cidofovir) used to control 
                        or treat the adverse effects of vaccinia 
                        inoculation or administration of any other 
                        countermeasure against smallpox.''.
    (c) Covered Person.--Section 224(p)(7)(B)(ii) of the Public Health 
Service Act (42 U.S.C. 233(p)(7)(B)(ii)) is amended to read as follows:
                            ``(ii) a health care entity, a State, or a 
                        political subdivision of a State under whose 
                        auspices such countermeasure was 
                        administered;''.
    (d) Effective Date.--This section shall take effect as of November 
25, 2002 (the date of enactment of the Homeland Security Act of 2002 
(Pub. L. 107-296; 116 Stat. 2135)).
                                 <all>