Summary:
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.

medical innovation_act bill amends public_health_service_act require certain drug manufacturers payments fund research supported food_and_drug_administration fda national_institutes_of_health nih drug manufacturer billion net income fiscal year entered settlement agreement previous years federal agency specified violations pay net income department_of_health_and_human_services hhs covered drugs covered drug drug billion net sales year developed federal investments medical research including drug patent contains information relates based federally funded research fiscal year hhs publish list manufacturers payments manufacturer covered drugs payment amounts payments divided fda nih proportion discretionary funding agencies excluding fda user fees payments disbursed appropriations fda nih lower prior fiscal year fda priority use payments include advancing regulatory science medical products nih priority use payments include supporting research fosters innovation research advances fundamental knowledge research related diseases disproportionately account federal health_care spending early career scientists covered drug manufacturer required payment considered misbranded sold payment


Summary:
Permanent Investment in Health Research Act of 2015

This bill amends the Public Health Service Act to make appropriations to the National Institutes of Health (NIH) for FY2016-FY2025:

 for FY2016, $32 billion; and for each fiscal year from FY2017-FY2025, the amount appropriated for the preceding fiscal year, adjusted by any percentage increase in nominal gross domestic product during the preceding calendar year. The bill amends the Balanced Budget and Emergency Deficit Control Act of 1985 (Gramm-Rudman-Hollings Act) to add NIH to the list of programs and activities exempt 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.

permanent investment health research_act bill amends public_health_service_act appropriations national_institutes_of_health nih fy2016 fy2025 fy2016 billion fiscal year fy2017 fy2025 appropriated preceding fiscal year adjusted percentage increase nominal gross domestic product preceding calendar year bill amends balanced_budget emergency deficit control act gramm rudman hollings act add nih list programs activities exempt sequestration sequestration process automatic usually board spending reductions budgetary resources permanently cancelled enforce specific budget policy goals


Summary:
Tick-Borne Disease Research Accountability and Transparency Act of 2015

Amends the Public Health Service Act to require the Department of Health and Human Services (HHS) to conduct or support epidemiological, basic, translational, and clinical research regarding Lyme disease and other tick-borne diseases.

Directs HHS to establish the Interagency Lyme and Tick-Borne Disease Working Group to review all HHS efforts concerning tick-borne diseases to ensure interagency coordination and examine research priorities. Requires the Working Group to: (1) provide a summary of tick-borne disease research, advances, and scientific viewpoints every two years; (2) make recommendations to HHS regarding tick-borne disease activities; and (3) hold annual public meetings.

Requires HHS to submit a strategic plan for tick-borne disease research within three years of enactment and every five years thereafter that includes: (1) budgetary requirements; (2) benchmarks for improving tick-borne disease diagnosis, treatment, outcomes, and prevention; and (3) a plan to disseminate Working Group summaries and other relevant information on tick-borne disease to health professionals and the public.

tick borne disease research accountability transparency_act amends public_health_service_act require department_of_health_and_human_services hhs conduct support epidemiological basic translational clinical research lyme disease tick borne diseases directs hhs establish interagency lyme tick borne disease working_group review hhs efforts concerning tick borne diseases ensure interagency coordination examine research priorities requires working_group provide summary tick borne disease research advances scientific viewpoints years recommendations hhs tick borne disease activities hold annual public meetings requires hhs submit strategic plan tick borne disease research years enactment years includes budgetary requirements benchmarks improving tick borne disease diagnosis treatment outcomes prevention plan disseminate working_group summaries relevant information tick borne disease health professionals public


Summary:
Expanding the Availability of Medicare Data Act

Expands the kinds of uses of Medicare data available to qualified entities for quality and patient care improvement activities.

(A "qualified entity" is a public or private entity that: [1] is qualified to use claims data to evaluate the performance of service providers and suppliers on measures of quality, efficiency, effectiveness, and resource use; and [2] agrees to meet specified requirements, such as ensuring data security.) Authorizes a qualified entity to use claims data combined with non-claims data the entity has received, as well as information derived from evaluation of service provider and supplier performance, to conduct additional non-public analyses and provide or sell them to authorized users for non-public use (including to assist service providers and suppliers to develop and participate in quality and patient care improvement activities, including new models of care).

Defines "authorized users" as service providers, suppliers, employers, health insurance issuers, medical societies or hospital associations, or any other entities approved by the Secretary of Health and Human Services.

