‘‘(III) the proposed statistical 
tests are not possible with the avail-
able data; or 
‘‘(ii) the researchers fail to dem-
onstrate core competencies in the basic 
skills needed to analyze the relevant data; 
‘‘(C) shall provide for transparency, includ-
ing by— 
‘‘(i) making publicly available the re-
sults of studies conducted through the Vac-
cine Safety Datalink Project; and 
‘‘(ii) maintaining archives of data sets 
in the Vaccine Safety Datalink Project for 
not less than 7 years; 
‘‘(D) shall ensure that, when external re-
searchers access data that is collected through 
the Vaccine Safety Datalink Project, individ-
ually identifiable information is removed to the 
extent necessary to preserve patient confiden-
tiality; and 
‘‘(E) may take such other actions and im-
pose such requirements as the Director for Vac-
cine Safety Evaluation deems necessary to fa-
cilitate external or public access to the database 
without compromising patient confidentiality. 
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‘‘(e) REVIEW OF INTERNATIONAL ACTIVITIES.—Not 
later than 18 months after the date of the enactment of 
this subtitle, the Director for Vaccine Safety Evaluation 
shall— 
‘‘(1) complete a thorough review of all functions 
transferred to the Agency under section 2144 relat-
ing to international agreements, partnerships, and 
activities in which the United States Government 
has a fiduciary role, identify any related conflicts of 
interest, and develop and implement a plan to re-
duce such conflicts to the extent possible; and 
‘‘(2) submit a report to the Congress containing 
the results of the review conducted under paragraph 
(1), describing the conflicts of interests identified 
under such paragraph, and including the plan devel-
oped under such paragraph. 
‘‘(f) FELLOWSHIP PROGRAM.— 
‘‘(1) ESTABLISHMENT.—The Director for Vac-
cine Safety Evaluation may establish a program of 
awarding fellowships to individuals for research on 
vaccine safety. 
‘‘(2) REQUIREMENTS.—The Director for Vac-
cine Safety Evaluation may not award a fellowship 
to an individual for research under this subsection 
unless the individual agrees— 
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‘‘(A) to refrain from accepting any pay-
ment or other benefit for such research from a 
manufacturer of a vaccine or vaccine component 
to be subject to the research; 
‘‘(B) to refrain from employment by, or ac-
ceptance of payment from, a vaccine manufac-
turer or any organization that receives substan-
tial funding from a vaccine manufacturer before 
the date that is 2 years after the end of such 
research; and 
‘‘(C) to disclose (and update every 6 
months) all potential conflicts of interest. 
‘‘(3) APPLICATION.—To seek a fellowship under 
this subsection, an individual shall submit to the Di-
rector for Vaccine Safety Evaluation an application 
in such form, in such manner, and containing such 
information as the Director for Vaccine Safety Eval-
uation may reasonably require. 
‘‘(4) PEER REVIEW.—The Director for Vaccine 
Safety Evaluation shall establish peer review mecha-
nisms to evaluate applications for fellowships under 
this subsection. 
‘‘(g) PEER REVIEW.— 
‘‘(1) IN GENERAL.—The requirements of sec-
tion 492 (relating to peer review) shall apply to re-
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