Summary: Heart Disease Education, Analysis Research, and Treatment for Women Act or the HEART for Women Act - Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary of Health and Human Services to deny a new drug application if the application fails to include required information on clinical investigations.Directs the Secretary to: (1) require that a new drug application include any clinical data possessed by the applicant that relates to the safety and effectiveness of the drug involved by gender, age, and racial subgroup; and (2) develop guidance for the staff of the Food and Drug Administration (FDA) to ensure that new drug applications are adequately reviewed to determine whether they include the required clinical data.Authorizes the Secretary to place a clinical hold on an investigation under an investigational new drug application if the sponsor of the investigation fails to meet the requirements of an annual report on the status of each study in progress. Applies provisions relating to clinical data submission for new drug applications to applications for an investigational new drug, a biologics license for a biological product, premarket approval for a class III device, and investigational use of a device.Amends the Public Health Service Act to require the Secretary to provide that all nonidentifiable patient safety work product reported to and among the network of patient safety databases be identified by sex.Directs that analyses of statistics of information reported to the network of patient safety databases take into account data that specifically relates to women and any disparities between treatment and the quality of care between males and females.Requires the Director of the Agency for Healthcare Research and Quality to support research and demonstrations to identify and evaluate clinical and organizational strategies to improve the quality of and access to care for women with heart disease, stroke, and other cardiovascular diseases.Requires the Secretary to: (1) distribute to females age 65 or older and appropriate health care professionals educational materials relating to the prevention diagnosis and treatment of heart disease, stroke, and cardiovascular diseases in women; and (2) conduct an education and awareness campaign for health care professionals relating to such diagnosis and treatment. Expands the grant program authorizing the Secretary to award grants for preventive health services to all states.

heart disease education analysis research treatment women act heart women act_-_amends federal food drug cosmetic act allow secretary health_and_human_services deny new drug application application fails include required information clinical investigations directs secretary require new drug application include clinical data possessed applicant relates safety effectiveness drug involved gender age racial subgroup develop guidance staff food_and_drug_administration fda ensure new drug applications adequately reviewed determine include required clinical data authorizes secretary place clinical hold investigation investigational new drug application sponsor investigation fails meet requirements annual report status study progress applies provisions relating clinical data submission new drug applications applications investigational new drug biologics license biological product premarket approval class iii device investigational use device amends public_health_service_act require secretary provide patient safety work product reported network patient safety databases identified sex directs analyses statistics information reported network patient safety databases account data specifically relates women disparities treatment quality care males females requires director agency healthcare_research_and_quality support research demonstrations identify evaluate clinical organizational strategies improve quality access care women heart disease stroke cardiovascular diseases requires secretary distribute females age older appropriate health_care professionals educational materials relating prevention diagnosis treatment heart disease stroke cardiovascular diseases women conduct education awareness campaign health_care professionals relating diagnosis treatment expands grant program authorizing secretary award grants preventive health services states


Summary: Stem Cell Research Enhancement Act of 2009 - 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 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.

stem cell research enhancement_act amends public_health_service_act require secretary health_and_human_services conduct support research utilizes human stem cells regardless date stem cells derived human embryo limits research stem cells meet following requirements stem cells derived human donated vitro fertilization clinics created purposes fertility treatment excess needs individuals seeking treatment prior donation determined implanted woman individuals seeking fertility treatment donated written informed consent received financial inducements requires secretary develop techniques isolation production testing stem cells capable producing cell types developing body result improved understanding treatments diseases adverse health conditions derived human embryo requires secretary provide guidance concerning steps required additional research prioritize research greatest potential near term clinical benefit account techniques outlined president council appropriate techniques research


Summary: Psoriasis and Psoriatic Arthritis Research, Cure, and Care Act of 2009 - Requires the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (NIH), to continue to expand and intensify research and related NIH activities with respect to psoriasis and psoriatic arthritis. Requires the Directors of the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute of Allergy and Infectious Diseases to continue to conduct and 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 undertake psoriasis and psoriatic arthritis data collection and develop a psoriasis and psoriatic arthritis patient registry. Encourages the Secretary to convene a summit on federal efforts regarding psoriasis and psoriatic arthritis research, treatment, education, quality-of-life, and data collection. Directs the Secretary to enter into an agreement with the Institutes of Medicine to study insurance coverage of psoriasis and psoriatic arthritis.

research cure care act requires secretary health_and_human_services acting director national_institutes_of_health nih continue expand intensify research related nih activities respect requires directors national institute musculoskeletal skin diseases national_institute_of_allergy_and_infectious_diseases continue conduct support research expand understanding causes find cure requires secretary acting director centers_for_disease_control_and_prevention cdc undertake data collection develop patient registry encourages secretary convene summit federal efforts research treatment education quality life data collection directs secretary enter agreement institutes medicine study insurance coverage


Summary: 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 National Institutes of Health (NIH) to develop the Blueprint for Neuroscience Research to: (1) identify pervasive challenges in neuroscience and any technological barriers to solving such challenges; and (2) support the development of new tools, training opportunities, and other resources to assist neuroscientists in basic and clinical research. Directs the Commissioner of Food and Drugs to require the Directors of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health to improve the timelines of the review process for neurology and psychiatry.Requires the Director of the National Neurotechnology Coordination Office to establish the American Neurotechnology Study Center.

national initiative act defines mean science_and_technology allows individual analyze understand treat heal brain nervous system requires secretary health_and_human_services implement national initiative secretary shall establish goals priorities metrics evaluation federal research development commercialization increase investment federal research development translational programs achieve goals increase interagency coordination requires secretary establish national coordination office national advisory_council requires director national_institutes_of_health nih develop neuroscience research identify pervasive challenges neuroscience technological barriers solving challenges support development new tools training opportunities resources assist basic clinical research directs commissioner food_and_drugs require directors center_for_drug_evaluation_and_research center_for_biologics_evaluation_and_research center_for_devices_and_radiological_health improve timelines review process psychiatry requires director national coordination office establish american study center


Summary: 21st Century Cancer ALERT (Access to Life-Saving Early detection, Research and Treatment) Act - Amends the Public Health Service Act to revise provisions related to the National Cancer Program, including to require the establishment of an entity within the National Cancer Institute (NCI) to augment ongoing efforts to advance new technologies in cancer research, support the national collection of tissues for cancer research purposes, and ensure the quality of tissue collection. Sets forth provisions governing clinical trials, including ethical and privacy standards. Requires the Secretary of Health and Human Services to award grants for research on cancers with a low five-year survival rate and rare cancers. Expands coverage of colorectal screenings, including through providing grants and allowing states to provide coverage for such screenings under Medicaid. Provides for biomarkers research. Amends the Employee Retirement Income Security Act of 1974 (ERISA) to prohibit a group health plan from discriminating against participants and beneficiaries participating in cancer clinical trials. Sets forth provisions regarding retirement pay for nurses retiring from the Armed Forces. Requires the Secretary to study the current and future cancer care workforce needs. Prohibits the Secretary from awarding patient navigator grants unless entities provide assurances that patient navigators meet minimum core proficiencies. Provides for coverage under Medicare for payment of routine costs of care furnished to individuals participating in cancer clinical trials. Requires the Secretary to conduct a demonstration project under which payment for comprehensive cancer care planning services will be made under Medicare. Provides for coverage of tobacco cessation products. Provides for research on cancer survivorship related to childhood cancer and health disparities in outcomes. Requires the Secretary to convene a Workforce Development Collaborative on Psychosocial Care During Chronic Medical Illness.

