zli12321/Bills huggingface dataset:
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.

Date: 2015-03-25
Topic: Health (R&D)
Subject: Health
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.

Date: 2015-03-25
Topic: Health (R&D)
Subject: Health
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.

Date: 2015-04-15
Topic: Health (R&D)
Subject: Health
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.

Date: 2015-04-28
Topic: Health (R&D)
Subject: Health
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.

Date: 2015-04-29
Topic: Health (R&D)
Subject: Health
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.

Date: 2015-04-30
Topic: Health (R&D)
Subject: Government operations and politics
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.

Date: 2015-05-13
Topic: Health (R&D)
Subject: Health
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.

Date: 2015-05-13
Topic: Health (R&D)
Subject: Health
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.

Date: 2015-05-14
Topic: Health (R&D)
Subject: Health
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.

Date: 2015-05-14
Topic: Health (R&D)
Subject: Health
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.

Date: 2015-05-19
Topic: Health (R&D)
Subject: Health
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.

Date: 2015-05-19
Topic: Health (R&D)
Subject: Health
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.

Date: 2015-05-19
Topic: Health (R&D)
Subject: Health
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.

Date: 2015-05-19
Topic: Health (R&D)
Subject: Health
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.

Date: 2015-05-19
Topic: Health (R&D)
Subject: Health
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.

Date: 2015-05-19
Topic: Health (R&D)
Subject: Health
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.

Date: 2015-05-19
Topic: Health (R&D)
Subject: Health
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.

Date: 2015-05-19
Topic: Health (R&D)
Subject: Health
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.

Date: 2015-05-19
Topic: Health (R&D)
Subject: Health
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.

Date: 2015-05-19
Topic: Health (R&D)
Subject: Health
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.

Date: 2015-05-19
Topic: Health (R&D)
Subject: Health
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.)

Date: 2015-05-20
Topic: Health (R&D)
Subject: Health
Pediatric Research Improvement Act of 2015

This bill amends the Public Health Service Act to revise the Pediatric Research Initiative to require collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Development and require establishment of a National Pediatric Research Network comprised of pediatric research consortia.

The National Institutes of Health must award funding to entities supporting pediatric research consortia. Supported consortia must, upon request, provide assistance to the Centers for Disease Control and Prevention for patient registries and other surveillance systems.

Date: 2015-05-21
Topic: Health (R&D)
Subject: Health
This bill amends the HITECH Act to require the Department of Health and Human Services (HHS) to revise or clarify the privacy rule established under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to allow the use and disclosure of protected health information for research purposes without the individual's authorization, approval from an Institutional Review Board or Privacy Board, or representations from the researcher regarding limited use of the information.

These disclosures may only be made to entities subject to HIPAA for health care operations or to business associates that are complying with the privacy rule for health care operations or data aggregation.

There is no limitation on payments for these disclosures. Currently, payment is limited to the cost to prepare and transmit the information.

An individual's protected health information may be disclosed without the authorization or agreement of the individual for research related to a product or activity that is regulated by the Food and Drug Administration.

 A researcher is allowed remote access to protected health information if security and privacy safeguards are maintained and the researcher does not retain the information.

An individual's authorization to use protected health information for future research is sufficient for a research purpose if the authorization reasonably describes the research and provides instruction to the individual on how to revoke the authorization.

Date: 2015-05-21
Topic: Health (R&D)
Subject: Health
Professional's Access To Health Workforce Integration Act of 2015

Directs the Department of Health and Human Services, acting through the Bureau of Health Workforce within the Health Resources and Services Administration, the National Institute on Minority Health and Health Disparities, or the Office of Minority Health (HHS), to award grants to eligible entities to:

 provide services to assist unemployed and underemployed skilled immigrants residing in the United States, who have legal, permanent work authorization and who are internationally educated health professionals, in entering into and advancing in the American health workforce with employment matching their health professional skills, education, and expertise; provide training opportunities to reduce barriers to entry and advancement in the health workforce for skilled, internationally educated immigrants; educate employers regarding the abilities and capacities of internationally educated health professionals; assist in the evaluation of foreign credentials; and facilitate access to contextualized and accelerated courses on English as a second language. Includes as an eligible entity a clinical, public health, or health services organization, a community-based or nonprofit entity, an academic institution, a faith-based organization, a state, county, or local government, or an Area Health Education Center that submits an application that meets HHS requirements.