Prohibits a qualified entity from charging a fee to provide Medicare claims data.

Requires a qualified entity and an authorized user to enter into a data use agreement, and prohibits the use of data or analyses for marketing purposes or, except in certain circumstances, its redisclosure.

Directs the Secretary to provide Medicare data to qualified clinical data registries for purposes of linking it with clinical outcomes data and performing risk-adjusted, scientifically valid analyses and research to support quality improvement or patient safety. Requires charging a fee to a registry for such data.

Amends title XVIII (Medicare) of the Social Security Act (SSAct) to include among standardized extracts of Medicare claims data that may be made available to qualified entities, if the Secretary determines appropriate, also claims data under SSAct titles XIX (Medicaid) and XXI (State Children's Health Insurance) (CHIP).

Requires any fees charged for making standardized extracts available to qualified entities to be deposited into the Centers for Medicare & Medicaid Services Program Management Account (currently, into the Federal Supplementary Medical Insurance Trust Fund).

expanding availability medicare data act expands kinds uses medicare data available qualified entities quality patient care improvement activities qualified entity public private entity qualified use claims data evaluate performance service providers suppliers measures quality efficiency effectiveness resource use agrees meet specified requirements ensuring data_security authorizes qualified entity use claims data combined non claims data entity received information derived evaluation service provider supplier performance conduct additional non public analyses provide sell authorized users non public use including assist service providers suppliers develop participate quality patient care improvement activities including new models care defines authorized users service providers suppliers employers health insurance issuers medical societies hospital associations entities approved secretary health_and_human_services prohibits qualified entity charging fee provide medicare claims data requires qualified entity authorized user enter data use agreement prohibits use data analyses marketing purposes certain circumstances directs secretary provide medicare data qualified clinical data registries purposes linking clinical outcomes data performing risk adjusted scientifically valid analyses research support quality improvement patient safety requires charging fee registry data amends title xviii medicare social_security_act ssact include standardized medicare claims data available qualified entities secretary determines appropriate claims data ssact titles xix medicaid xxi state children health insurance chip requires fees charged making standardized available qualified entities deposited centers medicare medicaid_services program management account currently federal_supplementary_medical_insurance_trust_fund


Summary:
Facilitating Participation in Clinical Data Registries Act of 2015

This bill requires the Office for Human Research Protections of the Department of Health and Human Services to issue guidance within one year on the application of the Common Rule, which provides protections for human research subjects, to clinical data registries.

facilitating participation clinical data registries act bill requires office human research protections department_of_health_and_human_services issue guidance year application common rule provides protections human research subjects clinical data registries


Summary:
Accelerating the End of Breast Cancer Act of 2015

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

Directs the Commission to: (1) identify opportunities and ideas within government and the private sector that are key components in achieving the end of breast cancer and which have been overlooked, yet are ripe for collaboration and investment; (2) recommend projects to leverage such opportunities and ideas in the areas of the primary prevention of breast cancer and the causes and prevention of breast cancer metastasis; and (3) ensure that its activities are coordinated with, and do not duplicate the efforts of, programs and laboratories of other government agencies.

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

Terminates the Commission on June 1, 2020.

accelerating end breast cancer act directs president establish commission accelerate end breast cancer help end breast cancer january directs commission identify opportunities ideas government private sector key components achieving end breast cancer ripe collaboration investment recommend projects leverage opportunities ideas areas primary prevention breast cancer causes prevention breast cancer ensure activities coordinated duplicate efforts programs laboratories government agencies directs president enter agreement institute_of_medicine evaluation commission progress terminates commission june


Summary:
America's Fund for Future Opportunities and Outcomes in the United States Act of 2015 or the America's FOCUS Act of 2015

Establishes a separate account in the U.S. Treasury to be known as the America's FOCUS Fund, into which shall be deposited: (1) revenue generated by civil and criminal fines and penalties for violations or alleged violations of federal law; (2) revenue generated by legal settlements reached between corporations and the federal government for violations or alleged violations of federal law; and (3) gifts, bequests, or donations to the Fund from private entities or individuals.

Requires that, of the total revenue in the Fund: (1) up to 33% be used to award grants for youth mentoring and science, technology, engineering, and mathematics (STEM) education; (2) up to 33% be used to award grants for justice reinvestment; (3) up to 33% be used to award grants and prizes for innovations in medical research and development; and (4) the remaining revenue be used to reduce the federal budget deficit or, if there is no deficit, to reduce the federal debt.

