I 

111TH CONGRESS 

2D SESSION H. R. 5440 

To secure the promise of personalized medicine for all Americans by expanding and accelerating genomics research and initiatives to improve the 

accuracy of disease diagnosis, increase the safety of drugs, and identify 

novel treatments, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 27, 2010 

Mr. KENNEDY (for himself and Ms. ESHOO) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL 

To secure the promise of personalized medicine for all Americans by expanding and accelerating genomics research 

and initiatives to improve the accuracy of disease diagnosis, increase the safety of drugs, and identify novel 

treatments, 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. 

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

5 ‘‘Genomics and Personalized Medicine Act of 2010’’. 

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

7 this Act is as follows: 

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Sec. 1. Short title. 

Sec. 2. Definitions. 

TITLE I—OFFICE OF PERSONALIZED HEALTHCARE 

Sec. 101. Office of Personalized Healthcare. 

TITLE II—EXPANSION AND ACCELERATION OF RESEARCH FOR 

GENOMICS AND PERSONALIZED MEDICINE 

Subtitle A—Acceleration of Genomics and Personalized Medicine Research 

Sec. 201. Grants for research in genomics and personalized medicine. 

Sec. 202. National biobank. 

Sec. 203. Biobank initiative grants. 

Sec. 204. Authorization of appropriations. 

Subtitle B—Committee on the Evaluation of Genomic Applications in Practice 

and Prevention 

Sec. 211. Establishment. 

TITLE III—GENOMICS AND PERSONALIZED MEDICINE IN 

CLINICAL PRACTICE AND PUBLIC HEALTH 

Sec. 301. Genomics and personalized medicine education and training. 

TITLE IV—REALIZING THE POTENTIAL OF PERSONALIZED 

MEDICINE 

Sec. 401. Reducing the redundancy of clinical laboratory requirements. 

Sec. 402. Committee on public engagement. 

Sec. 403. Study by the Institute of Medicine. 

Sec. 404. Food and Drug Administration. 

Sec. 405. Adverse events. 

Sec. 406. Termination of certain advertising campaigns. 

Sec. 407. Centers for Disease Control and Prevention. 

Sec. 408. Authorization of appropriations. 

1 SEC. 2. DEFINITIONS. 

2 In this Act: 

3 (1) BIOBANK.—The term ‘‘biobank’’ means a 

4 shared repository of human biological specimens col5 lected for medical or research purposes that may in6 clude biobank data. 

7 (2) BIOBANK DATA.—The term ‘‘biobank 

8 data’’— 

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1 (A) means data associated with a human 

2 biological specimen stored in a biobank collected 

3 for medical or research purposes; and 

4 (B) includes, if feasible, health informa5 tion, demographic, genotype, and molecular pro6 file data, and environmental data associated 

7 with a specimen. 

8 (3) BIOMARKER.—The term ‘‘biomarker’’ 

9 means a substance or chemical constituent found in 

10 or derived from a human biological specimen that is 

11 objectively measured and evaluated as an indicator 

12 of normal biologic processes, pathogenic processes, 

13 or pharmacologic responses to a therapeutic inter14 vention. 

15 (4) ENVIRONMENT; ENVIRONMENTAL.—The 

16 terms ‘‘environment’’ and ‘‘environmental’’ refer to 

17 conditions or circumstances that are nongenetic, but 

18 may have a health impact and affect the expression 

19 of genes. 

20 (5) CEGAPP.—The term ‘‘CEGAPP’’ means 

21 the Committee on the Evaluation of Genomic Appli22 cations in Practice and Prevention established under 

23 section 211. 

24 (6) CLIA.—The term ‘‘CLIA’’ means section 

25 353 of the Public Health Service Act (42 U.S.C. 18 

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1 263a; commonly referred to as the ‘‘Clinical Labora2 tory Improvement Amendments of 1988’’). 

3 (7) COMPANION DIAGNOSTIC TEST.—The term 

4 ‘‘companion diagnostic test’’ means a genetic or 

5 genomic test used in conjunction with a specific 

6 treatment that measures and evaluates a specific 

7 biomarker as an indicator of normal biologic proc8 esses, pathogenic processes, or pharmacologic re9 sponses to a therapeutic intervention for an individ10 ual’s condition. 

11 (8) GENETIC AND GENOMIC TESTS.— 

12 (A) IN GENERAL.—The term ‘‘genetic or 

13 genomic tests’’ means analyses of human chro14 mosomes, deoxyribonucleic acid, ribonucleic 

15 acid, genes, gene products (such as enzymes 

16 and other types of proteins), or metabolites, 

17 that— 

18 (i) are predominately used to detect 

19 hereditable or somatic mutations, 

20 genotypes, or phenotypes related to disease 

21 and health; and 

22 (ii) may be used to screen newborns, 

23 identify carriers of inherited mutations, 

24 predict risk of disease, establish prenatal 

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1 formation, diagnose malignancies, guide 

2 clinical management, identify targets for 

3 therapy, monitor results to therapy, and 

4 evaluate for early relapse. 

5 (B) EXCLUSIONS.—The term ‘‘genetic and 

6 genomic tests’’ excludes— 

7 (i) tests conducted exclusively for fo8 rensic and identity purposes; 

9 (ii) tests conducted purely for re10 search purposes; 

11 (iii) tests that are used primarily for 

12 other purposes but that may contribute to 

13 diagnosing a genetic disease or disorder 

14 (such as blood smears and certain serum 

15 chemistries); 

16 (iv) an analysis of proteins or metabo17 lites that does not indicate genotypes, 

18 mutations, or chromosomal changes; or 

19 (v) an analysis of proteins or metabo20 lites that is directly related to a manifested 

21 disease, disorder, or pathological condition 

22 that could reasonably be detected by a 

23 health care professional with appropriate 

24 training and expertise in the field of medi25 cine involved. 

