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Also tagged in: Budgets, Federal aid to health facilities, Government information, Government publicity, Health education, Imaging systems in medicine, Medical care, Medical research, Medical screening, Medical tests, Medicine, Minorities, Minority health, Prostate cancer, Science policy
Latest Action: 06/28/2007 - Sponsor introductory remarks on measure. (CR S8705) Bill TextA bill to provide for prostate cancer imaging research and education. 6/28/2007--Introduced. Prostate Research, Imaging, and Men's Education Act or the PRIME Act - Requires the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (NIH), to expand and intensify research to develop advanced imaging technologies for prostate cancer detection, diagnosis, and treatment comparable to mammogram technology.Directs the Secretary: (1) to carry out a national campaign to increase awareness and knowledge with respect to the need for prostate cancer screening and for improved detection technologies; (2) in developing such campaign, to recognize and address the racial disparities in the incidences of prostate cancer and mortality rates; (3) to establish a program to award grants to nonprofit private entities to test alternative outreach and education strategies; (4) to carry out research to develop an improved prostate cancer screening [...] show full description
Also tagged in: Aged, Ambulances, Cancer, Chronically ill, Data banks, Depreciation and amortization, Drugs, Employee training, Health facilities, Health policy, Hospital rates, Income tax, Investment tax credit, Job training, Long-term care, Medicaid, Medical care, Medical savings accounts, Medical tests, Medicare, Medicine, Nurses, Nursing homes, Paramedical personnel, Tax credits, Tax deductions, Tax exclusion, Tax exemption, Taxation, Technology, Welfare
Latest Action: 08/02/2007 - Sponsor introductory remarks on measure. (CR S10816-10817) Bill TextA bill to improve the quality of, and access to, long-term care. 8/2/2007--Introduced. Long-term Care Quality and Modernization Act of 2007 - Requires the Secretary of Health and Human Service to conduct a demonstration program under which the Secretary shall require a state to establish a process for joint training and education of surveyors and providers for skilled nursing facilities and nursing facilities at least annually.Amends title XVIII (Medicare) and title XIX (Medicaid) of the Social Security Act to set forth provisions related to resumption of nursing aid training programs for skilled nursing facilities after correction of deficiencies.Authorizes the Secretary to exclude from the Medicare prospective payment system for skilled nursing facilities: (1) high cost and low probability cancer treatment drugs; and (2) all ambulance services.Authorizes a physician, nurse practitioner, or clinical nurse specialist to certify under Medicare that a prescribed [...] show full description
Also tagged in: Administrative procedure, Budgets, Caregivers, Child health, Children, Communications, Consumer education, Consumers, Corrosion, Data banks, Day care, District of Columbia, Education, Educational facilities, Electronic government information, Electronic mail systems, Elementary and secondary education, Environmental protection, Environmental Protection Agency, Executive departments, Families, Federal aid to water resources development, Federal office buildings, Government information, Government paperwork, Government publicity, Hazardous substances, Health policy, Health warnings, Infants, Infrastructure, Internet, Laboratories, Landowners, Language and languages, Lead, Lead poisoning, Medical care, Medical tests, Medicine, Municipal services, Parent-school relationships, Parents, Planning, Plumbing, Pollution measurement, Potable water, Pregnant women, Product safety, Public buildings, School buildings, School health programs, Science policy, Standards, State and local government, Technology, Telecommunication, Telephone, Water pollution, Water pollution control, Water resources, Water supply, Women
Latest Action: 04/30/2007 - Sponsor introductory remarks on measure. (CR E891) Bill TextTo amend the Safe Drinking Water Act to ensure that the District of Columbia and States are provided a safe, lead-free supply of drinking water. 4/30/2007--Introduced. Lead-Free Drinking Water Act of 2007 - Amends the Safe Drinking Water Act to direct the Administrator of the Environmental Protection Agency (EPA) to review and revise the national primary drinking water regulation for lead to provide the maximum feasible protection for individuals affected by lead contamination, particularly vulnerable populations (e.g., infants, children, and pregnant and lactating women). Requires the revised regulation to establish: (1) a maximum contaminant level for lead in drinking water as measured at the tap; or (2) a drinking water treatment technique that meets specified criteria. Directs community water systems or nontransient noncommunity water systems to: (1) annually replace a percentage of non-lead free service lines until all such lines are replaced; (2) provide [...] show full description
