Summary: Heart Disease Education, Analysis, Research, and Treatment for Women Act or the HEART for Women Act - Directs the Comptroller General to report on whether the presentation of clinical study safety and effectiveness data by sex, age, and racial subgroups complies with Food and Drug Administration (FDA) requirements. Requires the Secretary of Health and Human Services (HHS) to submit a response to such report, including a corrective action plan as needed. Requires the Director of the Office of Women's Health of FDA to report on the compliance of clinical studies of women's health with such FDA requirements, including requirements regarding: (1) the adequacy of representation of females, racial and ethnic minorities, and adults of all ages in approved clinical studies; and (2) the extent to which a summary of product safety and effectiveness data disaggregated by sex, age, and racial subgroup is available to the public. Requires the Director of the Office of Minority Health of FDA to submit a report that includes such information with respect to clinical studies of minority health. Amends the Public Health Service Act to require the Secretary to report on the quality of, and access to, care for women with heart disease, stroke, and other cardiovascular diseases and to include recommendations for eliminating disparities in, and improving the treatment of, heart disease, stroke, and other cardiovascular diseases in women. Reauthorizes a program to award grants for preventive heath services and referrals for medical treatment for women through entities that are screening women for breast or cervical cancer. Requires the Secretary to study the impact of the Patient Protection and Affordable Care Act on such services and make recommendations for improvement.

heart women act directs comptroller general report presentation clinical study safety effectiveness data sex age racial subgroups complies food_and_drug_administration fda requirements requires secretary health_and_human_services hhs submit response report including corrective action plan needed requires director report compliance clinical studies women health fda requirements including requirements adequacy representation females racial ethnic minorities adults ages approved clinical studies extent summary product safety effectiveness data disaggregated sex age racial subgroup available public requires director submit report includes information respect clinical studies minority health amends public_health_service_act require secretary report quality access care women heart disease stroke cardiovascular diseases include recommendations eliminating disparities improving treatment heart disease stroke cardiovascular diseases women reauthorizes program award grants preventive heath services referrals medical treatment women entities screening women breast cervical cancer requires secretary study impact patient_protection affordable care act services recommendations improvement


Summary: Colorectal Cancer Prevention, Early Detection, and Treatment Act - Amends the Public Health Service Act to allow the Secretary of Health and Human Services (HHS), acting through the Director of the Centers for Disease Control and Prevention (CDC), to make grants to states and Indian tribes to carry out programs to increase quality colorectal cancer screening. Requires such a program to include: (1) providing recommended colorectal cancer screening to individuals who are over 50 years of age or at high risk for such cancer; (2) providing case management and referrals for medical treatment; (3) ensuring the full continuum of follow-up and cancer care for individuals screened; (4) carrying out activities to improve the education, training, and skills of health professionals to ensure the use of evidence-based recommended and quality screening and follow-up in the prevention, detection, and control of colorectal cancer; and (5) developing and disseminating public information and education programs for the prevention, detection, and control of colorectal cancer and promoting the benefits of receiving screenings through this program. Gives priority to low-income individuals who lack adequate coverage under health insurance and health plans with respect to screenings for colorectal cancer. Allows the Secretary to provide training and technical assistance with respect to the planning, development, and operation of programs funded by a grant under this Act. Amends title XIX (Medicaid) of the Social Security Act to allow states to provide medical assistance to individuals who have been screened for colorectal cancer under this Act and who need treatment for complications due to screening or colorectal cancer. Applies provisions related to breast and cervical cancer programs to programs under this Act.

colorectal cancer prevention early detection treatment act amends public_health_service_act allow secretary health_and_human_services hhs acting director centers_for_disease_control_and_prevention cdc grants states indian tribes carry programs increase quality colorectal cancer screening requires program include providing recommended colorectal cancer screening individuals years age high risk cancer providing case management referrals medical treatment ensuring continuum follow cancer care individuals screened carrying activities improve education training skills health professionals ensure use evidence based recommended quality screening follow prevention detection control colorectal cancer developing disseminating public information education programs prevention detection control colorectal cancer promoting benefits receiving screenings program gives priority low income individuals lack adequate coverage health insurance health plans respect screenings colorectal cancer allows secretary provide training technical assistance respect planning development operation programs funded grant act amends title xix medicaid social security act allow states provide medical assistance individuals screened colorectal cancer act need treatment complications screening colorectal cancer applies provisions related breast cervical cancer programs programs act


Summary: Adult Day Achievement Center Enhancement Act - Requires the Assistant Secretary for Aging to initiate a comprehensive survey of current adult day programs that provide care and support to individuals living with neurological diseases or conditions, including multiple sclerosis, Parkinson's disease, or traumatic brain injury. Requires the Assistant Secretary to identify ongoing successful adult day programs and develop a set of best practices to help guide the establishment and replication of additional successful adult day programs. Directs the Assistant Secretary to establish a competitive grant program for awarding grants annually to fund adult day programs. Defines an "adult day program" as a program that provides comprehensive and effective care and support services to individuals living with neurological diseases or conditions and to their family caregivers and that may assist them in ways that: (1) maintain or improve their functional abilities or otherwise help them adjust to their changing functional abilities; (2) prevent the onset of complications associated with severe forms of the disease or condition; (3) promote alternatives to placement in nursing homes; (4) reduce the strain on family caregivers taking care of a family member living with such a disease or condition; (5) focus on supporting the emotional, social, and intellectual needs of a younger adult population; or (6) address the needs of veterans living with such a disease or condition.

adult day achievement center enhancement act requires assistant secretary aging initiate comprehensive survey current adult day programs provide care support individuals living neurological diseases conditions including multiple sclerosis parkinson disease traumatic brain injury requires assistant secretary identify ongoing successful adult day programs develop set best practices help guide establishment replication additional successful adult day programs directs assistant secretary establish competitive grant program awarding grants annually fund adult day programs defines adult day program program provides comprehensive effective care support services individuals living neurological diseases conditions family caregivers assist ways maintain improve functional abilities help adjust changing functional abilities prevent onset complications associated severe forms disease condition promote alternatives placement nursing homes reduce strain family caregivers taking care family member living disease condition focus supporting emotional social intellectual needs younger adult population address needs veterans living disease condition


Summary: Lung Cancer Mortality Reduction Act of 2011 - Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS) to implement a comprehensive program to achieve a 50% reduction in the mortality rate of lung cancer by 2020. Requires the program to include initiatives throughout HHS, including: (1) a strategic review and prioritization by the National Cancer Institute of research grants; (2) the establishment by the Food and Drug Administration (FDA) of quality standards and guidelines for facilities that conduct computed tomography screening for lung cancer; and (3) the provision of funds to the Centers for Disease Control and Prevention (CDC) to establish a Lung Cancer Early Detection Program that provides low-income, uninsured, and underserved populations that are at high risk for lung cancer access to early detection services. Requires the Secretary of Defense (DOD) and the Secretary of Veterans Affairs (VA) to coordinate with the Secretary of HHS in implementing this Act and implementing coordinated care programs for military personnel and veterans diagnosed with lung cancer. Requires the Secretary of HHS to establish: (1) the Lung Cancer Computed Tomography Screening and Treatment Demonstration Project; and (2) the Lung Cancer Advisory Board to monitor the programs established under this Act.

lung cancer mortality reduction act amends public_health_service_act require secretary health_and_human_services hhs implement comprehensive program achieve reduction mortality rate lung cancer requires program include initiatives hhs including strategic review prioritization national_cancer_institute research grants establishment food_and_drug_administration fda quality standards guidelines facilities conduct computed tomography screening lung cancer provision funds centers_for_disease_control_and_prevention cdc establish lung cancer early detection program provides low income uninsured underserved populations high risk lung cancer access early detection services requires secretary defense dod secretary veterans_affairs coordinate secretary hhs implementing act implementing coordinated care programs military personnel veterans diagnosed lung cancer requires secretary hhs establish monitor programs established act


Summary: Tom Lantos Pulmonary Hypertension Research and Education Act of 2011 - Expresses the sense of Congress that: (1) the Secretary of Health and Human Services (HHS), acting through the Director of the National Institutes of Health (NIH) and the Director of the National Heart, Lung, and Blood Institute, should continue aggressive work on pulmonary hypertension; and (2) the Director of the Institute should continue research to expand the understanding of the causes of, and to find a cure for, pulmonary hypertension. Requires inclusion of information on the status of pulmonary hypertension research at NIH in biennial reports to Congress. Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to carry out an educational campaign to increase public awareness of pulmonary hypertension, which may include information on pulmonary hypertension and its symptoms, the incidence and prevalence of pulmonary hypertension, diseases and conditions that can lead to pulmonary hypertension as a secondary diagnosis, the importance of early diagnosis, and the availability of a range of treatment options. Requires the Secretary, acting through the Administrator of the Health Resources and Services Administration (HRSA) and the Director of CDC, to carry out an educational campaign to increase awareness of pulmonary hypertension among health care providers, which may include information on: (1) the symptoms of pulmonary hypertension, (2) the importance of early diagnosis, (3) current diagnostic criteria, and (4) Food and Drug Administration (FDA)-approved therapies for the disease. Requires such campaign to target health care providers, including cardiologists, pulmonologists, rheumatologists, primary care physicians, pediatricians, and nurse practitioners.

