1.
(a)This Act may be cited
as the Genomics and Personalized
Medicine Act of 2010
.
(b)The table of contents of this Act is as follows:
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.
2.In this Act:
(1)The
term biobank means a shared repository of human biological
specimens collected for medical or research purposes that may include biobank
data.
(2)The term biobank data—
(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 information, demographic, genotype, and molecular profile
data, and environmental data associated with a specimen.
(3)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 intervention.
(4)Environment;
environmentalThe 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)The
term CEGAPP means the Committee on the Evaluation of Genomic
Applications in Practice and Prevention established under section 211.
(6)The
term CLIA means section 353 of the Public Health Service Act (42
U.S.C. 18 263a; commonly referred to as the Clinical Laboratory
Improvement Amendments of 1988
).
(7)Companion
diagnostic testThe 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 processes, pathogenic processes, or pharmacologic responses to a
therapeutic intervention for an individual’s condition.
(8)Genetic and
genomic tests
(A)The term genetic or genomic tests means
analyses of human chromosomes, 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
information, diagnose malignancies, guide clinical management, identify targets
for therapy, monitor results to therapy, and evaluate for early relapse.
(B)The
term genetic and genomic tests excludes—
(i)tests conducted
exclusively for forensic and identity purposes;
(ii)tests conducted
purely for research 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 metabolites that does not indicate genotypes,
mutations, or chromosomal changes; or
(v)an
analysis of proteins or metabolites 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 medicine involved.
(9)Human biological
specimenThe 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 specimens including associated health information, demographic,
genotype, and molecular profile data, and environmental data.
(10)The
term OPH means the Office of Personalized Healthcare established
under section 101.
(11)The term personalized medicine means any
clinical practice model that emphasizes the systematic use of preventive,
diagnostic, and therapeutic interventions that use genome and family history
information to improve health outcomes.
(12)
(A)The term pharmacogenomics means the study of
individual variations in DNA and RNA characteristics and sequences and the
relationship of such variations to drug response, including absorption,
distribution, metabolism, and elimination (pharmacokinetics) or drug action
(pharmacodynamics). Such variations include nucleotide polymorphism
rearrangements, insertions, and deletions. Such variations may also include
alterations in gene expression or inactivation in the genes encoding drug
transporters, receptors, metabolizing enzymes, or any other proteins that are
implicated in pharmacological function and therapeutic response.
(B)For
purposes of this paragraph, the variations referred to in subparagraph (A) may
affect a single nucleotide or more than one region in a single gene or reflect
alterations in more than one gene.
(13)The
term SACGHS means the Secretary’s Advisory Committee on Genomics,
Health, and Society.
(14)The
term Secretary means the Secretary of Health and Human Services.
<enum>I</enum><header>OFFICE OF
PERSONALIZED HEALTHCARE</header>
<section id="HD6ADA80C04FA486584CF74A38687AA3D"><enum>101.</enum><header>Office of
Personalized Healthcare</header>
<subsection id="HEA35BD5F4E8942FB86C184D13ABC2D1B"><enum>(a)</enum><header>In
general</header><text>The Secretary shall establish the Office of Personalized
Healthcare within the Office of the Secretary.</text>
</subsection><subsection id="H1CF4DCC41C4C436492F76C9531A19295"><enum>(b)</enum><header>Director</header><text>The
OPH shall be headed by a director, to be appointed by the Secretary.</text>
</subsection><subsection id="H51C6F69B75BB49408A4A68BCC3615771"><enum>(c)</enum><header>Purpose</header><text>The
purpose of the OPH is to coordinate the activities related to genomics and
personalized medicine of the Department of Health and Human Services 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 validity and utility.</text>
</subsection><subsection id="H90774D1B0A7D48D2AD7FAC1366D20150"><enum>(d)</enum><header>Duties</header><text>The
Secretary, acting through the Director 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—</text>
<paragraph id="H1AAB458F230C454393CE860C3E9017BA"><enum>(1)</enum><text>develop a
strategic, long-term plan to advance research and development relevant to
personalized medicine for coordinating basic science and translational research
in personalized medicine;</text>
</paragraph><paragraph id="HB3379E6DD1374BA9930225D6E607C475"><enum>(2)</enum><text>identify,
prioritize, and address challenges in translational research on products used
for personalized medicine, including genetic and genomic tests that impact both
product development and regulation, including any ongoing initiatives;</text>
</paragraph><paragraph id="HAAB5429BABE64B6AAED7D10767A2A919"><enum>(3)</enum><text>assure that
coverage and reimbursement decisions for products used for personalized
medicine take into account the best data available for such decisions without
violating the data sharing constraints;</text>
</paragraph><paragraph id="H5EE96A28510347CEBB316B4EDE7E70A2"><enum>(4)</enum><text>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;</text>
</paragraph><paragraph id="H79CD4B477FFE4ABC9C15A40F5CF553EC"><enum>(5)</enum><text>clarify and
simplify the regulation of products used for personalized medicine to ensure
that guidelines are consistent and intra-agency regulations do not
conflict;</text>
</paragraph><paragraph id="H936D7536557140C6929512F30517B7FB"><enum>(6)</enum><text>educate and
consult with developers of products used for personalized medicine concerning
evidence requirements for reimbursement and regulatory purposes, to facilitate
development of more cost-effective clinical trial programs for new
products;</text>
</paragraph><paragraph id="H29BC7A2AF77C4636BD25FCE8F9328D7F"><enum>(7)</enum><text>ensure that the
Federal regulatory approach to information technology-based clinical decision
support systems is evidence based and appropriately targeted;</text>
</paragraph><paragraph id="H76ACB7685F6341379271547C9F5D0B69"><enum>(8)</enum><text>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 findings and recommendations of the SACGHS and CEGAPP
or any other such council or committee established for the purpose of advising
the Secretary on personalized medicine; and</text>
</paragraph><paragraph id="H9FE324A1306B4BA5BA40723DE00220A6"><enum>(9)</enum><text>provide a forum
and mechanism to coordinate across agencies and the private sector with regard
to discussing genomics priorities and the standards needed for personalized
medicine to become feasible.</text>
</paragraph></subsection><subsection id="H349D8CB4E71E4CA8A4457387E5DF5C19"><enum>(e)</enum><header>Annual
reports</header><text>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 committees of the
Congress a report. Each such report shall describe—</text>
<paragraph id="H1F3B48AC8B174B7B9F88C168735454BC"><enum>(1)</enum><text>progress of
cross-agency coordination related to personalized medicine;</text>
</paragraph><paragraph id="HDE3E26A1C3E54F7CA7CF2983CB7E5B06"><enum>(2)</enum><text>innovations in
genomics and personalized medicine;</text>
</paragraph><paragraph id="HFC7A600B833245DF94ABCB82BEEE9209"><enum>(3)</enum><text>emerging and
persistent challenges related to personalized medicine;</text>
</paragraph><paragraph id="H5DABBBC0292841D2A6BE29D67E4A6B5D"><enum>(4)</enum><text>key barriers in
research, regulation, and reimbursement and their impact on innovation,
development, and implementation of medical product development for personalized
medicine;</text>
</paragraph><paragraph id="H7CCD3133CE2642F7BA3A2AEA622EBC53"><enum>(5)</enum><text>medical, ethical,
legal, and social impacts of personalized medicine; and</text>
