(4) translation of genomic information into mo-
lecular genetic screening tools, diagnostics, and 
therapeutics, through well-conducted clinical trials 
and studies; 
(5) translation of genomic information into 
tools for public health investigations and ongoing 
biosurveillance and monitoring; 
(6) systematic review of data on analytic valid-
ity and clinical validity of molecular genetic tests; 
(7) comprehensive studies of clinical utility, in-
cluding cost-effectiveness and cost-benefit analyses, 
of molecular genetic tests and therapeutics; 
(8) population-based studies to assess the 
awareness, knowledge, and use of genetic tests and 
their impact on the population health and health dis-
parities; and 
(9) methods to enhance provider uptake or 
adoption of pharmacogenomic products into practice. 
(b) NATIONAL BIOBANKING INITIATIVE.— 
(1) IN GENERAL.—The Secretary shall advance 
the field of genomics and personalized medicine 
through establishment of a national biobanking dis-
tributed database for the collection and integration 
of genomic data, and associated environmental and 
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clinical health information, which shall facilitate syn-
thesis and pooled analysis of such data. 
(2) DATABASE.—With respect to the national 
biobanking distributed database, the Secretary 
shall— 
(A) adhere to relevant guidelines, policies, 
and recommendations of the IWG, pursuant to 
section 4; 
(B) establish, directly or by contract, a sin-
gle point of authority to manage operations of 
the database; 
(C) incorporate biobanking data from fed-
erally conducted or supported genomics initia-
tives, as feasible; 
(D) encourage voluntary submission of bio-
banking data obtained or analyzed with private 
or non-Federal funds; 
(E) facilitate submission of data, including 
secure and efficient electronic submission; 
(F) allow public use of data only— 
(i) with appropriate privacy safe-
guards in place; and 
(ii) for health research purposes; 
(G) determine appropriate procedures for 
access by nongovernmental entities to biobank 
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data for research and development of new or 
improved tests and treatments, and submission 
of data generated from such samples to the 
Food and Drug Administration as part of the 
approval process for drugs and devices; 
(H) conduct, directly or by contract, ana-
lytical research, including clinical, epidemiolog-
ical, and social research, using biobank data; 
and 
(I) make analytic findings from biobanking 
initiatives supported by Federal funding pub-
licly available within an appropriate timeframe 
to be determined by the Secretary. 
(3) RULE OF CONSTRUCTION.—Nothing in this 
subsection shall be construed to require the submis-
sion or acceptance of biological specimens. 
(c) BIOBANK INITIATIVES GRANTS.— 
(1) IN GENERAL.—The Secretary shall establish 
a grant program for eligible entities to develop or ex-
pand biobanking initiatives to increase under-
standing of how genomics interacts with environ-
mental factors to cause disease, and to accelerate 
the development of genomic-based tests and treat-
ments. 
(2) ELIGIBLE ENTITIES.— 
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(A) IN GENERAL.—For purposes of this 
subsection, eligible entities include academic 
medical centers and other entities determined 
appropriate by the Secretary. Eligible entities 
desiring a grant under this subsection shall 
submit an application to the Secretary in ac-
cordance with this subsection, at such time, in 
such manner, and containing such additional 
information as the Secretary may require. 
(B) PRIORITY.—Academic medical centers 
that partner with health care professionals 
within their communities in order to obtain di-
verse genomic samples shall be given priority 
for awards made under this subsection. 
(3) REQUIREMENTS.—The Secretary shall en-
sure that biobanks supported by grant awards under 
this subsection— 
(A) adhere to guidelines and recommenda-
tions developed pursuant to section 4; 
(B) are established to complement activi-
ties related to the implementation of current 
Federal biobanking research initiatives, as fea-
sible; 
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(C) are based on well-defined populations, 
including population-based registries of disease 
and family-based registries; 
(D) collect data from participants with di-
verse genomic profiles, demographics, environ-
mental exposures, and presence or absence of 
health conditions and diseases, as appropriate; 
(E) meet quality standards developed by 
the IWG pursuant to section 4 for the collec-
tion, processing, archiving, storage, and dis-
semination of data; 
(F) have practical experience and dem-
onstrated expertise in genomics and its clinical 
and public health applications; 
(G) establish mechanisms to ensure patient 
privacy and protection of information from non-
health applications and, as feasible, patient ac-
cess to genomic samples for clinical testing pur-
poses; and 
(H) contribute genomic and associated 
clinical and environmental data and analyses to 
the national biobanking distributed database, 
established pursuant to subsection (b). 
(4) USE OF FUNDS.—An eligible entity that re-
ceives a grant under this subsection shall use the 
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grant funds to develop or expand a biobanking ini-
tiative, which may include the following activities: 
(A) Support for scientific and community 
advisory committees. 
(B) Recruitment and education of partici-
pants. 
(C) Development of consent protocols. 
(D) Obtaining genetic samples and associ-
ated environmental and clinical information. 
(E) Establishment and maintenance of se-
cure storage for genetic samples and clinical in-
formation. 
(F) Conduct of data analyses and evidence- 
based systemic reviews that allow for the fol-
lowing: 
(i) Identification of biomarkers and 
other surrogate markers to improve pre-
dictions of onset of disease, response to 
therapy, and clinical outcomes. 
(ii) Increased understanding of gene 
environment interactions. 
(iii) Development of genetic screening, 
diagnostic, and therapeutic interventions. 
(iv) Genotypic characterization of tis-
sue samples. 