21st century cancer alert access life saving early detection research treatment act_-_amends public_health_service_act revise provisions related national cancer program including require establishment entity national_cancer_institute augment ongoing efforts advance new technologies cancer research support national collection tissues cancer research purposes ensure quality tissue collection sets forth provisions governing clinical trials including ethical privacy standards requires secretary health_and_human_services award grants research cancers low year survival rate rare cancers expands coverage colorectal screenings including providing grants allowing states provide coverage screenings medicaid provides biomarkers research amends employee retirement income security act erisa prohibit group health plan discriminating participants beneficiaries participating cancer clinical trials sets forth provisions retirement pay nurses retiring armed_forces requires secretary study current future cancer care workforce needs prohibits secretary awarding patient navigator grants entities provide assurances patient navigators meet minimum core provides coverage medicare payment routine costs care furnished individuals participating cancer clinical trials requires secretary conduct demonstration project payment comprehensive cancer care planning services medicare provides coverage tobacco cessation products provides research cancer survivorship related childhood cancer health disparities outcomes requires secretary convene workforce development collaborative psychosocial care chronic medical illness


Summary: Cures Acceleration Network and National Institutes of Health Reauthorization Act of 2009 - Establishes the Cures Acceleration Network, an independent agency, to awards grants and contracts to eligible entities to accelerate the development of cures and treatments of diseases, including through the development of medical products and behavioral therapies. Defines "medical product" as a drug, device, biological product, or product that is a combination of drugs, devices, and biological products. Sets forth the functions of the Network. Establishes the Cures Acceleration Network Review Board. Directs the Chairperson of the Board to award matching grants and contracts to eligible entities to: (1) accelerate the development of cures and treatments, including through the development of medical products, behavioral therapies, and biomarkers that demonstrate the safety or effectiveness of medical products; or (2) establish protocols that comply with the standards of the Food and Drug Administration (FDA) and otherwise meet regulatory requirements at all stages of development, manufacturing, review, approval, and safety surveillance of a medical product. Sets forth provisions governing conflict of interest policies for the Network. Amends the Public Health Service Act to rename the National Center on Minority Health and Health Disparities as the National Institute on Minority Health and Health Disparities. Requires the Director of the National Institutes of Health (NIH) to develop and enforce NIH's conflict of interest policies and respond in a timely manner when such policies have been violated by a recipient of funds provided under a grant or contract. Reauthorizes appropriations for NIH for FY2010-FY2012.

cures acceleration network national_institutes_of_health reauthorization act establishes cures acceleration network independent agency awards grants contracts eligible entities accelerate development cures treatments diseases including development medical products behavioral therapies defines medical product drug device biological product product combination drugs devices biological products sets forth functions network establishes cures acceleration network review board directs chairperson board award matching grants contracts eligible entities accelerate development cures treatments including development medical products behavioral therapies biomarkers demonstrate safety effectiveness medical products establish protocols comply standards food_and_drug_administration fda meet regulatory requirements stages development manufacturing review approval safety surveillance medical product sets forth provisions governing conflict interest policies network amends public_health_service_act rename national_center_on_minority_health_and_health_disparities national institute minority health health disparities requires director national_institutes_of_health nih develop enforce nih conflict interest policies respond timely manner policies violated recipient funds provided grant contract reauthorizes appropriations nih fy2010 fy2012


Summary: Inflammatory Bowel Disease Research and Awareness Act - Amends the Public Health Service Act to: (1) require the Centers for Disease Control and Prevention (CDC) to conduct, support, and expand existing epidemiology research on inflammatory bowel disease (i.e., Crohn's disease and ulcerative colitis) in both pediatric and adult populations; (2) authorize the CDC to award grants and enter into cooperative agreements to develop and administer such epidemiology research; and (3) direct the CDC to award grants to increase awareness of inflammatory bowel disease among the general public and health care providers. Expresses the sense of Congress that the Directors of the National Institutes of Health (NIH) and the National Institute of Diabetes and Digestive and Kidney Diseases should support specified research and training goals for inflammatory bowel diseases.

disease research awareness act_-_amends public_health_service_act require centers_for_disease_control_and_prevention cdc conduct support expand existing epidemiology research disease disease pediatric adult populations authorize cdc award grants enter cooperative agreements develop administer epidemiology research direct cdc award grants increase awareness disease general public health_care providers expresses sense congress directors national_institutes_of_health nih national institute diabetes kidney diseases support specified research training goals diseases


Summary: Arthritis Prevention, Control, and Cure Act of 2009 - Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS): (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.

prevention control cure act amends public_health_service_act require secretary health_and_human_services hhs develop implement national action plan acting director centers_for_disease_control_and_prevention cdc conduct support promote coordination diseases research requires secretary award grants support specific research projects centers prevention research cdc support state comprehensive control prevention programs public health surveillance prevention control activities assist implementation national strategy control prevention requires secretary coordinate national education outreach program diseases requires secretary establish diseases interagency_coordinating_committee improve coordination federal research activities related diseases convene summit provide detailed overview current federal research requires director national_institutes_of_health nih expand intensify juvenile research allows secretary acting director cdc award grants support juvenile data collection requires secretary acting director cdc support development national juvenile patient registry requires secretary promote support pediatric training including allowing secretary establish loan repayment program requires comptroller_general conduct study economic impact workplace


Summary: SMA Treatment Acceleration Act of 2009 - Amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH) to establish a national clinical trials network for spinal muscular atrophy by upgrading and unifying spinal muscular atrophy clinical trial sites and recruiting new investigators and sites. Requires the Director to ensure that such network: (1) conducts coordinated, multisite, clinical trials of therapies and clinical approaches to the treatment of spinal muscular atrophy; and (2) rapidly and efficiently disseminates scientific findings to the field. Requires the Director to: (1) establish a data coordinating center with respect to spinal muscular atrophy; and (2) expand and intensify NIH programs with respect to preclinical translation research related to spinal muscular atrophy. Requires the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention (CDC), to enhance and support a spinal muscular atrophy patient registry to provide for expanded epidemiological research towards improving awareness, management, treatment, and prevention of spinal muscular atrophy. Requires the Secretary to ensure the collection and analysis of longitudinal data related to individuals of all ages. Directs the Secretary to establish the Interagency Spinal Muscular Atrophy Research Coordinating Committee. Sets forth the duties of the Committee, including to develop a comprehensive strategy related to spinal muscular atrophy research and other related neurological diseases and disorders. Requires the Secretary to establish a program to provide information and education on spinal muscular atrophy to health professionals and the general public.

treatment acceleration act amends public_health_service_act require director national_institutes_of_health nih establish national clinical trials network spinal upgrading spinal clinical trial sites recruiting new investigators sites requires director ensure network conducts coordinated multisite clinical trials therapies clinical approaches treatment spinal rapidly efficiently disseminates scientific findings field requires director establish data coordinating center respect spinal expand intensify nih programs respect preclinical translation research related spinal requires secretary health_and_human_services acting director centers_for_disease_control_and_prevention cdc enhance support spinal patient registry provide expanded epidemiological research improving awareness management treatment prevention spinal requires secretary ensure collection analysis longitudinal data related individuals ages directs secretary establish interagency spinal research coordinating committee sets forth duties committee including develop comprehensive strategy related spinal research related neurological diseases disorders requires secretary establish program provide information education spinal health professionals general public


Summary: Patient-Centered Outcomes Research Act of 2009 - Amends title XI (General Provisions, Peer Review, and Administrative Simplification) of the Social Security Act (SSA) to provide for a program of comparative effectiveness research for health care. Defines "comparative effectiveness research" as research evaluating and comparing the implications and outcomes of two or more health care strategies to address a particular medical condition for specific patient populations. Establishes the Patient-Centered Outcomes Research Institute (PCORTI) as a nonprofit, nongovernmental corporation to conduct Iresearch on the effectiveness of health care treatments, including pharmaceuticals, medical devices and procedures, and other therapies. Requires the PCORTI to: (1) identify national priorities for comparative clinical effectiveness research; (2) establish and update a research project agenda for comparative clinical effectiveness research and provide for peer review of primary research; (3) establish a standing methodology committee for developing the science of comparative effectiveness research; and (4) disseminate research findings. Amends the Internal Revenue Code to establish in the Treasury the Patient-Centered Outcomes Research Trust Fund. Imposes a fee on certain accident or health insurance policies and self-insured health plans to create revenue for the Fund. Amends the American Recovery and Reinvestment Act of 2009 to require the Federal Coordinating Council for Comparative Effectiveness Research to support the PCORTI. Directs the Comptroller General of the United States to report to Congress on the process for making national coverage determinations under SSA title XVIII (Medicare).

