lcalvobartolome/proxann_data huggingface dataset:
Topic: Health — R&D
Subject: International affairs
Date: 2015-03-19 00:00:00

Global Brain Health Act of 2015

Directs the U.S. Agency for International Development (USAID) to establish and administer a health and education grant program (Global Autism Assistance Program) to: (1) support activities by nongovernmental organizations and other service providers, including advocacy groups, focused on autism in developing countries; and (2) establish a "teach the teachers" program to train health and education professionals working with autistic children in developing countries.

 Amends the Foreign Assistance Act of 1961 to authorize the President to provide assistance to support a network of trained medical practitioners to treat hydrocephalus in children at pediatric hospitals and hydrocephalus treatment centers in developing countries.

Requires such assistance to provide for surgeon training and establishment of at least 20 treatment centers.

 Directs the Secretary of Health and Human Services to:

 negotiate with the World Health Organization to develop a plan for addressing Alzheimer's disease and other forms of dementia globally, to be known as the Global Alzheimer's Disease and Dementia Action Plan; and seek to establish the Global Alzheimer's Disease and Dementia Fund to support implementation of the Global Alzheimer's Disease and Dementia Action Plan. Expresses the sense of Congress that the Group of Eight (G8) nations, working with the Group of Twenty (G20) nations, the Group of Seventy-Seven (G77) nations, and other organizations should investigate systems to monitor and provide care to individuals with Alzheimer's disease and other forms of dementia in developing countries.

 Directs the President to:

 appoint a high-level official to lead federal efforts to develop the Global Alzheimer's Disease and Dementia Action Plan and the Global Alzheimer's Disease and Dementia Fund, and facilitate partnerships between the federal government and the private sector to identify new treatment approaches for Alzheimer's disease and other forms of dementia. Directs the Administrator of USAID to investigate the foreign aid implications of Alzheimer's disease and other forms of dementia.
Topic: Health — R&D
Subject: Health
Date: 2015-03-19 00:00:00

Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act

This bill amends the Public Health Service Act to revise requirements for medical rehabilitation research.

The purpose of the National Center for Medical Rehabilitation Research (NCMRR) is revised to include coordination of research and research training.

The NCMRR must develop and periodically update a comprehensive research plan for medical rehabilitation research. Currently, this research plan is developed and updated by the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

The NCMRR must: (1) annually report on progress in achieving the objectives, benchmarks, and guiding principles described in the research plan; and (2) develop guidelines governing the funding for medical rehabilitation research by the National Institutes of Health.

The Medical Rehabilitation Coordinating Committee must periodically host a scientific conference or workshop on medical rehabilitation research.

The Department of Health and Human Services must enter into interagency agreements to coordinate medical rehabilitation research.
Topic: Health — R&D
Subject: Armed forces and national security
Date: 2015-03-24 00:00:00

Integrated Electronic Health Records (iEHR) for Military and Veterans Act - Directs the Secretaries of Defense (DOD) and Veterans Affairs (VA) to jointly carry out a program to award a cash prize ($50 million) and contract to an entity that develops a fully-integrated electronic health records program for national use by DOD and VA. Directs the Secretaries to: (1) widely advertise the prize competitions and announce each one in the Federal Register, and (2) create a joint panel to establish criteria for the program's development.

 Requires the prize recipient to be awarded a contract with DOD and VA to provide the program, including maintenance and support, and to be compensated at $25 million per year for five years. Reverts to the federal government, after such period, any intellectual property developed under the contract.

Authorizes the Secretaries to require competition participants to waive claims against the federal government (except for willful conduct) arising from such participation. Requires participants to obtain liability insurance.
Topic: Health — R&D
Subject: Health
Date: 2015-03-25 00:00:00

Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act

This bill amends the Public Health Service Act to revise requirements for medical rehabilitation research.

The purpose of the National Center for Medical Rehabilitation Research (NCMRR) is revised to include coordination of research and research training.

The NCMRR must develop and periodically update a comprehensive research plan for medical rehabilitation research. Currently, this research plan is developed and updated by the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

The NCMRR must: (1) annually report on progress in achieving the objectives, benchmarks, and guiding principles described in the research plan; and (2) develop guidelines governing the funding for medical rehabilitation research by the National Institutes of Health.

The Medical Rehabilitation Coordinating Committee must periodically host a scientific conference or workshop on medical rehabilitation research.

The Department of Health and Human Services must enter into interagency agreements to coordinate medical rehabilitation research.
Topic: Health — R&D
Subject: Health
Date: 2015-03-25 00:00:00

Vaccine Safety Study Act

Requires the National Institutes of Health (NIH) to conduct a comprehensive study to: (1) compare total health outcomes, including the incidence and risk of autism, between vaccinated and unvaccinated U.S. populations; and (2) determine whether exposure to vaccines or vaccine components is associated with autism spectrum disorders, chronic conditions, or other neurological conditions.

