I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Vaccine Safety and Public Confidence Assurance Act of 

6 2009’’. 

7 (b) TABLE OF CONTENTS.—The table of contents of 

8 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. 


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1 SEC. 2. FINDINGS. 

2 The Congress finds as follows: 

3 (1) The Nation’s vaccine program has greatly 

4 reduced human suffering from infectious disease by 

5 preventing and reducing the outbreak of vaccine-pre6 ventable diseases. 

7 (2) The prestigious scientific journal Nature 

8 has noted that to maintain public confidence in vac9 cines ‘‘there is a strong case for a well-resourced 

10 independent agency that commends the trust of both 

11 the government and the public’’. Nature 439, 1–2. 

12 (3) Public confidence in governmental vaccine13 safety monitoring agencies is critical to building and 

14 maintaining public confidence in vaccine safety. 

15 (4) Actual or perceived conflicts of interest un16 dermine the credibility of vaccine-safety assurances 

17 and reports issued by those with conflicts of interest. 

18 (5) The Federal Government has a responsi19 bility to take all steps feasible to ensure that re20 search evaluating the safety of existing and future 

21 vaccines is of the highest quality and free from con22 flicts of interest. 

23 (6) The Centers for Disease Control and Pre24 vention is responsible for promoting both high im25 munization rates and vaccine safety, duties perceived 

26 by some to constitute a conflict of interest. 


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1 (7) The actual or perceived conflict of interest 

2 between vaccine promotion and vaccine safety has 

3 been compounded by the fact that vaccine-safety 

4 programs and the National Immunization Program 

5 have needed to compete against each other for 

6 funds. Funding for vaccine-safety research should be 

7 completely independent from other vaccine-related 

8 budget priorities. 

9 (8) There are numerous vaccines presently in 

10 the development pipeline for disease prevention and 

11 treatment, and it is critical that the Nation develop 

12 longer term and more specific safety monitoring 

13 mechanisms. 

14 (9) It is critical that the Federal Government 

15 revamp vaccine-safety monitoring programs to focus 

16 increasingly on developing prevaccination screening 

17 tools to prevent injury, thereby raising public con18 fidence and reducing vaccine injuries. 

19 (10) The current structure for monitoring for 

20 vaccine safety, postlicensure, primarily focuses on 

21 epidemiology. There is inadequate funding directed 

22 toward independent research, including research di23 rected at understanding underlying biological mecha24 nisms and biological susceptibilities and designed to 


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1 understand why some children and adults develop 

2 serious adverse outcomes after vaccination. 

3 (11) Because most serious adverse reactions to 

4 vaccines are rare, epidemiology studies may be lim5 ited in their ability to establish or rule out causal as6 sociation or biological plausibility. 

7 (12) The vaccine-safety monitoring functions of 

8 the Department of Health and Human Services have 

9 tended to focus on monitoring for acute adverse 

10 events rather than chronic adverse events. There is 

11 little coordination and inadequate effort to inves12 tigate the biological mechanisms underlying vaccine13 related adverse events. 

14 SEC. 3. PURPOSE. 

15 The purpose of this Act is to direct that vaccine safe16 ty monitoring and research focus on active surveillance, 

17 researching biological mechanisms for acute and chronic 

18 adverse events following vaccination, developing 

19 prevaccination screening methods within a framework that 

20 is free from actual and perceived biases, and developing 

21 a vaccine safety research agenda. 


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1 SEC. 4. ESTABLISHMENT OF AGENCY FOR VACCINE SAFETY 

2 EVALUATION. 

3 Title XXI of the Public Health Service Act (42 

4 U.S.C. 300aa–1 et seq.) is amended by adding at the end 

5 the following: 

6 ‘‘Subtitle 3—Agency for Vaccine 

7 Safety Evaluation 

8 ‘‘SEC. 2141. ESTABLISHMENT. 

9 ‘‘There is established in the Office of the Secretary 

10 the Agency for Vaccine Safety Evaluation, to be headed 

11 by the Director for Vaccine Safety Evaluation. 

12 ‘‘SEC. 2142. AUTHORITIES. 