patient centered outcomes research_act amends title general_provisions peer_review administrative simplification social_security_act ssa provide program comparative effectiveness research health_care defines comparative effectiveness research research evaluating comparing implications outcomes health_care strategies address particular medical condition specific patient populations establishes patient centered outcomes research institute nonprofit nongovernmental corporation conduct effectiveness health_care treatments including pharmaceuticals medical devices procedures therapies requires identify national priorities comparative clinical effectiveness research establish update research project agenda comparative clinical effectiveness research provide peer_review primary research establish standing methodology committee developing science comparative effectiveness research disseminate research findings amends_the_internal_revenue_code establish treasury patient centered outcomes research trust_fund imposes fee certain accident health insurance policies self insured health plans create revenue fund amends american_recovery_and_reinvestment_act require federal coordinating council comparative effectiveness research support directs comptroller_general_of_the_united_states report congress process making national coverage determinations ssa title xviii medicare


Summary: Scleroderma Research and Awareness Act - Requires the Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases to expand, intensify, and coordinate the research and training activities with respect to scleroderma. Directs the Centers for Disease Control and Prevention (CDC) to carry out an educational campaign to increase public awareness of scleroderma.

research awareness act_-_requires director national institute musculoskeletal skin diseases expand intensify coordinate research training activities respect directs centers_for_disease_control_and_prevention cdc carry educational campaign increase public awareness


Summary: (This measure has not been amended since it was introduced. The summary of that version is repeated here.) Improving Access to Clinical Trials Act of 2009 - Amends title XVI (Supplemental Security Income) (SSI) of the Social Security Act (SSA) to exclude from income for SSI eligibility purposes any compensation in the amount of the first $2,000 per year received by an individual for participation in clinical trials involving research and testing of treatments for rare diseases or conditions. Amends SSA title XIX (Medicaid) to make a similar exclusion from income of such compensation for the purposes of eligibility under the Medicaid program. Directs the Comptroller General to study and report to Congress on the impact of this Act on enrollment of individuals who receive SSI benefits in clinical trials for rare diseases or conditions.

measure amended introduced summary version repeated improving access clinical trials act amends title xvi supplemental security income ssi social_security_act ssa exclude income ssi eligibility purposes compensation year received individual participation clinical trials involving research testing treatments rare diseases conditions amends ssa title xix medicaid similar exclusion income compensation purposes eligibility medicaid program directs comptroller_general study report congress impact act enrollment individuals receive ssi benefits clinical trials rare diseases conditions


Summary: Family Asthma Act - Amends the Public Health Service Act to authorize the National Institutes of Health (NIH) to award grants for pilot projects to prevent and control asthma symptoms and to reduce asthma attacks and improve self-management for individuals and families. Requires the Secretary of Health and Human Services (HHS), acting through the Director of NIH, in awarding grants, to give: (1) priority to entities that serve populations disproportionately impacted by asthma; and (2) consideration to an adequate national understanding of asthma prevalence. Authorizes additional appropriations for FY2010-FY2014 to the National Heart, Lung, and Blood Institute to develop a National Asthma Action Plan and to fund a report to Congress by the National Asthma Education and Prevention Program on federal asthma activities. Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to: (1) collaborate with state and local health departments to conduct activities to inform and educate the public regarding asthma; (2) conduct asthma surveillance activities to collect data on the prevalence and severity of asthma, the effectiveness of public heath asthma intervention, and the quality of asthma management; and (3) compile and annually publish data on childhood and adult asthma.

family asthma act_-_amends public_health_service_act authorize national_institutes_of_health nih award grants pilot projects prevent control asthma symptoms reduce asthma attacks improve self management individuals families requires secretary health_and_human_services hhs acting director nih awarding grants priority entities serve populations disproportionately impacted asthma consideration adequate national understanding asthma prevalence authorizes additional appropriations fy2010 fy2014 national_heart lung blood_institute develop national asthma action plan fund report congress national asthma education prevention program federal asthma activities requires secretary acting director centers_for_disease_control_and_prevention cdc collaborate state local health departments conduct activities inform educate public asthma conduct asthma surveillance activities collect data prevalence severity asthma effectiveness public heath asthma intervention quality asthma management compile annually publish data childhood adult asthma


Summary: Gulf Oyster Industry Jobs Protection Act - Prohibits the use of funds made available to the Secretary of Health and Human Services (HHS) to require that oysters be treated with post-harvest processing or other treatment or cooking requirements that result in a prohibition on selling or consuming raw oysters. Directs the Secretary, acting through the Commissioner of Food and Drugs (FDA) and in cooperation with the oyster industry and the Interstate Shellfish Sanitation Conference, to conduct an education campaign to increase awareness of the risks associated with consuming raw oysters. Prohibits any proposed regulation or guidance issued by the Secretary that affects the harvesting, processing, or transportation of seafood harvested in the United States from becoming final or taking effect until the Secretary submits to the appropriate congressional committees a report that contains: (1) a cost-benefit analysis, economic impact study, and health impact analysis of such proposed regulation or guidance; and (2) an analysis that compares such proposed regulation or guidance to any similar regulations or guidance with respect to other regulated foods and that compares the risks associated with seafood and the instances of those risks in such other regulated foods.

gulf oyster industry jobs protection act prohibits use funds available secretary health_and_human_services hhs require oysters treated post harvest processing treatment cooking requirements result prohibition selling consuming raw oysters directs secretary acting commissioner food_and_drugs fda cooperation oyster industry interstate shellfish sanitation conference conduct education campaign increase awareness risks associated consuming raw oysters prohibits proposed regulation guidance issued secretary affects harvesting processing transportation seafood harvested united_states final taking effect secretary submits appropriate congressional committees report contains cost benefit analysis economic impact study health impact analysis proposed regulation guidance analysis compares proposed regulation guidance similar regulations guidance respect regulated foods compares risks associated seafood instances risks regulated foods


Summary: Brittany Wilkinson Mitochondrial Disease Research and Treatment Enhancement Act - Amends the Public Health Service Act to establish the Office of Mitochondrial Disease within the National Institutes of Health (NIH). Requires the Director of the Office to develop, make publicly available, and implement a written plan to facilitate and coordinate research into mitochondrial disease. Authorizes the Director to award grants for: (1) integrated, multi-project research programs related to mitochondrial disease and planning activities associated with such programs; and (2) the establishment of Mitochondrial Disease Centers of Excellence to promote interdisciplinary research and training related to mitochondrial disease. Requires the Director of the Centers for Disease Control and Prevention (CDC) to establish: (1) a national registry of medical information collected from patients with mitochondrial disease for research purposes; and (2) a national biodepository of tissues and DNA collected from patients with mitochondrial disease for research purposes.

disease research treatment enhancement act_-_amends public_health_service_act establish office disease national_institutes_of_health nih requires director office develop publicly available implement written plan facilitate coordinate research disease authorizes director award grants integrated multi project research programs related disease planning activities associated programs establishment disease centers_of_excellence promote interdisciplinary research training related disease requires director centers_for_disease_control_and_prevention cdc establish national_registry medical information collected patients disease research purposes national tissues dna collected patients disease research purposes


Summary: Comprehensive Problem Gambling Act of 2010 - Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS), acting through the Administrator of the Substance Abuse and Mental Health Services Administration, to: (1) establish and implement programs for the identification, prevention, and treatment of pathological and other problem gambling; (2) carry out a national campaign to increase knowledge and raise awareness of problem gambling; (3) establish and implement a national program of research on problem gambling; and (4) make grants to states, local and tribal governments, and nonprofit agencies to provide comprehensive services with respect to treatment and prevention of, and education about, problem gambling. Authorizes the Secretary, in carrying out the national campaign, to: (1) administer and coordinate the voluntary donation of resources to assist in implementing new programs and augmenting and supporting existing national campaigns; and (2) encourage media outlets to provide information aimed at preventing problem gambling. Requires the Secretary to target radio and television audiences of events including sporting and gambling events. Directs the Secretary to develop a treatment improvement protocol for problem gambling.

comprehensive problem gambling act amends public_health_service_act require secretary health_and_human_services hhs acting administrator substance_abuse_and_mental_health_services_administration establish implement programs identification prevention treatment pathological problem gambling carry national campaign increase knowledge raise awareness problem gambling establish implement national program research problem gambling grants states local tribal governments nonprofit agencies provide comprehensive services respect treatment prevention education problem gambling authorizes secretary carrying national campaign administer coordinate voluntary donation resources assist implementing new programs augmenting supporting existing national campaigns encourage media outlets provide information aimed preventing problem gambling requires secretary target radio television audiences events including sporting gambling events directs secretary develop treatment improvement protocol problem gambling