Directs the Secretary of Education to award the grants for youth mentoring programs, and the Associate Administrator for Education for the National Aeronautics and Space Administration (NASA) to award the grants for STEM education programs, to: (1) national non-profit, community-based organizations with at least two years of experience in administering such programs; and (2) state or local governments.

Requires that, of the funds available for justice reinvestment, the Department of Justice (DOJ): (1) award 50% to state and local governments for justice reinvestment projects, (2) use up to 25% of the funds to support federal justice reinvestment projects, and (3) allocate up to 25% of the funds to grant programs established under the Second Chance Act within DOJ.

Requires the Director of the National Institutes of Health to use the revenue designated for medical innovation to fund entities that conduct innovative medical research and development. Authorizes the Director to use up to 15% of those funds to award monetary prizes to entities that have used their own funding and research facilities to produce innovative results.

Requires that the grant funds be used to supplement, not supplant, other federal, state, and local funds designated to carry out those activities.

america fund future opportunities outcomes united_states act america focus act establishes separate account treasury known america focus fund shall deposited revenue generated civil criminal fines penalties violations alleged violations federal law revenue generated legal settlements reached corporations federal_government violations alleged violations federal law gifts bequests donations fund private entities individuals requires total revenue fund award grants youth mentoring science technology engineering mathematics stem education award grants justice reinvestment award grants prizes innovations medical research development remaining revenue reduce federal budget deficit deficit reduce federal debt directs secretary education award grants youth mentoring programs associate_administrator education national_aeronautics_and_space_administration nasa award grants stem education programs national non profit community based organizations years experience administering programs state local governments requires funds available justice reinvestment department_of_justice doj award state local governments justice reinvestment projects use funds support federal justice reinvestment projects allocate funds grant programs established second chance act doj requires director national_institutes_of_health use revenue designated medical innovation fund entities conduct innovative medical research development authorizes director use funds award monetary prizes entities funding research facilities produce innovative results requires grant funds supplement supplant federal state local funds designated carry activities


Summary:
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.

global brain health act directs agency international_development usaid establish administer health education grant program global autism assistance program support activities nongovernmental organizations service providers including advocacy groups focused autism developing countries establish teach teachers program train health education professionals working autistic children developing countries amends foreign assistance_act authorize president provide assistance support network trained medical practitioners treat children pediatric hospitals treatment centers developing countries requires assistance provide surgeon training establishment treatment centers directs secretary health_and_human_services negotiate world_health_organization develop plan addressing alzheimer disease forms dementia globally known global alzheimer disease dementia action plan seek establish global alzheimer disease dementia fund support implementation global alzheimer disease dementia action plan expresses sense congress group nations working group nations group seven nations organizations investigate systems monitor provide care individuals alzheimer disease forms dementia developing countries directs president appoint high level official lead federal efforts develop global alzheimer disease dementia action plan global alzheimer disease dementia fund facilitate partnerships federal_government private sector identify new treatment approaches alzheimer disease forms dementia directs administrator usaid investigate foreign aid implications alzheimer disease forms dementia


Summary:
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.

enhancing visibility medical rehabilitation research nih act bill amends public_health_service_act revise requirements medical rehabilitation research purpose national center medical rehabilitation research revised include coordination research research training develop periodically update comprehensive research plan medical rehabilitation research currently research plan developed updated eunice kennedy shriver national institute child health human development annually report progress achieving objectives benchmarks guiding principles described research plan develop guidelines governing funding medical rehabilitation research national_institutes_of_health medical rehabilitation coordinating committee periodically host scientific conference workshop medical rehabilitation research department_of_health_and_human_services enter interagency agreements coordinate medical rehabilitation research


Summary:
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.

integrated electronic health records military veterans act_-_directs secretaries_of_defense dod veterans_affairs jointly carry program award cash prize million contract entity develops fully integrated electronic health records program national use dod directs secretaries widely advertise prize competitions announce federal_register create joint panel establish criteria program development requires prize recipient awarded contract dod provide program including maintenance support compensated million year years reverts federal_government period intellectual property developed contract authorizes secretaries require competition participants waive claims federal_government willful conduct arising participation requires participants obtain liability insurance


Summary:
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.