Defines "health professional" as an individual trained for employment or intended employment in specified fields, including public health, health management, dentistry, health administration, medicine, nursing, pharmacy, psychology, social work, psychiatry, and other mental and behavioral health, allied health, and community health or wellness work.

Date: 2015-06-10
Topic: Health (R&D)
Subject: Health
(This measure has not been amended since it was reported to the Senate on December 3, 2015. The summary of that version is repeated here.)

Stem Cell Therapeutic and Research Reauthorization Act of 2015

(Sec. 2) This bill amends the Public Health Service Act and the Stem Cell Therapeutic and Research Act of 2005 to revise and extend through FY2020 the C.W. Bill Young Cell Transplantation Program and the National Cord Blood Inventory program. (These programs help match patients in need of a transplant with unrelated bone marrow and cord blood donors.)

The Department of Health and Human Services (HHS) must review the state of the science of using adult stem cells and birthing tissues to develop new therapies and consider the inclusion of new therapies in the C.W. Bill Young Cell Transplantation Program. (Sec. 3) Requirements for HHS contracts under the Stem Cell Therapeutic and Research Act of 2005 are revised.

(Sec. 4) HHS must determine whether to include peripheral blood stem cells and umbilical cord blood in the definition of human organ.

Date: 2015-06-18
Topic: Health (R&D)
Subject: Health
Neglected Infections of Impoverished Americans Act of 2015

This bill requires the Department of Health and Human Services to report to Congress on the epidemiology of, impact of, and appropriate funding required to address neglected diseases of poverty, including Chagas disease, cysticercosis, toxocariasis, toxoplasmosis, trichomoniasis, soil-transmitted helminth infection, and other related diseases. The report should provide the information necessary to guide future health policy to evaluate the current state of knowledge concerning such diseases and address the threat of such diseases.

Date: 2015-06-25
Topic: Health (R&D)
Subject: Health
Patients First Act of 2015

This bill amends the Public Health Service Act to require the Department of Health and Human Services (HHS) 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, provided that the 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.

HHS must issue guidelines 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.

HHS must report on peer reviewed stem cell research proposals that were not funded.

Date: 2015-06-25
Topic: Health (R&D)
Subject: Health
Treatment of Certain Payments in Eugenics Compensation Act

Excludes payments made under a state eugenics compensation program from classification as income or resources in determining eligibility for, or the amount of, any federal public benefit. Defines "state eugenics compensation program" as a state program for compensating individuals who were sterilized under the authority of the state.

Date: 2015-07-07
Topic: Health (R&D)
Subject: Social welfare
Research Excellence and Advancements for Dyslexia Act or the READ Act

(Sec. 3) This bill requires the National Science Foundation (NSF) to include in its annual congressional budget justification the amount requested for its Research in Disabilities Education program, which advances the goal of broadening the participation and achievement of learners with disabilities in science, technology, engineering, and mathematics.

(Sec. 4) Subject to the availability of appropriations, NSF must devote specified funding to support research on learning disabilities, including dyslexia, with the goal of practical application. 

Date: 2015-07-13
Topic: Health (R&D)
Subject: Education
Reducing Disparities Using Care Models and Education Act of 2015

This bill requires the Department of Health and Human Services (HHS) to contract with the National Academy of Medicine (formerly known as the Institute of Medicine) to study health disparities, existing programs and policies intended to reduce disparities, and priorities for, and expansion of, programs targeting disparities.

HHS must develop guidelines for entities to develop and implement programs to reduce health disparities. HHS must incorporate these guidelines into its activities.

HHS may award grants for programs to reduce health disparities.

The Innovation Center of the Centers for Medicare & Medicaid Services must test a payment and service delivery model that includes incentives for reducing health disparities.

Date: 2015-07-29
Topic: Health (R&D)
Subject: Health
Human Cloning Prohibition Act of 2105 

This bill amends the federal criminal code to prohibit human cloning for reproductive and research purposes.

Specifically, the bill makes it a crime for any public or private person or entity to:

 perform, attempt to perform, or participate in an attempt to perform human cloning; or ship, receive, or import a product of human cloning for any purpose. It defines "human cloning" as asexual reproduction by replacing a fertilized or unfertilized egg nucleus with a human somatic (body) cell nucleus to produce a living organism with a human or predominantly human genetic constitution.

A person or entity convicted of a human cloning offense is subject to a fine, up to 10 years in prison, or both. A person or entity who profits from such offense is also subject to a civil penalty of at least $1,000,000.

This bill does not restrict scientific research using nuclear transfer or other cloning techniques to produce molecules, DNA, cells other than human embryos, tissues, organs, plants, or animals other than humans.

