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[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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