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SEC. 304. CONDUCT OF CERTAIN PUBLIC HEALTH-RELATED
ACTIVITIES. 19
(a) IN GENERAL.—With respect to civilian human 20
health-related research and development activities relating 21
to countermeasures for chemical, biological, radiological, 22
and nuclear and other emerging terrorist threats carried 23
out by the Department of Health and Human Services (in- 24
cluding the Public Health Service), the Secretary of 25
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Health and Human Services shall set priorities, goals, ob- 1
jectives, and policies and develop a coordinated strategy 2
for such activities in collaboration with the Secretary of 3
Homeland Security to ensure consistency with the national 4
policy and strategic plan developed pursuant to section 5
302(2). 6
(b) EVALUATION OF PROGRESS.—In carrying out 7
subsection (a), the Secretary of Health and Human Serv- 8
ices shall collaborate with the Secretary in developing spe- 9
cific benchmarks and outcome measurements for evalu- 10
ating progress toward achieving the priorities and goals 11
described in such subsection. 12
(c) ADMINISTRATION OF COUNTERMEASURES 13
AGAINST SMALLPOX.—Section 224 of the Public Health 14
Service Act (42 U.S.C. 233) is amended by adding the 15
following: 16
‘‘(p) ADMINISTRATION OF SMALLPOX COUNTER- 17
MEASURES BY HEALTH PROFESSIONALS.— 18
‘‘(1) IN GENERAL.—For purposes of this sec- 19
tion, and subject to other provisions of this sub- 20
section, a covered person shall be deemed to be an 21
employee of the Public Health Service with respect 22
to liability arising out of administration of a covered 23
countermeasure against smallpox to an individual 24
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during the effective period of a declaration by the 1
Secretary under paragraph (2)(A). 2
‘‘(2) DECLARATION BY SECRETARY CON- 3
CERNING COUNTERMEASURE AGAINST SMALLPOX.— 4
‘‘(A) AUTHORITY TO ISSUE DECLARA- 5
TION.— 6
‘‘(i) IN GENERAL.—The Secretary 7
may issue a declaration, pursuant to this 8
paragraph, concluding that an actual or 9
potential bioterrorist incident or other ac- 10
tual or potential public health emergency 11
makes advisable the administration of a 12
covered countermeasure to a category or 13
categories of individuals. 14
‘‘(ii) COVERED COUNTERMEASURE.— 15
The Secretary shall specify in such dec- 16
laration the substance or substances that 17
shall be considered covered counter- 18
measures (as defined in paragraph (8)(A)) 19
for purposes of administration to individ- 20
uals during the effective period of the dec- 21
laration. 22
‘‘(iii) EFFECTIVE PERIOD.—The Sec- 23
retary shall specify in such declaration the 24
beginning and ending dates of the effective 25
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period of the declaration, and may subse- 1
quently amend such declaration to shorten 2
or extend such effective period, provided 3
that the new closing date is after the date 4
when the declaration is amended. 5
‘‘(iv) PUBLICATION.—The Secretary 6
shall promptly publish each such declara- 7
tion and amendment in the Federal Reg- 8
ister. 9
‘‘(B) LIABILITY OF UNITED STATES ONLY 10
FOR ADMINISTRATIONS WITHIN SCOPE OF DEC- 11
LARATION.—Except as provided in paragraph 12
(5)(B)(ii), the United States shall be liable 13
under this subsection with respect to a claim 14
arising out of the administration of a covered 15
countermeasure to an individual only if— 16
‘‘(i) the countermeasure was adminis- 17
tered by a qualified person, for a purpose 18
stated in paragraph (7)(A)(i), and during 19
the effective period of a declaration by the 20
Secretary under subparagraph (A) with re- 21
spect to such countermeasure; and 22
‘‘(ii)(I) the individual was within a 23
category of individuals covered by the dec- 24
laration; or 25
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‘‘(II) the qualified person admin- 1
istering the countermeasure had reasonable 2
grounds to believe that such individual was 3
within such category. 4
‘‘(C) PRESUMPTION OF ADMINISTRATION 5
WITHIN SCOPE OF DECLARATION IN CASE OF 6
ACCIDENTAL VACCINIA INOCULATION.— 7
‘‘(i) IN GENERAL.—If vaccinia vaccine 8
is a covered countermeasure specified in a 9
declaration under subparagraph (A), and 10
an individual to whom the vaccinia vaccine 11
is not administered contracts vaccinia, 12
then, under the circumstances specified in 13
clause (ii), the individual— 14
‘‘(I) shall be rebuttably presumed 15
to have contracted vaccinia from an 16
individual to whom such vaccine was 17
administered as provided by clauses 18
(i) and (ii) of subparagraph (B); and 19
‘‘(II) shall (unless such presump- 20
tion is rebutted) be deemed for pur- 21
poses of this subsection to be an indi- 22
vidual to whom a covered counter- 23
measure was administered by a quali- 24
fied person in accordance with the 25
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terms of such declaration and as de- 1
scribed by subparagraph (B). 2
‘‘(ii) CIRCUMSTANCES IN WHICH PRE- 3
SUMPTION APPLIES.—The presumption 4
and deeming stated in clause (i) shall 5
apply if— 6
‘‘(I) the individual contracts 7
vaccinia during the effective period of 8
a declaration under subparagraph (A) 9
or by the date 30 days after the close 10
of such period; or 11
‘‘(II) the individual resides or has 12
resided with an individual to whom 13
such vaccine was administered as pro- 14
vided by clauses (i) and (ii) of sub- 15
paragraph (B) and contracts vaccinia 16
after such date. 17
‘‘(3) EXCLUSIVITY OF REMEDY.—The remedy 18
provided by subsection (a) shall be exclusive of any 19
other civil action or proceeding for any claim or suit 20
this subsection encompasses. 21
‘‘(4) CERTIFICATION OF ACTION BY ATTORNEY 22
GENERAL.—Subsection (c) applies to actions under 23
this subsection, subject to the following provisions: 24
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