cense is in effect under section 351 of the Public 
Health Service Act; 
‘‘(3) shall develop a vaccine safety research 
agenda; 
‘‘(4) shall conduct or support research across a 
range of disciplines, including molecular genetics, 
toxicology, pharmacokinetics, cell biology, neurology, 
immunology, pharmacogenomics, virology, and epide-
miology; 
‘‘(5) shall conduct or support research to ad-
dress issues raised in claims of injury brought before 
the Secretary, the Attorney General of the United 
States, and State and Federal courts; 
‘‘(6) 
shall 
develop, 
evaluate, 
and 
test 
hypotheses, when appropriate, about potential ad-
verse reactions, including those generated by the De-
partment of Defense, the National Institutes of 
Health, the Centers for Disease Control and Preven-
tion, the Food and Drug Administration, the Health 
Resources and Services Administration, other gov-
ernmental agencies, and external researchers; 
‘‘(7) shall, on a regular basis, evaluate, report 
on, and explore means to promote the compliance of 
health care providers and vaccine manufacturers 
with Federal requirements for reporting adverse re-
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actions related to licensed vaccines, including the re-
quirements of section 2125(b); 
‘‘(8) shall conduct or support research to evalu-
ate reports of injury following vaccine administration 
for the purpose of developing tests to prescreen indi-
viduals and subpopulations at greater risk of injury; 
‘‘(9) shall conduct or support research to evalu-
ate biological mechanisms of injury for the purpose 
of eliminating or reducing the risk of such injury 
through better prescreening tools or through modi-
fication of vaccines; 
‘‘(10) shall conduct long-term monitoring of 
new or altered vaccines, including by monitoring the 
effects of changes to the recommended childhood 
and adolescent immunization schedule of the Centers 
for Disease Control and Prevention; and 
‘‘(11) shall provide, in conjunction with the Na-
tional Library of Medicine, a clearinghouse for 
prelicensure and postlicensure studies of vaccines 
and make such clearinghouse publicly accessible by 
means of the Internet. 
‘‘(b) PERSONNEL.—In carrying out this subtitle, the 
Director for Vaccine Safety Evaluation— 
‘‘(1) may not employ any individual as an offi-
cer or employee in a position in level I, II, III, IV, 
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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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‘‘(I) a clarification of the types of 
studies possible with the Vaccine 
Safety Datalink Project; 
‘‘(II) a categorization of the 
types of studies possible with the Vac-
cine Safety Datalink Project; and 
‘‘(III) a delineation of the skills 
necessary to work with the Vaccine 
Safety Datalink Project; and 
‘‘(B) in carrying out subparagraph (A), 
may deny access to the Vaccine Safety Datalink 
Project for purposes of research that is not con-
ducted or supported by the Agency only if the 
Director for Vaccine Safety Evaluation deter-
mines that— 
‘‘(i) the research is not technically 
feasible because— 
‘‘(I) the requested data are not 
available in the database; 
‘‘(II) enough individuals are not 
represented in the database with the 
exposures and outcomes of interest to 
study the proposed hypothesis; or 
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‘‘(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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search and development conducted or supported by 
the Agency in the same manner and the to same ex-
tent as such requirements apply to research and de-
velopment conducted or supported by the National 
Institutes of Health. 
‘‘(2) TECHNICAL AND SCIENTIFIC PEER REVIEW 
GROUPS.—The Director for Vaccine Safety Evalua-
tion may, without regard to the provisions of title 5, 
United States Code, governing appointments in the 
competitive service, and without regard to the provi-
sions of chapter 51 and subchapter III of chapter 53 
of such title relating to classification and General 
Schedule pay rates, establish such technical and sci-
entific peer review groups as are needed to carry out 
the requirements of this subtitle and appoint and 
pay the members of such groups, except that officers 
and employees of the United States shall not receive 
additional compensation for service as members of 
such groups. 
‘‘(h) FDA INFORMATION.—At the request of the Di-
rector for Vaccine Safety Evaluation, the Commissioner 
of Food and Drugs shall provide the Director with com-
plete access to all vaccine-related information submitted 
to the Food and Drug Administration by vaccine manufac-
turers, irrespective of whether the information was sub-
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mitted before or after approval of the vaccine under sec-
tion 351. The Director shall keep such information con-
fidential to the same extent as the Commissioner of Food 
and Drugs is required to keep such information confiden-
tial, and the Director shall not disclose such information 
under section 552 of title 5, United States Code . 
