Summary: Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2010 - Amends the Public Health Service Act to require personnel who perform or plan the technical component of either medical imaging examinations or radiation therapy procedures for medical purposes to possess, effective January 1, 2013: (1) certification in each medical imaging or radiation therapy modality and service they plan or perform from a certification organization designated by the Secretary of Health and Human Services (HHS); or (2) state licensure or certification where such services and modalities are within the scope of practice as defined by the state for such profession and where the requirements for licensure, certification, or registration meet or exceed the standards established by the Secretary. Exempts physicians, nurse practitioners, and physician assistants from the requirements of this Act. Directs the Secretary to: (1) establish minimum standards for personnel who perform, plan, evaluate, or verify patient dose for medical imaging examinations or radiation therapy procedures; (2) establish a program for designating certification organizations after consideration of specified criteria; (3) provide a process for individuals whose training or experience are determined to be equal to, or in excess of, those of a graduate of an accredited educational program in that specialty to demonstrate that their experience meets the educational standards for qualified personnel in their imaging modality or radiation therapy procedures; and (4) publish a list of approved accrediting bodies for such certification organizations. Authorizes the Secretary to develop alternative standards for rural or health professional shortage areas as appropriate to ensure access to quality medical imaging. Amends title XVIII (Medicare) of the Social Security Act to allow Medicare payment for medical imaging and radiation therapy services, only if the examination or procedure is planned or performed by an individual who meets this Act's requirements.

consistency accuracy responsibility excellence medical imaging radiation therapy act amends public_health_service_act require personnel perform plan technical component medical imaging examinations radiation therapy procedures medical purposes possess effective january certification medical imaging radiation therapy modality service plan perform certification organization designated secretary health_and_human_services hhs state licensure certification services modalities scope practice defined state profession requirements licensure certification registration meet exceed standards established secretary exempts physicians nurse practitioners physician assistants requirements act directs secretary establish minimum standards personnel perform plan evaluate verify patient dose medical imaging examinations radiation therapy procedures establish program designating certification organizations consideration specified criteria provide process individuals training experience determined equal excess graduate accredited educational program specialty demonstrate experience meets educational standards qualified personnel imaging modality radiation therapy procedures publish list approved accrediting bodies certification organizations authorizes secretary develop alternative standards rural health professional shortage areas appropriate ensure access quality medical imaging amends title xviii medicare social security act allow medicare payment medical imaging radiation therapy services examination procedure planned performed individual meets act requirements


Summary: Drug Court Reauthorization Act - Amends the Omnibus Crime Control and Safe Streets Act of 1968 to authorize appropriations for the drug courts program for FY2012-FY2018 and to modify certain program requirements relating to grant authority, grant applications, and the distribution and allocation of grants to states and local and tribal governments.

drug court reauthorization act amends omnibus_crime_control_and_safe_streets_act authorize appropriations drug courts program fy2012-fy2018 modify certain program requirements relating grant authority grant applications distribution allocation grants states local tribal governments


Summary: Prescription Drug Affordability Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to repeal provisions restricting the importation of prescription drugs. Allows a person who meets applicable legal requirements to be an importer of prescription drugs upon application to the Secretary of Health and Human Services (HHS). Requires the Secretary to approve such an application if the drug meets all FFDCA requirements for admission into the United States, including that the drug has been approved by the Food and Drug Administration (FDA) and is not adulterated or misbranded. Prohibits the Secretary from taking any action against any of the persons involved with the interstate sale of a prescription drug through an Internet site if: (1) the sale was made in compliance with FFDCA, the Controlled Substances Act, and applicable state laws; and (2) accurate information regarding compliance with such laws is posted on the Internet site. Makes this Act effective one year after enactment, without regard to whether the Secretary has promulgated regulations.

prescription drug affordability act amends cosmetic act ffdca repeal provisions restricting importation prescription drugs allows person meets applicable legal requirements importer prescription drugs application secretary health_and_human_services hhs requires secretary approve application drug meets ffdca requirements admission united_states including drug approved food_and_drug_administration fda adulterated misbranded prohibits secretary taking action persons involved interstate sale prescription drug internet site sale compliance ffdca controlled substances act applicable state laws accurate information compliance laws posted internet site makes act effective year enactment regard secretary promulgated regulations


Summary: Protecting Our Kids' Medicine Act - Amends the Federal Food, Drug, and Cosmetic Act to require a liquid formulation of an over-the-counter drug to be packaged with a dosage delivery device meeting specified requirements.  Defines "dosage delivery device" as an object that is designed to measure the dosage of a drug in liquid form and deliver that drug to an individual and includes calibrated cups, droppers, syringes, and spoons.Sets forth requirements for such a dosage delivery device, which include that such device: (1) is calibrated in units of measure specified in the dosage directions on the outside packaging of the drug, the bottle, or written instructions on the label; (2) uses the same abbreviations  as the directions and conforms to international or national standards for abbreviations; (3) has clearly printed decimals or fractions; (4) contains leading zeros before decimal points to avoid tenfold dosing errors; (5) has smaller font sizes for numerals in fractions compared to the size of the font used for numerals not in fractions; (6) contains no extraneous or unnecessary markings that may be confusing to consumers; and (7) uses markings that are clearly visible when the drug is added to the device.Deems a drug to be misbranded if it does not meet the requirements of this Act.Makes this Act effective one year after enactment.

protecting kids medicine act amends cosmetic act require liquid formulation counter drug packaged dosage delivery device meeting specified requirements defines dosage delivery device object designed measure dosage drug liquid form deliver drug individual includes syringes sets forth requirements dosage delivery device include device units measure specified dosage directions outside packaging drug bottle written instructions label uses directions conforms international national standards clearly printed contains leading points avoid dosing errors smaller font sizes compared size font contains unnecessary markings consumers uses markings clearly visible drug added device deems drug misbranded meet requirements act makes act effective year enactment


Summary: Health Care Cost Reduction Act of 2012 - Amends the Internal Revenue Code to: (1) repeal the excise tax on medical devices; (2) repeal restrictions on payments from health savings accounts, Archer medical savings accounts, and health flexible spending and reimbursement arrangements to only prescription drugs or insulin (thus allowing distributions from such accounts for over-the-counter drugs); (3) allow amounts in a flexible spending arrangement (FSA), up to $500, that are not spent for medical care to be distributed to the FSA participant as taxable income after the close of a plan year (currently, such unspent amounts are forfeited); and (4) repeal the limitation on the recapture of advance payments of the tax credit for health insurance premium assistance that exceed the allowable credit amount for a taxable year.

amends internal revenue code repeal excise tax medical devices repeal restrictions payments health savings accounts archer medical savings accounts health flexible spending reimbursement arrangements prescription drugs insulin allowing distributions accounts counter drugs allow amounts flexible spending arrangement fsa spent medical care distributed fsa participant taxable income close plan year currently unspent amounts forfeited repeal limitation recapture advance payments tax credit health insurance premium assistance exceed allowable credit taxable year


Summary: Say No to Drug Ads Act - Amends the Internal Revenue Code to deny a tax deduction for the cost of direct-to-consumer advertisement of a prescription drug.

drug ads act amends internal revenue code deny tax deduction cost direct consumer advertisement prescription drug


Summary: Repeals the provision of the Internal Revenue Code, added by the Health Care and Education Reconciliation Act of 2010, that imposes an excise tax on medical devices. Rescinds $39 billion of appropriated but unobligated discretionary funds. Exempts unobligated funds of the Department of Defense (DOD) or the Department of Veterans Affairs (VA). Requires the Director of the Office of Management and Budget (OMB) to determine and identify from which appropriation accounts such recissions shall apply and report to the Secretary of the Treasury and Congress on such recissions.

repeals provision internal_revenue_code added health_care_and_education reconciliation act imposes excise tax medical devices rescinds billion appropriated unobligated discretionary funds exempts unobligated funds department_of_defense dod department_of_veterans_affairs requires director office_of_management_and_budget omb determine identify appropriation accounts shall apply report secretary treasury congress


Summary: Amends the Federal Food, Drug, and Cosmetic Act to prohibit a holder of a new, approved drug application from commencing to manufacture, market, sell, or distribute a generic version of such drug from the time of the receipt of notice from the generic manufacturer that an abbreviated new drug application has been submitted for approval until the expiration or forfeiture of the exclusivity period granted to the generic manufacturer.

amends cosmetic act prohibit holder new approved drug application commencing manufacture market sell distribute generic version drug time receipt notice generic manufacturer abbreviated new drug application submitted approval expiration forfeiture exclusivity period granted generic manufacturer


