Summary:
Value Based Insurance Design for Better Care Act of 2014 or the VBID for Better Care Act of 2014 - Directs the Secretary of Health and Human Services (HHS) to establish a three-year demonstration program to test the use of value-based insurance design methodologies under the eligible Medicare plans offered by Medicare Advantage organizations under part C (Medicare+Choice) of title XVIII (Medicare) of the Social Security Act.

Defines "value-based insurance design methodology" as one for identifying specific prescription medications, and clinical services reimbursable under Medicare, for which copayments, coinsurance, or both should be reduced or eliminated because of the high-value and effectiveness of these medications and services for specific chronic clinical conditions (as approved by the Secretary).

Directs the Secretary to expand the demonstration program to implement, on a permanent basis, those components beneficial to Medicare beneficiaries and the Medicare program, unless a required evaluation of the program states that it: (1) increases expenditures under Medicare with respect to participating beneficiaries, or (2) decreases the quality of health care services furnished to such beneficiaries.

value based insurance design better care act better care act directs secretary health_and_human_services hhs establish year demonstration program test use value based insurance design methodologies eligible medicare plans offered medicare_advantage organizations title xviii medicare social_security_act defines value based insurance design methodology identifying specific prescription medications clinical services reimbursable medicare copayments coinsurance reduced eliminated high value effectiveness medications services specific chronic clinical conditions approved secretary directs secretary expand demonstration program implement permanent basis components beneficial medicare beneficiaries medicare program required evaluation program states increases expenditures medicare respect participating beneficiaries decreases quality health_care services furnished beneficiaries


Summary:
(Sec. 1) Requires the Department of Health and Human Services (HHS) to consult with clinical experts and make recommendations for the use of clinical data registries to improve patient care.

Directs HHS to include in the recommendations: (1) standards to allow exchange of information between electronic health records and registries, (2) how registries can be used to evaluate models and methods of care, (3) how registries can be used to monitor the safety and efficacy of products approved by the Food and Drug Administration (FDA), (4) how registry data can inform health care professionals on the prevention of disease and how educational resources derived from registry data can be disseminated, and (5) how registries can promote preventive health care.

sec requires department_of_health_and_human_services hhs consult clinical experts recommendations use clinical data registries improve patient care directs hhs include recommendations standards allow exchange information electronic health records registries registries evaluate models methods care registries monitor safety efficacy products approved food_and_drug_administration fda registry data inform health_care professionals prevention disease educational resources derived registry data disseminated registries promote preventive health_care


Summary:
Reducing Disparities Using Care Models and Education Act of 2014 - Requires the Secretary of Health and Human Services (HHS) to contract with the Institute of Medicine to study: (1) health disparities; (2) existing programs and policies intended to reduce disparities; and (3) priorities for, and expansion of, programs targeting disparities.

Requires the Secretary to develop guidelines for entities to develop and implement programs to reduce health disparities. Directs the Secretary to incorporate these guidelines into HHS activities.

Authorizes the Secretary to award grants for programs to reduce health disparities.

Requires the Innovation Center of the Centers for Medicare and Medicaid Services (CMS) to test a payment and service delivery model that includes incentives for reducing health disparities.

reducing disparities care models education act requires secretary health_and_human_services hhs contract institute_of_medicine study health disparities existing programs policies intended reduce disparities priorities expansion programs targeting disparities requires secretary develop guidelines entities develop implement programs reduce health disparities directs secretary incorporate guidelines hhs activities authorizes secretary award grants programs reduce health disparities requires innovation center centers medicare medicaid_services cms test payment service delivery model includes incentives reducing health disparities


Summary:
Low-Dose Radiation Research Act of 2014 - Requires the Director of the Department of Energy (DOE) Office of Science to carry out a research program on low dose radiation to enhance the scientific understanding of and reduce uncertainties associated with the effects of exposure to low dose radiation.

Requires the Director to enter into an agreement with the National Academies to conduct a study assessing the current status and development of a long-term strategy for low dose radiation research.

Requires such study to:

 identify current scientific challenges for understanding the long-term effects of ionizing radiation, assess the status of current low dose radiation research, formulate overall scientific goals for the future of low-dose radiation research, recommend a long-term strategic and prioritized research agenda to address scientific research goals for overcoming the identified scientific challenges in coordination with other research efforts, define the essential components of a research program that would address this research agenda within the universities and the National Laboratories, and assess the effectiveness of such a program. Directs the Secretary of Energy to deliver to Congress a five-year research plan that responds to the study's findings and recommendations and identifies and prioritizes research needs.

Makes DOE's limitation on human research inapplicable to research under this Act.

low dose radiation research_act requires director department_of_energy doe office_of_science carry research program low dose radiation enhance scientific understanding reduce associated effects exposure low dose radiation requires director enter agreement national academies conduct study assessing current status development long term strategy low dose radiation research requires study identify current scientific challenges understanding long term effects radiation assess status current low dose radiation research formulate overall scientific goals future low dose radiation research recommend long term strategic prioritized research agenda address scientific research goals identified scientific challenges coordination research efforts define essential components research program address research agenda universities national_laboratories assess effectiveness program directs secretary energy deliver congress year research plan responds study findings recommendations identifies prioritizes research needs makes doe limitation human research inapplicable research act


Summary: Accelerating Biomedical Research Act - Amends the Balanced Budget and Emergency Deficit Control Act of 1985 to require certain adjustments to discretionary spending limits in FY2015-FY2021 to accommodate increases in appropriations to the National Institutes of Health (NIH) at the Department of Health and Human Services (HHS).

accelerating biomedical research act_-_amends balanced_budget emergency deficit control act require certain adjustments discretionary spending limits fy2015 fy2021 accommodate increases appropriations national_institutes_of_health nih department_of_health_and_human_services hhs


Summary:
Permanent Investment in Health Research Act of 2014 - Amends the Public Health Service Act to replace the current authorization of appropriations for the National Institutes of Health (NIH) with specified actual appropriations for FY2015-FY2024.

Appropriates $32 billion for FY2015, and for each of FY2016-FY2024 the amount for the preceding fiscal year adjusted by the percentage increase in nominal gross domestic product during the preceding calendar year.

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 that are exempt from a sequestration. (A sequestration is a process of automatic, usually across-the-board spending reductions under which budgetary resources are permanently canceled to enforce specific budget policy goals.)

permanent investment health research_act amends public_health_service_act replace current authorization appropriations national_institutes_of_health nih specified actual appropriations fy2015 fy2024 appropriates billion fy2015 fy2016 fy2024 preceding fiscal year adjusted percentage increase nominal gross domestic product preceding calendar year 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 canceled enforce specific budget policy goals


Summary:
Adding Ebola to the FDA Priority Review Voucher Program Act - Amends the Federal Food, Drug, and Cosmetic Act to add filoviruses, a family of viruses that includes the Ebola virus, to the list of tropical diseases under the priority review voucher program, which awards vouchers to sponsors of human drug applications that are approved to prevent or treat tropical diseases. (A voucher entitles the holder to have a future human drug application acted upon by the Food and Drug Administration (FDA) within six months.)

Changes the process by which infectious diseases that do not significantly impact developed nations and disproportionately affect poor and marginalized populations can be designated as tropical diseases from rulemaking to order of the Secretary of Health and Human Services (HHS).

Allows priority review vouchers to be transferred between sponsors of human drug applications any number of times.

Reduces from 365 days to 90 days the advance notice required before submitting a human drug application subject to a priority review voucher.

adding ebola fda priority review voucher program act_-_amends federal food drug cosmetic act add family viruses includes ebola virus list tropical diseases priority review voucher program awards vouchers sponsors human drug applications approved prevent treat tropical diseases voucher entitles holder future human drug application acted food_and_drug_administration fda months changes process infectious diseases significantly impact developed nations disproportionately affect poor marginalized populations designated tropical diseases rulemaking order secretary health_and_human_services hhs allows priority review vouchers transferred sponsors human drug applications number times reduces days days advance notice required submitting human drug application subject priority review voucher


Summary:
Health Prizes Rewarding Innovation, Savings, and Effectiveness Act of 2014 - Amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH) to design prize competitions open to competitors worldwide to realize innovations that improve health outcomes thereby reducing federal expenditures on health programs.

Requires the NIH to identify as the subject of the competitions diseases or health conditions for which the federal government spends at least $5 billion per year on prevention and treatment, and the research investment is disproportionately small in comparison to other diseases with similar or greater federal expenditures on treatment and prevention.

