WorldCat Identities
Fri Mar 21 17:15:46 2014 UTClccn-no20090810570.00Statutory inspectors general legislative developments and legal issues /0.871.00The Special Inspector General for the Troubled Asset Relief Program (SIGTARP)88547557no20090810578121375lccn-n79061321Library of CongressCongressional Research Servicelccn-n98023525Feder, Jodylccn-nr99034741Cohen, Henry1949-lccn-n80126147United StatesFood and Drug Administrationnp-redhead, c stephenRedhead, C. Stephenlccn-no2008183976Troubled Asset Relief Program (U.S.)lccn-no2006067954Manuel, Katelccn-nr99031619Halstead, T., brian tYeh, Brian T.lccn-no2009087461United StatesOffice of the Special Inspector General for the Troubled Asset Relief ProgramBurrows, Vanessa K.United StatesTortsGovernment liabilityPharmacy--Law and legislationDrugs--PrescribingInternet in medicine--Law and legislationPharmaceutical industry--Technological innovationsInternet--Law and legislationImports--Law and legislationDrugs--Prices--Law and legislationConstitutional lawInfluenza--PreventionCommunicable diseases--PreventionArmed Forces--Medical personnel--MalpracticeSoldiers--Legal status, laws, etcUnited States.--Food and Drug AdministrationExecutive powerAuditors--Legal status, laws, etcGovernmental investigationsPardonCigarette industry--Law and legislationTobacco industry--Law and legislationAdult services in public libraries--EvaluationLaw reformTroubled Asset Relief Program (U.S.)Public health lawsSmoking cessationSmoking--Law and legislationTobacco use--PreventionPublic contractsSmoking--PreventionElectronic commerce--Law and legislationDrugs--PackagingPeanut productsExecutive ordersMeat--PackagingDrugs--Law and legislationGovernment paperworkExecutive departments--Officials and employeesMedical instruments and apparatus industryCarbon monoxide--Health aspectsFishery products--PackagingPaperwork Reduction Act of 1995 (United States)Drugs--LabelingFood law and legislationPrescription pricing--Law and legislationFederal Tort Claims Act (United States)United States.--Office of Management and BudgetCosmetics--Law and legislationAdministrative procedure200720082009201020111402657JK1108456ocn312097769book20070.93Burrows, Vanessa KLegal issues related to prescription drug sales on the internet185ocn316213408book20070.94Cohen, HenryPandemic flu liability limitation legislationDivision E of House Conference Report 109-359 (agreed to by the House on December 19, 2005), which accompanies H.R. 2863, which is the Department of Defense appropriations for FY2006, would limit liability with respect to pandemic flu countermeasures. Specifically, upon a declaration by the Secretary of Health and Human Services of a public health emergency or the credible risk of such emergency, Division E would, with respect to a "covered countermeasure," eliminate liability, with one exception, for the United States, and for manufacturers, distributors, program planners, persons who prescribe, administer or dispense the countermeasure, and employees of any of the above. The exception would be that a defendant who engaged in willful misconduct would be subject to liability under a new federal cause of action, though not under state tort law. Division E's limitation on liability would be a more severe restriction on victims' ability to recover than exists in most federal tort reform statutes. However, victims could, in lieu of suing, accept payment under a new "Covered Countermeasure Process Fund," if Congress appropriates money for this fund163ocn259254352book20070.93Feder, JodyPrescription drug importation and internet sales a legal overview85ocn406524383com20090.96Redhead, C. StephenFDA tobacco regulation the Family Smoking Prevention and Tobacco Control Act of 2009The 111th Congress is considering legislation that would give the Food and Drug Administration (FDA) broad new statutory authority to regulate the manufacture and marketing of cigarettes and smokeless tobacco products under the Federal Food, Drug, and Cosmetic Act (FFDCA). On April 2, 2009, the House passed the Family Smoking Prevention and Tobacco Control Act (H.R. 1256; H.Rept. 111-58, part 1 and 2). On May 20, the Senate Committee on Health, Education, Labor and Pensions approved an almost identical bill (S. 982). Similar legislation was first introduced in the 108th Congress and passed the Senate in 2004 and the House in 2008 with strong bipartisan support. The Administration strongly supports H.R. 1256/S. 982. H.R. 1256/S. 982 would create a new FFDCA Chapter IX solely for the regulation of tobacco products. While the bill's language draws extensively on the FFDCA's existing provisions for regulating pharmaceutical products and medical devices, tobacco products would be regulated under new legal authority based on a public health standard rather than the safety and effectiveness standard by which the FDA regulates drugs and devices. Under the new language, FDA would have to demonstrate that any proposed tobacco product regulation was appropriate for the protection of public health, taking into consideration the risks and benefits to the population as a whole. Among its many provisions, H.R. 1256/S. 982 would require all tobacco product manufacturers to register with FDA. All registered facilities would be inspected every two years. H.R. 1256/S. 982 would require the FDA to reissue its 1996 tobacco rule, which was struck down by the U.S. Supreme Court in 2000. The rule