[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2618 Introduced in House (IH)]
111th CONGRESS
1st Session
H. R. 2618
To improve vaccine safety research, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 21, 2009
Mrs. Maloney (for herself and Mr. Smith of New Jersey) introduced the
following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
A BILL
To improve vaccine safety research, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Vaccine Safety and
Public Confidence Assurance Act of 2009''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Establishment of Agency for Vaccine Safety Evaluation.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) The Nation's vaccine program has greatly reduced human
suffering from infectious disease by preventing and reducing
the outbreak of vaccine-preventable diseases.
(2) The prestigious scientific journal Nature has noted
that to maintain public confidence in vaccines ``there is a
strong case for a well-resourced independent agency that
commends the trust of both the government and the public''.
Nature 439, 1-2.
(3) Public confidence in governmental vaccine-safety
monitoring agencies is critical to building and maintaining
public confidence in vaccine safety.
(4) Actual or perceived conflicts of interest undermine the
credibility of vaccine-safety assurances and reports issued by
those with conflicts of interest.
(5) The Federal Government has a responsibility to take all
steps feasible to ensure that research evaluating the safety of
existing and future vaccines is of the highest quality and free
from conflicts of interest.
(6) The Centers for Disease Control and Prevention is
responsible for promoting both high immunization rates and
vaccine safety, duties perceived by some to constitute a
conflict of interest.
(7) The actual or perceived conflict of interest between
vaccine promotion and vaccine safety has been compounded by the
fact that vaccine-safety programs and the National Immunization
Program have needed to compete against each other for funds.
Funding for vaccine-safety research should be completely
independent from other vaccine-related budget priorities.
(8) There are numerous vaccines presently in the
development pipeline for disease prevention and treatment, and
it is critical that the Nation develop longer term and more
specific safety monitoring mechanisms.
(9) It is critical that the Federal Government revamp
vaccine-safety monitoring programs to focus increasingly on
developing prevaccination screening tools to prevent injury,
thereby raising public confidence and reducing vaccine
injuries.
(10) The current structure for monitoring for vaccine
safety, postlicensure, primarily focuses on epidemiology. There
is inadequate funding directed toward independent research,
including research directed at understanding underlying
biological mechanisms and biological susceptibilities and
designed to understand why some children and adults develop
serious adverse outcomes after vaccination.
(11) Because most serious adverse reactions to vaccines are
rare, epidemiology studies may be limited in their ability to
establish or rule out causal association or biological
plausibility.
(12) The vaccine-safety monitoring functions of the
Department of Health and Human Services have tended to focus on
monitoring for acute adverse events rather than chronic adverse
events. There is little coordination and inadequate effort to
investigate the biological mechanisms underlying vaccine-
related adverse events.
SEC. 3. PURPOSE.
The purpose of this Act is to direct that vaccine safety monitoring
and research focus on active surveillance, researching biological
mechanisms for acute and chronic adverse events following vaccination,
developing prevaccination screening methods within a framework that is
free from actual and perceived biases, and developing a vaccine safety
research agenda.
SEC. 4. ESTABLISHMENT OF AGENCY FOR VACCINE SAFETY EVALUATION.
Title XXI of the Public Health Service Act (42 U.S.C. 300aa-1 et
seq.) is amended by adding at the end the following:
``Subtitle 3--Agency for Vaccine Safety Evaluation
``SEC. 2141. ESTABLISHMENT.
``There is established in the Office of the Secretary the Agency
for Vaccine Safety Evaluation, to be headed by the Director for Vaccine
Safety Evaluation.
``SEC. 2142. AUTHORITIES.
``(a) In General.--With respect to vaccines, the Director for
Vaccine Safety Evaluation--
``(1) shall conduct or support safety research, including
research on--
``(A) acute and chronic adverse reactions,
including with respect to subpopulations;
``(B) components of vaccines, including additives,
adjuvants, and preservatives;
``(C) delivery mechanisms; and
``(D) the potential presence of adventitious agents
in vaccines; and
``(2) shall conduct or support long- and short-term
monitoring of vaccines for which a biologics license 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 epidemiology;
``(5) shall conduct or support research to address 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 adverse reactions, including those
generated by the Department of Defense, the National Institutes
of Health, the Centers for Disease Control and Prevention, the
Food and Drug Administration, the Health Resources and Services
Administration, other governmental 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 reactions related to licensed vaccines,
including the requirements of section 2125(b);
``(8) shall conduct or support research to evaluate reports
of injury following vaccine administration for the purpose of
developing tests to prescreen individuals and subpopulations at
greater risk of injury;
``(9) shall conduct or support research to evaluate
biological mechanisms of injury for the purpose of eliminating
or reducing the risk of such injury through better prescreening
tools or through modification 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 National
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 officer or
employee in a position in level I, II, III, IV, or V of the
Executive Schedule or level GS-15 of the General Schedule if
the individual has been employed within the preceding 5 years--
``(A) by the Centers for Disease Control and
Prevention or the Food and Drug Administration to carry
out any function relating to monitoring, or research
on, adverse reactions related to a licensed vaccine or
any function related to vaccine development;
``(B) by the National Institutes of Health to carry
out any function relating to vaccine development; 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 financial 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 interest;
``(2) shall provide all disclosures under paragraph (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 outcomes of vaccine-
safety research, such as receiving money or an in-kind
contribution from a manufacturer of the particular
vaccine or vaccine 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).