tom_lantos pulmonary hypertension research education act expresses sense congress secretary health_and_human_services hhs acting director national_institutes_of_health nih director national_heart lung blood_institute continue aggressive work pulmonary hypertension director institute continue research expand understanding causes find cure pulmonary hypertension requires inclusion information status pulmonary hypertension research nih biennial reports congress requires secretary acting director centers_for_disease_control_and_prevention cdc carry educational campaign increase public awareness pulmonary hypertension include information pulmonary hypertension symptoms incidence prevalence pulmonary hypertension diseases conditions lead pulmonary hypertension secondary diagnosis importance early diagnosis availability range treatment options requires secretary acting administrator health_resources_and_services_administration hrsa director cdc carry educational campaign increase awareness pulmonary hypertension health care providers include information symptoms pulmonary hypertension importance early diagnosis current diagnostic criteria food_and_drug_administration therapies disease requires campaign target health care providers including primary care physicians pediatricians nurse practitioners


Summary: National Black Clergy for the Elimination of HIV/AIDS Act of 2011 - Authorizes the Director of the Office of Minority Health of the Department of Health and Human Services (HHS) to make grants to public health agencies and faith-based organizations to conduct HIV/AIDS prevention, testing, and related outreach activities to reduce HIV/AIDS in the African-American community. Authorizes the Administrator of the Substance Abuse and Mental Health Services Administration to make grants to: (1) public health agencies and faith-based organizations to conduct HIV/AIDS and sexually transmitted disease outreach, prevention, and testing activities and substance abuse testing and mental health services targeted to the African-American community; and (2) faith- and community-based organizations to provide services to youth who are HIV positive or at risk for HIV/AIDS and who have run away from home, are homeless, or reside in a detention center or foster care. Authorizes the Director of the Centers for Disease Control and Prevention (CDC) to make grants to faith-based organizations for public health intervention and prevention activities in the African-American community to reduce HIV/AIDS, sexually transmitted diseases, tuberculosis, and viral hepatitis. Requires the Director of CDC to: (1) expand and intensify HIV/AIDS activities in African-American communities and educational activities targeting black women, youth, and men who have sex with men; (2) expand funding to build the capacity of African-American communities to respond to HIV/AIDS; and (3) implement a national media outreach campaign on getting tested. Authorizes the Director of the National Institutes of Health (NIH) to research behavioral strategies to reduce the transmission of HIV/AIDS in the African-American community. Authorizes the Director of the National Center on Minority Health and Health Disparities to make grants for the study of biological and behavioral factors that lead to increased HIV/AIDS prevalence in the African-American community and for behavioral and structural network research and interventions. Amends the Public Health Service Act to authorize the Administrator of the Health Resources and Services Administration to award grants for: (1) training health care providers in HIV/AIDS prevention and care, (2) developing policies for providing culturally relevant and sensitive treatment to individuals with HIV/AIDS, (3) HIV/AIDS telemedicine programs, (4) certification programs for providers in HIV/AIDS care, (5) establishment of comfort care centers for people with HIV/AIDS, and (6) incentive payments to health care providers to implement HIV/AIDS testing.

elimination hiv aids act authorizes director hhs grants public health agencies faith based organizations conduct hiv aids prevention testing related outreach activities reduce hiv aids african american community authorizes administrator substance_abuse_and_mental_health_services_administration grants public health agencies faith based organizations conduct hiv aids sexually transmitted disease outreach prevention testing activities substance abuse testing mental health services targeted african american community community based organizations provide services youth hiv positive risk hiv aids run away home homeless reside detention center foster care authorizes director centers_for_disease_control_and_prevention cdc grants faith based organizations public health intervention prevention activities african american community reduce hiv aids sexually transmitted diseases tuberculosis viral hepatitis requires director cdc expand intensify hiv aids activities african american communities educational activities targeting black women youth men sex men expand funding build capacity african american communities respond hiv aids implement national media outreach campaign getting tested authorizes director national_institutes_of_health nih research behavioral strategies reduce transmission hiv aids african american community authorizes director national_center_on_minority_health_and_health_disparities grants study biological behavioral factors lead increased hiv aids prevalence african american community behavioral structural network research interventions amends public_health_service_act authorize administrator health_resources_and_services_administration award grants training health care providers hiv aids prevention care developing policies providing culturally relevant sensitive treatment individuals hiv aids hiv aids telemedicine programs certification programs providers hiv aids care establishment comfort care centers people hiv aids incentive payments health care providers implement hiv aids testing


Summary: Nutria Eradication and Control Act of 2011 - Amends the Nutria Eradication and Control Act of 2003 to revise the nutria eradication program by authorizing the Secretary of the Interior to  provide financial assistance to Delaware, Louisiana, Maryland, North Carolina, Oregon, Virginia, and Washington (currently, only to Maryland and Louisiana). Establishes the goals of such Program as: (1) eradicating nutria in Maryland; (2) eradicating or controlling nutria in Louisiana, Delaware, North Carolina, Oregon, Virginia, and Washington; and (3) restoring wetlands damaged by nutria. Requires that the Maryland program consist of management, research, and public education activities carried out in accordance with the United States Fish and Wildlife Service's document entitled "Eradication Strategies for Nutria in the Chesapeake and Delaware Bay Watersheds," dated March 2002 and updated in March 2009. Authorizes appropriations for such program for FY2012-FY2016 for financial assistance to the state of Maryland, the state of Louisiana, and on a competitive basis, to other coastal states. Requires the Secretary and the National Invasive Species Council to develop long-term nutria control or eradication programs to: (1) significantly reduce and restore nutria damaged wetlands in Delaware, Oregon, North Carolina, Virginia, and Washington; and (2) promote voluntary, public-private partnerships to eradicate or control nutria and restore nutria-damaged wetlands in such states.

nutria_eradication control act amends nutria eradication control act revise nutria eradication program authorizing secretary interior provide financial assistance delaware louisiana maryland north_carolina oregon virginia washington currently maryland louisiana establishes goals program eradicating nutria maryland eradicating controlling nutria louisiana delaware north_carolina oregon virginia washington restoring wetlands damaged nutria requires maryland program consist management research public education activities carried accordance united_states fish_and_wildlife_service document entitled eradication strategies nutria chesapeake delaware bay watersheds dated march updated march authorizes appropriations program fy2012-fy2016 financial assistance state maryland state louisiana competitive basis coastal states requires secretary national_invasive_species_council develop long term nutria control eradication programs significantly reduce restore nutria damaged wetlands delaware oregon north_carolina virginia washington promote voluntary public private partnerships eradicate control nutria restore nutria damaged wetlands states


Summary: Bone Health Promotion and Research Act of 2011 - Amends the Public Health Service Act to authorize the Secretary of Health and Human Services (HHS) to develop and implement a National Bone Health Program under which: (1) the Director of the Centers for Disease Control and Prevention (CDC) may conduct, support, and promote the coordination of research, investigations, demonstrations, training, and studies relating to the control, prevention, and surveillance of osteoporosis and related bone diseases; (2) the Secretary may coordinate and carry out national education and outreach activities to support, develop, and implement education initiatives and outreach strategies appropriate for osteoporosis and related bone diseases; and (3) the Secretary may award grants to states and Indian tribes for comprehensive osteoporosis and related bone disease control and prevention programs. Requires the Director of CDC to establish the Osteoporosis and Related Bone Disease Advisory Committee to advise the Secretary and the Assistant Secretary for Health on activities addressing such diseases. Directs the Director of the National Institutes of Health (NIH) to expand and intensify NIH research programs for osteoporosis and related bone diseases, including by awarding planning grants or contracts for the establishment or enhancement of research programs for such diseases. Authorizes the Director of CDC to award grants or enter into cooperative agreements for the collection, analysis, and reporting of data on such diseases.

amends public_health_service_act authorize secretary health_and_human_services hhs develop implement director centers_for_disease_control_and_prevention cdc conduct support promote coordination research investigations demonstrations training studies relating control prevention surveillance osteoporosis related bone diseases secretary coordinate carry national education outreach activities support develop implement education initiatives outreach strategies appropriate osteoporosis related bone diseases secretary award grants states indian tribes comprehensive osteoporosis related bone disease control prevention programs requires director cdc establish advise secretary assistant secretary health activities addressing diseases directs director national_institutes_of_health nih expand intensify nih research programs osteoporosis related bone diseases including awarding planning grants contracts establishment enhancement research programs diseases authorizes director cdc award grants enter cooperative agreements collection analysis reporting data diseases


