zli12321/Bills huggingface dataset:
Tom Lantos Pulmonary Hypertension Research and Education Act of 2008 - Title I: Research on Pulmonary Hypertension - (Sec. 101) Expresses the sense of the Congress that: (1) the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (NIH) and the Director of the National Heart, Lung, and Blood Institute, should continue aggressive work on pulmonary hypertension; and (2) the Director of the Institute should continue research to expand the understanding of the causes of, and to find a cure for, pulmonary hypertension.Requires inclusion of information on the status of pulmonary hypertension research at NIH in biennial reports to Congress. Title II: Increasing Awareness of Pulmonary Hypertension - (Sec. 201) Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to carry out an educational campaign to increase public awareness of pulmonary hypertension, which may include information on: (1) pulmonary hypertension and its symptoms; (2) the incidence and prevalence of pulmonary hypertension; (3) diseases and conditions that can lead to pulmonary hypertension as a secondary diagnosis; (4) the importance of early diagnosis; and (5) the availability of a range of treatment options.(Sec. 202) Requires the Secretary, acting through the Administrator of the Health Resources and Services Administration (HRSA) and the Director of CDC, to carry out an educational campaign to increase awareness of pulmonary hypertension among health care providers, which may include information on: (1) the symptoms of pulmonary hypertension; (2) the importance of early diagnosis; (3) current diagnostic criteria; and (4) Food and Drug Administration-approved therapies for the disease. Requires such campaign to target health care providers, including cardiologists, pulmonologists, rheumatologists, primary care physicians, pediatricians, and nurse practitioners.Sets forth reporting requirements.Authorizes appropriations for FY2009-FY2011.

Date: 2008-07-22
Topic: Health (R&D)
Subject: Health
Bone Marrow Failure Disease Research and Treatment Act of 2008 - Amends the Public Health Service Act to require the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention (CDC), to: (1) develop a system to collect data on acquired bone marrow failure diseases; (2) establish the National Acquired Bone Marrow Failure Disease Registry; and (3) establish the Advisory Committee on Acquired Bone Marrow Failure Diseases to provide recommendations to the Secretary on the Registry.Allows the Secretary, acting through the Director, to award grants to, and enter to contracts and cooperative agreements with, public or private nonprofit entities for the management of the Registry.Requires the Secretary, acting through the Administrator of the Agency for Toxic Substances and Disease Registry, to conduct pilot studies to determine which environmental factors may cause acquired bone marrow failure diseases.Requires the Secretary, acting through the Deputy Assistant Secretary for Minority Health, to: (1) establish outreach and information programs targeted to minority populations affected by such diseases; (2) undertake a coordinated outreach effort to connect Hispanic, Asian American, and Pacific Islander communities with comprehensive services focused on treatment of, and information about, such diseases; and (3) awards grants to, or enter into cooperative agreements with, entities to perform research on such diseases.Requires the Secretary, acting through the Director of the Agency for Healthcare Research and Quality (AHRQ), to award grants to entities to improve diagnostic practices and quality of care with respect to patients with such diseases.

Date: 2008-09-11
Topic: Health (R&D)
National Plan to Advance Pancreatic Cancer Act of 2008 - Amends the Public Health Service Act to require the Secretary of Health and Human Services to establish and implement a Pancreatic Cancer Initiative to assist in coordinating activities to address the high mortality rate associated with pancreatic cancer.Requires the Secretary to establish the Interdisciplinary Pancreatic Cancer Coordinating Committee to: (1) provide advice on overall research objectives and benchmarks for pancreatic cancer research; (2) develop and annually update a strategic plan for pancreatic cancer research awareness; and (3) conduct evaluations and make recommendations to the Secretary, the Director of the National Institutes of Health (NIH), and the Director of the National Cancer Institute regarding the prioritization and award of NIH research grants relating to pancreatic cancer.Requires the Secretary to develop a primary care provider education program on pancreatic cancer.Requires the Director of NIH and the Director of the Centers for Disease Control and Prevention (CDC) to develop a communication tool kit for patients and their families that focuses on specific pancreatic cancer issues relating to patient choices and patient care.Allows the Secretary to award grants to research institutions for use in developing innovative compounds or technologies for the prevention, early detection, or treatment of those cancers with five-year survival rates of less than 50%. Requires the Secretary to focus on pancreatic cancer during the initial five fiscal years of awarding such grants.Allows the Secretary to designate two additional Specialized Programs of Research Excellence focusing solely on pancreatic cancer research.