Date: 2015-09-11
Topic: Health (R&D)
Subject: Crime and law enforcement
Gestational Diabetes Act of 2015 or the GEDI Act

This bill amends the Public Health Service Act to direct 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. 

The Department of Health and Human Services (HHS) must 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.

The CDC must: (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: 2015-09-30
Topic: Health (R&D)
Subject: Health
Scleroderma and Fibrosis Research Enhancement Act of 2015

This bill requires the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) to establish the National Commission on Scleroderma and Fibrosis Research. (Scleroderma and fibrosis are connective tissue conditions that cause hardening or scarring of skin and organs.)

The commission must develop a long-term, comprehensive plan for scleroderma and fibrosis research. The plan must: (1) prioritize research that has cross-cutting value and requires coordination across NIH, and (2) include specific steps for implementation of the research.

The commission must establish working groups to make research recommendations for the various organs and systems impacted by fibrotic illness.

The commission must be terminated not later than two years after establishment.

The NIAMS must create the Scleroderma and Fibrosis Working Group to oversee and assist with implementation of the long-term plan.

Date: 2015-10-01
Topic: Health (R&D)
Subject: Health
Rare Disease Fund Act or the RaD Fund Act

This bill requires the National Institutes of Health (NIH) to organize the Rare Disease Therapeutics Corporation to purchase rights to, fund the development of, and sell ownership interests in drugs, biological products, and medical devices for rare diseases.

The NIH must sell stock in the corporation to investors as soon as practicable. The corporation and the NIH may enter into an agreement under which the NIH maintains an ownership interest in the corporation in exchange for providing the corporation with intellectual property or other assistance. The corporation is prohibited from paying dividends on its stock.

The corporation must sell its interest in a rare disease therapy prior to the therapy entering large-scale clinical trials.

The corporation must issue bonds guaranteed by the United States and may issue bonds backed by the corporation. For purposes of securities laws, the securities of the corporation are not issued or guaranteed by the federal government.

The bill establishes within the NIH the Rare Disease Therapeutics Corporation Science Advisory Council to advise the corporation on the purchase, sale, and development of rare disease therapies.

Date: 2015-10-09
Topic: Health (R&D)
Subject: Health
Congenital Heart Futures Reauthorization Act of 2015

This bill amends the Public Health Service Act to replace the authorization for a National Congenital Heart Disease Surveillance System with a requirement for the Centers for Disease Control and Prevention (CDC), regarding congenital heart disease, to enhance and expand research and surveillance infrastructure, and plan and implement a public outreach and education campaign. (Congenital heart disease is a condition caused by a heart defect that is present at birth.)

The CDC must award grants to nonprofit entities to conduct: (1) a cohort study of congenital heart disease, from birth to adulthood, that considers health care utilization, demographic factors, and outcomes; and (2) an awareness, outreach, and education campaign regarding congenital heart disease.

The National Heart, Lung, and Blood Institute must report on its ongoing research efforts regarding congenital heart disease, future plans for such research, and areas of greatest need for such research.

Date: 2015-11-05
Topic: Health (R&D)
Subject: Health
Adding Zika Virus to the FDA Priority Review Voucher Program Act

This bill amends the Federal Food, Drug, and Cosmetic Act to add the Zika virus to the list of tropical diseases under the priority review voucher program, which awards a voucher to the sponsor of a new drug or biological product that is approved to prevent or treat a tropical disease. (A voucher entitles the holder to have a future new drug or biological product application acted upon by the Food and Drug Administration within six months.)

Date: 2016-02-01
Topic: Health (R&D)
Subject: Health
Firefighter Cancer Registry Act of 2016

This bill requires the Centers for Disease Control and Prevention (CDC) to develop and maintain a voluntary patient registry to monitor, collect, and make available epidemiological information related to cancer incidence and trends among firefighters. The CDC should seek to include specified information in the registry, including the number and type of fire incidents attended by an individual.

To collect information for the registry, the CDC may incorporate questions into existing public health surveys, questionnaires, and other databases.

The CDC must: (1) encourage the inclusion in the registry of data on minority, female, and volunteer firefighters; and (2) seek feedback on the registry from nonfederal experts.

The CDC must develop an approval process for making registry data available for research without a fee if findings or publications derived from the research are made public or available to stakeholders.

