jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Health
Date: 2008-07-31 00:00:00

Independent Drug Education and Outreach Act of 2008 - Amends the Public Health Service Act to require the Secretary of Health and Human Services, acting through the Director of the Agency for Healthcare Research and Quality, to award grants or contracts for: (1) the development and production of educational materials concerning the evidence available on the relative safety, effectiveness, and cost of prescription drugs, nonprescription drugs, and nondrug interventions for treating selected conditions, to be distributed and presented to health care providers who prescribe such drugs and their patients; and (2) the development and implementation of a program to appropriately train and deploy health professionals to distribute such materials to, and otherwise educate, physicians and other drug prescribers concerning such drugs and interventions. Requires that grantees receive no support from any entity that manufactures products used to treat the medical conditions discussed.
Topic: Health — Drug Industry
Subject: Health
Date: 2008-07-31 00:00:00

Medicare Clinical Diagnostic Laboratory Fee Schedule Modernization Act of 2008 - Directs the Secretary of Health and Human Services to: (1) establish a negotiated rulemaking committee to negotiate and develop a proposed rule for a Medicare modernized clinical diagnostic laboratory fee schedule; (2) report to Congress on the fee schedule; and (3) promulgate final regulations to establish it.
Topic: Health — Drug Industry
Date: 2008-09-11 00:00:00

Medicare Orthotics and Prosthetics Improvement Act of 2008 - Amends title XVIII (Medicare) of the Social Security Act with respect to recognized independent accreditation organizations which apply quality standards to which suppliers of items and services relating to prosthetic devices and orthotics and prosthetics. Directs the Secretary of Health and Human Services (HHS) to designate and approve an independent accreditation organization for such purposes only if it is the American Board for Certification in Orthotics and Prosthetics, Inc., the Board for Orthotist/Prosthetist Certification, or a program that the Secretary determines has accreditation and approval standards essentially equivalent to those of such a Board. Requires application to prosthetic devices and orthotics and prosthetics generally of existing accreditation and licensure requirements for certain prosthetics and custom-fabricated orthotics. Directs the Secretary to report to Congress on: (1) the steps taken by the Department of HHS to ensure that such licensure and accreditation requirements are enforced; and (2) the effect of the requirements of this Act on the occurrence of fraud and abuse under the Medicare program with respect to prosthetic devices and orthotics and prosthetics. Modifies the Medicare payment methodology for prosthetic devices and orthotics and prosthetics to account for practitioner qualifications and complexity of care.
Topic: Health — Drug Industry
Date: 2008-09-26 00:00:00

Science Free Speech Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to provide that a food or dietary supplement is not a drug solely because a claim is made regarding legitimate scientific research in accordance with this Act.States that a food is not misbranded if its label makes a claim regarding legitimate scientific research in accordance with this Act.Declares that the use of truthful and not misleading information on legitimate scientific research in connection with the sale or distribution of a food or dietary supplement to consumers shall not be treated as a violation under the FFDCA and shall not be deemed evidence of an intent to sell a drug.Prohibits the Secretary of Health and Human Services from: (1) restricting in any way the distribution of truthful and not misleading information on legitimate scientific research; or (2) prohibiting manufacturers or distributors of foods or dietary supplements from including citations to legitimate scientific research in the labeling of a food or dietary supplement, even if the citation expressly or implicitly references a disease or a disease condition.Places the burden of proof on the Secretary in any administrative or judicial proceeding in which the Secretary contests the use of material being disseminated or cited as legitimate scientific research.Prohibits the Secretary from prohibiting or restricting a retailer or wholesaler of any agricultural product, including fresh produce, in any way from: (1) testing any of its agricultural products for any pathogens that may potentially be transmitted to humans or potentially cause illness or disease in humans; or (2) communicating the results of such tests to the public.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-01-04 00:00:00