vaccine safety study act requires national_institutes_of_health nih conduct comprehensive study compare total health outcomes including incidence risk autism vaccinated populations determine exposure vaccines vaccine components associated autism spectrum disorders chronic conditions neurological conditions requires nih seek include study populations traditionally remained religious reasons directs nih ensure preservation data collected purposes study facilitate research nih declares act shall construed authorize conduct support study individual population encouraged remain


Summary:
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.

end neglected tropical diseases act bill expands programs address neglected tropical diseases infections caused pathogens including viruses microbes disproportionately impact individuals living extreme poverty especially developing countries program agency international_development expanded including adding morbidity management treatment plans addressing additional establishing research development program bill amends state_department basic authorities act expand duties coordinator united_states_government activities combat hiv aids globally include coordination hiv aids activities activities particularly areas highly female disease president direct representatives united_nations international bank reconstruction development urge actions including programs department_of_health_and_human_services continue promote need programs activities interagency groups international forums centers_for_disease_control_and_prevention report congress united_states bill amends public_health_service_act authorize national_institute_of_allergy_and_infectious_diseases health_resources_and_services_administration support centers_of_excellence research training treatment national_institutes_of_health establish panel evaluate issues relating infections including potential solutions medicines


Summary:
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.

consortium act bill amends public_health_service_act require national_institutes_of_health establish administer coordinate national consortium award grants research causes risk factors biomarkers associated neurological disease leading blindness paralysis assemble panel experts provide ongoing guidance recommendations research design protocols designate central laboratory collect analyze aggregate data research data analysis available researchers


Summary:
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.

american cures act bill amends balanced_budget emergency deficit control act require certain adjustments discretionary spending limits fy2016 fy2021 accommodate increases appropriations agencies perform biomedical research adjustments required national_institutes_of_health centers diseases control prevention department_of_defense health program department_of_veterans_affairs medical prosthetics research program bill requires annual appropriations programs agencies referenced bill appropriated fy2015 bill exempts appropriations provided pursuant bill sequestration sequestration process automatic usually board spending reductions budgetary resources permanently cancelled enforce specific budget policy goals


Summary:
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.

breast cancer research stamp reauthorization act bill reauthorizes december provisions requiring postal_service issue special postage stamp class mail costs regular class stamp raise funds breast cancer research agencies receiving funds postal_service use breast cancer research


Summary:
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.

functional disorders research enhancement_act bill amends public_health_service_act require national_institutes_of_health expand intensify coordinate activities respect functional disorders including expanding basic clinical research implementing research recommendations national_commission diseases providing support establishment centers_of_excellence supporting innovative approaches educating health_care providers patients strategies improve patient provider relationships care directing national institute diabetes kidney diseases provide necessary funding continued expansion advancement research portfolio directing eunice kennedy shriver national institute child health human development expand research impact children department_of_health_and_human_services engage public awareness education activities increase understanding recognition


Summary:
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.

advancing research act amends public_health_service_act require centers_for_disease_control_and_prevention enhance expand infrastructure activities track epidemiology condition fluid brain incorporate information obtained activities national surveillance system requires department_of_health_and_human_services hhs ensure system facilitates research requires hhs provide collection storage information including incidence prevalence information extent practicable requires hhs information analysis system available public including researchers ensure privacy security protections applicable system stringent protections health_insurance_portability_and_accountability_act


Summary:
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.

stop tampering prescription act bill amends federal food drug cosmetic act require food_and_drug_administration fda deny approval new oral opioid drug effects similar opium properties drug significantly difficult abuse abuse deterrent drug containing opioid available fda approve opioid drug abuse deterrent approval necessary prevent alleviate drug shortage address significant unmet public health need approved fda generic version abuse deterrent brand drug abuse deterrent active components differ material respect brand drug approved generic drug therapeutic effect brand drug abuse deterrent generic drug abuse deterrent approval generic oral opioid withdrawn brand drug abuse deterrent available approved abuse deterrent drug available contains opioid dose approval oral opioid withdrawn drug abuse deterrent approved abuse deterrent drug available contains opioid withdrawal approval waived fda drug intended special needs population fda delay withdrawal drug sponsor opportunity obtain approval abuse deterrent formulation drug


Summary:
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.

bill amends federal food drug cosmetic act require food_and_drug_administration fda establish processes entity seeking develop patient experience data submit initial research concepts feedback fda request receive entity draft guidance documents data summaries analyses data patient experience data considered risk benefit assessment new drug patient experience data data collected patients intended facilitate fda risk benefit assessments including information impact disease therapy patients lives fda convene workshops publish guidance patient experience data processes described