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1 (9) HUMAN BIOLOGICAL SPECIMEN.—The term 

2 ‘‘human biological specimen’’ means any human 

3 body fluid, tissue, blood, or cell; any material derived 

4 from any human body fluid, tissue, blood, or cell; 

5 and, as feasible, any data associated with such speci6 mens including associated health information, demo7 graphic, genotype, and molecular profile data, and 

8 environmental data. 

9 (10) OPH.—The term ‘‘OPH’’ means the Of10 fice of Personalized Healthcare established under 

11 section 101. 

12 (11) PERSONALIZED MEDICINE.—The term 

13 ‘‘personalized medicine’’ means any clinical practice 

14 model that emphasizes the systematic use of preven15 tive, diagnostic, and therapeutic interventions that 

16 use genome and family history information to im17 prove health outcomes. 

18 (12) PHARMACOGENOMICS.— 

19 (A) IN GENERAL.—The term 

20 ‘‘pharmacogenomics’’ means the study of indi21 vidual variations in DNA and RNA characteris22 tics and sequences and the relationship of such 

23 variations to drug response, including absorp24 tion, distribution, metabolism, and elimination 

25 (pharmacokinetics) or drug action 

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1 (pharmacodynamics). Such variations include 

2 nucleotide polymorphism rearrangements, inser3 tions, and deletions. Such variations may also 

4 include alterations in gene expression or inac5 tivation in the genes encoding drug trans6 porters, receptors, metabolizing enzymes, or any 

7 other proteins that are implicated in pharma8 cological function and therapeutic response. 

9 (B) VARIATIONS.—For purposes of this 

10 paragraph, the variations referred to in sub11 paragraph (A) may affect a single nucleotide or 

12 more than one region in a single gene or reflect 

13 alterations in more than one gene. 

14 (13) SACGHS.—The term ‘‘SACGHS’’ means 

15 the Secretary’s Advisory Committee on Genomics, 

16 Health, and Society. 

17 (14) SECRETARY.—The term ‘‘Secretary’’ 

18 means the Secretary of Health and Human Services. 

19 TITLE I—OFFICE OF 

20 PERSONALIZED HEALTHCARE 

21 SEC. 101. OFFICE OF PERSONALIZED HEALTHCARE. 

22 (a) IN GENERAL.—The Secretary shall establish the 

23 Office of Personalized Healthcare within the Office of the 

24 Secretary. 

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1 (b) DIRECTOR.—The OPH shall be headed by a di2 rector, to be appointed by the Secretary. 

3 (c) PURPOSE.—The purpose of the OPH is to coordi4 nate the activities related to genomics and personalized 

5 medicine of the Department of Health and Human Serv6 ices with those of other relevant agencies and public and 

7 private entities to ensure that personalized medicine meets 

8 the highest standards of safety, efficacy, and clinical valid9 ity and utility. 

10 (d) DUTIES.—The Secretary, acting through the Di11 rector of the OPH, shall coordinate cross-agency activities 

12 and collaboration of the Department of Health and 

13 Human Services related to genomics and personalized 

14 medicine, and shall work with relevant departments and 

15 agencies and representatives of the private sector to— 

16 (1) develop a strategic, long-term plan to ad17 vance research and development relevant to person18 alized medicine for coordinating basic science and 

19 translational research in personalized medicine; 

20 (2) identify, prioritize, and address challenges 

21 in translational research on products used for per22 sonalized medicine, including genetic and genomic 

23 tests that impact both product development and reg24 ulation, including any ongoing initiatives; 

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1 (3) assure that coverage and reimbursement de2 cisions for products used for personalized medicine 

3 take into account the best data available for such 

4 decisions without violating the data sharing con5 straints; 

6 (4) identify and prioritize gaps in the evidence 

7 base concerning outcomes and cost-effectiveness of 

8 genomics-based diagnostics and to develop research 

9 or consensus development initiatives to address those 

10 gaps; 

11 (5) clarify and simplify the regulation of prod12 ucts used for personalized medicine to ensure that 

13 guidelines are consistent and intra-agency regula14 tions do not conflict; 

15 (6) educate and consult with developers of prod16 ucts used for personalized medicine concerning evi17 dence requirements for reimbursement and regu18 latory purposes, to facilitate development of more 

19 cost-effective clinical trial programs for new prod20 ucts; 

21 (7) ensure that the Federal regulatory approach 

22 to information technology-based clinical decision 

23 support systems is evidence based and appropriately 

24 targeted; 

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1 (8) leverage and network existing agency and 

2 private sector expertise to address the needs in 

3 translating genomics into the implementation and 

4 practice of personalized medicine, including the find5 ings and recommendations of the SACGHS and 

6 CEGAPP or any other such council or committee es7 tablished for the purpose of advising the Secretary 

8 on personalized medicine; and 

9 (9) provide a forum and mechanism to coordi10 nate across agencies and the private sector with re11 gard to discussing genomics priorities and the stand12 ards needed for personalized medicine to become fea13 sible. 

14 (e) ANNUAL REPORTS.—Not later than 24 months 

15 after the date of the enactment of this Act, and annually 

16 after submission of the initial report, the Director of the 

17 OPH shall prepare and submit to the appropriate commit18 tees of the Congress a report. Each such report shall de19 scribe— 

20 (1) progress of cross-agency coordination re21 lated to personalized medicine; 

22 (2) innovations in genomics and personalized 

23 medicine; 

24 (3) emerging and persistent challenges related 

25 to personalized medicine; 

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1 (4) key barriers in research, regulation, and re2 imbursement and their impact on innovation, devel3 opment, and implementation of medical product de4 velopment for personalized medicine; 

5 (5) medical, ethical, legal, and social impacts of 

6 personalized medicine; and 

7 (6) the extent to which the findings and rec8 ommendations of the SACGHS, CEGAPP, and 

9 other Federal entities are used to inform policy10 making on personalized medicine within the Depart11 ment of Health and Human Services. 