Summary: Culture of Safety Hospital Accountability Act of 2010 - Directs the Secretary of Heatlh and Human Services (HHS) to study for a report made available on the Internet website of the Centers for Medicare and Medicaid Services: (1) existing activities and programs in hospitals for quality assurance, patient safety, and performance improvement; and (2) any best practices that should be replicated in hospitals to improve patient safety and quality of care, consistent with the quality assessment and performance improvement program, as required by the conditions of participation for hospitals under title XVIII (Medicare) of the Social Security Act. Directs the Secretary to establish the Culture of Safety Hospital Accountability demonstration program to support establishing partnerships and other cooperative approaches among hospitals, state health care agencies, and HHS to promote and implement the best practices.

culture safety hospital accountability_act directs secretary human services hhs study report available internet website centers medicare medicaid_services existing activities programs hospitals quality assurance patient safety performance improvement best practices replicated hospitals improve patient safety quality care consistent quality assessment performance improvement program required conditions participation hospitals title xviii medicare social_security_act directs secretary establish culture safety hospital accountability demonstration program support establishing partnerships cooperative approaches hospitals state health_care agencies hhs promote implement best practices


Summary: Great Ape Protection Act of 2010 - Prohibits: (1) conducting invasive research on great apes; (2) knowingly breeding, possessing, renting, loaning, donating, purchasing, selling, housing, maintaining, leasing, borrowing, transporting, moving, delivering, or receiving a great ape for the purpose of conducting such research; or (3) using federal funds to conduct such research. Defines "invasive research" as research that may cause death, bodily injury, pain, distress, fear, injury, or trauma to great apes, including drug testing or exposure to a substance that may be detrimental to the ape's health or psychological well-being. Requires the Secretary of Health and Human Services (HHS) and other appropriate federal authorities to provide for the permanent retirement of all great apes that are owned or under the control of the federal government and that are being maintained in any facility for the purpose of breeding for, holding for, or conducting invasive research. Sets forth civil penalties for violations of this Act.

great ape protection act prohibits conducting invasive research great apes knowingly breeding possessing renting loaning donating purchasing selling housing maintaining leasing borrowing transporting moving delivering receiving great ape purpose conducting research federal funds conduct research defines invasive research research cause death bodily injury pain distress fear injury trauma great apes including drug testing exposure substance detrimental ape health psychological requires secretary health_and_human_services hhs appropriate federal authorities provide permanent retirement great apes owned control federal_government maintained facility purpose breeding holding conducting invasive research sets forth civil penalties violations act


Summary: Stem Cell Therapeutic and Research Reauthorization Act of 2010 - (Sec. 2) Amends the Stem Cell Therapeutic and Research Act of 2005 to revise provisions related to the National Cord Blood Inventory (the Inventory), including to establish an inventory goal of at least 150,000 new units of cord blood to be made available under the C.W. Bill Young Cell Transplantation Program (the Program). (Currently, the number of units of cord blood is capped at 150,000). Revises application requirements for cord blood banks participating in the Inventory to require such banks to: (1) make assurances that cord blood units will be available for direct transplantation until the cord blood unit is released for transplantation for a first degree relative; (2) participate in the Program for a period of at least ten years beginning on the last date on which the recipient receives federal funds under a contract; (3) provide a plan to increase cord blood unit collections at collection sites that exist at the time of application, assist with the establishment of new collection sites, or contract with new collection sites; and (4) annually provide to the Secretary of Health and Human Services (HHS) a plan for, and demonstrate, ongoing measurable progress toward achieving self-sufficiency of cord blood unit collection and banking operations. Revises the requirements for a contract extension to make a qualified cord blood bank eligible for a five-year extension if the bank demonstrates a superior ability to satisfy the requirements of the contract and achieve the overall goals for which the contract was awarded. Redefines the term "first-degree relative" to exclude a parent. Authorizes appropriations for FY2011-FY2015 for the Inventory. Amends the Public Health Service Act to require the Program to support and expand studies and demonstration and outreach projects that focus on: (1) remote collection of cord blood units; and (2) novel approaches or incentives to encourage innovative technological advances that could be used to collect cord blood units. Defines "remote collection" to mean the collection of cord blood units at locations that do not have written contracts with cord blood banks for collection support. Requires the Secretary to: (1) set an annual goal of increasing collections of high quality cord blood units; (2) identify at least one demonstration or outreach project to replicate and expand nationwide, as appropriate; and (3) submit a plan for meeting such goal to the relevant congressional committees if no such project can be identified. Revises privacy requirements to protect the identity and privacy of patients and donors in accordance with federal and state law. Requires the Secretary to submit an interim report to Congress within 180 days of enactment of this Act describing: (1) the methods to distribute federal funds to cord blood banks; (2) how cord blood banks contract with collection sites for the collection of cord blood units; and (3) recommendations for improving the methods to distribute federal funds to encourage the efficient collection of high-quality and diverse cord blood units. Directs the Advisory Council on Blood Stem Cell Transplantation to submit recommendations to the Secretary with respect to remote collection of cord blood units. Authorizes appropriations for FY2011-FY2015 to carry out the Program. Directs the Comptroller General to submit to the relevant congressional committees and the Secretary a report reviewing studies, demonstration programs, and outreach efforts for the purpose of increasing cord blood unit donation and collection for the Inventory to ensure a high-quality and genetically diverse inventory of cord blood units.

stem cell therapeutic research reauthorization act sec amends stem cell therapeutic research_act revise provisions related national cord blood inventory inventory including establish inventory goal new units cord blood available bill young cell transplantation program program currently number units cord blood capped revises application requirements cord blood banks participating inventory require banks assurances cord blood units available direct transplantation cord blood unit released transplantation degree relative participate program period years beginning date recipient receives federal funds contract provide plan increase cord blood unit collections collection sites exist time application assist establishment new collection sites contract new collection sites annually provide secretary health_and_human_services hhs plan demonstrate ongoing measurable progress achieving self sufficiency cord blood unit collection banking operations revises requirements contract extension qualified cord blood bank eligible year extension bank demonstrates superior ability satisfy requirements contract achieve overall goals contract awarded redefines term degree relative exclude parent authorizes appropriations fy2011 fy2015 inventory amends public_health_service_act require program support expand studies demonstration outreach projects focus remote collection cord blood units novel approaches incentives encourage innovative technological advances collect cord blood units defines remote collection mean collection cord blood units locations written contracts cord blood banks collection support requires secretary set annual goal increasing collections high quality cord blood units identify demonstration outreach project replicate expand nationwide appropriate submit plan meeting goal relevant congressional committees project identified revises privacy requirements protect identity privacy patients donors accordance federal state law requires secretary submit interim report congress days enactment act describing methods distribute federal funds cord blood banks cord blood banks contract collection sites collection cord blood units recommendations improving methods distribute federal funds encourage efficient collection high quality diverse cord blood units directs advisory_council blood stem cell transplantation submit recommendations secretary respect remote collection cord blood units authorizes appropriations fy2011 fy2015 carry program directs comptroller_general submit relevant congressional committees secretary report reviewing studies demonstration programs outreach efforts purpose increasing cord blood unit donation collection inventory ensure high quality genetically diverse inventory cord blood units


Summary: Stem Cell Research Advancement Act of 2010 - Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS) to conduct and support research that utilizes human stem cells, including human embryonic stem cells. 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 reproductive treatment, and were in excess of the needs of the individuals seeking such treatment; (2) it was determined through consultation with the individuals seeking reproductive treatment that the embryos would never be implanted in a woman and would otherwise be discarded; and (3) the individuals seeking reproductive treatment donated the embryos with written informed consent and received no financial or other inducements. Requires the Secretary to maintain, review every three years, and update as scientifically warranted, guidelines applicable to the conduct or support of human stem cell research by HHS. Prohibits the Secretary from using any funds for the conduct or support of human cloning. Requires the Director of the National Institutes of Health (NIH) to include in its biennial report to Congress a summary of research activities on human stem cells.