Summary: Preservation of Antibiotics for Medical Treatment Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to deny an application for a new animal drug that is a critical antimicrobial animal drug unless the applicant demonstrates that there is a reasonably certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Defines "critical antimicrobial animal drug" as a drug intended for use in food-producing animals that contains specified antibiotics or other drugs used in humans to treat or prevent disease or infection caused by microorganisms. Requires the Secretary to withdraw approval of a nontherapeutic use of such drugs in food-producing animals two years after the date of enactment of this Act unless certain safety requirements are met. Directs specified congressional committees to hold hearings on the implementation of such a withdrawal of approval.

preservation_of_antibiotics_for_medical_treatment_act amends cosmetic act require secretary health_and_human_services hhs deny application new animal drug critical antimicrobial animal drug applicant demonstrates reasonably certainty harm human health development antimicrobial resistance attributable nontherapeutic use drug defines critical antimicrobial animal drug drug intended use food producing animals contains specified antibiotics drugs humans treat prevent disease infection caused microorganisms requires secretary withdraw approval nontherapeutic use drugs food producing animals years date enactment act certain safety requirements met directs specified congressional committees hold hearings implementation withdrawal approval


Summary: Fairness in Medicare Bidding Act or FIMBA - Amends part B (Supplementary Medical Insurance Benefits for Aged and Disabled) of title XVIII (Medicare) of the Social Security Act to repeal the Medicare competitive acquisition program for durable medical equipment and prosthetics, orthotics, and supplies (DMEPOS). Rescinds specified unobligated balances of all discretionary appropriations, except those for the Department of Defense (DOD) or the Department of Veterans Affairs (VA). Directs the Office of Management and Budget (OMB) to determine and identify each account, program, project, and activity to which this rescission and its amount shall apply.

fairness amends supplementary medical insurance benefits aged disabled title xviii medicare social security act repeal medicare competitive acquisition program durable medical equipment prosthetics orthotics supplies dmepos rescinds specified unobligated balances discretionary appropriations department_of_defense dod department_of_veterans_affairs directs office_of_management_and_budget omb determine identify account program project activity rescission shall apply


Summary: Amends the Internal Revenue Code to exempt a qualified emergency medical device from the excise tax on medical devices. Defines "qualified emergency medical device" as a medical device furnished by first responders or ambulance services in providing out-of-hospital or pre-hospital care, or transport to a medical care facility, for individuals with illnesses, injuries, or other medical emergencies or in need of medical transport, extrication, or evacuation.

amends internal revenue code exempt qualified emergency medical device excise tax medical devices defines qualified emergency medical device medical device furnished responders ambulance services providing hospital pre hospital care transport medical care facility individuals illnesses injuries medical emergencies need medical transport evacuation


Summary: Stop Oxy Abuse Act of 2011 - Directs the Commissioner of Food and Drugs (FDA), within 90 days, to take such actions as may be necessary to modify the approval of, and limit any subsequent approval of, any drug containing controlled-release oxycodone hychloride to use for the relief of severe-only pain instead of moderate-to-severe pain. Applies any such modification to drugs introduced into interstate commerce 180 days after enactment of this Act.

stop abuse act directs commissioner food drugs fda days actions necessary modify approval limit subsequent approval drug containing controlled release use relief severe pain instead moderate severe pain applies modification drugs introduced interstate commerce days enactment act


Summary: Free Speech About Science Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to set forth conditions under which a food or dietary supplement label may characterize the relationship of a nutrient in the food or supplement to a disease or health-related claim. Permits such a label on food if the claim: (1) is based on legitimate scientific research; (2) is in compliance with other FFDCA provisions; (3) is an accurate, balanced summary of such research; (4) enables the public to comprehend the information provided in the claim and the relative significance of such information in the context of a total daily diet; and (5) identifies each party that funded research to support the claim. Permits such a label on a dietary supplement that claims to diagnose, treat, cure, or prevent a specific disease or class of diseases if: (1) the claim is based on legitimate scientific research; (2) the manufacturer has substantiation that such statement is truthful and not misleading; (3) the statement includes a disclaimer that it has not been evaluated by the Food and Drug Administration (FDA); and (4) the claim includes a citation to the research supporting such claim and identifies each party that funded such research. Prohibits the Secretary of Health and Human Services (HHS) from restricting the distribution of information that is not false or misleading and that is based on legitimate scientific research in connection with the sale of food. Amends the Federal Trade Commission Act to exempt the dissemination of legitimate scientific research in connection with the sale or distribution of a food or dietary supplement to consumers from being determined to be false advertising by virtue of the fact that the research does not directly correlate to such food or dietary supplement if the dissemination discloses that information. Places the burden of proof on the Federal Trade Commission (FTC) to establish that the literature being disseminated is not legitimate scientific research.

free speech science act amends cosmetic act ffdca set forth conditions food dietary supplement label characterize relationship nutrient food supplement disease health related claim permits label food claim based legitimate scientific research compliance ffdca provisions accurate balanced summary research enables public information provided claim relative significance information context total daily diet identifies party funded research support claim permits label dietary supplement claims diagnose treat cure prevent specific disease class diseases claim based legitimate scientific research manufacturer substantiation statement truthful misleading statement includes disclaimer evaluated food_and_drug_administration fda claim includes citation research supporting claim identifies party funded research prohibits secretary health_and_human_services hhs restricting distribution information false misleading based legitimate scientific research connection sale food amends federal_trade_commission act exempt dissemination legitimate scientific research connection sale distribution food dietary supplement consumers determined false advertising virtue fact research directly food dietary supplement dissemination discloses information places burden proof federal_trade_commission ftc establish literature disseminated legitimate scientific research


Summary: Integrity in Medicare Advanced Diagnostic Imaging Act of 2011 - Amends title XVIII (Medicare) of the Social Security Act to exclude certain advanced diagnostic imaging services from the in-office ancillary services exception to the prohibition on physician self-referral. (Thus prohibits a physician [or an immediate family member] who has an ownership or investment relationship or compensation arrangement with an entity from referring a patient to the entity for certain advanced diagnostic imaging services for which a Medicare payment otherwise may be made.)

integrity medicare advanced diagnostic imaging act amends title xviii medicare social security act exclude certain advanced diagnostic imaging services office ancillary services exception prohibition physician self referral prohibits physician immediate family member ownership investment relationship compensation arrangement entity referring patient entity certain advanced diagnostic imaging services medicare payment


Summary: Hearing Aid Assistance Tax Credit Act 2011 - Amends the Internal Revenue Code to allow a nonrefundable income tax credit of up to $500 for the purchase of a qualified hearing aid for an individual who is either: (1) age 55 or older; or (2) is claimed as a dependent of the taxpayer. Denies such tax credit to any taxpayer whose modified adjusted gross income exceeds $200,000.

hearing aid assistance tax credit act amends internal revenue code allow nonrefundable income tax credit purchase qualified hearing aid individual age older claimed dependent taxpayer denies tax credit taxpayer modified adjusted gross income exceeds


Summary: Medicare Access to Diabetes Supplies Act of 2011 - Amends title XVIII (Medicare) of the Social Security Act to exempt from Medicare competitive acquisition programs blood glucose self-testing equipment and supplies furnished by small retail community pharmacies.

medicare access diabetes supplies act amends title xviii medicare social security act exempt medicare competitive acquisition programs blood glucose self testing equipment supplies furnished small retail community pharmacies


Summary: Medicare Orthotics and Prosthetics Improvement Act of 2011 - Amends title XVIII (Medicare) of the Social Security Act, for application of quality standards for certain accredited suppliers of prosthetic devices, orthotics, and certain prosthetics, to require the Secretary of Health and Human Services (HHS) to designate and approve an independent accreditation organization with respect to such suppliers only if that organization is the American Board for Certification in Orthotics and Prosthetics, Inc. or the Board for Orthotist/ Prosthetist Certification (or a program with essentially equivalent accreditation and approval standards). Exempts from such standards any suppliers who: (1) are physicians, occupational therapists, or physical therapists licensed or otherwise regulated by the state in which they practice; and (2) receive Medicare payments. Applies to custom-fitted orthotics the special payment rules for certain prosthetics and customfabricated orthotics. Modifies the Medicare payment rules for orthotics and prosthetics to account for practitioner qualifications and complexity of care. Directs the Secretary to report to Congress on: (1) HHS steps taken to ensure that the state licensure and accreditation requirements are enforced, and (2) the effects of requirements of this Act on the occurrence of Medicare fraud and abuse with respect to orthotics and prosthetics. Requires the Chief Actuary of the Centers for Medicare and Medicaid Services to submit to Congress a projection of the effect on cumulative federal spending under Medicare part B (Supplementary Medical Insurance) for 2012-2016 that will result from implementation of this Act. Requires the Secretary, if the Chief Actuary projects that implementation of this Act will not result in a cumulative spending reduction of at least $250 million for 2012-2016, to issue an interim final regulation to strengthen the licensure, accreditation, and quality standards applicable to orthotics and prosthetics suppliers in order to produce such a cumulative reduction by the end of 2016. Exempts from such regulation any qualified physical therapist or qualified occupational therapist.