Date: 2008-09-24
Topic: Health (R&D)
Subject: Health
Prevention, Awareness, and Research of Autoimmune Diseases Act of 2008 - Amends the Public Health Service Act to require the Secretary of Health and Human Services, acting through the Director of the National Institute of Environmental Health Sciences, to award grants for the conduct or support of research on environmental triggers that can cause the initiation of autoimmune diseases in genetically predisposed individuals. Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to award grants to eligible entities to conduct public and professional awareness activities regarding autoimmune diseases. Allows grantees to use grant funds to: (1) promote increased awareness of early intervention and treatment to significantly improve the quality of life for people with autoimmune diseases; (2) target minority communities that may be underserved or disproportionately affected by such diseases; and (3) target women to help reduce the amount of time taken for correct diagnosis of such diseases. Requires the Secretary, acting through the Administrator of the Health Resources and Services Administration (HRSA), to: (1) award grants to eligible entities for the education of health care providers on potential links between autoimmune diseases and cognitive and mood disorders, such as depression; and (2) establish an educational loan repayment program for physicians agreeing to conduct research on autoimmune diseases.

Date: 2008-09-25
Topic: Health (R&D)
Rachel's Act of 2008 - Directs the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (NIH), to award a prize payment to the first person who develops a cure for clear cell sarcoma of the tendons and aponeuroses.

Date: 2008-09-26
Topic: Health (R&D)
Protection for Participants in Research Act of 2008 - Amends the Public Health Service Act to require all human subject research conducted, supported, or otherwise subject to federal regulation, to be conducted in accordance with the Common Rule and the vulnerable-population rules, as set forth in the Code of Federal Regulations. Requires the Secretary of Health and Human Services to review and harmonize such regulations. Requires informed consent before an individual may be a subject of human research. Requires an Institutional Review Board to approve all human subject research proposals. Directs the Secretary to establish criteria for identifying and monitoring high-risk human subject research projects. Prohibits grants or awards to a public entity or private academic institution that does not have a program to educate investigators and Board members on the protection of human research subjects. Prohibits the use of federal funds for classified human subject research if: (1) the Board has waived the informed consent requirement; or (2) the research is exempt from Board review. Establishes the Office of Human Research Protections within the Office of the Secretary. Requires the Director of the Office to: (1) provide for the protection of human research subjects; (2) establish criteria regarding assurance of compliance with Common Rule requirements; and (3) coordinate federal activities with respect to the protection of human research subjects. Authorizes the Director to make grants for a model education program. Requires the Secretary to: (1) promulgate regulations enhancing the protection of people with diminished decisionmaking capacity participating in human subject research; and (2) study whether the number of certain members of Institutional Review Boards should be increased.

Date: 2008-09-26
Topic: Health (R&D)
Subject: Health
Stem Cell Research Enhancement Act of 2008 - Amends the Public Health Service Act to require the Secretary of Health and Human Services to conduct and support research that utilizes human embryonic stem cells, regardless of the date on which the stem cells were derived from a human embryo. Limits such research to stem cells that meet the following requirements: (1) the stem cells were derived from human embryos donated from in vitro fertilization clinics, were created for the purposes of fertility treatment, and were in excess of the needs of the individuals seeking such treatment; (2) prior to donation, it was determined that the embryos would never be implanted in a woman and would otherwise be discarded; and (3) the individuals seeking fertility treatment donated the embryos with written informed consent and received no financial or other inducements.Requires the Director of the National Institutes of Health (NIH) to issue guidelines on research involving human embryonic stem cells. Authorizes the Director to issue guidelines on research involving other human stem cells, as scientifically warranted. Provides for updates of guidelines under this Act. Directs the Secretary to take into consideration guidelines on human stem cell research developed by nationally- and internationally- recognized scientific organizations.Requires NIH research to comply with guidelines under this Act.Requires the Director to: (1) determine the extent to which the guidelines under this Act apply to research on human embryonic stem cells derived before the effective date of such guidelines; and (2) include in its biennial report to Congress a summary of research activities on human stem cells.

Date: 2008-09-26
Topic: Health (R&D)
Subject: Health
Directs the Secretary of the Interior, acting through the U.S. Geological Survey, to: (1) establish a National Biological Data Center to collect nonhuman biological data and make such data available for public use; and (2) contract with a small business to manage the Center. Sets forth duties of the Center, including the collection of nonhuman biological data from federal, public, private, and nonprofit entities and the development of partnerships with public and private entities, academic and scientific institutions to allow the Center to develop a digital network for the storage and retrieval of nonhuman biological data.

