jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Health
Date: 2009-10-14 00:00:00

Access to Affordable Medicines Act - Amends the Federal Food, Drug, and Cosmetic Act to provide that an application for a generic drug the proposed labeling of which is different from the labeling at the time the Secretary of Health and Human Services (HHS) evaluates the application shall be eligible for approval (and such drug shall not be considered misbranded) if: (1) the revision has been approved by the Secretary within 60 days of the expiration of the patent or exclusivity period for the drug; (2) the Secretary has not determined the applicable labeling text when such period expires; (3) the labeling revision does not include a change to the warnings section; (4) the Secretary does not deem that the continued presence in commerce of the labeling before the revision adversely impacts the safe use of the drug; and (5) the sponsor of the application agrees to submit revised labeling not later than 60 days after the notification of any changes required by the Secretary.
Topic: Health — Drug Industry
Subject: Foreign trade and international finance
Date: 2009-10-29 00:00:00

Amends the Harmonized Tariff Schedule of the United States to reduce temporarily the duty no frames and mountings for spectacles, goggles, or the like, the foregoing of plastics.
Topic: Health — Drug Industry
Subject: Health
Date: 2010-01-21 00:00:00

Nanotechnology Safety Act of 2010 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to establish within the Food and Drug Administration (FDA) a program for the scientific investigation of nanoscale materials included or intended for inclusion in FDA-regulated products to address: (1) the potential toxicology of such materials; (2) the effects of such materials on biological systems; and (3) the interaction of such materials with biological systems.
Topic: Health — Drug Industry
Subject: Crime and law enforcement
Date: 2010-04-28 00:00:00

Amends the Controlled Substances Act to revise the definition of "dispense" to include the delivery of a controlled substance through the use of an intrathecal pump by a practitioner acting in the usual course of professional practice.
Topic: Health — Drug Industry
Subject: Agriculture and food
Date: 2010-05-25 00:00:00

Dietary Supplement Full Implementation and Enforcement Act of 2010 - Authorizes appropriations for FY2011-FY2014 to carry out the Dietary Supplement Health and Education Act of 1994 (DSHEA) and other provisions under the Federal Food, Drug, and Cosmetic Act (FFDCA) that apply to dietary supplements. Requires the allocation of funds appropriated to the Food and Drug Administration (FDA) for FY2010 for the purpose of enhancing food safety to be expended to effectively and fully implement and enforce DSHEA and other FFDCA provisions that apply to dietary supplements. Authorizes appropriations for FY2010-FY2014 for expanded research and development of consumer information on dietary supplements by the Office of Dietary Supplements at the National Institutes of Health (NIH). Requires the Secretary of Health and Human Services (HHS) to report to Congress annually on the implementation and enforcement of DSHEA and its amendments. Amends the FFDCA to require the Secretary to publish guidance that clarifies when a dietary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor of a dietary ingredient or dietary supplement should provide the Secretary with safety information, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing the identity of a new dietary ingredient. Requires the Secretary to notify the Drug Enforcement Agency (DEA) if information in a new dietary ingredient notification is inadequate to establish that a dietary supplement containing such ingredient will reasonably be expected to be safe because the ingredient may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid.
Topic: Health — Drug Industry
Subject: Health
Date: 2010-05-25 00:00:00

Fair Pricing for Prescription Drugs Act - Pharmaceutical Market Access and Drug Safety Act of 2010 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions governing the importation of prescription drugs. Waives the limitation on importation of prescription drugs that have been exported from the United States. Prohibits the importation of a qualifying drug unless such drug is imported by: (1) a registered importer; or (2) an individual for personal use. Establishes registration conditions for importers and exporters. Requires the Secretary of Health and Human Services (HHS) to inspect places of business, verify chains of custody, inspect facilities, and determine compliance with registration conditions. Sets forth provisions governing the importation of qualifying drugs that are different from U.S. label drugs, including standards for judging such differences. Prohibits manufacturers from: (1) discriminating against registered exporters or importers; (2) causing there to be a difference in a prescription drug distributed in the United States and one distributed in a permitted country; (3) engaging in actions to restrict, prohibit, or delay the importation of a qualifying drug; or (4) engaging in any action that the Federal Trade Commission (FTC) determines discriminates against a person that engages or attempts to engage in the importation of a qualifying drug. States that the resale in the United States of prescription drugs that were properly sold abroad is not patent infringement. Requires the Secretary to educate consumers regarding prescription drug importation. Sets forth provisions governing the sale of prescription drugs through an Internet site. Includes the dispensing or selling of a prescription drug in violation of this Act as a prohibited act under FFDCA. Prohibits the introduction of restricted transactions with unregistered foreign pharmacies into a payment system or the completion of such transactions using a payment system. Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to direct the Secretary to negotiate with pharmaceutical manufacturers the prices that may be charged to Medicare part D prescription drug plan (PDP) sponsors and MedicareAdvantage (MA) organizations for covered part D drugs for part D eligible individuals who are enrolled under a PDP or an MA-Prescription Drug plan.
Topic: Health — Drug Industry
Subject: Health
Date: 2010-08-03 00:00:00

Drug Safety and Accountability Act of 2010 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require each registered drug producer to have in effect and implement a quality management plan to ensure the quality and safety of: (1) each drug; (2) each active and inactive ingredient of each drug; and (3) materials used in the manufacture of each active ingredient. Authorizes the Secretary of Health and Human Services (HHS) to order an establishment to promptly revise its quality management plan in response to a significant threat to public health. Requires each registered drug producer to report on each producer, manufacturer, distributor, and shipper involved in the production of a drug or the production or transport of the active ingredients of a drug. Requires the Secretary to develop and maintain information systems to track and assess every establishment that is involved in the manufacturing, preparation, propagation, compounding, or processing of a drug or active ingredient of a drug. Deems a drug to be adulterated if it was produced in an establishment that does not comply with the requirements of this Act. Gives the Secretary authority to: (1) order an immediate cessation of distribution, or a recall, of a drug; and (2) administer oaths and issue subpoenas. Revises provisions regarding civil penalties for FFDCA violations related to drugs for human use, including to consider each day a violation continues to be a separate violation. Authorizes the Secretary to share information subject to a trade secret exemption with: (1) other federal, state, or local agencies, foreign government agencies, and relevant international organizations; and (2) the public, as necessary to protect the public health. Sets forth whistleblower protection provisions.
Topic: Health — Drug Industry
Subject: Health
Date: 2010-08-05 00:00:00

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.
Topic: Health — Drug Industry
Subject: Crime and law enforcement
Date: 2011-01-05 00:00:00

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.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-01-05 00:00:00

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.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-01-19 00:00:00

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.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2011-01-25 00:00:00

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.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2011-02-15 00:00:00

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.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2011-02-16 00:00:00

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.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-02-16 00:00:00

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.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-03-09 00:00:00

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.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-03-11 00:00:00

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.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2011-04-01 00:00:00

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.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-04-01 00:00:00

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.
Topic: Health — Drug Industry
Subject: Agriculture and food
Date: 2011-04-05 00:00:00

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.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-04-12 00:00:00

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.)
Topic: Health — Drug Industry
Subject: Taxation
Date: 2011-04-12 00:00:00

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.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-05-23 00:00:00

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.