Citizen Petition Fairness and Accuracy Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require that any citizen petition or request for stay of action related to an abbreviated new drug application include a statement that to the petitioner's best knowledge and belief, the petition: (1) includes all information and views on which the petitioner relies; (2) is well grounded in fact and is warranted by law; (3) is not submitted for an improper purpose; and (4) does not contain a materially false, misleading, or fraudulent statement. Requires the Secretary of Health and Human Services to investigate any petition that does not comply with such requirements. Allows the Secretary to impose penalties for knowingly and willfully submitting a petition for an improper purpose or that contains a materially false, misleading or fraudulent statement. Provides that such penalties may include: (1) imposition of a civil penalty; (2) suspension or revocation of the petitioner's authority to submit such a petition; and (3) dismissal of the petition. Requires the Secretary to refer such a violative petition to the Federal Trade Commission (FTC) for further action. Sets forth the factors that the Secretary shall consider in taking an enforcement action or determining the penalty. Permits any person aggrieved by a petition that may contain violations to submit a request, with a certification of good faith, for the Secretary to initiate an investigation. Subjects such person to civil penalties for knowing and intentional submission of a violative request. Requires the Secretary to take final agency action on such a petition within six months. Prohibits the Secretary from extending the review period for any reason.
Topic: Health — Drug Industry
Subject: Public lands and natural resources
Date: 2007-01-04 00:00:00

Private Property Rights Protection Act - Makes ineligible for federal funds any condemning authority or acquiring party that engages or participates in a taking or condemnation of any real property interest not for a public use or public purpose using the power of eminent domain, without the owner's consent. Requires any entity applying for federal funds to certify eligibility. Allows the Commissioner of the Internal Revenue Service (IRS) to audit any condemning authority or acquiring party that has made such a certification. Allows a property owner who is notified that his or her property will be taken to file for and attach a Fifth Amendment property protection statement (PPS) indicating that the condemning entity is exceeding its authority, which shall prohibit any acquiring party from claiming any benefit, deduction, or tax credit related to any activities conducted within the geographical boundaries comprising the jurisdiction of the condemning authority. Allows the condemning entity to seek a judicial determination of the statement's validity and an order releasing the PPS if not valid. Prohibits any government from engaging or participating in a taking or condemnation of any private real property interest under the power of eminent domain for any purpose that is not for a public purpose or a public use. Applies such prohibition to an exercise of eminent domain: (1) by the federal government; (2) related to a program or activity receiving federal financial assistance; or (3) that would affect commerce with foreign nations, among the states, or with Indian tribes. Allows a person to assert a violation of this act as a claim or defense in a judicial proceeding. Allows the United States to bring an action for injunctive or declaratory relief to enforce compliance with this Act.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-01-10 00:00:00

Pharmaceutical Market Access Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to promulgate regulations permitting pharmacists, pharmacies, and wholesalers to import qualifying drugs from certain countries into the United States. Sets forth registration requirements for exporters. Requires the Secretary to: (1) educate consumers with regard to the availability of qualifying drugs for import for personal use; (2) inspect the facilities and records of importers and registered exporters to ensure compliance with this Act; and (3) establish a registration fee program to collect an annual fee from registered exporters. Deems a prescription drug to be misbranded unless the packaging of such drug complies with the requirements for counterfeit-resistant technologies. Prohibits: (1) failing to register in accordance with this Act; and (2) importing or offering to import a prescription drug in violation of a suspension order. Declares that selling or importing a patented drug in the United States that was first sold abroad by or under authority of the owner or licensee of the patent is not patent infringement. Prohibits drug manufacturers from discriminating against a person that engages in the importation of a prescription drug, including by charging higher prices or denying supplies of the drug. Allows the Secretary to suspend or terminate the registration of an exporter for failing to maintain substantial compliance with all registration conditions.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-01-30 00:00:00

Fair Prescription Drug Competition Act - 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: Crime and law enforcement
Date: 2007-01-31 00:00:00

John R. Justice Prosecutors and Defenders Incentive Act of 2007 - Amends the Omnibus Crime Control and Safe Streets Act of 1968 to add a program for student loan repayment for prosecutors and public defenders. Defines "prosecutor" and "public defenders" to include individuals engaged in the supervision, education, or training of other prosecutors and public defenders. Includes within the definition of "public defender" full-time employees of nonprofit organizations who devote substantially all their time providing indigent criminal defense services and federal public defenders. Requires prosecutors and public defenders to prosecute or provide representation for juvenile delinquency cases.Directs the Attorney General to establish a program to assume the obligation to repay the student loans of any borrowers who are employed as prosecutors or public defenders and are not in default on their loans. Sets forth requirements for such program, including that: (1) the borrower will remain employed as a prosecutor or public defender for not less than three years; and (2) the borrower will repay to the Attorney General any repayment benefits received if the borrower is fired from employment for misconduct or voluntarily separates from employment.Limits the amount payable under such program to $10,000 per year for any borrower and to an aggregate total of $60,000 for any borrower.Authorizes the Attorney General to enter into subsequent agreements with a borrower for another three-year period or a lesser period.Requires the Attorney General to give priority in granting repayment benefits to borrowers who have the least ability to repay their loans.Authorizes the Attorney General to issue regulations to carry out this Act.Directs the Government Accountability Office to study and report to Congress on the impact of law school accreditation requirements and other factors on law school costs and access, including the impact of such requirements on racial and ethnic minorities.Authorizes appropriations.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-02-01 00:00:00