12 (f) REPORT ON THE REGULATION OF PRODUCTS

13 USED FOR PERSONALIZED MEDICINE.—Not later than 18 

14 months after the date of the enactment of this Act, the 

15 Director of the OPH shall submit to the Secretary and 

16 the appropriate committees of the Congress, and publish 

17 a report on, recommendations for the regulation of prod18 ucts used for personalized medicine (including genetic and 

19 genomic tests). Such report shall include recommendations 

20 regarding— 

21 (1) which products used for personalized medi22 cine should require regulation, and, for such prod23 ucts which are recommended in the report to require 

24 regulation, recommendations regarding— 

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1 (A) the appropriate regulatory submission 

2 requirements and timeframes for such submis3 sions; 

4 (B) the appropriate level of evidence nec5 essary for approval of such products; and 

6 (C) resubmission requirements for those 

7 products used for personalized medicine that 

8 undergo modifications; 

9 (2) a clear delineation between the roles and re10 sponsibilities of the Food and Drug Administration 

11 and the Centers for Medicare & Medicaid Services in 

12 regulation and enforcement of products used for per13 sonalized medicine, including laboratory-developed 

14 tests, and the resolution of any conflicts or 

15 redundancies between the 2 agencies, including 

16 under section 401; 

17 (3) a means by which to decrease the burden 

18 associated with the initial and subsequent submis19 sion of any required regulatory documents by clinical 

20 laboratories; and 

21 (4) an evaluation of any current Federal reg22 istries for products used for personalized medicine 

23 (including those for genetic and genomic tests) to 

24 determine the appropriateness of establishing a man25 datory registry for such products (including specific 

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1 recommendations pertaining to the purpose, imple2 mentation, maintenance, and use of the registry). 

3 (g) AUTHORIZATION OF APPROPRIATIONS.—To carry 

4 out this section, there are authorized to be appropriated 

5 $5,000,000 for fiscal year 2011, and such sums as may 

6 be necessary for each of fiscal years 2012 through 2016. 

7 TITLE II—EXPANSION AND AC8 CELERATION OF RESEARCH 

9 FOR GENOMICS AND PERSON10 ALIZED MEDICINE 

11 Subtitle A—Acceleration of 

12 Genomics and Personalized 

13 Medicine Research 

14 SEC. 201. GRANTS FOR RESEARCH IN GENOMICS AND PER15 SONALIZED MEDICINE. 

16 (a) IN GENERAL.—The Secretary, acting through the 

17 Directors of the Centers for Disease Control and Preven18 tion and other relevant agencies (as determined by the 

19 Secretary), shall increase and accelerate research and pro20 grams to collect, evaluate, and disseminate genetic and 

21 genomic data that will advance the field of genomics and 

22 personalized medicine, which may include— 

23 (1) studies of diseases and health conditions 

24 with substantial public health impact; 

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1 (2) population-based studies of genotype preva2 lence, gene-disease association, gene-drug response 

3 association, and interactions between genes and the 

4 environment; 

5 (3) systematic review and synthesis of the re6 sults of population-based studies using methods of 

7 human genome epidemiology; 

8 (4) translation of genomic information into mo9 lecular genetic and genomic screening tools, 

10 diagnostics, and therapeutics by supporting proc11 esses and studies that lead to effective and safe ap12 plications in clinical and public health practice; 

13 (5) translation of genomic information into 

14 tools for public health investigations and ongoing 

15 biosurveillance and monitoring; 

16 (6) comprehensive studies of clinical utility, in17 cluding cost-effectiveness and cost-benefit analyses, 

18 of molecular genetic and genomic tests and thera19 peutics; 

20 (7) implementation and postimplementation re21 search to facilitate studies for evaluating effective22 ness and utility in clinical and policy decision23 making; 

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1 mentation of high-quality standards of practice 

2 using evidence-based clinical and public health 

3 guidelines for genetic and genomic tests; 

4 (9) systematic review of data on analytic valid5 ity, clinical validity, and clinical utility of products 

6 used for personalized medicine, and data on imple7 mentation and dissemination of evidence-based prac8 tices; 

9 (10) studies to assess the awareness, knowl10 edge, and use of products used for personalized med11 icine and their impact on population health and 

12 health disparities; 

13 (11) bioinformatics research designed to inte14 grate genomics and personalized medicine into clin15 ical practice; and 

16 (12) research to fill gaps in clinical knowledge 

17 as determined by the CEGAPP. 

18 (b) GRANTS.— 

19 (1) IN GENERAL.—The Secretary may award 

20 grants to eligible entities to carry out the activities 

21 described in subsection (a). 

22 (2) PRIORITY.—In awarding grants under this 

23 subsection, the Secretary shall give priority to eligi24 ble entities that— 

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1 (A) enter into collaborative research with 

2 public and private entities; or 

3 (B) propose to address priorities identified 

4 by the CEGAPP under subtitle B. 

5 (3) DEFINITION.—In this subsection, the term 

6 ‘‘eligible entity’’ includes any nonprofit organization 

7 with expertise in genomics and personalized medi8 cine. 

9 SEC. 202. NATIONAL BIOBANK. 

10 (a) IN GENERAL.—The Director of the National In11 stitutes of Health, in consultation with the Director of 

12 Centers for Disease Control and Prevention, shall estab13 lish and maintain a national biobank to advance the field 

14 of genomics and personalized medicine. The Director shall 

15 coordinate activities under this section with the activities 

16 of other public or private biobank or genomic database ini17 tiatives, including initiatives funded under section 203. 