medicare_orthotics prosthetics improvement act amends title xviii medicare social security act application quality standards certain accredited suppliers prosthetic devices orthotics certain prosthetics require secretary health_and_human_services hhs designate approve independent accreditation organization respect suppliers organization program essentially equivalent accreditation approval standards exempts standards suppliers physicians occupational therapists physical therapists licensed regulated state practice receive medicare payments applies custom fitted orthotics special payment rules certain prosthetics orthotics modifies medicare payment rules orthotics prosthetics account practitioner qualifications complexity care directs secretary report congress hhs steps taken ensure state licensure accreditation requirements enforced effects requirements act occurrence medicare fraud abuse respect orthotics prosthetics requires chief actuary centers medicare medicaid_services submit congress projection effect cumulative federal spending medicare supplementary_medical_insurance result implementation act requires secretary chief actuary projects implementation act result cumulative spending reduction million issue interim final regulation strengthen licensure accreditation quality standards applicable orthotics prosthetics suppliers order produce cumulative reduction end exempts regulation qualified physical therapist qualified occupational therapist


Summary: States' Medical Marijuana Patient Protection Act - Requires the Secretary of Health and Human Services (HHS), within six months of enactment of this Act, to submit to the Administrator of the Drug Enforcement Administration (DEA) a recommendation on the listing of marijuana within the Controlled Substances Act (CSA) and to recommend listing it as other than a Schedule I or Schedule II substance. Requires the Administrator of DEA, within 12 months of enactment of this Act, based upon the recommendation of the National Academy of Sciences, to issue a notice of proposed rulemaking for the rescheduling of marijuana within the CSA, which shall include a recommendation to list marijuana as other than a Schedule I or Schedule II substance. Declares that no provision of the CSA or the Federal Food, Drug and Cosmetic Act shall prohibit or otherwise restrict, in a state in which the medical use of marijuana is legal under state law: (1) the prescription or recommendation of marijuana for medical use by a medical professional or the certification by a medical professional that a patient has a condition for which marijuana may have therapeutic benefit; (2) an individual from obtaining, manufacturing, possessing, or transporting within their state marijuana for medical purposes, provided the activities are authorized under state law; (3) a pharmacy or other entity authorized to distribute medical marijuana from obtaining, possessing, or distributing marijuana to authorized individuals; or (4) an entity authorized by a state or local government from producing, processing, or distributing marijuana for such purposes.

states medical marijuana patient protection act requires secretary health_and_human_services hhs months enactment act submit administrator drug_enforcement_administration dea recommendation listing marijuana controlled substances act csa recommend listing schedule schedule substance requires administrator dea months enactment act based recommendation national_academy_of_sciences issue notice proposed rulemaking marijuana csa shall include recommendation list marijuana schedule schedule substance declares provision csa shall prohibit restrict state medical use marijuana legal state law prescription recommendation marijuana medical use medical professional certification medical professional patient condition marijuana therapeutic benefit individual obtaining manufacturing possessing transporting state marijuana medical purposes provided activities authorized state law pharmacy entity authorized distribute medical marijuana obtaining possessing distributing marijuana authorized individuals entity authorized state local government producing processing distributing marijuana purposes


Summary: Small Business Tax Equity Act of 2011 - Amends the Internal Revenue Code to allow a tax deduction for expenses incurred in the trade or business of selling marihuana intended for patients for medical purposes pursuant to state law.

amends internal revenue code allow tax deduction expenses incurred trade business selling marihuana intended patients medical purposes pursuant state law


Summary: Freedom of Health Speech Act - Amends the Federal Trade Commission Act to prohibit the content of any publication from being considered advertising regulated under the Act unless the content is intended by a product seller to promote that product's sale and the content includes the name of the product, an express offer to sell, and a purchase price. Prohibits any content excerpted in whole or part from a peer-reviewed scientific publication from being considered advertising regulated under the Act. Prohibits the Federal Trade Commission (FTC) from attributing to an advertiser any advertising statement not actually made by that advertiser. Requires the FTC to notify an advertiser of a dietary supplement before authorizing an investigation of false advertisement and include a date by which the advertiser may voluntarily discontinue use of the statement. Prohibits the FTC from beginning an investigation of possible false advertising regarding a dietary supplement or a dietary ingredient unless the FTC already possesses clear and convincing evidence that the advertisement is false and misleading. Places the burden of proof on the FTC to show, by clear and convincing evidence, that an advertisement for a dietary supplement or dietary ingredient is false, that the advertisement actually caused consumers to be misled into believing to be true that which is false, and that, but for the false advertising content, the consumer would not have made the purchase at the price paid. Requires the FTC to prove that a health claim alleged to be false advertising is false based on expert scientific opinion and published peer-reviewed scientific evidence.

freedom health speech act amends federal_trade_commission act prohibit content publication considered advertising regulated act content intended product seller promote product sale content includes product express offer sell purchase price prohibits content peer reviewed scientific publication considered advertising regulated act prohibits federal_trade_commission ftc advertising statement actually requires ftc notify dietary supplement authorizing investigation false advertisement include date voluntarily discontinue use statement prohibits ftc beginning investigation possible false advertising dietary supplement dietary ingredient ftc possesses clear convincing evidence advertisement false misleading places burden proof ftc clear convincing evidence advertisement dietary supplement dietary ingredient false advertisement actually caused consumers believing true false false advertising content consumer purchase price paid requires ftc prove health claim alleged false advertising false based expert scientific opinion published peer reviewed scientific evidence


Summary: Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2011 - Amends the Public Health Service Act to require personnel who perform or plan the technical component of either medical imaging examinations or radiation therapy procedures for medical purposes to possess, effective January 1, 2014: (1) certification in each medical imaging or radiation therapy modality and service they plan or perform from a certification organization designated by the Secretary of Health and Human Services (HHS); or (2) state licensure or certification where such services and modalities are within the scope of practice as defined by the state for such profession and where the requirements for licensure, certification, or registration meet or exceed the standards established by the Secretary. Exempts physicians, nurse practitioners, and physician assistants from the requirements of this Act. Directs the Secretary to: (1) establish minimum standards for personnel who perform, plan, evaluate, or verify patient dose for medical imaging examinations or radiation therapy procedures; (2) establish a program for designating certification organizations after consideration of specified criteria; (3) provide a process for the certification of individuals whose training or experience are determined to be equal to, or in excess of, those of a graduate of an accredited educational program; and (4) publish a list of approved accrediting bodies for such certification organizations. Authorizes the Secretary to develop alternative standards for rural or health professional shortage areas as appropriate to ensure access to quality medical imaging. Amends title XVIII (Medicare) of the Social Security Act to allow Medicare payment for medical imaging and radiation therapy services, only if the examination or procedure is planned or performed by an individual who meets this Act's requirements.

consistency accuracy responsibility excellence medical imaging radiation therapy act amends public_health_service_act require personnel perform plan technical component medical imaging examinations radiation therapy procedures medical purposes possess effective january certification medical imaging radiation therapy modality service plan perform certification organization designated secretary health_and_human_services hhs state licensure certification services modalities scope practice defined state profession requirements licensure certification registration meet exceed standards established secretary exempts physicians nurse practitioners physician assistants requirements act directs secretary establish minimum standards personnel perform plan evaluate verify patient dose medical imaging examinations radiation therapy procedures establish program designating certification organizations consideration specified criteria provide process certification individuals training experience determined equal excess graduate accredited educational program publish list approved accrediting bodies certification organizations authorizes secretary develop alternative standards rural health professional shortage areas appropriate ensure access quality medical imaging amends title xviii medicare social security act allow medicare payment medical imaging radiation therapy services examination procedure planned performed individual meets act requirements


Summary: Medical Gas Safety Act - Amends the Federal Food, Drug, and Cosmetic Act to set forth provisions regarding the regulation of medical gases, including to establish a certification and approval process for medical gases. Lists designated medical gases, including oxygen, nitrous oxide, and medical air. Requires the Secretary to: (1) approve a certification for designated medical gases; and (2) establish by rule appropriate procedures for the approval of medical gases that are not designated medical gases. Requires the Secretary to establish regulations for medical gases, including: (1) appropriate current good manufacturing practice requirements, (2) separate labeling requirements, (3) separate wholesale distribution requirements, (4) a streamlined electronic process for registration and listing of medical gases, and (5) separate and proportionate product tracking and anti-counterfeiting rules for medical gases. Requires the Secretary to establish: (1) a separate risk-based inspection regime specific to medical gas manufacturers that ensures coordination with state and local inspection activities, and (2) the Medical Gas Advisory Committee to provide the Secretary with regular guidance and specific advice on medical gas regulatory activities. Directs the Secretary to assess and collect fees with respect to drugs that are non-designated medical gases, and establish the amount of fees to generate the total amount of costs of the Food and Drug Administration's (FDA's) regulation of non-designated medical gases. Exempts medical gases from new drug fees and new animal drug fees.

