zli12321/Bills huggingface dataset:
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.

Date: 2009-07-30
Topic: Health (R&D)
Subject: Health
(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.

Date: 2009-09-15
Topic: Health (R&D)
Subject: Social welfare
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.

Date: 2009-10-07
Topic: Health (R&D)
Subject: Health
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.

Date: 2009-11-09
Topic: Health (R&D)
Subject: Health
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.

Date: 2009-12-09
Topic: Health (R&D)
Subject: Health
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.

Date: 2010-05-25
Topic: Health (R&D)
Subject: Health
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.

Date: 2010-07-15
Topic: Health (R&D)
Subject: Health
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.

Date: 2010-08-03
Topic: Health (R&D)
Subject: Animals
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.

Date: 2010-09-13
Topic: Health (R&D)
Subject: Health
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.

Date: 2010-09-29
Topic: Health (R&D)
Subject: Health
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.

Date: 2010-11-18
Topic: Health (R&D)
Subject: Health
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.

Date: 2010-12-09
Topic: Health (R&D)
Subject: Taxation
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.

Date: 2011-01-26
Topic: Health (R&D)
Subject: Government operations and politics
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.

Date: 2011-02-08
Topic: Health (R&D)
Subject: Health
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.

Date: 2011-02-10
Topic: Health (R&D)
Subject: Health
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.

Date: 2011-02-10
Topic: Health (R&D)
Subject: Health
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.

Date: 2011-02-16
Topic: Health (R&D)
Subject: Health
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.

Date: 2011-03-11
Topic: Health (R&D)
Subject: Health
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.

Date: 2011-03-15
Topic: Health (R&D)
Subject: Health
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.

Date: 2011-05-02
Topic: Health (R&D)
Subject: Health
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.

Date: 2011-05-12
Topic: Health (R&D)
Subject: Health
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.

Date: 2011-05-13
Topic: Health (R&D)
Subject: Health
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.

Date: 2011-05-24
Topic: Health (R&D)
Subject: Health
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.

Date: 2011-05-25
Topic: Health (R&D)
Subject: Taxation
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.

Date: 2011-05-26
Topic: Health (R&D)
Subject: Health
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.

Date: 2011-06-15
Topic: Health (R&D)
Subject: Health
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.

Date: 2011-06-15
Topic: Health (R&D)
Subject: Health
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.

Date: 2011-06-16
Topic: Health (R&D)
Subject: Health
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.

Date: 2011-06-24
Topic: Health (R&D)
Subject: Health
Research Participants Protection Modernization Act of 2011 - Amends the Public Health Service Act to require all human subject research conducted or supported by the Department of Health and Human Services (HHS) or otherwise subject to HHS regulation to be conducted in accordance with HHS Human Subject Regulations and, if applicable, the vulnerable-population rules. Requires all human subject research on drugs or biological products to be conducted in accordance with Food and Drug Administration (FDA) regulations and, if applicable, the vulnerable populations rule. Requires the Secretary of HHS to make assistance available to any federal department or agency seeking to: (1) improve the regulation or oversight of human subject research, or (2) apply the HHS Human Subject Regulations or the vulnerable populations rules. Requires the Secretary to determine whether any HHS Human Subject Regulations should be modified after considering specified matters, including financial conflicts of interest. Sets forth notification requirements for investigators submitting a proposal for human subject research to an institutional review board, including regarding any significant financial interest. Requires the institution served by an institutional review board to review such significant financial interests and seek to eliminate or manage any conflict of interest. Prohibits the Secretary from awarding a grant, cooperative agreement, or contract to a public entity or private academic institution for research unless the entity or institution maintains or contracts for a program to educate investigators and board members on the protection of human subjects in research. Codifies the establishment of the Office for Human Research Protections in the Office of Secretary of HHS. Authorizes the Director of such Office to make grants for the development of model education programs that may be used by institutions served by institutional review boards to promote best practices in institutional management of human subject research.

Date: 2011-07-22
Topic: Health (R&D)
Subject: Health
Life Sciences Jobs and Investment Act of 2011 - 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 solely 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 2016. 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.

