I 
111TH CONGRESS 
2D SESSION 
H. R. 5440 
To secure the promise of personalized medicine for all Americans by expand-
ing 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 Ameri-
cans by expanding and accelerating genomics research 
and initiatives to improve the accuracy of disease diag-
nosis, increase the safety of drugs, and identify novel 
treatments, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Genomics and Personalized Medicine Act of 2010’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
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. 
SEC. 2. DEFINITIONS. 
In this Act: 
(1) BIOBANK.—The term ‘‘biobank’’ means a 
shared repository of human biological specimens col-
lected for medical or research purposes that may in-
clude biobank data. 
(2) 
BIOBANK
DATA.—The 
term 
‘‘biobank 
data’’— 
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(A) means data associated with a human 
biological specimen stored in a biobank collected 
for medical or research purposes; and 
(B) includes, if feasible, health informa-
tion, demographic, genotype, and molecular pro-
file data, and environmental data associated 
with a specimen. 
(3) 
BIOMARKER.—The 
term 
‘‘biomarker’’ 
means a substance or chemical constituent found in 
or derived from a human biological specimen that is 
objectively measured and evaluated as an indicator 
of normal biologic processes, pathogenic processes, 
or pharmacologic responses to a therapeutic inter-
vention. 
(4) 
ENVIRONMENT; 
ENVIRONMENTAL.—The 
terms ‘‘environment’’ and ‘‘environmental’’ refer to 
conditions or circumstances that are nongenetic, but 
may have a health impact and affect the expression 
of genes. 
(5) CEGAPP.—The term ‘‘CEGAPP’’ means 
the Committee on the Evaluation of Genomic Appli-
cations in Practice and Prevention established under 
section 211. 
(6) CLIA.—The term ‘‘CLIA’’ means section 
353 of the Public Health Service Act (42 U.S.C. 18 
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263a; commonly referred to as the ‘‘Clinical Labora-
tory Improvement Amendments of 1988’’). 
(7) COMPANION DIAGNOSTIC TEST.—The term 
‘‘companion diagnostic test’’ means a genetic or 
genomic test used in conjunction with a specific 
treatment that measures and evaluates a specific 
biomarker as an indicator of normal biologic proc-
esses, pathogenic processes, or pharmacologic re-
sponses to a therapeutic intervention for an individ-
ual’s condition. 
(8) GENETIC AND GENOMIC TESTS.— 
(A) IN GENERAL.—The term ‘‘genetic or 
genomic tests’’ means analyses of human chro-
mosomes, deoxyribonucleic acid, ribonucleic 
acid, genes, gene products (such as enzymes 
and other types of proteins), or metabolites, 
that— 
(i) are predominately used to detect 
hereditable 
or 
somatic 
mutations, 
genotypes, or phenotypes related to disease 
and health; and 
(ii) may be used to screen newborns, 
identify carriers of inherited mutations, 
predict risk of disease, establish prenatal 
or clinical diagnoses, provide prognostic in-
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formation, diagnose malignancies, guide 
clinical management, identify targets for 
therapy, monitor results to therapy, and 
evaluate for early relapse. 
(B) EXCLUSIONS.—The term ‘‘genetic and 
genomic tests’’ excludes— 
(i) tests conducted exclusively for fo-
rensic and identity purposes; 
(ii) tests conducted purely for re-
search purposes; 
(iii) tests that are used primarily for 
other purposes but that may contribute to 
diagnosing a genetic disease or disorder 
(such as blood smears and certain serum 
chemistries); 
(iv) an analysis of proteins or metabo-
lites that does not indicate genotypes, 
mutations, or chromosomal changes; or 
(v) an analysis of proteins or metabo-
lites that is directly related to a manifested 
disease, disorder, or pathological condition 
that could reasonably be detected by a 
health care professional with appropriate 
training and expertise in the field of medi-
cine involved. 
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(9) HUMAN BIOLOGICAL SPECIMEN.—The term 
‘‘human biological specimen’’ means any human 
body fluid, tissue, blood, or cell; any material derived 
from any human body fluid, tissue, blood, or cell; 
and, as feasible, any data associated with such speci-
mens including associated health information, demo-
graphic, genotype, and molecular profile data, and 
environmental data. 
(10) OPH.—The term ‘‘OPH’’ means the Of-
fice of Personalized Healthcare established under 
section 101. 
(11) PERSONALIZED
MEDICINE.—The term 
‘‘personalized medicine’’ means any clinical practice 
model that emphasizes the systematic use of preven-
tive, diagnostic, and therapeutic interventions that 
use genome and family history information to im-
prove health outcomes. 
(12) PHARMACOGENOMICS.— 
(A) 
IN
GENERAL.—The 
term 
‘‘pharmacogenomics’’ means the study of indi-
vidual variations in DNA and RNA characteris-
tics and sequences and the relationship of such 
variations to drug response, including absorp-
tion, distribution, metabolism, and elimination 
(pharmacokinetics) 
or 
drug 
action 
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(pharmacodynamics). Such variations include 
nucleotide polymorphism rearrangements, inser-
tions, and deletions. Such variations may also 
include alterations in gene expression or inac-
tivation in the genes encoding drug trans-
porters, receptors, metabolizing enzymes, or any 
other proteins that are implicated in pharma-
cological function and therapeutic response. 