18 The national biobank shall be designed to collect and inte19 grate human biological specimens and biobank data for 

20 research purposes associated with genomics and personal21 ized medicine. 

22 (b) REQUIREMENTS.—In carrying out subsection (a), 

23 the Director of the National Institutes of Health shall— 

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1 (1) establish, directly or by contract, a single 

2 point of authority to manage operations of the na3 tional biobank; 

4 (2) establish and disseminate quality standards 

5 and guidelines for the collection, processing, 

6 archiving, storage, and dissemination of human bio7 logical specimens and biobank data for research and 

8 clinical purposes; 

9 (3) develop and promulgate guidelines regard10 ing procedures, protocols, and policies for the safe11 guarding of the privacy of human biological speci12 mens and biobank data, in accordance with applica13 ble Federal and State regulations, guidelines, and 

14 policies, as appropriate; 

15 (4) review and make recommendations to ad16 dress ownership, patient access issues, and analyses 

17 with respect to human biological specimens and 

18 biobank data; 

19 (5) develop and promulgate guidelines regard20 ing procedures, protocols, and policies for access to 

21 human biological specimens and biobank data by 

22 nongovernmental entities for research purposes; 

23 (6) develop and disseminate guidelines for 

24 structuring informed consent forms that address— 

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1 (A) privacy and confidentiality of human 

2 biological specimens and biobank data; 

3 (B) understanding of research procedures, 

4 benefits, risks, rights, and responsibilities; 

5 (C) continuous voluntary participation; 

6 (D) the development of informed consent 

7 agreements that allow for future research in ad8 vance of clear research objectives; and 

9 (E) the right of an individual to opt out of 

10 research at any time; 

11 (7) develop mechanisms for informing the pub12 lic about the national biobank; 

13 (8) ensure the inclusion of underrepresented 

14 populations with health disparities in the activities 

15 of the national biobank, pursuant to the goals of 

16 Healthy People 2010; 

17 (9) incorporate human biological specimens and 

18 biobank data from federally conducted or supported 

19 genomics initiatives, as feasible; 

20 (10) encourage voluntary submission of human 

21 biological specimens and biobank data obtained or 

22 analyzed with private or non-Federal funds; 

23 (11) facilitate submission of biobank data, in24 cluding secure and efficient electronic submission; 

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1 (12) allow public use of human biological speci2 mens and biobank data only— 

3 (A) with appropriate privacy safeguards in 

4 place; and 

5 (B) for research purposes; 

6 (13) determine appropriate procedures for ac7 cess by nongovernmental entities to human biological 

8 specimens and biobank data for research and devel9 opment of new or improved tests and treatments, 

10 and submission of data generated from research and 

11 development to the Food and Drug Administration 

12 or appropriate agencies as part of the approval proc13 ess for products used for personalized medicine; 

14 (14) conduct, directly or by contract, analytical 

15 research, including clinical, epidemiological, and so16 cial-science, using human biological specimens and 

17 biobank data including the development of a long18 term population cohort for investigating genetic and 

19 environmental health impacts; and 

20 (15) make aggregate research findings from 

21 biobank initiatives supported by Federal funding 

22 publicly available within an appropriate timeframe 

23 (as determined by the Secretary). 

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1 SEC. 203. BIOBANK INITIATIVE GRANTS. 

2 (a) IN GENERAL.—The Secretary shall establish a 

3 program of awarding grants to eligible entities for the de4 velopment or expansion of a biobank initiative for the pur5 poses of— 

6 (1) increasing understanding of how genomics 

7 interacts with lifestyle factors and the environment 

8 to cause disease; 

9 (2) examining the effectiveness of using 

10 genomic information in health management and 

11 medical decisionmaking; 

12 (3) discovering genomic variations that affect 

13 drug toxicity and efficacy; and 

14 (4) accelerating the development of products 

15 used for personalized medicine. 

16 (b) USE OF FUNDS.—As a condition on receipt of 

17 a grant under subsection (a), an eligible entity shall agree 

18 to use the grant, consistent with the purposes described 

19 in such subsection, to develop or expand a biobank initia20 tive. Such development or expansion may include any of 

21 the following activities: 

22 (1) Support for the scientific community and 

23 medical advisory committees. 

24 (2) Recruitment and education of diverse par25 ticipants, especially underrepresented races, 

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1 ethnicities, and genders pursuant to the goals of 

2 Healthy People 2010. 

3 (3) Development of consent protocols. 

4 (4) Provision of genetic counseling services to 

5 participants, as appropriate. 

6 (5) Obtaining human biological specimens and 

7 biobank data. 

8 (6) Obtaining necessary equipment for data col9 lection, analysis, and storage. 

10 (7) Establishment and maintenance of secure 

11 storage for human biological specimens and biobank 

12 data. 

13 (8) Conducting data analyses and evidence14 based systematic reviews that allow for the following: 

15 (A) Identification of biomarkers and other 

16 surrogate markers to improve predictions of 

17 onset of disease, response to therapy, and clin18 ical outcomes. 

19 (B) Increased understanding of gene and 

20 environment interactions. 

21 (C) Development of personalized medicine 

22 screening, diagnostic, and therapeutic interven23 tions. 

24 (D) Genotypic characterization of human 

25 biological specimens and biobank data. 

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1 (9) Development of protocols for providing to 

2 health care providers and patients, by means of elec3 tronic health records in accordance with title XXX 

4 of the Public Health Service Act (42 U.S.C. 300jj 

5 et seq.), genomic information obtained during the 

6 course of research or treatment, for the purpose of 

7 improving patient care and outcomes. 

