‘‘(i) is accessible to the public at no 
charge; 
‘‘(ii) is open to all prospective reg-
istrants; 
‘‘(iii) is managed by a nonprofit orga-
nization or a Federal, State, or local gov-
ernmental entity; 
‘‘(iv) has in effect a mechanism to en-
sure the validity of the registration data; 
‘‘(v) is electronically searchable; and 
‘‘(vi) includes, for each clinical trial, 
each category of information described in 
paragraph (2). 
‘‘(5) APPLICATION.—This subsection applies 
only with respect to clinical trials that are ongoing 
on, or start on or after, July 1, 2007. 
‘‘SEC. 2144. TRANSFER OF CDC FUNCTIONS RELATING TO 
MONITORING ADVERSE REACTIONS RELATED 
TO LICENSED VACCINES. 
‘‘(a) TRANSFER OF CDC FUNCTIONS.—Effective on 
the date that is 1 year after the date of the enactment 
of this subtitle, there are transferred to the Agency all 
the functions, assets, and obligations of the Centers for 
Disease Control and Prevention relating to— 
‘‘(1) the Vaccine Safety Datalink Project; 
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‘‘(2) the Clinical Immunization Safety Assess-
ment Centers; or 
‘‘(3) any other post-licensure vaccine safety 
monitoring activities. 
‘‘(b) ORDERLY TRANSFER.—The Secretary of Health 
and Human Services shall take such steps as are nec-
essary to ensure the orderly transfer under this section 
of functions, assets, and obligations from the Centers for 
Disease Control and Prevention. 
‘‘(c) RULE OF CONSTRUCTION.—Except with respect 
to the activities specified in subsection (a), nothing in this 
subtitle shall be construed to transfer or limit the author-
ity of the Director of the Centers for Disease Control and 
Prevention to conduct surveillance and response activities 
with respect to vaccine safety or effectiveness, including 
with respect to acute adverse reactions. 
‘‘SEC. 2145. ADVISORY COUNCIL. 
‘‘(a) ESTABLISHMENT.—The Secretary shall estab-
lish in the Agency an advisory council. 
‘‘(b) DUTIES.—The advisory council shall— 
‘‘(1) formulate recommendations on the need 
for new or improved research on licensed vaccines; 
‘‘(2) develop and annually update a vaccine 
safety research agenda; 
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‘‘(3) recommend individuals and research proto-
cols for purposes of section 2143(a)(2)(A); 
‘‘(4) if potentially vaccine-related toxicological 
damage or subacute infection is observed in vitro, in 
laboratory animals, or in clinical testing, formulate 
recommendations on conducting laboratory and clin-
ical research even in the absence of epidemiological 
evidence; 
‘‘(5) not later than 2 weeks after each quarterly 
meeting of the advisory council, submit to the Agen-
cy a report that includes a summary of the presen-
tations made at the meeting, a list of hypotheses 
proposed, and the recommendations of the advisory 
council on research described in paragraph (1); 
‘‘(6) review each application submitted to the 
Director for Vaccine Safety Evaluation for a grant 
or other assistance related to vaccine research; 
‘‘(7) make recommendations to the Director for 
Vaccine Safety Evaluation regarding each such ap-
plication; 
‘‘(8) make recommendations to the Secretary of 
Health and Human Services regarding vaccine safe-
ty; 
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‘‘(9) not less than quarterly, submit a report to 
the Secretary of Health and Human Services regard-
ing vaccine safety efforts; and 
‘‘(10) make publicly available— 
‘‘(A) each report submitted under para-
graph (9); and 
‘‘(B) a transcript of each meeting of the 
advisory council. 
‘‘(c) EFFECT OF RECOMMENDATIONS.—The Director 
for Vaccine Safety Evaluation may not approve any appli-
cation for a grant or other assistance related to vaccine 
research until the Director has considered the rec-
ommendations of the advisory council regarding such re-
search. If the Director decides to approve or disapprove 
any such application contrary to the recommendations of 
the advisory council, the Director shall provide the advi-
sory council with, and make publicly available, a detailed, 
written explanation of the reasons for the decision. 
‘‘(d) MEMBERSHIP.— 
‘‘(1) COMPOSITION.—The advisory council shall 
be composed of 18 members appointed by the Sec-
retary, including the following: 
‘‘(A) Not more than 2 representatives of 
the vaccine manufacturing industry. 
‘‘(B) One practicing pediatrician. 
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