13 ‘‘(a) IN GENERAL.—With respect to vaccines, the Di14 rector for Vaccine Safety Evaluation— 

15 ‘‘(1) shall conduct or support safety research, 

16 including research on— 

17 ‘‘(A) acute and chronic adverse reactions, 

18 including with respect to subpopulations; 

19 ‘‘(B) components of vaccines, including ad20 ditives, adjuvants, and preservatives; 

21 ‘‘(C) delivery mechanisms; and 

22 ‘‘(D) the potential presence of adventitious 

23 agents in vaccines; and 

24 ‘‘(2) shall conduct or support long- and short25 term monitoring of vaccines for which a biologics liVerDate Nov 24 2008 00:08 May 27, 2009 Jkt 079200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2618.IH H2618

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1 cense is in effect under section 351 of the Public 

2 Health Service Act; 

3 ‘‘(3) shall develop a vaccine safety research 

4 agenda; 

5 ‘‘(4) shall conduct or support research across a 

6 range of disciplines, including molecular genetics, 

7 toxicology, pharmacokinetics, cell biology, neurology, 

8 immunology, pharmacogenomics, virology, and epide9 miology; 

10 ‘‘(5) shall conduct or support research to ad11 dress issues raised in claims of injury brought before 

12 the Secretary, the Attorney General of the United 

13 States, and State and Federal courts; 

14 ‘‘(6) shall develop, evaluate, and test 

15 hypotheses, when appropriate, about potential ad16 verse reactions, including those generated by the De17 partment of Defense, the National Institutes of 

18 Health, the Centers for Disease Control and Preven19 tion, the Food and Drug Administration, the Health 

20 Resources and Services Administration, other gov21 ernmental agencies, and external researchers; 

22 ‘‘(7) shall, on a regular basis, evaluate, report 

23 on, and explore means to promote the compliance of 

24 health care providers and vaccine manufacturers 

25 with Federal requirements for reporting adverse reVerDate Nov 24 2008 00:08 May 27, 2009 Jkt 079200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2618.IH H2618

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1 actions related to licensed vaccines, including the re2 quirements of section 2125(b); 

3 ‘‘(8) shall conduct or support research to evalu4 ate reports of injury following vaccine administration 

5 for the purpose of developing tests to prescreen indi6 viduals and subpopulations at greater risk of injury; 

7 ‘‘(9) shall conduct or support research to evalu8 ate biological mechanisms of injury for the purpose 

9 of eliminating or reducing the risk of such injury 

10 through better prescreening tools or through modi11 fication of vaccines; 

12 ‘‘(10) shall conduct long-term monitoring of 

13 new or altered vaccines, including by monitoring the 

14 effects of changes to the recommended childhood 

15 and adolescent immunization schedule of the Centers 

16 for Disease Control and Prevention; and 

17 ‘‘(11) shall provide, in conjunction with the Na18 tional Library of Medicine, a clearinghouse for 

19 prelicensure and postlicensure studies of vaccines 

20 and make such clearinghouse publicly accessible by 

21 means of the Internet. 

22 ‘‘(b) PERSONNEL.—In carrying out this subtitle, the 

23 Director for Vaccine Safety Evaluation— 

24 ‘‘(1) may not employ any individual as an offi25 cer or employee in a position in level I, II, III, IV, 


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1 or V of the Executive Schedule or level GS–15 of the 

2 General Schedule if the individual has been em3 ployed within the preceding 5 years— 

4 ‘‘(A) by the Centers for Disease Control 

5 and Prevention or the Food and Drug Adminis6 tration to carry out any function relating to 

7 monitoring, or research on, adverse reactions 

8 related to a licensed vaccine or any function re9 lated to vaccine development; 

10 ‘‘(B) by the National Institutes of Health 

11 to carry out any function relating to vaccine de12 velopment; or 

13 ‘‘(C) by a vaccine manufacturer; and 

14 ‘‘(2) shall ensure that all personnel assigned to 

15 carry out functions relating to vaccine monitoring or 

16 research on adverse reactions related to vaccines do 

17 not have any related professional, familial, or finan18 cial conflict of interest. 

