jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Health
Date: 2012-07-11 00:00:00

Preventing Abuse of Cough Treatments Act of 2012 or the PACT Act - Amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale or offering for sale of a drug containing dextromethorphan, and not subject to practitioner supervision requirements, to an individual under age 18, except if the sale is: (1) made pursuant to a validly issued prescription; or (2) to an individual who provides proof of being married, the parent of a child, or actively enrolled in the military. Imposes civil monetary penalties that escalate upon repeated violation. Deems to be adulterated any unfinished dextromethorphan that is possessed, received, or distributed in violation of this Act. Prohibits a person from: (1) possessing or receiving unfinished dextromethorphan unless the person is registered with the Secretary of Health and Human Services (HHS) as a producer of a drug or device or otherwise registered, licensed, or approved pursuant to federal or state law to engage in the practice of pharmacy, pharmaceutical production, or manufacture or distribution of drug ingredients; or (2) distributing unfinished dextromethorphan to any person other than a registered or otherwise authorized person. Excludes from such prohibitions common carriers that possess, receive, or distribute unfinished dextromethorphan for purposes of distributing it between registered, licensed, or approved persons. Imposes additional civil monetary penalties for such possession and distribution violations.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-07-17 00:00:00

Taking Essential Steps for Testing Act or the TEST Act - Amends the Public Health Service Act to revise sanctions for laboratories that intentionally refer proficiency testing samples required for certification to another laboratory for analysis by: (1) giving the Secretary of Health and Human Services (HHS) discretion to substitute intermediate sanctions for such violations instead of the two-year prohibition against ownership or operation which would otherwise apply, and (2) making the one-year certificate revocation for such a laboratory optional rather than mandatory.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-08-02 00:00:00

Ethical Pathway Act of 2012 - Directs the Commissioner of Food and Drugs (FDA) to establish a mechanism by which an applicant to sell any new pharmaceutical drug, vaccine, biologic product, or medical device that requires regulatory approval by the Secretary of Health and Human Services (HHS) (regulated product) may request a cost-sharing arrangement under which the applicant shall: (1) verify that intended clinical investigations involving humans or vertebrate animals have not been performed or initiated by another person; (2) make reasonable efforts to obtain voluntary agreements to use existing evidence regarding the safety and efficacy of new pharmaceutical drugs or biological products used to obtain marketing approval for use in humans or vertebrate animals (regulatory test data); and (3) notify the Commissioner if there is a failure to reach a voluntary agreement, at which point the Commissioner shall ask the parties to agree to binding arbitration to determine the reasonable and fair fee for relying upon relevant regulatory test data. Permits such applicant to request such arrangement if, but for the arrangement: (1) the applicant would be required to conduct clinical investigations involving human subjects that violate Article 20 of the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects in order to obtain regulatory approval of the regulated product, or (2) the duplication of the clinical investigations required for such application would violate other applicable ethical standards concerning the testing of products on humans or other vertebrate animals. Requires the fee for reliance by the applicant on such regulatory test data to be determined after considering: (1) the actual out-of-pocket costs of the applicable clinical investigations; (2) the risks of the investigations; (3) any federal grants, tax credits, or other subsidies; (4) the expected share of the global market for the product involved; and (5) the amount of time the holders of the relevant applications or licenses have benefited from exclusive rights and the cumulative revenue earned on the products that relied upon the data at issue. Directs the Secretary to adopt procedures and rules under which sufficient information about costs and fees will be made public.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-09-13 00:00:00

Medicaid Information Technology to Enhance Community Health Act of 2012 or MITECH Act - Amends title XIX (Medicaid) of the Social Security Act to extend payments to encourage the adoption and use of certified electronic health record (EHR) technology to qualified safety net clinics (QSNCs). Defines a QSNC as a clinic or network of clinics operated by a private non-profit or public entity at least 30% percent of whose patient volume is attributable to needy individuals. Defines a "QSNC-based" individual as one who furnishes substantially all of his or her professional services in a QSNC and through use of the clinic's facilities and equipment, including qualified EHRs. Directs the Secretary of Health and Human Services (HHS) to establish a procedure through which a QSNC may demonstrate meaningful use of certified EHR technology in order to receive incentive payments.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-01-03 00:00:00

Small Supplier Fairness in Bidding Competition Act of 2013 - 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).

Requires the Administrator of the Centers for Medicare & Medicaid Services (CMS) to report to Congress on the impact of competitive bidding on small clinical laboratories.