Directs the NIH to award contracts to perform a simulation of the designed prize competitions to assess the effectiveness of the design.

Requires the NIH to contract with private entities to implement the competitions.

Allows the Secretary of Health and Human Services (HHS) and the Food and Drug Administration (FDA) to provide competitors with guidance and access to testing facilities.

Prohibits the federal government from gaining an interest in intellectual property development by a participant without the participant's written consent.

Amends the Internal Revenue Code to exclude prizes from gross income.

health prizes rewarding innovation savings effectiveness act amends public_health_service_act require director national_institutes_of_health nih design prize competitions open competitors worldwide realize innovations improve health outcomes reducing federal expenditures health programs requires nih identify subject competitions diseases health conditions federal_government spends billion year prevention treatment research investment disproportionately small comparison diseases similar greater federal expenditures treatment prevention directs nih award contracts perform simulation designed prize competitions assess effectiveness design requires nih contract private entities implement competitions allows secretary health_and_human_services hhs food_and_drug_administration fda provide competitors guidance access testing facilities prohibits federal_government gaining interest intellectual property development participant participant written consent amends_the_internal_revenue_code exclude prizes gross income


Summary: Funding Scientists at the Peak Age of Discovery Act of 2014 - Amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH) to ensure that the median age of first-time researchers receiving R series (research) grants is under 40 years of age by January 1, 2019, under 39 years of age by January 1, 2022, and under 38 years of age by January 1, 2025. Excludes grants for small business innovation research, small business technology transfer, or clinical trial planning.

funding scientists peak age discovery act amends public_health_service_act require director national_institutes_of_health nih ensure median age time researchers receiving series research grants years age january years age january years age january excludes grants small_business_innovation_research small_business_technology_transfer clinical trial planning


Summary:
YES to Cures Act of 2014 - Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS) to allocate for research by emerging scientists funds that otherwise would be used to evaluate the implementation and effectiveness of National Institutes of Health (NIH) programs.

Requires NIH to explain why there has been an increase in the average age of grant recipients over the past 30 years and describe the steps taken to address this trend.

cures act amends public_health_service_act require secretary health_and_human_services hhs allocate research emerging scientists funds evaluate implementation effectiveness national_institutes_of_health nih programs requires nih explain increase average age grant recipients past years describe steps taken address trend


Summary:
Strengthening Protections for Children and Communities From Disease Clusters Act - Requires the Administrator of the Environmental Protection Agency (EPA) to: (1) develop, publish, and update guidelines on an approach to investigate suspected or potential disease clusters, environmental pollutants or toxic substances associated with such clusters, or potential causes of such clusters; (2) establish and operate Regional Disease Cluster Information and Response Centers and Regional Disease Cluster Information and Response Teams; (3) ensure that the Office of Children's Health Protection has a prominent role in developing and updating such guidelines and in establishing and operating such Centers and Teams; (4) establish Community Disease Cluster Advisory Committees to provide oversight, guidance, and advice relating to such investigations; (5) provide support to individuals on such Teams and Committees through grants and cooperative agreements with institutions of higher education; (6) compile and update a publicly available, online database that provides information relating to disease clusters; and (7) use available authorities and programs to compile, research, and analyze information generated by actions authorized under this Act.

Authorizes any person to submit a petition to the EPA Administrator, the Administrator of the Agency for Toxic Substances and Disease Registry, and the Director of the National Institute of Environmental Health Sciences that requests that a Response Team conduct an investigation or take action to address the potential causes of disease clusters.

Authorizes the Administrator to make grants to any group of individuals that may be affected by such clusters.

strengthening protections children communities disease clusters act_-_requires administrator environmental_protection_agency epa develop publish update guidelines approach investigate suspected potential disease clusters environmental pollutants toxic substances associated clusters potential causes clusters establish operate regional disease cluster information response centers regional disease cluster information response teams ensure office children health protection prominent role developing updating guidelines establishing operating centers teams establish community disease cluster advisory committees provide oversight guidance advice relating investigations provide support individuals teams committees grants cooperative agreements institutions higher education compile update publicly available online database provides information relating disease clusters use available authorities programs compile research analyze information generated actions authorized act authorizes person submit petition epa administrator administrator agency toxic substances disease registry director national_institute_of_environmental_health_sciences requests response team conduct investigation action address potential causes disease clusters authorizes administrator grants group individuals affected clusters


Summary: Ethical Stem Cell Research Tax Credit Act of 2013 - 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:
Citrus Disease Research and Development Trust Fund Act of 2013 - Amends the Trade Act of 1974 to establish the Citrus Disease Research and Development Trust Fund, consisting of revenues from duties paid on imported citrus or citrus products, to support scientific research, technical assistance, and development activities to combat both domestic and invasive citrus diseases and pests harming the United States.

 Establishes the Citrus Disease Research and Development Trust Fund Advisory Board.

Makes Fund amounts available to the Secretary of Agriculture to develop a coordinated program of research and product development relating to: (1) scientific research of both domestic and invasive diseases and pests afflicting the citrus industry; and (2) support for the dissemination and commercialization of relevant information, techniques, and technologies discovered through Fund research or other research projects intended to solve problems caused by citrus production diseases and invasive pests.

Requires the President to notify certain congressional committees before entering into a trade agreement that could result in a decrease in the amount of: (1) duties paid on imported citrus or citrus products, and (2) funds transferred into the Fund.

Prescribes a formula for required estimated tax payments otherwise due in each of the quarters of 2018 from corporations with assets of at least $1 billion.

Amends the Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA) to extend certain customs users fees for the processing of merchandise entered into the United States between October 23, 2021, and November 6, 2021, and other specified customs users fees for merchandise entered between October 30, 2021, and November 13, 2021.

citrus disease research development trust_fund act amends trade act establish citrus disease research development trust_fund consisting revenues duties paid imported citrus citrus products support scientific research technical assistance development activities combat domestic invasive citrus diseases pests harming united_states establishes citrus disease research development trust_fund advisory_board makes fund amounts available secretary agriculture develop coordinated program research product development relating scientific research domestic invasive diseases pests citrus industry support dissemination commercialization relevant information techniques technologies discovered fund research research projects intended solve problems caused citrus production diseases invasive pests requires president notify certain congressional committees entering trade agreement result decrease duties paid imported citrus citrus products funds transferred fund prescribes formula required estimated tax payments quarters corporations assets billion amends consolidated_omnibus_budget_reconciliation_act cobra extend certain customs users fees processing merchandise entered united_states october november specified customs users fees merchandise entered october november


Summary:
National Pediatric Research Network Act of 2013 - Amends the Public Health Service Act to authorize the Director of the National Institutes of Health (NIH), in carrying out the Pediatric Research Initiative, to act through the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development to provide for the establishment of a National Pediatric Research Network.

Authorizes the Director of the Institute to award funding to public or private nonprofit entities for: (1) planning, establishing, or strengthening pediatric research consortia; and (2) providing basic operating support for such consortia, including to meet unmet needs for pediatric research through basic, clinical and behavioral translational research and the training of researchers in pediatric research techniques. Authorizes the Director of NIH to make awards for not more than 20 pediatric research consortia, which must be formed from a collaboration of cooperating institutions, coordinated by a lead institution, agree to disseminate scientific findings, and meet requirements prescribed by the Director of NIH. Allows such support to be for a period of five years, with additional extensions at the discretion of the Director of NIH.

Requires the Director of NIH to provide for the coordination of activities among the consortia and to require the periodic preparation and submission of reports on their activities. Requires each pediatric research consortium receiving an award to assist the Centers for Disease Control and Prevention (CDC) in the establishment or expansion of patient registries and other surveillance systems as appropriate and upon request by the CDC.

Requires the Director of NIH to ensure that an appropriate number of such awards are awarded to consortia that agree to: (1) focus primarily on pediatric rare diseases or conditions; and (2) conduct or coordinate multi-site clinical trials of therapies for, or approaches to, the prevention, diagnosis, or treatment of pediatric rare diseases or conditions.

Requires the Director of NIH to establish a data coordinating center to: (1) distribute such findings; (2) provide assistance in the design and conduct of collaborative research projects and the management, analysis, and storage of data associated with such projects; and (3) organize and conduct multi-site monitoring activities.