19 ‘‘(c) GRANT APPLICANTS.—In awarding any grant 

20 relating to research on adverse reactions to vaccines, the 

21 Director for Vaccine Safety Evaluation— 

22 ‘‘(1) shall require applicants to disclose (and 

23 update every 6 months) all potential conflicts of in24 terest; 


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1 ‘‘(2) shall provide all disclosures under para2 graph (1) to the advisory council for consideration 

3 as part of the council’s review of the application for 

4 the grant; and 

5 ‘‘(3) shall ensure that the applicant for the 

6 grant does not have— 

7 ‘‘(A) any financial conflict of interest that 

8 might compromise the research findings, such 

9 as holding a related patent or having a family 

10 member who holds a related patent; or 

11 ‘‘(B) any conflict of interest resulting from 

12 the applicant’s association with an entity with 

13 direct or indirect financial interest in the out14 comes of vaccine-safety research, such as receiv15 ing money or an in-kind contribution from a 

16 manufacturer of the particular vaccine or vac17 cine components to be investigated pursuant to 

18 the grant. 

19 ‘‘(d) VACCINE SAFETY DATALINK PROJECT.— 

20 ‘‘(1) IN GENERAL.—The Director for Vaccine 

21 Safety Evaluation shall have the responsibility for 

22 maintaining access to and overseeing the Vaccine 

23 Safety Datalink Project (and any successor vaccine 

24 database). 


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1 ‘‘(2) RELATION TO CDC AND FDA.—The Direc2 tor for Vaccine Safety Evaluation— 

3 ‘‘(A) shall ensure that the Director of the 

4 Centers for Disease Control and Prevention and 

5 the Commissioner of Food and Drugs have ac6 cess to the Vaccine Safety Datalink Project to 

7 the full extent necessary to conduct or support 

8 monitoring, or research on, acute adverse reac9 tions related to any licensed vaccine; and 

10 ‘‘(B) shall consider any comments or rec11 ommendations of the Director of the Centers 

12 for Disease Control and Prevention and the 

13 Commissioner of Food and Drugs regarding the 

14 Vaccine Safety Datalink Project. 

15 ‘‘(3) RESPONSIBILITIES.—In carrying out this 

16 subsection, the Director for Vaccine Safety Evalua17 tion— 

18 ‘‘(A) shall facilitate external access to the 

19 Vaccine Safety Datalink Project for purposes of 

20 research, including by— 

21 ‘‘(i) requiring each participating 

22 health care provider or health maintenance 

23 organization to use a facilitator and suffi24 cient staff for the purpose of assisting ex25 ternal researchers in navigating the data 


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1 collection systems of the provider or orga2 nization; 

3 ‘‘(ii) at the discretion of the Director, 

4 reimbursing the provider or organization 

5 for the salaries of such facilitator and staff 

6 and any other expenses incurred for such 

7 purpose; 

8 ‘‘(iii) allowing researchers to access 

9 data that is collected through the Vaccine 

10 Safety Datalink Project, or published after 

11 derivation from data that is so collected, 

12 for review and duplication; 

13 ‘‘(iv) requiring a researcher seeking 

14 such access to demonstrate, for the pro15 posed research, the approval of not more 

16 than one institutional review board— 

17 ‘‘(I) from not more than one par18 ticipating health care provider or 

19 health maintenance organization; or 

20 ‘‘(II) established by the Secretary 

21 or an agency of the Department of 

22 Health and Human Services; and 

23 ‘‘(v) developing guidelines for data 

24 sharing, including guidelines for making 

25 publicly accessible— 


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1 ‘‘(I) a clarification of the types of 

2 studies possible with the Vaccine 

3 Safety Datalink Project; 

4 ‘‘(II) a categorization of the 

5 types of studies possible with the Vac6 cine Safety Datalink Project; and 

7 ‘‘(III) a delineation of the skills 

8 necessary to work with the Vaccine 

9 Safety Datalink Project; and 

10 ‘‘(B) in carrying out subparagraph (A), 

11 may deny access to the Vaccine Safety Datalink 

12 Project for purposes of research that is not con13 ducted or supported by the Agency only if the 

14 Director for Vaccine Safety Evaluation deter15 mines that— 

16 ‘‘(i) the research is not technically 

17 feasible because— 

18 ‘‘(I) the requested data are not 

19 available in the database; 

20 ‘‘(II) enough individuals are not 

21 represented in the database with the 

22 exposures and outcomes of interest to 

23 study the proposed hypothesis; or 


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1 ‘‘(III) the proposed statistical 