Also tagged in: Budgets, Federal aid to health facilities, Government information, Government publicity, Health education, Imaging systems in medicine, Medical care, Medical research, Medical screening, Medical tests, Medicine, Minorities, Minority health, Prostate cancer, Science policy
Latest Action: 09/18/2007 - Referred to the Subcommittee on Health. Bill TextTo provide for prostate cancer imaging research and education. 9/18/2007--Introduced. Prostate Research, Imaging, and Men's Education Act of 2007 or the PRIME Act of 2007 - Requires the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (NIH), to: (1) carry out a program to expand and intensify research to develop advanced imaging technologies for prostate cancer detection, diagnosis, and treatment comparable to mammogram technology; and (2) utilize the National Institute of Biomedical Imaging and Bioengineering and the National Cancer Institute for advanced stages of research in prostate imaging. Requires the Secretary, acting through the Administrator of the Health Resources and Services Administration, to: (1) carry out a grant program to encourage the early stages of research in prostate imaging to develop and implement new ideas, proof of concepts, and pilot studies for high-risk technologic innovation; and [...] show full description
Also tagged in: Administrative procedure, Consumers, Data banks, Department of Health and Human Services, Electronic data interchange, Executive departments, Food and Drug Administration (FDA), Genetics, Government information, Government paperwork, Government publicity, Internet, Labeling, Law, Medical care, Medical instruments and apparatus, Medical laboratories, Medical supplies, Medical tests, Medicine, Standards, Technology, Telecommunication, Tissue banks, Web sites
Latest Action: 03/01/2007 - Sponsor introductory remarks on measure. (CR S2502-2503) Bill TextA bill to provide for the regulation and oversight of laboratory tests. 3/1/2007--Introduced. Laboratory Test Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to deem a laboratory-developed test that is a direct-to-consumer test to be a prescription test if it satisfies the requirements of this Act. Deems any laboratory-developed test to be a medical device.Sets forth labeling and registration requirements for laboratory-developed tests.Requires the manufacturer of a laboratory-developed test that has not been cleared or approved for its intended use to submit the analytical and clinical validity of the test for its intended use to the Secretary of Health and Human Services. Requires the Secretary to include such information in a public database.Requires the Secretary to provide guidance to: (1) facilitate the use of reviews of the peer-reviewed biomedical literature and other information and data about the clinical validity [...] show full description
Also tagged in: Aged, Authorization, Budgets, Child health, Children, Energy, Energy assistance for the poor, Energy conservation, Environmental health, Environmental protection, Federal advisory bodies, Government information, Government publicity, Hazardous substances, Health education, Health policy, Housing, Housing for the aged, Housing for the disabled, Income tax, Lead, Lead poisoning, Low-income housing, Medicaid, Medical care, Medical screening, Medical tests, Medicine, Minorities, Minority health, Paints and varnishes, Pregnant women, Risk, Strategic planning, Tax credits, Taxation, Welfare, Women, Women's health, Women's health services
Latest Action: 10/25/2007 - Sponsor introductory remarks on measure. (CR S13456-13457) Bill TextA bill to require the Secretary of Health and Human Services to carry out demonstration projects and outreach programs for the identification and abatement of lead hazards, to establish the Joint Task Force on Lead-Based Hazards and the Task Force on Children's Environmental Health and Safety, to strengthen the authority of the Secretary of Housing and Urban Development, and for other purposes. 10/25/2007--Introduced. Lead Elimination, Abatement, and Poisoning Prevention Act of 2007 or the LEAPP Act of 2007 - Requires the Secretary of Health and Human Services to carry out demonstration projects and outreach programs for the identification and abatement of lead hazards.Requires the Secretary, in conjunction with the Administrator of the Environmental Protection Agency (EPA) and the Secretary of Housing and Urban Development, to establish the Joint Task Force on Lead-Based Hazards.Requires the President, in conjunction with the Administrator, to establish the [...] show full description