Enhancing Drug Safety and Innovation Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for approval for a new drug or biological product to include a proposed risk evaluation and mitigation strategy, which must include: (1) labeling for the drug for use by health care providers; (2) submission of reports for the drug; and (3) a statement as to whether the analysis and surveillance are sufficient to assess the serious risks of the drug. Establishes a Drug Safety Oversight Board. Requires the Secretary of Health and Human Services to establish the Reagan-Udall Institute for Applied Biomedical Research as a nonprofit corporation to advance the Critical Path Initiative to modernize medical product development, accelerate innovation, and enhance product safety. Requires the Institute to have a Board of Directors. Allows the Board to coordinate and collaborate with other entities to conduct research, education, and outreach and to modernize the sciences of developing, manufacturing, and evaluating the safety and effectiveness of diagnostics, devices, biologics, and drugs. Amends the Public Health Service Act to require the Secretary, acting through the Director of the National Institutes of Health (NIH), to establish and administer a clinical trial registry database and a clinical trial results database. Requires a responsible part for a clinical trial to submit clinical trial information to the Director for inclusion in the databases. Requires each individual under consideration for a term on an advisory committee providing advice or recommendations to the Secretary regarding FDA activities to disclose industry financial interests.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-02-01 00:00:00

Living Kidney Organ Donation Clarification Act of 2007 - Provides that for purposes of provisions of the National Organ Transplant Act that prohibit the transfer of any human organ for use in human transplantation for valuable consideration, kidney paired donation does not involve such a transfer. Requires the Secretary of Health and Human Services to report to the appropriate congressional committees annually on progress toward understanding the long-term health effects of living organ donation.
Topic: Health — Drug Industry
Subject: Agriculture and food
Date: 2007-02-08 00:00:00

Rural Opportunities Act of 2007 - Amends the Security and Rural Investment Act of 2002 to direct the Secretary of Agriculture to: (1) make state grants for extension, education, applied research, and development activities at institutions of higher education, state agencies, or partnerships for local and regional bioenergy and biobased product use and production; and (2) provide funds for basic research on next generation technology. Authorizes the Secretary to make supplemental rural cooperative development grants. Amends the Agricultural Research, Extension, and Education Reform Act of 1998 to direct the Secretary to: (1) establish regional bonus grant funds for bioenergy and biobased products competitive research, education, and extension programs; and (2) carry out agroforestry conversion and cellulosic production pilot programs. Extends: (1) the renewable energy systems and energy improvements program; and (2) the value-added agricultural grant program. Amends the Consolidated Farm and Rural Development Act to direct the Secretary to make state grants for development of the next generation of farmers, ranchers, and other land managers. Directs the Secretary to carry out specified pilot programs. Amends the Farm Security and Rural Investment Act of 2002 to extend: (1) the beginning farmer and rancher development program; and (2) the organic certification cost-share program. Directs the Secretary to identify barriers to small, beginning, limited resource, and socially disadvantaged producers in conservation and farm support programs. Authorizes funds for rural technology transfers. Amends the Food, Agriculture, Conservation, and Trade Act of 1990 to extend the best utilization of biological applications program. Establishes a federal-state matching grant program. Extends: (1) the national training program; (2) the organic agriculture research and extension program; and (3) the socially disadvantaged farmers and ranchers outreach and technical assistance program. Amends the Organic Foods Production Act of 1990 to direct the Secretary to establish a national organic agriculture conversion and stewardship incentives program. Authorizes geographic produce and food procurement preferences for certain Department of Defense and Department of Agriculture programs. Amends the Child Nutrition Act of 1966 to extend the women, infants, and children (WIC) farmers' market nutrition program. Amends the Farmer-to-Consumer Direct Marketing Act of 1976 to extend the farmers market promotion program. Amends the Food Stamp Act of 1977 to extend, and revise funding provisions for, assistance for community food projects. Requires: (1) broadband service providers to provide the Federal Communications Commission (FCC) with specified information; and (2) the FCC to provide Congress with demographic information for underserved areas. Sets forth specified offset provisions.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-02-12 00:00:00