2 tests are not possible with the avail3 able data; or 

4 ‘‘(ii) the researchers fail to dem5 onstrate core competencies in the basic 

6 skills needed to analyze the relevant data; 

7 ‘‘(C) shall provide for transparency, includ8 ing by— 

9 ‘‘(i) making publicly available the re10 sults of studies conducted through the Vac11 cine Safety Datalink Project; and 

12 ‘‘(ii) maintaining archives of data sets 

13 in the Vaccine Safety Datalink Project for 

14 not less than 7 years; 

15 ‘‘(D) shall ensure that, when external re16 searchers access data that is collected through 

17 the Vaccine Safety Datalink Project, individ18 ually identifiable information is removed to the 

19 extent necessary to preserve patient confiden20 tiality; and 

21 ‘‘(E) may take such other actions and im22 pose such requirements as the Director for Vac23 cine Safety Evaluation deems necessary to fa24 cilitate external or public access to the database 

25 without compromising patient confidentiality. 


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1 ‘‘(e) REVIEW OF INTERNATIONAL ACTIVITIES.—Not 

2 later than 18 months after the date of the enactment of 

3 this subtitle, the Director for Vaccine Safety Evaluation 

4 shall— 

5 ‘‘(1) complete a thorough review of all functions 

6 transferred to the Agency under section 2144 relat7 ing to international agreements, partnerships, and 

8 activities in which the United States Government 

9 has a fiduciary role, identify any related conflicts of 

10 interest, and develop and implement a plan to re11 duce such conflicts to the extent possible; and 

12 ‘‘(2) submit a report to the Congress containing 

13 the results of the review conducted under paragraph 

14 (1), describing the conflicts of interests identified 

15 under such paragraph, and including the plan devel16 oped under such paragraph. 

17 ‘‘(f) FELLOWSHIP PROGRAM.— 

18 ‘‘(1) ESTABLISHMENT.—The Director for Vac19 cine Safety Evaluation may establish a program of 

20 awarding fellowships to individuals for research on 

21 vaccine safety. 

22 ‘‘(2) REQUIREMENTS.—The Director for Vac23 cine Safety Evaluation may not award a fellowship 

24 to an individual for research under this subsection 

25 unless the individual agrees— 


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1 ‘‘(A) to refrain from accepting any pay2 ment or other benefit for such research from a 

3 manufacturer of a vaccine or vaccine component 

4 to be subject to the research; 

5 ‘‘(B) to refrain from employment by, or ac6 ceptance of payment from, a vaccine manufac7 turer or any organization that receives substan8 tial funding from a vaccine manufacturer before 

9 the date that is 2 years after the end of such 

10 research; and 

11 ‘‘(C) to disclose (and update every 6 

12 months) all potential conflicts of interest. 

13 ‘‘(3) APPLICATION.—To seek a fellowship under 

14 this subsection, an individual shall submit to the Di15 rector for Vaccine Safety Evaluation an application 

16 in such form, in such manner, and containing such 

17 information as the Director for Vaccine Safety Eval18 uation may reasonably require. 

19 ‘‘(4) PEER REVIEW.—The Director for Vaccine 

20 Safety Evaluation shall establish peer review mecha21 nisms to evaluate applications for fellowships under 

22 this subsection. 

23 ‘‘(g) PEER REVIEW.— 

24 ‘‘(1) IN GENERAL.—The requirements of sec25 tion 492 (relating to peer review) shall apply to reVerDate Nov 24 2008 00:08 May 27, 2009 Jkt 079200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\H2618.IH H2618

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1 search and development conducted or supported by 

2 the Agency in the same manner and the to same ex3 tent as such requirements apply to research and de4 velopment conducted or supported by the National 

5 Institutes of Health. 

6 ‘‘(2) TECHNICAL AND SCIENTIFIC PEER REVIEW

7 GROUPS.—The Director for Vaccine Safety Evalua8 tion may, without regard to the provisions of title 5, 

9 United States Code, governing appointments in the 

10 competitive service, and without regard to the provi11 sions of chapter 51 and subchapter III of chapter 53 

12 of such title relating to classification and General 

13 Schedule pay rates, establish such technical and sci14 entific peer review groups as are needed to carry out 

15 the requirements of this subtitle and appoint and 

16 pay the members of such groups, except that officers 

17 and employees of the United States shall not receive 

18 additional compensation for service as members of 

19 such groups. 

