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[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5440 Introduced in House (IH)]

111th CONGRESS
  2d Session
                                H. R. 5440

  To secure the promise of personalized medicine for all Americans by 
expanding and accelerating genomics research and initiatives to improve 
 the accuracy of disease diagnosis, increase the safety of drugs, and 
           identify novel treatments, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                              May 27, 2010

Mr. Kennedy (for himself and Ms. Eshoo) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
  To secure the promise of personalized medicine for all Americans by 
expanding and accelerating genomics research and initiatives to improve 
 the accuracy of disease diagnosis, increase the safety of drugs, and 
           identify novel treatments, and for other purposes.

    Be it enacted by the Senate and House of Representatives 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:

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 collected for medical 
        or research purposes that may include biobank data.
            (2) Biobank data.--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) 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 
        intervention.
            (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 Applications 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 263a; commonly referred 
        to as the ``Clinical Laboratory 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 processes, pathogenic processes, or pharmacologic 
        responses to a therapeutic intervention for an individual's 
        condition.
            (8) Genetic and genomic tests.--
                    (A) In general.--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) Exclusions.--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 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 
        specimens including associated health information, demographic, 
        genotype, and molecular profile data, and environmental data.
            (10) OPH.--The term ``OPH'' means the Office 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 preventive, diagnostic, and therapeutic 
        interventions that use genome and family history information to 
        improve health outcomes.
            (12) Pharmacogenomics.--
                    (A) In general.--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) Variations.--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) 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.
    (b) Director.--The OPH shall be headed by a director, to be 
appointed by the Secretary.
    (c) Purpose.--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.
    (d) Duties.--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--
            (1) 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;
            (2) 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;
            (3) 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;
            (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 products used 
        for personalized medicine to ensure that guidelines are 
        consistent and intra-agency regulations do not conflict;
            (6) 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;
            (7) ensure that the Federal regulatory approach to 
        information technology-based clinical decision support systems 
        is evidence based and appropriately targeted;
            (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 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
            (9) 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.
    (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 committees of the Congress a report. Each such report shall 
describe--
            (1) progress of cross-agency coordination related to 
        personalized medicine;
            (2) innovations in genomics and personalized medicine;
            (3) emerging and persistent challenges related to 
        personalized medicine;
            (4) key barriers in research, regulation, and reimbursement 
        and their impact on innovation, development, and implementation 
        of medical product development for personalized medicine;
            (5) medical, ethical, legal, and social impacts of 
        personalized medicine; and
            (6) 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.
    (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 products used for personalized 
medicine (including genetic and genomic tests). Such report shall 
include recommendations regarding--
            (1) which products used for personalized medicine should 
        require regulation, and, for such products which are 
        recommended in the report to require regulation, 
        recommendations regarding--
                    (A) the appropriate regulatory submission 
                requirements and timeframes for such submissions;
                    (B) the appropriate level of evidence necessary 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 
        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;
            (3) a means by which to decrease the burden associated with 
        the initial and subsequent submission of any required 
        regulatory documents by clinical laboratories; and
            (4) 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).
    (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 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.

    (a) In General.--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--
            (1) studies of diseases and health conditions with 
        substantial public health impact;
            (2) population-based studies of genotype prevalence, gene-
        disease association, gene-drug response association, and 
        interactions between genes and the environment;
            (3) systematic review and synthesis of the results of 
        population-based studies using methods of human genome 
        epidemiology;
            (4) 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;
            (5) translation of genomic information into tools for 
        public health investigations and ongoing biosurveillance and 
        monitoring;
            (6) comprehensive studies of clinical utility, including 
        cost-effectiveness and cost-benefit analyses, of molecular 
        genetic and genomic tests and therapeutics;
            (7) implementation and postimplementation research to 
        facilitate studies for evaluating effectiveness and utility in 
        clinical and policy decisionmaking;
            (8) 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;
            (9) 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;
            (10) studies to assess the awareness, knowledge, and use of 
        products used for personalized medicine and their impact on 
        population health and health disparities;
            (11) bioinformatics research designed to integrate genomics 
        and personalized medicine into clinical 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 eligible entities that--
                    (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 medicine.

SEC. 202. NATIONAL BIOBANK.

    (a) In General.--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.
    (b) Requirements.--In carrying out subsection (a), the Director of 
the National Institutes of Health shall--
            (1) establish, directly or by contract, a single point of 
        authority to manage operations of the national biobank;
            (2) 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;
            (3) 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;
            (4) review and make recommendations to address ownership, 
        patient access issues, and analyses with respect to human 
        biological specimens and biobank data;
            (5) develop and promulgate guidelines regarding 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--
                    (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 advance 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 public 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, including 
        secure and efficient electronic submission;
            (12) allow public use of human biological specimens and 
        biobank data only--
                    (A) with appropriate privacy safeguards in place; 
                and
                    (B) for research purposes;
            (13) 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;
            (14) 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
            (15) make aggregate research findings from biobank 
        initiatives supported by Federal funding publicly available 
        within an appropriate timeframe (as determined by the 
        Secretary).

SEC. 203. BIOBANK INITIATIVE GRANTS.