medical gas safety act amends cosmetic act set forth provisions regulation medical gases including establish certification approval process medical gases lists designated medical gases including oxygen nitrous oxide medical air requires secretary approve certification designated medical gases establish rule appropriate procedures approval medical gases designated medical gases requires secretary establish regulations medical gases including appropriate current good manufacturing practice requirements separate labeling requirements separate wholesale distribution requirements streamlined electronic process registration listing medical gases separate proportionate product tracking anti counterfeiting rules medical gases requires secretary establish separate risk based inspection regime specific medical gas manufacturers ensures coordination state local inspection activities provide secretary regular guidance specific advice medical gas regulatory activities directs secretary assess collect fees respect drugs non designated medical gases establish fees generate total costs food_and_drug_administration fda regulation non designated medical gases exempts medical gases new drug fees new animal drug fees


Summary: Preserving Access to Life-Saving Medications Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the manufacturer of a prescription drug marketed in interstate commerce to notify the Secretary of Health and Human Services (HHS) of a discontinuance or interruption in the manufacture of such drug. Requires the notification to be submitted six months prior to the date of a discontinuance or interruption, if possible. Allows the reduction of the notification period if the manufacturer certifies to the Secretary that good cause exists for the reduction. Authorizes the Secretary to reduce the notification period based on the type of discontinuance or interruption at issue or any other factor. Treats any information provided to the Secretary under this Act as a trade secret or confidential information. Establishes civil monetary penalties for violations. Requires the Secretary to publish on the website of the Food and Drug Administration (FDA) and distribute to the appropriate health care providers and patient organizations information on discontinuances, interruptions, and drug shortages. Requires the Secretary to notify a manufacturer of: (1) any determination by the Secretary that a drug may be vulnerable to a drug shortage, and (2) the Secretary's duty to collaborate to improve continuity of supply. Prohibits the Secretary from requiring a manufacturer to: (1) manufacture a drug in the event of a discontinuance or interruption, or (2) delay or alter a discontinuance or interruption. Declares that no provision of federal law shall be construed to prohibit a manufacturer from, or penalize a manufacturer for, allocating distribution of its products in order to manage an actual or potential drug shortage. Requires the Comptroller General to examine issues related to drug shortages.

preserving access life saving medications act amends cosmetic act require manufacturer prescription drug marketed interstate commerce notify secretary health_and_human_services hhs discontinuance interruption manufacture drug requires notification submitted months prior date discontinuance interruption possible allows reduction notification period manufacturer certifies secretary good cause exists reduction authorizes secretary reduce notification period based type discontinuance interruption issue factor treats information provided secretary act trade secret confidential information establishes civil monetary penalties violations requires secretary publish website food_and_drug_administration fda distribute appropriate health care providers patient organizations information interruptions drug shortages requires secretary notify manufacturer determination secretary drug vulnerable drug shortage secretary duty collaborate improve continuity supply prohibits secretary requiring manufacturer manufacture drug event discontinuance interruption delay alter discontinuance interruption declares provision federal law shall construed prohibit manufacturer penalize manufacturer allocating distribution products order manage actual potential drug shortage requires comptroller general examine issues related drug shortages


Summary: Access to Birth Control Act - Amends the Public Health Service Act to require pharmacies to comply with certain rules related to contraceptives, including: (1) providing a customer a contraceptive without delay if it is in stock; (2) immediately informing a customer if the contraceptive is not in stock and either transferring the prescription to a pharmacy that has the contraceptive in stock or expediting the ordering of the contraceptive and notifying the customer when it arrives, based on customer preference, except for pharmacies that do not ordinarily stock contraceptives in the normal course of business; and (3) ensuring that pharmacy employees do not take certain actions relating to a request for contraception, including intimidating, threatening, or harassing customers, interfering with or obstructing the delivery of services, intentionally misrepresenting or deceiving customers about the availability of contraception or its mechanism of action, breaching or threatening to breach medical confidentiality, or refusing to return a valid, lawful prescription. Provides that a pharmacy is not prohibited from refusing to provide a contraceptive to a customer if: (1) it is unlawful to dispense the contraceptive to the customer without a valid, lawful prescription and no such prescription is presented; (2) the customer is unable to pay for the contraceptive; or (3) the employee of the pharmacy refuses to provide the contraceptive on the basis of a professional clinical judgment. Provides that this Act does not preempt state law or any professional obligation of a state board that provides greater protections for customers. Sets forth civil penalties and establishes a a private cause of action for violations of this Act.

access birth control act amends public_health_service_act require pharmacies comply certain rules related contraceptives including providing customer contraceptive delay stock immediately informing customer contraceptive stock transferring prescription pharmacy contraceptive stock expediting ordering contraceptive notifying customer arrives based customer preference pharmacies ordinarily stock contraceptives normal course business ensuring pharmacy employees certain actions relating request contraception including intimidating threatening harassing customers interfering obstructing delivery services intentionally misrepresenting deceiving customers availability contraception mechanism action breaching threatening breach medical confidentiality refusing return valid lawful prescription provides pharmacy prohibited refusing provide contraceptive customer unlawful dispense contraceptive customer valid lawful prescription prescription presented customer unable pay contraceptive employee pharmacy refuses provide contraceptive basis professional clinical judgment provides act preempt state law professional obligation state board provides greater protections customers sets forth civil penalties establishes private cause action violations act


Summary: Preserving Access to Orphan Drugs Act of 2011 - Amends the Patient Protection and Affordable Care Act (PPACA) to exclude any drug or biological product which is approved or licensed by the Food and Drug Administration (FDA) for marketing solely for one or more rare diseases or conditions from the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million. Makes this Act effective as if included in PPACA.

preserving access orphan drugs act amends patient protection affordable care act ppaca exclude drug biological product approved licensed food_and_drug_administration fda marketing solely rare diseases conditions annual fee manufacturers importers branded prescription drug sales exceeding million makes act effective included ppaca


Summary: Testimonial Free Speech Act of 2011 - Prohibits any federal official or employee from restricting the dissemination of a testimonial containing a consumer's actual perception of the mitigative, preventive, or curative properties of any food or dietary supplement based on the consumer's experience with that food or dietary supplement. Declares that a person is not violating federal law if such person disseminates a testimonial that he or she reasonably believed is covered by this Act. Applies this Act to the dissemination of a testimonial by the manufacturer of a food or dietary supplement for purposes of marketing.

free speech act prohibits federal official employee restricting dissemination containing consumer actual perception preventive properties food dietary supplement based consumer experience food dietary supplement declares person violating federal law person disseminates reasonably believed covered act applies act dissemination manufacturer food dietary supplement purposes marketing


Summary: Pharmaceutical Stewardship Act of 2011 - Establishes the National Pharmaceutical Stewardship Organization as a nonprofit private corporation whose board of directors shall be appointed by the Administrator of the Environmental Protection Agency (EPA). Requires the Organization to begin implementation of a certified national pharmaceutical stewardship program within two years. Requires each manufacturer and brand owner of a drug marketed in the United States to participate in such program or another certified national pharmaceutical stewardship program. Establishes requirements for program certification, including requirements to: (1) provide a system to facilitate the collection and disposal of any drug that is a household waste, as defined under the Resource Conservation and Recovery Act, that is delivered to the program by an individual in the United States; and (2) collect and dispose of drugs in a manner that is safe and secure, that results in incineration of the drug in accordance with the hazardous waste incineration requirements under the Solid Waste Disposal Act, that protects patient information, and that is accessible and, in the case of a controlled substance, consistent with the Controlled Substances Act. Prohibits programs from imposing fees on individuals for delivery or disposal of a drug. Establishes a program certification process, including requiring the Administrator to consult with the Administrator of the Drug Enforcement Agency (DEA) on the adequacy of the proposed program's security measures for collection, transportation, and disposal of drugs, disposal systems, and mechanisms for secure tracking and handling. Authorizes the Administrator to suspend certification of a program if necessary to protect the public from imminent danger. Requires the Director of National Drug Control Policy to establish a campaign to increase public awareness of how drugs may be lawfully disposed consistent with public safety, public health, and environmental protection. Requires the Administrator to establish an interagency commission, to be known as the Commission on Drug Disposal and its Public Safety, Public Health, and Environmental Impacts, to develop a strategy to: (1) prevent the entry of drugs into the nation's water supply and environment consistent with current public safety standards, and (2) protect public health and promote public safety by reducing diversion and the risk of abuse and accidental overdose. Requires the Comptroller General (GAO) to report on drugs and drug byproducts in surface water and groundwater in the United States within a year.