20 ‘‘(h) FDA INFORMATION.—At the request of the Di21 rector for Vaccine Safety Evaluation, the Commissioner 

22 of Food and Drugs shall provide the Director with com23 plete access to all vaccine-related information submitted 

24 to the Food and Drug Administration by vaccine manufac25 turers, irrespective of whether the information was subVerDate Nov 24 2008 00:08 May 27, 2009 Jkt 079200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\H2618.IH H2618

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1 mitted before or after approval of the vaccine under sec2 tion 351. The Director shall keep such information con3 fidential to the same extent as the Commissioner of Food 

4 and Drugs is required to keep such information confiden5 tial, and the Director shall not disclose such information 

6 under section 552 of title 5, United States Code. 

7 ‘‘(i) REPORT.— 

8 ‘‘(1) SUBMISSION.—Not less than twice each 

9 year, the Director for Vaccine Safety Evaluation 

10 shall submit a report on the Agency’s activities 

11 under this section to the Advisory Committee on Im12 munization Practices, the National Vaccine Advisory 

13 Committee, the National Vaccine Program Office, 

14 the National Vaccine Injury Compensation Program, 

15 the Health Resources and Services Administration, 

16 and any other entity deemed appropriate by the Di17 rector or by the Secretary of Health and Human 

18 Services. 

19 ‘‘(2) PUBLIC AVAILABILITY.—The Director for 

20 Vaccine Safety Evaluation shall make each report 

21 under this subsection publicly available. 

22 ‘‘SEC. 2143. POSTMARKETING VACCINE SAFETY. 

23 ‘‘(a) SURVEILLANCE AND CLINICAL TRIALS.— 

24 ‘‘(1) IN GENERAL.—The Director for Vaccine 

25 Safety Evaluation, in consultation with the CommisVerDate Nov 24 2008 00:08 May 27, 2009 Jkt 079200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\H2618.IH H2618

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1 sioner of Food and Drugs, shall require the manu2 facturer of each covered vaccine to provide for post3 marketing surveillance and clinical testing for any 

4 acute or chronic adverse reactions associated with 

5 the vaccine. 

6 ‘‘(2) REQUIREMENTS.—The Director for Vac7 cine Safety Evaluation shall require the following: 

8 ‘‘(A) Postmarketing surveillance and clin9 ical testing under paragraph (1) shall be con10 ducted— 

11 ‘‘(i) by one or more individuals re12 ferred to the advisory council by the manu13 facturer or by the Agency, recommended 

14 by the advisory council under section 

15 2145(b)(3), and approved by the Director 

16 for Vaccine Safety Evaluation under para17 graph (3); and 

18 ‘‘(ii) in accordance with a research 

19 protocol referred to the advisory council by 

20 the manufacturer or by the Agency, rec21 ommended by the advisory council under 

22 section 2145(b)(3), and approved by the 

23 Director for Vaccine Safety Evaluation. 

24 ‘‘(B) The data and analysis of post25 marketing surveillance and clinical testing 


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1 under paragraph (1) shall be made available for 

2 objective, independent evaluation. 

3 ‘‘(3) APPROVAL OF RESEARCHERS.—The Direc4 tor for Vaccine Safety Evaluation may not approve 

5 an individual for the purpose of conducting post6 marketing surveillance or clinical testing under para7 graph (1) unless the individual demonstrates to the 

8 Director’s satisfaction that the individual has no 

9 present conflict of interest that might compromise 

10 such surveillance or testing, including any employ11 ment or financial relationship with a vaccine manu12 facturer. 

13 ‘‘(4) DEFINITION.—For purposes of this sub14 section, the term ‘covered vaccine’ means a vaccine 

15 licensed under section 351 after January 1, 2009. 

16 ‘‘(b) RELATION TO CDC, FDA, AND VAERS.—This 

17 subtitle shall not be construed to diminish the authority 

18 of the Director of the Centers for Disease Control and 

19 Prevention or the Commissioner of Food and Drugs to im20 plement the Vaccine Adverse Event Reporting System. 

21 The postmarketing surveillance conducted by the Director 

22 for Vaccine Safety Evaluation under this section shall be 

23 in addition to the postmarkeing surveillance conducted 

24 under the Vaccine Adverse Event Reporting System. 