Requires the NIH to seek to include in the study populations that have traditionally remained unvaccinated for religious or other reasons.

Directs the NIH to ensure the preservation of all data collected or used for purposes of the study to facilitate further research by the NIH or others. Declares that nothing in this Act shall be construed to authorize the conduct or support of any study in which an individual or population is encouraged or incentivized to remain unvaccinated.
Topic: Health — R&D
Subject: Health
Date: 2015-04-15 00:00:00

End Neglected Tropical Diseases Act

This bill expands programs to address neglected tropical diseases (NTDs), which are infections caused by pathogens, including viruses, microbes, and helminths (parasitic worms), that disproportionately impact individuals living in extreme poverty, especially in developing countries.

The NTDs Program of the U.S. Agency for International Development must be expanded, including by: (1) adding morbidity management to treatment plans, (2) addressing additional NTDs, and (3) establishing a research and development program.

This bill amends the State Department Basic Authorities Act of 1956 to expand the duties of the Coordinator of United States Government Activities to Combat HIV/AIDS Globally to include coordination of HIV/AIDS activities with NTD activities, particularly in areas that are highly endemic for female genital schistosomiasis, a parasitic worm disease.

The President must direct the U.S. representatives to the United Nations and the International Bank for Reconstruction and Development to urge actions on NTDs, including deworming programs.

The Department of Health and Human Services must continue to promote the need for NTDs programs and activities through interagency groups and international forums.

The Centers for Disease Control and Prevention must report to Congress on NTDs in the United States.

This bill amends the Public Health Service Act to authorize the National Institute of Allergy and Infectious Diseases or the Health Resources and Services Administration to support one or more centers of excellence for NTD research, training, and treatment.

The National Institutes of Health must establish a panel to evaluate issues relating to worm infections, including potential solutions such as deworming medicines.
Topic: Health — R&D
Subject: Health
Date: 2015-04-28 00:00:00

Neuromyelitis Optica Consortium Act

This bill amends the Public Health Service Act to require the National Institutes of Health to establish, administer, and coordinate a National Neuromyelitis Optica (NMO) Consortium to:

 award grants for research on the causes of, and the risk factors and biomarkers associated with, NMO (a neurological disease leading to blindness and paralysis); assemble a panel of experts to provide ongoing guidance and recommendations on research design and protocols; and designate a central laboratory to collect, analyze, and aggregate data from this research and to make the data and analysis available to researchers.
Topic: Health — R&D
Subject: Health
Date: 2015-04-29 00:00:00

American Cures Act 

This bill amends the Balanced Budget and Emergency Deficit Control Act of 1985 to require certain adjustments to discretionary spending limits in FY2016-FY2021 to accommodate increases in appropriations for agencies that perform biomedical research. Adjustments are required for the National Institutes of Health, the Centers for Diseases Control and Prevention, the Department of Defense health program, and the Department of Veterans Affairs medical and prosthetics research program.

The bill also requires annual appropriations for each of the programs and agencies referenced in this bill to be at least the amount appropriated in FY2015.

The bill exempts appropriations provided pursuant to this bill from sequestration. Sequestration is a process of automatic, usually across-the-board spending reductions under which budgetary resources are permanently cancelled to enforce specific budget policy goals.
Topic: Health — R&D
Subject: Government operations and politics
Date: 2015-04-30 00:00:00

Breast Cancer Research Stamp Reauthorization Act of 2015

This bill reauthorizes through December 31, 2019, provisions requiring the U.S. Postal Service to issue a special postage stamp for first-class mail that costs more than the regular first-class stamp to raise funds for breast cancer research. Agencies receiving these funds from the Postal Service must use them on breast cancer research.
Topic: Health — R&D
Subject: Health
Date: 2015-05-13 00:00:00

Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2015

This bill amends the Public Health Service Act to require the National Institutes of Health to expand, intensify, and coordinate its activities with respect to functional gastrointestinal and motility disorders (FGIMDs), including by:

 expanding basic and clinical research into FGIMDs by implementing the research recommendations of the National Commission on Digestive Diseases, providing support for the establishment of centers of excellence on FGIMDs, supporting innovative approaches to educating health care providers and patients regarding strategies that improve patient-provider relationships and care, directing the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to provide the necessary funding for the continued expansion and advancement of the FGIMDs research portfolio, and directing NIDDK and the Eunice Kennedy Shriver National Institute of Child Health and Human Development to expand research into FGIMDs that impact children. The Department of Health and Human Services may engage in public awareness and education activities to increase understanding and recognition of FGIMDs.
Topic: Health — R&D
Subject: Health
Date: 2015-05-13 00:00:00

Advancing Research for Hydrocephalus Act of 2015

Amends the Public Health Service Act to require the Centers for Disease Control and Prevention to: (1) enhance and expand infrastructure and activities to track the epidemiology of hydrocephalus (a condition in which fluid accumulates in the brain); and (2) incorporate information obtained through those activities into a National Hydrocephalus Surveillance System. Requires the Department of Health and Human Services (HHS) to ensure that the System facilitates further research on hydrocephalus.

