Drug Safety, Medical Device, And Laboratory Regulation
US Congress 112th Congress
FDA Renewing Efficiency From Outside Reviewer Management Act of 2011 [HB-3205]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
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
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Sponsored by: Sen. Marsha Blackburn
Referred To The Subcommittee On Health. on 10/18/2011
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Guidance Accountability and Transparency Act of 2011 [HB-3204]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Science ]
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
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Sponsored by: Sen. Marsha Blackburn
Referred To The Subcommittee On Health. on 10/18/2011
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Novel Device Regulatory Relief Act of 2011 [HB-3203]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
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.
Sponsored by: Sen. Marsha Blackburn
Referred To The Subcommittee On Health. on 10/18/2011
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Creating Hope Act of 2011 [HB-3059]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Children and Youth ]
Creating Hope Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise the priority review voucher program for tropical diseases to: (1) include rare pediatric diseases; (2) allow unlimited transfers of vouchers under the program; and (3) require a sponsor intending to use a voucher to notify the Secretary of Health and Human Services (HHS) at least 90 days (currently, 365 days) before submission of the application. Revises provisions regarding the priority review user fee, including to make it payable upon notification of the Secretary
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Sponsored by: Rep. Ted Poe
Referred To The Subcommittee On Health. on 09/26/2011
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Safeguarding America's Pharmaceuticals Act of 2011 [HB-3026]
[Pharmaceuticals ]
[Healthcare ]
[Consumer Protection ]
[Public Health ]
[Law Enforcement ]
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
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Sponsored by: Rep. Brian Bilbray
Referred To The Subcommittee On Health. on 09/26/2011
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Health Equity and Accountability Act of 2011 [HB-2954]
[Healthcare ]
[Medicare and Medicaid ]
[Public Health ]
[Mental Health ]
[Race and Civil Rights ]
[Veterans ]
[Criminal Justice ]
[Human Services ]
[Pharmaceuticals ]
[Poverty ]
[Food ]
Health Equity and Accountability Act of 2011 - Amends the Public Health Service Act, the Social Security Act, and the Federal Food, Drug, and Cosmetic Act to expand the collection and analysis of data in programs of the Department of Health and Human Services (HHS). Sets forth provisions to improve cultural competence in federal health care programs and services, including by establishing the Robert T. Matsui Center for Cultural and Linguistic Competence in Health Care. Requires the Secretary of Health and Human Services (Secretary) to engage in
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Sponsored by: Rep. Raul Grijalva
Referred To The Subcommittee On Higher Education And Workforce Training. on 11/18/2011
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Pharmaceutical Stewardship Act of 2011 [HB-2939]
[Pharmaceuticals ]
[Public Health ]
[Environmental ]
[Waste Management / Recycling ]
[Overdose Prevention ]
[Healthcare ]
[Water ]
[Public Safety ]
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
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Sponsored by: Rep. Louise Slaughter
Referred To The Subcommittee On Health. on 09/20/2011
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Access to Medical Treatment Act [HB-2736]
[Healthcare ]
[Public Health ]
[Pharmaceuticals ]
[Consumer Protection ]
Access to Medical Treatment Act - Gives an individual the right to be treated by a health care practitioner with any medical treatment that the individual desires, including a treatment that is not approved, certified, or licensed by the Secretary of Health and Human Services (HHS), if: (1) the practitioner has personally examined the individual and agrees to treat the individual, and (2) the administration of such treatment does not violate licensing laws. Authorizes health care practitioners to provide any method of treatment to such an individual
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Sponsored by: Rep. Peter DeFazio
Referred To The Subcommittee On Health. on 08/05/2011
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Pandemic and All-Hazards Preparedness Reauthorization Act of 2011 [HB-2405]
[Healthcare ]
[Public Health ]
[Pharmaceuticals ]
[Science ]
[National Security ]
[Defense ]
[Funding ]
[Grants ]