(B) VARIATIONS.—For purposes of this 
paragraph, the variations referred to in sub-
paragraph (A) may affect a single nucleotide or 
more than one region in a single gene or reflect 
alterations in more than one gene. 
(13) SACGHS.—The term ‘‘SACGHS’’ means 
the Secretary’s Advisory Committee on Genomics, 
Health, and Society. 
(14) 
SECRETARY.—The 
term 
‘‘Secretary’’ 
means the Secretary of Health and Human Services. 
TITLE I—OFFICE OF 
PERSONALIZED HEALTHCARE 
SEC. 101. OFFICE OF PERSONALIZED HEALTHCARE. 
(a) IN GENERAL.—The Secretary shall establish the 
Office of Personalized Healthcare within the Office of the 
Secretary. 
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(b) DIRECTOR.—The OPH shall be headed by a di-
rector, to be appointed by the Secretary. 
(c) PURPOSE.—The purpose of the OPH is to coordi-
nate the activities related to genomics and personalized 
medicine of the Department of Health and Human Serv-
ices with those of other relevant agencies and public and 
private entities to ensure that personalized medicine meets 
the highest standards of safety, efficacy, and clinical valid-
ity and utility. 
(d) DUTIES.—The Secretary, acting through the Di-
rector of the OPH, shall coordinate cross-agency activities 
and collaboration of the Department of Health and 
Human Services related to genomics and personalized 
medicine, and shall work with relevant departments and 
agencies and representatives of the private sector to— 
(1) develop a strategic, long-term plan to ad-
vance research and development relevant to person-
alized medicine for coordinating basic science and 
translational research in personalized medicine; 
(2) identify, prioritize, and address challenges 
in translational research on products used for per-
sonalized medicine, including genetic and genomic 
tests that impact both product development and reg-
ulation, including any ongoing initiatives; 
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(3) assure that coverage and reimbursement de-
cisions for products used for personalized medicine 
take into account the best data available for such 
decisions without violating the data sharing con-
straints; 
(4) identify and prioritize gaps in the evidence 
base concerning outcomes and cost-effectiveness of 
genomics-based diagnostics and to develop research 
or consensus development initiatives to address those 
gaps; 
(5) clarify and simplify the regulation of prod-
ucts used for personalized medicine to ensure that 
guidelines are consistent and intra-agency regula-
tions do not conflict; 
(6) educate and consult with developers of prod-
ucts used for personalized medicine concerning evi-
dence requirements for reimbursement and regu-
latory purposes, to facilitate development of more 
cost-effective clinical trial programs for new prod-
ucts; 
(7) ensure that the Federal regulatory approach 
to information technology-based clinical decision 
support systems is evidence based and appropriately 
targeted; 
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(8) leverage and network existing agency and 
private sector expertise to address the needs in 
translating genomics into the implementation and 
practice of personalized medicine, including the find-
ings and recommendations of the SACGHS and 
CEGAPP or any other such council or committee es-
tablished for the purpose of advising the Secretary 
on personalized medicine; and 
(9) provide a forum and mechanism to coordi-
nate across agencies and the private sector with re-
gard to discussing genomics priorities and the stand-
ards needed for personalized medicine to become fea-
sible. 
(e) ANNUAL REPORTS.—Not later than 24 months 
after the date of the enactment of this Act, and annually 
after submission of the initial report, the Director of the 
OPH shall prepare and submit to the appropriate commit-
tees of the Congress a report. Each such report shall de-
scribe— 
(1) progress of cross-agency coordination re-
lated to personalized medicine; 
(2) innovations in genomics and personalized 
medicine; 
(3) emerging and persistent challenges related 
to personalized medicine; 
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(4) key barriers in research, regulation, and re-
imbursement and their impact on innovation, devel-
opment, and implementation of medical product de-
velopment for personalized medicine; 
(5) medical, ethical, legal, and social impacts of 
personalized medicine; and 
(6) the extent to which the findings and rec-
ommendations of the SACGHS, CEGAPP, and 
other Federal entities are used to inform policy-
making on personalized medicine within the Depart-
ment of Health and Human Services. 