pharmaceutical stewardship act establishes nonprofit private corporation board directors shall appointed administrator environmental_protection_agency epa requires organization begin implementation certified national pharmaceutical stewardship program years requires manufacturer brand owner drug marketed united_states participate program certified national pharmaceutical stewardship program establishes requirements program certification including requirements provide system facilitate collection disposal drug household waste defined recovery_act delivered program individual united_states collect dispose drugs manner safe secure results drug accordance hazardous waste requirements solid waste disposal act protects patient information accessible case controlled substance consistent controlled substances act prohibits programs imposing fees individuals delivery disposal drug establishes program certification process including requiring administrator consult administrator dea adequacy proposed program security measures collection transportation disposal drugs disposal systems mechanisms secure tracking handling authorizes administrator suspend certification program necessary protect public imminent danger requires director national_drug_control_policy establish campaign increase public awareness drugs lawfully disposed consistent public safety public health environmental protection requires administrator establish interagency commission known develop strategy prevent entry drugs nation water supply environment consistent current public safety standards protect public health promote public safety reducing diversion risk abuse accidental overdose requires comptroller general gao report drugs drug byproducts surface water groundwater united_states year


Summary: Safeguarding America's Pharmaceuticals Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of the Treasury to destroy imported counterfeit drugs and adulterated or misbranded imported drugs with a value of less than $2,000. Requires the manufacturer of a prescription drug to provide to its wholesale distributors or dispensers a packing list or comparable document containing identifying information, including the National Drug Code number, container size, and lot number of the drug. Requires each manufacturer or repackager of a prescription drug to: (1) apply a standardized numerical identifier that is unique to each unit of the drug to at least 50% of its drugs by January 1, 2015, and to all of its drugs by January 1, 2016; and (2) notify the Secretary of Health and Human Services (HHS) of the method it will use to meet such requirement. Requires the Secretary to establish an effective drug identification and tracking system to authenticate the wholesale distribution history of any prescription drug that is subject to a requirement for a standardized numerical identifier. Expands the requirements for the licensing of wholesale distributors, including to require mandatory background checks. Disqualifies a person who has been convicted of certain felonies or who has engaged in a pattern of violative behavior. Establishes civil monetary penalties for violations of this Act. Requires penalties paid to the United States to be used by the Secretary of HHS to prevent and address unlawful counterfeiting and diversion of drugs. Authorizes a state to enforce the requirements of this Act under certain circumstances. Requires the Secretary of HHS to study threats to the domestic prescription drug supply chain.

safeguarding_america pharmaceuticals act amends cosmetic act require secretary treasury destroy imported counterfeit drugs adulterated misbranded imported drugs value requires manufacturer prescription drug provide wholesale distributors dispensers packing list comparable document containing identifying information including national drug code number container size lot number drug requires manufacturer repackager prescription drug apply standardized numerical identifier unique unit drug drugs january drugs january notify secretary health_and_human_services hhs method use meet requirement requires secretary establish effective drug identification tracking system authenticate wholesale distribution history prescription drug subject requirement standardized numerical identifier expands requirements licensing wholesale distributors including require mandatory background checks disqualifies person convicted certain felonies engaged pattern behavior establishes civil monetary penalties violations act requires penalties paid united_states secretary hhs prevent address unlawful counterfeiting diversion drugs authorizes state enforce requirements act certain circumstances requires secretary hhs study threats domestic prescription drug supply chain


Summary: Medicare Safe Needle Disposal Coverage Act of 2011 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to cover as a part D drug any devices approved for home use by the Food and Drug Administration (FDA) for the safe and effective containment, removal, decontamination, and disposal of home-generated needles, syringes, and other sharps through a sharps container, decontamination/destructive device, or sharps-by-mail program or similar program.

medicare_safe_needle_disposal_coverage_act amends voluntary prescription drug benefit program title xviii medicare social security act cover drug devices approved home use food_and_drug_administration fda safe effective containment removal decontamination disposal home generated needles syringes sharps sharps container decontamination destructive device sharps mail program similar program


Summary: Novel Device Regulatory Relief Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise the process for requesting classification for a type of medical device that has not been previously classified by removing the requirement that a person can only file a request for classification of a new medical device after the Secretary of Health and Human Services (HHS) classifies the device as a class III device in response to the person filing a notice of intent to market the device.

novel device regulatory relief act amends cosmetic act revise process requesting classification type medical device previously classified removing requirement person file request classification new medical device secretary health_and_human_services hhs classifies device class iii device response person filing notice intent market device


Summary: Guidance Accountability and Transparency Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), when issuing guidance documents that set forth initial interpretations of a statute or regulation, set forth changes in interpretation or policy that are of more than a minor nature, include complex scientific issues, or cover highly controversial issues (Level 1 guidance documents), to: (1) publish notice in the Federal Register of the Secretary's intent to prepare such a document at least three months before issuance of a draft, and (2) meet with interested stakeholders and solicit public comment during preparation and before issuance of a draft. Includes within such guidance documents a notice to industry guidance letter, a notice to industry advisory letter, and any similar notice. Sets forth other procedures if the Secretary for good cause finds compliance with such requirements is impracticable, unnecessary, or contrary to the public interest. Requires the Secretary: (1) upon issuing a draft, to designate it as proposed or final; and (2) to issue a final draft within 12 months after issuing a proposed draft. Treats the proposed draft as null and void if the Secretary fails to finalize the draft within such time. Directs the Secretary to conduct a retrospective analysis of a final Level 1 guidance document not less than every five years to ensure it is not outmoded, ineffective, insufficient, or excessively burdensome and to modify or repeal the document accordingly.

guidance accountability transparency act amends cosmetic act direct secretary health_and_human_services hhs issuing guidance documents set forth initial interpretations statute regulation set forth changes interpretation policy minor nature include complex scientific issues cover highly controversial issues level guidance documents publish notice federal_register secretary intent prepare document months issuance draft meet interested stakeholders solicit public comment preparation issuance draft includes guidance documents notice industry guidance letter notice industry advisory letter similar notice sets forth procedures secretary good cause finds compliance requirements impracticable unnecessary contrary public interest requires secretary issuing draft designate proposed final issue final draft months issuing proposed draft treats proposed draft null void secretary fails finalize draft time directs secretary conduct retrospective analysis final level guidance document years ensure outmoded ineffective insufficient excessively burdensome modify repeal document accordingly


Summary: FDA Renewing Efficiency From Outside Reviewer Management Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise and extend through October 1, 2017, provisions authorizing accredited persons to provide classification reports for a medical device and to inspect class II device or class III device facilities. Deems a recommendation of an accredited person as to the classification of a medical device to be accepted by the Secretary of Health and Human Services (HHS) if the Secretary fails to make a determination with respect to the recommendation within 30 days. Requires the Secretary to regularly publish: (1) detailed decision summaries for each clearance of a device, classification of a device, approval of an application of a device, or grant of exemption for a device occurring after the enactment of this Act; and (2) total product life cycles information for devices. Expands the devices for which an accredited person may perform a review to include: (1) a class II device for which clinical data is required in the report, and (2) a class II device which is intended to be permanently implantable or life sustaining or supporting only if notification is provided to the Secretary before such a review. Deems the review permissible if the Secretary does not object within 60 days. Requires the Secretary to provide for the initial training and periodic updating of training of accredited persons. Makes accreditation valid for three years. Sets forth provisions regarding reaccreditation. Prohibits an accredited person from being a sole practitioner. Provides that the prohibitions against an accredited person being owned or controlled by a manufacturer, supplier, or vendor of devices or engaging in the design, manufacture, promotion, or sale of devices shall apply only if the devices are of the same type for which the person is accredited.

amends cosmetic act revise extend october provisions authorizing accredited persons provide classification reports medical device inspect class device class iii device facilities deems recommendation accredited person classification medical device accepted secretary health_and_human_services hhs secretary fails determination respect recommendation days requires secretary regularly publish detailed decision summaries clearance device classification device approval application device grant exemption device occurring enactment act total product life cycles information devices expands devices accredited person perform review include class device clinical data required report class device intended permanently implantable life sustaining supporting notification provided secretary review deems review permissible secretary object days requires secretary provide initial training periodic updating training accredited persons makes accreditation valid years sets forth provisions prohibits accredited person sole practitioner provides prohibitions accredited person owned controlled manufacturer supplier vendor devices engaging design manufacture promotion sale devices shall apply devices type person accredited


Summary: Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise provisions related to financial interests of Food and Drug Administration (FDA) advisory committee members to require the Secretary of Health and Human Services (HHS) to ensure that individual appointments to advisory committees are made to promote scientific and technical expertise while at the same time minimizing any potential conflicts of interest. Requires the Secretary to consider, with respect to any financial interest constituting a potential conflict of interest, the type, nature, and magnitude of the financial interest. Declares that no specific factor shall be dispositive in the Secretary's evaluation of a particular financial interest. Repeals the prohibition specifically applicable to FDA that prevents a member of an advisory committee from participating with respect to a particular matter if such individual or an immediate family member of such individual has a financial interest that could be affected by the advice given to the Secretary.