Summary: Birth Defects Prevention, Risk Reduction, and Awareness Act of 2011 - Requires the Secretary of Health and Human Services (HHS), acting through the Director of the Centers for Disease Control and Prevention (CDC), to establish and implement a birth defects prevention and public awareness program, which includes: (1) a nationwide media campaign to increase awareness among health care providers and at-risk populations about pregnancy and breastfeeding information services; (2) grants for the provision of, or campaigns to increase awareness about, pregnancy and breastfeeding information services; and (3) grants for the conduct or support of surveillance of or research on maternal exposures that may influence the risk of adverse pregnancy outcomes and maternal exposures that may influence health risks to a breastfed infant, or of networking to facilitate such surveillance or research.

risk reduction awareness act requires secretary health_and_human_services hhs acting director centers_for_disease_control_and_prevention cdc establish implement birth defects prevention public awareness program includes nationwide media campaign increase awareness health care providers risk populations pregnancy breastfeeding information services grants provision campaigns increase awareness pregnancy breastfeeding information services grants conduct support surveillance research maternal exposures influence risk adverse pregnancy outcomes maternal exposures influence health risks infant networking facilitate surveillance research


Summary: Prostate Research, Outreach, Screening, Testing, Access, and Treatment Effectiveness Act of 2011 or the PROSTATE Act - Requires the Secretary of Veterans Affairs (VA) to establish the Interagency Prostate Cancer Coordination and Education Task Force, with duties to include: (1) developing a summary of advances in federal prostate cancer research and compile a list of best practices that warrant broader adoption in health care programs; (2) considering establishing guidance to enable physicians to allow screening of men over age 74; (3) coordinating information on federal research and health care program activities relating to prostate cancer; and (4) submitting recommendations regarding federal research and health care programs. Directs the Secretary to establish and carry out a program to coordinate and intensify prostate cancer research, including by developing advances in diagnostic and prognostic methods and tests, better understanding the etiology of the disease, and establishing clinical registries for prostate cancer and awarding research grants. Establishes in the Office of the Chief Scientist of the Food and Drug Administration (FDA) a Prostate Cancer Scientific Advisory Board to be responsible for accelerating real-time sharing of the latest research data and accelerating movement of new medicines to patients. Directs the Secretary of VA, the Secretary of Defense (DOD) and the Secretary of Health and Human Services (HHS) to establish four-year telehealth pilot projects to analyze the clinical outcomes and cost effectiveness associated with telehealth services in a variety of geographic areas that contain high proportions of medically underserved populations and those in rural areas. Requires the Secretary of VA to develop a national education campaign for prostate cancer.

prostate_research outreach screening testing access treatment effectiveness act prostate act requires secretary veterans_affairs establish duties include developing summary advances federal prostate cancer research compile list best practices warrant broader adoption health care programs considering establishing guidance enable physicians allow screening men age coordinating information federal research health care program activities relating prostate cancer submitting recommendations federal research health care programs directs secretary establish carry program coordinate intensify prostate cancer research including developing advances diagnostic methods tests better understanding disease establishing clinical registries prostate cancer awarding research grants establishes fda prostate cancer scientific advisory board responsible accelerating real time sharing latest research data accelerating movement new medicines patients directs secretary secretary defense dod secretary health_and_human_services hhs establish year telehealth pilot projects analyze clinical outcomes cost effectiveness associated telehealth services variety geographic areas contain high proportions medically underserved populations rural areas requires secretary develop national education campaign prostate cancer


Summary: Gestational Diabetes Act of 2011 or the GEDI Act - Amends the Public Health Service Act to direct the Director of the Centers for Disease Control and Prevention (CDC) to develop a multisite gestational diabetes research project within the diabetes program of the CDC to expand and enhance surveillance data and public health research on gestational diabetes.  Requires the Secretary of Health and Human Services (HHS) to expand and intensify public health research on gestational diabetes, including; (1) developing and testing novel approaches for improving postpartum testing or screening and for preventing type 2 diabetes in women with a history of gestational diabetes; and (2) conducting research to further understanding of the factors and health systems that influence the risk of gestational diabetes and the development of type 2 diabetes in women with a history of gestational diabetes. Requires the Director to: (1) award grants for demonstration projects to reduce the incidence of gestational diabetes, the recurrence of such disease in subsequent pregnancies, and the development of type 2 diabetes in women with a history of gestational diabetes; and (2) work with state and Indian tribal-based diabetes prevention and control programs assisted by the CDC to encourage postpartum follow-up after gestational diabetes to reduce the incidence of gestational diabetes and its recurrence, the development of type 2 diabetes in at-risk women, and related complications.

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


Summary: Border Health Security Act of 2011 - Amends the United States-Mexico Border Health Commission Act to revise the duties of the United States-Mexico Border Health Commission to include serving as an independent and objective body to both recommend and implement initiatives that solve border health issues. Authorizes a member of the Commission to provide advice or recommendations to Congress concerning issues that are considered by the Commission. Requires the Secretary of Health and Human Services (HHS), acting through the Commissioners, to award grants to eligible entities to improve the health of border residents. Requires the Secretary to award grants under the Early Warning Infectious Disease Surveillance project to eligible entities for infection disease surveillance activities in the border area. Requires the Commission to: (1) prepare a binational strategic plan to guide the operations of the Commission, and (2) develop and approve an operational work plan and budget based on the strategic plan. Requires the Government Accountability Office (GAO) to conduct an evaluation of Commission activitie. Requires the Secretary to enter into a contract with the Institute of Medicine for a study concerning binational health infrastructure (including trauma and emergency care) and health insurance efforts. Authorizes the Secretary to coordinate with the Secretary of Homeland Security (DHS) in establishing a health alert system that: (1) alerts clinicians and public health officials of emerging disease clusters and syndromes along the border area; and (2) is alerted to signs of health threats, disasters of mass scale, or bioterrorism along the border area.

border health security act amends act revise duties include serving independent objective body recommend implement initiatives solve border health issues authorizes member commission provide advice recommendations congress concerning issues considered commission requires secretary health_and_human_services hhs acting commissioners award grants eligible entities improve health border residents requires secretary award grants early warning infectious disease surveillance project eligible entities infection disease surveillance activities border area requires commission prepare binational strategic plan guide operations commission develop approve operational work plan budget based strategic plan requires government_accountability_office gao conduct evaluation commission requires secretary enter contract institute_of_medicine study concerning binational health infrastructure including trauma emergency care health insurance efforts authorizes secretary coordinate secretary homeland_security dhs establishing health alert system alerts clinicians public health officials emerging disease clusters border area signs health threats disasters mass scale bioterrorism border area


Summary: Amends the Internal Revenue Code to repeal the 10% excise tax on indoor tanning services.

amends internal revenue code repeal excise tax indoor tanning services


Summary: Generating Antibiotic Incentives Now Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to extend the exclusivity period for a new prescription drug by five years for a drug that the Secretary of Health and Human Services (HHS) determines to be a qualified infectious disease product. Defines "qualified infectious disease product" to mean an antibiotic drug for treating, detecting, preventing, or identifying a qualifying pathogen (certain pathogens that are resistant to antibiotics). Excludes drugs that are: (1) a supplement to a new drug application for which an extension is in effect or has expired; or (2) a subsequent application for a change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or strength, or a modification to the structure of the product that does not result in a change in safety or effectiveness. Extends such period of exclusivity an additional six months for a sponsor or manufacturer of a qualified infectious disease product that identifies a companion diagnostic test. Requires the Secretary to give priority review to any drug determined to be a qualified infectious disease product. Includes qualified infectious disease products as fast track products for which the Secretary shall facilitate development and expedite review. Directs the Comptroller General to study the need for incentives to encourage the research, development, and marketing of qualified infectious disease biological products. Requires the Secretary to: (1) review Food and Drug Administration (FDA) guidelines for clinical trials of antibiotic drugs; and (2) revise such guidelines, as appropriate, to reflect developments in scientific and medical information and technology and to ensure clarity regarding the procedures and requirements for approval of an antibiotic drug.

