Biomedical engineering Legislation - Federal Government

A bill to amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act to improve drug safety and oversight, and for other purposes. 2/1/2007--Introduced. Enhancing Drug Safety and Innovation Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for approval for a new drug or biological product to include a proposed risk evaluation and mitigation strategy, which must include: (1) labeling for the drug for use by health care providers; (2) submission of reports for the drug; and (3) a statement as to whether the analysis and surveillance are sufficient to assess the serious risks of the drug. Establishes a Drug Safety Oversight Board. Requires the Secretary of Health and Human Services to establish the Reagan-Udall Institute for Applied Biomedical Research as a nonprofit corporation to advance the Critical Path Initiative to modernize medical product development, accelerate innovation, and enhance product [...]

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To amend the Federal Food, Drug, and Cosmetic Act with respect to drug safety, and for other purposes. 1/31/2007--Introduced. Food and Drug Administration Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to establish the Center for Postmarket Evaluation and Research for Drugs and Biologics within the Food and Drug Administration (FDA). Requires the Director of the Center to conduct activities to ensure the safety and effectiveness of FDA-approved drugs and licensed biological products, including by: (1) conducting postmarket risk assessment and surveillance of such drugs and products; (2) determining whether a postmarket study is required; (3) contracting, or requiring the sponsor of such a drug or product to contract, with the holders of domestic and international patient databases to conduct epidemiologic and other observational studies; (4) determining whether a drug or product may present an unreasonable risk to the health of patients or the [...]

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A bill to improve the process for the development of needed pediatric medical devices. 3/8/2007--Introduced. Pediatric Medical Device Safety and Improvement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for the approval of a medical device or a product development protocol to include: (1) a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and (2) the number of affected pediatric patients. Excludes a medical device distributed pursuant to the humanitarian device exemption from the prohibition that no device be sold for an amount that exceeds the cost of the device if: (1) the device is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients; and (2) other specified requirements are met. Requires the Director of the National Institutes of Health (NIH) to designate a contact point to help [...]

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A bill to provide for a comprehensive Federal effort relating to early detection of, treatments for, and the prevention of cancer, and for other purposes. 3/29/2007--Introduced. National Cancer Act of 2007 - Amends the Public Health Service Act to require the Director of the National Cancer Institute to establish a loan repayment program for health professionals agreeing to engage in cancer prevention research. Provides for research on cancer treatments that target cancer cells, the cancer care workforce, cancer survivorship, environmental risk factors for cancer, and treatment disparities.Requires the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention (CDC), to carry out demonstration programs on: (1) lung cancer early detection using Computer Tomography (CT) scanning; and (2) colorectal screening.Amends the Federal Food, Drug, and Cosmetic Act to set forth provisions for chemoprevention [...]

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An act to amend the Federal Food, Drug, and cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products, and for other purposes. 5/9/2007--Passed Senate amended.    (There are 2 other summaries) Food and Drug Administration Revitalization Act - Title I: Prescription Drug User Fees - (Sec. 101) - Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to set forth as a purpose that authorized prescription drug fees be dedicated toward expediting the drug development process, the process for the review of human drug applications, and postmarket drug safety. Sets forth reporting requirements, including requiring the Secretary of Human Services (the Secretary) to present to Congress recommendations developed for achieving certain goals for the review process of human drug applications and for reauthorization of user [...]

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To improve the process for the development of needed pediatric medical devices. 3/13/2007--Introduced. Pediatric Medical Device Safety and Improvement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for the approval of a medical device or a product development protocol to include: (1) a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and (2) the number of affected pediatric patients. Excludes a medical device distributed pursuant to the humanitarian device exemption from the prohibition that no device be sold for an amount that exceeds the cost of the device if: (1) the device is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients; and (2) other specified requirements are met. Requires the Director of the National Institutes of Health (NIH) to designate a contact point to help innovators [...]

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To amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act to improve drug safety and oversight, and for other purposes. 3/19/2007--Introduced. Enhancing Drug Safety and Innovation Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for approval for a new drug or biological product to include a proposed risk evaluation and mitigation strategy, which must include: (1) labeling for the drug for use by health care providers; (2) submission of reports for the drug; and (3) a statement as to whether the analysis and surveillance are sufficient to assess the serious risks of the drug. Establishes a Drug Safety Oversight Board. Requires the Secretary of Health and Human Services to establish the Reagan-Udall Institute for Applied Biomedical Research as a nonprofit corporation to advance the Critical Path Initiative to modernize medical product development, accelerate innovation, and enhance product safety.[...]