Requires the Director of NIH to: (1) require the data coordinating center to provide regular reports to the Director of NIH and the Commissioner of Food and Drugs (FDA) on research conducted by consortia, including information on enrollment in clinical trials and the allocation of resources with respect to such research; and (2) incorporate such information into NIH's biennial reports.

national pediatric research network act amends public_health_service_act authorize director national_institutes_of_health nih carrying pediatric research initiative act director eunice kennedy shriver national institute child health human development provide establishment national pediatric research network authorizes director institute award funding public private nonprofit entities planning establishing strengthening pediatric research consortia providing basic operating support consortia including meet unmet needs pediatric research basic clinical behavioral translational research training researchers pediatric research techniques authorizes director nih awards pediatric research consortia formed collaboration cooperating institutions coordinated lead institution agree disseminate scientific findings meet requirements prescribed director nih allows support period years additional extensions discretion director nih requires director nih provide coordination activities consortia require periodic preparation submission reports activities requires pediatric research consortium receiving award assist centers_for_disease_control_and_prevention cdc establishment expansion patient registries surveillance systems appropriate request cdc requires director nih ensure appropriate number awards awarded consortia agree focus primarily pediatric rare diseases conditions conduct coordinate multi site clinical trials therapies approaches prevention diagnosis treatment pediatric rare diseases conditions requires director nih establish data coordinating center distribute findings provide assistance design conduct collaborative research projects management analysis storage data associated projects organize conduct multi site monitoring activities requires director nih require data coordinating center provide regular reports director nih commissioner food_and_drugs fda research conducted consortia including information enrollment clinical trials allocation resources respect research incorporate information nih biennial reports


Summary:
Prize Fund for HIV/AIDS Act - Denies any person the exclusive right to manufacture, distribute, sell, or use in interstate commerce a qualifying treatment for HIV/AIDS, or to a manufacturing process for such a treatment, including the exclusive right to rely on health registration data or the 30-month stay-of-effectiveness period for Orange Book patents. Prescribes remuneration, in the form of prize payments from a Prize Fund for HIV/AIDS, in lieu of such market exclusivity.

Exempts from this elimination of exclusive rights any dual use product that is a qualifying treatment for HIV/AIDS which also has a significant use for other diseases, but only with respect to its use for other diseases. Applies the elimination of exclusive rights with respect to a qualifying HIV/AIDS treatment even in a dual use product.

Establishes the Prize Fund for HIV/AIDS. Requires the Secretary of Health and Human Services (HHS) to designate a Prize Fund Director to administer the Fund.

Directs the Prize Fund Director to award prize payments for medical innovation relating to a qualifying treatment for HIV/AIDS, or a new manufacturing process for such a treatment, to: (1) the first person to receive market clearance with respect to the drug or biological product; (2) the holder of the patent with respect to a manufacturing process; or (3) persons or communities that as an open source contribution openly shared knowledge, data, materials, and technology on a royalty-free and nondiscriminatory basis.

Allows the Prize Fund Director to authorize multiple nonprofit intermediaries to manage Fund payments to reward projects for: (1) interim research and development of new qualifying treatments for HIV/AIDS, or (2) open source dividend prizes.

Establishes an annual fee for health insurers to fund this Act.

Establishes the Donor Innovation Prize Fund to enable the Secretary to reward owners and developers of products that permit open competition for low-cost generic drugs for the treatment of HIV/AIDS in developing countries.

prize fund hiv aids act denies person exclusive right manufacture distribute sell use interstate commerce qualifying treatment hiv aids manufacturing process treatment including exclusive right rely health registration data month stay effectiveness period orange book patents prescribes remuneration form prize payments prize fund hiv aids lieu market exclusivity exempts elimination exclusive rights dual use product qualifying treatment hiv aids significant use diseases respect use diseases applies elimination exclusive rights respect qualifying hiv aids treatment dual use product establishes prize fund hiv aids requires secretary health_and_human_services hhs designate prize fund director administer fund directs prize fund director award prize payments medical innovation relating qualifying treatment hiv aids new manufacturing process treatment person receive market clearance respect drug biological product holder patent respect manufacturing process persons communities open source contribution openly shared knowledge data materials technology royalty free nondiscriminatory basis allows prize fund director authorize multiple nonprofit intermediaries manage fund payments reward projects interim research development new qualifying treatments hiv aids open source dividend prizes establishes annual fee health insurers fund act establishes donor innovation prize fund enable secretary reward owners developers products permit open competition low cost generic drugs treatment hiv aids developing countries


Summary:
Collaborative Academic Research Efforts for Tourette Syndrome Act of 2013 - Amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH) to expand, intensify, and coordinate NIH programs and activities regarding Tourette syndrome.

Requires the Director to develop a system to collect data on Tourette syndrome, including epidemiological information regarding its incidence and prevalence in the United States, primary data, and data on the availability of medical and social services for individuals with Tourette syndrome and their families.

 Requires the Director to award grants and contracts to public or nonprofit private entities to pay costs of planning, establishing, improving, and providing basic operating support for between four and six centers of excellence in different regions of the United States to conduct basic and clinical research on Tourette syndrome.

Requires the Director 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 director national_institutes_of_health nih expand intensify coordinate nih programs activities syndrome requires director develop system collect data syndrome including epidemiological information incidence prevalence united_states primary data data availability medical social_services individuals syndrome families requires director award grants contracts public nonprofit private entities pay costs planning establishing improving providing basic operating support centers_of_excellence different regions united_states conduct basic clinical research syndrome requires director designate portion amounts available carry nih programs activities fiscal year carry programs activities respect syndrome


Summary: Health Outcomes, Planning, and Education for Alzheimer's Act - Amends title XVIII (Medicare) of the Social Security Act to provide for comprehensive Alzheimer's disease diagnosis and services.

health outcomes planning education alzheimer act_-_amends title xviii medicare social_security_act provide comprehensive alzheimer disease diagnosis services


Summary:
Accelerating the End of Breast Cancer Act of 2013 - Establishes the Commission to Accelerate the End of Breast Cancer to help end breast cancer by January 1, 2020.

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

Requires the Commission to: (1) submit within six months to the President and to the relevant congressional committees a description of the Commission's strategic plan; (2) submit an annual report to the President, Congress, and the public; and (3) ensure that its activities are coordinated with, and 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 to evaluate the Commission's progress.

Terminates the Commission on June 1, 2020.

accelerating end breast cancer act establishes_the_commission accelerate end breast cancer help end breast cancer january directs commission identify recommend promote initiatives partnerships research public private sectors basic applied sciences epidemiology turned strategies prevent breast cancer breast cancer giving priority prioritized public sector unlikely achieved private sector technical financial uncertainty requires commission submit months president relevant congressional committees description commission strategic plan submit annual report president congress public ensure activities coordinated duplicate efforts programs laboratories government agencies directs president enter agreement institute_of_medicine evaluate commission progress terminates commission june


Summary:
Amends the Public Health Service Act to authorize the Secretary of Health and Human Services (HHS) to: (1) establish a working group made up of representatives from various Institutes and Centers within the National Institutes of Health (NIH) to update and streamline NIH rehabilitation research priorities, and (2) enter into interagency agreements relating to the coordination of rehabilitation research conducted by agencies outside of HHS.

Requires the Secretary to report to Congress on the feasibility of implementing the changes proposed in the Blue Ribbon Panel Recommendations on Rehabilitation Research.

amends public_health_service_act authorize secretary health_and_human_services hhs establish working_group representatives institutes centers national_institutes_of_health nih update streamline nih rehabilitation research priorities enter interagency agreements relating coordination rehabilitation research conducted agencies outside hhs requires secretary report congress feasibility implementing changes proposed blue ribbon panel recommendations rehabilitation research


Summary:
Directs the United States Postal Service (USPS) to issue and sell an Alzheimer's Disease Research Semipostal Stamp.

Requires proceeds from the sale of the stamp to be transferred to the National Institutes of Health.

Requires the stamp to be made available to the public for six years.

directs united_states_postal_service usps issue sell alzheimer disease research semipostal stamp requires proceeds sale stamp transferred national_institutes_of_health requires stamp available public years


Summary:
Cavernous Angioma Research Resource Act of 2013 - Amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH), acting through the Director of the National Institute of Neurological Disorders and Stroke, to expand and intensify NIH programs regarding research and related activities concerning cavernous angioma. Authorizes grants and cooperative agreements to public or nonprofit private entities for such activities.