act amends cosmetic act extend exclusivity period new prescription drug years drug secretary health_and_human_services hhs determines qualified infectious disease product defines qualified infectious disease product mean antibiotic drug treating detecting preventing identifying qualifying pathogen certain pathogens resistant antibiotics excludes drugs supplement new drug application extension effect expired subsequent application change results new indication route administration dosing schedule dosage form delivery system delivery device strength modification structure product result change safety effectiveness extends period exclusivity additional months sponsor manufacturer qualified infectious disease product identifies companion diagnostic test requires secretary priority review drug determined qualified infectious disease product includes qualified infectious disease products fast track products secretary shall facilitate development expedite review directs comptroller general study need incentives encourage research development marketing qualified infectious disease biological products requires secretary review food_and_drug_administration fda guidelines clinical trials antibiotic drugs revise guidelines appropriate reflect developments scientific medical information technology ensure clarity procedures requirements approval antibiotic drug


Summary: Access to Appropriate Immunizations for Veterans Act of 2011 - Includes within authorized preventive health services available to veterans through the Department of Veterans Affairs (VA) immunizations against infectious diseases, including each immunization on the recommended adult immunization schedule established by the Advisory Committee on Immunization Practices. Requires the inclusion, in an annual report from the Secretary of Veterans Affairs on VA preventive health services, of programs conducted to ensure that veterans have received each immunization on such immunization schedule at the appropriate time. Directs the Secretary to develop and implement quality measures and metrics to ensure that veterans receiving VA medical services receive each immunization at the time indicated on the schedule. Requires statistics related to such quality measures and metrics to be included in the annual report described above. Provides deadlines for the establishment and implementation of the measures and metrics.

access appropriate immunizations veterans act includes authorized preventive health services available veterans department_of_veterans_affairs immunizations infectious diseases including immunization recommended adult immunization schedule established advisory_committee_on_immunization_practices requires inclusion annual report secretary veterans_affairs preventive health services programs conducted ensure veterans received immunization immunization schedule appropriate time directs secretary develop implement quality measures metrics ensure veterans receiving medical services receive immunization time indicated schedule requires statistics related quality measures metrics included annual report described provides deadlines establishment implementation measures metrics


Summary: Viral Hepatitis Testing Act of 2011 - Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS) to carry out surveillance, education, and testing programs with respect to hepatitis B (HBV) and hepatitis C (HCV) virus infections. Requires the Secretary to establish a national system with respect to HBV and HCV to: (1) determine the prevalence of such infections, (2) carry out testing programs to increase the number of individuals who are aware of their infection, (3) disseminate public information and education programs for the detection and control of such infections, (4) provide referrals for counseling and medical treatment and ensure the provision of follow-up services, and (5) improve the training of health professionals in the treatment of such infections. Directs the Secretary to determine the populations that are considered at high risk. Requires the Director of the Centers for Disease Control and Prevention (CDC) to complete the revision of CDC guidelines for screening individuals with HCV, taking into account: (1) the effectiveness issues that have been raised with respect to the current CDC guidelines for screening, (2) the importance of responding to the perception that receiving such screening may be stigmatizing, and (3) whether age-based screening would be effective. Requires the Director of the Agency for Healthcare Research and Quality (AHRQ) to: (1) develop HCV screening recommendations, taking into account the guidelines established by CDC and new and improved treatments for HCV; and (2) develop HBV screening recommendations, taking into account the guidelines the CDC recommended in 2008.

viral hepatitis testing act amends public_health_service_act require secretary health_and_human_services hhs carry surveillance education testing programs respect hepatitis hepatitis hcv virus infections requires secretary establish national system respect hcv determine prevalence infections carry testing programs increase number individuals aware infection disseminate public information education programs detection control infections provide referrals counseling medical treatment ensure provision follow services improve training health professionals treatment infections directs secretary determine populations considered high risk requires director centers_for_disease_control_and_prevention cdc complete revision cdc guidelines screening individuals hcv taking account effectiveness issues raised respect current cdc guidelines screening importance responding perception receiving screening age based screening effective requires director agency healthcare_research_and_quality ahrq develop hcv screening recommendations taking account guidelines established cdc new improved treatments hcv develop screening recommendations taking account guidelines cdc recommended