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A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to drug safety, and for other purposes. 1/31/2007--Introduced. Food and Drug Administration Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to establish the Center for Postmarket Evaluation and Research for Drugs and Biologics within the Food and Drug Administration (FDA). Requires the Director of the Center to conduct activities to ensure the safety and effectiveness of FDA-approved drugs and licensed biological products, including by: (1) conducting postmarket risk assessment and surveillance of such drugs and products; (2) determining whether a postmarket study is required; (3) contracting, or requiring the sponsor of such a drug or product to contract, with the holders of domestic and international patient databases to conduct epidemiologic and other observational studies; (4) determining whether a drug or product may present an unreasonable risk to the health of patients [...]

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To amend the Internal Revenue Code of 1986 to modernize the tax treatment of biomedical research corporations. 7/31/2007--Introduced. American Life Sciences Competitiveness Act of 2007 - Amends the Internal Revenue Code to allow biomedical research corporations to: (1) engage in investment activity involving shifts in ownership without incurring limitations on net operating loss carryforwards; (2) claim a full research and development tax credit for contract research expenses (currently, limited to 65%); (3) claim a business tax credit for 20% of eligible countermeasures research expenses (for biomedical threats); and (4) claim a tax-free rollover of gain from stock sales reinvested in another biomedical research corporation.Expands the tax credit for clinical testing expenses for drugs to treat rare diseases (orphan drugs) to include expenses incurred after an application is made to the Food and Drug Administration (FDA) but before receipt of an orphan drug designation.[...]

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To direct the Secretary of Health and Human Services to implement a National Neurotechnology Initiative, and for other purposes. 5/7/2008--Introduced. National Neurotechnology Initiative Act - Defines "neurotechnology" to mean the science and technology that allows an individual to analyze, understand, treat, and heal the brain and nervous system.Requires the Secretary of Health and Human Services to implement a National Neurotechnology Initiative, under which the Secretary shall: (1) establish goals, priorities, and metrics for evaluation for federal neurotechnology research, development, and commercialization; (2) increase the investment in federal research, development, and translational programs in neurotechnology to achieve such goals; and (3) increase interagency coordination.Requires the Secretary to establish the National Neurotechnology Coordination Office and the National Neurotechnology Advisory Council.Requires the Director of the [...]

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A bill to direct the Secretary of Health and Human Services to implement a National Neurotechnology Initiative, and for other purposes. 5/7/2008--Introduced. National Neurotechnology Initiative Act - Defines "neurotechnology" to mean the science and technology that allows an individual to analyze, understand, treat, and heal the brain and nervous system.Requires the Secretary of Health and Human Services to implement a National Neurotechnology Initiative, under which the Secretary shall: (1) establish goals, priorities, and metrics for evaluation for federal neurotechnology research, development, and commercialization; (2) increase the investment in federal research, development, and translational programs in neurotechnology to achieve such goals; and (3) increase interagency coordination.Requires the Secretary to establish the National Neurotechnology Coordination Office and the National Neurotechnology Advisory Council.Requires the Director [...]

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To direct the Secretary of Health and Human Services to implement a National Neurotechnology Initiative, and for other purposes. 5/7/2008--Introduced. National Neurotechnology Initiative Act - Defines "neurotechnology" to mean the science and technology that allows an individual to analyze, understand, treat, and heal the brain and nervous system.Requires the Secretary of Health and Human Services to implement a National Neurotechnology Initiative, under which the Secretary shall: (1) establish goals, priorities, and metrics for evaluation for federal neurotechnology research, development, and commercialization; (2) increase the investment in federal research, development, and translational programs in neurotechnology to achieve such goals; and (3) increase interagency coordination.Requires the Secretary to establish the National Neurotechnology Coordination Office and the National Neurotechnology Advisory Council.Requires the Director of the [...]

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To amend the Internal Revenue Code of 1986 to modernize the tax treatment of biomedical research corporations. 7/31/2007--Introduced. American Life Sciences Competitiveness Act of 2007 - Amends the Internal Revenue Code to allow biomedical research corporations to: (1) engage in investment activity involving shifts in ownership without incurring limitations on net operating loss carryforwards; (2) claim a full research and development tax credit for contract research expenses (currently, limited to 65%); (3) claim a business tax credit for 20% of eligible countermeasures research expenses (for biomedical threats); and (4) claim a tax-free rollover of gain from stock sales reinvested in another biomedical research corporation.Expands the tax credit for clinical testing expenses for drugs to treat rare diseases (orphan drugs) to include expenses incurred after an application is made to the Food and Drug Administration (FDA) but before receipt of an orphan drug designation.[...]