8 (10) Development of interactive, Web-based 

9 portals to provide participants access to their per10 sonal genetic profile. 

11 (11) Any other related activities deemed appro12 priate by the Secretary. 

13 (c) BIOBANK REQUIREMENTS.—The Secretary shall 

14 ensure that any biobank supported under this section— 

15 (1) supports genomics and personalized medi16 cine research; 

17 (2) adheres to standards, guidelines, and rec18 ommendations developed under section 202(b); 

19 (3) is established to complement activities re20 lated to the implementation of current public 

21 biobank research initiatives, as feasible; 

22 (4) is based on well-defined populations, includ23 ing population-based registries of disease and family24 based registries; 

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1 (5) collects data from participants with diverse 

2 genomic profiles, demographics, environmental expo3 sures, and presence or absence of diverse health con4 ditions and diseases, as appropriate; 

5 (6) has practical experience and demonstrated 

6 expertise in genomics and its clinical and public 

7 health applications; 

8 (7) establishes mechanisms to ensure patient 

9 privacy and protection of information from non10 health applications and, as feasible, patient access to 

11 human biological specimens and biobank data for 

12 clinical testing purposes; and 

13 (8) contributes biobank data to the national 

14 biobank established under section 202. 

15 (d) PRIORITY.—In awarding grants under this sec16 tion, the Secretary shall give priority to eligible entities 

17 with experience in conducting population-based genetic re18 search studies (such as focused whole genome, and 

19 epigenetics studies) or genomic research on heritable or 

20 somatic mutations. 

21 (e) QUALITY ASSURANCE.—The Secretary may enter 

22 into a contract with an external entity to evaluate grantees 

23 under this section to ensure that quality standards estab24 lished under section 202(b) are met. 

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1 (f) APPLICATION OF PRIVACY RULES.—Nothing in 

2 this section shall be construed to supersede the require3 ments for the protection of patient privacy under— 

4 (1) HIPAA privacy and security law (as defined 

5 in section 3009(a) of the Public Health Service Act 

6 (42 U.S.C. 300jj–19(a)); 

7 (2) sections 552 and 552a of title 5, United 

8 States Code (5 U.S.C. App.); 

9 (3) the Genetic Information Nondiscrimination 

10 Act of 2008 (Public Law 110–233); 

11 (4) part 46 of title 45, Code of Federal Regula12 tions (or any successor regulations); or 

13 (5) part 50 of title 21, Code of Federal Regula14 tions (or any successor regulations). 

15 (g) DEFINITION.—In this section, the term ‘‘eligible 

16 entity’’ includes an academic medical center, a university, 

17 a private nonprofit biomedical research institution, and 

18 any other entity determined appropriate by the Secretary. 

19 SEC. 204. AUTHORIZATION OF APPROPRIATIONS. 

20 To carry out this subtitle, there are authorized to be 

21 appropriated $150,000,000 for fiscal year 2011, and such 

22 sums as may be necessary for each of fiscal years 2012 

23 through 2016. 

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1 Subtitle B—Committee on the Eval2 uation of Genomic Applications 

3 in Practice and Prevention 

4 SEC. 211. ESTABLISHMENT. 

5 (a) IN GENERAL.—The Secretary, acting through the 

6 Director of the Centers for Disease Control and Preven7 tion, shall establish (pursuant to section 222 of the Public 

8 Health Service Act (42 U.S.C. 217(a)) an advisory com9 mittee, composed of members from the public and private 

10 sectors, to expand and accelerate knowledge related to the 

11 clinical validity and utility of genomics and personalized 

12 medicine through the analysis of current literature, and 

13 determination of gaps in evidence. Such committee shall 

14 be known as the Committee on the Evaluation of Genomic 

15 Applications in Practice and Prevention. 

16 (b) DUTIES.—The CEGAPP shall expand the 

17 breadth of knowledge related to the clinical validity and 

18 utility of genomics and personalized medicine by— 

19 (1) establishing, testing, and publishing proc20 esses and methods for evidence-based reviews and 

21 recommendation development that are optimized for 

22 genetic and genomic tests and other products used 

23 for personalized medicine in transition from research 

24 to clinical and public health practice; 

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1 (2) identifying, prioritizing, and selecting topics 

2 for systematic evidence-based review; 

3 (3) publishing evidence-based reviews and rec4 ommendations for clinical practice and areas for ad5 ditional research for such topics; 

6 (4) publishing experiences with systematic evi7 dence-based review; 

8 (5) publishing gaps in knowledge, as deter9 mined through reviews and recommendations under 

10 paragraph (3), to assist in carrying out section 201; 

11 (6) integrating existing recommendations on 

12 implementation of genetic and genomic tests and 

13 other products used for personalized medicine from 

14 professional organizations and advisory committees; 

15 (7) integrating knowledge and experience 

16 gained from existing processes for evaluation and 

17 appraisal, previous public and private initiatives, and 

18 the international health technology assessment expe19 rience; 

20 (8) advising the Centers for Medicare & Med21 icaid Services on whether current evidence supports 

22 the coverage of specific products used for personal23 ized medicine (including genetic and genomic tests 

24 used for the screening of diseases in cases where a 

25 family history of such disease is present); 

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1 (9) developing or adapting processes for recog2 nizing promising new products used for personalized 

3 medicine and supporting their translation to clinical 

4 and public health practice; and 

5 (10) developing processes for the collection of 

6 data reflective of analytic and clinical validity and 

7 utility and quality measures indicative of good clin8 ical and laboratory practices for tests early in their 

9 translation or adoption cycle. 

10 (c) AUTHORIZATION OF APPROPRIATIONS.—There 

11 are authorized to be appropriated to carry out this section 

12 $5,000,000 for fiscal year 2011, and such sums as may 

13 be necessary for each of fiscal years 2012 through 2016. 