Includes CMS (solely with respect to its capacity to issue rules governing the Medicare part B fee schedule for clinical laboratory services) as an agency for purposes of the requirement to assure the opportunity for participation of small entities in the making of rules that will have a significant economic impact on them.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-01-14 00:00:00

Amends title XVIII (Medicare) of the Social Security Act to authorize direct payment under part B (Supplementary Medical Insurance Benefits for the Aged and Disabled) to a pharmacy for certain covered compound drugs prepared by the pharmacy for a specific beneficiary for the effective use of an implanted infusion pump.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-02-04 00:00:00

Stop Tampering of Prescription Pills Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to prescribe new drug application requirements for abuse-deterrent drugs: (1) containing as an active moiety (the part of the drug that makes it work the way it does) a controlled substance classified as opium, an opiate, or a derivative; (2) formulated for oral administration; (3) exhibiting physicochemical properties making them significantly more difficult or ineffective in altering the drug's characteristics for purposes of misuse or abuse; and (4) containing one or more additional ingredients intended to deter abuse through potential pharmacological effects.

Requires the Secretary to refuse a new drug application for any new (brand name) drug containing opium, an opiate, or a derivative as an active moiety that is not abuse-deterrent if an abuse-deterrent drug containing the same active moiety has been approved and has not been discontinued from marketing. Authorizes the Secretary to approve an application failing to meet such requirements, however, if approval is necessary to prevent or alleviate a drug shortage or otherwise address a significant unmet public health need.

Requires an abbreviated new (generic) drug application for an abuse-deterrent drug to include testing information demonstrating that the generic drug resists manipulation or the effect of manipulation to a degree at least comparable to the listed drug. Authorizes the Secretary to deny approval of a generic application if the listed drug is abuse-deterrent and one or more of the generic drug's active moieties differ in any material respect from those of the listed drug.

Declares that an approved generic drug shall not be considered bioequivalent to, or as having the same therapeutic effect as, a listed drug if the listed drug becomes abuse-deterrent unless and until the generic drug demonstrates that it resists manipulation or the effect of manipulation to a degree at least comparable to the listed drug.

Prescribes requirements governing when a drug which is not abuse-deterrent may have its approval withdrawn or suspended.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2013-02-06 00:00:00

Protect Medical Innovation Act of 2013 - Amends the Internal Revenue Code to repeal the excise tax on medical device manufacturers and importers.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2013-02-06 00:00:00

First Responder Medical Device Tax Relief Act - 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: 2013-02-06 00:00:00

Amends the National Organ Transplant Act to prohibit acquiring, receiving, or otherwise transferring a cord blood unit (the neonatal blood collected from the placenta and umbilical cord of a single newborn baby) for valuable consideration for use in human transplantation if the transfer affects interstate commerce.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-02-15 00:00:00

Amends part B (Supplementary Medical Insurance) of title XVIII (Medicare) of the Social Security Act to exclude from the average sales price in calculating Medicare payments for drugs and biologicals any customary prompt pay discounts from manufacturers to wholesalers.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2013-02-28 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: Health
Date: 2013-03-14 00:00:00

Preservation of Antibiotics for Medical Treatment Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to require an applicant for approval of a new animal drug that is a medically important antimicrobial to demonstrate that there is a reasonable certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Requires the Secretary of Health and Human Services (HHS) to refuse approval if the applicant fails to make such a demonstration.

Defines “medically important antimicrobial” as a drug intended for use in food-producing animals and composed wholly or partly of: (1) any kind of specified antibiotics, including penicillin and tetracycline; or (2) a drug from an antimicrobial class that is listed on the World Health Organization’s list of critically important antimicrobials.

Requires the Secretary to withdraw approval for the nontherapeutic use in food-producing animals of a medically important antimicrobial marketed for human use unless the Secretary makes a final written determination that, based on either the application holder's demonstration or an HHS risk analysis, there is a reasonable certainty of no harm to human health due to the development of antimicrobial resistance attributable to the drug's nontherapeutic use.

Requires the Secretary to rescind approval of an exemption for investigational use of, or of approval of a new drug application for, a medically important antimicrobial for its nontherapeutic use in a food-producing animal two years after the exemption is granted or the application for approval is submitted. Exempts from this requirement any drugs for which there has been found a reasonable certainty of no harm to human health.