cultivating scientific expertise foster innovation patients act amends cosmetic act revise provisions related financial interests food_and_drug_administration fda advisory committee members require secretary health_and_human_services hhs ensure individual appointments advisory committees promote scientific technical expertise time minimizing potential conflicts interest requires secretary consider respect financial interest constituting potential conflict interest type nature magnitude financial interest declares specific factor shall secretary evaluation particular financial interest repeals prohibition specifically applicable fda prevents member advisory committee participating respect particular matter individual immediate family member individual financial interest affected advice given secretary


Summary: Modernizing Laboratory Test Standards for Patients Act of 2011 - Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS) to establish a single publicly accessible test registry data bank of laboratory-developed tests and direct-to-consumer DNA tests, which shall include information on the purpose of each test, the claimed use or uses of each test, and information regarding the analytical validity of each test. Requires notification to the Secretary: (1) before marketing such a test, (2) after any significant modification of such a test, or (3) if the evidence of clinical validity is inadequate to support one or more of the claimed uses. Requires the Secretary, within 90 days of receiving such notification, to determine whether the notification demonstrates clinical validity. Deems the Secretary to have authorized marketing of the test if no response is received within 90 days. Gives the Secretary authority to order a laboratory or test-offering entity to cease offering or marketing a test if the information submitted in notifications does not demonstrate the clinical validity of the claimed uses and the test poses a risk of immediate harm to the public health. Sets forth requirements for: (1) registration of a test-offering entity, (2) information that must be included in disseminated materials and advertising, (3) notice to the Secretary if a test may have caused or contributed to a death or serious bodily injury, and (4) sanctions for violations of this Act. Requires the Secretary to administer this section solely through the Centers for Medicare and Medicaid Services (CMS).

modernizing laboratory test standards patients act amends public_health_service_act require secretary health_and_human_services hhs establish single publicly accessible test registry data bank laboratory developed tests direct consumer dna tests shall include information purpose test claimed use uses test information analytical validity test requires notification secretary marketing test significant modification test evidence clinical validity inadequate support claimed uses requires secretary days receiving notification determine notification demonstrates clinical validity deems secretary authorized marketing test response received days gives secretary authority order laboratory test offering entity cease offering marketing test information submitted notifications demonstrate clinical validity claimed uses test poses risk immediate harm public health sets forth requirements registration test offering entity information included disseminated materials advertising notice secretary test caused contributed death bodily injury sanctions violations act requires secretary administer section solely centers medicare medicaid_services cms


Summary: Patients Come First Act of 2011 - Directs the Secretary of Health and Human Services (HHS): (1) within 90 days after enactment of this Act, to establish the schedule required under the Federal Food, Drug, and Cosmetic Act for the promulgation of regulations requiring premarket approval for medical devices required to remain in class III; and (2) not later than one year after the schedule is established, to issue a final regulation for each such device. Directs the Secretary to: (1) establish a program to assess information relating to device recalls and use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices, (2) clarify procedures for conducting device recall audit checks to improve the ability of investigators to perform those checks in a consistent manner, (3) develop detailed criteria for assessing whether a person performing a device recall has performed an effective correction or action plan for the recall, and (4) document the basis for each Food and Drug Administration (FDA) termination of a device recall.

patients come act directs secretary health_and_human_services hhs days enactment act establish schedule required cosmetic act promulgation regulations requiring premarket approval medical devices required remain class iii later year schedule established issue final regulation device directs secretary establish program assess information relating device recalls use information proactively identify strategies mitigating health risks presented defective unsafe devices clarify procedures conducting device recall audit checks improve ability investigators perform checks consistent manner develop detailed criteria assessing person performing device recall performed effective correction action plan recall document basis food_and_drug_administration fda termination device recall


Summary: Premarket Predictability Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to assign a tracking number to a medical device upon submission of: (1) an application for an exemption of a device for investigational use, (2) a request to classify a device, or (3) a premarket report or notification related to a device. Requires the Secretary to use the tracking number to record interactions between the Secretary and applicant with respect to the device. Directs the Secretary to: (1) assign a reviewer with prior review experience with the type of of device or technology involved or other relevant expertise to review an application for an exemption of a device for investigational use, and (2) evaluate whether the investigational study can be conducted ethically with reasonable risk in determining whether to grant an exemption for investigational use. Prohibits the Secretary from disapproving an application because the investigation does not or may not meet any requirement relating to the approval or clearance of a device because the Secretary believes that a different clinical testing design or plan could produce data more relevant to an approval or clearance decision. Revises the procedures relating to submission of an application to investigate a class II or a class III device, which may include a plan for determining whether the device is substantially equivalent to or is at least as safe and effective as a legally marketed device that is not subject to premarket approval requirements. Sets forth requirements for the Secretary to meet in determining the least burdensome appropriate means of evaluating medical device effectiveness that would have a reasonable likelihood of resulting in approval. Requires the Secretary to document the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding device review, approval, or exemption. Sets forth appeal procedures. Requires the Secretary to regularly publish detailed decision summaries for each clearance of a device not requiring premarket approval.

premarket predictability act amends cosmetic act require secretary health_and_human_services hhs assign tracking number medical device submission application exemption device investigational use request classify device premarket report notification related device requires secretary use tracking number record interactions secretary applicant respect device directs secretary assign reviewer prior review experience type device technology involved relevant expertise review application exemption device investigational use evaluate investigational study conducted reasonable risk determining grant exemption investigational use prohibits secretary disapproving application investigation meet requirement relating approval clearance device secretary believes different clinical testing design plan produce data relevant approval clearance decision revises procedures relating submission application investigate class class iii device include plan determining device substantially equivalent safe effective legally marketed device subject premarket approval requirements sets forth requirements secretary meet determining burdensome appropriate means evaluating medical device effectiveness reasonable likelihood resulting approval requires secretary document scientific regulatory rationale significant decision center_for_devices_and_radiological_health device review approval exemption sets forth appeal procedures requires secretary regularly publish detailed decision summaries clearance device requiring premarket approval


Summary: Humanitarian Device Reform Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to repeal provisions that prohibit the sale of a medical device approved under the humanitarian device exemption (available for devices designed to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States) for an amount that exceeds the costs of research and development, fabrication, and distribution of the device. Adds provisions clarifying that the 4,000 individuals that must be affected in the United States under the humanitarian device exemption is 4,000 individuals per year so affected.

humanitarian device reform act amends cosmetic act repeal provisions prohibit sale medical device approved humanitarian device exemption available devices designed treat diagnose disease condition affects fewer individuals united_states exceeds costs research development fabrication distribution device adds provisions clarifying individuals affected united_states humanitarian device exemption individuals year affected


Summary: Keeping America Competitive Through Harmonization Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to enter into agreements with listed countries (countries eligible for exports of drugs or biological products that have not been approved under certain circumstances) regarding methods and approaches to harmonizing regulatory requirements for premarket review, inspections, and common international labeling symbols. Requires the Secretary to report on the agreements entered under this Act and to itemize the methods and approaches that have been harmonized pursuant to this Act.

keeping america competitive harmonization act amends cosmetic act require secretary health_and_human_services hhs enter agreements listed countries countries eligible exports drugs biological products approved certain circumstances methods approaches regulatory requirements premarket review inspections common international labeling symbols requires secretary report agreements entered act itemize methods approaches harmonized pursuant act


Summary: Affordable Medicines Utilization Act of 2011 - Amends title XIX (Medicaid) of the Social Security Act (SSA), with respect to FY2012-FY2014, to require an increase in the quarterly Medicaid payment to a state by 50% of the generic drug utilization savings amount if the state's generic substitution rate for the most recent preceding fiscal year for which data is available is greater than its rate for the most recent second preceding fiscal year for which data is available. Directs the Secretary of Health and Human Services (HHS) to determine the state's generic substitution rate for such fiscal years. Defines "generic substitution rate" as the share of all drug units for which Medicaid payment is made to a state for the 20 most widely prescribed multiple source drugs under the state program that have a specific National Drug Code. Directs the Secretary to provide for payments to eligible states for implementation of programs to achieve reductions in expenditures under Medicaid or under SSA title XVIII (Medicare) (innovative health care savings program).

affordable medicines utilization act amends title xix medicaid social security act ssa respect fy2012-fy2014 require increase quarterly medicaid payment state generic drug utilization savings state generic substitution rate recent preceding fiscal year data available greater rate recent second preceding fiscal year data available directs secretary health_and_human_services hhs determine state generic substitution rate fiscal years defines generic substitution rate share drug units medicaid payment state widely prescribed multiple source drugs state program specific national drug code directs secretary provide payments eligible states implementation programs achieve reductions expenditures medicaid ssa title xviii medicare innovative health care savings program