Requires HHS to provide for the collection and storage of information on hydrocephalus, including the incidence, prevalence, and other information, to the extent practicable.

Requires HHS to: (1) make information and analysis in the System available to the public, including researchers; and (2) ensure that privacy and security protections applicable to the System are at least as stringent as the protections under the Health Insurance Portability and Accountability Act.
Topic: Health — R&D
Subject: Health
Date: 2015-05-14 00:00:00

Stop Tampering of Prescription Pills Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to deny approval to a new oral opioid (a drug with effects similar to opium, such as morphine) that does not have properties that make the drug significantly more difficult to abuse if an abuse-deterrent drug containing the same opioid is available. The FDA may approve an opioid drug that is not abuse-deterrent if approval is necessary to prevent or alleviate a drug shortage or to address a significant unmet public health need.

To be approved by the FDA, a generic version of an abuse-deterrent brand name drug must be at least comparably abuse-deterrent and its active components must not differ in any material respect from the brand name drug.

An approved generic drug is not bioequivalent to, and does not have the same therapeutic effect as, a brand name drug that becomes abuse-deterrent unless the generic drug is at least comparably abuse-deterrent.

Approval of a generic oral opioid is withdrawn if the brand name drug is not abuse-deterrent and not available and there is an approved abuse-deterrent drug available that contains the same opioid in the same dose.

Approval of an oral opioid is withdrawn if the drug is not abuse-deterrent and there is an approved abuse-deterrent drug available that contains the same opioid. Withdrawal of approval may be waived by the FDA for a drug intended for a special needs population. The FDA must delay withdrawal to give the drug sponsor an opportunity to obtain approval for an abuse-deterrent formulation of the drug.
Topic: Health — R&D
Subject: Health
Date: 2015-05-14 00:00:00

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish processes under which: (1) an entity seeking to develop patient experience data may submit initial research concepts for feedback; (2) the FDA may request or receive from such an entity draft guidance documents, data, and summaries and analyses of data; and (3) patient experience data may be considered in the risk-benefit assessment of a new drug.

“Patient experience data” is data collected by patients or others that is intended to facilitate the FDA's risk-benefit assessments, including information about the impact of a disease or a therapy on patients' lives.

The FDA must convene workshops and publish guidance on the patient experience data processes described above.
Topic: Health — R&D
Subject: Health
Date: 2015-05-19 00:00:00

This bill amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH) to appoint the directors of the national research institutes and national centers (excluding the National Cancer Institute) instead of the Secretary of Health and Human Services (HHS). Directors appointed by the Director of NIH have five-year terms.

This bill amends the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 1993 to remove a provision that makes appropriations available for compensation of consultants or individual scientists appointed for limited periods of time to the Public Health Service.

Before a national research institute or national center awards a grant for a research project (R-series grant) the director of the institute or center must review and approve the award, taking into consideration the mission and priorities of the institute or center and whether other agencies are funding projects to accomplish the same goal.

HHS must enter an arrangement with the National Academy of Medicine (formerly known as the Institute of Medicine) under which a study is completed on the extent to which federally funded biomedical research is duplicative and recommendations are made on preventing such duplication.
Topic: Health — R&D
Subject: Health
Date: 2015-05-19 00:00:00

This bill amends the Federal Food, Drug, and Cosmetic Act to define “valid scientific evidence” to include well-documented case histories or studies published in peer-reviewed journals for purposes of the Food and Drug Administration (FDA) determining the effectiveness of a medical device without clinical investigation. Under specified conditions, the FDA may request the data underlying a study that is offered as valid scientific evidence.
Topic: Health — R&D
Subject: Health
Date: 2015-05-19 00:00:00

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to provide an opportunity for a person whose premarket submission for a medical device is subject to review by a classification panel to provide recommendations on the expertise needed among the members of the panel.

The FDA must consider these recommendations and ensure that panels include at least two members with expertise clinically relevant to the device and at least one member who is knowledgeable about the technology of the device.