Also tagged in: Blood banks, Budgets, Clinical trials, Data banks, Epidemiology, Executive departments, Federal advisory bodies, Federal aid to health facilities, Federal aid to research, Health policy, Laboratories, Medical care, Medical research, Medical screening, Medical statistics, Medical tests, Medicine, Nonprofit organizations, Ovarian cancer, Research centers, Research grants, Risk, Science policy, Social services, Technology, Tissue banks, Urinalysis, Women, Women's health, Women's health services
Latest Action: 11/08/2007 - Referred to the Subcommittee on Health. Bill TextTo amend the Public Health Service Act to authorize the Director of the National Cancer Institute to make grants for the discovery and validation of biomarkers for use in risk stratification for, and the early detection and screening of, ovarian cancer. 9/27/2007--Introduced. Ovarian Cancer Biomarker Research Act of 2007 - Amends the Public Health Service Act to require the Director of the National Cancer Institute to enter into cooperative agreements with, or make grants to, public or nonprofit entities to establish and operate centers to conduct research on biomarkers for use in risk stratification for, and the early detection and screening of, ovarian cancer. Designates each center as an Ovarian Cancer Biomarker Center of Excellence.Allows federal payments under such an agreement or grant to be used for research on: (1) the development and characterization of new biomarkers and the refinement of existing biomarkers; (2) the clinical and laboratory validation of such [...] show full description
Also tagged in: Blood banks, Budgets, Clinical trials, Data banks, Epidemiology, Executive departments, Federal advisory bodies, Federal aid to health facilities, Federal aid to research, Health policy, Laboratories, Medical care, Medical research, Medical screening, Medical statistics, Medical tests, Medicine, Nonprofit organizations, Ovarian cancer, Research centers, Research grants, Risk, Science policy, Social services, Technology, Tissue banks, Urinalysis, Women, Women's health, Women's health services
Latest Action: 01/29/2008 - Sponsor introductory remarks on measure. (CR S448) Bill TextA bill to amend the Public Health Service Act to authorize the Director of the National Cancer Institute to make grants for the discovery and validation of biomarkers for use in risk stratification for, and the early detection and screening of, ovarian cancer. 1/29/2008--Introduced. Ovarian Cancer Biomarker Research Act of 2008 - Amends the Public Health Service Act to require the Director of the National Cancer Institute to enter into cooperative agreements with, or make grants to, public or nonprofit entities to establish and operate centers to conduct research on biomarkers for use in risk stratification for, and the early detection and screening of, ovarian cancer. Designates each center as an Ovarian Cancer Biomarker Center of Excellence.Allows federal payments under such an agreement or grant to be used for research on: (1) the development and characterization of new biomarkers and the refinement of existing biomarkers; (2) the clinical and laboratory validation [...] show full description
Also tagged in: Aged, Ambulances, Budgets, Cancer, Communications, Congress, Congressional reporting requirements, Curricula, Data banks, Depreciation and amortization, Drugs, Education, Emergency management, Employee training, Executive departments, Federal advisory bodies, Federal aid to education, Governmental investigations, Health information systems, Health policy, Higher education, Hospital rates, Income tax, Job training, Kidney diseases, Labor, Long-term care, Medicaid, Medical care, Medical tests, Medicare, Medicine, Nurse practitioners, Nurses, Nursing education, Nursing homes, Occupational therapy, Paramedical personnel, Physical therapy, Physicians, Quality of care, Recruiting of employees, Scholarships, Speech disorders, Student loan funds, Tax deductions, Taxation, Teacher supply and demand, Technology, Telecommunication, Telemedicine, Transportation, Welfare
Latest Action: 11/06/2007 - Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the commi Bill TextTo improve the quality of, and access to, long-term care. 11/6/2007--Introduced. Long-term Care Quality and Modernization Act of 2007 - Directs the Secretary of Health and Human Service to conduct a demonstration program requiring a state to establish a process for joint training and education of surveyors and providers for skilled nursing facilities (SNFs) and nursing facilities at least annually. Amends title XVIII (Medicare) and title XIX (Medicaid) of the Social Security Act to allow resumption of nursing aid training programs in SNFs after correction of deficiencies. Authorizes the Secretary to exclude from the Medicare prospective payment system (PPS) for SNFs: (1) certain (high cost and low probability) cancer treatment drugs, including antineoplastic drugs, antiemitics, and supportive medications; (2) all ambulance services, including those furnished to an individual in conjunction with renal dialysis services; and (3) other appropriate items and services.[...] show full description