Date: 2008-09-26
Topic: Health (R&D)
Subject: Public lands and natural resources
Stem Cell Research Enhancement Act of 2007 - (Sec. 2) Amends the Public Health Service Act to require the Secretary of Health and Human Services to conduct and support research that utilizes human embryonic stem cells, regardless of the date on which the stem cells were derived from a human embryo. Limits such research to stem cells that meet the following ethical requirements: (1) the stem cells were derived from human embryos donated from in vitro fertilization clinics for the purpose of fertility treatment and were in excess of the needs of the individuals seeking such treatment; (2) the embryos would never be implanted in a woman and would otherwise be discarded; and (3) such individuals donate the embryos with written informed consent and receive no financial or other inducements. Directs the Secretary to: (1) issue final guidelines to carry out this Act within 60 days; and (2) submit annual reports on activities and research conducted under this Act. (Sec. 3) Requires the Secretary to develop techniques for the isolation, derivation, production, or testing of stem cells that are capable of producing all or almost all of the cell types of the developing body and may result in improved understanding of treatments for diseases and other adverse health conditions, but that are not derived from a human embryo. Requires the Secretary to: (1) provide guidance concerning the next steps required for additional research; (2) prioritize research with the greatest potential for near-term clinical benefit; and (3) take into account techniques outlined by the President's Council on Bioethics and any other appropriate techniques and research. Sets forth reporting requirements. Authorizes appropriations.

Date: 2007-01-04
Topic: Health (R&D)
Subject: Health
Hope Offered through Principled and Ethical Stem Cell Research Act or the HOPE Act - (Sec. 3) Amends the Public Health Service Act to require the Secretary of Health and Human Services to develop techniques for the isolation, derivation, production, or testing of stem cells, including pluripotent stem cells that have the flexibility of embryonic stem cells (whether or not they have an embryonic source), that may result in improved understanding of or treatments for diseases and other adverse health conditions, provided that such techniques do not involve: (1) the creation of a human embryo or embryos for research purposes; or (2) the destruction or discarding of, or risk of injury to, a human embryo of embryos other than those that are naturally dead. Requires the Secretary to: (1) provide guidance concerning the next steps required for additional research; (2) prioritize research with the greatest potential for near-term clinical benefits; (3) take into account techniques outlined by the President's Council on Bioethics and any other appropriate techniques and research; and (4) require assurances from grant applicants, in the case of research involving stem cells from a naturally dead embryo, that no alteration of the timing, methods, or procedures used to create, maintain, or intervene in the development of a human embryo was made solely for the purpose of deriving the stem cells. Sets forth reporting requirements. Authorizes appropriations. (Sec. 4) Directs the Secretary to enter into a contract with the Institute of Medicine to conduct a study to: (1) recommend an optimal structure for an amniotic and placental stem cell bank program; and (2) address pertinent issues to maximize the potential of such technology.

Date: 2007-03-29
Topic: Health (R&D)
Subject: Health
Pluripotent Stem Cell Therapy Enhancement Act of 2007 - Amends the Public Health Service Act to require the Secretary of Health and Human Services to develop techniques for the isolation, derivation, production, or testing of pluripotent stem cells that have the flexibility of embryonic stem cells (whether or not they have an embryonic source) and that may result in improved understanding of, or treatments for, diseases and other adverse health conditions, provided that such techniques do not involve: (1) the creation of a viable human embryo for research purposes; or (2) the destruction or discarding of a human embryo or embryos; or (3) knowingly subjecting a human embryo or embryos to risk of injury or death greater than that allowed for federal research on fetuses in utero under current law. Requires the Secretary to: (1) provide guidance concerning the next steps required for additional research; (2) prioritize research with the greatest potential for near-term clinical benefit; and (3) take into account techniques outlined by the President's Council on Bioethics and any other appropriate techniques and research.

Date: 2007-01-04
Topic: Health (R&D)
Subject: Health
National Center for Social Work Research Act - Amends the Public Health Service Act to establish the National Center for Social Work Research as an agency of the National Institutes of Health (NIH) to conduct, support, and disseminate targeted research on social work methods and outcomes related to problems of significant social concern. Authorizes the Director of the Center to: (1) provide research training and instruction; (2) establish research traineeships and fellowships; (3) provide stipends and allowances; and (4) make grants to nonprofit institutions to provide such training, instruction, traineeships, and fellowships. Directs the Secretary of Health and Human Services to establish an advisory council for the Center.

Date: 2007-01-04
Topic: Health (R&D)
Subject: Social welfare
Establishes in the Uniformed Services University of the Health Sciences the United States Military Cancer Institute, headed by a Director, to carry out research studies on: (1) the epidemiological features of cancer among populations of various ethnic origins, as well as complementary research on oncologic nursing; (2) the prevention and early detection of cancer; and (3) basic, translational, and clinical investigation matters relating to such studies. Directs the Institute to conduct the study in collaboration with other cancer research organizations and entities selected by the Institute.