Authorizes the Director of NIH to: (1) conduct basic, clinical, and translational research on cavernous angioma; (2) identify and support the development of a clinical and research coordinating center with the potential of coordinating a multi-site clinical drug trial for cavernous angioma; and (3) identify and support the development of clinical and research participation centers with the potential to participate in such a trial.

Requires coordinating and participation centers to expand training programs for medical and allied health clinicians and scientists in clinical practice and research relevant to cavernous angioma.

Authorizes the Director to provide for the participation of NIH agencies in a consortium (to include at least one patient advocacy organization) to facilitate the exchange of information and increase the efficiency and effectiveness of the research effort.

Authorizes the Secretary of Health and Human Services (HHS) to award grants and cooperative agreements, including technical assistance, to public or nonprofit private entities for: (1) the collection, analysis, and reporting of data on cavernous angioma; and (2) epidemiological activities, including collecting and analyzing information on the number, incidence, correlates, and symptoms of cases and the clinical utility of specific practice patterns. Requires establishment of a national surveillance program as part of such activities.

Requires the Commissioner of Food and Drugs (FDA) to: (1) work with clinical centers, investigators, and advocates to support appropriate investigational new drug applications under the Federal Food, Drug, and Cosmetic Act in order to hasten the pace of clinical trials for cavernous angioma; and (2) where applicable in rare subpopulations of cavernous angioma requiring unique pharmacological intervention, including those with the Common Hispanic Mutation or CCM3 gene mutations, support appropriate requests for designations of orphan drugs.

research resource act amends public_health_service_act require director national_institutes_of_health nih acting director national institute neurological disorders stroke expand intensify nih programs research related activities concerning authorizes grants cooperative agreements public nonprofit private entities activities authorizes director nih conduct basic clinical translational research identify support development clinical research coordinating center potential coordinating multi site clinical drug trial identify support development clinical research participation centers potential participate trial requires coordinating participation centers expand training programs medical allied health clinicians scientists clinical practice research relevant authorizes director provide participation nih agencies consortium include patient advocacy organization facilitate exchange information increase efficiency effectiveness research effort authorizes secretary health_and_human_services hhs award grants cooperative agreements including technical assistance public nonprofit private entities collection analysis reporting data epidemiological activities including collecting analyzing information number incidence symptoms cases clinical utility specific practice patterns requires establishment national surveillance program activities requires commissioner food_and_drugs fda work clinical centers investigators advocates support appropriate investigational new drug applications federal food drug cosmetic act order pace clinical trials applicable rare subpopulations requiring unique pharmacological intervention including common hispanic support appropriate requests designations orphan drugs


Summary:
Scleroderma Research and Awareness Act - Requires the Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases to expand, intensify, and coordinate the Institute's activities with respect to scleroderma, with particular emphasis on: (1) research focused on the etiology of scleroderma and the development of new treatment options, (2) clinical research to evaluate new treatment options, (3) basic research on the relationship between scleroderma and secondary conditions, (4) establishment of scleroderma patient registries, and (5) support for training of new clinicians and investigators with expertise in scleroderma.

Directs the Secretary of Health and Human Services (HHS), acting through the Director of the Centers for Disease Control and Prevention (CDC), to carry out an educational campaign to increase public awareness of scleroderma.

research awareness act_-_requires director national institute musculoskeletal skin diseases expand intensify coordinate institute activities respect particular emphasis research focused development new treatment options clinical research evaluate new treatment options basic research relationship secondary conditions establishment patient registries support training new clinicians investigators expertise directs secretary health_and_human_services hhs acting director centers_for_disease_control_and_prevention cdc carry educational campaign increase public awareness


Summary:
Pediatric, Adolescent, and Young Adult Cancer Survivorship Research and Quality of Life Act of 2013 - Amends the Public Health Service Act to allow the Secretary of Health and Human Services (HHS) to make grants to eligible entities to establish pilot programs to develop, study, or evaluate model systems for monitoring and caring for childhood cancer survivors.

Authorizes the Secretary to convene a Workforce Development Collaborative on Medical and Psychosocial Care for Pediatric Cancer to establish a plan to meet specified objectives relating to medical and psychosocial care workforce development, including: (1) disseminating to health care educators information relevant to providing medical and psychosocial services to individuals with pediatric cancers, (2) adapting curricula for continuing education of the existing workforce, and (3) strengthening the emphasis on psychosocial health care in educational accreditation standards and professional licensing and certification.

pediatric adolescent young adult cancer survivorship research quality life act amends public_health_service_act allow secretary health_and_human_services hhs grants eligible entities establish pilot programs develop study evaluate model systems monitoring caring childhood cancer survivors authorizes secretary convene workforce development collaborative medical psychosocial care pediatric cancer establish plan meet specified objectives relating medical psychosocial care workforce development including disseminating health_care educators information relevant providing medical psychosocial services individuals pediatric cancers adapting curricula continuing education existing workforce strengthening emphasis psychosocial health_care educational accreditation standards professional licensing certification


Summary:
Next Generation Research Act - Amends the Public Health Service Act to establish the Next Generation of Research Initiative in the Office of the Director of the National Institutes of Health (NIH) for coordination of all NIH policies and programs aimed at promoting and providing opportunities for new researchers.

Requires the Director to: (1) promote existing policies and programs to improve opportunities for new researchers; (2) develop or modify policies, including to strengthen mentorship programs and enhance diversity efforts; and (3) request the National Academy of Sciences, as part of the required studies concerning biomedical and behavioral research personnel, to conduct a comprehensive study and report on policies affecting the next generation of researchers.

generation research act_-_amends public_health_service_act establish generation research initiative office_of_the_director national_institutes_of_health nih coordination nih policies programs aimed promoting providing opportunities new researchers requires director promote existing policies programs improve opportunities new researchers develop modify policies including strengthen mentorship programs enhance diversity efforts request national_academy_of_sciences required studies concerning biomedical behavioral research personnel conduct comprehensive study report policies affecting generation researchers


Summary:
American Cures Act - Establishes a Biomedical Research Fund to be administered by the Secretary of the Treasury to provide for an expanded and sustained national investment in biomedical research.

Requires amounts to be transferred from the Fund for each fiscal year to accounts related to the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Department of Defense (DOD) health program, and the medical and prosthetics research program of the Department of Veterans Affairs (VA) to ensure that funding for such programs and agencies does not fall below 105% of the level of funding provided for the preceding fiscal year and an additional amount to account for any increases in the Gross Domestic Product for the year involved.

Requires that amounts appropriated for each of such programs and agencies for a fiscal year be not be less than the amounts appropriated for FY2014. Authorizes and appropriates to the Fund such sums as necessary in each fiscal year to enable such transfers.

Amends the Balanced Budget and Emergency Deficit Control Act to exempt the Fund from any sequestration order issued under such Act.

american cures act establishes biomedical research fund administered secretary treasury provide expanded sustained national investment biomedical research requires amounts transferred fund fiscal year accounts related national_institutes_of_health nih centers_for_disease_control_and_prevention cdc department_of_defense dod health program medical prosthetics research program department_of_veterans_affairs ensure funding programs agencies fall level funding provided preceding fiscal year additional account increases gross domestic product year involved requires amounts appropriated programs agencies fiscal year amounts appropriated fy2014 authorizes appropriates fund sums necessary fiscal year enable transfers amends balanced_budget emergency deficit control act exempt fund sequestration order issued act


Summary:
Regenerative Medicine Promotion Act of 2014 - Requires the Comptroller General to submit to Congress a report identifying all ongoing federal programs and activities regarding regenerative medicine.