Date: 2016-02-25
Topic: Health (R&D)
Subject: Health
(Sec. 1) This bill requires the Department of Health and Human Services to convene a Pain Management Best Practices Inter-Agency Task Force to: (1) review, modify, and update best practices for pain management and prescribing pain medication; and (2) examine and identify the need for, development of, and availability of medical alternatives to opioids (drugs with effects similar to opium, such as certain pain medications).

The task force must submit a report that includes: (1) the modified and updated best practices; (2) a strategy for disseminating the best practices; (3) the feasibility of linking the best practices to Drug Enforcement Administration registration of manufacturers, distributors, and dispensers of controlled substances; (4) recommendations for effectively applying the best practices at medical facilities; and (5) recommendations regarding medical alternatives to opioids.

Date: 2016-02-26
Topic: Health (R&D)
Subject: Health
Ensuring Useful Research Expenditures is Key for Alzheimer's Act or the EUREKA Act

This bill amends the Public Health Service Act to require the National Institutes of Health (NIH) to establish EUREKA prize competitions to achieve high-priority breakthroughs in Alzheimer's disease and dementia prevention, diagnosis, treatment, and care.

The NIH must: (1) convene an advisory council of nongovernmental experts in Alzheimer's disease and dementia to develop the EUREKA prize competitions, and (2) appoint a panel of judges to evaluate submissions. The council and panel are not subject to the Federal Advisory Committee Act.

Support for EUREKA prize competitions may be provided by private organizations and individuals.

Date: 2016-04-27
Topic: Health (R&D)
Subject: Health
Fourth Amendment Integrity Restoration in Surveillance Act of 2016 or the F.A.I.R. Surveillance Act of 2016

This bill specifies that an agreement between a federal and state or local law enforcement agency regarding the acquisition or use of a cell simulator device must require such state or local law enforcement agency to use the device in compliance with the federal agency's guidance and policies.

The term "cell simulator device" means a device that: (1) simulates a cell tower to provide an electronic communication service, or (2) functions as a cell tower to locate cellular devices or identify their unique identifiers.

Date: 2016-04-29
Topic: Health (R&D)
Subject: Crime and law enforcement
Cyber Act of War Act of 2016

This bill directs the President to: (1) develop a policy for determining when an action carried out in cyberspace constitutes a use of force against the United States, and (2) revise the Department of Defense Law of War Manual accordingly.

In developing this policy, the President shall consider: (1) the ways in which a cyber attack's effects may be equivalent to a conventional attack's effects, including physical destruction or casualties; and (2) intangible effects of significant scope or duration.

Date: 2016-05-12
Topic: Health (R&D)
Subject: International affairs
Safe Treatments and Opportunities to Prevent Pain Act or the STOP Pain Act

This bill authorizes the National Institutes of Health (NIH) to intensify and coordinate NIH research into the understanding of pain, therapies for chronic pain, and alternatives to opioids (drugs with effects similar to opium) for pain treatments.

The prioritization and direction of federally funded pain research must consider recommendations made by the Interagency Pain Research Coordinating Committee.

Date: 2016-05-16
Topic: Health (R&D)
Subject: Health
FDA Cross-Center Collaboration Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish one or more Intercenter Institutes. Each institute must coordinate activities applicable to a major disease area among the FDA centers that review products. Activities may include coordinating staff with relevant expertise, streamlining product review, and enhancing interactions with patients, sponsors, and the biomedical community.

Date: 2016-06-08
Topic: Health (R&D)
Subject: Health
United States-Israel Alzheimer's Disease Cooperation Act

This bill directs the Department of Health and Human Services (HHS) to establish a program of grants to support research on the development and commercialization of tools, treatments, and cures for Alzheimer's disease and other dementias. Supported projects must be joint ventures between U.S. and Israeli non-governmental entities or the U.S. and Israeli governments.

 HHS must establish an advisory board to monitor the method by which grants are awarded and to provide performance reviews of actions taken to carry out this bill.

Date: 2016-07-06
Topic: Health (R&D)
Subject: Health
Ellie Helton, Lisa Colagrossi, Teresa Anne Lawrence, and Jennifer Sedney Focused Research Act or Ellie's Law

This bill authorizes the National Institute of Neurological Disorders and Stroke to conduct or support research on unruptured brain aneurysms in a patient population diversified by age, sex, and race.

Date: 2016-09-27
Topic: Health (R&D)
Subject: Health
Enhancing Minority and Women Representation in NIH Medical Research Act of 2016

This bill amends the Public Health Service Act to require the National Institutes of Health (NIH), in assessing research priorities, to publish data on certain clinical research study populations. The NIH must foster collaboration among clinical research projects that use human subjects and that collect similar data to increase the number and diversity of subjects.