(f) REPORT ON THE REGULATION OF PRODUCTS 
USED FOR PERSONALIZED MEDICINE.—Not later than 18 
months after the date of the enactment of this Act, the 
Director of the OPH shall submit to the Secretary and 
the appropriate committees of the Congress, and publish 
a report on, recommendations for the regulation of prod-
ucts used for personalized medicine (including genetic and 
genomic tests). Such report shall include recommendations 
regarding— 
(1) which products used for personalized medi-
cine should require regulation, and, for such prod-
ucts which are recommended in the report to require 
regulation, recommendations regarding— 
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(A) the appropriate regulatory submission 
requirements and timeframes for such submis-
sions; 
(B) the appropriate level of evidence nec-
essary for approval of such products; and 
(C) resubmission requirements for those 
products used for personalized medicine that 
undergo modifications; 
(2) a clear delineation between the roles and re-
sponsibilities of the Food and Drug Administration 
and the Centers for Medicare & Medicaid Services in 
regulation and enforcement of products used for per-
sonalized medicine, including laboratory-developed 
tests, and the resolution of any conflicts or 
redundancies between the 2 agencies, including 
under section 401; 
(3) a means by which to decrease the burden 
associated with the initial and subsequent submis-
sion of any required regulatory documents by clinical 
laboratories; and 
(4) an evaluation of any current Federal reg-
istries for products used for personalized medicine 
(including those for genetic and genomic tests) to 
determine the appropriateness of establishing a man-
datory registry for such products (including specific 
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recommendations pertaining to the purpose, imple-
mentation, maintenance, and use of the registry). 
(g) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there are authorized to be appropriated 
$5,000,000 for fiscal year 2011, and such sums as may 
be necessary for each of fiscal years 2012 through 2016. 
TITLE II—EXPANSION AND AC-
CELERATION OF RESEARCH 
FOR GENOMICS AND PERSON-
ALIZED MEDICINE 
Subtitle 
A—Acceleration 
of 
Genomics 
and 
Personalized 
Medicine Research 
SEC. 201. GRANTS FOR RESEARCH IN GENOMICS AND PER-
SONALIZED MEDICINE. 
(a) IN GENERAL.—The Secretary, acting through the 
Directors of the Centers for Disease Control and Preven-
tion and other relevant agencies (as determined by the 
Secretary), shall increase and accelerate research and pro-
grams to collect, evaluate, and disseminate genetic and 
genomic data that will advance the field of genomics and 
personalized medicine, which may include— 
(1) studies of diseases and health conditions 
with substantial public health impact; 
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(2) population-based studies of genotype preva-
lence, gene-disease association, gene-drug response 
association, and interactions between genes and the 
environment; 
(3) systematic review and synthesis of the re-
sults of population-based studies using methods of 
human genome epidemiology; 
(4) translation of genomic information into mo-
lecular 
genetic 
and 
genomic 
screening 
tools, 
diagnostics, and therapeutics by supporting proc-
esses and studies that lead to effective and safe ap-
plications in clinical and public health practice; 
(5) translation of genomic information into 
tools for public health investigations and ongoing 
biosurveillance and monitoring; 
(6) comprehensive studies of clinical utility, in-
cluding cost-effectiveness and cost-benefit analyses, 
of molecular genetic and genomic tests and thera-
peutics; 
(7) implementation and postimplementation re-
search to facilitate studies for evaluating effective-
ness and utility in clinical and policy decision-
making; 
(8) comprehensive studies of clinical and labora-
tory practices necessary to ensure effective imple-
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mentation of high-quality standards of practice 
using evidence-based clinical and public health 
guidelines for genetic and genomic tests; 
(9) systematic review of data on analytic valid-
ity, clinical validity, and clinical utility of products 
used for personalized medicine, and data on imple-
mentation and dissemination of evidence-based prac-
tices; 
(10) studies to assess the awareness, knowl-
edge, and use of products used for personalized med-
icine and their impact on population health and 
health disparities; 
(11) bioinformatics research designed to inte-
grate genomics and personalized medicine into clin-
ical practice; and 
(12) research to fill gaps in clinical knowledge 
as determined by the CEGAPP. 
(b) GRANTS.— 
(1) IN GENERAL.—The Secretary may award 
grants to eligible entities to carry out the activities 
described in subsection (a). 
(2) PRIORITY.—In awarding grants under this 
subsection, the Secretary shall give priority to eligi-
ble entities that— 
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(A) enter into collaborative research with 
public and private entities; or 
(B) propose to address priorities identified 
by the CEGAPP under subtitle B. 
(3) DEFINITION.—In this subsection, the term 
‘‘eligible entity’’ includes any nonprofit organization 
with expertise in genomics and personalized medi-
cine. 
SEC. 202. NATIONAL BIOBANK. 
(a) IN GENERAL.—The Director of the National In-
stitutes of Health, in consultation with the Director of 
Centers for Disease Control and Prevention, shall estab-
lish and maintain a national biobank to advance the field 
of genomics and personalized medicine. The Director shall 
coordinate activities under this section with the activities 
of other public or private biobank or genomic database ini-
tiatives, including initiatives funded under section 203. 
The national biobank shall be designed to collect and inte-
grate human biological specimens and biobank data for 
research purposes associated with genomics and personal-
ized medicine. 