stem cell research advancement act amends public_health_service_act require secretary health_and_human_services hhs conduct support research utilizes human stem cells including human stem cells limits research stem cells meet following requirements stem cells derived human donated vitro fertilization clinics created purposes reproductive treatment excess needs individuals seeking treatment determined consultation individuals seeking reproductive treatment implanted woman individuals seeking reproductive treatment donated written informed consent received financial inducements requires secretary maintain review years update scientifically warranted guidelines applicable conduct support human stem cell research hhs prohibits secretary funds conduct support human cloning requires director national_institutes_of_health nih include biennial report congress summary research activities human stem cells


Summary: Ethical Pathway Act of 2010 - Directs the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs (FDA), to establish a mechanism by which an applicant for an abbreviated new drug application submitted under the Federal Food, Drug, and Cosmetic Act, for license of a biosimilar biological product submitted under the Public Health Service Act, or for a license to sell in the United States a drug that has been approved for marketing in a foreign country may request a cost-sharing arrangement under which the applicant and the holders of relevant applications or licenses shall make every effort to ensure that any regulatory test data and results of clinical investigations involving humans and vertebrate animals conducted regarding such applications or licenses is shared, including the regulatory test data necessary to obtain marketing approval from the Secretary. Permits such applicant to request such arrangement if, but for the arrangement: (1) the applicant would be required to conduct clinical investigations involving human subjects that violate Article 20 of the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects in order to obtain the Secretary's approval or licensure; or (2) the duplication of the clinical investigations required for such application would violate other applicable ethical standards concerning the testing of products on humans or other vertebrate animals. Sets forth provisions regarding: (1) the responsibility of an applicant that intends to perform clinical investigations involving humans or vertebrate animals to verify that those investigations have not been performed or initiated by another person, (2) agreement between an applicant and the holders of the relevant applications or licenses on a fee that is reasonable and fair that permits the applicant to rely upon information from such regulatory test data, and (3) procedures to determine such fee or required payment when such parties fail to reach such an agreement. Requires the fee for reliance on such regulatory test data to be determined after considering: (1) the actual out-of-pocket costs of the applicable clinical investigations; (2) the risks of the investigations; (3) any federal grants, tax credits, or other subsidies; (4) the expected share of the global market for the product involved; and (5) the amount of time the holders of the relevant applications or licenses have benefited from exclusive rights and the cumulative revenue earned on the products that relied upon the data at issue. Directs the Secretary to adopt procedures and rules under which sufficient information about costs and fees will be made public.

ethical pathway act directs secretary health_and_human_services hhs acting commissioner food_and_drugs fda establish mechanism applicant abbreviated new drug application submitted federal food drug cosmetic act license biosimilar biological product submitted public_health_service_act license sell united_states drug approved marketing foreign country request cost sharing arrangement applicant holders relevant applications licenses shall effort ensure regulatory test data results clinical investigations involving humans animals conducted applications licenses shared including regulatory test data necessary obtain marketing approval secretary permits applicant request arrangement arrangement applicant required conduct clinical investigations involving human subjects violate article declaration ethical principles medical research involving human subjects order obtain secretary approval licensure duplication clinical investigations required application violate applicable ethical standards concerning testing products humans animals sets forth provisions responsibility applicant intends perform clinical investigations involving humans animals verify investigations performed initiated person agreement applicant holders relevant applications licenses fee reasonable fair permits applicant rely information regulatory test data procedures determine fee required payment parties fail reach agreement requires fee reliance regulatory test data determined considering actual pocket costs applicable clinical investigations risks investigations federal grants tax credits subsidies expected share global market product involved time holders relevant applications licenses benefited exclusive rights cumulative revenue earned products relied data issue directs secretary adopt procedures rules sufficient information costs fees public


Summary: Gestational Diabetes Act of 2010 or the GEDI Act - Amends the Public Health Service Act to direct the Secretary of Health and Human Services (HHS), acting through the Director of the Centers for Disease Control and Prevention (CDC), to develop a multisite gestational diabetes research project within the diabetes program of the CDC to expand and enhance surveillance data and public health research on gestational diabetes.  Requires such research project to address: (1) procedures to establish accurate and efficient systems for the collection of gestational diabetes data; (2) the progress of collaborative activities with the National Vital Statistics System, the National Center for Health Statistics, and state health departments to improve surveillance of gestational diabetes; (3) postpartum methods of tracking women with gestational diabetes after delivery and targeted interventions to lower the incidence of type 2 diabetes in such women; (4) variations in the distribution of diagnosed and undiagnosed gestational diabetes; and (5) factors and culturally sensitive interventions that influence risks and reduce the incidence of gestational diabetes and related complications during childbirth. Requires the Secretary to expand and intensify public health research on gestational diabetes, including; (1) developing and testing novel approaches for improving postpartum testing or screening and for preventing type 2 diabetes in women with a history of gestational diabetes; and (2) conducting research to further understanding of the factors and health systems that influence the risk of gestational diabetes and the development of type 2 diabetes in women with a history of gestational diabetes. Requires the Secretary, acting through the Director of the CDC, to: (1) award grants for demonstration projects that implement evidence-based interventions to reduce the incidence of gestational diabetes, the recurrence of such disease in subsequent pregnancies, and the development of type 2 diabetes in women with a history of gestational diabetes; and (2) work with state and Indian tribal-based diabetes prevention and control programs assisted by the CDC to encourage postpartum follow-up after gestational diabetes to reduce the incidence of gestational diabetes and its recurrence, the development of type 2 diabetes in at-risk women, and related complications.

gestational diabetes act gedi act_-_amends public_health_service_act direct secretary health_and_human_services hhs acting director centers_for_disease_control_and_prevention cdc develop multisite gestational diabetes research project diabetes program cdc expand enhance surveillance data public health research gestational diabetes requires research project address procedures establish accurate efficient systems collection gestational diabetes data progress collaborative activities national vital statistics system national_center_for_health_statistics state health departments improve surveillance gestational diabetes postpartum methods tracking women gestational diabetes delivery targeted interventions lower incidence type diabetes women variations distribution diagnosed gestational diabetes factors culturally sensitive interventions influence risks reduce incidence gestational diabetes related complications childbirth requires secretary expand intensify public health research gestational diabetes including developing testing novel approaches improving postpartum testing screening preventing type diabetes women history gestational diabetes conducting research understanding factors health systems influence risk gestational diabetes development type diabetes women history gestational diabetes requires secretary acting director cdc award grants demonstration projects implement evidence based interventions reduce incidence gestational diabetes recurrence disease subsequent pregnancies development type diabetes women history gestational diabetes work state indian tribal based diabetes prevention control programs assisted cdc encourage postpartum follow gestational diabetes reduce incidence gestational diabetes recurrence development type diabetes risk women related complications


Summary: Life Sciences Jobs and Investment Act of 2010 - Amends the Internal Revenue Code to allow: (1) an increased research tax credit for qualified initial life sciences research expenses; and (2) certain corporations a tax deduction for dividends received which are reinvested in the United States to hire scientists and researchers engaged in life science research, fund life science research at research consortia, eligible small businesses, universities, and federal laboratories, or build or lease new facilities to be used primarily for qualified life sciences research. Terminates such tax incentives after 2015. Defines "qualified initial life sciences research expenses" as amounts, up to $150 million, attributable to the study of biology, biochemistry, biophysics, bioengineering, microbiology, genetics, or physiology, but excluding sociology or psychology. Directs the Commissioner of Internal Revenue to take necessary steps to ensure full compliance with the provisions of this Act and to report to Congress on the status of such compliance and related enforcement.

life sciences jobs investment act amends_the_internal_revenue_code allow increased research tax credit qualified initial life sciences research expenses certain corporations tax deduction dividends received reinvested united_states hire scientists researchers engaged life science research fund life science research research consortia eligible small businesses universities federal laboratories build lease new facilities primarily qualified life sciences research terminates tax incentives defines qualified initial life sciences research expenses amounts million attributable study biology excluding psychology directs commissioner internal_revenue necessary steps ensure compliance provisions act report congress status compliance related enforcement