Date: 2007-01-04
Topic: Health (R&D)
Subject: Armed forces and national security
Stem Cell Research Expansion Act - Authorizes the Department of Health and Human Services to provide funding for research on embryonic stem cell lines that were created prior to January 23, 2006, that does not result in the use of federal funding to destroy an embryo.

Date: 2007-01-23
Topic: Health (R&D)
Subject: Health
Hope Offered through Principled, Ethically-Sound Stem Cell Research Act or the HOPE Act - Requires the Secretary of Health and Human Services to conduct and support research to develop techniques for the isolation, derivation, production, or testing of pluripotent stem cells that have the flexibility of embryonic stem cells and that may result in improved understanding of, or treatments for, diseases and other adverse health conditions, provided that such techniques do not involve: (1) the creation of a viable human embryo for research purposes; (2) the destruction or discarding of a human embryo; or (3) knowingly subjecting a human embryo to risk of injury or death greater than that allowed on fetuses in utero. Establishes the National Stem Cell Research Review Board to: (1) monitor research to ensure that it is in compliance with this Act; (2) prioritize research with the greatest potential for near term benefits; and (3) ensure fair consideration of both embryonic and adult stem cell research for funding. Sets forth consent requirements for the donation of materials for research. Applies federal provisions protecting individually identifiable health information to donors. Amends the National Organ Transplant Act to prohibit the transfer of any human ovum, human blastocyst, human embryo, or stem cell derived from a human embryo for valuable consideration. Amends the Public Health Service Act to prohibit any person from knowingly receiving any valuable consideration for any therapy that: (1) affects interstate commerce or is funded by federal assistance; and (2) utilizes cells from a human embryo if the process of deriving such cells destroyed the embryo.

Date: 2007-01-23
Topic: Health (R&D)
Subject: Health
Fair Access to Clinical Trials Act of 2007 or the FACT Act - Amends the Public Health Service Act to require the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (NIH), to establish and operate a data bank of information on clinical trials, to include: (1) a clinical trials registry of health-related interventions conducted to test the safety or effectiveness of any drug, biological product, or device intended to treat serious or life-threatening diseases and conditions; and (2) a clinical trial results database of health-related interventions to test the safety or effectiveness of any drug, biological product, or device. Requires the Commissioner of Food and Drugs to make available to the public: (1) the full reviews conducted by the Food and Drug Administration (FDA) of new or supplemental new drug applications, including documentation of significant differences of opinion and the resolution of those differences; and (2) copies of written consultations on a drug's safety conducted by the Office of Surveillance and Epidemiology. Requires the Secretary to assess civil monetary penalties for knowingly submitting inaccurate information to the FDA. Allows the Secretary to correct any information included in the registry or database that is factually and substantively inaccurate, false, or misleading. Extends requirements of this Act to clinical trials conducted outside of the United States under certain circumstances. Prohibits a responsible person or a manufacturer from performing any act that prohibits, limits, or imposes unreasonable delays on the ability of an individual to discuss or publish the results of a clinical trial. Requires the Secretary to enter into a contract with the Institute of Medicine to study the extent to which data submitted to the registry has impacted the public health.

Date: 2007-01-31
Topic: Health (R&D)
Subject: Health
Breast Cancer and Environmental Research Act of 2007 - Amends the Public Health Service Act to require the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (NIH), to make grants to public or nonprofit private entities to conduct collaborative multidisciplinary and multi-institutional research on environmental factors that may be related to the etiology of breast cancer. Requires grantees to: (1) include community organizations representing a broad geographical area; (2) be a consortium of cooperating institutions and community groups; and (3) be supported under this Act for a period of not more than five years, with additional periods allowed after review and recommendation. Requires the Secretary to establish a Breast Cancer and Environmental Research Panel to: (1) develop a comprehensive research strategy for collaborative research; (2) make recommendations with respect to the mechanisms, peer review criteria, and allocations under this Act; (3) assist in the overall program evaluations; and (4) make recommendations for the dissemination of information on program process. Requires the Director of NIH to provide for coordination of information among, and an equitable geographical distribution of, grantees. Provides that nothing in this Act shall be construed to interfere with the technical and scientific peer review process at NIH. Authorizes appropriations for FY2008-FY2012.