(b) REQUIREMENTS.—In carrying out subsection (a), 
the Director of the National Institutes of Health shall— 
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(1) establish, directly or by contract, a single 
point of authority to manage operations of the na-
tional biobank; 
(2) establish and disseminate quality standards 
and 
guidelines 
for 
the 
collection, 
processing, 
archiving, storage, and dissemination of human bio-
logical specimens and biobank data for research and 
clinical purposes; 
(3) develop and promulgate guidelines regard-
ing procedures, protocols, and policies for the safe-
guarding of the privacy of human biological speci-
mens and biobank data, in accordance with applica-
ble Federal and State regulations, guidelines, and 
policies, as appropriate; 
(4) review and make recommendations to ad-
dress ownership, patient access issues, and analyses 
with respect to human biological specimens and 
biobank data; 
(5) develop and promulgate guidelines regard-
ing procedures, protocols, and policies for access to 
human biological specimens and biobank data by 
nongovernmental entities for research purposes; 
(6) develop and disseminate guidelines for 
structuring informed consent forms that address— 
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(A) privacy and confidentiality of human 
biological specimens and biobank data; 
(B) understanding of research procedures, 
benefits, risks, rights, and responsibilities; 
(C) continuous voluntary participation; 
(D) the development of informed consent 
agreements that allow for future research in ad-
vance of clear research objectives; and 
(E) the right of an individual to opt out of 
research at any time; 
(7) develop mechanisms for informing the pub-
lic about the national biobank; 
(8) ensure the inclusion of underrepresented 
populations with health disparities in the activities 
of the national biobank, pursuant to the goals of 
Healthy People 2010; 
(9) incorporate human biological specimens and 
biobank data from federally conducted or supported 
genomics initiatives, as feasible; 
(10) encourage voluntary submission of human 
biological specimens and biobank data obtained or 
analyzed with private or non-Federal funds; 
(11) facilitate submission of biobank data, in-
cluding secure and efficient electronic submission; 
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(12) allow public use of human biological speci-
mens and biobank data only— 
(A) with appropriate privacy safeguards in 
place; and 
(B) for research purposes; 
(13) determine appropriate procedures for ac-
cess by nongovernmental entities to human biological 
specimens and biobank data for research and devel-
opment of new or improved tests and treatments, 
and submission of data generated from research and 
development to the Food and Drug Administration 
or appropriate agencies as part of the approval proc-
ess for products used for personalized medicine; 
(14) conduct, directly or by contract, analytical 
research, including clinical, epidemiological, and so-
cial-science, using human biological specimens and 
biobank data including the development of a long- 
term population cohort for investigating genetic and 
environmental health impacts; and 
(15) make aggregate research findings from 
biobank initiatives supported by Federal funding 
publicly available within an appropriate timeframe 
(as determined by the Secretary). 
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SEC. 203. BIOBANK INITIATIVE GRANTS. 
(a) IN GENERAL.—The Secretary shall establish a 
program of awarding grants to eligible entities for the de-
velopment or expansion of a biobank initiative for the pur-
poses of— 
(1) increasing understanding of how genomics 
interacts with lifestyle factors and the environment 
to cause disease; 
(2) examining the effectiveness of using 
genomic information in health management and 
medical decisionmaking; 
(3) discovering genomic variations that affect 
drug toxicity and efficacy; and 
(4) accelerating the development of products 
used for personalized medicine. 
(b) USE OF FUNDS.—As a condition on receipt of 
a grant under subsection (a), an eligible entity shall agree 
to use the grant, consistent with the purposes described 
in such subsection, to develop or expand a biobank initia-
tive. Such development or expansion may include any of 
the following activities: 
(1) Support for the scientific community and 
medical advisory committees. 
(2) Recruitment and education of diverse par-
ticipants, 
especially 
underrepresented 
races, 
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ethnicities, and genders pursuant to the goals of 
Healthy People 2010. 
(3) Development of consent protocols. 
(4) Provision of genetic counseling services to 
participants, as appropriate. 
(5) Obtaining human biological specimens and 
biobank data. 
(6) Obtaining necessary equipment for data col-
lection, analysis, and storage. 
(7) Establishment and maintenance of secure 
storage for human biological specimens and biobank 
data. 
(8) Conducting data analyses and evidence- 
based systematic reviews that allow for the following: 
(A) Identification of biomarkers and other 
surrogate markers to improve predictions of 
onset of disease, response to therapy, and clin-
ical outcomes. 
(B) Increased understanding of gene and 
environment interactions. 
(C) Development of personalized medicine 
screening, diagnostic, and therapeutic interven-
tions. 
(D) Genotypic characterization of human 
biological specimens and biobank data. 
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(9) Development of protocols for providing to 
health care providers and patients, by means of elec-
tronic health records in accordance with title XXX 
of the Public Health Service Act (42 U.S.C. 300jj 
et seq.), genomic information obtained during the 
course of research or treatment, for the purpose of 
improving patient care and outcomes. 
(10) Development of interactive, Web-based 
portals to provide participants access to their per-
sonal genetic profile. 
(11) Any other related activities deemed appro-
priate by the Secretary. 