14 TITLE III—GENOMICS AND PER15 SONALIZED MEDICINE IN 

16 CLINICAL PRACTICE AND 

17 PUBLIC HEALTH 

18 SEC. 301. GENOMICS AND PERSONALIZED MEDICINE EDU19 CATION AND TRAINING. 

20 (a) IN GENERAL.—The Secretary shall make grants, 

21 contracts, or cooperative agreements to eligible entities to 

22 improve the adequacy of genomics and personalized medi23 cine training for specimen collection, diagnosis, treatment, 

24 and counseling of adults and children for both rare and 

25 common disorders, through support of efforts to— 

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1 (1) develop and disseminate model education 

2 and training programs across all health profes3 sionals, including medical student, graduate medical, 

4 and continuing education, that reflect the new 

5 knowledge and evolving practice of genetics and 

6 genomics including the appropriate use of products 

7 used in personalized medicine; 

8 (2) assist with the review of board and other 

9 certifying examinations by professional societies and 

10 accreditation bodies to ensure adequate focus on the 

11 fundamental principles of genomics and personalized 

12 medicine and applications to clinical decisionmaking; 

13 (3) identify, evaluate, and develop options for 

14 distance or online learning for degree or continuing 

15 education programs; 

16 (4) identify gaps and opportunities to strength17 en continuing education programs for health care 

18 professionals; 

19 (5) develop and disseminate model programs to 

20 train pathologists on the specialized mechanisms of 

21 collection and storage of human biological specimens 

22 for biobanks; and 

23 (6) develop exchange programs for student, 

24 residents, and fellows to learn techniques and pracmstockstill on DSKH9S0YB1PROD with BILLS

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1 tices to augment genomics and personalized medi2 cine. 

3 (b) INTEGRATION.—The Secretary, in consultation 

4 with medical professional societies, accreditation bodies, 

5 associations of health professional schools, and other pub6 lic and private entities, shall support initiatives to increase 

7 the integration of genomics and personalized medicine into 

8 all aspects of clinical and public health practice by pro9 moting genomics and personalized medicine competency 

10 across all clinical, public health, and laboratory disciplines 

11 through— 

12 (1) the development and dissemination of health 

13 professional guidelines which shall— 

14 (A) include focus on appropriate tech15 niques for collection and storage of genomics 

16 samples, administration and interpretation of 

17 genetic and genomic tests, and subsequent clin18 ical and public health decisionmaking; and 

19 (B) specifically target health professionals 

20 without formal training or experience in the 

21 field of genomics; 

22 (2) the development and dissemination of evi23 dence-based clinical decision support tools for imple24 mentation at the point of care in consultation with 

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1 the Office the National Coordinator for Health In2 formation Technology; 

3 (3) the development, cataloging, and dissemina4 tion of case studies and practice models relating to 

5 the use of products of personalized medicine; 

6 (4) the dissemination of both public and private 

7 systematic reviews on and technology assessments of 

8 the clinical validity and utility of products of person9 alized medicine in coordination with the CEGAPP to 

10 facilitate the development of clinical practice guide11 lines; 

12 (5) the facilitation of the development of evi13 dence-based clinical practice guidelines and dosing 

14 guidelines for product use for personalized medicine 

15 by supporting consensus-building efforts, which shall 

16 include— 

17 (A) development of standards that define 

18 the minimal levels of evidence required to sup19 port guidelines decisions; and 

20 (B) the clinical contexts (such as preven21 tion, diagnosis, and treatment) in which genetic 

22 and genomic tests may be offered; and 

23 (6) the encouragement of public and private 

24 sector entities to submit clinical practice guidelines 

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1 tablished clinical practice guidelines clearinghouses 

2 to facilitate dissemination and encourage implemen3 tation and use of such guidelines. 

4 (c) DEFINITION.—In this section, the term ‘‘eligible 

5 entity’’ includes any professional genetics and genomics 

6 society, accreditation body, health care professional orga7 nization, academic institution, and any other entity as de8 termined appropriate by the Secretary. 

9 (d) AUTHORIZATION OF APPROPRIATIONS.—To carry 

10 out this section, there are authorized to be appropriated 

11 $30,000,000 for fiscal year 2011, and such sums as may 

12 be necessary for each of fiscal years 2012 through 2016. 

13 TITLE IV—REALIZING THE PO14 TENTIAL OF PERSONALIZED 

15 MEDICINE 

16 SEC. 401. REDUCING THE REDUNDANCY OF CLINICAL LAB17 ORATORY REQUIREMENTS. 

18 (a) IN GENERAL.—The Secretary, acting through the 

19 Administrator of the Centers for Medicare & Medicaid 

20 Services and the Commissioner of Food and Drugs, shall 

21 establish a committee to carry out a comparative analysis 

22 of laboratory review requirements under CLIA to— 

23 (1) assess and reduce unnecessary differences 

24 in such requirements; and 

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1 (2) identify opportunities to eliminate 

2 redundancies and decrease the burden of review, as 

3 practicable, of the Centers for Medicare & Medicaid 

4 Services, the Food and Drug Administration, and 

5 private laboratory certifying entities. 

6 (b) REPRESENTATION.—The membership of the com7 mittee established under this section shall include rep8 resentatives of the agencies of the Public Health Service, 

9 other appropriate Federal departments and agencies, pri10 vate laboratories, and private laboratory accreditation or11 ganizations. 

12 (c) PUBLIC INPUT.—The Secretary shall conduct 

13 open public meetings and develop a process to allow for 

14 public comment on such comparative analysis. 