Summary: Extends, for four years, the authority of the U.S. Postal Service (USPS) to issue a semipostal to contribute to funding for breast cancer research.

extends years authority postal_service usps issue semipostal contribute funding breast cancer research


Summary: Preserving Patients' Choices Act - Repeals provisions of the Patient Protection and Affordable Care Act providing for the establishment and funding of the Patient-Centered Outcomes Research Institute to identify priorities for, and establish, update, and carry out, a national comparative outcomes research project agenda. Restores provisions of law as if such provisions had not been enacted. Rescinds the unobligated balance of funds made available for such Institute. Repeals the health information technology provisions of the American Recovery and Reinvestment Act of 2009 (ARRA). Restores provisions of law as if such provisions had not been enacted. Rescinds all unobligated balances remaining available for the Office of the National Coordinator for Health Information Technology. Requires the total amount rescinded by this Act to be deposited in the Treasury to pay down the national debt.

preserving patients choices act repeals provisions patient_protection affordable care act providing establishment funding patient centered outcomes research institute identify priorities establish update carry national comparative outcomes research project agenda restores provisions law provisions enacted rescinds unobligated balance funds available institute repeals health information technology provisions american_recovery_and_reinvestment_act arra restores provisions law provisions enacted rescinds unobligated balances remaining available office national coordinator health information technology requires total rescinded act deposited treasury pay national debt


Summary: Making Investments Now for Dementia Act of 2011 - Authorizes the Secretary of the Treasury (the Secretary) to issue bonds to aid in the funding of Alzheimer's research in consultation with the Secretary of Health and Human Services (HHS) and the Director of the National Institutes of Health (NIH). Declares that the bonds authorized under this Act shall be in such form and denominations, and shall be subject to such terms and conditions of issue, conversion, redemption, maturation, payment, and rate of interest, as the Secretary may prescribe. Requires the Secretary to submit an annual report to Congress describing the actions taken by the Secretaries during the year, with the first such report describing the implementation of the program and subsquent reports describing the use of funds and the status of the program. Authorizes appropriations to the Director of NIH for research on Alzheimer's research equal to the amounts received by the Secretary from the sale of bonds under this Act, less amounts determined by the Secretary to be necessary for administration of such sales. Expresses the sense of Congress that any funds collected pursuant to this Act are in addition to yearly appropriated funds and are not to be used to supplement current funding.

making investments dementia act authorizes secretary treasury secretary issue bonds aid funding alzheimer research consultation secretary health_and_human_services hhs director national_institutes_of_health nih declares bonds authorized act shall form shall subject terms conditions issue conversion redemption payment rate interest secretary prescribe requires secretary submit annual report congress describing actions taken secretaries year report describing implementation program reports describing use funds status program authorizes appropriations director nih research alzheimer research equal amounts received secretary sale bonds act amounts determined secretary necessary administration sales expresses sense congress funds collected pursuant act addition yearly appropriated funds supplement current funding


Summary: Bone Marrow Failure Disease Research and Treatment Act of 2011 - Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS), 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.

bone marrow failure disease research treatment act amends public_health_service_act require secretary health_and_human_services hhs acting director centers_for_disease_control_and_prevention cdc develop system collect data acquired bone marrow failure diseases establish national acquired bone marrow failure disease registry establish advisory_committee acquired bone marrow failure diseases provide recommendations secretary registry allows secretary acting director award grants enter contracts cooperative agreements public private nonprofit entities management registry requires secretary acting administrator agency toxic substances disease registry conduct pilot studies determine environmental factors cause acquired bone marrow failure diseases requires secretary acting deputy assistant secretary minority health establish outreach information programs targeted minority populations affected diseases undertake coordinated outreach effort connect hispanic asian american pacific islander communities comprehensive services focused treatment information diseases awards grants enter cooperative agreements entities perform research diseases requires secretary acting director agency healthcare_research_and_quality ahrq award grants entities improve diagnostic practices quality care respect patients diseases


Summary: Recalcitrant Cancer Research Act of 2012 - Amends the Public Health Service Act to require the Director of the National Cancer Institute (NCI) to develop a scientific framework for research on recalcitrant cancers (cancer with a 5-year relative survival rate below 50%), which includes: (1) a review of the status of research, such as a summary of findings, identification of promising scientific advances, a description of the availability of qualified scientific researchers, and the identification of resources available to facilitate research; (2) identification of research questions that have not been adequately addressed; and (3) recommendations for actions to advance research and for appropriate benchmarks to measure progress on achieving such actions. Requires the Director to develop the framework within 18 months and review and update it every 5 years. Requires the Director to identify within 6 months 2 or more recalcitrant cancers that have a 5-year relative survival rate of less than 20%, and are estimated to cause the death of at least 30,000 individuals in the United States per year. Authorizes the Director to identify additional such cancers and to consider additional metrics of progress (such as incidence and mortality rates) against such cancer. Requires the Director to convene a working group for each identified cancer to provide expertise on, and assist in developing, a scientific framework under this Act. Requires the Director to consider each relevant scientific framework developed under this Act when making recommendations for exception funding for grant applications.

cancer research_act amends public_health_service_act require director national_cancer_institute develop scientific framework research cancers cancer year relative survival rate includes review status research summary findings identification promising scientific advances description availability qualified scientific researchers identification resources available facilitate research identification research questions adequately addressed recommendations actions advance research appropriate benchmarks measure progress achieving actions requires director develop framework months review update years requires director identify months cancers year relative survival rate estimated cause death individuals united_states year authorizes director identify additional cancers consider additional metrics progress incidence mortality rates cancer requires director convene working_group identified cancer provide expertise assist developing scientific framework act requires director consider relevant scientific framework developed act making recommendations exception funding grant applications


Summary: Stillbirth Awareness and Research Act of 2011 - Amends the Public Health Service Act to direct the Secretary of Health and Human Services (HHS), acting through the Director of the Centers for Disease Control and Prevention (CDC), to establish and maintain a scientific registry of stillbirths in the United States, which shall include for each stillbirth information on the stillborn fetus and the mother's health and pregnancy as collected and submitted by states on the U.S. Standard Report of Fetal Death. Requires the Secretary to: (1) provide for the development of a standard definition of stillbirth and a standard protocol for stillbirth data collection and surveillance, and (2) carry out a national campaign to increase public and state awareness of such definition and protocol and public awareness and knowledge of stillbirths. Expresses the sense of Congress that the Director of the National Institutes of Health (NIH) should increase the allocation of funds and other resources for stillbirth research.

awareness research_act amends public_health_service_act direct secretary health_and_human_services hhs acting director centers_for_disease_control_and_prevention cdc establish maintain scientific registry united_states shall include information fetus mother health pregnancy collected submitted states standard report fetal death requires secretary provide development standard definition standard protocol data collection surveillance carry national campaign increase public state awareness definition protocol public awareness knowledge expresses sense congress director national_institutes_of_health nih increase allocation funds resources research


Summary: Pediatric Research Consortia Establishment Act - Amends the Public Health Service Act to authorize the Director of the National Institutes of Health (NIH), acting through the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, to award grants, contracts, or cooperative agreements to public or nonprofit private entities to pay all or part of the cost of planning, establishing, and providing basic operating support for up to 20 national pediatric research consortia. Requires the Director of NIH to take unmet research needs into account when making awards under this Act. Declares that research conducted under this Act shall supplement, but not replace, research that is otherwise conducted or supported as part of the comprehensive pediatric research portfolio. Requires consortia to conduct basic, clinical, behavioral, social, or translational research, as well as training in, and demonstration of, advanced diagnostic and treatment methods relating to pediatrics. Requires the Director of NIH to: (1) provide for the coordination of information and ensure regular communication between consortia, and (2) require periodic reports on the activities of the consortia. Requires each consortium under this Act to be formed from a collaboration of cooperating institutions with a lead institution, meeting requirements that may be prescribed by the Director of NIH. Declares that payments made under this Act may be provided for a period of five years and extended for additional five-year periods with enhanced funding opportunities based on an appropriate scientific review of the operations.