(c) BIOBANK REQUIREMENTS.—The Secretary shall 
ensure that any biobank supported under this section— 
(1) supports genomics and personalized medi-
cine research; 
(2) adheres to standards, guidelines, and rec-
ommendations developed under section 202(b); 
(3) is established to complement activities re-
lated to the implementation of current public 
biobank research initiatives, as feasible; 
(4) is based on well-defined populations, includ-
ing population-based registries of disease and family- 
based registries; 
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(5) collects data from participants with diverse 
genomic profiles, demographics, environmental expo-
sures, and presence or absence of diverse health con-
ditions and diseases, as appropriate; 
(6) has practical experience and demonstrated 
expertise in genomics and its clinical and public 
health applications; 
(7) establishes mechanisms to ensure patient 
privacy and protection of information from non- 
health applications and, as feasible, patient access to 
human biological specimens and biobank data for 
clinical testing purposes; and 
(8) contributes biobank data to the national 
biobank established under section 202. 
(d) PRIORITY.—In awarding grants under this sec-
tion, the Secretary shall give priority to eligible entities 
with experience in conducting population-based genetic re-
search studies (such as focused whole genome, and 
epigenetics studies) or genomic research on heritable or 
somatic mutations. 
(e) QUALITY ASSURANCE.—The Secretary may enter 
into a contract with an external entity to evaluate grantees 
under this section to ensure that quality standards estab-
lished under section 202(b) are met. 
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(f) APPLICATION OF PRIVACY RULES.—Nothing in 
this section shall be construed to supersede the require-
ments for the protection of patient privacy under— 
(1) HIPAA privacy and security law (as defined 
in section 3009(a) of the Public Health Service Act 
(42 U.S.C. 300jj–19(a)); 
(2) sections 552 and 552a of title 5, United 
States Code (5 U.S.C. App.); 
(3) the Genetic Information Nondiscrimination 
Act of 2008 (Public Law 110–233); 
(4) part 46 of title 45, Code of Federal Regula-
tions (or any successor regulations); or 
(5) part 50 of title 21, Code of Federal Regula-
tions (or any successor regulations). 
(g) DEFINITION.—In this section, the term ‘‘eligible 
entity’’ includes an academic medical center, a university, 
a private nonprofit biomedical research institution, and 
any other entity determined appropriate by the Secretary. 
SEC. 204. AUTHORIZATION OF APPROPRIATIONS. 
To carry out this subtitle, there are authorized to be 
appropriated $150,000,000 for fiscal year 2011, and such 
sums as may be necessary for each of fiscal years 2012 
through 2016. 
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Subtitle B—Committee on the Eval-
uation of Genomic Applications 
in Practice and Prevention 
SEC. 211. ESTABLISHMENT. 
(a) IN GENERAL.—The Secretary, acting through the 
Director of the Centers for Disease Control and Preven-
tion, shall establish (pursuant to section 222 of the Public 
Health Service Act (42 U.S.C. 217(a)) an advisory com-
mittee, composed of members from the public and private 
sectors, to expand and accelerate knowledge related to the 
clinical validity and utility of genomics and personalized 
medicine through the analysis of current literature, and 
determination of gaps in evidence. Such committee shall 
be known as the Committee on the Evaluation of Genomic 
Applications in Practice and Prevention. 
(b) DUTIES.—The CEGAPP shall expand the 
breadth of knowledge related to the clinical validity and 
utility of genomics and personalized medicine by— 
(1) establishing, testing, and publishing proc-
esses and methods for evidence-based reviews and 
recommendation development that are optimized for 
genetic and genomic tests and other products used 
for personalized medicine in transition from research 
to clinical and public health practice; 
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(2) identifying, prioritizing, and selecting topics 
for systematic evidence-based review; 
(3) publishing evidence-based reviews and rec-
ommendations for clinical practice and areas for ad-
ditional research for such topics; 
(4) publishing experiences with systematic evi-
dence-based review; 
(5) publishing gaps in knowledge, as deter-
mined through reviews and recommendations under 
paragraph (3), to assist in carrying out section 201; 
(6) integrating existing recommendations on 
implementation of genetic and genomic tests and 
other products used for personalized medicine from 
professional organizations and advisory committees; 
(7) 
integrating 
knowledge 
and 
experience 
gained from existing processes for evaluation and 
appraisal, previous public and private initiatives, and 
the international health technology assessment expe-
rience; 
(8) advising the Centers for Medicare & Med-
icaid Services on whether current evidence supports 
the coverage of specific products used for personal-
ized medicine (including genetic and genomic tests 
used for the screening of diseases in cases where a 
family history of such disease is present); 
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(9) developing or adapting processes for recog-
nizing promising new products used for personalized 
medicine and supporting their translation to clinical 
and public health practice; and 
(10) developing processes for the collection of 
data reflective of analytic and clinical validity and 
utility and quality measures indicative of good clin-
ical and laboratory practices for tests early in their 
translation or adoption cycle. 
(c) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
$5,000,000 for fiscal year 2011, and such sums as may 
be necessary for each of fiscal years 2012 through 2016. 
TITLE III—GENOMICS AND PER-
SONALIZED 
MEDICINE 
IN 
CLINICAL 
PRACTICE 
AND 
PUBLIC HEALTH 
SEC. 301. GENOMICS AND PERSONALIZED MEDICINE EDU-
CATION AND TRAINING. 