The strategic plans of the national research institutes must ensure that future activities take into account women and minorities and are focused on reducing health disparities. Advisory council reports must include certain demographic data for clinical research subjects. The results of NIH-funded clinical trials that include women and minorities must be submitted to NIH's clinical trial data bank.

The National Institute on Minority Health and Health Disparities may foster partnerships among the national research institutes and encourage the funding of collaborative research projects to achieve NIH goals related to minority health and health disparities.

The NIH must develop policies for NIH-funded basic research projects to assess how differences between male and female cells, tissues, or animals may be examined and analyzed.

Date: 2016-09-28
Topic: Health (R&D)
Subject: Health
Ethical Stem Cell Research Tax Credit Act of 2015

Amends the Internal Revenue Code to allow a tax credit for 30% of qualified stem cell research expenses paid or incurred in a taxable year. Defines "qualified stem cell research expenses" as expenses for carrying out 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. Prohibits a tax credit for any research expenses that may involve: (1) the creation of a human embryo for research purposes; (2) the destruction of or discarding of, or risk of injury to, a human embryo; or (3) the use of any stem cell for prohibited purposes.

Date: 2015-01-07
Topic: Health (R&D)
Subject: Taxation
This measure has not been amended since it was introduced. The expanded summary of the Senate-passed version is repeated here.) Ensuring Access to Clinical Trials Act of 2015 

(Sec. 2) This bill amends the Improving Access to Clinical Trials Act of 2009 to repeal the sunset of, and so extend indefinitely, the exclusion from resources under titles XVI (Supplemental Security Income) and XIX (Medicaid) of the Social Security Act, for eligibility purposes, of compensation in the amount of the first $2,000 per year received by individuals who participate in clinical trials for rare diseases or conditions.

Date: 2015-01-08
Topic: Health (R&D)
Subject: Health
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.

Date: 2015-01-28
Topic: Health (R&D)
Subject: Health
Accelerating Biomedical Research 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 to the National Institutes of Health at the Department of Health and Human Services.

Date: 2015-01-29
Topic: Health (R&D)
Subject: Health
Medical Innovation Act of 2015

This bill amends the Public Health Service Act to require certain drug manufacturers to make payments to fund research supported by the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).

A drug manufacturer with over $1 billion in net income in a fiscal year that has entered into a settlement agreement in the previous five years with a federal agency regarding specified violations must pay 1% of its net income to the Department of Health and Human Services (HHS) for each of its covered blockbuster drugs. A covered blockbuster drug is a drug that has at least $1 billion in net sales in a year and was developed, in whole or in part, through federal investments in medical research, including a drug for which a patent contains information that relates to, or is based upon, federally-funded research.

Each fiscal year, HHS must publish a list of manufacturers that make payments, each manufacturer's covered blockbuster drugs, and payment amounts.

Payments are divided between the FDA and the NIH in proportion to the discretionary funding of those agencies, excluding FDA user fees. Payments are not disbursed if appropriations for the FDA or the NIH are lower than in the prior fiscal year.

The FDA's priority use for payments must include advancing regulatory science for medical products.

The NIH's priority use for payments must include supporting: (1) research that fosters radical innovation, (2) research that advances fundamental knowledge, (3) research related to diseases that disproportionately account for federal health care spending, and (4) early career scientists.

A covered blockbuster drug for which a manufacturer has not made a required payment is considered misbranded and cannot be sold until payment is made.

Date: 2015-01-29
Topic: Health (R&D)
Subject: Health
Accelerating the End of Breast Cancer Act of 2015

Establishes the Commission to Accelerate the End of Breast Cancer to help end breast cancer by January 1, 2020.

Directs the Commission to identify, recommend, and promote initiatives, partnerships, and research that can be turned into strategies to prevent breast cancer and breast cancer metastasis while giving priority to those that are: (1) not prioritized in the public sector, and (2) unlikely to be achieved by the private sector due to technical and financial uncertainty.

Requires the Commission to: (1) submit within six months to the President and to the relevant congressional committees a description of the Commission's strategic plan; (2) submit an annual report to the President, Congress, and the public; and (3) ensure that its activities are coordinated with, and not duplicative of, programs and laboratories of other government agencies.

Directs the President to enter into an agreement with the Institute of Medicine to evaluate the Commission's progress.

Terminates the Commission on June 1, 2020.

Date: 2015-03-16
Topic: Health (R&D)
Subject: Health