Summary: Dietary Supplement Protection Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to exempt dietary supplements containing a dietary ingredient marketed before January 1, 2007 (currently, October 15, 1994) from the requirement to provide premarket evidence of safety for the dietary ingredient to the Secretary of Health and Human Services (HHS).

dietary supplement protection act amends cosmetic act exempt dietary supplements containing dietary ingredient marketed january currently october requirement provide premarket evidence safety dietary ingredient secretary health_and_human_services hhs


Summary: Everson Walls and Ron Springs Gift for Life Act of 2011 - Amends the Public Health Service Act to direct the Secretary of Health and Human Services (HHS), acting through the Administrator of the Health Resources and Services Administration, to establish a National Organ and Tissue Donor Registry Resource Center, which shall: (1) advance the development, expansion, and evaluation of state organ and tissue donor registries; (2) facilitate timely access to, and the exchange of accurate donor information between, such registries; (3) ensure that registries funded through this Act comply with applicable requirements; (4) provide technical assistance to states for such registries; and (5) maintain a registry information clearinghouse to collect, synthesize, and disseminate best practices information. Requires the Secretary to award grants or cooperative agreements to states for the development, enhancement, expansion, and evaluation of organ and tissue donor registries. Sets forth requirements for registries, including that such registries: (1) allow a donor to include a statement or symbol that the donor has made, amended, or revoked an anatomical gift; (2) allow organ procurement organizations to access that information, at or near the donor's death; and (3) bar the use or disclosure of personally identifiable information for any other purpose without the donor's consent. Prohibits any person from being held civilly liable for having harvested or taken an individual's organs or tissues without obtaining valid consent if: (1) such person verified that the individual was registered as a donor with a state organ and tissue donor registry, and (2) the harvesting or taking was within the scope of the consent given for purposes of such registration. Directs the Comptroller General to report on the feasibility of establishing a living donor database to track health effects for donors associated with living organ donation.

life act amends public_health_service_act direct secretary health_and_human_services hhs acting administrator health_resources_and_services_administration establish shall advance development expansion evaluation state organ tissue donor registries facilitate timely access exchange accurate donor information registries ensure registries funded act comply applicable requirements provide technical assistance states registries maintain registry information clearinghouse collect synthesize disseminate best practices information requires secretary award grants cooperative agreements states development enhancement expansion evaluation organ tissue donor registries sets forth requirements registries including registries allow donor include statement symbol donor amended revoked gift allow organ procurement organizations access information near donor death bar use disclosure personally identifiable information purpose donor consent prohibits person held civilly liable having harvested taken individual organs tissues obtaining valid consent person verified individual registered donor state organ tissue donor registry harvesting taking scope consent given purposes registration directs comptroller general report feasibility establishing living donor database track health effects donors associated living organ donation


Summary: Unlocking Lifesaving Treatments for Rare-Diseases Act or ULTRA - Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services (HHS) to approve an application for a drug as a fast track product using a surrogate endpoint, based on the existence of reasonable scientific data that support and qualify the relevance of such endpoint to the disease state and treatment, if the Secretary: (1) makes an initial determination that the drug is eligible for approval as a drug designated for a rare disease or condition (orphan drug) and as a fast track product, and (2) determines that the drug is a treatment for a disease or condition that affects a small number of patients in the United States. Prohibits the Secretary from requiring clinical treatment or other historical clinical data on such endpoint as a prerequisite to assessment of that endpoint if such scientific data is not available. Directs the Secretary to issue guidance providing details and options for qualifying surrogate endpoints without clinical data, taking into account and balancing: (1) the unmet need served by the drug and the adverse effects of the rare disease or condition on quality and length of life, (2) the very low likelihood that clinical data would exist or that clinical studies would be completed to support a surrogate endpoint due to the small size of the U.S. patient population and other significant barriers inherent in performing such studies due to the prevalence of the disease or related factors, and (3) the full scope of available basic scientific data and information that the Secretary deems reasonably predictive of a clinical benefit in the absence of clinical data.

unlocking lifesaving treatments rare diseases act cosmetic act authorize secretary health_and_human_services hhs approve application drug fast track product surrogate endpoint based existence reasonable scientific data support qualify relevance endpoint disease state treatment secretary makes initial determination drug eligible approval drug designated rare disease condition orphan drug fast track product determines drug treatment disease condition affects small number patients united_states prohibits secretary requiring clinical treatment historical clinical data endpoint prerequisite assessment endpoint scientific data available directs secretary issue guidance providing details options qualifying surrogate endpoints clinical data taking account balancing unmet need served drug adverse effects rare disease condition quality length life low likelihood clinical data exist clinical studies completed support surrogate endpoint small size patient population significant barriers inherent performing studies prevalence disease related factors scope available basic scientific data information secretary deems reasonably predictive clinical benefit absence clinical data


Summary: Drug Shortage Prevention Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to: (1) define the term "critical drug" based on the medical necessity and vulnerability to shortage of a drug or biological product; (2) establish, make publicly available, and update semiannually a list identifying each critical drug and its manufacturers; (3) promptly remove from such list any drug or biological product that no longer meets such definition; and (4) establish, make publicly available, and update monthly a list identifying each critical drug that is in a critical drug shortage in the United States, the severity of and reason for the shortage, alternate therapies and regions particularly affected, and an estimated date by which the necessary quantities of the drug will begin reaching providers. Allows manufacturers to request removal of a drug from such lists on the basis that it doesn't meet the definition of "critical drug" or is not in a critical drug shortage. Directs the Secretary to: (1) establish a proactive system for giving notice to the public concerning modifications to the critical drug shortage list, (2) establish a system for giving notice of any imminent critical drug shortage to critical drug manufacturers and wholesale distributors and manufacturers of alternative therapies, (3) notify the Attorney General of any critical drug shortage, (4) study the feasibility of creating a national contingency plan addressing critical drug shortages, (5) expedite the review of applications for approval of critical drugs and requests by sponsors of such drugs to approve manufacturing process changes or alternate suppliers of active ingredients, and (6) improve the process for regulating critical drugs. Express the sense of Congress that the Food and Drug Administration (FDA) should increase the number of personnel responsible for identifying and addressing critical drug shortages. Amends the Controlled Substances Act to direct the Attorney General to increase a quota as appropriate for a drug listed in a critical drug shortage that is or contains a controlled substance.

drug shortage prevention act amends cosmetic act direct secretary health_and_human_services hhs define term critical drug based medical necessity vulnerability shortage drug biological product establish publicly available update semiannually list identifying critical drug manufacturers promptly remove list drug biological product longer meets definition establish publicly available update monthly list identifying critical drug critical drug shortage united_states severity reason shortage alternate therapies regions particularly affected estimated date necessary quantities drug begin reaching providers allows manufacturers request removal drug lists basis meet definition critical drug critical drug shortage directs secretary establish proactive system giving notice public concerning modifications critical drug shortage list establish system giving notice imminent critical drug shortage critical drug manufacturers wholesale distributors manufacturers alternative therapies notify attorney general critical drug shortage study feasibility creating national contingency plan addressing critical drug shortages expedite review applications approval critical drugs requests sponsors drugs approve manufacturing process changes alternate suppliers active ingredients improve process regulating critical drugs express sense congress food_and_drug_administration fda increase number personnel responsible identifying addressing critical drug shortages amends controlled substances act direct attorney general increase quota appropriate drug listed critical drug shortage contains controlled substance


Summary: Safety Of Untested and New Devices Act of 2012 or the SOUND Devices Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to require a medical device company seeking approval of a new device based on a determination of substantial equivalence to a predicate device to inform the Food and Drug Administration (FDA) if any predicate lineage products have harmed device recipients and to explain how the current device avoids past flaws. Prohibits finding a new device substantially equivalent to a predicate device if the predicate has been removed from the market by the Secretary of Health and Human Services (HHS) or determined to be misbranded or adulterated by judicial order. Permits the FDA to reject a claim of substantial equivalency for a device whose predicate has been corrected or removed from the market by its sponsor. Requires the Secretary to maintain an up-to-date database for purposes of determining whether devices are eligible for use as a predicate device. Requires each manufacturer's corrective action or removal of device report to contain the root cause of each defect leading to the corrective action or removal. Requires a manufacturer's report for devices in the same lineage as devices that have been subject to corrections or removals and requires such report to explain why the subsequent device does not share the flaws of its predecessor device. Requires the Secretary to conduct a review of all covered devices to identify any such devices with respect to which a predicate device, or any device in the full device lineage, has been corrected or removed from the market pursuant to a Class I or Class II recall.