(a) IN GENERAL.—The Secretary shall make grants, 
contracts, or cooperative agreements to eligible entities to 
improve the adequacy of genomics and personalized medi-
cine training for specimen collection, diagnosis, treatment, 
and counseling of adults and children for both rare and 
common disorders, through support of efforts to— 
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(1) develop and disseminate model education 
and training programs across all health profes-
sionals, including medical student, graduate medical, 
and continuing education, that reflect the new 
knowledge and evolving practice of genetics and 
genomics including the appropriate use of products 
used in personalized medicine; 
(2) assist with the review of board and other 
certifying examinations by professional societies and 
accreditation bodies to ensure adequate focus on the 
fundamental principles of genomics and personalized 
medicine and applications to clinical decisionmaking; 
(3) identify, evaluate, and develop options for 
distance or online learning for degree or continuing 
education programs; 
(4) identify gaps and opportunities to strength-
en continuing education programs for health care 
professionals; 
(5) develop and disseminate model programs to 
train pathologists on the specialized mechanisms of 
collection and storage of human biological specimens 
for biobanks; and 
(6) develop exchange programs for student, 
residents, and fellows to learn techniques and prac-
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tices to augment genomics and personalized medi-
cine. 
(b) INTEGRATION.—The Secretary, in consultation 
with medical professional societies, accreditation bodies, 
associations of health professional schools, and other pub-
lic and private entities, shall support initiatives to increase 
the integration of genomics and personalized medicine into 
all aspects of clinical and public health practice by pro-
moting genomics and personalized medicine competency 
across all clinical, public health, and laboratory disciplines 
through— 
(1) the development and dissemination of health 
professional guidelines which shall— 
(A) include focus on appropriate tech-
niques for collection and storage of genomics 
samples, administration and interpretation of 
genetic and genomic tests, and subsequent clin-
ical and public health decisionmaking; and 
(B) specifically target health professionals 
without formal training or experience in the 
field of genomics; 
(2) the development and dissemination of evi-
dence-based clinical decision support tools for imple-
mentation at the point of care in consultation with 
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the Office the National Coordinator for Health In-
formation Technology; 
(3) the development, cataloging, and dissemina-
tion of case studies and practice models relating to 
the use of products of personalized medicine; 
(4) the dissemination of both public and private 
systematic reviews on and technology assessments of 
the clinical validity and utility of products of person-
alized medicine in coordination with the CEGAPP to 
facilitate the development of clinical practice guide-
lines; 
(5) the facilitation of the development of evi-
dence-based clinical practice guidelines and dosing 
guidelines for product use for personalized medicine 
by supporting consensus-building efforts, which shall 
include— 
(A) development of standards that define 
the minimal levels of evidence required to sup-
port guidelines decisions; and 
(B) the clinical contexts (such as preven-
tion, diagnosis, and treatment) in which genetic 
and genomic tests may be offered; and 
(6) the encouragement of public and private 
sector entities to submit clinical practice guidelines 
on products of personalized medicine to federally es-
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tablished clinical practice guidelines clearinghouses 
to facilitate dissemination and encourage implemen-
tation and use of such guidelines. 
(c) DEFINITION.—In this section, the term ‘‘eligible 
entity’’ includes any professional genetics and genomics 
society, accreditation body, health care professional orga-
nization, academic institution, and any other entity as de-
termined appropriate by the Secretary. 
(d) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there are authorized to be appropriated 
$30,000,000 for fiscal year 2011, and such sums as may 
be necessary for each of fiscal years 2012 through 2016. 
TITLE IV—REALIZING THE PO-
TENTIAL OF PERSONALIZED 
MEDICINE 
SEC. 401. REDUCING THE REDUNDANCY OF CLINICAL LAB-
ORATORY REQUIREMENTS. 
(a) IN GENERAL.—The Secretary, acting through the 
Administrator of the Centers for Medicare & Medicaid 
Services and the Commissioner of Food and Drugs, shall 
establish a committee to carry out a comparative analysis 
of laboratory review requirements under CLIA to— 
(1) assess and reduce unnecessary differences 
in such requirements; and 
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(2) 
identify 
opportunities 
to 
eliminate 
redundancies and decrease the burden of review, as 
practicable, of the Centers for Medicare & Medicaid 
Services, the Food and Drug Administration, and 
private laboratory certifying entities. 
(b) REPRESENTATION.—The membership of the com-
mittee established under this section shall include rep-
resentatives of the agencies of the Public Health Service, 
other appropriate Federal departments and agencies, pri-
vate laboratories, and private laboratory accreditation or-
ganizations. 
(c) PUBLIC INPUT.—The Secretary shall conduct 
open public meetings and develop a process to allow for 
public comment on such comparative analysis. 
(d) REPORTING.—The Secretary shall require the 
committee established under this section to submit— 
(1) a draft report on such comparative analysis, 
including recommendations on opportunities identi-
fied under subsection (a)(1), to the Secretary not 
later than 12 months after the date of the enact-
ment of this Act; and 
(2) a final such report to the Secretary not 
later than 24 months after such date. 
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SEC. 402. COMMITTEE ON PUBLIC ENGAGEMENT. 