Summary:
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.

bill amends public_health_service_act require director national_institutes_of_health nih appoint directors national research institutes national centers excluding national_cancer_institute instead secretary health_and_human_services hhs directors appointed director nih year terms bill amends departments_of_labor health_and_human_services education related agencies appropriations act remove provision makes appropriations available compensation consultants individual scientists appointed limited periods time public_health_service national research institute national center awards grant research project series grant director institute center review approve award taking consideration mission priorities institute center agencies funding projects accomplish goal hhs enter arrangement national academy medicine known institute_of_medicine study completed extent federally funded biomedical research duplicative recommendations preventing duplication


Summary: 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.

bill amends federal food drug cosmetic act define valid scientific evidence include documented case histories studies published peer reviewed purposes food_and_drug_administration fda determining effectiveness medical device clinical investigation specified conditions fda request data underlying study offered valid scientific evidence


Summary:
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.

bill amends federal food drug cosmetic act require food_and_drug_administration fda provide opportunity person premarket submission medical device subject review classification panel provide recommendations expertise needed members panel fda consider recommendations ensure panels include members expertise clinically relevant device member knowledgeable technology device person device review designate representative accompanied experts participate panel meetings


Summary: 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.

bill amends federal food drug cosmetic act revise board_of_directors membership executive director compensation accounting reagan udall foundation food_and_drug_administration


Summary:
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.

bill requires national_institutes_of_health nih convene workshop days enactment act appropriate age groupings age exclusions human research later days conclusion workshop nih publish guidelines addressing consideration age human research nih publish number children included nih research disaggregated age group race gender


Summary:
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.

bill amends public_health_service_act revise senior biomedical research service remove limit number members expand eligibility appointment set maximum pay rate remove option members contribute retirement system institution higher education department_of_health_and_human_services report implementation amendments including amendments improved ability food_and_drug_administration hire retain qualified experts fulfill obligations user fee agreements


Summary:
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.

bill amends public_health_service_act require department_of_health_and_human_services hhs establish loan repayment program health professionals engaging research maximum awards loan repayment programs minority health disparities research aids research research respect contraception infertility research employee national_institutes_of_health clinical researchers disadvantaged backgrounds clinical researchers pediatric research increased adjusted inflation hhs


Summary: 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.

bill expresses sense congress participation sponsorship scientific conferences meetings essential mission food_and_drug_administration


Summary:
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.

bill amends public_health_service_act require national_institutes_of_health nih develop maintain biomedical research strategic plan nih use strategic plan identify research opportunities develop individual strategic plans national research institutes national centers strategic plans identify strategic focus areas manner considers return investment biomedical research contributes expanding knowledge improve public health strategic focus areas include mission priority focus areas serve goal preventing eliminating burden medical condition nih ensure rare pediatric diseases conditions remain priority strategic plan publish initial strategic plan days conduct progress reviews strategic focus area annually update strategic plan years


Summary: 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.

bill amends public_health_service_act require national research institute conduct support high risk high reward research innovative approaches major biomedical challenges national_institutes_of_health determines percentage funding national research institute set aside research


Summary: 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.

bill amends public_health_service_act allow national_institutes_of_health nih require sharing scientific data generated research fully funded nih


Summary:
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.)

clinical awareness research education act care act bill amends public_health_service_act require national_institutes_of_health nih strengthen coordinate efforts concerning condition blood vessels brain spinal cord lead seizures paralysis hearing vision loss brain nih award grants enter cooperative agreements research nih award grants contracts plan provide support network clinical research centers identify support additional centers facilitate medical research develop cure enhance medical care convene research consortium develop programs clinicians scientists patients centers_for_disease_control_and_prevention award grants enter cooperative agreements collection analysis reporting data department_of_health_and_human_services award grants enter cooperative agreements epidemiological activities related provide national surveillance program food_and_drug_administration coordinate clinical centers investigators advocates support investigational new drug applications order clinical trials support appropriate requests designation drugs use rare subpopulations patients orphan drugs orphan drugs drugs developed treat rare medical conditions eligible certain incentives


Summary:
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.