Summary: Pandemic and All-Hazards Preparedness Act Reauthorization of 2011 - Title I: Strengthening National Preparedness and Response for Public Health Emergencies - (Sec. 101) Amends the Public Health Service Act (PHSA) to require the Secretary of Health and Human Services (HHS) to submit the National Health Security Strategy to the relevant congressional committees in 2014. Requires the Strategy to include: (1) provisions for increasing the preparedness, response capabilities, and surge capacity of dental health facilities and critical care service systems; (2) plans for optimizing a coordinated and flexible approach to the medical surge capacity of hospitals, other health care facilities, and trauma care and emergency medical systems; (3) provisions taking into account the unique needs of individuals with disabilities in a public health emergency; and (4) strategic initiatives to advance countermeasures to diagnose, mitigate, prevent, or treat harm from any biological agent or toxin or any chemical, radiological, or nuclear agent or agents, whether naturally occurring, unintentional, or deliberate. Requires the Secretary to: (1) monitor emerging issues and concerns as they relate to medical and public health preparedness and response for at-risk individuals in the event of a public health emergency; (2) disseminate and update novel and best practices of outreach to and care of at-risk individuals before, during, and following public health emergencies in as timely a manner as is practicable, including from the time a public health threat is identified; and (3) ensure that public health and medical information distributed by HHS during a public health emergency is delivered in a manner that takes into account the range of communication needs of the intended recipients, including at-risk individuals. (Sec. 102) Requires the Assistant Secretary for Preparedness and Response to provide integrated policy coordination and strategic direction with respect to all matters related to federal public health and medical preparedness and execution and deployment of the federal response for public health emergencies and incidents covered by the National Response Plan before, during, and following public health emergencies. Give the Assistant Secretary direct authority over and responsibility for: (1) the Medical Reserve Corps, (2) the Emergency System for Advance Registration of Volunteer Health Professionals, and (3) administering grants and related authorities related to trauma care. Authorizes the Assistant Secretary to exercise the responsibilities and authorities of the Secretary with respect to the coordination of the Public Health Emergency Preparedness Cooperative Agreement Program. Requires the Assistant Secretary to: (1) align and coordinate medical and public health grants and cooperative agreements as applicable to preparedness and response activities authorized under PHSA; and (2) carry out drills and operational exercises to identify, inform, and address gaps in and policies related to all-hazards medical and public health preparedness. Requires the Secretary, acting through the Assistant Secretary, to: (1) conduct periodic meetings with the Assistant to the President for National Security Affairs to provide an update on, and to discuss, medical and public health preparedness and response activities; (2) develop a coordinated strategy and accompanying implementation plan for medical countermeasures to address chemical, biological, radiological, and nuclear threats. Requires the Government Accountability Office (GAO) to conduct an independent evaluation on the strategy and implementation plan. Requires the Secretary to: (1) develop and annually update a five-year budget plan based on medical countermeasures and priorities; (2) report to the relevant congressional committees regarding coordination with the Department of Defense (DOD) regarding countermeasure activities to address chemical, biological, radiological, and nuclear threats; and (3) ensure that information and items that could compromise national security are not disclosed. (Sec. 103) Requires the Secretary to establish the National Advisory Committee on Children and Disasters. Terminates the Committee after five years. (Sec. 104) Revises and reauthorizes through FY2016 the National Disaster Medical System. Requires the Secretary to take steps to ensure that a range of public health and medical capabilities are represented in the System, which take into account the needs of at-risk individuals, in the event of a public health emergency. Authorizes the Secretary to determine and pay claims for reimbursement for services provided through the System directly or through contracts that provide for payment in advance or by way of reimbursement. (Sec. 105) Reauthorizes through FY2016 a program for public health emergency readiness of the Department of Veterans Affairs (VA) medical centers. Title II: Optimizing State and Local All-Hazards Preparedness and Response - (Sec. 201) Revises and reauthorizes for FY2012-FY2016 a program of cooperative agreements to improve state and local public health security. Revises requirements for the All-Hazards Public Health Emergency Preparedness and Response Plan. Requires the Secretary to: (1) periodically update criteria for an effective state plan for responding to pandemic influenza, and (2) require the integration of such criteria into the benchmarks and standards that measure levels of preparedness. Provides that amounts provided to an eligible entity under a cooperative agreement to achieve preparedness goals for a fiscal year that are unobligated at the end of such year shall remain available to such entity for the next fiscal year. Makes continued availability of such funds contingent upon achieving benchmarks and submitting a pandemic influenza plan. Eliminates provisions limiting the amount of an award that an entity may carry over to the succeeding fiscal year. Reauthorizes appropriations for FY2012-FY2016 for the influenza vaccine tracking and distribution program in an influenza pandemic. Requires GAO to conduct an evaluation of federal programs at HHS that support medical and public health preparedness and response programs at the state and local levels. (Sec. 202) Includes dental entities among entities that may carry out education and training activities to improve responses to public health emergencies. Reauthorizes the Emergency System for Advance Registration of Health Professions Volunteers (ESAR-VHP) for FY2012-FY2016, which provides a single national interoperable network of systems to verify the credentials and licenses of health care professionals who volunteer to provide health services during a public health emergency. Reauthorizes through FY2016 the Medical Reserve Corps to provide for an adequate supply of volunteers in the case of a public health emergency. Revises such provisions to require the training exercises to incorporate the needs of at-risk individuals in the event of a public health emergency. Revises and reauthorizes appropriations for FY2012-FY2016 for a program of grants and cooperative agreements to improve surge capacity and enhance community and hospital preparedness. Makes community health centers eligible for such a program. Provides that amounts provided to an eligible entity under such program for a fiscal year that are unobligated at the end of such year shall remain available to such entity for the next fiscal year for the purposes for which such funds were provided. Makes continued availability of such funds contingent upon achieving benchmarks and submitting a pandemic influenza plan. (Sec. 203) Reauthorizes appropriations for FY2012-FY2016 for a program to improve public health alert communications and surveillance and public health situational awareness capability. Includes poison control centers in the integrated system of public health alert communications and surveillance networks. Requires the Secretary to submit to the appropriate congressional committees a coordinated strategy and an accompanying implementation plan that identifies and demonstrates the measurable steps the Secretary will carry out to: (1) develop, implement, and evaluate the public health situation awareness systems; and (2) modernize and enhance biosurveillance activities. Requires the network to include data from community health centers and health centers. Requires the National Biodefense Science Board to provide expert advice and guidance regarding the measurable steps the Secretary should take to modernize and enhance biosurveillance activities pursuant to the efforts of HHS to ensure comprehensive, real-time all-hazards biosurveillance capabilities. Title III: Enhancing Medical Countermeasure Review - (Sec. 301) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions governing special protocol assessments to include agreements on the design and size of animal and any associated clinical trials which, in combination, are intended to form the primary basis of an effectiveness claim for a countermeasure or epidemic or pandemic product when human efficacy studies are not ethical or feasible. (Sec. 302) Revises provisions permitting the Secretary to authorize the use of unapproved medical products or the unapproved use of an approved product, including to: (1) allow the Secretary to base the determination on a threat (rather than a specific threat as under current law); (2) allow the Secretary to base the determination on a significant potential for a public health emergency; (3) allow the Secretary to base the determination on the identification of a material threat sufficient to affect national security or the health and security of U.S. citizens abroad; (4) eliminate the one-year expiration date; and (5) allow a person to revise the label to reflect the new expiration date. Authorizes the Secretary to extend the expiration date of eligible medical countermeasures if the Secretary determines: (1) that the extension will help protect public health; (2) the extension is supported by scientific evaluation that is conducted or accepted by the Secretary; (3) what changes to the product labeling, if any, are required or permitted; and (4) that any other conditions that the Secretary deems appropriate have been met. Authorizes the Secretary to permit deviations from good manufacturing practice requirements when the circumstances of a domestic, military, or public health emergency or material threat so warrant. Authorizes the Secretary to waive requirements for a risk evaluation and mitigation strategy for domestic, military, and public health emergencies (currently, such waiver authority applies only to public health emergencies) and for the identification of a material threat sufficient to affect national security or the health and security of U.S. citizens abroad. Permits a government entity to introduce into interstate commerce a product intended for emergency use if that product is intended to be held and not used, and is held and not used, unless and until it is: (1) approved, cleared, or licensed; (2) authorized for investigational use; or (3) authorized for emergency use. Requires the Secretary to: (1) ensure the appropriate involvement of FDA personnel in interagency activities related to countermeasure advanced research and development, (2) ensure the appropriate involvement and consultation of FDA personnel in flexible manufacturing activities, (3) promote countermeasure expertise within the FDA, and (4) maintain teams composed of FDA personnel with expertise on countermeasures. Requires the Secretary to establish a procedure by which a sponsor or applicant that is developing a countermeasure for which human efficacy studies are not ethical or practicable, and that has an approved investigational new drug application or investigation device exemption, may request and receive: (1) a meeting to discuss proposed animal model development activities, and (2) a meeting prior to initiating pivotal animal studies. Requires such meetings to include discussion of animal models for pediatric populations, as appropriate. Requires the Secretary to take into account the material threat posed by the chemical, biological, radiological, or nuclear agent for which the countermeasure under review is intended when evaluating a countermeasure for approval, licensure, or clearance. Directs that, when practicable and appropriate, teams of FDA personnel reviewing applications or submissions shall include a reviewer with sufficient training or experience with countermeasures pursuant to established protocols. Requires the Secretary to establish a formal process for obtaining scientific feedback and interactions regarding the development and regulatory review of eligible countermeasures by facilitating the development of written regulatory management plans. Allows prioritization of countermeasures to receive regulatory management plans if the Commissioner of Food and Drugs determines that resources are not available to establish regulatory management plans for all eligible countermeasures. Directs the Secretary to submit to the specified congressional committees a report detailing the countermeasure development and review activities of the FDA. Requires the Secretary to solicit input from the Assistant Secretary for Preparedness and Response and the Director of the Biomedical Advanced Research and Development Authority (BARDA) regarding pediatric studies for medical countermeasures. Requires the Secretary to notify the Assistant Secretary and the Director of BARDA of all pediatric studies in the written request for a pediatric study issued by the Commissioner of Food and Drugs. Title IV: Accelerating Medical Countermeasure Advanced Research and Development - (Sec. 401) Reauthorizes appropriations for FY2014-FY2018 for the Special Reserve Fund. Requires the Secretary to report to the appropriate congressional committees if the amount in such Fund falls below a specified threshold. Extends from eight years to ten years: (1) the time during which a security countermeasure should qualify for approval or licensing for inclusion in Project Bioshield, and (2) the duration of a procurement contract for a security countermeasure. Requires a contract to procure security countermeasures to include a clear statement of defined government purpose limited to uses related to a security countermeasure. Authorizes the Secretary to enter into contracts and other agreements that are in the best interest of the government in meeting identified security countermeasure needs, including reimbursement of the cost of advanced research and development as a reasonable, allowable, and allocable direct cost of the contract involved. Revises provisions governing BARDA. Expands the program authorizing the Secretary to support innovation to include promotion of dose sparing technologies, efficacy increasing technologies, and platform technologies. Authorizes the Secretary, acting through the Director of BARDA, to enter into an agreement with an independent non-profit entity to support innovation related to medical countermeasures. Terminates such authority on October 1, 2016. Requires the Secretary to provide a clear statement of defined government purpose related to BARDA activities for the awarding of contracts, grants, and cooperative agreements for a qualified countermeasure or qualified pandemic or epidemic product. Revises and reauthorizes for FY2012-FY2016 the Biodefense Medical Countermeasure Development Fund used to support BARDA to accelerate countermeasure and product advanced research and development. Extends the Freedom of Information Act (FOIA) exemption for specific technical data or scientific information that is created or obtained during countermeasure and product advanced research and development carried out under PHSA that reveals significant and not otherwise known vulnerabilities of existing medical or public health defenses against biological, chemical, nuclear, or radiological threats. Extends the antitrust exemption to permit meetings and consultations to discuss the development of security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products. Requires GAO to report on activities carried out to facilitate flexible manufacturing capacity. Includes within the definition of a qualified countermeasure and a qualified pandemic or epidemic product a product or technology intended to enhance the use or effect of a drug, biological product, or device that is a medical countermeasure. (Sec. 403) Reauthorizes the Strategic National Stockpile through FY2016. Requires the Secretary to submit to Congress the annual review of the contents of the Stockpile and to identify and address the potential depletion of, and ensure appropriate replenishment of, medical countermeasures. Directs the Secretary to submit to the appropriate congressional committees a report on the stockpiling of potassium iodide. (Sec. 404) Revises membership requirements for the National Biodefense Science Board. Requires the Board to provide any recommendation, finding, or report provided to the Secretary to the appropriate congressional committees.