Directs the Secretary of Health and Human Services (HHS) to establish a Regenerative Medicine Coordinating Council, which shall:

 prepare a national strategy to support research into regenerative medicine and enable the development of drugs, biological products, medical devices, and biomaterials for use in regenerative medicine; develop national goals for regenerative medicine research and product development; prepare a plan specifying priorities for research into regenerative medicine; identify sources of funding for research into regenerative medicine and areas where such funding is inadequate or duplicative; make recommendations regarding federal policies to support development and marketing of regenerative medicine products; develop consensus standards regarding scientific issues critical to regulator approval of regenerative medicine products; and determine the need for establishing centers of excellence or consortia to further advance regenerative medicine. Directs the Council to: (1) adopt procedures to ensure the receipt of public input; and (2) submit an annual report on its activities to Congress, the Director of the National Institutes of Health (NIH), and the Commissioner of Food and Drugs (FDA).

medicine promotion act requires comptroller_general submit congress report identifying ongoing federal programs activities medicine directs secretary health_and_human_services hhs establish medicine coordinating council shall prepare national strategy support research medicine enable development drugs biological products medical devices use medicine develop national goals medicine research product development prepare plan specifying priorities research medicine identify sources funding research medicine areas funding inadequate duplicative recommendations federal policies support development marketing medicine products develop consensus standards scientific issues critical regulator approval medicine products determine need establishing centers_of_excellence consortia advance medicine directs council adopt procedures ensure receipt public input submit annual report activities congress director national_institutes_of_health nih commissioner food_and_drugs fda


Summary:
Independent Innovator and Repurposing Act - Establishes procedures under which the term of an unexpired patent claiming a method of using a biological product shall be extended for five years from its original expiration date.

 Requires an application for such an extension to demonstrate that: (1) the patent was issued to an independent innovator, and (2) the owner of record is the independent innovator or a small business (with fewer than 500 employees and which is not affiliated with the holder of the marketing application approved under licensing requirements of the Public Health Service Act for the commercial marketing of such biological product) in which the independent innovator has an ownership interest.

Defines "independent innovator" as a person or entity that obtains a method of use patent for a biological product and is not, at the time of invention or patent filing, affiliated with the holder of an approved application for the commercial marketing of the product.

independent innovator act establishes procedures term unexpired patent claiming method biological product shall extended years original expiration date requires application extension demonstrate patent issued independent innovator owner record independent innovator small business fewer employees affiliated holder marketing application approved licensing requirements public_health_service_act commercial marketing biological product independent innovator ownership interest defines independent innovator person entity obtains method use patent biological product time invention patent filing affiliated holder approved application commercial marketing product


Summary: Alzheimer's Accountability Act of 2014 - Amends the National Alzheimer's Project Act to require the Director of the National Institutes of Health (NIH), for each fiscal year through FY2025, to submit to the President for review and transmittal to Congress, after reasonable opportunity for comment (but without change) by the Secretary of Health and Human Services (HHS) and the Advisory Council on Alzheimer's Research, Care, and Services, an annual budget estimate (including regarding personnel needs) for the NIH initiatives under the Act.

alzheimer accountability_act amends national alzheimer project act require director national_institutes_of_health nih fiscal year fy2025 submit president review transmittal congress reasonable opportunity comment change secretary health_and_human_services hhs advisory_council alzheimer research care services annual budget estimate including personnel needs nih initiatives act


Summary: Accelerating Biomedical Research Act - Amends the Balanced Budget and Emergency Deficit Control Act of 1985 to require certain adjustments to discretionary spending limits in FY2015-FY2021 to accommodate increases in appropriations to the National Institutes of Health (NIH) at the Department of Health and Human Services (HHS).

accelerating biomedical research act_-_amends balanced_budget emergency deficit control act require certain adjustments discretionary spending limits fy2015 fy2021 accommodate increases appropriations national_institutes_of_health nih department_of_health_and_human_services hhs


Summary:
Family Asthma Act - Amends the Public Health Service Act to require the Director of the Centers for Disease Control and Prevention (CDC) to collaborate with state and local health departments to: (1) conduct activities regarding asthma, including deterring the harmful consequences of uncontrolled asthma, and disseminating health education and information regarding prevention of asthma episodes and strategies for managing asthma; and (2) develop state plans incorporating public health responses to reduce the burden of asthma, particularly regarding disproportionately affected populations.

 Revises and expands requirements for asthma surveillance activities.

 Requires the Director to coordinate data collection activities to maximize the comparability of results.

Requires the Secretary of Health and Human Services (HHS) to submit an assessment of current activities related to asthma prevention, management and surveillance along with recommendations for the future direction of asthma activities.

family asthma act_-_amends public_health_service_act require director centers_for_disease_control_and_prevention cdc collaborate state local health departments conduct activities asthma including deterring harmful consequences uncontrolled asthma disseminating health education information prevention asthma strategies managing asthma develop state plans incorporating public health responses reduce burden asthma particularly disproportionately affected populations revises expands requirements asthma surveillance activities requires director coordinate data collection activities maximize comparability results requires secretary health_and_human_services hhs submit assessment current activities related asthma prevention management surveillance recommendations future direction asthma activities


Summary:
Reducing Disparities Using Care Models and Education Act of 2014 - Requires the Secretary of Health and Human Services (HHS) to contract with 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.

Requires the Secretary to develop guidelines for entities to develop and implement programs to reduce health disparities. Directs the Secretary to incorporate these guidelines into HHS activities.

Authorizes the Secretary to award grants for programs to reduce health disparities.

Requires the Innovation Center of the Centers for Medicare and Medicaid Services (CMS) to test a payment and service delivery model that includes incentives for reducing health disparities.

reducing disparities care models education act requires secretary health_and_human_services hhs contract institute_of_medicine study health disparities existing programs policies intended reduce disparities priorities expansion programs targeting disparities requires secretary develop guidelines entities develop implement programs reduce health disparities directs secretary incorporate guidelines hhs activities authorizes secretary award grants programs reduce health disparities requires innovation center centers medicare medicaid_services cms test payment service delivery model includes incentives reducing health disparities


Summary:
Collaborative Academic Research Efforts for Tourette Syndrome Act of 2014 - Amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH) to expand, intensify, and coordinate NIH research on Tourette syndrome.

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


Summary:
(This measure has not been amended since it was introduced. The expanded summary of the Senate reported version is repeated here.)

Adding Ebola to the FDA Priority Review Voucher Program Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to add filoviruses, a family of viruses that includes the Ebola virus, to the list of tropical diseases under the priority review voucher program, which awards vouchers to sponsors of human drug applications that are approved to prevent or treat tropical diseases. (A voucher entitles the holder to have a future human drug application acted upon by the Food and Drug Administration (FDA) within six months.)

Changes the process by which infectious diseases that do not significantly impact developed nations and disproportionately affect poor and marginalized populations can be designated as tropical diseases from rulemaking to order of the Secretary of Health and Human Services (HHS).

Allows priority review vouchers to be transferred between sponsors of human drug applications any number of times.

Reduces from 365 days to 90 days the advance notice required before submitting a human drug application subject to a priority review voucher.

measure amended introduced expanded summary senate reported version repeated adding ebola fda priority review voucher program act sec amends federal food drug cosmetic act add family viruses includes ebola virus list tropical diseases priority review voucher program awards vouchers sponsors human drug applications approved prevent treat tropical diseases voucher entitles holder future human drug application acted food_and_drug_administration fda months changes process infectious diseases significantly impact developed nations disproportionately affect poor marginalized populations designated tropical diseases rulemaking order secretary health_and_human_services hhs allows priority review vouchers transferred sponsors human drug applications number times reduces days days advance notice required submitting human drug application subject priority review voucher


Summary:
Dormant Therapies Act of 2014 - Requires the Department of Health and Human Services (HHS) to designate medicines being, or intended to be, investigated to address unmet medical needs as dormant therapies. Gives a dormant therapy a 15-year protection period during which no drug can be approved by relying on the approval of the dormant therapy absent a right of reference from the holder of the approved application for the dormant therapy.

Requires the sponsor of a potential dormant therapy to have a clinical plan to investigate the medicine and intend to file an application for approval or licensure of the medicine as a new drug or biological product. Prohibits the active moiety of the medicine from being the same as an active moiety in a drug or highly similar to one in a biological product for which an application has been submitted.

Requires the sponsor of a potential dormant therapy to list their patents that apply to the medicine and waive rights to those patents at the end of the dormant therapy protection period if the medicine is approved.

Allows a sponsor to withdraw a dormant therapy designation request unless the medicine has been approved or licensed.

Entitles the sponsor of a dormant therapy to extend patents that apply to the medicine to the end of the protection period.

Prohibits a dormant therapy from receiving specified protections that apply to pediatric, infectious disease, or rare disease or condition medicines.