(a) IN GENERAL.—The Secretary shall establish a 
committee, to be composed of representatives from the pri-
vate sector who are engaged in genomics and personalized 
medicine, to— 
(1) examine barriers in research, regulation, 
and reimbursement to innovation, development, and 
implementation of medical product development for 
personalized medicine and the impact of such bar-
riers; and 
(2) make recommendations to address such bar-
riers. 
(b) COLLABORATION WITH OPH.—The Secretary 
shall ensure that, to the extent possible, such committee 
carries out this section in collaboration with the OPH. 
(c) REPORTING.—The Secretary shall require such 
committee to submit a draft report on the committee’s rec-
ommendations under subsection (a)(2) to the Secretary 
not later than 24 months after the date of the enactment 
of this Act and annually thereafter. 
SEC. 403. STUDY BY THE INSTITUTE OF MEDICINE. 
(a) IN GENERAL.—The Secretary shall enter into an 
agreement with the Institute of Medicine, in consultation 
with public and private sector entities involved in personal-
ized medicine, to provide an independent, external review 
of the current billing, coverage, and reimbursement meth-
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odologies for products and services used for personalized 
medicine (including genetic and genomic tests). 
(b) REQUIREMENTS.—The agreement under sub-
section (a) shall provide for preparation of a report by the 
Institute of Medicine. Such report shall include— 
(1) a review of the current billing, coverage, 
and reimbursement policies for products and services 
used for personalized medicine (including genetic 
and genomic tests); 
(2) specific recommendations for billing, cov-
erage, and reimbursement models by public and pri-
vate insurers that promote research and development 
of products used for personalized medicine (includ-
ing genetic and genomic tests), taking into account 
the overall impact of such products on patient out-
comes (as demonstrated by evidence from clinical 
trials and other well-designed empirical studies), the 
value of such products to the health care system, 
market-based pricing of such products, and savings 
accrued from test utilization to the health care sys-
tem through disease management and early diag-
nosis; 
(3) recommendations for clinical trial designs to 
provide evidence sufficient to support coverage of 
products used for personalized medicine (including 
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genetic and genomic tests) by public and private 
payors, including reimbursement during the evidence 
development phase of well-designed studies; 
(4) recommendations for the reimbursement of 
health care professionals providing genetic coun-
seling services to— 
(A) define which health professionals, tak-
ing into consideration certification, licensure, 
and training and scope of practice under State 
law, are qualified to provide genetic counseling 
services; 
(B) define which professionals should be 
able to practice, consistent with their scope of 
practice under State law, without physician su-
pervision, direction, responsibility, or control, 
and, thereby, bill payers directly for their serv-
ices; and 
(C) assess the adequacy of existing current 
procedural terminology evaluation and manage-
ment codes and their associated relative values 
with respect to genetic counseling services; 
(5) recommendations for appropriate mecha-
nisms to promote research and development to ad-
vance personalized medicine (which may include tax 
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credits, grant programs, or extensions of patent or 
exclusivity) to include costs and benefits to society; 
(6) incentives to encourage development of 
products used for personalized medicine, including 
development of genetic and genomic tests for pa-
tients with rare disorders; 
(7) criteria for defining when a family history 
should be considered a personal history of disease 
for reimbursement purposes under title XVIII of the 
Social Security Act; and 
(8) identification or recommendations regarding 
such other issues as determined appropriate by the 
Secretary. 
(c) STAKEHOLDER INPUT.—The agreement under 
subsection (a) shall require the Institute of Medicine, in 
preparing the report under this section, to work in con-
sultation with each category of public and private stake-
holders involved in personalized medicine, including 
genomics and personalized medicine consumers, physicians 
and other health care providers including pathologists, sci-
entists and researchers, private payors, representatives 
from clinical and academic laboratories, and representa-
tives from the biotechnology, pharmaceutical, and 
diagnostics industries. 
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(d) REPORT.—Not later than 12 months after the 
date of the enactment of this Act, the Secretary shall sub-
mit the report prepared under this section to the Com-
mittee on Finance and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the Com-
mittee on Ways and Means and the Committee on Energy 
and Commerce of the House of Representatives. 
SEC. 404. FOOD AND DRUG ADMINISTRATION. 
(a) ENCOURAGEMENT OF COMPANION DIAGNOSTIC 
TESTING.—The Secretary, acting through the Commis-
sioner of Food and Drugs, may require the sponsor of a 
drug or biological product— 
(1) to develop a companion diagnostic test in 
connection with the submission of an investigational 
new drug application or a new drug application 
under section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) to address significant 
safety concerns of the drug or biological product; 
(2) to develop a companion diagnostic test if 
data from postmarketing clinical trials demonstrate 
significant safety or effectiveness concerns with use 
of the drug or biological product and include in the 
label of the drug or biological product a rec-
ommendation to use a companion diagnostic test if 
data demonstrate— 
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(A) significant safety concerns with the 
drug or biologic product; and 
(B) improved outcomes with the adminis-
tration of a companion diagnostic test; and 
(3) to conduct additional postmarket studies to 
identify genetic and other biological, social, behav-
ioral, and environmental factors that may underlie 
the differential drug effects when drugs are shown 
to be more or less effective in certain racial and eth-
nic subpopulations. 