pediatric research consortia establishment act_-_amends public_health_service_act authorize director national_institutes_of_health nih acting director eunice kennedy shriver national institute child health human development award grants contracts cooperative agreements public nonprofit private entities pay cost planning establishing providing basic operating support national pediatric research consortia requires director nih unmet research needs account making awards act declares research conducted act shall supplement replace research conducted supported comprehensive pediatric research portfolio requires consortia conduct basic clinical behavioral social translational research training demonstration advanced diagnostic treatment methods relating pediatrics requires director nih provide coordination information ensure regular communication consortia require periodic reports activities consortia requires consortium act formed collaboration cooperating institutions lead institution meeting requirements prescribed director nih declares payments act provided period years extended additional year periods enhanced funding opportunities based appropriate scientific review operations


Summary: Scleroderma Research and Awareness Act of 2011 - Amends the Public Health Service Act to authorize the Director of the National Institutes of Health (NIH) to expand, intensify, and coordinate NIH activities with respect to scleroderma, with particular emphasis on: (1) research focused on the etiology of scleroderma and the development of new treatment options; (2) clinical research to evaluate new treatments options; and (3) basic research on the relationship between scleroderma and secondary conditions, such as pulmonary hypertension, gastroparesis, Raynaud's phenomenon, and Sjogren's Syndrome. Authorizes the Secretary of Health and Human Services (HHS) to carry out an educational campaign to increase public awareness of scleroderma. Permits print, video, and web-based materials distributed through this campaign to include: (1) basic information on scleroderma and its symptoms; and (2) information on the incidence and prevalence of scleroderma, diseases and conditions affiliated with scleroderma, or the importance of early diagnosis and treatment of scleroderma.

research awareness act amends public_health_service_act authorize director national_institutes_of_health nih expand intensify coordinate nih activities respect particular emphasis research focused development new treatment options clinical research evaluate new treatments options basic research relationship secondary conditions pulmonary hypertension syndrome authorizes secretary health_and_human_services hhs carry educational campaign increase public awareness permits print video web based materials distributed campaign include basic information symptoms information incidence prevalence diseases conditions affiliated importance early diagnosis treatment


Summary: Regenerative Medicine Promotion Act of 2011 - Requires the Comptroller General to submit to Congress a report identifying all ongoing federal programs and activities regarding regenerative medicine. Directs the Secretary of Health and Human Services (HHS) to establish a Regenerative Medicine Coordinating Council in the Office of the Secretary, the duties of which shall include: (1) preparing a national strategy to support research into regenerative medicine and the development of drugs, biological products, medical devices, and biomaterials for use in regenerative medicine; (2) identifying sources of funding for research into regenerative medicine and areas where such funding is inadequate; and (3) making recommendations regarding federal policies to support development and marketing of regenerative medicine products. Authorizes the Secretary, acting through the Director of the National Institutes of Health (NIH), to make grants for: (1) basic or preclinical research into regenerative medicine; (2) research and development of drugs, biological products, medical devices, and biomaterials for use in regenerative medicine; and (3) the making of an investigational new drug application or an investigational device exemption application within four years of receiving such grant. Amends the Public Health Service Act to authorize the Director of NIH to award grants, contracts, or cooperative agreements to accelerate the development of high need cures through the development of medical products and behavioral therapies for use in regenerative medicine. Authorizes the Secretary, acting through the Commissioner of Food and Drugs, to: (1) conduct, support, or collaborate in regulatory research to assist the Food and Drug Administration (FDA) in performing its functions with respect to regenerative medicine; or (2) make grants to fund regulatory research for such purpose.

medicine promotion act requires comptroller_general submit congress report identifying ongoing federal programs activities medicine directs secretary health_and_human_services hhs establish medicine coordinating council office_of_the_secretary duties shall include preparing national strategy support research medicine development drugs biological products medical devices use medicine identifying sources funding research medicine areas funding inadequate making recommendations federal policies support development marketing medicine products authorizes secretary acting director national_institutes_of_health nih grants basic preclinical research medicine research development drugs biological products medical devices use medicine making investigational new drug application investigational device exemption application years receiving grant amends public_health_service_act authorize director nih award grants contracts cooperative agreements accelerate development high need cures development medical products behavioral therapies use medicine authorizes secretary acting commissioner food_and_drugs conduct support collaborate regulatory research assist food_and_drug_administration fda performing functions respect medicine grants fund regulatory research purpose


Summary: Alzheimer's Breakthrough Act of 2011 - Amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH) to coordinate and focus all Alzheimer's research activities of NIH, which shall include: (1) the establishment of a strategic Alzheimer's research plan to expedite therapeutic outcomes for individuals with or at risk for Alzheimer's; and (2) the provision of budget estimates, without regard to the probability that such amounts will be appropriated, of the amounts required to carry out the strategic plan. Requires NIH to make available contracts, grants, or cooperative agreements to facilitate partnerships between public and private entities to execute the Alzheimer's research plan, support the development of diagnostic technologies and protocols, and develop and diffuse data sharing practices. Expands the Alzheimer's Disease Center program to include translational research and research into outcome measures.

alzheimer breakthrough act amends public_health_service_act require director national_institutes_of_health nih coordinate focus alzheimer research activities nih shall include establishment strategic alzheimer research plan expedite therapeutic outcomes individuals risk alzheimer provision budget estimates regard probability amounts appropriated amounts required carry strategic plan requires nih available contracts grants cooperative agreements facilitate partnerships public private entities execute alzheimer research plan support development diagnostic technologies protocols develop data sharing practices expands alzheimer disease center program include translational research research outcome measures


Summary: National Childhood Brain Tumor Prevention Network Act - Amends the Public Health Service Act to require the Director of the Centers for Disease Control and Prevention (CDC) to establish, administer, and coordinate within the National Center for Environmental Health a National Childhood Brain Tumor Prevention Network to: (1) provide grants for research on the causes of and risk factors associated with childhood brain tumors; (2) assemble a panel of experts to provide ongoing guidance and recommendations on research funded by the Network, including on a common study design and standard protocols; and (3) designate a central laboratory to collect, analyze, and aggregate data with respect to research funded by the Network and to make such data and analysis available to researchers.

national childhood brain prevention network act_-_amends public_health_service_act require director centers_for_disease_control_and_prevention cdc establish administer coordinate national center environmental health national childhood brain prevention network provide grants research causes risk factors associated childhood brain tumors assemble panel experts provide ongoing guidance recommendations research funded network including common study design standard protocols designate central laboratory collect analyze aggregate data respect research funded network data analysis available researchers


Summary: Qualifying Therapeutic Discovery Project Tax Credit Extension Act of 2011 - Amends the Internal Revenue Code to extend for an additional five-year period the authority to invest in and allocate credit amounts for a qualifying therapeutic discovery project (a project that is designed to: (1) treat or prevent diseases by conducting pre-clinical activities, clinical trials, and clinical studies, or by carrying out research projects to approve new drugs or other biologic products; (2) diagnose diseases or conditions to determine molecular factors related to diseases or conditions; or (3) develop a product, process, or technology to further the delivery or administration of therapeutics). Extends for an additional five-year period the authority of the Secretary of the Treasury to award grants for investment in a qualifying therapeutic discovery project in lieu of a tax credit and the funding for such grants.

qualifying therapeutic discovery project tax credit extension act amends_the_internal_revenue_code extend additional year period authority invest allocate credit amounts qualifying therapeutic discovery project project designed treat prevent diseases conducting pre clinical activities clinical trials clinical studies carrying research projects approve new drugs biologic products diagnose diseases conditions determine molecular factors related diseases conditions develop product process technology delivery administration extends additional year period authority secretary treasury award grants investment qualifying therapeutic discovery project lieu tax credit funding grants


Summary: Psoriasis and Psoriatic Arthritis Research, Cure, and Care Act of 2011 - Authorizes the Director of the Centers for Disease Control and Prevention (CDC) to undertake psoriasis and psoriatic arthritis data collection efforts to collect information regarding: (1) the prevalence of psoriasis and psoriatic arthritis in the United States; (2) the age of onset; (3) health-related quality of life; (4) health care utilization; (5) the burden of such disease; (6) direct and indirect costs; (7) health disparities, including with respect to age, gender, race, and ethnicity; and (8) comorbidities and the natural history of such disease. Allows such data collection efforts to include: (1) incorporating questions into public health surveys, questionnaires, and other databases in existence as of the date of the enactment of this Act; and (2) the consideration and development of a patient registry. Encourages the Director of the National Institutes of Health to explore the development of a virtual Center of Excellence for Collaborative Discovery in Psoriasis and Comorbid Research or some other mechanism through which public and private sector findings regarding psoriasis and its comorbid conditions can be regularly shared and leveraged.