    (a) In General.--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--
            (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 initiative. 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 participants, 
        especially underrepresented races, 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 collection, 
        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 clinical outcomes.
                    (B) Increased understanding of gene and environment 
                interactions.
                    (C) Development of personalized medicine screening, 
                diagnostic, and therapeutic interventions.
                    (D) Genotypic characterization of human biological 
                specimens and biobank data.
            (9) 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.
            (10) Development of interactive, Web-based portals to 
        provide participants access to their personal genetic profile.
            (11) Any other related activities deemed appropriate by the 
        Secretary.
    (c) Biobank Requirements.--The Secretary shall ensure that any 
biobank supported under this section--
            (1) supports genomics and personalized medicine research;
            (2) adheres to standards, guidelines, and recommendations 
        developed under section 202(b);
            (3) is established to complement activities related to the 
        implementation of current public biobank research initiatives, 
        as feasible;
            (4) is based on well-defined populations, including 
        population-based registries of disease and family-based 
        registries;
            (5) collects data from participants with diverse genomic 
        profiles, demographics, environmental exposures, and presence 
        or absence of diverse health conditions 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 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.
    (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 established under section 202(b) are met.
    (f) Application of Privacy Rules.--Nothing in this section shall be 
construed to supersede the requirements 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 Regulations (or 
        any successor regulations); or
            (5) part 50 of title 21, Code of Federal Regulations (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.

  Subtitle B--Committee on the Evaluation 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 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.
    (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 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;
            (2) identifying, prioritizing, and selecting topics for 
        systematic evidence-based review;
            (3) publishing evidence-based reviews and recommendations 
        for clinical practice and areas for additional research for 
        such topics;
            (4) publishing experiences with systematic evidence-based 
        review;
            (5) publishing gaps in knowledge, as determined 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 experience;
            (8) 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);
            (9) developing or adapting processes for recognizing 
        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 clinical 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 PERSONALIZED MEDICINE IN CLINICAL PRACTICE AND 
                             PUBLIC HEALTH

SEC. 301. GENOMICS AND PERSONALIZED MEDICINE EDUCATION 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 medicine training for specimen collection, 
diagnosis, treatment, and counseling of adults and children for both 
rare and common disorders, through support of efforts to--
            (1) 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;
            (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 strengthen 
        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 practices to augment genomics 
        and personalized medicine.
    (b) Integration.--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--
            (1) the development and dissemination of health 
        professional guidelines which shall--
                    (A) 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
                    (B) specifically target health professionals 
                without formal training or experience in the field of 
                genomics;
            (2) 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;
            (3) the development, cataloging, and dissemination 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 personalized medicine in 
        coordination with the CEGAPP to facilitate the development of 
        clinical practice guidelines;
            (5) 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--
                    (A) development of standards that define the 
                minimal levels of evidence required to support 
                guidelines decisions; and
                    (B) the clinical contexts (such as prevention, 
                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 established clinical 
        practice guidelines clearinghouses to facilitate dissemination 
        and encourage implementation 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 organization, academic institution, and 
any other entity as determined 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 POTENTIAL OF PERSONALIZED MEDICINE

SEC. 401. REDUCING THE REDUNDANCY OF CLINICAL LABORATORY 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
            (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 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.
    (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 identified under subsection 
        (a)(1), to the Secretary not later than 12 months after the 
        date of the enactment of this Act; and
            (2) a final such report to the Secretary not later than 24 
        months after such date.

SEC. 402. COMMITTEE ON PUBLIC ENGAGEMENT.

    (a) In General.--The Secretary shall establish a committee, to be 
composed of representatives from the private 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 barriers; and
            (2) make recommendations to address such barriers.
    (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 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.

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 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).
    (b) Requirements.--The agreement under subsection (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, 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;
            (3) 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;
            (4) recommendations for the reimbursement of health care 
        professionals providing genetic counseling services to--
                    (A) 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;
                    (B) 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
                    (C) assess the adequacy of existing current 
                procedural terminology evaluation and management codes 
                and their associated relative values with respect to 
                genetic counseling services;
            (5) 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;
            (6) incentives to encourage development of products used 
        for personalized medicine, including development of genetic and 
        genomic tests for patients 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 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.
    (d) Report.--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.

SEC. 404. FOOD AND DRUG ADMINISTRATION.

    (a) Encouragement of Companion Diagnostic Testing.--The Secretary, 
acting through the Commissioner 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 recommendation to use a companion diagnostic test if 
        data demonstrate--
                    (A) significant safety concerns with the drug or 
                biologic product; and
                    (B) improved outcomes with the administration of a 
                companion diagnostic test; and
            (3) 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.
    (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 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;
            (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 personalized 
        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 resulting from products 
        used for personalized medicine, including laboratory developed 
        test; and
            (3) develop systems to appropriately respond to any adverse 
        events resulting from products used for personalized medicine.

SEC. 406. TERMINATION OF CERTAIN ADVERTISING CAMPAIGNS.

    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.

SEC. 407. CENTERS FOR DISEASE CONTROL AND PREVENTION.

    (a) Public Awareness.--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--
            (1) 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);
            (2) 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;
            (3) integration of the use of validated genetic and genomic 
        tests in public health programs, as appropriate; and
            (4) evaluation of laboratory standards and practices 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 
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--
            (1) conduct an analysis of the public health impact of 
        direct-to-consumer marketing to the extent possible from 
        available data sources;
            (2) 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
            (3) 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).

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 Laboratories.--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.
    (c) Committee on Public Engagement.--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.
    (d) CDC Public Awareness Activities.--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.
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