</paragraph><paragraph id="H00A040B339D34569A31257BC0AC1E94D"><enum>(6)</enum><text>the extent to
which the findings and recommendations of the SACGHS, CEGAPP, and other Federal
entities are used to inform policymaking on personalized medicine within the
Department of Health and Human Services.</text>
</paragraph></subsection><subsection id="H0CF1F901708142E7B23627434183DFDC"><enum>(f)</enum><header>Report on the
regulation of products used for personalized medicine</header><text display-inline="yes-display-inline">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 products used for personalized
medicine (including genetic and genomic tests). Such report shall include
recommendations regarding—</text>
<paragraph id="HFBB1EA9159BE4E2190CBA8F13CBED56B"><enum>(1)</enum><text>which products
used for personalized medicine should require regulation, and, for such
products which are recommended in the report to require regulation,
recommendations regarding—</text>
<subparagraph id="H0F35EA06026F4536AC08F1CB2FE59359"><enum>(A)</enum><text>the appropriate
regulatory submission requirements and timeframes for such submissions;</text>
</subparagraph><subparagraph id="HA762BFFF84D44304A04D6C909E169B7D"><enum>(B)</enum><text>the appropriate
level of evidence necessary for approval of such products; and</text>
</subparagraph><subparagraph id="H197F08A154244EE1BC08E207DF6029B4"><enum>(C)</enum><text>resubmission
requirements for those products used for personalized medicine that undergo
modifications;</text>
</subparagraph></paragraph><paragraph id="H566C7AEC5C714AE58E5CD1BAD56C6323"><enum>(2)</enum><text>a
clear delineation between the roles and responsibilities of the Food and Drug
Administration and the Centers for Medicare & Medicaid Services in
regulation and enforcement of products used for personalized medicine,
including laboratory-developed tests, and the resolution of any conflicts or
redundancies between the 2 agencies, including under section 401;</text>
</paragraph><paragraph id="H055F44F9ADAA4A9BB237FCA58252A4EF"><enum>(3)</enum><text>a
means by which to decrease the burden associated with the initial and
subsequent submission of any required regulatory documents by clinical
laboratories; and</text>
</paragraph><paragraph id="HC11CEEF3E8834C2C926CAD8800DAFEF2"><enum>(4)</enum><text>an evaluation of
any current Federal registries for products used for personalized medicine
(including those for genetic and genomic tests) to determine the
appropriateness of establishing a mandatory registry for such products
(including specific recommendations pertaining to the purpose, implementation,
maintenance, and use of the registry).</text>
</paragraph></subsection><subsection id="H870EC9798CB14889976A61AA9B33E264"><enum>(g)</enum><header>Authorization of
appropriations</header><text>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.</text>
</subsection></section><enum>II</enum><header>EXPANSION AND
ACCELERATION OF RESEARCH FOR GENOMICS AND PERSONALIZED MEDICINE</header>
<subtitle id="H2B5BC3E5D1BA4507B9202E289F79D15C"><enum>A</enum><header>Acceleration of
Genomics and Personalized Medicine Research</header>
<section id="HECF0F9698A0542CDA0E83D7D7094C6A7"><enum>201.</enum><header>Grants for
research in genomics and personalized medicine</header>
<subsection id="H273A83B560344B0ABB7EBECBE166B687"><enum>(a)</enum><header>In
general</header><text>The Secretary, acting through the Directors of the
Centers for Disease Control and Prevention and other relevant agencies (as
determined by the Secretary), shall increase and accelerate research and
programs to collect, evaluate, and disseminate genetic and genomic data that
will advance the field of genomics and personalized medicine, which may
include—</text>
<paragraph id="HE64CFCB3195043DC8D0F75CF1383036F"><enum>(1)</enum><text>studies of
diseases and health conditions with substantial public health impact;</text>
</paragraph><paragraph id="HC44EB32CD96B434EA108C9FEFA93CCF3"><enum>(2)</enum><text>population-based
studies of genotype prevalence, gene-disease association, gene-drug response
association, and interactions between genes and the environment;</text>
</paragraph><paragraph id="HA09F496678AD4AFAAA3D75657161FAF0"><enum>(3)</enum><text>systematic review
and synthesis of the results of population-based studies using methods of human
genome epidemiology;</text>
</paragraph><paragraph id="H4D9816F4F093457B8B08B55B64494CFF"><enum>(4)</enum><text>translation of
genomic information into molecular genetic and genomic screening tools,
diagnostics, and therapeutics by supporting processes and studies that lead to
effective and safe applications in clinical and public health practice;</text>
</paragraph><paragraph id="HFCB86756F8D44D2099AF71FDFB8C169D"><enum>(5)</enum><text>translation of
genomic information into tools for public health investigations and ongoing
biosurveillance and monitoring;</text>
</paragraph><paragraph id="H1D75BA901A054F60AD1FC87AAE518A00"><enum>(6)</enum><text>comprehensive
studies of clinical utility, including cost-effectiveness and cost-benefit
analyses, of molecular genetic and genomic tests and therapeutics;</text>
</paragraph><paragraph id="H4707C6C8C6CF47EA8F8A04BDBA342149"><enum>(7)</enum><text>implementation and
postimplementation research to facilitate studies for evaluating effectiveness
and utility in clinical and policy decisionmaking;</text>
</paragraph><paragraph id="H0F5B68DDA20649C3AB91C7CF5937580C"><enum>(8)</enum><text>comprehensive
studies of clinical and laboratory practices necessary to ensure effective
implementation of high-quality standards of practice using evidence-based
clinical and public health guidelines for genetic and genomic tests;</text>
</paragraph><paragraph id="H8CE5EA91A0854BCD9B724CE377E3DEB2"><enum>(9)</enum><text>systematic review
of data on analytic validity, clinical validity, and clinical utility of
products used for personalized medicine, and data on implementation and
dissemination of evidence-based practices;</text>
</paragraph><paragraph id="HBF22A825C0FA43ADBA0E6B8784A7B651"><enum>(10)</enum><text>studies to assess
the awareness, knowledge, and use of products used for personalized medicine
and their impact on population health and health disparities;</text>
</paragraph><paragraph id="H67F2A08145974F039C2442894C73B230"><enum>(11)</enum><text>bioinformatics
research designed to integrate genomics and personalized medicine into clinical
practice; and</text>
</paragraph><paragraph id="H345A00AE4A6646E68E452ED7BEA0014A"><enum>(12)</enum><text>research to fill
gaps in clinical knowledge as determined by the CEGAPP.</text>
</paragraph></subsection><subsection id="HD23166B6C80A49BD8405AB1C91470B11"><enum>(b)</enum><header>Grants</header>
<paragraph id="H24629AB788A840339EA9B696E73E5AB5"><enum>(1)</enum><header>In
general</header><text>The Secretary may award grants to eligible entities to
carry out the activities described in subsection (a).</text>
</paragraph><paragraph id="H7422F468967D45D8A9746FE974597D7A"><enum>(2)</enum><header>Priority</header><text>In
awarding grants under this subsection, the Secretary shall give priority to
eligible entities that—</text>
<subparagraph id="HE10490F1856042959FB29213705A89E7"><enum>(A)</enum><text>enter into
collaborative research with public and private entities; or</text>
</subparagraph><subparagraph id="HE85A5921EC8D42F280C98E4FFB06A85B"><enum>(B)</enum><text>propose to address
priorities identified by the CEGAPP under subtitle B.</text>
</subparagraph></paragraph><paragraph id="HAAE7170343204465A7FE0915CA9D2644"><enum>(3)</enum><header>Definition</header><text>In
this subsection, the term <term>eligible entity</term> includes any nonprofit
organization with expertise in genomics and personalized medicine.</text>
</paragraph></subsection></section><section id="H574AB7017692492B967EBBEF528EF7FE"><enum>202.</enum><header>National
biobank</header>
<subsection id="HDAEEAA83C94F4774B5842A8AE7DE71C8"><enum>(a)</enum><header>In
general</header><text>The Director of the National Institutes of Health, in
consultation with the Director of Centers for Disease Control and Prevention,
shall establish 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 initiatives, including initiatives funded under section 203.