pediatric research improvement act bill amends public_health_service_act revise pediatric research initiative require collaboration eunice kennedy shriver national institute child health human development require establishment national pediatric research network comprised pediatric research consortia national_institutes_of_health award funding entities supporting pediatric research consortia supported consortia request provide assistance centers_for_disease_control_and_prevention patient registries surveillance systems


Summary:
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.

bill amends act require department_of_health_and_human_services hhs revise clarify privacy rule established health_insurance_portability_and_accountability_act hipaa allow use disclosure protected health information research purposes individual authorization approval institutional review board privacy board representations limited use information disclosures entities subject hipaa health_care operations business associates complying privacy rule health_care operations data aggregation limitation payments disclosures currently payment limited cost prepare transmit information individual protected health information disclosed authorization agreement individual research related product activity regulated food_and_drug_administration allowed remote access protected health information security privacy safeguards maintained retain information individual authorization use protected health information future research sufficient research purpose authorization reasonably describes research provides instruction individual revoke authorization


Summary:
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.

professional access health workforce integration act directs_the_department_of_health_and_human_services acting bureau health workforce health_resources_and_services_administration national institute minority health health disparities office_of_minority_health hhs award grants eligible entities provide services assist unemployed skilled immigrants residing united_states legal permanent work authorization internationally educated health professionals entering advancing american health workforce employment matching health professional skills education expertise provide training opportunities reduce barriers entry advancement health workforce skilled internationally educated immigrants educate employers abilities capacities internationally educated health professionals assist evaluation foreign credentials facilitate access accelerated courses english second language includes eligible entity clinical public health health services organization community based nonprofit entity academic institution faith based organization state county local government area health education center submits application meets hhs requirements defines health professional individual trained employment intended employment specified fields including public health health management dentistry health administration medicine nursing pharmacy psychology social work psychiatry mental behavioral health allied health community health wellness work


Summary:
(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.

measure amended reported senate december summary version repeated stem cell therapeutic research reauthorization act sec bill amends public_health_service_act stem cell therapeutic research_act revise extend fy2020 bill young cell transplantation program national cord blood inventory program programs help match patients need transplant unrelated bone marrow cord blood donors department_of_health_and_human_services hhs review state science adult stem cells tissues develop new therapies consider inclusion new therapies bill young cell transplantation program sec requirements hhs contracts stem cell therapeutic research_act revised sec hhs determine include peripheral blood stem cells umbilical cord blood definition human organ


Summary:
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.

neglected infections impoverished americans act bill requires department_of_health_and_human_services report congress epidemiology impact appropriate funding required address neglected diseases poverty including disease soil transmitted infection related diseases report provide information necessary guide future health policy evaluate current state knowledge concerning diseases address threat diseases


Summary:
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.

patients act bill amends public_health_service_act require department_of_health_and_human_services hhs conduct support basic applied research develop techniques isolation production testing human clinical use stem cells result improved understanding treatments diseases adverse health conditions provided techniques involve creation human embryo research purposes destruction risk injury living human embryo use stem cell provision inconsistent act hhs issue guidelines ensure research including clinical trial supported act clearly consistent standards established act conducted human cells prioritized terms potential near term clinical benefit human patients hhs report peer reviewed stem cell research proposals funded


Summary:
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.

treatment certain payments compensation act excludes payments state compensation program classification income resources determining eligibility federal public benefit defines state compensation program state program compensating individuals authority state


Summary:
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.

research excellence advancements act read act sec bill requires national_science_foundation nsf include annual congressional_budget justification requested research disabilities education program advances goal broadening participation achievement learners disabilities science technology engineering mathematics sec subject availability appropriations nsf specified funding support research learning disabilities including goal practical application


Summary:
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.

reducing disparities care models education act bill requires department_of_health_and_human_services hhs contract national academy medicine known institute_of_medicine study health disparities existing programs policies intended reduce disparities priorities expansion programs targeting disparities hhs develop guidelines entities develop implement programs reduce health disparities hhs incorporate guidelines activities hhs award grants programs reduce health disparities innovation center centers medicare medicaid_services test payment service delivery model includes incentives reducing health disparities


Summary:
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.

human cloning prohibition act bill amends federal criminal code prohibit human cloning reproductive research purposes specifically bill makes crime public private person entity perform attempt perform participate attempt perform human cloning ship receive import product human cloning purpose defines human cloning reproduction replacing egg human somatic body cell produce living organism human predominantly human genetic constitution person entity convicted human cloning offense subject fine years prison person entity profits offense subject civil penalty bill restrict scientific research nuclear transfer cloning techniques produce dna cells human tissues organs plants animals humans


Summary:
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.