Date: 2007-02-14
Topic: Health (R&D)
Subject: Health
Arthritis Prevention, Control, and Cure Act of 2007 - Amends the Public Health Service Act to require the Secretary of Health and Human Services: (1) to develop and implement a National Arthritis Action Plan; and (2) acting through the Director of the Centers for Disease Control and Prevention (CDC), to conduct, support, and promote the coordination of arthritis and other rheumatic diseases research. Requires the Secretary to award grants to: (1) support arthritis-specific research projects at the Centers for Prevention Research by the CDC; (2) support state comprehensive arthritis control and prevention programs and public health surveillance, prevention, and control activities; and (3) assist in the implementation of a national strategy for arthritis control and prevention. Requires the Secretary to coordinate a national education and outreach program on arthritis and other rheumatic diseases. Requires the Secretary to establish an Arthritis and Rheumatic Diseases Interagency Coordinating Committee to: (1) improve coordination of federal research activities related to arthritis and rheumatic diseases; and (2) convene a summit to provide a detailed overview of such current federal research. Requires the Director of the National Institutes of Health (NIH) to expand and intensify juvenile arthritis research. Allows the Secretary, acting through the Director of the CDC, to award grants to support juvenile arthritis data collection. Requires the Secretary, acting through the Director of the CDC, to support the development of a National Juvenile Arthritis Patient Registry. Requires the Secretary to promote and support pediatric rheumatology training, including by allowing the Secretary to establish a loan repayment program. Requires the Comptroller General to conduct a study on the economic impact of arthritis in the workplace.

Date: 2007-02-15
Topic: Health (R&D)
Subject: Health
Catastrophic Disaster Recovery Improvements Act of 2007 - Amends the Small Business Act to authorize the Administrator of the Small Business Administration (SBA), in providing SBA disaster relief assistance, to waive the prohibition on the duplication of benefits, including whether damage or destruction has been compensated for, credit is available from, or funds have been made available from any other source. Applies such amendment to any SBA assistance provided on or after August 29, 2005 (thereby ensuring applicability and retroactivity for victims of Hurricanes Katrina, Rita, and Wilma).

Date: 2007-02-27
Topic: Health (R&D)
Subject: Commerce
Human Cloning Ban and Stem Cell Research Protection Act of 2007 - Prohibits: (1) conducting or attempting to conduct human cloning; (2) shipping the product of nuclear transplantation in interstate or foreign commerce for the purpose of human cloning in the United States or elsewhere; or (3) exporting to a foreign country an unfertilized blastocyst if such country does not prohibit human cloning. Sets forth criminal and civil penalties for violations. Requires the Comptroller General to report to the relevant congressional committees on: (1) actions taken to enforce such prohibitions; (2) actions of state attorneys general to enforce similar state laws; (3) coordination of federal, state, and local enforcement; and (4) international laws relating to human cloning. Amends the Public Health Service Act to require research involving nuclear transplantation to be conducted in accordance with applicable federal regulations regarding the protection of human subjects and Institutional Review Boards. Prohibits: (1) a somatic cell nucleus from being transplanted into a human oocyte (egg) that has undergone or will undergo fertilization; (2) an unfertilized blastocyst from being maintained after more than 14 days from its first cell division, not counting storage times at temperatures less than zero degrees centigrade; (3) an oocyte from being used in nuclear transplantation research unless donated voluntarily with the donor's informed consent; (4) a human oocyte or unfertilized blastocyst from being acquired, received, or transferred for valuable consideration in interstate commerce; and (5) nuclear transplantation in a laboratory in which human oocytes are subject to assisted reproductive technology treatments or procedures. Sets forth civil penalties for violations.

Date: 2007-03-08
Topic: Health (R&D)
Subject: Health
Safety of Seniors Act of 2007 - Amends the Public Health Service Act to authorize the Secretary of Health and Human Services to: (1) oversee and support a national education campaign focusing on reducing falls among older adults and preventing repeat falls; and (2) award grants, contracts, or cooperative agreements to design and carry out local education campaigns. Allows the Secretary to conduct and support research to: (1) improve the identification of older adults who have a high risk of falling; (2) improve data collection and analysis to identify fall risk and protective factors; (3) design, implement, and evaluate the most effective fall prevention interventions; (4) tailor effective strategies to reduce falls to specific populations of older adults; (5) maximize the dissemination of proven, effective fall prevention interventions; (6) improve the diagnosis, treatment, and rehabilitation of elderly fall victims and older adults at high risk for falls; and (7) assess the risks of falls occurring in various settings. Authorizes the Secretary to: (1) conduct research concerning the barriers to the adoption of proven fall prevention interventions; (2) conduct research to develop, implement, and evaluate the most effective approaches to reduce falls among high-risk older adults living in communities and long-term care and assisted living facilities; (3) evaluate the effectiveness of community programs; (4) provide professional education for physicians and allied health professionals in fall prevention; (5) oversee and support specified demonstration and research projects; (6) award grants to design, implement, and evaluate fall prevention programs using proven intervention strategies and carry out a multistate demonstration project; (7) give priority in awarding grants under this Act to entities that explore the use of cost-sharing to ensure the institutional commitment of the recipients of such assistance to the funded projects; and (8) report to Congress on the effects of falls on health care costs, the potential for reducing falls, and the most effective strategies for reducing associated health care costs.