Directs HHS to require a sponsor to certify that the clinical plan for a dormant therapy has been completed and that approval was based on investigations in the clinical plan.

therapies act requires department_of_health_and_human_services hhs designate medicines intended investigated address unmet medical needs therapies gives therapy year protection period drug approved relying approval therapy absent right reference holder approved application therapy requires sponsor potential therapy clinical plan investigate medicine intend file application approval licensure medicine new drug biological product prohibits active medicine active drug highly similar biological product application submitted requires sponsor potential therapy list patents apply medicine waive rights patents end therapy protection period medicine approved allows sponsor withdraw therapy designation request medicine approved licensed entitles sponsor therapy extend patents apply medicine end protection period prohibits therapy receiving specified protections apply pediatric infectious disease rare disease condition medicines directs hhs require sponsor certify clinical plan therapy completed approval based investigations clinical plan


Summary:
21st Century Cures Act

(Sec. 2) The NIH and Cures Innovation Fund is established and funds are appropriated: (1) for biomedical research, including high-risk, high-reward research and research conducted by early stage investigators; (2) to develop and implement a strategic plan for biomedical research; and (3) to carry out specified provisions of this Act.

TITLE I--DISCOVERY

Subtitle A--National Institutes of Health Funding

(Sec. 1001) This bill amends the Public Health Service Act to reauthorize the National Institutes of Health (NIH) through FY2018.

(Sec. 1002) The NIH must establish an Innovation Prizes Program to fund areas of biomedical science that could realize significant advancements or improve health outcomes.

Subtitle B--National Institutes of Health Planning and Administration

(Sec. 1022) Directors of national research institutes and national centers have five-year terms in office.

(Sec. 1023) The NIH must reduce the administrative burdens of researchers funded by the NIH.

(Sec. 1027) The support the National Center for Advancing Translational Sciences may provide to clinical trials is extended through a later clinical trial phase.

(Sec. 1028) Each national research institute must conduct or support high-risk, high-reward research.

Subtitle C--Supporting Young Emerging Scientists

(Sec. 1041) A loan repayment program is established for health professionals engaging in research. The maximum awards of other loan repayment programs are increased.

Subtitle D--Capstone Grant Program

(Sec. 1061) Capstone Awards are established to support outstanding scientists in concluding research programs. Recipients cannot be principal investigators on subsequent NIH awards.

Subtitle E--Promoting Pediatric Research through the National Institutes of Health

(Sec. 1081) The Pediatric Research Initiative is revised to require establishment of a National Pediatric Research Network comprised of pediatric research consortia.

(Sec. 1083) The NIH must convene a workshop on appropriate age groupings and age exclusions in human research and must publish the number of children included in NIH research.

Subtitle F--Advancement of the National Institutes of Health Research and Data Access

(Sec. 1101) The NIH must standardize data in the clinical trial registry data bank.

Subtitle G--Facilitating Collaborative Research

(Sec. 1121) The NIH and the Food and Drug Administration (FDA) must implement a system that allows further research on clinical trial data.

(Sec. 1122) The Centers for Disease Control and Prevention (CDC) must expand surveillance of neurological diseases.

(Sec. 1124) The Department of Health and Human Services (HHS) must revise health information privacy rules to allow: (1) use of protected information for research purposes to be treated as use for health care operations, (2) remote access to information by researchers, and (3) individuals to authorize future use of their information for research.

Subtitle H--Council for 21st Century Cures

(Sec. 1141) The Council for 21st Century Cures, a nonprofit corporation, is established to accelerate the discovery, development, and delivery of innovative cures, treatments, and preventive measures.

TITLE II--DEVELOPMENT

Subtitle A--Patient-Focused Drug Development

(Sec. 2001) This bill amends the Federal Food, Drug, and Cosmetic Act to require the FDA to establish processes under which patient experience data may be considered in the risk-benefit assessment of a new drug.

Subtitle B--Qualification and Use of Drug Development Tools

(Sec. 2021) The FDA must establish a process to qualify drug development tools (methods, materials, or measures that aid drug development and regulatory review) as reliable for use in supporting approval or investigational use of a drug.

(Sec. 2022) The sponsor of a drug for a serious condition may request that the FDA agree to an accelerated approval development plan. The plan must include the design of the drug study.

Subtitle C--FDA Advancement of Precision Medicine

(Sec. 2041) The FDA must define “precision” drugs and the evidence needed to support their use in a subset of patients. To expedite clinical development of precision drugs for the treatment of serious or rare conditions, the FDA may rely upon data previously submitted for a different approved drug or indication.

Subtitle D--Modern Trial Design and Evidence Development

(Sec. 2061) The FDA must issue guidance that addresses using alternative statistical methods in clinical trials and in the development and review of drugs.

(Sec. 2062) To support approval of a drug for a new indication, the FDA must evaluate the use of evidence from clinical experience (in place of evidence from clinical trials) and establish a streamlined data review program.

Subtitle E--Expediting Patient Access

(Sec. 2082) Manufacturers and distributors of investigational drugs for serious conditions must publish their policies on expanded access (also known as “compassionate use”).

Subtitle F--Facilitating Responsible Manufacturer Communications

(Sec. 2101) The definition of, and requirements for, health care economic information that is provided to entities selecting drugs for coverage or reimbursement are revised.

Subtitle G--Antibiotic Drug Development

(Sec. 2121) At the request of the sponsor of an antibacterial or antifungal drug for treatment of a serious infection, the FDA may agree on a process for developing data to support approval of the drug for use in a limited population of patients.

HHS must monitor the use of antibacterial and antifungal drugs and resistance to these drugs.

(Sec. 2122) The FDA must identify and publish susceptibility test interpretive criteria for antimicrobial drugs. (These criteria characterize the drug resistance of microbes.) The FDA may allow marketing of devices that use these criteria without premarket approval.

(Sec. 2123) This bill amends title XVIII (Medicare) of the Social Security Act (SSAct) to require the Centers for Medicare & Medicaid Services (CMS) to provide an additional payment to certain hospitals for providing certain new antimicrobial drugs (DISARM drugs) to inpatients. Total additional payments cannot exceed 0.02% of total payments to hospitals.

Subtitle H--Vaccine Access, Certainty, and Innovation

(Sec. 2141) The Advisory Committee on Immunization Practices must expedite review of certain vaccines. The CDC must provide a vaccine developer, upon request, with information on public health needs and priorities and certain epidemiological analyses or data.

Subtitle I--Orphan Product Extensions Now; Incentives for Certain Products for Limited Populations

(Sec. 2151) The marketing exclusivity period of a drug approved for a new indication that is a rare disease or condition is extended by six months.

(Sec. 2152) The priority review voucher program for rare pediatric diseases is extended through 2018 and revised to apply only to serious diseases.

Subtitle J--Domestic Manufacturing and Export Efficiencies

(2162) This bill amends the Controlled Substances Import and Export Act to allow unimpeded re-exportation of certain exported controlled substances within the European Economic Area.

 Subtitle K--Enhancing Combination Products Review

(Sec. 2181) The FDA must describe the responsibilities of each agency center charged with reviewing drugs, medical devices, or biological products when reviewing a product that is a combination of drug, medical device, or biological product.

Subtitle L--Priority Review for Breakthrough Devices

(Sec. 2201) The FDA must establish a program for priority review of breakthrough medical devices.

Subtitle M--Medical Device Regulatory Process Improvements

(Sec. 2221) The FDA must accredit third parties to certify device manufactures’ quality systems as meeting FDA criteria. The FDA must rely on this certification when determining the safety and effectiveness of certain changes to medical devices.

(Sec. 2222) “Valid scientific evidence” is defined for purposes of the FDA determining the effectiveness of a medical device without clinical investigations.

(Sec. 2223) FDA employees that review premarket submissions of medical devices must receive training regarding the “least burdensome appropriate means” concept.

(Sec. 2225) The FDA must identify types of medical devices that do not require submission of a report prior to commercial marketing.

(Sec. 2227) The FDA may exempt from effectiveness requirements certain medical devices intended to benefit fewer than 8,000 individuals.

Subtitle N--Sensible Oversight for Technology Which Advances Regulatory Efficiency

(Sec. 2241) “Health software” is defined and, with specified exceptions, exempted from FDA regulation.

Subtitle O--Streamlining Clinical Trials

(Sec. 2262) Institutional Review Boards responsible for reviewing plans for clinical testing of a medical device no longer need to be local.

(Sec. 2263) Clinical testing of medical devices or drugs no longer requires the informed consent of the subjects if the testing poses no more than minimal risk and includes safeguards.

Subtitle P--Improving Scientific Expertise and Outreach at FDA

(Sec. 2281) The Silvio O. Conte Senior Biomedical Research Service is revised to remove the limit on the number of members and make other changes.