Date: 2011-07-25
Topic: Health (R&D)
Subject: Taxation
Trisomy 21 Research Centers of Excellence of 2011- Amends the Public Health Service Act to require 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 expand and intensify NIH programs with respect to research and related activities concerning Down syndrome. Requires the Director of NIH to publish a research plan on Down syndrome and update it every five years or as appropriate. Requires the Director of NIH to award grants and contracts to public or nonprofit private entities to pay all or part of the cost of planning, establishing, improving, and providing basic operating support for centers of excellence regarding translational research on Down syndrome. Sets forth requirements for such centers, which shall include: (1) contributing to a comprehensive research portfolio for Down syndrome, (2) having a primary focus on Down syndrome, (3) providing an optimal venue and infrastructure for patient-oriented research, and (4) conducting basic, clinical, and translational research on Down syndrome in specified areas. Authorizes the Director of NIH to establish a Down Syndrome Consortium to facilitate the exchange of information and to make the research effort on Down syndrome more efficient and effective.

Date: 2011-07-29
Topic: Health (R&D)
Subject: Health
Trisomy 21 Research Resource Act of 2011 - Amends the Public Health Service Act to require 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 expand and intensify NIH programs with respect to research and related activities concerning Down syndrome. Requires the Director of NIH to publish a research plan on Down syndrome and update it every five years or as appropriate. Authorizes the Director of NIH to: (1) conduct basic, clinical, and translational research on Down syndrome; (2) award a grant or contract for a registry of individuals with Down syndrome; (3) establish a database including the names, contact information, and each medical condition of individuals with Down syndrome; and (4) expand one or more tissue banks maintained or supported by NIH to identify any tissue harvested from a tissue donor with Down syndrome. Requires consent before including an individual's information in the registry, the database, or the tissue bank. Authorizes the Director of NIH to provide for the participation of NIH agencies in a consortium to facilitate the exchange of information and to make the research effort on Down syndrome more efficient and effective by ensuring consistent communication, minimizing duplication of effort, and integrating the varied perspectives of partner agencies, organizations, and individuals. Authorizes the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to: (1) award grants and cooperative agreements for the collection, analysis, and reporting of data on Down syndrome; and (2) carry out epidemiological activities regarding Down syndrome.

Date: 2011-07-29
Topic: Health (R&D)
Subject: Health
Patients First Act of 2011 - Amends the Public Health Service Act to require the Secretary of Health and Human Services to conduct and support basic and applied research to develop techniques for the isolation, derivation, production, testing, and human clinical use of stem cells that may result in improved understanding of, or treatments for, diseases and other adverse health conditions, including pluripotent stem cells that have the flexibility of embryonic stem cells (whether or not such pluripotent stem cells have an embryonic source), provided that such techniques will not involve: (1) the creation of a human embryo for research purposes; (2) the destruction or discarding of, or risk of injury to, a living human embryo; or (3) the use of any stem cell the derivation or provision of which would be inconsistent with this Act. Requires the Secretary to issue guidelines implementing this Act to ensure that any research (including any clinical trial) supported under this Act: (1) is clearly consistent with the standards established in this Act, if conducted using human cells; and (2) is prioritized in terms of potential for near-term clinical benefit in human patients.Requires the Secretary to report on peer reviewed stem cell research proposals that were not funded.

Date: 2011-09-15
Topic: Health (R&D)
Subject: Health
Medical Checklist Act of 2011 - Requires the Director of the Agency for Healthcare Research and Quality, acting through the Center for Quality Improvement and Patient Safety, to conduct research and a study regarding the development and efficacy of medical checklists, including regarding: (1) the testing of different models of medical checklists; (2) an examination of checklist development and use in other industries; and (3) a measurement of the effects of the use of medical checklists on patient safety and health outcomes. Requires dissemination of the results of such study to patient safety organizations. Defines "medical checklist" as a predetermined, evidence-based, well-defined set of steps that should be completed during a designated medical clinical encounter or medical procedure. Requires the HIT Policy Committee to develop policy recommendations regarding: (1) the extent to which the use of medical checklists should be incorporated into health information technology systems; and (2) measures to determine the effectiveness of such use. Requires the Secretary to enter into an agreement with the Institute of Medicine and the National Academy of Engineering of the National Academies to conduct a study on medical checklists that includes: (1) a review of available medical checklists and similar quality improvement techniques; (2) an identification of areas of research needed to improve medical checklists; (3) an analysis of organizational impediments to the adoption and use of medical checklists; and (4) a determination of whether the availability of an increased number of medical checklists would improve patient safety and health outcomes.

Date: 2011-11-04
Topic: Health (R&D)
Subject: Health
Taxpayers' Cancer Research Funding Act of 2011 - Amends the Internal Revenue Code to allow taxpayers to designate on their tax returns a $5 contribution to the Breast and Prostate Cancer Research Fund ($10 for joint returns). Establishes in the Treasury the Breast and Prostate Cancer Research Fund to award grants for breast or prostate cancer research.

Date: 2011-11-17
Topic: Health (R&D)
Subject: Taxation