H.R. 5440, The Genomics and Personalized Medicine Act of 2010
H.R. 5440 would 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.
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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.
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.