15 (d) REPORTING.—The Secretary shall require the 

16 committee established under this section to submit— 

17 (1) a draft report on such comparative analysis, 

18 including recommendations on opportunities identi19 fied under subsection (a)(1), to the Secretary not 

20 later than 12 months after the date of the enact21 ment of this Act; and 

22 (2) a final such report to the Secretary not 

23 later than 24 months after such date. 

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1 SEC. 402. COMMITTEE ON PUBLIC ENGAGEMENT. 

2 (a) IN GENERAL.—The Secretary shall establish a 

3 committee, to be composed of representatives from the pri4 vate sector who are engaged in genomics and personalized 

5 medicine, to— 

6 (1) examine barriers in research, regulation, 

7 and reimbursement to innovation, development, and 

8 implementation of medical product development for 

9 personalized medicine and the impact of such bar10 riers; and 

11 (2) make recommendations to address such bar12 riers. 

13 (b) COLLABORATION WITH OPH.—The Secretary 

14 shall ensure that, to the extent possible, such committee 

15 carries out this section in collaboration with the OPH. 

16 (c) REPORTING.—The Secretary shall require such 

17 committee to submit a draft report on the committee’s rec18 ommendations under subsection (a)(2) to the Secretary 

19 not later than 24 months after the date of the enactment 

20 of this Act and annually thereafter. 

21 SEC. 403. STUDY BY THE INSTITUTE OF MEDICINE. 

22 (a) IN GENERAL.—The Secretary shall enter into an 

23 agreement with the Institute of Medicine, in consultation 

24 with public and private sector entities involved in personal25 ized medicine, to provide an independent, external review 

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1 odologies for products and services used for personalized 

2 medicine (including genetic and genomic tests). 

3 (b) REQUIREMENTS.—The agreement under sub4 section (a) shall provide for preparation of a report by the 

5 Institute of Medicine. Such report shall include— 

6 (1) a review of the current billing, coverage, 

7 and reimbursement policies for products and services 

8 used for personalized medicine (including genetic 

9 and genomic tests); 

10 (2) specific recommendations for billing, cov11 erage, and reimbursement models by public and pri12 vate insurers that promote research and development 

13 of products used for personalized medicine (includ14 ing genetic and genomic tests), taking into account 

15 the overall impact of such products on patient out16 comes (as demonstrated by evidence from clinical 

17 trials and other well-designed empirical studies), the 

18 value of such products to the health care system, 

19 market-based pricing of such products, and savings 

20 accrued from test utilization to the health care sys21 tem through disease management and early diag22 nosis; 

23 (3) recommendations for clinical trial designs to 

24 provide evidence sufficient to support coverage of 

25 products used for personalized medicine (including 

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1 genetic and genomic tests) by public and private 

2 payors, including reimbursement during the evidence 

3 development phase of well-designed studies; 

4 (4) recommendations for the reimbursement of 

5 health care professionals providing genetic coun6 seling services to— 

7 (A) define which health professionals, tak8 ing into consideration certification, licensure, 

9 and training and scope of practice under State 

10 law, are qualified to provide genetic counseling 

11 services; 

12 (B) define which professionals should be 

13 able to practice, consistent with their scope of 

14 practice under State law, without physician su15 pervision, direction, responsibility, or control, 

16 and, thereby, bill payers directly for their serv17 ices; and 

18 (C) assess the adequacy of existing current 

19 procedural terminology evaluation and manage20 ment codes and their associated relative values 

21 with respect to genetic counseling services; 

22 (5) recommendations for appropriate mecha23 nisms to promote research and development to ad24 vance personalized medicine (which may include tax 

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1 credits, grant programs, or extensions of patent or 

2 exclusivity) to include costs and benefits to society; 

3 (6) incentives to encourage development of 

4 products used for personalized medicine, including 

5 development of genetic and genomic tests for pa6 tients with rare disorders; 

7 (7) criteria for defining when a family history 

8 should be considered a personal history of disease 

9 for reimbursement purposes under title XVIII of the 

10 Social Security Act; and 

11 (8) identification or recommendations regarding 

12 such other issues as determined appropriate by the 

13 Secretary. 

14 (c) STAKEHOLDER INPUT.—The agreement under 

15 subsection (a) shall require the Institute of Medicine, in 

16 preparing the report under this section, to work in con17 sultation with each category of public and private stake18 holders involved in personalized medicine, including 

19 genomics and personalized medicine consumers, physicians 

20 and other health care providers including pathologists, sci21 entists and researchers, private payors, representatives 

22 from clinical and academic laboratories, and representa23 tives from the biotechnology, pharmaceutical, and 

24 diagnostics industries. 

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1 (d) REPORT.—Not later than 12 months after the 

2 date of the enactment of this Act, the Secretary shall sub3 mit the report prepared under this section to the Com4 mittee on Finance and the Committee on Health, Edu5 cation, Labor, and Pensions of the Senate and the Com6 mittee on Ways and Means and the Committee on Energy 

7 and Commerce of the House of Representatives. 

8 SEC. 404. FOOD AND DRUG ADMINISTRATION. 

9 (a) ENCOURAGEMENT OF COMPANION DIAGNOSTIC

10 TESTING.—The Secretary, acting through the Commis11 sioner of Food and Drugs, may require the sponsor of a 

12 drug or biological product— 

13 (1) to develop a companion diagnostic test in 

14 connection with the submission of an investigational 

15 new drug application or a new drug application 

16 under section 505 of the Federal Food, Drug, and 

17 Cosmetic Act (21 U.S.C. 355) to address significant 

18 safety concerns of the drug or biological product; 

19 (2) to develop a companion diagnostic test if 

20 data from postmarketing clinical trials demonstrate 

21 significant safety or effectiveness concerns with use 

22 of the drug or biological product and include in the 

23 label of the drug or biological product a rec24 ommendation to use a companion diagnostic test if 

25 data demonstrate— 

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1 (A) significant safety concerns with the 

2 drug or biologic product; and 

3 (B) improved outcomes with the adminis4 tration of a companion diagnostic test; and 

5 (3) to conduct additional postmarket studies to 

6 identify genetic and other biological, social, behav7 ioral, and environmental factors that may underlie 

8 the differential drug effects when drugs are shown 

9 to be more or less effective in certain racial and eth10 nic subpopulations. 