pandemic hazards preparedness act reauthorization title strengthening national preparedness sec amends public_health_service_act phsa require secretary health_and_human_services hhs submit relevant congressional committees requires strategy include provisions increasing preparedness response capabilities surge capacity dental health facilities critical care service systems plans optimizing coordinated flexible approach medical surge capacity hospitals health care facilities trauma care emergency medical systems provisions taking account unique needs individuals disabilities public health emergency strategic initiatives advance countermeasures diagnose mitigate prevent treat harm biological agent toxin chemical radiological nuclear agent agents naturally occurring unintentional deliberate requires secretary monitor emerging issues concerns relate medical public health preparedness response risk individuals event public health emergency disseminate update novel best practices outreach care risk individuals following public health emergencies timely manner practicable including time public health threat identified ensure public health medical information distributed hhs public health emergency delivered manner takes account range communication needs intended recipients including risk individuals sec requires assistant secretary preparedness response provide integrated policy coordination strategic direction respect matters related federal public health medical preparedness execution deployment federal response public health emergencies incidents covered national response plan following public health emergencies assistant secretary direct authority responsibility medical_reserve_corps emergency system advance registration volunteer health professionals administering grants related authorities related trauma care authorizes assistant secretary exercise responsibilities authorities secretary respect coordination requires assistant secretary align coordinate medical public health grants cooperative agreements applicable preparedness response activities authorized phsa carry drills operational exercises identify inform address gaps policies related hazards medical public health preparedness requires secretary acting assistant secretary conduct periodic meetings assistant president provide update discuss medical public health preparedness response activities develop coordinated strategy accompanying implementation plan medical countermeasures address chemical biological radiological nuclear threats requires government_accountability_office gao conduct independent evaluation strategy implementation plan requires secretary develop annually update year budget plan based medical countermeasures priorities report relevant congressional committees coordination department_of_defense dod countermeasure activities address chemical biological radiological nuclear threats ensure information items compromise national security disclosed sec requires secretary establish terminates committee years sec revises reauthorizes fy2016 requires secretary steps ensure range public health medical capabilities represented system account needs risk individuals event public health emergency authorizes secretary determine pay claims reimbursement services provided system directly contracts provide payment advance way reimbursement sec reauthorizes fy2016 program public health emergency readiness department_of_veterans_affairs medical centers title optimizing state local hazards preparedness response sec revises reauthorizes fy2012-fy2016 program cooperative agreements improve state local public health security revises requirements requires secretary periodically update criteria effective state plan responding pandemic influenza require integration criteria benchmarks standards measure levels preparedness provides amounts provided eligible entity cooperative agreement achieve preparedness goals fiscal year unobligated end year shall remain available entity fiscal year makes continued availability funds contingent achieving benchmarks submitting pandemic influenza plan eliminates provisions limiting award entity carry succeeding fiscal year reauthorizes appropriations fy2012-fy2016 influenza vaccine tracking distribution program influenza pandemic requires gao conduct evaluation federal programs hhs support medical public health preparedness response programs state local levels sec includes dental entities entities carry education training activities improve responses public health emergencies reauthorizes emergency system advance registration health professions volunteers fy2012-fy2016 provides single national interoperable network systems verify credentials licenses health care professionals volunteer provide health services public health emergency reauthorizes fy2016 medical_reserve_corps provide adequate supply volunteers case public health emergency revises provisions require training exercises incorporate needs risk individuals event public health emergency revises reauthorizes appropriations fy2012-fy2016 program grants cooperative agreements improve surge capacity enhance community hospital preparedness makes community health centers eligible program provides amounts provided eligible entity program fiscal year unobligated end year shall remain available entity fiscal year purposes funds provided makes continued availability funds contingent achieving benchmarks submitting pandemic influenza plan sec reauthorizes appropriations fy2012-fy2016 program improve public health alert communications surveillance public health situational awareness capability includes poison control centers integrated system public health alert communications surveillance networks requires secretary submit appropriate congressional committees coordinated strategy accompanying implementation plan identifies demonstrates measurable steps secretary carry develop implement evaluate public health situation awareness systems modernize enhance activities requires network include data community health centers health centers requires provide expert advice guidance measurable steps secretary modernize enhance activities pursuant efforts hhs ensure comprehensive real time hazards capabilities title iii enhancing medical countermeasure review sec amends cosmetic act ffdca revise provisions governing special protocol assessments include agreements design size animal associated clinical trials combination intended form primary basis effectiveness claim countermeasure epidemic pandemic product human efficacy studies ethical feasible sec revises provisions permitting secretary authorize use unapproved medical products unapproved use approved product including allow secretary base determination threat specific threat current law allow secretary base determination significant potential public health emergency allow secretary base determination identification material threat sufficient affect national security health security citizens abroad eliminate year expiration date allow person revise label reflect new expiration date authorizes secretary extend expiration date eligible medical countermeasures secretary determines extension help protect public health extension supported scientific evaluation conducted accepted secretary changes product labeling required permitted conditions secretary deems appropriate met authorizes secretary permit deviations good manufacturing practice requirements circumstances domestic military public health emergency material threat warrant authorizes secretary waive requirements risk evaluation mitigation strategy domestic military public health emergencies currently waiver authority applies public health emergencies identification material threat sufficient affect national security health security citizens abroad permits government entity introduce interstate commerce product intended emergency use product intended held held approved cleared licensed authorized investigational use authorized emergency use requires secretary ensure appropriate involvement fda personnel interagency activities related countermeasure advanced research development ensure appropriate involvement consultation fda personnel flexible manufacturing activities promote countermeasure expertise fda maintain teams composed fda personnel expertise countermeasures requires secretary establish procedure sponsor applicant developing countermeasure human efficacy studies ethical practicable approved investigational new drug application investigation device exemption request receive meeting discuss proposed animal model development activities meeting prior initiating animal studies requires meetings include discussion animal models pediatric populations appropriate requires secretary account material threat posed chemical biological radiological nuclear agent countermeasure review intended evaluating countermeasure approval licensure clearance directs practicable appropriate teams fda personnel reviewing applications submissions shall include reviewer sufficient training experience countermeasures pursuant established protocols requires secretary establish formal process obtaining scientific feedback interactions development regulatory review eligible countermeasures facilitating development written regulatory management plans allows prioritization countermeasures receive regulatory management plans commissioner food drugs determines resources available establish regulatory management plans eligible countermeasures directs secretary submit specified congressional committees report detailing countermeasure development review activities fda requires secretary solicit input assistant secretary preparedness response director pediatric studies medical countermeasures requires secretary notify assistant secretary director pediatric studies written request pediatric study issued title accelerating medical countermeasure advanced research development sec reauthorizes appropriations fy2014-fy2018 requires secretary report appropriate congressional committees fund falls specified threshold extends years years time security countermeasure qualify approval licensing inclusion project duration procurement contract security countermeasure requires contract procure security countermeasures include clear statement defined government purpose limited uses related security countermeasure authorizes secretary enter contracts agreements best interest government meeting identified security countermeasure needs including reimbursement cost advanced research development reasonable allowable allocable direct cost contract involved revises provisions governing expands program authorizing secretary support innovation include promotion dose technologies efficacy increasing technologies platform technologies authorizes secretary acting director enter agreement independent non profit entity support innovation related medical countermeasures terminates authority october requires secretary provide clear statement defined government purpose related activities awarding contracts grants cooperative agreements qualified countermeasure qualified pandemic epidemic product revises reauthorizes support accelerate countermeasure product advanced research development extends freedom information act foia exemption specific technical data scientific information created obtained countermeasure product advanced research development carried phsa reveals significant known vulnerabilities existing medical public health defenses biological chemical nuclear radiological threats extends antitrust exemption permit meetings consultations discuss development security countermeasures qualified countermeasures qualified pandemic epidemic products requires gao report activities carried facilitate flexible manufacturing capacity includes definition qualified countermeasure qualified pandemic epidemic product product technology intended enhance use effect drug biological product device medical countermeasure sec reauthorizes strategic national stockpile fy2016 requires secretary submit congress annual review contents stockpile identify address potential depletion ensure appropriate replenishment medical countermeasures directs secretary submit appropriate congressional committees report stockpiling potassium iodide sec revises membership requirements requires board provide recommendation finding report provided secretary appropriate congressional committees


Summary: Cavernous Angioma CARE Center Act of 2012 - Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS) to establish the Cavernous Angioma Clinical Care, Awareness, Research, and Education Center of Excellence at a university health sciences research and clinical center in the southwest United States to: (1) provide basic, translational, and clinical research with respect to new diagnostic, prevention, and novel treatment methodology for individuals with cavernous angioma; and (2) serve as a model for, and provide support to, medical schools and research institutions. Requires the Director of the Center to: (1) ensure that the Center provides community-, family-, and patient-centered culturally sensitive care; (2) encourage and coordinate opportunities for individuals to participate in clinical research studies that will advance medical research and care; and (3) develop the Center as a model and training facility for other facilities throughout the United States that are engaged in research regarding, and care for individuals with, cavernous angioma.

care center act amends public_health_service_act require secretary health_and_human_services hhs establish clinical care awareness research education center excellence university health sciences research clinical center southwest united_states provide basic translational clinical research respect new diagnostic prevention novel treatment methodology individuals serve model provide support medical schools research institutions requires director center ensure center provides family- patient centered culturally sensitive care encourage coordinate opportunities individuals participate clinical research studies advance medical research care develop center model training facility facilities united_states engaged research care individuals