Prohibits the administration of a medically important antimicrobial (including by means of animal feed) to a food-producing animal for nonroutine disease control unless there is a significant risk that a disease or infection present on the premises will be transmitted to the food-producing animal. Requires the administration of the antimicrobial to be: (1) necessary to prevent or reduce the risk of transmission; (2) for the shortest duration possible to prevent or reduce the risk of transmission; and (3) at a scale no greater than the barn, house, or pen level and to the fewest animals possible to prevent or reduce the risk of transmission.
Topic: Health — Drug Industry
Subject: Environmental protection
Date: 2013-03-15 00:00:00

Asthma Inhalers Relief Act of 2013 - Directs the Administrator of the Environmental Protection Agency (EPA) to: (1) permit the distribution, sale, and consumption in the United States of remaining inventories of CFC epinephrine inhalers manufactured pursuant to the exception for medical devices under the Clean Air Act; (2) not take any enforcement action or otherwise seek to restrict the distribution, sale, or consumption of such inhalers on the basis of any federal law implementing the Montreal Protocol on Substances that Deplete the Ozone Layer; and (3) issue, in response to a request of any distributor or seller of such inhalers, a No Action Assurance Letter stating that the EPA will not initiate an enforcement action relating to the distribution or sale of any such inhaler occurring prior to August 1, 2013.

Defines "CFC epinephrine inhaler" to mean any epinephrine inhaler containing chlorofluorocarbons that was manufactured and classified as over-the-counter before January 1, 2012.

Terminates this Act on August 1, 2013.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2013-03-21 00:00:00

Hearing Aid Assistance Tax Credit Act 2013 - 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 the taxpayer, the taxpayer's spouse, or 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: 2013-03-21 00:00:00

Stop Oxy Abuse Act of 2013 - 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.
Topic: Health — Drug Industry
Subject: Commerce
Date: 2013-03-21 00:00:00

Safe Cosmetics and Personal Care Products Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to provide for the regulation of cosmetics by the Secretary of Health and Human Services (HHS).

Requires any brand owner engaged in bringing a cosmetic to market for use in the United States to register annually and pay a fee for oversight and enforcement of this Act.

Requires the Secretary to: (1) establish labeling requirements, (2) establish a safety standard that provides a reasonable certainty of no harm from exposure to a cosmetic or an ingredient in a cosmetic and that protects the public from any known or anticipated adverse health effects associated with the cosmetic or ingredient, and (3) issue guidance prescribing good manufacturing practices for cosmetics and ingredients.

Requires brand owners to submit to the Secretary safety data for the ingredients listed on the cosmetic label and the cosmetic itself, which shall be published in a database.

Requires the Secretary to review and evaluate the safety of cosmetics and ingredients of cosmetics that are marketed in interstate commerce, including nanotechnology and contaminants of concern linked to severe acute reactions or long-term adverse health effects.

Requires the Secretary, based on an initial review and evaluation, to establish three lists for ingredients: (1) a prohibited and restricted list, (2) a safe without limits list, and (3) a priority assessment list.

Authorizes the Secretary to order a recall or cease of distribution for a cosmetic that is adulterated, misbranded, or otherwise in violation of the FFDCA.

 Requires reporting of any serious adverse event associated with cosmetics.

Requires the Secretary to take action to minimize the use of animal testing of ingredients and cosmetics.

Establishes an Interagency Council on Cosmetic Safety.

Requires the Secretary of Labor to promulgate an occupational safety and health standard relating to cosmetics for professional use.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-04-09 00:00:00

Title I: Animal Drug User Fee Amendments - Animal Drug User Fee Amendments of 2013 - (Sec. 103) Amends the Federal Food, Drug, and Cosmetic Act to extend for FY2014-FY2018 the authority of the Food and Drug Administration (FDA) to collect animal drug user fees, specifically new animal drug application or supplemental animal drug application fees, animal drug product fees, animal drug establishment fees, and animal drug sponsor fees.

Revises the due date for annual user fees to the later of January 31 of each year or the first business day after enactment of an appropriations act providing for the collection and obligation of fees for the fiscal year.

Establishes the amount of revenue such fees can generate. Specifies percentages of the total revenue that shall be derived from each type of user fee.

Requires the Secretary of Health and Human Services (HHS) to adjust the total revenue amounts for FY2015 and subsequent fiscal years for inflation.

Authorizes the Secretary to accept payment of user fees prior to their due date.