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


Summary:
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.

fibrosis research enhancement_act bill requires national institute musculoskeletal skin diseases establish national_commission fibrosis research fibrosis tissue conditions cause skin organs commission develop long term comprehensive plan fibrosis research plan prioritize research cross cutting value requires coordination nih include specific steps implementation research commission establish working groups research recommendations organs systems impacted illness commission terminated later years establishment create fibrosis working_group oversee assist implementation long term plan


Summary:
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.

rare disease fund act fund act bill requires national_institutes_of_health nih organize rare disease corporation purchase rights fund development sell ownership interests drugs biological products medical devices rare diseases nih sell stock corporation investors soon practicable corporation nih enter agreement nih maintains ownership interest corporation exchange providing corporation intellectual property assistance corporation prohibited paying dividends stock corporation sell interest rare disease therapy prior therapy entering large scale clinical trials corporation issue bonds guaranteed united_states issue bonds backed corporation purposes securities laws securities corporation issued guaranteed federal_government bill establishes nih rare disease corporation science advisory_council advise corporation purchase sale development rare disease therapies


Summary:
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.

congenital heart futures reauthorization act bill amends public_health_service_act replace authorization national congenital heart disease surveillance system requirement centers_for_disease_control_and_prevention cdc congenital heart disease enhance expand research surveillance infrastructure plan implement public outreach education campaign congenital heart disease condition caused heart defect present birth cdc award grants nonprofit entities conduct cohort study congenital heart disease birth adulthood considers health_care utilization demographic factors outcomes awareness outreach education campaign congenital heart disease national_heart lung blood_institute report ongoing research efforts congenital heart disease future plans research areas greatest need research


Summary:
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.)

adding zika virus fda priority review voucher program act bill amends federal food drug cosmetic act add zika virus list tropical diseases priority review voucher program awards voucher sponsor new drug biological product approved prevent treat tropical disease voucher entitles holder future new drug biological product application acted food_and_drug_administration months


Summary:
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.

firefighter cancer registry act bill requires centers_for_disease_control_and_prevention cdc develop maintain voluntary patient registry monitor collect available epidemiological information related cancer incidence trends firefighters cdc seek include specified information registry including number type fire incidents attended individual collect information registry cdc incorporate questions existing public health surveys databases cdc encourage inclusion registry data minority female volunteer firefighters seek feedback registry nonfederal experts cdc develop approval process making registry data available research fee findings publications derived research public available stakeholders


Summary:
(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.

sec bill requires department_of_health_and_human_services convene pain management best practices inter agency task_force review modify update best practices pain management prescribing pain medication examine identify need development availability medical alternatives opioids drugs effects similar opium certain pain medications task_force submit report includes modified updated best practices strategy disseminating best practices feasibility linking best practices drug_enforcement_administration registration manufacturers distributors dispensers controlled substances recommendations effectively applying best practices medical facilities recommendations medical alternatives opioids


Summary:
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.

ensuring useful research expenditures key alzheimer act act bill amends public_health_service_act require national_institutes_of_health nih establish prize competitions achieve high priority breakthroughs alzheimer disease dementia prevention diagnosis treatment care nih convene advisory_council nongovernmental experts alzheimer disease dementia develop prize competitions appoint panel judges evaluate submissions council panel subject federal_advisory_committee_act support prize competitions provided private organizations individuals


Summary:
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.

fourth amendment integrity restoration surveillance act surveillance act bill specifies agreement federal state local law enforcement agency acquisition use cell device require state local law enforcement agency use device compliance federal agency guidance policies term cell device means device cell tower provide electronic communication service functions cell tower locate cellular devices identify unique identifiers


Summary:
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.

cyber act war act bill directs president develop policy determining action carried cyberspace constitutes use force united_states revise department_of_defense law war manual accordingly developing policy president shall consider ways cyber attack effects equivalent conventional attack effects including physical destruction casualties intangible effects significant scope duration


Summary:
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.

safe treatments opportunities prevent pain act stop pain act bill authorizes national_institutes_of_health nih intensify coordinate nih research understanding pain therapies chronic pain alternatives opioids drugs effects similar opium pain treatments prioritization direction federally funded pain research consider recommendations interagency pain research coordinating committee


Summary:
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.