Date: 2007-03-12
Topic: Health (R&D)
Subject: Social welfare
Amniotic Fluid and Placental Stem Cell Banking Act of 2007 - Directs the Secretary of Health and Human Services to enter into one-time contracts with qualified amniotic fluid and placental stem cell banks to assist in the collection and maintenance of 100,000 new units of high-quality amniotic fluid and placental stem cells to be made available for treatment though the C.W. Bill Young Cell Transplantation and Treatment Program. Sets forth provisions relating to requirements for contract recipients, the duration of such contracts, and extensions of funding under such contracts. Amends the Public Health Service Act to revise the Program to provide for amniotic fluid and placental stem cell functions, recruitment, and educational activities.Authorizes appropriations for the Program through FY2012.

Date: 2007-03-22
Topic: Health (R&D)
Subject: Health
Genomics and Personalized Medicine Act of 2007 - Directs the Secretary of Health and Human Services to: (1) establish the Genomics and Personalized Medicine Interagency Working Group (IWG) to facilitate collaboration, coordination, and integration of activities among federal agencies relating to genomic research and initiatives; (2) establish a national biobanking distributed database for the collection and integration of genomic data and associated environmental and clinical health information; (3) establish a grant program for academic medical centers and other entities to develop or expand biobanking initiatives; (4) improve genetics and genomics training for diagnosis, treatment, and counseling of adults and children for both rare and common disorders; (5) contract with the National Academy of Sciences to study incentives to encourage companion diagnostic test development; and (6) make information available on the safety and efficacy of genetic tests and commission a study for improving federal oversight and regulation of such tests. Requires the Director of the Centers for Disease Control and Prevention to: (1) conduct an analysis of the public health impact of direct-to-consumer marketing of genetic tests; and (2) expand efforts to educate the public about genomics and its health applications.

Date: 2007-03-23
Topic: Health (R&D)
Subject: Health
Pediatric Research Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to direct an applicant seeking to waive submission requirements related to pediatric assessments of the safety and effectiveness of a drug or biological product to submit to the Secretary of Health and Human Services documentation detailing why a pediatric formulation cannot be developed. Requires an applicant seeking to defer submission of some or all of such assessments to submit to the Secretary a timeline for the completion of pediatric studies.Requires the Secretary to create an internal committee to review pediatric assessment requests issued, pediatric assessments conducted, and deferral and waiver requests. Considers a supplement to a new drug or biological license application proposing a labeling change as a result of any pediatric assessments to be a priority supplement. Sets forth dispute resolution procedures for labeling changes for pediatric drugs.Requires the Commissioner of the Food and Drug Administration (FDA) to make available to the public the medical, statistical, and clinical pharmacology reviews of pediatric assessments.Requires the Secretary to: (1) require sponsors of the assessments that result in labeling changes to distribute such information to physicians and other health care providers; (2) ensure that all adverse event reports that have been received for such a drug are referred to the Office of Pediatric Therapeutics for one year after a labeling change; and (3) contract with the Institute of Medicine to study and report to Congress regarding the pediatric studies conducted pursuant to FFDCA since 1997.Requires the Comptroller General to report to Congress on the effectiveness of FFDCA provisions relating to pediatric studies in ensuring that medicines used by children are tested and properly labeled.

Date: 2007-03-27
Topic: Health (R&D)
Subject: Health
Stem Cell Research Enhancement Act of 2007 - Amends the Public Health Service Act to require the Secretary of Health and Human Services to conduct and support research that utilizes human embryonic stem cells, regardless of the date on which the stem cells were derived from a human embryo. Limits such research to stem cells that meet the following ethical requirements: (1) the stem cells were derived from human embryos donated from in vitro fertilization clinics for the purpose of fertility treatment and were in excess of the needs of the individuals seeking such treatment; (2) the embryos would never be implanted in a woman and would otherwise be discarded; and (3) such individuals donate the embryos with written informed consent and receive no financial or other inducements. Requires the Secretary to develop techniques for the isolation, derivation, production, or testing of stem cells that are capable of producing all or almost all of the cell types of the developing body and may result in improved understanding of treatments for diseases and other adverse health conditions, but that are not derived from a human embryo. Requires the Secretary to: (1) provide guidance concerning the next steps required for additional research; (2) prioritize research with the greatest potential for near-term clinical benefit; and (3) take into account techniques outlined by the President's Council on Bioethics and any other appropriate techniques and research.