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(G) Other activities, as determined appro-
priate by the Secretary. 
(5) QUALITY ASSURANCE.—The Secretary may 
enter into a contract with an external entity to 
evaluate grantees under this subsection to ensure 
that quality standards are met. 
(d) APPLICATION OF PRIVACY RULES.—Nothing in 
this Act or the amendments made by this Act shall be 
construed to supercede the requirements for the protection 
of patient privacy under— 
(1) the Federal regulations promulgated under 
section 264(c) of the Health Insurance Portability 
and Accountability Act of 1996 (42 U.S.C. 1320d– 
2 note); 
(2) sections 552 and 552a of title 5, United 
States Code (5 U.S.C. App.); or 
(3) the Genetic Information Nondiscrimination 
Act of 2008 (Public Law 110–233). 
(e) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section, 
$150,000,000 for fiscal year 2009, and such sums as may 
be necessary for each of fiscal years 2010 through 2014. 
SEC. 6. GENOMICS WORKFORCE AND TRAINING. 
(a) GENETICS AND GENOMICS TRAINING.—The Sec-
retary, directly or through contracts or grants to eligible 
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entities, which shall include professional genetics and 
genomics societies, academic institutions, and other enti-
ties as determined appropriate by the Secretary, shall im-
prove the adequacy of genetics and genomics training for 
diagnosis, treatment, and counseling of adults and chil-
dren for both rare and common disorders, through support 
of efforts to— 
(1) develop and disseminate model training pro-
gram and residency curricula and teaching materials 
that reflect the new knowledge and evolving practice 
of genetics and genomics; 
(2) assist the review of board and other certi-
fying examinations by professional societies and ac-
creditation bodies to ensure adequate focus on the 
fundamental principles of genomics; and 
(3) identify and evaluate options for distance or 
on-line learning for degree or continuing education 
programs. 
(b) INTEGRATION.—The Secretary, in collaboration 
with medical professional societies and accreditation bod-
ies and associations of health professional schools, shall 
support initiatives to increase the integration of genetics 
and genomics into all aspects of clinical and public health 
practice by promoting genetics and genomics competency 
across all clinical, public health, and laboratory disciplines 
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through the development and dissemination of health pro-
fessional guidelines which shall— 
(1) include focus on appropriate techniques for 
collection and storage of genomics samples, adminis-
tration and interpretation of genetic and genomic 
tests, and subsequent clinical and public health deci-
sionmaking; and 
(2) specifically target health professionals with-
out formal training or experience in the field of 
genomics. 
(c) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
$10,000,000 for fiscal year 2009, and such sums as may 
be necessary for each of fiscal years 2010 through 2014. 
SEC. 7. REALIZING THE POTENTIAL OF PERSONALIZED 
MEDICINE. 
(a) PUBLIC REGISTRY OF INFORMATION ON VALID-
ITY OF LABORATORY-DEVELOPED GENETIC TESTS.— 
(1) REGISTRY.— 
(A) IN GENERAL.—Section 520 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360j) is amended by adding at the end the fol-
lowing: 
‘‘(o) REGISTRY ON ANALYTICAL AND CLINICAL VA-
LIDITY OF LABORATORY-DEVELOPED GENETIC TESTS.— 
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‘‘(1) The Secretary shall establish and maintain a 
registry on the analytical and clinical validity of labora-
tory-developed genetic tests. 
‘‘(2) The registry under paragraph (1) shall consist 
of information on the analytical and clinical validity of lab-
oratory-developed genetic tests submitted to the Sec-
retary— 
‘‘(A) under section 510(c), 515, or 520 for 
clearance or approval of such tests (whether sub-
mitted before or after the date of the enactment of 
this subsection); and 
‘‘(B) under paragraph (3). 
‘‘(3)(A) Unless a laboratory-developed genetic test is 
cleared under section 510(k) or approved under section 
515 or 520(m) for its intended use, the manufacturer of 
the test shall electronically submit to the Secretary infor-
mation (in a form specified by the Secretary and certified 
as truthful and accurate) on the analytical and clinical va-
lidity of the test for its intended use. 
‘‘(B) If the intended use of a laboratory-developed ge-
netic test is limited solely to the measurement of an ana-
lytical property or characteristic, the manufacturer of the 
test shall not submit any information with respect to the 
clinical validity of the test under subparagraph (A) other 
than the following statement: ‘This test is intended to 
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measure only the property or characteristic that is re-
ported as a result of use of the test. The test is not in-
tended to be used to diagnose or screen for any disease 
or condition, or to otherwise aid in decisionmaking with 
respect to health, and this laboratory makes no represen-
tations as to its usefulness for any such purpose.’. 
‘‘(4) In this subsection: 
‘‘(A) The term ‘genetic test’ means an analysis 
of human DNA, RNA, chromosomes, proteins, or 
metabolites, that detects genotypes, mutations, or 
chromosomal changes. 
‘‘(B) The term ‘laboratory-developed genetic 
test’ means a genetic test that is designed, validated, 
conducted, and offered as a service by a clinical lab-
oratory subject to section 353 of the Public Health 
Service Act (commonly referred to as the ‘Clinical 
Laboratory Improvement Amendments of 1988’) 
using either commercially available analyte specific 
reagents (Food and Drug Administration-regulated), 
reagents prepared by the laboratory (not Food and 
Drug Administration-regulated), or some combina-
tion thereof.’’. 
(B) CONFORMING
AMENDMENT.—Section 
501 of the Federal Food, Drug, and Cosmetic 
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