The person whose device is under review may designate a representative (who may be accompanied by experts) to participate in panel meetings.
Topic: Health — R&D
Subject: Health
Date: 2015-05-19 00:00:00

This bill amends the Federal Food, Drug, and Cosmetic Act to revise Board of Directors membership, Executive Director compensation, and accounting for the Reagan-Udall Foundation for the Food and Drug Administration.
Topic: Health — R&D
Subject: Health
Date: 2015-05-19 00:00:00

This bill requires the National Institutes of Health (NIH) to convene a workshop within 180 days of enactment of this Act on appropriate age groupings and age exclusions in human research. Not later than 180 days after the conclusion of the workshop, the NIH must publish guidelines addressing consideration of age in human research.

The NIH must publish the number of children included in NIH research disaggregated by age group, race, and gender.
Topic: Health — R&D
Subject: Health
Date: 2015-05-19 00:00:00

This bill amends the Public Health Service Act to revise the Silvio O. Conte Senior Biomedical Research Service to: (1) remove the limit on the number of members, (2) expand eligibility for appointment, (3) set a maximum pay rate, and (4) remove the option for members to contribute to the retirement system of an institution of higher education.

The Department of Health and Human Services must report on the implementation of these amendments, including whether the amendments improved the ability of the Food and Drug Administration to hire and retain qualified experts to fulfill obligations under user fee agreements.
Topic: Health — R&D
Subject: Health
Date: 2015-05-19 00:00:00

This bill amends the Public Health Service Act to require the Department of Health and Human Services (HHS) to establish a loan repayment program for health professionals engaging in research.

The maximum awards of the loan repayment programs for minority health disparities research, AIDS research, research with respect to contraception and infertility, research as an employee of the National Institutes of Health, clinical researchers from disadvantaged backgrounds, clinical researchers, and pediatric research are increased and may be adjusted for inflation by HHS.
Topic: Health — R&D
Subject: Health
Date: 2015-05-19 00:00:00

This bill expresses the sense of Congress that participation in or sponsorship of scientific conferences and meetings is essential to the mission of the Food and Drug Administration.
Topic: Health — R&D
Subject: Health
Date: 2015-05-19 00:00:00

This bill amends the Public Health Service Act to require the National Institutes of Health (NIH) to develop and maintain a biomedical research strategic plan.

The NIH must use the strategic plan to identify research opportunities and to develop individual strategic plans for each of the national research institutes and national centers. Strategic plans must identify strategic focus areas in a manner that considers the return on investment of biomedical research and contributes to expanding knowledge to improve the public's health. Strategic focus areas must include overarching Mission Priority Focus Areas, which serve the goal of preventing or eliminating the burden of a medical condition.

The NIH must: (1) ensure that rare and pediatric diseases and conditions remain a priority under the strategic plan, (2) publish the initial strategic plan within 270 days, (3) conduct progress reviews for each strategic focus area at least annually, and (4) update the strategic plan every five years.
Topic: Health — R&D
Subject: Health
Date: 2015-05-19 00:00:00

This bill amends the Public Health Service Act to require each national research institute to conduct or support high-risk, high-reward research that pursues innovative approaches to major biomedical challenges. The National Institutes of Health determines the percentage of funding each national research institute must set aside for this research.
Topic: Health — R&D
Subject: Health
Date: 2015-05-19 00:00:00

This bill amends the Public Health Service Act to allow the National Institutes of Health (NIH) to require the sharing of scientific data generated from research that is fully funded by the NIH.
Topic: Health — R&D
Subject: Health
Date: 2015-05-20 00:00:00

Cerebral Cavernous Malformations Clinical Awareness, Research, and Education Act of 2015 or the CCM-CARE Act

This bill amends the Public Health Service Act to require the National Institutes of Health (NIH) to strengthen and coordinate its efforts concerning cerebral cavernous malformation (CCM). (CCM is a condition in which blood vessels in the brain and spinal cord become enlarged, which can lead to seizures, paralysis, hearing or vision loss, or bleeding in the brain.) The NIH may award grants and enter into cooperative agreements for CCM research.

The NIH must: (1) award grants and contracts to plan and provide support for a network of CCM Clinical Research Centers; (2) identify and support additional centers to facilitate medical research to develop a cure for CCM and enhance medical care for CCM; and (3) convene a Cerebral Cavernous Malformations Research Consortium to develop programs for clinicians, scientists, and patients.

The Centers for Disease Control and Prevention may award grants and enter into cooperative agreements for the collection, analysis, and reporting of data on CCM.

The Department of Health and Human Services must award grants and enter into cooperative agreements for epidemiological activities related to CCM and must provide for a national CCM surveillance program.

The Food and Drug Administration must: (1) coordinate with clinical centers, investigators, and advocates to support investigational new drug applications in order to hasten clinical trials for CCM, and (2) support appropriate requests for designation of drugs for use in rare subpopulations of CCM patients as orphan drugs. (Orphan drugs are drugs developed to treat rare medical conditions and are eligible for certain incentives.)