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The Federal Food Safety System: A Primer
This report discusses concerns about food safety, the resources required to ensure food safety, and whether federal food safety laws themselves, first enacted in the early 1900s, have kept pace with the significant changes that have occurred in the food production, processing, and marketing sectors since then.
Regulation of Clinical Tests: In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests
In vitro diagnostic (IVD) devices are used in the analysis of human samples, such as blood or tissue, to provide information in making health care decisions. Examples of IVDs include pregnancy test kits or blood glucose tests for home use; laboratory tests for infectious disease, such as HIV or hepatitis, and routine blood tests, such as cholesterol and anemia; and tests for various genetic diseases or conditions. More recently, a specific type of diagnostic test--called a companion diagnostic--has been developed that may be used to select the best therapy, at the right dose, at the correct time for a particular patient; this is often referred to as personalized or precision medicine. This report provides an overview of federal regulation of IVDs by FDA, through the Federal Food, Drug, and Cosmetics Act (FFDCA) and the Public Health Service Act (PHSA), and by CMS, through the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
Medicare: Beneficiary Cost-Sharing Under Proposed Prescription Drug Benefits
This report examines these proposals as well as the “Medicare Rx Drug Benefit and Discount Act of 2003,” which was introduced by Representative Charles Rangel, the ranking member of the House Ways and Means Committee. Specifically, this report provides background on how the cost-sharing and premium provisions under each bill would affect the amount that a beneficiary pays annually for prescription drugs.
Veterans' Medical Care: FY2006 Appropriations
The Department of Veterans Affairs (VA) provides benefits to veterans who meet certain eligibility rules. Benefits to veterans range from disability compensation and pensions to hospital and medical care. VA provides these benefits to veterans through three major operating units: the Veterans Health Administration (VHA), the Veterans Benefits Administration (VBA) and the National Cemetery Administration (NCA). VHA is primarily a direct service provider of primary care, specialized care, and related medical and social support services to veterans through an integrated health care system.
AIDS: Ryan White CARE Act
This report discusses the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act, which makes federal funds available to metropolitan areas and states to assist in health care costs and support services for individuals and families affected by the human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS). This report discusses related legislation and appropriations.
Medicare Prescription Drug Benefit: Estimates of Beneficiaries Who Fall Below Countable Income Thresholds, by State
This report provides state-by-state estimates of the percentage and number of beneficiaries who fall below various low-income thresholds, using the definition of income specified in the law.
Military Construction, Military Quality of Life and Veterans' Affairs, FY2007 Appropriations
This report is a guide to one of the regular appropriations bills that Congress considers each year. It is designed to supplement the information provided by the House Military Quality of Life and Veterans Affairs and Senate Military Construction and Veterans Affairs Appropriations Subcommittees. It summarizes the status of the bill, its scope, major issues, funding levels, and related congressional activity, and is updated as events warrant.
Genetically Engineered Soybeans: Acceptance and Intellectual Property Rights Issues in South America
This report discusses issues regarding genetically engineered soybeans in South America. U.S. soybean growers and trade officials charge that Argentina and Brazil–the United States’ two major export competitors in international soybean markets–gain an unfair trade advantage by routinely saving genetically-engineered (GE), Roundup Ready (RR) soybean seeds from the previous harvest (a practice prohibited in the United States) for planting in subsequent years.
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