(Sec. 2283) Changes are made to the Reagan-Udall Foundation for the Food and Drug Administration to revise Board of Directors membership, Executive Director compensation, and accounting.

(Sec. 2285) The FDA is granted additional hiring authority for scientific, technical, or professional positions within certain centers.

Subtitle Q--Exempting from Sequestration Certain User Fees

(Sec. 2301) This bill amends the Balanced Budget and Emergency Deficit Control Act of 1985 to exempt from sequestration FDA administrative expenses funded through certain user fees.

Subtitle R--Other Provisions

(Sec. 2321) This bill expresses the sense of Congress that recording unique medical device identifiers in electronic health records could enhance medical surveillance.

TITLE III--DELIVERY

Subtitle A--Interoperability

(Sec. 3001) Requirements are established for interoperability and certification of health information technology. Practices that discourage the exchange of electronic health information are prohibited.

Subtitle B--Telehealth

(Sec. 3021) The CMS and Medicare Payment Advisory Commission must provide information to Congress regarding telehealth.

Subtitle C--Encouraging Continuing Medical Education for Physicians

(Sec. 3041) Part A (General Provisions) of title XI of the SSAct is amended to remove the requirement that manufacturers of medical products report payments to physicians for certain educational activities.

Subtitle D--Disposable Medical Technologies

The CMS must pay home health agencies for certain disposable medical devices furnished to individuals receiving home health services under Medicare.

Subtitle E--Local Coverage Decision Reforms

(Sec. 3081) Medicare administrative contractors must publish local coverage determinations.

Subtitle F--Medicare Pharmaceutical and Technology Ombudsman

(Sec. 3101) A pharmaceutical and technology ombudsman within the CMS must receive and respond to complaints from manufacturers of medical products regarding Medicare coverage of their products.

Subtitle G--Medicare Site-of-Service Price Transparency

(Sec. 3121) The CMS must publish estimated Medicare beneficiary prices for items and services provided by hospital outpatient departments or ambulatory surgical centers.

Subtitle H--Medicare Part D Patient Safety and Drug Abuse Prevention

(Sec. 3141) Medicare prescription drug plan sponsors may limit the access of certain beneficiaries to frequently abused drugs.

TITLE IV--MEDICAID, MEDICARE, AND OTHER REFORMS

Subtitle A--Medicaid and Medicare Reforms

(Sec. 4001) Aggregate Medicaid payments to states for durable medical equipment are limited to the amount that would be paid under Medicare, effective January 1, 2020.

(Sec. 4002) Generic drugs authorized by the brand name drug manufacturer are excluded from the calculation of average manufacturer price when determining rebates under Medicaid.

(Sec. 4003) Medicare payments are reduced for x-ray imaging that uses film or an imaging plate (instead of a digital sensor). After 2016, a multiple procedure payment reduction policy cannot be applied to a physician’s imaging services until the CMS publishes an analysis of any efficiencies that may exist when more than one study is performed on the same patient on the same day.

(Sec. 4004) Medicare payments for infusion drugs and biologicals furnished through durable medical equipment are revised.

(Sec. 4005) CMS must expand and extend through August 31, 2018, the Prior Authorization of Power Mobility Devices Demonstration.

(Sec. 4006) For HHS grants, contracts, or other agreements, monetary penalties are established for fraudulent claims, fraudulent statements, and failure to provide timely access to the Inspector General of HHS. Subtitle B--Other Reforms

(Sec. 4041) The Department of Energy must sell crude oil from the Strategic Petroleum Reserve.

Subtitle C--Miscellaneous

(Sec. 4061) HHS must: (1) conduct or support research on Lyme disease and other tick-borne diseases, (2) establish the Interagency Lyme and Tick-Borne Disease Working Group, and (3) submit a strategic plan for tick-borne disease research.

21st century cures act sec nih cures innovation_fund established funds appropriated biomedical research including high risk high reward research research conducted early stage investigators develop implement strategic plan biomedical research carry specified provisions act title discovery subtitle national_institutes_of_health funding sec bill amends public_health_service_act reauthorize national_institutes_of_health nih fy2018 sec nih establish innovation prizes program fund areas biomedical science realize significant advancements improve health outcomes subtitle national_institutes_of_health planning administration sec directors national research institutes national centers year terms office sec nih reduce administrative burdens researchers funded nih sec support national center advancing translational sciences provide clinical trials extended later clinical trial phase sec national research institute conduct support high risk high reward research subtitle supporting young emerging scientists sec loan repayment program established health professionals engaging research maximum awards loan repayment programs increased subtitle grant program sec awards established support outstanding scientists concluding research programs recipients principal investigators subsequent nih awards subtitle promoting pediatric research national_institutes_of_health sec pediatric research initiative revised require establishment national pediatric research network comprised pediatric research consortia sec nih convene workshop appropriate age groupings age exclusions human research publish number children included nih research subtitle advancement national_institutes_of_health research data access sec nih standardize data clinical trial registry data bank subtitle facilitating collaborative research sec nih food_and_drug_administration fda implement system allows research clinical trial data sec centers_for_disease_control_and_prevention cdc expand surveillance neurological diseases sec department_of_health_and_human_services hhs revise health information privacy rules allow use protected information research purposes treated use health_care operations remote access information researchers individuals authorize future use information research subtitle council 21st century cures sec council 21st century cures nonprofit corporation established accelerate discovery development delivery innovative cures treatments preventive measures title development subtitle patient focused drug development sec bill amends federal food drug cosmetic act require fda establish processes patient experience data considered risk benefit assessment new drug subtitle qualification use drug development tools sec fda establish process qualify drug development tools methods materials measures aid drug development regulatory review reliable use supporting approval investigational use drug sec sponsor drug condition request fda agree accelerated approval development plan plan include design drug study subtitle fda advancement precision medicine sec fda define precision drugs evidence needed support use subset patients expedite clinical development precision drugs treatment rare conditions fda rely data previously submitted different approved drug indication subtitle modern trial design evidence development sec fda issue guidance addresses alternative statistical methods clinical trials development review drugs sec support approval drug new indication fda evaluate use evidence clinical experience place evidence clinical trials establish streamlined data review program subtitle expediting patient access sec manufacturers distributors investigational drugs conditions publish policies expanded access known compassionate use subtitle facilitating responsible manufacturer communications sec definition requirements health_care economic information provided entities selecting drugs coverage reimbursement revised subtitle antibiotic drug development sec request sponsor antibacterial antifungal drug treatment infection fda agree process developing data support approval drug use limited population patients hhs monitor use antibacterial antifungal drugs resistance drugs sec fda identify publish susceptibility test interpretive criteria antimicrobial drugs criteria characterize drug resistance microbes fda allow marketing devices use criteria premarket approval sec bill amends title xviii medicare social_security_act ssact require centers medicare medicaid_services cms provide additional payment certain hospitals providing certain new antimicrobial drugs drugs total additional payments exceed total payments hospitals subtitle vaccine access certainty innovation sec advisory_committee_on_immunization_practices expedite review certain vaccines cdc provide vaccine developer request information public health needs priorities certain epidemiological analyses data subtitle orphan product extensions incentives certain products limited populations sec marketing exclusivity period drug approved new indication rare disease condition extended months sec priority review voucher program rare pediatric diseases extended revised apply diseases subtitle domestic manufacturing export efficiencies bill amends controlled_substances_import_and_export_act allow unimpeded exportation certain exported controlled substances european economic area subtitle enhancing combination products review sec fda describe responsibilities agency center charged reviewing drugs medical devices biological products reviewing product combination drug medical device biological product subtitle priority review breakthrough devices sec fda establish program priority review breakthrough medical devices subtitle medical device regulatory process improvements sec fda accredit parties certify device manufactures quality systems meeting fda criteria fda rely certification determining safety effectiveness certain changes medical devices sec valid scientific evidence defined purposes fda determining effectiveness medical device clinical investigations sec fda employees review premarket submissions medical devices receive training burdensome appropriate means concept sec fda identify types medical devices require submission report prior commercial marketing sec fda exempt effectiveness requirements certain medical devices intended benefit fewer individuals subtitle sensible oversight technology advances regulatory efficiency sec health software defined specified exceptions exempted fda regulation subtitle streamlining clinical trials sec institutional review boards responsible reviewing plans clinical testing medical device longer need local sec clinical testing medical devices drugs longer requires informed consent subjects testing poses minimal risk includes safeguards subtitle improving scientific expertise outreach fda sec senior biomedical research service revised remove limit number members changes sec changes reagan udall foundation food_and_drug_administration revise board_of_directors membership executive director compensation accounting sec fda granted additional hiring authority scientific technical professional positions certain centers subtitle exempting sequestration certain user fees sec bill amends balanced_budget emergency deficit control act exempt sequestration fda administrative expenses funded certain user fees subtitle provisions sec bill expresses sense congress recording unique medical device identifiers electronic health records enhance medical surveillance title iii delivery subtitle interoperability sec requirements established interoperability certification health information technology practices discourage exchange electronic health information prohibited subtitle telehealth sec cms medicare_payment_advisory_commission provide information congress telehealth subtitle encouraging continuing medical education physicians sec general_provisions title ssact amended remove requirement manufacturers medical products report payments physicians certain educational activities subtitle disposable medical technologies cms pay home health agencies certain disposable medical devices furnished individuals receiving home health services medicare subtitle local coverage decision reforms sec medicare administrative contractors publish local coverage determinations subtitle medicare pharmaceutical technology ombudsman sec pharmaceutical technology ombudsman cms receive respond complaints manufacturers medical products medicare coverage products subtitle medicare site service price transparency sec cms publish estimated medicare beneficiary prices items services provided hospital outpatient departments ambulatory surgical centers subtitle medicare patient safety drug abuse prevention sec medicare_prescription_drug plan sponsors limit access certain beneficiaries frequently abused drugs title medicaid medicare reforms subtitle medicaid medicare reforms sec aggregate medicaid payments states durable medical equipment limited paid medicare effective january sec generic drugs authorized brand drug manufacturer excluded calculation average manufacturer price determining rebates medicaid sec medicare payments reduced ray imaging uses film imaging instead digital sensor multiple procedure payment reduction policy applied physician imaging services cms publishes analysis efficiencies exist study performed patient day sec medicare payments infusion drugs biologicals furnished durable medical equipment revised sec cms expand extend august prior authorization power mobility devices demonstration sec hhs grants contracts agreements monetary penalties established fraudulent claims fraudulent statements failure provide timely access inspector_general hhs subtitle reforms sec department_of_energy sell crude oil strategic_petroleum_reserve subtitle miscellaneous sec hhs conduct support research lyme disease tick borne diseases establish interagency lyme tick borne disease working_group submit strategic plan tick borne disease research