Date: 2007-03-27
Topic: Health (R&D)
Subject: Health
Human Cloning Prohibition Act of 2007 - Amends the Public Health Service Act to prohibit any person or entity, in or affecting interstate commerce, from knowingly: (1) performing or attempting to perform human cloning; (2) participating in such an attempt; or (3) shipping or receiving an embryo produced by human cloning or any product derived from such an embryo. Prohibits knowingly importing such an embryo. Sets forth criminal and civil penalties. Provides that nothing in this Act restricts areas of scientific research not specifically prohibited, including research in the use of nuclear transfer or other cloning techniques to produce molecules, DNA, cells other than human embryos, tissues, organs, plants, or animals other than humans. Directs the Government Accountability Office (GAO) to assess the need to amend such prohibition, including through: (1) a discussion of new developments, the need for somatic cell transfer to produce medical advances, current public attitudes and prevailing ethical views concerning its use, and potential legal implications of somatic cell transfer research; and (2) a review of any technological developments that may require technical changes to such prohibition.

Date: 2007-03-29
Topic: Health (R&D)
Subject: Health
Lupus Research, Education, Awareness, Communication, and Healthcare Amendments of 2007 - Amends the Public Health Service Act to require the Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases to expand research on lupus to include: (1) basic research to discover the pathogenesis and pathophysiology of the disease; and (2) research to validate lupus biomarkers. Requires the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention (CDC), to work with a consortium of academic health institutions to undertake an epidemiological study to determine the prevalence and incidence of lupus in the United States. Requires the Director of CDC to: (1) enter into a cooperative agreement with such consortium to develop, implement, and manage a system for lupus data collection and analysis; and (2) ensure that such consortium represents different geographic areas and includes individuals of racial and ethnic backgrounds disproportionately affected by lupus. Requires the Secretary to enter into a contract with the Institute of Medicine to study and make recommendations related to lupus, to include: (1) evaluating federal and state activities related to lupus and recommending ways to expand such activities; (2) identifying gaps in federal research; and (3) recommending ways to improve the quality of life for people with lupus. Requires the Secretary, acting through the Director of the Office on Women's Health, to conduct and support a national lupus public awareness and health professional education campaign, with an emphasis on reaching populations at highest risk for the disease.

Date: 2007-05-10
Topic: Health (R&D)
Subject: Health
ALS Registry Act - (Sec. 2) Amends the Public Health Service Act to authorize the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention (CDC), if scientifically advisable, to: (1) develop a system to collect data on amyotrophic lateral sclerosis (ALS) and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, or progress to ALS; and (2) establish a national registry for the collection and storage of such data to develop a population-based registry of cases. Authorizes the Secretary, acting through the Director, to establish the Advisory Committee on the National ALS Registry, which may review information and make recommendations to the Secretary concerning: (1) the development and maintenance of the registry; (2) the type of information to be included; (3) the manner in which data is to be collected; (4) the use and availability of such data; and (5) the collection of information about diseases and disorders that primarily affect motor neurons that are considered essential to furthering the study and cure of ALS. Allows the Secretary, acting through the Director, to award grants to, and enter into contracts and cooperative agreements with, public or private nonprofit entities for the collection, analysis, and reporting of data on ALS and other motor neuron disorders. Authorizes the Secretary, acting through the Director, to: (1) identify, build upon, expand, and coordinate among existing data and surveillance systems, surveys, registries, and other federal public health and environmental infrastructure wherever possible; and (2) provide for research access to ALS data as recommended by the Advisory Committee in a manner that protects personal privacy. Allows the Secretary to ensure that epidemiological and other types of information is made available to the National Institutes of Health (NIH) and the Department of Veterans Affairs (VA). (Sec. 3) Authorizes the Secretary to report to the appropriate congressional committees on ALS registries, including: (1) the registries currently under way and future planned registries; (2) the criteria involved in determining what registries to conduct, defer, or suspend; (3) the scope of those registries; and (4) the activities the Secretary undertakes to establish partnerships with research and patient advocacy communities to expand registries.

