or V of the Executive Schedule or level GS–15 of the 
General Schedule if the individual has been em-
ployed within the preceding 5 years— 
‘‘(A) by the Centers for Disease Control 
and Prevention or the Food and Drug Adminis-
tration to carry out any function relating to 
monitoring, or research on, adverse reactions 
related to a licensed vaccine or any function re-
lated to vaccine development; 
‘‘(B) by the National Institutes of Health 
to carry out any function relating to vaccine de-
velopment; or 
‘‘(C) by a vaccine manufacturer; and 
‘‘(2) shall ensure that all personnel assigned to 
carry out functions relating to vaccine monitoring or 
research on adverse reactions related to vaccines do 
not have any related professional, familial, or finan-
cial conflict of interest. 
‘‘(c) GRANT APPLICANTS.—In awarding any grant 
relating to research on adverse reactions to vaccines, the 
Director for Vaccine Safety Evaluation— 
‘‘(1) shall require applicants to disclose (and 
update every 6 months) all potential conflicts of in-
terest; 
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‘‘(2) shall provide all disclosures under para-
graph (1) to the advisory council for consideration 
as part of the council’s review of the application for 
the grant; and 
‘‘(3) shall ensure that the applicant for the 
grant does not have— 
‘‘(A) any financial conflict of interest that 
might compromise the research findings, such 
as holding a related patent or having a family 
member who holds a related patent; or 
‘‘(B) any conflict of interest resulting from 
the applicant’s association with an entity with 
direct or indirect financial interest in the out-
comes of vaccine-safety research, such as receiv-
ing money or an in-kind contribution from a 
manufacturer of the particular vaccine or vac-
cine components to be investigated pursuant to 
the grant. 
‘‘(d) VACCINE SAFETY DATALINK PROJECT.— 
‘‘(1) IN GENERAL.—The Director for Vaccine 
Safety Evaluation shall have the responsibility for 
maintaining access to and overseeing the Vaccine 
Safety Datalink Project (and any successor vaccine 
database). 
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‘‘(2) RELATION TO CDC AND FDA.—The Direc-
tor for Vaccine Safety Evaluation— 
‘‘(A) shall ensure that the Director of the 
Centers for Disease Control and Prevention and 
the Commissioner of Food and Drugs have ac-
cess to the Vaccine Safety Datalink Project to 
the full extent necessary to conduct or support 
monitoring, or research on, acute adverse reac-
tions related to any licensed vaccine; and 
‘‘(B) shall consider any comments or rec-
ommendations of the Director of the Centers 
for Disease Control and Prevention and the 
Commissioner of Food and Drugs regarding the 
Vaccine Safety Datalink Project. 
‘‘(3) RESPONSIBILITIES.—In carrying out this 
subsection, the Director for Vaccine Safety Evalua-
tion— 
‘‘(A) shall facilitate external access to the 
Vaccine Safety Datalink Project for purposes of 
research, including by— 
‘‘(i) 
requiring 
each 
participating 
health care provider or health maintenance 
organization to use a facilitator and suffi-
cient staff for the purpose of assisting ex-
ternal researchers in navigating the data 
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collection systems of the provider or orga-
nization; 
‘‘(ii) at the discretion of the Director, 
reimbursing the provider or organization 
for the salaries of such facilitator and staff 
and any other expenses incurred for such 
purpose; 
‘‘(iii) allowing researchers to access 
data that is collected through the Vaccine 
Safety Datalink Project, or published after 
derivation from data that is so collected, 
for review and duplication; 
‘‘(iv) requiring a researcher seeking 
such access to demonstrate, for the pro-
posed research, the approval of not more 
than one institutional review board— 
‘‘(I) from not more than one par-
ticipating health care provider or 
health maintenance organization; or 
‘‘(II) established by the Secretary 
or an agency of the Department of 
Health and Human Services; and 
‘‘(v) developing guidelines for data 
sharing, including guidelines for making 
publicly accessible— 
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