new devices act sound devices act amends cosmetic act require medical device company seeking approval new device based determination substantial equivalence predicate device inform food_and_drug_administration fda predicate products harmed device recipients explain current device avoids past prohibits finding new device substantially equivalent predicate device predicate removed market secretary health_and_human_services hhs determined misbranded adulterated judicial order permits fda reject claim substantial equivalency device predicate corrected removed market sponsor requires secretary maintain date database purposes determining devices eligible use predicate device requires manufacturer corrective action removal device report contain root cause defect leading corrective action removal requires manufacturer report devices devices subject corrections removals requires report explain subsequent device share predecessor device requires secretary conduct review covered devices identify devices respect predicate device device device corrected removed market pursuant class class recall


Summary: Amends the Pediatric Medical Device Safety and Improvement Act to authorize appropriations through FY2017 for grants for demonstration projects to promote pediatric device development. Amends the Federal Food, Drug, and Cosmetic Act to allow an exception to the prohibition against selling a device that is designed to treat or diagnose a disease or condition which affects fewer than 4,000 individuals in the United States and that is exempt from the effectiveness requirements of such Act for an amount that exceeds the costs of research and development, fabrication, and distribution of the device where the request for such exemption is submitted on or before October 1, 2017 (currently, October 1, 2012). Requires the proposed rule issued by the Commissioner of Food and Drugs (FDA) entitled "Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure" to take effect on January 1, 2013, unless such Commissioner issues the final rule before such date.

amends authorize appropriations fy2017 grants demonstration projects promote pediatric device development amends cosmetic act allow exception prohibition selling device designed treat diagnose disease condition affects fewer individuals united_states exempt effectiveness requirements act exceeds costs research development fabrication distribution device request exemption submitted october currently october requires proposed rule issued fda entitled medical devices requirement submission information pediatric subpopulations suffer disease condition device intended treat diagnose cure effect january commissioner issues final rule date


Summary: Religious Liberty Protection Act of 2012 - Prohibits the Secretary of Health and Human Services (HHS) from implementing or enforcing any provision of the interim final rule published on July 19, 2010, related to the coverage of preventive health services under the Patient Protection and Affordable Care Act (PPACA) or any amendment to such rule insofar as such provision or amendment require any individual or entity to provide coverage of sterilization or contraceptive services to which the individual or entity is opposed on the basis of religious belief. Amends PPACA to declare that a health plan shall not be considered to have failed to provide essential health benefits, to fail to be a qualified health plan, or to fail to fulfill any other requirements on the basis that the plan does not provide or pay for coverage of sterilization or contraceptive services because: (1) providing or paying for such coverage is contrary to the religious or moral beliefs of the sponsor, issuer, or other entity offering the plan; or (2) such coverage, in the case of individual coverage, is contrary to the religious or moral beliefs of the purchaser or beneficiary of the coverage.

religious liberty protection act prohibits secretary health_and_human_services hhs implementing enforcing provision interim final rule published july related coverage preventive health services patient_protection affordable care act ppaca amendment rule insofar provision amendment require individual entity provide coverage sterilization contraceptive services individual entity opposed basis religious belief amends ppaca declare health plan shall considered failed provide essential health benefits fail qualified health plan fail fulfill requirements basis plan provide pay coverage sterilization contraceptive services providing paying coverage contrary religious moral beliefs sponsor issuer entity offering plan coverage case individual coverage contrary religious moral beliefs purchaser beneficiary coverage


Summary: Generic Drug and Biosimilar User Fee Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), beginning FY2013, to assess and collect the following fees related to generic drugs: (1) a one-time backlog fee for abbreviated new drug applications pending on October 1, 2012; (2) a drug master file fee; (3) an abbreviated new drug application and prior approval supplement filing fee, as well as an additional fee for active pharmaceutical ingredient information not included by reference to Type II active pharmaceutical ingredient drug master file; and (4) a generic drug facility fee and active pharmaceutical ingredient facility fee. Provides that submission of an application for a positron emission tomography drug or active pharmaceutical ingredient for a positron emission tomography drug shall not require the payment of any fee. Sets forth provisions relating to fee amounts and due dates. Terminates the above provisions on October 1, 2017. Requires the Secretary to report to Congress on the progress of the Food and Drug Administration (FDA) in achieving specified safety, access, and transparency goals with respect to generic drugs. Biosimilar User Fee Act of 2012 - Directs the Secretary, beginning FY2013, to assess and collect the following fees related to biosimilar biological products: (1) biosimilar program development fees, encompassing an initial biosimilar biological development fee, an annual biosimilar biological product development fee, and a reactivation fee; (2) a biosimilar biological product application and supplement fee; (3) a biosimilar biological product establishment fee; and (4) a biosimilar biological product fee. Waives the above fees for the first biosimilar biological product application of a small business. Terminates the above provisions on October 1, 2017. Requires the Secretary to report to Congress on the progress of the Food and Drug Administration (FDA) in achieving specified goals with respect to biosimilar biological products.

biosimilar user fee act amends cosmetic act direct secretary health_and_human_services hhs beginning fy2013 assess collect following fees related generic drugs time backlog fee abbreviated new drug applications pending october drug master file fee abbreviated new drug application prior approval supplement filing fee additional fee active pharmaceutical ingredient information included reference type active pharmaceutical ingredient drug master file generic drug facility fee active pharmaceutical ingredient facility fee provides submission application positron emission tomography drug active pharmaceutical ingredient positron emission tomography drug shall require payment fee sets forth provisions relating fee amounts dates terminates provisions october requires secretary report congress progress food_and_drug_administration fda achieving specified safety access transparency goals respect generic drugs biosimilar user fee act directs secretary beginning fy2013 assess collect following fees related biosimilar biological products biosimilar program development fees encompassing initial biosimilar biological development fee annual biosimilar biological product development fee reactivation fee biosimilar biological product application supplement fee biosimilar biological product establishment fee biosimilar biological product fee waives fees biosimilar biological product application small business terminates provisions october requires secretary report congress progress food_and_drug_administration fda achieving specified goals respect biosimilar biological products


Summary: Protecting Consumer Access to Generic Drugs Act of 2012 - Prohibits, as an unfair and deceptive act or practice and an unfair method of competition in or affecting interstate commerce, any person from being a party to any agreement resolving or settling a patent infringement claim in which: (1) an abbreviated new drug (generic) application filer receives anything of value; and (2) such filer agrees not to research, develop, manufacture, market or sell the generic drug. Excludes a resolution or settlement that includes no more than: (1) the right to market the generic drug before the expiration of the patent or other exclusivity period, or (2) the waiver of a patent infringement claim for damages. Authorizes the Federal Trade Commission (FTC) to exempt agreements in furtherance of market competition and for the benefit of consumers. Amends the Federal Food, Drug, and Cosmetic Act to deem an applicant to have forfeited market exclusivity if the applicant enters into an agreement that violates this Act. Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to revise reporting requirements related to agreements between a generic drug applicant and a brand name drug company to include: (1) a description of the subject matter of other agreements between the parties; and (2) a certification that the materials filed represent the complete, final, and exclusive agreement between the parties.

protecting consumer access generic drugs act prohibits unfair deceptive act practice unfair method competition affecting interstate commerce person party agreement resolving settling patent infringement claim abbreviated new drug generic application filer receives value filer agrees research develop manufacture market sell generic drug excludes resolution settlement includes right market generic drug expiration patent exclusivity period waiver patent infringement claim damages authorizes federal_trade_commission ftc exempt agreements furtherance market competition benefit consumers amends cosmetic act deem applicant forfeited market exclusivity applicant enters agreement violates act amends medicare_prescription_drug improvement modernization act revise reporting requirements related agreements generic drug applicant brand drug company include description subject matter agreements parties certification materials filed represent complete final exclusive agreement parties


Summary: Science and Technology Regulatory Relief Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit a state or political subdivision from conducting or requiring an inspection of a factory, warehouse, or establishment in which a drug or device is manufactured, processed, packed, or held by a manufacturer or wholesale distributor for introduction into interstate commerce, or after such introduction, for purposes of verifying compliance with such Act, Public Health Service Act requirements regarding the regulation of biological products, or any similar requirements established pursuant to state law. Makes exceptions for such an inspection if: (1) the state or subdivision makes a determination that a drug or device presents a threat of serious adverse health consequences or death; (2) the Secretary of Health and Human Services (HHS) orders a recall of a drug, biological product, or device manufactured, processed, packed, or held at the factory, warehouse, or establishment; or (3) the Secretary requests or authorizes the state to conduct or require the inspection.

relief act amends cosmetic act prohibit state political subdivision conducting requiring inspection factory warehouse establishment drug device manufactured processed packed held manufacturer wholesale distributor introduction interstate commerce introduction purposes verifying compliance requirements regulation biological products similar requirements established pursuant state law makes exceptions inspection state subdivision makes determination drug device presents threat adverse health consequences death secretary health_and_human_services hhs orders recall drug biological product device manufactured processed packed held factory warehouse establishment secretary requests authorizes state conduct require inspection