I 
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. MAR-
KEY) introduced the following bill; which was referred to the Committee 
on Energy and Commerce, and in addition to the Committee on Edu-
cation and the Workforce, for a period to be subsequently determined by 
the Speaker, in each case for consideration of such provisions as fall with-
in 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 Representa-
tives 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 coun-
termeasure’’ and ‘‘covered countermeasure against small-
pox’’ have the meanings given to those terms in section 
224(p)(7)(A). 
‘‘SEC. 2902. GRANTS TO ASSIST STATE AND LOCAL GOVERN-
MENTS IN MEETING THE COSTS OF SMALL-
POX INOCULATION PROGRAMS. 
‘‘(a) IN GENERAL.—
‘‘(1) GRANTS.—For the purposes described in 
paragraph (2), the Secretary shall make an allot-
ment 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 al-
lotment 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 in-
formation 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 pur-
poses: 
‘‘(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 in-
dividuals receiving such countermeasures. 
‘‘(C) Providing for the conduct of epide-
miological 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 de-
scribed 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 estab-
lish an education program to provide to each in-
dividual to whom a covered countermeasure 
against smallpox is proposed to be administered 
an explanation of—
‘‘(i) the screening and medical surveil-
lance and evaluation programs available 
under paragraphs (3) and (4); 
‘‘(ii) the risks and benefits from ad-
ministration of such countermeasure for 
such individuals and those individuals with 
whom they have close contact; 
‘‘(iii) the availability of the compensa-
tion 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
individual to whom a covered countermeasure 
against smallpox is proposed to be adminis-
tered—
‘‘(i) provide without charge counseling 
services that describe conditions which may 
exacerbate the risks of receiving such coun-
termeasure; 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 immuno-
deficiency virus, eczema or other signifi-
cant chronic skin irritation, pregnancy, 
and such other conditions as determined 
appropriate by the Secretary. 
‘‘(B) RESULTS.—The results or other in-
formation (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