under paragraph (1) shall be made available for 
objective, independent evaluation. 
‘‘(3) APPROVAL OF RESEARCHERS.—The Direc-
tor for Vaccine Safety Evaluation may not approve 
an individual for the purpose of conducting post-
marketing surveillance or clinical testing under para-
graph (1) unless the individual demonstrates to the 
Director’s satisfaction that the individual has no 
present conflict of interest that might compromise 
such surveillance or testing, including any employ-
ment or financial relationship with a vaccine manu-
facturer. 
‘‘(4) DEFINITION.—For purposes of this sub-
section, the term ‘covered vaccine’ means a vaccine 
licensed under section 351 after January 1, 2007. 
‘‘(b) RELATION TO CDC, FDA, AND VAERS.—This 
subtitle shall not be construed to diminish the authority 
of the Director of the Centers for Disease Control and 
Prevention or the Commissioner of Food and Drugs to im-
plement the Vaccine Adverse Event Reporting System. 
The postmarketing surveillance conducted by the Director 
for Vaccine Safety Evaluation under this section shall be 
in addition to the postmarkeing surveillance conducted 
under the Vaccine Adverse Event Reporting System. 
‘‘(c) RECOMMENDATIONS ON VACCINE SAFETY.— 
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‘‘(1) GRANTS.—If more than 1 vaccine is li-
censed under section 351 for the purpose of pre-
venting or mitigating the effects of the same disease, 
the Director for Vaccine Safety Evaluation may 
award grants to conduct comparative studies to de-
termine, for each such vaccine, whether the vaccine 
is associated with fewer acute or chronic serious ad-
verse reactions (in the population as a whole or in 
any subpopulation) than any other vaccine licensed 
for the purpose of preventing or mitigating the ef-
fects of the same disease. Such studies may focus on 
administering vaccines in isolation or in combination 
with other vaccines. 
‘‘(2) DETERMINATION.—If the Director for 
Vaccine Safety Evaluation determines that a vaccine 
described in paragraph (1) is associated with fewer 
acute or chronic adverse reactions (in the population 
as a whole or in any subpopulation) than another 
vaccine licensed for the purpose of preventing or 
mitigating the effects of the same disease, the Direc-
tor shall make this determination publicly available. 
‘‘(d) REGISTRATION OF CLINICAL TRIALS.— 
‘‘(1) REQUIREMENT.—The Director for Vaccine 
Safety Evaluation shall require the manufacturer of 
a vaccine that is licensed under section 351, or for 
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which the manufacturer will seek licensure under 
section 351, to register in a qualified public registry 
each clinical trial conducted or supported by the 
manufacturer with respect to the vaccine, irrespec-
tive of whether such trial is suspended before com-
pletion. 
‘‘(2) MINIMUM INFORMATION.—In carrying out 
subsection (a), the Director for Vaccine Safety Eval-
uation shall require the manufacturer to include in 
the registration for each clinical trial the following 
information: 
‘‘(A) A unique identifying number. 
‘‘(B) A statement of each intervention and 
comparison studied. 
‘‘(C) A statement of the study hypothesis. 
‘‘(D) Definitions of the primary and sec-
ondary outcome measures. 
‘‘(E) Eligibility criteria. 
‘‘(F) Key trial dates (including the reg-
istration date, the anticipated or actual start 
date, the anticipated or actual date of last fol-
low-up, the planned or actual date of closure to 
data entry, and the date on which trial data is 
considered to be complete). 
‘‘(G) The target number of subjects. 
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‘‘(H) The funding source. 
‘‘(I) Contact information for the principal 
investigator. 
‘‘(J) Such other information as the Direc-
tor may require. 
‘‘(3) TIMING OF REGISTRATION.—In carrying 
out subsection (a), the Director for Vaccine Safety 
Evaluation shall require the manufacturer to reg-
ister each clinical trial— 
‘‘(A) if the trial starts on or after the date 
of the enactment of this section, not later than 
the onset of patient enrollment; and 
‘‘(B) if the trial starts before the date of 
the enactment of this section, not later than the 
end of the 90-day period following such date of 
enactment. 
‘‘(4) DEFINITIONS.—In this subsection: 
‘‘(A) The term ‘clinical trial’ means a re-
search project that prospectively assigns human 
subjects to intervention or comparison groups 
to study the cause-and-effect relationship be-
tween a medical intervention and a health out-
come. 
‘‘(B) The term ‘qualified public registry’ 
means a registry that— 
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