research cure care act authorizes director centers_for_disease_control_and_prevention cdc undertake data collection efforts collect information prevalence united_states age onset health related quality life health_care utilization burden disease direct indirect costs health disparities including respect age gender race ethnicity natural history disease allows data collection efforts include incorporating questions public health surveys databases existence date enactment act consideration development patient registry encourages director national_institutes_of_health explore development virtual center_of_excellence collaborative discovery research mechanism public private sector findings conditions regularly shared leveraged


Summary: Generating Antibiotic Incentives Now Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to extend the exclusivity period for a new prescription drug by five years for a drug that the Secretary of Health and Human Services (HHS) determines to be a qualified infectious disease product. Defines "qualified infectious disease product" to mean an antibiotic drug for treating, detecting, preventing, or identifying a qualifying pathogen (certain pathogens that are resistant to antibiotics). Excludes drugs that are: (1) a supplement to a new drug application for which an extension is in effect or has expired; or (2) a subsequent application for a change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or strength, or a modification to the structure of the product that does not result in a change in safety or effectiveness. Extends such period of exclusivity an additional six months for a sponsor or manufacturer of a qualified infectious disease product that identifies a companion diagnostic test. Requires the Secretary to give priority review to any drug determined to be a qualified infectious disease product. Includes qualified infectious disease products as fast track products for which the Secretary shall facilitate development and expedite review. Directs the Comptroller General to study the need for incentives to encourage the research, development, and marketing of qualified infectious disease biological products. Requires the Secretary to: (1) review Food and Drug Administration (FDA) guidelines for clinical trials of antibiotic drugs; and (2) revise such guidelines, as appropriate, to reflect developments in scientific and medical information and technology and to ensure clarity regarding the procedures and requirements for approval of an antibiotic drug.

generating antibiotic incentives act amends federal food drug cosmetic act extend exclusivity period new prescription drug years drug secretary health_and_human_services hhs determines qualified infectious disease product defines qualified infectious disease product mean antibiotic drug treating detecting preventing identifying qualifying pathogen certain pathogens resistant antibiotics excludes drugs supplement new drug application extension effect expired subsequent application change results new indication route administration dosing schedule dosage form delivery system delivery device strength modification structure product result change safety effectiveness extends period exclusivity additional months sponsor manufacturer qualified infectious disease product identifies companion diagnostic test requires secretary priority review drug determined qualified infectious disease product includes qualified infectious disease products fast track products secretary shall facilitate development expedite review directs comptroller_general study need incentives encourage research development marketing qualified infectious disease biological products requires secretary review food_and_drug_administration fda guidelines clinical trials antibiotic drugs revise guidelines appropriate reflect developments scientific medical information technology ensure clarity procedures requirements approval antibiotic drug


Summary: Gestational Diabetes Act of 2011 or the GEDI Act - Amends the Public Health Service Act to direct the Director of the Centers for Disease Control and Prevention (CDC) to develop a multisite gestational diabetes research project within the diabetes program of the CDC to expand and enhance surveillance data and public health research on gestational diabetes.  Requires the Secretary of Health and Human Services (HHS) to expand and intensify public health research on gestational diabetes, including; (1) developing and testing novel approaches for improving postpartum testing or screening and for preventing type 2 diabetes in women with a history of gestational diabetes; and (2) conducting research to further understanding of the factors and health systems that influence the risk of gestational diabetes and the development of type 2 diabetes in women with a history of gestational diabetes. Requires the Director to: (1) award grants for demonstration projects to reduce the incidence of gestational diabetes, the recurrence of such disease in subsequent pregnancies, and the development of type 2 diabetes in women with a history of gestational diabetes; and (2) work with state and Indian tribal-based diabetes prevention and control programs assisted by the CDC to encourage postpartum follow-up after gestational diabetes to reduce the incidence of gestational diabetes and its recurrence, the development of type 2 diabetes in at-risk women, and related complications.

gestational diabetes act gedi act_-_amends public_health_service_act direct director centers_for_disease_control_and_prevention cdc develop multisite gestational diabetes research project diabetes program cdc expand enhance surveillance data public health research gestational diabetes requires secretary health_and_human_services hhs expand intensify public health research gestational diabetes including developing testing novel approaches improving postpartum testing screening preventing type diabetes women history gestational diabetes conducting research understanding factors health systems influence risk gestational diabetes development type diabetes women history gestational diabetes requires director award grants demonstration projects reduce incidence gestational diabetes recurrence disease subsequent pregnancies development type diabetes women history gestational diabetes work state indian tribal based diabetes prevention control programs assisted cdc encourage postpartum follow gestational diabetes reduce incidence gestational diabetes recurrence development type diabetes risk women related complications


Summary: Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2011 - Amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH) to expand, intensify, and coordinate NIH activities with respect to functional gastrointestinal and motility disorders (FGIMDs), including by: (1) expanding basic and clinical research into FGIMDs by implementing the research recommendations of the National Commission on Digestive Diseases, (2) providing support for the establishment of centers of excellence on FGIMDs, (3) directing the National Institute of Diabetes and Digestive and Kidney Diseases to provide the necessary funding for the continued expansion and advancement of the FGIMDs research portfolio through intramural and extramural research, and (4) directing such Institute and the Eunice Kennedy Shriver National Institute of Child Health and Human Development to expand research into FGIMDs that impact children. Authorizes the Secretary of Health and Human Services (HHS) to engage in public awareness and education activities to increase understanding and recognition of FGIMDs.

functional disorders research enhancement_act amends public_health_service_act require director national_institutes_of_health nih expand intensify coordinate nih activities respect functional disorders including expanding basic clinical research implementing research recommendations national_commission diseases providing support establishment centers_of_excellence directing national institute diabetes kidney diseases provide necessary funding continued expansion advancement research portfolio intramural extramural research directing institute eunice kennedy shriver national institute child health human development expand research impact children authorizes secretary health_and_human_services hhs engage public awareness education activities increase understanding recognition


Summary: Stem Cell Research Advancement Act of 2011 - Amends the Public Health Service Act to require the Secretary of Health and Human Services to conduct and support research that utilizes human stem cells, including human embryonic stem cells. Limits such research to human embryonic 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 reproductive treatment, and were in excess of the clinical need of the individuals seeking such treatment; (2) it was determined that the embryos would never be implanted in a woman and would otherwise be discarded; and (3) the individuals seeking reproductive treatment donated the embryos with written informed consent and without receiving any financial or other inducements. Requires the Secretary to maintain, review, and update as scientifically warranted guidelines applicable to the conduct or support of human stem cell research by the Department of Health and Human Services (HHS). Prohibits the Secretary from using any funds for the conduct or support of human cloning. Defines “human cloning” to mean the implantation of the product of transferring the nuclear material of a human somatic cell into an egg cell from which the nuclear material has been removed or rendered inert into a uterus or the functional equivalent of a uterus. Requires the Secretary to update the guidelines maintained pursuant to this Act for consistency with such prohibition. Requires the Director of the National Institutes of Health (NIH) to include information on human stem cells in the biennial report to Congress.

stem cell research advancement act amends public_health_service_act require secretary health_and_human_services conduct support research utilizes human stem cells including human stem cells limits research human stem cells meet following requirements stem cells derived human donated vitro fertilization clinics created purposes reproductive treatment excess clinical need individuals seeking treatment determined implanted woman individuals seeking reproductive treatment donated written informed consent receiving financial inducements requires secretary maintain review update scientifically warranted guidelines applicable conduct support human stem cell research department_of_health_and_human_services hhs prohibits secretary funds conduct support human cloning defines human cloning mean product transferring nuclear material human somatic cell egg cell nuclear material removed rendered inert functional equivalent requires secretary update guidelines maintained pursuant act consistency prohibition requires director national_institutes_of_health nih include information human stem cells biennial report congress