Date: 2007-05-14
Topic: Health (R&D)
Subject: Health
Inflammatory Bowel Disease Research Enhancement Act - Requires the Director of the National Institute of Diabetes and Digestive and Kidney Diseases to expand, intensify, and coordinate the Institute's research activities on inflammatory bowel disease, with a focus on: (1) genetic research on susceptibility for inflammatory bowel disease; (2) research targeted to increase knowledge about the causes and complications of inflammatory bowel disease in children; (3) animal model research; (4) clinical research; (5) expansion of the Institute's Inflammatory Bowel Disease Centers program with a focus on pediatric research; (6) training of qualified health professionals in biomedical research focused on inflammatory bowel disease; and (7) other research priorities identified in specified scientific agendas.Requires the Director of the Centers for Disease Control and Prevention (CDC) to expand the Inflammatory Bowel Disease Epidemiology Program to include additional studies focused on: (1) the incidence and prevalence of pediatric inflammatory bowel disease in the United States; (2) genetic and environmental factors associated with the disease; (3) age, race or ethnicity, gender, and family history of individuals diagnosed with the disease; and (4) treatment approaches and outcomes.

Date: 2007-05-15
Topic: Health (R&D)
Subject: Health
Uterine Fibroid Research and Education Act of 2007 - Requires the Director of the National Institutes of Health (NIH) to expand, intensify, and coordinate programs for the conduct and support of uterine fibroids research. Directs the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention (CDC), to develop and disseminate to the public information regarding uterine fibroids, including information on: (1) the incidence and prevalence of uterine fibroids among women; (2) the elevated risk for minority women; and (3) the availability of a range of treatment options. Requires the Secretary, acting through the Administrator of the Health Resources and Services Administration (HRSA), to develop and disseminate uterine fibroids information to health care providers.

Date: 2007-05-16
Topic: Health (R&D)
Subject: Health
Directs the Medical Follow-Up Agency of the Institute of Medicine of the National Academy of Sciences (Agency) to maintain and manage the assets (including electronic data files and biological specimens of study participants) transferred to the Agency from the Air Force Health Study. Authorizes the Agency, during FY2007-FY2011, to conduct additional research on such assets toward the goal of understanding the determinants of health, and promoting wellness, in veterans. Requires an Agency report to Congress assessing the feasibility and advisability of conducting additional research on such assets after the end of FY2011.

Date: 2007-05-17
Topic: Health (R&D)
Subject: Armed forces and national security
Psoriasis and Psoriatic Arthritis Research, Cure, and Care Act of 2007 - Requires the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (NIH), to expand and intensify research and related NIH activities with respect to psoriasis and psoriatic arthritis. Requires the Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases to conduct or support research to expand understanding of the causes of, and to find a cure for, psoriasis and psoriatic arthritis. Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to establish a national psoriasis and psoriatic arthritis patient registry. Directs the Secretary to: (1) enter into cooperative agreements to develop, implement, and manage a system for psoriasis and psoriatic arthritis patient data collection and analysis; (2) ensure the collection and analysis of longitudinal data related to individuals of all ages; (3) convene a summit on current federal activities to conduct or support research, treatment, education, and quality-of-life activities with respect to psoriasis and psoriatic arthritis; and (4) enter into an agreement with the Institute of Medicine to study insurance coverage of psoriasis and psoriatic arthritis.

Date: 2007-05-23
Topic: Health (R&D)
Subject: Health
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 blood test using in-vitro detection; and (5) to certify compliance with this Act within one year.

Date: 2007-06-28
Topic: Health (R&D)
Subject: Health
SMA Treatment Acceleration Act - Requires the Director of the National Institutes of Health (NIH) to upgrade and unify existing spinal muscular atrophy (SMA) clinical trial sites to establish a national clinical trials network for SMA. Requires the Director of NIH to ensure that such network: (1) conducts coordinated, multisite, clinical trials of pharmacological approaches to the treatment of SMA; and (2) rapidly and effectively disseminates scientific findings to the field.Requires the Director of NIH to: (1) establish an SMA data coordinating center; and (2) expand and intensify NIH programs with respect to preclinical translation research and medicinal chemistry related to SMA.Requires the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention (CDC), to enhance and provide ongoing support to the existing SMA patient registry to provide for expanded research on the epidemiology of SMA. Directs the Secretary to ensure the collection and analysis of longitudinal data related to individuals of all ages with SMA.Requires the Secretary to establish the Spinal Muscular Atrophy Coordinating Committee to: (1) coordinate activities across NIH and with other federal health programs and activities relating to SMA; and (2) conduct a study to identify barriers to the development of drugs for treating SMA and similar genetic disorders.Requires the Director of NIH to establish a trans-National Institutes of Health cooperative research initiative on SMA to ensure the success of the SMA projects led by the National Institute of Neurological Disorders and Stroke. Requires the Secretary to submit recommendations to Congress to improve and expand on incentives provided under the Orphan Drug Act and related statutes to promote SMA drug development.

Date: 2007-09-12
Topic: Health (R&D)
Subject: Health