would place new restrictions on youth access to tobacco products, end all remaining brand-name sponsorship of sporting and other entertainment events, and limit tobacco advertising in publications with a significant youth readership to black-on-white text only. In addition, the existing health warnings on tobacco product packaging and advertising would be replaced with more explicit and conspicuous health warnings. H.R. 1256/S. 982 would give FDA the authority to develop regulations restricting the sale, distribution, advertising, and promotion of tobacco products, to the extent permitted by the First Amendment. The agency also would have the authority to require changes in the design and characteristics of current and future tobacco products, such as the reduction or elimination of harmful ingredients and additives. FDA would not have the authority to reduce nicotine yields to zero or ban tobacco products. Under H.R. 1256/S. 982, manufacturers would have to obtain FDA approval in order to market a new tobacco product, unless FDA determined that it was substantially equivalent to a product already on the market, or a minor modification of an existing product. The bill would prohibit the use of descriptors such as "light" and "mild" and require manufacturers seeking FDA approval tomarket a product for which they intend to make a reduced-risk claim to provide evidence substantiating that claim. H.R. 1256/S. 982 would require FDA to develop new requirements for testing and reporting tobacco product ingredients and smoke constituents, and to issue new recordkeeping requirements to help counter the illicit trade of tobacco products. FDA's new regulatory activities would be paid for by user fees assessed on the manufacturers. This report provides a detailed summary of the provisions in H.R. 1256/S. 982 and discusses some of the public health and legal issues it raises. A companion report, CRS Report R40196, FDA Tobacco Regulation: History of the 1996 Rule and Related Legislative Activity, 1998-2008, by C. Stephen Redhead and Vanessa K. Burrows, provides more background on the FDA rule and past efforts to give the agency the authority to regulate tobacco products83ocn299803116file20090.66Burrows, Vanessa KAn overview of the presidential pardoning power41ocn744928011com0.47Burrows, Vanessa KPresidential authority to impose requirements on federal contractors44ocn665084753book20091.00Burrows, Vanessa KThe Special Inspector General for the Troubled Asset Relief Program (SIGTARP)44ocn682577642book20091.00Redhead, C. StephenFDA tobacco regulation history of the 1996 rule and related legislative activity, 1998-200841ocn252866261file20080.94Cohen, HenryFederal tort reform legislation constitutionality and summaries of selected statutes43ocn190832898file20070.95Cohen, HenryFederal Tort Claims Act current legislative and judicial issuesThe Federal Tort Claims Act is the statute by which the United States authorizes tort suits to be brought against itself. With exceptions, it makes the United States liable for injuries caused by the negligent or wrongful act or omission of any federal employee acting within the scope of his employment, in accordance with the law of the state where the act or omission occurred. Three major exceptions, under which the United States may not be held liable, even in circumstances where a private person could be held liable under state law, are the Feres doctrine, which prohibits suits by military personnel for injuries sustained incident to service; the discretionary function exception, which immunizes the United States for acts or omissions of its employees that involve policy decisions; and the intentional tort exception, which precludes suits against the United States for assault and battery, among some other intentional torts, unless they are committed by federal law enforcement or investigative officials. This report discusses, among other things, the application of the Feres doctrine to suits for injuries caused by medical malpractice in the military, the prohibition of suits by victims of atomic testing, Supreme Court cases interpreting the discretionary function exception, the extent to which federal employees may be held liable for torts they commit in the scope of their employment, and the government contractor defense to products liability design defect suits. In the 110th Congress, two bills have been introduced that would amend the Federal Tort Claims Act: H.R. 2249, the Federal Tort Claim Reform Act of 2007, and H.R. 6093, the Carmelo Rodriguez Military Medical Accountability Act of 200821ocn595550129comBurrows, Vanessa KExecutive orders issuance and revocationExecutive orders and proclamations are used extensively by Presidents to achieve policy goals, set uniform standards for managing the executive branch, or outline a policy view intended to influence the behavior of private citizens. The Constitution does not define these presidential instruments and does not explicitly vest the President with the authority to issue them. Nonetheless, such orders are accepted as an inherent aspect of presidential power, and, if based on appropriate authority, they have the force and effect of law. This report discusses the nature of executive orders and proclamations, with a focus on the scope of presidential authority to execute such instruments and judicial and congressional responses thereto21ocn173260074file2007Burrows, Vanessa KStatutory inspectors general legislative developments and legal issuesCongress has long taken a leadership role in establishing and sustaining offices of inspector general (OIGs), which now exist in more than 60 federal departments and agencies. This effort began with Congress's initiation of the first of the contemporary statutory inspectors general (IGs) in 1976; it has continued with passage of the broadly encompassing 1978 Inspector General Act and 1988 Amendments as well as with additions and modifications in the meantime. 