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Latest Legislation - View All
Also tagged in: Blood banks, Budgets, Clinical trials, Data banks, Epidemiology, Executive departments, Federal advisory bodies, Federal aid to health facilities, Federal aid to research, Health policy, Laboratories, Medical care, Medical research, Medical screening, Medical statistics, Medical tests, Medicine, Nonprofit organizations, Ovarian cancer, Research centers, Research grants, Risk, Science policy, Social services, Technology, Tissue banks, Urinalysis, Women, Women's health, Women's health services
Latest Action: 01/29/2008 - Sponsor introductory remarks on measure. (CR S448) Bill TextA bill to amend the Public Health Service Act to authorize the Director of the National Cancer Institute to make grants for the discovery and validation of biomarkers for use in risk stratification for, and the early detection and screening of, ovarian cancer. 1/29/2008--Introduced. Ovarian Cancer Biomarker Research Act of 2008 - Amends the Public Health Service Act to require the Director of the National Cancer Institute to enter into cooperative agreements with, or make grants to, public or nonprofit entities to establish and operate centers to conduct research on biomarkers for use in risk stratification for, and the early detection and screening of, ovarian cancer. Designates each center as an Ovarian Cancer Biomarker Center of Excellence.Allows federal payments under such an agreement or grant to be used for research on: (1) the development and characterization of new biomarkers and the refinement of existing biomarkers; (2) the clinical and laboratory validation [...] show full description
Also tagged in: Aged, Ambulances, Budgets, Cancer, Communications, Congress, Congressional reporting requirements, Curricula, Data banks, Depreciation and amortization, Drugs, Education, Emergency management, Employee training, Executive departments, Federal advisory bodies, Federal aid to education, Governmental investigations, Health information systems, Health policy, Higher education, Hospital rates, Income tax, Job training, Kidney diseases, Labor, Long-term care, Medicaid, Medical care, Medical tests, Medicare, Medicine, Nurse practitioners, Nurses, Nursing education, Nursing homes, Occupational therapy, Paramedical personnel, Physical therapy, Physicians, Quality of care, Recruiting of employees, Scholarships, Speech disorders, Student loan funds, Tax deductions, Taxation, Teacher supply and demand, Technology, Telecommunication, Telemedicine, Transportation, Welfare
Latest Action: 11/06/2007 - Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the commi Bill TextTo improve the quality of, and access to, long-term care. 11/6/2007--Introduced. Long-term Care Quality and Modernization Act of 2007 - Directs the Secretary of Health and Human Service to conduct a demonstration program requiring a state to establish a process for joint training and education of surveyors and providers for skilled nursing facilities (SNFs) and nursing facilities at least annually. Amends title XVIII (Medicare) and title XIX (Medicaid) of the Social Security Act to allow resumption of nursing aid training programs in SNFs after correction of deficiencies. Authorizes the Secretary to exclude from the Medicare prospective payment system (PPS) for SNFs: (1) certain (high cost and low probability) cancer treatment drugs, including antineoplastic drugs, antiemitics, and supportive medications; (2) all ambulance services, including those furnished to an individual in conjunction with renal dialysis services; and (3) other appropriate items and services.[...] show full description
Also tagged in: Aged, Authorization, Budgets, Child health, Children, Energy, Energy assistance for the poor, Energy conservation, Environmental health, Environmental protection, Federal advisory bodies, Government information, Government publicity, Hazardous substances, Health education, Health policy, Housing, Housing for the aged, Housing for the disabled, Income tax, Lead, Lead poisoning, Low-income housing, Medicaid, Medical care, Medical screening, Medical tests, Medicine, Minorities, Minority health, Paints and varnishes, Pregnant women, Risk, Strategic planning, Tax credits, Taxation, Welfare, Women, Women's health, Women's health services
Latest Action: 10/25/2007 - Sponsor introductory remarks on measure. (CR S13456-13457) Bill TextA bill to require the Secretary of Health and Human Services to carry out demonstration projects and outreach programs for the identification and abatement of lead hazards, to establish the Joint Task Force on Lead-Based Hazards and the Task Force on Children's Environmental Health and Safety, to strengthen the authority of the Secretary of Housing and Urban Development, and for other purposes. 10/25/2007--Introduced. Lead Elimination, Abatement, and Poisoning Prevention Act of 2007 or the LEAPP Act of 2007 - Requires the Secretary of Health and Human Services to carry out demonstration projects and outreach programs for the identification and abatement of lead hazards.Requires the Secretary, in conjunction with the Administrator of the Environmental Protection Agency (EPA) and the Secretary of Housing and Urban Development, to establish the Joint Task Force on Lead-Based Hazards.Requires the President, in conjunction with the Administrator, to establish the [...] show full description