25 ‘‘(c) RECOMMENDATIONS ON VACCINE SAFETY.— 


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1 ‘‘(1) GRANTS.—If more than 1 vaccine is li2 censed under section 351 for the purpose of pre3 venting or mitigating the effects of the same disease, 

4 the Director for Vaccine Safety Evaluation may 

5 award grants to conduct comparative studies to de6 termine, for each such vaccine, whether the vaccine 

7 is associated with fewer acute or chronic serious ad8 verse reactions (in the population as a whole or in 

9 any subpopulation) than any other vaccine licensed 

10 for the purpose of preventing or mitigating the ef11 fects of the same disease. Such studies may focus on 

12 administering vaccines in isolation or in combination 

13 with other vaccines. 

14 ‘‘(2) DETERMINATION.—If the Director for 

15 Vaccine Safety Evaluation determines that a vaccine 

16 described in paragraph (1) is associated with fewer 

17 acute or chronic adverse reactions (in the population 

18 as a whole or in any subpopulation) than another 

19 vaccine licensed for the purpose of preventing or 

20 mitigating the effects of the same disease, the Direc21 tor shall make this determination publicly available. 

22 ‘‘(d) REGISTRATION OF CLINICAL TRIALS.— 

23 ‘‘(1) REQUIREMENT.—The Director for Vaccine 

24 Safety Evaluation shall require the manufacturer of 

25 a vaccine that is licensed under section 351, or for 


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1 which the manufacturer will seek licensure under 

2 section 351, to register in a qualified public registry 

3 each clinical trial conducted or supported by the 

4 manufacturer with respect to the vaccine, irrespec5 tive of whether such trial is suspended before com6 pletion. 

7 ‘‘(2) MINIMUM INFORMATION.—In carrying out 

8 subsection (a), the Director for Vaccine Safety Eval9 uation shall require the manufacturer to include in 

10 the registration for each clinical trial the following 

11 information: 

12 ‘‘(A) A unique identifying number. 

13 ‘‘(B) A statement of each intervention and 

14 comparison studied. 

15 ‘‘(C) A statement of the study hypothesis. 

16 ‘‘(D) Definitions of the primary and sec17 ondary outcome measures. 

18 ‘‘(E) Eligibility criteria. 

19 ‘‘(F) Key trial dates (including the reg20 istration date, the anticipated or actual start 

21 date, the anticipated or actual date of last fol22 low-up, the planned or actual date of closure to 

23 data entry, and the date on which trial data is 

24 considered to be complete). 

25 ‘‘(G) The target number of subjects. 


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1 ‘‘(H) The funding source. 

2 ‘‘(I) Contact information for the principal 

3 investigator. 

4 ‘‘(J) Such other information as the Direc5 tor may require. 

6 ‘‘(3) TIMING OF REGISTRATION.—In carrying 

7 out subsection (a), the Director for Vaccine Safety 

8 Evaluation shall require the manufacturer to reg9 ister each clinical trial— 

10 ‘‘(A) if the trial starts on or after the date 

11 of the enactment of this section, not later than 

12 the onset of patient enrollment; and 

13 ‘‘(B) if the trial starts before the date of 

14 the enactment of this section, not later than the 

15 end of the 90-day period following such date of 

16 enactment. 

17 ‘‘(4) DEFINITIONS.—In this subsection: 

18 ‘‘(A) The term ‘clinical trial’ means a re19 search project that prospectively assigns human 

20 subjects to intervention or comparison groups 

21 to study the cause-and-effect relationship be22 tween a medical intervention and a health out23 come. 

24 ‘‘(B) The term ‘qualified public registry’ 

25 means a registry that— 


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1 ‘‘(i) is accessible to the public at no 

2 charge; 

3 ‘‘(ii) is open to all prospective reg4 istrants; 

5 ‘‘(iii) is managed by a nonprofit orga6 nization or a Federal, State, or local gov7 ernmental entity; 

8 ‘‘(iv) has in effect a mechanism to en9 sure the validity of the registration data; 

10 ‘‘(v) is electronically searchable; and 

11 ‘‘(vi) includes, for each clinical trial, 

12 each category of information described in 

13 paragraph (2). 