Pandemic and All-Hazards Preparedness Reauthorization Act of 2011 - (Sec. 2) Amends the Public Health Service Act (PHSA) to reauthorize appropriations for FY2012-FY2016 for the influenza vaccine tracking and distribution program in an influenza pandemic. Revises and reauthorizes appropriations for FY2012-FY2016 for a program of cooperative agreements to improve state and local public health security. Requires eligible entities to include in their application to the Secretary of Health and Human Services (HHS) a description of any activities that
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Sponsored by: Rep. Anna Eshoo
Received In The Senate And Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 12/07/2011
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Medical Gas Safety Act [HB-2227]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
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
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Sponsored by: Rep. Leonard Lance
Referred To The Subcommittee On Health. on 06/22/2011
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Ending Defensive Medicine and Encouraging Innovative Reforms Act of 2011 [HB-2205]
[Healthcare ]
[Insurance ]
[Public Health ]
[Disaster Relief ]
[Law Enforcement ]
Ending Defensive Medicine and Encouraging Innovative Reforms Act of 2011 - Sets conditions for lawsuits arising from health care liability claims regarding health care goods or services or any medical product affecting interstate commerce. Provides for periodic payment of future damages. Makes each party liable only for the amount of damages directly proportional to such party's percentage of responsibility. Requires the dismissal of any lawsuit for which a qualified specialist does not submit an affidavit to the court as to whether there is a reasonable
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Sponsored by: Rep. Charles Dent
Referred To The Subcommittee On The Constitution. on 08/25/2011
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Generating Antibiotic Incentives Now Act of 2011 [HB-2182]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Science ]
Generating Antibiotic Incentives Now Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to extend the exclusivity period for a new prescription drug by five years for a drug that the Secretary of Health and Human Services (HHS) determines to be a qualified infectious disease product. Defines "qualified infectious disease product" to mean an antibiotic drug for treating, detecting, preventing, or identifying a qualifying pathogen (certain pathogens that are resistant to antibiotics). Excludes drugs that are: (1) a supplement to a new drug
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Sponsored by: Rep. H. Morgan Griffith
Referred To The Subcommittee On Health. on 06/16/2011
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Skin Cancer Prevention, Education, and Consumer Right-To-Know Act [HB-2132]
[Healthcare ]
[Consumer Protection ]
[Public Health ]
[Education ]
[Pharmaceuticals ]
Skin Cancer Prevention, Education, and Consumer Right-To-Know Act - Requires the proposed rule issued by the Commissioner of Food and Drugs (FDA) pertaining to over-the-counter sunscreen drug products to take effect 180 days after enactment of this Act, unless the Commissioner issues a final rule that includes formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection before such time. Directs the Secretary of Health and Human Services (HHS) to implement a general, nationwide education
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Sponsored by: Rep. Nita Lowey
Referred To The House Committee On Energy And Commerce. on 06/03/2011
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Ryan Creedon Act of 2011 [HB-2119]
[Healthcare ]
[Public Health ]
[Pharmaceuticals ]
[Overdose Prevention ]
[Crime ]
Ryan Creedon Act of 2011 - Amends the Controlled Substances Act to require: (1) the Attorney General to require practitioners, as a condition on registering or renewing registration to dispense controlled substances in schedules II, III, IV, or V, to obtain particular training or special certification meeting standards established by the Secretary of Health and Human Services (HHS) on controlled substance addiction and abuse and on appropriate and safe use of such controlled substances; and (2) such training or certification to be provided by a
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Sponsored by: Rep. Stephen Lynch
Referred To The Subcommittee On Crime, Terrorism, And Homeland Security. on 07/11/2011
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Consolidated and Further Continuing Appropriations Act, 2012 [HB-2112]
[Agriculture ]
[Food ]
[Budget and Spending ]
[Trade ]
[Telecommunications ]
[Technology and Innovation ]
[Science ]
[Aerospace ]
[Transportation and Motor Vehicles ]
[Housing ]
[Community Development ]
[Economic Development ]
[Disaster Relief ]
[Energy ]
[Environmental ]
[Water ]
[Public Health ]
[Law Enforcement ]
[Criminal Justice ]
[Cybersecurity ]
[National Security ]
[Construction ]
[Small Business ]
[Labor, Jobs, Employment ]
[Consumer Protection ]
[Human Rights ]
[Human Services ]
[Funding ]
[Grants ]
[Taxes ]
[Property Tax ]
[Public Safety ]
[Race and Civil Rights ]
[Medicare and Medicaid ]
[Children and Youth ]
[Family-Related Legislation ]
[Reproductive Rights / Abortion ]
[Firearms/Gun Control ]