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An act to amend the Federal Food, Drug, and cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products, and for other purposes. 5/9/2007--Passed Senate amended.    (There are 2 other summaries) Food and Drug Administration Revitalization Act - Title I: Prescription Drug User Fees - (Sec. 101) - Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to set forth as a purpose that authorized prescription drug fees be dedicated toward expediting the drug development process, the process for the review of human drug applications, and postmarket drug safety. Sets forth reporting requirements, including requiring the Secretary of Human Services (the Secretary) to present to Congress recommendations developed for achieving certain goals for the review process of human drug applications and for reauthorization of user [...]

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A bill to provide for a comprehensive Federal effort relating to early detection of, treatments for, and the prevention of cancer, and for other purposes. 3/29/2007--Introduced. National Cancer Act of 2007 - Amends the Public Health Service Act to require the Director of the National Cancer Institute to establish a loan repayment program for health professionals agreeing to engage in cancer prevention research. Provides for research on cancer treatments that target cancer cells, the cancer care workforce, cancer survivorship, environmental risk factors for cancer, and treatment disparities.Requires the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention (CDC), to carry out demonstration programs on: (1) lung cancer early detection using Computer Tomography (CT) scanning; and (2) colorectal screening.Amends the Federal Food, Drug, and Cosmetic Act to set forth provisions for chemoprevention [...]

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To amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act to improve drug safety and oversight, and for other purposes. 3/19/2007--Introduced. Enhancing Drug Safety and Innovation Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for approval for a new drug or biological product to include a proposed risk evaluation and mitigation strategy, which must include: (1) labeling for the drug for use by health care providers; (2) submission of reports for the drug; and (3) a statement as to whether the analysis and surveillance are sufficient to assess the serious risks of the drug. Establishes a Drug Safety Oversight Board. Requires the Secretary of Health and Human Services to establish the Reagan-Udall Institute for Applied Biomedical Research as a nonprofit corporation to advance the Critical Path Initiative to modernize medical product development, accelerate innovation, and enhance product safety.[...]

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To improve the process for the development of needed pediatric medical devices. 3/13/2007--Introduced. Pediatric Medical Device Safety and Improvement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for the approval of a medical device or a product development protocol to include: (1) a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and (2) the number of affected pediatric patients. Excludes a medical device distributed pursuant to the humanitarian device exemption from the prohibition that no device be sold for an amount that exceeds the cost of the device if: (1) the device is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients; and (2) other specified requirements are met. Requires the Director of the National Institutes of Health (NIH) to designate a contact point to help innovators [...]

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A bill to improve the process for the development of needed pediatric medical devices. 3/8/2007--Introduced. Pediatric Medical Device Safety and Improvement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for the approval of a medical device or a product development protocol to include: (1) a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and (2) the number of affected pediatric patients. Excludes a medical device distributed pursuant to the humanitarian device exemption from the prohibition that no device be sold for an amount that exceeds the cost of the device if: (1) the device is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients; and (2) other specified requirements are met. Requires the Director of the National Institutes of Health (NIH) to designate a contact point to help [...]

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A bill to amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act to improve drug safety and oversight, and for other purposes. 2/1/2007--Introduced. Enhancing Drug Safety and Innovation Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for approval for a new drug or biological product to include a proposed risk evaluation and mitigation strategy, which must include: (1) labeling for the drug for use by health care providers; (2) submission of reports for the drug; and (3) a statement as to whether the analysis and surveillance are sufficient to assess the serious risks of the drug. Establishes a Drug Safety Oversight Board. Requires the Secretary of Health and Human Services to establish the Reagan-Udall Institute for Applied Biomedical Research as a nonprofit corporation to advance the Critical Path Initiative to modernize medical product development, accelerate innovation, and enhance product [...]

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To amend the Federal Food, Drug, and Cosmetic Act with respect to drug safety, and for other purposes. 1/31/2007--Introduced. Food and Drug Administration Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to establish the Center for Postmarket Evaluation and Research for Drugs and Biologics within the Food and Drug Administration (FDA). Requires the Director of the Center to conduct activities to ensure the safety and effectiveness of FDA-approved drugs and licensed biological products, including by: (1) conducting postmarket risk assessment and surveillance of such drugs and products; (2) determining whether a postmarket study is required; (3) contracting, or r