Requires the total fees collected for FY2016-FY2018 to be increased by the cumulative amount, if any, by which the amount of user fees collected and appropriated for prior fiscal year falls below the cumulative amount of fees authorized.

(Sec. 104) Extends requirements for the FDA to report to Congress on achieving goals related to animal drug development and review processes and implementation of authority to collect animal drug user fees.

(Sec. 107) Terminates the authority to collect user fees October 1, 2018.

Title II: Animal Generic Drug User Fee Amendments - Animal Generic Drug User Fee Amendments of 2013 - (Sec. 202) Extends for FY2014-FY2018 the authority of the FDA to collect generic animal drug user fees, specifically abbreviated application fees for generic new animal drugs, generic new animal drug product fees, and generic new animal drug sponsor fees.

Subjects generic animal drug applications to a fee 50% of the amount of the normal fee if the application is for an animal drug which contains more than one active ingredient, or the labeling of the drug prescribes, recommends, or suggests use of the drug in combination with one or more other animal drugs, and the active ingredients or drugs intended for use in the combination have previously been separately approved.

Revises the due date for annual generic animal drug user fees to the later of January 31 of each year or the first business day after enactment of an appropriations act providing for the collection and obligation of fees for the fiscal year.

Establishes the total amount of revenue each type of generic user fee shall generate.

Authorizes the Secretary to accept payment of user fees prior to their due date.

(Sec. 203) Extends requirements for the FDA to report to Congress on achieving goals related to the generic animal drug development and review process and the implementation of the authority to collect generic animal drug fees.

(Sec. 206) Terminates the authority to collect generic animal drug user fees October 1, 2018.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-04-16 00:00:00

Medicare Drug Savings Act of 2013 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA) to require drug manufacturers to pay the Secretary of Health and Human Services (HHS) drug rebates for rebate eligible (low-income) individuals. Excludes from Medicare coverage as a part D drug any drug or biological manufactured by a manufacturer that has not entered into and have in effect a rebate agreement with the Secretary.

Requires a rebate agreement to require a drug or biological manufacturer to provide to the Secretary a rebate, determined according to a specified formula, for each rebate period ending after December 31, 2011, for any covered Medicare part D drug dispensed after that date to any rebate eligible individual for which payment was made by a prescription drug plan (PDP) sponsor or MedicareAdvantage (MA) organization for such period.

Specifies a formula for determination of Medicaid rebate amounts for such drugs or biologicals.

Amends SSA title XIX (Medicaid) to exclude any amounts paid under a rebate agreement from the determination of best price and average manufacturer price under the Medicaid program.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-04-24 00:00:00

Medicare DMEPOS Market Pricing Program Act of 2013 - Amends part B (Supplementary Medical Insurance) of title XVIII (Medicare) of the Social Security Act (SSA) to establish a market pricing program for durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS) as a replacement for the competitive acquisition program, which is terminated as of December 31, 2013. Terminates contracts awarded before enactment of this Act on July 1, 2013.

Prescribes requirements for transitional payments for items and services, including payments for diabetic supplies and off-the-shelf orthotics, in areas designated for rounds 1 and 2 of the erstwhile phase-in of the competitive acquistion program, as well as during the initial two-year period of the market pricing program.

Directs the Secretary to: (1) conduct market-priced auctions in eligible auction areas throughout the United States for the furnishing of market priced items and services, (2) establish an auction design through a specified process and meeting certain requirements, and (3) ensure that the first auction will be conducted for all eligible auction areas not later than 14 months after contracting with an auction expert.

Directs the Secretary to: (1) select a combination of two categories of items and services for each auction, (2) establish a lead product for each product category, (3) establish for each market priced item and service a clearing price equal to the highest cost bid that will meet capacity targets in the market area, (4) award a contract to any entity in an auction's eligible market area whose bid is at or below the clearing price, and (5) monitor the performance of suppliers that are awarded a contract to ensure their compliance with certain requirements. Requires the Secretary, through the Office of the Assistant Secretary for Planning and Evaluation, to contract with an auction expert and a market monitor to assist in the design, development, implementation, and functioning of the auction. Requires the market monitor, on an ongoing basis, also to monitor suppliers and the effects of the market pricing program.

Rescinds unobligated balances of all discretionary appropriations for each fiscal year (except those for accounts, programs, projects and activities operated by the Department of Defense [DOD] or the Department of Veterans Affairs [VA]) in an amount necessary to make this Act budget neutral for such fiscal year.