Also tagged in: Blood banks, Budgets, Clinical trials, Data banks, Epidemiology, Executive departments, Federal advisory bodies, Federal aid to health facilities, Federal aid to research, Health policy, Laboratories, Medical care, Medical research, Medical screening, Medical statistics, Medical tests, Medicine, Nonprofit organizations, Ovarian cancer, Research centers, Research grants, Risk, Science policy, Social services, Technology, Tissue banks, Urinalysis, Women, Women's health, Women's health services
Latest Action: 11/08/2007 - Referred to the Subcommittee on Health. Bill TextTo amend the Public Health Service Act to authorize the Director of the National Cancer Institute to make grants for the discovery and validation of biomarkers for use in risk stratification for, and the early detection and screening of, ovarian cancer. 9/27/2007--Introduced. Ovarian Cancer Biomarker Research Act of 2007 - Amends the Public Health Service Act to require the Director of the National Cancer Institute to enter into cooperative agreements with, or make grants to, public or nonprofit entities to establish and operate centers to conduct research on biomarkers for use in risk stratification for, and the early detection and screening of, ovarian cancer. Designates each center as an Ovarian Cancer Biomarker Center of Excellence.Allows federal payments under such an agreement or grant to be used for research on: (1) the development and characterization of new biomarkers and the refinement of existing biomarkers; (2) the clinical and laboratory validation of such [...] show full description
Also tagged in: Budgets, Federal aid to health facilities, Government information, Government publicity, Health education, Imaging systems in medicine, Medical care, Medical research, Medical screening, Medical tests, Medicine, Minorities, Minority health, Prostate cancer, Science policy
Latest Action: 09/18/2007 - Referred to the Subcommittee on Health. Bill TextTo provide for prostate cancer imaging research and education. 9/18/2007--Introduced. Prostate Research, Imaging, and Men's Education Act of 2007 or the PRIME Act of 2007 - Requires the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (NIH), to: (1) carry out a program to expand and intensify research to develop advanced imaging technologies for prostate cancer detection, diagnosis, and treatment comparable to mammogram technology; and (2) utilize the National Institute of Biomedical Imaging and Bioengineering and the National Cancer Institute for advanced stages of research in prostate imaging. Requires the Secretary, acting through the Administrator of the Health Resources and Services Administration, to: (1) carry out a grant program to encourage the early stages of research in prostate imaging to develop and implement new ideas, proof of concepts, and pilot studies for high-risk technologic innovation; and [...] show full description
Also tagged in: Aged, Ambulances, Cancer, Chronically ill, Data banks, Depreciation and amortization, Drugs, Employee training, Health facilities, Health policy, Hospital rates, Income tax, Investment tax credit, Job training, Long-term care, Medicaid, Medical care, Medical savings accounts, Medical tests, Medicare, Medicine, Nurses, Nursing homes, Paramedical personnel, Tax credits, Tax deductions, Tax exclusion, Tax exemption, Taxation, Technology, Welfare
Latest Action: 08/02/2007 - Sponsor introductory remarks on measure. (CR S10816-10817) Bill TextA bill to improve the quality of, and access to, long-term care. 8/2/2007--Introduced. Long-term Care Quality and Modernization Act of 2007 - Requires the Secretary of Health and Human Service to conduct a demonstration program under which the Secretary shall require a state to establish a process for joint training and education of surveyors and providers for skilled nursing facilities and nursing facilities at least annually.Amends title XVIII (Medicare) and title XIX (Medicaid) of the Social Security Act to set forth provisions related to resumption of nursing aid training programs for skilled nursing facilities after correction of deficiencies.Authorizes the Secretary to exclude from the Medicare prospective payment system for skilled nursing facilities: (1) high cost and low probability cancer treatment drugs; and (2) all ambulance services.Authorizes a physician, nurse practitioner, or clinical nurse specialist to certify under Medicare that a prescribed [...] show full description
Also tagged in: Budgets, Federal aid to health facilities, Government information, Government publicity, Health education, Imaging systems in medicine, Medical care, Medical research, Medical screening, Medical tests, Medicine, Minorities, Minority health, Prostate cancer, Science policy