The national biobank shall be designed to collect and integrate human
biological specimens and biobank data for research purposes associated with
genomics and personalized medicine.</text>
</subsection><subsection id="HF25764EBB1404411BA65E25022744113"><enum>(b)</enum><header>Requirements</header><text>In
carrying out subsection (a), the Director of the National Institutes of Health
shall—</text>
<paragraph id="HA09CD7D4D9FA4290B69CFE0B6D88CC3A"><enum>(1)</enum><text>establish,
directly or by contract, a single point of authority to manage operations of
the national biobank;</text>
</paragraph><paragraph id="H447DD1F40F55475A82BEBC63EF027DDC"><enum>(2)</enum><text>establish and
disseminate quality standards and guidelines for the collection, processing,
archiving, storage, and dissemination of human biological specimens and biobank
data for research and clinical purposes;</text>
</paragraph><paragraph id="HAB430E6D984644B4B0017658EBF65918"><enum>(3)</enum><text>develop and
promulgate guidelines regarding procedures, protocols, and policies for the
safeguarding of the privacy of human biological specimens and biobank data, in
accordance with applicable Federal and State regulations, guidelines, and
policies, as appropriate;</text>
</paragraph><paragraph id="H7EC1138F4C8546C7BFBAF9C45755820A"><enum>(4)</enum><text>review and make
recommendations to address ownership, patient access issues, and analyses with
respect to human biological specimens and biobank data;</text>
</paragraph><paragraph id="HB542609DF6494009A880192C24F15FA4"><enum>(5)</enum><text>develop and
promulgate guidelines regarding procedures, protocols, and policies for access
to human biological specimens and biobank data by nongovernmental entities for
research purposes;</text>
</paragraph><paragraph id="HB5D267F683804521AA34CCD745726321"><enum>(6)</enum><text display-inline="yes-display-inline">develop and disseminate guidelines for
structuring informed consent forms that address—</text>
<subparagraph id="HBCF9E35A85BB4275BCF0ECA19ECF5F0B"><enum>(A)</enum><text>privacy and
confidentiality of human biological specimens and biobank data;</text>
</subparagraph><subparagraph id="H331F87813E9046BE85685ABDA733F756"><enum>(B)</enum><text>understanding of
research procedures, benefits, risks, rights, and responsibilities;</text>
</subparagraph><subparagraph id="H41EEA1D854FD45A997FBA58D7B73334B"><enum>(C)</enum><text>continuous
voluntary participation;</text>
</subparagraph><subparagraph id="HEDC0FC8CAFD144D3A0987F3E658C3625"><enum>(D)</enum><text>the development of
informed consent agreements that allow for future research in advance of clear
research objectives; and</text>
</subparagraph><subparagraph id="H22F87E5FA04B4E5D9C7451B7ED6B2BED"><enum>(E)</enum><text>the right of an
individual to opt out of research at any time;</text>
</subparagraph></paragraph><paragraph id="H9BFDE53CF1D54264ABFC72694E8E7B2E"><enum>(7)</enum><text>develop mechanisms
for informing the public about the national biobank;</text>
</paragraph><paragraph id="H5173076776E84B9086DDFD6E65F72200"><enum>(8)</enum><text>ensure the
inclusion of underrepresented populations with health disparities in the
activities of the national biobank, pursuant to the goals of Healthy People
2010;</text>
</paragraph><paragraph id="H84B0207B9A0C4B49B206AFB1D6185335"><enum>(9)</enum><text>incorporate human
biological specimens and biobank data from federally conducted or supported
genomics initiatives, as feasible;</text>
</paragraph><paragraph id="H6CACA2F9AB7746BDA558798F919DD11D"><enum>(10)</enum><text>encourage
voluntary submission of human biological specimens and biobank data obtained or
analyzed with private or non-Federal funds;</text>
</paragraph><paragraph id="H24D38075EECA4148A0A9837207ED2445"><enum>(11)</enum><text>facilitate
submission of biobank data, including secure and efficient electronic
submission;</text>
</paragraph><paragraph id="H33591D1CBC4B48F0B4E8770FC047F1D7"><enum>(12)</enum><text>allow public use
of human biological specimens and biobank data only—</text>
<subparagraph id="H46571A546B084836BEE00332F1E52F58"><enum>(A)</enum><text>with appropriate
privacy safeguards in place; and</text>
</subparagraph><subparagraph id="H80D0E46584974CC4B8C1082600816B3C"><enum>(B)</enum><text>for research
purposes;</text>
</subparagraph></paragraph><paragraph id="HA91B5CEB29EA44C1872C89BC59872CB4"><enum>(13)</enum><text>determine
appropriate procedures for access by nongovernmental entities to human
biological specimens and biobank data for research and development 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 process for products used for personalized medicine;</text>
</paragraph><paragraph id="HA315540F36AD41D58736D596BBA08602"><enum>(14)</enum><text display-inline="yes-display-inline">conduct, directly or by contract,
analytical research, including clinical, epidemiological, and social-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</text>
</paragraph><paragraph id="H5AA3937BFCAF4C94A11EDD0A0601EA26"><enum>(15)</enum><text>make aggregate
research findings from biobank initiatives supported by Federal funding
publicly available within an appropriate timeframe (as determined by the
Secretary).</text>
</paragraph></subsection></section><section id="H7569CFDB1A3E44218052239AFA25C46A"><enum>203.</enum><header>Biobank
initiative grants</header>
<subsection id="H0B912449525845BE91B5B3DD1AA6B4D8"><enum>(a)</enum><header>In
general</header><text>The Secretary shall establish a program of awarding
grants to eligible entities for the development or expansion of a biobank
initiative for the purposes of—</text>
<paragraph id="H4251CF66F9AA4D5CADC7BCDD5F0124D4"><enum>(1)</enum><text>increasing
understanding of how genomics interacts with lifestyle factors and the
environment to cause disease;</text>
</paragraph><paragraph id="H03E76AA9EF5642C1BF583B0E55C3E6E8"><enum>(2)</enum><text>examining the
effectiveness of using genomic information in health management and medical
decisionmaking;</text>
</paragraph><paragraph id="HD7803D9FC3504D8F808A2260D2E49712"><enum>(3)</enum><text>discovering
genomic variations that affect drug toxicity and efficacy; and</text>
</paragraph><paragraph id="H9F8CCCC4ACF14EEF8C0D02422861FD5F"><enum>(4)</enum><text>accelerating the
development of products used for personalized medicine.</text>
</paragraph></subsection><subsection id="HC7C1811D4AFA4062BA41BFA78D8023B3"><enum>(b)</enum><header>Use of
funds</header><text>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 initiative. Such