Preservation of Antibiotics for Medical Treatment Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services 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 of Health and Human Services 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.Authorizes the Secretary of Agriculture to make payments to livestock or poultry producers to defray the costs of reducing the use of such drugs, with priority given to family-owned or small farms and ranches.Amends the Farm Security and Rural Investment Act of 2002 to direct the Secretary of Agriculture to award grants to colleges and universities to establish programs to phase out the nontherapeutic use of such drugs in livestock or poultry.Requires the manufacturer of such a drug or an animal feed for food-producing animals containing such a drug to report sales information to the Secretary of Health and Human Services.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-02-14 00:00:00

Safe Internet Pharmacy Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to set forth the conditions under which a licensed Internet pharmacy may dispense or offer to dispense a prescription drug to a person in the United States. Requires an Internet pharmacy to: (1) maintain patient medication profiles; (2) ensure patient confidentiality; (3) offer interactive and meaningful consultation by a licensed pharmacist to the caregiver or patient; (4) establish a mechanism for patients to report errors and suspected and adverse drug reactions and for the pharmacy to document its response and report such information to the Food and Drug Administration (FDA); and (5) verify the validity of prescriptions. Allows an Internet pharmacy to dispense a prescription for a controlled substance only if the treating provider confirms the accuracy of the prescription by direct communication.Allows the Secretary of Health and Human Services to suspend or terminate the license of an Internet pharmacy. Directs the Board of Governors of the Federal Reserve System to promulgate regulations to establish policies and procedures that are reasonably designed to prevent the introduction or completion of restricted transactions with unlicensed Internet pharmacies into a designated payment system.Requires the Secretary to provide for a system to identify and report Internet pharmacy websites in violation of federal or state law.Prohibits: (1) the ownership or operation of an Internet pharmacy in violation of this Act; and (2) the representation by an Internet pharmacy that a prescription drug may be obtained without a prescription. Sets forth penalties for violations of this Act.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-02-15 00:00:00

Access to Life-Saving Medicine Act - Amends the Public Health Service Act to establish a process for the approval of an abbreviated biological product application for products that contain the same or similar active ingredients as a previously licensed biological product (the reference product). Allows a person to file an abbreviated biological product application with the Secretary of Health and Human Services that includes: (1) data demonstrating that the product is comparable to or interchangeable with the reference product; (2) information to show that the conditions or conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product; and (3) information to show that the route of administration, the dosage form, and the strength of the biological product are the same as those of the reference product. Sets forth conditions for approval of such an application by the Secretary. Allows an applicant to request that the Secretary make a determination as to the interchangeability of a comparable product and the reference product based on whether a product can be expected to produce the same clinical result as the reference product in any given patient. Provides market exclusivity to such an interchangeable product. Requires the Secretary to defer issuing a determination of interchangeability for a subsequent comparable biological product during the period of market exclusivity for a prior interchangeable comparable biological product. Requires the Secretary to establish requirements for the efficient review, approval, suspension, and revocation of comparable biological product applications. Sets forth provisions governing patent infringement claims against an applicant or prospective applicant for a comparable biological product license.
Topic: Health — Drug Industry
Subject: Commerce
Date: 2007-02-16 00:00:00

Tanning Accountability and Notification Act of 2007 - Requires the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to determine whether: (1) the labeling requirements for indoor tanning devices provide sufficient information to consumers regarding the risks that the use of such devices pose for the development of irreversible damage to the eyes and skin, including skin cancer; (2) adding the warning suggested by the American Academy of Dermatology or any other additional warning to the current warning label would communicate such risks more effectively; and (3) there is no warning that would be capable of adequately communicating such risks. Requires the Secretary, in making such determinations, to: (1) conduct appropriate consumer testing using the best available methods for determining consumer understanding of label warnings; and (2) hold public hearings and solicit comments from the public.