11 (b) CLARIFICATION AND GUIDANCE.—The Secretary, 

12 acting through the Commissioner of Food and Drugs, 

13 shall clarify and issue guidance regarding— 

14 (1) the criteria and procedures for determining 

15 when labeling of a product used for personalized 

16 medicine will incorporate information on related 

17 companion diagnostic tests, as well as establish the 

18 circumstances under which such tests will be either 

19 recommended or required; 

20 (2) the standards of evidence that must be met 

21 for information pertaining to pharmacogenomics (as 

22 defined in section 2) to be included in the label of 

23 a product used for personalized medicine, such as 

24 with respect to the analytical validity, clinical valid25 ity, clinical utility, dosing, adverse events, and drug 

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1 selection, for use by clinicians when making treat2 ment decisions based on the results of genetic and 

3 genomic tests; 

4 (3) the regulation of automated clinical decision 

5 support systems; and 

6 (4) the collection and analysis of genetic and 

7 other biological factors that may be better biological 

8 predictors of individual differences in drug response 

9 than broad categories such as race, ethnicity, and 

10 gender. 

11 SEC. 405. ADVERSE EVENTS. 

12 The Secretary, in consultation with the Commissioner 

13 of Food and Drugs and the Administrator of the Centers 

14 for Medicare & Medicaid Services, shall— 

15 (1) facilitate the use of products used for per16 sonalized medicine, as feasible, to assess risk for, 

17 and reduce incidence of, adverse drug reactions; 

18 (2) develop or expand adverse event reporting 

19 systems to encompass reports of adverse events re20 sulting from products used for personalized medi21 cine, including laboratory developed test; and 

22 (3) develop systems to appropriately respond to 

23 any adverse events resulting from products used for 

24 personalized medicine. 

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1 SEC. 406. TERMINATION OF CERTAIN ADVERTISING CAM2 PAIGNS. 

3 The Commissioner of Food and Drugs shall collabo4 rate with the Federal Trade Commission to identify and 

5 terminate, pursuant to section 5 of the Federal Trade 

6 Commission Act (15 U.S.C. 45), advertising campaigns 

7 that make false, misleading, deceptive, or unfair claims 

8 about the benefits or risks of products used for personal9 ized medicine. 

10 SEC. 407. CENTERS FOR DISEASE CONTROL AND PREVEN11 TION. 

12 (a) PUBLIC AWARENESS.—The Director of the Cen13 ters for Disease Control and Prevention shall expand ef14 forts to educate and increase awareness of the general 

15 public about genomics and personalized medicine and its 

16 applications to improve health, prevent disease, and elimi17 nate health disparities. Such efforts shall include— 

18 (1) ongoing development and dissemination of 

19 evidence-based informational resources and materials 

20 on the validity and utility of products used for per21 sonalized medicine (including genetic and genomic 

22 tests); 

23 (2) ongoing collection of data on the awareness, 

24 knowledge, and use of genetic and genomic tests 

25 through public health surveillance systems, and anal26 ysis of the impact of such tests on population health; 

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1 (3) integration of the use of validated genetic 

2 and genomic tests in public health programs, as ap3 propriate; and 

4 (4) evaluation of laboratory standards and prac5 tices for quality laboratory services. 

6 (b) DIRECT-TO-CONSUMER MARKETING.—Not later 

7 than 12 months after the date of the enactment of this 

8 Act, the Director of the Centers for Disease Control and 

9 Prevention, in conjunction with the Food and Drug Ad10 ministration and the Federal Trade Commission, with re11 spect to products used for personalized medicine (includ12 ing genetic and genomic tests) for which consumers have 

13 direct access, shall— 

14 (1) conduct an analysis of the public health im15 pact of direct-to-consumer marketing to the extent 

16 possible from available data sources; 

17 (2) analyze the validity of claims made in di18 rect-to-consumer marketing to determine whether 

19 such claims are substantiated by competent and reli20 able scientific evidence; and 

21 (3) make recommendations to the Secretary re22 garding necessary interventions to protect the public 

23 from potential harms of direct-to-consumer mar24 keting and access to products used for personalized 

25 medicine (including genetic and genomic tests). 

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1 SEC. 408. AUTHORIZATION OF APPROPRIATIONS. 

2 (a) IN GENERAL.—To carry out sections 403, 404, 

3 405, and 406, there are authorized to be appropriated 

4 $40,000,000 for fiscal year 2011, and such sums as may 

5 be necessary for each of fiscal years 2012 through 2016. 

6 (b) REDUCING THE REDUNDANCY OF CLINICAL LAB7 ORATORIES.—To carry out section 401, there are author8 ized to be appropriated $5,000,000 for fiscal year 2011, 

9 and such sums as may be necessary for fiscal year 2012. 

10 (c) COMMITTEE ON PUBLIC ENGAGEMENT.—To 

11 carry out section 402, there are authorized to be appro12 priated $1,000,000 for fiscal year 2011, and such sums 

13 as may be necessary for each of fiscal years 2012 through 

14 2016. 

15 (d) CDC PUBLIC AWARENESS ACTIVITIES.—To 

16 carry out section 407, there are authorized to be appro17 priated $20,000,000 for fiscal year 2011, and such sums 

18 as may be necessary for each of fiscal years 2012 through 

19 2016. 

Æ 

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