Summary:
(This measure has not been amended since it was introduced. The summary of that version is repeated here.)

Low-Dose Radiation Research Act of 2015

Requires the Director of the Department of Energy (DOE) Office of Science to carry out a research program on low dose radiation to enhance the scientific understanding of and reduce uncertainties associated with the effects of exposure to low dose radiation.

Requires the Director to enter into an agreement with the National Academies to conduct a study assessing the current status and development of a long-term strategy for low dose radiation research.

Requires such study to:

 identify current scientific challenges for understanding the long-term effects of ionizing radiation, assess the status of current low dose radiation research, formulate overall scientific goals for the future of low-dose radiation research, recommend a long-term strategic and prioritized research agenda to address scientific research goals for overcoming the identified scientific challenges in coordination with other research efforts, define the essential components of a research program that would address this research agenda within the universities and the National Laboratories, and assess the effectiveness of such a program. Directs the Secretary of Energy to deliver to Congress a five-year research plan that responds to the study's findings and recommendations and identifies and prioritizes research needs.

Makes DOE's limitation on human research inapplicable to research under this Act.

measure amended introduced summary version repeated low dose radiation research_act requires director department_of_energy doe office_of_science carry research program low dose radiation enhance scientific understanding reduce associated effects exposure low dose radiation requires director enter agreement national academies conduct study assessing current status development long term strategy low dose radiation research requires study identify current scientific challenges understanding long term effects radiation assess status current low dose radiation research formulate overall scientific goals future low dose radiation research recommend long term strategic prioritized research agenda address scientific research goals identified scientific challenges coordination research efforts define essential components research program address research agenda universities national_laboratories assess effectiveness program directs secretary energy deliver congress year research plan responds study findings recommendations identifies prioritizes research needs makes doe limitation human research inapplicable research act


Summary:
Triple-Negative Breast Cancer Research and Education Act of 2015

Requires the National Institutes of Health to expand, intensify, and coordinate programs for the conduct and support of research on triple-negative breast cancer (breast cancers whose cells are negative for estrogen receptors, progesterone receptors, and the HER2 protein).

Directs the Centers for Disease Control and Prevention to develop and disseminate to the public information regarding triple-negative breast cancer, including information on: (1) the incidence and prevalence of triple-negative breast cancer among women, (2) the elevated risk for minority women, and (3) the availability of a range of treatment options.

Requires the Health Resources and Services Administration to develop and disseminate information on triple-negative breast cancer to health care providers.

triple negative breast cancer research education act requires national_institutes_of_health expand intensify coordinate programs conduct support research triple negative breast cancer breast cancers cells negative protein directs centers_for_disease_control_and_prevention develop disseminate public information triple negative breast cancer including information incidence prevalence triple negative breast cancer women elevated risk minority women availability range treatment options requires health_resources_and_services_administration develop disseminate information triple negative breast cancer health_care providers


Summary:
Ensuring Access to Clinical Trials Act of 2015

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.

ensuring access clinical trials act 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:
Advancing Research for Neurological Diseases 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 neurological diseases, including multiple sclerosis and Parkinson's disease; and (2) incorporate information obtained through those activities into a National Neurological Diseases Surveillance System. Requires the Department of Health and Human Services (HHS) to ensure that the System facilitates further research on neurological diseases.

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

Requires HHS to: (1) make information and analysis in the System available to federal agencies and 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 neurological diseases act amends public_health_service_act require centers_for_disease_control_and_prevention enhance expand infrastructure activities track epidemiology neurological diseases including multiple sclerosis parkinson disease incorporate information obtained activities national neurological diseases surveillance system requires department_of_health_and_human_services hhs ensure system facilitates research neurological diseases requires hhs provide collection storage information neurological diseases including incidence prevalence information extent practicable requires hhs information analysis system available federal agencies public including researchers ensure privacy security protections applicable system stringent protections health_insurance_portability_and_accountability_act


Summary:
Expanding Care for Veterans Act

Directs the Secretary of Veterans Affairs (VA) to develop a plan to expand the scope of VA's research and education on, and delivery and integration of, complementary and alternative medicine services.

Requires the Secretary to carry out, through VA's Office of Patient Centered Care and Cultural Transformation, a three-year program to: (1) assess the feasibility and advisability of integrating the delivery of complementary and alternative medicine services selected by the Secretary with other VA health care services for veterans, and (2) identify and resolve barriers to providing such services and integrating them with other VA health services.

Requires such program to be conducted, at not fewer than 15 VA medical centers, by integrating the provision of complementary and alternative medicine services with other VA health care services provided to veterans who have a mental health condition, experience chronic pain, or have a chronic condition. Requires veterans' participation to be voluntary.

Directs the Secretary to contract with a qualified independent entity for comprehensive studies of the barriers encountered by veterans in receiving, and by administrators and clinicians in providing, complementary and alternative medicine services through VA. Provides for the conduct of such studies through surveys of veterans and VA administrators and clinicians.

Requires the Secretary to carry out a three-year program awarding grants to public or private nonprofit entities to assess the feasibility and advisability of using wellness programs to complement the provision of mental health care to veterans and family members who are eligible for readjustment counseling from VA.

expanding care veterans act directs secretary veterans_affairs develop plan expand scope research education delivery integration complementary alternative medicine services requires secretary carry office patient centered care cultural transformation year program assess feasibility advisability integrating delivery complementary alternative medicine services selected secretary health_care services veterans identify resolve barriers providing services integrating health services requires program conducted fewer medical centers integrating provision complementary alternative medicine services health_care services provided veterans mental health condition experience chronic pain chronic condition requires veterans participation voluntary directs secretary contract qualified independent entity comprehensive studies barriers encountered veterans receiving administrators clinicians providing complementary alternative medicine services provides conduct studies surveys veterans administrators clinicians requires secretary carry year program awarding grants public private nonprofit entities assess feasibility advisability wellness programs complement provision mental health_care veterans family members eligible readjustment counseling


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


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