[International ]
[Animals ]
[Arts and Culture ]
[Veterans ]
[Education ]
[Infrastructure ]
[Real Estate ]
[Crime ]
Consolidated and Further Continuing Appropriations Act, 2012 - Division A: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies - Title I: Agricultural Programs - Appropriates FY2012 funds for the following Department of Agriculture (USDA) programs and services: (1) Office of the Secretary of Agriculture (Secretary); (2) Office of Tribal Relations; (3) Office of the Chief Economist; (4) National Appeals Division; (5) Office of Budget and Program Analysis; (6) Office of Homeland Security and Emergency Coordination; (7)
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Sponsored by: Rep. Jack Kingston
Signed By President. on 11/18/2011
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Health Freedom Act [HB-2044]
[Healthcare ]
[Consumer Protection ]
[Food ]
[Public Health ]
[Pharmaceuticals ]
Health Freedom Act - Prohibits the federal government from preventing the use of a claim describing any nutrient in a food or dietary supplement as mitigating, treating, or preventing any disease, disease symptom, or health-related condition unless, in a final order following a trial on the merits, a federal court finds clear and convincing evidence, based on qualified expert opinion and published peer-reviewed scientific research, that: (1) the claim is false and misleading in a material respect; and (2) there is no less speech-restrictive alternative
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Sponsored by: Rep. Dan Burton
Referred To The Subcommittee On Health. on 06/03/2011
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Regenerative Medicine Promotion Act of 2011 [HB-1862]
[Healthcare ]
[Science ]
[Pharmaceuticals ]
[Public Health ]
[Funding ]
[Grants ]
Regenerative Medicine Promotion Act of 2011 - Requires the Comptroller General to submit to Congress a report identifying all ongoing federal programs and activities regarding regenerative medicine. Directs the Secretary of Health and Human Services (HHS) to establish a Regenerative Medicine Coordinating Council in the Office of the Secretary, the duties of which shall include: (1) preparing a national strategy to support research into regenerative medicine and the development of drugs, biological products, medical devices, and biomaterials for
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Sponsored by: Rep. James Langevin
Referred To The Subcommittee On Health. on 05/13/2011
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Drug Free Water Act of 2011 [HB-1677]
[Environmental ]
[Healthcare ]
[Water ]
[Public Health ]
[Pharmaceuticals ]
Drug Free Water Act of 2011 - Requires the Administrator of the Environmental Protection Agency (EPA) to convene a task force to develop: (1) recommendations on the proper disposal of unused pharmaceuticals to prevent or reduce the detrimental effects caused by introducing such materials into water systems and for limiting the disposal of unused pharmaceuticals through treatment works in accordance with the Federal Water Pollution Control Act (commonly known as the Clean Water Act), and (2) a strategy for educating the public on such recommendations.
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Sponsored by: Rep. Candice Miller
Referred To The Subcommittee On Water Resources And Environment. on 05/03/2011
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Tanning Bed Cancer Control Act of 2011 [HB-1676]
[Healthcare ]
[Public Health ]
[Consumer Protection ]
Tanning Bed Cancer Control Act of 2011 - Directs the Commissioner of Food and Drugs (FDA): (1) to complete a study to examine the classification of ultraviolet tanning lamps as class I medical devices; and (2) not later than one year after completion of such study, to either issue a rule providing for the reclassification of an ultraviolet tanning lamp as a class II or class III device or submit to Congress a report providing a justification for not issuing such a rule. Requires the Commissioner to: (1) complete a study on the adequacy of performance
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Sponsored by: Rep. Gerald Connolly
Referred To The Subcommittee On Health. on 05/05/2011
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Drug Safety Enhancement Act of 2011 [HB-1483]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Consumer Protection ]
[Law Enforcement ]
[Criminal Justice ]
[Overdose Prevention ]
[Crime ]
Drug Safety Enhancement Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand drug establishment registration requirements to include foreign drug establishments and establishments manufacturing, preparing, propagating, compounding, or processing excipients of drugs (i.e., inactive drug additives). Requires the Secretary of Health and Human Services (HHS) to collect registration fees. Requires drug manufacturers to: (1) implement an effective quality system that requires compliance with current good manufacturing practices
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Sponsored by: Rep. Barbara Lee
Referred To The Subcommittee On Health. on 04/15/2011