Summary: Comprehensive Cancer Care Improvement Act of 2012 - Amends title XVIII (Medicare) of the Social Security Act to provide for coverage of comprehensive cancer care planning services. Directs the Secretary of Health and Human Services (HHS) to make grants to eligible entities to improve the quality of: (1) graduate and postgraduate training of physicians, nurses, and other health care providers in developing cancer care plans for, and communicating such plans to, patients; and (2) continuing professional education regarding the development and communication of written cancer care plans that outline a system of care that coordinates active treatment and palliative care. Requires the Secretary to provide investment, through existing programs, for research on topics related to cancer care planning and coordination, symptom management, palliative care, and comprehensive survivorship care.

comprehensive cancer care improvement act amends title xviii medicare social security act provide coverage comprehensive cancer care planning services directs secretary health_and_human_services hhs grants eligible entities improve quality graduate postgraduate training physicians nurses health care providers developing cancer care plans communicating plans patients continuing professional education development communication written cancer care plans outline system care coordinates active treatment palliative care requires secretary provide investment existing programs research topics related cancer care planning coordination symptom management palliative care comprehensive survivorship care


Summary: Cardiomyopathy Health Education, Awareness, Risk Assessment, and Training in the Schools (HEARTS) Act of 2012 - Amends the Public Health Service Act to direct the Secretary of Health and Human Services (HHS), in conjunction with the Director of the Centers for Disease Control and Prevention (CDC), to develop and provide for dissemination to school administrators, educators, school health professionals, coaches, and families, as well as to state and local health departments, pediatricians, hospitals, and other health professionals, of public education and awareness materials and resources that include: (1) background information to increase education and awareness of cardiomyopathy and other related causes of sudden cardiac death; (2) a cardiomyopathy risk assessment worksheet for use by parents, guardians, or other caregivers; (3) guidelines regarding the placement of automated external defibrillators in schools and child care centers; (4) training information on defibrillators and cardiopulmonary resuscitation; and (5) recommendations for how schools and child care centers can develop and implement a cardiac emergency response plan. Encourages the Secretary, in support of such effort, to: (1) establish an advisory panel, and (2) engage in a memorandum of understanding or cooperative agreement with a national nonprofit advocacy organization expert in all forms of cardiomyopathy.

cardiomyopathy health education training schools hearts act amends public_health_service_act direct secretary health_and_human_services hhs conjunction director centers_for_disease_control_and_prevention cdc develop provide dissemination school administrators educators school health professionals coaches families state local health departments pediatricians hospitals health professionals public education awareness materials resources include background information increase education awareness cardiomyopathy related causes sudden cardiac death cardiomyopathy risk assessment use parents guardians caregivers guidelines placement automated external defibrillators schools child care centers training information defibrillators cardiopulmonary resuscitation recommendations schools child care centers develop implement cardiac emergency response plan encourages secretary support effort establish advisory panel engage memorandum understanding cooperative agreement national nonprofit advocacy organization expert forms cardiomyopathy


Summary: Kidney Disease Equitable Access, Prevention, and Research Act of 2012 - Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS), in specified circumstances, to accept the results of a state licensure survey for purposes of determining federal certification of the compliance of a renal dialysis facility (RDF) with the conditions of Medicare participation. Allows the Secretary to assess and collect reasonable fees for the initial Medicare survey from an RDF. Revises Medicare requirements for group health plans to extend from 12 to 42 months after an individual becomes eligible for Medicare part A (Hospital Insurance Benefits for the Aged and Disabled) benefits the period during which a group health plan is a primary payer (and Medicare the secondary payer) for ESRD patients. Requires such a plan to: (1) provide adequate, advanced, written notice to patients regarding changes to dialysis service benefits, new restrictions on out-of-network access, or reductions in rates paid for out-of-network benefits; (2) allow patients to continue using their existing provider or facility for dialysis services for at least 24 months after a plan or issuer notice of any change; (3) hold patients harmless from a provider network change if the change requires unreasonable drive time or disrupts the physician-patient relationship; (4) ensure that out-of-pocket payments for such services apply to the Medicare part C (Medicare+Choice Program) out-of-pocket maximums and are treated as non-routine for copayment purposes; and (5) meet minimum network adequacy standards. Prohibits such a plan from: (1) restricting the duration or number of dialysis sessions for patients to less than the number for which payment may be made; (2) requiring assignment of benefits for such services; or (3) denying or limiting coverage for patients for such services if premiums, copayments, or other payments are made by third parties on their behalf. Directs the Secretary to study: (1) the social, behavioral, and biological factors leading to kidney disease; and (2) efforts to slow the progression of kidney disease in minority populations that are disproportionately affected by it. Directs the Secretary to report to Congress on the research gaps with respect to the development of quality metrics and care management metrics for ESRD patients. Directs the Comptroller General to evaluate the transportation barriers facing dialysis patients that result in less than 100% compliance with their plan of care under the Medicare program. Includes as a person qualified to furnish kidney disease education services an RDF with a physician or a physician assistant, nurse practitioner, or clinical nurse specialist. Declares that the mandatory single payment to an RDF or other provider of renal dialysis services shall not take into account the amount of payment for kidney disease education services. Revises the definition of “kidney disease education services” to specify education services furnished to individuals: (1) with stage V (as well as those with stage IV) chronic kidney disease, and (2) who are not receiving dialysis services.

research_act amends title xviii medicare social security act direct secretary health_and_human_services hhs specified circumstances accept results state licensure survey purposes determining federal certification compliance renal dialysis facility conditions medicare participation allows secretary assess collect reasonable fees initial medicare survey revises medicare requirements group health plans extend months individual eligible medicare hospital insurance benefits aged disabled benefits period group health plan primary payer medicare secondary payer esrd patients requires plan provide adequate advanced written notice patients changes dialysis service benefits new restrictions network access reductions rates paid network benefits allow patients continue existing provider facility dialysis services months plan issuer notice change hold patients harmless provider network change change requires unreasonable drive time disrupts physician patient relationship ensure pocket payments services apply medicare program pocket treated non routine copayment purposes meet minimum network adequacy standards prohibits plan restricting duration number dialysis sessions patients number payment requiring assignment benefits services denying limiting coverage patients services premiums copayments payments parties behalf directs secretary study social behavioral biological factors leading kidney disease efforts slow progression kidney disease minority populations disproportionately affected directs secretary report congress research gaps respect development quality metrics care management metrics esrd patients directs comptroller general evaluate transportation barriers facing dialysis patients result compliance plan care medicare program includes person qualified furnish kidney disease education services physician physician assistant nurse practitioner clinical nurse specialist declares mandatory single payment provider renal dialysis services shall account payment kidney disease education services revises definition kidney disease education services specify education services furnished individuals stage stage chronic kidney disease receiving dialysis services


Summary: Abstinence Education Reallocation Act of 2012 - Authorizes the Administrator of the Health Resources and Services Administration (HRSA) to award grants for qualified sexual risk avoidance education to youth and their parents. Requires eligible education to meet certain criteria, including: (1) being age-appropriate, medically accurate, and evidence-based; (2) having as its sole purpose the teaching of the skills and benefits of sexual abstinence as the optimal sexual health behavior for youth; and (3) teaching the benefits of refraining from nonmarital sexual activity, the advantage of reserving sexual activity for marriage as a key factor in the prevention of poverty and the preservation of physical and emotional health, and the foundational components of a healthy relationship and the advantages of bearing children within the context of a committed marital relationship for healthy marriages. Gives priority to programs that serve youth ages 12 to 19 and that will promote the protective benefits of parent-child communication regarding healthy sexual decision-making.

abstinence education reallocation act authorizes administrator health_resources_and_services_administration hrsa award grants qualified sexual risk avoidance education youth parents requires eligible education meet certain criteria including age appropriate medically accurate evidence based having sole purpose teaching skills benefits sexual abstinence optimal sexual health behavior youth teaching benefits refraining sexual activity advantage reserving sexual activity marriage key factor prevention poverty preservation physical emotional health foundational components healthy relationship advantages bearing children context committed marital relationship healthy marriages gives priority programs serve youth ages promote protective benefits parent child communication healthy sexual decision making


Summary: CT Colonography Screening for Colorectal Cancer Act of 2012 - Amends title XVIII (Medicare) of the Social Security Act to: (1) provide Medicare coverage for screening computed tomography colonography (CTC) as a colorectal cancer (CRC) screening test, and (2) exclude screening CTC from the meaning of "imaging services" for which there is a special rule regarding outpatient services department (OPD) fee schedule payments. Directs the Secretary of Health and Human Services (HHS) to submit a preliminary report to Congress on the status of coverage of CTC as a CRC screening test under Medicare, including the extent to which such coverage as required by this Act has been implemented.