(b) CLARIFICATION AND GUIDANCE.—The Secretary, 
acting through the Commissioner of Food and Drugs, 
shall clarify and issue guidance regarding— 
(1) the criteria and procedures for determining 
when labeling of a product used for personalized 
medicine will incorporate information on related 
companion diagnostic tests, as well as establish the 
circumstances under which such tests will be either 
recommended or required; 
(2) the standards of evidence that must be met 
for information pertaining to pharmacogenomics (as 
defined in section 2) to be included in the label of 
a product used for personalized medicine, such as 
with respect to the analytical validity, clinical valid-
ity, clinical utility, dosing, adverse events, and drug 
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selection, for use by clinicians when making treat-
ment decisions based on the results of genetic and 
genomic tests; 
(3) the regulation of automated clinical decision 
support systems; and 
(4) the collection and analysis of genetic and 
other biological factors that may be better biological 
predictors of individual differences in drug response 
than broad categories such as race, ethnicity, and 
gender. 
SEC. 405. ADVERSE EVENTS. 
The Secretary, in consultation with the Commissioner 
of Food and Drugs and the Administrator of the Centers 
for Medicare & Medicaid Services, shall— 
(1) facilitate the use of products used for per-
sonalized medicine, as feasible, to assess risk for, 
and reduce incidence of, adverse drug reactions; 
(2) develop or expand adverse event reporting 
systems to encompass reports of adverse events re-
sulting from products used for personalized medi-
cine, including laboratory developed test; and 
(3) develop systems to appropriately respond to 
any adverse events resulting from products used for 
personalized medicine. 
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SEC. 406. TERMINATION OF CERTAIN ADVERTISING CAM-
PAIGNS. 
The Commissioner of Food and Drugs shall collabo-
rate with the Federal Trade Commission to identify and 
terminate, pursuant to section 5 of the Federal Trade 
Commission Act (15 U.S.C. 45), advertising campaigns 
that make false, misleading, deceptive, or unfair claims 
about the benefits or risks of products used for personal-
ized medicine. 
SEC. 407. CENTERS FOR DISEASE CONTROL AND PREVEN-
TION. 
(a) PUBLIC AWARENESS.—The Director of the Cen-
ters for Disease Control and Prevention shall expand ef-
forts to educate and increase awareness of the general 
public about genomics and personalized medicine and its 
applications to improve health, prevent disease, and elimi-
nate health disparities. Such efforts shall include— 
(1) ongoing development and dissemination of 
evidence-based informational resources and materials 
on the validity and utility of products used for per-
sonalized medicine (including genetic and genomic 
tests); 
(2) ongoing collection of data on the awareness, 
knowledge, and use of genetic and genomic tests 
through public health surveillance systems, and anal-
ysis of the impact of such tests on population health; 
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(3) integration of the use of validated genetic 
and genomic tests in public health programs, as ap-
propriate; and 
(4) evaluation of laboratory standards and prac-
tices for quality laboratory services. 
(b) DIRECT-TO-CONSUMER MARKETING.—Not later 
than 12 months after the date of the enactment of this 
Act, the Director of the Centers for Disease Control and 
Prevention, in conjunction with the Food and Drug Ad-
ministration and the Federal Trade Commission, with re-
spect to products used for personalized medicine (includ-
ing genetic and genomic tests) for which consumers have 
direct access, shall— 
(1) conduct an analysis of the public health im-
pact of direct-to-consumer marketing to the extent 
possible from available data sources; 
(2) analyze the validity of claims made in di-
rect-to-consumer marketing to determine whether 
such claims are substantiated by competent and reli-
able scientific evidence; and 
(3) make recommendations to the Secretary re-
garding necessary interventions to protect the public 
from potential harms of direct-to-consumer mar-
keting and access to products used for personalized 
medicine (including genetic and genomic tests). 
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SEC. 408. AUTHORIZATION OF APPROPRIATIONS. 
(a) IN GENERAL.—To carry out sections 403, 404, 
405, and 406, there are authorized to be appropriated 
$40,000,000 for fiscal year 2011, and such sums as may 
be necessary for each of fiscal years 2012 through 2016. 
(b) REDUCING THE REDUNDANCY OF CLINICAL LAB-
ORATORIES.—To carry out section 401, there are author-
ized to be appropriated $5,000,000 for fiscal year 2011, 
and such sums as may be necessary for fiscal year 2012. 
(c) COMMITTEE
ON
PUBLIC
ENGAGEMENT.—To 
carry out section 402, there are authorized to be appro-
priated $1,000,000 for fiscal year 2011, and such sums 
as may be necessary for each of fiscal years 2012 through 
2016. 
(d) CDC PUBLIC
AWARENESS
ACTIVITIES.—To 
carry out section 407, there are authorized to be appro-
priated $20,000,000 for fiscal year 2011, and such sums 
as may be necessary for each of fiscal years 2012 through 
2016. 
Æ 
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