fda cross center collaboration act bill amends federal food drug cosmetic act require food_and_drug_administration fda establish institutes institute coordinate activities applicable major disease area fda centers review products activities include coordinating staff relevant expertise streamlining product review enhancing interactions patients sponsors biomedical community


Summary:
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.

united_states-israel alzheimer disease cooperation act bill directs_the_department_of_health_and_human_services hhs establish program grants support research development commercialization tools treatments cures alzheimer disease dementias supported projects joint ventures israeli non governmental entities israeli governments hhs establish advisory_board monitor method grants awarded provide performance reviews actions taken carry bill


Summary:
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.

lawrence focused research_act law bill authorizes national institute neurological disorders stroke conduct support research brain patient population diversified age sex race


Summary:
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.

enhancing minority women representation nih medical research_act bill amends public_health_service_act require national_institutes_of_health nih assessing research priorities publish data certain clinical research study populations nih foster collaboration clinical research projects use human subjects collect similar data increase number diversity subjects strategic plans national research institutes ensure future activities account women minorities focused reducing health disparities advisory_council reports include certain demographic data clinical research subjects results nih funded clinical trials include women minorities submitted nih clinical trial data bank national institute minority health health disparities foster partnerships national research institutes encourage funding collaborative research projects achieve nih goals related minority health health disparities nih develop policies nih funded basic research projects assess differences male female cells tissues animals examined analyzed


Summary:
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.

ethical stem cell research tax credit act amends_the_internal_revenue_code allow tax credit qualified stem cell research expenses paid incurred taxable year defines qualified stem cell research expenses expenses carrying basic applied research develop techniques isolation production testing human clinical use stem cells result improved understanding treatments diseases adverse health conditions prohibits tax credit research expenses involve creation human embryo research purposes destruction risk injury human embryo use stem cell prohibited purposes


Summary:
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.

measure amended introduced expanded summary senate passed version repeated ensuring access clinical trials act sec bill amends improving access clinical trials act repeal sunset extend indefinitely exclusion resources titles xvi supplemental security income xix medicaid social_security_act eligibility purposes compensation year received individuals participate clinical trials rare diseases conditions


Summary:
Collaborative Academic Research Efforts for Tourette Syndrome Act of 2015

Amends the Public Health Service Act to require the National Institutes of Health (NIH) to expand, intensify, and coordinate NIH research on Tourette syndrome.

Requires the NIH to develop a system to collect data on Tourette syndrome, including epidemiological information, primary data, and data on the availability of medical and social services for individuals with Tourette syndrome and their families.

 Requires the NIH to award grants and contracts to public or nonprofit private entities to support four to six Collaborative Research Centers for Tourette Syndrome in different regions to conduct basic and clinical research on Tourette syndrome.

 Requires the NIH to award grants for research on the full range of symptoms within the Tourette syndrome clinical spectrum and the efficacy of treatment options for particular patient subpopulations.

Requires the NIH to designate a portion of the amounts made available to carry out NIH programs and activities for a fiscal year to carry out programs and activities with respect to Tourette syndrome.

collaborative academic research efforts syndrome act amends public_health_service_act require national_institutes_of_health nih expand intensify coordinate nih research syndrome requires nih develop system collect data syndrome including epidemiological information primary data data availability medical social_services individuals syndrome families requires nih award grants contracts public nonprofit private entities support collaborative research centers syndrome different regions conduct basic clinical research syndrome requires nih award grants research range symptoms syndrome clinical spectrum efficacy treatment options particular patient subpopulations requires nih designate portion amounts available carry nih programs activities fiscal year carry programs activities respect syndrome


Summary:
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.

american cures act bill amends balanced_budget emergency deficit control act require certain adjustments discretionary spending limits fy2016 fy2021 accommodate increases appropriations agencies perform biomedical research adjustments required national_institutes_of_health centers diseases control prevention department_of_defense health program department_of_veterans_affairs medical prosthetics research program bill requires annual appropriations programs agencies referenced bill appropriated fy2015 bill exempts appropriations provided pursuant bill sequestration sequestration process automatic usually board spending reductions budgetary resources permanently cancelled enforce specific budget policy goals


Summary:
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.

accelerating biomedical research_act bill amends balanced_budget emergency deficit control act require certain adjustments discretionary spending limits fy2016 fy2021 accommodate increases appropriations national_institutes_of_health department_of_health_and_human_services