Latest Action: 06/28/2007 - Sponsor introductory remarks on measure. (CR S8705) Bill TextA bill to provide for prostate cancer imaging research and education. 6/28/2007--Introduced. Prostate Research, Imaging, and Men's Education Act or the PRIME Act - Requires the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (NIH), to expand and intensify research to develop advanced imaging technologies for prostate cancer detection, diagnosis, and treatment comparable to mammogram technology.Directs the Secretary: (1) to carry out a national campaign to increase awareness and knowledge with respect to the need for prostate cancer screening and for improved detection technologies; (2) in developing such campaign, to recognize and address the racial disparities in the incidences of prostate cancer and mortality rates; (3) to establish a program to award grants to nonprofit private entities to test alternative outreach and education strategies; (4) to carry out research to develop an improved prostate cancer screening [...] show full description
Also tagged in: Administrative procedure, Budgets, Caregivers, Child health, Children, Communications, Consumer education, Consumers, Corrosion, Data banks, Day care, District of Columbia, Education, Educational facilities, Electronic government information, Electronic mail systems, Elementary and secondary education, Environmental protection, Environmental Protection Agency, Executive departments, Families, Federal aid to water resources development, Federal office buildings, Government information, Government paperwork, Government publicity, Hazardous substances, Health policy, Health warnings, Infants, Infrastructure, Internet, Laboratories, Landowners, Language and languages, Lead, Lead poisoning, Medical care, Medical tests, Medicine, Municipal services, Parent-school relationships, Parents, Planning, Plumbing, Pollution measurement, Potable water, Pregnant women, Product safety, Public buildings, School buildings, School health programs, Science policy, Standards, State and local government, Technology, Telecommunication, Telephone, Water pollution, Water pollution control, Water resources, Water supply, Women
Latest Action: 04/30/2007 - Sponsor introductory remarks on measure. (CR E891) Bill TextTo amend the Safe Drinking Water Act to ensure that the District of Columbia and States are provided a safe, lead-free supply of drinking water. 4/30/2007--Introduced. Lead-Free Drinking Water Act of 2007 - Amends the Safe Drinking Water Act to direct the Administrator of the Environmental Protection Agency (EPA) to review and revise the national primary drinking water regulation for lead to provide the maximum feasible protection for individuals affected by lead contamination, particularly vulnerable populations (e.g., infants, children, and pregnant and lactating women). Requires the revised regulation to establish: (1) a maximum contaminant level for lead in drinking water as measured at the tap; or (2) a drinking water treatment technique that meets specified criteria. Directs community water systems or nontransient noncommunity water systems to: (1) annually replace a percentage of non-lead free service lines until all such lines are replaced; (2) provide [...] show full description
Also tagged in: Administrative procedure, Consumers, Data banks, Department of Health and Human Services, Electronic data interchange, Executive departments, Food and Drug Administration (FDA), Genetics, Government information, Government paperwork, Government publicity, Internet, Labeling, Law, Medical care, Medical instruments and apparatus, Medical laboratories, Medical supplies, Medical tests, Medicine, Standards, Technology, Telecommunication, Tissue banks, Web sites
Latest Action: 03/01/2007 - Sponsor introductory remarks on measure. (CR S2502-2503) Bill TextA bill to provide for the regulation and oversight of laboratory tests. 3/1/2007--Introduced. Laboratory Test Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to deem a laboratory-developed test that is a direct-to-consumer test to be a prescription test if it satisfies the requirements of this Act. Deems any laboratory-developed test to be a medical device.Sets forth labeling and registration requirements for laboratory-developed tests.Requires the manufacturer of a laboratory-developed test that has not been cleared or approved for its intended use to submit the analytical and clinical validity of the test for its intended use to the Secretary of Health and Human Services. Requires the Secretary to include such information in a public database.Requires the Secretary to provide guidance to: (1) facilitate the use of reviews of the peer-reviewed biomedical literature and other information and data about the clinical validity [...] show full description
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