development or expansion may include any of the following activities:</text>
<paragraph id="HA61BC18C5365478AAF23DA116422A86E"><enum>(1)</enum><text>Support for the
scientific community and medical advisory committees.</text>
</paragraph><paragraph id="HB734222ECCF94C00BA20EBC66F802B62"><enum>(2)</enum><text>Recruitment and
education of diverse participants, especially underrepresented races,
ethnicities, and genders pursuant to the goals of Healthy People 2010.</text>
</paragraph><paragraph id="H27B3E909DE0A4F31ABEAF2891E2B4DE4"><enum>(3)</enum><text>Development of
consent protocols.</text>
</paragraph><paragraph id="H0B07559F2C474EC48A4A9388CB010A16"><enum>(4)</enum><text>Provision of
genetic counseling services to participants, as appropriate.</text>
</paragraph><paragraph id="H9F861A5DA8194B54885D47BAC3AFE932"><enum>(5)</enum><text>Obtaining human
biological specimens and biobank data.</text>
</paragraph><paragraph id="H8F62C8B998DE4B01AFCF061F0FC77813"><enum>(6)</enum><text>Obtaining
necessary equipment for data collection, analysis, and storage.</text>
</paragraph><paragraph id="H077294E597A24F0E91E4D507850C8C0B"><enum>(7)</enum><text>Establishment and
maintenance of secure storage for human biological specimens and biobank data.</text>
</paragraph><paragraph id="HCBE0A1455F7E4833B0B17DEB711F40BC"><enum>(8)</enum><text>Conducting data
analyses and evidence-based systematic reviews that allow for the following:</text>
<subparagraph id="HA7EC993783BA4BA1A9C24BC4222C15D2"><enum>(A)</enum><text>Identification of
biomarkers and other surrogate markers to improve predictions of onset of
disease, response to therapy, and clinical outcomes.</text>
</subparagraph><subparagraph id="HECD954F3A1C442959A05823515C32A1C"><enum>(B)</enum><text>Increased
understanding of gene and environment interactions.</text>
</subparagraph><subparagraph id="H52131AA5E0D04EE08DA4AC52733F54DD"><enum>(C)</enum><text>Development of
personalized medicine screening, diagnostic, and therapeutic interventions.</text>
</subparagraph><subparagraph id="HC7CEDFD9492A45B5917F84AEFF26197E"><enum>(D)</enum><text>Genotypic
characterization of human biological specimens and biobank data.</text>
</subparagraph></paragraph><paragraph id="HAEE9CA0DAFBA4DCDA0782ACBDCC35DD8"><enum>(9)</enum><text>Development of
protocols for providing to health care providers and patients, by means of
electronic 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.</text>
</paragraph><paragraph id="HFA1F24CFA58A477FB9664B72E53F6859"><enum>(10)</enum><text>Development of
interactive, Web-based portals to provide participants access to their personal
genetic profile.</text>
</paragraph><paragraph id="HED6D185EC7414719A61A1F28133C2AA0"><enum>(11)</enum><text>Any other related
activities deemed appropriate by the Secretary.</text>
</paragraph></subsection><subsection id="HEAA30DF1AB7344C1869C9EEC4E967452"><enum>(c)</enum><header>Biobank
requirements</header><text>The Secretary shall ensure that any biobank
supported under this section—</text>
<paragraph id="H8E2A5F55A3FF4E79AB184776606C9BEF"><enum>(1)</enum><text>supports genomics
and personalized medicine research;</text>
</paragraph><paragraph id="H818A18CD2B374C3D931791E39A9E270E"><enum>(2)</enum><text>adheres to
standards, guidelines, and recommendations developed under section 202(b);</text>
</paragraph><paragraph id="H096735AD42F4494986166E4A64BA274C"><enum>(3)</enum><text>is established to
complement activities related to the implementation of current public biobank
research initiatives, as feasible;</text>
</paragraph><paragraph id="H5AADF6B95D24422497ED31B63DA06802"><enum>(4)</enum><text>is based on
well-defined populations, including population-based registries of disease and
family-based registries;</text>
</paragraph><paragraph id="H497FF41E380A438EA574D02467A64D0C"><enum>(5)</enum><text>collects data from
participants with diverse genomic profiles, demographics, environmental
exposures, and presence or absence of diverse health conditions and diseases,
as appropriate;</text>
</paragraph><paragraph id="H6D90955EC0734FA59E1C1E333697966C"><enum>(6)</enum><text>has practical
experience and demonstrated expertise in genomics and its clinical and public
health applications;</text>
</paragraph><paragraph id="H1F4AC39323524FD2ABFB27391CE1F372"><enum>(7)</enum><text>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</text>
</paragraph><paragraph id="H457F31F2732A4514AE50300150F9320D"><enum>(8)</enum><text>contributes
biobank data to the national biobank established under section 202.</text>
</paragraph></subsection><subsection id="HFD7BAE3BEDD44D4AAD41D54FC266CDFC"><enum>(d)</enum><header>Priority</header><text>In
awarding grants under this section, the Secretary shall give priority to
eligible entities with experience in conducting population-based genetic
research studies (such as focused whole genome, and epigenetics studies) or
genomic research on heritable or somatic mutations.</text>
</subsection><subsection id="HA2D2C6A796774148BD89A9170C820C24"><enum>(e)</enum><header>Quality
assurance</header><text>The Secretary may enter into a contract with an
external entity to evaluate grantees under this section to ensure that quality
standards established under section 202(b) are met.</text>
</subsection><subsection id="H84F595904F064B50BAB43413D89F28B6"><enum>(f)</enum><header>Application of
privacy rules</header><text>Nothing in this section shall be construed to
supersede the requirements for the protection of patient privacy under—</text>
<paragraph id="HE736BC4457664483AB90BCB1CF02A2BF"><enum>(1)</enum><text>HIPAA privacy and
security law (as defined in section 3009(a) of the Public Health Service Act
(42 U.S.C. 300jj–19(a));</text>
</paragraph><paragraph id="H5B4E0B20F3A14CF9AA8CA2A1B144327F"><enum>(2)</enum><text>sections 552 and
552a of title 5, United States Code (5 U.S.C. App.);</text>
</paragraph><paragraph id="H62C1A6DBF3F842C7AD7B9F8A6492A78F"><enum>(3)</enum><text>the Genetic
Information Nondiscrimination Act of 2008 (Public Law 110–233);</text>
</paragraph><paragraph id="HD19AC37CCEB54142A434FEE78E2C3C25"><enum>(4)</enum><text>part 46 of title
45, Code of Federal Regulations (or any successor regulations); or</text>
</paragraph><paragraph id="H94270A4C491944E9A461B148D1C3F5D0"><enum>(5)</enum><text>part 50 of title
21, Code of Federal Regulations (or any successor regulations).</text>
</paragraph></subsection><subsection id="H699A5E7872F7416B85F066FE45B375FF"><enum>(g)</enum><header>Definition</header><text>In
this section, the term <term>eligible entity</term> includes an academic