``(2) Relation to cdc and fda.--The Director 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 access to the Vaccine Safety
Datalink Project to the full extent necessary to
conduct or support monitoring, or research on, acute
adverse reactions related to any licensed vaccine; and
``(B) shall consider any comments or
recommendations 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 Evaluation--
``(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
sufficient staff for the purpose of assisting
external researchers in navigating the data
collection systems of the provider or
organization;
``(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 proposed
research, the approval of not more than one
institutional review board--
``(I) from not more than one
participating 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--
``(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
Vaccine 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 conducted or supported
by the Agency only if the Director for Vaccine Safety
Evaluation determines 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
``(III) the proposed statistical
tests are not possible with the
available data; or
``(ii) the researchers fail to demonstrate
core competencies in the basic skills needed to
analyze the relevant data;
``(C) shall provide for transparency, including
by--
``(i) making publicly available the results
of studies conducted through the Vaccine 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 researchers
access data that is collected through the Vaccine
Safety Datalink Project, individually identifiable
information is removed to the extent necessary to
preserve patient confidentiality; and
``(E) may take such other actions and impose such
requirements as the Director for Vaccine Safety
Evaluation deems necessary to facilitate external or
public access to the database without compromising
patient confidentiality.
``(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 relating 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 reduce 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 developed under such paragraph.
``(f) Fellowship Program.--
``(1) Establishment.--The Director for Vaccine Safety
Evaluation may establish a program of awarding fellowships to
individuals for research on vaccine safety.
``(2) Requirements.--The Director for Vaccine Safety
Evaluation may not award a fellowship to an individual for
research under this subsection unless the individual agrees--
``(A) to refrain from accepting any payment 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 acceptance
of payment from, a vaccine manufacturer or any
organization that receives substantial 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 Director for
Vaccine Safety Evaluation an application in such form, in such
manner, and containing such information as the Director for
Vaccine Safety Evaluation may reasonably require.
``(4) Peer review.--The Director for Vaccine Safety
Evaluation shall establish peer review mechanisms to evaluate
applications for fellowships under this subsection.
``(g) Peer Review.--
``(1) In general.--The requirements of section 492
(relating to peer review) shall apply to research and
development conducted or supported by the Agency in the same
manner and the to same extent as such requirements apply to
research and development conducted or supported by the National
Institutes of Health.
``(2) Technical and scientific peer review groups.--The
Director for Vaccine Safety Evaluation may, without regard to
the provisions of title 5, United States Code, governing
appointments in the competitive service, and without regard to
the provisions of chapter 51 and subchapter III of chapter 53
of such title relating to classification and General Schedule
pay rates, establish such technical and scientific 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 Director for Vaccine
Safety Evaluation, the Commissioner of Food and Drugs shall provide the
Director with complete access to all vaccine-related information
submitted to the Food and Drug Administration by vaccine manufacturers,
irrespective of whether the information was submitted before or after
approval of the vaccine under section 351. The Director shall keep such
information confidential to the same extent as the Commissioner of Food
and Drugs is required to keep such information confidential, 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 Immunization 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 Director 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 Commissioner of Food and
Drugs, shall require the manufacturer of each covered vaccine
to provide for postmarketing surveillance and clinical testing
for any acute or chronic adverse reactions associated with the
vaccine.
``(2) Requirements.--The Director for Vaccine Safety
Evaluation shall require the following:
``(A) Postmarketing surveillance and clinical
testing under paragraph (1) shall be conducted--
``(i) by one or more individuals referred
to the advisory council by the manufacturer or
by the Agency, recommended by the advisory
council under section 2145(b)(3), and approved
by the Director for Vaccine Safety Evaluation
under paragraph (3); and
``(ii) in accordance with a research
protocol referred to the advisory council by
the manufacturer or by the Agency, recommended
by the advisory council under section
2145(b)(3), and approved by the Director for
Vaccine Safety Evaluation.