‘‘(i) REPORT.— 
‘‘(1) SUBMISSION.—Not less than twice each 
year, the Director for Vaccine Safety Evaluation 
shall submit a report on the Agency’s activities 
under this section to the Advisory Committee on Im-
munization Practices, the National Vaccine Advisory 
Committee, the National Vaccine Program Office, 
the National Vaccine Injury Compensation Program, 
the Health Resources and Services Administration, 
and any other entity deemed appropriate by the Di-
rector or by the Secretary of Health and Human 
Services. 
‘‘(2) PUBLIC AVAILABILITY.—The Director for 
Vaccine Safety Evaluation shall make each report 
under this subsection publicly available. 
‘‘SEC. 2143. POSTMARKETING VACCINE SAFETY. 
‘‘(a) SURVEILLANCE AND CLINICAL TRIALS.— 
‘‘(1) IN GENERAL.—The Director for Vaccine 
Safety Evaluation, in consultation with the Commis-
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sioner of Food and Drugs, shall require the manu-
facturer of each covered vaccine to provide for post-
marketing surveillance and clinical testing for any 
acute or chronic adverse reactions associated with 
the vaccine. 
‘‘(2) REQUIREMENTS.—The Director for Vac-
cine Safety Evaluation shall require the following: 
‘‘(A) Postmarketing surveillance and clin-
ical testing under paragraph (1) shall be con-
ducted— 
‘‘(i) by one or more individuals re-
ferred to the advisory council by the manu-
facturer or by the Agency, recommended 
by the advisory council under section 
2145(b)(3), and approved by the Director 
for Vaccine Safety Evaluation under para-
graph (3); and 
‘‘(ii) in accordance with a research 
protocol referred to the advisory council by 
the manufacturer or by the Agency, rec-
ommended by the advisory council under 
section 2145(b)(3), and approved by the 
Director for Vaccine Safety Evaluation. 
‘‘(B) The data and analysis of post-
marketing surveillance and clinical testing 
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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, 2006. 
‘‘(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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‘‘(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, 2006. 
‘‘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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‘‘(C) One infectious disease expert. 
‘‘(D) Five adults who are each— 
‘‘(i) a victim of a vaccine injury; or 
‘‘(ii) a parent of the victim of a vac-
cine-related injury. 
‘‘(E) One representative of the general 
public who— 
‘‘(i) is not the victim of a vaccine in-
jury; and 
‘‘(ii) does not have a conflict of inter-
est described in paragraph (1)(A), (1)(B), 
or (2) of section 2142(b). 
‘‘(F) One toxicologist. 
‘‘(G) One neurologist. 
‘‘(H) One geneticist. 
‘‘(I) One immunologist. 
‘‘(J) One State or local public health offi-
cer. 
‘‘(K) Not less than 4 and not more than 
6 additional representatives. 
‘‘(2) 
QUALIFICATIONS.—In 
appointing 
the 
members of the Commission, the Secretary shall en-
sure that not less than one-third of the members of 
the advisory council are selected from among indi-
viduals who have a vaccine-related injury or who 
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have an immediate family member with a vaccine-re-
lated injury (irrespective of whether there is a judi-
cial or administration finding of such injury). 
‘‘(3) CONFLICTS OF INTEREST.—In appointing 
the members of the Commission, the Secretary shall 
ensure that such members do not have any related 
financial conflict of interest. For purposes of this 
paragraph, the Secretary shall not treat as a conflict 
of interest the following: 
‘‘(A) In the case of a member appointed 
under paragraph (1)(A) who is employed in the 
vaccine manufacturing industry, the receipt of a 
salary or other benefits for such employment. 
‘‘(B) In the case of 2 of the members ap-
pointed under paragraph (1)(D), any pending 
claim for compensation for a vaccine-related in-
jury. 
‘‘SEC. 2146. FULL-TIME LIAISON. 
‘‘The Director for Vaccine Safety Evaluation shall 
designate an employee of the Agency to serve as a full- 
time liaison between the Agency and the Department of 
Defense, the National Institutes of Health, the Food and 
Drug Administration, and the Centers for Disease Control 
and Prevention, and any other agency as the Director de-
termines necessary. 
VerDate Aug 31 2005 
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