medical center, a university, a private nonprofit biomedical research
institution, and any other entity determined appropriate by the Secretary.</text>
</subsection></section><section id="HA8A19C01CC854A1AA4417096DBA39715"><enum>204.</enum><header>Authorization
of appropriations</header><text display-inline="no-display-inline">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.</text>
</section></subtitle><subtitle id="H33C2D7CA57354F64A85397135256549A"><enum>B</enum><header>Committee on the
Evaluation of Genomic Applications in Practice and Prevention</header>
<section id="HA16109B23C3D4C83A22086AD90898987"><enum>211.</enum><header>Establishment</header>
<subsection id="HFCD8B445D99B4116B513E34509DE6402"><enum>(a)</enum><header>In
General</header><text>The Secretary, acting through the Director of the Centers
for Disease Control and Prevention, shall establish (pursuant to section 222 of
the Public Health Service Act (42 U.S.C. 217(a)) an advisory committee,
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.</text>
</subsection><subsection id="H22F24ABBA49E450FA0B163DFDD800943"><enum>(b)</enum><header>Duties</header><text>The
CEGAPP shall expand the breadth of knowledge related to the clinical validity
and utility of genomics and personalized medicine by—</text>
<paragraph id="H17842E06D6CA450B913DF24BE71ECB52"><enum>(1)</enum><text>establishing,
testing, and publishing processes 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;</text>
</paragraph><paragraph id="H1CA97209DB564D4EA1964661749FB13B"><enum>(2)</enum><text>identifying,
prioritizing, and selecting topics for systematic evidence-based review;</text>
</paragraph><paragraph id="H3462284FB7D44DA1A566C4A70E0DC32B"><enum>(3)</enum><text>publishing
evidence-based reviews and recommendations for clinical practice and areas for
additional research for such topics;</text>
</paragraph><paragraph id="H05A21B25FE934F5DA22995E8D080E744"><enum>(4)</enum><text>publishing
experiences with systematic evidence-based review;</text>
</paragraph><paragraph id="H1BF6518E787A426092FBC8312DF9C298"><enum>(5)</enum><text>publishing gaps in
knowledge, as determined through reviews and recommendations under paragraph
(3), to assist in carrying out section 201;</text>
</paragraph><paragraph id="H2FF01E8959514F5EB4B95C815974C587"><enum>(6)</enum><text>integrating
existing recommendations on implementation of genetic and genomic tests and
other products used for personalized medicine from professional organizations
and advisory committees;</text>
</paragraph><paragraph id="HDB26ADF2A04045F4B9F8437231BA2CAF"><enum>(7)</enum><text>integrating
knowledge and experience gained from existing processes for evaluation and
appraisal, previous public and private initiatives, and the international
health technology assessment experience;</text>
</paragraph><paragraph id="H5F84076949E7422799A118F08B5BB275"><enum>(8)</enum><text>advising the
Centers for Medicare & Medicaid Services on whether current evidence
supports the coverage of specific products used for personalized medicine
(including genetic and genomic tests used for the screening of diseases in
cases where a family history of such disease is present);</text>
</paragraph><paragraph id="H84CE6A95BF1B4F74AE689A5DDD966B85"><enum>(9)</enum><text>developing or
adapting processes for recognizing promising new products used for personalized
medicine and supporting their translation to clinical and public health
practice; and</text>
</paragraph><paragraph id="HC5224589AC0E4AEB847F242775D0B8DE"><enum>(10)</enum><text>developing
processes for the collection of data reflective of analytic and clinical
validity and utility and quality measures indicative of good clinical and
laboratory practices for tests early in their translation or adoption
cycle.</text>
</paragraph></subsection><subsection id="H52FCEDABD38B4406B31EB493E8CF4A13"><enum>(c)</enum><header>Authorization of
appropriations</header><text>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.</text>
</subsection></section></subtitle><enum>III</enum><header>GENOMICS AND
PERSONALIZED MEDICINE IN CLINICAL PRACTICE AND PUBLIC HEALTH</header>
<section id="H3E2F303D94374F43BABFD98846D41845"><enum>301.</enum><header>Genomics and
personalized medicine education and training</header>
<subsection id="HF0EAB42A9FB44F8E93C401FB5341CF5E"><enum>(a)</enum><header>In
general</header><text>The Secretary shall make grants, contracts, or
cooperative agreements to eligible entities to improve the adequacy of genomics
and personalized medicine training for specimen collection, diagnosis,
treatment, and counseling of adults and children for both rare and common
disorders, through support of efforts to—</text>
<paragraph id="HEDB064290D344BB4AE4CB6A4CE982B5E"><enum>(1)</enum><text>develop and
disseminate model education and training programs across all health
professionals, 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;</text>
</paragraph><paragraph id="H479AE4990E5C4D30BC49711F04B0D9A9"><enum>(2)</enum><text>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;</text>
</paragraph><paragraph id="H15190CE27CB54666B97F3FB093CD60D3"><enum>(3)</enum><text>identify,
evaluate, and develop options for distance or online learning for degree or
continuing education programs;</text>
</paragraph><paragraph id="HF6E1DE2994D2456C995D176A05E3E809"><enum>(4)</enum><text>identify gaps and
opportunities to strengthen continuing education programs for health care
professionals;</text>
</paragraph><paragraph id="HF629F4194C76435190D19838C9F4D4B9"><enum>(5)</enum><text>develop and
disseminate model programs to train pathologists on the specialized mechanisms
of collection and storage of human biological specimens for biobanks; and</text>
</paragraph><paragraph id="HEE48066F34D947D0A9B5831E438F8061"><enum>(6)</enum><text>develop exchange
programs for student, residents, and fellows to learn techniques and practices
to augment genomics and personalized medicine.</text>
</paragraph></subsection><subsection id="H434E0D119957468BAB6FCD2E4295F8A4"><enum>(b)</enum><header>Integration</header><text>The
Secretary, in consultation with medical professional societies, accreditation
bodies, associations of health professional schools, and other public 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 promoting genomics and personalized medicine competency
across all clinical, public health, and laboratory disciplines through—</text>
<paragraph id="H29C8C4DC30144A29B4B5755B87AC7E59"><enum>(1)</enum><text>the development