14 ‘‘(5) APPLICATION.—This subsection applies 

15 only with respect to clinical trials that are ongoing 

16 on, or start on or after, July 1, 2009. 

17 ‘‘SEC. 2144. TRANSFER OF CDC FUNCTIONS RELATING TO 

18 MONITORING ADVERSE REACTIONS RELATED 

19 TO LICENSED VACCINES. 

20 ‘‘(a) TRANSFER OF CDC FUNCTIONS.—Effective on 

21 the date that is 1 year after the date of the enactment 

22 of this subtitle, there are transferred to the Agency all 

23 the functions, assets, and obligations of the Centers for 

24 Disease Control and Prevention relating to— 

25 ‘‘(1) the Vaccine Safety Datalink Project; 


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1 ‘‘(2) the Clinical Immunization Safety Assess2 ment Centers; or 

3 ‘‘(3) any other post-licensure vaccine safety 

4 monitoring activities. 

5 ‘‘(b) ORDERLY TRANSFER.—The Secretary of Health 

6 and Human Services shall take such steps as are nec7 essary to ensure the orderly transfer under this section 

8 of functions, assets, and obligations from the Centers for 

9 Disease Control and Prevention. 

10 ‘‘(c) RULE OF CONSTRUCTION.—Except with respect 

11 to the activities specified in subsection (a), nothing in this 

12 subtitle shall be construed to transfer or limit the author13 ity of the Director of the Centers for Disease Control and 

14 Prevention to conduct surveillance and response activities 

15 with respect to vaccine safety or effectiveness, including 

16 with respect to acute adverse reactions. 

17 ‘‘SEC. 2145. ADVISORY COUNCIL. 

18 ‘‘(a) ESTABLISHMENT.—The Secretary shall estab19 lish in the Agency an advisory council. 

20 ‘‘(b) DUTIES.—The advisory council shall— 

21 ‘‘(1) formulate recommendations on the need 

22 for new or improved research on licensed vaccines; 

23 ‘‘(2) develop and annually update a vaccine 

24 safety research agenda; 


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1 ‘‘(3) recommend individuals and research proto2 cols for purposes of section 2143(a)(2)(A); 

3 ‘‘(4) if potentially vaccine-related toxicological 

4 damage or subacute infection is observed in vitro, in 

5 laboratory animals, or in clinical testing, formulate 

6 recommendations on conducting laboratory and clin7 ical research even in the absence of epidemiological 

8 evidence; 

9 ‘‘(5) not later than 2 weeks after each quarterly 

10 meeting of the advisory council, submit to the Agen11 cy a report that includes a summary of the presen12 tations made at the meeting, a list of hypotheses 

13 proposed, and the recommendations of the advisory 

14 council on research described in paragraph (1); 

15 ‘‘(6) review each application submitted to the 

16 Director for Vaccine Safety Evaluation for a grant 

17 or other assistance related to vaccine research; 

18 ‘‘(7) make recommendations to the Director for 

19 Vaccine Safety Evaluation regarding each such ap20 plication; 

21 ‘‘(8) make recommendations to the Secretary of 

22 Health and Human Services regarding vaccine safe23 ty; 


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1 ‘‘(9) not less than quarterly, submit a report to 

2 the Secretary of Health and Human Services regard3 ing vaccine safety efforts; and 

4 ‘‘(10) make publicly available— 

5 ‘‘(A) each report submitted under para6 graph (9); and 

7 ‘‘(B) a transcript of each meeting of the 

8 advisory council. 

9 ‘‘(c) EFFECT OF RECOMMENDATIONS.—The Director 

10 for Vaccine Safety Evaluation may not approve any appli11 cation for a grant or other assistance related to vaccine 

12 research until the Director has considered the rec13 ommendations of the advisory council regarding such re14 search. If the Director decides to approve or disapprove 

15 any such application contrary to the recommendations of 

16 the advisory council, the Director shall provide the advi17 sory council with, and make publicly available, a detailed, 

18 written explanation of the reasons for the decision. 