colonography screening colorectal cancer act amends title xviii medicare social security act provide medicare coverage screening computed tomography colonography ctc colorectal cancer screening test exclude screening ctc meaning imaging services special rule outpatient services department opd fee schedule payments directs secretary health_and_human_services hhs submit preliminary report congress status coverage ctc screening test medicare including extent coverage required act implemented


Summary: Expanding and Promoting Expertise in Rare Treatments Act of 2012 or EXPERT Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to ensure that opportunities exist for consultation with external experts to promote the efficiency of and inform the review by the Food and Drug Administration (FDA) of drugs and biologic products for rare diseases and drugs and biologic products that are genetically targeted. Requires the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research to seek the opinion of external experts on topics that may include: (1) rare diseases; (2) the severity of rare diseases; (3) the unmet medical need associated with rare diseases; (4) the willingness and ability of individuals with a rare disease to participate in clinical trials; (5) an assessment of the benefits and risks, including side effects, of current and investigational therapies; (6) the design of clinical trials for rare disease populations and subpopulations; and (7) demographics and the clinical description of patient populations. Authorizes: (1) external experts to request the opportunity to meet with a review division regarding any such topic, and (2) external experts who are consulted to be considered special government employees. Declares that nothing in this Act shall be construed to: (1) create a right for any external expert to obtain access to proprietary information of a sponsor without that sponsor's permission or a legal right for a consultation on any matter, or (2) require the Secretary to meet with any particular expert.

expanding promoting expertise rare treatments act expert act amends cosmetic act direct secretary health_and_human_services hhs ensure opportunities exist consultation external experts promote efficiency inform review food_and_drug_administration fda drugs biologic products rare diseases drugs biologic products genetically targeted requires center drug evaluation research center_for_biologics_evaluation_and_research seek opinion external experts topics include rare diseases severity rare diseases unmet medical need associated rare diseases willingness ability individuals rare disease participate clinical trials assessment benefits risks including effects current investigational therapies design clinical trials rare disease populations subpopulations demographics clinical description patient populations authorizes external experts request opportunity meet review division topic external experts consulted considered special government employees declares act shall construed create right external expert obtain access proprietary information sponsor sponsor permission legal right consultation matter require secretary meet particular expert


Summary: Tanning Transparency and Notification Act of 2012 - Directs the Commissioner of Food and Drugs (FDA) to carry out the recommendations made in the report submitted under the Food and Drug Administration Amendments Act of 2007 regarding the labeling of indoor tanning devices to provide information to consumers about the health risks posed by such devices.

tanning transparency notification act directs commissioner food drugs fda carry recommendations report submitted labeling indoor tanning devices provide information consumers health risks posed devices


Summary: Accelerating the End of Breast Cancer Act of 2012 - Establishes the Commission to Accelerate the End of Breast Cancer to help end breast cancer by January 1, 2020. Directs the Commission to: (1) identify opportunities and ideas within the public and private sectors, basic and applied sciences, and epidemiology that can be turned into real world strategies to prevent breast cancer and breast cancer metastasis; (2) recommend projects to leverage such opportunities and ideas in the areas of the primary prevention of breast cancer and the causes and prevention of breast cancer metastasis; (3) promote ideas that are intellectually compelling and innovative; (4) accelerate potentially transformational scientific advances that are not being prioritized within the federal government and that are unlikely to be achieved by the private sector; (5) identify promising but underdeveloped areas of research that would benefit from a cluster of support from government, industry, and academia to rapidly advance knowledge into practices; (6) create opportunities for transdisciplinary, cross-cutting collaborations; (7) submit its strategic vision within six months after its initial members are appointed; and (8) ensure that its activities are coordinated with, and do not duplicate the efforts of, programs and laboratories of other government agencies. Directs the President to enter into an agreement with the Institute of Medicine for an evaluation of the Commission's progress. Establishes the Accelerating the End of Breast Cancer Fund to carry out this Act. Terminates the Commission on June 1, 2020.

accelerating end breast cancer act establishes commission accelerate end breast cancer help end breast cancer january directs commission identify opportunities ideas public private sectors basic applied sciences epidemiology turned real world strategies prevent breast cancer breast cancer recommend projects leverage opportunities ideas areas primary prevention breast cancer causes prevention breast cancer promote ideas compelling innovative accelerate potentially transformational scientific advances prioritized federal government unlikely achieved private sector identify promising areas research benefit cluster support government industry academia rapidly advance knowledge practices create opportunities cross cutting collaborations submit strategic vision months initial members appointed ensure activities coordinated duplicate efforts programs laboratories government agencies directs president enter agreement institute_of_medicine evaluation commission progress establishes accelerating end breast cancer fund carry act terminates commission june


Summary: Immunization Improvements Act of 2012 - Directs the Secretary of Health and Human Services (HHS) to establish a demonstration project under title XVIII (Medicare) of the Social Security Act (SSA) to evaluate the ability of state and local health departments to act as providers in the purchase and reimbursement of influenza and pneumoccal vaccinations for Medicare beneficiaries. Covers vaccines recommended for routine use by the Advisory Committee on Immunizations Practices and their administration under part B (Child and Family Services) of the Medicare program with no beneficiary cost-sharing. Directs the Administrator of the Centers for Medicare and Medicaid Services and the Director of the Centers for Disease Control and Prevention (CDC) to jointly: (1) review the regional maximum charge for vaccine administration for each state established under the Vaccines for Children program to determine the appropriateness and adequacy of such rates; (2) update such rates, as appropriate, based on the results of such review and taking into account all appropriate administrative costs; and (3) establish the regional minimum charge for vaccine administration for each state. Requires the state, for purposes of a provider who imposes a fee for the administration of a qualified pediatric vaccine, to pay such provider an amount equal to the administrative fee established under the state plan, which shall not be less than the regional minimum charge for vaccine administration for such state, as established by the Secretary. Directs the Secretary to pay each state amounts necessary for the state to reimburse each program-registered provider in the state for an administration fee imposed for the administration of a qualified pediatric vaccine to a federally vaccine-eligible child who is not otherwise eligible under SSA title XIX (Medicaid). Includes as a hospital for purposes of payment under Medicare an institution which develops an active surveillance program to track and record disaggregated influenza vaccination levels among health care workers, including vaccinations obtained outside of the facility, and reports those levels annually to the Secretary. Requires skilled nursing facilities (SNFs) and nursing facilities to develop such an active surveillance program.

immunization improvements act directs secretary health_and_human_services hhs establish demonstration project title xviii medicare social security act ssa evaluate ability state local health departments act providers purchase reimbursement influenza vaccinations medicare beneficiaries covers vaccines recommended routine use administration child family services medicare program beneficiary cost sharing directs administrator centers medicare medicaid_services director centers_for_disease_control_and_prevention cdc jointly review regional maximum charge vaccine administration state established vaccines children program determine appropriateness adequacy rates update rates appropriate based results review taking account appropriate administrative costs establish regional minimum charge vaccine administration state requires state purposes provider imposes fee administration qualified pediatric vaccine pay provider equal administrative fee established state plan shall regional minimum charge vaccine administration state established secretary directs secretary pay state amounts necessary state reimburse program registered provider state administration fee imposed administration qualified pediatric vaccine federally vaccine eligible child eligible ssa title xix medicaid includes hospital purposes payment medicare institution develops active surveillance program track record disaggregated influenza vaccination levels health care workers including vaccinations obtained outside facility reports levels annually secretary requires skilled nursing facilities snfs nursing facilities develop active surveillance program


Summary: Prostate Cancer Detection Research and Education Act - Requires the Secretary of Health and Human Services (HHS), acting through the Director of the National Institutes of Health (NIH), to establish an advisory council on prostate cancer to draft a plan for the development and validation of an accurate test or tests to detect and diagnose prostate cancer. Terminates the advisory council on December 31, 2016. Requires the Director of the National Institutes of Health (NIH) to coordinate and intensify research in accordance with the plan developed under this Act, with particular attention provided to leveraging existing research to develop and validate a test or tests, such as biomarkers or imaging, to detect and accurately diagnose prostate cancer. Requires the Secretary to: (1) carry out a national campaign to increase the awareness and knowledge of prostate cancer, and (2) award grants to nonprofit private entities to test alternative outreach and education strategies to increase the awareness and knowledge of Americans with respect to prostate cancer.

education act requires secretary health_and_human_services hhs acting director national_institutes_of_health nih establish advisory council prostate cancer draft plan development validation accurate test tests detect diagnose prostate cancer terminates advisory council december requires director national_institutes_of_health nih coordinate intensify research accordance plan developed act particular attention provided leveraging existing research develop validate test tests biomarkers imaging detect accurately diagnose prostate cancer requires secretary carry national campaign increase awareness knowledge prostate cancer award grants nonprofit private entities test alternative outreach education strategies increase awareness knowledge americans respect prostate cancer