and dissemination of health professional guidelines which shall—</text>
<subparagraph id="H7CADFB2463DE46E8819F0DA36CB74885"><enum>(A)</enum><text>include focus on
appropriate techniques for collection and storage of genomics samples,
administration and interpretation of genetic and genomic tests, and subsequent
clinical and public health decisionmaking; and</text>
</subparagraph><subparagraph id="H5C87524268E4439A921DCD298887AC64"><enum>(B)</enum><text>specifically
target health professionals without formal training or experience in the field
of genomics;</text>
</subparagraph></paragraph><paragraph id="H215D33A9CE574ED999F4627D183C0D05"><enum>(2)</enum><text>the development
and dissemination of evidence-based clinical decision support tools for
implementation at the point of care in consultation with the Office the
National Coordinator for Health Information Technology;</text>
</paragraph><paragraph id="H4C0F361842F8465986A1A8B87383BCCE"><enum>(3)</enum><text>the development,
cataloging, and dissemination of case studies and practice models relating to
the use of products of personalized medicine;</text>
</paragraph><paragraph id="H5FD92C5946F94D0DB4A5F2E8595E5E83"><enum>(4)</enum><text>the dissemination
of both public and private systematic reviews on and technology assessments of
the clinical validity and utility of products of personalized medicine in
coordination with the CEGAPP to facilitate the development of clinical practice
guidelines;</text>
</paragraph><paragraph id="HA961045F845B413B9482C2DC327A38A5"><enum>(5)</enum><text>the facilitation
of the development of evidence-based clinical practice guidelines and dosing
guidelines for product use for personalized medicine by supporting
consensus-building efforts, which shall include—</text>
<subparagraph id="H8E0EE4FEB1044F979AE58DA1E7A5E9C3"><enum>(A)</enum><text>development of
standards that define the minimal levels of evidence required to support
guidelines decisions; and</text>
</subparagraph><subparagraph id="HCD3517B681684E58BBBF295781361E67"><enum>(B)</enum><text>the clinical
contexts (such as prevention, diagnosis, and treatment) in which genetic and
genomic tests may be offered; and</text>
</subparagraph></paragraph><paragraph id="H345FB30C0B6C44C0A5A683C513E9ABC0"><enum>(6)</enum><text>the encouragement
of public and private sector entities to submit clinical practice guidelines on
products of personalized medicine to federally established clinical practice
guidelines clearinghouses to facilitate dissemination and encourage
implementation and use of such guidelines.</text>
</paragraph></subsection><subsection id="H1D1DFDC2D8454826A0B88BDFF311FA94"><enum>(c)</enum><header>Definition</header><text>In
this section, the term <term>eligible entity</term> includes any professional
genetics and genomics society, accreditation body, health care professional
organization, academic institution, and any other entity as determined
appropriate by the Secretary.</text>
</subsection><subsection id="H7F6FFBEC9E8E4946A1C3CF87375075E7"><enum>(d)</enum><header>Authorization of
appropriations</header><text>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.</text>
</subsection></section><enum>IV</enum><header>REALIZING THE
POTENTIAL OF PERSONALIZED MEDICINE</header>
<section id="HD609885462E84C73A0805984B3B8507A"><enum>401.</enum><header>Reducing the
redundancy of clinical laboratory requirements</header>
<subsection id="H123AA1F9E774435E83E768164B1A2963"><enum>(a)</enum><header>In
general</header><text>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—</text>
<paragraph id="HDBF3810E515E4263B8D10BF2221C7F89"><enum>(1)</enum><text>assess and reduce
unnecessary differences in such requirements; and</text>
</paragraph><paragraph id="HA9F00ADA50DC49B2BA63A04AB0C0A0C1"><enum>(2)</enum><text>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.</text>
</paragraph></subsection><subsection id="H8B1A3412CB8641EBBB7CD482C3F52A22"><enum>(b)</enum><header>Representation</header><text display-inline="yes-display-inline">The membership of the committee established
under this section shall include representatives of the agencies of the Public
Health Service, other appropriate Federal departments and agencies, private
laboratories, and private laboratory accreditation organizations.</text>
</subsection><subsection id="H3C692FDF81D34A2E81B346608E1C9B23"><enum>(c)</enum><header>Public
input</header><text>The Secretary shall conduct open public meetings and
develop a process to allow for public comment on such comparative analysis.</text>
</subsection><subsection id="HF06FC7344C4648BF8565644D2182F09A"><enum>(d)</enum><header>Reporting</header><text>The
Secretary shall require the committee established under this section to
submit—</text>
<paragraph id="H3CAE385905B247A988B022F9A0CD2C03"><enum>(1)</enum><text>a
draft report on such comparative analysis, including recommendations on
opportunities identified under subsection (a)(1), to the Secretary not later
than 12 months after the date of the enactment of this Act; and</text>
</paragraph><paragraph id="H255980F5B66D43F49078AAC0A10B7474"><enum>(2)</enum><text>a
final such report to the Secretary not later than 24 months after such
date.</text>
</paragraph></subsection></section><section id="H181454ED38EC43239CEBAA63E54A9C1D"><enum>402.</enum><header>Committee on
public engagement</header>
<subsection id="H8011C088E0AE4544AC95B46087A327E9"><enum>(a)</enum><header>In
general</header><text>The Secretary shall establish a committee, to be composed
of representatives from the private sector who are engaged in genomics and
personalized medicine, to—</text>
<paragraph id="H2E98C69285D849FD80C039122929CC8B"><enum>(1)</enum><text>examine barriers
in research, regulation, and reimbursement to innovation, development, and
implementation of medical product development for personalized medicine and the
impact of such barriers; and</text>
</paragraph><paragraph id="HE2EFB775141840E69524303405946101"><enum>(2)</enum><text>make
recommendations to address such barriers.</text>
</paragraph></subsection><subsection id="H14430501A8D74A49A86236ED7A619417"><enum>(b)</enum><header>Collaboration
with OPH</header><text>The Secretary shall ensure that, to the extent possible,
such committee carries out this section in collaboration with the OPH.</text>
</subsection><subsection id="HD331B1F370B94047BBBCD7182D2AA308"><enum>(c)</enum><header>Reporting</header><text>The
Secretary shall require such committee to submit a draft report on the
committee’s recommendations under subsection (a)(2) to the Secretary not later