19 ‘‘(d) MEMBERSHIP.— 

20 ‘‘(1) COMPOSITION.—The advisory council shall 

21 be composed of 18 members appointed by the Sec22 retary, including the following: 

23 ‘‘(A) Not more than 2 representatives of 

24 the vaccine manufacturing industry. 

25 ‘‘(B) One practicing pediatrician. 


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1 ‘‘(C) One infectious disease expert. 

2 ‘‘(D) Five adults who are each— 

3 ‘‘(i) a victim of a vaccine injury; or 

4 ‘‘(ii) a parent of the victim of a vac5 cine-related injury. 

6 ‘‘(E) One representative of the general 

7 public who— 

8 ‘‘(i) is not the victim of a vaccine in9 jury; and 

10 ‘‘(ii) does not have a conflict of inter11 est described in paragraph (1)(A), (1)(B), 

12 or (2) of section 2142(b). 

13 ‘‘(F) One toxicologist. 

14 ‘‘(G) One neurologist. 

15 ‘‘(H) One geneticist. 

16 ‘‘(I) One immunologist. 

17 ‘‘(J) One State or local public health offi18 cer. 

19 ‘‘(K) Not less than 4 and not more than 

20 6 additional representatives. 

21 ‘‘(2) QUALIFICATIONS.—In appointing the 

22 members of the Commission, the Secretary shall en23 sure that not less than one-third of the members of 

24 the advisory council are selected from among indi25 viduals who have a vaccine-related injury or who 


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1 have an immediate family member with a vaccine-re2 lated injury (irrespective of whether there is a judi3 cial or administration finding of such injury). 

4 ‘‘(3) CONFLICTS OF INTEREST.—In appointing 

5 the members of the Commission, the Secretary shall 

6 ensure that such members do not have any related 

7 financial conflict of interest. For purposes of this 

8 paragraph, the Secretary shall not treat as a conflict 

9 of interest the following: 

10 ‘‘(A) In the case of a member appointed 

11 under paragraph (1)(A) who is employed in the 

12 vaccine manufacturing industry, the receipt of a 

13 salary or other benefits for such employment. 

14 ‘‘(B) In the case of 2 of the members ap15 pointed under paragraph (1)(D), any pending 

16 claim for compensation for a vaccine-related in17 jury. 

18 ‘‘SEC. 2146. FULL-TIME LIAISON. 

19 ‘‘The Director for Vaccine Safety Evaluation shall 

20 designate an employee of the Agency to serve as a full21 time liaison between the Agency and the Department of 

22 Defense, the National Institutes of Health, the Food and 

23 Drug Administration, and the Centers for Disease Control 

24 and Prevention, and any other agency as the Director de25 termines necessary. 


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1 ‘‘SEC. 2147. DEFINITIONS. 

2 ‘‘In this subtitle: 

3 ‘‘(1) The term ‘advisory council’ means the ad4 visory council established pursuant to section 2145. 

5 ‘‘(2) The term ‘Agency’ means the Agency for 

6 Vaccine Safety Evaluation. 

7 ‘‘(3) The term ‘assets’ includes contracts, facili8 ties, property, records, unobligated or unexpended 

9 balances of appropriations, and other funds or re10 sources (other than personnel). 

11 ‘‘(4) The term ‘functions’ includes authorities, 

12 powers, rights, privileges, immunities, programs, 

13 projects, activities, duties, and responsibilities. 

14 ‘‘(5) The term ‘licensed vaccine’ means a vac15 cine with a biologics license in effect under section 

16 351 of the Public Health Service Act (42 U.S.C. 

17 262). 

18 ‘‘(6) The term ‘personnel’ means officers and 

19 employees. 

20 ‘‘(7) The term ‘Project’ means the Vaccine 

21 Safety Datalink Project. 

22 ‘‘SEC. 2148. AUTHORIZATION OF APPROPRIATIONS. 

23 ‘‘There is authorized to be appropriated— 

24 ‘‘(1) for conducting and supporting research 

25 under this subtitle, $80,000,000 for fiscal year 

26 2010; and 


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1 ‘‘(2) for carrying out responsibilities under this 

2 subtitle other than the conduct or support of re3 search, such sums as may be necessary for fiscal 

4 year 2010.’’. 

Æ 


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