1 In the 110th Congress, several bills designed to increase the IGs' independence and accountability or otherwise modify specific provisions have been introduced -- H.R. 928, approved by the House Committee on Oversight and Government Reform, and S. 1723. The major changes include: a fixed term of office for IGs; removal for cause only; apprisal of the intention to remove or transfer an IG given to the Congress 15 or 30 days in advance; notification of the annual IG budget request to Congress and to the Office of Management and Budget, when the IG submits it to agency administration; establishment of a Council of Inspectors General on Integrity and Efficiency, replacing the two current councils operating under executive order; and creation of an Integrity Committee composed of Council members to investigate allegations of wrongdoing by an inspector general or officials in the office. This report, which will be updated as developments dictate, covers the main provisions of the proposals22ocn698462719book20091.00Burrows, Vanessa KPenalties under the Federal Food, Drug, and Cosmetic Act (FFDCA) that may pertain to adulterated peanut products22ocn699566053book20091.00Burrows, Vanessa KFDA guidance regarding the promotion of off-label uses of drugs legal issues21ocn183304252com20070.47Burrows, Vanessa KFederal regulation of substances generally recognized as safe (GRAS) and the use of carbon monoxide in packaging for meat and fishThe use of carbon monoxide (CO) in the packaging of meat and fish has generated considerable debate. The presence of CO results in the meat turning a bright red color that lasts longer than the color in untreated meat. Additionally, fish treated with CO gain a fresher appearance and a red tint. The meat industry, consumer groups, scientists, and policy makers disagree as to whether the use of CO in meat and fish packaging should be regulated by the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA), through labeling or otherwise, and whether CO should be a substance Generally Recognized As Safe (GRAS) under current and proposed FDA rules. Two bills have been introduced in the 110th Congress regarding the use of carbon monoxide in meat and poultry products: H.R. 3115 (the Carbon Monoxide Treated Meat, Poultry, and Seafood Safe Handling, Labeling, and Consumer Protection Act) and H.R. 3610 (the Food and Drug Import Safety Act of 2007). Both bills propose to amend section 201 of the Federal Food, Drug, and Cosmetic Act (FFDCA). Under the proposals, if CO is used to treat meat, poultry, or seafood that is intended for human consumption, and if the conditions of that use would affect the color of the products, CO must be treated as a color additive under FFDCA, unless the product's label includes a statement that is prominently and conspicuously placed to notify the consumer of the use of CO and to warn the consumer of proper factors to judge the safety of the product. This report provides an overview of the FDA's regulation of GRAS substances, which are exempt from the premarket approval process for food additives. The report next discusses the FDA's 1997 proposed rule, which would create a notification procedure for GRAS substances through which manufacturers can notify the FDA of their "determination that a particular use of a substance is GRAS." The FDA has been using this GRAS notification procedure since the publication of the proposed rule on an "interim policy" basis. The roles of the USDA and FDA are also discussed, including the 2000 Memorandum of Understanding regarding review of substances used in the production of meat and poultry products. Finally, the report examines GRAS notices regarding intended uses of carbon monoxide22ocn710051677book20091.00Burrows, Vanessa KRiegel v. Medtronic, Inc. federal preemption of state tort law regarding medical devices with FDA premarket approval22ocn756206740book20091.00Copeland, Curtis WPaperwork Reduction Act (PRA) OMB and agency responsibilities and burden estimates22ocn761220751book20091.00Burrows, Vanessa KStatutory Offices of Inspectors General methods of appointment and legislative proposals22ocn665080832book20091.00Burrows, Vanessa KThe Special Inspector General (SIG) for the Troubled Asset Relief Program (TARP)11ocn713644294book2011Burrows, Vanessa KA brief overview of rulemaking and judicial reviewThe Administrative Procedure Act (APA) applies to all executive branch agencies, including socalled independent regulatory agencies. The APA prescribes procedures for agency actions such as rulemaking, as well as standards for judicial review of agency actions. Rulemaking is the "agency process for formulating, amending, or repealing a rule," where a rule is defined as "an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency." This report provides a legal overview of APA rulemakingFri Mar 21 15:26:36 EDT 2014batch22168