than 24 months after the date of the enactment of this Act and annually
thereafter.</text>
</subsection></section><section id="HE75DC76AE78B449BB4118A4649035898"><enum>403.</enum><header>Study by the
Institute of Medicine</header>
<subsection id="H4D4563609AAF4FCEAB5CB130160D883E"><enum>(a)</enum><header>In
general</header><text>The Secretary shall enter into an agreement with the
Institute of Medicine, in consultation with public and private sector entities
involved in personalized medicine, to provide an independent, external review
of the current billing, coverage, and reimbursement methodologies for products
and services used for personalized medicine (including genetic and genomic
tests).</text>
</subsection><subsection id="H4D795862B9D84D5FB24A9547DE0E4AC5"><enum>(b)</enum><header>Requirements</header><text display-inline="yes-display-inline">The agreement under subsection (a) shall
provide for preparation of a report by the Institute of Medicine. Such report
shall include—</text>
<paragraph id="H7C67AB920C9D4618A1E386DD7359356F"><enum>(1)</enum><text>a
review of the current billing, coverage, and reimbursement policies for
products and services used for personalized medicine (including genetic and
genomic tests);</text>
</paragraph><paragraph id="HBFB162696F6E4855A54D4A21CA646DB2"><enum>(2)</enum><text>specific
recommendations for billing, coverage, and reimbursement models by public and
private insurers that promote research and development of products used for
personalized medicine (including genetic and genomic tests), taking into
account the overall impact of such products on patient outcomes (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 system through disease management and early diagnosis;</text>
</paragraph><paragraph id="H47D2F03AC61C4E3395040909C18DFA6A"><enum>(3)</enum><text>recommendations
for clinical trial designs to provide evidence sufficient to support coverage
of products used for personalized medicine (including genetic and genomic
tests) by public and private payors, including reimbursement during the
evidence development phase of well-designed studies;</text>
</paragraph><paragraph id="H09E9BB090691465E964DFB80592CCD02"><enum>(4)</enum><text>recommendations
for the reimbursement of health care professionals providing genetic counseling
services to—</text>
<subparagraph id="HEC226938EA734F0698D4813591CB31C6"><enum>(A)</enum><text>define which
health professionals, taking into consideration certification, licensure, and
training and scope of practice under State law, are qualified to provide
genetic counseling services;</text>
</subparagraph><subparagraph id="H8BAAD0B2CCE249D387EF3EA57D00FED2"><enum>(B)</enum><text>define which
professionals should be able to practice, consistent with their scope of
practice under State law, without physician supervision, direction,
responsibility, or control, and, thereby, bill payers directly for their
services; and</text>
</subparagraph><subparagraph id="HBCEA6ED6C19849388BDBAE66B4ED009C"><enum>(C)</enum><text>assess the
adequacy of existing current procedural terminology evaluation and management
codes and their associated relative values with respect to genetic counseling
services;</text>
</subparagraph></paragraph><paragraph id="H0B8B47462AC74A5C8929859FA0B346BD"><enum>(5)</enum><text>recommendations
for appropriate mechanisms to promote research and development to advance
personalized medicine (which may include tax credits, grant programs, or
extensions of patent or exclusivity) to include costs and benefits to
society;</text>
</paragraph><paragraph id="H3BEA055F515442FAA3233D678F11E63B"><enum>(6)</enum><text>incentives to
encourage development of products used for personalized medicine, including
development of genetic and genomic tests for patients with rare
disorders;</text>
</paragraph><paragraph id="HD7A14BA385874332A3F11B1FDD6EF464"><enum>(7)</enum><text>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</text>
</paragraph><paragraph id="H7247C9F7DEF34B9B9831B6E83D813A46"><enum>(8)</enum><text>identification or
recommendations regarding such other issues as determined appropriate by the
Secretary.</text>
</paragraph></subsection><subsection id="H4CE1C64646BC4C68B88C3C473F9F1B87"><enum>(c)</enum><header>Stakeholder
input</header><text display-inline="yes-display-inline">The agreement under
subsection (a) shall require the Institute of Medicine, in preparing the report
under this section, to work in consultation with each category of public and
private stakeholders involved in personalized medicine, including genomics and
personalized medicine consumers, physicians and other health care providers
including pathologists, scientists and researchers, private payors,
representatives from clinical and academic laboratories, and representatives
from the biotechnology, pharmaceutical, and diagnostics industries.</text>
</subsection><subsection id="H297F20E3448E4DCC92CA87001C5A8EDC"><enum>(d)</enum><header>Report</header><text>Not
later than 12 months after the date of the enactment of this Act, the Secretary
shall submit the report prepared under this section to the Committee on Finance
and the Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Ways and Means and the Committee on Energy and Commerce of the
House of Representatives.</text>
</subsection></section><section id="HFDDA1DB9525B467DA38716DA28C4B24E"><enum>404.</enum><header>Food and Drug
Administration</header>
<subsection id="HD0D682E0830043A8B9A3B522EE358C82"><enum>(a)</enum><header>Encouragement of
companion diagnostic testing</header><text>The Secretary, acting through the
Commissioner of Food and Drugs, may require the sponsor of a drug or biological
product—</text>
<paragraph id="HBB1272154D37483881182F527532142C"><enum>(1)</enum><text>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;</text>
</paragraph><paragraph id="H9D9501AB66C14B948C64A7429020B6D1"><enum>(2)</enum><text>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 recommendation to use a companion diagnostic test if data
demonstrate—</text>
<subparagraph id="H494612DEA7994A0DBE1EB1DBE7C76D52"><enum>(A)</enum><text>significant safety
concerns with the drug or biologic product; and</text>
</subparagraph><subparagraph id="HC684D02E196A48569996429E587C0F23"><enum>(B)</enum><text>improved outcomes
with the administration of a companion diagnostic test; and</text>
</subparagraph></paragraph><paragraph id="HBBFD5A162C24447CA655240503096579"><enum>(3)</enum><text>to conduct
additional postmarket studies to identify genetic and other biological, social,