``(B) The data and analysis of postmarketing
surveillance and clinical testing under paragraph (1)
shall be made available for objective, independent
evaluation.
``(3) Approval of researchers.--The Director for Vaccine
Safety Evaluation may not approve an individual for the purpose
of conducting postmarketing surveillance or clinical testing
under paragraph (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 employment or financial relationship
with a vaccine manufacturer.
``(4) Definition.--For purposes of this subsection, the
term `covered vaccine' means a vaccine licensed under section
351 after January 1, 2009.
``(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
implement 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.--
``(1) Grants.--If more than 1 vaccine is licensed under
section 351 for the purpose of preventing or mitigating the
effects of the same disease, the Director for Vaccine Safety
Evaluation may award grants to conduct comparative studies to
determine, for each such vaccine, whether the vaccine is
associated with fewer acute or chronic serious adverse
reactions (in the population as a whole or in any
subpopulation) than any other vaccine licensed for the purpose
of preventing or mitigating the effects 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 Director 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 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, irrespective of
whether such trial is suspended before completion.
``(2) Minimum information.--In carrying out subsection (a),
the Director for Vaccine Safety Evaluation 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 secondary
outcome measures.
``(E) Eligibility criteria.
``(F) Key trial dates (including the registration
date, the anticipated or actual start date, the
anticipated or actual date of last follow-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.
``(H) The funding source.
``(I) Contact information for the principal
investigator.
``(J) Such other information as the Director may
require.
``(3) Timing of registration.--In carrying out subsection
(a), the Director for Vaccine Safety Evaluation shall require
the manufacturer to register 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 research
project that prospectively assigns human subjects to
intervention or comparison groups to study the cause-
and-effect relationship between a medical intervention
and a health outcome.
``(B) The term `qualified public registry' means a
registry that--
``(i) is accessible to the public at no
charge;
``(ii) is open to all prospective
registrants;
``(iii) is managed by a nonprofit
organization or a Federal, State, or local
governmental entity;
``(iv) has in effect a mechanism to ensure
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, 2009.
``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;
``(2) the Clinical Immunization Safety Assessment 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 necessary 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 authority 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 establish 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;
``(3) recommend individuals and research protocols 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 clinical 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 Agency a report that
includes a summary of the presentations 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 application;
``(8) make recommendations to the Secretary of Health and
Human Services regarding vaccine safety;
``(9) not less than quarterly, submit a report to the
Secretary of Health and Human Services regarding vaccine safety
efforts; and
``(10) make publicly available--
``(A) each report submitted under paragraph (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 application for a grant or other
assistance related to vaccine research until the Director has
considered the recommendations of the advisory council regarding such
research. If the Director decides to approve or disapprove any such
application contrary to the recommendations of the advisory council,
the Director shall provide the advisory 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 Secretary, including the
following:
``(A) Not more than 2 representatives of the
vaccine manufacturing industry.
``(B) One practicing pediatrician.
``(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 vaccine-
related injury.
``(E) One representative of the general public
who--
``(i) is not the victim of a vaccine
injury; and
``(ii) does not have a conflict of interest
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 officer.
``(K) Not less than 4 and not more than 6
additional representatives.
``(2) Qualifications.--In appointing the members of the
Commission, the Secretary shall ensure that not less than one-
third of the members of the advisory council are selected from
among individuals who have a vaccine-related injury or who have
an immediate family member with a vaccine-related injury
(irrespective of whether there is a judicial 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 appointed
under paragraph (1)(D), any pending claim for
compensation for a vaccine-related injury.
``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 determines
necessary.
``SEC. 2147. DEFINITIONS.
``In this subtitle:
``(1) The term `advisory council' means the advisory
council established pursuant to section 2145.
``(2) The term `Agency' means the Agency for Vaccine Safety
Evaluation.
``(3) The term `assets' includes contracts, facilities,
property, records, unobligated or unexpended balances of
appropriations, and other funds or resources (other than
personnel).
``(4) The term `functions' includes authorities, powers,
rights, privileges, immunities, programs, projects, activities,
duties, and responsibilities.
``(5) The term `licensed vaccine' means a vaccine with a
biologics license in effect under section 351 of the Public
Health Service Act (42 U.S.C. 262).
``(6) The term `personnel' means officers and employees.
``(7) The term `Project' means the Vaccine Safety Datalink
Project.
``SEC. 2148. AUTHORIZATION OF APPROPRIATIONS.
``There is authorized to be appropriated--
``(1) for conducting and supporting research under this
subtitle, $80,000,000 for fiscal year 2010; and
``(2) for carrying out responsibilities under this subtitle
other than the conduct or support of research, such sums as may
be necessary for fiscal year 2010.''.
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