behavioral, and environmental factors that may underlie the differential drug
effects when drugs are shown to be more or less effective in certain racial and
ethnic subpopulations.</text>
</paragraph></subsection><subsection id="HF30E69D27DFB4F0F9277270ED48436EE"><enum>(b)</enum><header>Clarification
and guidance</header><text>The Secretary, acting through the Commissioner of
Food and Drugs, shall clarify and issue guidance regarding—</text>
<paragraph id="HCBB838188D8F4609AD75BBE8AAF2B37A"><enum>(1)</enum><text>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;</text>
</paragraph><paragraph id="H3D8C8896BFCE4FDFAF15D21144833FAD"><enum>(2)</enum><text>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 validity, clinical utility, dosing, adverse events, and drug
selection, for use by clinicians when making treatment decisions based on the
results of genetic and genomic tests;</text>
</paragraph><paragraph id="H9E955840638C4FE89B4BBDA45ECDE46C"><enum>(3)</enum><text>the regulation of
automated clinical decision support systems; and</text>
</paragraph><paragraph id="HB20FC496A305442F98A1E29FFAEC32EE"><enum>(4)</enum><text>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.</text>
</paragraph></subsection></section><section id="H3CB028ADE5C846F59BC532CCB8403162"><enum>405.</enum><header>Adverse
events</header><text display-inline="no-display-inline">The Secretary, in
consultation with the Commissioner of Food and Drugs and the Administrator of
the Centers for Medicare & Medicaid Services, shall—</text>
<paragraph id="H24207F97350A4D68B8F5224593500EB4"><enum>(1)</enum><text>facilitate the use
of products used for personalized medicine, as feasible, to assess risk for,
and reduce incidence of, adverse drug reactions;</text>
</paragraph><paragraph id="H47C4EC3C886746CF843F76389BACBC7F"><enum>(2)</enum><text>develop or expand
adverse event reporting systems to encompass reports of adverse events
resulting from products used for personalized medicine, including laboratory
developed test; and</text>
</paragraph><paragraph id="HFF33891F43004E0DB6B0CECCAF08AE50"><enum>(3)</enum><text>develop systems to
appropriately respond to any adverse events resulting from products used for
personalized medicine.</text>
</paragraph></section><section id="H231536184EE64E38A6E0F28144BA5A53"><enum>406.</enum><header>Termination of
certain advertising campaigns</header><text display-inline="no-display-inline">The Commissioner of Food and Drugs shall
collaborate 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 personalized medicine.</text>
</section><section id="H6C93942918A74EB986548411C0E822D8"><enum>407.</enum><header>Centers for
Disease Control and Prevention</header>
<subsection id="HE80EB32DA20C43A986941764014428F4"><enum>(a)</enum><header>Public
awareness</header><text>The Director of the Centers for Disease Control and
Prevention shall expand efforts to educate and increase awareness of the
general public about genomics and personalized medicine and its applications to
improve health, prevent disease, and eliminate health disparities. Such efforts
shall include—</text>
<paragraph id="H5844AEBECACF4046802FD551E45440D0"><enum>(1)</enum><text>ongoing
development and dissemination of evidence-based informational resources and
materials on the validity and utility of products used for personalized
medicine (including genetic and genomic tests);</text>
</paragraph><paragraph id="H198E621259194BBE971CDB82BEEC4E61"><enum>(2)</enum><text>ongoing collection
of data on the awareness, knowledge, and use of genetic and genomic tests
through public health surveillance systems, and analysis of the impact of such
tests on population health;</text>
</paragraph><paragraph id="H0036C27C5E2B4890BC8DA8293A7D7DF2"><enum>(3)</enum><text>integration of the
use of validated genetic and genomic tests in public health programs, as
appropriate; and</text>
</paragraph><paragraph id="H0F9AB65E7CF740E08BB5197823950FD2"><enum>(4)</enum><text>evaluation of
laboratory standards and practices for quality laboratory services.</text>
</paragraph></subsection><subsection id="H1BB1028905CC4578A0335C8CD7D44FAB"><enum>(b)</enum><header>Direct-to-Consumer
marketing</header><text>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 Administration and the
Federal Trade Commission, with respect to products used for personalized
medicine (including genetic and genomic tests) for which consumers have direct
access, shall—</text>
<paragraph id="HDFF42EAE8D3C4F12A24DB59A051708BF"><enum>(1)</enum><text>conduct an
analysis of the public health impact of direct-to-consumer marketing to the
extent possible from available data sources;</text>
</paragraph><paragraph id="HA9BDB98B58574647BBF2AB54A7C961FB"><enum>(2)</enum><text>analyze the
validity of claims made in direct-to-consumer marketing to determine whether
such claims are substantiated by competent and reliable scientific evidence;
and</text>
</paragraph><paragraph id="H75A823C3F17F411BB1BB3BB1302AB20A"><enum>(3)</enum><text>make
recommendations to the Secretary regarding necessary interventions to protect
the public from potential harms of direct-to-consumer marketing and access to
products used for personalized medicine (including genetic and genomic tests).</text>
</paragraph></subsection></section><section id="H6C7BC0FB23B04402B1EC586354A811FB"><enum>408.</enum><header>Authorization
of appropriations</header>
<subsection id="H4AEAECE6CD314FA3A58BE4BF40F63EEF"><enum>(a)</enum><header>In
general</header><text>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.</text>
</subsection><subsection id="HA9D288D1703C47C6BE96EA90919E032E"><enum>(b)</enum><header>Reducing the
redundancy of clinical laboratories</header><text>To carry out section 401,
there are authorized to be appropriated $5,000,000 for fiscal year 2011, and
such sums as may be necessary for fiscal year 2012.</text>
</subsection><subsection id="HEB942C871E704720A59E2263FA86D340"><enum>(c)</enum><header>Committee on
public engagement</header><text>To carry out section 402, there are authorized
to be appropriated $1,000,000 for fiscal year 2011, and such sums as may be
necessary for each of fiscal years 2012 through 2016.</text>
</subsection><subsection id="HA1F0576D948E4AECB3F7FCD7E4864B79"><enum>(d)</enum><header>CDC public
awareness activities</header><text>To carry out section 407, there are
authorized to be appropriated $20,000,000 for fiscal year 2011, and such sums
as may be necessary for each of fiscal years 2012 through 2016.</text>
</subsection></section>